News Articles

5Qs with AusBiotech’s Tamlyn O’Connor: Strengthening global pathways for Australia’s life sciences sector

Tue, 25 Nov 2025 00:00:00 +1100

In our 5Qs with… series in THRIVE, we speak with leaders across Australia’s life sciences sector — from CEOs and C-suite executives to key decision-makers — to hear their perspectives on the ecosystem and their vision for its future.

This edition features Tamlyn O’Connor, AusBiotech’s new Head of Global Trade and Partnerships. Tamlyn leads AusBiotech’s national TradeStart partnership with the Australian Trade and Investment Commission (Austrade), a collaboration designed to accelerate the global growth of Australia’s biotechnology, medical technology, pharmaceutical, and digital health companies. With more than 20 years of experience spanning industry development, trade engagement, and ecosystem building, she brings deep expertise to this newly created national role.

1. What are you most looking forward to in your new role as Head of Global Trade and Partnerships?

“I’m most looking forward to working closely with Australia’s innovators and helping them take their breakthrough science to global markets. Our sector is full of extraordinary ideas and companies with real potential to change lives, and I’m passionate about supporting them through the next stage of their growth.

“This role gives AusBiotech and Austrade another opportunity to champion Australian capabilities internationally, build strategic partnerships, and help strengthen the commercial pathways that turn world-class research into global impact.”

2. How will the TradeStart partnership strengthen opportunities for Australian life sciences companies?

“The Austrade TradeStart partnership brings together the complementary strengths of both organisations: AusBiotech’s deep national connections across biotech and medtech, and Austrade’s unparalleled global reach and in-market expertise.

“Together, we can provide companies with a seamless pathway from local capability building to international market entry. This collaboration ensures that exporters receive both sector-specific guidance and global commercial intelligence, expanding their opportunities to grow, connect, and compete internationally.”

3. What opportunities do you see for Australian life sciences companies as they expand into international markets?

“There is strong global demand for innovative health solutions, and Australia consistently delivers high-quality science, trusted clinical evidence, and advanced technologies. As companies gear up to export into markets internationally, they have opportunities to tap into rapidly growing markets and attract global partnerships.

“There is increasing appetite worldwide for Australian cutting-edge health innovations. Australian companies are well placed to scale and succeed on the global stage taking world class innovations to patients worldwide.”

4. How will your role connect Australian companies with international partners, markets, and export pathways through the TradeStart network?

“In this new role, I’m laser-focused on opening doors — targeting the right international partners, connecting companies with in-market specialists, and guiding them through export pathways that align with their growth strategies.

“Through the TradeStart network, we will work with both emerging and established companies to help them navigate market entry, understand regulatory and commercial environments, and build relationships that support long-term expansion. Ultimately, it’s about ensuring Australian innovation reaches the people and markets where it can have the greatest impact.”

5. Why is international trade so critical for the future of Australia’s life sciences sector, and how do you see your work contributing to that growth?

“International trade is essential for a thriving life sciences sector. It strengthens Australia’s economic resilience, supports high-value job creation, boosts our global competitiveness, and enhances health security by enabling deeper international collaboration.

“By supporting companies to export and scale globally, AusBiotech and Austrade will help accelerate the commercial impact of Australian innovation. The more we connect our capabilities with global markets, the more we can reinforce Australia’s position as a trusted leader in life sciences.”

Queensland to host AusBiotech International Conference 2026-27

Fri, 24 Oct 2025 00:00:00 +1100

AusBiotech is delighted to announce the Queensland Government and Tourism and Events Queensland as the Host State Partners for the AusBiotech Invest and AusBiotech International Conference 2026 and 2027 — the premier events on the Asia-Pacific region's life sciences calendar.

The AusBiotech Invest and AusBiotech International Conferences are the flagship events of Australia’s biggest week in biotech, convening the full breadth of the life sciences ecosystem and connecting partners from around the world.

Deputy Premier and Minister for State Development, Infrastructure and Planning Jarrod Bleijie said today’s announcement was a strategic win for Queensland.

“Biomedical is a priority industry for the Crisafulli Government — and hosting the AusBiotech International Conference and AusBioInvest will help us showcase our strengths, attract global investment, strengthen our international partnerships, and grow our sovereign capability,” Deputy Premier Bleijie said.

“These events will be hosted in Brisbane and the Gold Coast, showcasing not only our cutting-edge biomedical capabilities but our enviable lifestyle as well.

“In the lead up to the 2032 Games and beyond, Queensland is the place to do business and we want as many biomedical industry leaders to bring their skills, staff and products to our State.

“The Crisafulli Government recently opened applications for its new $180.6 million Sovereign Industry Development Fund, which will invest in investment-ready projects across the biomedical, defence and biofuels industries in Queensland.

Andrew Powell MP, Minister for the Environment and Tourism and Minister for Science and Innovation, said: “Queensland’s health innovation ecosystem is thriving so we’re proud to support events like AusBiotech through Tourism and Events Queensland. These conferences elevate Australia’s reputation as a leader in research and commercialisation while also delivering strong economic outcomes for our state and its tourism sector.”

“I look forward to welcoming delegates from around the globe to Queensland and encourage everyone to stay a little longer and explore our incredible destinations, from the reef to the rainforest and beyond.”

Rebekah Cassidy, CEO AusBiotech said: “As the peak body representing and convening Australia’s thriving life sciences sector, AusBiotech is proud to unite our national innovation ecosystem and connect it with the world.

"Taking the AusBiotech Invest and AusBiotech International Conferences to Queensland for two consecutive years highlights Queensland’s focus on becoming a hub for life sciences innovation.”

"Queensland is home to a growing, world-class health innovation ecosystem with the capability to translate, develop and commercialise outstanding medical research outcomes into globally
competitive products and companies. The biomedical sector in Queensland already contributes an estimated $2.8 billion in annual gross value added to Queensland's economy”.

The AusBiotech and AusBiotech Invest Conferences were held in Victoria in 2024 and 2025, with this year’s Conference wrapping up this week.

"We sincerely thank the Victorian Government for its generous support as Host State Partner over the past two years. This partnership has been instrumental in helping us showcase Australia’s thriving biotechnology industry to the world and connecting the local ecosystem,” said Rebekah.

The AusBiotech International Conference is one of the largest biotechnology conferences in the southern hemisphere. Annually drawing delegates from more than 20 countries, uniting industry leaders, researchers, service providers, investors, and policymakers to exchange ideas, collaborate, and accelerate breakthroughs.

Australia's biggest week in biotech will be heading to the Gold Coast in 2026 and Brisbane in 2027.

ENDS

Media inquiries
Emma Boscheinen, AusBiotech Director of Communications / +61 437 075 209 / eboscheinen@ausbiotech.org

About AusBiotech
AusBiotech is Australia's leading national and global advocate for life sciences, working to help its more than 3000 members thrive by shaping policy, creating connections, and fostering knowledge sharing. With an unrivalled national convening power, AusBiotech supports its members’ growth by building an Australian life sciences ecosystem that leads in development and commercialisation, creating high-quality, innovative life sciences companies.

AusBiotech welcomes the re-election of Dr Marthe D’Ombrain to its Board of Directors

Fri, 24 Oct 2025 00:00:00 +1100

AusBiotech is pleased to announce the re-election of Dr Marthe D’Ombrain, Head of Global Research Innovation at CSL, to its Board of Directors. Dr D’Ombrain brings more than two decades of leadership and experience spanning research, commercialisation, and innovation across the life sciences sector, both in Australia and internationally.

AusBiotech Chair Dr James Campbell said: "We are delighted to welcome Dr D’Ombrain back to the AusBiotech Board. Her deep experience in global research innovation and proven leadership in advancing translational science will continue to strengthen our mission to champion the Australian life sciences sector.”

Marthe currently serves as the Executive Director and Head of Global Research Innovation at CSL and plays a key role in building and diversifying CSL’s global R&D portfolio. At CSL, Marthe championed the creation of an early-stage fund — the CSL Research Acceleration Initiative — that establishes partnerships between CSL and global research organisations and invests in promising discoveries to accelerate translation of innovative biotherapies to address unmet patient needs.

Marthe also played a key leadership role in the establishment of Jumar Bioincubator — an incubator for biotechnology startups, located in CSL’s global corporate headquarters in the Melbourne Biomedical Precinct.

AusBiotech CEO Rebekah Cassidy said: “Marthe’s vision and commitment to collaboration across academia and industry align perfectly with AusBiotech’s purpose. We look forward to her continued contributions as we advance the sector’s collective impact.

“Our Board has strong representation from across Australia, including leaders from some of Australia’s largest companies, directors from innovative SMEs, and voices from both research and industry — reflecting the strength and diversity of our sector.”

Dr Marthe D’Ombrain said: “I am thrilled to be re-elected to the AusBiotech Board, and I am grateful to our members for entrusting me with a second term. It has been a privilege to serve on the Board for the past three years.

“I am excited about the opportunities to further grow and advance Australia’s national life sciences agenda and to strengthen our collective contribution to positively impact the lives of patients both in Australia and around the globe.”

ENDS

Media inquiries
Emma Boscheinen, AusBiotech Director of Communications / +61 437 075 209 / eboscheinen@ausbiotech.org

AusBiotech and Austrade appoint new national TradeStart role to support global growth of Australia’s life sciences sector

Thu, 23 Oct 2025 00:00:00 +1100

AusBiotech, Australia’s peak body for the life sciences sector, is delighted to announce the appointment of Tamlyn O’Connor as their new Head of Global Trade and Partnerships. The role is part of the AusBiotech and the Australian Trade and Investment Commission (Austrade) TradeStart partnership, designed to accelerate the global growth of Australian life science companies.

In her new role, Tamlyn will support biotechnology, pharmaceutical, medical technology, and digital health companies to scale and grow internationally. Embedded within the AusBiotech team, Tamlyn will work directly with life sciences companies across Australia, connecting them with Austrade’s global services, networks, and export programs.

AusBiotech is the first life sciences peak body to join the TradeStart network as a national partner, joining peak bodies from other sectors in the program.

Tamlyn brings more than 20 years of experience across life sciences industry development, communications, stakeholder engagement and trade, in both the public and private sectors.

Comments from Tamlyn O’Connor:
"Australia’s life sciences sector is thriving with world-class innovation and global ambition. Through this new TradeStart partnership, I’m excited to support Australian companies as they take their innovations to international markets, unlocking opportunities for global health, growth and collaboration.

“International trade is critical to the success of this sector. By combining AusBiotech’s deep sector connections with Austrade’s global reach, we can strengthen Australia’s position as a leading player in the global life sciences community."

Comments from AusBiotech CEO Rebekah Cassidy:
“Tamlyn’s appointment marks an exciting next step in our TradeStart partnership with Austrade. Her deep experience across small, medium and large life sciences companies and Australian trade and export markets — in addition to her passion for supporting Australian innovation — stand her in very good stead to help local companies navigate international markets and accelerate their commercial success.

“By embedding this role within AusBiotech, we and Austrade will further strengthen the bridge between Australian life sciences expertise and global opportunities.”

About Tamlyn O’Connor
Tamlyn is a seasoned life sciences professional with more than 20 years of experience across industry development, communications, and trade engagement roles spanning both the public and private sectors. She brings a strong track record of generating and facilitating translational research and commercial collaboration opportunities with global partners and innovation networks, driving growth for the Australian life sciences sector.

Passionate about advancing Australian innovation and impact, Tamlyn has delivered a suite of successful ecosystem activation campaigns in her previous roles with Johnson & Johnson Innovation, AusBiotech and MTPConnect, championing the commercial success of local innovators.

She is also a dedicated advocate for diversity and inclusion, having developed programs that support the advancement of women in life sciences leadership roles and strengthen Australia’s future talent pipeline.

ENDS

Media inquiries
Emma Boscheinen, AusBiotech Director of Communications / +61 437 075 209 / eboscheinen@ausbiotech.org

About Austrade
The Australian Trade and Investment Commission (Austrade) is the Australian Government's trade, investment and education promotion agency, also responsible for tourism policy, programs and research. Austrade helps grow Australia’s prosperity by delivering quality trade and investment services to businesses, accelerates growth in Australia’s tourism sector and promotes Australia’s education to the world.

Global engagement surges as AusBiotech 2025 welcomes delegates from more than 20 countries

Thu, 23 Oct 2025 00:00:00 +1100

Australia’s biotechnology industry is gathering in record numbers at the annual AusBiotech International Conference, held in Melbourne this week.

The four-day conference, regarded as one of the pre-eminent life sciences conferences in the Asia-Pacific region, has once again drawn a record-breaking audience, with more than 1600 delegates from across Australia and around the world.

International participation strengthened significantly this year, with delegates from more than 20 countries representing nearly 20 per cent of total attendance.

Senator Michelle Ananda-Rajah addressed delegates, highlighting the growing importance of the life sciences sector to Australia’s future innovation.

Senator Ananda-Rajah emphasised the remarkable capabilities of the nation’s health and medical innovators and the sector’s vital role in driving a more diversified and resilient Australian economy.

AusBiotech CEO Rebekah Cassidy said she was honoured by the level of engagement and enthusiasm shown from the life sciences ecosystem, from homegrown innovators, global companies, investors, researchers, clinical researchers, manufacturers, and State and Federal government representatives.

“We were honoured to have Senator Ananda-Rajah address delegates and to see the strong recognition of biotechnology and life sciences as a critical sector to Australia’s future innovation driven economy," Rebekah said.

“This Government's vision on building sovereign capability, advancing innovation, and strengthening the commercialisation pipeline aligns strongly with our sector’s vision. A vision that sees more world-leading Australian health and medical innovation turned into products that improve lives and boost national resilience, and critical to the health and wealth of this nation."

With more than 2,900 life sciences organisations employing one in every 60 Australians, the sector represents a powerful future national strength with growing international relevance.
“Australia’s life sciences sector is ready to stand as a cornerstone of Australia's future. Bold reform is needed now to strengthen every stage of the pipeline from research to manufacturing, empowering Australian companies to compete and thrive globally,” Rebekah said.

The four-day conference is designed to connect, inform and inspire, bringing together over 250 expert speakers across 60 sessions, covering themes such as biotechnology innovation, medical technology, clinical trials, investment, and policy.

It continues to serve as the flagship event of Australia’s biggest week in biotech.

Program highlights included:
• Millis Oration (Sponsored by CSL): Dr Christian Behrenbruch, Managing Director and Group CEO of Telix Pharmaceuticals, spoke on global leadership in radiopharma, opportunities and challenges.
• Depaz Oration (Sponsored by Sanofi): Adjunct Professor Alison Todd AM, FTSE, PhD, Co-Founder and Chief Scientific Officer SpeeDx, celebrated Australia’s capacity for innovation, particularly in the pursuit of better health outcomes.
• Panel sessions: ‘Driving tomorrow – how Australia’s tech sectors are shaping our innovation-driven economy’, ‘Navigating global shifts in biotech policy and partnerships’, and ‘Strengthening Australia’s role in the global commercialisation ecosystem’, were just a few of the incredible line up of panels for attendees to explore.
• International Showcase: This dedicated stream brought together global delegations — from New Zealand, Hong Kong, France, China, India, and Taiwan — to spotlight their strengths, capabilities, and opportunities to collaborate with Australia’s life sciences community.
• Cell and Gene and Personalised Medicine: These focused sessions unpacked the therapies redefining the future of medicine, offering potentially curative treatments for cancer, autoimmune disorders, and genetic diseases.
• AgriBiotech and Biosecurity: This summit, co-hosted by CSIRO and Agriculture Victoria Services, explores the interconnection between agriculture and the wider biotechnology and health ecosystem — research institutions that underpin them all.

ENDS

Media inquiries
Emma Boscheinen, AusBiotech Director of Communications / +61 437 075 209 / eboscheinen@ausbiotech.org

AusBiotech and Taiwan Bio Industry Organization sign MOU to strengthen global life sciences collaboration

Thu, 23 Oct 2025 00:00:00 +1100

AusBiotech, Australia’s peak industry body representing more than 3,000 life sciences members, has formalised a new partnership with the Taiwan Bio Industry Organization (Taiwan BIO), which represents Taiwan’s innovative life sciences and biotechnology sector and works to connect the Asian ecosystem globally to drive impactful innovation.

The signing of this Memorandum of Understanding (MOU) marks a new chapter in strengthening collaboration between Australia and Taiwan’s thriving life sciences sectors.

This MOU reinforces Australia’s deep interconnectedness with the global life sciences ecosystem, recognising that trade, innovation, and international relationships are critical to the success of AusBiotech’s members and the broader biotechnology industry.

With more than 1,600 Australian biotechnology and medical technology companies operating in global markets, the Asia–Pacific region remains a significant and growing focus for partnerships, research, and investment.

AusBiotech Chair, Dr James Campbell said: “We are thrilled to deepen our collaboration with peer organisations across the life sciences sector. This MOU reflects our commitment to building enduring global relationships that help drive innovation, commercialisation, and the sustainable growth of Australia’s biotechnology sector.”

Dr Lee-Cheng Liu, chairman of Taiwan BIO, the first and the most cross-disciplinary biotech industry association established in Tiawan since 1989, said: "Collaboration without boundaries is the spirit of the MOU, that will enhance the global impacts from biotech hubs of Oceania and Asia, Australia and Taiwan."

The signing took place during the AusBiotech International Conference 2025, Australia’s largest life sciences conference, celebrating innovation, collaboration, and international engagement across the biotechnology and life sciences community.

ENDS

Media inquiries
Emma Boscheinen, AusBiotech Director of Communications / +61 437 075 209 / eboscheinen@ausbiotech.org

AusBiotech Invest kicks off Australia's biggest week in biotech

Tue, 21 Oct 2025 00:00:00 +1100

Australia’s premier life sciences investment conference, AusBiotech Invest 2025, opens today, welcoming investors, innovators, and global partners to connect with some of Australia’s most investable biotechnology and medical technology companies.

Australia’s life sciences industry is at a pivotal point, demonstrating credible deal flow, strong momentum in commercialisation, and an increasing rate of global partnerships.

Today, Australia’s ecosystem is home to nearly 1,600 biotech and medtech companies – double the number of just eight years ago. The sector employs one in 60 jobs in Australia, and a market capitalisation of ASX-listed companies that has surged fivefold from $50 billion in 2017 to around $250 billion today.

“AusBiotech Invest continues to evolve as a strategic platform to connect capital with innovation,” said Kerri Lee Sinclair, Head of Investment, AusBiotech.

“The calibre of investors and companies participating this year reflects the maturity of Australia’s life sciences sector. We’re not just seeing promising science. We’re seeing repeatable commercial success and globally significant deal flow.”

AusBiotech Invest welcomed close to 300 delegates to view presentations featuring 23 innovative private and listed Australian biotech companies, representing a significant opportunity for investors and potential partners to connect directly with companies seeking funding and collaborative development.

Presenting companies include; Amplia Therapeutics Ltd (ASX: ATX), Arovella Therapeutics (ASX: ALA) Avecho Biotechnology (ASX: AVE), BiomeBank, BlinkLab Ltd (ASX: BB1), Chimeric Therapeutics (ASX: CHM), Exosome Biosciences, Filamon, Goliver Australia Pty, Haemalogix Ltd, Humble Bee Bio Pty, Immuron Ltd (ASX: IMC), Invion, ISOBiotech, MLS Bio, Myopharm Limited, Neuroscientific Biopharmaceuticals (ASX:NSB), Polyactiva Pty Ltd, Prescient Therapeutics Ltd (ASX: PTX), QBiotics Group Ltd, S2n.bio, Terra Australis Pharmaceuticals Pty Ltd and Tiba Biotech.

Program highlights

The 2025 program delivers thought leadership from local and global investment leaders, in-depth discussions on capital formation, and insights into emerging technologies driving the next phase of biotech growth.

Opening Session: Megan Hooton, President, IQVIA Biotech, and Sarah Meibusch, Partner, OneVentures discussing how global trends, data-driven strategy, and AI are redefining clinical success. The session will provide actionable insights for investors and biotech executives seeking to improve trial efficiency and asset performance across development stages.

Panel Discussion: 'Building Australia’s Future Life Sciences Capital Stack – Repeatable Success Stories' featuring Medard Fischer, VP Strategic Investments, Cochlear R&D; Rowena Gracey, Director, ARCHIMED; Sarah Meibusch, Partner, OneVentures; Chris Nave, Founding Partner & Managing Director, Brandon Capital; Aaron Ray, Managing Partner, 5 Horizons Ventures, and Kerri Lee Sinclair, Head of Investment, AusBiotech, unpacking the ingredients of sustainable investment success and examines how Australia can strengthen its capital stack to support global growth.

Keynote: Biotech Breakthroughs: ASX Market Performance and Insights with Blair Harrison, Head of Listings – New Zealand, ASX. A deep dive into the market dynamics and trends shaping ASX-listed biotech performance, investor sentiment, and global competitiveness.

Keynote: Global venture capitalist Nick Pachuda shares how Australia can build global life sciences leaders locally, adapting proven international models to deepen its capital base.

ENDS

Media inquiries

Emma Boscheinen, AusBiotech Director of Communications / +61 437 075 209 / eboscheinen@ausbiotech.org

About AusBiotech

AusBiotech is Australia's leading national and global advocate for life sciences, working to help its more than 3000 members thrive by shaping policy, creating connections, and fostering knowledge sharing. With an unrivalled national convening power, AusBiotech supports its members’ growth by building an Australian life sciences ecosystem that leads in development and commercialisation, creating high-quality, innovative life sciences companies.

Victorian Ministers to speak during Australia’s biggest week in biotech

Wed, 15 Oct 2025 00:00:00 +1100

AusBiotech is pleased to announce that the Hon Danny Pearson, Victorian Minister for Economic Growth and Jobs and Minister for Finance; the Hon Ros Spence, Victorian Minister for Agriculture, Community Sport, Carers and Volunteers; and Ms Michaela Settle, Parliamentary Secretary for Regional Victoria, will all speak at the flagship events of Australia’s biggest week in biotech — AusBiotech Invest and the AusBiotech International Conference 2025.

The Victorian State Government is the Host State Partner for this year’s AusBiotech Invest and AusBiotech International Conferences in Melbourne (21–24 October).

AusBiotech CEO Rebekah Cassidy said the Victorian Government’s partnership is a vital contributor to Australia’s thriving life sciences sector.

“As one of the Asia-Pacific’s pre-eminent biotechnology events, AusBiotech’s four-day conference brings together Australia’s leading life science companies and a global audience of delegates and investors,” Ms Cassidy said.

“We’re delighted that Minister Pearson, Minister Spence, and Ms Michaela Settle MP will each address key sessions, highlighting Victoria’s broad engagement across the life sciences and the Victorian Government’s ongoing support for the sector’s growth across health, agriculture, and the wider economy.”

Minister Pearson will officially open the AusBiotech Invest Conference on Tuesday, 21 October. The one-day investor forum will welcome more than 250 delegates representing Australia’s leading life science companies alongside local and global investors, at Crown Towers, Melbourne.

He will also will officially open the AusBiotech International Conference, welcoming more than 1,600 delegates, including representatives from around the world, at the Melbourne Convention and Exhibition Centre.

"Victoria’s world-class biotech sector continues to foster innovation, create high-skilled jobs and improve lives. We're proud to once again host AusBioInvest and the AusBiotech Conference, showcasing how Victoria is fuelling economic growth and advancing the future of biotechnology,” Minister Pearson said.

On Thursday, 23 October, Minister Spence will open day two and address delegates at the AusBiotech International Conference.

"We’re excited to showcase how Victoria leads the way in agriculture innovation at Australia’s largest biotechnology conference. This is part of the Government’s investment to transformative science and technology developments to grow our $20 billion agricultural sector,” Minister Spence said.

We are also pleased to announce that Ms Settle will officially open the AgriBiotech and BioSecurity Summit at the AusBiotech International Conference.

"Biotechnology plays a vital role in shaping the future of our agriculture — building stronger, more resilient crops, lifting food production, and driving innovation in animal breeding. This conference brings together our local knowledge and global expertise, opening the door to new ideas, fresh partnerships, and smarter ways to support our farmers and grow the entire sector,” Ms Settle said.

AusBiotech thanks the Victorian State Government for its partnership as Host State Partner for the AusBiotech Invest Conference and the AusBiotech International Conference in 2025.

ENDS

Media inquiries

Emma Boscheinen, AusBiotech Director of Communications / +61 437 075 209 / eboscheinen@ausbiotech.org

About AusBiotech

New TGA guidance relating to selection criteria for medical device application audits

Thu, 09 Oct 2025 00:00:00 +1100

AusBiotech welcomes the release of new guidance, Understanding Selection Criteria for Medical Device Application Audits, by the Therapeutic Goods Administration (TGA).

A key focus of our advocacy efforts on behalf of our medtech members, the new guidance is crucial for all medical device sponsors seeking to register a new product in Australia. The criteria used to select applications for audit focus on those that pose the highest risk to patient safety and public health.

As outlined in the guidance, the TGA conducts both mandatory (applicant pays a fee) and non-mandatory (no fee payable) audits. While the TGA can select any application for an audit, it mainly uses four risk-based criteria for non-mandatory audits:

Criteria 1: Aspects related to the application and the device
Criteria 2: Kinds of devices subject to regulatory reforms
Criteria 3: Post-market signals
Criteria 4: Factors related to the sponsor or manufacturer

For our medtech members, understanding these audit selection criteria will enable them to be better prepared, submit stronger applications, and potentially minimise regulatory timelines and costs. Read more

AusBiotech’s Annual Report captures a defining year for life sciences

Mon, 06 Oct 2025 00:00:00 +1100

AusBiotech has delivered is 2024-25 Annual Report outlining a pivotal year of renewal, growth, and strengthened national advocacy on behalf of Australia’s life science sector.

Chair of AusBiotech, Dr James Campbell, said the past year has been “both transformational and defining” for the organisation.

"The role of national peak bodies has never been more important, as critical sectors like ours navigate global headwinds and shifting geopolitical dynamics. These pressures demand agility and leadership, and AusBiotech has shown up where it matters for our members.

“Across the 2024-25 financial year, AusBiotech invested in new capabilities, built stronger advocacy and communications functions, and enhanced our member engagement, ensuring we are a trusted advocate, connector, and enabler for our thriving ecosystem,” Dr Campbell said.

AusBiotech CEO, Rebekah Cassidy, said the report comes at a pivotal time as the sector navigates complex global challenges and expanding opportunities.

“Every day, our members deliver health and medical breakthroughs that not only change lives, but also have the potential to strengthen Australia’s economic resilience, health security and homegrown capability,” Ms Cassidy said.

“As our sector matures and the global environment continues to shift, our role as the national peak body is clear: to advocate, convene, and amplify the collective voice of more than 3,000 members shaping the future of Australian life sciences here and globally.”

This year's report reinforces the enormous potential of Australia’s life sciences sector, which is home to more than 2,900 organisations and employs one in every 60 Australian workers. Key highlights from the year include:

• Policy leadership: Advanced a revitalised advocacy and policy agenda that strengthened our wide-ranging discussions with governments, regulators, and international partners.

• Convening the ecosystem: Hosted flagship events that engaged more than 7,000 people nationwide, including the largest-ever AusBiotech and AusMedtech conferences, and the inaugural Women in Life Sciences Leadership Summit, alongside our continued state events and new webinars.

• Global engagement: Strengthened bilateral and multilateral relationships, including progressing the proposed Australia–UK BioBridge, engaging as Australia’s member of the International Council of Biotechnology Organisations, and continuing to strengthen cross-border collaborations with peak international peers.

• Sustainable growth: Invested strategically in organisational capabilities, supported by a strong financial position and continued growth in membership and event revenue.

As the sector continues to mature, AusBiotech is calling for greater recognition of life sciences as a national priority and stands ready to support members and government partners in realising the sector’s extraordinary potential in Australia and on the international stage.

"Over the past year, we have transformed every part of our organisation. From advocacy to member engagement, with investments in new capabilities, programs, and strategic projects designed to better position us for long-term growth.

“With continued sustainable financial investment, a renewed strategic policy agenda and strong cross-sector partnerships, AusBiotech is well positioned to support the growth of our sector and cement our sector’s role in shaping a healthier, more innovative and prosperous Australia, " said Rebekah.

ENDS
Media inquiries
Emma Boscheinen, AusBiotech Director of Communications / +61 437 075 209 / eboscheinen@ausbiotech.org

About AusBiotech
AusBiotech is Australia's leading national and global advocate for life sciences, working to help its more than 3000 members thrive by shaping policy, creating connections, and fostering knowledge sharing. With an unrivalled national convening power, AusBiotech supports its members’ growth by building an Australian life sciences ecosystem that leads in development and commercialisation, creating high-quality, innovative life sciences companies.

AusBiotech welcomes $13.6M Federal investment to strengthen clinical trials

Fri, 03 Oct 2025 00:00:00 +1000

AusBiotech welcomes the Albanese Government’s announcement of a $13.6 million investment to progress national health and medical research reforms and further strengthen Australia’s clinical trials ecosystem.

The funding, announced by the Hon Mark Butler MP, Federal Minister for Health and Ageing, will support the design of the National One Stop Shop (NOSS) for clinical trials, the development of national standard operating procedures, implementation of the National Clinical Trials Governance Framework, and an accreditation scheme for human research ethics committees.

AusBiotech, working alongside peers in the Research and Development Taskforce (RDTF) — a collaboration between AusBiotech, Medicines Australia and the Medical Technology Association of Australia— has long advocated for clinical trials reform and national coordination, and funding to back that up.

In parallel, AusBiotech’s Clinical Trials Advisory Group has worked closely with the Department of Health and Ageing to highlight the sector’s priorities, and AusBiotech looks forward to ensuring the NOSS delivers for Australia’s diverse and world-leading clinical trials sector.

Today’s announcement marks a significant milestone after years of sustained advocacy and collaboration.

Australia has continued to demonstrate global leadership as a destination for clinical trials, built on world-class infrastructure, research expertise, and a collaborative ecosystem. This investment represents an important step in maintaining and strengthening that position.

While this is a positive step for the sector and Australian patients, AusBiotech continues to call for national coordination across the entire health innovation pipeline.

AusBiotech CEO, Rebekah Cassidy, said the organisation applauds the Albanese Government’s investment in this once in a generation reform, but it must be underpinned by a broader strategic approach to life sciences.

"We also have a once in a generation opportunity to prioritise the entire pipeline.

"That's why we continue to advocate for a unified, whole-of-government strategic approach to the life sciences industry, whose numerous policy touchpoints — from research through to manufacturing — are currently dispersed across over nine different Australian Government portfolios.

"If we only make incremental changes in isolated parts of the pipeline, we will fall short of the reform that is urgently need.

“With more than 1,600 biotech and medtech companies in Australia, we must ensure they can thrive. Global competition for our homegrown capabilities is intensifying.

"We need to back innovation right here where it begins so our economy, health security, and most importantly our people, have access to Australian health innovation," Rebekah said.

Throughout 2025, AusBiotech has campaigned for a policy agenda focused on four key asks of the Federal Government:

Developing Australia’s first whole-of-government National Life Sciences Strategy to set clear policy priorities and eliminate gaps and overlaps.
Establishing an Australian Life Sciences Council, and a partnership between industry and government to drive this Strategy, address sector challenges and ensure value for investment.
Investing in data collection to drive innovation and improve policy and decision-making.
Recognising life sciences as a priority under the government’s industry policy frameworks.

AusBiotech looks forward to working with government, industry, and the research community to ensure reforms like the NOSS are implemented effectively, while also advancing a broader strategic framework that secures Australia’s position as a global leader in clinical research and life sciences innovation.

ENDS

Media inquiries

Emma Boscheinen, AusBiotech Director of Communications / +61 437 075 209 / eboscheinen@ausbiotech.org

AusBiotech welcomes new members in third quarter

Thu, 02 Oct 2025 00:00:00 +1000

In the third quarter of 2025, AusBiotech has proudly welcomed a significant number of new members.

Our latest members span biotechnology, medical technology, pharmaceuticals, digital health, research and professional services, highlighting the continued growth and diversity of our ecosystem in Australia.

We are thrilled to introduce the following new members:

Neuphoria Therapeutics Inc
Seer Financial Group
Novoroo Bioscience Pty Ltd
CMBIO
Wexford Hayes Pty Limited
iyarn
Veeva Australia Pty Ltd (NSW)
Veritus Research Pty Ltd (VIC)
Research Infrastructure Connected (VIC)
CRScube
The University of Western Australia (UWA)
Magellan Stem Cells Pty Ltd (VIC)
Formulytica
Perspicacité
ISOBiotech Pty Ltd
spagonano medical
RNA Australia
Trelleborg Medical Solutions aka Baron Rubber
The Kids Research Institute Australia
Apop Biosciences Pty Ltd
Myopharm
Australis Pharma, Inc.
Filamon
ZRG Partners

Joining AusBiotech creates new connections across the life science ecosystem, helps members stay informed of current trends and issues, and supports the advocacy that promotes our growing life science industry in Australia.

Find out more about AusBiotech’s member benefits here.

AusBiotech and Medicines Australia launch new advisory group to accelerate advanced therapies

Wed, 01 Oct 2025 00:00:00 +1000

AusBiotech and Medicines Australia are inviting expressions of interest from current members to join the newly established Advanced Therapies Advisory Group, which will provide input into strategic leadership initiatives supporting Australia’s growing advanced therapies sector.

Building on the legacy of the two-year Cell and Gene Catalyst, which laid the groundwork for Australia’s cell and gene industry, the Advisory Group will support national coordination and enable collaborative policy discussions to address the sector’s most pressing opportunities and challenges.

The urgency for greater coordination is underlined by the Australian Cell and Gene Therapies Innovation Investment Report, released today in partnership with Deloitte. The report reveals:

91% of respondents agree national coordination is essential to advance Australia’s capabilities.
Industry is growing rapidly and moving towards maturity.
71% of respondents plan to increase R&D investment.
Challenges remain in manufacturing, workforce and patient access.

The Advisory Group will act on these findings and lead policy development and advocacy across the critical areas, including manufacturing capacity, workforce, and strengthening patient pathways to new therapies.

Representation will span membership from both peak bodies, with additional representation from the Solutions for Manufacturing Advanced Regenerative Therapies Cooperative Research Centre (SMART CRC), which will also play a central role.

AusBiotech CEO, Rebekah Cassidy:

“Australia’s advanced therapies sector is entering a phase of maturation, and national coordination is essential to ensuring patients, industry, and the healthcare system benefit from these innovations.

“Through this new Advisory Group, we will ensure industry voice is heard across priority areas as we shape policy discussions designed to grow Australia’s leadership in advanced therapies."

Medicines Australia CEO, Elizabeth de Somer:

“Collaboration is essential to maintain momentum in the delivery of advanced therapies – cell and gene technologies - to the community. This Advisory Group represents a very important step forward in unifying industry and other stakeholders to consider and address critical policies and delivery mechanisms to ensure we fully harness and maximise these important therapeutics now and into the future.”

Professor Simon Cool, Chief Executive Officer SMART CRC:

"This Advisory Group is a timely and strategic move for Australia’s regenerative therapies sector. The SMART CRC strongly supports this initiative, which reflects our commitment to building a collaborative, industry-led ecosystem that delivers scalable, cutting-edge therapies to patients. We’re proud to represent the voice of our 63 partners and look forward to contributing to meaningful health and economic outcomes for Australians”.

Deloitte Global Investment and Innovation Incentive Partner, Greg Pratt:

“The report underscores a critical opportunity for government to help unlock the full potential of Australia’s cell and gene therapy sector. With clear signals of growing private sector momentum, targeted government investment can play a catalytic role — strengthening infrastructure, building workforce capability, and enabling national coordination. By supporting the development of a connected, end-to-end CGT ecosystem, we can accelerate translation, attract global investment, and ultimately deliver better health and economic outcomes for Australia.”

The Advisory Group will provide a unified voice to government, industry, and the community, ensuring Australia seizes the opportunity to become a leading hub for advanced therapies and delivers better health outcomes for patients.

AusBiotech and Medicines Australia members interested in joining the new group should use this EOI form here to register their interest. The closing date for nominations will be Wednesday, 22 October.

-ENDS-

Media inquiries:

Emma Boscheinen, AusBiotech / Tel. +61 437 075 209 / eboscheinen@ausbiotech.org
Anne-Marie Sparrow, Medicines Australia / Tel. +61 417 421 560 / anne-marie@cube.com.au

About AusBiotech:

AusBiotech is Australia’s life sciences organisation, working on behalf of more than 3,000 members for more than 39 years, to provide advocacy and services that promote the global growth of the Australian life sciences industry. With our unrivalled membership breadth and national convening power, we drive the advancement of life sciences and our members’ success in translating clinical research and technologies into real-world solutions while fostering knowledge sharing and collaboration to help life sciences innovators thrive.

About Medicines Australia:

Medicines Australia leads the research-based pharmaceutical industry of Australia. Our members discover, develop and manufacture the medicines that are the foundation of a healthy and prosperous society, including prescription pharmaceutical products, biotherapeutic products and vaccines. Our members invest in Australian medical research and take local discoveries and developments to the world.

About SMART CRC:

The Solutions for Manufacturing Advanced Regenerative Therapies (SMART) Cooperative Research Centre (CRC) is a nationally coordinated initiative that brings together expertise from across the regenerative therapy value chain. With 63 foundation partners spanning industry, government and research, the SMART CRC fosters collaboration to grow Australia’s regenerative therapy ecosystem, accelerate breakthrough technologies and deliver life-changing treatments. Together, we will mature a self-sufficient, sustainable pipeline of technologies and talent, unlocking its full potential to benefit Australia’s economy, healthcare, and patients.

Federal Minister for Industry and Innovation and Minister for Science to address the AusBiotech International Conference

Thu, 25 Sep 2025 00:00:00 +1000

AusBiotech is delighted to announce that Senator the Hon Tim Ayres MP, Federal Minister for Industry and Innovation and Minister for Science, will join AusBiotech, the life sciences industry, international delegates and investors during Australia’s biggest week in biotech this October.

The AusBiotech International Conference is the flagship event of Australia’s biggest week in biotech — convening the breadth of the life sciences ecosystem with partners from around the world. With more than 1,600 participants expected this year, including delegates from more than 20 countries, the Conference will showcase companies and innovations set to shape the future health and wellbeing of Australians, while continuing to grow the impact of our innovations globally.

Minister Ayres’ attendance underscores that biotechnology and life sciences are critical sectors for Australia’s future — from delivering medical breakthroughs to strengthening high-tech manufacturing and sovereign capability, and driving productivity. It is a recognition that our sector is central not only to the nation’s health, but also to its prosperity and place in the world.
AusBiotech CEO Rebekah Cassidy said the organisation was honoured to have Minister Ayres join the Conference at such a critical time for the sector.

“The world around us is changing. International markets and countries are hungry for health innovation. With biotechnology marked as a critical sector here in Australia, the time is now for deep conversations about our role in building global health solutions and strengthening Australia's national resilience and sovereign capabilities,” Ms Cassidy said.

"This year’s Conference comes at an important juncture. Australia’s life sciences sector is maturing and ready to take on a greater role as part of our future innovation-driven economy at a time when the world is rapidly changing with shifting trade dynamics, health security challenges, aging populations, and a changing climate — all of which bring new health access challenges.

"The conversations set to unfold at this year’s AusBiotech International Conference will not only showcase the extraordinary success and future potential of Australia’s life sciences sector but also place it within the context of these global shifts and emerging opportunities that are shaping our sector’s future worldwide."

With more than 2,900 life sciences organisations employing one in every 60 Australians, this sector is a national strength and has the potential to be a greater part of the global innovation stage.

AusBiotech 2025 will deliver an industry-leading program with more than 250 speakers across 60 sessions, creating a platform for discussion, debate and collaboration on the most pressing issues facing biotech and medical technology today.

"Year-on-year, our Conference breaks attendance records, a clear sign that the sector is growing in confidence and scale. In 2025, the world is not only watching Australia’s life sciences sector, but also coming to Australia to partner, invest, and collaborate with Australian companies," said Rebekah.

ENDS

Media inquiries
Emma Boscheinen, AusBiotech Director of Communications / +61 437 075 209 / eboscheinen@ausbiotech.org

Share your story: Global Biotech Week

Fri, 05 Sep 2025 00:00:00 +1000

This September, AusBiotech will be celebrating Global Biotech Week (21–27 September), an international initiative designed to raise public and policymaker awareness of the biotechnology industry's importance and global potential. Together, these milestones shine a light on the people, organisations, and innovations driving better health outcomes in Australia and around the world.

As Australia’s life sciences peak body, we’re proud to showcase the contributions of our 3,000+ members across biotechnology, medical technologies, and digital health. From pioneering new therapies and vaccines to advancing diagnostics and devices, our members are shaping the future of health.

Get involved: Feature your work

We invite members to take part in our LinkedIn campaign by sharing your story.

What to submit:

A short paragraph (100–150 words) describing your work and its impact
OR a quote from a team member or leader on why this work matters
A high-resolution image (e.g. lab, product, team, or facility photo)
Your name, job title, and organisation

Selected submissions will be profiled to AusBiotech’s 34,000+ LinkedIn followers and showcased in our member-only newsletter, highlighting the breadth of talent and innovation across our ecosystem.

Email your story to communications@ausbiotech.org by Monday 22 September 2025.

Let’s celebrate the people and companies advancing breakthroughs in biotechnology, pharmacy, and heart health — and show the world the strength of Australia’s life sciences sector.

AusBiotech welcomes release of draft National Health and Medical Research Strategy

Fri, 29 Aug 2025 00:00:00 +1000

AusBiotech welcomes the Federal Government’s release of the draft National Health and Medical Research Strategy. Announced by the Hon Mark Butler MP, Minister for Health and Ageing, the 10-year plan will undergo further consultation before the final strategy is delivered by the end of 2025.

This marks a significant step towards a national approach to health and medical research, one that nurtures Australia’s world-leading discoveries and ensures our scientific excellence has the potential to be translated, developed, and commercialised into global health innovations.

AusBiotech has engaged with Ms Rosemary Huxtable AO PSM, Chair of the National Strategy, and her departmental colleagues as they have developed the draft Strategy and is continuing to engage its broad membership.

AusBiotech CEO Rebekah Cassidy said a strong health and medical research sector is foundational to the success of Australia's life sciences industry: “For our sector to thrive, it needs a coordinated and well-invested research sector. Without research, there is no pipeline of health innovation, no pipeline of companies, and no ecosystem to sustain them.

“Australia’s life science sector has almost 2,900 organisations and employs one in every 60 jobs. We only want those numbers to grow. Our world-class health and medical research are critical to long-term growth and global impact of our broader sector.”

AusBiotech welcomes the draft Strategy’s focus on research translation, the critical role of commercialisation and industry growth, and the importance of a robust clinical trials sector. We are also encouraged by its recognition of the need to strengthen sovereign manufacturing capability, streamline regulatory pathways, and incentivise local procurement of medical products to build sovereign capability and supply chain resilience.

"There is a race for innovation globally,” Rebekah said. “Especially in health, countries are taking active steps to grow their biotechnology and medical technology industries, to improve the wellbeing of their citizens, while strengthening both economic resilience and health security. Now is the time for Australia to similarly invest, across the entire health innovation pipeline.

“Our peer nations are investing in their life sciences sectors via clearly articulated, whole-of-government life sciences strategies. If Australia’s doesn’t act urgently, our homegrown capabilities — from research through to companies on the cusp of commercialisation— will be snapped up by countries that are hungry for our innovation and willing to invest.

"We are currently leaving enormous opportunities on the table – including benefits to the health and wellbeing of our people, our economy and our health security.”

AusBiotech continues to advocate for a unified whole-of-government strategic approach to the life sciences industry, whose numerous policy touchpoints, including research, are currently dispersed across over nine different Australian Government portfolios.

Throughout 2025, AusBiotech has campaigned for a policy agenda focused on four key asks of the Federal Government:

• Developing Australia’s first whole-of-government National Life Sciences Strategy to set clear policy priorities and eliminate gaps and overlaps.
• Establishing an Australian Life Sciences Council, and a partnership between industry and government to drive this Strategy, address sector challenges and ensure value for investment.
• Investing in data collection to drive innovation and improve policy and decision-making.
• Recognising life sciences as a priority under the government’s industry policy frameworks.
AusBiotech will continue to engage with its 3,000-strong member network throughout the National Health and Medical Research Strategy's consultation process and looks forward to working with government as it is finalised.

Media inquiries
Emma Boscheinen, AusBiotech Director of Communications / +61 437 075 209 / eboscheinen@ausbiotech.org

5Qs with Tenmile’s Dr Steve Burnell: Backing Australia’s next generation of biotech and medtech innovators

Wed, 20 Aug 2025 00:00:00 +1000

In our 5Qs with… series in THRIVE, we speak with leaders across Australia’s life sciences sector — from CEOs and C-suite executives to key decision-makers — to hear their perspectives on the ecosystem and their vision for its future.

This edition features Dr Steve Burnell, Managing Director of Tenmile and Chair of its Investment Committee. Steve shares his entrepreneurial journey, insights from judging AusBiotech’s Early-Stage Innovation Forum (ESIF), and the trends shaping early-stage biotech and medtech in Australia.

In what ways have you been active in the startup and/or early-stage community?

“I’ve been an entrepreneur at heart since before I could spell the word, creating solutions to problems, organising resources and taking calculated risks to make a difference. This path took me from starting my own businesses in Australia and the US to an intrapreneurial career building new partnerships and businesses within the world’s largest biotech, Roche-Genentech. Since returning to Australia in 2019, I’ve focused on supporting local entrepreneurs through philanthropy and early-stage venture capital, helping to bring new innovations to patients.

“I’m passionate about the intersections of science, technology, healthcare and climate. Tenmile is a natural extension of this, and my work with Minderoo Foundation advances the latter. I’m incredibly grateful to Andrew and Nicola Forrest, both entrepreneurs who understand the inherent relationship between risk and failure, for their commitment to using capital for good.”

Why is early-stage exposure through initiatives like the Early-Stage Innovation Forum (ESIF) so critical for life sciences (biotech and medtech) startups in Australia?

“The best ideas often come from those closest to the problem. I’m a strong advocate for clinician-led innovation, backed by management teams that understand clinical workflows and health system realities as well as the patient experiences their solutions create.

“Many founders lack the strategy, business or marketing expertise needed to effectively commercialise their ideas. That’s why initiatives like AusBiotech’s ESIF are so important. Having been a judge for several years, I’ve seen how the exposure, feedback, connections and experience these companies and founders receive is invaluable as they embark on the long and challenging company-building journey.”

From the perspective of an ESIF judge, what distinctive qualities or signals do you see in startups that benefit most from early investment exposure?

“The great thing about ESIF is that it gives founders at the very start of their journey the chance to test their pitch and get honest feedback. The sweet spot is later-stage institutional research teams contemplating spinning out, or newly-formed companies raising their first round of equity capital.

“A clearly articulated Target Product Profile (TPP) is always a strong signal. It acts as a North Star for early innovation teams, whether they’re working on a device, diagnostic, therapeutic or digital health app. The most compelling early-stage pitches combine a solid TPP with a capable, dedicated team and a clear view of how their solution fits into the complex status quo and competitive landscape. Passion and humility always go a long way for me, too.”

How does AusBiotech’s approach to elevating early-stage innovators contribute to Australia's broader innovation ecosystem — and how have you seen it make a difference in the companies you mentor or invest in?

“Australia’s world-class tertiary education system and sensible government innovation incentives provide a solid foundation for early-stage ideas. But unlike the US, Europe and now parts of Asia, we lack the depth of private risk capital needed to take full advantage of this. Many companies struggle to raise enough to complete their clinical programs and scale internationally – some never make it.

“That’s why visibility to all possible sources of capital is critical, and AusBiotech’s forums attract a diverse investor audience, helping to bridge that gap. I like to think Tenmile sees most early-stage investment opportunities in our space through our current pipeline and the great relationships we have with research institutes across the country. Despite this, one of the ESIF presenters in 2024, Proton Intelligence, was not known to us. We went on to lead their seed round with a multi-million-dollar investment. That’s a tangible example of why these forums matter.”

What emerging trends do you see reshaping early-stage biotech and medtech in the years ahead?

“International interest in Australia’s differentiated intellectual property, Phase 1/2 clinical trials ecosystem and R&D Tax Incentive is definitely on the rise. This is helping to build stronger global investment syndicates, giving Australian startups capital as well as access to experienced management talent, regulatory expertise, market insights and strategic partnerships. This increased international collaboration will help keep homegrown companies here longer.

“Despite a challenging global backdrop, I strongly believe that the future for Australian biotech and medtech is bright. An explicit part of Tenmile’s mission is to help build a globally significant health science and technology sector in Australia, and we’re excited to be supporting that future.”

Steve Burnell is the Managing Director of Tenmile and Chair of the Investment Committee. Tenmile is an Australian health technology venture capital company owned by Tattarang, one of Australia’s largest private companies. Steve’s professional experience spans research, philanthropy, strategy consulting, M&A, and operating global businesses in fields as diverse as ecology, digital health, and precision oncology. He is relentlessly passionate about the power of new technology to positively impact human health and mitigate our climate impacts. Prior to his current role, Steve managed a global business, led M&A and established a new informatics and real-world data business for the world’s largest biotech, Roche-Genentech based in the USA. He remains a senior strategic advisor to Minderoo Foundation where he has led large initiatives focused on COVID-19, Cancer, and Ocean Genomics amongst others. He holds a B.Sc. (Hons.) in Biology and a Ph.D. in Population Biology from the University of Sydney.

Australian-first on-demand biomanufacturing facility named

Wed, 20 Aug 2025 00:00:00 +1000

AusBiotech was proud to partner with the Translational Research Institute (TRI) for a BioBriefing event where we welcomed Queensland’s Deputy Premier, the Hon Jarrod Bleijie MP, who announced the new name of the TRI’s Australia-first on-demand cGMP biomanufacturing facility: ENTRI.

The name reflects TRI’s ambitions of removing barriers for biomanufacturing in Australia – and enabling translation of medical science by creating an integrated pipeline from the laboratory bench, through clinical trials, to the bedside.

The Hon Jarrod Bleijie MP, Deputy-Premier of Queensland, made the announcement as part of a site visit, an innovation showcase and the AusBiotech Queensland BioBriefing event. The innovation showcase also featured presentations from TRI-based industry residents Microbio, AdvanCell [AusBiotech members], and EMVision.

ENTRI is proudly supported by the Queensland Government and TRI – and is due to be completed in early 2026.

The Deputy Premier acknowledged the importance of the facility to Queensland and Australia.

“ENTRI is ideally situated on the Princess Alexandra Hospital campus and within Brisbane’s thriving Boggo Road Innovation Precinct, and will launch Queensland as the epicentre of biomanufacturing in Australia,” he said.

“As part of the Queensland Government’s re-focus on three new priority industries, including biomedical, I’m looking forward to seeing the industry development and innovation that will take shape at ENTRI and the broader precinct.”

ENTRI will provide maturing, high-potential, biotech, pharma and medtech companies the environment and expertise to scale up manufacturing for clinical trials, while allowing them to retain their intellectual property.

It will feature Australia's first on-demand cGMP cleanrooms to advance development of a range of products, including RNA-based therapies, cell therapies, biologics, vaccines and drug-device combination products.

TRI CEO Professor Maher Gandhi says stakeholders are excited by the opportunity the facility provides to forge connections with government and regulatory bodies, industry and the research sector.

“We are confident our new capability will be attractive to international companies because it enables the integration of manufacturing with clinical trials in Australia, enabling internationals to take advantage of Australia’s speed to the clinic and further reducing the overall cost of development programs through Australia’s R&D Tax Incentive.”

AusBiotech CEO Rebekah Cassidy has welcomed the ENTRI announcement, saying it sends a signal regarding the Queensland Government’s ongoing commitment to strengthening critical capabilities and accelerating the scale-up of Australian health innovation.

“Australia’s life sciences sector is thriving, with close to 1600 biotech and medtech companies nationwide. ENTRI will be a game-changer, enabling companies to scale and manufacture on home soil. We look forward to supporting the pipeline of innovation this investment will unlock.”

Celebrating science: From discovery to commercialisation

Wed, 20 Aug 2025 00:00:00 +1000

Last week, Australians came together to mark National Science Week — a celebration of the people and companies transforming discovery into innovations that improve lives.

This year’s theme — Decoding the Universe: Exploring the unknown with nature’s hidden language — invited us to reflect on the power of science across disciplines, from DNA and biology to quantum technologies and diagnostics.

For Australia’s life sciences sector, science is where every breakthrough begins. Across the country, AusBiotech’s 3,000+ members are shaping the future of health through pioneering research, translation, advanced manufacturing, and commercialisation. From start-ups and ASX-listed companies to global leaders, these innovators are tackling the toughest health challenges, working collaboratively across research, industry, and investment.

National Science Week is an opportunity to shine a light on this vital work — to celebrate the people who move science from concept to clinic, from prototype to patient.

Driving innovation for better health

Erica Bremner Kneipp, Research Director for Human Health at CSIRO and Deputy Chair of AusBiotech, reflected on the national importance of science-led policy and investment.

“My career has been focused on harnessing health and medical innovation for healthcare system improvements and improved patient outcomes… My commitment to driving innovation finds me now leading a brilliant group of scientists at CSIRO working on communicable and non-communicable disease prevention, preparedness and response.”

Science as the foundation of innovation

For Noxopharm CEO, Dr Gisela Mautner, science is inseparable from impact.

“Science is the foundation of so much of our innovation, especially in the medical field where breakthroughs are made that benefit millions of people and save lives,” Mautner said.

It is collaboration and commercialisation that are foundational to turning years of research into solutions.

"As a collaborative company developing new technologies targeting inflammation, we are dedicated to maximising the potential of years of deep scientific research and expertise,” she added.

"We are also grateful to be doing this in Australia, a country that punches above its weight in biotech R&D and offers so much promise by creating new companies and career opportunities while improving our national health and wellbeing."

Harnessing science to tackle disease

A/Prof Michael Gantier, Research Group Head at the Hudson Institute of Medical Research, emphasised the role of science in addressing urgent unmet needs.

“Like many others I have dedicated my working life to science and finding new ways to tackle disease. My research focuses on harnessing the potential of RNA therapeutics to revolutionise autoimmune disease treatments, blocking disease at its source.”

"This is important because so many Australians and others around the world suffer from these diseases and hope to see new medical advances that can help them."

He added that Australia’s collaborative ecosystem is critical to translating research into therapies.

“Australia is a great place to conduct this work as we have a thriving community of researchers and companies that collaborate to develop the most promising drugs and bring them to market, delivering results for the people who need them most.”

Science as a passport to opportunity

For Dr Robyn Lindner, Director, State and Committee Engagement at AusBiotech, a background in science has opened doors across careers.

“A background in science is an incredible passport to opportunity – from fundamental research in universities, to medical discoveries, industry roles developing innovations that improve health, and public health initiatives that change lives. For me, science has been the foundation of a varied and rewarding career, always driven by curiosity and a desire to make a positive difference.”

Innovation beyond the lab

For Tim Oldham, CEO and Managing Director of AdAlta and Chair of Skin2Neuron, science cannot reach patients without innovation at every step of the pipeline.

“How do we deliver better health outcomes to patients in Australia and around the world? It takes more than just great discovery research – it also needs innovation in manufacturing, clinical study design, supply chains, regulatory science, reimbursement and clinical practice.”

Oldham sees cell and gene therapies as a prime example of this multidisciplinary innovation.

“At AdAlta Ltd we are working to modify a patient’s own immune cells to be able to recognise and kill cancer. And at Skin2Neuron Pty Ltd we are working on an Australian invention focused on neurological diseases such as Alzheimer’s Disease and Parkinson’s Disease.

"It is an exciting time to be a scientist and help bring innovations not even dreamt about just a decade or two ago to standard of care.”

Science as Australia’s competitive advantage

Together, these voices demonstrate why science matters — not only for discovery, but for translation, development, and commercialisation. National Science Week is more than a celebration; it is a reminder that science fuels innovation, drives economic growth, and delivers health outcomes that change lives.

As Australia’s life sciences peak body, AusBiotech is proud to be the super-connector linking research, industry, investment, and government. By representing 3,000+ members across biotechnology, medical technologies, and digital health, we champion the translation of science into real-world impact.

Science is Australia’s competitive advantage. Celebrating it — and ensuring the ecosystem to support it thrives — is essential to our nation’s future.

Applications now open: Pitch at AusBiotech Invest 2025

Wed, 06 Aug 2025 00:00:00 +1000

Applications are now open for companies to pitch at AusBiotech Invest 2025 — Australia’s largest life sciences investment event, connecting innovators with capital to accelerate breakthroughs from research to commercialisation.

Held in Melbourne this October, AusBiotech Invest brings together local and global investors, corporate leaders, and entrepreneurs to explore the latest investment opportunities.

We invite companies from across the life sciences ecosystem to apply for the opportunity to present their story and showcase their growth potential.

This is your chance to position your company on an international stage, gain exposure to qualified investors, and help shape the future of health in Australia and beyond.

As Australia’s life sciences peak body, AusBiotech is proud to host this flagship event alongside host state partner, the Victorian State Government.

The event is part of our commitment to supporting the sector’s access to capital, capability building, and global connections.

Pitch to a targeted audience of local and international investors, industry leaders, and potential partners, joining an event that champions commercialisation success stories and highlights Australia’s world-class life sciences capabilities.

AusBiotech Invest 2025 is where life science leaders thrive — and we’re seeking ambitious companies ready to take the next step in their investment journey.

Applications close on Sunday, 7 September 2025. Places are limited, so we encourage early submissions.

To learn more and apply, visit the AusBiotech Invest website: https://ausbiotechinvest.com/apply/

We look forward to showcasing the strength and diversity of Australia’s life sciences sector on the global stage.

Senator Ananda-Rajah’s vision for science, sovereignty and scale

Wed, 06 Aug 2025 00:00:00 +1000

In her powerful and future-focused maiden speech to Parliament, Senator Michelle Ananda-Rajah (VIC) laid out a vivid 40-year vision for Australia driven by science, technology and resilient communities. Among the most compelling messages was her call to harness the nation’s strengths in biotechnology — and transform it into a sovereign economic powerhouse.

A physician, researcher and health advocate, Senator Ananda-Rajah believes that science-led innovation — from carbon-capturing kelp forests to universal vaccines — will underpin Australia’s health and economic prosperity over the next four decades. In her vision for Australia, the Senator imagined her granddaughter working in a “booming biotech sector, making nanoparticles that deliver chemotherapy directly to cancer cells”. This hopeful vignette serves as more than rhetoric — it’s a call to invest, scale and translate Australia’s biotech brilliance into tangible outcomes.

“Biotech, like clean energy, is an area where we are primed for success... But we have the mystery of the missing middle,” she stated, referring to the critical gap between research excellence and commercialisation.

Australia’s research sector ranks eighth globally and boasts 1,200 biotech companies — but not enough achieve scale domestically without the need to take their ingenuity offshore to commercialise. With sovereign capability now a national priority, Senator Ananda-Rajah advocates bridging this gap to create mid-sized biotech companies capable of global competitiveness — especially in clinical trials, where Australia’s multiculturalism offers a unique advantage.

At a time when the global clinical trials market is expected to surge past $700 billion within seven years, the Senator made the case that: “Australia could — should — be a clinical trials destination of the world”.

Her insights extend to the human capital challenge underpinning the sector. With over 8,500 PhDs produced annually and only one in six postdocs recommending academia as a viable path, she stressed the need for a diversified innovation economy that supports science careers beyond the university sector. She also exposed systemic inequities — particularly around gender and race — that hinder women-led and minority-founded startups.

As a former AI startup founder herself, Senator Ananda-Rajah didn’t shy away from the barriers. “Enabling women, including those with funny names, to sit rather than serve at the founder table means confronting the uncomfortable truth of unconscious bias,” she said — an acknowledgement of the structural reforms needed to unlock Australia’s full innovation potential.

Throughout the address, Senator Ananda-Rajah's message was clear: science must move beyond the lab to become a pillar of our national economic strategy, public health preparedness and regional development. Her call to action aligns squarely with AusBiotech’s policy and advocacy agenda: build sovereign biotech capability, scale innovation, deliver health, economic and national security outcomes, and create enduring, high-value jobs.

“Every single concept in this vignette is grounded in science rather than fiction,” she reminded the chamber. “It is a future where advances in science and tech lift up our living standards, making us more resilient, prosperous, and able to withstand whatever the world throws at us.”

Senator Ananda-Rajah’s speech signals not only a commitment to science, but a legislative intent to support the frameworks — policy, investment and talent — needed to optimise Australia’s biotech ecosystem.

United for innovation: AusBiotech and Medicines Australia celebrate Catalyst outcomes, further strengthen industry collaboration

Thu, 31 Jul 2025 00:00:00 +1000

AusBiotech and Medicines Australia have marked the two-year conclusion of the joint venture Cell & Gene Catalyst by celebrating its outcomes and committing to greater industry collaboration to unify the industry’s efforts and voice.

The Catalyst was established as a two-year joint venture between AusBiotech and Medicines Australia to activate Australia’s cell and gene industry by connecting key stakeholders.

With the support of Catalyst’s partners, and under the leadership of its Director, Dr Marguerite Evans Galea AM, the joint venture has successfully forged new pathways for national alignment, deepened sector understanding, and strengthened a unified voice on a range of topics from the healthcare workforce to precinct development, capability and capacity-building, market access, clinical trials and strategic investment to accelerate the cell and gene industry.

Rebekah Cassidy, CEO AusBiotech: “Our organisations are proud of the deep connections the Catalyst has built and the strong foundation it has laid for long-term cell & gene industry growth in Australia. Given the maturing of Australia’s cell and gene industry over recent years - evidenced by new entrants, new industry-led partnerships, and new collaborative programs like the SMART CRC - AusBiotech and Medicines Australia believe the time is right to move toward even greater industry unification to move critical discussions forward.”

Liz De Somer, CEO Medicines Australia: “Both peak bodies recognise the need for the sector to continue important discussions on key topics including access, workforce and manufacturing. Medicines Australia and AusBiotech will continue to champion and invest in new collaborative structures that further unite the voice of the sector.” Following the planned conclusion of the Catalyst in September 2025, AusBiotech and Medicines Australia will work with their members to develop a new program of engagements and partnerships, designed to further connect and unify the work of the industry.

To enable this change both organisations will:

1. Establish a joint AusBiotech and Medicines Australia Advanced Therapies Advisory Group focused on policy development and advocacy to address current and emerging opportunities and issues facing the advanced therapies community.

The Group will include member representation from both peak bodies and importantly, a representative of the SMART CRC, to progress and support strategic projects that foster continued growth of the industry.

AusBiotech and Medicines Australia will issue an EOI to register interest in this group soon.

2. Strengthen our sector collaboration through an ongoing strategic partnership agreement between AusBiotech and the SMART CRC.

3. Continue to collaborate on a range of whole-of-sector topics including those related to access, workforce and manufacturing through each organisation’s current and evolving working and advisory groups.

Professor Simon Cool, Chief Executive Officer SMART CRC: “The SMART CRC is excited to further strengthen its partnership with AusBiotech and Medicines Australia to help unify and advance Australia’s regenerative therapies sector. Together, we will support the newly formed Advanced Therapies Advisory Group, amplifying the voices of key stakeholders, including state governments, biotech and regenerative therapy companies, healthcare providers, universities, and research institutes. “By working collaboratively with AusBiotech and Medicines Australia, the SMART CRC aims to grow Australia’s sovereign manufacturing capabilities, expand the skilled workforce, anchor cutting-edge technologies onshore, and accelerate the delivery of breakthrough medical treatments that can transform lives”.

Dr Marguerite Evans-Galea AM, Catalyst Director: “The Catalyst has played a pivotal role in the evolution of Australia’s advanced therapies sector, with significant growth and activation, propelling the ecosystem toward a more collaborative and mature industry. It’s been an honour to drive positive change for advanced therapies with expert leaders within the sector and I am grateful for the goodwill and collaboration demonstrated during this time. "This progress bolsters the cell and gene industry and gives hope to Australia’s peoples”.

Media inquiries:

Emma Boscheinen, AusBiotech / Tel. +61 437 075 209 / eboscheinen@ausbiotech.org

Anne-Marie Sparrow, Medicines Australia / Tel. +61 417 421 560 / anne-marie@cube.com.au

National Science Week 2025: Showcasing Australia’s life sciences innovation

Wed, 23 Jul 2025 00:00:00 +1000

National Science Week (9–17 August 2025) is Australia’s annual celebration of science and technology, recognising the research, discovery, and innovation shaping our world. This year’s theme — ‘Decoding the Universe: Exploring the unknown with nature’s hidden language’ — invites us to explore the fundamental building blocks of life and DNA, from quantum science and biology to data and diagnostics.

As Australia’s life sciences peak body, AusBiotech is proud to take part in National Science Week by highlighting the world-leading scientific research and commercialisation taking place across our member network. With more than 3,000 members spanning biotechnology, medical technologies, digital health, and research, we represent a rich ecosystem advancing real-world outcomes — from lab breakthroughs to global markets.

To mark the week, AusBiotech is launching a LinkedIn campaign that celebrates the scientists and innovators helping to decode the unknown — whether that’s through pioneering therapeutics, regenerative medicine, bioinformatics, or molecular diagnostics. Our aim is to showcase the people and organisations translating Australian science into breakthroughs.

Get involved: Share your story

If you're a member of AusBiotech and your work is contributing to science that helps decode nature’s hidden language, we want to hear from you. We’re inviting members from across the life sciences sector — including researchers, scientists, commercialisation leaders, and startup founders — to be featured in our LinkedIn campaign.

What to submit:

A short paragraph (100–150 words) describing you (or your colleagues) contributions to Australia's world-class scientific
OR A quote from a team member or leader on why this work matters or what excites you about it
A high-resolution image (for example, lab, product, team, or facility photo)
Name, job title, and organisation

Selected submissions will be profiled to our 34,000+ LinkedIn followers, showcasing your contribution to Australia’s leadership in science, technology, and health innovation.

Email your story to communications@ausbiotech.org by Monday 4 August 2025.

Let’s celebrate the people and companies putting Australian science and technology on the map — and help the world see what Australia’s life sciences sector is capable of.

Stay connected on medtech and medtech regulatory news

Wed, 23 Jul 2025 00:00:00 +1000

AusBiotech is a member of the Regulatory and Technical Consultative Forum for medical devices (RegTech Forum). This forum, chaired by the TGA, meets quarterly and provides AusBiotech members a mechanism to raise regulatory or technical issues of concern, and identify opportunities to improve current regulatory practices.

The Regtech Forum is attended by AusBiotech and our Medtech Regulatory Affairs Advisory Group.

AusBiotech is keen to increase our ability to connect with our members working in the medical device sector. If you would be interested to receive communications from AusBiotech on Medtech and Medtech regulatory affairs issues and opportunities (including joining our Medtech Regulatory Affairs Advisory Group), then we encourage you to register your interest here.

A message from our CEO: Delivering impact, shaping the future

Wed, 23 Jul 2025 00:00:00 +1000

As we mark the midpoint of 2025, AusBiotech CEO Rebekah Cassidy reflects on our key achievements and the opportunities shaping the sector.

The first half of this year has been a pivotal one for AusBiotech as we have sought to advance the voice of our sector, strengthen strategic partnerships and progress new programs designed to support the sector’s, and our members’, success over the medium and long term.

My team and I are grateful to our members — long-standing and new — and sector partners for their continued openness and collaboration as we seek to shift the dial on long-standing challenges and advance new opportunities.

Policy agenda: Our message to government and policymakers has remained consistent. There has never been a more critical time for Australia to harness the potential of, invest in, and prioritise its life sciences sector.

In a rapidly changing world, the work of our sector and our members is central to our nation’s future health, economic growth, and health security. Continuing the decades-long approach to policy development for our sector, with well-intentioned but largely disconnected policies now spread across no less than nine different departments, won’t deliver the step change required.

As our global peer markets build new partnerships between government and industry, and launch new industrial strategies designed to foster national biotech growth, investment and trade partnerships, the time is now for Australia to:

Develop Australia’s first whole-of-government National Life Sciences Strategy to set policy priorities, eliminate gaps and overlaps, and bring Australia in line with other countries competing for global investment and building their national capabilities.
Establish a whole-of-government Life Sciences Council in partnership with industry to drive the strategy, address broader sector challenges, ensure value for investment and achievement of the government’s health, economic, security and employment priorities.
Recognise life sciences as a priority under the Future Made In Australia Act, creating the focus and cross-portfolio coordination required to maximise the sector’s contribution to Australia’s economic resilience, national security and health.
Invest in data to drive innovation, better understand global interdependencies, and improve policy and decision making.

We are continuing to advance these four core policy priorities through formal submissions to current reviews including the Strategic Examination of R&D and the National Health and Medical Research Strategy as well as through direct engagement with all levels of government and our wider stakeholder community.

At the same time, we have been advancing a number of important discussions with government on bespoke challenges across a range of subjects from the RDTI though to regulatory challenges facing our Medtech members, import procedures for some biologics and much more.

Investment and trade: Within an ever changing global trade context, we have been advancing discussions regarding the interconnectedness of global life sciences supply chains and our ecosystem more broadly. We have strengthened our role as a conduit between members and government across a number of topics including global trade challenges, the Australia-UK BioBridge opportunity, and through our role on the International Council of Biotechnology Associations, to advance Australia in discussions about the future of supply chains and evolving multilateral relationships.

We have also strengthened our relationship with important agencies like Austrade. We were proud to announce our new Trade Start partnership and look forward to updating on this and other parts of our collaborative relationship soon.

Connecting our members: We were thrilled by the overwhelming response to our State Committee EOI and the launch of our refreshed Committees. Our State Committees play a critical role in elevating the voice of our members and ensuring we are responding to and advancing our members’ needs across Queensland, Victoria, New South Wales, South Australia and Western Australia. We are now starting the refresh of our Advisory Groups and Panels, and will have more on this soon.

Advancing sector and global partnerships: We have continued to deepen important sector collaborations including through our new MoU with ANDHealth, and another with the UK BioIndustry Association (BIA).

Industry Activation Program: As an Industry Partner Organisation for the Australian Government’s Industry Growth Program, we have delivered a wide activation program for our cohort’s 30-plus participants. From tailored webinars and expert mentoring to national networking opportunities and investor engagement, we’re equipping early-stage innovators with the tools, connections, and confidence to scale.

Creating connections and enabling knowledge sharing: Our program of face-to-face and virtual events continues to grow as we seek to enable new connections and share knowledge across our sector. In the first half of 2025 alone our BioBriefings, BioCheers, Women in Life Sciences Luncheon and Summit, Webinars, Medtech Invest 2025 and AusMedtech 2025 have brought thousands of people together across more than 20 events.

As we gear up for what will be Australia’s biggest week in biotech and the AusBiotech International Conference 2025 in October, we look forward to welcoming even more people from across Australia and the world. If you haven’t yet, make sure you secure your early bird registration here.

Thank you to all of our members and sector partners for their ongoing support. We look forward to working together for a strong second half of 2025.

Announcing Spotlight episode two: Meet BiomeBank

Wed, 23 Jul 2025 00:00:00 +1000

At AusBiotech, we are proud to highlight Australian life sciences innovators through our Spotlight series — shining a light on local homegrown life sciences capabilities that reflect Australia’s broader vision for health innovation, commercialisation, and sovereign manufacturing.

Our next Spotlight features BiomeBank — an Adelaide-based biotech on a mission to restore gut microbial ecology. In 2023, BiomeBank made history with the world’s first approved microbial therapy, now available across Australia to treat Clostridioides difficile infection — a serious and potentially life-threatening condition.

With a proprietary platform that co-cultures complex microbial communities and the world’s largest gut microbiome culture collection, BiomeBank is charting new territory. The company is building a pipeline of live biotherapeutic products designed to replicate the complexity and function of a healthy gut microbiome — a capability unmatched globally.

Stories like these reflect the critical importance of translation, development, and commercialisation pathways for Australia’s life sciences breakthroughs. They underscore why AusBiotech continues to advocate for policy reform, investment attraction, and ecosystem development through initiatives such as the National Life Sciences Strategy and Future Made in Australia.

By profiling members like BiomeBank, we help connect Australia’s life sciences ecosystem — including innovators, investors, policymakers, and partners — and elevate out member voices to national and international audiences.

Since launching Spotlight, we have seen strong engagement. Our previous feature on medtech innovator Navbit attracted more than 5,000 views across our channels — a clear signal that there is strong interest in homegrown stories of innovation and commercialisation. We look forward to seeing BiomeBank’s story shared just as widely.

We look forward to sharing BiomeBank’s story as part of that ongoing conversation.

If you missed the first episode of Spotlight, you can watch it here.

Together, we are building a stronger, more connected Australian life sciences sector — one story at a time.

Australian Government set to host the Economic Reform Roundtable

Wed, 09 Jul 2025 00:00:00 +1000

The Albanese Government has signalled its intention to focus on boosting the nation’s sluggish productivity during this parliamentary term. Treasurer Jim Chalmers is kicking things off with an Economic Reform Roundtable at Parliament House in August. The roundtable will bring together a small cohort of senior leaders from business, unions, industry, and government with the aim of building consensus ways to improve productivity, economic resilience and strengthen budget sustainability.

In his speech to the National Press Club in June, the Treasurer outlined the Government's productivity agenda, which includes creating a more dynamic and resilient economy, as well as delivering quality care more efficiently. “The roundtable will be about shaping the direction for long term economic reform. Building consensus on national reform priorities for this term of government and beyond. And setting out some guiding reform principles and next steps to advance the agenda well beyond the roundtable itself,” Treasurer Jim Chalmers said.

We know Australia’s life sciences industry is central to the country’s productivity, health security and the health and wellbeing of all Australians. Our industry has unparalleled potential to develop, commercialise and manufacture medical innovation to drive better health outcomes. Unfortunately, in some cases, Australia is leaving economic and health benefits on the table.

Despite our strengths and potential, sometimes Australian health innovators need to make the difficult business decision to leave Australia’s shores to further develop and commercialise their innovations overseas. This means Australians are waiting longer to access new health technologies than people in other countries – or missing out entirely.

Having the right policy settings in place to create a high-performing life sciences industry is critical to unlocking the health and productivity gains from our sector. That’s why AusBiotech’s Government and Policy team are strongly advocating to Government that the contribution of our industry must be recognised and valued, as the Treasurer and his Cabinet colleagues chart an economic path forward for the nation.

A key part of our advocacy to Government is the need for the establishment of a Life Sciences Council to inform a whole-of-government approach to health innovation across the lifecycle, from early-stage research through to clinical trials, translation, development, and commercialisation, in partnership with industry. The aim is for the Council to work with industry to develop Australia’s first Life Sciences Strategy to establish clear priorities for translation, development, and commercialisation, thus providing policy certainty and industry confidence.

Towards a BioBridge: Strengthening the Innovation-to-Commercialisation Pathway

Wed, 09 Jul 2025 00:00:00 +1000

Progress towards the establishment of a ‘biobridge’ linking the life sciences industries in Australia and the United Kingdom continues apace. Getting the foundations right for the ‘biobridge’ will enable biotechnology companies and service providers in Australia and the UK access to more funders, clinical trials, and markets.

On 3 June 2025, Australian Minister for Trade and Tourism, Senator the Hon Don Farrell and UK Secretary of State for Business and Trade, the Rt Hon Jonathan Reynolds MP, met alongside the OECD 2025 Ministerial Council Meeting held in Paris for the second meeting of the Australia-United Kingdom Free Trade Agreement Joint Committee.

The Ministers noted that free and inclusive trade is a cornerstone of prosperity in both countries. To this end, the Ministers acknowledged the ongoing work under the FTA's Innovation Chapter to explore the potential for a ‘biobridge' between our countries to expedite new and innovative medicines, diagnostics, and therapeutics to market.

The Ministers also celebrated the strong trade and investment relationship between the UK and Australia. Two-way trade between our economies reached AUD36bn or GBP23bn in 2024. Recognising that open markets, and reliable legal and regulatory frameworks are essential for trade, the Ministers committed to strengthening the rules-based trading system.

With AusBiotech’s Memorandum of Understanding with the UK’s BioIndustry Association freshly inked at BIO25, we look forward to continuing to work with them to progress the biobridge and other areas of shared interest to foster the growth of our respective life sciences ecosystems. We also acknowledge the work of the Department of Industry, Science and Resources in leading the development of the ‘biobridge’ from the Australian side.

Leading global engagement to strengthen Australia's life sciences sector

Tue, 24 Jun 2025 00:00:00 +1000

AusBiotech, Australia’s peak body representing the innovative life sciences sector, has wrapped a significant week of bilateral and multilateral engagements at the BIO International Convention 2025 (BIO25) in Boston.

In alignment with the BIO25 theme, 'The World Can’t Wait', AusBiotech echoed the need for urgent action — affirming that the time is now for Australia to harness the potential of its life sciences sector as critical to the future health and wealth of our nation.

New MOU signed between AusBiotech and the BioIndustry Association (BIA)

In a significant development, AusBiotech and the UK BioIndustry Association (BIA) used their meeting at BIO25 to sign a Memorandum of Understanding focused on enhancing policy alignment and fostering deeper industry collaboration. This milestone was complemented by a high-level bilateral roundtable, jointly hosted by AusBiotech and BIA at BIO25.

The roundtable brought together representatives from government, industry, and research. Participants shared their views about the potential for a BioBridge between Australia and the UK to expedite the development and commercialisation of innovative medicines, diagnostics, and therapeutics. It built on months of ongoing engagement about the BioBridge initiative – at both the industry and government levels – reinforcing shared priorities and opportunities for collaboration between the two countries.

“Australia and the UK are already strong and trusted partners in the life sciences sector,” said AusBiotech CEO, Rebekah Cassidy. “Our complementary innovation systems and shared values have enabled deep collaboration across research, commercialisation, and trade. This MOU signals a shared intent to go further — to scale up our partnership and drive mutual growth through innovation.”

Advancing Australia at the International Council of Biotechnology Associations

As the Australian member of the International Council of Biotechnology Associations, coordinated by BIO, AusBiotech represented Australia’s life science priorities at a number of key roundtables covering topics from clinical trials and manufacturing capability to changing global supply chains.

AusBiotech CEO, Rebekah Cassidy said: “In a changing world there is a need for robust global co-operation to build a resilient, innovative biopharmaceutical and biotechnology ecosystem that benefits the health of people everywhere. The International Council of Biotechnology Associations plays a critical role in enabling global advocacy on the most important topics across our industry and AusBiotech is proud to lead Australia’s voice across these discussions.”

Leading bilateral engagements and creating connections to foster Australian biotech

As a major sponsor of the Team Australia delegation, AusBiotech played a central role in convening and joining bilateral and multilateral discussions with a number of international partners including:

Asia-Pacific engagement: AusBiotech led discussions with the Japan Bioindustry Association, Japanese Government, and Taiwan Bio Industry Organization (Taiwan BIO) among many others highlighting Australia’s strengths in clinical trials, tropical and infectious diseases, radiopharmaceuticals, and regenerative medicine.
North America engagement: AusBiotech met with its industry association peers in Canada and the US to discuss opportunities to work more closely in the future, touching on areas from workforce development through to opportunities for greater patient voice in product development.

Maximising opportunities while in Boston, AusBiotech also worked with its members Moderna and Sanofi, and joined the Australian Trade and Investment Commission (Austrade), Department of Industry, Science and Resources, Global Vic, and Canadian officials for site visits to Moderna and Sanofi’s R&D and manufacturing facilities — underscoring the positive ripple impacts of global organisation investments in the Australian ecosystem.

Comments from AusBiotech CEO, Rebekah Cassidy

"The urgency for action was loud and clear on the ground at BIO25. Advancing onshore biotech capability at speed is a priority for all our major peer markets. The time is now for Australia to heed the call with similar urgency.

“Australia’s life sciences sector has the potential to play an important role in a changing global market and AusBiotech is proud to be the super-connector working with our partners across government to link local strengths to global opportunity. We are committed to growing Australia's role in the global biotech ecosystem.

“At AusBiotech, we celebrate our members every day, but events like BIO25 offer a powerful platform to elevate their work, forge new partnerships, and reinforce Australia’s value as a trusted innovation partner.

“Congratulations to everyone who supported Team Australia on the ground at BIO25 including New South Wales, Victoria, Queensland, Western Australia and South Australia, the Department of Industry, Science and Resources, Austrade, CSIRO and MTP Connect.”

-ENDS-

Media inquiries

Emma Boscheinen, AusBiotech Director of Communications / +61 437 075 209 / eboscheinen@ausbiotech.org

About AusBiotech

AusBiotech attends Regulatory and Technical Consultative Forum for medical devices

Wed, 11 Jun 2025 00:00:00 +1000

AusBiotech and members of our MedTech Regulatory Affairs Advisory Group were pleased to participate in the RegTech Forum held at the Therapeutic Goods Administration (TGA) in Canberra on Thursday, 29 May.

The Regulatory and Technical Consultative Forum for medical devices, or RegTech Forum, is a quarterly meeting that provides members the opportunity to discuss issues relating to the regulation of medical devices or technical issues of concern, both current and emerging, and identify options to improve current regulatory practices and compliance. It is an excellent opportunity for AusBiotech to engage directly with the TGA and raise topical issues on behalf of members.

At the RegTech Forum on 29 May the TGA officially launched the Unique Device Identification (UDI) system and database. The launch followed amendments to the Medical Device Regulations by the Government on 24 March 2025 to establish Australia’s UDI system for identifying and tracking medical devices. Through this reform initiative, medical device manufacturers will supply unique identifiers with their high-risk devices. These identifiers can be used in hospital systems and patient records including MyHealth Record to clearly identify the model of medical device used or implanted. As part of this initiative, the TGA has released the Australian UDI database, a public database of device information that will allow patients to access the relevant information about their device. More information is available on the UDI Hub or contact the UDI Support Team at UDI@health.gov.au to join the mailing list.

Other key topics discussed at the RegTech Forum included:

The 2025 MDSAP Forum is being held in Amsterdam from 16-20 June. It will be attended by the five Regulatory Authority members, all Auditing Organisations, the Official Observers (WHO, EU Commission, UK MHRA and Singapore HSA), the MDSAP Affiliate member regulatory authorities, EU notified bodies, EU competent authorities, industry associations, and manufacturers. If any members are interested in virtual attendance at the Forum, please get in touch via MDSAPForum25RSVP@health.gov.au

An update of fees and charges – noting that a proposed 9% reduction in scheduled fees for design examinations related to both medical devices and IVDs has been recommended to the Minister. More public consultation on the fee reduction policy will occur in the coming months.

The TGA is reviewing their cost recovery arrangements for quality management system audits to increase pre-payment before they travel or do the audit, so they can reduce the costs of debt recovery of unpaid fees and charges. They will engage and consult about this work with RegTech members, noting that some of this may require regulation changes to implement fully.

To stay across Regtech forum updates, keep an eye out for future THRIVE editions.

AusBiotech and Austrade launch partnership to accelerate global expansion of Australia’s life sciences industry

Wed, 04 Jun 2025 00:00:00 +1000

AusBiotech, Australia’s peak body for the life sciences sector, and the Australian Government's Trade and Investment Commission (Austrade) are partnering to accelerate the global growth and expansion of Australian life science companies.

The partnership will deliver a new National TradeStart Adviser role, to support Australian biotechnology, pharmaceutical, medical technology, and digital health companies to scale and grow internationally. The National TradeStart Adviser, embedded within AusBiotech’s team, will work directly with life sciences companies across Australia, connecting them with Austrade services and programs globally.

AusBiotech is the first life sciences peak body to join with Austrade as a national partner in delivering TradeStart, joining other industry peak bodies in the program. It marks a significant step forward in AusBiotech’s mission to grow the Australian life science sector and support members in future-focused ways.

Comments from AusBiotech CEO Rebekah Cassidy

"We are delighted to be partnering with Austrade, to have a dedicated TradeStart Adviser to work with Australia’s life science innovators. It will ensure companies across our wider ecosystem have the right support, intelligence, and access to thrive globally.”

“Australia’s life sciences companies are innovating at pace, but navigating global markets can be complex. This new role will help to unlock growth and global pathways by embedding a new and sophisticated level of strategic support directly into our ecosystem.

“With the life sciences sector playing an increasingly strategic role in Australia’s economy, it’s an important proof point in how industry and government can work together to match that potential with the right structures of support.”

Comments from Austrade CEO Dr Paul Grimes PSM

Austrade CEO Dr Paul Grimes welcomed the partnership and the establishment of a new national TradeStart role.

“This partnership reinforces our commitment to supporting Australian life sciences companies as they scale their businesses globally. By working together with AusBiotech and Australia’s scaleups, we can create even more opportunities for the sector to expand and thrive.”

Applications for this new National TradeStart Adviser role are now open. Learn more about the role here: https://www.seek.com.au/job/84677972?tracking=SHR-WEB-SharedJob-anz-1

-ENDS-

Media inquiries

Rose Petrass, AusBiotech Communications Manager / 0457 867 780 / rpetrass@ausbiotech.org

About AusBiotech

About Austrade

The Australian Trade and Investment Commission (Austrade) is the Australian Government's trade, investment and education promotion agency, also responsible for tourism policy, programs and research. Austrade helps grow Australia’s prosperity by delivering quality trade and investment services to businesses, accelerates growth in Australia’s tourism sector and promotes Australia’s education to the world.

AusBiotech welcomes announcement of Federal Shadow Ministry and encourages bipartisan support for Australia’s life sciences sector

Mon, 02 Jun 2025 00:00:00 +1000

AusBiotech welcomes the announcement of Australia’s federal Shadow Ministry and looks forward to the continued opportunity for engagement with the newly appointed team, as part of its ongoing commitment to supporting a strong, innovative life sciences sector.

As Australia’s peak life sciences body, AusBiotech recognises the important role of the Shadow Ministry in contributing to national policy discussions and shaping long-term thinking on key industries, including life sciences.

AusBiotech extends its congratulations to the Leader of the Opposition, the Hon Sussan Ley MP, and to the newly announced Shadow Ministers, including:

Senator the Hon Anne Ruston, Deputy Leader of the Opposition in the Senate, Shadow Minister for Health and Aged Care, Shadow Minister for Disability and the National Disability Insurance Scheme, Shadow Minister for Sport, Senator for South Australia
The Hon Alex Hawke MP, Manager of Opposition Business in the House, Shadow Minister for Industry and Innovation, Member for Mitchell
The Hon Kevin Hogan MP, Deputy Leader of the National Party, Deputy Manager of Opposition Business in the House, Shadow Minister for Trade, Investment and Tourism, Nationals Member for Page
The Hon Melissa Price MP, Shadow Minister for Science, Shadow Minister for Cyber Security, Member for Durack

The announcement of the new Shadow Ministry provides an opportunity to continue bipartisan conversations that support Australia’s growing life sciences ecosystem — spanning biotechnology, pharmaceuticals, medical technology, and related industries.

Comments from AusBiotech CEO Rebekah Cassidy:

“With more than 2,900 life sciences organisations across the country, employing one in every 60 Australians, the life sciences sector is a significant contributor to both national health and economic outcomes.

“We believe that strong collaboration across all sides of politics is key to supporting a sustainable, competitive life sciences sector. We welcome the opportunity to continue sharing insights from across the sector with the Shadow Ministry as part of our policy work.”

AusBiotech’s key areas for engagement include:

A whole-of-government National Life Sciences Strategy to guide long-term policy, investment, and coordination.
The establishment of an Australian Life Sciences Council, bringing together government and industry to shape a shared vision and address sector-wide challenges.
Recognition of life sciences as a priority industry for national growth, innovation, and resilience.
Greater investment in data and evidence-based policy to support smarter decision-making and drive measurable outcomes.

“Australia has world-class strengths in research, clinical trials, and advanced manufacturing,” said Ms Cassidy. “With the right policy settings and partnerships, there is a significant opportunity to expand the sector’s contribution both locally and globally.”

AusBiotech looks forward to continued engagement with the Shadow Ministry, government, and broader stakeholders to support the long-term growth of Australia’s life sciences industry.

-ENDS -

Media inquiries

Rose Mary Petrass, AusBiotech Communications Advisor / +61 0457 867 780 / rpetrass@ausbiotech.org

About AusBiotech

From challenge to opportunity: Sector leaders chart the future of Australian medtech

Wed, 28 May 2025 00:00:00 +1000

At AusBiotech’s flagship medical technology event, AusMedtech 2025, nearly 500 delegates gathered in Sydney to explore the future of healthcare and hear directly from some of Australia’s most influential leaders.

In a packed theatre at the International Convention Centre, the session ‘A View from the Top: Shaping the Future of Medtech Through Innovation’ brought bold ideas and real-world insights to the fore.

Moderated by ANDHealth Chair Gavin Fox-Smith, the panel featured Telstra Health Managing Director Elizabeth Koff, Vitrafy Life Sciences Managing Director Kate Munnings, Medicines Australia Chair Sue MacLeman, and L.E.K. Consulting Managing Partner in ANZ Stephanie Newey.

Together, they painted a frank but forward-looking picture of the sector’s challenges and opportunities — from pressured healthcare costs and systemic fragmentation to the promise of digitisation, partnerships, and patient-centric innovation.

This high-profile panel exemplified AusBiotech’s commitment to connecting industry leaders, fostering innovation, and advancing Australia’s position as a global medtech hub.

This session is one of many in AusBiotech’s year-round program of national and international forums that bring the ecosystem together to drive commercialisation, collaboration, and impact across the sector.

Five forces shaping the future

Stephanie Newey opened the discussion with five core themes shaping healthcare innovation: sustainability, digitalisation and artificial intelligence, shifting care models, global pressures, and the enabling role of investment and partnerships.

One of the most pressing issues is healthcare’s “longer-term sustainability,” with Australia grappling with rising costs and an ageing population, similar to other OECD countries. Newey urged medtech innovators to focus not only on technical breakthroughs but on delivering “better outcomes for less — or better outcomes for the same cost”.

AI, precision medicine, and remote monitoring technologies are among the areas creating seismic shifts, but these also raise challenges around regulation, data access, and integration. “It may be that there’s a device that can help provide information,” Stephanie Newey noted, “but if it means it’s another system [clinicians] have to log into… they’re just not going to use it”.

The system is cracking — so why aren’t we acting?

Elizabeth Koff AM issued a stark warning against complacency in the face of increasing health system strain. “The same old narrative keeps coming out about the pressure that we’re under — hospital ramping, surgical waitlists,” she said, and despite ranking first in a recent Commonwealth Fund comparison of international health systems, “there are real health system pressures… and we must be brave enough to undertake reform”.

She stressed the need to move beyond siloed point solutions and enable scalable innovations that integrate care across varied healthcare settings. “If it’s too narrow, you’re never going to get the capacity and ability for widespread adoption,” she said.

Innovation must reduce costs — not just impress investors

Kate Munnings, now leading biotech start-up Vitrafy Life Sciences after years in large healthcare organisations, warned that health innovation often falls into a trap of being cost additive. “The challenge for the medtech sector is: how do you actually innovate to bring costs down as well as improve outcomes?” she said. But Munnings also cautioned about the commercialisation journey: “Surviving raising capital, surviving the regulatory pathway… the challenges are huge”.

Policy, culture, and capital: Barriers and levers

Sue MacLeman offered a candid assessment of the geopolitical and regulatory environment that could shape access and trade in the years ahead.

We need to see progress on healthcare reforms and ensure we have fit for purpose regulation for approval and market access of innovative medicines and medical products, she said, calling for the sector to push for recognition of the full value of innovation. Companies in the space contribute to research translation, clinical trials and education, she said, and have an eye to the megatrends and what best practise globally looks like.

When asked what lever companies can pull to enable policy change, panellists were unanimous: strong clinical data, patient advocacy, clinician champions, and economic modelling are all essential — but none alone is sufficient.

Enablers for impact

In closing, panellists each named a single enabler they believe will unlock Australia’s medtech potential.

For Stephanie Newey, it was partnerships — both domestic and global. “We’re a small ecosystem… so where can we partner internationally to get up the curve quicker?”

Elizabeth Koff called for ongoing support for research and innovation, coupled with “a willingness to accept failure” as part of the process.

Kate Munnings advocated for cross-disciplinary collaboration. “We’ve got to look outside of healthcare… engineering and other disciplines can bring a lot to health”.

Sue MacLeman zeroed in on investment: “Good technology backed by good teams with good IP are being invested in — but we must show clear return on investment to attract more capital”.

Bold action is needed

As Gavin Fox-Smith reflected in closing, despite the system’s complexity, Australia remains one of the most robust healthcare environments in the world. But achieving lasting impact will depend on bold leadership, scalable innovation, and a united sector committed to challenging old assumptions and advancing better care.

Unlocking Australia’s life sciences potential: Strategic Examination of R&D

Wed, 28 May 2025 00:00:00 +1000

The Australian Government's Strategic Examination of Australia's Research and Development (SERD) system is set help grow core science and innovation capability.

A strong R&D ecosystem boosts national productivity, security, and wellbeing by increasing the value of research across sectors – including the life sciences.

As the peak body for Australia’s life sciences sector, AusBiotech is calling for bold, coordinated reform to convert world-class research into real-world impact — while recognising the sector is already delivering for the nation’s future and economy.

This week, AusBiotech hosted a roundtable to support the Australian Government's Strategic Examination of Research and Development (SERD) consultation process. The online event brought together members from across the life sciences ecosystem to engage directly with SERD Chair Robyn Denholm, panel members Winthrop Professor Fiona Wood AO and Emeritus Professor Ian Chubb AC, and AusBiotech CEO Rebekah Cassidy.

The session reaffirmed our commitment to meaningful policy advocacy directly with decision makers and leaders, ensuring our members’ voices remain central to shaping a national R&D framework that drives innovation, commercialisation, and real impact.

Strategic focus on sovereignty capability

Globally, life sciences are increasingly recognised as a pillar of national sovereignty and economic diversification. The roundtable was a critical opportunity to bring strategic focus to life sciences as Australia looks at its economy, productivity and investment in critical industries for the future.

“Our global environment is evolving rapidly,” said Rebekah. “There has never been a more important time to act on Australia's R&D in life sciences.

"Now is the time for bold steps toward unlocking Australia’s innovation potential within our R&D ecosystem. We must supercharge our incredible world-class medical research, ensuring it translates into life-changing commercialised innovations," said Rebekah.

Addressing Australia's persistent ‘valley of death’

A strong consensus emerged during the virtual roundtable: while Australia’s research is world-class, fragmentation hinders its development and commercialisation of innovation. The conversation addressed inconsistent policy settings, siloed departmental initiatives, and unclear national priorities as barriers.

The call was clear — move beyond incremental reform. A system-wide reset is needed to reduce duplication, align policies across the R&D lifecycle, and improve decision-making.

The well-known and persistent ‘valley of death’ was addressed — the gap between research and viable commercial products. Despite producing world-class science, many life science companies stall due to funding gaps, regulatory delays, and unclear procurement pathways on home soil. The 'development' in R&D is not keeping pace with our peer OECD countries.

There was a shared view by several members that success in life sciences should be measured not only by research output, but by the ability to deliver technologies and therapies to patients. Many participants emphasised the importance of a national approach that supports the entire innovation pipeline.

Structural barriers for startups and Small and Medium-sized Enterprises (SMEs) were also highlighted. Delays in regulatory approvals, limited procurement access, and gaps in strategic capital — inhibit growth.

Australia’s life sciences sector is rich with innovation. However, challenges such as limited late-stage capital, constrained valuations, complex commercialisation pathways, and global competition for talent continue to make it difficult for companies to scale and commercialise locally — often pushing them to seek offshore opportunities.

While Australia is a global leader in scientific research, ranking top ten on the Global Innovation Index, we have fallen to 30th for research outputs.

The data released reveals a stark decline in R&D over the past 15 years: local investment in R&D is now only 1.66% of GDP, well below the OECD average of 2.7%.

Whole-of-government strategy needed

Current R&D policy is spread across departments and jurisdictions, making it difficult for businesses to scale. We are calling for a consolidated, whole-of-government strategy, supported by a national Life Sciences Council, to coordinate and guide long-term growth and productivity.

Such a strategy would provide the certainty needed for companies and investors to commit to Australian-based development.

Driving momentum

AusBiotech is committed to advancing these priorities with government and stakeholders.

The roundtable confirmed that the sector is contributing significantly to the economy and is ready to help shape Australia’s innovation future. A coordinated, whole-of-government approach — with industry at the table — is essential to unlocking the sector’s full potential.

Please engage with our Policy team if you have contributions to the review. policy@ausbiotech.org

Strengthening UK-Australia collaboration through BioBridge

Wed, 14 May 2025 00:00:00 +1000

AusBiotech is pleased to support the next United Kingdom-Australia BioBridge event, taking place on 26 May 2025, which will bring together senior leaders from across the biotechnology, healthcare, and life sciences sectors.

Hosted by the British Consulate-General, the member-only lunch reception will welcome special guest, the UK’s Medicines Discovery Catapult Chief Executive Officer Chris Molloy, Chief, alongside industry and policy leaders.

The proposed BioBridge initiative is a strategic collaboration that connects the UK and Australian life sciences ecosystems to foster innovation, commercial partnerships, and trade growth. The event will focus on sharing best practices for accelerating high-value biotech services, identifying opportunities for cross-border collaboration, and supporting bilateral growth in R&D and advanced manufacturing.

The partnership builds on the shared ambition of both countries to lead in life sciences innovation and drive global health outcomes. Events like this create valuable pathways for SMEs, researchers, and investors to explore new markets and strengthen international networks.

AusBiotech proudly champions cross-border connections that grow Australia’s life sciences sector and amplify our global impact.

To express interest in attending, please reach out to policy@ausbiotech.org by COB Thursday 15 May.

AusBiotech welcomes Albanese Government’s new ministry and looks forward to strengthening life sciences' partnership and impact

Tue, 13 May 2025 00:00:00 +1000

(13 May 2025): AusBiotech welcomes the Albanese Government's announcement of its new cabinet and federal ministry. As the national peak body for Australia’s life sciences sector, AusBiotech congratulates all returning and newly appointed Ministers. We look forward to working in close partnership to strengthen Australia’s innovation-driven economy and advance life sciences as a national priority.

Comments from AusBiotech CEO Rebekah Cassidy:

"We welcome the Prime Minister's announcement of his Ministry. This new ministry make-up presents an opportunity for renewed focus and bold leadership in unlocking the full potential of Australia’s life sciences sector, which is a critical national asset for productivity, health security and improved health outcomes for all Australians."

"We congratulate the Hon Mark Butler MP on his reappointment as Minister for Health and Ageing. Minister Butler is an advocate for a whole-pipeline approach for our sector – from discovery to start-up, clinical trials, manufacturing, export, access and reimbursement. We welcome his ongoing support for Australia’s life sciences sector and look forward to continuing our collaboration with him and his office to strengthen the nation’s health innovation ecosystem, from bench to bedside.

"We welcome the appointment of Senator the Hon Tim Ayres as Minister for Industry and Innovation, and Minister for Science, and Dr Andrew Charlton MP, as Assistant Minister for Science, Technology and the Digital Economy.

"As Australian industry navigates a rapidly evolving global context, we welcome Minister Ayres’ and Dr Chalton's depth of experience from across government and industry. We look forward to working closely with them to address immediate challenges and deliver meaningful outcomes for the life sciences sector, as well as advocate for its urgent prioritisation under the Future Made in Australia Act."

With more than 2,900 life sciences organisations across Australia, employing one in every 60 Australians, the sector is a significant contributor to national prosperity, global competitiveness, and the health of all Australians.

Welcoming new ministers in key portfolios

AusBiotech formally welcomes the appointment of Ministers across key portfolios, including:

Senator the Hon Tim Ayres, appointed as Minister for Industry and Innovation, and Minister for Science.
Dr Andrew Charlton MP, appointed as Cabinet Secretary and Assistant Minister for Science, Technology and the Digital Economy.

New appointments in the Health and Ageing Portfolio, Sam Rae MP as Minister for Aged Care and Seniors; and Rebecca White MP, as Assistant Minister for Health and Aged Care, Assistant Minister for Indigenous Health, and Assistant Minister for Women.

AusBiotech also looks forward to ongoing collaboration with:

The Hon Mark Butler MP, reappointed as Minister for Health and Ageing, with the addition of Minister for Disability and the National Disability Insurance Scheme (NDIS).
The Hon Emma McBride MP, reappointed as Assistant Minister for Mental Health and Suicide Prevention, and Assistant Minister for Rural and Regional Health.
The Hon Don Farrell MP, reappointed as Minister for Trade and Tourism, whose role is crucial in supporting Australia’s life sciences opportunities and industry growth within a globally dynamic context.
The Hon Jason Clare MP, reappointed as Minister for Education.

AusBiotech extends its sincere thanks to the outgoing Minister for Industry and Science, the Hon Ed Husic MP, and his office, who led the establishment of the Strategic Examination of Research and Development and championed early-stage innovators through the Industry Growth Program, of which AusBiotech is an Industry Partner Organisation.

We also acknowledge the Hon Ged Kearney MP, former Assistant Minister for Health and Aged Care, and thank her for her service and support of the sector. We also congratulate her on her new role as Assistant Minister for Social Services and Assistant Minister for the Prevention of Family Violence.

A whole-of-government approach: A national priority

“In a rapidly evolving global landscape — marked by geopolitical shifts, supply chain challenges, an ageing population, and rising chronic disease burdens — prioritising Australia's world-leading biotechnology and medical technology industry has never been more urgent,” said Cassidy.

“To unlock the full potential of Australia’s life sciences industry, a whole-of-government approach is essential. This includes the establishment of a National Life Sciences Council to serve as a strategic partnership between industry and government, ensuring cohesive, long-term policy and investment.”

AusBiotech looks forward to continued dialogue with the Albanese Government, as we work together to shape a strong and globally competitive future for Australian life sciences. Together, we can ensure the sector continues to deliver for Australia’s health, economic future, and security.

-ENDS-

Media inquiries

Emma Boscheinen, AusBiotech Director of Communications / +61 437 075 209 / eboscheinen@ausbiotech.org

About AusBiotech

AusMedtech 2025: Innovation to Impact — Australia’s leading medtech conference is underway in Sydney

Wed, 07 May 2025 00:00:00 +1000

AusBiotech, Australia’s peak body for life sciences, welcomes the start of AusMedtech 2025, which starts today in Sydney, New South Wales (7–8 May 2025).

AusMedtech, Australia’s leading medical technology conference, brings together leaders from across the country’s thriving medtech ecosystem. The annual event attracts hundreds of delegates, creating dialogue between industry, government, investors, and academia on the key issues shaping the future of medtech.

Under the 2025 theme Innovation to Impact, this year’s conference will highlight medtech’s vital role in addressing healthcare needs, improving access to life-saving technologies, and strengthening Australia’s capabilities at a time of unprecedented global change.

The Australia’s medtech sector continues to be a critical driver of growth within the nation’s life sciences ecosystem. With more than 900 thriving companies, the sector is a significant contributor to Australia’s innovation, economy, and global reputation in life sciences.

Comments from AusBiotech CEO Rebekah Cassidy:

“AusMedtech convenes the industry to drive critical conversations on the opportunities and challenges shaping the future of Australia’s innovative medtech sector, from development and manufacturing to regulatory and procurement,” AusBiotech CEO Rebekah Cassidy said.

"This event brings the sector together in a powerful way. Our program sparks critical dialogue between leaders across the ecosystem, at a time when collaboration has never been more essential.

"The world is rapidly changing — with issues like shifting geopolitics, supply chain disruptions, and rising health demands — so it is essential that Australia’s medtech sector remains unified, resilient, and future-focused.

"Medtech advances healthcare, strengthens Australia’s health security, and supports economic growth.

“AusMedtech 2025 is just one of the ways in which AusBiotech works to give Australia’s medtech sector a collective voice to help shape its future.”

Comments from the Minister for Medical Research, the Hon David Harris MP:

The Hon David Harris MP, NSW Minister for Medical Research, will address attendees. This underscores the NSW Government’s strong commitment to fostering innovation, economic development, and sector growth.

“The medical technology industry in NSW is the largest in Australia and we are proud to host this year’s AusMedtech conference in our state,” Harris said.

“AusMedtech brings together Australia’s best in medical technology to help shape the future of healthcare, not just in New South Wales but nationally and internationally.

“Conferences like this aren’t simply about the next new idea, device or technology, it’s also about how those innovations are going to change the lives of everyday people and the clinicians who support them.”

The Hon Anoulack Chanthivong MP, NSW Minister for Industry and Trade and Minister for Innovation, Science and Technology, will also join the conference on Thursday 8 May.

About AusMedtech

AusMedtech is one of AusBiotech's annual portfolio events, preceded by AusBiotech Medtech Invest held on 6 May, followed by AusBiotech Invest and AusBiotech International Conference in October, marking Australia's biggest week in biotech.

AusBiotech thanks our host state partner, the NSW Government, and sponsors for supporting this flagship event.

For full program details and speaker information, visit: www.ausmedtech.com.au

-ENDS-

Media inquiries: Emma Boscheinen, AusBiotech Director of Communications / +61 437 075 209 / eboscheinen@ausbiotech.org

About AusBiotech

With our unrivalled membership breadth and national convening power, we drive the advancement of life sciences and our members’ success in translating clinical research and technologies into real-world solutions while fostering knowledge sharing and collaboration to help life sciences innovators thrive.

Australia’s premier medtech investment event unites investors and innovators to boost sector growth

Tue, 06 May 2025 00:00:00 +1000

6 May 2025
AusBiotech's Medtech Invest 2025, Australia’s premier medical technology investment conference, opens today in Sydney — kicking off a landmark week fostering meaningful connections, advancing collaboration, and driving growth in devices and diagnostics.
Medtech Invest sets the stage for the country’s biggest week in medtech, with the main AusMedtech 2025 conference launching tomorrow, Wednesday 7 May.
Against a backdrop of a rapidly evolving global landscape marked by geopolitical and trade shifts, supply chain challenges, ageing populations, chronic disease and more, Medtech Invest 2025 brings together sector leaders to advance breakthroughs, connect capital with opportunity, and empower the medtech sector to deliver real-world health solutions.
Rebekah Cassidy, CEO of AusBiotech, said the investor-focused event will help accelerate the delivery of real-world, home growth, health solutions.
“With over 900 medtech companies operating in Australia, it’s clear the sector is thriving — but growth doesn’t happen without capital and investment. We’re proud to build on our strong legacy and commitment to investment, to connect innovators with the capital and connections they need to scale and succeed.”
Today's program offers a deep dive into the evolving medtech investment landscape — exploring capital flows, global market trends, and the critical role of intellectual property in driving investor confidence.
The conference brings together a diverse delegation of Australian and international investors, medtech companies, venture capitalists, private equity leaders, brokers, analysts, executives, and global thought leaders.
Medtech program
The half-day event features leading voices in medtech investment, including Dr Nicholas Pachuda from Peptilogics, Neovate Capital and Precision Life Science Partners, who brings global expertise in scaling breakthrough technologies. Kylie Frazer of Flying Fox Ventures will offer sharp insights into early-stage investment, while Elyse Shapiro of Canaccord Genuity will provide valuable market intelligence across biotechnology and diagnostics.
Medtech Invest will also feature a panel session exploring innovation, IP and commercialisation, with Gorjana Mitic, Business Development and Licensing Manager at Children’s Cancer Institute, chairing the discussion. She will be joined by Helen Mutimer, Head of IP Advisory at FB Rice; Dr Simon Puttick, Chief Scientific Officer at Advancell; and Prashanth Rajan, Associate at Brandon Capital.
A total of 11 private and ASX-listed medtech companies will present throughout the day, including ten early- to late-stage ventures delivering focused ten-minute pitch presentations. Investors will gain a view of emerging opportunities across diagnostics and devices. Presenting companies include: Convergence, CYBAN, EM Vision (ASX:EMV), Examin Holdings, Gelomics, Haemograph, HiFi-Ortho, Integrant, Kardiomics, Navi, and Venstra Medical. Read the full investee list here.
“AusBiotech's Invest event portfolio is another example of how we work to foster home grown medical innovation capability that’s good for the future health and wealth of our nation. Our investment events are about supporting innovators, forging partnerships that support commercial success,” says Rebekah.
“We are proud to champion Australia’s medtech ingenuity and ensure it gains the attention and investment it deserves.”
Medtech Invest builds on the success of AusBiotech Invest a flagship investment event, and its well-established investment attraction programme that for almost 16 years has helped empower Australian companies to be competitive on a global scale, while connecting Australian life sciences companies with international capital markets, and risk-tolerant investors with investment-seeking life science companies.
Medtech Invest signals the start of an exciting week in medtech, with AusMedtech 2025, Australia’s leading medtech conference, running in Melbourne from 7–8 May 2025.
For full program details and speaker information, visit: www.ausmedtech.com.au

-ENDS-
Media inquiries
Rose Mary Petrass, AusBiotech Communications Advisor / +61 457 867 780 / rpetrass@ausbiotech.org

About AusBiotech
AusBiotech is Australia’s life sciences organisation, working on behalf of more than 3,000 members for more than 39 years, to provide advocacy and services that promote the global growth of the Australian life sciences industry.
With our unrivalled membership breadth and national convening power, we drive the advancement of life sciences and our members’ success in translating clinical research and technologies into real-world solutions while fostering knowledge sharing and collaboration to help life sciences innovators thrive.

AusBiotech and ANDHealth partner to foster sector connection in digital health

Tue, 06 May 2025 00:00:00 +1000

AusBiotech, Australia’s leading national industry body representing more than 3,000 life sciences members, has signed a partnership agreement with ANDHealth, the country’s premier provider of commercialisation support and services for the rapidly expanding digital and connected health sector. This milestone agreement aims to enhance collaboration on mutual interests and support ongoing industry innovation.

Rebekah Cassidy, CEO of AusBiotech, commented:

“This agreement between AusBiotech and ANDHealth represents a significant step forward in our commitment to supporting digital innovation, technology development and commercialisation within the life sciences sector. By collaborating, we can unlock new opportunities for innovation and support Australian biotech and medtech companies seeking to thrive on the global stage.

"The rapid pace of digital and technological advancements demands that our homegrown life sciences companies stay at the forefront of the digital revolution. This partnership with ANDHealth signals our commitment to prioritising knowledge-sharing for the benefit of our members and the entire sector,”

CEO and Managing Director ANDHealth Bronwyn Le Grice, said:

“Digital and connected health is the fastest growing field in health and life science technology, outpacing the more mature medical devices and pharmaceutical sectors. It makes this a timely opportunity for ANDHealth and AusBiotech to work closer together to maximise the health and economic benefits from this emerging sector possible for all Australians.

“The future of healthcare is digital and that is spreading across all streams of health and life sciences. This partnership will show the benefits of collaboration across different sectors to continue to position Australia as a leading research, innovation and commercialisation player on the global health and medical technology stage.”

About AusBiotech

About AndHealth

ANDHealth is Australia’s only organisation specialised in the commercialisation of evidence-based digital health technologies. ANDHealth’s globally unique cooperative commercialisation model has led to significant growth within Australia’s nascent digital health sector and continues to be a driving force for the development of Australia’s capability in evidence-based, regulated, digital health technologies.

-ENDS-

Media enquiries: Emma Boscheinen, Director of Communications, AusBiotech,
eboscheinen@ausbiotech.org / M: +61 (0) 437 075 20

Media enquiries James Howe, General Manager – Corporate Affairs, ANDHealth james@andhealth.com.au / M: +61 (0) 488 065 0658

AusBiotech welcomes the re-election of the Albanese Government and calls for a renewed national focus on life sciences

Sun, 04 May 2025 00:00:00 +1000

AusBiotech welcomes the re-election of the Albanese Government and the opportunity to continue working in partnership to advance a productive, innovation-driven economy while deepening a whole of government focus on Australia’s life sciences sector at this critical juncture.

As the national peak body for life sciences, AusBiotech reaffirms its commitment to advancing the sector in partnership with the government. As a sector that has the potential to deliver improved health outcomes, greater economic prosperity and enhanced health security for Australia, now is the time to prioritise life sciences.

AusBiotech's CEO, Rebekah Cassidy, extended her congratulations to the Prime Minister, Anthony Albanese, on his decisive victory.

“The Albanese Government’s re-election presents a renewed opportunity to strengthen Australia's life sciences sector and deepen our collaborative efforts,” she said.

With more than 2,900 life science organisations across the country, employing 1 in every 60 Australians, the sector is a vital national asset. It contributes to the health of all Australians by translating world-leading research into life-changing health innovations.

"Now is the time to address the long held and stubborn challenges that have held Australia’s life sciences sector back. We need bold leadership and whole of government prioritisation, as we have seen in peer global markets,” said Rebekah.

"In a rapidly evolving global landscape, marked by geopolitical and trade shifts, supply chain challenges, ageing populations, chronic disease and more, the need to prioritise Australia's world-leading biotechnology and medical technology industry has never been more pressing.

"We need to continue building, scaling, and retaining our globally competitive biotechnology and medical technology capability as a national asset.

"To unlock the full potential of Australia’s life sciences industry, a whole-of-government approach is essential, starting with the establishment of a National Life Sciences Council as a strategic partnership between industry and government.

"This partnership is critical not only to address the challenges of a rapidly evolving global trade environment but also to drive a cohesive, long-term national strategy for the sector.”

AusBiotech is calling on the re-elected Australian Government to:

A whole-of-government National Life Sciences Strategy to guide long-term policy, investment, and coordination.
The establishment of an Australian Life Sciences Council, bringing together government and industry to shape a shared vision and address sector-wide challenges.
Recognition of life sciences as a priority industry for national growth, innovation, and resilience.
Greater investment in data and evidence-based policy to support smarter decision-making and drive measurable outcomes.

“We have a unique opportunity to continue to nurture and build a globally competitive life sciences sector by harnessing our strengths in medical research, clinical trials, and advanced manufacturing — and ensuring that more innovations are developed and commercialised onshore in Australia.”

AusBiotech looks forward to continued dialogue with the Albanese Government as we work together to shape a strong future for Australian life sciences.

-ENDS -

Media inquiries

Emma Boscheinen, AusBiotech Director of Communications / +61 437 075 209 / eboscheinen@ausbiotech.org

AusBiotech welcomes new members in the first quarter

Wed, 30 Apr 2025 00:00:00 +1000

In the first quarter of this year, AusBiotech proudly welcomed a significant number of new members.

We are thrilled to introduce the following new members:

Aurora Biosynthetics Pty Ltd
Emball'iso
Pulse Economics Consulting
BioNTech Australia Pty Ltd
AdvanCell Pty Limited
Adherium Limited
Facio BioTherapies Pty Ltd
Sartorius Australia Pty Ltd
New England Biolabs (Australia)
Enimera RegsPlus Pty Ltd
Miltenyi Biotec Australia Pty Ltd
Proclinical
Cicada Innovations
Prove Clinical Laboratories Pty Ltd
Celleo Biotech
Vertex Pharmaceuticals (Australia) Pty Limited
Mark Wainwright Analytical Centre

Find out more about AusBiotech’s member benefits here.

AusBiotech has made a submission to Australia’s R&D system review

Wed, 30 Apr 2025 00:00:00 +1000

In the 2024-25 Federal Budget, the Australian Department of Industry, Science and Resources announced a strategic examination of Australia’s research and development (R&D) policies.

The aim of the review is to strengthen R&D alignment with government priorities and improve innovation and R&D outcomes.

Since the announcement, the importance of having a high-functioning R&D system and strong sovereign capabilities has only grown, driven by the evolving geopolitical context and shifting global trade landscape.

The strategic examination is being led by an independent panel, chaired by experienced industry executive and current Tesla Chair Robyn Denholm. The panel also includes Professor Ian Chubb AC, Professor Fiona Wood AO, and Dr Kate Cornick. Their mandate is to:

Get more value from investment in research across universities, industry and government.
Harness and grow business investment in R&D.
Leverage Australia’s scientific strengths to help address national priorities and foster new industries.

In response to a discussion paper released in early April, AusBiotech made a submission advocating for a whole-of-government approach to R&D for life sciences. We emphasised that Australia’s life sciences industry should be recognised as essential to the country’s productivity, health security, and the health and wellbeing of all Australians.

To unlock the full potential of Australia’s health and life sciences capability, our submission outlined the need for a long-term, whole of government, bi-partisan national strategy for the sector. We highlighted the importance of playing to Australia's national strengths and competitive advantages, recognising that resources are finite and strategic focus is critical.

We also called for policy settings that incentivise the commercialisation of Australian ingenuity, foster local manufacturing, and encourage procurement of Australian-made health technologies.

As the independent panel continues its work, AusBiotech is engaging in the process in a number of ways to ensure that the future R&D system supports a thriving, resilient life sciences sector. We will keep our members up to date.

Read our full submission here.

Recce Phase 2 trial receives additional approval for treating diabetic patients with topical gel

Tue, 22 Apr 2025 00:00:00 +1000

Telix says IPAX-Linz study shows promising efficacy for glioma therapy candidate

Thu, 17 Apr 2025 00:00:00 +1000

Prescient's PTX-100 receives US FDA Fast Track Designation

Thu, 17 Apr 2025 00:00:00 +1000

Carina Biotech completes $5 million capital raise

Tue, 15 Apr 2025 00:00:00 +1000

Noxopharm announces SOF-SKN successfully passes final pre-trial study

Tue, 15 Apr 2025 00:00:00 +1000

Neuren confirms primary endpoints for Phase 3 Trial of NNZ-2591 in PMS

Tue, 15 Apr 2025 00:00:00 +1000

WEHI says study puts first long COVID treatment on horizon

Thu, 10 Apr 2025 00:00:00 +1000

Prescient Therapeutics announces the appointment of new non-executive director

Thu, 10 Apr 2025 00:00:00 +1000

Recce announces placement and entitlement offer to support late-stage trial.

Thu, 10 Apr 2025 00:00:00 +1000

Opthea updates investors, confirming significant staff reduction

Thu, 10 Apr 2025 00:00:00 +1000

Engage for Impact: Supporting members to navigate Australia’s political environment

Tue, 08 Apr 2025 00:00:00 +1000

We recently held our Engage for Impact event both in Sydney and online, designed to support members with the insights, skills, and networks needed to navigate Australia’s political landscape and build valuable connections for their organisations.

The Speaker of the Australian House of Representatives, the Hon Milton Dick MP — as well as public affairs experts H/Advisors— provided practical advice on how to navigate the political environment, effectively engage with local members and build political advocacy for your business or organisation.

With thanks to our host partner and AusBiotech member Grant Thornton, the event was a practical platform to build relationships, share knowledge and strengthen advocacy across the ecosystem.

To complement Engage for Impact, we’re pleased to share a suite of new practical resources designed to support our members — useful insights, tools and guidance to help you navigate Australia’s political environment and engage effectively with decision-makers.

Engage for Impact “represents another example of AusBiotech’s important programs to educate, enable and add value to its members and our broader industry,” FivepHusion CEO and Managing Director Dr Christian Toouli says.

Dr Toouli found the event insightful: “This was an incredibly valuable event,” he says. “It was great to meet the Speaker and to highlight the exciting work we are doing at FivepHusion to develop next generation cancer therapeutics for Australian and international patients.

“The event emphasised that advocacy can be most impactful for policy makers by contextualising the messaging to the needs of each parliamentarian’s own electorate, whether it be through the opportunity for creation of highly skilled employment, enablement of advanced manufacturing, or the treatment of local patients in clinical trials.”

Events like these reflect AusBiotech’s ongoing commitment to supporting our members — from early-stage innovators to established leaders — to engage effectively and advocate with clarity and confidence.

It’s part of our promise to deliver member value by creating connections, enabling knowledge-sharing, and supporting the translation of research into real-world solutions.

These events showcase how we bring the life sciences community together to advance shared goals and advocate for conditions that support innovation, commercialisation, and long-term sector growth.

As Australia’s life sciences peak body, AusBiotech remains committed to elevating the sector’s voice — and ensuring you are heard where it counts.

Check out the new Engage for Impact resources in our member portal here.

Time to prioritise life sciences: AusBiotech's Federal Election asks

Tue, 08 Apr 2025 00:00:00 +1000

AusBiotech has set out clear asks to all sides of politics ahead of the 2025 Federal Election on 3 May. It’s time for urgent action to ensure Australia’s thriving life sciences sector is recognised as a strategic national priority.

Australia is home to a life sciences ecosystem of nearly 3,000 organisations spanning every part of the health innovation lifecycle.

Despite this known strength, we continue to see the economic, security and health benefits of our health innovations realised offshore.

We want Australian life science companies to remain globally competitive, while contributing to Australia’s health, economic resilience, and national security.

With the global political context rapidly evolving, it is now more important than ever to stand up an Australian Life Sciences Council and develop a whole-of-government strategy.

AusBiotech is calling for immediate action to:

Develop Australia’s first whole-of-government National Life Sciences Strategy to set clear policy priorities and eliminate duplication.
Establish an Australian Life Sciences Council — a strategic partnership between industry and government to address the implications of the rapidly evolving trade environment, as well as deliver the National Strategy.
Recognise life sciences as the next priority within whole-of-government initiatives like the Future Made in Australia Act.
Invest in data to better understand global interdependencies, drive innovation and inform effective policy-making.

AusBiotech is engaging across the political spectrum to ensure the life sciences sector is prioritised as a pillar of our future economy and national health security.

We’re proud of Australia’s track record of world-first health innovations. Now, we must ensure those breakthroughs are fully realised in Australia — creating jobs, building resilience, and driving long-term economic returns.

AusBiotech State Committee EOIs: Deadline extended

Tue, 08 Apr 2025 00:00:00 +1000

AusBiotech is pleased to announce that the deadline to submit Expressions of Interest to join our influential NSW, QLD, SA, VIC, and WA State Committees has been extended to 16 May.

Our State Committees are a vital part of AusBiotech’s national network — they provide local insights, foster strong community connections, and help ensure our advocacy and initiatives are grounded in the real-world needs of our members across Australia.

“This is a fantastic chance to help shape our advocacy, events, and state priorities — and play a pivotal role in connecting our national ecosystem,” says AusBiotech Director of State and Committee Engagement, Dr Robyn Lindner. Dr Lindner’s is a new role designed to strategically elevate and unify member voices across AusBiotech’s State Committees and Advisory Groups.

NSW Leadership Committee Chair Lis Boyce (Piper Alderman Partner), says serving on a State Committee provides an opportunity to collaborate with your peers to bring AusBiotech's national strategy to life at a state level.

“We're well supported by the AusBiotech team so that our investment of time in Committee activities is efficient,” Lis says. "There's a genuine two-way flow of information and ideas between the State committee and the national team. This enriches AusBiotech's communications with federal and state governments, elevates the voice of members and ensures that important knowledge is shared.”

SA Chair Matthew Palmer (Accelagen Chief Growth and Commercial Officer) says being part of a State Committee is a great way to help support the sector and bring the needs of the local ecosystem to the national AusBiotech program.

“It is fantastic to be part of the initiatives that are emanating from AusBiotech and to help tailor the activities in each state; whether it be celebrating local victories, providing tailored education/briefings, networking or enhancing investment into the sector,” Palmer adds.

“It also provides a conduit for linking in local and federal government initiatives with the needs of the sector and to enhance the visibility to key stakeholders on the needs and activities crucial for growth.”

WA Chair Paul Anderson (Orthocell CEO and Managing Director) echoes these sentiments, saying he’s found his involvement empowering on several fronts.

“The ability to interact at a higher level with all state members has enhanced my collaborative opportunities,” Anderson explains. “The ability to assist in helping local members better understand what it is that AusBiotech does and has to offer to the broader life sciences community has been beneficial for the organisation, its members and for me personally.

“The State Committees are well supported by AusBiotech with ideas, concerns, issues and possibilities all taken on board and put into an Australia-wide forum for discussion.”

Participation in AusBiotech’s State Committees is voluntary, with up to 12 diverse, skilled individuals per state serving two-year terms. You must be a member of AusBiotech to join our Committees or Advisory Groups.

We invite you to register your interest until 16 May (extended)— don’t miss your chance to be involved. Submit your Expression of Interest here.

It’s also important to note that AusBiotech will be refreshing our advisory groups at a later date.

Read the Terms of Reference here.

Baker says advanced omics technology will supercharge cardiovascular research

Tue, 08 Apr 2025 00:00:00 +1000

Percheron updates shareholders after disappointing clinical trial result

Thu, 03 Apr 2025 00:00:00 +1100

Opthea announces decision to discontinue wet-AMD clinical trials

Tue, 01 Apr 2025 00:00:00 +1100

AusBiotech launches Industry Growth Program cohort, welcoming biotech and medtech startups

Thu, 27 Mar 2025 00:00:00 +1100

AusBiotech, Australia’s peak life sciences body, has officially launched its activation program as an Industry Partner Organisation under the Australian Government’s Industry Growth Program. Through this initiative, AusBiotech will deliver a range of activations designed to accelerate commercialisation and support the growth of chosen Industry Growth Program participants.

The Industry Growth Program was created by the Australian Government to support innovative SMEs and startups undertaking commercialisation or growth projects that will build Australian capabilities in priority areas — including life sciences.

Today, at the Translational Research Institute in Brisbane, AusBiotech welcomed 28 biotechnology and medical technology — SMEs and startups — from across Australia to its first national cohort. This group of companies will now be provided with AusBiotech-led, targeted activation, to help them learn and grow along their company’s innovation and commercialisation journey.

As part of its activation program AusBiotech will deliver a commercialisation advisory support service, leveraging our 3,000-strong industry network and almost 40 years of expertise to help translate and advance breakthrough research into globally competitive companies.

Comments from AusBiotech CEO, Rebekah Cassidy:

“The Industry Growth Program is an important pillar of the Australian Government’s support for our country’s growing and energetic life sciences start up ecosystem.”

“As an Industry Partner Organisation, AusBiotech’s activation program is focused on developing capabilities across the commercial pipeline, growing international partnerships and enabling opportunities for access to capital to these startups. It’s one of the many ways we’re supporting the growth of home-grown health innovation to support the long-term health of Australians and the wealth of our nation.

“AusBiotech’s member community comprises more than 3,000 health, medical and scientific professionals across our life sciences ecosystem. We are proud to support this cohort of 28 participants from across the country with our nearly 40 years of deep industry knowledge and a shared commitment to translating Aussie innovation into global success stories.”

Comments from AusBiotech Industry Growth Program Manager, Tamlyn O’Connor:

“The Industry Growth Program empowers Australian innovation with real-world tools, connections, and commercialisation know-how. AusBiotech is proud to support these companies through every step of their journey from the bench to bedside.”

About the Industry Growth Program

The Australian Government’s Industry Growth Program provides an Advisory Service for startups and SMEs undertaking innovative commercialisation and/or growth projects that are within the priority areas of the Australian Government’s National Reconstruction Fund (NRF) and help build Australia’s manufacturing capability for the future.

Industry Growth Program grants aim to translate more world-leading Australian know-how into viable businesses, growing the pipeline of investment-ready projects for the $15 billion NRF to consider. Industry Partner Organisations provide specialised advisory services to start-ups and high-growth SMEs who are participating in the programme, complementing the work of the IGP’s advisers.

-ENDS-

Media inquiries

Emma Boscheinen, AusBiotech Director of Communications / +61 437 075 209 / eboscheinen@ausbiotech.org

About AusBiotech

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Unlocking Australia’s life sciences: A ‘sleeping giant’ of our economy

Wed, 26 Mar 2025 00:00:00 +1100

While no new significant commitments were made for Australia’s life sciences sector in the 2025-26 Federal Budget, AusBiotech remains steadfast in its advocacy to unlock the full potential of this critical industry for Australia’s health, economic future, and security.

The Treasurer, the Hon Jim Chalmers MP outlined a commitment to making Australia’s economy stronger, more productive, and more resilient. This includes investing in our competitive advantage, fostering resilient supply chains, and building a ‘Future Made in Australia’. Australia’s life sciences sector is central to these priorities, providing essential contributions to health security, sovereign capability in medical manufacturing, and economic diversification, backed by considerable competitive advantages.

We welcome the continued investment in key industry programs, including the Industry Growth Program, National Reconstruction Fund, Cooperative Research Centres, and the research and development tax incentive. Additional funding of $10 million over four years has been allocated to CSIRO for gene technology research, and the first stage of a refit for the Australian Centre for Disease Preparedness has been approved. In the health portfolio, support remains for the Medical Research Future Fund and the National Health and Medical Research Council. However, it's also clear that R&D funding is not keeping pace with the need here in Australia.

Our slipping ranks in an evolving world

“While Australia is a global leader in scientific research, ranking in the top ten on the Global Innovation Index, we have fallen to 30th for research outputs. Now more than ever, Australia’s life sciences sector requires unified, coordinated, and collaborative representation between industry and government,” said AusBiotech CEO Rebekah Cassidy.

“The world is rapidly evolving, marked by geopolitical and trade shifts, supply chain challenges, pandemics, an ageing population, rising chronic disease, climate change. Australia’s thriving life sciences industry is a national asset that must be strengthened to support Australia’s economic resilience.

"The time is now to harness Australia's world-leading health and medical research, and continue building, scaling and retaining a globally competitive biotechnology and medical technology industry — one focused on translation, development, and commercialisation, supported by world-class manufacturing."

Life Sciences: A sleeping giant of Australia's economy

Australia’s life sciences sector has more than 2,900 organisations delivering world-first health innovations that are improving and saving lives around the world. More must be done to ensure these innovations continue to be translated, commercialised, and manufactured here in Australia.

“Since 2016, cumulatively, the biotechnology and medical technology industry has been Australia’s highest value-added export industry outside of primary industries, making it a sleeping giant of Australia’s future economy,” said Rebekah.

“There’s no doubt that the work of our members is crucial to the future health and wealth of our nation, and their capability is critical to our country’s ongoing health security. That’s why AusBiotech is focused on delivering a clear set of priorities to support the sector’s growth, both locally and globally.

AusBiotech’s policy platform

Progress happens when industry and government work together. AusBiotech will continue to amplify its advocacy efforts as we call upon the Government to:

Develop Australia’s first whole-of-government National Life Sciences Strategy to set policy priorities, eliminate gaps and overlaps.
Establish an Australian Life Sciences Council in partnership with industry and government to drive this strategy, address sector challenges and ensure value for investment.
Recognise life sciences as the next priority sector under the Future Made in Australia Act.
Invest in data collection to drive innovation and improve policy and decision making.

"Against the backdrop of a rapidly evolving world there has never been a more critical time for a unified, cohesive partnership between industry and government. We are calling for a whole-of-government National Life Sciences Strategy — developed with support from an expert, industry-driven Life Sciences Council,” said Rebekah.

For more information on the joint AusBiotech and MTPConnect 2025-26 Pre-Budget Submission, click here.

Media inquiries

Emma Boscheinen, AusBiotech Director of Communications / +61 437 075 209 / eboscheinen@ausbiotech.org

About AusBiotech

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AusBiotech and Medicines Australia gather industry leaders to accelerate action this International Women’s Day

Fri, 07 Mar 2025 00:00:00 +1100

AusBiotech and Medicines Australia are partnering to deliver the annual Women in Life Sciences luncheon, bringing together 600 leaders from across the sector to celebrate the contribution of women in life sciences and call for accelerated action toward gender equity.

For nearly a decade, AusBiotech and Medicines Australia have honoured the women who transform life sciences into a sector of innovation and profound impact for International Women’s Day. This year's luncheon highlights the significant contributions of women in Australia’s life sciences and offers a powerful platform for celebration and networking, while also recognising that there’s more to be done for women in positions of senior leadership.

Aligned with the IWD 2025 theme Accelerate Action, the luncheon will feature a panel conversation focusing on the need for equal opportunity at all levels within the industry. As the sector grows, ensuring gender balance in leadership positions remains paramount.

This year’s panel moderated by AusBiotech CEO Rebekah Cassidy, will explore the challenges and opportunities for women in leadership roles. The distinguished panel includes research, policy, governance, investment, and advocacy experts:

Dr Saraid Billiards, CEO, Association of Australian Medical Research Institutes
Christine Cockburn, CEO, Rare Cancers Australia
Naomi Edwards FAICD, Chair, Australian Institute of Company Directors
Dr Terence Fitzsimmons, Managing Director, Australian Gender Equality Council
Dr Rebecca McQualter, CEO, Chimeric Therapeutics
Chris Newton, Founder, Stakeholder Capital

AusBiotech CEO Rebekah Cassidy said, “What a privilege it is to be part of the annual Women in Life Sciences luncheon hosted by AusBiotech and Medicines Australia. Not only are we bringing together some of our country’s most influential female life science leaders and celebrating the contributions of women in our sector, but we will also recognise ongoing challenges and have data-led conversations about opportunities to accelerate action.”

“The quality of conversation today with our distinguished panel promises to be both insightful and impactful, sparking a deeper, ongoing dialogue on the critical issues shaping the future of the sector and the opportunities for greater gender equity in leadership."

Elizabeth de Somer Medicines Australia CEO added, “Medicines Australia is delighted to partner with AusBiotech again to host the Women in Life Sciences luncheon, where we will explore the challenges and opportunities for women in leadership roles, as well learn the importance of mentors and sponsors in accelerating action to close gender gaps across the life sciences sector.”

“Women play a crucial role in Australia’s life sciences sector, driving groundbreaking research and innovation, and public healthcare advancements. The diverse perspectives and leadership foster more inclusive discoveries and equitable medical solutions. We must make decisive steps to achieve a more equitable and inclusive working environment.”

The 2025 WILS Luncheon promises to be an inspiring and impactful event, shining a spotlight on the women who are advancing the life sciences sector and driving change. This year, the Luncheon not only celebrates their accomplishments but also sets the stage for future actions to ensure that the next generation of women leaders can rise to new heights in the sector.

-ENDS-

Media inquiries:

Emma Boscheinen, AusBiotech / 0437 075 209 / eboscheinen@ausbioch.org
Anne-Marie Sparrow, Medicines Australia /Cube / 0417 421 560 / media@medicinesaustralia.com.au

About AusBiotech

AusBiotech is Australia’s life sciences organisation, working on behalf of more than 3,000 members for more than 38 years, to provide advocacy and services that promote the global growth of the Australian life sciences industry. With our unrivalled membership breadth and national convening power, we drive the advancement of life sciences and our members’ success in translating clinical research and technologies into real-world solutions while fostering knowledge sharing and collaboration to help life sciences innovators thrive.

About Medicines Australia

We are trusted partners in the medicines ecosystem, ensuring that our conduct is of the highest ethical standard, and that the environment in which we provide access to our medicines is sustainable and fair.

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The Cell and Gene Catalyst mobilises 71 influential leaders to accelerate industry

Thu, 27 Feb 2025 00:00:00 +1100

Seventy-one experts from 54 organisations in Australia’s cell and gene ecosystem have been appointed to Cell & Gene Catalyst’s (the Catalyst) four expert working groups to action strategic projects that will benefit the industry.

The joint venture by AusBiotech and Medicines Australia, the Catalyst identified 71 leaders across the value chain to contribute to this important work: 43 in industry, 20 in academia and 8 in the public sector. These professionals will share their diverse expertise and experience as part of the Catalyst’s working groups in Policy & Advocacy, Collaboration & Knowledge-Sharing, Workforce Development and Manufacturing.

The expert working groups generate evidence and advice to inform the Catalyst Steering Group as they guide and advance the Catalyst’s strategic goals and priorities to accelerate Australia’s cell and gene industry.

Working group members were selected from 89 leaders who expressed their interest.

AusBitoech CEO, Rebekah Cassidy, said "This broad, sector-wide commitment demonstrates the value and importance of the cell and gene industry in positioning Australia as a leader in biotechnology globally.”

Jane Adams is Associate Director of Market Access with Catalyst partner, Novartis, and will co-chair the Policy & Advocacy working group. She said, “I’m proud to lead this expert working group to help increase access to these world class therapies and ensure they reach patients faster.”

Applying an ecosystem-wide lens and a solutions-driven approach, working groups will focus on strategically aligned projects based on the Catalyst’s core priority areas: sustainable reimbursement and regulatory pathways, boosting capacity and capability in manufacturing and commercialisation, and supporting research translation and business growth through coordinated communities of practice.

Bev Menner, co-chair of the manufacturing working group and CEO of the Catalyst partner organisation Cell Therapies, said, “It’s critical that we build a connected and collaborative manufacturing ecosystem that can service Australia and our region. Our aim is to co-design this with partners across the very broad range of Australian sectors and with governments at the state and federal levels.”

Medicines Australia CEO, Elizabeth de Somer emphasised the importance of bringing leaders together who are at the forefront of cell and gene therapies, “We are grateful to our members for contributing their skills and expertise. Collaborating in this way will drive better healthcare outcomes and strengthen Australia’s position as a world-class cell and gene hub.”

Each working group will meet every 4-6 weeks and will be supported by a Co-Chair and an Observer, as well as the Catalyst Director who also serves as Co-Chair for the groups.

Catalyst Director, Dr Marguerite Evans-Galea AM, said, “Coordination and collaboration as a sector are essential if we are to realise Australia’s full potential in cell and gene therapies and achieve our mission: Establishing an end-to-end value chain for the discovery, development, manufacture and distribution of cell and gene therapies, while promoting job creation, commercialising research, and exporting Australian innovation globally.”

Medicines Australia and AusBiotech value and appreciate the sector’s commitment to accelerating the growth of Australia’s cell and gene industry.

Read the Catalyst’s full working groups here

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AusBiotech welcomes national prioritisation of R&D to build a stronger Australia

Thu, 13 Feb 2025 00:00:00 +1100

AusBiotech welcomes the release of the Federal Government’s discussion paper on the Strategic Examination of R&D, underscoring the urgent need for reform to bolster Australia’s innovation ecosystem and global competitiveness.

The discussion paper presents a compelling case for rethinking Australia’s approach to R&D. Despite our world-leading research capabilities, Australia continues to lag in translating home-grown ingenuity into globally significant innovations.

Rebekah Cassidy, CEO, said AusBiotech strongly supports the objective for a long-term, bipartisan, and strategic national plan for R&D—one that capitalises on our strengths in life sciences, fosters collaboration between research and industry, and embraces risk-taking to spur innovation.

While Australia is a global leader in scientific research, ranking top ten on the Global Innovation Index, we have fallen to 30th for research outputs. The data released today reveals a stark decline in R&D over the past 15 years: local investment in R&D is now only 1.66% of GDP, well below the OECD average of 2.7%.

"The life sciences industry is central to Australia's productivity, health security, and the health and wellbeing of all Australians. Building a stronger and more productive R&D ecosystem is in our national interest," said Rebekah.

"AusBiotech looks forward to working with the Panel and the Government as it develops the strategy. We will also engage with leaders across our 3,000-strong member network as we develop our response to the Discussion Paper.

“We will also continue our urgent call for a unified whole-of-government strategic approach to the life sciences industry, whose numerous policy touchpoints, including R&D, are currently dispersed across over eight different Australian Government portfolios."

This call is outlined in our 2025-26 AusBiotech and MTPConnect joint pre-budget submission, which seeks a partnership with Government to deliver unified, cohesive and intentional prioritisation of Australia’s life sciences industry by:

The Australian Government, in partnership with industry, developing a National Life Sciences Strategy supported by the creation of a new National Life Sciences Council;
The life sciences industry being recognised as a priority under the Future Made in Australia Act; and
Industry capability being further strengthened through investment in data collection.

"Without cohesive, whole of Government action, Australia risks falling further behind our international peers and missing critical opportunities to commercialise breakthroughs that could benefit our economy and the health and well-being of all Australians.

"The discussion paper and assessment of our R&D ecosystem highlight the need for change. AusBiotech will continue advocating for Government partnership to drive a unified, whole of Government strategic prioritisation of the life sciences industry—with R&D playing a critical role in accelerating ideas into commercial innovations, "said Rebekah.

-ENDS-
Media enquiries: Emma Boscheinen, Director of Communications, AusBiotech,
eboscheinen@ausbiotech.org / M: +61 (0) 437 075 209

About AusBiotech: AusBiotech is Australia's leading national and global advocate for life sciences, working to help its more than 3000 members thrive by shaping policy, creating connections, and fostering knowledge sharing. With an unrivalled national convening power, AusBiotech supports its members’ growth by building an Australian life sciences ecosystem that leads in development and commercialisation, creating high-quality, innovative life sciences companies.

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AusBiotech and MTPConnect joint pre-budget submission lays pathway to supercharge Australia’s life sciences sector

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In a pre-budget submission, AusBiotech and MTPConnect have called for new investment in strategic initiatives to boost Australia’s life sciences sector which is central to the nation’s productivity, health security and the health and wellbeing of all Australians.

The submission highlights Australia’s proud history of groundbreaking, world-first health innovations and makes recommendations to support the sector’s development and address commercialisation gaps that leave our nation trailing behind OECD peers.

While Australia is a global leader in scientific research, ranking top ten on the Global Innovation Index, we have fallen to 30th for research outputs. The ingenuity and expertise required to bridge this gap is already present in local industry. Government and industry partnership is required to unlock that potential.

The pre-budget submission, for consideration in the 2025-26 Federal Budget, seeks partnership with Government to deliver unified, cohesive and intentional prioritisation of Australia’s life sciences industry by:

The Australian Government, in partnership with industry, developing a National Life Sciences Strategy supported by the creation of a new National Life Sciences Council;
The life sciences industry being recognised as a priority under the Future Made in Australia Act; and
Industry capability being further strengthened through investment in data collection.

The joint Submission not only highlights the industry's significant contribution to Australia's productivity through high-value jobs, advanced manufacturing, export growth and improved health outcomes but also the industry’s numerous policy touchpoints—spanning regulation, funding, investment, procurement, clinical trials, manufacturing, exports, education, and skills—which are currently dispersed across eight different Australian Government portfolios.

AusBiotech CEO Rebekah Cassidy said: “For too long, Australia’s life sciences policy landscape has left many of the potential health and economic benefits of our industry on the table.”

“Our nation’s life sciences industry – from our home grown SME’s to larger organisations - has the requisite expertise to develop, commercialise and manufacture new medical innovations to support the health of Australians, strengthen Australia’s economic resilience, and support our national health security priorities.

"With the global context continuing to change - from pandemics to supply chain resilience, chronic disease, aging populations, climate change, and geopolitical tension – the time is now for Australia to intentionally prioritise and support the growth of its life sciences sector.

“A unified whole of government national Life Sciences Strategy developed with the support of an expert Life Sciences Council is a necessary step. Making life sciences a priority sector under the Future Made in Australia Act will recognise the critical strategic importance of the life sciences industry and ensure the necessary level of focus, coordination, partnership and investment for future success.”

MTPConnect CEO Stuart Dignam said the joint submission lays out a plan for sensible investments and initiatives to better support the sector to realise its full economic and health potential.

"If we are serious about supporting homegrown medtech, biotech and pharma innovations, then broadening the Future Made in Australia plan to include life science is a must and will make a real difference for our start-ups and SMEs.

“A true National Life Sciences Council, bringing together industry expertise and whole-of-government clout will go a long way to ensuring we can address challenges, plug commercialisation gaps and build a fit-for-purpose workforce in a timely manner.

“It’s all about backing start-ups and SMEs to be able to bring their life-saving medical products from research labs to global markets which will drive resilient companies, a more robust economy and healthier communities,” he said.

Since 2016, the medtech, biotech and pharma sector has been cumulatively Australia’s greatest value-add export industry outside of primary industries, making it a vital contributor to Australia’s future as a diversified, more knowledge intensive and modern economy.

Read the 2025-2026 Pre-Budget Submission here.

-ENDS-

Media inquiries:

· Emma Boscheinen, AusBiotech / Tel. +61 437 075 209 / eboscheinen@ausbioch.org

· Caroline Duell, MTPConnect / Tel. +61 439 652 419 / media@mtpconnect.org.au

About AusBiotech: AusBiotech is Australia’s life sciences organisation, working on behalf of more than 3,000 members for more than 38 years, to provide advocacy and services that promote the global growth of the Australian life sciences industry. With our unrivalled membership breadth and national convening power, we drive the advancement of life sciences and our members’ success in translating clinical research and technologies into real-world solutions while fostering knowledge sharing and collaboration to help life sciences innovators thrive.

About MTPConnect: MTPConnect is Australia’s Life Sciences Innovation Accelerator – an independent, not-for-profit organisation championing growth of Australia’s vibrant medical products sector. MTPConnect operates accelerator programs to support the development of cutting-edge medical technology, biotechnology and pharmaceutical innovations.

AusBiotech congratulates members recognised in Australia Day Honours

Thu, 30 Jan 2025 00:00:00 +1100

AusBiotech proudly celebrates the outstanding achievements of members recognised in this year's Australia Day Honours List.

These honours highlight the excellence and innovation at the heart of Australia's thriving life sciences sector and showcase its impact on science, public health, and global research.

AusBiotech extends congratulations to all recipients and to the following AusBiotech members who have been recognised for their contributions:

Professor John Francis Fraser, Founder and Chief Medical Officer De Motu Cordis Pty Ltd, was appointed as an Officer of the Order of Australia (AO) for his service to medicine as an intensive care physician and surgeon, and to global critical care research.
Emeritus Professor Keith Alexander Nugent, Deputy Vice-Chancellor (Research & Innovation) at The Australian National University, was appointed as an Officer of the Order of Australia (AO) for distinguished service to tertiary education, to science as a physicist and to the advancement of optical physics.
Professor Lauren Ayton, Associate Dean of Innovation and Enterprise at The University of Melbourne, was appointed as a Member of the Order of Australia (AM) for her significant service to optometry, to ophthalmology, and to public health as a clinician and researcher.
Dr Craig Robert Rayner, Director of Regional Centre for Respiratory Medicines and Tropic Disease at Moderna, was appointed as a Member of the Order of Australia (AM) for his significant service to pharmacology in a range of roles and organisations.

"We are thrilled to recognise the significant contributions of members who have been honoured for their work. Their achievements are a testament to the world-class talent within Australia's life sciences ecosystem.

“These honours spotlight the dedication and ingenuity that drive our industry forward. The recipients remind us of our sector's profound impact in improving health outcomes, fostering innovation, and strengthening Australia's global reputation in life sciences.

"Celebrating these leaders reinforces the importance of their work and underscores the critical role of collaboration in advancing breakthroughs that have a lasting impact on society here and abroad," said Rebekah Cassidy, AusBiotech CEO.

-ENDS-
Media enquiries: Emma Boscheinen, Director of Communications, AusBiotech,
eboscheinen@ausbiotech.org / M: +61 (0) 437 075 209

About AusBiotech: AusBiotech is Australia's leading national and global advocate for life sciences, working to help its more than 3000 members thrive by shaping policy, creating connections, and fostering knowledge sharing. With an unrivalled national convening power, AusBiotech supports its members’ growth by building an Australian life sciences ecosystem that leads in development and commercialisation, creating high-quality, innovative life sciences companies.

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Catalyst Impact Report 2024: Mobilising Australia's Cell and Gene Sector

Thu, 19 Dec 2024 00:00:00 +1100

AusBiotech is proud to be powering Australia's Cell and Gene Catalyst (the Catalyst) together with Medicines Australia. Through the work of Marguerite Evans-Galea, the Catalyst Director, strategic partnerships, stakeholder engagement, and impactful events, the Catalyst is accelerating industry progress and aligning efforts to achieve transformative outcomes.

Highlights from the Catalyst's Impact Report;

Mobilising the ecosystem
The Catalyst is elevating the national profile of Australia's cell and gene industry by collaborating with two co-leading peak bodies, six industry partners, and 47 experts from 45 leading organisations. Together, they are aligning advocacy efforts and achieving strategic goals across the cell and gene value chain.

Engaging stakeholders
By delivering 5+ conference keynotes, 20+ events and talks, 200+ stakeholder meetings, and securing 11 media mentions, the Catalyst has effectively engaged both national and international audiences while leveraging social media to expand its reach.

Providing strategic advice
Offering evidence-based insights, the Catalyst has contributed to shaping the future of the sector through policy submissions, consultations, and reviews, including the Health Technology Assessment (HTA) Review and the Health Professionals Scope of Practice Review.

Hosting the Cell and Gene Summit
The Catalyst made history by hosting Australia's first industry-led Cell and Gene Summit during AusBiotech 2024. This event brought together 230+ delegates and 26 experts in market access, manufacturing, commercialisation, and clinical trials to explore opportunities and celebrate the sector's impact.

These efforts collectively underscore the Catalyst's pivotal role in shaping the future of Australia's cell and gene sector, demonstrating the power of partnership and collaboration in positioning Australia as a global leader in cell and gene innovation.

Read the full report here and see how the Catalyst is shaping the future of healthcare in Australia.

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Call for member contributions: April 2025 edition of Australasian Biotechnology Journal

Tue, 17 Dec 2024 00:00:00 +1100

AusBiotech invites member contributions for the April 2025 edition of the Australasian Biotechnology journal.

We are seeking abstracts from our members on advancing Australian medtech, focusing on themes such as local manufacturing capabilities in next-generation technologies, driving sustainability in medical technology, and harnessing artificial intelligence as an enabler for medtech innovation.

In addition, we are looking for articles that offer new approaches, insights, or analyses in these areas that are welcome for inclusion in the upcoming edition.

The journal will also feature a preview of AusMedtech 2025, Australia’s premier medtech conference. This flagship event will bring together local and global thought leaders to explore the latest breakthroughs, trends, and critical emerging topics across medical devices, diagnostics, and digital health, showcasing Australia’s contributions to the global stage.

Australasian Biotechnology is AusBiotech’s official biannual journal, published in September and April. Written by the sector, for the sector highlighting topics such as technology development, manufacturing excellence, sustainability, and strategies to strengthen Australia’s end-to-end life sciences value chain.

Renowned for its informed and authoritative editorials, the journal serves as a highly effective platform to reach stakeholders across the life sciences sector. It is mailed on a name-and-title basis to more than 3,000 AusBiotech members and investors and is also available digitally.

The readership spans companies, government bodies, universities, research institutes, biotechnology organisations, and professional service providers in Australia and key international markets.

Abstracts should be 200 words and submitted to Communications team at AusBiotech by 7 February 2025.

If your abstract is accepted, the full article will be required by 19 February 2025. Articles can be approximately 500 words (1 page) or 1,000 words (2 pages). High-resolution photos to accompany articles are encouraged.

As a benefit exclusive to AusBiotech members, contributions are welcome year-round on research, business news, and sector trends; however, space in each edition is limited and inclusion is not guaranteed.

Australian Medtech Manufacturing Alliance adds new steering group members

Tue, 17 Dec 2024 00:00:00 +1100

Immutep and Monash announce first publication detailing how human LAG-3 Binds to MHC Class II

Tue, 17 Dec 2024 00:00:00 +1100

AusBiotech and BioNSW sign MOU to deepen collaboration

Mon, 16 Dec 2024 00:00:00 +1100

AusBiotech, Australia’s leading national industry body representing more than 3,000 life sciences members, has formalised a new partnership with BioNSW, a rapidly growing not-for-profit organisation dedicated to harnessing the full potential of the New South Wales Life Sciences sector. The signing of this Memorandum of Understanding (MOU) represents a significant step forward in promoting a connected and thriving biotechnology ecosystem across NSW and beyond.

The partnership underscores a shared commitment to catalysing innovation, investment, and skills development across the sector. Together, AusBiotech and BioNSW will work to amplify the strengths of NSW’s biotechnology industry, accelerating cross-sector collaboration and promoting growth.

Rebekah Cassidy, CEO of AusBiotech, stated:

“I couldn’t be more pleased to sign this MOU with BioNSW. It reflects our shared commitment to growing Australia’s life sciences capabilities and reinforces AusBiotech’s commitment to fostering a connected biotechnology sector. I look forward to working with the BioNSW team to showcase the state’s strengths and offerings.”

“My consistent message has been that, as the leading national advocate, we have a responsibility to collaborate and deepen our relationships with our partners in each of the states, including New South Wales. Through our own thriving membership, we know that NSW's biotech and medtech community is exciting and strong. Coordinating locally and nationally to foster joint advocacy is a critical enabler for the future of our sector. Unifying the sector's voice must be one of our most critical, shared priorities.”

Brad Walsh, Acting Chair and Co-Founder of BioNSW, said:

“As Acting Chair and Co-Founder of BioNSW, I’m delighted to see the formalisation of this partnership with AusBiotech, a key step forward in strengthening the biotechnology ecosystem across New South Wales and beyond.

“The NSW LifeSciences Sector is significant in size and importance with the largest number of Biotech companies amongst the states – with the sector having doubled in size over the last 7 years.

“BioNSW is committed to amplifying the voice of our local Life Sciences organisations across all regions of the State, ensuring that the unique needs and opportunities of NSW’s Life Sciences community are well-represented at every level. This partnership with the national body AusBiotech underscores our role as a vital advocate, connecting businesses, fostering innovation, and promoting growth.

“By working together with AusBiotech, BioNSW is excited to help drive the development of a thriving, connected biotechnology sector in NSW, positioning the state as a leader in the global bio-economy.”

About AusBiotech

AusBiotech is Australia's leading national and global advocate for life sciences, working to help its more than 3000 members thrive by shaping policy, creating connections, and fostering knowledge sharing. With an unrivalled national convening power, AusBiotech supports its members’ growth by building an Australian life sciences ecosystem that leads in development and commercialisation, creating high-quality, innovative life sciences companies.  

About BioNSW

BioNSW is an ambitious State-Focused, Industry-led organisation dedicated to harnessing the full potential of the NSW Life Sciences sector - catalysing innovation as well as + investment, skills and jobs in the NSW Life Sciences sector and facilitating economic growth, prosperity and a healthier NSW community.

Established in 2023 as a Not-for-Profit Organisation, BioNSW is led by an experienced Cross-Sector Board and supported by a group of Expert Committees covering areas ranging from Biotech, MedTech, Digital Health through to Manufacturing, Commercialisation and Investment.

-ENDS-
Media enquiries: Emma Boscheinen, Director of Communications, AusBiotech,
eboscheinen@ausbiotech.org / M: +61 (0) 437 075 209

Media enquiries: Brad Walsh, Interim Chairman, BioNSW,

brad@bionsw.org / M +61 (0) 413 231 296

FivepHusion secures ResectAssist platform technology for the localised delivery of cancer drugs

Thu, 12 Dec 2024 00:00:00 +1100

QIMR Berghofer says cell therapy saving lives of immunocompromised patients

Thu, 12 Dec 2024 00:00:00 +1100

Immutep reports promising new data in head and neck cancer at ESMO immuno-oncology 2024

Thu, 12 Dec 2024 00:00:00 +1100

Neuren Pharmaceuticals confirms the completion of Priority Review Voucher sale

Thu, 12 Dec 2024 00:00:00 +1100

AusBiotech and BioMelbourne Network welcome the Victorian Government's Economic Growth Statement

Wed, 11 Dec 2024 00:00:00 +1100

AusBiotech, Australia’s leading national industry association representing more than 3000 members across the life sciences sector and BioMelbourne Network, Victoria’s leading industry association for organisations engaged in biotechnology, medical technology, and health innovation in Victoria have welcomed the release of Victoria’s Economic Growth Statement.

The Victorian Government's recognition of 'Health Technologies and Medical Research' as one of the states' top priorities reflects the incredible contribution of our sector, both socially and economically, as well as it's significant potential for sustained growth.

Both organisations are encouraged by the Statement’s support for the life sciences sector, particularly its focus on investment attraction, including growing venture capital pools and through the state's clinical trial activity.

The Statement’s focus on making it easier to do business is a step in the right direction, encouraging an open door culture and cutting red tape. The breadth and depth of the biotech sector means it can span across departmental and policy areas, so measures to simplify and unify investment attraction are welcome.

Victoria’s life science sector is diverse and mature, with more than 1,000 organisations employing more than 100,000 people. Both organisations are encouraged by the Statement’s focus on workforce development, building new skills in high-growth economic areas – life sciences being one of them.

Both organisations welcomed the Statement’s confirmation that enhanced coordination and reduced regulatory barriers have the potential to stimulate investment and innovation, taking Victorian innovations to the world.

AusBiotech and BioMelbourne Network look forward to continued engagement with the Victorian Government in driving Victoria’s economic growth, including their new industry policy, due to be released in early 2025.

Rebekah Cassidy, CEO of AusBiotech, stated:

“Our members transform ideas into world-leading health innovations that have the potential to support the health of Australian’s and the health of our economies We are encouraged to see the impact of our members and the sector as part of Victoria’s Economic Growth Statement.

"We echo the sentiment of the Hon. Jactina Allan MP, Premier of Victoria, when she said that the world is rapidly changing. Globally, sovereign capability in life sciences has never been so important. Indeed, standing still isn’t an option.

“A consistent message from AusBiotech is that Australia needs a unified and coordinated strategy when it comes to the life sciences. We look forward to working with the Victorian Government as they continue to engage our industry as it takes new health innovations to the world.”

Karen Parr, CEO of BioMelbourne Network, commented:

“BioMelbourne Network wholeheartedly welcomes the release of Victoria’s Economic Growth Statement. It reaffirms the vital role of health technologies and medical research in driving innovation and economic resilience in our state. It is gratifying to see BioMelbourne Network’s advocacy in collaboration with its partners in and for the sector recognised.

“Victoria is Australia’s leader in the life science sector – a position that continues to attract and retain global companies to call our state home.

“This renewed focus strengthens Victoria’s global lead, and we are excited that it will enable our sector to explore new pathways to expand our high-value exports even further, ensuring the sector’s growth benefits communities here and around the world.”

About AusBiotech:
AusBiotech is Australia's leading national and global advocate for life sciences, working to help its more than 3000 members thrive by shaping policy, creating connections, and fostering knowledge sharing. With an unrivalled national convening power, AusBiotech supports its members’ growth by building an Australian life sciences ecosystem that leads in development and commercialisation, creating high-quality, innovative life sciences companies.

About BioMelbourne Network:
BioMelbourne Network is the peak body representing the life science industry in Victoria. Since 2001, it has been actively fostering and growing an innovative, globally-competitive sector, and transforming its network as well as the broader Victorian ecosystem. With more than 6,000 members, BioMelbourne Network focuses on building an engaged and collaborative life science community through data and insights, promotes and advocates for sector growth, and provides members with opportunities to accelerate innovation.

-ENDS-

Media enquiries: Emma Boscheinen, Director of Communications, AusBiotech,
eboscheinen@ausbiotech.org | M: +61 (0) 437 075 209
Media enquiries: Claudia Loeber-Raab, Communications Manager, BioMelbourne Network,
cloeber-raab@biomelbourne.org | M: (0) 425 785 143

Paradigm completes $16 million capital raise to support global Phase 3 clinical trial

Tue, 10 Dec 2024 00:00:00 +1100

FivepHusion secures ethics approval of a Phase 1b deflexifol clinical trial

Tue, 10 Dec 2024 00:00:00 +1100

Recce receives approval from Indonesia’s regulator for registrational Phase 3 clinical trial

Tue, 10 Dec 2024 00:00:00 +1100

AusBiotech celebrates ESIF Winners

Thu, 05 Dec 2024 00:00:00 +1100

Monash University and The Florey Institute of Neuroscience and Mental Health researchers were announced as joint winners at AusBiotech 2024's Early-Stage Innovation Forum (ESIF), at our annual conference in Melbourne.

Dr David Bibby and Dr James Tran presented novel screening, optimization, and development of next-generation medicines for the treatment of key mental health disorders, and a novel platform to deliver next generation genetic medicines to the central nervous system (CNS), respectively, and both went home as ESIF winners.

The twice-annual ESIF competition featured presentations from Australia's research institutes, universities, hospitals and pre-series A companies in the areas of human therapeutics and enabling technologies. Fifteen presenters from across Australia pitched technologies to an expert panel, receiving feedback intended to be helpful to their technology’s commercialisation journey.

Monash University alumnus Dr David Bibby represented Monash University and Pacalis Therapeutics, a Monash spin-out pioneering the development of next-generation medicines, targeting serotonin signalling in the brain, which plays a crucial role in mood regulation.

Pacalis Therapeutics combines neuroscience and mental health expertise, high calibre drug discovery capability, and commercialisation. The team is developing a portfolio of best-in-class and first-in-class agents. The company was started, utilising Monash University's expertise in medicinal chemistry, pharmacology and pharmaceutical science, as well as the co-founder’s expertise in drug development and industry.

Their team is developing New Chemical Entities (NCEs) that act on the serotonin receptor as therapies for treatment-resistant mental health conditions. In targeting compounds that act on the 5-HT2A receptor, PacalisTherapeutics focuses on two approaches, being best-in-class, orally bioavailable agonists and first-in-class Positive Allosteric Modulators (PAMs) that act like a ‘rheostat’ to selectively increase the activity of the receptor.

Pacalis Therapeutics uses state-of-the-art computational and biochemical approaches to identify these NCEs. The research is in partnership with Monash University’s Neuromedicines Discovery Centre.

"I very much enjoyed the ESIF session. To present the work of Pacalis Therapeutics to such a well-regarded panel and an audience of industry peers is a great opportunity. Events such as the ESIF serve the dual purpose of getting the message out regarding the great science being developed by Australian biotechs and enable the start-ups themselves to gather important feedback on their efforts. My thanks to the panel and organising committee of AusBiotech 2024 Conference, " said Dr David Bibby.

Alastair Hick, Chief Commercialisation Officer, Monash University said "Monash Innovation has supported Pacalis Therapeutics with investment and mentoring since they were founded, through to becoming one of the first companies participating in the Monash Venture Studio. It is great to see their research and commercial progress to win this coveted award acknowledging their potential as they look to close their funding round.”

Dr James Tran, CEO of Centron Bio, a spin out company from The Florey Institute of Neuroscience and Mental Health, is developing next generation genetic medicines by leveraging a novel CNS delivery platform.

Centron Bio’s shuttle technology leverages stealth endogenous peptides combined with elegant click chemistry to create IV-administered CNS and neuromuscular therapeutics that enhance tissue uptake and cellular utilization of diverse cargos. These therapeutics bypass cellular machinery, such as lysosomes that often limit the effectiveness of such treatments. Centron Bio’s endogenously-derived peptides are non-immunogenic, avoiding immunogenicity concerns of naked genetic medicines, LNPs, and antibody shuttles.

The company is progressing their lead programs towards IND-enabling studies and accelerating their treatments to the clinic.

Dr James Tran said "I’m incredibly grateful for the opportunity to present at the AusBiotech Early Stage Innovation Forum to such an esteemed panel of investors and the broader AusBiotech community. The engagement and discussions that followed have been invaluable in shaping our path forward, as we work to further develop our therapeutics and bring them closer to patients in the clinic."

Race submits human ethics application package for RC220 Phase 1 solid tumour trial

Thu, 05 Dec 2024 00:00:00 +1100

Orthocell says it has achieved all endpoints in pivotal of nerve repair product

Tue, 03 Dec 2024 00:00:00 +1100

AusBiotech Welcomes Government’s review of R&D

Mon, 02 Dec 2024 00:00:00 +1100

AusBiotech, Australia’s leading voice for life sciences, welcomes the Federal Government’s Strategic Examination of Research and Development (R&D) as an important step toward unlocking Australia’s innovation potential and driving economic growth.

Rebekah Cassidy, AusBiotech CEO, expressed support for the review, emphasising the need for a unified approach to enhance Australia's R&D ecosystem.

“Australia regularly gets an A for medical research, but we fall down when it comes to supporting companies that are commercialising that brain power into local industries which can benefit both our health and economy,” she said.

“We consistently rank in the top ten worldwide on the Global Innovation Index but are currently ranked 30th for research outputs – demonstrating the clear and urgent need for targeted reform.

“Bridging this gap in Australia’s life sciences sector will bring more life-saving medical products and technologies out of the lab and into market, with all of the health and economic benefits that come along with that.

“Now is the time for Australia to be advancing our R&D system, with a focus on supercharging the D, especially in the biotech and medtech sector. This is fundamental to Australia’s competitive advantage.

“Globally, governments are recognising that a thriving home-grown biotech and medtech sector is key to a nation’s health security. We are behind. We hope this Examination will help us to catch up.

“We are encouraged by the deep life sciences expertise on the expert panel, and as Australia's leading voice for our sector, look forward to working with them.

“With close to 1600 biotechnology and medical technology companies now part of our country’s diverse life sciences sector, Australia has never been better positioned to take advantage of home-grown expertise and experiences, to help address the current barriers to development and commercialisation.”

With more than 3000 members across the life sciences ecosystem, AusBiotech has consistently advocated for evidence-based, tailored and specific policy reform to strengthen Australia’s life science Research, Development and Commercialisation. The organisation supports key areas outlined in the review, including the opportunities to:

Maximise the value of existing R&D investments to strengthen linkages between research and industry
Support the achievement of national priorities
Drive greater R&D investment
Uplift Australia’s overall R&D intensity

Rebekah highlighted the critical importance of viewing Australia’s R&D system holistically to unlock the D and supercharge our health development and commercialisation potential:

“The Government’s Review today is a positive step forward for the sector, but it is not the whole puzzle,” Rebekah said.

“Unlocking the full potential of Australia’s health and life sciences capability requires a national focus on biotech, medtech and digital health that captures the true breadth of the opportunities and issues across the whole of government including, health, foreign affairs and trade as well as the states and territories.

“This whole of government strategic opportunity needs to be harnessed by government in partnership with industry for the health of our nation.”

About AusBiotech

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Media enquiries: Emma Boscheinen, Director of Communications, AusBiotech, eboscheinen@ausbiotech.org / M: +61 (0) 437 075 209

AusBiotech welcomes new board director

Fri, 29 Nov 2024 00:00:00 +1100

Australia's leading advocate for life sciences, AusBiotech, today welcomes the appointment of Dr Dell Kingsford Smith to its Board of Directors.

Dell joins the Board with more than 20 years of experience in clinical and commercial strategy across medical technology, pharmaceuticals, and vaccines. Her depth of expertise spans discovery to full commercialisation.

Having recently served as AusBiotech’s 2024 Board Observer, Dell is currently Vice President of Medical Affairs, Market Access, and Government Affairs for Cochlear Ltd Asia Pacific (ASX: COH). In her current role, Dell leads a team that advances patient access through clinical evidence, regulatory policy, and stakeholder advocacy.

Prior to joining Cochlear, Dell spent more than a decade with Janssen, the Pharmaceutical Company of Johnson & Johnson (J&J), in local and global leadership roles spanning market access, pricing, and commercial strategy. Her impactful work with industry stakeholders and the Australian government to streamline regulatory and reimbursement processes earned her the esteemed Medicines Australia Pat Clear Award in 2010.

After relocating to the U.S. with J&J, she drove market access and pricing strategies across oncology, immunology, and infectious diseases. She also contributed to the strategic acquisition and successful commercial integration of several early-stage oncology and haematology biotechnology companies and later led Emerging Market Access and Global Access Policy, addressing evolving healthcare landscapes in the USA, Europe, Japan, and China.

Dr Dell Kingsford Smith said, “I am honoured to have the trust and support of the AusBiotech membership in being elected to the Board. I look forward to working across the broad range of Australian biotech and medtech stakeholders to further strengthen and grow this vital, innovative sector of our economy.”

AusBiotech’s Chair, Dr James Campbell, said, "On behalf of AusBiotech, I am pleased to welcome Dr Dell Kingsford Smith to our Board. Not only does she bring invaluable expertise from discovery to commercialisation, but also an unwavering passion for improving patient access. Her outstanding track record across the life sciences sector makes her an exceptional addition to the Board.”

AusBiotech CEO Rebekah Cassidy said, “I’m delighted that our members have chosen Dell to join our Board and am honoured to work alongside such a diversely experienced set of sector leaders. Their collective expertise and commitment support our organisation's clear and forward-thinking direction. Dell’s extensive knowledge and experience will provide crucial support in fostering the growth of our members and advancing Australia's thriving life sciences ecosystem.”

“We acknowledge and thank all the leaders nominated for the recent Board position. AusBiotech was built by industry to be the voice of the life sciences sector, and the commitment of many leaders in supporting our work is deeply appreciated, “said Rebekah.

Effective today the AusBiotech Board is:

Dr James Campbell, CEO, Patrys Ltd (ASX: PAB); Chair, AusBiotech
Ms Erica Bremner Kneipp, Research Director, Human Health, Health & Biosecurity, CSIRO; Deputy Chair, AusBiotech
Dr Megan Baldwin, Founder, Chief Innovation Officer, Opthea Ltd (ASX:OPT)
Dr Dean Moss, CEO, UniQuest Pty Ltd; Remuneration and Nomination Sub-Committee, Chair
Dr Marthe D’Ombrain, Executive Director & Head, Global Research Innovation, CSL Ltd
Professor John Skerritt, Enterprise Professor in Health Research Impact, University of Melbourne
Dr Liz Dallimore, CEO & Managing Director, Argenica Therapeutics Ltd; Risk and Audit Sub-Committee, Chair
Dr Dell Kingsford Smith, Vice President of Medical Affairs, Market Access and Government Affairs for Cochlear Ltd Asia Pacific
Ms Rebekah Cassidy, CEO & Managing Director, AusBiotech

National Biotech and Medtech Development and Commercialisation Summit: Outcomes and Communique

Wed, 27 Nov 2024 00:00:00 +1100

On Tuesday, 19 November 2024, AusBiotech and MTPConnect jointly delivered Australia’s first National Biotech and Medtech Development and Commercialisation Summit in Canberra.

The Summit brought together representatives from Australia’s life sciences industry, including start-ups, SMEs, multinational companies, service providers, investors, manufacturers, research institutes, universities, and peak bodies.

Representatives from the federal departments of Health and Aged Care, Industry, Science and Resources, Home Affairs, and state governments were also valuable contributors. In addition to the conversation in the room, many written submissions were made before the Summit.

The Summit discussion focused on the following four topics, detailed in the Summit Discussion Paper: Protecting and Advancing Australia’s Future Health, Moving Beyond Early-Stage Development and Commercialisation, Growing the Capital Pool and Optimising Its Use, and Building a ‘Development’ Focused Workforce.

We have seen an increasing convergence of national and global factors impacting life science innovation, including the combined pressures of pandemics, stressed supply chains, chronic disease, aging populations, climate change, geopolitical tensions, and rapid technological advancement.

In response, the industry called for renewed conversations – guided by data, contemporary insights and unified solutions – to harness the synergies between our sector’s growing maturity, the global context and Australia’s economic, health, security and science priorities to drive development and commercialisation outcomes.

In wrapping up the Summit, AusBiotech CEO, Rebekah Cassidy, and MTPConnect CEO, Stuart Dignam, reflected on the three key themes emerging from the day, including the need for:

A national strategy for the life sciences sector
Industry to be a unified, strategic and sophisticated partner
Greater leverage of the industry’s expertise and knowledge

Today, we are releasing a short joint Communique that seeks to capture the key themes from the day, however, there is much more work to do. The insights and ideas generated at the Summit and the responses to the Discussion Paper are now being fully collated, distilled and prioritised to generate actionable, forward-looking recommendations.

These will inform a joint pre-budget submission for the 2024/25 Federal Budget and an upcoming White Paper, outlining a roadmap for advancing Australia’s life sciences industry. All of this work will build upon the Biotechnology Blueprint produced by AusBiotech in 2022.

AusBiotech and MTPConnect will keep the sector up to date with our work and collaborate with partners further in the coming months.

GE HealthCare and Peter MacCallum Cancer Centre partner to advance cancer research

Tue, 26 Nov 2024 00:00:00 +1100

Omico's Professor David Thomas receives NSW Premier’s Award for Outstanding Cancer Researcher

Tue, 26 Nov 2024 00:00:00 +1100

LBT Innovations announces name change, to Clever Culture Systems

Tue, 26 Nov 2024 00:00:00 +1100

AusBiotech welcomes the announcement of the HTA Implementation Advisory Group

Mon, 25 Nov 2024 00:00:00 +1100

AusBiotech welcomes the newly appointed members of the independent Health Technology Assessment (HTA) Reform Implementation Advisory Group.

AusBiotech CEO Rebekah Cassidy said Australia's HTA system is a key enabler to the successful development and commercialisation of medical innovations in Australia, with a whole pipeline approach – from bench to bedside – required to bring more life changing medical innovations to patients.

"We welcome the appointment of Elizabeth de Somer, CEO of Medicines Australia, and Anne Harris, Board Deputy Chair of Medicines Australia and Managing Director of Pfizer Australia and New Zealand, as industry representatives."

"Both Liz and Anne are highly regarded industry leaders, with decades of experience across international and Australian markets. Their contributions are invaluable in shaping the future of health technology access in Australia.”

“We are also encouraged by the breadth of representation on the Implementation Advisory Group, including clinical and patient expertise."

AusBiotech looks forward to following the outcomes of the Implementation Advisory Group and the increased access to health technologies for Australian patients.

Race Oncology says it has discovered multiple novel FTO inhibitor candidates

Thu, 21 Nov 2024 00:00:00 +1100

New digital project to reveal medical research career opportunities

Thu, 21 Nov 2024 00:00:00 +1100

AusBiotech and MTPConnect Bring Together Australia’s Life Sciences Sector for a First-Ever National Summit

Tue, 19 Nov 2024 00:00:00 +1100

Today’s National Biotech and Medtech Development and Commercialisation Summit 2024 in Canberra brings together more than 100 of Australia’s leading industry figures, policy experts, and innovators to shape the future of the nation’s biotech and medtech sectors with a unified voice.

As the life sciences industry navigates both unprecedented opportunities and pressing global and national challenges, the Summit offers a vital platform for setting a roadmap that will advance the sector’s translation, development and commercialisation capacity.

Australia is a global leader in scientific research, consistently ranking in the top ten worldwide on the Global Innovation Index. However, with commercialisation efforts lagging—Australia currently ranks 30th for research outputs—there is an urgent need for targeted strategies that bridge this gap.

AusBiotech CEO, Rebekah Cassidy, said the Summit comes at pivotal time for Australian life sciences companies including innovators, manufacturers and service providers.

“The factors influencing life sciences investment and growth are changing rapidly, which is why it’s crucial that AusBiotech leverage its national convening power to elevate the sector’s voice and lead evidenced-based policy discussions. Now is the time for a unified strategy and roadmap focused on enhancing industry’s development and commercialisation capabilities to bring more life changing medical innovations to market.”

MTPConnect CEO Stuart Dignam says nurturing a culture of innovation and focus on commercialisation can make all the difference.

“We need a coordinated strategy for backing life sciences innovation and supporting startups and SMEs through the difficult early years of innovation so we capture more opportunities to develop and commercialise sovereign medical products that create jobs, exports and health improvements.”

In response to current and future pressures—such as pandemics, supply chain challenges, an aging population, and the global drive for health equity —Australia’s life sciences sector is critical in ensuring the nation’s health and economic security.

As the Government continues to prioritise biotechnology as a critical technology field, this Summit is a timely call to action to secure Australia’s competitive advantage and drive national productivity.

The Summit will address four central themes identified in the recently launched Discussion Paper:

Protecting and Advancing Australia’s Health: Developing strategies to strengthen Australia’s health security and ensure sovereign capabilities.
Moving Beyond Early-Stage Development: Tackling the “valleys of death” in commercialisation to build globally competitive, sustainable businesses.
Growing and Optimising the Capital Pool: Exploring innovative ways to increase and effectively deploy capital, crucial for scaling up biotech and medtech organisations.
Creating a Development-Focused Workforce: Addressing the skills gaps to build a sustainable workforce that can support a mature biotech and medtech ecosystem.

Through this Summit, both organisations hope to provide a clear roadmap to government and industry stakeholders that aligns our policies, funding, and capabilities to accelerate the commercialisation of Australian innovations and position Australia as a global leader.

The outcomes from today will inform a joint communique and a white paper, outlining a pathway for advancing Australia’s biotech and medtech industries.

-ENDS-

Media inquiries:

Emma Boscheinen, AusBiotech Tel.0437 075 209 / eboscheinen@ausbioch.org

Caroline Duell, MTPConnect / Tel. +61 439 652 419 / media@mtpconnect.org.au

About AusBiotech:

AusBiotech is Australia’s life sciences organisation, working on behalf of more than 3000 members for more than 38 years, to provide advocacy and services that promote the global growth of the Australian life sciences industry. With our unrivalled membership breadth and national convening power, we drive the advancement of life sciences and our members’ success in translating clinical research and technologies into real-world solutions while fostering knowledge sharing and collaboration to help life sciences innovators thrive.

About MTPConnect:

MTPConnect is Australia’s Life Sciences Innovation Accelerator – an independent, not-for-profit organisation championing growth of Australia’s vibrant medical products sector. MTPConnect operates accelerator programs to support the development of cutting-edge medical technology, biotechnology and pharmaceutical innovations.

AdAlta announces appointment of two new non-executive directors

Tue, 19 Nov 2024 00:00:00 +1100

Neurizon Therapeutics says candidate reduces aggregation of key ALS disease target

Tue, 19 Nov 2024 00:00:00 +1100

AusBiotech Announces the Inaugural Depaz Oration

Thu, 14 Nov 2024 00:00:00 +1100

AusBiotech is honoured to announce the establishment of the Depaz Oration, an annual keynote to be introduced at the AusBiotech Conference in 2025 in memory of the late Dr Iris Depaz.

In August of this year, AusBiotech was deeply saddened to learn of Dr Depaz’s sudden passing, a long-standing advocate and champion of Australia’s life sciences sector.

As an AusBiotech Board Member, Head of Medical Vaccines, and Managing Director of the Translational Science Hub in Queensland at Sanofi, Dr Depaz held an unwavering commitment to our sector and belief in the potential of Australia’s life sciences sector. She saw our sector as a transformative force for our economy and the future of healthcare in Australia.

Known for her infectious enthusiasm, warmth, and compassion, Dr Depaz was a source of joy and inspiration to all who knew her. She embodied the true essence of leadership, deeply caring for her colleagues while tirelessly advocating for the advancement of the entire biotechnology sector.

Dr Depaz’s leadership played a pivotal role in establishing Sanofi’s Translational Science Hub—a $280 million collaboration with the Queensland Government, the University of Queensland, and Griffith University. As the Hub’s Managing Director, one of her primary goals was to strengthen Australia’s biomedical ecosystem.

Beyond her work at Sanofi, Dr Depaz was a passionate advocate for digital technology and championed the advancement of digital healthcare platforms in Australia. She had previously served as a Director of a blockchain and AI start-up designed to empower patients with ownership of their healthcare data, enabling them to make informed decisions about their health.

Rebekah Cassidy, CEO of AusBiotech, said:
“The Depaz Oration will be a testament to Iris's enduring legacy and our respect for her contributions to our sector nationally.”

“The Depaz Oration will be held annually at our AusBiotech Conference starting in 2025. It will celebrate and continue Iris's mission of fostering innovation, collaboration, and growth in Australia’s life sciences community.

“The Oration will serve as a reminder of Iris's impact, ensuring her vision and passion for biotechnology live on. We are honoured to pay tribute to her remarkable life and career, and we look forward to inspiring future generations of leaders in the spirit of her dedication and vision.”

-ENDS-
Media enquiries: Emma Boscheinen, Director of Communications, AusBiotech,
eboscheinen@ausbiotech.org / M: +61 (0) 437 075 209

About AusBiotech

Amplia enters into preclinical collaboration with Korean drug screening company

Thu, 14 Nov 2024 00:00:00 +1100

Immutep says 'Efti' INSIGHT-003 lung cancer trial reveals positive survival data

Thu, 14 Nov 2024 00:00:00 +1100

AusBiotech and MTPConnect Launch Joint Discussion Paper on Critical Life Science Growth Issues Ahead of National Summit

Thu, 07 Nov 2024 00:00:00 +1100

AusBiotech and MTPConnect have released a Discussion Paper ahead of their upcoming National Biotech and Medtech Development and Commercialisation Summit, on 19 November 2024 in Canberra.

Australia's life sciences sector is an essential part of Australia’s economy, supporting high-paying and skilled jobs, manufacturing exports, and underpinning the health and wellbeing of Australians. It is rightly recognised by the Australian Government as a critical sector that is essential for Australia’s future.

Yet while we are in the top ten globally for research, we slip down to 30th for the translation and commercialisation of that research.

The upcoming National Biotech and Medtech Development and Commercialisation Summit will see AusBiotech and MTPConnect gather some of the country’s most senior medtech, biotech and pharma industry leaders to tackle the challenges of supercharging the “D” in Australia’s health and medical R&D strategies.

The joint discussion paper launched today unpacks Australian and global policy contexts, stubborn industry challenges, and barriers to achieving robust “Development and Commercialisation” outcomes.

“Australia is already recognised as a global incubator for outstanding medical research. How we build upon that to also be recognised for our capacity to translate, develop and commercialise those ideas to build more great Australian companies is the opportunity we need to harness,” said AusBiotech CEO, Rebekah Cassidy.

“The time is now for Australia to realise the potential of its growing biotech and medtech sector. By advancing our life sciences industry, bringing innovations to market quicker, ensuring we have the Australian based skills and capability we need to succeed – we can play a greater role in securing the health of Australians and our national competitive advantage.”

MTPConnect CEO Stuart Dignam said the discussion paper and 19 November Summit aim to harness industry insights and create a united voice to government ahead of the 2025 election.

“Medical products are one of Australia’s most significant value-add exports, but gaps in biomedical and medical technology product development limit our ability to fully realise the commercial potential of our innovation prowess,” Mr Dignam said.

“The Summit will explore issues ranging from supply chain vulnerabilities and sovereign capabilities to access to capital and people with the right skills to ensure our start-ups and SMEs can grow and scale. We look forward to engaging with Australia’s industry experts, innovators and policy makers in robust discussions on ways to drive growth of our sector,” he said.

Globally, the industry is positioned as a key to economic productivity and prosperity. At the same time, it sits at the nexus of multiple societal challenges, including pandemic response, supply chain resilience, chronic disease, aging populations, climate change, health equity, and geopolitical tensions.

Dynamic global and national environments underscore the need for intentional, unified solutions to help grow Australia’s life sciences sector.

Hearing the voice of the sector

Both organisations are encouraging the sector to participate in shaping the Summit's conversation. Those who are attending the Summit should read the discussion paper in advance and be ready to engage in the room on the day.

Those who aren’t attending but want to have their voice heard can provide their thoughts via an industry wide survey available here.

The survey will close on the evening of Friday 22 November 2024.

-ENDS-

Media inquiries:

Emma Boscheinen, AusBiotech / Tel. 0437 075 209 / eboscheinen@ausbioch.org
Caroline Duell, MTPConnect / Tel. +61 439 652 419 / media@mtpconnect.org.au

About AusBiotech: AusBiotech is Australia’s life sciences organisation, working on behalf of more than 3000 members for more than 38 years, to provide advocacy and services that promote the global growth of the Australian life sciences industry. With our unrivalled membership breadth and national convening power, we drive the advancement of life sciences and our members’ success in translating clinical research and technologies into real-world solutions while fostering knowledge sharing and collaboration to help life sciences innovators thrive.

About MTPConnect: MTPConnect is Australia’s Life Sciences Innovation Accelerator – an independent, not-forprofit organisation championing growth of Australia’s vibrant medical products sector. MTPConnect operates accelerator programs to support the development of cutting-edge medical technology, biotechnology and pharmaceutical innovations

Neuren to receive one-third of US$150m from sale of Priority Review Voucher

Thu, 07 Nov 2024 00:00:00 +1100

AusBiotech and Life Sciences Western Australia Sign First-Ever MOU to Deepen Partnership

Thu, 07 Nov 2024 00:00:00 +1100

AusBiotech, Australia’s leading national industry body representing more than 3,000 life sciences members, and Life Sciences Western Australia, the leading body representing life sciences in Western Australia, have joined forces with a new Memorandum of Understanding (MOU) designed to help unlock growth opportunities through closer collaboration. This partnership aligns with a shared vision to elevate Australia’s position as a leader in biotechnology, medical technology, and health innovation on both state and national levels.

In an evolving global landscape where health advancements and technology are increasingly critical, this MOU lays the groundwork for a deeper advocacy between Western Australia's strengths in life sciences with the broader Australian ecosystem. The partnership will facilitate strategic opportunities for knowledge-sharing, expand member networks, and create a stronger, unified voice advocating for Australia’s life sciences industry.

Rebekah Cassidy, CEO of AusBiotech, stated:
“Our new MOU with Life Sciences Western Australia reflects a shared commitment to building Australia’s life sciences capabilities. The quality of research and innovation across our sector, stemming from every corner of this vast country, is the backbone of our thriving life sciences industry.

"As the leading national advocate, AusBiotech has a responsibility to deepen our relationships with states and territories. There are opportunities and challenges facing the life sciences sector – here and abroad. We need to be coordinated nationally and be aware of and responsive to global changes such as global health concerns, supply chain vulnerabilities, and aging populations. This collaboration will help us leverage Western Australia’s unique strengths and ensure that life sciences across Australia are connected and thriving.”

Tobias Schoep, CEO of Life Sciences Western Australia, added:
"This is a significant milestone for Australia’s vibrant life sciences sector. As the peak body for life sciences in Western Australia, Life Sciences WA is dedicated to supporting and advocating for our members both locally and globally. Through our strengthened partnership with AusBiotech, we are better positioned to address national and global challenges, harnessing WA’s unique strengths in a strategic, unified approach. We look forward to sharing the innovative work, opportunities, and insights from our members with the broader AusBiotech community."

About Life Sciences Western Australia
Life Sciences WA is a dynamic coalition founded in 2021, bringing together key stakeholders from government, academia, research institutions, industry bodies, and corporate entities. As the peak body for life sciences in Western Australia, our mission is to promote the region’s innovative strengths on a global stage, while providing members with essential networking opportunities, market insights, and resources to fuel business growth and commercialisation.
Through fostering collaboration and attracting top talent and investment, Life Sciences WA plays a pivotal role in shaping the industry’s future and advocating for public policies that support the broader life sciences community.

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Media enquiries: Emma Boscheinen, Director of Communications, AusBiotech,
eboscheinen@ausbiotech.org / M: +61 (0) 437 075 20
Media enquiries: Rachel Hogan, Marketing & Stakeholder Engagement Manager, Life Sciences WA Rachel.hogan@lifescienceswa.com.au / M +61 (0) 423 123 467

Imugene says bile tract cancer patient maintains complete response in MAST study

Tue, 05 Nov 2024 00:00:00 +1100

Optiscan signs agreement with Monash to progress GI Scope

Tue, 05 Nov 2024 00:00:00 +1100

Recce says patient dosing in Phase 2 clinical trial advances to final stages

Tue, 05 Nov 2024 00:00:00 +1100

Amplia announces capital raise to support the completion of Phase 2a ACCENT trial

Thu, 31 Oct 2024 00:00:00 +1100

AusBiotech and Life Sciences Queensland Unite to Strengthen National Life Sciences Sector

Thu, 31 Oct 2024 00:00:00 +1100

AusBiotech, Australia’s leading national industry body representing more than 3,000 life sciences members, and Life Sciences Queensland (LSQ), the leading voice for Queensland’s biotechnology and health innovation sector, have signed a Memorandum of Understanding (MOU) to deepen collaboration and advance Australia’s life sciences industry.

This agreement represents a strategic commitment to support the growth and resilience of Australia’s life sciences ecosystem. The MOU outlines an ambitious framework for cooperation, emphasising member engagement, knowledge exchange, and a unified approach to sector advocacy.

Dr James Campbell, Chair of AusBiotech, said:

“We look forward to deepening our collaboration with LSQ and building synergies that amplify our shared strengths. Now is the time to unite our voices, drawing on the remarkable innovation and talent across states like Queensland. Queensland is a thriving hub for cutting-edge developments in biotechnology.

Together, we can create a more connected and collaborative sector.”

Rebekah Cassidy, CEO of AusBiotech, said:

“We are excited to announce this Memorandum of Understanding between AusBiotech and LSQ. It marks a significant step forward in uniting our efforts to drive growth and strengthen the life sciences ecosystem across Australia.

"By working together, we can leverage our combined strengths to advance research, support our members, and ultimately improve health outcomes for all Australians. Both of our organisations recognise the growing necessity to retain and nurture homegrown research, biotechnology, and medtech to protect against the evolving challenges of our global environment. Whether it’s climate change, future pandemic preparedness, pressures on supply chains and aging populations, we will be better prepared to support and grow the sector for the benefit of Australians if we work together.”

"I am so pleased we could sign this MOU at our AusBiotech Conference. I thank LSQ for their ongoing partnership and collaboration.”

Professor Trent Munro, LSQ Board Chair, said:

“We welcome the opportunity to work more closely with AusBiotech to ensure that Queensland’s unique perspectives and opportunities are embedded into the national conversation about Australia’s biotechnology and medtech ecosystem.”

“We look forward to working more closely with AusBiotech and forging a “Team Australia” approach on the international stage.”

Dr Ryan Parlett, Acting CEO LSQ, said:

“It’s an exciting time for the biotechnology sector both nationally and in Queensland, with new companies setting up, and existing companies establishing a presence here, creating skilled jobs and economic return for the state.

“We are delighted to sign this MOU and look forward to strengthening our partnership and collaboration with AusBiotech.”

About AusBiotech

About LSQ

Life Sciences Queensland is the peak industry body advancing Queensland’s life sciences sector by supporting health, biotech, and medtech innovation. The organisation connects stakeholders across industry, government, and academia, fostering an environment where collaboration drives the industry forward and strengthens Australia’s life sciences landscape.

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Media enquiries: Emma Boscheinen, Director of Communications, AusBiotech, eboscheinen@ausbiotech.org / M: +61 (0) 437 075 209

Media enquiries: Sally Dillon, Senior Communications Manager, Life Sciences Queensland, sdillon@lsq.com.au / M: +61 (04) 425 751 900

AusBiotech Conference attracts record numbers as biotech industry looks to future

Thu, 31 Oct 2024 00:00:00 +1100

Australia’s biotechnology industry has gathered in record numbers at the annual AusBiotech conference, held in Melbourne this week.

The four-day conference, seen as one of the pre-eminent life sciences gatherings in the Asia Pacific region, has attracted a record-breaking 1600 attendees across the week, itself a record. More than 200 delegates have joined from overseas including major delegations from Korea and Tiawan.

The Hon. Mark Butler MP, Federal Minister for Health and Aged Care, joined the event, saying:

"The medical advances we make in this country are always about improving the lives of Australians, as well as people around the world.” "To take full advantage of these incredible advances they need to be developed, realised and commercialised.

“But I also want to make clear my desire, the government’s desire, to continue to work with AusBiotech and its industry members to bridge the gap between invention and realisation.

“We need a whole pipeline approach – from discovery to start-up, clinical trials, manufacturing, export, access and reimbursement. “Health is at the beginning and the end of that pipeline.

"And, to the people in this room—from the start-ups, the small to medium enterprises, the research institutes, multinationals, investors and manufacturers I say, we are stronger together. “This is why we need to work on a whole-of-government and industry approach.”

AusBiotech CEO Rebekah Cassidy said, “we have been delighted by the level of interest in this year’s event from local and international life sciences leaders, investors, and from both Federal and State Governments.”

“We are grateful to the Hon. Mark Butler MP, Minister for Health and Aged Care for addressing our conference and are encouraged by his strong commitment and support of our sector.

“We value government partnership in addressing and advancing Australia’s life sciences sector and appreciate the national and state commitment to working with industry.

“Australia has every reason to focus on the future of our life sciences sector. With 2024 data showing that our sector now employs some 350,000 Australians, more than 2900 life science organisations present including almost 1600 biotech and medtech companies, and 168 life sciences companies listed on the ASX – we are ready to thrive.

“We already have many remarkable, entrepreneurial biotechnology and medtech companies leading on the global health innovation stage. The time is now to harness and build on that potential.

"Within the context of a changing and more disrupted world, the attention on our sector is warranted. My consistent message is that locally and globally, new pressures such as

pandemics, supply chain challenges, aging populations, and climate change among others mean that our home-grown life sciences capability must be viewed as a health security asset.

"The time is now for Australia to critically and strategically leverage our health and medical innovation capability - nurture and protect it - to ensure its long-term viability.”

The four-day AusBiotech Conference is designed to connect, inform and inspire delegates and attendees, with the overarching goal of supporting the sector to thrive. The quality of speakers, panellists and the interactions on the ground at this year's AusBiotech conference is unparalleled.

Speakers this week include US-based Australian innovator Dr Daniel Timms, whose company BiVACOR conducted the first human implant of a fully artificial heart earlier this year, and Dr Intan Oldakowska, Co-Founder and CEO of Earflo, which has developed a revolutionary approach to chronic ear infections aimed at providing fast and affordable relief to the millions of children diagnosed each year.

Global speakers include Michael Lopez-Algeria, Chief Astronaut (Axiom Space), sharing his experiences performing medical experiments aboard the International Space Station. And Michael Hund, Global Chief Executive Officer (EB Research Partnership), looking at innovative business models are speeding up the search for cures for rare diseases.

In total, the industry-led programme features more than 260 speakers across 60 sessions.

"As we celebrate over 38 years of AusBiotech led commitment to the sector, it’s incredibly rewarding to witness record-breaking attendance and enthusiasm this year. This milestone not only reflects the vitality of our industry but also reinforces AusBiotech’s role as the national convening power and lead advocate for biotechnology and medtech innovation and growth in Australia, "said Rebekah.

About AusBiotech

-ENDS-

Media enquiries: Emma Boscheinen, Director of Communications, AusBiotech, eboscheinen@ausbiotech.org / M: +61 (0) 437 075 209

A Decade of Collaboration - AusBiotech and Korean Health Industry Development Institute sign MoU

Wed, 30 Oct 2024 00:00:00 +1100

AusBiotech and the Korea Health Industry Development Institute (KHIDI) today signed a memorandum of understanding (MOU) establishing a framework for collaboration and cooperation that will support the growing biotechnology industry in Australia and Korea.

This milestone marks a decade of collaboration between the two organisations, both of which are thrilled to continue their productive and supportive partnership. Signed on the opening day of AusBiotech’s 2024 Conference—the leading biotech event in the Asia-Pacific—the MOU underscores the essential role of international cooperation in advancing global biotechnology ecosystems.

The MOU recognises the key role that biotechnology plays in national economic and social development, and the significant benefits of partnering internationally to support and accelerate industry advancement. It has been signed by KHIDI Present Dr Soon-do Cha, and AusBiotech CEO Rebekah Cassidy.

Rebekah Cassidy, CEO of AusBiotech, commented:

“I am immensely proud to be continuing this decade-long partnership with KHIDI. Innovation is not constrained by borders and, indeed, is enhanced by international collaboration. By working with KHIDI, we can provide opportunities and support to our members.

“The world is changing, and the need for organisations representing some of the world’s most impactful innovations to be agile to change is paramount. Today’s signing highlights how both of our organisations are embracing more strategic roles that extend beyond national borders, actively contributing to the global life sciences sector.

“In the face of this change, from global pressures – pandemics, supply chain challenges, aging populations, climate change, and more - Australia’s ability to strategically leverage its health and medical research strengths to grow and sustain a thriving life sciences sector is important.

“I also thank KHIDI for being present during AusBiotech 2024, we are grateful and value your attendance”.

-ENDS-
Media enquiries: Emma Boscheinen, Director of Communications, AusBiotech,
eboscheinen@ausbiotech.org / M: +61 (0) 437 075 209

About AusBiotech:

AusBiotech and BioMelbourne Network Strength Collaboration

Wed, 30 Oct 2024 00:00:00 +1100

AusBiotech, Australia’s leading national industry association representing more than 3000 members across the life sciences sector and BioMelbourne Network, Victoria’s leading industry association for organisations engaged in biotechnology, medical technology, and health innovation, have announced the signing of a Memorandum of Understanding (MOU) to promote stronger collaboration between both organisations.

The MOU marks a significant milestone as the organisations work to support the state and national growth agenda for the life sciences ecosystem. It recognises the opportunity that greater industry collaboration offers, as a key to unlocking the sector's full potential.

Under the terms of the MOU, AusBiotech and BioMelbourne Network will further their collaboration across the key areas of member connection, knowledge sharing and sector advocacy.

Rebekah Cassidy, CEO of AusBiotech, stated:

“I couldn’t be more delighted to formalise AusBiotech’s relationship with BioMelbourne Network. Both of our organisations have a proud history of advocating on behalf of our members and share common goals when it comes to furthering the opportunities for life sciences sector growth.

“The combined pressures of a changing world, including pandemics, supply chain stress, aging populations, climate change and geopolitical tension mean that Australia’s capacity to strategically build on its health and medical research strengths, by growing and retaining a thriving commercialised biotech and medtech sector, has never been more important.

These factors bring into sharp focus the need for all parts of our industry to collaborate and build cohesive voice that furthers Australia’s on shore biotechnology development and commercialisation capability. The signing of this MOU is an important step toward that.

Karen Parr, CEO of BioMelbourne Network, commented:

“This MOU represents more than just an agreement; it’s a commitment between BioMelbourne Network and AusBiotech for greater collaboration as we drive a shared vision for our sector’s healthy and robust future.”

“As the voice of Victoria's growing and thriving health tech sector, it’s critical that the depth of experience present in this state supports the national discussion, and that vice versa, so that together we create new opportunities and insights that strengthens the innovation present.

“Our organisations are dedicated to advocating for our members, and a united industry will elevate and build a sector that benefits from our shared success.”

About AusBiotech:

About BioMelbourne Network:

BioMelbourne Network is a peak body representing the healthtech industry in Melbourne. Since 2001, it has been actively fostering and growing an innovative, globally-competitive sector, and transforming its Network as well as the broader Victorian ecosystem. With more than 6,000 members, BioMelbourne Network focuses on building an engaged and collaborative healthtech community through data and insights, promotes and advocates for sector growth, and provides members with opportunities to accelerate innovation.

-ENDS-

Media enquiries: Emma Boscheinen, Director of Communications, AusBiotech, eboscheinen@ausbiotech.org / M: +61 (0) 437 075 209

Media enquiries: Karen Parr, CEO, BioMelbourne Network, kparr@biomelbourne.org / M +61 (0) 420 729 123

Vaxxas licenses RSV vaccine antigen candidate from the US National Institutes of Health

Tue, 29 Oct 2024 00:00:00 +1100

Actinogen appoints Andrew Udell as its chief commercial officer

Tue, 29 Oct 2024 00:00:00 +1100

Australia's biggest week in biotech officially begins at AusBioInvest

Tue, 29 Oct 2024 00:00:00 +1100

Australia's premier life science investment event, AusBioInvest 2024, is in Melbourne today. It features industry-leading international speakers, keynote addresses from global investment leaders, and pitch presentations from top biotechnology companies.

This year, AusBiotech’s one-day AusBioInvest event is welcoming more than 260 delegates from Australia's thriving life science companies, Australian and global investors, including venture capital firms, private equity firms, and individuals, as well as research analysts and brokers, industry executives, and major global stakeholders.

Rebekah Casiddy, AusBiotech CEO, said Australia's biggest week in biotech is officially here, with AusBioInvest 2024 starting today and the official AusBiotech 2024 three-day programme starting tomorrow.

"AusBioInvest is just one way that AusBiotech continues to ensure our investment programmes are designed to the evolving needs of our members at all stages of capital raising, with a laser focus on creating meaningful connections, "she said.

The AusBioInvest programme offers insights and opportunities, beginning with an opening keynote by Dr. Eric Shiozaki, Partner at DCVC Bio, exploring the transformative role of AI and technology in biotech, and sharing valuable perspectives on what drives success from an investor’s viewpoint.

Followed by thought-provoking panels featuring Sarah Meibusch, Partner at OneVentures, who will unpack investment trends and diverse funding options—public, private, debt, and equity; and Rhenu Bhuller, AusBiotech's Global Investment Lead, who will join experts Matt McNamara of Horizon 3 Healthcare and Bianca Ogden of Platinum Asset Management to discuss how investors and founders can effectively collaborate to drive biotech innovation.

The presentations at AusBioInvest, featuring 26 innovative private and listed Australian biotech companies, represent a significant opportunity for investors and potential partners to connect directly with companies seeking funding and collaborative development.

Presenting companies include Amplia Therapeutics Limited (ASX: ATX), Arovella Therapeutics (ASX: ALA), Atticus Medical, BiomeBank, Blinklab Limited (ASX:BB1), Cambium Bio Limited (ASX: CMB), Carina Biotech Limited, Chimeric Therapeutics (ASX: CHM), EBR Systems (ASX: EBR), Evithé Biotechnology, FivepHusion, Immuron Limited (ASX: IMC), Imugene (ASX: IMU), Invion Limited (ASX: IVX), Neurizon Therapeutics (ASX: NUZ), Neurotologix, Novapep, Nyrada Inc. (ASX: NYR), Esfam Biotech, Polyactiva Pty Ltd, Servatus Ltd, Syntara (ASX: SNT) and Vaxxas.

"Part of AusBiotech’s role is knowledge sharing and connection building including with the investment community. Our ‘Invest’ events help great Australian companies to attract capital while assisting investors in connecting with innovative Australian companies that may offer high-value returns,” said Rebekah.

"We are proud of our work to put Australia's homegrown innovation on the global stage with local and international investors.”

AusBioInvest officially marks the beginning of Australia's biggest week in biotech, with AusBiotech flagship conference, AusBiotech 2024, commencing tomorrow in Melbourne from 30 October – 1 November.

About AusBiotech

-ENDS-

Media enquiries: Emma Boscheinen, Director of Communications, AusBiotech, eboscheinen@ausbiotech.org / M: +61 (0) 437 075 209

FDA accepts application and grants priority review for Telix's brain cancer imaging agent

Thu, 24 Oct 2024 00:00:00 +1100

AdAlta appoints consultant chief medical officer for AdCella

Thu, 24 Oct 2024 00:00:00 +1100

Percheron Therapeutics (ASX:PER) will undertake a share purchase plan for eligible existing shareholders to allow them to participate in a recently announced institutional placemen

Thu, 24 Oct 2024 00:00:00 +1100

Minister for Economic Growth and Minister for Jobs and Industry to both speak during Australia’s biggest week in biotech

Tue, 22 Oct 2024 00:00:00 +1100

AusBiotech is pleased to announce that Tim Pallas MP, the Victorian Minister for Economic Growth, and the Hon. Natalie Hutchins MP, the Victorian Minister for Jobs and Industry, will both speak at Australia’s biggest week in biotech – AusBioInvest and AusBiotech 2024.

The Victorian State Government is the Host State Partner for this year’s AusBioInvest and AusBiotech Conference in Melbourne, running from Tuesday, 29 October until Friday 1 November.

AusBiotech CEO Rebekah Cassidy highlighted the Victorian Government's partnership and support as a vital contributor to Australia's thriving life sciences sector.

“One of the pre-eminent biotechnology industry conferences in the Asia-Pacific region, AusBiotech's four-day conference is Australia's largest annual biotechnology gathering. It convenes Australia’s leading life science players and attracts a global audience of delegates and investors,” she said.

Tim Pallas MP, Minister for Economic Growth, will officially open AusBioInvest on 29 October. The one-day AusBioInvest programme will welcome over 250 delegates representing Australia’s leading life science companies and local and global investors at the Park Hyatt, Melbourne.

“From the lab to clinical trials to manufacturing - Victoria has a thriving biotechnology sector that is providing great local jobs and breakthrough research. We are proud to host AusBioInvest and the AusBiotech Conference this year, and the hundreds of delegates who are investing in Victoria“ said Tim Pallas MP, Minister for Economic Growth.

AusBiotech CEO Rebekah Cassidy said we are honoured to have the Minister for Economic Growth join AusBioInvest.

“Minister Pallas has been a long-term supporter of Victoria and Australia’s thriving biotech ecosystem. We couldn’t be more pleased to have him open what is undoubtedly one of Australia’s premier life sciences investment events.”

The Hon. Natalie Hutchins MP, Minister for Jobs and Industry, will formally welcome the conference's more than 1,500 participants, including 200 international delegates from 20 countries, on 30 October at the Melbourne Convention and Exhibition Centre.

“Victoria is one of the leading technology hubs in the world, and we are proud to host both the 2024 AusBioInvest and AusBiotech conferences in our great state.

“Our health technology sector is one of Victoria’s greatest assets - creating more than $3 billion worth of exports, employing more than 51,000 people, and providing world class healthcare for all Victorians.” said Minister Hutchins.

Rebekah Cassidy said, "we are grateful to Minister Hutchins for her ongoing support of Australia’s thriving life sciences industry. We look forward to her officially opening AusBiotech 2024 and welcoming our members and delegates to Victoria".

“Our members are at the forefront of developing biotechnology and medtech innovations that will keep Australia competitive on the global healthcare stage. And as we continue to face global healthcare challenges, our capacity to innovate and commercialise cutting-edge medical advancements has never been more critical.”

The Hon. Ben Carroll, Victoria’s Minister for Medical Research, said, “It is a great opportunity for delegates to see firsthand Victoria's research precincts, showcasing our world-class medical research institutes and biotech industry, to spark new ideas and partnerships.”

AusBiotech thanks the Victorian State Government for their partnership as the Host State Partner for AusBioInvest and the AusBiotech Conference this year.

About AusBiotech

AusBiotech is Australia's leading national and global advocate for life sciences, working to help its more than 3000 members thrive by shaping policy, creating connections, and fostering knowledge sharing. With an unrivalled national convening power, AusBiotech supports its members’ growth by building an Australian life sciences ecosystem that leads in development and commercialisation, creating high-quality, innovative life sciences companies.  

-ENDS-
Media enquiries:  Emma Boscheinen, Director of Communications, AusBiotech,
eboscheinen@ausbiotech.org / M: +61 (0) 437 075 20

Chimeric secures commitments for placement to progress development of CHM CDH17

Tue, 22 Oct 2024 00:00:00 +1100

AusBiotech calls for Board of Director nominations

Mon, 21 Oct 2024 00:00:00 +1100

AusBiotech seeks to elect one new Board Director, and nominations are now open. As a member of AusBiotech, you are eligible to nominate for election. If you would like to make a greater contribution to AusBiotech and the Australian life sciences sector, we invite you to apply.

As Australia's leading national and global advocate for life sciences, AusBiotech is for its more than 3000 members, supporting their growth by building an Australian life sciences ecosystem that leads in development and commercialisation, creating high-quality, innovative life sciences companies.

AusBiotech’s Board provides strategic and corporate governance oversight. Comprised of up to nine members, including the CEO, our Board members bring extensive experience working within the Australian biotechnology industry and offer deep technical, commercial, and policy expertise.

We are seeking nominations from our diverse membership for one new Board member. Any member seeking to nominate is invited to submit the required documentation by 5 p.m. Thursday, November 7, 2024.

What is needed to submit a nomination;

Nomination form (found here)
350-word biography
Photo

Email the nomination form, 350-word biography, and a photo to election@ausbiotech.org

Those who would like to be nominated are invited to have a brief, confidential conversation with AusBiotech Chair James Campbell.

Important dates:

21 October - Nominations open.
7 November - Nominations close.
13 November - Online voting and access information is emailed to members.
22 November - Closing date for online ballot.

Nyrada says it has completed safety studies ahead of Phase 1 clinical trial

Thu, 17 Oct 2024 00:00:00 +1100

Respiri announces it has secured a major strategic investment

Tue, 15 Oct 2024 00:00:00 +1100

Immuron reports continued sales growth for Travelan

Tue, 15 Oct 2024 00:00:00 +1100

AusBiotech Board of Directors Election Notification 2024

Mon, 14 Oct 2024 00:00:00 +1100

Advance Australia's thriving biotechnology and medtech sector; participate in the upcoming election as AusBiotech seeks to elect one new Board Director.

We are now seeking nominations from our diverse membership for one new Board member.

All members will receive nomination instructions on Monday, 21 October. Those who are seeking to nominate will be able to submit a nomination form together with a 350-word biography and a photo by 5 p.m. by Thursday, 7 November 2024.

Those who are considering a nomination, are also warmly invited to have a short, confidential conversation with AusBiotech Chair, James Campbell.

Important dates

7 November 2024 - Nominations close.
13 November 2024 - Online voting and access information is emailed to members.
22 November 2024 - Closing date for online ballot.

Important: check your entitlement to vote in the upcoming election

If your company or organisation is an AusBiotech member, you may be eligible to vote in the forthcoming election. Each member organisation can nominate individuals to vote on its behalf.

To be eligible to vote, your name must be on your organisation’s membership list by 7 November.

How to check if you’re a member:

See if your company or organisation is listed on our Membership Directory.
Contact Tanya Daw, Director, Membership & Engagement, to see if your company or organisation's name is on the list.

Not a member?

Boost your connections, stay informed on industry trends, and support advocacy for Australia's growing life sciences sector. AusBiotech is your national voice, created by industry, for industry.

If your organisation has not yet renewed, you must do so before 7 November to ensure eligibility for the election. Contact membership@ausbiotech.org to discuss your options.

AusBiotech membership benefits include:

The ability to nominate and vote in the AusBiotech Board of Directors election.
Twice-weekly updates on sector news via Biotech Dispatch.
Subscription to Australasian Biotechnology journal.
Discounted entry to AusBiotech events.
Speaking opportunities at AusBiotech events.
Access to the Business Solutions Programme.
The chance to join AusBiotech Committees.

Amplia Therapeutics CEO shares Prime Minister's Prize for Innovation

Thu, 10 Oct 2024 00:00:00 +1100

TGA approves new indication for Telix’s Illuccix to include patient selection for PSMA-targeted therapy

Thu, 10 Oct 2024 00:00:00 +1100

Noxopharm contracts specialist manufacturer for SOF-SKN clinical trial

Thu, 10 Oct 2024 00:00:00 +1100

Federal Minister for Health and Aged Care to speak at Australia’s biggest week in biotech

Tue, 08 Oct 2024 00:00:00 +1100

AusBiotech is delighted to announce that The Hon. Mark Butler MP, Federal Minister for Health and Aged Care, will join AusBiotech industry members, international delegates, and investors during Australia’s biggest week in biotechnology.

One of the pre-eminent biotechnology industry conferences in the Asia-Pacific region, AusBiotech’s four-day conference is the largest annual biotechnology gathering in Australia. More than 1,500 participants are expected at this year’s Conference and associated events, including more than 200 international delegates from 25 countries.

Minister Butler’s decision to speak at AusBiotech 2024 underscores the importance of Australia’s medical innovators and the life sciences sector more broadly at the national level.

AusBiotech CEO Rebekah Cassidy said the organisation was honoured to have Minister Butler join the Conference this year, noting that there has never been a more important time for health innovation to be at the forefront of national discussions.

“Globally, the combined pressures of pandemics, stressed supply chains, chronic disease, aging populations, climate change, health inequities, and geopolitical tensions – along with the rapid pace of innovation – has elevated health innovation topics.

“Now is the time for deep conversations regarding our sector’s role in our nation’s future and as part of Australia’s modernised economy."

Rebekah said this year’s conference would lean into some of those important future-focused conversations while also playing the traditional role of connection and knowledge sharing.

“The AusBiotech Conference is a super-connector event. Our organisation was built by our members to be the voice of the industry and to support growth in the sector. Bringing the Australian life sciences ecosystem together at AusBiotech is a remarkable opportunity.”

The premier event is an industry-led program with more than 200 speakers across 60 sessions developed to inform, connect, educate, and celebrate the sector's success and challenges.

“This year, we are looking at record-breaking numbers of speakers and attendees. This tells us that the sector's growth is getting the attention of a bigger audience year on year. Our premier programme also carves out time for industry professionals from Australia and around the world to connect and develop meaningful connections to advance biotech, “ said Rebekah Cassidy.

-ENDS-

Media enquiries: Emma Boscheinen, Director of Communications, AusBiotech,

eboscheinen@ausbiotech.org / M: +61 (0) 437 075 20

About AusBiotech

Chimeric says cancer patient achieves complete response in CHM CORE-NK trial

Tue, 08 Oct 2024 00:00:00 +1100

Nyrada says lead drug candidate demonstrates significant cardioprotection

Thu, 03 Oct 2024 00:00:00 +1000

Australian company Vaxxas receives significant investment from Endpoints Capital

Thu, 03 Oct 2024 00:00:00 +1000

AusBiotech welcomes more new members from across Australia's life sciences ecosystem

Tue, 01 Oct 2024 00:00:00 +1000

AusBiotech has always been for its members. Built by our members, to be the national voice of our sector we are proud to support our member's growth and leverage our national convening power to shape policy, foster knowledge sharing, and collaborate to advance life sciences in our country. Together, we work to help our members thrive. 

We’ve been delighted to announce a number of new AusBiotech members over recent months, including 17 who have joined between July and September this year. This includes: Agriculture Victoria Services Pty Ltd, Atticus Medical Pty Ltd, BlinkLab, CAD-IT Australia, Cambium Bio Limited, Douglas Pharmaceuticals Ltd, Evaluate, Evithé Biotechnology, EZZ Life Science Holdings Limited, Global Pharma Solutions, JAG Process Solutions Pty Ltd, Kurraba Group, Lachesis Biosciences Ltd, Nova Eye Medical, PureCDM, Syngene International Ltd, Viral Vector Manufacturing Facility.

Our warmest welcome to the following companies. We're so pleased you have joined AusBiotech and our community of more than 3000 life sciences leaders. We can't wait to work with you and your teams. 

AusBiotech’s new members include:

Agriculture Victoria Services Pty Ltd (AVS) is a specialist, professional entity responsible for protecting and commercialising novel technologies created by the Agriculture Victoria Research branch (AVR) of the Department of Energy, Environment and Climate Action (DEECA). AVS maximises the commercial value and impact of Agriculture Victoria research & innovation, so that Victorian agriculture and related industries are strong, innovative, and sustainable.
Atticus Medical Pty Ltd (Atticus) is a clinical-stage biotechnology company focused on developing new and improved treatments for infectious diseases. Atticus’ priority is the development and commercialisation of these new medicines in high-income countries. Atticus works with its not-for-profit partner, Medicines Development for Global Health, to support the often-neglected diseases that affect people in high-, medium- and low-income countries.
BlinkLab Limited (ASX.BB1) is a company founded by neuroscientists at Princeton University. Over the past several years they have fully developed a smartphone based diagnostic platform for autism, ADHD, schizophrenia, and other neurodevelopmental conditions. Their most advanced product is an autism diagnostic test that leverages the power of smartphones, AI and machine learning to deliver screening tests specifically designed for children as young as 18 months old.
CAD-IT Australia has a vision to provide digital solutions for real-world business challenges. The aim is to achieve this by using the latest cutting-edge technologies, combined with superior services and extensive expertise. CAD-IT Australia believes it can help Australian manufacturing companies become more competitive in international markets and assist in streamlining and optimising the product development process, driving more innovation and new product introductions.
Cambium Bio Limited (ASX:CMB) is a Sydney-based clinical-stage regenerative medicine company focusing on the development of innovative biologics for ophthalmology and tissue regeneration applications. Cambium’s proprietary technology, based on human platelet lysate, is being leveraged to create a pipeline of novel therapeutics with a primary focus on ophthalmology. Cambium Bio's lead product candidate, Elate Ocular®, is being developed to address significant unmet medical needs in the treatment of dry eye disease. In addition, the Company's stem cell platform, Progenza™, is being applied to the development of therapies for knee osteoarthritis and other tissue repair indications.
Douglas Pharmaceuticals is a New Zealand success story – a family-owned pharmaceutical company with a reputation for high manufacturing standards, quality products and outstanding client service. Through contract development and manufacturing business, Douglas CDMO, offers expertise, unwavering attention, dedication, and leading technology. Douglas Pharmaceuticals partners with biotechnology and pharmaceutical companies to successfully bring their products to life and out to market.
Evaluate designs and measures initiatives which preserve and enhance access to healthcare and other social services. Evaluate has two core interests: social policy, including healthcare, ageing and education; and the regulation of market competition, both domestically and in cross-border trade.
Evithé Biotechnology aims to expand the global medicines toolbox by putting nature back into medicine. They are inspired by the way that plants have evolved over millions of years to defend themselves with a multi-target defence system. Evithé Biotechnology specialises in harnessing natures defence mechanisms for the production of novel botanical drugs to serve a global market.
EZZ Life Sciences (ASX:EZZ) is a genomic life sciences company with a mission to improve quality of life and human health. EZZ has a focus on genomic research and development to address four key human health challenges: genetic longevity, human papillomavirus (HPV), helicobacter pylori, and weight management. EZZ is passionate about investing in the future of consumer health through the development and distribution of high-quality products via omnichannel models across Australia, New Zealand, China and worldwide.
Global Pharma Solutions is composed of expert pharmaceutical professionals covering the ANZ, EU, US, and APAC jurisdictions. Collectively, they have more than 150 years of industry experience in global regulatory affairs, clinical development, quality, and pharmacovigilance across a broad range of products, including prescription (biotech products, stem cells, biologicals, biosimilars, small molecules, generics), OTC and complementary medicines, medical devices, and cosmetics. They provide clients with the highest quality support, practical assistance, and guidance through complex regulatory, clinical, quality, and pharmacovigilance requirements, all tailored to specific market needs.
JAG Process Solutions is a process engineering leader, planning and implementing the most challenging of process plants and automation solutions for the pharmaceuticals and biotech industries as well as for the food industry.
Kurraba Group is Australia's only exclusive life science focussed real estate development and investment management business. Kurraba offers an end-to-end approach, led by an experienced team in institutional property and complex development. They acquire, develop and manage innovative real estate assets serving the life sciences industry to make a positive impact that lasts.
Lachesis BioSciences is a clinical-stage biotechnology company targeting dementia caused by Alzheimer’s and Parkinson’s disease. Lachesis Biosciences is developing LBIO-R32, a rivastigmine nasal spray for the treatment of mild to severe Alzheimer's disease dementia and mild to moderate Parkinson’s disease dementia.
Nova Eye Medical Limited is a medical technology company that develops, manufactures and sells a portfolio of proprietary glaucoma treatment technologies. Used by eye surgeons in more than 100 countries globally, these technologies include iTrack™ minimally invasive glaucoma surgery (MIGS), a consumable surgical device that restores the eye’s natural outflow pathway to lower pressure inside the eye and to eliminate patient reliance on anti-glaucoma medications, and the Molteno3® glaucoma drainage device for cases of severe and complex glaucoma.
PureCDM is committed to creating and maintaining high-quality clinical data to support the development of new medicines and devices. With more than 25 years of local and global cross-functional expertise, they specialize in customizing technology and putting clinical data front and center as the company’s most valuable asset.
Syngene International Ltd is an integrated research, development, and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene's more than 6000 scientists offer both skills and the capacity to deliver great science, robust data security, and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. Syngene works with biotech companies pursuing leading-edge science as well as multinationals, including GSK, Zoetis and Merck KGaA.
Viral Vector Manufacturing Facility VVMF is the first and only commercial manufacturing facility of its kind in Australia, uniquely integrated in the largest health, education, research, and innovation precinct in the country. Supported by a world-class clinical trial ecosystem, VVMF will in partnership design, develop and manufacture viral vector solutions for companies, customers and patients.

Become a member of AusBiotech to strengthen your connections in the Australian life sciences industry, benefit from longstanding relationships across government, industry and academia, and shape advocacy efforts and help foster a sustainable and globally competitive sector.

Find out more about AusBiotech’s member benefits here.

Percheron Therapeutics updates on Avicursen primate toxicology study

Tue, 01 Oct 2024 00:00:00 +1000

PolyNovo announces the retirement of long-term non-executive director

Tue, 01 Oct 2024 00:00:00 +1000

Mesoblast option to issue up to US$50 million convertible notes for product launch

Tue, 01 Oct 2024 00:00:00 +1000

Insights to Innovation: Bridging the funding gap - AusBiotech’s Voice on Investment Survey 2024

Thu, 26 Sep 2024 00:00:00 +1000

AusBiotech’s biotech and medtech members are being invited to complete the organisation’s first annual AusBiotech Voice on Investment Survey. The Survey seeks critical member insights as AusBiotech builds a new strategies and programs to help bridge the gap between investor and company needs in the Australian biotech ecosystem.

According to the Beyond Borders: EY Biotechnology Report 2024 | EY - US, the biotech sector’s market size is projected to reach US$1.2 trillion by the end of 2024. Grand View Research (Biotechnology Market Size & Outlook, 2030 (grandviewresearch.com) projects the market to grow at a compound annual growth rate (CAGR) of 13.96% from 2024 to 2030 to a US$3.88 trillion market. The market is driven by continued innovation and strong clinical pipelines, increased dealmaking and a recovery in the financing environment as well as government support and a rising demand from population needs in areas such as personalised medicine and rare diseases.

Despite the strong market growth, it is well recognised that biotech firms encounter various obstacles when trying to attract investment due to the complex nature of the lifesciences industry. Simultaneously, the availability of capital and investor confidence can be impacted by fluctuations in the world financial markets. When investors are looking to invest in biotech companies, they examine the underlying science and technology, gauging the research's robustness, scalability, and proof of concept as well as the company's commercialisation strategy and the experience and performance history of the management team. With all these factors in play, finding investor-investee synergy can be challenging, but is possible as shown by a number of Australian success stories.

AusBiotech is considering new strategies to help bridge the gap between investor and company needs in the Australian biotech ecosystem. Our goal will be to enable greater synergies between these groups and help accelerate the path to commercialisation for our biotech and medtech members.

We are now gathering insights to ensure this work is evidence led. If you are a biotech or medtech company leader who has sought, is seeking, or plan to seek investment, please click here to complete AusBiotech’s ‘Voice of Founder’ survey by 15^th October 2024.

All responses will be deidentified and aggregated for analysis. If you have any queries, please contact AusBiotech’s Global Investment Lead, Rhenu Bhuller at rbhuller@ausbiotech.org.

Chimeric announces new collaboration with Achieve Clinics

Thu, 26 Sep 2024 00:00:00 +1000

Argenica reports positive results in IND-enabling trials

Thu, 26 Sep 2024 00:00:00 +1000

Notification of AGM 2024

Wed, 25 Sep 2024 00:00:00 +1000

Notice of AusBiotech AGM, Thursday 31 October 2024

To Members and other persons entitled to notice of Annual General Meetings (AGM) of AusBiotech Ltd, the 2024 AGM of AusBiotech Ltd will be held at the Melbourne Conference and Exhibition Centre and in accordance with the AusBiotech Constitution on Thursday 31 October 2024 at 12.30pm -1.30pm AEDT to transact the following business:

Ordinary Business

ANNUAL ACCOUNTS
To consider the annual report, financial statements and report of the Directors and auditor for the year ended 30 June 2024.
DIRECTOR APPOINTMENT/S
To note the Directors who are returning, in accordance with the Company’s Constitution.
OTHER BUSINESS
Any other business that may be brought forward at a general meeting in accordance with the Constitution.

Note: A Member who is entitled to vote at the meeting has a right to appoint a proxy and should use the proxy form available on request from AusBiotech Ltd on +61 419 394 097 or admin@ausbiotech.org.

The proxy form must be signed and dated by the Member or the Member’s attorney. Proxy forms and the original or a certified copy of the power of attorney (if the proxy form is signed by an attorney) must be received no later than 1.00pm AEDT Wednesday 23 October 2024 by email to admin@ausbiotech.org.

If you have any questions regarding the AGM please do not hesitate to contact the CEO, AusBiotech Ltd on +61 419 394 097 or admin@ausbiotech.org.

By Order of the Chair

Dr James Campbell

Chair

Telix to acquire North American manufacturing and distribution platform

Tue, 24 Sep 2024 00:00:00 +1000

Immutep receives $3.6 million R&D tax incentive from French Government

Tue, 24 Sep 2024 00:00:00 +1000

Cochlear announces chief financial officer appointment

Thu, 19 Sep 2024 00:00:00 +1000

Invion updates on Phase 2 prostate cancer trial of INV043

Thu, 19 Sep 2024 00:00:00 +1000

AusBiotech and MTPConnect partner to deliver Australian first National Summit

Thu, 19 Sep 2024 00:00:00 +1000

AusBiotech and MTPConnect have announced a new partnership to deliver Australia’s first National Biotech and Medtech Development and Commercialisation Summit, to be held in Canberra on 19 November 2024.

The Summit will focus on how Australia can supercharge the “D” in its medical R&D strategies and help future-proof the country’s access to biotech and medtech innovation.

AusBiotech CEO Rebekah Cassidy said, “Australia is at a critical juncture. Globally, the biotechnology industry is gaining unprecedented attention. The combined pressures of pandemics, chronic disease, aging populations, climate change, health inequities and geopolitical tension – along with the rapid pace of innovation – have made health security, medical sovereign capability, investment competition, system agility and skilled employment all matters of critical national importance.”

“Australia’s capacity to strategically build on its health and medical research strengths, by to growing and retaining a thriving commercialised biotech and medtech sector, has never been more important. It’s crucial that industry comes together with a stronger voice to be part of these discussions. I’m delighted that AusBiotech and MTPConnect are partnering to make this happen.”

MTPConnect CEO, Stuart Dignam said, “Biotech and medtech are an essential part of Australia’s future - backing start-ups and SMEs to bring life-saving medical products from research labs to market drives stronger companies, a more resilient economy and healthier communities.
“But we have challenges. Supply chains for medicines are vulnerable, sovereign capabilities remain limited and access to capital and people with the right skills is needed to grow our companies.

“The Summit is the first time ever our current and future industry has come together to tackle these issues with a crystalized voice to government and I couldn’t be more pleased to see MTPConnect and AusBiotech partnering in such a strategic way to drive growth of our sector,” he said.

The premier one-day National Biotech and Medtech Development and Commercialisation Summit will host Australia’s most senior industry experts, innovators, and policy makers to explore the opportunities and challenges for Australia in supercharging the “D”. It will also start to unlock the key drivers that will ensure health and medical commercialisation is serving the needs of Australia now and into the future.

AusBiotech and MTPConnect will be seeking a cross-section of senior leaders from across the biotech and medtech industry to participate in the Summit and contribute to these important discussions. With seats at the Summit limited by venue size, both organisations will be seeking representation across sectors, disciplines, geography and gender.

Some direct invitations will be extended to industry leaders, policy makers and other stakeholders. Sector members wishing to attend can also express their interest in joining the Summit by completing the EOI form here.

-ENDS-
Media enquiries: Rebekah Cassidy, CEO, AusBiotech,
rcassidy@ausbiotech.org / M: +61 (0) 437 075 209

About AusBiotech

AusBiotech is Australia's leading national and global advocate for life sciences, working to help its more than 3000 members thrive by shaping policy, creating connections, and fostering knowledge sharing. With an unrivalled national convening power, AusBiotech supports its members’ growth by building an Australian life sciences ecosystem that leads in development and commercialisation, creating high-quality, innovative life sciences companies.  

Remembering biotech trailblazer Leon Serry AM

Tue, 17 Sep 2024 00:00:00 +1000

As the father of Australian biotech, Leon Serry AM is remembered for his pioneering work as an investor and philanthropist founding Cicardian (now Opthea Ltd), establishing the foundation of Australia’s biotech investment industry.

Leon Serry was the founder and managing director of Circadian, the first ASX-listed biotech company, where he made an outstanding contribution to the Australian biotechnology industry and academic and commercial sectors.

Leon pioneered the development of a vibrant Australian biotechnology industry based on innovative technology transfer from the Australian medical research community throughout the last 20 years, overcoming significant scepticism and numerous funding crises.

Listing Circadian on the ASX in 1985, Leon Serry was notable investor, philanthropist, and company founder in Australia’s biotech sector, founding spin-out companies including Axon, Antisense (now Percheron Therapeutics Limited), Metabolic (now Polynovo Limited) and Optiscan Ltd.

He supported a number of other early-stage Australian biotechs, helping companies attract further funding from High-Net-Worths and investors after providing backing as an angle investor. He is also recognised for his contribution as a mentor and education the next generation of biotech leaders.

Leon was awarded a Member of the Order of Australia (AM) in the 2017 Australia Day Honours for “significant service to the biotechnology industry, to the development and commercialization of biomedical science, and as a mentor”.

According to The Australian, “[Leon] was born in Newcastle where his father ran the government parachute factory, and later moved to Melbourne. Mr Serry left Camberwell High School at 15 to work as a cost accountant and at age 19 became a qualified accountant, the youngest in Australia.”

Biotech Daily said in its tribute to Leon Serry, “Leon was generous with his time and was constantly concerned with the further development of the Australian biotechnology sector, but he invested in other ASX-listed and non-listed companies and was very well-known across the industry.”

Speaking on the inception of Circadian, Leon told Biotech Daily “I read the Time magazine article on Interferon as a potential treatment for cancer.

“I’d already made some money and wanted to give something back to the community and that’s when I started Circadian. I went to Monash University and found melatonin for jetlag and sleep disorders. “Universities don’t have a bent for commercialization, but you have to get funding for science - and to cure diseases you need commercialization.”

AusBiotech extends its condolences to Leon Serry’s family, friends, and close colleagues, and acknowledges the long-lasting impact Leon will have on Australia’s biotech industry.

Immutep says its candidate in combination delivered positive efficacy and safety profile

Tue, 17 Sep 2024 00:00:00 +1000

Immune cell could become ‘off-the-shelf’ rapid tissue, muscle and bone healing therapy

Tue, 17 Sep 2024 00:00:00 +1000

PharmAust says EMA pre-submission meeting paves the way for orphan designation request

Tue, 17 Sep 2024 00:00:00 +1000

AusBiotech welcomes release of HTA Review’s final report

Thu, 12 Sep 2024 00:00:00 +1000

The Federal Government has released the final report of the Health Technology Assessment (HTA) Review, marking the first comprehensive review of Australia’s HTA system in nearly 30 years.

AusBiotech has welcomed the release of the much-anticipated Health Technology Assessment (HTA) review report by the Federal Government.

HTA is one of the final gateways for getting medicines and vaccines to Australian patients. Too often this gateway has disincentivised medical investment and innovation, and has meant Australian patients have experienced delayed access to medicines.

AusBiotech CEO, Rebekah Cassidy said, “we are encouraged that the report acknowledges the need for broad system reform to provide Australians with more equitable, timely and safe access to medicines and vaccines.”

“Significantly, for the Australian life sciences sector, the recommendations also recognise that investment is needed to ensure the HTA system is equipped to evaluate emerging technologies in the future.

“Congratulations to our peers at Medicines Australia for their multi-year advocacy on this topic and to our own members who contributed during the consultation process. While there is more work to come to drive reform home, but this is a significant milestone that should be applauded.”

The 50 HTA Review recommendations have been made across a range of areas, such as improving access to new health technologies, tackling inequity, and making HTA processes simpler and easier to enhance participation from consumers and clinicians. The Federal Government also announced it will establish an independent implementation group to guide the HTA reform, led by an eminent Australian with representation from the Commonwealth and state and territory governments, industry, consumers and clinicians, with the expertise of a health economist.

Consultation included 28 deep dive discussions with experts and stakeholders, while more than 250 submissions were received across two public consultations, including from the Cell & Gene Catalyst, a joint venture of AusBiotech and Medicines Australia.

As part of the HTA Review, an Options Paper was published in January 2024 to present options for reform being considered by the reference committee to improve Australia’s HTA policies and methods and the funding and approval pathways.

The HTA Review Report is a consensus report overseen by a Reference Committee representing the views of experts and patient organisations, First Nations peoples, scientific and clinical practice, industry, and government.

The HTA report will play a key role in shaping the Federal Government’s health funding decisions, particularly through programs such as the Pharmaceutical Benefits Scheme, Medicare Benefits Schedule, and National Immunisation Program.

The Hon. Mark Butler, Minister for Health and Aged Care, said in a formal statement, ““The HTA Review Report is farsighted enough to be visionary, while being firmly grounded in the practicalities of the here and now.”

The HTA Review Report can be found here, and the Enhance HTA Report can be found here.

Vaxxas initiates Phase 1 clinical trial of pre-pandemic Avian Influenza A Virus vaccine

Thu, 12 Sep 2024 00:00:00 +1000

Brandon BioCatalyst’s CUREator Incubator boosts preclinical and health security innovations with new funding

Thu, 12 Sep 2024 00:00:00 +1000

Telix’s Phase 3 ZIRCON trial for kidney cancer imaging published in The Lancet Oncology

Thu, 12 Sep 2024 00:00:00 +1000

Victorians gain access to precision cancer therapies following landmark donation

Thu, 12 Sep 2024 00:00:00 +1000

AusBiotech appoints Industry Growth Program Manager

Tue, 10 Sep 2024 00:00:00 +1000

AusBiotech is pleased to announce the appointment of Tamlyn O’Connor as its new Industry Growth Program Manager.

Tamlyn will deliver AusBiotech’s ‘Innovation Activation Program’ for Australian biotech and medtech SMEs that are part of the Australian Government’s Industry Growth Program (IGP), after AusBiotech announced its appointment as an Industry Partner Organisation (IPO) for the IGP last month.

In this role, Tamlyn will provide support to SMEs moving through research translation and commercialisation, leveraging AusBiotech’s deep industry expertise and networks to support mentoring, connection, and collaboration for Australian SMEs with technology moving through the development phase.

“I am absolutely thrilled to lead and deliver AusBiotech’s Innovation Activation Program as part of the Industry Growth Program to support both Australian medtech and biotech SMEs. Leading this program, I am focused on opening doors for SMEs to potential partnerships through AusBiotech’s vast networks and developing relevant educational content to accelerate an SME’s commercialisation journey. I am really looking forward to making a real impact on commercial outcomes with our program for these SMEs and I’m excited to hit the ground running on this incredible project,” says Tamlyn O’Connor.

Rebekah Cassidy, CEO, AusBiotech, noted in the August announcement, “AusBiotech is a connected network of over 3,000 members representing the whole of Australia’s life sciences value chain from spin-outs and SMEs, through to research institutes to large international companies. As the leading voice of Australia’s biotech industry representing the interests of Australia’s innovative life sciences community, supporting SMEs to grow along their commercialisation journey has been at the heart of our work for almost 40 years.”

Tamlyn is a seasoned professional in the life sciences industry, with over twenty years of experience across industry development, communications and stakeholder engagement roles from both the public and private sectors. Tamlyn has a strong track record of generating and facilitating translational research and commercial collaboration opportunities with global partners and innovation networks for the Australian life sciences sector.

Tamlyn is passionate about driving Australian innovation and impact in the life sciences sector and enhancing the ecosystem. She has delivered a suite of successful ecosystem activation campaigns driving Australian innovation outcomes, particularly in her previous roles with Johnson & Johnson Innovation and MTPConnect. Tamlyn is also dedicated to building and promoting diverse and inclusive life sciences talent pipelines and has implemented several programs to support a sustainable future talent pipeline for women in life sciences leadership roles.

About the Industry Growth Program

Announced during the 2023-2024 Federal Budget, the Industry Growth Program provides an Advisory Service for startups and SMEs undertaking innovative commercialisation and/or growth projects that are within the priority areas of the Australian Government’s National Reconstruction Fund (NRF) and help build Australia’s manufacturing capability for the future.

The IGP grants aim to translate more world-leading Australian know-how into viable businesses, growing the pipeline of investment-ready projects for the $15 billion NRF to consider. The Industry Partner Organisations provide specialised advisory services to start-ups and high-growth SMEs who are participating in the programme, complementing the work of the IGP’s advisers.

ENA Respiratory secures extension of US funding for novel prophylactic antiviral

Tue, 10 Sep 2024 00:00:00 +1000

Dimerix announces that first patient enters DMX-200 open-label extension

Tue, 10 Sep 2024 00:00:00 +1000

Nyrada provides update on its brain injury program GLP studies

Tue, 10 Sep 2024 00:00:00 +1000

Biotron updates on BIT225-012 Phase 2 COVID-19 clinical trial

Tue, 10 Sep 2024 00:00:00 +1000

CSL announces sale of Wuhan plasma collection and fractionation operations

Fri, 06 Sep 2024 00:00:00 +1000

Strengthening Australia-Hong Kong health and investment ties

Thu, 05 Sep 2024 00:00:00 +1000

AusBiotech was pleased to be invited to participate in a HealthTech Roundtable and Business Luncheon with the Hong Kong Government’s Financial Secretary, Mr. Paul Chan, and members to discuss growth opportunities for Australian biotech in Hong Kong and Asia.

The roundtable, organised by Hong Kong Economic Trade Office and InvestHK, attracted attendees from a wide range of stakeholders including investors, start-ups, industry, professional services companies and business associations.

AusBiotech and its members had the opportunity to hear about the latest updates on the innovation and technology initiatives in Hong Kong, as well as discuss issues that they face in an interactive roundtable discussion.

With more than 100 people in attendance, the day included a business luncheon themed ‘Hong Kong's advantages as an innovation and technology hub’, which included a keynote and Q&A with Mr Chan, and a panel discussion with fintech scaleups and technology investors.

The roundtable discussion, themed ‘The development of Health Technology in Australia and Hong Kong as an innovation hub for global expansion’, explored opportunities for Australian healthtech innovators looking to expand key Asian markets like Hong Kong, and partnering with Hong Kong businesses and investors to develop commercial biomedical products, and recognised the strength of Australian innovation in this field.

This roundtable provided an excellent opportunity for companies involved in the health and medical sector to understand first-hand the latest updates on the innovation and technology initiatives in Hong Kong, as well as the support available from the Hong Kong Government for foreign investors.

Mr. Chan, the Finance Minister of Hong Kong, oversees the use of public funds in Hong Kong as well as how resources should be channelled to fuel the grow of the innovation and technology industry.
Thank you to our members who participated in the roundtable, including: 360biolabs’ Sharon Sim, AdAlta’s (ASX:1AD) Tim Oldham, Chimeric Therapeutics’ (ASX:CHM) Rebecca McQualter, and EZZ LifeSciences’ (ASX: EZZ) Glenn Cross.

AusBiotech’s engagement with InvestHK and the Hong Kong Economic Trade Office is part of its global strategy to facilitate international opportunities for investment, collaborations and partnerships, focusing on the markets important to members, as highlighted in AusBiotech’s Strategic Plan 2021-2024.

Opthea announces executive leadership changes and senior appointments

Thu, 05 Sep 2024 00:00:00 +1000

Noxopharm reports results from Chroma platform drug development program

Thu, 05 Sep 2024 00:00:00 +1000

AusBiotech cohosts Quantum Meets Health workshop

Tue, 03 Sep 2024 00:00:00 +1000

The workshop, in partnership by Australia’s Chief Scientist Dr Cathy Foley, aims to accelerate the take-up of and build the demand for quantum technologies in Australia’s health sciences sector.

Initiated by Dr Cathy Foley, and presented in partnership with AusBiotech, CSIRO, Queensland Government, TAFE Queensland and QUBIC, the full day Quantum Meets Health workshop will host industry and research leaders on Thursday 5 September in Brisbane, Queensland.

The workshop will include panel sessions with representatives from across the healthcare, quantum and life sciences industries, including academia, government, service providers, and consumer groups, breakout sessions, and an update on quantum funding opportunities. The sessions will explore themes such as the role of quantum in drug discovery, diagnosis, medical imaging, optimisation of supply chains, big data, and cybersecurity.

With the emergence of the quantum industry, Australian businesses must ensure they are prepared for the impact of quantum technology in their sector to maximise the opportunities it presents and build the demand.

In 2024, the ‘Quantum Meets…’ event series introduces the quantum opportunity to sectors across the Australian economy, bringing business, government, and researchers together to identify industry challenges that quantum could address and define the problems that need attention. The series also aims to accelerate the uptake of quantum technologies in Australia’s economy

Quantum technologies offer unparalleled new solutions to challenges encountered by a broad range of industry sectors.

The Office of the Chief Scientist noted in its communications, “Australian businesses should act early to understand potential impacts on their sector from emerging quantum technology – both in terms of how it can enhance Australia’s competitive advantage, but also to gauge critical shifts in the competitive landscape as competitors invest in quantum solutions.”

Interested in learning more about the intersection of quantum and biotechnology? Register for the AusBiotech 2024 National Conference to hear from Philipp Ernst, Vice President of Quantum Solutions & Business Development, PsiQuantum, who will present the keynote ‘Fault tolerant quantum computing: Hardware, algorithms and their applications in biotech’, highlighting PsiQuantum’s roadmap to deliver the world’s first utility-scale quantum computer in Australia. Register here: https://www.ausbiotechnc.org

Percheron Therapeutics announces positive preclinical data for avicursen

Tue, 03 Sep 2024 00:00:00 +1000

Race Oncology announces the detail of first phase of board renewal

Tue, 03 Sep 2024 00:00:00 +1000

AusBiotech appoints senior leaders focused on advocacy, policy and elevating the voice of industry

Thu, 29 Aug 2024 00:00:00 +1000

AusBiotech is delighted to welcome two new senior leaders to its team with both roles focused on elevating and amplifying the voice of our members as we work to accelerate the growth of Australia’s biotech and medtech industry.

Karyn McIntosh has been appointed as AusBiotech’s new Director Government & Policy and Emma Boscheinen as the new Director Communications.

AusBiotech CEO, Rebekah Cassidy said, “we couldn’t be happier to welcome Karyn and Emma to our team. Together they bring decades of well-honed advocacy, policy, international relations, strategic communications, media, and stakeholder engagement experience to the table. They are both incredibly well regarded in their fields and are excited by the opportunity to work with us and our members as we grow the Australian ecosystem and support more Australian biotech and medtech leaders to scale up and out.”

About Karyn McIntosh

Karyn is a government and public policy professional with over 15 years’ experience spanning law, politics, international relations and stakeholder and patient engagement in both the public and private sectors. Working across the R&D, medical manufacturing and pharmaceutical industries, Karyn is passionate about seeing breakthrough science and innovation inform good policy and advocating for policies that support a thriving and world leading life sciences ecosystem – from bench to bedside. Prior to joining AusBiotech, Kayn was Corporate Affairs Lead at global pharmaceutical company, Sanofi, with responsibility for leading political engagement, policy contribution and patient partnerships for the pharmaceutical portfolio. She also worked for the Australian Nuclear Science and Technology Organisation, leading their government affairs function, as well as representing Australia in international fora in areas of non-proliferation, nuclear law and women in nuclear. Karyn was admitted as a Solicitor in 2007, practicing in the areas of family and property law, civil litigation and administrative law.

Karyn said, “It’s a real privilege to be joining the AusBiotech team. I am looking forward to working alongside and advocating for the incredible people at the heart of Australia’s life sciences ecosystem. I have always been passionate about ensuring Australia’s policy landscape supports tangible outcomes for the health and well-being of Australian communities.”

Karyn joins the AusBiotech team from today, 28 August 2024.

About Emma Boscheinen

Emma Boscheinen is a senior practitioner with more than ten years’ experience leading strategic communications in the pharmaceutical industry. Most recently, she held a senior role in the Corporate Affairs team at Bristol Myers Squibb Australia and New Zealand (BMS). At BMS, she was responsible for driving the company's reputation through strategic media relations, executing digital media strategies, managing complex issues, and delivering national PR campaigns. She has demonstrated leadership skills in high-impact areas such as Inclusion and Diversity and led the company's first Reconciliation Action Plan. Before that, she held communications and advocacy positions in large and medium-sized companies. In 2023, she won the Health Industry Hub’s Corporate Communications Individual of the Year award.

“I am thrilled to join AusBiotech as its incoming Director Communications. With Australia’s life sciences sector poised for growth and opportunity, joining the team at such a critical time is a privilege. I look forward to working with members, amplifying their voices, and continuing to raise the profile of Australia's thriving life sciences industry. Ensuring our members' voices are heard within and beyond the sector will remain a top priority.”

Emma joins the AusBiotech team from 30 September 2024.

AusBiotech 2024 National Conference programme unveiled

Thu, 29 Aug 2024 00:00:00 +1000

AusBiotech 2024 is Australia’s premier life science conference and the flagship event of Australia’s biggest week in biotech. This year will be the biggest programme to date, featuring over 60 engaging sessions and more than 200 speakers in Melbourne from 30 October-1 November.

With the main conference opening to be delivered by The Hon. Natalie Hutchins MP, Minister for Jobs and Industry, Minister for Treaty and First Peoples, Minister for Women at Victorian Government, other programme highlights so far include:

Philipp Ernst, Vice President of Quantum Solutions & Business Development, PsiQuantum, will present Fault tolerant quantum computing: Hardware, algorithms and their applications in biotech to providing insights on PsiQuantum’s roadmap to deliver the world’s first utility-scale quantum computer in Australia, and how this technology unlocks the true potential of quantum algorithms applied to quantum chemistry problems and their relevance in biotech;
AusBiotech 2024’s, Millis Orator Dr Daniel Timms, founder, BiVACOR, will discuss his journey in developing the first permanent total artificial heart. The Millis Oration is named in honour of Emeritus Professor Nancy Millis's contribution to the industry, and is held annually at the AusBiotech conference together with continuous support from CSL. The Oration is a focal point of the annual industry gathering and is appropriately named in honour of this pioneer of Australia’s biotechnology industry;
Keynote Michael Hund, global Chief Executive Officer, EB Research Partnerships (EBRP), will present on Venture into cures: How patient foundations, biotech, and academia can unite via innovative business models to accelerate treatments and cures, which will discuss how EBRP, as the largest global nonprofit dedicated to curing Epidermolysis Bullosa (EB), has raised over $60 million to fund more than 140 global scientific projects and companies through its award winning venture philanthropy and business model, growing the clinical trial landscape from two to more than 40 clinical trials, and achieving the first two FDA approved treatments in 2023, and
Plenary and panel sessions exploring the trends, issues and opportunities for industry in radiopharmaceuticals, quantum computing, mRNA, ADCs, antimicrobial resistance, investment, clinical trials, manufacturing, commercialisation, intellectual property, artificial intelligence, and much more.

AusBiotech 2023 is created by industry, for industry; and for more than three decades it has created a forum to reflect on the sector’s achievements and exchange ideas to further advance the industry. The AusBiotech team is committed to delivering a diversity across the expert speaker, chair and panellist programme. Measuring gender diversity at our conferences is part of this commitment. In 2022 AusBiotech delivered a 45% female and 55% male split and in 2023 a 48% female and 52% male split. This year, we anticipate 250 speakers will join the final programme and we are striving for a 50/50 balance.

This year's programme features a one-day AgriBiotech & BioSecurity Summit, hosted in partnership with CSIRO, the Cell & Gene Summit, hosted in partnership with Australia’s Cell & Gene Catalyst a joint venture between AusBiotech and Medicines Australia, the Early-Stage Innovation Forum, the Merck-sponsored Conference Gala dinner, the Clinical Trials Dinner, and plenty of formal and informal networking opportunities.

Biotech’s biggest week also includes AusBioInvest 2024, Australia’s premier life science investment event, on 29 October in Melbourne, pre-conference workshops (more information to come), and site tours around Monash, Parkville, La Trobe health and innovation precincts on 29 October.

Join AusBiotech 2024 in-person to celebrate and connect with our thriving Australian and global biotechnology network. AusBiotech encourages delegates to take advantage of early-bird registrations before 27 September; register now.

AusBiotech’s premier biotech conferences are proudly sponsored by the Victorian Government. Download the full programme here.

Media are invited to register their interest for a conference media pass by emailing communications@ausbiotech.or

Novotech earns renewed certification as an employer of choice for gender equality

Thu, 29 Aug 2024 00:00:00 +1000

Chimeric says first patient dosed in trial of CDH17-directed CAR-T cell therapy

Thu, 29 Aug 2024 00:00:00 +1000

Telix submits NDA for TLX101-CDx brain cancer imaging agent

Thu, 29 Aug 2024 00:00:00 +1000

ATO to release report on entities utilising the R&D Tax Incentive

Tue, 27 Aug 2024 00:00:00 +1000

R&D entities are encouraged to ask questions or log amendments ahead of the Australian Taxation Office (ATO) publishing its first annual ‘Report of data about Research and Development tax incentive entities’ in late September 2024.

The report will list companies in various industries that have claimed a benefit under the R&D Tax Incentive (R&DTI) programme in the 2021-22 income year, as part of the Federal Government’s broader approach to taxation transparency.

The report will contain two components – the raw data published on data.gov.au, and an analysis of the data to be published on the ATO’s website.

The report will publish information the R&D entity provided in its company tax return, including: the name of the R&D entity claiming the R&DTI, the entity's Australian business number (ABN) or Australian company number (ACN), and total R&D expenditure.

By providing transparency around how much R&D entities are claiming, the report aims to provide greater openness about the programme’s administration and improve public accountability and voluntary compliance.

The ATO has been in touch with R&D entities that will have their data published in this first report, and their tax agents, to inform them and give them an opportunity to lodge an amendment to their R&DTI claim, if needed.

The ATO is required to publish the R&D data two years after the end of the financial year that the data relates to. The delay in publishing this information is designed to address any perceived commercial sensitivity of the data.

The R&DTI is a key programme for Australia’s biotech sector, with AusBiotech-led research revealing the R&DTI generated a return of $3.14 for each dollar of forgone tax revenue spent in the biotech sector in 2021.

AusBiotech has been a long-term, vocal proponent of the R&DTI, championing the programme and its significance to Australia’s biotech sector since 2012. AusBiotech, on behalf of industry, advocated to retain the programme after the RDTI Bill proposed amendments to the policy in 2019.

More information about the R&D tax transparency report can be found on the ATO’s website. Questions about the report can be sent to the ATO.

Eminent cancer researcher confirmed as new Translational Research Institute CEO

Tue, 27 Aug 2024 00:00:00 +1000

PharmAust reports positive interim study results from study in ALS

Tue, 27 Aug 2024 00:00:00 +1000

Moderna welcomes the Government's national science statement

Thu, 22 Aug 2024 00:00:00 +1000

TGA seeks sector views on proposed changes to Essential Principles for medical devices

Thu, 22 Aug 2024 00:00:00 +1000

The Therapeutic Goods Administration (TGA) is seeking industry feedback on proposed changes to the Australian Essential Principles for Safety and Performance of medical devices (Essential Principles), to align with new European regulations.

Industry feedback is being sought on proposed changes to the Essential Principles, to align with changes being implemented in the European General Safety and Performance Requirements (GSPR).

The TGA is aiming to ensure the Essential Principles remain relevant and to identify opportunities for potential strengthening to improve safety and performance of medical devices. It is seeking industry input on proposed alignment with the European GSPR from both the:

European Regulations 2017/745 on medical devices (MDR)
European Regulations 2017/746 for in vitro diagnostic medical devices (IVDR).

The Australian (AUS) Essential Principles set out the safety and performance characteristics of medical devices in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002. There are currently no Australia Essential Principles that align with the intent of the EU GSPRs, except for IVDR GSPR 19, which partly aligns with requirements of Essential Principle 15.

The TGA has been systematically reviewing the regulations and guidance materials relating to medical devices, with progress published on the TGA website.

As stated in the Consultation document, “The regulatory reforms in this consultation are based on the Government policy as agreed in 2016 in response to the Review of Medicine and Medical Devices Regulation^{^[1]}.

“It was agreed that the Australian Medical Device Framework be aligned, wherever possible, with the European Union Medical Device Framework. Of note was the existing alignment already between the two frameworks.”

The TGA conducted its first consultation (Part 1) on proposed changes to the Essential Principles in 20219, which indicated strong support for alignment with the GSPR for medical devices and in vitro diagnostic devices.

This consultation focuses on Part 2 of reviewing the Australian (AUS) Essential Principles for Safety and Performance of medical devices to ensure they remain relevant and robust.

Industry is invited to respond to the survey and make a submission via the TGA consultation hub. The consultation paper and attachment can be found on the TGA Consultation Hub.

The consultation closes on 16 October 2024.

[1] Australian Government response to the Review of Medicines and Medical Devices Regulation: https://www.tga.gov.au/news/news/australian-government-response-review-medicines-and-medical-devices-regulation#devices

Queensland researchers identify potential new treatment pathway for bladder cancer

Thu, 22 Aug 2024 00:00:00 +1000

Amplia says five patients recording sustained reduction in tumour size in trial

Thu, 22 Aug 2024 00:00:00 +1000

AusBioInvest 2024 keynote speaker announced

Tue, 20 Aug 2024 00:00:00 +1000

Seasoned life sciences investor Dr Eric Shiozaki, DCVC Bio, to headline AusBioInvest 2024, Australia’s premier life sciences investment conference, in Melbourne this October.

Dr Eric Shiozaki, Partner, DCVC Bio, formerly of Novo Ventures, the world-leading life science venture capital firm, has been announced as a keynote speaker.

Dr Shiozaki will deliver an engaging keynote, ‘Investing in innovation at the intersection of technology & biology’ at AusBioInvest in Melbourne on October 29, discussing the emerging applications of technology within the biotech sector.

During this keynote, attendees will gain an understanding of the critical factors for assessing new technologies and their potential commercial application, with a focus on the trends and themes impacting Biotechnology 4.0, before an audience Q&A.

This keynote, and conference, is ideal for both non-specialist investors wanting to dip their toes into biotech investing, as well as seasoned life science investors looking to inform their next investment.

As Partner at DCVC Bio, Dr Shiozaki contributes to strategic decision-making and business development, and is focused on identifying disruptive technologies in healthcare, particularly in drug development and medical technologies. He collaborates closely with entrepreneurs to build companies aimed at advancing medicine and promoting human health.

Dr Shiozaki holds diverse experience in both public and private investments. Prior to joining DCVC, Dr Shiozaki was a Partner at Novo Ventures where he managed the firm’s public equities strategy for SMIDcap and late-stage biotech and medtech companies. His earlier roles include Director at Apposite Capital and Associate at Burrill & Company. Trained as a structural biologist, Dr Shiozaki was a Leukemia & Lymphoma Society Post-Doctoral Fellow.

Dr Shiozaki is the first keynote speaker announced for AusBioInvest 2024, a premier one-day event featuring keynote presentations and panel discussions from local and international life science investment specialists on topics including industry trends and market updates.

AusBioInvest 2024 directly connects the investment community with innovative companies, enabling Australian life science companies to present their business case in an eight-minute pitch to a room full of investors. Its business partnering system and on-site networking lounge offer additional networking opportunities for both investors and companies.

AusBiotech invites qualified investors, including venture capital firms, private equity investors, high-net-worth individuals, research analysts, brokers, family offices, to access their complimentary tickets to attend AusBioInvest 2024, providing them with a valuable opportunity to make meaningful connections with companies, hear the latest market updates, and explore potential investment prospects. Register your interest here.

Biotech companies are also being invited to register their interest to pitch at AusBioInvest 2024 to a global audience of investors, industry executives, and key stakeholders. Join the investee cohort alongside BiomeBank, Evithé Biotechnology, Immuron Limited (AX:IMC), Invion (ASX:IVX), Nyrada (ASX:NYR), and PharmAust Limited.

Delegates can also register now.

AusBioInvest 2024 is proudly supported by Host State Partner the Victoria State Government.

Noxopharm targets clinical trial for first-in-class investigative therapy

Tue, 20 Aug 2024 00:00:00 +1000

Chimeric says Phase 1/2 CHM CDH17 CAR-T GMP manufacturing complete

Tue, 20 Aug 2024 00:00:00 +1000

De Motu Cordis welcomes FDA approval of needle-free anaphylaxis treatment

Tue, 20 Aug 2024 00:00:00 +1000

AusBiotech selected as Industry Partner Organisation for Australia’s Industry Growth Program

Thu, 15 Aug 2024 00:00:00 +1000

AusBiotech, Australia’s leading life science organisation, has been announced as an Industry Partner Organisation (IPO) under the Australian Government’s Industry Growth Program (IGP).

AusBiotech welcomed its selection as an Industry Partner Organisation to provide support for startups and small to medium enterprises (SMEs).

The program will see AusBiotech deliver a commercialisation advisory support service for Australian biotech and medtech companies that are part of the Industry Growth Program. AusBiotech will leverage its deep industry expertise and networks to support mentoring and connection for small to medium sized enterprises (SMEs) moving through research translation and commercialisation.

Comments from AusBiotech CEO, Rebekah Cassidy

“AusBiotech is a connected network of over 3,000 members representing the whole Australia’s life sciences value chain from spin-outs and SMEs, through to research institutes to large international companies. As the leading voice of Australia’s biotech industry representing the interests of Australia’s innovative life sciences community, supporting SMEs to grow along their commercialisation journey has been at the heart of our work for almost 40 years.”

“Now, as an Industry Partner Organisation with the Industry Growth Program, we are perfectly positioned to collaborate, and leverage our vast network and deep industry connection, for the benefit of Program participants.

“By engaging and collaborating across the sector we will support mentoring, capability building, international connection, and access to capital opportunities for participants.

“Almost 80 percent of Australia’s life sciences companies are SMEs with the majority pre-revenue and in the process of commercialisation or translation of research, which is why programs such as this are so important. We’re grateful to the Government for their ongoing support of our industry and are looking forward to working closely with the Industry Growth Program and other Industry Partner Organisations to support participant success”

About the Industry Growth Program

The IGP grants aim to translate more world-leading Australian know-how into viable businesses, growing the pipeline of investment-ready projects for the $15 billion NRF to consider. The Industry Partner Organisations will provide specialised advisory services to start-ups and high-growth SMEs who are participating in the programme, complementing the work of the IGP’s advisers.

-ENDS-
Media enquiries: Annabelle Dick, Communications & Media Manager, AusBiotech,
adick@ausbiotech.org / M: +61 (0) 437 075 209

About AusBiotech

AusBiotech is Australia’s biotechnology organisation, working on behalf of members for more than 38 years to provide representation and services to promote the global growth of Australian biotechnology. AusBiotech is a well-connected network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), food technology and agricultural sectors.

Remembering industry champion and leader Dr Iris Depaz

Thu, 15 Aug 2024 00:00:00 +1000

AusBiotech is deeply saddened by the loss of Dr Iris Depaz, a long-standing advocate, and champion of Australia’s biotech sector who was known for her visionary leadership and commitment to advancing Australia’s biotech sector.

As an AusBiotech Board Member, Head of Medical Vaccines and Managing Director of the Translational Science Hub in Queensland at Sanofi, Dr Depaz held an unwavering commitment to our sector. She was a hands-on advocate for Australian medical innovation and better health for all Australians. Beyond this, Iris was well known for her warmth, care and compassionate leadership.

Dr Iris Depaz was elected to the AusBiotech Board in November 2023, bringing with her more than 20 years of local, regional and global industry experience, and specialist skills and experience to support growth of Australia’s pharmaceutical and biotech sectors.

“Iris’s positive impact on Australia’s biotech ecosystem will be felt for decades to come,” said Rebekah Cassidy, CEO of AusBiotech.

“Her loss will be heavily felt by our AusBiotech Board and team, and anyone who had the pleasure of knowing her. Iris was not only a strong advocate and leader, but she was also a trusted advisor and dear friend. Our thoughts are with Iris’s family, friends, and close colleagues during this incredibly difficult time.”

Recognising the capability of Australia’s life sciences sector, Iris was deeply passionate about the opportunities investment in the sector could create for Australia as it seeks to diversify its economy and retain the significant talent that exists within our medical and scientific communities.

“Iris was a caring, enthusiastic, and fierce leader, who was passionate about the role Australia should play in the global industry,” said Dr James Campbell, Chair of AusBiotech.

“The AusBiotech Board saw her as a leading light for the sector and someone who deeply cared about advancing industry for the betterment of all Australians. Iris’s loss will have a profound impact on our Board, sector, and all of those who had the good fortune to work with her.”

Iris’s leadership was integral in the development of Sanofi’s Translational Science Hub, a $280 million partnership with the Queensland Government, University of Queensland and Griffith University. One of her key objectives as the Hub’s Managing Director was to enhance the Australian biomedical ecosystem.

Separate to her role at Sanofi, Dr Depaz was a staunch advocate of the power of digital technology and realising opportunities to evolve digital healthcare platforms in Australia. She has previously been a Director of a blockchain and AI start-up, that aimed to empower patients to make informed healthcare decisions via ownership of their own data.

An appropriate tribute will be held at the right time, this will be led by Sanofi who are supporting Iris’s family.

A funeral service will be held in Brisbane on Tuesday 20 August. Iris’s family extends an invitation to all who knew her. Details are available here.

Noxopharm announces CRO-67 results in complex pancreatic cancer studies

Thu, 15 Aug 2024 00:00:00 +1000

Immutep announces first participant dosed in Phase 1 study of IMP761

Thu, 15 Aug 2024 00:00:00 +1000

New clue into the curious case of our ageing immune system

Thu, 15 Aug 2024 00:00:00 +1000

Federal Government announces National Science Statement and National Science and Research Priorities

Tue, 13 Aug 2024 00:00:00 +1000

AusBiotech has noted the announcement of the new National Science Statement and National Science and Research Priorities, with the updated framework reflecting Australia’s need for resilient and sustainable solutions with science and innovation at the core.

The Statement lists five collective imperatives that will shape Australian science investment over the next decade. These include:

Australian scientists, science institutions, and infrastructure shaping Australia’s science future;
Science at the centre of Australian industry;
A diverse, skilled workforce to underpin the translation of science into new industries;
Embracing science to drive Australia’s regional and global interests; and
A science system prepared for future challenges.

In the Statement, each imperative includes three to four targets to recognise and implement the imperative into science activities.

AusBiotech was pleased to note that ‘Supporting healthy and thriving communities’ was noted as one of the five priorities that will guide government, university and private sector efforts:

Transitioning to a net zero future – to develop and adopt next generation technologies, particularly in clean energy and storage, advanced materials, artificial intelligence, quantum and robotics.
Supporting healthy and thriving communities – so more Australians can enjoy healthier lives from birth well into old age.
Elevating Aboriginal and Torres Strait Islander knowledge systems – to empower Aboriginal and Torres Strait Islander people particularly to have more of a say in advancing research that affects them.
Protecting and restoring Australia’s environment – to mitigate the impacts of climate change and protect our biodiversity, diverse landscapes and ecosystems.
Building a secure and resilient nation – to strengthen our democratic institutions while addressing economic, social, geopolitical, defence and national security challenges.

AusBiotech looks forward to continuing to work with the Federal Government to ensure industry voice is heard in the development of policies related to life sciences in Australia and help to bring ongoing clarity to the Federal Government’s priorities for our sector.

You can read more about the statement here, and more about the priorities here.

Cell therapy company Chimeric announces collaboration with Cell Therapies

Tue, 13 Aug 2024 00:00:00 +1000

CSL reports strong profit growth for full year 2024

Tue, 13 Aug 2024 00:00:00 +1000

'We think the life sciences sector should be central to our national growth'

Tue, 13 Aug 2024 00:00:00 +1000

New funding available for quantum technologies and advanced manufacturing

Thu, 08 Aug 2024 00:00:00 +1000

The first round of Australia’s Economic Accelerator (AEA) grants is now open, with $180 million in funding available for researchers and industry partners to commercialise research related to the Federal Government’s priority areas.

The AEA is designed to build a research commercialisation ecosystem from discovery research through to commercialisation, ensuring Australia reaps the benefits of investment in research within the university sector.

The $1.6 billion AEA programme currently offers funding through AEA Ignite (proof-of-concept) and AEA Innovate (proof-of-scale) grants for projects

AEA Ignite provides up to $500,000 per grant for TRL 3, 4, or 5 projects for up to 12 months, while AEA Innovate provides up to $5 million per grant for TRL 5, 6, or 7, for up to 24 months respectively.

AEA-funded projects must be in one of the National Reconstruction Fund (NRF) Corporation priority areas, which include renewables and low emission technologies, medical science, transport, value-add in the agriculture, forestry and fisheries, value-add in resources, defence capability, and enabling capabilities.

Within these priorities, the first round of AEA funding will prioritise projects that align with one or more of the following areas: critical and strategic minerals processing, sustainable fuels, digital agriculture, quantum, artificial intelligence (AI), and advanced manufacturing.

Organisations must be an Australian public university, Australian private university, or an Australian organisation in the ‘University College’ category to be eligible for funding.

The AEA will initially run over ten years from 2023 to 2032, supported with funding from the $1.6 billion investment by the Australian Government in the research commercialisation ecosystem. The program is part of the Australian Government’s research commercialisation agenda, and forms part of its efforts to supercharge commercialisation of Australia’s world leading research in the university sector.

Applications close 28 August 2024. Find out more and apply here.

Researchers develop ground-breaking immunotherapy for aggressive brain cancer

Thu, 08 Aug 2024 00:00:00 +1000

Pfizer upgrades Melbourne plant making it one of the most advanced facilities in Australia

Thu, 08 Aug 2024 00:00:00 +1000

AusBiotech announces Deputy CEO

Tue, 06 Aug 2024 00:00:00 +1000

AusBiotech is pleased to welcome Ms Rosanne Hyland as Deputy Chief Executive Officer after serving as Business Manager and Chief Operating Officer for five years.

Over the past five years, Rosanne has led the day-to-day operations of AusBiotech, covering finance, human resources, IT/operations and events. She also served as Acting CEO for the six months until May 2024, providing steadfast leadership and continuity of the organisation.

Within her new capacity as Deputy CEO, Rosanne will continue to oversee day to day operations while also working closely with the CEO, Rebekah Cassidy, to embed member value in all parts of the organisation’s operations.

AusBiotech CEO Rebekah Cassidy said:

“I couldn’t be more pleased to confirm Rosanne as AusBiotech’s Deputy CEO. Since joining the organisation, I have been impressed by her genuine dedication to our members and her passion for the growth of Australia’s life sciences sector.”

“As Australia’s peak body representing our life sciences industry, AusBiotech is always focused on meeting its members’ needs. However, we also have an opportunity to continually find new ways to hear the voices of our 3000+ members and ensure our organisation is orientating its activities and actions toward their quickly evolving environment. Rosanne’s passion for our members’ success, coupled with her two decades of leadership, operational, and financial management expertise, perfectly position her to help as we do this.”

Newly appointed Deputy CEO Rosanne Hyland said:

“I am privileged to be taking on the role of Deputy CEO, working closely with Rebekah to provide member focused leadership cross our organisation and our sector. There’s no doubt that Australia’s life sciences industry is poised for future growth. Making sure we can hear member voice at speed to enable their success must be one of our highest priorities. Getting to do that with our hardworking AusBiotech team, including our fantastic membership engagement team, is an honour.”

About Rosanne Hyland

Rosanne Hyland is a senior executive with more than 20 year’s experience growing teams and leading the operations of large, complex organisations. She joined AusBiotech in 2019 as Business Manager, was appointed Chief Operating Officer in 2021 and served as Acting CEO for the period between December 2023 and May 2024. Prior to joining AusBiotech, Rosanne was General Manager of The Prince Hospitality Group for 15 years where she was responsible for 20 individual businesses, employing over 700 people.

Personalised cancer vaccines to be produced at new UQ lab

Tue, 06 Aug 2024 00:00:00 +1000

Rosanne Hyland appointed AusBiotech Deputy CEO

Mon, 05 Aug 2024 00:00:00 +1000

Ms Rosanne Hyland has been appointed as Deputy Chief Executive Officer of AusBiotech, Australia’s peak association for the life sciences industry, after serving as Business Manager and Chief Operating Officer for five years.

AusBiotech CEO Rebekah Cassidy said:

Newly appointed Deputy CEO Rosanne Hyland said:

About Rosanne Hyland

-ENDS-

Media enquiries: Annabelle Dick, Communications & Media Manager, AusBiotech,
adick@ausbiotech.org / M: +61 (0) 437 075 209

About AusBiotech: AusBiotech is Australia’s biotechnology organisation, working on behalf of members for more than 38 years to provide representation and services to promote the global growth of Australian biotechnology. AusBiotech is a well-connected network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), and other sectors.

AusBiotech welcomes more new members in the second quarter

Thu, 01 Aug 2024 00:00:00 +1000

As the national peak body for life sciences and Australian life sciences innovators, AusBiotech welcomed a large number of new members between May and June this year including: AlphaRET, Canary Regulatory Affairs, CBE Pure Solutions, Charles River Laboratories Australia, Chimeric Therapeutics, Formrite Group, MahPharma, McCullough Robertson Lawyers, Nyrada Inc, PharmAust, TekCyte, UTS Faculty of Science, Viedoc Technologies AB, and Wellumio.

AusBiotech CEO, Rebekah Cassidy said, “We couldn’t be more pleased to welcome these new members to our 3,000+ strong nation-wide community of life science companies, services, senior leaders, researchers and experts from across our industry’s value chain.”

“AusBiotech’s ongoing strength of membership means we are perfectly positioned to truly hear and understand the evolving needs of our diverse and growing industry, build connections, and provide an informed, strong representative voice to government and other stakeholders.”

“My team and I are looking forward to working with our new members to provide value and collectively build Australia’s biotechnology ecosystem.”

AusBiotech’s new members include:

AlphaRET Pty Ltd is a wholly owned subsidiary of Nova Eye Medical Limited. AlphaRET Pty Ltd is a special purpose entity established to commercialise 2RT®, a nano-pulse ophthalmic laser technology that is a breakthrough treatment for Age related Macular Degeneration (AMD).
Canary Regulatory Affairs Pty Ltd is a consultancy established to help bring new treatments to patients globally. Canary assists companies at all stages of product development, from the selection and project management of suppliers for raw materials and specialised GMP, GLP and GCP compliant service providers, to the preparation of study protocols and reports. Canary supports product registration by establishing an early dialogue with international regulatory authorities and through the preparation of regulatory dossiers.
CBE Pure Solutions is an Australian-based contract manufacturing organisation, supporting companies in the development, translation, and commercialisation of a range of life science products through fill and finish and microbiological testing services.
Charles River Laboratories Australia Pty Ltd supports a wide range of microbial identification methods, endotoxin testing and Rapid microbial methods. Its Australian site offers a progressive portfolio of quality control testing solutions for the pharmaceutical, medical device, and consumer care industries to help bring products to market safely and efficiently.
Chimeric Therapeutics Ltd (ASX:CHM) is a clinical stage cell therapy company and focused on bringing the promise of cell therapy to life for more patients with cancer. Chimeric's team of cell therapy pioneers and experts is focused on the discovery, development, and commercialisation of the innovative and promising cell therapies. Chimeric currently has a diversified portfolio that includes two autologous CAR-T cell therapies and allogeneic NK cell therapies.
Formrite Group Pty Ltd is an NSW-based service provider that designs, manufactures, and distributes formed plastic packaging and displays, including custom designed medical packaging, for businesses across Australia.

MahPharma are experts in the storage, distribution, labelling and packing of clinical trial materials in APAC and Global regions. Its GMP is designed to meet the needs of clinical trial sponsors, contract research organizations (CROs), and other vendors involved in the clinical trial supply chain.
McCullough Robertson Lawyers is a leading independent Australian law firm with more than 350 employees located across offices in Brisbane, Sydney, and Canberra. Its life sciences team is one of the largest nationally with clients ranging from ASX-listed life sciences companies, to emerging companies, universities, and research institutes.
Nyrada Inc (ASX:NYR) is a US registered, Australia domiciled, drug discovery and development company specialising in first-in-class, small molecule drugs to treat neurological and cardiovascular diseases. Nyrada’s two main programmes are a cholesterol-lowering drug and a drug to treat brain injury, specifically stroke and traumatic brain injury (TBI).
PharmAust Limited is a clinical-stage biotechnology company developing new therapeutics for human and animal health applications. The company is repurposing monepantel for the treatment of cancer in dogs and neurodegenerative diseases in humans.

TekCyte was incorporated in May 2018 as a spin out of the CRC for Cell Therapy Manufacturing. It is a B2B enterprise developing novel nano-scale coatings that can improve the safety and performance of medical devices. The company’s main focus is on biofilm-resistant coatings to help reduce the incidence of infection associated with implantable devices.
University of Technology (UTS), Faculty of Science – as the University Technology of Sydney's science faculty, UTS Faculty of Science is committed to changing the world through exceptional graduates, impactful scientific research, and innovative technology. UTS Science currently homes over 2,500 undergraduate and postgraduate students and over 340 academic, technical and professional staff members.
Viedoc Technologies AB provides innovative software designed to increase collaboration across the clinical trials industry by streamlining the electronic data capture (EDC) process. Since 2003, its eClinical solution has supported more than 5,000 studies by collecting data from patients and allowing it to flow smoothly and securely across sites and countries.

Wellumio is a medical technology startup developing an ultra-portable MRI scanner (Axana) with a primary focus on early diagnostic triage for acute stroke, a leading cause of human mortality and disability. Co-founded in 2019 and led by co-CEOs Dr Shieak Tzeng and Dr Sergei Obruchkov, the company’s mission is to advance the availability and affordability of point-of-care imaging. Wellumio's second-generation scanner, Axana, achieves a 99% weight reduction compared to conventional MRI, establishing it as the most portable imaging system in the global USD15B mobile imaging services market.

ANU researchers working to unlock the full potential of RNA

Thu, 01 Aug 2024 00:00:00 +1000

Pharmaceutical manufacturer tops revenue guidance in latest update

Thu, 01 Aug 2024 00:00:00 +1000

Imagion Biosystems announces changes to its board of directors

Thu, 01 Aug 2024 00:00:00 +1000

TGA seeks views on therapeutic goods testing regulations

Tue, 30 Jul 2024 00:00:00 +1000

The Therapeutic Goods Administration (TGA) is seeking industry feedback on potential reforms to Part 5 of the Therapeutic Goods Regulation (the Regulations) 1990, with the aim of developing a modernised framework.

Part 5 of the Regulations sets out procedures for examination, testing and analysis of goods to be conducted under the TGA’s regulatory framework. Currently, this Part is applicable to only a subset of the regulators sampling and testing activities.

In line with the Department of Health & Aged Care’s Health Regulatory Policy Framework (HRPF), the TGA is conducting a review of the Regulations to determine the suitability of Part 5. Feedback is being sought from industry on proposed changes to the Regulations, to ensure the exercise effectively balances consumer safety without imposing unnecessary burden on industry.

The TGA has considered whether Part 5 of the Regulations is fit for purpose; takes into account the latest innovations; is efficient to comply with and administer; is effective in achieving its outcomes; and is fair transparent, and resilient. The review has found Part 5 does not meet these criteria.

Four key problems were identified in the review, specifically:

Limited application of the testing framework;
Prescriptive processes that are inflexible, unclear and burdensome;
Complex and inefficient procedures regarding the evidentiary certificate; and
Insufficient protection for staff while performing their duties.

A number of legislative reforms have been proposed to strengthen and modernise the legislative framework for the examination, testing, and analysis of therapeutic goods. These proposed changes aim to improve the clarity and functionality of the arrangements in Part 5. These include:

Broadening the application of the testing framework to increase the scope of samples that can be tested under the framework, as well as where and how samples can be obtained, or received for testing;
Clarifying and streamlining processes and definitions;
Amending procedures for the requirements, release of information and reliance on evidentiary certificate; and
Expanding the provision for offences relating to intimidation of staff members in the conduct of their duties.

The TGA is seeking feedback from both consumers and industry on proposed reforms to ensure this improvement activity strikes the right balance of safety for patients without imposing unnecessary regulatory burden on industry.

The consultation closes on 18 August. Read the full consultation paper here.

Race Oncology says Bisantrene meets predetermined efficacy criteria in Phase 2 trial

Tue, 30 Jul 2024 00:00:00 +1000

Monash welcomes funding for new national centre for mRNA medicines

Tue, 30 Jul 2024 00:00:00 +1000

Cochlear announces the appointment of Caroline Clarke to its board

Tue, 30 Jul 2024 00:00:00 +1000

Remembering Nobel Laureate Professor Robin Warren AC

Thu, 25 Jul 2024 00:00:00 +1000

Emeritus Professor (John) Robin Warren AC is remembered for his pioneering work discovering the bacterium Helicobacter pylori (H. pylori) and its role in gastritis and peptic ulcer disease, after passing away at age 87.

AusBiotech fondly remembers distinguished Australian pathologist Emeritus Professor Robin Warren AC, who is celebrated for his contributions to gastroduodenal disease treatment.

Professor Warren and Professor Barry Marshall AC were jointly awarded the Nobel Prize in Physiology or Medicine in 2005 for discovering the bacterium H. pylori played a key role in the development of stomach and intestinal ulcers and inflammation.

In 1979 while working in Perth, Professor Warren observed small, curved bacteria colonising the lower part of the stomach (antrum) in about 50% of patients from which biopsies had been taken. He made the crucial observation that signs of inflammation were always present in the gastric mucosa close to where the bacteria were seen.

Professor Marshall, then a young clinical fellow, became interested in Professor Warren’s findings. Professor Warren began to work with Professor Marshall in 1981 and together they initiated a study of biopsies from 100 patients.

After several attempts, Professor Marshall succeeded in cultivating a hitherto unknown bacterial species (later denoted Helicobacter pylori) from several of these biopsies. Together they found that the organism was present in almost all patients with gastric inflammation, duodenal ulcer or gastric ulcer.

This revolutionary discovery was at first rejected by the medical fraternity but ultimately led to a cure for peptic ulcers. Professor Warren also helped develop a convenient diagnostic test (14 C-urea breath-test) for detecting H. pylori in ulcer patients.

It was previously thought stomach ulcers were caused by stress and lifestyle factors. This trailblazing work has revolutionised the approach to gastroduodenal disease, and turned a long-term debilitating illness into a condition easily treated with antibiotics.

The pair, who were both professors at the University of Western Australia during this research, were the first recipients of a Nobel Prize to be awarded for research undertaken in WA.

In addition to the numerous scientific awards for their work on H. pylori they received Australia’s highest civilian honour, the Companion of the Order of Australia (AC).

Born in Adelaide in 1937, Professor Warren attended medical school at the University of Adelaide.

After training at the Royal Melbourne Hospital in 1967, Professor Warren was admitted to the Royal College of Pathologists of Australasia. He then moved to Perth to work as a senior pathologist at the Royal Perth Hospital, where he spent the majority of his career.

Professor Warren passed away peacefully on 23 July 2024 in Perth, Western Australia surrounded by family.

Telix completes significant raise that could be used for acquisitions

Thu, 25 Jul 2024 00:00:00 +1000

Orthocell moves ahead on global market expansion with seven new regulatory applications

Thu, 25 Jul 2024 00:00:00 +1000

AusBiotech Early-Stage Innovation Forum opens

Tue, 23 Jul 2024 00:00:00 +1000

AusBiotech is calling for expressions of interest from researchers and inventors interested in pitching their innovation at our upcoming Early Stage Innovation Forum (ESIF) to be held at the AusBiotech 2024 national conference in Melbourne.

The ESIF rapid-fire pitch competition provides presenters the opportunity to pitch their early-stage innovation to a panel of expert judges for feedback, with the October 30 ESIF competition focusing on early-stage human therapeutic and enabling technology projects.

This exclusive opportunity offers early-stage projects and technologies the chance to gather feedback essential for commercialising early-stage projects and technologies from a panel of industry experts as well as corporate VCs and early-stage investors.

During a seven-minute presentation, presenters will be required to outline the problem they are trying to address, their innovative approach to solving the problem, the technology’s competitive advantage, development plan and investment proposal. Submissions are open to investible projects from Australian research institutions or companies seeking seed or series A investment.

Companies that have advanced past seed and series A investment are encouraged to submit their expression of interest to present at Australia’s premier life science investment conference, AusBioInvest, in Melbourne on October 29.

The Forum is run bi-annually and, together, features presentations from Australia's local research institutes, universities, hospitals, and pre-series A companies, in the areas of human therapeutics, enabling technologies, medical devices, diagnostics, and digital health.

QIMR Berghofer’s A/Prof Michelle Wykes, joint winner of Best Translational Research at the AusBiotech 2023 ESIF, said: “I am so grateful for the opportunity to present my work as a medical researcher and founder to leading industry experts, VCs and investors at the Early-Stage Innovation Forum. My company Fovero Therapeutics [was] just six months old, and the event marked my first time making a public pitch to the investment community. I was incredibly excited to win and the experience has given me a huge shot of confidence as I continue promoting Fovero’s work to investors.

“At the end of the day, events like the ESIF keep spurring me forward in my ultimate goal - to improve outcomes for cancer patients who desperately need more treatment options.”

Read about the AusBiotech 2023 ESIF winners, A/Prof Michelle Wykes (QIMR Berghofer) and Dr Craig McIntosh (Murdoch University), in the April 2024 edition of the Australasian Biotechnology journal here (pages 16-18).

To register your project or company to present at the ESIF, visit the AusBiotech 2024 website.

Submissions received by 1 September will be reviewed by the appointed Advisory Group, and applicants will be contacted with further information once the evaluation process is complete on or before 11 September 2023.

Chimeric Therapeutics says first patient enrolled in cell therapy trial

Tue, 23 Jul 2024 00:00:00 +1000

Noxopharm says several companies evaluating its assets

Tue, 23 Jul 2024 00:00:00 +1000

Neuren secures Rare Paediatric Disease Designation from FDA

Tue, 23 Jul 2024 00:00:00 +1000

Views sought in National Health and Medical Research Workforce Audit

Thu, 18 Jul 2024 00:00:00 +1000

The Department of Health and Aged Care is undertaking the survey to understand the demographic features, work environment, challenges, and motivations of health and medical researchers across Australia.

The Department is conducting a national audit of the Health and Medical Research Workforce (the Audit) to help inform the development of the National Health and Medical Research Strategy (National Strategy), and support future policy planning on matters that impact health and medical researchers in Australia.

As part of this Audit, the Department is conducting a national survey to understand the demographic features, work environment, challenges, movements and motivations of health and medical researchers across Australia.

Views are being sought from individuals who have worked in Australia’s health and medical research space at some point. Individuals may be in:

a direct research role (performing research as a primary or secondary activity, in paid or unpaid roles including research students, and in university, medical research institutes, industry, health services or other settings), or
a supportive role (not directly performing research yourself but supporting those who do, e.g. clinical trial coordinator, research nurses, biostatistician, laboratory technician, medical product research and development, research support officer, etc), or
a non-research role currently, but have had one or more of the roles above in the past.

The Department will use the survey to form an accurate and broad picture of the health and medical research workforce to inform the Strategy.

In May 2024, the Department announced it will be developing the National Strategy to build on our national strengths and fill any gaps, while attracting researchers and investors to Australia. The need for a National Strategy has been one of the consistent messages the Government has heard from across the health and medical research sector.

The Government consulted with the sector throughout 2023 on ideas to better align the work of the NHMRC and MRFF, of which AusBiotech submitted an industry-led response to. The outcomes of that consultation are currently under consideration by the Government. The National Strategy will cover the entire sector and include all levels of government, industry, philanthropy, academia and consumers.

The survey can be accessed here and will be open until Friday 9 August.

It should take approximately 15 – 25 minutes to complete the survey, with the ability come back to the survey and complete it prior to submission.

Any enquiries regarding the survey or the Workforce Audit can be sent to HMRWorkforceAudit@health.gov.au.

Burnet senior research officer awarded Moderna Global Fellowship

Thu, 18 Jul 2024 00:00:00 +1000

Queensland-based De Motu Cordis progresses development of innovative anaphylaxis treatment

Thu, 18 Jul 2024 00:00:00 +1000

Alterity Therapeutics reports positive interim data from Multiple System Atrophy trial

Thu, 18 Jul 2024 00:00:00 +1000

New Perth based RNA facility to improve cancer outcomes

Thu, 18 Jul 2024 00:00:00 +1000

Dimerix awarded Bioshares Excellence Award

Tue, 16 Jul 2024 00:00:00 +1000

ASX-listed AusBiotech member Dimerix (ASX:DXB) takes out the Blake Award for Excellence after a knock-out year including an FDA conditional approval and key commercial partnerships.

Clinical-stage biopharmaceutical company Dimerix was awarded the Blake Award for Excellence (the Blakey) at the recent Bioshares Biotech Investment Summit in Fremantle, Western Australia.

In May 2024, Dimerix inked a deal worth AU$120.5 million with Taiba, providing Taiba with exclusive rights to register and commercialise DMX-200 for the treatment of kidney disease in key Middle East countries including United Arab Emirates (UAE), Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq.

This comes after Dimerix struck a $230m licensing deal with multinational pharmaceutical company Advanz in October 2023, which covers the European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand for commercialisation of DMX-200 for the treatment of focal segmental glomerulosclerosis (FSGS) following regulatory approval.

The FDA granted Dimerix conditional approval for the brand name QYTOVRA for its DMX-200 in September 2023. Since the FDA’s conditional approval was granted, Dimerix’s share price has risen from $0.070 (as at 25 September 2023) to $0.52 cents (as at 16 July 2024). Dimerix ranked #5 in the Q1 2024 top earner rankings according to the latest AusBioStocks data (March 2024) which tracks Australia’s 178 ASX-listed life science companies.

The drug development company was awarded the Blakey Award during the two-day summit held in Freemantle on 12-13 July, with company CEO Nina Webster accepting the accolade on behalf of the company.

Dimerix announced positive interim analysis results in March 2024 from its ACTION3 Phase 3 trial of DMX-200 in patients diagnosed with rare kidney disease FSGS. The positive Phase 3 interim analysis results pushes DXB-200 a step closer to potential market approval, following 12 years of work since the drug was first identified for use in the kidney.

Interim analysis indicates that DMX-200 is currently outperforming the placebo in reducing proteinuria, as measured statistically, within a significantly larger participant group compared to its earlier Phase 2 trial involving eight patients. Dimerix reported that the interim analysis suggests the potential for a statistically significant and clinically meaningful reduction in proteinuria at the study’s conclusion.

Dimerix’s ACTION3 clinical trial has now formally expanded into Part 2 of the study and to April 30, 2023, had randomised and dosed 98 patients with FSGS. The second interim analysis is planned to be carried out after the first 144 patients complete about 35 weeks of treatment.

Attracting round 200 of Australia’s leading company executives and investors, the Bioshares Biotech Investment Summit features around 25 speakers with special sessions, master classes, and presentations focused on central themes to explore in-depth business operations and challenges that are relevant to many companies in the sector.

The Bioshares Biotech Investment Summit was first founded by David Blake and Mark Pachacz, the co-editors and independent analysts behind the popular Bioshares publication.

The Summit was established to enable investors and CEOs to meet and gain greater insights, away from day-to-day business pressures. The Summit began as a high-level event that has become a feature of the biotech investment calendar in Australia as well as an excellent networking opportunity.

In 2022 the Blake Award for Excellence (‘The Blakey’) was introduced in recognition of Bioshares Co-Founder David Blake and the significant impact he had on the sector. The inaugural winner in 2022 was Telix Pharmaceuticals for the rapid commercialisation of its radiopharmaceutical pipeline, while Neuren Pharmaceuticals took out the 2023 award for the development, regulatory approval, and successful market launch of DAYBUE™ for Retts syndrome, with US partner Acadia.

Bio Innovation Hub opens opportunities for new disease treatments

Tue, 16 Jul 2024 00:00:00 +1000

Merck expands its fertility benefit to employees in New Zealand

Tue, 16 Jul 2024 00:00:00 +1000

Immutep reports positive results from trial of combination cancer therapy

Tue, 16 Jul 2024 00:00:00 +1000

Nominations sought for new shared MRFF and NHMRC advisory committees

Thu, 11 Jul 2024 00:00:00 +1000

Shared advisory committees to be established following the Australian Government’s consultation on improving the Department of Health’s Medical Research Future Fund (MRFF) and NHMRC’s Medical Research Endowment Account’s (MREA) alignment.

The Department of Health and Aged Care and the National Health and Medical Research Council (NHMRC) are seeking nominations for four advisory committees that will support both federal funds by advising on research strategies and funding policies.

This comes after the Australian Government’s 2023 national consultation on Improving alignment and coordination between the Medical Research Future Fund and NHMRC’s Medical Research Endowment Account (MREA), which AusBiotech responded to with an industry-led submission.

While the Government is considering its formal response on the consultation, the NHMRC and Department are progressing work to improve alignment and coordination, including establishing a range of shared advisory committees.

The four shared advisory committees are:

NHMRC-MRFF Consumer Advisory Group – to advise on consumer and community involvement in health and medical research, including on strengthening consumer involvement in MREA and MRFF grant programs
NHMRC-MRFF Industry, Philanthropy and Commercialisation Committee – to advise on industry and philanthropic involvement in health and medical research and strategies to foster greater research commercialisation
NHMRC-MRFF Public Health and Health Systems Committee – to advise on strategies for strengthening preventive health, public health, primary care and health services, and for embedding research translation in the Australian health system
NHMRC-MRFF Indigenous Advisory Group – to advise on health research involving Aboriginal and Torres Strait Islander communities and capacity building for health researchers who identify as Aboriginal or Torres Strait Islander.

Nominations are being sought from individuals interested in the role of research in improving health outcomes for the Australian community, including but not limited to; consumers and community members, industry representatives, philanthropy representatives, physicians and other clinicians, and researchers in all areas of health and medical research and at all career stages.

Nominees may be asked to serve more than one committee, noting that all committees will have a consumer representative/s and an Aboriginal and Torres Strait Islander representative/s.

To apply to be an advisory committee member, visit the NHMRC website here. A diagrammatic overview of the advisory committee structure is also available to download on the NHMRC website.

Nominations close 5PM AEST on Wednesday 31 July 2024.

The New Medicines Manufacturing Innovation Centre opens at Monash

Thu, 11 Jul 2024 00:00:00 +1000

Telix welcomes CMS proposal to improve payment for specialised diagnostic radiopharmaceuticals

Thu, 11 Jul 2024 00:00:00 +1000

Orthocell receives regulatory approval to commence sales of Striate+ in Canada

Thu, 11 Jul 2024 00:00:00 +1000

Dr James Campbell appointed AusBiotech Chair

Tue, 09 Jul 2024 00:00:00 +1000

Dr James Campbell, CEO & Managing Director, Patrys Limited, has been appointed as Chair of AusBiotech following a unanimous vote of the Board.

Dr Campbell was initially appointed as a Non-Executive Director of AusBiotech in April 2021 and has been interim Chair since November 2023. During this time, he has brought significant focus to AusBiotech’s role as the leading voice to government, investors and the international community on behalf of Australia’s growing life sciences sector. His appointment as Chair comes following a unanimous request from, and vote of, the Board.

Comments from AusBiotech Chair, Dr James Campbell

“It’s an extraordinary privilege to be appointed Chair of AusBiotech and to lead our organisation in partnership with the Board and our CEO, Rebekah Cassidy, at such a pivotal time for our members.”

“As Australia’s biotech, medtech, and diagnostics companies scale up and out, it’s crucial that AusBiotech continues to strengthen its role as the informed, leading and trusted voice of our sector. Our strategic trajectory over the coming years must be one of growth and transformation for the benefit of our members.

“With Australia continuing to modernise its economy and bring national focus to its sovereign capabilities in key industries including life sciences, AusBiotech has the opportunity to deliver a collaborative, clear and aligned voice that supports investment attraction and commercialisation success.

“I’m grateful to my fellow Board members for their invitation to become Chair and their unanimous support. I’m looking forward to continuing to work with them, our CEO, and the dedicated AusBiotech team to achieve our goals.”

Comments from AusBiotech CEO, Rebekah Cassidy

“James’ expansive leadership experience combined with his hands on expertise in commercialising and licensing innovative therapies for patient benefit is of immense value as we build a strong platform for AusBiotech’s renewed strategy.”

“As AusBiotech focuses on how we can collaboratively build the sector’s capabilities and capacity, Board understanding of the opportunities and challenges along the development pathway is critical.

“I’m personally grateful to James and the Board for their support over recent weeks. I’m looking forward to working closely as we lead a new way forward with our committed AusBiotech team.”

About Dr James Campbell

Dr Campbell brings nearly 30 years of international biotechnology management and leadership experience to the AusBiotech Board. He has been involved in the creation and/or transformation of several Australian and international biotechnology companies and is currently the CEO of Patrys Limited (ASX:PAB), an ASX-listed biotech company developing novel antibody therapeutics. Dr Campbell is focused on developing the company’s deoxymab platform where he plans to take Patrys’ lead candidate, PAT-DX1, through clinical trials shortly.

He was previously the CFO and COO of ChemGenex Pharmaceuticals Limited (ASX:CXS), where, as a member of the executive team, he was responsible for intellectual property management, licensing, and business development, and helped transform the research-based company with a market capitalization of $10M to a company with completed clinical trials and regulatory dossiers submitted to the FDA and EMA. In 2011 ChemGenex was sold to Cephalon for $230M.

Dr Campbell was a foundation executive of Evolve Biosystems and executive director of Invion Limited, and has assisted private biotechnology companies in Australia, New Zealand and the USA with successful capital raising and partnering negotiations. Dr Campbell is currently a Non-Executive Director of Prescient Therapeutics Limited (ASX:PTX), and has previously sat on university and CRC advisory boards and commercialisation committees as well as government advisory panels and investment committees of several biotech VCs.

The AusBiotech Board

Chair: Dr James Campbell, CEO, Patrys Ltd
Deputy Chair: Ms Erica Kneipp, Research Director, Human Health, CSIRO
Risk and Audit Sub-Committee, Chair: Dr Megan Baldwin, Chief Innovation Officer, Opthea Ltd (ASX:OPT)
Remuneration and Nomination Sub-Committee, Chair Dr Dean Moss, CEO, UniQuest Pty Ltd
Dr Marthe D’Ombrain, Head of Global Research Innovation, CSL Ltd
Dr Iris Depaz, Country Medical Lead & Head of Medical, Vaccines, Sanofi Australia & New Zealand
Professor John Skerritt, Enterprise Professor in Health Research Impact, University of Melbourne
Dr Liz Dallimore, CEO & Managing Director, Argenica Therapeutics Ltd
Dell Kingsford Smith, VP, Medical Affairs, Market Access & Government Affairs, Cochlear (Board Observer)
Ms Rebekah Cassidy, CEO, AusBiotech

-ENDS-
Media enquiries: Annabelle Dick, Communications & Media Manager, AusBiotech,
adick@ausbiotech.org / M: +61 (0) 437 075 209

Florey biotech spin-out secures seed investment from Curie.Bio

Tue, 09 Jul 2024 00:00:00 +1000

Genetic Technologies' GeneType to enter Canadian and New Zealand markets

Tue, 09 Jul 2024 00:00:00 +1000

Orthocell reports record quarterly and yearly revenue

Tue, 09 Jul 2024 00:00:00 +1000

AusBiotech Board appoints new Chair

Tue, 09 Jul 2024 00:00:00 +1000

Dr James Campbell, CEO & Managing Director, Patrys Limited (ASX:PAB), has been appointed as Chair of AusBiotech following a unanimous vote of the Board.

Dr Campbell, was initially appointed as a Non-Executive Director of AusBiotech in April 2021 and has been interim Chair since November 2023. During this time, he has brought significant focus to AusBiotech’s role as the leading voice to government, investors and the international community on behalf of Australia’s growing life sciences sector. His appointment as Chair comes following a unanimous request from, and vote of, the Board.

Comments from AusBiotech Chair, Dr James Campbell

Comments from AusBiotech CEO, Rebekah Cassidy

“I’m personally grateful to James and the Board for their support over recent weeks. I’m looking forward to working closely as we lead a new way forward with our committed AusBiotech team.”

About Dr James Campbell

He was previously the CFO and COO of ChemGenex Pharmaceuticals Limited (ASX:CXS), where, as a member of the executive team, he was responsible for intellectual property management, licensing, and business development, and helped transform the research-based company with a market capitalisation of $10M to a company with completed clinical trials and regulatory dossiers submitted to the FDA and EMA. In 2011 ChemGenex was sold to Cephalon for $230M.

The AusBiotech Board

Chair: Dr James Campbell, CEO, Patrys Ltd
Deputy Chair: Ms Erica Kneipp, Research Director, Human Health, CSIRO
Risk and Audit Sub-Committee, Chair: Dr Megan Baldwin, Chief Innovation Officer, Opthea Ltd (ASX:OPT)
Remuneration and Nomination Sub-Committee, Chair Dr Dean Moss, CEO, UniQuest Pty Ltd
Dr Marthe D’Ombrain, Head of Global Research Innovation, CSL Ltd
Dr Iris Depaz, Country Medical Lead & Head of Medical, Vaccines, Sanofi Australia & New Zealand
Professor John Skerritt, Enterprise Professor in Health Research Impact, University of Melbourne
Dr Liz Dallimore, CEO & Managing Director, Argenica Therapeutics Ltd
Dell Kingsford Smith, VP, Medical Affairs, Market Access & Government Affairs, Cochlear (Board Observer)
Ms Rebekah Cassidy, CEO, AusBiotech

Top performing ASX companies

Thu, 04 Jul 2024 00:00:00 +1000

ASX-listed life science companies report a new market capitalisation of $252 billion, with Singular Health (ASX:SHG) topping return rankings for Q1, while Biome Australia (ASX:BIO) and Arovella Therapeutic (ASX:ALA) lead in earnings for 2024.

AusBiostock data (March 2024) reveals the 178 ASX-listed life science companies have grown the market capitalisation by $21 billion over the past six months from $231 billion to $252 billion, highlighting the life science sector’s growing economic contribution to the Australian economy.

The data also shows seven percent of listed companies have a market cap of more than $1 billion, while 30 percent of companies are worth more than $100 million. Identified as a key metric in AusBiotech’s Biotechnology Blueprint decadal strategy, the proportion of biotech companies achieving market valuations greater than $100 million measures the industry’s ability to create companies of significant future value.

Biome Australia is reported as the top earner for the year, with a reported share price of $0.39 (as at 8 March 2024) and a market return of 457.14 percent (see full data below). Biome Australia’s share price has jumped from $0.080 to $0.39 over 12 months when comparing April 2023 and March 2024 AusBioStocks data.

Q1 2024 has revealed medical technology company Singular Health topped the rankings with a quarterly return of 237.84 percent, followed by Nyrada Inc (ASX:NYR) at 207.69 percent, PharmAust Ltd (ASX:PAA) at 166.67 percent, Biome Australia at 143.75 percent, and Dimerix Ltd (ASX:DXB) at 122.22 percent.

The variability in the returns listings between Q1 2023 versus 2024 demonstrates the unique nature of biotech investment and global market conditions. 2024 has been a positive year so far for healthcare as the S&P/ASX 200 Health Care index climbed 5 percent, reinforcing the sector’s resilience.

The medical technology sector has been a strong driver for the market with companies such as Pro Medicus Ltd (ASX:PME) and Cochlear Ltd (ASX:COH) both enjoying significant share price increases. Most analyst reports are bullish on healthcare for FY 2025, with strong indications that healthcare could "outperform over the medium-term", with the combination of strong earnings growth, and below-market valuations.

Past performance is not indicative of future returns. This article provides general information about the performance of ASX-listed biotech companies from the period 8 March 2024 to 18 April 2023. It does not constitute personalised investment advice or a recommendation to make any specific investments. All investors should conduct their own due diligence and consult a registered financial advisor before making investment decisions.

AusBiotech invites qualified investors, including venture capital firms, private equity investors, high-net-worth individuals, research analysts, brokers, and family offices, to access their complimentary tickets to attend AusBioInvest 2024, providing them with a valuable opportunity to make meaningful connections with companies, hear the latest market updates, and explore potential investment prospects. Register your interest here.

Biotech companies are also being invited to register their interest here to pitch at AusBioInvest to a global audience of investors, industry executives, and key stakeholders.

Top performers for Q1 2024
2024 (data collected 8 March 2024)			2023 (data collected 18 April 2023)
	Last price	Quarter return %		Last price	Quarter return %
Singular Health	$0.13	237.84	Arovella Therapeutic	$0.08	237.50
Nyrada Inc	$0.08	207.69	Avita Medical	$4.50	85.95
PharmAust Ltd	$0.28	166.67	4Dmedical Limited	$0.84	78.72
Biome Australia	$0.39	143.75	Kazia Therapeutics	$0.20	62.50
Dimerix Ltd	$0.30	122.22	Botanix Pharma Limited	$0.09	61.40
Nova EYE Medical	$0.22	84.01	Neuren Pharmaceuticals	$14.20	58.84
Immuron Ltd	$0.15	83.54	Impedimed Limited	$0.11	57.14
Clarity Pharma	$2.82	79.62	XRF Scientific	$1.29	56.36
Arovella Therapeutic	$0.16	76.14	Cyclopharma Limited	$2.19	46.33
Neurotech Int	$0.10	71.93	Radiopharma	$0.18	29.63

This year’s top ASX life science performers
2024 (data collected 8 March 2024)			2023 (data collected 18 April 2023)
	Last price	Annual return %		Last price	Quarter return %
Biome Australia	$0.39	457.14	Neuren Pharmaceuticals	$14.20	258.59
Arovella Therapeutic	$0.16	384.38	Avita Medical	$4.50	107.37
Oneview Healthcare	$0.36	271.13	Arovella Therapeutic	$0.08	102.50
PharmAust Ltd	$0.28	245.68	XRF Scientific	$1.29	97.74
Clarity Pharma	$2.82	229.82	Telix Pharmaceuticals	$8.89	90.36
Biotron Ltd	$0.08	118.46	Polynovo Limited	$1.71	53.60
Dimerix Ltd	$0.30	154.43	Cryosite Limited	$0.73	51.02
Neuren Pharmaceuticals	$19.95	153.82	Bioxyne Limited	$0.03	47.06
Botanix Pharma Ltd	$0.19	140.26	Cyclopharm Limited	$2.19	46.67
4Dmedical Ltd	$0.79	118.06	Aroa Biosurgery	$1.05	36.60

Dimerix says the recruitment of adolescent patients to commence in Phase 3 trial

Thu, 04 Jul 2024 00:00:00 +1000

Amplia anounces completion of recruitment of first 26 patients in Phase 2 trial

Thu, 04 Jul 2024 00:00:00 +1000

AusBiotech calls for journal articles

Tue, 02 Jul 2024 00:00:00 +1000

AusBiotech is calling for member contributions for the October 2024 edition of the Australasian Biotechnology journal.

AusBiotech is welcoming abstracts from valued members on advancing Australian life sciences with themes including ‘omics and advanced therapies, capital attraction, and complex manufacturing, with articles sought on new approaches, contributions or analyses to include in the October 2024 edition of the Australasian Biotechnology journal.

The journal will also feature a sneak peek into Australia’s premier life sciences conference, AusBiotech 2024, where local and global thought leaders will unite through innovation to highlight the latest advancements, trends, and opportunities currently facing the life sciences sector locally and globally.

Australasian Biotechnology is AusBiotech’s official biannual journal, and published in October and April. Its contributions are written by the sector, for the sector. Contributions can range on topics including technology development, manufacturing, Australian strengths and successes on the world stage, and approaches to strengthening Australia’s end-to-end life sciences value chain.

With its informed and authoritative editorials, Australasian Biotechnology is a highly-effective communications vehicle for those wanting to reach stakeholders in the life sciences sector. The journal is mailed on a name-and-title basis to more than 3,000 AusBiotech members and investors, as well as published digitally. Readership includes companies, government and university departments, research institutes, biotechnology and professional services providers nationally, and in key overseas markets.

Abstracts should be 200 words, and can be sent to AusBiotech Communications by 26 July 2024.

If your abstract is accepted, the full article will be required on or before 15 August 2024. Article lengths are approximately 500 words (1 page) or 1,000 words (2 pages). High resolution photos to accompany articles are encouraged.

Articles are an AusBiotech member-benefit, however there is limited space and so are not guaranteed to be included.

Abstracts are welcomed on research, business news, and sector trends for consideration at any time of the year.

Professor Peter van Wijngaarden to become next director and CEO of The Florey

Tue, 02 Jul 2024 00:00:00 +1000

First CEO for the Sydney-based Viral Vector Manufacturing Facility

Tue, 02 Jul 2024 00:00:00 +1000

Actinogen's phase 2a depression trial completes final patient visit

Tue, 02 Jul 2024 00:00:00 +1000

BioMelbourne Network board strengthened with five new appointments

Tue, 02 Jul 2024 00:00:00 +1000

Members sought for new Policy Taskforce

Thu, 27 Jun 2024 00:00:00 +1000

Expressions of interest open for AusBiotech's First 100 Days Policy Taskforce, with industry leaders being called on to help shape key policy positions ahead of the 2025 Federal Election.

With a new CEO at the helm, AusBiotech is developing the First 100 Days Policy Taskforce to support a refresh of AusBiotech’s policy positions across a number of key areas.

The Taskforce will take into account member feedback the CEO has received over recent weeks since her appointment, insights gleaned by the AusBiotech team through a series of CEO Policy Roundtables, and through ongoing work with industry to explore capital attraction options.

AusBiotech is looking to bring clarity to the challenges and opportunities ahead of industry, the role that industry can play in addressing challenges, and the role industry sees government playing, as the Federal Government moves to fulfil its current signature policies and reviews, including a Future Made in Australia, the Strategic Examination of Australian Research & Development (R&D), and a new National Health and Medical Research Strategy.

“In my first 30 days as AusBiotech’s new CEO, I have had the pleasure of meeting many people from across the life sciences and began discussions about the stubborn issues affecting our sector.

“In my first week as CEO, at AusMedtech 2024 we discussed opportunities for greater collaboration across our sector to start to break down some of the common issues. This week, while attending stakeholder meetings and events in Canberra, I had the opportunity to again discuss some of the same topics with peers from across the industry as well as the Department of Health and Aged Care.

“While my meetings with members and our stakeholders are continuing, the consistency of topics that have been raised presents an immediate window for more collaborative and focused discussion,” says Rebekah Cassidy, CEO, AusBiotech.

At BIO 2024 in San Diego, AusBiotech co-hosted a roundtable with BIO which brought together the Hon. Ed Husic MP, Minister for Science and Innovation, and leaders from Australian and international companies, to discuss the big impediments to attracting greater investment and advancing the next stage of growth in Australia’s life sciences sector. AusBiotech was also able to join international peers from the International Council of Biotechnology Associations in discussions about evolving global challenges and opportunities for the sector.

The Taskforce will meet three to four times over coming months with the goal of bringing a precision lens to a refresh of AusBiotech’s policies across a number of key areas including but not necessarily limited to:

Investment and funding;
Taxation;
Clinical trial capacity and growth;
Regulatory and market access;
Workforce, skills and talent; and
Sovereign manufacturing capability

AusBiotech is already a trusted source of expert, evidence-based advice about Australia’s life science ecosystem. The breadth of AusBiotech’s membership and its unique role in representing the entire lifecycle, from spin outs to SMEs, through to research institutes, universities and large companies, creates an irreplaceable voice in good policy development.

If you would like to join our First 100 Days Policy Taskforce, please express your interest by emailing Kate Donnellan at kdonnellan@ausbiotech.org by Thursday COB, 4 July 2024.

AusBiotech will then be in touch to discuss engagement in the taskforce and details on meeting expectations along with key dates. While places in the Taskforce will need to be limited, AusBiotech will be in touch to discuss opportunities for feedback in the process and engagement with all respondents.

Funding available for dementia and cognitive decline innovations through CUREator+

Thu, 27 Jun 2024 00:00:00 +1000

Immutep reports topline results from TACTI-003 Phase 2b trial

Thu, 27 Jun 2024 00:00:00 +1000

Actinogen Medical says positive Xanamem phase 2a biomarker trial published in key Journal

Thu, 27 Jun 2024 00:00:00 +1000

State Government Budget wrap for life sciences

Tue, 25 Jun 2024 00:00:00 +1000

New South Wales, Queensland, South Australia, Victoria, and Western Australia 2024-25 State budgets reflect evolving economic environment while continuing investments in life sciences infrastructure and commercialisation.

New South Wales

The New South Wales (NSW) State Budget, delivered on 18 June, saw $142 million committed over four years to the Sydney Biomedical Accelerator (SBA), a co-funded partnership project between the Sydney Local Health District and the University of Sydney. The Accelerator comprises a state-of-the-art biomedical research complex spanning the Royal Prince Alfred Hospital and the University campuses. The funding will be allocated over four years to 2027-28.

The John Hunter Health and Innovation Precinct in Newcastle will receive funding to the tune of $498.2 million over four years. The funding being used to deliver a significant expansion of health services, providing additional capacity and purpose-built infrastructure, and to enable implementation of contemporary models of care to local communities.

South Australia

The South Australia (SA) State Budget, delivered on 6 June, committed $6 million over four years to extend the investment attraction programme and the global expansion programme to support the state’s economic growth.

The 2024-25 Budget also provided further funding to support the Research and Innovation Fund, after it was announced the fund would receive an addition $20 million over four years in the 2023-24 Budget. The funding will support research excellence in SA, increase research and industry collaboration, translation and commercialisation, development and industry application of critical technologies and investments to support the growth of innovative early-stage business addressing national and international markets.

Queensland

The Queensland Government is heading into an election in October this year. The budget, delivered on 11 June, saw cost of living initiatives as a cornerstone. There was also a strong focus on infrastructure development to support population growth and the upcoming Olympics.

The Budget did see $25 million in funding in 2024-25 to continue the Made in Queensland grants programme and Manufacturing Hubs grant programme to assist small and medium-sized (SME) manufacturers to increase their international competitiveness, productivity and innovation.

Victoria

The Victoria State Budget, delivered on 23 May, announced a total investment of $57.3 million into the biotechnology ecosystem. This is a decrease from the 2023-24 Budget, with the Government attributing a decrease in the funding to the completion of the Melbourne Genomics Health Alliance.

The BioNTech mRNA ecosystem investment project will see BioNTech establish its Asia-Pacific mRNA clinical manufacturing facility, Innovation Centre, research-grade RNA manufacturing facility and AI Early Warning System in Victoria. The funding amount has not been disclosed in the budget papers.

Breakthrough Victoria, Victoria Government-backed entity investing in innovation-focused businesses, will have $380 million trimmed from its budget over the next four years. The life of fund however will be extended from 10 years to 15 years.

Also announced in the 2024-25 Budget, Launch Vic will receive an additional $40 million over four years to continue its functions to fuel the growth of Victoria’s startup ecosystem.

Western Australia

The Western Australia (WA) State Budget, delivered on 9 May, outlined a number of initiatives to support the local life sciences sector.

During 2023-24, the WA Government announced it will implement the WA Health and Medical Life Science Industry Strategy, to capitalise on the growing demand for health, medical technology, biotechnology, and pharmaceuticals and to move along the value chain from research to product development and commercialisation. The 2024-25 Budget provided an $8.6 million investment to continue supporting this Strategy.

The Government is also investing $15.3 million in 2024-25 to establish the Perth Health Innovation Hub as a dedicated centrally located and industry focused Hub that is accessible to the research, innovation and investment community. The Hub will “attract skilled scientists whilst solidifying the State’s position as a leader in research and innovation, supporting transformative change for health care and economic prosperity in Western Australia”.

The Budget also committed $53 million to establish a Founders Factory accelerator in WA to support entrepreneurs and start-ups, as well as to continue STEM initiatives.

While not in the budget papers, we note the recent announcement that Perth Biodesign has been awarded $300,000 to operate its annual seven-month part-time course over the next three years, and MTPConnect, via the WA Life Sciences Innovation Hub, has been awarded $125,000 to subsidise its industry training programs for 2024. Both of these projects are funded through the Health and Medical Life Sciences Industry Strategy funding.

Immutep signs exclusive license agreement with Cardiff University for anti-LAG-3 molecules

Tue, 25 Jun 2024 00:00:00 +1000

Ketamine slow-release tablet reduces symptoms of severe depression

Tue, 25 Jun 2024 00:00:00 +1000

Imugene doses the first patient in pioneering Phase 1 onCARlytics trial

Tue, 25 Jun 2024 00:00:00 +1000

Registrations open for Australia’s ‘biggest week in biotech’

Thu, 20 Jun 2024 00:00:00 +1000

AusBiotech 2024 and AusBioInvest 2024, Australia’s premier life science and life science investment conferences, have opened early bird registrations.

The countdown is on for Australia’s biggest week in biotech’ being held from 29 October-1 November in Melbourne, with early-bird registrations now open for the week’s flagship events.

AusBiotech 2024 will connect more than 1,200 delegates to ‘unite through innovation’ and highlight the latest advancements, trends, and opportunities currently facing the life sciences sector locally and globally.

Held from 30 October-1 November at the Melbourne Convention & Exhibition Centre, AusBiotech 2024 will feature an industry-led, gender diverse programme with more than 170 speakers across 50+ sessions developed to inform, educate, celebrate, and inspire the life science community.

The AusBiotech national conference has served as the leading international meeting place for the Australian life science community for over 38 years. This year’s conference will include:

Three days of programme sessions, featuring an impressive lineup of 120+ expert speakers;
Our industry partners - connect in the exhibition hall;
AusPartnering, AusBiotech's highly popular business matching programme, facilitating thousands of 1:1 meetings across the conference week;
Networking opportunities with other delegates and partners;
The AgriBiotech and BioSecurities Summit – a one-day agri-bio focused summit held onsite at AusBiotech 2024;
The Early-Stage Innovation Forum – discover emerging technologies at our rapid-fire pitch competition for researchers and pre-seed companies;
Lunch, morning and afternoon refreshments in the exhibition hall; and
Social highlight of the week – the AusBiotech 2023 gala dinner.

Individuals can register for AusBiotech here.

Connecting innovators with investors, the 18^th annual AusBioInvest conference will be held on Tuesday 29 October at the Park Hyatt in Melbourne.

The full-day programme will feature thought-provoking keynotes and panel sessions with leading investors and business leaders on the trends, themes, and market conditions shaping life science investing, in addition to up to 25 presentations from early to late-stage biotech companies seeking investment and strategic partners.

Qualified investors are invited to register for a complimentary pass here, while biotech companies interested in pitching are invited to apply to be an investee here. Presenting investees and investors will also gain access to the exclusive Investor CEO dinner that provides a forum for executives and investors to further network and discuss potential partnership opportunities after the event.

Other professionals interested in attending are encouraged to purchase a conference delegate pass here.

AusBiotech’s flagship conferences lift the profile of the Australian biotechnology industry, share new and ground-breaking knowledge, connect companies, and create access to greater funding sources for companies to develop world-class science into therapies, diagnostics and medical devices.

AusBiotech thanks its host state partner, the Victorian State Government, for its support of AusBiotech and AusBioInvest 2024.

Biotron says BIT225-011 meets objectives in HIV efficacy trial

Thu, 20 Jun 2024 00:00:00 +1000

Merck Life Science opens applications for 2024 ANZ Advance Biotech Grant Program

Thu, 20 Jun 2024 00:00:00 +1000

QUT joins Artificial Heart Frontiers Program consortium

Thu, 20 Jun 2024 00:00:00 +1000

New grant programme for quantum technologies

Tue, 18 Jun 2024 00:00:00 +1000

The Australian Government’s $36 million-dollar Critical Technologies Challenge Program (CTCP) will support local quantum technology businesses to develop innovative solutions addressing nationally-significant challenges.

The Australian Government has opened applications for its CTCP to capture the power and potential of quantum technologies, as part of its Future Made in Australia agenda.

The CTCP will support Australia’s world-class quantum technology businesses to work with researchers and end-users to develop innovative solutions to market-led challenges.

The programme focusses on funding businesses aiming to address four nationally-significant challenges, which are:

Optimise the performance, sustainability, and security of energy networks to help the transition to Net Zero;
Improve medical imaging and medical sensors to support diagnosis, treatment of disease and monitoring activities inside the human body;
Enhance communication with autonomous systems in varying environments; and
Optimise efficiency and reduce the impact of resource exploration, extraction, and mineral processing.

The programme will “accelerate the path to commercialisation for quantum technologies from early-stage when private capital is hard to secure, and drive greater awareness and uptake of quantum technologies in Australia.”

The Department of Industry, Science and Resources says the programme has two funding stages. “Stage one will offer successful applicants up to $500,000 funding for feasibility projects. In Stage two, applicants with successful stage one feasibility projects will be invited to apply for up to an extra $5 million to develop technology demonstrator projects and proof of concept.”

The Critical Technologies Challenge Program is a commitment of the first ever National Quantum Strategy released last year, and builds on previous quantum investments, including the creation of the Australian Centre for Quantum Growth, investments in Silicon Quantum Computing, and a partnership with Queensland Government and PsiQuantum to secure the world’s first fault-tolerant quantum computer in Australia and associated industry and research benefits.

The grant programme also builds on additional sources of capital for quantum companies, including through the $15 billion National Reconstruction Fund (NRF) and $392 million Industry Growth Program.

Grant applications for round one are open until Tuesday 2 July 5pm AEST. More information can be found here.

Mark Butler launches new biotech company targeting hard-to-treat cancers

Tue, 18 Jun 2024 00:00:00 +1000

US FDA grants rare paediatric disease designation to Race Oncology's RC220 bisantrene

Tue, 18 Jun 2024 00:00:00 +1000

Opthea completes placement and institutional component of entitlement offer

Tue, 18 Jun 2024 00:00:00 +1000

Cervical cancer screening pioneer among biotech sector’s King’s Birthday recipients

Thu, 13 Jun 2024 00:00:00 +1000

World-renowned cancer researcher Professor Karen Canfell and dozens of Australian clinicians and researchers have been celebrated in the King’s Birthday 2024 Honours List.

Leading cancer researcher and epidemiologist Prof Canfell has been appointed as a Companion of the Order of Australia (AC) for her eminent service to medicine, particularly through cancer research, to tertiary education, and as a mentor and leader.

Prof Canfell is the inaugural Director of the Daffodil Centre, a joint venture between the University of Sydney and Cancer Council NSW. As an epidemiologist, modeller, and a translationally-focused population health researcher, her research focusses on providing policy-makers with an evidence-base for decision making in cancer control, with her research impacting cancer-control policy nationally and globally.

Prof Canfell has led evaluations of new cancer screening approaches for government agencies in several countries. She currently leads an NHMRC Centre of Research Excellence in Cervical Cancer Control (C4) and co-leads Compass, Australia’s largest clinical trial (76,000 women) which is the first major international experience of cervical screening in an HPV-vaccinated population.

Prof Canfell’s team’s work underpins the 2017 transition of the National Cervical Screening Program in Australia from Pap smears to 5-yearly HPV-based screening. She currently has active collaborative modelling grants from the United States’ NIH and United Nations World Health Organization (WHO) to model cervical cancer prevention in the USA and globally, as well as active projects across cancer control.

Accompanying the Sydney-based Professor on the King’s Birthday 2024 Honours List are three researchers/clinicians, appointed as an Officer of the Order of Australia (AO) for services to medical research and/or health innovation, and 15 individuals who were awarded the Medal of the Order of Australia (AM).

AusBiotech heartily congratulates all recipients, including those appointed as an Officer of the Order of Australia (AO)

Monash University’s Professor Ross Coppel (VIC) for distinguished service to science as a microbiologist, to tertiary education, to board and advisory roles, and to innovation;
The University of Melbourne’s Professor Jo Douglass for distinguished service to medical research, to clinical immunology and allergy, to respiratory medicine, and to tertiary education; and
The Florey Institute of Neuroscience and Mental Health’s Professor John Furness (VIC) for distinguished service to medical research in the field of autonomic neuroscience and neurogastroenterology.

See the full list of Honours here.

Opthea taps investors to raise almost $230 million to fund late-stage trials

Thu, 13 Jun 2024 00:00:00 +1000

Race says bisantrene highly active in a mouse model of multiple myeloma

Thu, 13 Jun 2024 00:00:00 +1000

QBiotics says recruitment completed in Phase 2a clinical trial of tigilanol tiglate

Thu, 13 Jun 2024 00:00:00 +1000

Member views sought on TGA’s companion diagnostic guidance update

Tue, 11 Jun 2024 00:00:00 +1000

AusBiotech is seeking feedback on the Therapeutic Goods Administration (TGA)’s updated draft Companion Diagnostics (CDx) Guidance document to form an industry-led response.

The proposed updates aim to provide sponsors and manufacturers of medicines, biologicals and in vitro diagnostics (IVD) medical devices further clarification regarding the requirements for companion testing, including:

A CDx testing identification guide to assist them in identifying whether their medicine or biological indication requires companion testing,
An introduction to the concept of the ‘companion testing plan’ to recognise the CDx component evaluations undertaken as part of the medicine application,
Improved clarity on clinical and analytical performance requirements for CDx, and
Case studies to assist sponsors of medicines and devices on the regulatory process and the technical documentation required for an IVD CDx.

Companion diagnostics are tests or assays that help identify patients who are most likely to benefit from a particular treatment or medication. For every clinical indication of medicine, where IVD testing is essential for safe and effective use of that medicine, there are multiple factors that may determine the level of regulatory oversight of these devices.

According to the TGA, and consistent with the regulatory definition, a CDx is an IVD that is essential for the safe and effective use of a corresponding medicine or biological, where both:

the Product Information (PI) for the medicine (or Instructions for Use [IFU] for the biological) states that CDx testing is essential for the relevant use of the medicine or biological to be safe and effective, and
the IVD claims that it is intended for the relevant use of the medicine or biological.

As the wording of the medicine or biological PI and the IFU are determined during the medicine registration process, the TGA has developed the CDx testing identification guide to help identify whether a proposed medicine or biological indication requires CDx testing, independently of PI or IFU wording. The testing identification guide can be found in the draft guidance document here.

The intention of the identification guide is to assist in identifying tests that require inclusion in the Australian Register of Therapeutic Goods (ARTG) under the CDx framework for supply in Australia. This is to ensure the analytical and clinical performance of devices that are intended to conduct such testing are appropriate for use in conjunction with that medicine or biological.”

Importantly, the guidance document includes four case study examples that may assist device sponsors in understanding clinical and analytical requirements when submitting a CDx application.

AusBiotech, with the support of its AusMedtech Regulatory Affairs Advisory Group (AMRAAG), intends to make an industry-led submission, subject to member feedback.

Members are invited to share their views with Dr Robyn Lindner, General Manager of AusBioNSW, AusBiotech, at rlindner@ausbiotech.org by 12.00pm AEST, Friday 14 June.

The consultation will close on 17 June 2024. The draft guidance document can be read here.

MCRI and Incepta Pharmaceuticals partner to protect children from rotavirus

Tue, 11 Jun 2024 00:00:00 +1000

Fifth patient is treated with the OncoSil device in PANCOSIL trial

Tue, 11 Jun 2024 00:00:00 +1000

AusBiotech and BIO partner to deliver ‘Investing in Australia’ Roundtable at BIO 2024

Thu, 06 Jun 2024 00:00:00 +1000

AusBiotech and BIO co-hosted ‘Investing in Australia’ roundtable brought Australian BIO delegates together with global leaders to enablement opportunities for trade and investment in Australia.

The roundtable included the Hon. Ed Husic, Minister for Industry and Science, a cross-section of AusBiotech members representing the life sciences value chain, global companies, government representatives, and potential future investors to explore how the different parts of our sector can work together with intention to continue building Australia’s thriving life sciences ecosystem.

Led by Rebekah Cassidy, CEO, AusBiotech, and Justin Pine, Senior Director International Affairs, Biotechnology Innovation Organization (BIO), roundtable members discussed new opportunities to continue building expertise, skills and capability as Australian biotech scales up and out. Roundtable members also discussed new opportunities to foster partnership across the investor landscape and work together for the betterment of the biotechnology sector.

“It was a powerful discussion that offered a hothouse for new ideas and new ways to harness the momentum building behind Australian biotech. We’re looking forward to continuing the conversation with our members, the broader life sciences community and government when we’re back on home ground,” Rebekah Cassidy said.

Thank you to the Hon. Ed Husic MP and representatives from Acadia Pharmaceuticals, Argenica, AdAlta, Amgen Inc., Attentive Science, BeiGene, BioCina, Bristol Myers Squibb, CMAX, CSIRO, CSL, Cytiva, Dimerix, Eli Lilly, Gingko Bioworks, Illumina, Medicines Australia, Merck, Millipore Sigma Corporation, MTPConnect, Myeloid Therapeutics, Novartis, Novo Cina, Noxopharm, Nucleus Network, Opthea, Resolian, Sanofi, Southern Star, Vaxxas, and Viatris, for their engagement during the ‘Investing in Australia’ roundtable.

This year’s Team Australia delegation includes state representatives, AusBiotech, MTPConnect, hundreds of Australian companies, and delegates and more all standing united to shine a light on Australia’s burgeoning life science ecosystem.

Taking place in San Diego from 3-6 June and hosted by BIO, the BIO International Convention is the most influential event in the global life sciences calendar. This year’s conference is expected to draw more than 20,000 biotech and pharma leaders from 7,000 companies and 84 countries.

AusBiotech’s mission to BIO includes showcasing Australia's capabilities and capacity at the International Council of Biotechnology Associations (ICBA), hosting the global roundtable in partnership with the BIO and the Hon. Ed Husic MP on Investing in Australia, and showcasing the Australian delegation through 'Access Australia', an online platform that enables easy searching of and connection with the Australian delegation attending BIO 2024 – ensuring easier and quicker business development opportunities for our members during this global life science event.

Australia’s mission to the world’s largest life sciences convention continues to grow year-on-year, highlighting the industry’s commitment to fostering global collaborations and partnerships in key markets.

AusBiotech’s commitment to members at BIO is part of its global strategy to facilitate international opportunities for investment, collaborations and partnerships.

AusBiotech is proudly working in partnership with MTPConnect, Austrade, CSIRO and state governments: New South Wales Government, South Australian Government, Victorian Government, Queensland Government, and Western Australian Government, to drive a united ‘Team Australia’ approach that supports the whole ecosystem.

Genomic profiling PrOSPeCT achieves a significant patient milestone

Thu, 06 Jun 2024 00:00:00 +1000

AusBiotech supports Team Australia delegation at BIO 2024

Tue, 04 Jun 2024 00:00:00 +1000

AusBiotech’s CEO, Rebekah Cassidy, and COO Rosanne Hyland, are on the ground at BIO 2024 in San Diego – working to support this year’s BIO 2024 mission to showcase Australia’s outstanding life science innovations, innovators and capabilities.

This year’s Team Australia delegation includes the Hon. Ed Husic, Minister for Science and Innovation, state representatives, AusBiotech, MTPConnect, hundreds of Australian companies and delegates and more all standing united to shine a light on our sector.

Taking place in San Diego from 3-6 June and hosted by the Biotechnology Innovation Organization (BIO), the BIO International Convention is the most influential event in the global life sciences calendar. This year’s conference is expected to draw more than 20,000 biotech and pharma leaders from 7,000 companies and 84 countries.

AusBiotech is showcasing Australia's capabilities and capacity at the International Council of Biotechnology Associations, hosting a global roundtable in partnership with the Biotechnology Innovation Organisation and with Minister Husic on Investing in Australia, and showcasing the Australian delegation through 'Access Australia', an online platform that enables easy searching of and connection with the Australian delegation attending BIO 2024 – ensuring easier and quicker business development opportunities for our members during this global life science event.

Australia’s mission to the world’s largest life sciences convention continues to grow year-on-year, highlighting the industry’s commitment to fostering global collaborations and partnerships in key markets. AusBiotech’s commitment to members at BIO is part of its global strategy to facilitate international opportunities for investment, collaborations and partnerships, focusing on key markets.

AusBiotech is committed to supporting these ongoing opportunities for industry, which are crucial for the growth of the Australian life sciences sector, and, ultimately for continuing Australia’s position in the sector globally.

We’re grateful for our strong ongoing partnerships with MTPConnect, Australian Trade and Investment Commission (Austrade), CSIRO, state governments: Government of New South Wales (NSW Government), Government of South Australia, Victorian Government, Queensland Government, and Government of Western Australia to drive a united ‘Team Australia’ approach that supports the whole ecosystem.

World Intellectual Property Organization (WIPO) approves landmark treaty on IP and genetic resources

Tue, 04 Jun 2024 00:00:00 +1000

WIPO Member States approve treaty addressing intellectual property (IP), genetic resources, and associated traditional knowledge during a historic Conference in Geneva, Switzerland, after decades of discussions.

AusBiotech is working with IP Australia following the announcement of the landmark Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, after its approval by WIPO Member States at a Diplomatic Conference held from 13-24 May at United Nations WIPO’s Geneva headquarters.

This is the first WIPO Treaty to address the interface between intellectual property, genetic resources and traditional knowledge and the first WIPO Treaty to include provisions specifically for indigenous peoples as well as local communities.

WIPO said the aim of the treaty is to “enhance the efficacy, transparency and quality of the patent system”, and “prevent patents from being granted erroneously for inventions that are not novel or inventive with regard to genetic resources and traditional knowledge associated with genetic resources”.

The Treaty, once it enters into force with 15 contracting parties, will establish in international law a new disclosure requirement for patent applicants whose inventions are based on genetic resources and/or associated traditional knowledge. The disclosure requirement is set out in Article 3 of the Treaty and requires applicants to disclose the country of origin or the source of the genetic resources.

Article 3 states, where an invention is based on traditional knowledge associated with genetic resources, the applicant is required to disclose the indigenous peoples or local community, as applicable, who provided the traditional knowledge associated with genetic resources or, if not known, the source of the traditional knowledge associated with genetic resources. It also states that information is to be provided by the applicant in the form of a declaration affirming that the content of the declaration is true and correct to the best knowledge of the applicant.

Article 4 of the Treaty includes a non-retroactivity clause that the disclosure requirement will not apply to patent applications filed before the Treaty enters into force. The Treaty also includes provisions to allow opportunities to rectify a failure to disclose the required information, and to provide that a patent cannot be invalidated solely on the basis of a failure to meet the disclosure requirement.

Over 1,200 WIPO member state delegates, observers, including indigenous peoples, and stakeholders convened for the Diplomatic Conference on Genetic Resources and Associated Traditional Knowledge to approve the Treaty last month.

Negotiations for the Treaty began at WIPO in 2001, initiated in 1999 with a proposal by Colombia, where discussions were notable for their inclusion of indigenous peoples as well as local communities. The WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) was established in 2000 with negotiations beginning in 2001.

The Treaty will enter into force three months after 15 Member States of WIPO have deposited their instruments of ratification or accession. This Treaty will remain open for signature by any eligible party at WIPO’s headquarters for one year after its adoption. More information can be found on the WIPO website.

IP Australia has been actively engaging with Aboriginal and Torres Strait Islander people and other stakeholders to improve its understanding of the issues associated with the protection and management of indigenous knowledge. Following consultations in 2021, IP Australia is looking at possible changes to the Acts it administers to better support the cultural integrity and economic potential of indigenous knowledge held by Aboriginal and Torres Strait Islander peoples. This includes proposals for system enhancements for trade marks and designs for disclosure of source for patents and plant breeder's rights. See more information here.

AusBiotech looks forward to working with IP Australia to understand the impact for Australian innovators while respecting indigenous knowledge.

Immutep announces major capital raise and third collaboration with MSD

Tue, 04 Jun 2024 00:00:00 +1000

Best Translational Research awarded at AusMedtech 2024

Thu, 30 May 2024 00:00:00 +1000

The JiffyStent Inserter, a Class 1 medical device looking to revolutionise kidney stone management, has taken out the title of best early-stage project at AusMedtech 2024’s Early-Stage Innovation Forum (ESIF).

The twice-annual ESIF competition featured presentations from Australia's local research institutes, universities, hospitals and pre-series A companies, last week in the areas of medical devices and diagnostics, digital health and enabling technologies.

Held in Adelaide on 22 May at AusMedtech 2024, nine early-stage projects from across Australia received feedbackfrom an expert panel intended to be helpful to their technology’s commercialisation journey.

Associate Professor Joseph Ischia, Co-Founder & Chief Executive Officer, JiffyStent, presented the JiffyStent Inserter (JSI), a Class 1 medical device for the management of kidney stone pain. The JSI is a ureteral stent inserter designed for safe, swift, and secure stent placement, providing rapid relief from kidney stone pain.

Kidney stones are common, impacting 0.5 percent of the total population annually (approximately 40 million) and their global prevalence and recurrence are increasing. Presentations to the health system in primary markets sit at 5 million each year, with a surgical intervention rate of around 12 percent, or 600,000 procedures.

Problems exist with the current treatment of acute renal colic due to a kidney stone obstructing the ureter. The inefficient and costly current management comprises strong opioid pain relief medications, hospital admission, and the insertion of a ureteric stent in the operating theatre under general anaesthetic. With an average hospital stay of 1.7 days and utilisation of one hour of theatre time - for what is a 3-5-minute procedure - it currently costs Australian hospitals approximately $7,500AUD per intervention.

JiffyStent-developed JSI is a ureteric stent inserter that can be used in the emergency department. This provides patients with immediate pain relief, avoids the need for general anaesthetic, and frees up already stretched hospital resources.

The cost to the hospital per JSI intervention (device and reimbursement of hospital costs, including Emergency Room, Urologist, and the procedure) are expected to cost approximately $3,000AUD, substantially cheaper than the current standard of care.

The JSI is at the final prototype stage. The next stage of the project is to undertake in-human clinical trials, secure regulatory approvals and further patents, complete development of electronics and certification, confirm manufacturing plans, and commence production of the product.

The company is actively looking for investment to support the product’s development and to make it market ready.

The AusMedtech 2024 ESIF was judged by a panel of experts including Michelle Gallaher (Cerulea), Eddie Walker (FB Rice), Sarah Meibusch (OneVentures), Steve Burnell (Tenmile), and Mark Lawler (West Pharmaceuticals)

The next ESIF will be therapeutics focused and will be held at AusBiotech 2024 happening from 30 October – November 1 in Melbourne.

Sydney announced as host location for AusMedtech 2025

Tue, 28 May 2024 00:00:00 +1000

AusBiotech is bringing Australia’s premier medical technology event, AusMedtech, to Sydney, New South Wales, in 2025 – the first time the conference has ever been held in the state.

As the flagship event of Australia’s biggest week in medtech, the AusMedtech 2025 national conference will be hosted in NSW from 7-8 May at the ICC Sydney.

AusMedtech attracts more than 450 medical technology developers and professionals from across Australia and overseas, bringing the ecosystem together to discuss the latest medtech advancements and trends impacting the sector.

Running in its eighteenth year, AusMedtech 2025’s the two-day programme will include:

Cutting-edge insights: Building upon the success of previous years, AusMedtech 2025 offers a dynamic programme featuring 70+ thought-provoking keynotes and expert talks led by industry leaders. Explore a diverse range of topics, including Australian success stories, manufacturing, overcoming distribution challenges, advancements in diagnostics, and emerging technologies from Australia’s innovators.
Networking opportunities: Engage with industry leaders and potential partners through our exclusive AusPartnering business matching app. AusMedtech provides an ideal platform to exchange ideas, foster collaborations, and connect with like-minded professionals passionate about driving innovation in healthcare. Take advantage of the networking functions including the Welcome Reception, AusMedtech Conference Dinner, Closing Reception, and catering breaks in the Exhibition Hall.
Inspiring keynotes: Be inspired by our lineup of keynote speakers as they share fresh insights into the latest advancements shaping the future of healthcare technology.
Interactive panels: Participate in 25+ interactive panel discussions addressing key topics such as fostering innovation, the role of incubators and accelerators in medtech, waste and sustainability, and navigating regulatory and reimbursement landscapes. Learn from experts who have successfully navigated the intricacies of the industry.
Early-Stage Innovation Forum: Discover and support early-stage innovators with presentations from Australia's local research institutes, universities, hospitals, and pre-series A companies on emerging early-stage technologies, as they gather feedback from experts to support their commercialisation journey.
Clinical Trials Dinner: Join industry peers for an informal dinner to celebrate the progress of the clinical trials sector and connect face-to-face before the official start of AusMedtech 2025.
Site tours: Explore New South Wales’ vibrant life sciences ecosystem, and check out Australia’s world-class infrastructure via tours of key life science precincts, businesses, and more. More information to come.

AusMedtech is created by industry, for industry. Themes explored in the programme include workforce capabilities, intellectual property (IP), capital markets, market access, clinical trials, and manufacturing.

Australia’s life science ecosystem has experienced strong growth over the past five years. As revealed in AusBiotech-commissioned research, the sector is rapidly expanding, with 50 percent growth between 2019 and 2022, for the first time exceeding the number of therapeutic companies developing life-enhancing and life-saving technologies in Australia.

AusBiotech will call for AusMedtech 2025 programme session ideas in November this year. Sign up here to receive email updates on AusBiotech events.

Further conference details can be found on the AusMedtech website.

AusMedtech 2025 is supported by its host state partners the New South Wales Government, Investment NSW, and the AusMedtech programme committee.

Neuren says trial shows significant improvements in Pitt Hopkins syndrome

Tue, 28 May 2024 00:00:00 +1000

Dimerix announces Middle East license agreement for DMX-200

Tue, 28 May 2024 00:00:00 +1000

AusMedtech 2024 underway in Adelaide

Thu, 23 May 2024 00:00:00 +1000

Australia’s premier medical technology event, AusMedtech, is underway in Adelaide with more than 400 registered attendees.

The flagship event of Australia’s biggest week in medtech, the seventeenth annual AusMedtech national conference is well underway with than 400 registered attendees representing Australia and international markets.

Held in Adelaide from 22-23 May, the AusMedtech 2024 was officially opened by the Honourable Susan Close MP, Deputy Premier of South Australia, and the Minister for Industry, Innovation and Science; Minister for Climate, Environment and Water; and Minister for Workforce and Population Strategy, and Major Sumner AM (Uncle Moogy) at the Adelaide Convention Centre.

AusBiotech’s research shows that Australia is home to more than 577 medtech companies. As Australia’s fastest growing sector of the life sciences, there was 49 percent growth in the number of medtech companies between 2019 and 2021. Australia’s medtech industry is expected to reach a market value of US$7.96 billion this year. Medical devices representing the largest portion of this, with its market volume expected to reach US $6.73bn this year. As industry growth accelerates, Australian medtech continues to produce world-class solutions, showing increasing potential as a driver of economic growth and new skilled career pathways, all while improving health and patient outcomes.

The growth and success of Australia medtech ecosystem is reflected in the two-day conference, themed ‘Innovation + Collaboration + Synergy = Success’, and includes more than 110 local and international speakers, with inspirational keynotes from industry leaders and panel sessions on the latest medtech advancements and trends impacting the sector.

Professor Steve Wesselingh, Chief Executive Officer, National Health and Medical Research Council, discussed the NHMRC’s current priorities, provided an update on the alignment of the two key health and medical research funds, the Medical Research Endowment Account (MREA) and the Medical Research Future Fund (MRFF), as well as the National Health and Medical Research Strategy currently in early development; Professor Anthony Lawler, Deputy Secretary, Medical Devices & Product Quality Division, Therapeutic Goods Administration (TGA), discussed the sweeping reforms occurring globally and how the (TGA) is supporting the industry through these changes; and a panel of big medtech leaders had an invaluable discussion on partnering, prospecting, and support work in the Australian environment, in a plenary session hosted by Dell Kingsford Smith, AusBiotech Board; Vice President Medical Affairs, Market Access & Government Affairs, Asia Pacific, Cochlear.

AusMedtech has been created by industry, for industry. Other topics being explored across the programme include building workforce capabilities, capital markets, ethics and AI, market access, optimising clinical trial delivery, ESG, waste management, and issues facing healthcare in Australia.

Complementing the informative keynotes and panels, AusMedtech featured the Early-Stage Innovation Forum, proudly sponsored by West Pharmaceutical Services, which featured rapid-fire pitch presentations from Australia's local research institutes, universities, hospitals and pre-series A companies in the areas of medical devices and diagnostics, digital health and enabling technologies. Presenters received feedback that’s critical to their commercialisation journey from an expert investor panel. The winner of the Best Translation Research Award will be announced at the AUsMedtech 2024 closing ceremony.

The AusMedtech conference dinner, the social highlight of Australia’s biggest week in medtech, featured a fireside chat with the leaders of Red Dust, a non-profit health promotion charity that seeks to improve the physical, emotional, spiritual and cultural health and wellbeing of youth and families living in remote Indigenous communities. In a fireside hosted by Rebekah Cassidy, CEO, AusBiotech, Scott Stirling, CEO, Red Dust; Jonathon Lindsay-Tjapaltjarri Hermawan, Director of Programs and Strategy Lead, Red Dust; and Nathan Daly, Cultural Education and Partnerships Manager, Red Dust, discussed how Red Dust draws on the strengths of both western health knowledge and traditional cultural knowledges to create a positive influence on young people and improve outcomes for communities.

Red Dust uses positive health messages and local role models through its youth focused Healthy Living Program, their gender specific programs, the Strong Young Women’s’ Program, and Strong Young Men and Boy’s Program as well as a Storytelling Program – a program for Elders and Leaders that, collects, collates, and endorses Millenia-old cultural knowledges for use in all programs and to guide future generations.

Further conference details can be found on the AusMedtech website.

AusMedtech 2024 is supported by its host state partners Business Events Adelaide, the Government of South Australia, and Adelaide Convention Centre; event sponsors, exhibitors and the AusMedtech programme committee.

Telix completes proof-of-concept study of TLX592 in prostate cancer

Thu, 23 May 2024 00:00:00 +1000

Recognising Australia’s clinical trial capability at AusMedtech 2024

Tue, 21 May 2024 00:00:00 +1000

The AusMedtech 2024 Clinical Trials Sector Dinner celebrates Australia’s reputation as a go-to destination for conducting clinical trials, in recognition of International Clinical Trials Day on 20 May.

AusBiotech and its AusBiotech Clinical Trials Advisory Group are hosting the Clinical Trials Sector Dinner at AusMedtech 2024 this evening to celebrate the sector’s growth and Australia’s prominent reputation as a clinical trials destination.

This informal dinner provides an opportunity for those working in the clinical trials sector to connect face-to-face with other professionals and celebrate the sector’s progress, before the AusMedtech 2024 conference begins on 22 May in Adelaide.

Australia is a globally-renowned environment for clinical trials due to its strong foundation of research excellence, robust patent and regulatory laws, attractive tax incentives, the interconnected nature of medical research and healthcare provision in Australia, and the ease with which clinical trials can be conducted.

The dinner will host over 40 clinical trial professionals, with the initiative first launched at the AusBiotech 2023 national conference in Brisbane.

As Australia’s leading body representing the life sciences industry, AusBiotech understands how vital the clinical research sector is to not only the biotechnology industry, but for all of Australia.

Clinical trials contributed more than $1.4 billion to the Australian economy through direct expenditure or investment in 2019. The sector employed around 8,000 Australians, and more than 95,000 Australians participated in clinical trials that same year. Several other studies, in Australia and elsewhere, have demonstrated significant return on investment and improved health outcomes in systems with high clinical trial research participation.

Clinical trial activity improves the evidence base supporting clinical practice; helps patients access trials relevant to their health circumstances; contributes to the development of much-needed therapies; advances Australia’s medical research capabilities; and increases economic prosperity. However, the complex regulatory environment for trials in Australia can act as a barrier for companies looking for efficient and cost-effective locations.

Australia’s clinical trial activity continues to increase year-on-year. As of 20 May 2024, the Australian New Zealand Clinical Trial registry reported 8,366 clinical trials were currently underway in Australia.

There is national recognition at the policy level that clinical research is an important aspect of Australia’s economy. With the National One Stop Shop (NOSS) initiative for clinical trials receiving funding in the 2024-25 Federal Budget after more than two years of consultation, it is clear that the sector’s capacity, capability, size, and impact will only continue to grow.

Beyond a digital platform, the NOSS is an opportunity within the broader clinical trial and medical research reform underway, that will provide a single, harmonised, end-to-end process across the different Australian jurisdictions.

As more information is released about the NOSS, AusBiotech will continue to work with subject matter experts in the Clinical Trials Advisory Group and its members to develop appropriate advice and insights to inform its development on behalf of the sector.

Registrations for the AusMedtech 2024 Clinical Trials Sector Dinner are now closed. The next Clinical Trials Sector Dinner will be held at the AusBiotech 2024 national conference in Melbourne later this year.

Emerging Australian biotech appoints former health minister to its board

Tue, 21 May 2024 00:00:00 +1000

Pancreatic cancer research receives $8m philanthropic funding boost

Tue, 21 May 2024 00:00:00 +1000

New centre to bring more international eye clinical trials to Victoria

Tue, 21 May 2024 00:00:00 +1000

TGA seeks views on proposed medical device reform changes

Tue, 14 May 2024 00:00:00 +1000

The Therapeutic Goods Administration (TGA) is seeking industry feedback on the proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods (OTGs).

Recent work undertaken to refine the regulation of medical devices in Australia has led to an increase in the use of exemptions to remove barriers to supply where appropriate, according to the TGA.

The TGA says these changes have highlighted regulatory issues and risks associated with the use of exemptions, and feedback from external stakeholders indicates a review is required to ensure appropriate regulation for these kinds of products as, in many cases, the current arrangements for exempt medical devices and OTGs are not fit-for-purpose.

The TGA has identified three key proposals for change: require notification of supply; publish information about supply; and provision of information and samples.

Products that meet the legislative definition of a therapeutic good under the Therapeutic Goods Act 1989 (the Act) are regulated by the TGA and generally need to seek pre-market approval and be included in the Australian Register of Therapeutic Goods (ARTG) before they can be imported, exported or supplied. If the therapeutic good is a medical device, an application for inclusion in the ARTG must be supported by manufacturer’s evidence.

In some circumstances, it is not practical to require pre-market approval by the TGA and/or ARTG inclusion for a therapeutic good or there are existing risk-mitigating strategies in place. Exemption allows these kinds of products to be continually supplied without seeking pre-market approval by the TGA or inclusion in the ARTG.

An exemption may be given to devices and OTGs when: there are already suitable frameworks for the regulation of a product in place to manage risks associated with the manufacture of a product; when a device is not freely available on the market; and, in instances where a device is subject to a transition period due to the introduction of new regulatory requirements, such as patient-matched medical devices that were previously custom-made and are now transitioning to inclusion in the ARTG.

The TGA has outlined the following issues with the current use of exemptions for medical devices and OTGs:

Lack of information about exempt products. Where sponsors are not required to notify the TGA about the manufacture and/or supply of these kinds of products, there is a barrier to determining the supplier of exempt products and therefore to some post-market activities, including timely responses to adverse events and recall activities.
Expenditure on regulating exempt devices and exempt OTGs is continuing to rise as the number of exemptions increase. Without cost-recovery measures for the regulation of a widening scope of sponsors and products, pressure on available resources for post-market and reform work will continue to rise.
There are low rates of awareness of and compliance with regulatory requirements associated with some exempt products. Lack of available information identifying these sponsors further limits TGA’s ability to contact them for the purposes of education and communication.
Identification of exempt devices and OTGs that are complying with current regulatory requirements is difficult for stakeholders including members of the public and other government providers who use TGA approval as a basis for reimbursement. Healthcare providers, members of industry and consumers have all expressed a desire for increased transparency and accountability of exempt products.
Recent changes to the medical device regulatory framework mean supply of medical devices from smaller manufacturers, particularly in healthcare sectors, is likely to become constrained in the coming years as the cost of including devices in the ARTG becomes prohibitive. The use of exemptions to provide a pathway for the manufacture and supply of devices in these sectors is therefore likely to increase, compounding the existing issues.

The consultation will close on Sunday 9 June 2024.

AdAlta appoints Melbourne-based Cell Therapies as preferred manufacturing partner

Tue, 14 May 2024 00:00:00 +1000

PYC Therapeutics plans to progress candidate to human clinical trials

Tue, 14 May 2024 00:00:00 +1000

Cell & Gene Catalyst champions industry at BioKorea 2024

Thu, 09 May 2024 00:00:00 +1000

The Cell & Gene Catalyst (the Catalyst) profiled the opportunities present in the Australian cell and gene ecosystem this week during BioKorea 2024.

The presentation builds on previous AusBiotech showcases in Korea, providing an overview of the ecosystem and outlining the Catalyst’s national strategy. Delivered by Dr Marguerite Evans-Galea AM, Catalyst Director, it contributed to the “Partnering for successful regenerative medicine projects in Australia” session being hosted by MTPConnect and Austrade prior to BioKorea 2024.

The burgeoning field of cell and gene therapies offers significant potential and optimism, with many experts touting these therapies as the most critical discoveries of the future. The presentation presented the opportunities within the Australian industry, and informed international stakeholders on how to partner with Australian organisations across the value chain to develop advanced therapeutics.

The Catalyst is a national joint venture established and co-led by AusBiotech and Medicines Australia which aims to position Australia as a global leader in this field and to drive economic growth in the sector. To accelerate the development and commercialisation of cell and gene therapies in Australia, the Catalyst has a focus on strengthening the Australian ecosystem, with a particular emphasis on building the country's capabilities across the entire value chain.

Held from 8-10 May in Seoul, BioKorea 2024 is Asia’s premier life science conference. AusBiotech is proud to support the Australian Trade and Investment Commission’s (Austrade) BioKorea 2024 delegation to strengthen ties with international markets, and highlight investment opportunities in Australia and our national life science capabilities.

The Australian presence is strong, with industry representation from across all five major states. AusBiotech’s support of BioKorea 2024’s Australian delegation is part of its global strategy to facilitate international opportunities for investment, collaborations and partnerships, with a focus on the markets important to members, including growth markets.

The organiser of BioKorea, the Korea Health Industry Development Institute (KHIDI), has led large Korean delegations to AusBiotech for several years, demonstrating the strong interest Korean companies have in collaborating with Australia's biotech industry.

This year marks the 10-year anniversary of the AusBiotech-KHIDI partnership.

To find out more about BioKorea 2024, click here.

Novartis, Monash University and Monash Health partner for heart

Thu, 09 May 2024 00:00:00 +1000

Launch of new Queensland-based research and manufacturing hub targeting precision medicines

Thu, 09 May 2024 00:00:00 +1000

TGA seeks applicants for statutory advisory committees

Tue, 07 May 2024 00:00:00 +1000

The Therapeutic Goods Administration (TGA) is seeking professionals and consumers with expertise in relevant medical or scientific fields or consumer health issues, to support the world-class regulator’s functions.

The TGA has commenced the recruitment process for statutory advisory committee positions that will become vacant on 31 December 2024.

The regulator is seeking applications from professionals with relevant expertise in medicine and science, and consumers with relevant expertise in consumer perspectives and issues.

Committee members provide advice throughout the therapeutic product life cycle, from premarket evaluation to post market product safety.

Successful applicants will contribute significantly towards the TGA’s regulatory functions by providing independent expert advice relating to the regulation of medicines, devices, vaccines and other products and substances, to the following committees:

Advisory Committee on Biologicals
Advisory Committee on Medicines
Advisory Committee on Vaccines
Advisory Committee on Complementary Medicines
Advisory Committee on Medical Devices
Advisory Committee on Chemicals Scheduling
Advisory Committee on Medicines Scheduling

Individuals passionate about safeguarding and enhancing the health of Australians, who have relevant expertise, are urged to register here.

Having industry representation on the TGA’s statutory advisory committees maximises the contribution of industry knowledge and expertise in government and agency bodies, as outlined in AusBiotech’s Biotechnology Blueprint, a decadal strategy for Australia’s biotech sector (Subgoal 2.2, page 31).

Members are remunerated in accordance with the principles and rates set by the Remuneration Tribunal (Remuneration and Allowances for Holders of Part-time Public Office) Determination, with some committees meeting bi-monthly while others meet up to three times a year.

The Minister for Health and Aged Care appoints statutory advisory committee members, with appointment terms of up to three years.

Register for the TGA’s webinar event to hear first-hand from past and current members, and have your questions answered about the experience and expectations of these roles. The webinar will be recorded and published on the TGA’s website shortly thereafter.

Its anticipated new members will be appointed by November 2024, to commence on 1 January 2025.

Further information regarding the statutory advisory committees, along with the requirements for applying, can be found on the TGA’s website.

Enquiries can also be made by email to committee.vacancies@health.gov.au.

CUREator deploys $7.21 Million to propel local life sciences potential

Tue, 07 May 2024 00:00:00 +1000

PolyNovo announces appointment of general counsel and company secretary

Tue, 07 May 2024 00:00:00 +1000

Industry applauds $18.8m funding for National One Stop Shop for clinical trials

Thu, 02 May 2024 00:00:00 +1000

The biotechnology, medical technology and pharmaceutical industry has applauded the $18.8m funding announcement for the National One Stop Shop (NOSS) for clinical trials, with the Research and Development Taskforce (RDTF) welcoming the opportunity this presents to Australia and Australians.

Appropriate and sustainable Federal Government funding is key to ensuring the platform becomes a reality. The NOSS will help actively position Australia as a globally competitive R&D destination bringing the latest medical therapies to Australian patients and creating further jobs and growth in the sector.

The RDTF is a multi-sector collaboration between AusBiotech, Medicines Australia, and the Medical Technology Association of Australia (MTAA). The membership consists of research and development experts, particularly in clinical trials, and offers a unique industry perspective to stakeholders across Federal and State Governments as well as the broader health and research and development sector.

The life sciences sector has been advocating for a single, harmonised, end-to-end process across the different jurisdictions since the Federal Government established a Clinical Trials Action Group in 2009, with concerted engagement especially over the past two years.

The RDTF is committed to working collaboratively and closely with the Government to support the platform’s development and implementation and, importantly, to ensure it is built to accommodate both public and private healthcare organisations present across the nation.

Investing in the NOSS will serve to foster innovation, create jobs, and reinforce Australia’s position as a global leader in research and development. It will also increase opportunities for Australians to access the latest medical therapies through participation in increased trials.

Australia is a preferred destination for clinical trials, with excellent healthcare facilities, world-class researchers, a diverse population, and strong legal frameworks with robust IP protections. However, the complex regulatory environment for trials in Australia can act as a barrier for companies looking for efficient and cost-effective locations.

Harmonising these processes through the NOSS will ensure patients get access to the latest medical therapies and that Australia remains globally competitive as an R&D destination, benefiting both Australian patients and the economy.

-ENDS-
Media enquiries: Annabelle Dick, Communications & Media Manager, AusBiotech,
adick@ausbiotech.org / M: +61 (0) 437 075 209

About AusBiotech

About Medicines Australia

Medicines Australia leads the research-based medicines industry of Australia. Our members discover, develop and manufacture prescription pharmaceutical products, biotherapeutic products and vaccines that bring health, social and economic benefits to Australia. Our members invest in Australian medical research and take local discoveries and developments to the world.

About the Medical Technology Association of Australia

The Medical Technology Association of Australia (MTAA) is the national association representing companies in the medical technology industry. MTAA aims to ensure the benefits of modern, innovative, and reliable medical technology are delivered effectively to provide better health outcomes to the Australian community.

AusMedtechInvest keynote and panel speakers announced

Tue, 30 Apr 2024 00:00:00 +1000

The programme for Australia’s inaugural boutique medtech investment roundtable, AusMedtechInvest 2024, is packed and features speakers from leading investment firms ARCHIMED, Artesian, Brandon Capital, Main Sequence, OneVentures, and Tenmile, as well as investment pitch presentations from medtech executives.

The speaking programme for AusMedtechInvest 2024 is today announced, featuring an industry-led programme with thought-provoking keynotes and panel session with leading investors and business leaders.

Held during Australia’s ‘biggest week in medtech’, at the Adelaide Convention Centre on Tuesday 21 May, AusMedtechInvest 2024, provides a brand new forum to connect the investment community with investment-seeking innovators. Qualified investors invited to register for a complimentary investor pass.

The half-day event will feature keynote presentations from Rowena Gracey, Director, ARCHIMED, who will provide a keynote on how its investments have internationalised successfully; Dr Amandeep Hansra, Founder, Medical Angels, who will discuss the role of wholesale investors in Australia’s biotech community and partnering with angel investors; and Alex Romero, Analyst, Main Sequence Ventures, will deliver a keynote address on deep tech investing and its role in healthcare.

AusMedtechInvest will also feature a medtech investment insights and market intelligence panel session with leading investors, Sarah Meibusch, Partner, OneVentures, who will chair the panel, Dr Steve Burnell, Managing Director, Tenmile; Rohan Gray, VC Portfolio Manager, Artesian; Dr Chris Nave, Founding Partner & Managing Director, Brandon Capital; and Fredrik Nyberg, Managing Director, MedTech Innovator.

In addition, AusMedtechInvest 2024 features ten-minute presentations from ten Australasian medtech companies, spanning early- to late-stage, that are actively seeking investors or partners to support their funding and co-development. Presenting companies include: Cyban, Fusetec, OncoRes Medical, Vaxxas, and Wellumio. See a list of confirmed investees here.

Investors and presenting investees will also receive access to the AusPartnering business matching system for confidential discussions in the networking lounge.

AusMedtechInvest builds on the success of AusBioInvest, AusBiotech's flagship investment event, and its well-established investment attraction programme that for almost 15 years has helped empower Australian companies to be competitive on a global scale, while connecting Australian life sciences companies with international capital markets, and risk-tolerant investors with investment-seeking life science companies.

Investors who attend AusMedtechInvest 2024 can also access a free day pass and/or discounted registration to AusMedtech 2024, underway in Adelaide from 22-23 May.

Alterity Therapeutics presents new data demonstrating potential of ATH434

Tue, 30 Apr 2024 00:00:00 +1000

FivepHusion announces ethics approval of Phase 1b trial of deflexifol as first-line treatment

Tue, 30 Apr 2024 00:00:00 +1000

Opyl expands coverage TrialKey of clinical trial prediction and design optimisation

Tue, 30 Apr 2024 00:00:00 +1000

Mesoblast announces the appointment of new board chair

Tue, 30 Apr 2024 00:00:00 +1000

AusBiotech announces incoming CEO

Tue, 23 Apr 2024 00:00:00 +1000

Australia’s industry body for biotechnology, AusBiotech, has announced ex-Sanofi leader Rebekah Cassidy as its incoming Chief Executive Officer.

Rebekah is an experienced leader with extensive strategy, policy, and media proficiency, coupled with deep health industry expertise, and will commence the role on 20 May 2024.

Previously holding leadership roles in some of Australia’s largest corporations, for global organisations and in government, she is recognised for her ability to navigate complex stakeholder environments, forge trusted strategic partnerships, and drive meaningful change.

Most recently Sanofi’s Deputy Head of Corporate Affairs and Sustainability, Australia & New Zealand, Rebekah brings experience from companies working at the bench through to bedside, including The Royal Melbourne Hospital, and her broad experience has aided her understanding of Australia’s health ecosystem and the value the life sciences sector brings to Australia.

Interim Chair Dr James Campbell led the Board's welcome, “On behalf of the AusBiotech Board, I’m delighted to warmly welcome Rebekah to the team. Throughout this recruitment process, the selection panel was impressed not only by Rebekah’s exceptional past professional experience but by her ability to translate that experience in a way that’s relevant to the specific challenges and opportunities facing our sector.”

“Rebekah’s policy and stakeholder expertise, coupled with her track record in transparent and inclusive leadership and her clear passion for amplifying an aligned voice for life sciences in Australia, made her a standout candidate. The Board and I are looking forward to supporting Rebekah as she leads a new way forward for our committed AusBiotech team.”

Ms Cassidy noted, “I’m honoured to join AusBiotech as its incoming CEO, and to help the team build on the outstanding work delivered for members every day.”

"Australia is well known for the strength of its biotechnology community and we can all be immensely proud of both the exceptional science that the sector delivers as well as the social and economic value that members bring.

“Today and into the future, as our policy makers and leaders work to diversify and modernise our nation’s economy, shore up greater sovereign capability, and make more in Australia, it will be critical that our sector delivers a clear and aligned voice on the stubborn barriers to bolster investment attraction and commercialisation success.

“I’m hoping to hear many voices on these topics over coming months. I’m looking forward to listening intently and working to identify new opportunities for collaboration so that we can harness the opportunity in front of us, and continue to grow Australia’s life science community.”

Building an exemplary track record leading high performing multi-disciplinary teams, stakeholders and colleagues know Rebekah as an authentic leader who is enthusiastic about building organisations that actively challenge the status quo and walk the talk.

-ENDS-
Media enquiries: Karen Parr, Director, Policy & Communications, AusBiotech,
kparr@ausbiotech.org / M: +61 (0) 428 056 173

About AusBiotech

BMS and Australian venture capital firm back immunotherapy company Pathios Therapeutics

Tue, 23 Apr 2024 00:00:00 +1000

Tour de Cure backs further development of Noxopharm's preclinical brain cancer candidate

Tue, 23 Apr 2024 00:00:00 +1000

Mark Butler announces NHMRC funding for six telehealth research projects

Tue, 23 Apr 2024 00:00:00 +1000

AusBiotech submits response on NSW Innovation Blueprint

Thu, 18 Apr 2024 00:00:00 +1000

AusBiotech has outlined two key recommendations in its response to Investment NSW’s Innovation Blueprint consultation: invest in sector maturation, and foster a culture of entrepreneurship.

Investment NSW sought feedback on its proposed Innovation Blueprint, aimed at giving NSW the leading edge in the global battle to attract new investment, ideas, industries and talent.

The submission was developed as part of AusBiotech’s AusBioNSW initiative which supports a thriving NSW life sciences sector by connecting, advocating, and enabling the industry. The response, which aligns to AusBiotech’s decadal strategy for Australia’s biotechnology sector, the Biotechnology Blueprint, highlights the need for a bold Innovation Blueprint for NSW that: drives long term investment in life sciences; builds a thriving and high performing innovation ecosystem between business universities/research institutes and government; and supports building on-shore capability to maximise value creation and retention within NSW and Australia.

Investment NSW identified four key areas of focus for public consultation on the Blueprint, the four I's of innovation: ideas, investment, industrialisation, and internationalism.

On requesting ideas that increase the translation of ideas to products and businesses, AusBiotech identified the following tactics that NSW Government could deploy to invest in sector maturation: maximise funding to drive ideas maturation; diversify funding to drive commercialisation outputs; invest in performing mid-range companies as sector catalysts; elevate precincts; increase access to federal funding; and develop procurement processes that support local products.

AusBiotech also recommended that fostering a culture of entrepreneurship will also support the translation of ideas into products, suggesting the NSW Government should: support in-industry mentorship programmes that develop capabilities specific for life-sciences; facilitate migration of researchers between academia and industry to develop ideas; address expertise shortages; and support the early-stage pipeline.

As part of the consultation, AusBiotech also responded to questions regarding how to increase the amount and diversity of finance available to startups and scaleups, how to increase the volume and impact of highly-novel innovation outputs being generated by NSW businesses, and how to increase the number of innovating businesses selling locally-developed products into global markets.

To support the NSW Government's understanding of the innovation ecosystem’s priorities, challenges and opportunities, AusBiotech hosted a virtual roundtable discussion in March 2024 to discuss the priorities for the sector and issues, opportunities, and challenges the sector faces, in turn informing its submitted response.

The Innovation Blueprint was first announced in September 2023 by the (then) Minister for Innovation, Science and Technology, NSW Government, to guide how it supports the NSW innovation and technology ecosystem. A discussion paper was released in February, outlining specific areas for feedback and a set of criteria for respondents.

Read AusBiotech’s submission here.

Telix Pharmaceuticals records another quarter of strong revenue growth

Thu, 18 Apr 2024 00:00:00 +1000

Immutep appoints research institute to conduct first-in-human study of IMP761

Thu, 18 Apr 2024 00:00:00 +1000

AusBiotech welcomes the Medical Science Co-Investment Plan

Tue, 16 Apr 2024 00:00:00 +1000

The Australian Government has launched its Medical Science Co-Investment Plan, identifying four key investment opportunity areas in the medical science priority area: medical devices, complex therapeutics, digital health, and sustainability.

Today’s release of the Medical Science Co-Investment Plan (the Plan) marks the first of seven to be published, and industry applauds this new government initiative in its understanding of the underlying value drivers of the sector and the prevalent market failures present.

Welcoming today’s announcement from the Industry and Science Minister the Hon. Ed Husic MP, and Health and Aged Care Minister the Hon. Mark Butler MP, AusBiotech’s Interim Chair Dr James Campbell noted that, “The Co-Investment Plan outlines the unique environment that companies developing life-enhancing and life-saving technologies operate in, and is a strong indicator to investors of the areas of opportunity where Australia can diversify and grow its manufacturing capabilities.”

“Australia’s biotechnology industry has grown 40 per cent in the past two years, reinforcing the knowledge-based sector’s economic and social value and potential to Australia and Australians. In order for small and medium-sized companies to scale up and scale out, attraction of risk-tolerant patient capital across the pipeline remains critical.”

The Co-Investment Plan’s action statement provides an overarching mission for the medical science priority area so that Australia “will capture more value from our world-leading medical research by increasing our industrial capacity and capabilities, supporting the commercialisation of high-value products, and improving the international competitiveness of our medical science and technology sector.”

The Plan outlines four key investment opportunity areas: medical devices, complex therapeutics, digital health, and sustainability; and identifies six capabilities areas to advance the overarching mission: skills and capability availability; demand; collaboration and coordination; supply chain diversification; research translation and commercialisation, and regulation and business settings.

The Plan focuses on manufacturing opportunities related to a broad range of products for therapeutic use such as medical devices, medicines, personal protective equipment, and vaccines. It also advocates for strengthened pathways between academia and industry, digitally enabled product development and infrastructure, and national coordination across the medical ecosystem.

The Medical Science Co-Investment Plan is the first of seven proposed Plans that will “… identify investment opportunities that focus on Australia’s strengths and target areas with high economic potential that align with the government’s policy objectives. The Plans also outline potential broader actions for government and industry to build ecosystems that support sustainable manufacturing capabilities across the priority areas. By coordinating efforts, the Plans will help ensure Australia seizes future opportunities.”

AusBiotech was pleased to participate in the Department of Industry, Science and Resources’ medical science industry working group, and to submit a comprehensive submission in response to the National Reconstruction Fund, both of which fed into the development of the Plan. It is important to note that the Plan does not outline or direct National Reconstruction Fund Corporation (NRFC) investment. The NRFC Board will make investment decisions independently and consistent with its legislative framework, including its Investment Mandate. Rather, the Plan outlines the opportunities and strengths that Australia offers where co-investment would be beneficial.

Read the Medical Science Co-Investment Plan here.

First Turkish patient treated with OncoSil cancer treatment device

Tue, 16 Apr 2024 00:00:00 +1000

Next Science says study shows efficacy in reducing infection when used in knee arthroplasty

Tue, 16 Apr 2024 00:00:00 +1000

Telix's TLX101-CDx granted fast track designation by US FDA

Tue, 16 Apr 2024 00:00:00 +1000

AusBiotech welcomes the Medical Science Co-Investment Plan

Mon, 15 Apr 2024 00:00:00 +1000

Australia’s peak body for the biotechnology industry welcomes the launch of the Medical Science Co-Investment Plan today, as it identifies four key investment opportunity areas in the medical science priority area: medical devices, complex therapeutics, digital health, and sustainability.

Welcoming today’s announcement from the Industry and Science Minister the Hon. Ed Husic MP and Health and Aged Care Minister the Hon. Mark Butler MP, AusBiotech’s Interim Chair Dr James Campbell noted that, “The Co-Investment Plan outlines the unique environment that companies developing life-enhancing and life-saving technologies operate in, and is a strong indicator to investors of the areas of opportunity where Australia can diversify and grow its manufacturing capabilities.”

Read the Medical Science Co-Investment Plan here.

-ENDS-
Media enquiries: Annabelle Dick, Communications & Media Manager, AusBiotech,
adick@ausbiotech.org / M: +61 (0) 437 075 209

About AusBiotech

Join the Australian delegation to BIO 2024

Thu, 11 Apr 2024 00:00:00 +1000

AusBiotech and MTPConnect partner to support this year’s BIO 2024 mission to showcase Australia’s outstanding life science innovations, innovators, and unique capabilities.

The Australian delegation will see state governments, State Ministers, and hundreds of Australian companies and delegates standing united at the BIO International Convention.

Taking place in San Diego from 3-6 June and hosted by the Biotechnology Innovation Organisation (BIO), the BIO International Convention is the most influential event in the global life sciences calendar. This year’s conference is expected to draw more than 20,000 biotech and pharma leaders from 7,000 companies and 84 countries.

AusBiotech will be showcasing Australia's capabilities and capacity through Access Australia, an online platform that enables easy searching of and connection with the Australian delegation attending BIO 2024 – ensuring easier and quicker business development opportunities during the world’s largest life science event.

Facilitating the global development of the Australian biotech industry, AusBiotech is also proudly hosting an invitation-only roundtable discussion on bilateral investment, showcasing why Australia is a global partner of choice.

Australia’s delegation to the world’s largest life sciences convention continues to grow year-on-year, highlighting the industry’s commitment to fostering global collaborations and partnerships in key markets.

AusBiotech is working in strong partnership with MTPConnect, Austrade, CSIRO and state governments: New South Wales Government, South Australian Government, Victorian Government, Queensland Government, and Western Australian Government, to drive a united ‘Team Australia’ approach that supports the whole ecosystem.

MTPConnect is hosting the Team Australia pavilion and the ‘Australian Welcome and Business Reception’. Read more about it here.

Themed “Time for science to shine”, BIO 2024 includes a week of intensive networking and events, including panels, presentations, workshops, and networking events for life science professionals. The explored themes and topics include: therapeutic frontiers, the business of biotech, regulatory and policy outlooks, human capital, and more.

AusBiotech’s mission to BIO is part of its global strategy to facilitate international opportunities for investment, collaborations and partnerships, focusing on the markets important to members, as highlighted in AusBiotech’s Strategic Plan 2021-2024.

Register your attendance with your local state government representatives to ensure your company is including on the Access Australia platform.

New South Wales:

Michelle Havill Michelle.Havill@health.nsw.gov.au
Shaun McAlpine Shaun.McAlpine@sydneyaustralia.com

Queensland:

Nicky Piljic Nicky.Piljic@dsdilgp.qld.gov.au
Ana Blake Ana.Blake@dsdilgp.qld.gov.au
Sarah Roberts Sarah.Roberts@dsdilgp.qld.gov.au

South Australia:

Sandra Hack Sandra.Hack@sa.gov.au

Victoria:

Courtney Lavis Courtney.Lavis@global.vic.gov.au
Stuart Bland Stuart.Bland@global.vic.gov.au

Western Australia:

Clare Goodall Clare.Goodall@jtsi.wa.gov.au

Cell & Gene Catalyst webinar to highlight opportunities for sector

Tue, 09 Apr 2024 00:00:00 +1000

Australia’s Cell & Gene Catalyst (the Catalyst) invites the sector to join its first webinar outlining the opportunity it provides for Australia, and opportunity for engagement.

The joint Catalyst and AusBiotech webinar titled “Accelerating Australia’s cell and gene industry – are we ready?”, being held on 1 May, brings together ecosystem leaders to discuss the emerging cell and gene therapy sector in Australia.

Targeted at industry and researchers working in advanced therapeutics and stakeholders keen to understand the growing cell and gene therapy sector in Australia, this webinar will introduce the role of the Catalyst in fostering the development of the Australian ecosystem, its key objectives, and how those in the sector can contribute to the Catalyst.

Hosted by Dr Robyn Lindner, General Manager, AusBioNSW (an initiative of AusBiotech), the webinar will feature panellists Dr Marguerite Evans-Galea, Director, Cell & Gene Catalyst; Dr Phillip Thompson, Peter MacCallum Cancer Centre; Quentin Bracquart, IQVIA; and Sue MacLeman, Viral Vector Manufacturing Facility.

Cell and gene products are a new generation of medical treatments that involve delivering complex biological components. These therapies provide significant optimism in addressing medical challenges, and are already producing long-lasting and life-changing results for patients with rare diseases and cancer. The global cell and gene industry is accelerating and the demand for the growing and diversifying suite of therapies is high.

Australia’s Cell and Gene Catalyst is a national joint venture established and co-led by AusBiotech and Medicines Australia, with support from committed partners. The Catalyst aims to accelerate Australia’s cell and gene industry to ensure everyone in Australia has access to advanced therapeutics. It is particularly focussed on building Australia’s capabilities across the entire value chain. In doing so, there is the opportunity to position Australia as a regional leader in cell and gene manufacturing by providing world-leading manufacturing capabilities, research, clinical trials, and translational know-how.

The Catalyst is supported by Cell Therapies, CSL Behring, Novartis, Pfizer, Roche, and Therapeutic Innovation Australia as members of its Expert Steering Group.

The webinar is open to both AusBiotech members and non-members. Register here.

Starpharma partners with UK investment firm to create Petalion Therapeutics

Tue, 09 Apr 2024 00:00:00 +1000

Biotron provides update on preliminary analyses of data from BIT225 clinical trial

Tue, 09 Apr 2024 00:00:00 +1000

Sponsors given opportunity to review proposed benefits

Thu, 04 Apr 2024 00:00:00 +1100

Sponsors with medical device technologies on the Prescribed List (PL, formerly the Prostheses List) have four weeks to review their proposed benefits to inform the third and final reduction of PL benefits.

As part of the Prostheses List Reforms, the Independent Health and Aged Care Pricing Authority (IHACPA) has been recalculating the 2022/23 Weighted Average Price (WAP) for medical devices.

The updated WAP, which is calculated by comparing public hospital and private health insurance benefits (price paid to Sponsors by hospitals), will inform the third and final reduction of PL benefits.

The PL sets out the medical devices and human tissue products that private health insurers must pay benefits for to the patients who have appropriate insurance policies, with more than 11,000 items listed.

Sponsors with devices on the PL have been directly sent their latest proposed benefits, and have been given four weeks to review them and raise any concerns with the Department of Health and Aged Care.

The Department will also release a Private Health Insurance (PHI) circular to capture Sponsors that may not have been alerted in recent email communications.

The Prescribed List Reform Taskforce will refine the benefits as required based on issues raised by Sponsors. Sponsors have until the week commencing 22 April to provide feedback on proposed benefits before final refinement and uploading into the Health Products Portal (formerly the Prostheses List Management System).

National peak bodies AusBiotech and Medical Technology Association of Australia (MTAA) have been vocal advocates for industry during the Prostheses List Reform, working in collaboration to provide views on behalf industry.

AusBiotech has also had ongoing conversations with the Department regarding maintaining industry representation on the Prostheses List Advisory Committee, recently replaced by the Medical Devices and Human Tissue Advisory Committee.

The review of PL benefits is required under the Prostheses List Reforms Memorandum of Understanding (MoU) with MTAA.

Percheron Therapeutics provides update on ATL1102 Duchenne muscular dystrophy trial

Thu, 04 Apr 2024 00:00:00 +1100

Imugene's oncolytic virotherapy CF33 patent granted in China

Thu, 04 Apr 2024 00:00:00 +1100

Opthea appoints Sujal Shah to its board of directors

Thu, 04 Apr 2024 00:00:00 +1100

Call for sessions and speakers for Australia’s biggest week in biotech

Tue, 02 Apr 2024 00:00:00 +1100

Inspired by its theme ‘United through Innovation’, AusBiotech is welcoming submission for topics and speakers to inform Australia’s largest life science conference, AusBiotech 2024, held in Melbourne from October 30-1 November.

As the flagship event of Australia’s biggest week in biotech, AusBiotech 2024 unites more than 1,300 delegates each year and is the core event of Australia’s ‘biggest week in biotech’. Its programme committee is looking for high-calibre session submissions that explore current trends, critical and emerging topics, breakthroughs, and stories that are thought-provoking and encourage discussion.

The AusBiotech conference programme is developed by industry, for industry, and individuals are invited to submit your topic and speaker ideas for:

Keynote sessions (30 minutes in length, including Q&A)
Panel sessions (up to 90 minutes in length, with one chair and up to four speakers)
Individual panellists

Speaking at AusBiotech 2024 positions you as an international expert who tackles the most pressing issues in our industry, builds critical dialogue, sparks creative conversations, and profiles new technology.

For over 38 years, the AusBiotech conference has served as the leading international meeting place for the Australian life science community. It’s time to bring Australian life sciences to the world stage - exploring what’s possible across biotechnology, medical devices and agribiotech to heal and feed the world.

Biotechnology continues to unlock vast potential for improving human life. Join AusBiotech 2024, supported by the Victorian State Government, in Melbourne for in-person networking, cutting-edge programming and to advance our industry.

Click here for more information on session submission, which is open until 14 June 2024.

Explore partnership opportunities at AusBiotech 2024 and take advantage of the unique opportunity to showcase your brand to a global audience of over 1,300 biotech professionals.

As an AusBiotech 2024 partner, you will have maximum exposure to attendees - it's an ideal platform to demonstrate your support of the Australian biotechnology ecosystem. Find out about partnership opportunities here.

Exhibitors can network with potential clients in our exhibition hall, the hub of social activity during the event, with the welcome reception, refreshment breaks, and the closing ceremony all taking place in this thriving space. Find out how to become an exhibitor here.

Optiscan Imaging announces the appointment of US clinical and regulatory heads

Tue, 02 Apr 2024 00:00:00 +1100

AusMedtech 2024 programme launched

Thu, 28 Mar 2024 00:00:00 +1100

The programme has launched for Australia’s largest medical technology conference, AusMedtech 2024, which will bring together more than 450 medtech thought leaders for the annual event.

AusMedtech 2024, to be held in Adelaide 22 – 23 May, will spotlight the power of innovation, collaboration and synergy in achieving success in Australia's medtech sector. With expert keynotes, panel discussions, and Q&A sessions, you'll gain insights into the trends and breakthroughs that are propelling the industry forward.

AusBiotech's newly-released programme makes AusMedtech 2024 a must-attend event for anyone interested in the latest developments in the global medtech community. The programme is packed with essential and topical discussions, with topics including medical device regulation, workforce skills and capabilities, ESG, intellectual property, capital markets, reimbursement, market access, manufacturing, and clinical trial delivery.

Featuring industry leaders such as Maurice Ben-Mayor, President & Managing Director, Stryker; Mick Trevaskis, Chief Executive Officer, Device Technologies; Rebecca Cortiula, Senior Managing Director Australasia, Varian; Jane Crowe, Managing Director, ANZ Cardinal Health; Pat Williams, Vice President & Country Manager ANZ & Korea, Edwards Lifesciences; and more than 80 others, the AusMedtech 2024 programme offers a diverse range of sessions and topics that promise to engage, challenge, and inspire.

From cutting-edge research and technological breakthroughs to strategic partnerships and investment insights, AusBiotech is covering all bases to ensure you leave Australia’s leading medtech conference feeling enriched and empowered.

AusBiotech’s AusMedtech programme has been supported through an industry committee, Chaired by Peter Bradley, and is designed to support the growth and development of the industry.

The annual event will include key features:

Cutting-edge insights – building upon the success of previous years, AusMedtech 2024 offers a dynamic programme featuring 80+ thought-provoking keynotes and expert talks led by industry leaders. Explore a diverse range of topics, including Australian success stories, manufacturing, overcoming distribution challenges, advancements in diagnostics, and emerging technologies from Australia’s innovators.
Inspiring keynotes – be inspired by our lineup of keynote speakers as they share fresh insights into the latest advancements shaping the future of healthcare technology.
Interactive panels – participate in 25+ interactive panel discussions addressing key topics such as fostering innovation, the role of incubators and accelerators in medtech, waste and sustainability, and navigating regulatory and reimbursement landscapes. Learn from experts who have successfully navigated the intricacies of the industry.
Networking opportunities that foster synergy – valuable in-person networking opportunities are abound, with opportunities including the Welcome Function, closing ceremony and catering breaks in Exhibition Hall.
AusPartnering for one-to-one business matching – Reconnect and maximise your engagement through AusPartnering, AusBiotech’s highly-popular business matching programme, by scheduling one-on-one private meetings with other conference attendees and participants.
The Early-Stage Innovation Forum – discover emerging technologies via the rapid-fire, quick-pitch presentations on early-stage technologies and projects from local research institutes, universities, hospitals and pre-series A companies in the areas of medical devices and diagnostics, digital health and enabling technologies.
The AusMedtech conference dinner – join colleagues and friends, new and old, at the AusMedtech Conference Dinner, the social highlight of AusMedtech. The must-attend three course conference dinner is the perfect opportunity to network with Australian and international industry leaders. Tickets sold separately during the registration process.
The AusMedtech Exhibition Hall – profile your company, talent and ingenuity, build brand awareness, network with others and exchange information with delegates from your exhibition booth. Welcome function, closing ceremony and catering breaks are all taking place from the AusMedtech Exhibition Hall.

Dedicated to the development, growth and prosperity of the Australian medical technology industry, AusMedtech provides initiatives to facilitate success in product development, manufacturing, commercialisation, export success and representation on industry issues.

Check out the AusMedtech 2024 programme here.

Early-bird registration is open until Friday 26 April at https://www.ausmedtech.com.au/

Sector invited to support national strategy for non-animal research models

Tue, 26 Mar 2024 00:00:00 +1100

Australia’s life science ecosystem is invited to join AusBiotech in supporting Australian Ethical’s statement supporting non-animal research models as and call on the government to implement a national strategy.

The initiative is led by superannuation fund manager Australian Ethical, and aims to gather buy-in from across the sector to urge the Australian Government to implement five recommendations as part of a national strategy focussed on accelerating the development, validation and commercialisation of non-animal research models in Australia.

The statement noted, “The next 15 years will see an increase in the use of non-animal models across all stages of the medical product development process and growth of the non-animal testing market.

“The CSIRO’s 2023 report, ‘Non-animal models: A strategy for maturing Australia’s medical product development capabilities’, found that this period will provide unique and important opportunities for Australia if harnessed responsibly.”

The statement authors, and those supporting the pledge, are calling on the Australian Government (in co-ordination with State and Territory Governments where relevant) to implement the following five recommendations:

Recommendation 1: Establish a national centre or consortium to advance Australian non-animal model capabilities.
Recommendation 2: Provide dedicated funding towards the development, validation and commercialisation of non-animal research models.
Recommendation 3: Develop national data collection standards on the use of animals in scientific research, teaching and testing.
Recommendation 4: Improve regulatory processes and industry guidance to enable acceptance of non-animal model data where the data is strong enough to demonstrate efficacy and safety.
Recommendation 5: Develop a national biobanking and tissue collection network.

The global non-animal testing market, valued at $1.11 billion US in 2019, is expected to grow at a compound annual growth rate of 10.4 percent during 2019-25. The size of the global organoid market in 2022 was $1.62 billion and is expected to reach $30.91 billion by 2040, with a Compound Annual Growth Rate of 17.4 percent. This market is estimated to result in $1.28 billion in revenue and 4,200 jobs for Australia by 2040.

Australia has comparative global strengths in the development of some non-animal models. Between 2018 and 2023, Australia’s share of non-animal model publications was above 3 percent and ranked in the top 10 globally for specific organ system-model type combinations. Australia also possesses key foundational capabilities, including existing infrastructure, high-throughput screening capabilities, and the internationally-recognised capability and capacity for induced pluripotent stem cell generation, a key input for non-animal model development.

However, currently, the development, validation and commercialisation of non-animal models in Australia is being held back by a lack of a nationally coordinated effort and therefore investments.

Find out about the non-animal research models statement and become a signatory here.

Read the September 2023 Australasian Biotechnology journal article The future of drug discovery using next-generation technologies by Tessara Therapeutics CEO Dr Christos Papadimitriou here (page 13), as he discusses non-animal model alternatives for researchers and biotech companies in pre-clinical development.

Clarity Pharmaceuticals launches $121 million fully underwritten equity raising

Tue, 26 Mar 2024 00:00:00 +1100

'Reaching this point in the development of bisantrene is a major milestone and accomplishment'

Tue, 26 Mar 2024 00:00:00 +1100

Cochlear announces the resignation of non-executive director Yasmin Allen AM

Tue, 26 Mar 2024 00:00:00 +1100

Orthocell completes all nerve repair surgeries in Remplir US market authorisation study

Tue, 26 Mar 2024 00:00:00 +1100

Cell & Gene Catalyst submits feedback on HTA consultation

Thu, 21 Mar 2024 00:00:00 +1100

Australia’s Cell & Gene Catalyst (the Catalyst) has called for streamlined and equitable access for cell and gene (C&G) therapies in Australia in its response to the Department of Health and Aged Care’s Health Technology Assessment (HTA) Policy and Methods Review - Consultation 2.

As part of the HTA Review, an Options Paper was developed to present options for reform being considered by the reference committee to improve Australia’s HTA policies and methods and the funding and approval pathways.

The purpose of the HTA is to provide necessary information to understand the benefits and comparative value of health technologies and procedures. Commonly applied to pharmaceuticals including vaccines, diagnostic tests, medical devices and other public health interventions, the HTA assists government funding decisions.

In its submission, the Catalyst called for three options to be significantly strengthened to enable the growth, development, and translation of C&G therapies in Australia. These were:

Option 1.4: The Catalyst supports a nationally cohesive approach to HTA for technologies that are currently jointly funded, however considers the ideal way to simplify and streamline access pathways for cell and gene therapies is to both assess and fully fund these advanced therapeutics at the Federal level. Regular consultation, communication and collaboration with States and Territories will continue to be important for these products. To enable holistic consideration of product costs (therapy plus delivery), States and Territories would need to articulate the total costs of product delivery for inclusion as inputs into the HTA process from the beginning.
Option 3.3: Reducing the discount rate not only recognises the value of long-term future benefits – it also brings Australia in line with international best practice. Cell and gene therapies are designed to have a lifelong, potentially curative impact. Treatment involves an upfront cost followed by potentially lifelong benefits for the patient, their family and society in general. Australia’s high discount rate means our HTA system is ill-equipped to adequately value the lifelong benefit these treatments can offer.
Option 4.3: To ensure equal and equitable access to cell and gene therapies, a high-level principles-based framework for accepting and assessing real world evidence, non-randomised control trial evidence and surrogate health outcomes is required. Conditions treated by cell and gene therapies can be rare or extremely rare which means they can have small patient cohorts in Australia. This means recruiting participants for clinical trials is more challenging and generating randomised control trial evidence more difficult, emphasising the value of RWE. Real world evidence (RWE) and broader societal, health and economic benefits can be transparently considered and used in HTA decision-making – potentially leading to faster, more equitable patient access.

The submission stated, “Given Australia’s current systems were not set up for these potentially revolutionary therapies, addressing this priority areawill enable health system readiness and industry growth, ensuring everyone in Australia will have access to these advanced therapeutics.”

The Catalyst is a national joint venture of the industry peak bodies AusBiotech and Medicines Australia, and aims to accelerate Australia’s cell and gene industry to ensure everyone in Australia has access to world-class advanced therapeutics.

The Catalyst partners and Expert Steering Group, comprised of Cell Therapies, CSL, Novartis, Pfizer, Roche, and Therapeutic Innovation Australia, endorse Medicines Australia’s recommendations and responses to the HTA options paper in full.

The reference committee will consider all evidence and input received during Consultation 2 and throughout the review as it develops its final report and recommendations to the Australian Government. The review is due to be completed by 15 April 2024.

Read the Catalyst’s full submission here.

Applications open for Moderna's 2024 Australia Fellowship Program

Thu, 21 Mar 2024 00:00:00 +1100

Queensland’s biomedical grant programme opens

Tue, 19 Mar 2024 00:00:00 +1100

Queensland-based biomedical companies, universities and research institutes are invited to apply for the Queensland Biomedical Business Attraction Program’s (QBBAP) latest funding round.

The Queensland Department of State Development and Infrastructure has opened a fourth round of its QBBAP which will provide up to $1.5 million in funding, as announced by Minister the Hon. Grace Grace in Queensland Parliament in early March.

The QBBAP (previously the Queensland Biomedical Voucher Program) is designed to attract interstate and international biomedical industry to access Queensland’s biomedical capabilities. The programme supports eligible Queensland-based biomedical companies, universities and research institutes to provide eligible biomedical services to an interstate or overseas client at a reduced cost.

QBBAP will provide funding to meet up to one third of the cost of providing the services, while the client will pay at least two thirds of the fees for the proposed services, up to a cap of $250,000 per project (excluding GST).

QBBAP is a key initiative of the Queensland Biomedical 10-Year Roadmap and Action Plan designed to attract interstate and international biomedical industry to access Queensland’s biomedical capability.

Eligible businesses must: have a physical office in Queensland, be operating for at least 12 months, hold a valid ABN, are GST registered, and providing services to an interstate or overseas client.

Applications for the QBBAP are now open and due to close at 5.00pm AEST on Friday 31 May 2024.

An expert panel will then assess applications against criteria that will identify projects which offer the greatest benefit to the local biomedical industry, and to Queensland. Successful applicants are expected to be announced in August 2024.

For further information, including applicant guidelines, FAQs and template agreement, and to access the online application form, visit the Department’s website.

Any queries about the programme can be directed to the Department’s Biomedical Sector Team at biomedical@dsdilgp.qld.gov.au

CSIRO announces the appointment of new Australian Centre for Disease Preparedness director

Tue, 19 Mar 2024 00:00:00 +1100

Telix announces QDOSE platform partnership for personalised dosimetry in radiopharmaceutical therapy

Tue, 19 Mar 2024 00:00:00 +1100

AusBiotech appoints new Board Observer

Thu, 14 Mar 2024 00:00:00 +1100

AusBiotech, Australia’s national member-based biotechnology organisation, is thrilled to announce the appointment of Dell Kingsford Smith, VP, Medical Affairs, Market Access & Government Affairs, Cochlear, as AusBiotech Board Observer.

Dell Kingsford Smith is a senior life science executive, bringing with her 25 years of experience in clinical and commercial strategy in leading global organisations, from technology discovery to full commercialisation.

Dell is currently Vice President, Medical Affairs, Market Access and Government Affairs for Cochlear Asia Pacific, based at Cochlear Ltd headquarters on the Macquarie University campus in Sydney. In this role, Dell defines and ensures implementation of critical access strategies to drive the mid to long-term growth of new and existing implantable hearing solutions across Asia Pacific. This role requires identification of strategies that address barriers to patient access through clinical evidence generation, clinical guidelines, regulatory and payer policy and stakeholder advocacy.

Prior to joining Cochlear Ltd in 2019, Dell spent 13 years with Janssen, the pharmaceutical company of Johnson & Johnson, in Australia and New Zealand and then in the United States. In 2010, Dell was recognised with the Pat Clear Award, the Australian medicine industry's most prestigious award, for her work with the Australian Federal Government in expanding patient access through regulatory and reimbursement policy.

Dell Kingsford Smith said, “I am honoured to join the AusBiotech Board as an Observer, at such a pivotal time for Australia’s life science ecosystem as it expands its footprint and impact. I am passionate about increasing patients’ access to breakthrough medicines and medical devices that improve health, reduce the burden of disease and disability, and save lives. I look forward to providing a lens to the Board as the sector works with Government to speed up patient access to new medicines.”

After leaving Australia, she held a succession of senior roles within the Janssen Global Commercial Strategy Organisation in New Jersey in market access, access policy and global pricing. In these roles, Dell was involved in the diligence, acquisition and successful commercial integration of several early-stage oncology and haematology biotechnology companies; the pricing of immunology, oncology, diabetes, neuroscience, infectious diseases, and vaccines; and expanding commercial access in a range of middle-income countries.

On behalf of the AusBiotech Board, Dr James Campbell, AusBiotech’s Interim Chair, said that “Dell’s appointment brings extensive market access as well as government and policy experience to the Board. Her deep understanding of the regulation, market access and reimbursement pathways across the life sciences globally will greatly aid the AusBiotech Board and member organisations as Australia’s biotech ecosystem matures and more companies move into regulatory filing.”

The new AusBiotech Board line-up includes:

Dr James Campbell, CEO, Patrys Ltd; Interim Chair, AusBiotech
Ms Erica Kneipp, Research Director, Human Health, CSIRO; Deputy Chair, AusBiotech
Dr Megan Baldwin, Chief Innovation Officer, Opthea Ltd (ASX:OPT); Risk and Audit Sub-Committee, Chair
Dr Dean Moss, CEO, UniQuest Pty Ltd; Remuneration and Nomination Sub-Committee, Chair
Dr Marthe D’Ombrain, Head of Global Research Innovation, CSL Ltd
Dr Iris Depaz, Country Medical Lead & Head of Medical, Vaccines, Sanofi Australia & New Zealand
Professor John Skerritt, Enterprise Professor in Health Research Impact, University of Melbourne
Dr Liz Dallimore, CEO & Managing Director, Argenica Therapeutics Ltd
Dell Kingsford Smith, VP, Medical Affairs, Market Access & Government Affairs, Cochlear (Board Observer)
Ms Rosanne Hyland, Acting CEO, AusBiotech

-ENDS-

Media enquiries: Annabelle Dick, Communications & Media Manager, AusBiotech, adick@ausbiotech.org / M: +61 (0) 437 075 209

AusBiotech appoints new Board Observer

Thu, 14 Mar 2024 00:00:00 +1100

AusBiotech’s Board of Directors welcomes Dell Kingsford Smith, VP, Medical Affairs, Market Access & Government Affairs, Cochlear, as Board Observer.

Prior to joining Cochlear Ltd in 2019, Dell spent 13 years with Janssen, the pharmaceutical company of Johnson & Johnson, in Australia and New Zealand and then in the United States. In 2010, Dell was recognised with the Pat Clear Award, the Australian medicine industry's most prestigious award, for her work with the Australian Federal Government in expanding patient access through regulatory and reimbursement policy.

The new AusBiotech Board line-up includes:

Dr James Campbell, CEO, Patrys Ltd; Interim Chair, AusBiotech
Ms Erica Kneipp, Research Director, Human Health, CSIRO; Deputy Chair, AusBiotech
Dr Megan Baldwin, Chief Innovation Officer, Opthea Ltd (ASX:OPT); Risk and Audit Sub-Committee, Chair
Dr Dean Moss, CEO, UniQuest Pty Ltd; Remuneration and Nomination Sub-Committee, Chair
Dr Iris Depaz, Country Medical Lead & Head of Medical, Vaccines, Sanofi Australia & New Zealand
Dr Marthe D’Ombrain, Head of Global Research Innovation, CSL Ltd
Professor John Skerritt, Enterprise Professor in Health Research Impact, University of Melbourne
Dr Liz Dallimore, CEO & Managing Director, Argenica Therapeutics Ltd
Dell Kingsford Smith, VP, Medical Affairs, Market Access & Government Affairs, Cochlear (Board Observer)
Ms Rosanne Hyland, Acting CEO, AusBiotech

Dimerix raises $20 million to continue and expand late-stage clinical trial of DMX-200

Thu, 14 Mar 2024 00:00:00 +1100

LBT Innovations announces that its APAS PharmaQC product is commercially ready

Thu, 14 Mar 2024 00:00:00 +1100

AusBiotech launches ASX feed

Tue, 12 Mar 2024 00:00:00 +1100

A life science-specific Australian Stock Exchange (ASX) data feed has been launched on AusBiotech’s website with the aim of increasing the profile of and investment into Australia’s biotechnology companies.

As part of AusBiotech’s investment attraction programme, an ASX feed tracking the 178 ASX-listed biotechnology and pharmaceutical companies has been established.

The ASX feed, updated daily, lists stock price and key metrics such as latest price, earnings per share (EPS), and year return. The AusBiotech website homepage also includes a scrolling banner with the top 50 (by percentage change) ASX ticker information and stock prices.

AusBioStocks data (August 2023) revealed the 178 ASX-listed life science companies reported a market capitalisation of $231 billion. In contrast, the 161 ASX-listed life science companies were worth approximately $170 billion in 2019 highlighting the life science sector’s growing economic contribution to the Australian economy.

Data also shows 8.5 percent of listed companies have a market cap of more than $1 billion, while 31 percent of companies are worth more than $100 million. Identified in AusBiotech’s Biotechnology Blueprint decadal strategy, the market cap is one quantifiable measure of the life science sector’s economic contribution to the Australian economy, and the proportion of biotech companies achieving market valuations greater than $100 million measures the industry’s ability to create companies of significant future value.

AusBiotech invites qualified investors, including venture capital firms, private equity investors, high-net-worth individuals, research analysts, brokers, family offices, to access their complimentary registration to attend the inaugural AusMedtechInvest event at the Adelaide Convention Centre on 21 May, providing them with a valuable opportunity to make meaningful connections with both private and listed companies, hear the latest market updates, and explore potential investment prospects. Investors can also access a free pass to Day One of AusMedtech 2024 to attend the Early-Stage Innovation Forum rapid-fire pitch competition where emerging pre-seed and Series A medical technologies are pitched to a panel of industry experts. Find out more and register here.

As Australia’s largest national life sciences member organisation, AusBiotech seeks to demonstrate the value of the sector to investors, and develops, gathers, tracks, and promotes industry knowledge and data, to inform the industry’s competitive advantage.

Review the AusBiotech ASX-feed here, and order the list by code or percentage change.

Mesoblast says US FDA feedback indicates support for accelerated approval pathway

Tue, 12 Mar 2024 00:00:00 +1100

Anteris Technologies welcomes updated DurAVR THV for serious heart condition

Tue, 12 Mar 2024 00:00:00 +1100

AdAlta announces positive results from Phase 1 extension study of lead asset AD-214

Thu, 07 Mar 2024 00:00:00 +1100

‘Innovations in equality’ highlighted on International Women’s Day

Thu, 07 Mar 2024 00:00:00 +1100

More than 650 life science professionals will gather tomorrow for AusBiotech’s annual NSW Women in Life Sciences Luncheon to examine the pathways to greater economic inclusion for women in biotechnology.

Hosted by AusBiotech and Medicines Australia, the Luncheon will capitalise on the International Women’s Day 2024 theme Count Her In: Invest in Women. Accelerate Progress.

The 2024 Women in Life Sciences Luncheon will feature an expert panel consisting of Karen Hood, Country Lead & General Manager, General Medicines, Sanofi; Dr Deborah Burnett, Group Leader, Garvan Institute of Medical Research; Dr Terrance Fitzsimmons, Managing Director, Australian Gender Equality Council; Dr Gisela Mautner, CEO & Managing Director, Noxopharm (ASX:NOX); and Professor Doug Hilton AO, Chief Executive, CSIRO, who will share their experiences and insights on advancing women in the life sciences.

The theme of this year's Women in Life Sciences Luncheon, Innovations in equality: Investing in the future of women in life sciences, will delve into key strategies and initiatives aimed at nurturing diversity in the workplace, fuelling female ambition, and propelling women into leadership roles.

AusBiotech is behind efforts to raise awareness of the importance of gender equity, increasing diversity and inclusion, and inspiring positive change in the Australian life sciences sector.

The annual Women in Life Sciences Luncheon is timed to celebrate International Women’s Day, on 8 March, and brings together up to 650 leaders and future leaders from across Australia. It is focused on connecting the community to encourage, support, and further develop women in the life sciences sector in order to achieve a more equal standing in the biotech, pharma and medtech workplace.

The Luncheon also provides a practical opportunity for female leaders to support the next generation of life science leaders through the ‘Big Sister’ programme. The ‘Big Sisters’ programme has once again invited women advanced in their careers within the sector to sponsor a female student to attend the event and facilitate their networking during the event.

AusBiotech values their partnership with Medicine Australia, and the opportunity to demonstrate change in action around policies of equality and inclusion. Joining forces, this Luncheon brings stakeholders together to further galvanise the diversity required within life sciences. For this diversity is the underpinning to building a successful sector – a position supported regardless of gender.

Clarity Pharmaceuticals says SAR-bisPSMA detects PC lesions in the 2-millimetre range

Thu, 07 Mar 2024 00:00:00 +1100

Proteomics International retains its ISO 13485 certification

Thu, 07 Mar 2024 00:00:00 +1100

Member views sought to inform NSW’s Innovation Blueprint

Tue, 05 Mar 2024 00:00:00 +1100

AusBiotech Members are invited to register for a virtual discussion forum to support its industry-led response to Investment NSW’s Innovation Blueprint.

Investment NSW, the state’s economic development and attraction agency, is seeking feedback on its proposed Innovation Blueprint aimed at attracting new investment, ideas, industries and talent.

To support the NSW Government's understanding of the innovation ecosystem’s priorities, challenges and opportunities, AusBiotech’s AusBioNSW initiative intends to submit a response reflecting the capabilities present and priorities of the NSW life sciences sector.

To support this response, AusBiotech invites members to register for its virtual discussion forum on Tuesday, 19 March at 2pm (AEDT) to discuss the priorities for the sector and issues, opportunities, and challenges and the sector faces.

The Innovation Blueprint was first announced in September 2023 by the (then) Minister for Innovation, Science and Technology, NSW Government, to guide how it supports the NSW innovation and technology ecosystem. A discussion paper was released in February, outlining specific areas for feedback and a set of criteria for respondents.

As the voice of industry, AusBiotech works with Government to ensure industry’s rightful place as a key and growing economic and social driver, ensuring the Australian life sciences industry is structurally supported to capitalise on new technologies and growth opportunities. In line with its AusBioNSW strategic plan, this response will advocate for the NSW life sciences sector, increase awareness of NSW biotechnology strengths and offerings locally, and supports the driving of initiatives to attract investment and grow innovation and trade in NSW.

AusBiotech Members are warmly invited to register for this forum by contacting Robyn Lindner, General Manager, AusBioNSW. If Members are unavailable to attend but would still like to participate, written feedback is welcome; please reach out to Robyn for a copy of the questions.

Read more about the NSW Innovation Blueprint here.

Telix announces major acquisition of Canadian-based ARTMS

Tue, 05 Mar 2024 00:00:00 +1100

Invion announces positive results from pre-clinical study of INV043

Tue, 05 Mar 2024 00:00:00 +1100

AusBiotech submits feedback on TGA fees and charges consultation

Thu, 29 Feb 2024 00:00:00 +1100

AusBiotech has responded to the Therapeutic Goods Administration’s annual fees and charges consultation, urging the Government to reconsider how the TGA’s digital transformation is funded.

AusBiotech is supportive of the proposed fee increase of 4.7%, with the position in line with previous increases, and offering an approach where fees are commensurate with the opportunities for efficiency gains and is consistent with the Government’s policy for cost recovered activities.

However, it strongly recommends that the decision to fund the TGA’s digital transformation through increases to cost recovery arrangements is reconsidered.

The TGA is currently undergoing a digital transformation to enhance their business systems, including the establishment of a ‘single product portal’. And the consultation paper explains that to cover the long-overdue digital update, costs will be recovered from industry over five years, commencing from 1 January 2024.

AusBiotech’s Director Policy & Communications Karen Parr noted, “Industry is very supportive of the modern operating system that the digital update offers, and has been involved in the UDI system consultations for many years. However, the Australian Government’s cost recovery guidelines are clear that industry fees and charges should accurately reflect the fee for services provided directly to a specific individual or organisation.

“AusBiotech is yet to learn of any other government body, even those undertaking cost recoverable activities, that puts the costs of infrastructure updates onto its stakeholders. AusBiotech strongly recommends that the decision to fund the TGA’s digital transformation through increases to cost recovery arrangements is reconsidered.”

AusBiotech welcomed the Government’s additional funding for four years of public good activities in the 2023-2024 Federal Budget. As an internationally competitive regulator, Australia needs an agency that is empowered to contribute to the Australian economy and to the life sciences sector.

In light of this funding, it recommended the development and publication of metrics to demonstrate the value that this publicly-funded public good activities are delivering to Australians and Australia.

The TGA is world-class and plays a vital role in safeguarding the health of the Australian public, however its remit has evolved significantly and now includes a meaningful amount of ‘public health activities’ such as consumer education and the regulation of cannabis products, that go beyond evaluating, assessing and monitoring medicines and medical devices through which it collects its fees and charges.

AusBiotech fully supports the essential public health work that the TGA currently undertakes and urges the Government to do the same by providing appropriate funding for its work.

The development of metrics will support attaining sustainable public funding for the TGA that is commensurate with other similar national regulatory agencies, and that is in Australia’s national interest.

Submissions in response to this public consultation will be considered as part of the decision making of fees and charges for 2024-25, with the final consultation outcome to be published on the TGA website.

The AusBiotech submission was developed with the support of the AusMedtech Regulatory Affairs Advisory Group. Read AusBiotech’s submission here.

Neuren Pharmaceuticals reports fourth quarter royalties from DAYBUE sales

Thu, 29 Feb 2024 00:00:00 +1100

Recommendations made to increase diversity in Australia’s STEM industries

Tue, 27 Feb 2024 00:00:00 +1100

Recommendations to drive diversity and inclusion of people underrepresented in STEM education and jobs are outlined in the Federal Government’s Pathway to Diversity in STEM Review report.

Published by the Department of Industry, Science and Resources, the review found that “stronger leadership and coordination is essential to drive faster and more ambitious progress. There are many initiatives to increase diversity in STEM, but no central point to bring these together, identify gaps, and measure and share what works.”

The report contains 11 detailed recommendations to create structural and cultural change to increase the diversity of Australia’s STEM system, noting that “industry, governments, the education sector, not-for-profits and individuals all have a role to play.”

Nine of the recommendations are focused on changes the Federal Government should implement, while the remaining two are targeted at private organisations. These include:

Every Australian organisation employing STEM workers committing to the elimination of bullying, harassment and discrimination, including racism; and
Every Australian organisation employing STEM workers adopting, making public and implementing a plan to increase attraction, retention and promotion of underrepresented cohorts.

The panellists noted in the report, “The recommendations in this report reflect the urgency of supporting and retaining diverse people in our existing STEM workforce. We cannot afford to lose anyone. We must harness the potential of all people with a curious mind, a spark for problem-solving and a keenness to build up and change our world.”

The report states, “Organisations can fill immediate STEM workforce needs by drawing on people with diverse and valuable STEM skills and experience. This includes migrants with overseas STEM qualifications, people who are VET qualified, and First Nations people with STEM knowledge and experience. Industry also has a role to play in widening pathways to STEM opportunities and re-skilling their existing workforce with STEM competencies.”

The report includes an approach to develop a strategic suite of programmes that go beyond gender equity. This includes changes to the current suite of Women in STEM programs in the Australian Government’s Department of Industry, Science and Resources.

“The advisory council should have a role in designing, implementing and evolving these programs. It will ensure that programs are effective, fill genuine gaps and do not duplicate existing initiatives,” the report notes.

AusBiotech is committed to diversity and inclusion; its commitment follows four principles, and encourages industry to follow them too. Diversity in all aspects of business operations optimises the continued growth and success of the life sciences industry.

Read the Pathway to Diversity in STEM Review here.

Telix says strong revenue growth underpins investment in late-stage pipeline

Tue, 27 Feb 2024 00:00:00 +1100

Dimerix announces successful collection of data for first patients in ACTION3 trial

Tue, 27 Feb 2024 00:00:00 +1100

IVDs used in FMT screening exempt from Class 4 IVD requirement

Thu, 22 Feb 2024 00:00:00 +1100

AusBiotech welcomes the Therapeutic Goods Administration (TGA) decision to exempt laboratories’ requirement to register Class 4 in-house IVDs on the Australian Register of Therapeutic Goods (ARTG) for stool donor screening test kits.

Laboratories using Class 4 in-house IVDs to detect the presence of transmissible agents in samples to assess suitability for faecal microbiota transplants (FMT) no longer need to register on the ARTG, following public consultation.

The TGA notes that “The exemption is intended to allow laboratories time to work with the TGA to establish processes that allow adequate data to be generated which supports their performance as Class 4 in-house IVDs. This data will contribute to the clinical evidence needed to address some of the residual risks associated with detection of specific organisms in the stool samples of healthy donors, and their relevance to potential transmission.”

As the voice of industry, AusBiotech’s submission to the TGA’s draft Guidance for Class 4 in-house IVDs for screening Faecal Microbiota Transplant (FMT) donors outlined the need for the Class 4 IVD exemption for stool donor screening test kits be a permanent exemption, and shared the industry’s desire to work with the TGA to support and foster this emerging industry with a fit-for-purpose framework to screen FMT donors, given the small sample size, data validation and resourcing (cost, capacity and time) barriers being faced

Under the TGA's IVD Framework, an IVD is intended to detect the presence of, or exposure to, transmissible agents in blood, stool or other samples in order to assess suitability for FMT transplant is regulated as a Class 4 IVD (or Class 4 in-house IVD).

For the majority of blood tests being proposed for FMT donors, there are already Class 4 IVDs included in the ARTG that are intended for screening, however there are currently no Class 4 IVDs in the ARTG that are approved for testing of stool specimens for the purpose of screening donors for the manufacture of FMT products.

The amendments also provide for a requirement for these laboratories to notify the TGA so that the regulator is aware of the tests being used for donor screening purposes. The TGA will monitor and review this exemption to determine if it is still needed in the future.

The TGA notes that guidance will soon be published by the TGA Medical Devices Authorisation Branch to assist laboratories in meeting the new IVD regulatory amendments. These will outline the TGA's expectations around the technical considerations for these tests, in line with the conformity assessment procedures and National Pathology Accreditation Advisory Council (NPAAC) requirements.

Australia broke new ground as the first country globally to provide regulatory approval for faecal transplants when it approved an FMT therapy in late 2022. The introduction of faecal transplants has provided a new and welcome approach to treating difficult bacterial infections, with the number of approved therapies steadily growing globally.

LBT Innovations confirms deliver of APAS PharmaQC to Thermo Fisher

Thu, 22 Feb 2024 00:00:00 +1100

Certa Therapeutics’ FT011 granted US FDA fast track for systemic sclerosis

Wed, 21 Feb 2024 00:00:00 +1100

Inaugural AusMedtechInvest 2024 launched

Tue, 20 Feb 2024 00:00:00 +1100

AusMedtechInvest 2024, Australia’s inaugural boutique medtech investment roundtable forum, will provide a brand new forum to connect capital with innovation, with medical technology (devices and diagnostic) businesses and investors invited to register.

Access to capital remains one of the biggest opportunities for biotech companies in Australia. AusMedtechInvest builds on AusBiotech’s well-established investment attraction programme, and will be held during Australia’s ‘biggest week in medtech’, at the Adelaide Convention Centre on Tuesday 21 May. The intimate half-day programme will feature company presentations, keynote speakers, and informative market updates along with the opportunity of one-to-one investment partnering.

AusBiotech’s investment programme fosters meaningful connections between the investment community and investment-seeking life sciences companies, enabling great ideas to attract risk-tolerant capital while assisting investors to connect with innovative, Australian companies that offer high-value return-on-investment. AusMedtechInvest is designed to create connections that will contribute to the advancement of the sector, foster growth, and drive investment and collaboration in Australia’s life science sector.

Medical technology is a growing sector, with global impact for greater good: as revealed in AusBiotech-commissioned research, the sector is rapidly expanding, with 50 percent growth between 2019 and 2022, for the first time exceeding the number of therapeutic companies developing life-enhancing and life-saving technologies in Australia. Australia’s medtech industry is poised for further growth, with the sector expected to reach a market value of US$7.96 billion this year, with medical devices representing the largest segment, with its market volume expected to also reach US$6.73bn this year.

Globally recognised for its ground-breaking research & development and strong biotech innovation ecosystem, Australian medtech companies have created solutions that have advanced the quality of healthcare, improved patient outcomes, and ultimately saved lives across the world. From the bionic eye to the electronic pacemaker and spray-on artificial skin, Australia’s medtech industry punches above its weight and is today the largest sector within Australia’s life sciences industry.

At AusMedtechInvest 2024, presenting company executives have the opportunity to deliver a ten-minute investment pitch and share the latest company updates to room of risk-tolerant investors looking to invest in breakthrough technologies, while also receiving access to the AusPartnering business matching system for confidential discussions in the networking lounge.

Qualified investors are invited to register for a complimentary investor pass. Investors who attend AusMedtechInvest 2024 can also access discounted registration to AusMedtech 2024, underway in Adelaide from 22-23 May.

Other industry professionals interested in attending the roundtable can register as an AusMedtechInvest delegate.

Read more about the criteria and apply to be an AusMedtech 2024 Investee here. Medtech companies in the pre-seed phase are invited to register for the AusMedtech 2024 Early-Stage Innovation Forum pitch competition. Read more here.

Monash to lead Australian revolution in next generation heart devices

Tue, 20 Feb 2024 00:00:00 +1100

Government selects Brandon BioCatalyst, in partnership with ANDHealth, to deliver Dementia and Cognitive Decline Incubator

Thu, 15 Feb 2024 00:00:00 +1100

Clarity’s announces positive results of US-based COBRA prostate cancer study

Thu, 15 Feb 2024 00:00:00 +1100

Opthea completes enrolment in first pivotal trial with sozinibercept

Thu, 15 Feb 2024 00:00:00 +1100

Syntara launches new blood cancer trial of lead candidate

Thu, 15 Feb 2024 00:00:00 +1100

CSIRO launches free SME programme for medtech and digital health companies

Thu, 15 Feb 2024 00:00:00 +1100

CSIRO says the free 10-week online programme is specifically designed to assist Australian SMEs operating in critical sectors advance their innovative technologies, solutions and ideas through research and development (R&D).

CSIRO noted that participants will collaborate with a mentor from CSIRO or a university to address technical and business challenges, explore their R&D opportunities, learn tips for partnering with research organisations, and develop strong funding applications. Participants may also be eligible for dollar-matched R&D funding through the CSIRO Kick-Start programme.

The programme has supported more than 500 companies to date.

The 10-week programme involves webinars and a half-day virtual workshop with CSIRO industry and research experts and relevant industry SMEs. Key topics include trends within relevant sub-sectors, panel discussion with collaborating SMEs, and current funding opportunities for R&D.

Participants also take part in a self-paced online innovation programme to develop and test their research ideas and business cases, with two to three hours of time commitment required each week.

Programme participants must be an Australian registered and operating business; classified as a small to medium-sized business (less than 200 employees); either currently, or in the early stages of, exploring R&D opportunities; and operating in one of the below sub-sectors.

AusBiotech-commissioned research revealed Australia is home to more than 1,427 life science companies, ranging from small start-ups to multinational pharmaceutical companies. Almost 80 percent of the industry is comprised of small and medium sized companies (SMEs), of which the majority are pre-revenue and in the process of commercialisation or translation of research, highlighting why programmes such as this are important tools for supporting commercialisation.

Applications close on Sunday 18 February and places are limited. Visit Innovate to Grow to learn more and apply. The program commences 14 March 2024.

NSW Women in Life Sciences Luncheon 2024 speakers announced

Tue, 13 Feb 2024 00:00:00 +1100

With the announcement of the NSW Women in Life Sciences Luncheon 2024 speakers, industry is encouraged to register for the must-attend event taking place on International Women’s Day, as seats at the table are limited.

An expert panel consisting of Karen Hood, Country Lead & General Manager, General Medicines, Sanofi; Dr Deborah Burnett, Group Leader, Garvan Institute of Medical Research; Dr Terrance Fitzsimmons, Managing Director, Australian Gender Equality Council; Dr Gisela Mautner, CEO & Managing Director, Noxopharm (ASX:NOX); and Professor Doug Hilton AO, Chief Executive, CSIRO, has been formed to discuss ‘Innovations in equality: Investing in the future of women in life sciences’, at the NSW Women in Life Sciences Luncheon on Friday 8 March 2024.

Co-hosted by AusBiotech and Medicines Australia, the theme of this year's Women in Life Sciences Luncheon, Innovations in equality: Investing in the future of women in life sciences, will delve into key strategies and initiatives aimed at nurturing diversity in the workplace, fuelling female ambition, and propelling women into leadership roles, with panellists sharing their experiences and insights on advancing women in the life sciences.

The annual Women in Life Sciences Luncheon is timed to celebrate International Women’s Day, on 8 March, and brings together up to 550 leaders and future leaders from across Australia. It is focused on connecting the community to encourage, support, and further develop women in the life sciences sector in order to achieve a more equal standing in the biotech, pharma and medtech workplace.

Event details

When: Friday 8 March 2024

Where: Doltone House, Jones Bay Wharf, 48 Pirrama Road, Pyrmont NSW 2009

Time: 12.00pm - 3.30pm

Become a Big Sister or Little Sister

Make a commitment: The successful ‘Big Sisters’ programme invites leaders in the sector to connect with those aspiring to a career or career progression in the life sciences. It provides a practical and tangible way to support and encourage women in the late stages of their studies to enter a career in life sciences.

Big Sisters will sponsor women students to attend the event and meet their network during the Luncheon. Sponsorship of a Little Sister is for the duration of the Luncheon only. Up to 30 women students will be sponsored to attend the event and receive a one-year membership of AusBiotech. To include this sponsorship please select the checkbox during the registration process.

Applications to be a Little Sisters are also being received. To become a Little Sister, applicants must be enrolled in an under-graduate or post-graduate course in life sciences, identify as a woman, and live in NSW.

Learn more about how to become a Little Sister, sponsor a sister, and register as an individual or as a table of ten now.

CSL reports strong first half growth with immunoglobulins the highlight

Tue, 13 Feb 2024 00:00:00 +1100

Immuron reports record sales of Travelan immune supplement

Tue, 13 Feb 2024 00:00:00 +1100

Competition opens to elevate early-stage medtech pitches

Thu, 08 Feb 2024 00:00:00 +1100

Medtech entrepreneurs are being invited to the Early-Stage Innovation Forum (ESIF), a unique platform for developers to pitch their innovation at the 2024 AusMedtech national conference in Adelaide.

The ESIF rapid-fire pitch competition provides presenters with an opportunity to pitch their early-stage innovation to a panel of expert judges for feedback that will prepare them for their capital raising journey ahead.

This exclusive opportunity offers early-stage projects and technologies in the areas of medical devices and diagnostics, digital health and enabling technologies, the chance to gather feedback essential for commercialising, from a panel of industry experts as well as corporate VCs and early-stage investors.

During their seven-minute presentation, presenters will be required to outline the problem they are trying to address, their innovative approach to solving the problem, the technology’s competitive advantage, development plan and investment proposal.

Companies that have advanced beyond seed funding are encouraged to express their interest in AusMedtechInvest 2024, Australia’s inaugural boutique medtech investment roundtable forum, and aims to build meaningful personal connections between innovative medical technology (devices and diagnostic) businesses and investors, and help great ideas attract the capital needed to thrive in a fast-paced, competitive market. Investors are also invited to apply for their complementary pass here.

The ESIF is run bi-annually and features presentations from Australia's local research institutes, universities, hospitals, and pre-series A companies.

QIMR Berghofer’s A/Prof Michelle Hill, winner of Best Translational Research at the AusMedtech 2023 ESIF, said: “The feedback from the panel will help to further refine the pitch as I will be looking for investors for my startup to commercialise the discovered biomarkers to new blood tests for ovarian cancer diagnosis and early detection.”

Read more about A/Prof Hill’s novel ovarian cancer diagnostic tool in the October 2023 Australasian Biotechnology journal here.

Submissions received by 12 April will be reviewed by the appointed Advisory Group and applicants will be contacted with further information once the evaluation process is complete.

Recce Pharmaceuticals signs MoU with Indonesian partner to progress anti-infectives

Thu, 08 Feb 2024 00:00:00 +1100

Cochlear upgrades earnings guidance on better than expected implant revenue

Thu, 08 Feb 2024 00:00:00 +1100

First patient receives treatment in Chimeric's trial of CHM 0201 in AML

Thu, 08 Feb 2024 00:00:00 +1100

Sustainable funding sought for National One Stop Shop for clinical trials

Tue, 06 Feb 2024 00:00:00 +1100

A 2024-25 Pre-Budget submission urging for sustainable funding for the Government's National One Stop Shop for clinical trials has been submitted by the Research and Development Taskforce, a multi-sector collaboration between AusBiotech, Medicines Australia and the MTAA.

The group has urged the Government to provide appropriate and sustainable funding to the National One Stop Shop for clinical trials in the 2024–25 Federal Budget, so that the country remains a globally competitive R&D destination, and for Australian patients to have access to the latest medical therapies.

The National One Stop Shop (NOSS) for clinical trials is a digital platform that will provide a coordinated system of approval and reporting processes for human research, including clinical trials in Australia. Australia is a good destination for clinical trials, with excellent healthcare facilities, world-class researchers, a diverse population, and strong legal frameworks with robust IP protections. However, the complex regulatory environment for trials in Australia can act as a barrier for companies looking for efficient and cost-effective locations.

The RDTF said in its pre-Budget submission that failure to allocate funds to the NOSS poses significant risks to both patients and the broader healthcare landscape, and noted RDTF’s commitment to working collaboratively with the Government to support its development and implementation.

“Investing in the NOSS is not just a commitment to the health and well-being of Australians but also an economic imperative, fostering innovation, creating jobs, and positioning Australia as a global leader in research and development.

“Without adequate funding for the NOSS, Australia’s clinical trial landscape will fragment further as each jurisdiction continues to develop their own systems and processes that are not interoperable. Australian patients will experience prolonged wait times or, worse, miss out on the opportunity to access cutting-edge medical therapies.

“Additionally, the lack of sustainable funding for the NOSS may lead to a decline in clinical trial activity. Biopharmaceutical and medical technology companies may prioritise conducting trials in countries with more efficient and streamlined systems.”

The pre-Budget submission also noted that in 2022, the EU launched their own ‘One Stop Shop’, the Clinical Trials Information System (CTIS). The CTIS harmonises clinical trial processes between European Union Member States, European Economic Area countries and the European Commission, making it easier for sponsors to conduct trials.

“If Australia is to keep pace with the changing global landscape, we too, need a single, efficient, and streamlined clinical trial systems across the country.”

AusBiotech has supported the concepts of a National One Stop Shop since first mooted more than two years ago, through national speaking opportunities, formal submissions, and through its ongoing discussions with Ministers and departmental staff.

AusBiotech is dedicated to promoting Australia globally as a key destination to conduct clinical trials, and a well-designed National One Stop Shop will be instrumental in supporting this mission. Clinical trials play a pivotal role in the economy of the future; already supporting more than 8,000 innovative Australian jobs, in 2019 clinical trials contributed more than $1.4 billion to the Australian economy – demonstrating its value in supporting the country’s transition from a post-mining boom.

Read the pre-Budget submission here.

Deflexifol clinical data presented at ASCO Gastrointestinal Cancers Symposium

Tue, 06 Feb 2024 00:00:00 +1100

Cell & Gene Catalyst working groups members announced

Thu, 01 Feb 2024 00:00:00 +1100

Thirty-two experts from across the cell and gene ecosystem have been appointed to Australia’s Cell & Gene Catalyst’s (the Catalyst) three working groups.

The Catalyst today announces the appointment of 32 experts to its three expert working groups: Policy & advocacy, Collaboration & knowledge-sharing, and Workforce development.

A national joint venture of the industry peak bodies AusBiotech and Medicines Australia, the Catalyst aims to accelerate Australia’s cell and gene industry to ensure everyone in Australia has access to world-class advanced therapeutics.

The working groups announced today will join forces with the Catalyst Expert Steering Group to advance the Catalyst’s strategic goals and priorities, and accelerate Australia’s cell and gene industry.

Catalyst Director, Dr Marguerite Evans-Galea AM, says, “Working group members were selected from more than 50 leaders and rising stars who expressed their interest. This sector-wide commitment clearly demonstrates the value and importance of the cell and gene industry to Australia’s innovation-driven future.”

Working groups will focus on key strategic priorities identified through broad consultation with the sector. Examples include reimbursement and regulatory pathways for cell and gene therapies, market access, long term strategic investment in infrastructure and across the value chain, boosting capacity and capability in product development, and creating education and professional development opportunities to equip Australia’s current and future workforce.

Catalyst’s Expert Steering Group member Deniz Bagdadi, Business Unit Director, New Products, CSL, says, “Thank you to the vast network of professionals that applied for or were selected for the Catalyst’s working groups. The response is an overwhelming demonstration of the breadth of expertise and skills in the Australian cell and gene industry, and will be invaluable in creating tangible outcomes and impact as we implement the industry-developed strategy for Australia to become a world-class cell and gene hub.”

“The ecosystem’s collaboration is essential if we are to fully realise the opportunities of cell and gene within Australia’s rapidly growing sector and achieve our common mission: establishing an end-to-end value chain for the discovery, development, manufacture and distribution of cell and gene therapies, while promoting job creation, commercialising research, and exporting Australian innovation globally.”

Group members will volunteer their time and expertise throughout this year in support of the Catalyst’s goals and activities and commit to taking a collaborative, solutions-driven approach. Groups will apply an ecosystem-wide lens and members have diverse backgrounds and lived experiences to draw on during the meetings.

AusBiotech and Medicines Australia, value and appreciate this commitment to accelerating the growth of Australia’s cell and gene industry.

Policy & advocacy working group

Goal: Developing and implementing an advocacy strategy that effectively communicates the burning issues and recommended solutions for the cell and gene industry.

Members:

Neama Baho, Pro Pharma Group
Matt Banfield, Miltenyi Biotec Australia
Hassan Chaudhry, IQVIA
Daniel Getts, Myeloid Therapeutics
Lead Goodman, Biointelect
James McAdam, Bristol Myers Squibb
Megan Munsie, Murdoch Children's Research Institute, University of Melbourne
Mary Nteris, Fenix Innovation Group
Gabrielle O’Sullivan, Centenary Institute (Royal Prince Alfred Hospital)
Addison Ridge, Nexus Public Affairs
Anna Schulze, CSL Limited
Janet Tyler, Roche
Kelvin Yip, Monash University (observer)

Collaboration & knowledge-sharing working group

Goal: Develop and implement an engagement framework that provides meaningful opportunities to connect, exchange ideas and share knowledge and expertise to foster industry-led collaborations.

Members:

Helen Dodds, Sanofi
Jo Fleming, Australian Red Cross Lifeblood
Hamza Hassan, Decode Science
Sinthujan (Sinth) Jegaskanda, Myrio Therapeutics
Tracy Jones-Bower, Roche
Jo Karra, Sydney Children's Hospital Westmead
Jack Lambshead, Biointelect (observer)
Heather Main, Hoya Consulting / University of Melbourne
Cameron McDonald, CSIRO
Gerry McKiernan, Increment 4 (previously Cell Therapies)
Zlatibor Velickovic, Royal Perth Hospital
Elizabeth Wilson, IQVIA

Workforce development working group

Goal: Identify education and skills gaps and develop an evidence-based workforce development framework in partnership with the sector.

Members:

Walid Azir, Cartherics Pty Ltd
Jarrod Belcher, MTPConnect
Simon Cool, The University of Queensland
Marilyn Jones, MEXEC
Octavio Mejia, Telix Pharmaceuticals Limited
Mariyam Murtaza, Griffith University (observer)
Umesh Nair, Merck
Tom Parsons, Proclinical Global Growth Partners
Alice Pebay, CCRM Australia
Sharon Sagnella, Centenary Institute (Royal Prince Alfred Hospital)
Christine Wells, The University of Melbourne
Irene Wong, Australian Tax Office

Pioneering melanoma researchers named 2024 Australian of the Year

Tue, 30 Jan 2024 00:00:00 +1100

The contributions of dozens of Australian clinicians and researchers have been celebrated in the Australia Day 2024 Honours List, with two University of Sydney Professors named Australian of the Year.

The 2024 Australian of the Year award recognises the partnership between University of Sydney Professors Georgina Long AO and Richard Scolyer AO, co-medical directors of the Melanoma Institute Australia in New South Wales, that has saved thousands of lives from melanoma.

Profs Long and Scolyer’s scientific partnership has led to the use of immunotherapy in the treatment of melanoma, in turn making advanced melanoma, which was formerly a death sentence, a curable disease.

In June 2023, when Prof Scolyer was diagnosed with incurable grade 4 brain cancer, he and Prof Long developed a series of world-first treatments based on their melanoma breakthroughs. Prof Scolyer became the world’s first brain cancer patient to delay having his tumor removed to receive pre-surgery combination immunotherapy. By undertaking an experimental treatment with risk of shortening his life, he has advanced the understanding of brain cancer and is benefiting future patients.

Accompanying the Sydney-based Professors on the Australia Day 2024 Honours List are nine researchers/clinicians, appointed as an Officer of the Order of Australia (AO) for services to medical research and/or health innovation, and 22 individuals who were awarded the Medal of the Order of Australia (OAM).

AusBiotech heartily congratulates all recipients, including those appointed as an Officer of the Order of Australia (AO):

Plastic surgeon and burns specialist, Orthocell Board member and Telethon Kids Institute’s Winthrop Professor Fiona Wood AM (WA), for her distinguished service to plastic and reconstructive surgery, to medical research, and as clinician scientist and mentor;
The Peter MacCallum Cancer Centre’s Professor Joseph Trapani (VIC), for his distinguished service to medical research, particularly immunology and the development of immune-based cancer therapies, and to the community.
The Victor Chang Cardiac Research Institute’s Professor Sally Lewers (NSW), for distinguished service to medical research as an embryologist and geneticist, particularly in the field of foetal, and neonatal heart disease.
His Honour Professor the Honourable Hugh Crosby Heggie (NT), for distinguished service to medicine and medical research organisations, and as Administrator of the Northern Territory;
Biomedical engineer Dr Graham Grant (NSW), for distinguished service to biomedical engineering as a pioneer of innovative equipment development, and to medicine;
The University of Sydney’s Professor Julie-Anne Leask (NSW), for distinguished service to health and medical research, to policy advice, and to enhancing community understanding of immunisation;
The late Dr Peter Maher (VIC), for distinguished service to gynaecological medicine, to medical research and education, and to professional societies;
The University of Adelaide’s Professor Sarah Robertson (SA), for distinguished service to medical research, particularly reproductive biology and immunology, and to professional societies; and
The University of Sydney’s Professor Ian Hickie AM (NSW), for distinguished service to psychiatric research and reforms as an advocate for improved mental health care and awareness

See the full list of Honours here.

Arovella licences novel CARiNKT cell armouring technology

Tue, 30 Jan 2024 00:00:00 +1100

Starpharma says Viraleze shows antiviral efficacy in COVID-19 patients

Tue, 30 Jan 2024 00:00:00 +1100

AusBiotech members invited to capital attraction roundtable

Thu, 25 Jan 2024 00:00:00 +1100

AusBiotech members are invited to share their views at a virtual roundtable on capital attraction incentives, to help finalise AusBiotech’s Investment in industry-driven medical research policy paper.

The greatest barrier to the commercialisation of medical research via Australia’s biotechnology sector is the attraction of dilutive and non-dilutive investment - predominantly to enable pre-clinical work and clinical trials, but also to support manufacturing and expansion.

Developed in partnership with the AusBiotech membership, and following a dialogue with Minister for Industry and Science, the Hon Ed Husic MP in April 2023, this policy paper sets out a recommended position for joint Government and industry initiatives.

The virtual roundtable will focus on strengthening the paper’s positions on the Business Research and Innovation Initiative/SBIR; the MRFF/Biomedical Translation Fund; the Early-Stage Innovation Company (ESIC) incentive; and Superannuation funds, and invites member feedback, including case studies and additional supporting evidence that will aid future advocacy activities.

As identified in the Biotechnology Blueprint, Australia’s biotech industry’s decadal strategy, access to capital remains one of the largest challenges for biotech companies in Australia. To build, diversify and address gaps in access to capital across the industry, a significant increase in the flow of capital to the biotechnology sector of $1 billion annually is needed.

To help address this, AusBiotech has considered a raft of policy levers to address capital attraction, with this policy paper outlining the joint Government/industry initiatives considered to ‘most move the dial’. AusBiotech thanks those involved in the initial roundtable discussions, including Board and Investor Advisory Group members.

The AusBiotech online roundtable will be conducted on Thursday 8 February from 1.30 – 2.30 pm (AEDT). AusBiotech members can register their interest in attending the roundtable by contacting Karen Parr, Director, Policy & Communications.

Upon finalising the Investment in industry-driven medical research policy paper, AusBiotech will begin advocacy activities.

Members are invited to log into the AusBiotech website to download the draft policy paper here, or to contact Karen for a Word version.

Aravax closes funding round to accelerate development for peanut allergy therapy

Thu, 25 Jan 2024 00:00:00 +1100

New Years’ resolutions for a healthy future

Tue, 23 Jan 2024 00:00:00 +1100

It’s that time of year where we return at our most refreshed and teeming with ideas and resolutions to make this year the most successful yet. AusBiotech’s commitment to the sector remains stronger than ever, with the new year providing a timely opportunity to revise and refresh strategic priorities for the year ahead.

After a very successful 2023, where industry broke new ground and celebrated milestones and achievements that collectively elevated the entire ecosystem, AusBiotech is anticipating an even stronger 2024, with a focus on connecting the biotech community and advocating for the life science industry’s advancement.

Resolution one: bolster AusBiotech’s investment attraction programme to connect more innovators with investment

Access to capital remains one of the largest challenges for biotech companies in Australia. To support the building of meaningful connections between the investment community and investment-seeking life sciences companies, AusBiotech has a strategic focus on increasing access to capital for Australian biotechs.

After making significant strides within the investment attraction programme last year to develop metrics and resources to support the sector’s success, members will see a renewed focus for investment attraction this year via AusBiotech’s investment programme, events, and policy activities. AusBiotech will imminently be inviting member feedback on a capital attraction white paper with more information to be announced later this week.

We look forward to announcing our capital attraction initiatives other the next few months and throughout the year – watch this space for more details.

Resolution two: advocate for and on behalf of the sector to support its advancement

As the voice of industry, AusBiotech will continue its work on activities that support the priorities outlined in the Biotechnology Blueprint: A Decadal Strategy for the Australian Biotechnology Industry, after 2023 saw progress on developing metrics and benchmarks to track the Blueprint’s progress and success.

AusBiotech looks forward to the release of the National Reconstruction Fund’s sector-specific co-investment plans, after the higher-level investment mandate was released in November 2023. The summer also saw the Industry Growth Program’s advisors announced and applications open. Read about the Program here.

AusBiotech will also be continuing to respond to key consultations; providing a sector voice on key government programmes such as the National OneStop Shop; shaping policy positions to advocate for the advancement of Australia’s life sciences ecosystem; and running our annual invitation-only c-suite state-based roundtables in the first quarter of 2024 to engage members on AusBiotech’s advocacy plan ahead. It looks forward to working closely with members for the betterment of the sector.

In addition to the above, it will continue to promote opportunities to champion the sector and share the success of our members throughout the year.

Resolution three: connect industry through major life science events

Continuing to facilitate opportunities for collaborations, partnerships, and investment is crucial for the growth of Australian life sciences sector and ultimately for continuing Australia’s position in the life sciences sector globally. After a record-breaking year of event attendance during 2023, AusBiotech’s 2024 events programme is gearing up for the biggest year yet.

Save the dates below for more key industry events:

BioCheers: kicking off from February and March 2024 across the country. Watch this space.
NSW Women in Life Sciences Luncheon: 8 March 2024. Register now.
AusMedtech 2024: 22-23 May, Adelaide, South Australia. Save the date.
AusMedtechInvest 2024: 21 May, Adelaide, South Australia. Announcement coming soon…
BIO 2024: 3-6 June, San Diego, USA.
AusBioInvest 2024: 29 October, Melbourne, Victoria. Save the date
AusBiotech 2024: 30 October - 1 November, Melbourne, Victoria. Save the date

We look forward to a busy year ahead and working with members to make it the biggest yet.

Opthea receives additional funding under development funding agreement

Tue, 23 Jan 2024 00:00:00 +1100

Chimeric Therapeutics completes placement with shortfall commitments

Tue, 23 Jan 2024 00:00:00 +1100

AVITA Medical signs US distribution agreement with Stedical Scientific

Tue, 23 Jan 2024 00:00:00 +1100

A year of collective success: 2023 in review

Tue, 19 Dec 2023 00:00:00 +1100

The past 12 months have been significant in progressing Australia’s biotechnology industry. With the collective efforts and foresight of industry, we have many successes to be proud of, initiatives to celebrate, stories to share, and new ground that’s been broken.

When reflecting on the exponential growth and success of Australia’s biotechnology industry over the past year, it is something we can collectively be proud of. AusBiotech thanks its members for their engagement over the past year, and to the hundreds of national advisory group, state branch committee, and event programme committee members for their voluntary contributions throughout the year.

Please note that AusBiotech’s office will be closed from 12.00pm AEDT Friday 22 December 2023, reopening at 9.00 am on Tuesday 2 January 2024. BiotechDispatch will recommence from Tuesday 23 January 2024.

Highlights for 2023

Implementing the Biotechnology Blueprint

This year has focused on delivering towards goals identified in the industry-backed plan, after the launch of the Biotechnology Blueprint, Australia’s decadal biotech strategy in 2022. The Blueprint is a strong advocacy tool for our entire sector, developed to harness our potential and deliver more jobs, economic success, and better health and wellbeing of our citizens.

AusBiotech delivered two additional data projects this year, increasing the total metrics actively tracked, and building industry’s knowledge base. Delivering on these metrics is strategically important as it enables us to track the sector’s progress and allows us to understand and increase awareness of the sector’s social and economic contributions.

AusBiotech published a report with Deloitte Access Economics quantifying the economic impact of the R&D Tax Incentive in biotechnology in Australia. The report underlines the critical role of Government in developing and retaining fit-for-purpose policy beyond election cycles, and highlights what is possible with stable working policies that support the needs of industry. The report contributes to the metric identified in the Blueprint, Metric 3.1 ‘Return on Investment’ and revealed that, for biotech, for every dollar of forgone tax revenue, the incentive has generated a return of $3.14, in turn demonstrating the value add the industry has on the Australian economy.

AusBiotech launched its pilot foreign direct investment project, which saw the development of the US Investment in Australian Life Sciences Snapshot 2023 (the Snapshot), in partnership with Austrade, quantifying the amount of US-originated capital flowing into Australia’s life science companies. Increasing access to capital and attracting investment into the sector are key strategic priorities for the industry. This project marks the establishment of an evidence base for supporting foreign direct investment into Australian life sciences.

These projects will support AusBiotech’s advocacy activities, as we speak to governments, investors, and international companies seeking to partner with Australia.

As the voice of industry, AusBiotech has been championing policy and advocacy. Some of its advocacy highlights over the past year include:

uniting industry as it campaigned for Australia’s world-class regulator to be empowered through an updated funding model in line with international models, which has now been allocated $61 million over four years for its public good activities in the 2023-24 Federal Budget
responding to the proposed regulatory changes for medical device clinical trials, which led to confirmation that the Clinical Trials Notification (CTN) and Clinical Trials Approval (CTA) pathways will remain unchanged
AusBiotech’s CEO Policy Forum in Canberra with Hon. Ed Husic MP, Minister for Industry and Science, Departmental leaders, and staff to discuss and initiatives for capital attraction, diving into opportunities outlined in the Biotechnology Blueprint;
AusBiotech’s Industry Forum with Minister Husic, to discuss the importance, impact and value of key Government programmes for Australia’s biotechnology industry’s development;
responding to and supporting key Government programmes, the National Reconstruction Fund (NRF) and Industry Growth Program (IGP), on behalf of industry and voicing how policy design and understanding the unique characteristics of Australia’s life science industry will be fundamental to driving a thriving industry that delivers well-paid jobs developing quality manufactured products that result in strong economic returns and sovereign capabilities in medical manufacturing. We look forward to seeing programmes roll out in 2024 to support the biotech industry.

Investment attraction programme

This year has seen significant strides forward within AusBiotech’s investment programme, with the launch of new resources to support the growth and maturation of Australia’s burgeoning life sciences sector.

AusBiotech’s landmark A Practical Guide to ESG for Australian Life Sciences Companies (the Guide) was developed to support life science companies beginning on their ‘environmental, social, and governance’ (ESG) journey. The Guide is a world-first for the biotechnology sector, with Australia being the first nation to develop an ESG Guide specifically for biotechnology SMEs, after being recognised in the Biotechnology Blueprint as a strategically important resource for the sector.

Demonstrative of its commitment to early-stage innovators, AusBiotech launched its directory of accelerators and incubators relevant to Australian companies, the Australian Life Sciences Incubator and Accelerator Programmes, providing a valuable new resource for early-stage companies navigating the increasing number of programmes available in the Australian ecosystem.

With capital the lifeblood of the sector, rapidly increasing start-up and spinout company numbers, and a dearth of venture capital in Australia compared to other major countries, the thirst for capital continues. AusBiotech remains committed to fostering meaningful relationships between life science companies and investors. Members can expect to see more proactive policy activity on capital attraction in the new year.

AusBioNSW takes a step forward

AusBiotech’s AusBioNSW is the peak industry membership body for NSW, to represent, connect, and promote NSW organisations doing business in and with the local, national and global life sciences economy. Backed by AusBiotech’s national representation on advocacy activities, membership services, events and networks, for AusBiotech members in NSW, no additional membership is required.

Dr Robyn Lindner, General Manager, AusBioNSW, has been meeting with members and the wider ecosystem to understanding the opportunities and challenges facing the local sector, which has led to the development of an industry-led 2023-2025 strategy for the life sciences industry in NSW. To showcase the state’s success and connect members with information and opportunities, AusBiotech has increased its communications with NSW-based members, providing a dedicated monthly e-newsletter and dedicated news feed spotlighting news and media announcements made by NSW-based organisations.

Building Australia’s cell and gene ecosystem

AusBiotech, with the support of the Cell and Gene Manufacturing Taskforce, launched the National Cell and Gene Manufacturing Blueprint in July, outlining how, with a united and coordinated plan, Australia can realise its potential to become a cell and gene (C&G) manufacturing hub for within the Asia-Pacific (APAC) region. This industry-developed strategy presents a unified and collaborative approach to expanding sovereign C&G manufacturing capabilities and capacity in Australia. It outlines recommendations on how Australia’s ecosystem can work together to develop the necessary infrastructure, workforce and expertise, to position Australia as a regional leader and deliver a new generation of medical treatments.

Australia’s Cell and Gene Catalyst (Catalyst), a joint venture between AusBiotech and Medicines Australia, appointed Dr Marguerite Evans-Galea AM as Catalyst Director to drive the initiative. Dr Evans-Galea, with the support of the Catalyst’s Expert Steering Group (ESG) comprised of Cell Therapies, CSL Behring, Novartis, Pfizer, Roche, Therapeutic Innovation Australia, is responsible for leading the Catalyst’s strategic direction, development and delivery, with the aim of accelerating Australia’s cell and gene industry and ensuring everyone in Australia has access to advanced therapeutics.

A number of strategic priorities have been identified for the Catalyst, including: attracting, building, and retaining world-class talent; fostering collaboration and knowledge sharing; creating a clear regulatory and market access pathway; and building Australian capability across the entire value chain. The Catalyst called for Expressions of Interest (EOIs) for professionals interested in joining the Catalyst’s three working groups with working group members to be announced in early 2024.

2024 events break attendance records to date

Following on from a strong 2023, this year AusBiotech continued to break attendance records with many of our international, national and state-based events attracting their largest numbers to date, signalling Australia’s growing industry with a desire for connectedness and collaboration.

This year we have seen our largest numbers for AusBiotech 2023; BIO 2023; AusMedtech 2023; and our NSW Women in Life Sciences Luncheon. Revisit our event galleries here.

Connecting innovators with investors, AusBioInvest 2023 kicked off Australia’s biggest week in biotech (30 October – 3 November) in Melbourne with 280 attending delegates.

As the nation’s premier life science investment and partnering conference, AusBioInvest 2023 featured fire side chats with Jennifer Nason, Global Chairman, Investment Banking, J.P. Morgan, and Gurkee Singh, Vice President at Eli Lilly and Company, and a panel discussion with key industry figures representing key segments of the ecosystem, in addition to presentations from 26 Australia early to late-stage biotech companies seeking investment and strategic partners. Thank you to our Host State Partner the Victorian Government for its support.

The flagship event of Australia’s biggest week in biotech, AusBiotech 2023 connected more than 1,300 delegates in Brisbane to showcase how life sciences is ‘in our DNA’. More than 22 countries were represented amongst Australian and global life science leaders in attendance, highlighting the growing reach and importance of Australia’s life sciences sector.

AusBiotech 2023, held from 1-3 November, featured an industry-led, gender diverse programme with more than 170 speakers across 50 sessions developed to inform, educate, celebrate, and inspire the life science community.

We were pleased to have the Queensland Government’s strong support as Host State Partner, with (then) Deputy Premier of Queensland, the Hon. Dr Steven Miles, Minister for State Development, Infrastructure, Local Government and Planning; and the Hon. Cameron Dick MP, Treasurer and Minister for Trade and Investment, who spoke at the conference Opening Ceremony and conference dinner respectively.

Australia’s premier medtech conference AusMedtech 2023 also attracted one of its largest delegations to date, with more than 400 registered attendees from across the medical technology sector representing 12 different countries including China, India and the United States. The two-day conferenced headed ‘Back to the Future’, with more than 100 local and international speakers considering how to advance our world-class innovations and progress our sector.

AusBiotech was pleased to have the support of Host State Partner the Government of South Australia, with Honourable Chris Picton, Minister for Health and Wellbeing for South Australia officially opening the conference and the Honourable Susan Close, Deputy Premier for South Australia and Minister for Industry, Innovation & Science, Minister for Defence & Space Industries, Minister for Climate, Environment & Water, who opened the conference dinner.

AusBiotech’s state-based networking functions have been a huge hit this year, with our Women in Life Sciences Luncheon, Clinical Trials dinner, c-suite dinners, 18 BioCheers and End-of-Year function events giving almost 3,300 registered delegates the opportunity to network in an informal setting with other industry professionals in Melbourne, Brisbane, Sydney, Adelaide and Perth.

Save the date for 2024

BioCheers: kicking off around the country from February and March 2024.
NSW Women in Life Sciences Luncheon: 8 March 2024, Sydney. Register now.
AusMedtech 2024: 22-23 May, Adelaide, South Australia. Save the date and submit your programme ideas now.
BIO 2024: 3-6 June, San Diego, USA. Save the date.
AusBiotech 2024: 30 October - 1 November, Melbourne, Victoria. Save the date.
AusBioInvest 2024: 29 October, Melbourne, Victoria. Save the date.

Neuren Pharmaceuticals announces top-line results of Phase 2 NNZ-2591 trial

Tue, 19 Dec 2023 00:00:00 +1100

Carina Biotech doses first patient in Phase 1/2a trial of LGR5-Targeted CAR-T cell therapy

Tue, 19 Dec 2023 00:00:00 +1100

AusBiotech announces Acting CEO

Fri, 15 Dec 2023 00:00:00 +1100

AusBiotech today announces the appointment of its Chief Operating Officer (COO) Rosanne Hyland as Acting CEO, providing continuity and leadership until a new CEO is appointed.

As COO Ms Hyland leads the day-to-day operations of AusBiotech, covering events, finance, human resources and IT/operations. With 25 years’ commercial and operational experience across multiple businesses and industries, Ms Hyland has a proven track record in managing successful and diverse teams. Prior to joining AusBiotech, Ms Hyland was General Manager of The Prince Hospitality Group for 15 years where she was responsible for 20 individual businesses, employing over 700 staff.

Ms Hyland brings a strong work ethic and broad experience in financial management, and has a genuine passion for creating a highly engaged work force focused on positive outcomes.

“I am privileged to be taking on the role of Acting CEO, taking over from Lorraine Chiroiu to continue the provision of visionary and dedicated leadership to the organisation. With the unwavering support of the hardworking AusBiotech team, I look forward to working in service of our members to further progress and champion Australia’s life science sector,” Ms Hyland says.

On behalf of the Board, AusBiotech Interim Chair Dr James Campbell remarked “The Board is pleased to welcome Rosanne as Acting CEO, bringing with her nearly two decades of leadership, operational, and financial management expertise. Rosanne has been well-entrenched in AusBiotech’s activities for the past four years and has the institutional knowledge to support AusBiotech through the CEO transition period.”

The AusBiotech Board is currently undertaking a recruitment process for the CEO position.

-ENDS-

Media enquiries: Annabelle Dick, Communications & Media Manager, AusBiotech,
adick@ausbiotech.org / M: +61 (0) 437 075 209

About AusBiotech

AusBiotech is Australia’s biotechnology organisation, working on behalf of members for more than 37 years to provide representation and services to promote the global growth of Australian biotechnology. AusBiotech is a well-connected network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), food technology and agricultural sectors.

AusBiotech calls for journal articles

Thu, 14 Dec 2023 00:00:00 +1100

AusBiotech is calling for member contributions for the April 2024 edition of the Australasian Biotechnology journal.

AusBiotech is welcoming abstracts from valued members on advancing Australian medtech with themes including next-generation technologies, the power of partnerships, and scaling up and scaling out, with articles sought on new approaches, contributions or analyses to include in the April 2024 edition of the Australasian Biotechnology Journal.

The journal will also feature a sneak peek into Australia’s premier medtech conference, AusMedtech 2024, where local and global thought leaders will discuss the latest breakthroughs, trends, and critical and emerging topics within the medical device, diagnostics, and digital health sectors, and what Australia is bringing to the world-stage.

Australasian Biotechnology is AusBiotech’s official biannual journal, and published in September and April. Its contributions are written by the sector, for the sector. Contributions can range on topics including technology development, manufacturing, Australian strengths and successes on the world stage, and approaches to strengthening Australia’s end-to-end life sciences value chain.

Abstracts should be 200 words, and can be sent to Communications by 5 February 2024.

If your abstract is accepted, the full article will be required on or before 20 February 2024. Article lengths are approximately 500 words (1 page) or 1,000 words (2 pages). High resolution photos to accompany articles are encouraged.

Articles are an AusBiotech member-benefit, however there is limited space and so are not guaranteed to be included.

Abstracts are welcomed on research, business news, and sector trends for consideration at any time of the year.

FDA grants fast-track designation for EnGeneIC's pancreatic cancer candidate

Thu, 14 Dec 2023 00:00:00 +1100

Syntara commences dosing in phase 2 myelofibrosis trial of its pan-LOX inhibitor

Thu, 14 Dec 2023 00:00:00 +1100

CMAX Clinical Research preparing to celebrate three decades of continuous operations

Thu, 14 Dec 2023 00:00:00 +1100

Brooker Consulting launches two new initiatives for life science sector

Thu, 14 Dec 2023 00:00:00 +1100

Australia’s clinical trial sector connects at AusBiotech 2023

Tue, 12 Dec 2023 00:00:00 +1100

As part of Australia’s biggest week in biotech, clinical trial luminaries connected over dinner as part of a new initiative to celebrate the strength and success of Australia’s network.

The ‘Connecting Australia’s clinical trials sector’ dinner, held on October 31, brought together 40 professionals from across Australia, and from across the diverse sector.

The pilot event was identified by AusBiotech’s Clinical Trial Advisory Group as a way to connect this specialist segment of the life science ecosystem, and was hosted in Brisbane the evening before Australia’s largest life science event, AusBiotech 2023.

The dinner provided an opportunity for those working in the clinical trials sector to network informally and celebrate the collective success of Australia’s clinical trial sector. Attendees also received an update from AusBiotech on the policy and advocacy work underway, particularly as it relates to the clinical trials sector.

Australia offers a world class clinical trials ecosystem, and AusBiotech has been promoting and advocating for more than a decade to keep it in its principal position. Commencing over 1,000 clinical trials annually and employing more than 8,800 people, the sector represents an AU$1 billion industry investment.

After the success of the AusBiotech 2023 clinical trials sector dinner, which resulted in a waitlist, AusBiotech will be hosting a dinner for the clinical trials sector prior to AusMedtech 2024, taking place in Adelaide from May 22-23.

Programme submissions are currently being sought for AusMedtech 2024, with submissions closing Friday 9 February. See more information here.

Members interested in attending the AusMedtech 2024 clinical trials sector dinner can register their interest when AusMedtech 2024 registrations open early next year.

AusBiotech appoints Ex-TGA head and CEO of Argenica Therapeutics to its board

Tue, 12 Dec 2023 00:00:00 +1100

New leadership for Health Security Systems Australia

Tue, 12 Dec 2023 00:00:00 +1100

Victorian Government backs the development of Cyban's brain injury technology

Tue, 12 Dec 2023 00:00:00 +1100

Prescient announces the results of PTX-100 Phase 1b study in T-cell lymphoma patients

Tue, 12 Dec 2023 00:00:00 +1100

AusBiotech energised by new Board appointments

Mon, 11 Dec 2023 00:00:00 +1100

Australia’s national member-based biotechnology organisation, AusBiotech, is delighted to announce the appointment of two new Non-Executive Directors to its Board of Directors; Professor John Skerritt, Enterprise Professor in Health Research Impact at the University of Melbourne; and Dr Liz Dallimore, CEO and Managing Director, Argenica Therapeutics Ltd.

Seasoned health and life science leader Professor John Skerritt has been appointed to the AusBiotech Board, bringing decades of experience in research translation, commercialisation, policy and regulation. Professor Skerritt is the former Deputy Secretary of the Australian Department of Health and Aged Care, and led the Therapeutic Goods Administration (TGA) for 10 years, he was also responsible for regulation of gene technology and industrial chemicals and control of drug import, export, and production.

Professor Skerritt has played a major role in advising the Australian Government on the establishment of an mRNA vaccines and medicines industry. He was previously the most senior scientific leader in Australia’s Foreign Affairs portfolio, leading implementation of more than $1billion in collaborative scientific programs between Australia and regional countries. He helped lead Australia’s COVID-19 response and was one of the public media faces of the response.

Professor Skerritt said, “I am thrilled to have the opportunity to contribute to the success of Australia’s life sciences industry via the AusBiotech Board. I look forward to working with fellow Directors to advocate for Australia’s biotech industry and its tremendous potential in Australia’s health and economic wealth.”

Dr James Campbell, AusBiotech’s Interim Chair, said that “Professor Skerritt’s appointment brings extensive government and policy experience as well as deep scientific experience to the Board. His connectivity with national initiatives and the broader sector will aid AusBiotech in working collaboratively to drive policy that reinforces the strength of biotechnology in Australia’s future.”

Dr Liz Dallimore has also been appointed to the AusBiotech Board, and brings with her deep experience in both biotechnology and management consulting with more than 20 years’ experience across Australia and the UK.

As the CEO and Managing Director of Argenica Therapeutics (ASX:AGN), a West Australian clinical stage biotechnology company developing therapies to treat stroke and other neurological conditions, Dr Dallimore led the company’s ASX IPO in June 2021 and has advanced the company from pre-clinical research into a Phase 2 clinical trial in stroke patients. She is also the Co-Founder and Executive Chair of medical device company Inspiring Holdings, a company developing devices for improved inhaled drug delivery.

Dr Dallimore has previously held senior roles in management consulting as KPMG’s National Director of Research Engagement and Commercialisation, structuring technology commercialisation deals across a range of sectors. Prior to this, she held senior roles with Ernst & Young and PricewaterhouseCoopers. Dr Dallimore is also a Non-Executive Director of the Chamber of Commerce and Industry WA, and an industry advisor to Telethon Kids Institute and Curtin University.

“I am honoured to be appointed to the AusBiotech Board of Directors, joining a group of dedicated and passionate industry leaders who are motivated to further grow and develop Australia’s world-class life science ecosystem,” Dr Dallimore said.

On behalf of the AusBiotech Board, Dr Campbell stated his pleasure in welcoming both Professor Skerritt and Dr Dallimore to the Board as Non-Executive Directors. “These new appointments bring fresh perspectives and insight that will position AusBiotech to represent the best interests of our diverse membership at the national level.”

In addition to the two new appointments, Dr Megan Baldwin, Founder & Chief Innovation Officer, Opthea Ltd (ASX:OPT; NASDAQ:OPT), has been reappointed to the Board, formally commencing her third term as an appointed Non-Executive Director.

The new AusBiotech Board line-up includes:

Dr James Campbell, CEO, Patrys Ltd; Interim Chair, AusBiotech
Ms Erica Kneipp, Research Director, Human Health, CSIRO; Deputy Chair, AusBiotech
Dr Megan Baldwin, Chief Innovation Officer, Opthea Ltd (ASX:OPT); Risk and Audit Sub-Committee, Chair
Dr Dean Moss, CEO, UniQuest Pty Ltd; Remuneration and Nomination Sub-Committee, Chair
Dr Iris Depaz, Country Medical Lead & Head of Medical, Vaccines, Sanofi Australia & New Zealand
Dr Marthe D’Ombrain, Head of Global Research Innovation, CSL Ltd
Professor John Skerritt, Enterprise Professor in Health Research Impact, University of Melbourne
Dr Liz Dallimore, CEO & Managing Director, Argenica Therapeutics Ltd
Ms Lorraine Chiroiu, CEO & Managing Director, AusBiotech (until 15 December 2023)

-ENDS-

Media enquiries: Annabelle Dick, Communications & Media Manager, AusBiotech,
adick@ausbiotech.org / M: +61 (0) 437 075 209

Australia’s Cell and Gene Catalyst calls for Expressions of Interest

Thu, 07 Dec 2023 00:00:00 +1100

Three Expert Working Groups are being established to help support the Cell and Gene Catalyst’s (The Catalyst’s) strategic objectives in key priority areas.

The Catalyst is calling for Expressions of Interest (EOI) from industry professionals interested in supporting key priority areas: policy and advocacy; collaboration and knowledge-sharing; and workforce development.

The Catalyst, a national joint venture between industry peak bodies AusBiotech and Medicines Australia, aims to accelerate the development, manufacture and commercialisation of cell and gene therapies, in turn creating a prosperous cell and gene industry in Australia. It is supported by a steering group comprising Cell Therapies, CSL Behring, Novartis, Pfizer, Roche, and Therapeutic Innovation Australia.

The Catalyst’s vision is that Australian patients have access to world-class advanced therapies while simultaneously cultivating a thriving Australian cell and gene industry. Its mission is to establish an end-to-end value chain for the discovery, development, manufacture and distribution of world-class cell and gene therapies, while promoting job creation, commercialising research, and exporting Australian innovation globally.

A number of strategic priorities have been identified for the Catalyst, with four key areas of focus. These are: attracting, building, and retaining world-class talent; fostering collaboration and knowledge sharing; creating a clear regulatory and market access pathway; and building Australian capability across the entire value chain.

Members of the Expert Working Groups will be immersed within a network of change-makers and leaders within Australia’s cell and gene industry across the entire value chain. Importantly, the Expert Working Groups will be an active contribution to this rapidly growing sector which will positively impact Australia’s health and economy.

Successful applicants are required to volunteer approximately two to three hours each month during 2024 in support of the Catalyst’s goals and activities.

Please express interest in your preferred working group(s) by emailing catalyst@ausbiotech.org.

EOIs for the Expert Working Groups will close at 5:00PM AEDT on 15 December 2023.

Neuren Pharmaceuticals completes enrolment in Pitt Hopkins syndrome Phase 2 trial

Thu, 07 Dec 2023 00:00:00 +1100

Telix says the first patient dosed in European early access program for TLX250-CDx

Thu, 07 Dec 2023 00:00:00 +1100

Microba Life Sciences announces results of successful Phase IBD trial

Thu, 07 Dec 2023 00:00:00 +1100

Cynata Therapeutics secures approval for Phase 2 trial in Turkey

Thu, 07 Dec 2023 00:00:00 +1100

New AusBioNSW committee chair appointed, state strategy developed to drive state’s sector success

Tue, 05 Dec 2023 00:00:00 +1100

A NSW-focused strategy has been launched by AusBioNSW, to be led together with the newly appointed AusBioNSW Leadership Committee Chair Lis Boyce, Piper Alderman.

AusBioNSW, the leading life sciences organisation for NSW, has formalised its strategy for the state, with a focus on connecting industry with local policy makers and enhancing connectivity and collaboration.

Since the appointment of Dr Robyn Lindner as General Manager, AusBioNSW, in July this year, AusBioNSW has focused on meeting with representatives across NSW’s life sciences ecosystem to better understand the local challenges and opportunities facing members. These sector insights have informed the refreshed strategy for AusBioNSW, which includes five key goals.

As AusBioNSW looks to implement its strategy it will focus on: prioritising opportunities to connect industry with state government; enhancing networking within the sector, with a focus on delivering education and learning platforms; and working collaboratively across sector to support ecosystem growth and success within the state. AusBioNSW intends to launch an Expression of Interest in the new year for NSW-focused members interested in supporting these activities.

AusBioNSW was established in March 2022 to foster local connection and promote NSW organisations doing business in and with the local, national and global life sciences economy.

Backed by Australia’s life sciences organisation AusBiotech, AusBioNSW is uniquely placed to deliver locally-tailored programmes and services whilst leveraging the national advocacy activities, membership services, events and networks of AusBiotech.

AusBiotech is also pleased to announce the appointment of Lis Boyce, Partner, Piper Alderman, as the incoming Chair of AusBioNSW Leadership Committee.

The AusBioNSW Leadership Committee has been led by Graham McLean, Chair, Universal Biosensors Inc (ASX:UBI) throughout 2023, who will now step down.

Graham McLean, departing Chair, AusBioNSW Leadership Committee says, “It has been a privilege to lead the Leadership Committee, working alongside passionate industry leaders in New South Wales who provide their guidance, advice, and motivation to help advance the industry forward.

“I am thrilled to be handing over the role of Committee Chair to Lis Boyce, who has been an enthusiastic advocate for industry and an active contributor within the NSW Leadership Committee.”

Lis Boyce, incoming Chair, AusBioNSW Leadership Committee says, “I am honoured to take on the role of Leadership Committee Chair as AusBioNSW enters the next phase of implementing an industry-driven strategy to support life sciences success in NSW. I look forward to working with NSW General Manager Robyn Lindner, the rest of the NSW Leadership Committee and the wider AusBiotech organisation as we continue to serve the NSW life sciences community.”

The AusBioNSW Leadership Committee currently includes:

Lis Boyce, Partner, Piper Alderman (Chair)
Dr Peter Brown, Senior Associate, Griffith Hack
Leah Goodman, Strategic Advisor, Biointelect
Laura Issa, Integrated Medicines Partner, Roche Australia
Dr Chris Marquis, Director of the Recombinant Products Facility, University of NSW
Anita van der Meer, Chief Innovation Officer, Ingham Institute
Prof Brett Neilan, Head of School Environmental and Life Sciences, The University of Newcastle, Knowledge Exchange and Enterprise (KEE)
Dr Gavin Recchia, Partner, Davies Collison Cave
Professor Alison Todd, Chief Scientific Officer, SpeeDx Pty Ltd

AusBioNSW and its Leadership Committee look forward to celebrating a year of successes at the AusBiotech, ARCS and BioNSW NSW End-of-Year Function 2023 on 7 December. Members are invited to register for the event here.

Korean regulator approves Amplia Therapeutics' pancreatic cancer trial

Tue, 05 Dec 2023 00:00:00 +1100

OncoSil Medical onboards first patient in the PANCOSIL clinical trial

Tue, 05 Dec 2023 00:00:00 +1100

National Reconstruction Fund (NRF) investment mandate released

Thu, 30 Nov 2023 00:00:00 +1100

Publication of the NRF’s investment mandate is a welcome step forward in establishing the $15 billion programme for Australia’s innovation industries.

As the voice of industry, AusBiotech today welcomes the publication of the NRF’s investment mandate and it was positive to see the Fund will consider investment as noted in AusBiotech’s submission.

“Currently, incentives and structural supports along the pipeline are patchy, inconsistent and uncoordinated. There is a valuable opportunity for the NRF to support the development and growth of a balanced community of companies at all stages/sizes in their commercialisation journey,” the legislation stated.

Also noted in the legislation, NRF Board representation includes expertise specific to medical sciences. Dr Katharine Giles, CEO and Managing Director of OncoRes Medical, was appointed to the NRF Board in September 2023, signalling that the NRF will take the ecosystem and its unique characteristics into account in designing the programme and how it invests in biomedical science and enabling technologies.

The mandate stated a benchmark return of 2-3 per cent (average) above the five-year Australian Government bond rate (weighted to the size and time of investing) over the medium and long term. The Ministers intend to review this benchmark return in three years.

A promising signal for industry, the NRF mandate also noted that “patient capital is necessary for sustainable growth opportunities, with investments beginning at a minimum of 10 years.”

“Providing genuinely patient and risk-tolerant capital enables a great opportunity to co-invest and partner with these companies, to support their growth and accelerate progression through the commercialisation pathway to reach market, and to succeed in co-investing in the economy of today and tomorrow.”

It was also positive to note that considerations will be given to investments with different risk profiles, such as emerging technologies and industries, as opposed to a one-fits-all approach.

The NRF has a focus on seven key priority areas: medical science; renewables and low emissions technologies; transport; value-add in the agriculture, forestry and fisheries sectors; value-add in resources; defence capability; and enabling capabilities, with medical science and enabling capabilities being of particular interest to the sector.

The NRF is a key initiative of the Australian Government’s A Future Made in Australia policy, announced in the 2022-2023 October Federal Budget. The Fund will co-invest in independently assessed projects that drive economic growth across seven priority areas and over seven years, including $1.5 billion in ‘medical science’ as well as $1 billion each for critical technologies and advanced manufacturing.

Read the NRF’s investment mandate here.

Clarity’s theranostic prostate cancer trial progresses at the highest dose level cohort

Thu, 30 Nov 2023 00:00:00 +1100

Microba completes stage one screening for its autoimmune disease program

Thu, 30 Nov 2023 00:00:00 +1100

AusBiotech weighs in on Australia’s RNA future

Tue, 28 Nov 2023 00:00:00 +1100

AusBiotech urges policy makers to take a national approach to capability mapping and introduce targeted initiatives, in response to Federal Government’s discussion paper, Understanding our RNA potential.

As the voice of industry, AusBiotech has responded to the Department of Industry, Science and Resources’ consultation on understanding Australia’s RNA potential as government seeks to comprehend the challenges and opportunities for developing the nation’s RNA sector.

AusBiotech made four key recommendations in its submission, including:

Undertake national capabilities mapping, in order to appropriately prepare for Australia’s RNA future, and to track its progress;
Build, diversify and address gaps in access to capital across the industry by introducing a Small Business Innovation Research (SBIR) programme, modelled on that which has been successful in the USA, thus significantly increasing the flow of capital to the biotech sector;
RNA technology shows great potential, however, there is an urgent need for agreed regulatory guidance materials and to harmonise globally, where it makes sense; and,
Consider a targeted tax amendment in its multinational tax regime in order to make Australia globally attractive; these policy levers not only anchors the manufacturing, but fosters further R&D

In its submission, AusBiotech says taking a national approach to capability mapping will support the collaboration and cooperation between companies, and streamline efforts and investment opportunities. This will enable the RNA industry to thrive and drive benefits to Australia’s economy and health of its people.

“Locally, investment has recently been seen through multinational partnerships being penned with Sanofi and Moderna; the establishment of the NSW RNA Pilot facility; and further industry investment taking place across the country. However, Australia is underprepared to capitalise on the opportunities RNA can deliver as there is currently no clear visibility of the capabilities within the country in order to appropriately and proactively prepare for Australia’s RNA future, and to track its progress.”

AusBiotech recommends that national capability mapping is undertaken, mapping the stakeholders, location, company size (amongst other metrics), technologies and phases, to support collaboration and cooperation between companies, and streamline efforts and investment opportunities.

Additionally, having clarity on the size and shape of the local industry will help business cases be built for why Australia is a destination of choice for multi- and inter-national companies.

To build, diversify and address gaps in access to capital across the industry, and significantly increase the flow of capital to the biotechnology sector by $1 billion annually, AusBiotech recommended that Government and industry work to introduce a Small Business Innovation Research (SBIR) programme, modelled on that which has been successful in the USA.

Through a competitive awards-based programme, SBIR enables small businesses to explore technological potential and provides the incentive to profit from its commercialisation. The US’s SBIR programme provides awards for Phase I, $50,000 - $250,000 for six months and Phase II to continue the R/R&D efforts initiated in Phase I, with $750,000 for two years. Funding is based on the results achieved in Phase I and the scientific and technical merit and commercial potential of the project proposed in Phase II.

As an example of the model in action, the NSW Government established a SBIR programme that provides competitive grants to small and medium-sized enterprises (SMEs) to find and commercialise innovative solutions to well-defined problems for the state government’s agencies.

AusBiotech’s submission also emphasised the importance of developing agreed regulatory guidance materials and that harmonises with regulations globally, and creating a globally-competitive environment through a targeted tax amendment.

The Department says submissions will provide insights into Australia’s RNA sector capabilities and priorities for the next 10 years.

Read AusBiotech’s submission here.

Dimerix's ACTION3 investigational new drug approved in China

Tue, 28 Nov 2023 00:00:00 +1100

Medical science a 'priority area' for new Industry Growth Program

Tue, 28 Nov 2023 00:00:00 +1100

Federal government backs the development of treatment for childhood brain cancer

Tue, 28 Nov 2023 00:00:00 +1100

Antimicrobial resistance (AMR) highlighted in global campaign

Thu, 23 Nov 2023 00:00:00 +1100

AMR is an increasing global health priority, estimated to be directly responsible for 1.27 million deaths worldwide in 2019.

This week (November 18-24) marks World Antimicrobial Awareness Week, a global campaign celebrated annually to improve awareness and understanding of AMR.

AMR occurs when bacteria, viruses, fungi and parasites change over time and no longer respond to medicines, often due to the misuse and overuse of antimicrobials in humans, animals and plants.

The campaign encourages the use of best practices to reduce the emergence and spread of drug-resistant infections. Themed Preventing antimicrobial resistance together, the 2023 campaign calls for cross-sectoral collaboration to preserve the effectiveness of antimicrobials.

The World Health Organisation (WHO), which is driving the campaign, says to effectively reduce AMR, all sectors must use antimicrobials prudently and appropriately, take preventive measures to decrease the incidence of infections and follow good practices in disposal of antimicrobial contaminated waste.

In 2021, the WHO declared that AMR is one of the top 10 global health threats facing humanity, and that it required urgent action to avoid up to 10 million deaths per year by 2050. The global health body says the world faces an antibiotics pipeline and access crisis, suggesting there is an inadequate R&D pipeline in the face of rising levels of resistance, and urgent need for additional measures to ensure equitable access to new and existing vaccines, diagnostics and medicines.

AMR is estimated to be directly responsible for 1.27 million deaths worldwide, and associated with an estimated 4.95 million deaths, in 2019. If left unchecked, this is predicted to cause 10 million deaths by 2050.

In addition to death and disability, AMR has significant economic costs. The World Bank estimates that AMR could result in US$1 trillion additional healthcare costs by 2050, and US$1 trillion to US$ 3.4 trillion gross domestic product (GDP) losses per year by 2030.

In an initiative to assist industry in developing and translating technologies to address the threat of AMR in both human and animal health, the CSIRO’s Biomedical Manufacturing Program this week highlighted their AMR Technologies Market Area.

The Market Area will work closely with CSIRO’s Business Development teams and CSIRO's Minimising AMR Mission to grow CSIRO Biomedical Manufacturing Program’s portfolio of industry projects across three key areas: medical devices, therapeutics, and vaccines. The team will also be able to help identify funding available for organisations looking to work with CSIRO. For more information, contact Lewis.Blackman@csiro.au.

A number of AusBiotech members are focused on developing solutions to AMR, including BiomeBank, Griffith Institute for Drug Discovery, LBT Innovations, Lixa, Next Science, The Peter Doherty Institute for Infection and Immunity, Recce Pharmaceuticals, and SpeeDx.

The Cell and Gene Catalyst call for change in submission to scope of practice review

Thu, 23 Nov 2023 00:00:00 +1100

Alterity Therapeutics raises $4.8 million in new placement

Thu, 23 Nov 2023 00:00:00 +1100

Successful clinical trial for re-engineered UQ vaccine

Thu, 23 Nov 2023 00:00:00 +1100

Best early-stage projects awarded at AusBiotech 2023

Tue, 21 Nov 2023 00:00:00 +1100

QIMR Berghofer and Murdoch University researchers announced as joint winners at AusBiotech 2023’s Early-Stage Innovation Forum (ESIF) held in Brisbane on 3 November.

A novel immunotherapy (IO) for IO-resistant cancers and a personalised medicine for familial hypercholesterolemia patients, presented by Associate Professor Michelle Wykes and Dr Craig Macintosh respectively, were named Best Translational Research at the ESIF rapid-fire pitch event.

Recently held at AusBiotech 2023 in Brisbane, the twice-annual ESIF competition featured presentations from Australia's local research institutes, universities, hospitals and pre-series A companies in the areas of human therapeutics and enabling technologies. Fifteen presenters from across Australia pitched technologies to an expert panel, receiving feedback intended to be helpful to their technology’s commercialisation journey.

A/Prof Wykes represented QIMR Berghofer and Fovero Therapeutics, a spinout company commercialising the technology, to present a proprietary Galectin-9 pipeline to treat IO resistance in solid tumours.

Fovero Therapeutics therapeutic pipeline is underpinned by the idea that malaria, cancer, and autoimmune diseases share a common aetiology—dysregulated immune function. The company’s lead antibody aims to improve the efficiency of multiple immune cells to kill cancer cells, and indication where there is significant unmet need. In pre-clinical models, Fovero’s novel immunotherapy completely clears MSS Colon cancer and triple negative breast cancer and the cancer does not reoccur for 300 days even when given cancer again.

“I am so grateful for the opportunity to present my work as a medical researcher and founder to leading industry experts, VCs and investors at the Early-Stage Innovation Forum. My company Fovero Therapeutics is just six months old, and the event marked my first time making a public pitch to the investment community. I was incredibly excited to win and the experience has given me a huge shot of confidence as I continue promoting Fovero’s work to investors.

“Fovero is focused on leveraging my medical research to develop novel immunotherapies for hard-to-treat cancers. At the end of the day, events like the ESIF keep spurring me forward in my ultimate goal - to improve outcomes for cancer patients who desperately need more treatment options.” A/Prof Wykes said.

Fovero Therapeutics has been selected to be part of the Brisbane Economic Development Agency's MedTech Global Accelerator programme and received CUREator funding to conduct final due diligence before the technology, in readiness for progression to clinical trials.

Dr Craig Macintosh represented Murdoch University, in a submission prepared by Dr Sze How Bong, to present a personalised medicine for familial hypercholesterolemia patients’ mutations in the low density lipoprotein receptor (LDLR) gene.

Familial hypercholesterolemia (FH) is a heritable monogenic disorder with elevated plasma low-density lipoprotein- cholesterol (LDL-C) serum levels from birth, mainly due to mutations in the low-density lipoprotein receptor (LDLR) gene and defective LDLR activity.

FH affects about 1 in 250 people, and if left untreated, individuals develop premature atherosclerosis, cardiovascular disease and often die at a statistically younger age. Statins are the benchmark for lipid lowering management, however around 70-80 percent of FH patients treated do not reach the recommended guideline levels of LDL-C, while 10-15 percent of patients show intolerance to statin.

Dr Macintosh presented the laboratory’s novel strategy to rescue the activity of LDLR in individuals with mutations found in dispensable domains through splice modulation/exon skipping, as demonstrated by the team’s previous work in developing three FDA approved drugs for Duchenne Muscular Dystrophy (DMD).

Patients with mutations in the dispensable domain exhibit milder phenotypes and in vitro studies showed that deletion of the dispensable reduces LDL binding by 10 percent. The research team hypothesise that removing dispensable LDLR domain using antisense oligomer (AO)-mediated exon skipping technology is a plausible therapeutic strategy to rescue LDLR activity.

The team designed and assessed the efficacy of AOs to induce removal of the dispensable domain in patient-derived skin fibroblasts and analysed the changes in LDL uptake. Our lead compounds induced nearly 100 percent exon skipping and improved LDL uptake by nearly 3-fold (300 percent).

“The Early-Stage Innovation Forum (ESIF) at AusBiotech 2023 provided us with the opportunity to showcase an exciting proof-of-concept study for the treatment of familial hypercholesterolemia. The experience proved invaluable as we received expert advice on areas for improvement and gained insights into potential next steps. The feedback from our presentation was highly positive, and we are currently engaged in early discussions with potential investors and collaborators to formulate the most strategic plan for our future endeavours. We would like to express our sincere gratitude to the organisers of AusBiotech 2023 and the ESIF panel for accepting our talk and recognising us as one of the winners,” Dr Craig Macintosh says.

The AusBiotech 2023 ESIF winners each received a $5,000 travel award to cover the cost of participating in any future science conference of their choice, kindly gifted by Sanofi as ESIF competition sponsors.

he AusBiotech 2023 ESIF was judged by a panel of experts including Sarah Meibusch (OneVentures), Jean-Francois Toussaint (Sanofi), Mark Ashton (Griffith University), and Samantha South (University of Western Australia).

The next ESIF will be held at AusMedtech 2023 on May 22-23 in Adelaide, featuring medical devices, diagnostics, and digital health technologies.

Orthocell announces final positive results of cell therapy in 'tennis elbow' study

Tue, 21 Nov 2023 00:00:00 +1100

Anteris reports positive 30-Day haemodynamic results from trial

Tue, 21 Nov 2023 00:00:00 +1100

Certa Therapeutics presents positive data from Phase 2 clinical study of FT011

Thu, 16 Nov 2023 00:00:00 +1100

Alterity Therapeutics announces presentation of new data for ATH434

Thu, 16 Nov 2023 00:00:00 +1100

US FDA grants Argenica Therapeutics' ARG-007 orphan drug designation

Thu, 16 Nov 2023 00:00:00 +1100

Biotech headed to the Hill for AusBiotech’s Policy Forum

Thu, 16 Nov 2023 00:00:00 +1100

Parliament House Canberra hosted biotech leaders for a day of discussions and presentations with the government, as AusBiotech’s annual Policy Forum headed to the Hill.

With financial capital the ‘lifeblood’ of the biotech industry, the 2023 CEO delegation focused engagement on key topics and initiatives for capital attraction, diving into opportunities outlined in the Biotechnology Blueprint.

The Hon Ed Husic (MP), Minister for Industry and Science, along with representatives from the Department of Health and Aged Care, the Department of Industry, Science and Resources, and Treasury joined industry leaders to work collaboratively to enhance our sector and to learn how it is supporting the bioeconomy. Their active engagement is a continued demonstration of the Government’s resolve to further strengthen the growing life sciences industry.

The AusBiotech CEO Policy Forum provides an opportunity for biotech leaders to understand the government's vision and goals, and for the government to get deeper insights into the importance of life sciences to the economy and the benefits and returns it brings to Australia and Australians.

The Forum is also a powerful opportunity to bring to life the life science sector’s social and economic contributions to Australia, and facilitate the increased communication and collaboration between industry and government.

Key policies and topics discussed included quantum and what it means to the biotech industry; policy levers and initiatives to attract greater private investment; and government investment into the biotech industry. It also included a CEO workshop discussion on key proactive policy initiatives to support industry-driven medical research that will help shape AusBiotech’s policy and advocacy work into the future.

AusBiotech’s CEO Policy Forum is a fundamental element in our strategy to bring policy makers and industry together, to create dialogue and discussion and to create the right environment for the life sciences industry to realise its economic and social potential.

Learn more about the Biotechnology Blueprint and AusBiotech’s policy and advocacy work here

New report demonstrates benefit of long-term policy commitment

Tue, 14 Nov 2023 00:00:00 +1100

The AusBiotech-commissioned ‘Economic impact of the Research & Development Tax Incentive (RDTI) for the biotech industry’ report underlines the critical role of Government in developing and retaining fit-for-purpose policy beyond election cycles.

The newly-launched report, quantifying the impact of the Federal Government’s R&DTI programme in Australian biotech over a 10-year period, highlights how the long-term retention of appropriate policies enables compounding productivity and economic gains.

Developed with Deloitte Access Economics and launched at AusBiotech 2023 conference in Brisbane, the report reveals the RDTI generated an average return of $2.18 for each dollar of forgone tax revenue spent between 2011-2021, with the upward trajectory increasing this figure to $3.14 in 2021.

Australia’s biotechnology industry includes more than 1,400 companies, however, most of the sector is made up of small and medium-sized companies, a majority of which are pre-revenue and pre-market stage. The report noted that these relatively small companies have high research and development (R&D) intensity – for small companies, the average ratio of R&D expenditure to revenue in 2022 was around 43 percent.

To support the volume of high value R&D activity these companies undertake, the Australian Government has provided various R&D tax incentives through the years, with the transition to the RDTI in 2011 providing more opportunities for smaller companies in the pre-revenue stages to access the incentive and undertake R&D.

Since the RDTI programme was implemented, it has remained largely unchanged over the past ten years. This has provided industry companies with the confidence that the programme will continue to be retained, enabling Australian and offshore companies to forward plan R&D activities and capital requirements for undertaking R&D in Australia.

AusBiotech CEO Lorraine Chiroiu says, “This important piece of work showcases what is possible when policy design is fit for purpose and supports the needs of industry. The report reemphasises that the policy is appropriate and working for the sector, but more importantly, underscores that long-term commitment from Governments to retaining the RDTI programme without change has enabled such industry and economic success.”

The report estimates that between 2011 and 2021, the RDTI for the biotech industry increased Australian GDP by an estimated $9.1 billion.

The economic impact has grown over time, increasing more than five times over the period 2011-2021, from $308 million in 2011 to more than $1.6 billion in 2021. This reflects a substantial expansion in company numbers and compounding productivity gains, with the growing R&D base of the industry adding to Australia’s stock of knowledge.

The benefits of the RDTI for the Australian biotech industry extend beyond those that are quantified in terms of economic outcomes. The innovations from the biotech industry have supported and improved quality of life for many Australians. The case studies in this report demonstrate that the sector is responsible for innovations developed to combat health issues such as cancer detection, diagnosis and treatment, hearing loss and antibiotic resistance, just to name a few examples. The returns from the RDTI for biotech would be even higher if these social benefits were included.

AusBiotech has been a vocal proponent of the RDTI, championing the programme and its significance to Australia’s biotech sector since 2012. AusBiotech, on behalf of industry, advocated to retain the programme after the RDTI Bill proposed amendments to the policy in 2019.

The report contributes to the metric identified in AusBiotech’s Biotechnology Blueprint, Australia’s decadal biotech strategy, Metric 3.1 ‘Return on Investment’ to determine the dollar amount returned for every dollar invested into the biotechnology sector, in turn demonstrating the value add the industry has on the Australian economy.

Read the full report here.

Telix says first patient dosed in ProstACT study of prostate cancer candidate

Tue, 14 Nov 2023 00:00:00 +1100

Neuren Pharmaceuticals completes Phelan-McDermid syndrome Phase 2 trial

Tue, 14 Nov 2023 00:00:00 +1100

University of Queensland to establish world-leading mRNA laboratory

Tue, 14 Nov 2023 00:00:00 +1100

AusBiotech election results and board changes announced

Thu, 09 Nov 2023 00:00:00 +1100

AusBiotech’s Board of Directors welcomes Dr Iris Depaz, Sanofi Australia & New Zealand, to the Board, while farewelling three Directors and Board Observer at AusBiotech 2023 in Brisbane.

The latest elected member of AusBiotech’s Board of Directors, Dr Iris Depaz, Country Medical Lead & Head of Medical, Vaccines, Sanofi Australia & New Zealand, was announced at the AusBiotech Annual General Meeting on 2 November, bringing with her specialist skills and experience to support the growth of industry.

AusBiotech also farewelled three notable Directors, Mr Serg Duchini, Non-Executive Director, ESFAM Biotech; Mr Geoffrey Kempler, Chair, Alterity Therapeutics; and Ms Linda Peterson, Chief Operating Officer (Advisor), SYNthesis Research, and Honorary Staff Member, BioCurate, as well as Board Observer Mr Graham McLean, Chair, Universal Biosensors (ASX:UBI).

Dr Iris Depaz brings more than 20 years of local, regional and global industry experience, and sees opportunity for Australia to improve in areas such as eco-system level health policy creation and investment attraction. Recognising the capability of Australia’s life sciences sector and the growing desire, by governments at all levels, for our country to be widely recognised as a world-leading location for biotechnology investment, Iris is passionate about the opportunities this investment attraction could create for Australia as it seeks to diversify its economy and retain the significant talent that exists within our medical and scientific communities.

Most recently, Iris was integral in the process of developing Sanofi’s Translational Science Hub, a $280M partnership with the Queensland Government, University of Queensland and Griffith University. One of her key objectives as the Hub’s Managing Director is to enhance the Australian biomedical ecosystem.

Separate to her role at Sanofi, Dr Depaz is a staunch advocate of the power of digital technology and is keen to realise opportunities to evolve digital healthcare platforms in Australia. She has previously been a Director of a blockchain and AI start-up, that aimed to empower patients to make informed healthcare decisions via ownership of their own data.

AusBiotech’s Interim Chair, Dr James Campbell, said, “On behalf of the AusBiotech Board, I am delighted to welcome Dr Iris Depaz. Her perspective, expertise and passion to support innovation and commercialisation across the pipeline aligns to AusBiotech’s vision and mission as we work to foster a growing, sustainable and profitable biotech industry in Australia.”

“I also extend my sincere thanks to departing Board Members Serg Duchini, ESFAM Biotech; Geoffrey Kempler, Alterity Therapeutics; and Linda Peterson, SYNthesis Research, for not only their esteemed service, but also for their drive, passion, and considered guidance throughout their respective tenures.

“I would also like to acknowledge Graham McLean for his input and advice as Board Observer."

Serg is retiring from the AusBiotech Board after nine years of incredibly dedicated service as Director and Chair of the Risk and Audit Sub-Committee (RASC). He has played a key role in championing the importance of the R&D Tax Incentive (RDTI) to Australia’s life sciences sector and drove AusBiotech’s policy position when the RDTI amendments were being proposed in 2019.

As AusBiotech’s Chair, Geoffrey’s experience and expertise have supported the Board, and in turn, AusBiotech’s strategic focus and the organisation’s output.

Elected director, Ms Linda Peterson, has completed her term, including contributing to RASC for the past two years and has provided a translational and start-up perspective to the Board’s strategy.

The Board changes took effect as at the close of the AGM on Thursday 2 November 2023.

The new AusBiotech Board line-up includes:

Dr James Campbell, CEO, Patrys Ltd; Interim Chair, AusBiotech
Ms Erica Kneipp, Research Director, Human Health, CSIRO; Deputy Chair, AusBiotech
Dr Megan Baldwin, Chief Innovation Officer, Opthea Ltd (ASX:OPT); Risk and Audit Sub-Committee, Chair
Dr Dean Moss, CEO, UniQuest Pty Ltd; Remuneration and Nomination Committee, Chair
Dr Iris Depaz, Country Medical Lead & Head of Medical, Vaccines, Sanofi Australia & New Zealand
Dr Marthe D’Ombrain, Head of Global Research Innovation, CSL Ltd
Ms Lorraine Chiroiu, CEO & MD, AusBiotech

Dimerix receives first payment from UK-based partner for DMX-200

Thu, 09 Nov 2023 00:00:00 +1100

Immutep announces the completion of key stage of AIPAC-003 trial in metastatic breast cancer

Thu, 09 Nov 2023 00:00:00 +1100

Clarity says recruitment target achieved for Phase II SAR-Bombesin prostate cancer trial

Thu, 09 Nov 2023 00:00:00 +1100

AusBiotech Board election result announced

Thu, 02 Nov 2023 00:00:00 +1100

As Australia looks to build its end-to-end life science ecosystem, the latest elected member of AusBiotech’s Board of Directors, Dr Iris Depaz, Country Medical Lead & Head of Medical, Vaccines, Sanofi Australia & New Zealand, was announced at today’s Annual General Meeting, bringing with her specialist skills and experience to support growth of the industry.

AusBiotech has also farewelled three notable Directors, Mr Serg Duchini, Non-Executive Director, ESFAM Biotech; Mr Geoffrey Kempler, Chair, Alterity Therapeutics; and Ms Linda Peterson, Chief Operating Officer (Advisor), SYNthesis Research, and Honorary Staff Member, BioCurate, as well as Board Observer Mr Graham McLean, Universal Biosensors (ASX:UBI).

“I would also like to acknowledge Graham McLean for his input and advice as Board Observer.

“Serg is retiring from the AusBiotech Board after nine years of incredibly dedicated service as Director and Chair of the Risk and Audit Sub-Committee (RASC). He has played a key role in championing the importance of the R&D Tax Incentive (RDTI) to Australia’s life sciences sector and drove AusBiotech’s policy position when the RDTI amendments were being proposed in 2019.

“As AusBiotech’s Chair, Geoffrey’s experience and expertise have supported the Board, and in turn, AusBiotech’s strategic focus and the organisation’s output.

“Elected director, Ms Linda Peterson, has completed her term, including contributing to RASC for the past two years and has provided a translational and start-up perspective to the Board’s strategy.”

The Board changes took effect as at the close of the AGM on Thursday 2 November 2023.

The new AusBiotech Board line-up includes:

Dr James Campbell, CEO, Patrys Ltd; Interim Chair, AusBiotech
Ms Erica Kneipp, Research Director, Human Health, CSIRO; Deputy Chair, AusBiotech
Dr Megan Baldwin, Chief Innovation Officer, Opthea Ltd (ASX:OPT); Risk and Audit Sub-Committee, Chair
Dr Dean Moss, CEO, UniQuest Pty Ltd; Remuneration and Nomination Committee, Chair
Dr Iris Depaz, Country Medical Lead & Head of Medical, Vaccines, Sanofi Australia & New Zealand
Dr Marthe D’Ombrain, Head of Global Research Innovation, CSL Ltd
Ms Lorraine Chiroiu, CEO & MD, AusBiotech

-ENDS-

Media enquiries: Annabelle Dick, Communications & Media Manager, AusBiotech,
adick@ausbiotech.org / M: +61 (0) 437 075 209

About AusBiotech

AusBiotech 2023 underway in Queensland

Thu, 02 Nov 2023 00:00:00 +1100

The flagship event of Australia’s biggest week in biotech, AusBiotech 2023 connected delegates in Brisbane to showcase how life sciences is ‘in our DNA’.

Held from 1-3 November, AusBiotech 2023 features an industry-led programme with more than 170 speakers across 50 sessions developed to inform, educate, celebrate, and inspire the life science community.

Australia’s largest life science conference also provides an opportunity for industry professionals from Australia and around the world to connect and develop meaningful connections with the aim of advancing biotech.

Key highlights include: Emeritus Professor Ian Frazer, The University of Queensland; Director, Microba, who addressed Australia’s biotechnology landscape, the challenges, opportunities, and solutions to building a successful life sciences ecosystem and bioeconomy; Professor Michelle Haber, Executive Director, Children’s Cancer Institute, who shared her inspiring story on developing novel therapeutic and diagnostic approaches to improve the outcome of children with acute lymphoblastic leukaemia and neuroblastoma; and Dr Sam Costello, CEO & Co-founder, BiomeBank, who delivered a keynote on donor-derived microbiome therapies, after BiomeBank became the first company globally to receive regulatory approval for a donor-derived microbiome therapy.

AusBiotech Lorraine Chiroiu says, “AusBiotech 2023 aims to lift the profile of Australia’s biotechnology industry, share new and ground-breaking knowledge, connect companies, and facilitate access to greater funding sources for companies to develop world-class science into therapies, diagnostics and medical devices.

“This year’s record-breaking turn out highlights the growing relevance and importance of the biotechnology industry in Australia.”

The Queensland Government has embraced the opportunity with two ministers in attendance. The Deputy Premier Dr. Steven Miles joined CEO Lorraine Chiroiu to open AusBiotech 2023, while the Hon. Cameron Dick MP, Treasurer and Minister for Trade and Investment, will speak at the Conference Dinner.

AusBiotech 2023 is created by industry, for industry. This year's programme includes a one-day AgriBiotech Summit, the Early-Stage Innovation Forum, a conference dinner, and pre-conference workshops and clinical trials dinner.

Biotech’s biggest week also includes pre and post-conference trip tours around Queensland’s health and innovations districts, including Boggo Road Innovation Precinct, Sunshine Coast Health Precinct, Gold Coast Health and Knowledge Precinct, Herston and Springfield Innovation Precinct, and TropiQ – Townsville, and AusBioInvest 2023, Australia’s premier life science investment event, held on 30 October in Melbourne.

AusBiotech 2023 is proudly supported by Host State Partner the Queensland Government.

New report quantifies the importance of R&D Tax Incentive on Australian economy

Thu, 02 Nov 2023 00:00:00 +1100

Imugene says next cohort reached in intravenous arms of monotherapy and combination study

Thu, 02 Nov 2023 00:00:00 +1100

It’s in our DNA: Australia’s biggest week in life sciences to advance biotech

Wed, 01 Nov 2023 00:00:00 +1100

AusBiotech 2023 national conference kicks off today in Brisbane, attracting a record-breaking number of delegates from 22 different nations.

Held in Brisbane from 1-3 November, Australia’s biggest week in biotech features its flagship event, AusBiotech 2023, which today launches with more than 1,200 registered delegates.

Running for more than 37 years, AusBiotech 2023 features an industry-led programme with more than 170 speakers across 50 sessions developed to inform, educate, celebrate, and inspire the life science community.

Key highlights include: Emeritus Professor Ian Frazer, The University of Queensland; Director, Microba, who will address Australia’s biotechnology landscape, the challenges, opportunities, and solutions to building a successful life sciences ecosystem and bioeconomy; Professor Michelle Haber, Executive Director, Children’s Cancer Institute, will share her inspiring story on developing novel therapeutic and diagnostic approaches to improve the outcome of children with acute lymphoblastic leukaemia and neuroblastoma; and Dr Sam Costello, CEO & Co-founder, BiomeBank, will deliver a keynote on donor-derived microbiome therapies, after BiomeBank became the first company globally to receive regulatory approval for a donor-derived microbiome therapy.

“This year’s record-breaking turn out highlights the growing relevance and importance of the biotechnology industry in Australia.”

The Queensland Government has embraced the opportunity with two ministers in attendance. The Deputy Premier Dr. Steven Miles will join CEO Lorraine Chiroiu to open AusBiotech 2023 and will speak at the conference’s Welcome Reception; while Hon. Cameron Dick MP, Treasurer and Minister for Trade and Investment, will speak at the Conference Dinner.

Premier Annastacia Palaszczuk said Queensland’s life sciences sector was booming.

“This sector employs over 13,000 people and already injects more than $2.2 billion into the state’s economy annually, with an estimated export value of more than $534 million,” Ms Palaszczuk said.

“As the home of cutting-edge medical research like mRNA vaccine development and needle-free vaccine delivery, we’re creating a wealth of opportunities for Queensland’s best and brightest minds.”

“We’re only looking to grow from here with the opportunities from Queensland’s Quantum and Advanced Technology Strategy for medicines, diagnostics and sports tech.”

Deputy Premier Steven Miles said Queensland was going from strength to strength as the place to work and invest in science.

“Queensland is fast becoming a globally competitive research and innovation hub thanks to our government’s investment in state-of-the-art facilities, talent attraction and partnerships,” Mr Miles said.

“Importantly, we’re growing high-value industries and jobs of the future for Queenslanders, while driving the development of new healthcare solutions on home soil.”

AusBiotech 2023 is proudly supported by Host State Partner the Queensland Government.

-ENDS-

Media enquiries: Annabelle Dick, Communications and Media Manager, AusBiotech,
adick@ausbiotech.org / M: +61 (0) 437 075 209

Notes

Media are invited to register for a complimentary media pass to AusBiotech 2023 in Brisbane. Please email Annabelle Dick (adick@ausbiotech.org) to register.

About AusBiotech

About the AusBiotech 2023 national conference

AusBiotech’s national conference is the largest annual event for the biotechnology and life sciences industry in Australia and the Asia Pacific Region. For access to the full programme see www.ausbiotechnc.org

New report quantifies the impact of R&D Tax Incentive (RDTI) in Australia’s life sciences sector

Wed, 01 Nov 2023 00:00:00 +1100

The newly-launched ‘Economic impact of the Research & Development Tax Incentive for the biotech industry’, report has quantified the far-reaching impact of the Federal Government’s RDTI programme in Australian biotech, revealing the incentive has generated a return of $3.14 for each dollar of forgone tax revenue spent in 2021.

Developed with Deloitte Access Economics, the report estimates that between 2011 and 2021, the RDTI for the biotech industry increased Australian GDP by an estimated $9.1 billion.

For each dollar of forgone tax revenue, the RDTI has generated an average return of $2.18 for the economy. Similar to the GDP and employment impacts, the return to the economy increases substantially over time, from an estimated $1.32 in 2013 to $3.14 in 2021.

AusBiotech CEO Lorraine Chiroiu says, “This new report demonstrates the value of sustained investment in the sector over time. Highlighted by the compounding productivity gains the RDTI scheme has delivered between 2011-2021, the programme is particularly relevant to the life science sector with its longer lead times and the sector’s pre-revenue characteristics.

“It also showcases what is possible when policy design is fit for purpose and supports the needs of industry. The foresight of the Federal Government to implement such a scheme in 2011 has led to a significant uptick in economic activity which will be felt for decades to come.”

Australia’s biotechnology industry includes more than 1,400 companies and employs over 260,000 people, with 178 companies listed on the ASX representing a market capitalisation of $255 billion. However, most of the sector is made up of small and medium-sized companies, with over 80 percent of companies within this category, and the majority of these being in the pre-revenue and pre-market stage.

The biotech industry thrives on its ability to engage in high value R&D activity, and to support this, the Australian Government has provided various R&D tax incentives through the years, with the transition to the RDTI in 2011 providing more opportunities for smaller companies in the pre-revenue stages to access the incentive and undertake R&D.

The report noted that these relatively small companies have high research and development (R&D) intensity – for small companies, the average ratio of R&D expenditure to revenue in 2022 was around 43 percent.

The Australian biotech sector also serves as a catalyst for attracting both domestic and foreign investment. Over the period 2011 to 2021, the industry attracted an estimated $7 billion in additional investment.

The benefits of the RDTI for the Australian biotech industry extend beyond those that are quantified in terms of economic outcomes, with the industry’s innovations having improved quality of life for many Australians. The case studies in this report demonstrate that the sector is responsible for innovations developed to combat health issues such as cancer detection, diagnosis and treatment, hearing loss and antibiotic resistance. It is important to note that returns from the RDTI for biotech would be even higher if these social benefits were quantified and included.

The report delivers on the metric identified in AusBiotech’s Biotechnology Blueprint, Australia’s decadal biotech strategy, Metric 3.1 ‘Return on Investment’ to determine the dollar amount returned for every dollar invested into the biotechnology sector, in turn demonstrating the value add the industry has on the Australian economy. It was launched during the AusBiotech 2023 national conference.

Read the full report here.

-ENDS-

Media enquiries: Annabelle Dick, Communications & Media Manager, AusBiotech,
adick@ausbiotech.org / M: +61 (0) 437 075 209

About AusBiotech

AusBioInvest 2023 connects innovators with investment

Tue, 31 Oct 2023 00:00:00 +1100

Kicking of Australia’s biggest week in biotech, investors and delegates flocked to Melbourne on Monday to hear the latest insights in life science investing and drive investment and partnership outcomes with local biotech companies.

As Australia’s pre-eminent life science investment event, AusBioInvest offers the opportunity for potential partners and investors, including global pharma representatives, to engage with Australia’s world-leading biotech companies as they present the latest, detailed information about their business case and technologies.

The programme featured thought-provoking fire side chats with leading investors and business leaders including, Jennifer Nason, Global Chairman, Investment Banking, J.P. Morgan, who provided an update on global capital market trends, conditions and themes and what it means for Australian biotechs; while Gurkeerat Singh, Vice President Search and Evaluation, Eli Lilly, spoke on considerations US investors make when evaluating a \deal.

In a panel discussion chaired by Dr Amanda Gillon, Senior Partner, Bioscience Managers, experts discussed investment approaches to building Australia’s life science ecosystem, how to unlock the funds already in Australia (such as superannuation capital) to increase access to capital for biotech companies, and why it is critical to attract offshore investors to Australia.

Delegates also received an update and insights on public markets conditions in Australia during a keynote from Ajita Tynan, Manager, Listed Company Services, Australian Securities Exchange (ASX).

AusBioInvest also connected key decision makers from the pharma and investment community, including venture capitalists, private equity firms and investment bankers, to hear pitches from 26 Australian biotech companies that are actively seeking investors or partners to support their funding and co-development.

Presenting companies included: Arovella Therapeutics (ASX:ALA), Avecho Biotechnology (ASX:AVE), BiomeBank, Carina Biotech, Celosia Therapeutics, Cyban, Dimerix (ASX:DXB), EBR Systems (ASX:EBR), Encapsolutions, ESFAM Biotech, FivepHusion, Genofax, Imagion Biosystems (ASX:IBX), Immuron Limited (ASX:IMC), InhaleRx (ASX:IRX), Invion (ASX: IVX), LBT Innovations (ASX:LBT), Microba, Noxopharm Limited (ASX:NOX), PolyActiva, Prescient Therapeutics (ASX:PTX), Respiri (ASX:RSH), Snoretox, TruScreen (ASX:TRU), Tessara Therapeutics, and Vaxxas.

AusBioInvest 2023 was rounded out with an exclusive Investor CEO dinner to provide a forum for presenting executives and investors to further network and discuss potential partnership opportunities.

AusBioInvest 2023 is proudly support by Host State Partner the Victorian State Government. Thank you to AusBiotech’s Investment Advisory Group for their support in developing the programme.

Official event photography will be shared with delegates shortly.

Opthea announces leadership transition with the appointment of US-based executives

Tue, 31 Oct 2023 00:00:00 +1100

Emyria secures ethics endorsement for MDMA authorised prescriber application

Tue, 31 Oct 2023 00:00:00 +1100

AusBioInvest 2023 marks beginning of Australia’s biggest week in biotech

Mon, 30 Oct 2023 00:00:00 +1100

Australia’s premier life science investment event, AusBioInvest 2023, kicks off in Melbourne with keynotes from international investment leaders and pitch-for-investment presentations from leading biotech executives.

Australia’s biggest week is officially underway, with AusBioInvest 2023 kicking off today in Melbourne to an audience of investors and life science executives.

AusBiotech 2023 features an industry-led programme with thought-provoking keynote and panel sessions of leading investors and business leaders, in addition to the 26 Australian biotech companies, spanning early- to late-stage, that are actively seeking investors or partners to support their funding and co-development.

Held at the Parky Hyatt in Melbourne, AusBioInvest will today welcome 280 delegates representing Australia’s leading life science companies and Australian and global investors representing venture capital firms, private equity firms, high net worth individuals, research analysts and brokers, industry executives and major global stakeholders.

The programme features thought-provoking keynote and panel sessions with leading investors and business leaders, including US-based Jennifer Nason, Global Chairman, Investment Banking, J.P. Morgan, who will provide an update on global capital market trends, conditions and themes and what it means for Australian biotechs; and Kanishka Pothula, Partner, Nextech, who will participate in a fireside on considerations US investors make when evaluating a deal, with a focus on non-specialist investors; while Ajita Tynan, Manager, Listed Company Services, Australian Securities Exchange, will provide an update on the public markets in Australia.

In addition, AusBioInvest features presentations from 26 private and listed Australian biotech companies, that are actively seeking investors or partners to support their funding and co-development.

Presenting companies include: Arovella Therapeutics (ASX:ALA), Avecho Biotechnology (ASX:AVE), BiomeBank, Carina Biotech, Celosia Therapeutics, Cyban, Dimerix (ASX:DXB), EBR Systems (ASX:EBR), Encapsolutions, ESFAM Biotech, FivepHusion, Genofax, Imagion Biosystems (ASX:IBX), Immuron Limited (ASX:IMC), InhaleRx (ASX:IRX), Invion (ASX: IVX), LBT Innovations (ASX:LBT), Microba, Noxopharm Limited (ASX:NOX), PolyActiva, Prescient Therapeutics (ASX:PTX), Respiri (ASX:RSH), Snoretox, TruScreen (ASX:TRU), Tessara Therapeutics, and Vaxxas.

AusBiotech CEO Lorraine Chiroiu says, “Access to capital remains one of the biggest opportunities for biotech companies in Australia. AusBioInvest fosters meaningful connections between the investment community and investment-seeking life sciences companies, enabling great ideas to attract risk-tolerant capital while assisting investors to connect with innovative, Australian companies that offer high-value return-on-investment.”

AusBioInvest officially marks the beginning of Australia’s ‘biggest week in biotech’, with AusBiotech’s flagship national conference, AusBiotech 2023, underway in Brisbane from 1-3 November.

AusBioInvest 2023 will open with an official welcome from the Treasurer of Victoria, the Hon. Tim Pallas MP.

AusBioInvest 2023 is proudly supported by Host State Partner the Victorian State Government.

-ENDS-

Media enquiries: Annabelle Dick, Communications and Media Manager, AusBiotech,
adick@ausbiotech.org / M: +61 (0) 437 075 209

Notes

Media are invited to register for a complimentary media pass to AusBioInvest 2023 in Melbourne. Please email Annabelle Dick (adick@ausbiotech.org) to register.

About AusBiotech

About AusBioInvest 2023

Australia's premier life sciences investment conference, AusBioInvest, is designed to drive investment outcomes and foster collaboration in life sciences and medical research. This flagship national conference offers the opportunity for companies to pitch to an audience of investors, including venture capital, private equity, high net worth individuals, research analysts and brokers, industry executives and major global stakeholders. For access to the full programme see www.ausbiotechinvestment.com.au

Top performing ASX life science companies

Thu, 26 Oct 2023 00:00:00 +1100

ASX-listed Impedimed Limited Pharmaceuticals (ASX:IDP), Avita Medical (ASX:AVH), and Neuren Pharmaceutical (ASX:NEU) lead in share price increase for 2023 while Lumos Diagnostics (ASX: LDX) tops Q3 rankings.

AusBiostock data (August 2023) reveals the market capitalisation of the 178 ASX-listed life science companies has decreased $231 billion, reflecting the broader stock market trends and declines globally. AusBiotech previously reported in April 2023 that the market capitalisation for Australia life sciences sector had grown to $255 billion.

The data also shows 8.5 per cent of listed companies have a market cap of more than $1 billion, while 31 percent of companies are worth more than $100 million. Identified as a key metric in AusBiotech’s Biotechnology Blueprint decadal strategy, the proportion of biotech companies achieving market valuations greater than $100 million measures the industry’s ability to create companies of significant future value.

Impedimed Limited is reported as the top performer for the year, with a reported share price of $0.20 (as at 4 August 2023) and a market return of 170.27 percent (see full data below). This is a solid increase when comparing Impedimed’s current share price to the $0.07 share price it had during the same period in the year prior (August 2022).

In an Australasian Biotechnology Journal September 2022 article authored by Scott Power, Senior Research Analyst, Morgans Financial, Scott “called out” two listed life science companies he felt were underpriced, including Impedimed.

“IPD is waiting for a decision from the National Comprehensive Cancer Network as to whether its technology will be included in the cancer treatment guidelines. Positive outcomes for this company will see a significant re-rating of share price.”

Meanwhile, Avita Medical (ASX:AVH) and Neuren Pharmaceuticals (ASX:NEU) come in second and third respectively for annual share price increase, with Avita reporting a share price of $4.95 and a market return of 156.48 percent while Neuren reported a share price of $12.15 and market return of 125 percent.

AusBiostock Q1 2023 data revealed Avita Medical had the second best quarterly return of all listed life science companies at 85.95 percent, while Neuren Pharmaceutical had reported the highest share price increase for 2023 and boasted a Q1 quarterly return of 258.59 percent.

At the end of Q3 2023, Lumos Diagnostics has topped the Q3 rankings with a quarterly return of 453.33 percent.

In the first biotech IPO on the ASX since April 2022, Curvebeam AI (ASX:CVB) made its debut on the ASX in early August after concluding its pre-initial public offering (IPO) private placement of $25 million.

AusBiotech invites qualified investors, including venture capital firms, private equity investors, high-net-worth individuals, research analysts, brokers, family offices, to access their complimentary tickets to attend AusBioInvest 2023, providing them with a valuable opportunity to make meaningful connections with both private and listed companies, hear the latest market updates, and explore potential investment prospects.

Top performers for Q3
2022 (data collected 4 August 2022)			2023 (data collected 21 August 2023)
	Last price	Quarter return %		Last price	Quarter return %
Polynovo Limited	$1.81	106.86	Lumos Diagnostics	$0.08	453.33
Telix Pharmaceutical	$7.75	90.89	Advanced Health	$0.24	167.05
Neurotech International	$0.09	77.36	Botanix Pharma Limited	$0.18	114.29
ResApp Health Limited	$0.19	65.22	Hexima	$0.02	109.09
Anteris Technologies	$27.50	64.18	Opyl Limited	$0.05	92.00
Living Cell Technologies	$0.01	50.00	Resonance Health	$0.07	71.43
Imugene Limited	$0.26	50.00	Biome Australia Limited	$0.13	71.23
Audeara	$0.12	48.15	Noumi Limited	$0.12	60.00
Global Health Limited	$0.35	45.83	Firebrick Pharma	$0.26	59.38
Neuren Pharmaceutical	$5.27	42.43	Artrya Limited	$0.35	55.56

Top ASX life science performers for the year
2022 (data collected 4 August 2022)			2023 (data collected 21 August 2023)
	Last price	Annual return %		Last price	Annual return %
Resapp Health Limited	$0.19	287.76	Impedimed Limited	$0.20	170.27
Anteris Technologies	$27.50	241.19	Avita Medical	$4.95	156.48
Neuren Pharmaceuticals	$5.27	229.38	Neuren Pharmaceuticals	$12.15	125.00
Cronos Australia	$0.30	160.87	Botanix Pharma Limited	$0.18	114.29
Argenica	$0.42	112.82	XRF Scientific	$1.23	100.80
Vita Life Sciences	$2.12	104.46	Arovella Therapeutic	$0.05	84.62
Neurotech International	$0.09	88.00	Hexima	$0.02	84.00
Ridley Corporation	$1.69	52.98	Microba Life Sciences	$0.37	72.09
Cryosite Limited	$0.67	52.87	BCAL Diagnostics	$0.14	68.75
Rhythm Biosciences	$1.42	49.09	Advanced Health	$0.24	67.86

Imugene announces phase 1 clinical trial opens with onCARlytics CD19 virus technology

Thu, 26 Oct 2023 00:00:00 +1100

Anteris reports positive results from interim analysis of its US-EFS Trial for DurAVR THV

Thu, 26 Oct 2023 00:00:00 +1100

AusBioInvest 2023 programme launched

Tue, 24 Oct 2023 00:00:00 +1100

Australia’s premier life science investment conference unveils esteemed speaker line up and 26 Australian biotech companies pitching for partnerships.

The programme for AusBioInvest 2023 is now live, featuring an industry-led programme with thought-provoking keynote and panel sessions with leading investors and business leaders.

The programme includes a fireside chat with Jennifer Nason, Global Chairman, Investment Banking, J.P. Morgan, who will provide an update on global capital market trends, conditions and themes and what it means for Australian biotechs; Kanishka Pothula, Partner, Nextech, will participate in a fireside on considerations US investors make when evaluating a deal, with a focus on non-specialist investors navigating the sector; while Ajita Tynan, Manager, Listed Company Services, Australian Securities Exchange, will provide an update on the public markets in Australia.

In addition, AusBioInvest 2023 features presentation from 26 Australian biotech companies, spanning early- to late-stage, that are actively seeking investors or partners to support their funding and co-development.

Presenting companies include: Arovella Therapeutics (ASX:ALA), Avecho Biotechnology (ASX:AVE), BiomeBank, Carina Biotech, Celosia Therapeutics, Cyban, Dimerix (ASX:DXB), EBR Systems (ASX:EBR), Encapsolutions, ESFAM Biotech, FivepHusion, Genofax, Imagion Biosystems (ASX:IBX), Immuron Limited (ASX:IMC), InhaleRx (ASX:IRX), Invion (ASX: IVX), LBT Innovations (ASX:LBT), Microba (ASX:MAP), Noxopharm Limited (ASX:NOX), PolyActiva, Prescient Therapeutics (ASX:PTX), Respiri (ASX:RSH), Snoretox, TruScreen (ASX:TRU), Tessara Therapeutics, and Vaxxas.

AusBiotech CEO Lorraine Chiroiu says, “Access to capital remains one of the biggest barriers for biotech companies in Australia. AusBioInvest fosters meaningful connections between the investment community and investment-seeking life sciences companies, enabling great ideas to attract risk-tolerant capital while assisting investors to connect with innovative, Australian companies that offer high-value return-on-investment.”

Stepping onto the stage of, AusBioInvest 2023, delegates can hear the latest insights and trends in life science investing from global and local experts, and make meaningful connections with leading local biotech executives from publicly-listed and privately-owned companies as they pitch their breakthrough health innovations to investors.

Held at the Parky Hyatt in Melbourne, AusBioInvest’s registered delegates represent Australia’s leading life science companies, and Australian and global investors representing venture capital firms, private equity firms, high net worth individuals, research analysts and brokers, industry executives and major global stakeholders.

Qualified investors are invited to register for their complimentary pass today and to hear from their peers as well as the latest from Australian innovators. Delegates that do not fit within the Qualified Investor criteria are invited to register as an AusBioInvest 2023 delegate.

Thank you to AusBiotech’s Investment Advisory Group for their support in developing the programme.

Positive efficacy result for Immutep’s 'efti' in combination with MSD's pembrolizumab

Tue, 24 Oct 2023 00:00:00 +1100

AdAlta reports favourable patient tolerability after third dose in AD-214 extension study

Tue, 24 Oct 2023 00:00:00 +1100

FDA grants Certa Therapeutics’ FT011 orphan drug designation for systemic sclerosis

Tue, 24 Oct 2023 00:00:00 +1100

J.P. Morgan’s chairman of investment banking announced as AusBioInvest keynote

Thu, 19 Oct 2023 00:00:00 +1100

Jennifer Nason, Global Chairman of Investment Banking, J.P. Morgan, to share insights on global capital markets and what that means for Australian biotech at AusBioInvest on October 30 in Melbourne.

Considered one of Australia's most successful global business leaders and one of the most senior and influential women on Wall Street, Australian ex-pat Jennifer Nason will fly in from New York to share insights on global capital markets during a fireside chat at Australia’s premier life science investment event AusBioInvest 2023.

With the capital markets that Australian biotechs usually look to for investment severely impacted by post-pandemic macroeconomic turbulence, Jennifer Nason’s fireside chat will shed light on the latest shifts and trends in the global capital markets and what that means for the biotech sector both globally and in Australia.

The self-proclaimed "accidental banker", Jennifer Nason has been with J.P. Morgan for 38 years having first joined the Melbourne, Australia office. Co-founding and chairing the Investment Banking Women’s Network at J.P. Morgan in the mid-1990s, today Jennifer is a Global Chair of the Investment Banking practice, sits on the Executive Committee of Investment Banking, and is responsible for many of the firm’s key investment banking relationships around the world.

Jennifer has advised on some of the world’s biggest deals in the tech and telecommunications sectors, such as Discovery’s $US43 billion buyout of Warner Media from AT&T, and Oracle’s $US20 billion capital raising in March last year. She also serves as a director of Rio Tinto, PLC FTSE 100 company and Chairs the American Australian Association's Business Council.

Qualified investors are invited to register for their complimentary pass today and to hear from their peers as well as the latest from Australian innovators, including ESFAM Biotech, Imagion Biosystems, Invion, Cyban, Vaxxas, and Respiri which have joined the investee cohort. Delegates that do not fit within the Qualified Investor criteria are invited to register as an AusBioInvest 2023 delegate.

Shortage in regional nuclear medicine workforce attracts new financial support

Thu, 19 Oct 2023 00:00:00 +1100

Australian biotechnologists and scientists celebrated in Prime Minister’s Prizes for Science

Tue, 17 Oct 2023 00:00:00 +1100

Professor Michelle Simmons, Professor Chris Greening, Professor Glenn King, and Associate Professor Lara Herrero have been recognised for their extraordinary contributions to science at the 2023 Prime Minister’s Science awards in Canberra.

Leading Australian quantum scientist Prof Michelle Simmons AO, UNSW Sydney, has taken out the $250,000 Prime Minister’s Prize for Science for her pioneering developments in quantum computing.

Prof Simmons founded Australia’s first quantum computing company in 2017, Silicon Quantum Computing, and alongside her team pioneered a new precise style of manufacturing that forms the basis for a new approach to quantum computing. It is the only company to manufacture quantum computing components at the atomic scale.

Prof Simmons’ efforts have the potential to be applied across several other fields, including therapeutic drug design, reducing the cost of airline fuel, and creating better fertilisers for agriculture. She was previously Australian of the Year in 2018 and was made an officer of the order of Australia the following year.

Entrepreneur Prof Glenn King, University of Queensland’s Institute for Molecular Bioscience and Infensa Bioscience, received the 2023 Prime Minister’s Prize for Innovation for his ground-breaking discovery that peptides from the venom of the Australian funnel web spider can be used for sustainable crop protection and to develop pharmaceuticals that treat chronic pain, epilepsy and stroke.

Prof Chris Greening, Monash University, was awarded the 2023 Frank Fenner Prize for Life Scientist of the Year for his world-first discovery that microbes live on air, which led to the understanding that microbes help regulate climate change and air pollution by removing 350 million tonnes of gases such as carbon monoxide from the atmosphere each year.

Hear more from Prof Greening at the AusBiotech 2023 CSIRO-sponsored conference panel Curbing AMR: beyond the medicines on Thursday 2 November in Brisbane.

Meanwhile, A/Prof Lara Herrero, Griffith University, took out the 2023 Prime Minister’s Prize for New Innovators. With a focus on Ross River virus (RRV) and other mosquito-transmitted viruses associated with arthritis, A/Prof Herrero translated her research into a world-first drug with potential to treat these diseases in humans with long-term debilitating symptoms in less than 10 years.

She repurposed a known drug, and has now successfully commercialised the IP for the novel therapeutic. This is through an exclusive, royalty-bearing licence deal between Griffith University and ASX-listed biotechnology company Paradigm Biopharmaceuticals (ASX:PAR).

Prime Minister Anthony Albanese MP says, “The achievements of the 2023 recipients reflect the world-class quality of Australia’s science and research sector and the dedication of our STEM teachers. It confirms the future of Australian science is stronger than ever.”

For more information, see the Prime Minister’s Prizes for Science – Science Prizes.

Prescient to announce Phase 1b cancer trial results at world’s largest haematology conference

Tue, 17 Oct 2023 00:00:00 +1100

Victoria backing Australia's first stem cell trial for rare genetic disorder

Tue, 17 Oct 2023 00:00:00 +1100

Posthumous recognition of benevolent billionaire

Thu, 12 Oct 2023 00:00:00 +1100

Inaugural AusBiotech Life Sciences Legacy Award winner Mr Chuck (Charles) Feeney AC is remembered for his significant contributions to Australia’s medical research and life sciences sector, after passing away aged 92.

The American businessman who dedicated his later life to quietly giving away his $8 billion fortune is being remembered by Australia’s bioscience community for his transformational impact on the life sciences ecosystem, having donated about $550 million to Australian organisations during his lifetime.

Under Chuck’s ‘Giving While Living’ philosophy, donations from his foundation The Atlantic Philanthropies helped deliver more than 20 outstanding research facilities across Australia.

The University of Queensland (UQ) says his donations of more than $100 million helped establish UQ’s Institute for Molecular Bioscience (IMB), Queensland Brain Institute (QBI), the Australian Institute of Bioengineering and Nanotechnology (AIBN), UQ’s Centre for Clinical Research, the Frazer Institute, the UQ Centre and UQ Art Museum.

Other Australian institutes to benefit from Chuck’s contributions include: The Kirby Institute - University of NSW, Victor Chang Cardiac Research Institute, The Menzies Institute for Medical Research at the University of Tasmania, The Murdoch Children's Research Institute, Royal Children's Hospital International, Baker Heart and Diabetes Institute, Royal Melbourne Institute of Technology, The Bio21 Institute, The Queensland Head and Neck Cancer Centre at the Princess Alexandra Hospital, The Institute of Health and Biomedical Innovation at the Queensland University of Technology, The Royal Brisbane and Women's Hospital Stroke Unit, QIMR Berghofer Medical Research Institute, and the Translational Research Institute.

Thanks to Chuck’s support, these institutes have made world-leading discoveries in vaccine development, dementia, heart disease and motor neurone disease, and their research will continue to make a profound difference for the foreseeable future.

Chuck received the inaugural AusBiotech Life Sciences Legacy Award at the 2019 AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards in recognition of his “tremendous and unprecedented support of the Australian life sciences ecosystem across many decades”. The award was accepted by Dr Dave Kennedy, Founder, iGIVEonepercent.org, on Chuck’s behalf.

At the time of Awards, Hon Peter Beattie AC, Former Premier of Queensland, said, "The partnership my government's Smart State strategy enjoyed with Chuck Feeney reshaped biotechnology research in Queensland. The legacy of his investments left world class research institutions producing outcomes which are savings lives. His selfless philanthropic investments are the largest in Australian history. He was one of the most inspirational people I have ever worked with."

Chuck was appointed an Honorary Companion in the General Division of the Order of Australia for his services to Australian health, research and higher education.

Email re: ‘AusBiotech 2023 contact lists’ or 'AusBioInvest 2023 contact lists'

Thu, 12 Oct 2023 00:00:00 +1100

It has come to our attention that a company is seeking to sell a contact list that is titled with AusBiotech’s name - in an unapproved manner.

We wish to advise that this activity is not associated with AusBiotech in any way, and that our database remains secure. We cannot verify the quality of the list and note that proceeds are not being returned to support the industry. Please see below for an example. Many different marketing executives’ names and domains are seeking to sell exactly the same product and we believe this is emanating from the same source.

Dear Exhibitor,

I’m glad to inform you that “AusBiotech 2023” / "AusBioInvest 2023" Attendees/Visitors/Registrants list is available now.

Counts:1,500

30 October 2023 / 1-3 November 2023

Key Benefits – Direct Email Marketing/ Email Campaign, Cold Calling, Network with Attendees etc.

Let me know if you are interested to acquire the list so that I can send you the cost and the additional details.

Awaiting your response.

Thanks & Regards,
Cendy Pacheco
Event Coordinator

AusBiotech does not share (or sell) the contact details of event attendees and maintains privacy of information according to its privacy policy (https://www.ausbiotech.org/privacy-policy).

Kind regards,

Lorraine Chiroiu
Chief Executive Officer
AusBiotech Ltd

Oculus BioMed partners with The Centre for Eye Research Australia in a deal to develop 'SwitchGene'

Thu, 12 Oct 2023 00:00:00 +1100

Arovella Therapeutics licences monoclonal antibody for cell therapy development

Thu, 12 Oct 2023 00:00:00 +1100

Training session on new Prescribed List products

Tue, 10 Oct 2023 00:00:00 +1100

An introductory in-person training on the new Prescribed List (PL) products is occurring on 8 November for sponsors to gain critical insights for PL applications.

With the introduction of new processes and the release of the new PL (formerly the Prostheses List) Guide, the MTAA is conducting a training session with the Department of Health and Aged Care for sponsors of Prescribed List products.

The unique training opportunity will provide an introduction to the new PL Guide, technical requirements for new and amended applications, and evidence levels for various types of applications, with the aim of educating sponsors on how to successfully meet the requirements for new and amendment applications.

AusBiotech is promoting the paid-for training opportunity with its member base, after ongoing conversations with the Department regarding the Prostheses List Advisory Committee (PLAC), recently replaced by the Medical Devices and Human Tissue Advisory Committee (MDHTAC), and maintaining industry representation.

The training is an opportunity for sponsors to gain critical insights on the new PL Guide and technical requirements for applications in a forum with the Department.

The PL Guide, released by the Department in September, assists applicants to prepare an application to list a product on the Prescribed List of Benefits for Medical Devices and Human Tissue Products (the PL), or to amend an existing billing code.

Presenters include: Emeritus Professor Terry Campbell AM, Chair of the Medical Device and Human Tissue Advisory Committee and Ms Irina Tsyganova, Director of the Prescribed List Administration Section. Former industry representatives on Clinical Advisory Groups (CAGs) will also join for additional insights.

The training session will also include a Q&A with the Department of Health and Aged Care.

The training will be held on 8 November in Sydney at Pullman Sydney Airport. Register here to attend.

FivepHusion announces the appointment of experienced industry executive to its board

Tue, 10 Oct 2023 00:00:00 +1100

Director appointed to Australia’s Cell and Gene Catalyst

Thu, 05 Oct 2023 00:00:00 +1100

Australia’s Cell and Gene Catalyst (Catalyst), has a new leader at the helm with the appointment of accomplished scientist and executive Dr Marguerite Evans-Galea AM as Catalyst Director.

The Catalyst is a joint venture between AusBiotech and Medicines Australia and aims to accelerate the development, manufacture and commercialisation of cell and gene therapies, in turn creating a prosperous cell and gene industry in Australia.

Dr Evans-Galea, with the support of the Expert Steering Group (ESG) of industry partners, will be responsible for leading the Catalyst’s strategic direction, development and delivery, with the aim of ensuring everyone in Australia has ready access to world-class advanced therapeutics such as CAR-T immunotherapies for cancer, and cell and gene therapies and gene-editing for debilitating inherited diseases.

“I am thrilled to be appointed as Director to the Catalyst and look forward to facilitating connections, opportunities and growth of Australia’s dynamic and vibrant advanced cell and gene sector. A thriving cell and gene sector will provide many benefits to Australia; as a former research scientist in this field, my personal driver is to help people living with debilitating diseases by making breakthrough treatments available in Australia,” Dr Evans-Galea says.

AusBiotech CEO Lorraine Chiroiu says, “We are so pleased to welcome Dr Marguerite Evans-Galea to the team to lead this important initiative. Her expertise as a disease-focussed cell and gene scientist, and experience with academia, workforce development, public policy, and national programme management will be of huge benefit to the Catalyst. We look forward to engaging more with the ecosystem on what’s next for the Catalyst as Dr Evans-Galea settles into her role.”

The Catalyst originated from the work of AusBiotech’s Regenerative Medicine Consortium Project and the Strategic Roadmap for the Regenerative Medicine sector in Australia. The landmark strategy outlines key objectives and priority actions, underpinned by a comprehensive discussion of the primary obstacles facing the sector locally. The strategy identified five strategic goals: capabilities/workforce; collaboration; funding; regulation and policy; and infrastructure, aiming to identify how to support the development and commercialisation of the most advanced therapies in the world locally.

Leveraging the Regenerative Medicines Consortium Project’s exceptional foundation work throughout 2020-2021 that has cemented and benchmarked Australia’s place on the global RM map, the Catalyst will advance regenerative medicines policy, mobilise resources, build community engagement, establish shared measurement practices and support aligned activities.

The Catalyst is supported by Cell Therapies, CSL Behring, Novartis, Pfizer, Roche, Therapeutic Innovation Australia, and the Victoria Government’s Australian Medtech Manufacturing Centre (AMMC).

Prior to joining the Catalyst, Dr Evans-Galea was Director, STEM Careers Strategy at the Australian Academy of Technological Sciences & Engineering (ATSE) where she led the strategic development and delivery of ATSE’s $43M portfolio of prestigious national STEM Careers initiatives. During her 18-year research career, Dr Evans-Galea led international pre-clinical research programs in cell and gene therapy for inherited diseases at St. Jude Children’s Research Hospital in the United States and at the Murdoch Children’s Research Institute in Australia. She has received multiple awards for her research and leadership. Dr Evans-Galea is also an experienced consultant, editor, author and peer reviewer.

An advocate for STEM research, education and innovation, Dr Evans-Galea routinely engages and collaborates across multiple professional sectors in the broader STEM ecosystem and has served with government advisory groups.

Dr Evans-Galea is also a fierce advocate for women and diversity in STEMM, having co-founded and led the Women in STEMM Australia initiative, and participated in the Women in Leadership Development (WILD) Program which provides career development opportunities for senior women in Australia’s STEMM industries.

Connect with Dr Marguerite Evans-Galea on email at mevansgalea@ausbiotech.org or by phone on +61 488 438 001.

US FDA grants Orphan Drug Designation for Noxopharm's CRO-67

Thu, 05 Oct 2023 00:00:00 +1100

Dimerix and Advanz Pharma enter agreement to commercialise DMX-200 in major markets

Thu, 05 Oct 2023 00:00:00 +1100

CSL announces seven new Global Research Acceleration Initiative projects

Thu, 05 Oct 2023 00:00:00 +1100

Amended Notice of AusBiotech's AGM 2023

Wed, 04 Oct 2023 00:00:00 +1100

Notice of AusBiotech AGM, Thursday 2 November 2023

This amended Notice of AusBiotech’s AGM for the AGM scheduled for Thursday, 2 November 2023 replaces (in full) the original notice of AusBiotech’s AGM circulated on August 14, 2023.

This amended Notice is being circulated as the Board wishes to propose a new item of business, number 3, concerning remuneration of the Chair.

Consequently, the original Notice has been amended by the insertion of a new item of business number 3 in relation to approval of remuneration of the Chair. All other items of business remain unchanged.

To Members and other persons entitled to notice of Annual General Meetings (AGM) of AusBiotech Ltd, the 2023 AGM of AusBiotech Ltd will be held at the Brisbane Convention & Exhibition Centre and in accordance with the AusBiotech Constitution on Thursday 2 November at 12.30pm - 1.20pm (AEST) to transact the following business:

Ordinary Business

1. ANNUAL ACCOUNTS

To consider the annual report, financial statements and report of the Directors and auditor for the year ended 30 June 2023.

2. RESULTS OF DIRECTOR APPOINTMENT/S

To note the Directors who return, and the appointment of the new Director/s in accordance with the Company’s Constitution.

Special Business

3. APPROVAL OF REMUNERATION OF CHAIR

To consider and if thought fit to pass as an ordinary resolution:

“That, for the purpose of clause 9.1 of the Company’s Constitution:

(a) the Company be authorised to pay to the chair of the Board, while they hold that position, remuneration determined by the Board which is no more than a value consistent with industry norms for a non-executive chair of a small to medium sized biotechnology company; and

(b) this authorisation operate with effect from the next appointment of a chair who takes office after the date of this resolution.”

4. OTHER BUSINESS

Any other business that may be brought forward at a general meeting in accordance with the Constitution.

Note: A Member who is entitled to vote at the meeting has a right to appoint a proxy and should use the proxy form available on request from AusBiotech Ltd on 0437 126 843, election@ausbiotech.org or online here. The proxy form must be signed and dated by the Member or the Member’s attorney. Proxy forms and the original or a certified copy of the power of attorney (if the proxy form is signed by an attorney) must be received no later than 1.00pm (AEST) Wednesday 1 November 2023.

If you have already completed and returned a proxy form with reference to the previous notice of meeting, please request a new one and return it to the Company no later than 1.00 pm (AEST) Wednesday, 1 November 2023. If you have already delivered a valid proxy form to the Company, and do not deliver a completed amended proxy form, your earlier proxy form will remain valid, however you will be taken not to have voted on business item 3.

Questions?
If you have any questions regarding the new item of business or the AGM in general, please do not hesitate to contact the CEO, AusBiotech Ltd on 0437 126 843 or admin@ausbiotech.org.

By Order of the Chair

Geoffrey Kempler
Chair

Explanatory note on new item 3

The role of Chairman of the Board of AusBiotech – including leadership of the Board, acting as a sounding board for the CEO and representing AusBiotech in the public arena -- is becoming increasingly significant. The Board of AusBiotech has decided that in future it would be desirable to pay the chair of the Board in recognition of the time commitment involved.

AusBiotech has been fortunate in attracting high calibre individuals to act as Board members and to chair the Board. However, the Board recognises that a number of excellent candidates who would be a good “fit” as chair of the AusBiotech Board have “portfolio careers” where they hold a number of non-executive board roles and where their ability to take on multiple voluntary roles is limited.

The Constitution of AusBiotech allows for remuneration of directors only if approved by members. The relevant provision in the Company’s Constitution, clause 9.1, says:

“The Company must not, without the approval of the members at the general meeting:

(a) appoint a Director to any salaried office of the Company or any office of the Company paid by fees; or

(b) pay or give a Director remuneration or other benefit in money or money’s worth except, with the approval of the Board, repayment of out-of-pocket expenses and reasonable interest on money lent or reasonable rent for premises leased to the Company.”

If the resolution is passed, it will not authorise remuneration of the current chair of the Board. However the ability to offer remuneration may widen the potential range of candidates when the Board next wishes to appoint a Chair.

To ensure that the remuneration will be reasonable, having regard to the responsibilities of the role, the Board will benchmark the fees against industry norms for non-executive chairs of small to medium biotechnology companies. Data on non-executive director remuneration is readily obtainable and therefore the Board will be able to ensure that the remuneration is appropriate.

Increase your company profile via global life sciences Directory

Tue, 03 Oct 2023 00:00:00 +1100

Prepare your company profile in the Australian Life Sciences Innovation Directory ahead of AusBiotech 2023 and AusBioInvest 2023.

With Australia’s biggest week in biotech less than a month away, now is the time for life science professionals to highlight their company and capabilities.

As international investors and life science leaders prepare to attend AusBiotech 2023 and AusBioInvest 2023 between 30 October and 3 November, this is an opportune time to highlight you or your company’s unique selling position with aim of attracting potential partners.

Visit: https://www.ausbiotech.org/biotechnology-industry/australian-life-science-and-innovation-directory to create a new profile, update details or search for the capabilities you are seeking.

This AusBiotech-supported fully-searchable platform offers access to information on more than 1,400 biotechnology and life science companies and organisations across Australia, with profiles already demonstrating the thriving landscape.

Integrated within the larger Biotechgate global life science database, which includes more than 66,000 company and organisation profiles, this platform helps to promote Australian biotechnology on a global scale.

Build awareness of your company to national and international audiences: profiles are free of charge for all; AusBiotech members receive an extended company profile in the directory.

With flexible search functionality, filter via AusBiotech membership, sector, or free text; and display as a listing or a map.

A name change and significant sale as Pharmaxis becomes Syntara

Tue, 03 Oct 2023 00:00:00 +1100

PolyNovo receives an additional US$10 million in funding from BARDA

Tue, 03 Oct 2023 00:00:00 +1100

Novel therapeutics development highlighted in Australasian Biotechnology journal

Thu, 28 Sep 2023 00:00:00 +1000

Australia’s life science strengths and success stories highlighted in the latest edition of Australasian Biotechnology, AusBiotech’s official journal, in anticipation of the upcoming AusBiotech 2023 and AusBioInvest 2023 conferences.

The sector’s recent successes have been significant in progressing Australia’s biotechnology industry, with Australia’s position in the global biotech ecosystem stronger than ever.

This edition of the journal offers local insights into global issues and trends impacting the sector and provides homegrown approaches to tackling challenges such as talent attraction and workforce retention, 3Rs alternatives, and patent protection for artificial intelligence-developed therapies. These topics and more will be expanded upon at the AusBiotech 2023 national conference in Brisbane.

Read compelling insights from sector leaders, including Navigating the future: predictions and potentials of Australian biotechnology by Emeritus Professor Ian Frazer AC FRS, Frazer Institute, The University of Queensland, Introducing Australia’s powerhouse for innovative biotech ventures, by Dr Andrew Nash, CSL; Professor Alan Cowman AC, WEHI; and Professor Mark Hargreaves AM, The University of Melbourne, and Creating an industry – small biotech and the RNA revolution, by Dr Gisela Mautner, CEO and Managing Director, Noxopharm.

The journal also reflects on AusMedtech 2023, the biggest AusMedtech to date, and the AusMedtech 2023 Early-Stage Innovation Forum, which showcased emerging medtech innovations and experts who are developing breakthrough solutions for patients.

This edition also contains regular features, including the AusBiotech CEO Report, and AusBioStock – an exclusive report from David Nayagam, Evans & Partners. The journal welcomes new AusBiotech members, and holds a list of AusBiotech corporate members.

In-depth commentary on the Australian and global biotechnology sector will continue at AusBiotech 2023, from 1-3 November in Brisbane, and AusBioInvest 2023 on 30 October in Melbourne. AusBiotech thanks the support of Host State Partners, Queensland Government and Victoria State Government (respectively).

The next edition of Australasian Biotechnology will be released in April 2024 and will feature Australian and international medtech success stories.

Contact communications@ausbiotech.org if you are interested in contributing, or to find out about advertising opportunities.

Australasian Biotechnology is published bi-annually in partnership with Executive Media. Download the Australasian Biotechnology journal today.

UQ and Oxford Nanopore Technologies team up to accelerate research into testing for mRNA vaccines

Thu, 28 Sep 2023 00:00:00 +1000

National team to advance innovative biopolymer particle-based platform technology

Thu, 28 Sep 2023 00:00:00 +1000

Starpharma announces the presentation of DEP irinotecan combination data

Thu, 28 Sep 2023 00:00:00 +1000

HealthTech InnovationAus award finalists announced

Tue, 26 Sep 2023 00:00:00 +1000

Tessara Therapeutics, Harrison.ai, and Baymatob selected as finalists in 2023 InnovationAus Awards for Excellence’s HealthTech category.

Australia’s healthtech superstars are being celebrated at the 2023 InnovationAus Awards for Excellence, which recognises the leading technology and innovation contributors in Australia.

The 2023 InnovationAus Awards for Excellence recently unveiled finalists for 11 awards categories, which includes more than 30 Australian companies representing technologies and sectors ranging from quantum computing to artificial intelligence, to hydrogen production, healthcare, and food.

Australian healthtech companies Baymatob, Harrison.ai and Tessara Therapeutics were announced as HealthTech Award finalists for their respective products and recent advancements.

Tessara Therapeutics’ RealBrain platform – Developed by Melbourne-based Tessara Therapeutics, RealBrain® are microscopic 3D models of healthy and diseased brain tissues that can be used to study and discover superior and more sustainable drugs to treat neurological diseases. RealBrain® models feature human cells in 3D architecture with functional neural networks. As a result of these features, Tessara’s RealBrain® models more accurately predict the responses of human brain tissue in a highly scalable and reproducible way. The RealBrain® platform also enables faster identification of better drug candidates, de-risks drug development and reduces the use of animals in research.

Annalise Enterprises CXR – developed by harrison.ai and I-MED Radiology in a joint venture, annalise.ai’s technology encompasses artificial intelligence (AI) that empowers chest X-ray clinicians with a second pair of eyes. In doing so, the system detects and improves efficiencies on up to 124 different findings on chest X-rays. Annalise.ai last week announced it had become the first-ever radiology triage device to receive US FDA approval, confirming the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the triage and notification of obstructive hydrocephalus (OHCP) on non-contrast brain CT scans.

Oli PPH is Sydney-based Baymatob’s first AI-guided medical product based on the Oli maternity sensor, monitoring and diagnostic platform. Its distinct claim to fame is that Oli PPH is the only product to have ever demonstrated the ability to identify women who are at higher risk of developing postpartum haemorrhage, well before they give birth and allowing for clinical actions that prevent complications.

The HealthTech Award attracted interest from a range of digital health platforms, as well as related technology innovations such as devices, diagnostic and therapeutics, plus MedTech, pharmaceuticals and biotech innovation.

Outside of the HealthTech Award category, Femtek, a digital health company developing the first ever menstrual health-focused smart ring, has also been nominated for both the Translation Hero Award and Creative Technology and Software Award.

These finalists were selected by a panel of eminent judges, representing business, government, industry, and academia.

Voting for the People’s Choice Award will open in the coming weeks, where all finalists across all 11 categories are eligible to be nominated.

The InnovationAus Awards for Excellence 2023 winners will be announced at the Gala Dinner on Wednesday, 1 November in Sydney. Find out more here.

US FDA grants conditional approval to the brand name of Dimerix's DMX-200

Tue, 26 Sep 2023 00:00:00 +1000

PolyNovo updates investors with significant revenue growth

Tue, 26 Sep 2023 00:00:00 +1000

AusBiotech announces CEO departure

Thu, 21 Sep 2023 00:00:00 +1000

AusBiotech CEO, Ms Lorraine Chiroiu, has announced she will hand over the leadership of AusBiotech, after more than five years at the helm and 15 years of successful and dedicated service to the organisation and the life sciences sector - effective from 15 December 2023.

Ms Chiroiu has been pivotal in the growth of the organisation and strengthened its position as the peak industry body for the biotechnology sector. Lorraine has been a fierce advocate for the sector, representing the industry to government bodies to maintain continuity of the Research and Development (R&D) Tax Incentive and shape policy that benefits all members of the Australian biotechnology community. She leaves a lasting legacy for the industry and the organisation in a strong financial position.

On behalf of the Board, AusBiotech Chair Mr Geoffrey Kempler remarked “Lorraine is a respected and dedicated leader and has made numerous and significant contributions to the biotechnology industry during her tenure at AusBiotech, most notably in her role as CEO. We are grateful and proud of Lorraine’s sustained service and loyalty to AusBiotech and sincerely thank her for her dedication and achievements.”

Ms Chiroiu has been a passionate leader in support of policy to drive the industry’s growth, as well as shaping the culture and financial performance of AusBiotech. She has been instrumental in a range of strategic policy campaigns, holding very successful conferences and events and attracting industry support. Her responsive and effective leadership during the pandemic enabled the organisation to adapt to the evolving challenges and continued achievement of impressive results.

The AusBiotech board has initiated a recruitment process for the CEO position.

Emyria secures local MDMA to start PTSD clinical trial dosing

Thu, 21 Sep 2023 00:00:00 +1000

BioCurate and Takeda renew alliance to accelerate discoveries

Thu, 21 Sep 2023 00:00:00 +1000

Immutep welcomes authorisation of commercial manufacturing of 'Efti' for clinical trial use

Thu, 21 Sep 2023 00:00:00 +1000

Australian-developed drug receives US FDA approval

Tue, 19 Sep 2023 00:00:00 +1000

Momentous announcement from GSK marks key inflection point in Professor Andrew Wilks’ 20-year journey.

GlaxoSmithKline’s Ojjaara (momelotinib), a JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor with origins in Australia, has received approval from US regulators for the treatment of myelofibrosis.

The treatment was developed as candidate CYT387 at Cytopia, an Australian biotech company founded by Professor Andrew Wilks in 1999 and headed by Prof Wilks, Dr Chris Burns, and Andrew Macdonald.

Prof Wilks and his team at the Ludwig Institute for Cancer Research discovered and developed a suite of patents around JAK1 and JAK2, which were licensed by Cytopia and taken through preclinical and early clinical development.

Myelofibrosis, rare a bone cancer, can lead to severely low blood counts, including anaemia and thrombocytopaenia; constitutional symptoms such as fatigue, night sweats, and bone pain; and splenomegaly. To date, Ojjaara it is the only approved medicine for both newly diagnosed and previously treated myelofibrosis patients with anemia that addresses the key manifestations of the disease.

While initially approved as a treatment for myelofibrosis, a media release said the molecule has the potential to gain additional approvals for treating a number of inflammatory diseases.

In 2009, the then ASX-listed Cytopia was acquired by Toronto-based YM Biosciences for $AU14 million; in 2012, Gilead Sciences acquired YM Biosciences, whose lead drug was the Melbourne-developed CYT387, for $US510 million; in 2018 Gilead was reported to have sold the drug to Vancouver’s Sierra Oncology for $US3 million up-front; and last year Sierra sold CYT387 to GlaxoSmithKline for $US1.9 billion ($A2.9 billion), making it the highest acquisition amount paid for a drug invented in Australia.

AusBiotech CEO Lorraine Chiroiu says, “This approval is a huge moment for all of those involved in the development of momelotinib, and Australia’s biotech community, as it showcases Australia’s world-class research capabilities and pioneering talent in translating breakthrough discoveries into much-needed therapies that benefit patients’ lives. It is rewarding to see more than 20 years of development, all of which started in a Melbourne laboratory, lead to the approval of a therapy to treat patients with myelofibrosis.”

Prof Wilks is now managing director of SYNthesis Bioventures, a fund focused on early-stage therapeutics, while Dr Burns is CEO of Amplia Therapeutics, a biotech company developing small molecule inhibitors to treat cancer and fibrotic diseases.

Moderna marks half-way point in construction of mRNA manufacturing facility

Tue, 19 Sep 2023 00:00:00 +1000

Optiscan Imaging correlates with histology in breast cancer study

Tue, 19 Sep 2023 00:00:00 +1000

AgriBiotech Summit 2023 programme launched

Thu, 14 Sep 2023 00:00:00 +1000

The one-day agricultural biotechnology event held onsite alongside the AusBiotech 2023 national conference has launched its programme, featuring sessions on sustainable food production, First Nation partnerships, and capital raising in the agritech sector.

Agriculture and biotechnology converge at the one-day AgriBiotech Summit on 2 November, which today launches its programme of sessions and speakers, highlighting Australia’s innovative agribiotech capabilities and solutions.

The AgriBiotech Summit includes a keynote from Joanne Todd, Challenge Director, High Value Nutrition, who will speak on how the government-backed High Value Nutrition Challenge brings together New Zealand’s top scientists to work collaboratively to develop high-value foods with validated health benefits while driving economic growth.

The Summit also features panel sessions focused on the role of biotech in renewable energy production and biosecurity, partnering with First Nations for natural product discovery, and the role of open-source info and patent analytics in agritech/foodtech innovation.

Held on 2 November, delegates can purchase a day pass to attend the AgriBiotech Summit, or attend as part of their AusBiotech 2023 full conference pass registration

Aimed at highlighting the challenges and opportunities facing people and planet, the AgriBiotech Summit showcases innovative approaches to biosecurity, food production and natural product development, and the ground-breaking growth and opportunities available for the sector.

AusBiotech 2023, Australia’s premier life sciences event hosted in Brisbane from 1-3 November, will feature over 50 engaging sessions and more than 100 speakers, highlighting Australia’s role in advancing biotechnology on the world stage.

Take advantage of the AusBiotech 2023 early-bird conference pass rate and save up to $280 before it ends on 18 September. Your pass provides access to:

The AgriBiotech Summit – a one-day agri-bio focused summit held onsite at AusBiotech 2023
Programme sessions featuring an impressive lineup of speakers
Our industry partners - connect in the exhibition hall
Networking opportunities with other delegates and partners
The Early-Stage Innovation Forum – a rapid-fire pitch competition for researchers and pre-seed companies
Lunch, morning and afternoon refreshments in the exhibition hall
AusPartnering, AusBiotech's highly popular business matching programme, facilitating thousands of 1:1 meetings across the conference week.

Join the AgriBiotech Summit at AusBiotech 2023 to celebrate and connect with our thriving Australian ecosystem by registering here.

Download the full AgriBiotech Summit programme here.

Investors boost Starpharma in response to interim data from clinical trial

Thu, 14 Sep 2023 00:00:00 +1000

New leadership for vaccine platform technology company Sementis

Thu, 14 Sep 2023 00:00:00 +1000

Adapt Ideations announces the appointment of chief operating officer

Thu, 14 Sep 2023 00:00:00 +1000

Early diagnosis a step closer for those at risk of oesophageal cancer

Thu, 14 Sep 2023 00:00:00 +1000

Feedback sought on Employee Share Schemes policy

Tue, 12 Sep 2023 00:00:00 +1000

Member feedback is invited on a new draft policy whitepaper supporting access to great talent through the Employee Share Schemes (ESS), as AusBiotech works to ensure Australia’s future as an internationally-competitive environment for biotechnology.

Whilst Australia’s current ESS policy is supportive, there is potential to make it more effective for biotech SMEs.

As a thriving knowledge economy, access to skills and global talent is a fundamental driver within the biotechnology industry, and there is a shift in the requirement for globally-experienced people in a range of areas, including some of the areas that haven’t yet fully developed such as cell and gene manufacturing.

Skills can be rare, and are still developing across the globe, including within Australia. While there is focus on developing these, Australian companies, particularly SMEs, need the mechanisms available to access those with existing experience and skills within the Australian environment to be able to develop our industry appropriately.

In Australia, ESS play an important role in helping start-ups through to established companies in attracting and retaining core talent. ESS give employees a benefit, such as shares in the company they work for at a discounted price or the opportunity to buy shares in the company in the future. By complementing cash remuneration and making salary packaging appear more substantive and attractive, they help attract high-quality employees and give employees a vested interest in the company’s success.

The advantages of ESS could be amplified in the life science sector, where the pre-revenue phase is typically extended by the need to clear regulatory hurdles before revenue can be earned, which can exceed a decade.

However, the current rules are overly complex and inconsistent, and Australia has the opportunity to deliver on this by taking biotechnology’s unique characteristics into consideration and turning Australia’s good incentive into a great incentive.

AusBiotech is testing and refining the policy position presented in its whitepaper, and invites members across the life sciences sector to respond to the discussion questions posed within the whitepaper by 30 September 2023.

Members are invited to download the draft whitepaper here. To provide feedback, or to receive a Word version of this white paper, email Karen Parr, Director, Communications and Policy.

Once finalised, AusBiotech will ‘walk the halls’ to speak with the Federal Government on how to support Australia innovators attract and retain great talent.

Imugene secures new patent in Japan for PD1-Vaxx clinical drug candidate

Tue, 12 Sep 2023 00:00:00 +1000

BCAL Diagnostics says it has locked down crucial breast cancer signature

Tue, 12 Sep 2023 00:00:00 +1000

Save $350 with AusBiotech 2023 early-bird rates

Thu, 07 Sep 2023 00:00:00 +1000

Secure your early-bird registration to Australia’s premier life sciences event, AusBiotech 2023, before 18 September, save up to $350, and join industry in celebrating Australia’s biggest week in biotech.

The AusBiotech 2023 national conference, hosted in Brisbane from 1-3 November, will feature over 50 engaging sessions and more than 120 speakers, highlighting Australia’s role in advancing biotechnology on the world stage.

The largest life sciences event in Australia provides access to:

Three days of programme sessions, featuring an impressive lineup of 120+ expert speakers
Our industry partners - connect in the exhibition hall
AusPartnering, AusBiotech's highly popular business matching programme, facilitating thousands of 1:1 meetings across the conference week.
Networking opportunities with other delegates and partners
The AgriBiotech Summit – a one-day agri-bio focused summit held onsite at AusBiotech 2023
The Early-Stage Innovation Forum – discover emerging technologies at our rapid-fire pitch competition for researchers and pre-seed companies
Lunch, morning and afternoon refreshments in the exhibition hall
Social highlight of the week – the AusBiotech 2023 conference dinner.

The AusBiotech 2023 programme features a broad array of Australian and global industry leaders including company CEOs, investors, policy makers, intellectual property experts, and service providers.

Providing an invaluable opportunity to hear from heads of pharma search, evaluation and venture investment leads on challenges and trends facing both global and medium-sized pharmaceutical companies on the global stage, panellists include: Dr Jessica Droge, VP External R&D, Amgen; Dr Michelle Booden, Director Business Development & Licensing, MSD; Dr Frank DeRosa, Chief Technology Officer & Global Head of Research, mRNA Centre of Excellence, Sanofi; Dr Donmienne Leung, Director, AbbVie Ventures; and Dr Richard Woodfield, Country Medical Director, Roche.

Keynote Dr Sam Costello, Chief Executive Officer & Co-Founder of BiomeBank, the inventor of BIOMICTRA™, will present First-in-class donor-derived microbiome therapy informing drug discovery to share how BiomeBank is using BIOMICTRA in other diseases to inform drug discovery of second-generation cultured microbiome-based therapies.

AusBiotech 2023’s, Millis Orator Emeritus Professor Ian Frazer, The University of Queensland; Director, Microba, will address Navigating the future: Predictions and potential of Australian biotechnology. The Millis Oration is named in honour of Emeritus Professor Nancy Millis's contribution to the industry, and is held annually at the AusBiotech conference together with continuous support from CSL.

Keynote Dr Lisa Haile, Partner, DLA Piper, will be joined by Prof. Nick Opie, CIO, Synchron, to present on Dancing with patents, where they’ll navigate the US regulatory environment, and the consequences and risks of not surveying the patent landscape well in advance, using others’ data within your own patent applications and tips on how to manage your company’s IP risks as part of your overall business strategy.

Keynote Dr Francis Gurry, Strategic Director, IPH Group & Ex-Director General at World Intellectual Property Organisation (WIPO), will shed light on the trends that are shaping IP strategy internationally and how these may have significant impact on your organisation’s ability to protect inventions, attract investment, and grow the business locally and abroad in his keynote Global IP Trends.

AusBiotech 2023 is created by industry, for industry; and for almost four decades it has created a forum to reflect on and celebrate the sector’s achievements and exchange ideas to further advance the industry. The 2023 national conference is proudly sponsored by the Queensland Government.

Join AusBiotech 2023 in-person to celebrate and connect with our thriving Australian ecosystem by registering here.

Actinogen Medical closes $10 million rights issue offer

Thu, 07 Sep 2023 00:00:00 +1000

FivepHusion says first patient treated in paediatric brain cancer trial

Thu, 07 Sep 2023 00:00:00 +1000

Non-animal models could deliver $1.5B growth

Tue, 05 Sep 2023 00:00:00 +1000

A new report has been released on ‘Non-animal models: a strategy for maturing Australia’s medical product development capabilities’, with CSIRO highlighting how by acting now, Australia can secure a key role and deliver around $1.5B in growth in this emerging capability.

To support the coordination of Australia’s efforts, and research and infrastructure strengths, 10 recommendations are offered in how Australia can accelerate non-animal model applications’ demonstration, scaling, and commercial success.

Policy shifts have recently been seen in the US and Europe to encourage the transition away from animal testing and to address risks in animal model supply chains. It is expected that these shifts will likely support the existing growth trajectory of the global non-animal testing market, that was valued at USD 1.11 billion in 2019.

The newly published report notes how “Australia has comparative global strengths in non‑animal models for several organ systems likely to disrupt the status quo about the use of animal models over the next 15 years … including existing infrastructure, high throughput screening capabilities, and internationally recognised capacity for induced pluripotent stem cell generation, a key input for non-animal model development. These emerging models will also be critical to protect and further strengthen Australia’s $1.4 billion clinical trials sector.”

“The complexity of non-animal models is rapidly increasing, equating to or surpassing the performance of traditionally used animal models in several applications. Due to their enhanced biological relevance, non-animal models can increase productivity and reduce costs by identifying unsuitable medical products earlier in development and re-investing savings in more promising candidates. These models also support broader global ‘3Rs’ objectives to replace, reduce and refine the use of animals for research and testing purposes.”

AusBiotech was pleased to be one of the 103 individuals from 66 organisations consulted from across industry, research and government.

In recognition of the recent and powerful advances of animal model alternatives and Environmental, Social, and Governance (ESG) progress, an expert panel discussion is taking place at AusBiotech 2023 conference on ‘Animal model alternatives: the future of drug screening is driven by human biology’.

This panel will explore how the role of new approach methods and animal tests will evolve as the industry strives to identify the most accurate methods for predicting patient responses to new therapeutic candidates and pave the way for a new era of more reliable and effective therapies that will bring benefits to a larger number of patients. Chaired by Associate Professor Tam Nguyen, St Vincent’s Hospital Melbourne, speakers include: Dr Christos Papadimitriou, Tessara Therapeutics and Greg Williams, CSIRO Futures.

Read CSIRO’s full report here.

Emyria announces capital raise to progress mental healthcare programs

Tue, 05 Sep 2023 00:00:00 +1000

Evaluation of MRFF’s Clinical Trials Activity initiative released

Thu, 31 Aug 2023 00:00:00 +1000

An evaluation of the MRFF’s Clinical Trials Activity initiative has found that MRFF-funded trials have enhanced research translation, by involving industry, consumers, and professional organisations in trials, increased research into unmet need particularly in rare cancers, and helped more Australians access clinical trials.

The evaluation looked at the investments in clinical trials made through the MRFF, approaches for clinical trials overseas and in Australia, and ways to improve funding and granting arrangements for clinical trials through the initiative and the MRFF more broadly.

The Clinical Trials Activity Initiative, established in 2016, will provide $750 million over 10 years between 2022-23 and 2031-32 to increase clinical trial activity in Australia.

Its initial focus addressed rare cancers and diseases, and unmet needs, and on bringing investigator-led international clinical trials to Australia. This has now expanded to enable funding of research projects focused on any disease or condition meeting the grant’s objectives.

Findings included:

Increased focus of research on areas of unmet need. The clinical conditions studied were broad and similar, with the most notable exception being the number of cancer trials, particularly of rarer cancers, which was more common for MRFF-funded trials – however, this difference aligns with the priorities and calls of MRFF based on unmet needs.
Workforce development in clinician-researchers to undertake translational research. The majority of MRFF funded trials were led by academics and clinicians, with fewer led by consumers, policymakers, or non-government organisations. A critical issue is the need to support clinician-researchers who have the skills to understand the important clinical questions and an understanding of trial design. However, stakeholders suggested the degree of involvement of professional organisations, non-government organisations, industry, and consumers is encouraging. This involvement is likely to improve translation of findings into practice.
Site recruitment and individual patient recruitment were identified as the most common problems for barriers to successful completion for most trials.

Due to the lengthy timeframes it takes to complete clinical trials, as well as the impact of the pandemic, few trials have yet been reported and translated into practice. This will need to be monitored in the years to come.

Read the Evaluation of the Medical Research Future Fund Clinical Trials Activity Final Report here.

Clinical trials reform in Australia is a national priority, with the National One Stop Shop offering an opportunity to enhance the clinical trials and health and medical research operating environment, and making it easier for patients, researchers and sponsors to participate in and conduct trials and research. AusBiotech is supportive of the proposed platform, and encourages funding in MYEFO, in order to retain Australia’s global competitive advantage and ensure greater patient access to clinical trials.

ENA respiratory expands leadership team and extends US Department of Defense funding

Thu, 31 Aug 2023 00:00:00 +1000

Chimeric Therapeutics announces changes to its board of directors

Thu, 31 Aug 2023 00:00:00 +1000

Recognition for Vetter in annual Frost & Sullivan awards

Thu, 31 Aug 2023 00:00:00 +1000

Pharmaxis announces the publication of positive preclinical data for PXS-5505

Thu, 31 Aug 2023 00:00:00 +1000

Feedback sought on FMT exemption and draft guidance

Tue, 29 Aug 2023 00:00:00 +1000

AusBiotech is calling for feedback on newly drafted TGA guidance on the requirements for Class 4 in-house IVDs used for screening Faecal Microbiota Transplant (FMT) donors, and on the proposal to cease the current exemption for these IVDs that are used for FMT donor screening from inclusion in the ARTG from 1 July 2025.

While there are several Class 4 IVDs already included in the ARTG for the majority of FMT donor screening tests that are intended to detect specific blood-borne diseases, there are currently none that are approved for testing stool specimens for screening donors for the manufacture of FMT products.

An extension was granted to temporarily exempt these devices to allow legal supply and create time for providers to generate sufficient data to support the performance of these devices, however, generating sufficient data in such small sample sizes has proven challenging, and removing the exemption will increase the time and financial burdens significantly. AusBiotech is concerned that this will impact the emerging industry without increasing the existing quality and safety requirements and seeks commensurate regulatory measures.

The purpose of the guidance is to assist testing laboratories to understand the requirements around the regulatory and technical considerations for these tests, so to demonstrate compliance with the relevant essential principles and the conformity assessment procedures.

AusBiotech is developing a response to the draft guidance through its Regulatory Affairs Advisory Group, and invites its members to contact Karen Parr, Director, Policy and Communications, by Monday 4 September for a copy of the draft guidance and to share their views.

Gordon Brothers Ritchie Bros. Alliance facilitates auction of Ellume assets

Tue, 29 Aug 2023 00:00:00 +1000

Botanix Pharmaceuticals elevates chief operating officer to CEO position

Tue, 29 Aug 2023 00:00:00 +1000

First participant treated at the highest dose level in Clarity’s theranostic prostate cancer trial

Tue, 29 Aug 2023 00:00:00 +1000

AusBioInvest 2023 keynote speaker announced

Thu, 24 Aug 2023 00:00:00 +1000

A US venture capitalist, with a track record of successful investing in Australian biotech, will headline Australia’s premier life sciences investment conference, AusBioInvest 2023, in October.

Kanishka Pothula, Partner of Nextech Ventures (US), formerly with BVF Partners, a premier biotechnology-focused hedge fund where he had several billion under management, has been announced as a keynote speaker.

The US-based Australian ex-pat will deliver an engaging and interactive fireside discussion on ‘What biotech investors consider when evaluating a deal: a how-to for non-specialist investors’ at AusBioInvest in Melbourne on October 30, discussing health investment, and why it’s important to know what drives US investors when Australian companies are seeking seed and expansion capital offshore.

During this interactive fireside, Kanishka will provide insights on how US investors operate, factors US investors consider in dealmaking, and how this compares to Australian investment and dealmaking models, before passing to the audience for Q&A.

This keynote, and conference, is ideal for non-specialist investors wanting to dip their toes into biotech investing, as well as those more experienced and looking to inform their next investment.

With diverse experience in both public and private investments, Kanishka currently heads the public market efforts for Nextech Ventures, a cancer therapeutics-focused venture capital (VC) firm investing in drug discovery-stage companies with investments spanning company inceptions to crossover rounds.

Prior to this, Kanishka spent over a decade with BVF Partners, a premier biotechnology-focused hedge fund where he helped manage the growth of the fund from several hundred million to several billion under management, starting as an Analyst and being promoted to Managing Director.

Kanishka is the first keynote speaker announced for AusBioInvest 2023, a premier one-day event featuring keynote presentations and panel discussions from local and international life science investment specialists on topics including industry trends and market updates.

AusBioInvest 2023 directly connects the investment community with innovative companies, enabling Australian life science companies to present their business case in an eight-minute pitch to a room full of investors. Its business partnering system and on-site networking lounge offer additional networking opportunities for both investors and companies.

AusBiotech invites qualified investors, including venture capital firms, private equity investors, high-net-worth individuals, research analysts, brokers, family offices, to access their complimentary tickets to attend AusBioInvest 2023, providing them with a valuable opportunity to make meaningful connections with companies, hear the latest market updates, and explore potential investment prospects. Register your interest here.

Biotech companies are also being invited to register their interest to pitch at AusBioInvest 2023 to a global audience of investors, industry executives, and key stakeholders. Join the investee cohort alongside Arovella Therapeutics, Carina Biotech, Celosia Therapeutics, EncapSolutions, FivepHusion, Genofax, Immuron, InhaleRx, LBT Innovations, Microba, Noxopharm, Prescient Therapeutics, Snoretox Ltd, Tessara Therapeutics, and Vaxxas.

Delegates can also register now.

AusBioInvest 2023 is proudly supported by Host State Partner the Victoria State Government.

Vaxxas awarded Wellcome grant for needle-free typhoid vaccine patch study

Thu, 24 Aug 2023 00:00:00 +1000

Telix says result reflects its transition to a sustainable commercial-stage company

Thu, 24 Aug 2023 00:00:00 +1000

Opthea announces placement and fully underwritten entitlement offer to raise $80m

Thu, 24 Aug 2023 00:00:00 +1000

Nominations open for AusBiotech Board

Tue, 22 Aug 2023 00:00:00 +1000

Help advance Australia’s biotechnology sector: nominations are open for the AusBiotech Board of Directors, as it seeks to elect one new director.

As the industry’s member organisation for more than 37 years, AusBiotech works for the success of Australian biotechnology by providing the largest dedicated network in the country and one of the largest in the world.

Its Directors are elected to provide strategic guidance and corporate management-related policies, and is comprised of up to nine members, including the CEO & MD. Each Board member is an experienced leader that brings extensive experience of working in the Australian biotechnology industry, representing technical, commercial and policy expertise.

AusBiotech is a well-connected national network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), digital health, and agri-biotech sectors, and encourages nominations from all corners of its membership.

Members interested in joining the AusBiotech Board are invited to submit their nomination form together with a 350-word biography and photo by 17 September 2023 to elections@ausbiotech.org.

AusBiotech warmly invites those interested in this position to have a confidential conversation with AusBiotech CEO, Lorraine Chiroiu, who can bring the role ‘to life’ and answer any questions you may have.

The election outcome will be announced at the 2023 Annual General Meeting of AusBiotech Ltd, which will be held in-person at the national AusBiotech 2023 conference in Brisbane on Thursday 2 November at 12.30pm - 1.20pm (AEST) – to which all members are invited to attend.

If an election is required, the on-line voting and access information will be emailed to eligible members on 20 September 2023.

Dates:

14 August 2023: Nominations open
17 September 2023: Nominations close
20 September 2023: If an election is required, on-line voting and access information is emailed to members
13 October 2023: Closing date for on-line ballot

Meet the current AusBiotech Board here.

AusBiotech 2023 programme launched

Thu, 17 Aug 2023 00:00:00 +1000

The AusBiotech 2023 national conference programme is today launched featuring over 50 engaging sessions and more than 100 speakers in Brisbane from 1-3 November, highlighting Australia’s role in advancing biotechnology on the world stage.

Programme highlights include:

South Australian-based company BiomeBank delivered the world’s first approved microbiome-based therapy, BIOMICTRA™, after it was listed on the Australian Register of Therapeutic Goods (ARTG) in November 2022. Dr Sam Costello, Chief Executive Officer & Co-Founder of BiomeBank, the inventor of BIOMICTRA™, will present First-in-class donor-derived microbiome therapy informing drug discovery to provide insights on how BiomeBank is using BIOMICTRA in other diseases to inform drug discovery of second-generation cultured microbiome-based therapies.
AusBiotech 2023’s, Millis Orator Emeritus Professor Ian Frazer, The University of Queensland; Director, Microba, will address Navigating the future: Predictions and potential of Australian biotechnology. The Millis Oration is named in honour of Emeritus Professor Nancy Millis's contribution to the industry, and is held annually at the AusBiotech conference together with continuous support from CSL. The Oration is a focal point of the annual industry gathering and is appropriately named in honour of this pioneer of Australia’s biotechnology industry.
Keynote Dr Lisa Haile, Partner, DLA Piper, will present on Dancing with patents, which will discuss navigating the US regulatory environment, consequences and risks of not surveying the patent landscape well in advance, using others’ data within your own patent applications and tips on how to manage your company’s IP risks as part of your overall business strategy.
Keynote Dr Francis Gurry, Strategic Director, IPH Group & Ex-Director General at World Intellectual Property Organisation (WIPO), will shed light on the trends that are shaping IP strategy internationally and how these may have significant impact on your organisation’s ability to protect inventions, attract investment, and grow the business locally and abroad in his keynote Global IP Trends.

This year's programme features a one-day AgriBiotech Summit, the Early-Stage Innovation Forum, conference gala dinner, and plenty of formal and informal networking opportunities.

Biotech’s biggest week also includes AusBioInvest 2023, Australia’s premier life science investment event, on 30 October in Melbourne, a pre-conference workshop Biotech-Pharma Product and Company Valuation – an introduction with Dr Patrik Frei, and site tours around Queensland’s health and innovations precincts on 31 October in Brisbane.

Join AusBiotech 2023 in-person to celebrate and connect with our thriving Australian and global biotechnology network. AusBiotech encourages delegates to take advantage of early-bird registrations before 18 September; register now.

AusBiotech’s premier biotech conferences is proudly sponsored by the Queensland Government. Download the full programme here.

CUREator+ delivers funding boost to commercially focused BioMedTech startups

Thu, 17 Aug 2023 00:00:00 +1000

Imugene licenses allogeneic CAR-T with a potential registration study in 2024

Thu, 17 Aug 2023 00:00:00 +1000

Biotron completes clinical phase of BIT225 COVID-19 clinical trial

Thu, 17 Aug 2023 00:00:00 +1000

AusBiotech 2023 Millis Orator announced

Tue, 15 Aug 2023 00:00:00 +1000

Distinguished Australian scientist Emeritus Professor Ian Frazer AC to deliver Millis Oration at AusBiotech 2023 national conference in Brisbane.

As the 2023 Millis Orator, Prof. Frazer, Frazer Institute, University of Queensland; Director, Microba (ASX:MAP), will share his assessment of the sector's current state and predictions for Australian biotechnology, and identify the challenges to address for Australia to develop more revolutionary health treatments while building our sovereign vaccine and drug manufacturing capabilities.

In the wake of a global pandemic, Australia's immediate focus is on sovereign vaccine manufacturing capacity expansion. In broadening the nation’s agenda, it will require talent, and bolstered capacity along the entire bench to bedside pathway. This is necessary not only to ensure Australia’s future health, but also to contribute to our national prosperity.

With unwavering determination and endless passion, 2023’s Millis Orator Prof. Frazer will delve into what part of this agenda we meet currently, and what are the challenges that hinder our progress towards the rest, as Australia paves the way for more, revolutionary global health advancements.

The significant global impact of distinguished scientist Emeritus Professor Ian Frazer AC’s transformative research led to the Gardasil® vaccine, thereby crystallising him as a household name for Australian biotechnology and beyond.

Gaining FDA approval in 2006, Gardasil® set a relentless pace and dominated the global HPV vaccine market: it’s now available in more than 120 countries with more than 100 million doses having been distributed around the world.

The Millis Oration is named in honour of Emeritus Professor Nancy Millis' contribution to the industry, and is held annually at the national AusBiotech conference, together with CSL. The Oration is a focal point of the annual industry gathering and is appropriately named in honour of this pioneer of Australia’s biotechnology industry.

Chaired by Dr Andrew Nash, Chief Scientific Officer, CSL, register today to hear the Millis Oration, and 100+ more leaders from across the sector at AusBiotech 2023, Australia’s largest life science conference. Delivered for industry, by industry, AusBiotech 2023 will take place in Brisbane on 1 – 3 November.

AusBiotech 2023 is created by industry, for industry; and for more than three decades it has created a forum to reflect on the sector’s achievements and exchange ideas to further advance the industry. This year's programme features an all-day AgriBiotech Summit, the Early-Stage Innovation Forum, conference gala dinner, and an array of networking opportunities, both formal and informal.

AusBiotech 2023, is proudly sponsored by the Queensland Government. Register now for AusBiotech 2023 to celebrate and connect with our thriving Australian and global biotechnology network.

AusBiotech encourages delegates to take advantage of early-bird registrations before 18 September; register now.

A major day for Moderna as the company builds its Australian presence

Tue, 15 Aug 2023 00:00:00 +1000

CSL reports strong profit growth with record plasma collections

Tue, 15 Aug 2023 00:00:00 +1000

Chimeric reports positive in-vitro data for CHM 0301 next-generation cell platform

Tue, 15 Aug 2023 00:00:00 +1000

Notification of AGM 2023 and forthcoming elections

Mon, 14 Aug 2023 00:00:00 +1000

Notice of AusBiotech AGM, Thursday 2 November 2023

Ordinary Business

ANNUAL ACCOUNTS
To consider the annual report, financial statements and report of the Directors and auditor for the year ended 30 June 2023.
RESULTS OF DIRECTOR APPOINTMENT/S
To note the Directors who return, and the appointment of the new Director/s in accordance with the Company’s Constitution.
OTHER BUSINESS
Any other business that may be brought forward at a general meeting in accordance with the Constitution.

Note: A Member who is entitled to vote at the meeting has a right to appoint a proxy and should use the proxy form available on request from AusBiotech Ltd on 0437 126 843 or election@ausbiotech.org. The proxy form must be signed and dated by the Member or the Member’s attorney. Proxy forms and the original or a certified copy of the power of attorney (if the proxy form is signed by an attorney) must be received no later than 1.00pm (AEST) Wednesday 1 November 2023.

Notice of Election to the AusBiotech Ltd Board of Directors

This notice relates to the Election for the Board of Directors of AusBiotech Ltd for 2023. The Board has determined that there is currently one (1) vacancy for a Director on the Board. The new Board will be announced at the AusBiotech AGM (details above).

Call for nominations will open today, Monday 14 August 2023. Please find the nomination form here.

Dates

14 August 2023 - Nominations open
17 September 2023 - Nominations close
20 September 2023 - If an election is required, on-line voting and access information is emailed to members
13 October 2023 - Closing date for on-line ballot

If you have any questions regarding the AGM please do not hesitate to contact the CEO, AusBiotech Ltd on 0437 126 843 or admin@ausbiotech.org.

By Order of the Chair

Geoffrey Kempler
Chair

AusBiotech launches world-first ESG Guide for biotech SMEs

Thu, 10 Aug 2023 00:00:00 +1000

AusBiotech’s landmark A Practical Guide to ESG for Australian Life Sciences Companies is launched to help SMEs attract investment and navigate environmental, social and governance (ESG) reporting.

After more than a year of collaborative development with industry leaders, AusBiotech is proud to launch A Practical Guide to ESG for Australian Life Sciences Companies (the Guide) as a pragmatic and easy-to-use ESG tool for biotechs.

Targeted at biotech SMEs, the Guide intends to build ESG reporting capabilities within life science companies, as part of AusBiotech’s broader mission to increase and diversify investment into the Australian biotech sector via its investment programme.

Developed with support of the AusBiotech ESG Working Group comprised of investors, life science companies, and experts, the Guide enables a consistent approach to proactively identifying and reporting on key ESG factors that are particularly relevant to life science companies. 

The Guide is a world-first for the biotechnology sector, with Australia being the first nation to develop an ESG Guide specifically for biotechnology SMEs. 

Due to the evolving nature of ESG reporting and regulation, and the level of subjectivity on what’s most relevant and important to each company, there are no agreed universal standards, tools or metrics to guide companies on their ESG programme. The lack of standardisation underpins the rationale for this new ESG Guide: a voluntary set of guidelines tailored specifically for Australian SME companies operating in the life sciences sector.

“It was very important for us to empower SMEs in the biotech sector who are heavily dependent on investment and venture capital to start their ESG journey,” said AusBiotech CEO Lorraine Chiroiu.

It is also intended to be a useful resource for investors as a guide to understanding the priority ESG considerations for life sciences companies, as criteria for assessing their ESG credentials. 

Globally, awareness of the importance of ESG factors has grown over the past decade and it is increasingly regarded as an integral aspect of contemporary best practice for companies and for investors. The life sciences industry is distinctive by virtue of its inherent link to social good as the innovators and advancers of science and technology to deliver potentially life-changing and life-saving therapies, vaccines, diagnostics, devices and digital health solutions that have global significance for humankind.

Australia’s life sciences industry currently boasts over 1,400 companies undertaking research and development, the majority of which are small to medium sized enterprises (SMEs). Supporting these nascent companies to develop and communicate proactive ESG strategies, policies and practices will enhance the reputation and credibility of our sector, lead to increased investor confidence and attraction, and assist to deliver timely and innovative health outcomes.

However, with 93 per cent of small cap companies in Australia currently not reporting on ESG, there exists an opportunity for companies to differentiate themselves within the market and in the eyes of potential investors.

AusBiotech developed the Guide to increase the attractiveness of Australia’s business environment to international and local investors and collaborators, having been identified in AusBiotech’s Biotechnology Blueprint, the sector’s decadal strategy written by the industry, for the industry.

Download the full guide here.

Australian vaccine breakthrough offers hope against EBV-associated cancers and MS

Thu, 10 Aug 2023 00:00:00 +1000

Merck partners to pilot the first DeadlyLabs kit

Thu, 10 Aug 2023 00:00:00 +1000

Clarity’s theranostic prostate cancer trial advances to highest dose level

Thu, 10 Aug 2023 00:00:00 +1000

AusBiotech weighs in on Industry Growth Program consultation

Tue, 08 Aug 2023 00:00:00 +1000

AusBiotech urges Federal Government to take biotechnology industry’s unique characteristics into account when designing $392.4 million Industry Growth Program.

As the voice of industry, AusBiotech has responded to the Department of Industry, Science and Resources’ consultation on the new Industry Growth Program (the Program) with an industry-led submission.

The Program, announced during the 2023-24 Federal Budget, will be aimed at supporting Australian SMEs and startups to commercialise ideas and grow operations, with an alignment to the National Reconstruction Fund (NRF)’s seven priority areas. This positions SMEs to seek potential funding through the NRF or gain other investment interest in the future.

AusBiotech’s submission included four key recommendations, including:

Take medical science sector’s unique characteristics into consideration when determining eligibility criteria for SMEs;
Reconsider the intention for matched funding to be a criterion for grants for the pre-revenue medical science sector. At any amount, it is high bar to entry for a company relying on capital flow from investors and grants and, therefore, AusBiotech recommended a pre-approved concession for the sector is recommended
Careful application of Technology Readiness Levels (TRLs) assessments, with the need to consider the unique characteristics of the sector, and subsectors within medical science; and,
Industry Partner Organisations to offer expertise where there are currently gaps in the market and where SMEs initially struggle to access.

Bio/medical technology differs from traditional business and non-medical technology in both its development challenges and in its potentially world-changing technologies. Around 80 per cent of Australia’s biotech companies are classified as SMEs and are working to commercialise their research, with an important number developing new and novel technologies – the majority of which are pre-revenue.

In its submission, AusBiotech recommended that pre-market companies and those with turnover up to $20 million (if applied as in the R&D Tax Incentive) be considered an SME. These companies are typically also pre-revenue and pre-regulatory approval.

“It should be noted that an SME in this sector, will not be analogous to an SME in another sector. For example, a biopharma company that has received a once-off payment of $10 million and a prospective royalty stream upon development milestones, will not be equivalent in character to an IT company with a $10 million stream of revenue that is following year-on-year,” AusBiotech said.

AusBiotech has been engaging with the Department to ensure the policy design behind the $392.4 million programme takes the unique characteristics of the biotechnology industry into account, through an intimate roundtable discussion and via its formal submission.

AusBiotech has stressed a broad approach to assessing eligibility could negatively influence the programme, noting as an example that annual turnover, FTE, and net asset caps are not appropriate eligibility criteria for the medical sciences.

“The sector’s main unique characteristics include being highly regulated, usually requiring expensive and extensive clinical trial data before any product can be approved, and having longer than usual development times. It typically can take 7 – 15 years and up to $2.5 billion to bring one bio/medical product from early research to market, with little or no revenue.

“These differences are why, unless a policy takes these unique characteristics into consideration during the policy design phase, the sector can be severely disadvantaged.”

AusBiotech’s submission also emphasised the importance of capturing and reporting non-financial metrics, such as technology impact, sector-specific metrics including patient access to clinical trials and anticipated patient outcomes; and diversity and inclusion metrics like gender of founders and CEOs, and level of Indigenous Peoples’ participation and success.

Read AusBiotech’s full submission here.

Dimerix announces successful completion of second DSMB review of ACTION3 trial

Tue, 08 Aug 2023 00:00:00 +1000

New AusBiotech report shows increasing US investment in Australian biotechs

Thu, 03 Aug 2023 00:00:00 +1000

Australia continues to attract significant investment from US investors, with the total figure of US investment into Australian life science companies totaling US1.43 billion and a strong growth trend over the five-year period, between 2018-2022.

An analysis of investment data by AusBiotech shows 100 deals between US-based investors and Australian-headquartered life sciences companies over the analysis period.

Fourteen deals totaling US$139.058 million were reported in 2018, 21 deals totaling US$229.269 million in 2019, 15 deals totaling US$125.619 million in 2020, 26 deals totaling US$294.75 million in 2021, and 24 deals totaling US$642.341 million in 2022.

The data includes both private and ASX-listed companies across the following subsectors: biotech, therapeutics, drug discovery, and medtech/medical devices; digital health; medical imaging and monitoring/sensors; surgical, dental and other medical devices; and agribiotech companies, including bio-based products, medicines for animal health, microbial technology, feed supplements to reduce methane emissions, and technologies.

The two most common metrics when describing investment transactions are number of deals and quantum of funds. The most commonly reported transaction type involving eligible companies was private investment into public companies (PIPE) (37 transactions), followed by seed funding (22 transactions), early-stage VC (19 transactions) and late-stage VC (16 transactions).

Notably, there has been a rise of ‘digital health’ companies receiving and reporting significant investment from the US market over the five-year period, including companies such as Eucalyptus (approx. US$71 million plus an undisclosed seed round), ResAPP Health (acquired by Pfizer for approx. US$121 million), Harrison.ai (US$62 million of venture capital), Omniscient (US$30 million Series B), Sonder (Series A raise of US$16 million, and Series B US$24 million), Honeysuckle Health (formed as a JV for AUD$20 million), WeGuide (received a US$10 million from the Bill & Melinda Gates Foundation), and HeidiHealth (Series A US$5 million raise).

Grants, incubator and accelerator funding, and M&A have been excluded in the overall figure and analysis, however figures have still been separately tracked, with a reported US$60.3 million in grants and incubator/accelerator funds being awarded to Australian companies from the US over the five-year period.

AusBiotech worked in partnership with Austrade’s US health investment team, with data collected from Pitchbook and Orbis databases, and manual news searches. It is important to note not all deals disclosed a dollar value. This is particularly relevant for private company transactions where parties are not compelled to disclose commercial deals.

The data analysis is a pilot to report on metrics identified in the Biotechnology Blueprint, Australia’s decadal biotech strategy, in particular Metric 2.1 “Direct foreign investment in Australian companies”. By tracking foreign investment into the sector, it provides indicators of the industry’s local standing and Australia’s position as a global leader. It also provides an evidence base for supporting industry growth long-term.

To read the full report, click here.

Immutep receives positive scientific advice from the European Medicines Agency

Thu, 03 Aug 2023 00:00:00 +1000

Peter Mac selects BindiMaps to launch Victoria’s first hospital ‘Google Maps for indoors’

Thu, 03 Aug 2023 00:00:00 +1000

AusBiotech responds to research funds consultation

Tue, 01 Aug 2023 00:00:00 +1000

AusBiotech states process must not overtake purpose behind funds, in response to consultation paper Improving alignment and coordination between the Medical Research Future Fund and NHMRC’s Medical Research Endowment Account (MREA).

As the voice of industry, AusBiotech delivered a submission in response to the Department of Health and Aged Care’s consultation paper seeking industry views on improving alignment between Australia’s two key Commonwealth research funds.

In July, the Federal Government announced a national consultation on improving alignment and coordination between the MRFF and MREA (managed by the NHMRC), to provide the greatest benefit for publicly-funded health and medical research.

The consultation paper noted how with closer coordination of MRFF and MREA support, increased efficiency and effectiveness of the two funds’ investments could be achieved. Several models were proposed including: a coordination of funds; management of both funds by NHMRC; and, merging of the two funds with new governance arrangements.

AusBiotech sought member views to support an industry-led submission, with the submission highlighting the important distinction between each programmes’ purpose, and between translation and commercialisation, in any new/amended model that is adopted.

The NHMRC has predominantly funded a broad range of investigator-initiated research, especially through fellowships and project grants, with more limited priority-driven research; the MRFF balances this by supporting priority-driven research with a focus on research translation, whether directly through improvements in health and healthcare or, where appropriate, through commercial development.

The submission stated, “The intentional focus on commercial development for the MRFF and the differentiation between these two programmes is well-received by industry, and there is a strong need for this to be retained. Ensuring the unique purposes are preserved in the governance and administrative constructs will be critical to its continuation, with the proposed joint models risking conflation and risking process overtaking purpose.”

The importance of retaining each programme’s purpose, capabilities, governance and administration was particularly stressed.

“While it’s acknowledged that there are some gaps that could be addressed through a coordinated strategy, the MRFF is still relatively new and the broader impacts it will deliver for Australia’s economic and social development are yet to be seen. In the same vein, any shifts, even subtle ones, to the balance between priority-driven research and instigator-led research will take time to be seen. Therefore, it is strongly recommended that, irrespective of the design choices determined, metrics are promptly developed and implemented, including tracking the amount of MRFF funds applied to commercialisation,” the submission noted.

The need for MRFF metrics was also identified in AusBiotech’s Biotechnology Blueprint, the decadal strategy developed by industry, for industry.

AusBiotech is supportive of coordinating and aligning the two funds, suggesting coordination also enables knowledge sharing and internal capability building between the MRFF and NHMRC.

“By coordinating, rather than merging, the capabilities present across the two Funds, it acknowledges their individual functions and yet facilitates the exchange of knowledge, skills and experience and thereby creates a greater understanding of the research and development pipeline that goes on to support Australian products being available on market. Coordinating commercialisation knowledge enables a dual focus on efforts and collaborations across both academia and industry, builds awareness of roles, value and capabilities, and supports collaborative structures.”

In June 2023, AusBiotech attended the first invitation-only Ministerial roundtable with The Hon. Mark Butler MP, Minister for Health and Aged Care, to discuss the proposed changes and improvements as strategic alignment, management and deployment of the two Commonwealth funds is sought.

The first phase of consultation will focus on governance and administration, while the second phase will focus on the funds’ investment strategies. AusBiotech plans to engage with its members during the second phase to develop an industry-led response.

Allarity Therapeutics and FivepHusion announce collaboration for the development of Deflexifol with DRP Companion Diagnostics

Tue, 01 Aug 2023 00:00:00 +1000

The nation’s largest cancer genomics initiative was launched in Sydney last week with the goal of saving or extending the lives of thousands of Australians battling incurable or

Tue, 01 Aug 2023 00:00:00 +1000

Neuren Pharmaceuticals wins Bioshares Excellence Award

Thu, 27 Jul 2023 00:00:00 +1000

ASX-listed AusBiotech member Neuren Pharmaceuticals (ASX:NEU) swoops up Blake Award for Excellence after a knock-out year including an FDA approval and key commercial partnerships.

Australia’s top performing ASX-listed life science company for 2023, Neuren Pharmaceuticals (Neuren), was awarded the Blake Award for Excellence (the Blakey) at the recent Bioshares Biotech Investment Summit in Hobart.

In March 2023, Neuren, through its US partner Acadia Pharmaceuticals (NASDAQ:ACAD), gained FDA approval for DAYBUE™ (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. DAYBUE is the first and only drug approved for the treatment of the neurodevelopmental disorder Rett syndrome.

The neurological drug developer was awarded the Blakey Award during the two-day summit held in Hobart on 24-25 July, with company CEO Jon Pilcher accepting the accolade on behalf of the company.

AusBiotech CEO Lorraine Chiroiu said, “It was great to witness Jon and the Neuren Pharmaceuticals team receive much-deserved recognition for the work they have done to commercialise therapies targeting unmet medical needs. Successfully taking a breakthrough product to market, in an indication where there are no approved therapies, should be heralded as a huge success for both the Australian biotech community and Retts syndrome patients globally.”

Neuren has announced it received a US$40 million milestone payment following the first commercial sale of DAYBUE™, and is eligible to receive ongoing royalties on net sales in North America plus milestone payments of up to US$350 million. Acadia provided encouraging insights into the US launch of DAYBUE, expecting net sales of US$21-23 million in Q2 2023 and US$45-55 million in Q3 2023.

In June, it also announced the expansion of its global partnership with Acadia for trofinetide, which under the new agreement, expands Acadia’s North America licence to a worldwide exclusive licence. Neuren will receive US$100 million up-front, plus additional potential milestone payments of up to US$427 million and royalties on net sales of trofinetide outside North America.

Neuren was reported as the top earner for 2023, with a reported share price of $14.20 (as at 18 April 2023) and a market return of 258.59 percent. This followed a strong 2022, where Neuren Pharmaceuticals was listed as the second top returner in AusBiotech’s AusBioStocks April 2022 data. Neuren Pharmaceutical reported a share price of $4.18 at the end of Q1 2022, which had soared to $14.20 by the end of Q1 2023.

Neuren is conducting Phase 2 trials of its second drug candidate, NNZ-2591, for each of Phelan-McDermid syndrome, Angelman syndrome, Pitt Hopkins syndrome and Prader-Willi syndrome.

The Bioshares Biotech Investment Summit was first founded by David Blake and Mark Pachacz, the co-editors and independent analysts behind the popular Bioshares publication.

HaemaLogiX and Peter MacCallum Cancer Centre announce CAR-T clinical trial agreement

Thu, 27 Jul 2023 00:00:00 +1000

Chimeric receives patent allowance for chlorotoxin in Japan

Thu, 27 Jul 2023 00:00:00 +1000

Report reviewing gender equity initiatives launched

Tue, 25 Jul 2023 00:00:00 +1000

The Federal Government’s Women for STEM Ambassador releases systemic review of gender equity initiatives in Australia with recommendations on effectively implementing programmes in STEM workforce.

A new report, titled ‘Workforce gender equity initiatives: A rapid systemic review’, evaluating literature on peer-reviewed workforce gender equity initiatives has been released, alongside recommendations on how to successfully implement and evaluate gender equity initiatives in STEM.

Led by the Office of Australia’s Women in STEM Ambassador, the report revealed three key recommendations: 1) Gender equity initiatives are most effective when policies and programmes are implemented together; 2) Central coordination of gender equity initiatives leads to effective management, longevity, and resource maximisation; and, 3) Gender equity initiatives need to be evaluated to assess how well they work.

Australia Government Women in STEM Ambassador Professor Lisa Harvey-Smith notes in the report, “Our focus to date has been to summarise the evidence on workplace gender equity initiatives – what works to shift the dial on gender equity in the STEM sector?”

The report assesses evidence on initiatives that benefit gender equity in STEM; evidence that supports effective implementation of STEM gender equity initiatives; and discusses how STEM gender equity initiatives are evaluated. It then summarises the evidence for each section to support the relating recommendations.

The report provides a snapshot of evidence that exists in peer-reviewed literature on the efficacy of workforce initiatives addressing gender equity, ranging from career development and mentorship programmes to fellowships. This is combined with peer-reviewed studies on initiatives not covered in the initial search, including pay transparency policies, bullying and sexual harassment initiatives, and quotas.

One hundred and twelve initiatives were identified, with initiatives broken down by the following categories: policies (pay transparency, workplace policies), career development (training, workshops, programmes), fellowships, mentoring, and workplace programmes.

The initial report findings and recommendations have been presented to the Diversity in STEM Review Panel and Taskforce for consideration. The next phase of research will focus on bullying and harassment in the workplace, the gender pay gap and leave policies. The team also plans to provide recommendations on effective workplace equity programmes targeting identities beyond gender.

The team will work with Associate Professor Marnee Shay (University of Queensland) to examine the strengths and contributions of Aboriginal and Torres Strait Islander peoples in STEM fields and the systemic and cultural barriers that hinder Aboriginal and Torres Strait Islander engagement in STEM jobs.

To read the full report, click here.

Dimerix updates on expected timing of DMX-200 Phase 3 kidney trial outcome

Tue, 25 Jul 2023 00:00:00 +1000

AusBiotech launches National Cell and Gene Manufacturing Blueprint

Thu, 20 Jul 2023 00:00:00 +1000

A new National Cell and Gene Manufacturing Blueprint launched today, outlining how, with a united and coordinated plan, Australia can realise its potential to become a cell and gene (C&G) manufacturing hub for within the Asia-Pacific (APAC) region.

As the global C&G industry continues to develop apace, this industry-developed strategy presents a unified and collaborative approach to expanding sovereign C&G manufacturing capabilities and capacity in Australia. It outlines recommendations on how Australia’s ecosystem can work together to develop the necessary infrastructure, workforce and expertise, to position Australia as a regional leader and deliver a new generation of medical treatments.

AusBiotech CEO Lorraine Chiroiu says, “This report is an opportunity to harness Australia’s role in the global cell and gene ecosystem, and to ensure that we are best-placed as a nation to be involved in and benefit from these life-changing therapeutic approaches now and into the future. In order to secure Australia's position as a critical hub for cell and gene manufacturing, timely Government support and funding is essential to fully realising opportunity lying in front of us.”

Cell and gene therapies (C&G products) are a new frontier in medicine, having already demonstrated life-saving and life-changing results for patients with rare diseases and cancer, and show promise in addressing additional, more common conditions. While the initial scientific challenges of C&G products have been overcome, the manufacturing and delivery requirements remain complex and diverse, with the increasing number of therapies pushing global manufacturing capabilities and capacity to the limit.

The Blueprint addresses five key areas outlined in the strategic roadmap from the 2021 AusBiotech-led Regenerative Medicine Consortium Project: workforce skills development, long-term investment opportunities, strengthened collaboration across the value chain, capability across the value chain, and clear market access pathways aligned with leading global markets.

National objectives within each category were developed, refined, and assessed for support, before a second consultation phase was undertaken to develop tactics for achieving those objectives. Eleven key recommendations to support local C&G manufacturing have been identified in order to overcome four key challenges:

Challenge 1: Addressing critical and growing skills gaps in cell and gene manufacturing

Challenge 2: Building critical mass in Australia’s cell and gene manufacturing ecosystem

Challenge 3: Optimising Australia’s contributions to the C&G product pipeline

Challenge 4: Tracking and guiding industry growth.

The Blueprint also provides approaches to each challenge, tactics to meet key objectives, and key metrics for tracking industry growth.

The Blueprint has been developed with both industry and government in mind. For industry, the report presents and opportunity to shape the field for the future, and to build a sustainable and growing ecosystem that attracts and supports local and international operators, while for government it presents an opportunity to strategically invest and therefore maximise the socioeconomic potential of C&G manufacturing, including job creation and healthcare outcomes.

The Blueprint will support AusBiotech’s policy and advocacy work and discussions with Federal Government.

The National Cell and Gene Manufacturing Blueprint was funded by the Victorian Government’s Australian Medtech Manufacturing Centre (AMMC).

To read the full report, click here.

Industry-led cell and gene manufacturing strategy to develop Australia as APAC hub launched

Thu, 20 Jul 2023 00:00:00 +1000

AusBiotech has today launched the Australian biotechnology sector-led National Cell and Gene Manufacturing Blueprint, providing a unified and collaborative approach to expanding sovereign cell and gene (C&G) manufacturing capabilities and capacity in Australia.

Without such a plan, we risk missing out on the benefits of C&G manufacturing to both the Australian economy and healthcare system, including for patients in desperate need of novel therapies.

The AusBiotech-commissioned Blueprint, which has been developed with both industry and government in mind, outlines recommendations on how Australia’s ecosystem can work together to develop the necessary workforce, expertise and infrastructure, to position Australia as a regional leader and deliver a new generation of medical treatments.

As the global C&G industry continues to develop apace, this industry-developed strategy provides a roadmap for Australia to become a regional C&G manufacturing hub for the Asia-Pacific, and provides a vision for manufacturing C&G products in Australia; outlines where we are now as a country; and recommends a ‘blueprint’ of implementation strategies for manufacturing C&G therapies locally.

C&G products are a new frontier in medicine, and having already demonstrated life-saving and life-changing results for patients with rare diseases and cancer, and showing promise in addressing additional, more common conditions, the demand for the growing and diversifying suite of therapies is high. While the initial scientific challenges of C&G products have been overcome, the manufacturing and delivery requirements remain complex and diverse, with the increasing number of therapies pushing global manufacturing capabilities and capacity to the limit.

For industry, the report presents an opportunity to shape the field for the future, and to build a sustainable and growing ecosystem that attracts and supports local and international operators, while for government it presents an opportunity to strategically invest and therefore maximise the socioeconomic potential of C&G manufacturing, including job creation and healthcare outcomes.

Project partner Biointelect was pleased to have partnered with AusBiotech on developing the strategy. Co-founder Jenny Herz says, “Cell and gene therapies are at the forefront of healthcare innovation and with a robust pipeline of therapies addressing increasingly common conditions, we have a unique opportunity to leverage our local strengths in research and clinical trials, improve access for Australian patients and drive the growth of an export industry. The report lays out strategic pathways to attract international C&G developers to manufacture in Australia, with a specific focus on delivering to emerging Asian markets.”

Eleven key recommendations to support local C&G manufacturing have been identified in order to overcome four key challenges:

Challenge 1: Addressing critical and growing skills gaps in cell and gene manufacturing
Challenge 2: Building critical mass in Australia’s cell and gene manufacturing ecosystem
Challenge 3: Optimising Australia’s contributions to the C&G product pipeline
Challenge 4: Tracking and guiding industry growth.

Supported by the Victorian Government’s Australian Medtech Manufacturing Centre (AMMC), the Blueprint was developed by AusBiotech, the Cell and Gene Manufacturing Taskforce, and Biointelect with both industry and government in mind. Thank you to the individual contributors and the Cell and Gene Manufacturing Taskforce, comprised of Guillaume Herry (Acura Bio), Ian Wisenberg (BioCina, Bridgewest Group), Silvio Tiziani (CCRM Australia), Jennifer Hollands (Cell Therapies Pty Ltd) and Susie Nilsson (CSIRO), Margret Schuller (NSW Stem Cell Network), and Heather Donaghy (Therapeutic Innovation Australia).

The Blueprint addresses five key areas outlined in the Strategic Roadmap for the Regenerative Medicine Sector: workforce skills development, long-term investment opportunities, strengthened collaboration across the value chain, capability across the value chain, and clear market access pathways aligned with leading global markets.

To read the full report, click here.

-ENDS-
Media enquiries: Annabelle Dick, Communications and Media Manager, AusBiotech,
adick@ausbiotech.org / M: +61 (0) 437 075 209

About AusBiotech

BioCurate in new partnership with the European Healthtech Venture Builder

Thu, 20 Jul 2023 00:00:00 +1000

First patient dosed in study of Telix's TLX250 with Merck's peposertib

Thu, 20 Jul 2023 00:00:00 +1000

Sensible approach for medtech clinical trials

Tue, 18 Jul 2023 00:00:00 +1000

AusBiotech welcomes the Therapeutic Goods Administration’s (TGA) confirmation that the Clinical Trials Notification (CTN) and Clinical Trials Approval (CTA) pathways remain unchanged, following consultation on ‘proposed changes for clinical trials of medical devices’.

“Inclusion of medical device clinical trials in the existing GCP inspection programme is supported by industry, and furthers strengthens trust in Australia’s medical device clinical trials ecosystem domestically and globally.”

Australia’s bio-medical technology industry is supportive of the TGA’s risk-based regulatory approach where regulation is commensurate with the risks posed by the therapeutic good to best protect and advance public health.

A thorough process is already in place for assessing risk, with Australia’s world-class regulation in place to best protect patients. Whilst, over time, medical devices have increased in their complexity with advances in technology such as the materials used (including 3D printed materials), and the interaction with software, patient safety remains at the heart of the existing processes and is provided for through Australia’s existing scientific and ethical review system, along with the mandatory safety reporting requirements of the TGA.

Under the CTN scheme, scientific and ethical review is delegated to and provided by a human research ethics committee (HREC), with subsequent notification to the TGA. Under the CTA scheme, the TGA has a direct role in the review of trial scientific data and must give an ‘approval’ for the proposed trial programme to go ahead; however, HREC review is still required.

The TGA also recommended that medical devices be included in the current GCP Inspection Program, an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. Compliance with GCP provides assurance that the rights, safety and well-being of clinical trial participants are protected and that the trial data generated are credible. Historically only medicines and biologicals had been regulated under the GCP programme in Australia.

AusBiotech thanks its Clinical Trial Advisory Group, AusMedtech Advisory Group and AusMedtech Regulatory Affairs Advisory Group for contributing to its advocacy activities during this period.

Read AusBiotech’s joint submission here.

Neuren Pharmaceuticals announces global expansion of agreement with Acadia

Tue, 18 Jul 2023 00:00:00 +1000

Actinogen CMO presents academic poster to Alzheimer’s Association International Conference

Tue, 18 Jul 2023 00:00:00 +1000

Henry Schein Medical expands distribution partnership with Lumos Diagnostics

Tue, 18 Jul 2023 00:00:00 +1000

Early-Stage Innovation Forum opens

Thu, 13 Jul 2023 00:00:00 +1000

The Early-Stage Innovation Forum (ESIF) is calling for expressions of interest from developers interested in pitching their innovation at the 2023 AusBiotech national conference in Brisbane.

The ESIF rapid-fire pitch competition provides presenters the opportunity to pitch their early-stage innovation to a panel of expert judges for feedback, with the November 3 ESIF competition focusing on early-stage human therapeutic and enabling technology projects.

Hear more about A/Prof Hill’s presentation on a novel ovarian cancer diagnostic tool here, and read about AusBiotech 2022 ESIF winners, Dr Melissa Knight (QIMR Berghofer) and Jonathan Bernadini (WEHI), here.

To register your project or company to present at the ESIF, with the conference website.

Submissions received by 8 September will be reviewed by the appointed Advisory Group and applicants will be contacted with further information once the evaluation process is complete on or before 22 September 2023.

Pharmaxis reports positive analysis of data from phase 2 PXS-5505 study

Thu, 13 Jul 2023 00:00:00 +1000

Victoria invites expressions of interest for Industry R&D Infrastructure Fund grants

Thu, 13 Jul 2023 00:00:00 +1000

Build your profile through BiotechDispatch

Tue, 11 Jul 2023 00:00:00 +1000

Members of AusBiotech are encouraged to share news and announcements for prioritised inclusion in twice-weekly industry news updates.

AusBiotech members are being encouraged to send sector announcements and media releases to BiotechDispatch, Australia’s leading outlet for biotechnology news.

BiotechDispatch welcomes news and media releases on research findings, company appointments, partnerships, business, and sector trends relating to the above sectors.

Owned and published by Daily Dispatch, BiotechDispatch is an independent news service providing coverage, opinion and analysis on the Australian biotechnology and life science sectors. The outlet aims to provide perspective on policy, funding, political and sector specific matters via twice-weekly new updates published each Tuesday and Thursday.

BiotechDispatch is delivered to all AusBiotech members, of which includes life science companies, ranging from start-ups to multinationals, research institutes and universities, specialist service professionals, corporate, institutional, individual and student members from Australia and globally, and further independent subscribers. AusBiotech amplifies member news featured in BiotechDispatch through the AusBiotech website and LinkedIn and Twitter accounts to a combined 30,000 followers.

Through illustrating industry achievements and issues and telling the dynamic and innovative Australian biotech story, AusBiotech raises the profile of the sector; positions it as a driver for Australia’s future; and amplifies industry news and achievements.

To have your news considered for publication, email editor Paul Cross at paul@dailydispatch.com.au.

AdAlta releases new data on Phase 1 trial of AD-214 in Idiopathic Pulmonary Fibrosis

Tue, 11 Jul 2023 00:00:00 +1000

FDA fast-track designation for Kazia Therapeutics' cancer candidate

Tue, 11 Jul 2023 00:00:00 +1000

First cohort dosed in RECCE 327 rapid infusion UTI clinical trial

Tue, 11 Jul 2023 00:00:00 +1000

Lumos completes placement and launches share purchase plan

Tue, 11 Jul 2023 00:00:00 +1000

AusBioNSW General Manager appointed

Thu, 06 Jul 2023 00:00:00 +1000

Accomplished scientist and partnership executive Dr Robyn Lindner has been appointed as General Manager, AusBioNSW, bringing with her more than 25 years’ experience in life sciences.

Dr Robyn Lindner (BSc (Hons), PhD, GDM, GAICD) has commenced in her role as General Manager of AusBioNSW, the peak industry membership body for NSW state launched by AusBiotech last year.

Dr Lindner is an experienced strategic partnerships and executive leader with a track record in establishing and driving effective business partnerships and stakeholder relationships. In her role as General Manager, she will be responsible for promoting and facilitating AusBioNSW activities, including state membership growth and engagement, policy and advocacy, and strategic projects in NSW.

AusBioNSW was established in March 2022 to foster local connection and promote NSW organisations doing business in and with the local, national and global life sciences economy. AusBioNSW is backed by AusBiotech’s national representation on advocacy activities, membership services, events and networks – and for AusBiotech members in NSW, no additional membership subscription is required.

Trained as a scientist, Dr Lindner joins AusBiotech, with over 25 years’ experience across academia, medical research, biotechnology and the public health sector. Most recently, she has worked in the health sector establishing collaborations to deliver national health programs and new business opportunities.

Past appointments have included Chief Scientific Officer at Tyrian Diagnostics, VP Discovery at Proteome Systems, research roles at the University of Wollongong and the Heart Research Institute, and programme leader roles focused on driving research, development and commercialisation of biomarkers and diagnostics. In each of these roles, Dr Lindner has been responsible for driving national and international strategic partnerships across government, universities, industry and community. 

AusBioNSW General Manager Dr Lindner said, “It’s an exciting time for the life sciences industry and I look forward to working with the NSW sector to support a vibrant, connected and sustainable industry that makes a positive contribution to people’s lives.”

Dr Lindner’s remit is broad, with her responsibilities including building business development and commercialisation capabilities in NSW, driving initiatives to attract investment and grow innovation and trade in NSW, and developing programs that strengthen NSW-based companies' abilities to commercialise and grow investment, so as to create jobs and growth for the State.

AusBioNSW Leadership Committee Chair and AusBiotech Board Observer Graham McLean said, “We’re thrilled to see the appointment of Dr Robyn Lindner as General Manager for AusBioNSW. Her leadership will provide a dedicated local voice for NSW’s thriving life sciences sector, supporting and working on behalf of industry to fully capitalise on opportunities for NSW members.”

Dr Lindner has a first-class honours degree in science and a PhD in biochemistry from the University of Sydney, a postgraduate diploma in business management from the Australian Graduate School of Management, and is a graduate of the Australian Institute of Company Directors. 

Dr Lindner will be attending the AusBioNSW BioCheers on Wednesday 26 July at Deloitte Sydney to connect with AusBioNSW members. Register here to attend. If you miss registration, you can sign up to the waitlist by emailing events@ausbiotech.org.

Dr Lindner can be contacted directly at rlindner@ausbiotech.org.

Genetic discovery could help prevent irreversible blindness in people with glaucoma

Thu, 06 Jul 2023 00:00:00 +1000

Dimerix receives European approval for paediatric investigation plan

Thu, 06 Jul 2023 00:00:00 +1000

Moderna submits RSV vaccine to global regulatory agencies

Thu, 06 Jul 2023 00:00:00 +1000

Takeda’s COCKPI-T programme calls for applications

Tue, 04 Jul 2023 00:00:00 +1000

Takeda Pharmaceutical is inviting Australian researchers and companies to submit early-stage research proposals for neuroscience, oncology, gastroenterology and platform technology projects.

The COCKPI-T 2023 funding programme is calling for projects to submit applications to receive up to AUD $104,000 in research funding.

The funding programme, launched in Australia in 2018, provides researchers affiliated with universities, research institutes or companies to submit proposals for early-stage research projects that align with the company’s areas of therapeutic interest.

Takeda Pharmaceutical’s is offering approx. AUD $104,000 (or up to JPY $10 million) in funding for therapeutics-oriented projects and approx. AUD $83,000 (or up to JPY $8 million) for platform technology-oriented projects. Successful applicants also have the opportunity to work closely with Takeda drug discovery experts to help build a robust preliminary proof of concept (PoC).

Through the program, Takeda is aiming to catalyse the translation of early-stage research into innovative therapeutics or drug discovery platforms, with the ultimate aim of strengthening Takeda’s early pipeline.

Proposals should outline the competitive advantage of the research over existing therapeutics or technologies, as well as timelines within the one-year project term. Proposals should also include any non-confidential preliminary data produced by the applicant as well as publicly available data or information.

Any researcher affiliated with a university, research institute or company located in Australia is eligible to apply. Applications close on 1 August, with final winners announced on 14 November 2023.

For further details of the programme, including criteria, the application process and timelines, visit the COCKPI-T funding website.

Questions relating to the programme can be emailed to COCKPI-T@takeda.com.

Cynata Therapeutics announces CEO succession and board changes

Tue, 04 Jul 2023 00:00:00 +1000

Nutromics to progress wearable diagnostic platform with latest capital raise

Tue, 04 Jul 2023 00:00:00 +1000

Industry Growth Program consultation opens

Thu, 29 Jun 2023 00:00:00 +1000

AusBiotech is calling for member feedback on the design of the Federal Government’s new $392.4 million Industry Growth Program that will provide expert advice and funding to innovative Australian SMEs.

Announced in the 2023-24 Federal Budget, the Department of Industry, Science and Resources’ (DISR) new Industry Growth Program aims to support SMEs to commercialise ideas and grow operations.

The programme’s focus on commercialisation and early-stage business growth advice, combined with grants, aims to attract investment, grow the workforce, and increase revenue. It has been designed to align with the National Reconstruction Fund (NRF) by driving early-stage investment across the seven priority areas, including medical science and enabling capabilities.

The DISR intends to engage expert advice and partner with industry organisations thereby drawing on their expertise and networks.

Matched funding grants will range from $50,000 to $250,000 for very early-stage commercialisation projects; the remainder of the grant programme will range from $100,000 to $5 million, project periods for all grants will be up to 24 months.

The consultation paper notes that the Industry Growth Program is designed to provide a bridge during ‘valley of death’ that early-stage companies often face, and to support them to be in a position to seek potential funding through the NRF or gain other investment elsewhere.

As the voice of industry, AusBiotech is calling for written feedback for its submission, and invites expressions of interest for a virtual roundtable on Tuesday 18 July. Please contact Karen Parr, Director, Communications and Policy, by Friday 21 July.

Consultation questions include:

project and company eligibility criteria;
diversity and inclusion considerations;
beneficial capabilities and resources for industry partner organisations;
governance and grant assessment; and,
success measures.

Read the full consultation paper here.

Australian company Microba launches clinical development of IBD candidate

Thu, 29 Jun 2023 00:00:00 +1000

Neuren opens first site in US for Prader-Willi syndrome Phase 2 trial

Thu, 29 Jun 2023 00:00:00 +1000

Telix releases further data from pivotal Phase 3 ZIRCON study of TLX250-CDx

Thu, 29 Jun 2023 00:00:00 +1000

AusBiotech calls for journal articles

Tue, 27 Jun 2023 00:00:00 +1000

AusBiotech is calling for member contributions for the September 2023 edition of the Australasian Biotechnology journal.

AusBiotech is welcoming abstracts from valued members on advancing Australian capabilities with themes including medicines and manufacturing, and taking Australian Inc global, with articles sought on new approaches, contributions or analyses to include in the September 2023 edition of the Australasian Biotechnology Journal.

The journal will also feature a sneak peek into the October’s premier annual conferences, AusBiotech 2023 and AusBioInvest 2023, where local and global thought leaders discuss the latest research, technologies, challenges and market access strategies, and what Australia is bringing to the life sciences world-stage.

Australasian Biotechnology is AusBiotech’s official biannual journal, and published in September and April. Its contributions are written by the sector, for the sector. Contributions can range on topics including innovative medicine development, mass manufacturing, Australian strengths and successes on the world stage, and approaches to strengthening Australia’s end-to-end life sciences value chain.

With its informed and authoritative editorials, Australasian Biotechnology is a highly-effective communications vehicle for those wanting to reach stakeholders in the life sciences sector. The journal is mailed on a name-and-title basis to more than 3,000 AusBiotech members and investors, as well as published digitally. Readership includes companies, government and university departments, research institutes, biotechnology and professional services providers nationally, and in key overseas markets.

Abstracts should be 200 words, and can be sent to Communications by 20 July 2023.

If your abstract is accepted, the full article will be required on or before 3 August 2023. Article lengths are approximately 500 words (1 page) or 1,000 words (2 pages). High resolution photos to accompany articles are encouraged.

Articles are an AusBiotech member-benefit, however there is limited space and so are not guaranteed to be included.

Abstracts are welcomed on research, business news, and sector trends for consideration at any time of the year.

EpiAxis Therapeutics nominates epiresatide as 'flagship candidate'

Tue, 27 Jun 2023 00:00:00 +1000

Mark Butler announces $73 million for 19 medtech and facility grants

Tue, 27 Jun 2023 00:00:00 +1000

Top performing ASX life science companies

Thu, 22 Jun 2023 00:00:00 +1000

ASX-listed life science companies report a new market capitalisation of $255 billion, with Arovella Therapeutic (ASX: ALA) and Avita Medical (ASX: AVH) topping return rankings for Q1 while Neuren Pharmaceuticals (ASX:NEU) leads in earnings for 2023.

AusBiostock data (April 2023) reveals the 178 ASX-listed life science companies have grown the market capitalisation by $7 billion over the past year, from $248 billion to $255 billion, highlighting the life science sector’s growing economic contribution to the Australian economy.

The data also shows eight percent of listed companies have a market cap of more than $1 billion, while 33 percent of companies are worth more than $100 million. Identified as a key metric in AusBiotech’s Biotechnology Blueprint decadal strategy, the proportion of biotech companies achieving market valuations greater than $100 million measures the industry’s ability to create companies of significant future value.

Neuren Pharmaceuticals is reported as the top earner for the year, with a reported share price of $14.20 (as at 18 April 2023) and a market return of 258.59 percent (see full data below).

This follows a strong 2022, where Neuren Pharmaceuticals was listed as the second top returner in the AusBioStock’s April 2022 data (see below), after Incannex Healthcare (ASX:IHL) reported a 233.33 percent return over the past year. At the end of Q1 2022, Neuren Pharmaceutical reported a share price of $4.18 (as at 8 March 2022) and annual return of 213.11 percent, revealing Neuren Pharmaceutical’s stock price jumped from $4.18 to $14.20 between April 2022 and April 2023.

Discover ‘The secret sauce to biotech investor relations’ directly from Neuren Pharmaceuticals CEO Jon Pilcher, who shares his tips in tricks in the September 2022 Australasian Biotechnology Journal (page 39).

Q1 2023 has revealed WA-based Arovella Therapeutics topped the rankings with a quarterly return of 237.50 percent, followed by Avita Medical at 85.95 percent, 4Dmedical Limited (ASX:4DX) at 78.72 percent, Kazia Therapeutics (ASX:KZA) at 62.50 percent, and Botanix Pharma Limited (ASX:BOT) at 61.40 percent.

The variability in the returns listings between Q1 2022 versus 2023 demonstrates the unique nature of biotech investment, and reflects the make-up of the sector, with the vast majority of companies being small, early-stage, pre-revenue and pre-clinical.

Notably, there has been no new biotech company listings on the ASX since April 2022. This is in contrast to a busy 2020-2021 listing period where 26 new biotech and medical technology companies listed on the ASX, which was an unusual period but in line with global trends.

AusBiotech invites qualified investors, including venture capital firms, private equity investors, high-net-worth individuals, research analysts, brokers, family offices, to access their complimentary tickets to attend AusBioInvest 2023, providing them with a valuable opportunity to make meaningful connections with companies, hear the latest market updates, and explore potential investment prospects. Register your interest here.

Biotech companies are also being invited to register their interest to pitch at AusBioInvest to a global audience of investors, industry executives, and key stakeholders.

Top performers for Q1
2022 (data collected 8 March 2022)			2023 (data collected 18 April 2023)
	Last price	Quarter return %		Last price	Quarter return %
Anteris Technologies	$19.23	81.42	Arovella Therapeutic	$0.08	237.50
Cronos Australia	$0.29	45.00	Avita Medical	$4.50	85.95
Resapp Health Limited	$0.08	44.83	4Dmedical Limited	$0.84	78.72
Bio-Gene Technology	$0.26	44.44	Kazia Therapeutics	$0.20	62.50
Paragon Care Limited	$0.45	38.18	Botanix Pharma Limited	$0.09	61.40
Resonance Health	$0.14	35.00	Neuren Pharmaceuticals	$14.20	58.84
Incannex Healthcare	$0.70	30.84	Impedimed Limited	$0.11	57.14
Wellnex Life Limited	$0.12	27.66	XRF Scientific	$1.29	56.36
Monash IVF Group Limited	$1.22	24.95	Cyclopharma Limited	$2.19	46.33
Botanix Pharma Limited	$0.07	24.56	Radiopharma	$0.18	29.63

This year’s top ASX life science performers
2022 (data collected 8 March 2022)			2023 (data collected 18 April 2023)
	Last price	Annual return %		Last price	Quarter return %
Incannex Healthcare	$0.70	233.33	Neuren Pharmaceuticals	$14.20	258.59
Neuren Pharmaceuticals	$4.18	213.11	Avita Medical	$4.50	107.37
Actinogen Medical	$0.10	212.50	Arovella Therapeutic	$0.08	102.50
Cogstate Limited	$2.08	136.36	XRF Scientific	$1.29	97.74
Hexima	$0.35	133.33	Telix Pharmaceuticals	$8.89	90.36
XRF Scientific	$0.62	128.57	Polynovo Limited	$1.71	53.60
Imugene Limited	$0.26	126.09	Cryosite Limited	$0.73	51.02
Heramed Limited	$0.20	108.33	Bioxyne Limited	$0.03	47.06
Cronos Australia	$0.29	107.14	Cyclopharm Limited	$2.19	46.67
Emyria Limited	$0.35	102.94	Aroa Biosurgery	$1.05	36.60

The new 'Jumar Bioincubator' calls for biotechnology start-ups

Thu, 22 Jun 2023 00:00:00 +1000

Imagion Biosystems announces the appointment of new CEO

Thu, 22 Jun 2023 00:00:00 +1000

State Government Budget wrap for life sciences

Tue, 20 Jun 2023 00:00:00 +1000

Life sciences is a growing priority on state government agendas, with South Australia, Queensland, Victoria, and Western Australia 2023-24 State budgets earmarking a combined $179.1 million to provide industry, SMEs and manufacturing support.

The recently-announced 2023-24 budgets delivered by the South Australian, Queensland, Victoria, and Western Australia governments collectively deliver up to $179.1 million and a range of initiatives to support industry development in respective states.

South Australia

The South Australia (SA) State Budget, delivered on 15 June, committed an additional $20.0 million over four years to the Research and Innovation Fund. The funding will support research excellence in SA, increase research and industry collaboration, translation and commercialisation, development and industry application of critical technologies and investments to support the growth of innovative early-stage business addressing national and international markets. Funding will also provide continued funding support to management and operations at Lot Fourteen.

SA also made a future commitment to the Economic Recovery Fund, earmarking $22 million in 2026-27 to support initiatives that build advanced capabilities, increased productivity, innovative technologies and long-term employment opportunities in South Australia. The new commitment increases the value of the Economic Recovery Fund to $122 million.

The SA Government will also invest $20.9 million over four years to support operations of six SA-based National Collaborative Research Infrastructure Strategy facilities, including new funding to upgrade equipment to support leading-edge research and innovation.

Queensland

The Queensland (QLD) State Budget, delivered on 13 June, saw $32.2 million made available through the 'Made in Queensland’ programme to assist small to medium-sized manufacturers to increase international competitiveness, productivity, and innovation via the adoption of new technologies, systems and processes, and to generate high-skilled jobs for the future.

While the programme is sector agnostic, applications from manufacturers in the QLD Government’s priority industry sectors, which includes the biomedical sector, are being encouraged[i].

The QLD Government also has committed $16.3 million to support women’s economic security, including grants, training, and increased investment for women in business and innovation, women in male-dominated industries, and disadvantaged and vulnerable women.

Victoria

The Victoria State Budget, delivered on 23 May, announced $21 million for a Manufacturing and Industry Sovereignty Fund and support for Victorian businesses to access the Commonwealth’s $15 billion National Reconstruction Fund (NRF), in order to support local industries and promote economic growth within the state.

The Victoria Government also announced the inception of a $15 million Industry R&D Infrastructure Fund to incentivise private industry investment into research and development. While the programme designs are still to be finalised, both funds are understood to be sector agnostic with life sciences outlined as one of the key industries identified.

To further support Victoria’s growing mRNA industry, the budget also included an additional $12 million to assist mRNA manufacturing by supporting the delivery of major sovereign mRNA manufacturing facilities in Victoria.

Western Australia

The Western Australia (WA) State Budget, delivered on 11 May, outlined a number of initiatives to support the local life sciences sector. During 2023-24, the WA Government will implement the WA Health and Medical Life Science Industry Strategy, to capitalise on the growing demand for health, medical technology, biotechnology, and pharmaceuticals and to move along the value chain from research to product development and commercialisation.

To attract investment and new industries, new initiatives were announced, including a commitment of $10.1 million to establish a new Americas hub in Austin, Texas and the development of a ten-year vision for WA to become a globally-renowned hub of invention, investment, innovation and impact.

To support innovation and the digital economy, the New Industries Fund will receive a further $9.1 million to further drive innovation, develop and attract entrepreneurs, create jobs, and deliver targeted support for female and Indigenous founders and businesses seeking to commercialise their products.

WA Government also plans on investing $500,000 to develop a Digital Economy Strategy, and supporting a Life Sciences Innovation Hub to build capability, economic resilience, jobs and connect small and medium-sized enterprises to local, national and international networks.

AusBiotech looks forward to providing a life science-focused wrap on the New South Wales State Budget announcement due on 19 September.

[i] Page 13. https://www.rdmw.qld.gov.au/__data/assets/pdf_file/0005/1645142/miq-program-round-5-guidelines.pdf

Vaxxas opens needle-free vaccine manufacturing site and global HQ in Brisbane

Tue, 20 Jun 2023 00:00:00 +1000

WEHI's Professor Doug Hilton appointed chief executive of CSIRO

Tue, 20 Jun 2023 00:00:00 +1000

AVITA Medical announces FDA approval of RECELL for skin repigmentation in vitiligo patients

Tue, 20 Jun 2023 00:00:00 +1000

First patient dosed in study of TLX250-CDx exploring indication expansion

Tue, 20 Jun 2023 00:00:00 +1000

Views sought on coordination of research funds

Thu, 15 Jun 2023 00:00:00 +1000

Consultation has opened on improving the alignment between Commonwealth funds, the Medical Research Future Fund (MRFF) and Medical Research Endowment Account (MREA), and as the national voice of industry, AusBiotech is seeking its members’ views.

The Australian Government recently announced that a national consultation has opened, seeking views on improving alignment and coordination between the MRFF and MREA (managed by the NHMRC), to provide the greatest benefit for publicly-funded health and medical research.

The consultation paper notes how with closer coordination of MRFF and MREA support, for example during COVID where there was a greater focus on a national approach to the most important research questions, increased efficiency and effectiveness of the two funds’ investments could be achieved.

Last week, AusBiotech attended the first invitation-only Ministerial roundtable with The Hon. Mark Butler MP, Minister for Health and Aged Care, to discuss the proposed changes and improvements as strategic alignment, management and deployment of the two Commonwealth funds is sought. The first phase of consultation will focus on governance and administration, while the second phase will focus on the funds’ investment strategies.

In its submission, AusBiotech will be highlighting the important distinction between each programmes’ purpose, and between translation and commercialisation, in any new/amended model that is adopted.

AusBiotech CEO Lorraine Chiroiu says, “While there are opportunities for improvements, the MRFF is still young relative to the NHMRC, with full disbursements only in operation for three years.

“As we seek to address the gaps and preserve the benefits delivered to date, this is also an opportunity to highlight the opportunity to build metrics and diversity into the Funds, specifically the amount of MRFF funds applied to commercialisation. In measuring the Australian biotechnology industry’s global and local standing, a key metric noted by industry in AusBiotech’s Biotechnology Blueprint was that whilst the MRFF is cognisant of the importance of translation, tracking the amount invested once research is transferred could provide fresh insight.”

As AusBiotech develops its submission, members are invited to share their thoughts on the opportunities and risks on the proposed models for improving governance and administration of the two funds; please send feedback to Karen Parr, Director, Communications and Policy by Friday 7 July.

FivepHusion announces strategic collaboration with Treehill Partners and Syneos Health

Thu, 15 Jun 2023 00:00:00 +1000

AZD0466 clinical data presented by AstraZeneca at international congress

Thu, 15 Jun 2023 00:00:00 +1000

Former AusBiotech CEO awarded King’s Birthday Honour

Tue, 13 Jun 2023 00:00:00 +1000

Dr Anna Lavelle has been awarded a Member of the Order in the King’s Birthday Honours for her significant service to science and innovation.

AusBiotech today congratulates Dr Anna Lavelle, the inaugural Chief Executive Officer of AusBiotech, for her recent appointment to the Member of Order as announced by the Governor-General in Canberra yesterday.

Dr Lavelle led AusBiotech as CEO from 2005 to 2016, where she initiated the transformation of the organisation and the industry with her pioneering approach to policy impacting the commercialisation of medical research and biotechnology industry development, including the Victorian pilot of a PhD mentoring program (IMNIS) that has moved to a national base and remains today a critical development programme for Victorian PhD students.

AusBiotech CEO Lorraine Chiroiu says, “I am delighted to see Anna recognised for her unwavering contribution to biotechnology and innovation. Anna is a trailblazer in every sense of the term and she remains connected, proactive and supportive to this day. As well as the significant policy change that she led to develop the R&D Tax Incentive, her dedication over more than a decade has been of great benefit the biotechnology sector in Australia, and to AusBiotech.

“Anna was recognised for her efforts through Honorary Life Membership of AusBiotech in 2016. Her leadership was pivotal in the development of the Victorian and Australian biotechnology industry, and she remains a tireless advocate for change and improvement; challenging the status quo in a respectful and intelligent way.”

Dr Lavelle is the Chair of Medicines Australia and Avatar Brokers, and a Non-Executive Director for Sementis Ltd, Island Pharmaceuticals, Cyban Pty Ltd and Hemideina. Past Chair roles include ANDHealth and North Richmond Community Health, while Dr Lavelle has also held past directorships BioMedVic, Haemokinesis Pty Ltd, Vaccine Technology CRC and Research Australia.

In recognition of her contributions to the sector, Dr Lavelle has received a number of awards and accolades over time for her commitment to the sector, including the 2018 AusBiotech Johnson and Johnson Excellence Award for Industry Leadership and the 2019 BioMelbourne Women in Leadership - Impact for Industry Award.

Dr Lavelle was also named amongst the 100 Most Influential People in Global Life Sciences in Scientific American Worldwide’s A Global Biotechnology Perspective edition in 2015.

Telix opens European radiopharmaceutical production facility

Tue, 13 Jun 2023 00:00:00 +1000

Anteris Technologies reports positive 30 day data from first-in-human study

Tue, 13 Jun 2023 00:00:00 +1000

Clinical Trials One Stop Shop report released

Thu, 08 Jun 2023 00:00:00 +1000

The long-awaited National One Stop Shop for clinical trials consultation report has been released by the Australian Commission on Safety and Quality in Health Care, revealing five key recommendations for implementing a single, national clinical trials platform.

Providing a public interface for the community and establishing enduring cross-jurisdictional governance arrangements for platform management are a part of a handful of recommendations given to support the implementation of Australia’s ‘National One Stop Shop’.

Twenty-three findings were identified through consultation, informing five key recommendations that, if funded and resourced, will support the Department of Health and Aged Care in implementing the National One Stop Shop and public facing website as a nationally consistent approach to realising a harmonised operating environment for the approval and management of clinical trials and health-related research: one nation-wide, cross-government, platform.

The five key recommendations are:

Implement a high-quality, fit-for-purpose National One Stop Shop and public facing website for the community by December 2025;
Enduring cross-jurisdictional governance arrangements for the management and implementation of the national platform must be established. The governing body would be responsible for the implementation and management of the platform;
The platform architecture should deliver as a minimum, all requirements gathered and tested through the consultation process;
The National One Stop Shop should provide a public interface so the community and their carers can easily identify trial and research options (previously referred to as the National Clinical Trials Front Door), and;
The development of the platform should be accompanied by a targeted communication strategy and education campaign tailored to meet the needs of the community.

The two-part consultation was chaired by Professor Ian Chubb AC, and gathered jurisdictional and sector stakeholder preferences for the National One Stop Shop, captured a detailed understanding of the workflow systems currently in place in the sector, identified future requirements and evaluated the challenges and high-level risks involved in the development and implementation of a National One Stop Shop. The findings from the consultation also informed the Proof of Concept for the National One Stop Shop and public facing website (the National Clinical Trials Front Door).

More than 1,400 stakeholders took part in the consultation through workshops, focus groups, meetings, webinars, surveys and written submissions, with AusBiotech acting as a conduit to Australian life science SMEs and the biotechnology industry broadly through its 3,000+ member base.

AusBiotech has supported the concepts of a National One Stop Shop and a National Clinical Trials Front Door since they were mooted, through national speaking opportunities, formal submissions, and through its ongoing discussions with Ministers and departmental staff. Previous Health Minister Greg Hunt has previously acknowledged these as a “golden” opportunity for Australian clinical trials.

The report noted, “For Australians to maximise the return to them of their investment in health and medical research, there is a time-critical need to coordinate the way in which research is both strategically supported and translated to care... Any substantial competition is with other countries, not between our jurisdictions.”

“A resourced and staffed office within the Australian Government Department of Health and Aged Care will be required to underpin the development and continuous maintenance and refinement of the One Stop Shop, and its evolution, so it remains fit-for-purpose.”

AusBiotech looks forward to a response from the Federal Government on this report, to ensure the initiation of the report’s recommendations.

AusBiotech supports Australia’s continued global standing as a key destination to conduct clinical trials, and a well-designed National One Stop Shop will be instrumental in this mission. Clinical trials play a pivotal role in the economy of the future; already supporting more than 8,000 innovative Australian jobs, in 2019 clinical trials contributed more than $1.4 billion to the Australian economy – demonstrating its value in supporting the country’s transition from a post-mining boom.

For more information on the National One Stop Shop consultation report, click here.

Neuren Pharmaceuticals receives milestone payment from US partner

Thu, 08 Jun 2023 00:00:00 +1000

Vaxxas appoints former Pfizer executive as chief medical officer

Thu, 08 Jun 2023 00:00:00 +1000

Team Australia shines at BIO 2023

Tue, 06 Jun 2023 00:00:00 +1000

Australia’s largest-ever delegation to the world’s largest life sciences convention, led by AusBiotech, highlights industry’s commitment to fostering global collaborations and partnerships.

The Australian delegation will see a number of state governments, the Australian Ambassador to the United States, State Ministers, over 170 companies and 320 delegates standing united at the BIO International Convention.

Taking place in Boston from 5-8 June and hosted by the Biotechnology Innovation Organisation (BIO), the BIO International Convention is the most influential event in the global life sciences calendar. It draws more than 15,000 biotech and pharma leaders from 7,000 companies and 84 countries, and includes more than 1,500 exhibitors and 850 speakers.

AusBiotech will host the Australian Wine Tasting Event this week, a hallmark feature of the Australian Pavilion (booth 2765), thanks to support from the Brisbane Economic Development Agency, NSW Health, Queensland Brain Institute - The University of Queensland, Institute for Molecular Bioscience - The University of Queensland, and Translational Research Institute Australia.

The Pavilion features major supporters, including MTPConnect, Austrade, CSIRO and state governments: New South Wales Government, South Australian Government, Victorian Government, Queensland Government and Western Australian Government.

BIO 2023 includes a week of intensive networking and events including panels, presentations, workshops, and networking events for life science professionals. Themes and topics being explored include infectious diseases, oncology, COVID-19, gene therapy, and digital health.

AusBiotech’s mission to BIO is part of its global strategy to facilitate international opportunities for investment, collaborations and partnerships, with a focus on the markets important to members, as highlighted in AusBiotech’s Strategic Plan 2021-2024.

AusBiotech looks forward to publishing a gallery of official event photos, including state delegations and the Australian Wine Tasting Event.

Aravax launches new Phase 2 trial of peanut allergy candidate

Tue, 06 Jun 2023 00:00:00 +1000

Starpharma announces that Viraleze approved in Malaysia

Tue, 06 Jun 2023 00:00:00 +1000

Anatara Lifesciences updates on GaRP irritable bowel syndrome trial

Tue, 06 Jun 2023 00:00:00 +1000

New ESG guide seeks industry feedback

Thu, 01 Jun 2023 00:00:00 +1000

A Guide to support Australian life sciences companies navigate their ‘environmental, social and governance’ (ESG) reporting has been developed, and AusBiotech is seeking industry feedback to finalise the resource for industry implementation.

AusBiotech is proud to share the draft ESG Guide for Australian Life Science Companies, after nearly a year of collaborative development with industry leaders to create a pragmatic and easy-to-use ESG tool for biotechs, and in particular for SMEs.

The draft Guide, developed with support of the AusBiotech ESG Working Group comprised of investors, life science companies, pharma, has been developed as a beneficial opportunity to increase the attractiveness of Australia’s business environment to international and local investors and collaborators, having been identified in AusBiotech’s Biotechnology Blueprint, the sector’s decadal strategy written by the industry, for the industry.

The Guide enables a consistent approach to proactively identifying and reporting on key ESG factors that are particularly relevant to life science companies.

The Guide is designed to be a reference for company executives and boards to highlight the importance of establishing ESG programmes, understand the materiality of factors specific to the life sciences industry and their own individual company, initiate a process to assess strengths and gaps, and provide a starting point for implementation and communication. It is also intended to be a useful resource for investors as a guide to understanding the priority ESG considerations for life sciences companies, as criteria for assessing their ESG credentials.

The life sciences industry is distinctive by virtue of its inherent link to social good as the innovators and advancers of science and technology to deliver potentially life-changing and life-saving therapies, vaccines, diagnostics, devices and digital health solutions that have global significance for humankind.

This Guide intends to build reporting capabilities within life science companies, as part of AusBiotech’s broader mission to increase and diversify investment into the Australian biotech sector via its investment programme.

In particular, AusBiotech is seeking feedback from industry on:

The guide’s practicality for biotech companies;
The ESG considerations captured in Section 4.0 and whether the considerations are categorised appropriately (basic versus advance), and;
Suggestions on recommended frameworks which have not been included in the Guide.

Industry is invited to provide feedback on the ESG Guide by Friday, 23 June, to admin@ausbiotech.org.

Download a copy of AusBiotech’s draft ESG Guide for Australian Life Science Companies here.

Chimeric Therapeutics announces new trial for CHM 1101 in glioblastoma

Thu, 01 Jun 2023 00:00:00 +1000

Imugene doses first patient in PD1-Vaxx and immune checkpoint inhibitor trial

Thu, 01 Jun 2023 00:00:00 +1000

Zelira Therapeutics announces the appointment of new non-executive director

Thu, 01 Jun 2023 00:00:00 +1000

Optiscan Imaging launches entitlement offer to raise $16.7 million

Thu, 01 Jun 2023 00:00:00 +1000

Best early-stage project at awarded at AusMedtech 2023

Tue, 30 May 2023 00:00:00 +1000

A project from QIMR Berghofer was announced the winner of the Best Translational Research at AusMedtech 2023’s Early-Stage Innovation Forum (ESIF) held in Adelaide last week.

A novel ovarian blood cancer diagnostic presented by QIMR Berghofer Associate Professor Michelle Hill was named the ultimate winner at the ESIF rapid-fire pitch event.

Recently held at AusMedtech 2023 in Adelaide, 13 presenters from across Australia received feedback intended to be helpful to their technology’s commercialisation journey from an expert panel.

A/Prof Hill represented QIMR Berghofer Precision & Systems Biomedicine Laboratory to present a novel glycosylation-focused proteomics platform to examine blood protein glycosylation changes that are known to occur during cancer development.

Ovarian cancer is the most common cause of gynaecological cancer death. It has been dubbed the “silent killer” because most patients are diagnosed at late stages, when only 20 percent of patients survive five years post-diagnosis. If caught early, ovarian cancer has a high rate of survival (93 percent).

Applying this platform to age-matched case-control serum samples from the UK and Australia, the Laboratory discovered and validated 62 biomarkers that are significantly different from patients with ovarian cancer and those with benign conditions or healthy women. In addition to blood samples taken at diagnosis, evaluated a small set of blood samples that were collected several months before ovarian cancer diagnosis (average 11 months). Excitingly, four markers were already altered months before diagnosis, showing great promise for ovarian cancer screening.

“It was a really uplifting experience to hear all the presentations and chat with some of the presenters afterwards. The feedback from the panel will help to further refine the pitch as I will be looking for investors for my startup to commercialise the discovered biomarkers to new blood tests for ovarian cancer diagnosis and early detection,” A/Prof Hill said.

A/Prof Hill and team published the above findings in Proteomics Clinical Applications in April 2023.

The next stage of the project is to validate the biomarkers in further samples, prior to finalising ovarian cancer diagnostic and screening blood tests for clinical studies to establish clinical utility. The ultimate goal is to obtain regulatory approval for these new ovarian cancer tests, which will transform women’s health management.

The AusMedtech 2023 ESIF was judged by a panel of experts including Ashley Wittorf (Johnson & Johnson Medtech), Rachel Hooke (FB Rice), Michelle Gallaher (Opyl), Amanda Gillon (BioScience Managers), and Kumaran Mani (Astrazeneca).

The next ESIF will be therapeutics focused and will be held at AusBiotech 2023 happening from November 1-3 in Brisbane.

Orthocell taps former health sector leader to chair its board of directors

Tue, 30 May 2023 00:00:00 +1000

Immutep selects Charles River Laboratories for IMP761’s GLP toxicology study

Tue, 30 May 2023 00:00:00 +1000

Kazia Therapeutics participates in 'Cancer Moonshot Brain Cancers' forum

Tue, 30 May 2023 00:00:00 +1000

Dr Robert Lin named named the new CEO of GreenLight Clinical

Tue, 30 May 2023 00:00:00 +1000

Oncosil Medical announces first patient treatment in Italy

Thu, 25 May 2023 00:00:00 +1000

CSIRO launches free SME programme

Thu, 25 May 2023 00:00:00 +1000

CSIRO’s newly-launched ‘Innovate to Grow’ virtual programme is now seeking applications from Australian life science companies interested in accessing knowledge and tools to support company R&D business planning.

CSIRO says the 10-week programme is suitable for SMEs looking to turn an idea into a viable R&D opportunity and access industry experts to support commercialisation of their idea.

AusBiotech commissioned research that revealed Australia’s life science industry saw a 40 percent growth in the number of companies developing technologies from 2019 to 2022. Australia is home to more than 1,427 life science companies, ranging from small start-ups to multinational pharmaceutical companies. Almost 80 percent of the industry is comprised of small and medium sized companies (SMEs), of which the majority are pre-revenue and in the process of commercialisation or translation of research, highlighting why programmes such as this are important instruments for supporting commercialisation.

A CSIRO programme spokesperson said participants will work with a mentor to examine their technical and business challenges, explore their R&D opportunities, learn tips for partnering with research organisations, and develop strong funding applications. Eligible participants may be able to access continued support through CSIRO, such as being connected to national research expertise or dollar-matched R&D funding to keep moving their ideas forward.

Participants then move through the self-paced online innovation programme to develop and test their research ideas and business cases, with two to three hours of time commitment required each week.

Health & Nutrition
Digital Health
Botanical pharmaceuticals and nutraceuticals
Diagnostics, Biosensors & Biomedical Devices
Biopharmaceuticals
Drug Discovery
Vaccines & Biologic Therapeutics

Applications close 12 June and places are limited. Visit Innovate to Grow to learn more and apply.

Pharmaxis reports positive results from trial of PXS‐6302

Thu, 25 May 2023 00:00:00 +1000

AusMedtech 2023 kicks off in Adelaide

Tue, 23 May 2023 00:00:00 +1000

Australia’s premier medical technology event, AusMedtech, starts tomorrow with more than 400 registered attendees.

Held in Adelaide from 24-25 May, the sixteenth annual AusMedtech national conference opens tomorrow to more than 400 registered attendees from across the medical technology sector representing 12 different countries including China, India and the United States.

Themed ‘Back to the Future’, the conference will be officially opened by the Honorable Chris Picton, Minister for Health and Wellbeing for South Australia, and Major Sumner AM (Uncle Moogy) at the Adelaide Convention Centre.

While therapeutics have traditionally dominated Australia’s biotech sector, medtech now eclipses in terms of company numbers. Since 2019, the number of medtech companies in Australia has grown 49 percent, with AusBiotech’s research showing that Australia is home to 577 medtech companies.

The breadth of opportunities available is reflected in the two-day conference that has been created by industry for industry, and includes more than 100 local and international speakers, with inspirational keynotes from industry leaders and panel sessions on the latest medtech advancements and trends.

Tracey Duffy, First Assistant Secretary, Medical Devices & Product Quality Division, Therapeutic Goods Administration, will discuss the challenges of regulating new and emerging technologies and what this means for Australian patients. Chief Scientist for South Australia, Professor Caroline McMillen and the Honourable Stephen Dawson MLC, Minister for Innovation and the Digital Economy; and Medical Research, Government of Western Australia, will discuss state-government driven public policy and their role in policy development, with Lorraine Chiroiu, AusBiotech CEO.

Other topics being explored include creating effective working relationships with investors, sensors and wearables, the medtech industry response to ChatGPT and LLMs, and the role of technology in the future of positive ageing.

Complementing the informative keynotes and panels, AusMedtech will feature the Early-Stage Innovation Forum, a rapid-fire pitch event featuring presentations from Australia's local research institutes, universities, hospitals and pre-series A companies in the areas of medical devices and diagnostics, digital health and enabling technologies. Presenters will receive feedback that’s critical to their commercialisation journey from an expert investor panel.

The AusMedtech conference dinner, the social highlight of Australia’s biggest week in medtech, will be opened the Honorable Susan Close, Deputy Premier for South Australia and Minister for Industry, Innovation & Science, Minister for Defence & Space Industries, Minister for Climate, Environment & Water, with Chris Bond OAM PLY, Australian wheelchair rugby player and Paralympic gold medallist, and Ross Pinder, Performance Insights and Innovation Lead, Paralympics Australia, to provide insights on why Paralympic sport is a rich environment for innovation in technologies during the conference dinner fireside.

Further conference details can be found on the AusMedtech website. In-person registrations remain open.

AusMedtech 2023 is supported by its host state partners Business Events Adelaide, the Government of South Australia, and Adelaide Convention Centre; event sponsors, exhibitors and the AusMedtech programme committee.

Amplia Therapeutics receives grant to collaborate with CSIRO

Tue, 23 May 2023 00:00:00 +1000

Victorian-based digital health companies selected for inaugural ANDHealth ACTIVATE program

Tue, 23 May 2023 00:00:00 +1000

Celebrating Australia’s clinical trial capabilities

Thu, 18 May 2023 00:00:00 +1000

In recognition of International Clinical Trials Day on 20 May, AusBiotech celebrates Australia’s global reputation as a go-to destination for conducting clinical trials.

Australia is an attractive environment for clinical trials due to our strong foundation of research excellence, robust patent and regulatory laws, attractive tax incentives, the interconnected nature of medical research and healthcare provision in Australia, and the ease with which clinical trials can be conducted.

Clinical trial activity in Australia improves the evidence base supporting clinical practice; helps patients access trials relevant to their health circumstances; contributes to the development of much-needed therapies; advances Australia’s medical research capabilities; and increases economic prosperity.

Australia’s clinical trial activity has increased significantly in the past five years. As of 17 May 2023, the Australian New Zealand Clinical Trial registry reported 8,103 clinical trials were currently underway in Australia.

There is national recognition at the policy level that clinical research is an important aspect of Australia’s economy. Clinical trials contributed more than $1.4 billion to the Australian economy through direct expenditure or investment. The sector employs around 8,000 Australians, and more than 95,000 Australians participated in clinical trials in 2019. Several other studies, in Australia and elsewhere, have demonstrated significant return on investment and improved health outcomes in systems with high clinical trial research participation.

Australia’s clinical research sector is growing steadily, but there is opportunity to do more to capitalise on the sector’s success to date.

While the Federal Government has established initiatives to further develop Australia’s clinical trial excellence, such as the $750m ‘Clinical Trials Activity’ initiative announced in March 2022 to fund research projects and attract investigator-led international clinical trials to Australia to increase domestic clinical trial activity over the next 10 years, industry is waiting to hear more on the National One Stop Shop initiative for clinical trials, after two years of consultation has been undertaken.

AusBiotech will continue to work with subject matter experts in the Clinical Trials Advisory Group to develop policy advice and advocate for a more effective environment for clinical trials on behalf of the sector.

AusBiotech looks forward to facilitating these conversations with Federal Health Minister Mark Butler to further develop our clinical trial capabilities for the benefit of patients, industry, and Australia’s economy as a whole.

Positive results for Immutep's cancer candidate in combination with MSD's Keytruda

Thu, 18 May 2023 00:00:00 +1000

Optiscan Imaging oral study published in international medical journal

Thu, 18 May 2023 00:00:00 +1000

Silverstone receives approval for advanced life sciences facility in Brisbane

Thu, 18 May 2023 00:00:00 +1000

Avecho Biotechnology commences manufacturing for Phase 3 insomnia study

Thu, 18 May 2023 00:00:00 +1000

New report calls on national cell and gene therapy plan

Tue, 16 May 2023 00:00:00 +1000

A new white paper reveals how system change is required to ensure Australians can access the 2,000 cell and gene therapies (CGTs) currently in development globally, and recommendations on how best to prepare the national health landscape to seize the opportunity.

The number of CGTs both in development and on market has grown exponentially in the past decade, presenting both opportunities and challenges for the health landscape as Australian patients expect access to technologies which often cater to unmet medical needs.

The report ‘Cell and Gene Therapies: Rising to the Challenge’, commissioned by Novartis and developed by EvoHealth, assessed what needs to happen within Australia to prepare for and accommodate the growing number of CGTs.

The report notes, “CGTs are not limited to a single disease or therapeutic area. They can treat not only inherited genetic disorders but also some cancers and viral infections. Many CGTs target rare diseases that have a high unmet need. These diseases often have limited or no treatment options, such as cystic fibrosis, some ocular and a range of neuromuscular conditions.”

Differing from traditional small molecule therapeutics, CGTs are not specifically a product, device or a service and can be a combination thereof, often with complex manufacturing, delivery, supply chains and high cost of goods. CGTs often target small patient populations with severe unmet need and can significantly change the course of the disease.

It goes on to state, “The majority of rare diseases (>80 per cent) are genetic in origin. These patients carry a significantly higher disease burden, and an unmet clinical need. By treating these conditions, CGTs will provide treatment options for the first time to many vulnerable Australians. This is what society expects.”

The report argues CGTs provide an opportunity for the Australian Government to address health inequities, and provides a list of seven key recommendations for Government to action, including:

Establishing an Office for Rare Diseases as a portfolio agency of Department of Health;
Leveraging recommendations from the National Strategic Action Plan for Rare Disease;
Developing incentives for CGTs to create opportunities for trials, manufacturing and commercial success in Australia;
Develop a national strategic approach to equitable and timely clinical care for CGTs via the National Health Reform Agreement framework
Establish a CGT expert advisory group to provide input and advice to the key evaluation bodies;
Enhance the role of horizon scanning via the Health Technology Reference Group, or equivalent; and
The Minister for Health to establish a cross-functional working group including Departments of Health (both Federal and State/Territory), industry, patients and academics to consider current Health Technology Assessment processes for CGTs.

The EvoHealth report is in line with AusBiotech’s work to the harness the opportunities presented by CGTs in Australia through the Regenerative Medicines Consortium Project, and the Australia Cell and Gene Catalyst (the Catalyst), which builds on work of the Consortium. These initiatives aim to provide Australian patients access to world-class advanced therapies while simultaneously cultivating a thriving cell and gene industry and end-to-end value chain in Australia.

Chimeric Therapeutics announces new capital raise

Tue, 16 May 2023 00:00:00 +1000

Merck backing indigenous communities in creating a new approach to STEM skills

Tue, 16 May 2023 00:00:00 +1000

Federal 2023-24 Budget wrap up for biotech

Thu, 11 May 2023 00:00:00 +1000

Following the 2023 Federal Budget announcements, AusBiotech has welcomed support for SMEs and start-ups through a new ’Industry Growth Programme’ and potential procurement measures, and lamented the noticeable absence of Australia’s One Stop Shop for clinical trials, a sustainable funding model for the TGA, and the end of the EMDG progamme.

The sector is impacted by multiple portfolios, and this is reflected in Tuesday’s announcements.

Announcements in the 2023 Federal Budget have both encouraged and disappointed the biotech sector, with new programmes introduced, timely updates on priority areas, and inaction on critical industry initiatives.

For the biotech industry, the key Federal Budget takeaways include the reiteration of the commitment to the National Reconstruction Fund (NRF), and its complementary addition of a new and welcome SME support programme, the 'Industry Growth Program', to replace and expand on the Entrepreneur's Programme; further information on the 'Buy Australia' procurement programme; and a number of other announcements, both encouraging and disappointing.

AusBiotech welcomes the announcement to establish the ‘Industry Growth Programme’, after the last budget signalled the end of the Entrepreneur’s Programme when 75 percent of funding was slashed. The Industry Growth Programme has been established to align with the Federal Government's National Reconstruction Fund (NRF) priorities, and aims to support Australian SMEs and startups to commercialise their ideas and grow their operations SMEs and startups.

The Budget also included a number of encouraging updates, such as the announcement of $18.1m over four years for the procurement programme ‘Buy Australia’, with the aim of providing greater access to procurement which would offer the biotech sector much needed demand security for those in the process of technology development.

It is promising to see a commitment to critical and emerging industries, including $116 million over five years to support artificial intelligence and quantum growth, and $3.2 million for the preparatory work for implementing new legislation and modernising the National Gene Technology Scheme.

While there were several positive signals, the Budget also included some notable disappointments. After years of advocating for a patent box scheme, industry will be disappointed to hear the Federal Government has indicated the regime will no longer proceed.

The Budget failed to mention funding for Australia’s One Stop Shop for clinical trials, a proposal aiming to improve coordination and harmonisation across jurisdictions and offer a single point of access for clinical trials, in spite of years of development and two years of consultation. Many people in industry will also be discouraged to note that $61m has been slashed from the Export Market Development Grants as part of the Government’s 'efficiency gains'.

Finally, the Federal Budget did not address the need for a sustainable funding model for our world-class regulator, the Therapeutic Goods Administration.

This is despite AusBiotech’s efforts in uniting the life science industry to communicate the need to appropriately fund the TGA and its very worthy public health initiatives. With other Government departments being offered this support in this Budget, AusBiotech hopes that this will be reflected for the TGA in future Budgets. Whilst the Budget included measures to fund vaping related projects, this will not support the breadth of public good activities that the TGA undertakes.

As the national voice of the biotechnology sector for more than 37 years, AusBiotech has been committed to communicating industry’s concerns, reducing barriers and amplifying opportunities. It is pleased to deliver a wrap-up of announcements for life sciences.

Amplia Therapeutics says third cohort enrolment completed in ACCENT clinical trial

Thu, 11 May 2023 00:00:00 +1000

Showcasing Australian biotech at BioKorea 2023

Tue, 09 May 2023 00:00:00 +1000

AusBiotech is proud to support Austrade’s BioKorea 2023 delegation to strengthen ties with international markets, and highlight investment opportunities in Australia and our national life science capabilities.

Australia’s biotech industry is preparing to highlight the nation’s strengths at Asia’s premier life science conference, BioKorea 2023, this week.

Partnering with the Australian Trade and Investment Commission (Austrade), AusBiotech is backing the Team Australia delegation attending BioKorea, taking place from 10-12 May.

The Australian presence will be strong, with industry representation from across all five major states as well as several Australian thought leaders providing local insights during BioKorea’s conference sessions, including presentations on regenerative medicines, and securing vaccine sovereignty through global collaborations. Several Australian companies are also expected to pitch at BioKorea’s Invest Fair which brings together leading investors, venture capitalists, and biotech startups to pitch for investment and partnership.

AusBiotech’s support of BioKorea 2023’s Australian delegation is part of its global strategy to facilitate international opportunities for investment, collaborations and partnerships, with a focus on the markets important to members, including growth markets in Asia.

Australian Ambassador to the Republic of Korea, H.E. Catherine Raper, is flying Team Australia’s flag at BioKorea’s official opening ceremony on 9 May; Global Victoria is hosting an Australian clinical trial seminar on 9 May; and the Australian delegation networking event, co-hosted by Korea Health Industry Development Institute (KHIDI), will take place on 11 May.

AusBiotech is committed to supporting these ongoing opportunities for industry, which are crucial for the growth of the Australian life sciences sector, and ultimately for continuing Australia’s position in the sector globally. The organiser of BioKorea, KHIDI, has led large Korean delegations to AusBiotech for several years, demonstrating the strong interest Korean companies have in collaborating with Australia's biotech industry. Adsotech’s long-standing MoU with KHIDI will continue to make a solid platform for further international collaborations.

To find out more about BioKorea 2023, click here.

FDA removes clinical hold on Immuron's new campylobacter ETEC therapeutic

Tue, 09 May 2023 00:00:00 +1000

Telix to supply Bayer with Illuccix for global late-stage prostate cancer study

Tue, 09 May 2023 00:00:00 +1000

Antisense Therapeutics announces the appointment of new CEO and managing director

Tue, 09 May 2023 00:00:00 +1000

LBT Innovations begins search for new board chair

Tue, 09 May 2023 00:00:00 +1000

Opportunity to invest in Australian biotech companies

Thu, 04 May 2023 00:00:00 +1000

Registrations for AusBioInvest 2023, the largest investment and partnering conference in the Australian life sciences sector, have opened, and investors, company executives and delegates are invited to register today.

Creating meaningful connections between businesses and investors, this premier event enables great ideas to get the funding they need as Australian biotech companies present their investment opportunity.

This year’s programme will feature informative and insightful keynotes and panel discussions from global venture capital and investment experts sharing insights to support informed investment decisions in a complex scientific field, and up to 30 presentations from public and private Australian biotechnology companies, spanning early- to late-stage, that are presenting their investment opportunity.

Australia’s pre-eminent life science investment event offers the opportunity for potential partners and investors, including global pharma representatives, to engage with Australia’s world-leading biotech companies as they present the latest, detailed information about their business case and technologies.

The event draws key decision makers from the investment community, including venture capitalists, private equity firms and investment bankers; as well as research analysts and representatives from pharmaceutical companies, and from governments. It merges market intelligence with investment opportunities and acts as a guide to successful biotech investment.

AusBiotech’s premier event will lift the profile of the Australian biotechnology industry and create access to greater funding sources for local companies to develop world-class science into therapies, diagnostics and medical devices.

AusBioInvest 2023 is proudly sponsored by the Victorian Government.

Carina Biotech to present details of planned trial of CAR-T cell therapy candidate

Thu, 04 May 2023 00:00:00 +1000

Patent granted in India and Notice of Allowance Issued in Israel for CLTX Car Technology

Thu, 04 May 2023 00:00:00 +1000

Find and be found: Utilising free global life sciences Directory

Tue, 02 May 2023 00:00:00 +1000

Get ready to find potential partners and ensure you can be found through the Australian Life Sciences Innovation Directory.

With AusBiotech-led and supported delegations heading to BIO and BioKorea, and international investors and life science leaders preparing to attend AusBiotech 2023 and AusBioInvest 2023, our local capabilities are - rightly - in the spotlight.

Visit: https://www.ausbiotech.org/biotechnology-industry/australian-life-science-and-innovation-directory to create a new profile, update details or search for the capabilities you are seeking.

Build awareness of your company to national and international audiences: profiles are free of charge for all; AusBiotech members receive an extended company profile in the directory.

With flexible search functionality, filter via AusBiotech membership, sector, or free text; and display as a listing or a map.

Cytiva supports BioCina with first GMP production and development facility for mRNA

Tue, 02 May 2023 00:00:00 +1000

New approval for trial of Immutep's 'efti' with Merck's PD-L1 inhibitor

Tue, 02 May 2023 00:00:00 +1000

Minister engages in Industry Forum

Thu, 27 Apr 2023 00:00:00 +1000

AusBiotech has welcomed Minister Husic’s attendance and engagement at an Industry Forum, held in Sydney last week with key CEOs, to discuss the Biotechnology Blueprint, a decadal plan for the industry’s future.

AusBiotech CEO, Lorraine Chiroiu, conveyed thanks to the Minister and noted the industry's appreciation for “his level of interest, engagement and insightful questions.”

The attending CEOs provided an overview of the sector and the Blueprint, and brought lived-experience and vignettes pertinent to building understanding of the current environment in which the sector is operating.

The meeting held at SpeeDx, discussed the importance, impact and value of key Government programmes for Australia’s biotechnology industry’s development and sought to empower all to collectively work together to foster a growing and strong biotechnology and life science industry.

A key discussion was the development of the National Reconstruction Fund, now that the new Fund has been legislated.

OncoSil announces new presentation of clinical outcomes data

Thu, 27 Apr 2023 00:00:00 +1000

Emyria adds to its pipeline with new high potency cannabidiol dose form

Thu, 27 Apr 2023 00:00:00 +1000

Regulatory changes for medical device clinical trials not needed

Thu, 20 Apr 2023 00:00:00 +1000

Based on flimsy rationale and opposition from medical devices developers, AusBiotech is urging the Federal Government not to push ahead with the proposed regulatory changes that will see a more onerous approval process for numerous implantable medical device clinical trials - which will cause delays and red tape, but may not enhance patient safety.

Industry united last year through the Research and Development Taskforce (RDTF) to respond to the Therapeutic Goods Administration’s (TGA) consultation on proposed changes for clinical trials of medical devices and make a joint submission on maintaining regulation commensurate with risk.

Patient safety is at the heart of Australia’s existing regulatory processes, and industry is supportive of the sound patient protection provided through Australia’s existing scientific and ethical review system in place for high-risk devices, along with the TGA’s mandatory safety reporting requirements.

While industry agrees with the TGA that over time, medical devices have increased in their complexity - with advances in technology such as the materials used, including 3D printed materials, and the interaction with software, it contends that these developments do not infer that the risk has increased – as indicated, without evidence, in the consultation paper.

Australia has a thorough process and world-class regulation in place to assess risk and best protect patients, and the RDTF suggested in its submission that implementing the proposed changes will not better protect patients’ health, and equally, it will also disadvantage public health activities.

There was overall support from industry for the TGA’s proposal to include all medical device clinical trials in Australia’s Good Clinical Practice (GCP) Inspection Program (to enable selected trials and documentation supporting these trials to be inspected).

As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science sector.

The RDTF is a multi-sector collaboration between AusBiotech, the Medical Technology Association of Australia and Medicines Australia, to thoroughly review the current design of clinical trials oversight, and highlighted in its submission that there is evidence demonstrating that Australia’s current process is safe and efficient for participants in first in human studies.

Together with the RDTF, the response was also developed together with AusBiotech’s Clinical Trials Advisory Group, AusMedtech Advisory Group, and AusMedtech Regulatory Affairs Advisory Group, which each provide guidance and advice on operational and policy-related regulatory matters.

Read the full submission now.

Telix reports its first quarter of $100 million in revenue

Thu, 20 Apr 2023 00:00:00 +1000

Major milestone for Australian pharmaceutical company, Neuren

Thu, 20 Apr 2023 00:00:00 +1000

Assessors needed for industry PhD program

Tue, 18 Apr 2023 00:00:00 +1000

The National Industry PhD Program is seeking suitably qualified individuals with an interest in being industry-based assessors.

The Australian Government is investing $296 million to “build a bedrock of research talent skilled in university–industry collaboration across the sector under the Increase Workforce Mobility initiative. This includes funding to establish the National Industry PhD Program to support the Government’s commitment to add 1,800 Industry PhDs over 10 years.”

Assessors will be asked to review applications that are in, or close to, their qualifications and areas of interest. The review will be in relation to the academic and industrial experience of the team supervising the PhD student, and their relevant standing in the field of research. This assessment will be conducted alongside university-based specialists.

The National Industry PhD Program is a doctoral program that will support PhD candidates to undertake industry-focused research projects and develop the knowledge and skills to better translate university research into commercialisation outcomes. It will also give PhD candidates an opportunity to gain practical and research experience in both industry and university settings.

The Program consists of two streams:

Industry Linked PhD stream: This stream is for outstanding PhD candidates to undertake research projects co-designed by university and industry, with opportunities to be embedded in an industry setting and participate in a 12-week training program.
Industry Researcher PhD stream: This stream is for highly capable industry professionals who are supported by their employers to undertake PhD projects in partnership with a university, while retaining industry employment and salary benefits.

The initial assessment period is scheduled for late April-May 2023, with the Assessment Committee Meeting on Monday 15 May. There will be two further rounds in 2023. Remuneration will be provided for assisting with the assessments.

For individuals interested in participating, please provide your:
Name
Email Address
Contact number
Expertise (brief bio)

For further information please contact: Dr Elane Zelcer (elane.zelcer@campusplus.com.au/ 0418 563 562) or Ms Holly Bell (hollie.bell@campusplus.com.au/ 0413 666 345) or Visit: National Industry PhD Program - Department of Education, Australian Government.

Proto Axiom invests in University of Sydney spin-out, EndoAxiom

Tue, 18 Apr 2023 00:00:00 +1000

Focus turns to all things medtech

Thu, 13 Apr 2023 00:00:00 +1000

As we approach the final runway to the medtech conference of the year, AusMedetch 2023, those in medical devices and diagnostics are invited to register and get involved, to pitch, partner, network and learn what’s on the horizon for the medtech industry.

Expecting more than 400 delegates, the medtech industry will gather in Adeliade 24 – 26 May for a programme jam-packed with over 100 expert speakers. Hear from leading medtech figures, including Professor Anton van den Hengel, who will talk about ‘ChatGPT, LLMs, and why they really matter’.

Director of Applied Science at Amazon & Director of the Centre for Augmented Reasoning at the Australian Institute for Machine Learning (AIML), The University of Adelaide, Professor Hengel will deep dive into the world of artificial intelligence and the effect it will have on the Australian Medical Technology industry.

AI models like ChatGPT are getting a lot of attention due to the amazing things they can do and the mistakes the models make while doing so. The question for the Australian Medical Technology industry is how we will respond to these challenges, and opportunities?

What’s really interesting about these ‘foundation models’, however, is that they decrease the human effort required to solve complex problems. In medicine this means:

A massive reduction in the amount of human-labelled data required to develop an AI-based solution, to the point where some problems will be solvable based on a single example.
A significant reduction in the cost of developing an AI-based medical solution, and maintaining it.
A new generation of natural-language interfaces that patients can’t distinguish from humans.

See the full programme and register at: www.ausmedtech.com.au

Pharmaxis adds combination arm to PXS‐5505 myelofibrosis study

Thu, 13 Apr 2023 00:00:00 +1000

Cynata receives ethics approval for proposed aGvHD Phase 2 clinical trial

Thu, 13 Apr 2023 00:00:00 +1000

ATSE seek views on commercialisation

Tue, 11 Apr 2023 00:00:00 +1000

The Australian Academy of Technological Sciences & Engineering (ATSE) is undertaking a survey in partnership with the Department of Education to research translation and commercialisation in Australia.

The project will develop a series of future-focused reports highlighting areas of research with translation and commercialisation potential among Australian universities and businesses. These reports will inform the development and implementation of Government policies and programs relating to research translation and commercialisation in Australia.

A short survey forms a key part of the project. The survey is open now, closes Thursday 20th April 2023, and will around take 10 – 15 minutes to complete. In the survey, respondents are invited to identify up to three current and emerging areas of research that display strong translation and commercialisation potential in Australian industry.

Programmes and policies that will be informed by the survey results Include:

Australia’s Economic Accelerator (AEA)
CSIRO’s Main Sequence Ventures
Start-up Year loan program (SY-HELP)
Industry-focused PhDs and fellowship programs
Trailblazers Universities Program

The intention is to make all reports in this series publicly available. For enquiries, please contact academypolicyteam@atse.org.au or call +61 2 6185 3240.

Immutep announces changes to its board of directors

Tue, 11 Apr 2023 00:00:00 +1000

Recce Pharmaceuticals announces planned grant of 'Patent Family 4' for anti-infectives

Tue, 11 Apr 2023 00:00:00 +1000

Consultation on Australia's science priorities nears its end

Thu, 06 Apr 2023 00:00:00 +1000

Australia’s Chief Scientist, Dr Cathy Foley, is leading a national conversation on Science and Research Priorities, which is in its final stages.

The Review and renewal was initiated by the Minister for Industry and Science, Ed Husic, last year to establish a “unified sense of purpose for our science and research communities to address our most pressing national challenges.”

Australia’s current priorities and the National Science Statement were published in 2015 and 2017, respectively. Both these policy frameworks, which set the Government’s direction and vision for Australian science, are being renewed.

The public consultation has officially closed today, but the opportunity to contribute is still available via AusBiotech. The work to revitalise Australia’s Science and Research Priorities and National Science Statement includes extensive consultation with science, research and industry stakeholders, as well as the public consultation.

The Review is taking into account other Government initiatives, such as the National Reconstruction Fund, and reflect Australia’s strategic interests and comparative advantages.

This work will also complement related reviews and initiatives, such as the review of women in STEM programs, strategies to support the quantum and robotics sectors, the review of the Australian Research Council and the development of a Universities Accord.

See more information at: https://consult.industry.gov.au/sciencepriorities1

Botanix secures investor commitments to progress its lead development program

Thu, 06 Apr 2023 00:00:00 +1000

Alterity Therapeutics enrols first patient in trial of ATH434 for Multiple System Atrophy

Thu, 06 Apr 2023 00:00:00 +1000

Pitch your early-stage medtech

Tue, 04 Apr 2023 00:00:00 +1000

AusMedtech 2023 will feature an early-stage innovation pitching event featuring presentations from Australia's emerging early-stage medical technologies.

The Early-Stage Innovation Forum (ESIF), to be held on Thursday 25 May at the Adelaide Convention Centre, will feature rapid fire rounds of quick-pitch presentations on early-stage medical technologies and projects from local research institutes, universities, hospitals and pre-series A companies in the areas of medical devices and diagnostics, digital health and enabling technologies.

Early-stage project leaders are invited to submit their expressions of interest to pitch to an expert and investor panel during AusMedtech 2023.

ESIF 2023 Prize:

Two tickets to AusMedtech 2024
Complimentary membership to AusBiotech
Win the award for Best Translational Research for AusMedtech 2023
Announcement of your win AusBiotech’s social media community of more than 20,000
Featured in BiotechDispatch
Featured in AusBiotech’s 2023 Journal; Australasian Biotechnology

Successful submissions will have the opportunity to:

Present an in-person pitch of their project to a panel of experts and investors.
Receive feedback from our expert investor panel to assist with commercialising their technology.
Feature in AusBiotech publications and media channels

All applicants must have the ability to present, in-person at the Adelaide Convention Centre on 25 May.

Applicants are invited to submit their project before 14 April 2023 to be considered for a presentation slot on the programme. All projects submitted will be reviewed and shortlisted by our appointed Advisory Group.

Considerations: Submissions from each state will be considered to ensure representation across Australia. AusBiotech is committed to diversity and inclusion, and actively incorporates gender balance, diversity and inclusion in all aspects of its event programmes.

To be considered to present your early-stage technology in the forum, you are required to answer six questions via the online portal.

Emyria and Aspen Australia sign binding licensing and commercialisation term sheet

Tue, 04 Apr 2023 00:00:00 +1000

Learn about the clinical trials governance framework implementation

Thu, 30 Mar 2023 00:00:00 +1100

Ahead of assessments commencing under the National Safety and Quality Health Service Standards, you are invited to join online workshops on the National Clinical Trials Governance Framework.

Assessments are due to commence from 30 May 2023 and the Health and Safety Commision's Dr Bernadette Aliprandi-Costa, (Manager, Safety and Quality Improvement Systems and Intergovernmental Relations) will host workshops to provide insights and advice on:

Reporting on your clinical trial operations
Sampling clinical trial services
Conducting a self-assessment
Understanding the maturity scale.

Wednesday, 5 April, 10:00 - 11:30am
Wednesday, 19 April, 12:00 - 1:30pm
Wednesday, 3 May, 10:00 - 11:30am

Industry groups welcome Senate backing of National Reconstruction Fund

Thu, 30 Mar 2023 00:00:00 +1100

AusMedtech goes back to the future

Tue, 28 Mar 2023 00:00:00 +1100

The programme for this year’s national medical technology conference, AusMedtech 2023, has launched with a focus on the future of healthcare.

AusMedtech 2023, to be held in Adelaide 24 – 25 May, will feature the latest advances in medtech that will shape the future of the industry and healthcare. With expert keynotes, panel discussions, and Q&A sessions, you'll gain insights into the trends and breakthroughs that are propelling the industry forward.

AusBiotech's newly-released programme makes AusMedtech 2023 a must-attend event for anyone interested in the latest developments in the global medtech community. The programme’s journey to the future of medtech is packed with essential and topical content that will captivate and inspire.

The industry committee leading the programme, headed up by Peter Bradley, has designed the speaking line-up to support the growth and development of the industry.

The annual event will include key features:

Gain the latest insights, trends and lessons learnt from the AusMedtech network of experts, industry leaders and leading companies through keynotes, expert panel discussions and interactive Q&A.
Reconnect and maximise your engagement through AusPartnering, AusBiotech’s highly-popular business matching programme, by scheduling one-on-one private meetings with other conference attendees and participants.
Early-Stage Innovation Forum, will feature rapid fire rounds of quick-pitch presentations on early-stage technologies and projects from local research institutes, universities, hospitals and pre-series A companies in the areas of medical devices and diagnostics, digital health and enabling technologies.
Profile your company, talent and ingenuity through the AusMedtech Exhibition, build brand awareness, network with others and exchange information with delegates from your exhibition booth. Welcome function, closing ceremony and catering breaks are all taking place from the AusMedtech Exhibition Hall.
Networking opportunities, in-person networking is valuable and opportunities include the Welcome Function, closing ceremony and catering breaks in Exhibition Hall in your full conference pass.
AusMedtech Conference Dinner, join colleagues and friends, new and old, at the AusMedtech Conference Dinner. Tickets sold separately during the registration process.

Early-bird registration is open until Friday 21 April at https://www.ausmedtech.com.au/ .

Noxopharm initiates development of novel mRNA vaccine enhancer

Tue, 28 Mar 2023 00:00:00 +1100

IDT achieves milestone with TGA-approved expansion of manufacturing

Tue, 28 Mar 2023 00:00:00 +1100

Radiopharm Theranostics and GenesisCare partner on development of radiopharmaceutical

Tue, 28 Mar 2023 00:00:00 +1100

Directory of Australian accelerators and incubators launched

Thu, 23 Mar 2023 00:00:00 +1100

AusBiotech has launched a directory of accelerators and incubators relevant to Australian life sciences companies, providing a valuable new resource for biotech, medtech and digital health companies in the early stages of their development.

Access to capital and opportunities to accelerate strategic planning in the early stages of development are often two of the biggest challenges facing early-stage companies in the biotech sector. Participating in incubator or accelerator programmes provides opportunities to gain access to expertise, funding and introductions to potential investors, as well as programmes designed to drive innovations toward real-world outcomes.  

Incubators offer intensive strategy support and often provide shared office and/or laboratory facilities for small and very early-stage companies. They are sponsored or run by venture capital (VC) firms, angel investors, government entities, or major corporations.

Accelerators are an intensive development-focused programme designed to advance significantly a company’s progress along the pathway towards commercialisation. A typical accelerator programme has a strong focus on building capability in business and commercial strategy, securing investment, IP protection and regulatory requirements, and support in clarifying the product’s market entry strategy.

The AusBiotech summary of Australian Life Sciences Incubator and Accelerator Programmes features programmes that are currently active, directly relevant to Australian life science companies and are available to registered Australian companies with established proof of concept. The majority of programmes listed provide funding: this can be in grant form, via SAFE notes, or as seed funding (non-dilutive and in some cases for equity). Each programme has specific eligibility and selection criteria and companies are encouraged to explore which option best suits their needs.

The programmes listed are designed and managed by life-science professionals who have significant experience in the industry and offer a deep understanding of both technical and commercial requirements for companies to succeed. All programmes offer connection with investors and the opportunity to ‘pitch’, and capability-building activities commonly focused on strengthening commercialisation strategy, capital raising and bringing innovative technologies closer to market.  

Access to the new directory can be found here.

Chimeric Therapeutics reports 'positive feedback' on plan for CHM 2101

Thu, 23 Mar 2023 00:00:00 +1100

Support for passage of NRF legislation through Senate

Tue, 21 Mar 2023 00:00:00 +1100

Industry and research organisations representing Australian health innovators have joined together to reiterate the sector’s considerable support for the National Reconstruction Fund (NRF) - calling on all parties to support the NRF Corporation Bill 2022 through the Senate.

The statement co-signed by Research Australia, AusBiotech, MTAA, Medicines Australia, BioMelbourne Network and Genetic Technologies Australia seeks to ensure that Australia’s future is one of well-paid jobs manufacturing products that result in strong economic returns, as well as one where we are self-sufficient in vital health and medical products.

The statement, sent to Parliamentarians, says Australia must do better to commercialise research to secure its economic future and supporting the passage of the legislation through the Senate is the next step in securing the NRF.

There are a number of areas of health commercialisation, including pharmaceuticals, medical technology, digital health and biotechnologies, that are sensible areas for Australia to seek to expand its capability.

Last year, while Australia spent $8.38 billion on medical research, medical device commercialisation funding was relatively small, receiving an annual average of $62 million.

Medical research funding is not being matched by the necessary institutional venture capital required to commercialise critical goods such as medical devices - impacting on Australia’s ability to sustain domestic medical device manufacturing. This is where the NRF represents an avenue to stimulate co-investment initiatives in health technology commercialisation.

In the case of pharmaceuticals, for example, in 2019, Australia exported US$3.2 billion of pharmaceutical products or 0.55% of global exports.3 In the same year (2019), Australia imported pharmaceutical products valued at US$7.38 billion, or 1.27% of global pharmaceutical imports. It is an area where security of supply is paramount; it is also an area where we have existing expertise in manufacturing and world leading expertise in life sciences that we can leverage. It is a growing market, and one where capability is relatively well dispersed around the developed world.

The NRF can help Australia achieve the ambition to be a net exporter of not only pharmaceuticals but also play a much larger role in the clinical trials and advanced manufacturing space.

Investing in medical manufacturing is crucial to addressing supply chain vulnerabilities and building sovereign capability in medical devices, medicines and vaccines.

Brandon BioCatalyst with ANDHealth to deliver BioMedTech Incubator Program

Tue, 21 Mar 2023 00:00:00 +1100

Call for speakers for biggest week in biotech

Thu, 16 Mar 2023 00:00:00 +1100

With the theme ‘Advancing Biotech - It’s in our DNA’, AusBiotech is welcoming submissions for topics and speakers to inform Australia's largest life sciences conference programme.

AusBiotech 2023 is to be held in Brisbane 1 – 3 November. Together with its programme committee, AusBiotech is looking for high-calibre session submissions that explore current trends, critical and emerging topics, breakthroughs, and stories that are thought-provoking and encourage discussion.

You are invited to submit your topic and speaker ideas for:

Keynote sessions (30 minutes in length, including Q&A)
Panel sessions (up to 90 minutes in length, with one chair and up to four speakers)
Themes for specialty streams (composed of three sessions).

Speaking at AusBiotech 2023 positions you as an international expert who tackles the most pressing issues in our industry, builds critical dialogue, sparks creative conversations, and profiles new technology.

For over 37 years, the AusBiotech conference has served as the leading international meeting place for the Australian life science community.

Biotechnology continues to unlock vast potential for improving human life. Join us at AusBiotech 2023 in Brisbane for in-person networking, cutting-edge programming and to advance our industry.

It’s time to bring Australian life sciences to the world stage - exploring what’s possible across biotechnology, medical devices and agri-tech to heal and feed the world.

We look forward to your input as we make our 2023 conference programme bigger and better than ever before.

See https://www.ausbiotechnc.org/call-for-submissions-2023 for more information, Submissions are open until 26 May 2023.

Patrys' says preclinical data supports synthetic lethality mechanism

Thu, 16 Mar 2023 00:00:00 +1100

Interim analysis shows accuracy of Optiscan Imaging platform

Thu, 16 Mar 2023 00:00:00 +1100

Proteomics says it will resubmit PromarkerD predictive test for Medicare funding

Thu, 16 Mar 2023 00:00:00 +1100

National Reconstruction Fund moves closer to reality

Tue, 14 Mar 2023 00:00:00 +1100

The passing of the $15bn National Reconstruction Fund (NRF) Corporation Bill through the House of Representatives is a positive step forward for all Australians, as it takes the fund closer to reality.

AusBiotech welcomes the milestone as the fund would represents a valuable investment in the life sciences sector, enabling new technologies, innovations and capabilities to develop and progress, with significant benefits to Australians and the economy.

The legislation enabling the establishment of the Fund is a key initiative of the Australian Government’s A Future Made in Australia policy. The fund will co-invest in independently assessed projects across seven priority areas and over seven years, including $1.5 billion in ‘medical manufacturing’ as well as $1 billion each for critical technologies and advanced manufacturing.

As the voice of the Australian life sciences industry for nearly 40 years, AusBiotech put forward a number of recommendations in its submission regarding the Fund, which aims to “add value and develop capability … to create high quality, sustainable industries and jobs”.

These include the proposal for a ‘fund of funds’ where greater private and public investment into the sector can be added, for example, superannuation funds. This could then create a mechanism to both attract and build (diversify) investments, as well as to overcome key skills gaps that the sector is currently facing.

The submission also highlighted the need for patient capital for sustainable growth opportunities; the need to consider companies of all sizes; that success should be measured through a set of balanced financial and non-financial objectives such as patient outcomes and skills and learning development; and the need for biotech-specific expertise at high-level appointments to maximise the contribution of industry knowledge and skills.

The submission was developed following a number of member engagement initiatives including being a key topic of discussion at AusBiotech’s CEO Policy Forum that brought together 27 biotech company CEOs to exchange on key topics in the Biotechnology Blueprint (Blueprint).

AusBiotech looks forward to the passing of the Bill that will help to boost our sovereign capability, diversify the nation’s economy, and importantly, help create secure jobs.

US approval for Neuren's innovative treatment for Rett syndrome

Tue, 14 Mar 2023 00:00:00 +1100

Sanofi launches recruitment drive for its Translational Science Hub in Queensland

Tue, 14 Mar 2023 00:00:00 +1100

Mark Butler announces funding for mitochondrial donation pilot program

Tue, 14 Mar 2023 00:00:00 +1100

Immutep announces the initiation of a new breast cancer trial

Tue, 14 Mar 2023 00:00:00 +1100

Biotech stocks back on road to recovery, according to latest report

Thu, 09 Mar 2023 00:00:00 +1100

Australian biotech stocks were only down slightly in 2022 compared to 2021 and remain higher than pre-Covid levels, despite the first half of the year being the worst biotech half year on record, according to Bioshares’ latest report.

Over $1.45 billion total capital was raised by Australian biotech across the year, boosted by a $371 million raise by Opthea. This is down from the 2021 record figure of $8 billion (that includes a $6.3bn raise by CSL) but remains significantly higher than the $1.08bn raised in 2019.

Following a 41% drop in the first half, the capital raised showed an upturn of 8.1% in the second half of the year, despite no new biotech listings in 2022. It is in line with the US market which declined 20.7% in the first half and rose 12.4% in the second.

Bioshares expects that Australian stocks will “continue their recovery into 2023”.

The report also identified three other significant capital raises during the period, namely by AusBiotech members Paradigm Biopharmaceuticals ($66 million), Mesoblast ($65 million) and Polynovo ($53 million).

AusBiotech is committed to fostering relationships between life science companies and investors, in connecting with innovative, Australian companies that offer high-value return-on-investment.

It has developed a range of resources for investors and companies that is specific to the life sciences sector, including the Guide to Life Science Investing – that aims to build an improved understanding of the unique life sciences sector to increase the quantity and quality of investment in life sciences companies. See AusBiotech’s investment resources here.

AusBiotech will present investment opportunities in-person at AusBioInvest 2023 in Melbourne on 30 October 2023, with support from Host State Partner the Victorian Government, and invites investors to save the date.

'Women in Leadership Development' program expands with 'Advance'

Thu, 09 Mar 2023 00:00:00 +1100

Bionomics reports updated analysis from PREVAIL Phase 2 Study of BNC210

Thu, 09 Mar 2023 00:00:00 +1100

FDA grants 'orphan' designation to PTX-100 for broader TCL indications

Thu, 09 Mar 2023 00:00:00 +1100

Chimeric Therapeutics advances manufacture of CHM 2101 viral vector

Thu, 09 Mar 2023 00:00:00 +1100

Embracing equity in the life sciences sector

Tue, 07 Mar 2023 00:00:00 +1100

In celebration of International Women’s Day (IWD) this week, more than 520 life science leaders will gather this Friday for AusBiotech’s annual NSW Women in Life Sciences Luncheon, to encourage, support and further develop opportunities to Embrace Equity in the life sciences sector.

Hosted by AusBiotech and Medicines Australia, the Luncheon will capitalise on the IWD 2023 theme Embrace Equity, with two renowned expert keynote speakers and the ‘Big Sisters’ programme that helps to facilitate career development for women in the industry.

International Women's Day is held annually on March 8 to celebrate “the social, economic, cultural and political achievements of women…[and] marks a call to action for accelerating women’s equality.” The IWD 2023 campaign theme aims to “drive worldwide understanding why Equal opportunities aren't enough!”

AusBiotech is behind efforts to raise awareness of the importance of gender equity and to inspire positive change in the Australian life sciences sector.

The 2023 Women in Life Sciences Luncheon will feature two high profile keynote speakers: Gender equality expert and thought leader, Dr Kathryn J Evans, and the CEO of Cochlear, Dig Howitt.

Dr Evans has over 25 years of international management experience working with world leading life science companies, such as Roche, Cochlear and Sanofi, and is the author of the recently published Advance Australia Fairly: How a Plan for Gender Equality can Drive Australia’s Economic Success. At this must-attend event for the life sciences sector, she will share some evidence-based insights from her research and why Australia needs a national plan towards gender equality.

She will be joined by the CEO and President of Cochlear Limited Dig Howitt. Mr Howitt has been committed to the Champions of Change Coalition's mission to help achieve gender equality and increase the representation of women in leadership since 2018 when he joined the coalition's STEM group.

The luncheon will not only celebrate leadership that nurtures female ambition but provides a practical way of enabling that. The successful ‘Big Sisters’ programme has once again invited women advanced in their careers within the sector to sponsor a female student to attend the event and facilitate their networking during the event, with six ‘Little Sisters’ being supported at the 2023 event. The programme and luncheon are part of AusBiotech’s broader commitment to increasing diversity and inclusion.

GreenLight Clinical and Cure Therapeutics look to future collaboration

Tue, 07 Mar 2023 00:00:00 +1100

Starpharma announces the appointment of chief financial officer

Tue, 07 Mar 2023 00:00:00 +1100

Emyria partners with specialist trauma psychiatric service to advance MDMA-assisted therapy

Tue, 07 Mar 2023 00:00:00 +1100

The Australian Cell and Gene Catalyst takes step forward

Thu, 02 Mar 2023 00:00:00 +1100

AusBiotech and Medicines Australia have announced the next phase of their joint venture, the Cell and Gene Catalyst (the Catalyst), with the appointment of a new General Manager to drive the initiative, key priority areas identified and expert working groups currently being established.

The Catalyst aims to accelerate the development, manufacture and commercialisation of cell and gene therapies in Australia, positioning the country as a global leader in this field and driving economic growth. It will focus on strengthening the Australian ecosystem for cell and gene therapies, with a particular emphasis on building the country’s capabilities across the entire value chain. This national joint venture is a collaborative effort between the two peak industry bodies, along with a steering group comprising CSL Behring, Novartis, Pfizer, Therapeutic Innovation Australia, and Cell Therapies.

Dr Jessica Morison has been appointed as the new General Manager to drive the initiative towards its strategic goals, and the workplan has now been finalised. A number of strategic priorities have been identified, with four key areas of focus now being worked on. These are: attracting, building, and retaining world-class talent; fostering collaboration and knowledge sharing; creating a clear regulatory and market access pathway; and building Australian capability across the entire value chain.

The Catalyst is now calling for interested members and other industry partners to join their task and finish groups to contribute to these priority areas, and to the growth of the cell and gene therapy sector in Australia. There will be two groups established: Talent, Skills and Collaboration; and Market Access and Capability Building.

The groups will bring together experts from across the sector to address these specific focus areas and develop solutions that will support the growth of the ecosystem. They will involve representatives from industry, academia, government, and other key stakeholders.

"We believe that a thriving cell and gene therapy industry in Australia will have significant benefits for patients, the economy, and the global healthcare industry," said Dr. Morison. "Through our work at Cell and Gene Catalyst, we are committed to making this vision a reality."

The Cell and Gene Catalyst originated from the work of AusBiotech’s Regenerative Medicine Consortium Project and the Strategic Roadmap for the Regenerative Medicine sector in Australia. The landmark strategy outlines key objectives and priority actions, underpinned by a comprehensive discussion of the primary obstacles facing the sector locally. The strategy identified five strategic goals: capabilities/workforce; collaboration; funding; regulation and policy; and infrastructure, aiming to identify how to support the development and commercialisation of the most advanced therapies in the world locally.

"We are thrilled to be entering the next phase of our operations with a new General Manager and a clear vision for the future," said Lorraine Chiroiu, CEO AusBiotech. "These key areas of focus will help us achieve our goal of advancing the field of cell and gene therapies in Australia and making a significant contribution to the global industry."

“The future of medicine is rapidly evolving, and cell and gene therapies are leading the charge,” said Elizabeth de Somer, CEO of Medicines Australia. “There are currently 140 of these therapies in the final stages of development around the world, however, only a few of these innovative treatments are currently approved and funded in Australia.

“Australian patients must be able to access these innovative cell and gene therapies. The Health Technology Assessment (HTA) Review is a prime opportunity to reform our health system and speed up the time it takes to access them,” she said.

Learn more about Cell and Gene Catalyst here. To get involved in the task and finish groups, please register your interest here.

CSL Seqirus secures Australia-NZ rights to cardiovascular therapy

Thu, 02 Mar 2023 00:00:00 +1100

Microba Life Sciences announces new distribution agreements in Europe

Thu, 02 Mar 2023 00:00:00 +1100

Neuren Pharmaceuticals appoints experienced industry executive to board

Thu, 02 Mar 2023 00:00:00 +1100

AusBiotech to propose overhaul of TGA funding

Tue, 28 Feb 2023 00:00:00 +1100

AusBiotech urges a Federal Government review of the TGA funding model, as it prepares its response to the annual TGA fees and charges proposal released last week.

The Government is proposing to substantially increase TGA fees and charges for pharmaceutical and medical technology companies in order to recover the increased costs its facing, including through its digital transformation and public good activities.

AusBiotech has been advocating for an overhaul of the current outdated funding model, including uniting other life science industry bodies to write to the Treasurer, and Ministers for Finance, Health and Aged Care, and Industry and Science as part of a pre-Budget submission. Increasing charges to the industry risks jeopardising the strength and competitiveness of the Australian healthcare sector, and the subsequent health of all Australians.

It is proposed that costs are passed onto industry by increasing the fees and charges for services substantially. It is clear that the current funding model – where 92% of the TGA’s costs are recovered from industry - has not evolved to take these new activities into account. While these public health programmes represent about a third of the TGA’s work, only about 8% of the TGA’s funding is provided through public funds. Compared to other well-respected and effective regulatory agencies around the world, the TGA is alone in receiving such a small amount and percentage of public funding.

AusBiotech fully supports the essential public health work that the TGA currently undertakes and urges the Government to do the same by providing appropriate funding for its work.

AusBiotech is working with its AusMedtech Regulatory Affairs Advisory Group and AusMedtech Advisory Group as it responds to this consultation.

Members are invited to read the consultation paper here, and to contact AusBiotech’s Director, Communications and Policy, Karen Parr, with your feedback by Friday 10 March 2023.

Peter Mac and Cartherics in new collaboration to develop CAR-T therapy

Tue, 28 Feb 2023 00:00:00 +1100

CSL reports positive results from pivotal late-stage trial of first-in-class garadacimab

Tue, 28 Feb 2023 00:00:00 +1100

Incannex launches new trial assessing IHL-675A in rheumatoid arthritis

Tue, 28 Feb 2023 00:00:00 +1100

AusBiotech leads Australian Pavilion to BIO with exclusive rate for Australian delegates

Thu, 23 Feb 2023 00:00:00 +1100

The highly-popular Australian Pavilion will be back at BIO in Boston this year, showcasing the Australian biotech industry at the world’s largest and most influential global life sciences conference.

AusBiotech has negotiated a discounted early-bird rate of up to USD$400 off the Premier Access Pass*, which offers access to the main stage programming, receptions and exhibition with the added benefit of BIO One-on-one partnering opportunities. This offer is open to delegates that register through AusBiotech by 14 March 2023.

The Australian biotechnology community is invited to join the AusBiotech delegation and benefit from the wealth of opportunities that BIO brings.

As the national voice of the Australian biotech community, AusBiotech has led the Australian delegation to BIO and hosted the Pavilion for over ten years. The Pavilion will showcase Australian capabilities and promote the strength of the national life sciences sector, helping attendees to foster global connections.

The annual mission to BIO is closely aligned with AusBiotech’s strategic plan, which seeks to facilitate global engagement in strong established markets, including North America and growth markets in Asia. The BIO International Convention attracts 15,000+ biotechnology and pharma leaders for one week of intensive networking to discover new opportunities and promising partnerships. View the full schedule & programme.

To benefit from the AusBiotech early-bird rate, click here to register by 14 March 2023.

*Earlybird AusBiotech Premier Access Pass rate for BIO (USA) members is USD$2400 (standard early-bird rate is USD$2600), and for non-BIO members is USD$2800 (standard early-bird rate is USD$3200). Registrants will be charged in AUD.

Cyban says trial reveals the potential benefit of alternative to invasive intracranial monitoring

Thu, 23 Feb 2023 00:00:00 +1100

Clinical program with the Lambert Initiative expands to include Avecho’s oral cannabidiol

Thu, 23 Feb 2023 00:00:00 +1100

Noxopharm to present Sofra study at international LUPUS 2023 conference

Thu, 23 Feb 2023 00:00:00 +1100

TGA provisionally approves Moderna’s new bivalent COVID-19 vaccine

Thu, 23 Feb 2023 00:00:00 +1100

AusBiotech develops report to boost cell and gene manufacturing

Tue, 21 Feb 2023 00:00:00 +1100

AusBiotech has commissioned research into what is required in order for Australia to manufacture more cell and gene products.

There is an opportunity for Australia to be a regional hub in the Asia Pacific region for cell and gene manufacturing, yet there are a number of barriers. These include quality control processes, infrastructure and large gaps in the people-based capability for manufacturing. Unlocking Australia’s opportunities requires a much better understanding and coordination of our capabilities and addressing where the gaps lie.

The project is funded by the Victorian Government’s Australian Medtech Manufacturing Centre (AMMC) and is being developed by strategic planning and commercialisation firm for the biopharmaceutical and medical device sector, Biointelect. It will outline a strategy and specific recommendations to help the industry unlock opportunities in cell and gene manufacturing.

It will also include updated data from Australia’s Regenerative Medicine Manufacturing Capacity & Capability report, which was previously published in 2021.

AusBiotech has launched an online survey seeking comment on a series of objectives that have been developed as the core of this national strategy. It is estimated that this survey will take no more than 15 minutes to complete and will be emailed to AusBiotech members. Others wishing to contribute to the report are invited to contact Karen Parr, Director Communications and Policy.

International recognition for emerging Brisbane medical technology companies

Tue, 21 Feb 2023 00:00:00 +1100

Europe approves CSL's first gene therapy for Haemophilia B

Tue, 21 Feb 2023 00:00:00 +1100

Dr Joe Smith reappointed as chair of the Agricultural Biotechnology Council of Australia

Tue, 21 Feb 2023 00:00:00 +1100

WA launches inaugural Health and Medical Research Strategy

Thu, 16 Feb 2023 00:00:00 +1100

AusBiotech welcomes WA’s recently-launched Health and Medical Research Strategy 2023 – 2033, which recognises the importance that biotech delivers socially and economically to Australia.

The first state-wide strategy of its kind in WA, it aims to “enhance the State's research and commercial opportunities, support researchers and align WA's vibrant health and medical research sector to create new opportunities.”

The strategy identifies six priority areas including regional and remote health, Aboriginal health, precision medicine, digital health, consumer engagement and prevention.

AusBiotech is pleased to see that sustainable global research translation is a key target, achieved through “ongoing investment and promotion of research capabilities”, and that it recognises the importance of “facilitating the translation of research into economic growth, improved health and investment from international markets”.

It is also encouraged that precision medicine in WA has been recognised for “producing world-standard therapeutically-relevant health and medical research and therapeutics”, and that the strategy will support its ongoing development and growth.

Equally, digital health has been highlighted for the significant role it plays in providing solutions to provide effective, seamless healthcare.

WA has a growing life sciences sector, with the number of organisations more than doubling from 119 in 2017 to 244 in 2022, and the number of employees jumping from around 17,000 to nearly 24,000 over the same period.* It is therefore important that there are effective strategies in place to enhance and support local talent on the commercialisation pathway.

The Strategy builds on a number of related documents, including the Department of Jobs, Tourism, Science and Innovation, Department of Health’s Health and Medical Life Sciences Industry Strategy 2021. Learn more about the WA Health and Medical Research Strategy 2023-2033 here.

*Reference: Ausbiotech Australian Biotechnology Sector Snapshot 2022

Key franchise delivers for CSL as plasma collections top pre-pandemic levels

Thu, 16 Feb 2023 00:00:00 +1100

Unit growth for Cochlear as markets return to pre-pandemic levels

Thu, 16 Feb 2023 00:00:00 +1100

Clarity reaches recruitment milestone for neuroendocrine tumour diagnostic trial

Thu, 16 Feb 2023 00:00:00 +1100

AnteoTech announces the appointment of chief marketing officer

Thu, 16 Feb 2023 00:00:00 +1100

AusBiotech develops first biotech ESG guidance

Tue, 14 Feb 2023 00:00:00 +1100

A group of dedicated AusBiotech leaders have banded together to develop an Australian biotech first, a sector-specific ‘environmental, social and governance’ (ESG) tool, to help companies attract investment and navigate ESG reporting.

AusBiotech’s ESG Working Group is working on the global industry’s first ever guide to tracking and communicating priority ESG considerations.

The resource will assist organisations in their approach to ESG issues relevant to their own company’s circumstances, including suggestions for how to incorporate priority ESG considerations more effectively into policies and procedures. While the resource will draw on global best practice, it has been developed by, and for, Australia’s biotechnology community, and features suggestions for metrics that can be used for measuring and communicating progress.

The life sciences sector, by nature, contributes much to improving lives and the environment, but stakeholders, including investors, are increasingly wanting to be clearly told how companies are doing that. Reporting on a wide range of ESG issues is becoming the norm in many industries, and for life sciences companies this can mean the difference between attracting investment or not.

AusBiotech wishes to acknowledge the significant input and expertise offered by the members of the ESG Working Group:

Joanne Boag, CEO, Oncology One
Michelle Burke, Non-executive director, Cell Therapies
Rebekah Cassidy, Deputy Head of Corporate Affairs, Australia/NZ, Sanofi
Helen Fisher, CEO & MD, BioCapital Impact Fund
Maria Halasz, Lifespan Ventures
Matthew Hoskin, CEO Nirtek
Rhiannon Jones, COO Amplia
Brooke O’Rourke, Director Government Affairs & Sustainability, Cochlear
Siro Perez, Partner & Head of Life Sciences, APAC, IP Group Australia
Rebecca Wilson, EVP International, WE Communications
Lisa Renkin, Director, Investment, AusBiotech

Acknowledging that there are no agreed standards, tools or metrics as yet, this new resource will highlight a range of existing approaches to developing an ESG strategy that can be tailored to each company’s stage along the ESG journey.

The new resource is intended to be a pragmatic, practical, easy-to-use guide for Australian life sciences and biotech companies looking to begin or to expand their ESG strategy and approach to reporting. It is also intended to be useful for investors, highlighting what the priority ESG-related considerations are for biotech companies, and what investors might expect to see from these companies when assessing their ESG credentials.

AusBiotech’s ESG Working Group will shortly be releasing a draft version of the resource, seeking feedback from the sector.

AcuraBio partners with Cytiva to alleviate supply constraints for mRNA, cell and gene therapies

Tue, 14 Feb 2023 00:00:00 +1100

Genetic Technologies says new publication highlights benefits of GeneType test

Tue, 14 Feb 2023 00:00:00 +1100

Call for feedback on revised clinical quality registries framework

Thu, 09 Feb 2023 00:00:00 +1100

The Australian Commission on Safety and Quality in Healthcare has launched a public consultation on its revised clinical quality registries framework, and AusBiotech members impacted by the guidance are invited to get in touch.

First published in 2014, the updated Framework for Australian Clinical Quality Registries Second Edition (the Framework 2nd edition) provides best practice principles and guidance for establishing and operating Australian national clinical quality registries (CQRs).

The Framework has been revised to provide more up-to-date guidance on governance and national infrastructure and security compliance in order to optimise the operational efficiencies of CQRs. It is intended to support the best use of data in reporting and ultimately improve patient outcomes.

AusBiotech is considering submitting recommendations on the Framework, and any member impacted by the revision should contact the policy team to discuss their concerns.

CQRs are an important element of Australia’s healthcare system as they help to identify variations in health outcomes which can be further analysed via clinical trials. In this way, they are an important part of the eco-system of data that supports the understanding of health outcomes and the development of evidence-based clinical guidelines and standards.

For further information and to read the Framework, consult the Commission’s website. AusBiotech members are invited to provide their concerns and feedback to Karen Parr, Director of Policy by 24 March 2023.

Certa Therapeutics announces positive results in phase 2 scleroderma study

Thu, 09 Feb 2023 00:00:00 +1100

Dimerix announces successful conclusion of clinical trial review

Thu, 09 Feb 2023 00:00:00 +1100

Argenica Therapeutics releases preclinical study data on its ARG007

Thu, 09 Feb 2023 00:00:00 +1100

AusBiotech responds to National Reconstruction Fund consultation

Tue, 07 Feb 2023 00:00:00 +1100

On behalf of its members representing the Australian life sciences industry, AusBiotech has welcomed the opportunity to respond to the $15 billion National Reconstruction Fund (NRF) consultation and put forward a number of recommendations in its submission as the Fund seeks to “add value and develop capability … to create high quality, sustainable industries and jobs”.

As the voice and champion of the life sciences sector, AusBiotech’s submission responds to the 21 questions by recommending the optimal design of the Fund for biotech companies to ensure valuable return to Australia both economically and socially.

Highlighting the unique characteristics of the sector when compared to other priority sectors included in the Fund, key messages included the need for patient capital for sustainable growth opportunities; the need to consider companies of all sizes; that success should be measured through a set of balanced financial and non-financial objectives such as patient outcomes and skills and learning development; and the need for biotech-specific expertise at high-level appointments to maximise the contribution of industry knowledge and skills.

In addition, the submission highlighted the opportunity to reframe the National Reconstruction Fund into a ‘fund of funds’ where greater private and public investment into the sector can be added, for example, superannuation funds. This could then create a mechanism to both attract and build (diversify) investments, as well as to overcome key skills gaps that the sector is currently facing.

The NRF is a key initiative of the Australian Government’s A Future Made in Australia policy, announced in October’s Federal Budget. The Fund will co-invest in independently assessed projects that drive economic growth across seven priority areas and over seven years, including $1.5 billion in ‘medical science’ as well as $1 billion each for critical technologies and advanced manufacturing.

The submission refers strongly to the Biotechnology Blueprint, which is the shared vision for the Australian biotechnology ecosystem aimed at delivering benefits and returns to all Australians.

Read the full submission now.

Emyria to expand MDMA programs following TGA psychedelic decision `

Tue, 07 Feb 2023 00:00:00 +1100

Immutep reaches enrolment target for INSIGHT-003 trial in first line NSCLC

Tue, 07 Feb 2023 00:00:00 +1100

Genetic Technologies announces registered direct offering

Tue, 07 Feb 2023 00:00:00 +1100

Optiscan Imaging announces collaboration with Canadian-based company

Tue, 07 Feb 2023 00:00:00 +1100

Agilex Biolabs announces the appointment of new CEO

Thu, 02 Feb 2023 00:00:00 +1100

GTG to form strategic alliance with global testing leader QIAGEN

Thu, 02 Feb 2023 00:00:00 +1100

Antisense Therapeutics announces outcomes in DMD combination animal study

Thu, 02 Feb 2023 00:00:00 +1100

Keynote speaker announced for Women in Life Sciences Luncheon

Thu, 02 Feb 2023 00:00:00 +1100

Gender equality expert and thought leader Dr Kathryn J Evans has been announced as the keynote speaker for the Women in Life Sciences Luncheon in Sydney on 10 March 2023, co-hosted by AusBiotech and Medicines Australia.

As one of Australia’s leading experts in research on women in senior leadership, Dr Evans was awarded a Doctor of Business Administration for her work in this field and in 2020 her research findings were published in the Asia Pacific Journal of Human Resources.

At the Women in Life Sciences Luncheon 2023, Dr Evans will reveal her findings on where Australia sits in world rankings when it comes to gender equity, what progress has been made and what more needs to be done. Importantly, she will share some of her own personal experiences and demonstrate how closing the gender gap can contribute significantly to Australia’s economic success.

The annual Women in Life Sciences Luncheon is timed to celebrate International Women’s Day, on 8 March, and brings together up to 550 leaders and future leaders. It is focused on connecting the community to encourage, support, and further develop women in the life sciences sector in order to achieve a more equal standing in the biotech, pharma and medtech workplace.

Event details

When: Friday 10 March 2023

Where: Doltone House, Jones Bay Wharf, 48 Pirrama Road, Pyrmont NSW 2009

Time: 12.00pm - 3.30pm

The NSW Women in Life Sciences Luncheon 2023 will celebrate leadership at all levels. Leaders that nurture female ambition, elevate and inspire others to achieve their aspirations, and ultimately influence and drive new benchmarks in support of greater diversity in senior leadership positions.

Become a Big Sister

Make a commitment: The successful ‘Big Sisters’ programme will again invite women advanced in their careers in the sector to sponsor a student to attend the event and facilitate their networking during the Luncheon. Up to 30 women students will be sponsored to attend the event and receive a one-year membership of AusBiotech.

Sponsorship of a sister is for the Luncheon only, and a practical and tangible way that leaders in the life sciences can provide support and encouragement to a woman in early stages of her career in life sciences. Sponsors will be recognised at the event and the sponsored sister seated at the same table. To include this sponsorship please select the checkbox during the registration process.

AusBiotech values their partnership with Medicine Australia, and the opportunity to demonstrate change in action around policies of equality and inclusion. Joining forces, this luncheon brings stakeholders together to further galvanise the diversity required within life sciences. For this diversity is the underpinning to building a successful sector – a position supported regardless of gender.

Learn more about how to sponsor a sister and register as an individual or as a table of ten now.

Applications to be a Little Sisters are also being received.

AusBiotech strengthens Board with new appointments

Wed, 01 Feb 2023 00:00:00 +1100

AusBiotech is pleased to announce the latest appointment to its Board of Directors, Erica Kneipp, who brings with her extensive government expertise and policy experience, relevant to the Australian health sector.

Ms Kneipp was a leading figure in the establishment of the $20b Medical Research Future Fund and its $500m+ Biomedical Translation Fund, which doubled Australia’s investment in health and medical research. She also led the Government’s agenda on clinical trial reform enhanced by a collaborative industry forum with state agreed National Partnerships and worked to secure the R&D Tax Incentive clinical trial determination.

Ms Kneipp is currently the Research Director for the Human Health program within the Commonwealth Scientific and Industrial Research Organisation (CSIRO).

She was the driving force behind the Commonwealth’s Health portfolio first representation at the Biotechnology Innovation Organization (BIO) Convention leading the 2018 Ministerial delegation. To this day she remains a strong advocate for the Team Australia approach to promoting our nation’s great biotechnology innovation offerings.

“The life science ecosystem in Australia is vibrant and leading the way in the new innovation economy,” she said.

“The pandemic has reinforced the sector’s worth and has revolutionised its capabilities and sovereign capacity. AusBiotech is a champion of advocacy, and I cannot wait to make a positive contribution to ensuring the settings are right for our sector to thrive.”

In addition, Graham McLean has been appointed as a Board Observer. Graham brings with him a rich and varied experience in healthcare, including 16 years in executive leadership roles at global medtech company Stryker, where he successfully accelerated technology-led growth in multiple businesses.

Based in Sydney, Graham currently serves as the Chair of the Board of Universal Biosensors (ASX:UBI), is a non-executive director at CleanSpace (ASX:CSX)(a high quality respirator manufacturer) and Suicide Prevention Australia and advisory roles and investments in a number of smaller Australian bio/medtech companies including MedTech Actuator. He is also Chair of the AusBiotech NSW Committee (AusBioNSW) which provides support, advocacy and events for NSW members.

“I am thrilled to take on this role as a Board Observer during this exciting phase of significant innovation and growth in our industry. I am passionate about growing the Australian-based biotechnology sector and look forward to working with members to contribute significantly to the success of our industry over the coming years.”

AusBiotech Chair, Mr Geoffrey Kempler, said: “On behalf of the AusBiotech Board, I am thrilled to welcome Erica Kneipp and Graham McLean. Their passion for and commitment to the Australian biotech industry, coupled with Erica’s outstanding achievements and in-depth knowledge of government and policy and Graham’s expertise and success in medtech and commercialisation will be a valuable contribution to the work of AusBiotech in helping the sector to realise its full potential.”

AusBiotech CEO, Lorraine Chiroiu, added: “AusBiotech is the champion of the biotech sector and we are proud to be guided by a Board with such relevant, high calibre experience. Erica and Graham’s rich experience and expertise is reflective of our value, and our ambitious goals and vision. I look forward to working more closely with them as we continue to drive the sector forward and create opportunities to enable its world-class innovation and technologies make a positive contribution to Australia, and the world.”

The new AusBiotech Board, effective today, includes:

Geoffrey Kempler, Chair, Alterity Therapeutics
Dr Megan Baldwin, Managing Director and CEO, Opthea Limited
Lorraine Chiroiu, CEO, AusBiotech
Serg Duchini, Non-Executive Director, ESFAM Biotech
Dr Dean Moss, CEO, UniQuest Pty Ltd

Linda Peterson, Chief Operating Officer and Company Secretary, BioCurate
Dr James Campbell, CEO, Patrys Ltd
Dr Marthe D’Ombrain, Head of Global Research Innovation, CSL Ltd
Erica Kneipp, Research Director, Human Health CSIRO

AusBiotech advocates for sustainable funding model for TGA

Tue, 31 Jan 2023 00:00:00 +1100

AusBiotech has united with industry groups to urge the Government to retain and empower Australia’s world-leading regulator by addressing the outdated funding model it operates under, and to fund its worthy public health initiatives through the upcoming Federal Budget.

In its joint Federal Budget letter, AusBiotech, Medicines Australia, the Medical Technology Association of Australia, ANDHealth, BioMelbourne Network, Life Sciences Queensland, and Life Sciences WA have emphasised that the Therapeutic Goods Administration (TGA)’s current funding model – which is predominantly cost-recovered by industry - is outdated, no longer works for the needs of Australian society and should be brought in line with the models of comparative markets such as the FDA in the US and the EMA in Europe.

While AusBiotech has previously welcomed Government’s commitment to build on the strength of the Australian life sciences industry through ambitious initiatives, such as the $15 billion National Reconstruction Fund (NRF), the Trailblazer Universities Program to support select regional universities to boost research and development, and the establishment of an Australian Centre for Disease Control (CDC), these are at odds with the lack of sustainable federal funding for the TGA.

The TGA plays a vital role in safeguarding the health of the Australian public, however, its remit has evolved significantly and now includes a significant amount of ‘public health activities’ that go beyond evaluating, assessing and monitoring medicines and medical devices. This work now includes management of medicine shortages, providing education to consumer and healthcare professionals, regulation of cannabis products, and management of nicotine vaping products.

Yet the funding model has not evolved to take these new activities into account. While these public health programs represent about a third of the TGA’s work, only about 7% of the TGA’s funding is provided through public funds. The remaining 93% of the TGA’s budget is funded through industry fees and charges. Compared to other well-respected and effective regulatory agencies around the world, the TGA is alone in receiving such a small amount and percentage of public funding.

AusBiotech fully supports the essential public health work that the TGA currently undertakes and urges the Government to do the same by providing appropriate funding for its work.

The Government has an opportunity in the next Federal Budget to enable the TGA to strengthen its position as a globally leading regulator, stay up to date with the increasing pace of innovation, and respond quickly to future health emergencies. If such public funding is not secured it has the potential to diminish the Government’s otherwise ambitious life sciences initiatives, weaken the life sciences ecosystem, and most concerningly, undermine the health of all Australians.

Download the joint submission on the AusBiotech website here.

Alterity’s ATH434 prevents loss of brain cells in Parkinson’s Disease animal model

Tue, 31 Jan 2023 00:00:00 +1100

Centenary Institute announces its new executive director

Tue, 31 Jan 2023 00:00:00 +1100

Emyria confirms the first dosing for EMD-RX5 Phase 3 trial

Tue, 31 Jan 2023 00:00:00 +1100

NSW launches Biosciences Fund to boost the state’s world-class innovators

Tue, 24 Jan 2023 00:00:00 +1100

AusBiotech welcomes the recent announcement of a $40 million Biosciences Fund (BioSF) for NSW startups, researchers, and entrepreneurs to help them realise their full potential and assist them to bring their innovations to market.

The funding will benefit companies in the medical and life sciences, agriculture/agrifoods, and clean energy and waste industries, whose work aligns with the technology applications stated in the State’s 20-Year R&D Roadmap.

In announcing the fund, Minister for Science, Innovation and Technology Alister Henskens said the BioSF “will provide financial and entrepreneurial support for startups developing cutting-edge technologies, helping navigate the often difficult transition between early-stage development and commercial success.”

AusBiotech CEO Lorraine Chiroiu said funds like this are particularly important in an industry where access to capital can dictate whether or not a product makes it to market.

“The biosciences sector in Australia has some of the best researchers and entrepreneurs in the world, developing lifesaving treatments and therapies. Funds like this are an important tool to help them progress on the commercialisation pathway in order to contribute to Australia’s economic success and the wellbeing of all Australians.”

She added that, as the industry is expanding and our researchers and start-ups are creating more complex and innovative solutions to the meet global healthcare needs, the need for a diversity of investment sources has grown.

“Initiatives such as the Biosciences Fund are critical to the future of this industry and help to enable the promise and potential benefits of biotechnology for Australia to be realised. The entire ecosystem needs to work in synergy to ensure our stability and competitiveness in a global environment.”

AusBiotech represents Australia’s dynamic, world-class life sciences industry, which includes biotherapeutics, medical technology (devices and diagnostics), and agricultural biotechnology sectors. As the voice of the industry, it collaborates actively with its members to deliver recommendations to government on the best use of the public funding such as the National Reconstruction Fund, in order to maximise the significant social and economic contribution it makes.

Learn more about the NSW Biosciences Fund.

Chimeric Therapeutics updates on CLTX CAR T clinical trial

Tue, 24 Jan 2023 00:00:00 +1100

FDA approves IND for Prader-Willi syndrome study of Neuren's NNZ-2591

Tue, 24 Jan 2023 00:00:00 +1100

AusBiotech’s draft National Reconstruction Fund submission open for comment

Thu, 19 Jan 2023 00:00:00 +1100

AusBiotech is inviting member feedback on its draft submission to the Australian Government’s $15 billion National Reconstruction Fund (NRF) consultation.

AusBiotech has welcomed the opportunity to submit a response and highlighted how the design of the Fund – particularly given biotechnology’s unique market and development pathways compared to the other priority sectors – will be critical to successfully delivering on its purpose.

The draft submission responds to the 21 consultation questions presented, including how to best define and measure ‘medical science’; its investment needs and opportunities; returns, financial instruments and working with other investors/crowding-in further private investors; and complementary reforms. AusBiotech’s responses build on united positions highlighted in the industry’s strategic plan, the Biotechnology Blueprint, as well as the ideas discussed during the active and engaged members’ roundtable that AusBiotech held in December.

The NRF is a key initiative of the Australian Government’s A Future Made in Australia policy, that was announced in October’s Federal Budget and passed through Parliament in November 2022. The $15 billion fund will co-invest in independently-assessed projects that drive economic growth across seven priority areas and over seven years, including $1.5 billion in ‘medical science’ as well as $1 billion each for critical technologies and advanced manufacturing.

Providing finance (including loans, guarantees and equity) to drive investments that add value and develop capability, it will operate commercially to deliver a positive rate of return.

Read the Government’s consultation papers here; log into the AusBiotech website to read the draft submission here.

To submit feedback on AusBiotech’s draft submission, please contact Karen Parr, Director Communications and Policy by Tuesday 31 January.

US recruitment milestone for trial of Immuron's Travelan

Thu, 19 Jan 2023 00:00:00 +1100

New Year’s resolutions for a healthy future

Tue, 17 Jan 2023 00:00:00 +1100

It’s that time of year again when we return from the festive break brimming with energy, new ideas and resolutions. At AusBiotech, our commitment to the sector is even greater, with a firm resolution to amplify our efforts even further in supporting and advocating for the growth of the life sciences industry.

After a strong 2022, we are looking forward to an even stronger 2023, focused on doing what we do best: bringing the biotech community together to forge valuable partnerships and increase opportunities to access capital; advocating for government policies that enable the sector to realise their potential and continue to add value to the economy; and supporting the industry to continue to improve the lives of people in Australia and beyond.

Resolution one: Take a big(ger) leap on your ESG journey
While the life sciences industry, by nature, contributes much to improving lives and the environment, stakeholders and investors are increasingly wanting to be clearly told how. Reporting on a wide range of Environmental, Social and Governance (ESG) issues is becoming the norm in many industries, and for life sciences companies can mean the difference between attracting investment or not.

Most investors now use ESG considerations when assessing new opportunities. Having an ESG strategy or plan, measuring risk and impact, and documenting progress are no longer ‘nice to have’ – they’re business critical.

AusBiotech’s ESG Working Group will soon be launching for consultation a draft version of a resource designed to help biotech companies do just that: developed by industry, for industry, taking into account companies’ specific needs and challenges.

The resource will be a valuable resource for companies in the early stages of their ESG journey, outlining the key considerations that biotechs need to consider and providing tools and advice on the most appropriate metrics to use.

Keep an eye on the AusBiotech website for more details.

Resolution two: connect the industry through major Australian life science events
Continuing to facilitate opportunities for investment discussions, collaborations and partnerships is crucial for the growth of Australian life sciences sector and ultimately for continuing Australia’s position in the life sciences sector globally.

AusBiotech’s 2023 events programme is already in full swing, beginning with AusBiotech’s Australian Hub in San Fransisco, enabling local life sciences companies to connect with international businesses and investors during JP Morgan week.

Save the dates below for more key industry events.

BioCheers: kicking off from February and March 2022 across the country. Register now
NSW Women in Life Sciences Luncheon: 10 March 2023. Save the date
AusMedtech 2023: 24-25 May, Adelaide, South Australia. Save the date
BIO 2023: 5-8 June, Boston, USA. Announcement coming soon…
AusBioInvest 2023: 30 October, Melbourne, Victoria. Save the date
AusBiotech 2023: 1-3 November, Brisbane, Queensland. Save the date.

Resolution three: Advocate for the advancement of the biotech sector
As the champion of the sector, AusBiotech will continue its work on activities that support the priorities outlined in the Biotechnology Blueprint: A Decadal Strategy for the Australian Biotechnology Industry, which is the shared industry vision for the biotech ecosystem as it aspires to help the industry realise its full potential.

This includes responding to the National Reconstruction Fund consultation, and AusBiotech’s response will be out for member consultation imminently – watch this space. We will also be responding to the annual TGA fees and charges consultation, due to be released later this month; helping to shape a newly proposed ‘TGA Learn’ programme that aims to support the life sciences industry to successfully navigate the regulatory pathway and support post market compliance activities; and running our annual invitation-only c-suite state-based roundtables in the first quarter of 2023 to engage members on AusBiotech’s advocacy plan ahead.

Other activities in the pipeline include continuing the revision of The Code of Best Practice for Reporting by Life Sciences Companies (the Code) which will be distributed to members for feedback in the near future, along with the development of a policy position on the value of end-to-end tax incentives, with more information to follow soon.

In addition, we will continue to promote opportunities to champion the sector and share the success of our members. It will be a busy year, and we look forward to working with you all to make it a great one.

Dimerix confirms the outcomes of a meeting with the FDA on paediatric plan for DMX-200

Tue, 17 Jan 2023 00:00:00 +1100

Victorian program aims to connect organisations with digital talent pool

Tue, 17 Jan 2023 00:00:00 +1100

2022: The year we came alive (again)

Tue, 20 Dec 2022 00:00:00 +1100

It has been a year to remember, when the biotech sector ‘came alive’ and reunited in person once more, as witnessed in the record attendance at our national conference and other industry events. Despite the many challenges, the life sciences sector has continued to push boundaries with innovative approaches and technologies at the forefront.

As the national voice of the biotech industry, AusBiotech’s achievements are a continuing reflection of the commitment of our members, as dedicated as we are to advance the sector and enable it to continue to realise its potential.

Highlights from 2022

Biotechnology Blueprint

For the first time in 20 years, involving more than two years of work and 350 stakeholders, AusBiotech was excited to launch the Biotechnology Blueprint: A Decadal Strategy for the Australian Biotechnology Industry – a shared industry vision and ‘blueprint’ navigating the biotech ecosystem as it aspires to build solid companies, create more jobs, commercialise more iotechnologies, build sovereign capabilities and deliver greater benefits and returns to Australia and all Australians.

Making biotech a ‘beacon on the Hill’, a one-day AusBiotech CEO Policy Forum united 27 CEOs with the Hon. Ed Husic MP, Minister for Industry and Science, Commonwealth Departments and a peak industry body to discuss the key topics of the Biotechnology Blueprint and how, together, we can enhance our sector and support Australia’s bioeconomy.

Read the Blueprint here.

Record-breaking attendance at AusBiotech events

In line with sector-wide record-breaking stats, we are tremendously proud of the successes we have seen in our international, national and state-based events. This year we have seen our largest numbers for AusBiotech 2022; AusBioInvest 2022; BIO 2022; AusMedtech 2022; and our NSW Women in Life Sciences Luncheon.

Held this year in Perth from 26-28 October, Australia’s ‘biggest week in biotech’ included AusBiotech 2022, Australia’s largest life science conference attracting more than 1,000 registered attendees, and AusBioInvest, the sector’s premier investment conference with more than 300 registered.

Running for more than 37 years, AusBiotech 2022 featured an industry-led programme of more than 160 thought leaders across over 40 sessions that succeeded in inspiring, informing, engaging and enhancing the biotech community.

AusBioInvest 2022, the largest investment and partnering conference in the Australian life sciences sector, featured a programme rich with informative and insightful presentations from global venture capital and investment experts, in addition to the 29 Australian early to late-stage biotech companies seeking funding partners that showcased their projects.

We were pleased to have th strong support of the WA Government, with Deputy Premier of Western Australia, Hon. Roger Cook MLA; the Hon. Stephen Dawson MLC, Minister for Innovation and ICT; Medical Research; Emergency Services; Volunteering; the Hon. Amber-Jade Sanderson MLA; and Western Australia’s Chief Scientist Professor Peter Klinken engaging throughout the week.

AusBiotech, in partnership with Johnson & Johnson Innovation, delivered three 2022 Industry Excellence Awards during the annual Awards ceremony. Congratulations again to:

Emerging Company of the Year - Fusetec
Company of the Year - Telix Pharmaceuticals
Industry Leadership Award - Professors Steve Wilton AO and Sue Fletcher AO

In addition the AusBiotech Life Sciences Legacy Award went to Dr Andrew Forrest AO and Nicola Forrest AO.

Revisit the event at the photo galleries here.

AusBioNSW

Earlier this year AusBiotech was proud to launch AusBioNSW, a new peak industry membership body for NSW, to represent, connect, and promote NSW organisations doing business in and with the local, national and global life sciences economy.

The prosperous NSW community of medtech and biotech companies is now supported by a dedicated local body to foster local connection, and ensure it is structurally connected to national and global happenings and supported to capitalise on growth opportunities and on new technologies.

Advancing cell and gene accessibility in Australia

The inaugural Steering Group to lead the Celle and Gene Catalyst (the Catalyst) was established, comprising of AusBiotech, Medicines Australia, CSL Behring, Novartis, Pfizer, Therapeutic Innovation Australia and Cell Therapies.

The Catalyst will bring to life the Regenerative Medicines in Australia: A Strategic Roadmap for the Regenerative Medicines Sector through leadership, advice and support, as the Catalyst seeks to create an end-to-end world-class value chain that can discover, develop, manufacture, and distribute cell and gene therapies to Australian patients, while creating jobs, commercialising research, and exporting Australian therapies to the world. Learn more here.

Save the dates for 2023 events

Australian Hub at JP Morgan Week: 9-12 January 2023. Register now.
BioCheers: kicking off around the country from February and March 2022. Register now
NSW Women in Life Sciences Luncheon: 10 March 2023. Register now.
AusMedtech 2023: 24-25 May, Adelaide, South Australia. Save the date and submit your programme ideas now
BIO 2023: 5-8 June, Boston, USA. Save the date, announcement coming soon…
AusBiotech 2023: 1-3 November, Brisbane, Queensland. Save the date.
AusBioInvest 2023: 30 October, Melbourne, Victoria. Save the date

Summer break office closure

The AusBiotech office will be closed over the holiday period from Wednesday 21 December 2022 until Tuesday 03 January 2023. Biotech Dispatch will resume on Tuesday 17 January 2023.

AusBiotech thanks its members for a fantastic year and their ongoing support, wishes them a happy and safe festive period, and looks forward to working together during 2023.

Dimerix completes recruitment in first part of DMX-200 trial

Tue, 20 Dec 2022 00:00:00 +1100

LBT Innovations subsidiary appoints APAS Independence distributor for Europe

Tue, 20 Dec 2022 00:00:00 +1100

Bionomics reports topline results in PREVAIL study of BNC210

Tue, 20 Dec 2022 00:00:00 +1100

ARCS Signature Program launched for senior leaders

Thu, 15 Dec 2022 00:00:00 +1100

ARCS has recently launched the ARCS Signature Program, aimed at equipping senior industry leaders with local industry knowledge.

Research done by ARCS identified a gap in the training of senior pharmaceutical, medical technology and biotechnology executives in Australia, where a deep understanding of the local environment from a commercialisation perspective was sometimes lacking.

This new initiative is aimed at senior executives heading up Australian affiliates of multinationals and those at small and medium enterprises who have strong product knowledge but don’t fully understand the local environment. Australian expats with international experience returning to Australia could also benefit.

According to ARCS, the Signature Program “will build on participants’ strong competency in their field, provide an opportunity to expand each leader’s business acumen and build a comprehensive knowledge of the landscape and the competencies needed to be a successful healthcare executive in Australia.”

The topics covered include the healthcare business environment, commercialisation and leadership practice.

For more details and how to apply see ARCS Australia’s website.

Have your say on the National Reconstruction Fund with AusBiotech

Tue, 13 Dec 2022 00:00:00 +1100

Consultations on the National Reconstruction Fund (NRF) have now opened, and AusBiotech is inviting members to join its roundtable discussion to have their say and shape industry’s submission so it best meets the sector’s needs.

The NRF is a key initiative of the Australian Government’s A Future Made in Australia policy, announced in October’s Federal Budget and passed through Parliament last month. The $15 billion fund will co-invest in independently assessed projects that drive economic growth across seven priority areas and over seven years, including $1.5 billion in ‘medical science’ as well as $1 billion each for critical technologies and advanced manufacturing.

As the voice and champion of the life sciences sector, AusBiotech is developing a submission recommending the optimal design of the Fund to ensure valuable return to Australia both economically and socially.

To ensure the submission best represents member’s views on how the funding should be allocated to best enable the translation of Australian biotech ideas, AusBiotech is holding an online roundtable on Wednesday 14 December and is inviting interested members to attend.

The key areas that our submission will include:

Identifying the types of life sciences projects or investments industry believes the Government should direct the NRF to focus on;
How industry ‘transformation’, ‘diversification’ and ‘value add’ be defined and measured for biotech;
The manufacturing and other capabilities needed to support them;
The gaps and barriers to private sector investment in biotech; and
How the NRF can help build or encourage stronger pathways for Australian-developed innovation and research and encourage additional private investment.

The AusBiotech online roundtable will be conducted on Wednesday 14 December from 2.45pm – 4pm. To get involved and have your say, register your place today by contacting Karen Parr, Director Communications and Policy.

CSL announces the appointment of its new CEO and managing director

Tue, 13 Dec 2022 00:00:00 +1100

Major industry award for Australian scientist at the forefront of genetic breast cancer research

Tue, 13 Dec 2022 00:00:00 +1100

Nominations open for PM’s Prizes for Science

Thu, 08 Dec 2022 00:00:00 +1100

AusBiotech is encouraging the biotech sector to nominate talented industry colleagues for the 2023 Prime Minister’s Prizes for Science, Australia’s most prestigious awards for outstanding achievements in science.

Ranging between $50,000 - $250,000, the prizes reward excellence in scientific research, research-based innovation and excellence in science teaching, with a total of up to $750,000 up for grabs.

The Science Prizes are a valuable opportunity for the life sciences community to showcase their outstanding expertise and the value that their work contributes to the Australian economy and to the health of Australians and others worldwide.

The Prime Minister’s Prizes for Science include:

Prime Minister’s Prize for Science ($250,000)
Prime Minister’s Prize for Innovation ($250,000)
Malcolm McIntosh Prize for Physical Scientist of the Year ($50,000)
Frank Fenner Prize for Life Scientist of the Year ($50,000)
Prize for New Innovators ($50,000)

Last month AusBiotech congratulated AusBiotech members Adjunct Professor Alison V. Todd PhD FTSE and Dr Elisa Mokany, co-founders of SpeeDx Pty Ltd, for winning the 2022 Prime Minister’s Prize for Innovation for their ‘outstanding contribution to public health’. Together they founded the successful Australian biotech company, pioneering and commercialising diagnostic tests identifying cancer and infection diseases, including bacteria and resistance to antibiotics, thus helping in the global war against antimicrobial resistance.

The Prime Minister’s Prizes for Science is part of the Inspiring Australia – Science Engagement Program.

Nominations close 9 February 2023.

For more information, see the Prime Minister’s Prizes for Science – Science Prizes.

CSL opens its new 'Australian Plasma Fractionation Facility' in Melbourne

Thu, 08 Dec 2022 00:00:00 +1100

Novotech awarded the Asia Pacific CRO of the Year 2022 for 'Best Practices in Clinical Trials'

Thu, 08 Dec 2022 00:00:00 +1100

Contributions now open for upcoming Australasian Biotechnology`

Tue, 06 Dec 2022 00:00:00 +1100

Medtech will take centre stage as the key theme for the April 2023 edition of AusBiotech’s Australasian Biotechnology journal, and industry experts interested in sharing their insights and innovations are invited to get in touch.

AusBiotech is welcoming thought leadership articles from our valued members on the following themes: medtech, artificial intelligence and big data; real-world evidence; telehealth and; robotics.

The journal will also include a preview of AusMedtech 2023, Australia’s premier medtech conference that will be held on 24-25 May in Adelaide, South Australia. The high-profile event will bring together the key players in Australian devices and diagnostics to exchange new findings and discuss new insights in order to challenge current thinking and advance the sector.

Australasian Biotechnology is AusBiotech’s official biannual journal, published in April and October each year. It features informative and insightful articles about latest technologies and the most up-to-date solutions to the pressing issues and challenges that the industry faces.

A leading voice in the biotech sector, Australasian Biotechnology reaches over 3,000 AusBiotech members and investors, and is also available online. Its readership includes companies, government and university departments, research institutes, biotechnology and professional services providers nationally, and in key overseas markets.

Members with an idea for a submission are invited to send a 200-word abstract on the proposed topic to the AusBiotech communications team by 30 January 2023.

If accepted, the full article (500-1000 words) will be due by 10 February 2023, accompanied by high resolution photos.

Any questions or queries about your submission should be directed to the AusBiotech communications team

Tessara Therapeutics and NETRI in new organ-on-chip collaboration

Tue, 06 Dec 2022 00:00:00 +1100

Sanofi partners with Queensland to create the 'mRNA Translational Science Hub'

Tue, 06 Dec 2022 00:00:00 +1100

Collaboration with the University of SA and successful capital raise

Tue, 06 Dec 2022 00:00:00 +1100

Noxopharm provides an update on trial of its oncology drug candidate

Tue, 06 Dec 2022 00:00:00 +1100

Vaxxas appoints Doug Cubbin as its new chief financial officer

Tue, 06 Dec 2022 00:00:00 +1100

National Reconstruction Fund takes a step forward

Thu, 01 Dec 2022 00:00:00 +1100

The introduction of the $15bn National Reconstruction Fund (NRF) has been welcomed by AusBiotech as a positive step forward, and the investment of the ‘medical science’ funds moving closer to reality.

The legislation enabling the establishment of the Fund is a key initiative of the Australian Government’s A Future Made in Australia policy. It was announced in October’s Federal Budget and is expected to be introduced to Parliament this week.

The fund will co-invest in independently assessed projects across seven priority areas and over seven years, including $1.5 billion in ‘medical science’ as well as $1 billion each for critical technologies and advanced manufacturing.

Industry and Science Minister Ed Husic noted in his National Press Club speech this week that the Fund will be governed by an independent board.

Mr Husic said the Fund will “help drive economic development in our regions and outer suburbs, boosting our sovereign capability, diversify the nation’s economy, and importantly, help create secure jobs”.

AusBiotech CEO Lorraine Chiroiu said: “Australia’s health and medical researchers are world class, and investments such as the National Reconstruction Fund are vital to enabling home-grown biotechnologies to realise their potential and deliver the benefits of research and innovation to all Australians.”

“The Fund is seeking to leverage Australia’s competitive strengths through co-investment vehicles – which is different from grant programmes that we’ve previously seen. We look forward to continuing to engage with Minister Husic and the Department of Industry, Science and Resources to ensure the design of the Fund will support the high-value biotechnology opportunities that are abundant in Australia”.

AusBiotech is dedicated to the development, growth, and prosperity of the Australian life science industry. To this end, the National Reconstruction Fund was one key topic of discussion at AusBiotech’s recent CEO Policy Forum that brought together 27 biotech company CEOs to exchange on key topics in the Biotechnology Blueprint (Blueprint). The day-long meeting highlighted the complexity of biotech policy, as industry and government departments, including Minister Husic, convened in its goal to support Australia’s transformative biotechnologies.

As the national voice of the biotech industry for more than 35 years, AusBiotech will convene a roundtable policy discussion on how the NRF design would best enable the translation of our home-grown biotech ideas and invites AusBiotech members to express their interest in attending.

The industry-focused roundtable will be hosted later this month to recommend how the fund may best deliver value for Australia, as outlined in the Blueprint, as it aspires to build solid companies, create more jobs, commercialise more biotechnologies, build sovereign capabilities, and deliver greater benefits and returns to Australia and all Australians.

Discussion will include consideration of recommendations for the size of a co-investment, the return-on-investment period, and the scope of the investment vehicles, for example whether non-financial return should be considered when building Australia’s sovereign capabilities.

AusBiotech members are invited to attend this roundtable, hosted by AusBiotech CEO Lorraine Chiroiu, and should register their interest with Karen Parr, Director, Communications & Policy by 7 December.

Developer announces plans for new medical research facility in Brisbane

Thu, 01 Dec 2022 00:00:00 +1100

WEHI scientist recognised with CSL Florey Medal for malaria research

Thu, 01 Dec 2022 00:00:00 +1100

Pre-clinical data for Kazia Therapeutics' EVT801 published in cancer journal

Thu, 01 Dec 2022 00:00:00 +1100

Artificial intelligence high on life sciences’ agenda

Tue, 29 Nov 2022 00:00:00 +1100

AusBiotech welcomes a new report on artificial intelligence (AI) from CSIRO, designed to help those in the science sectors get a greater understanding of AI, how it’s changed and what the future holds for Australia in particular.

CSIRO’s Artificial intelligence for science – adoption trends and future development pathways report has recently been published to help science managers, science organisations and investors understand plausible development pathways for AI.

The report states that health and life sciences are leading the way in the use and development of AI, making up 22 percent and 20 percent respectively of publishing volume of the global research effort, thereby helping to address some of the world’s greatest challenges.

Case studies illustrate the importance of AI in the sector, such as in the case of using deep learning to develop a model to identify drugs for antibiotic-resistant bacteria.

It also highlights the importance of quality data in our sector and predicts these areas are likely to “invest greater effort in developing higher quality and fit-for-purpose data sets”.

Recognising the importance and potential of AI in health, the upcoming AusMedtech 2023, Australia’s premier medical technology conference, will feature discussions and presentations from experts in the field on what AI means for the sector and how to benefit most.

It will also be featured in the upcoming issue Australasian Biotechnology Journal published in April 2023.

Registrations for AusMedtech 2023, to be held 24 – 25 May, will be opening soon.

Sonic Healthcare takes a major strategic stake in Microba

Tue, 29 Nov 2022 00:00:00 +1100

Emyria accepted into US National Institutes of Health research program

Tue, 29 Nov 2022 00:00:00 +1100

Immutep announces new collaboration for cancer treatment combination

Tue, 29 Nov 2022 00:00:00 +1100

AusBiotech gets behind campaign to combat the ‘silent pandemic’

Thu, 24 Nov 2022 00:00:00 +1100

Antimicrobial resistance is a ‘silent pandemic’, estimated to kill 10 million people every year from 2050, according to a new video from the International Council of Biotechnology Associations (ICBA), which includes AusBiotech.

The video was launched as part of the United Nation’s World Antimicrobial Awareness Week (WAAW) and AusBiotech is supporting global efforts to raise awareness of the impacts of antimicrobial resistance (AMR) and encourage the biotech sector to get behind it. Increased awareness and improved best practices by the health sector and the general public all help to reduce its emergence and spread.

The theme of this year’s WAAW is Preventing Antimicrobial Resistance Together. “We call on all sectors to encourage the prudent use of antimicrobials and to strengthen preventive measures addressing AMR, working together collaboratively through a One Health approach,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus.

Rising antimicrobial resistance was identified as one of nine key macro trends that would impact the biotech industry in AusBiotech’s Biotechnology Blueprint, and thus a key consideration in AusBiotech’s vision to drive and grow the Australian biotechnology ecosystem to advance the sector and improve the lives of all Australians.

AusBiotech CEO Lorraine Chiroiu said antimicrobial resistance is a global public health concern and the entire biotech sector needs to work together to find solutions to address it.

“Australia has specific strengths and capabilities in science and research related to immunity and infectious diseases, as well as some unique pathogens of concern to Australia and the neighbours in our region,” she said.

“It is important we mobilise these strengths and support global efforts to ensure it remains top of the agenda to encourage best practices to minimise its spread, and new treatments and technologies to combat it.”

Learn more about the urgent need to address AMR in the video from ICBA and SwedenBIO, ‘The Silent Pandemic’.

Learn more about what AMR means for Australia in CSIRO and AAMRNet’s recently released ‘Antimicrobial Resistance (AMR) Impact Report: How big is Australia’s AMR threat?’.

CSL secures US approval for breakthrough one-time haemophilia gene therapy

Thu, 24 Nov 2022 00:00:00 +1100

Australian venture capital fund joins partners in backing new immunotherapy

Thu, 24 Nov 2022 00:00:00 +1100

AusBiotech Policy Forum: Biotech leaders head to Parliament

Tue, 22 Nov 2022 00:00:00 +1100

Parliament House Canberra will today host biotech leaders for a day of discussions and presentations with the government. The delegation of 27 CEOs will exchange on key topics in the Biotechnology Blueprint.

The Hon Ed Husic (MP), Minister for Industry and Science, along with representatives from the Department of Health and Aged Care and the Department of Industry, Science and Resources will join industry leaders to work collaboratively to enhance our sector and to learn how it is supporting the bioeconomy.

The Forum is also a powerful opportunity to bring the life science sector’s economic and social contributions to Australia to the forefront and facilitate increased communication and collaboration between industry and government.

Key policies and topics to be discussed include the National Medicines Policy and HTA review; the Medical Research Future Fund; the National One Stop Shop and Clinical Trials Front Door; focus areas of the TGA; the evolving landscape of IP; the University Research Commercialisation Plan and more.

Learn more about the Biotechnology Blueprint and AusBiotech’s policy and advocacy work.

Phase 2 trial of ChulaCov19 BNA159 mRNA Vaccine to start in Australia

Tue, 22 Nov 2022 00:00:00 +1100

IND approval from the US FDA for theranostic SARBombesin trial in prostate cancer

Tue, 22 Nov 2022 00:00:00 +1100

Zelira Therapeutics announces successful enrolment in new trial Zelira Therapeutics

Tue, 22 Nov 2022 00:00:00 +1100

AusBiotech connects the sector to celebrate 2022

Thu, 17 Nov 2022 00:00:00 +1100

Join us for our Australia-wide end-of-year functions to network with colleagues and friends and reflect on the year we’ve had.

It’s been a year to remember and in true AusBiotech style, we want to bring the biotech community together to celebrate it.

The AusBiotech End-of-Year Functions are now open for registration and members are invited to sign up to our events being held in Victoria, New South Wales and Queensland.

A chance to connect with industry colleagues in your state, the events are also an opportunity to celebrate the year that was, reflect on the challenges and achievements and enjoy some festive cheer.

Bringing the Australian biotech community together is a key part of AusBiotech’s mission and vision, recognising that connection and collaboration is vital to enabling the development of the sector’s world-class and innovative products and technologies.

Register now for the AusBiotech End-of-Year functions held in Queensland on the 29th November, New South Wales on the 7th December and Victoria on the 14th December.

Commercialisation a key priority in future MRFF decisions

Tue, 15 Nov 2022 00:00:00 +1100

AusBiotech has welcomed the inclusion of commercialisation as a key priority in the recently launched Australian Medical Research and Innovation Priorities 2022-2024.

‘Translation and commercialisation’ is one of the nine priorities, emphasising a focus on ‘research translation implementation and commercialisation by facilitating collaborations between the research sector, industry and community’.

The independent Australian Medical Research Advisory Board (AMRAB) develops the five-year Australian Medical Research and Innovation Strategy, and the priorities will be in force for two years.

AusBiotech CEO Lorraine Chiroiu said this is good news for the sector but the focus needs to be maintained over the long term to have a positive effect.

“Australia’s health and medical researchers are world class, and by prioritising commercialisation as part of the overall strategy, the fund can truly deliver the benefits of their research and innovation to all Australians,” she said.

The $20 billion MRFF was developed as a long-term investment to support Australia’s world-class health and medical research and innovation. The goal of the fund is that it will help to build the economy, contribute to a more sustainable health system and to improving the lives of Australians.

The other 2022-2024 Priorities are:

Research infrastructure and capability
Health and medical researcher capacity and capability
Comparative effectiveness research
Consumer-driven research
Preventive and public health research
Primary care research support
Priority Populations
Aboriginal and Torres Strait Islander Health

Learn more about the MRFF Strategy and Priorities and the responses to the public consultation submissions.

Telix acquires US radiochemistry business Optimal Tracers

Tue, 15 Nov 2022 00:00:00 +1100

QIMR and WEHI take home prizes for best early-stage project

Thu, 10 Nov 2022 00:00:00 +1100

Projects from QIMR Berghofer Medical Research Institute and WEHI - The Walter and Eliza Hall Institute were this year’s joint winners of the AusBiotech 2022 Early-Stage Investment Forum (ESIF) after winning the pitching event judged by an independent expert investment panel.

Chair of the panel, Kathy Connell, Senior Director External Innovation Australia & New Zealand, Johnson & Johnson Innovation said they were so impressed with the calibre of the presentations that it was extremely difficult to reach consensus on one winner, so at the last minute they decided to offer two.

“It was exciting to hear from the next generation of Australian scientists, innovators entrepreneurs at Early-Stage Investment Forum. We saw innovative technologies which have the potential to deliver much needed health benefits for patients and the potential to deliver meaningful return for healthtech, biotech and medtech investors globally,” she said.

Dr Melissa Knight from Knight Life Consulting represented QIMR Berghofer Medical Research Institute pitching Prof Rajiv Khanna and Dr Paulo Martins’ off-the-shelf CMV EphA3 CAR T cell therapy. The novel cellular immunotherapy combines an EphA3-CAR with allogeneic CMV-specific T cells allowing a dual-targeted approach to treat EphA3 positive solid-tumours with glioblastoma multiforme (GBM) as the lead indication.

Dr Knight said she was excited to receive the award to draw attention to this potentially life-saving treatment.

“There is an urgent need to develop new treatments for GBM patients as prognosis remains poor. I am hopeful Prof Khanna’s therapy will overcome current limitations in treating solid tumours with CAR T cell therapies, and being off-the-shelf, will reduce time to treatment which is important for such aggressive tumours.”

Joint winner WEHI was recognised for Jonathan Bernardini’s presentation of BioTACs, the next generation of Cell-Surface Targeted Protein Degraders. This new technology, called BioTACs, re-trains the cell's own recycling machinery to degrade disease-causing proteins on the cell surface.

Dr Bernardini commented: "We are developing an exciting new degrader platform technology for potential applications in inflammation, immunotherapy and cancers. Having the opportunity to pitch this programme to industry leaders was invaluable. The feedback and conversations that followed have really helped to refine our thinking and have got us a step further to spinning out this exciting programme."

The winners were selected from 22 presentations from research institutes, universities, hospitals and pre-series A companies in the area of human therapeutics and enabling technologies.

The Early-Stage Investment Forum, a key element of the AusBiotech 2022 programme and proudly supported by WEHI, encourages, recognises and rewards some of Australian life sciences’ most promising early-stage technology and projects and offers them the chance to gather feedback essential for commercialising early-stage projects and technologies.

Running at AusBiotech’s premier annual conference, AusBiotech, since 2018 and AusMedtech, Australia’s leading medical technology conference, since 2021, the ESIF is a key aspect of AusBiotech’s work in empowering start-ups and SMEs during their commercialisation journey.

The Forum features quick-pitch presentations to a panel of industry experts, giving applicants the opportunity to gather valuable feedback that will help them to commercialise their projects and technologies.

Joining Ms Connell on the independent expert panel was Dr Samantha South, Executive Director, Argenica Therapeutics; Dr Siro Perez, Partner & Head of Life Sciences APAC, IP Group Australia; and Rob Crombie, Senior Commercialisation Facilitator, Accelerating Commercialisation.

AusBiotech 2022 was proudly supported by Host State Partners, the Western Australian Government and Business Events Perth.   

Vaxxas launches clinical trial of needle-free COVID-19 vaccine candidate

Thu, 10 Nov 2022 00:00:00 +1100

BiomeBank announces world first regulatory approval for donor derived microbiome drug

Thu, 10 Nov 2022 00:00:00 +1100

Brandon Capital Invests in neuroscience company NRG Therapeutics

Thu, 10 Nov 2022 00:00:00 +1100

EpiAxis Therapeutics in new agreement with US research hospital

Thu, 10 Nov 2022 00:00:00 +1100

Join Australians in biotech during JP Morgan Week 2023

Tue, 08 Nov 2022 00:00:00 +1100

Registrations are now open to use AusBiotech's Australia Hub, which will be available to Australians heading to San Francisco during the annual JP Morgan Week in January 2023.

The AusBiotech Australia Hub provides delegates with a central base from which to work in the heart of the action, close to Union Square in San Francisco where JP Morgan week activities are held. It offers delegates a valuable opportunity to network and interact with other industry colleagues while providing a convenient base from which to conduct their business.

Located on the top floor of The Box SF, at 1069 Howard Street San Francisco (Howard St at Moss between 6th and 7th Streets), the space is in a prime location and will accommodate up to 50 people at any given time across two rooms.

AusBiotech members can now register two delegates per membership free of charge to utilise the Hub for up to four days between 9 - 12 January 2023, while non-members can purchase a day pass for $300, or four days’ access for $1,000. Places are allocated on a first come first served, as numbers are limited. Hub access also includes complimentary tea, coffee and water. 

Register here by Wednesday 23 November. Any questions about the Hub can be directed to the AusBiotech Events team, or call 0439 234 023 during business hours.

Certa Therapeutics welcomes 'ground-breaking' results from research

Tue, 08 Nov 2022 00:00:00 +1100

Alterity Therapeutics updates on Multiple System Atrophy study

Tue, 08 Nov 2022 00:00:00 +1100

Telix announces positive topline results of late-stage imaging study

Tue, 08 Nov 2022 00:00:00 +1100

New AusBiotech Board fit for the era

Thu, 03 Nov 2022 00:00:00 +1100

In an era of innovation commercialisation, the latest election to AusBiotech’s Board of Directors, Dr Marthe D’Ombrain (Head of Global Research Innovation, CSL Limited), was announced at today’s Annual General Meeting and brings appropriate skills and experience to support growth of the industry.

AusBiotech has also farewelled two important Directors, Dr Jan Tennent, Founder & Principal, ConnectBio, and Dr Serge Scrofani, Vice President, Strategy & Corporate Development, CSL Limited.

Dr Marthe D’Ombrain brings experience encompassing research, commercialisation, licensing, strategy, business development, project management, partnerships, and fundraising.

Marthe has worked in the life sciences sector for over 20 years and has extensive leadership experience across industry and academia, both locally and internationally. She plays a key role in building and diversifying CSL’s global R&D portfolio, and has championed the establishment of an early-stage fund – the CSL Research Acceleration Initiative – that establishes partnerships between CSL and global research organisations and invests in promising discoveries to accelerate translation and fast-track the development of innovative biotherapies to address unmet patient needs.

Recently, Marthe has been involved in establishing a new biomedical incubator that will be located at CSL’s new global corporate headquarters in the world-leading Melbourne Biomedical Precinct. The incubator will support Australian and international start-up companies to translate promising medical research into commercial outcomes.

AusBiotech Chair, Mr Geoffrey Kempler, said, “On behalf of the AusBiotech Board, I am delighted to welcome Dr Marthe D’Ombrain. Her perspective, experience and passion to support biotech companies across the pipeline aligns to AusBiotech’s vision and mission as we work to foster a growing, strong and profitable biotech industry in Australia.”

“I also extend my sincere thanks to Dr Jan Tennent, ConnectBio, and Dr Serge Scrofani, CSL Limited, for their service and considered guidance and advice throughout their tenures. Jan has retired from the AusBiotech Board after five years of dedicated service. As Chair of our Remuneration and Nomination Committee, Jan has been instrumental in developing and driving a range of processes, and pivotal in the governance of AusBiotech. Serge has retired after three years’ service to the Board, where he contributed via the Remuneration and Nomination Committee.”

The new AusBiotech Board line up, effective today, includes:

Geoffrey Kempler, Chair, Alterity Therapeutics
Dr Megan Baldwin, Managing Director and CEO, Opthea Limited
Lorraine Chiroiu, CEO, AusBiotech
Serg Duchini, Non-Executive Director, ESFAM Biotech
Dr Dean Moss, CEO, UniQuest Pty Ltd
Linda Peterson, Chief Operating Officer and Company Secretary, BioCurate
Dr James Campbell, CEO, Patrys Ltd
Dr Marthe D’Ombrain, Head of Global Research Innovation, CSL Ltd

-ENDS-
Media enquiries: Karen Parr, Director, Communications & Policy, AusBiotech,
kparr@ausbiotech.org / M: +61 (0) 428 056 173

About AusBiotech

AusBiotech is Australia’s biotechnology organisation, working on behalf of members for more than 35 years to provide representation and services to promote the global growth of Australian biotechnology. AusBiotech is a well-connected network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), food technology and agricultural sectors.

Orthocell's Remplir added to Australia's Prostheses List

Tue, 01 Nov 2022 00:00:00 +1100

Australia rises in global rankings of early and mid-stage clinical trials

Tue, 01 Nov 2022 00:00:00 +1100

Life sciences industry’s highest achievers celebrated at prestigious Awards ceremony

Thu, 27 Oct 2022 00:00:00 +1100

AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards

Industry Leadership Award: Professors Steve Wilton AO and Sue Fletcher AO
Company of the Year: Telix Pharmaceuticals
Emerging Company of the Year: Fusetec

AusBiotech Life Sciences Legacy Award: Dr Andrew Forrest AO and Nicola Forrest AO

Biotech’s illustrious Industry Excellence Awards were announced today at the AusBiotech 2022 national conference in Perth – recognising outstanding contribution and achievement. The AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards recognise innovative companies and individuals in Australia’s world-class biotechnology, medical technology and healthcare sectors.

Dr Andrew Forrest AO and Nicola Forrest AO were also awarded the AusBiotech Life Sciences Legacy Award in recognition of their generous and active support of medical research and Australian life science innovation.

AusBiotech’s Chief Executive Officer, Lorraine Chiroiu, said: “These prestigeous Awards act as a celebration of the cutting-edge innovation excellence happening across the country and the extraordinary progress that these individuals and companies have contributed to the health of Australians, and to the growth of the sector.”

“Congratulations to the recipients, who demonstrate what can be achieved when innovation, passion, and drive are accompanied by the vision and leadership needed to bring novel medicines, medical devices and other new technologies to patients.”

Announcing the awards, Ms Kathy Connell, Senior Director, External Innovation Partnering, ANZ, Johnson & Johnson Innovation, said: “Johnson & Johnson Innovation is proud to sponsor these awards, and to celebrate and recognise these exceptional recipients for their commitment to lifescience innovation excellence. The discovery, development and commercialisation of biomedical research takes a global effort from diverse ecosystem including scientists, entrepreneurs, philanthropists and industry partners. This years’ awardees represents contributions from across Australia and we commend their work as they seek to advance healthcare for humanity around the world.”

Dr Forrest said: “We are passionate about finding ethical and sustainable solutions to a range of issues that impact people and the planet, and we trust that our commitment and passion, in both our philanthropy work and the commercial investments we make, is helping to make the world a better place.

“We back Australian research and businesses, as well as partner with people across the world to share information and accelerate the development of breakthrough therapies, life-changing products and medical treatments. We are investing in the future of Australian healthcare innovation in a way that hasn’t been done here before.”

More on the 2022 winners

Industry Leadership Award Professor Steve Wilton AO, Director Centre for Molecular Medicine and Innovative Therapeutics and Foundation Chair in Molecular Therapies, Murdoch University and Director Perron Institute for Neurological and Translational Science Perth, WA; and Professor Sue Fletcher AO, Principal Research Fellow Centre for Molecular Medicine and Innovative Therapeutics Murdoch University and Chief Scientific Officer, PYC Therapeutics Perth, WA.

Professors Steve Wilton and Sue Fletcher’s collaboration and pioneering research has resulted in the development of three FDA-approved “exon-skipping” medicines that overcome specific genetic mutations that cause Duchenne Muscular Dystrophy (DMD).

Their contribution to Australia’s biotech industry spans more than 25 years, and their work in antisense oligomer-induced exon skipping puts Australia’s medical research into rare diseases and neuromuscular science on the map. All three medicines (Exondys 51, Vyondys 53 and Amondys 45) were developed at the Perron Institute for Neurological and Translational Science with The University of Western Australia and has been commercialised in partnership with US company Sarepta Therapeutics.

Company of the Year: Telix Pharmaceuticals

Melbourne-headquartered biopharmaceutical company Telix Pharmaceuticals Limited (Telix) is focused on the development and commercialisation of diagnostic and therapeutic (‘theranostic’) radiopharmaceuticals. Founded in 2015, Telix has moved its lead product Illuccix®, a PSMA PET imaging agent for the detection and staging of prostate cancer, from academic proof-of-concept to a commercially-proven product in the space of three short years, with FDA and TGA approval gained during late 2021 (now reimbursed in both markets), and Health Canada approval in October 2022.

Commerically launching Illuccix® in the US in April 2022, Telix has since generated USD$50 million (AUD$73 million) in sales; in addition to Australia, it now has commerical operations in the US, Europe and Japan. The first patient was imaged in Australia in September 2022, and US-distribution has rapidly expanded with a network of more than 150 radiopharmacies nationwide; the US total addressable market for PSMA PET imaging for prostate cancer is estimated at USD$1-1.5 billion annually. Telix’s has further theranostics for oncology and rare diseases progressing through the pipeline, with more than 20 Telix sponsored and investigator-led clinical trials spanning Phases 1 – 3.

Emerging Company of the Year: Fusetec

Established in 2017, Fusetec’s medical technology is already revolutionising medical training globally. Through its advanced additive manufacturing, Fusetec’s realistic, anatomically accurate bone, skin and muscle is used during surgical training and reducing the need for medical students, residents and surgeons to practice on real patients or extremely expensive cadavers. These medical devices are made to order, and can be designed and manufactured to simulate specific pathology. Currently available are models in orthopaedics, otolaryngology, neurology and gynecology, with more surgical displines under development.

Fusetec has secured global partnerships and opened a world-first 3D Advanced Surgical Training Clinic in South Australia, creating 157 direct jobs in the fields of research, production and administration; it expects to create an additional 800 indirect jobs in South Australia within the supply chain, medical tourism and higher education sectors.

AusBiotech Life Sciences Legacy Award: Dr Andrew Forrest AO and Nicola Forrest AO

Dr Andrew Forrest AO and Nicola Forrest AO have demonstrated a deep commitment to finding ethical and sustainable solutions to a range of global issues as diverse as childhood cancer, ending modern slavery, and ocean conservation.

Among Australia’s most active philanthropists and investors, they have invested more than $2.6 billion since 2001 through the Minderoo Foundation which they co-Chair.

Their commitment to improving equitable health outcomes and Australia’s medical and biotechnology ecosystem through their philanthropic and investment activities, are proving transformational for the Australian life sciences sector.

Minderoo’s Collaborate Against Cancer initiative works with global partners to overcome the greatest barriers to cancer prevention, diagnosis and treatment. Through Minderoo, the Forrests are accelerating research and discovery of breakthrough therapies to make world-class cancer care accessible to everyone, no matter their address or background. In 2020, Minderoo mounted a pivotal response to the COVID-19 pandemic to buffer Australia’s diagnostic testing capacity and personal protective equipment stockpiles in a time of critical need.

Beyond their philanthropy, the Forrest family’s Tarrarang Group has supported Australian life science companies and recently launched Tenmile, a $250-million venture capital fund dedicated to supporting innovators and companies to create and nurture impactful health technology and biotech solutions. Tenmile seeks to address unmet needs in healthcare and scale an Australian health science and technology sector of global significance.

-ENDS-
Media enquiries: Karen Parr, Director, Communications & Policy, AusBiotech,
kparr@ausbiotech.org / M: +61 (0) 428 056 173

About AusBiotech

Federal Budget mostly ‘vanilla’, with a bit of sting

Thu, 27 Oct 2022 00:00:00 +1100

The Federal Budget, the first for the new Government, has delivered on the Government’s election promises, confirming a range of commitments with a notable cut to the Entrepreneurs’ programme.

Delivered on the eve of AusBiotech 2022, sector experts will be dissecting the Budget announcements, its implications for biotechnology and how will the new Budget will help or hinder the sector’s hard-won progress, during an engaging panel session on Friday.

The biotech sector was not specifically called out in top-line announcements, however, programmes around resilience still place ‘medical science’ as a key priority area.

The announcements included the confirmation of the establishment of a $15 billion National Reconstruction Fund that will co-invest in independently-assessed projects; the establishment of a ‘Future Made in Australia Office’ to deliver the ‘Buy Australian’ Plan; support for manufacturing skills, STEM talent, and leadership; and the redirection of the Modern Manufacturing Strategy funds to the National Reconstruction Fund.

The Government will provide welcome support of $23.3 million over two years for the TGA’s modernisation, despite some minor changes to cost recovery arrangements.

There has been a concerning cut to the Entrepreneurs' Programme; while AusBiotech understands the cuts are aimed at the delivery process, it will cut 75 per cent of the programme’s funds and therefore it’s unclear at this stage if it leaves a workable programme.

As the national voice of the biotechnology sector for more than 35 years, AusBiotech remains committed to communicating industry’s concerns, reducing barriers and amplifying opportunities.

World-class, locally developed: Australia’s largest annual biotech week kicks off

Tue, 25 Oct 2022 00:00:00 +1100

Record numbers of life science delegates attend AusBiotech 2022; strong line-up at AusBioInvest 2022 held in the same week.

Held this year in Perth from 26-28 October, Australia’s ‘biggest week in biotech’ includes AusBiotech 2022, Australia’s largest life science conference attracting more than 1,000 registered attendees, and AusBioInvest, the sector’s premier investment conference with more than 300 registered. The events will feature a wide range of national and international experts and keynote speakers.

Running for more than 37 years, AusBiotech 2022 features an industry-led programme of more than 160 thought leaders across over 40 sessions that will inspire, inform, engage and enhance the biotech community.

It also gives companies a valuable opportunity to meet and connect, creating opportunities to access funding and partnerships to enable the development of world-class therapies, diagnostics and medical devices.

Key highlights include: Professor Fiona Wood AM, Director, Burns Service of WA & Director, Burn Injury Research Unit UWA who will share her story about the revolutionary spray-on skin cells treatment, used to treat burns victims of the Bali Bombings; Professor Marvin Caruthers, Distinguished Professor from the University of Colorado who will share his insights on the biotechnology industry transformation through ground-breaking DNA synthesis chemistry; and Elizabeth Koff AM, Managing Director, Telstra Health who will talk about realising the full potential of our Australian health system.

AusBioInvest 2022, the largest investment and partnering conference in the Australian life sciences sector, facilitates meaningful connections between businesses and investors, enabling great ideas to get the funding they need. This year’s programme features informative and insightful presentations from global venture capital and investment experts in addition to the 29 Australian biotech companies, spanning early- to late-stage, that are actively seeking investors or partners to support their funding and co-development.

Highlights include presentations from Australian ex-pats Dr. Arjun Goyal, Co-Founder and Managing Director of US-based life sciences VC firm Vida Ventures, and Dr. Nilay Thakar, Principal at global VC fund ARCH Venture Partners. They will share their perspectives on emerging funding models and strategies for capital raising and provide their expertise on matching appropriate sources of capital to a company's point on the development pathway.

In addition, the Australian Securities Exchange (ASX)'s General Manager, Listings, James Posnett, joins AusBioInvest 2022 to provide an up-to-date market analysis, including opportunities and headwinds for Australian life sciences.

The Government of Western Australia has embraced the opportunity with three ministers in attendance. The Deputy Premier of Western Australia, Hon. Roger Cook MLA, will speak at the conference’s Welcome Reception; the Minister for Innovation and ICT; Medical Research; Emergency Services; Volunteering, Hon. Stephen Dawson MLC will join AusBiotech CEO Lorraine Chiroiu to open AusBiotech 2022; and the Hon Amber-Jade Sanderson MLA will introduce the Plenary on the final day. Western Australia’s Chief Scientist Professor Peter Klinken was also present.

AusBiotech 2022 and AusBioInvest 2022 are proudly supported by their Host State Partners, the Western Australian Government and Business Events Perth.  

For more information about AusBiotech 2022 see the programme here, and for AusBioInvest 2022 see the programme here.

AusBiotech’s virtual 2022 AGM open to members

Thu, 20 Oct 2022 00:00:00 +1100

AusBiotech is inviting members to register for its upcoming 2022 Annual General Meeting (AGM), which will recognise and celebrate the achievements of the AusBiotech membership this year.

This year’s meeting will be held virtually on Thursday 3 November at 1.00pm - 2.00pm (AEDT), featuring an update from AusBiotech Chair Geoffrey Kempler on industry highlights and developments during his first year in the role.

A new director of the AusBiotech board will be announced, as voted by the membership in the recent elections, who will play an active role in supporting efforts to promote the global growth of the Australian life sciences industry.

Members can also learn more about AusBiotech achievements in the recently published 2022 Annual Report, which demonstrates how AusBiotech continues to deliver as the national voice of the biotechnology industry.

Members can register for AusBiotech’s virtual AGM, here.

FDA submission triggers milestone payment for Neuren Pharmaceuticals

Thu, 20 Oct 2022 00:00:00 +1100

Ag-Biotech Summit to feature sustainable food

Tue, 18 Oct 2022 00:00:00 +1100

AusBiotech’s 2022 conference will feature a one-day AgBiotech Summit on Thursday 27 October 2022 in Perth, including a session on sustainable proteins in a nod to World Food Day. The Summit will profile Australia’s innovative agricultural biotechnology and promote the sector that's contributing to Australia’s food development process, from farm to plate.

The AgBiotech Summit also includes a keynote and numerous panel sessions focused on the challenges and opportunities facing industry today that will discuss the ground-breaking growth and opportunities available for the sector.

This includes the programme session ‘Australian protein – meeting the needs of global menus’, where experts will discuss how global consumer demand for sustainable protein sources is increasing and Australia has a unique opportunity to harness science and the power of microbes to create alternate protein sources.

Leading agri-biotech expert, Dr Joe Smith, Chair, Agricultural Biotechnology Council of Australia, will deliver a keynote at AusBiotech 2022 on ‘Agricultural biotechnology – past, present and future’ and will share his more than 40 years' experience and leadership in diverse public and private sector roles, and how the sector has experienced innovation in the challenges that it has faced.

AusBiotech’s Australian Biotechnology Sector Snapshot 2022 explains in its key findings the growth in food and agriculture biotechnology companies Australia, from 270 companies in 2017 to 302 in 2022. This demonstrates the critical investment Australian companies are placing in the sector.

AusBiotech joins CropLife Australia, the national peak industry organisation for the plant science sector, which recognises the importance of innovation in the agricultural biotechnology sector by marking World Food Day on 16 October 2022.

“.. Biotech innovations are also helping farmers to reduce their environmental footprint with scientists and researchers developing food crops that are more resistant to drought, heat, salinity and pests,” said Mr Matthew Cossey, CEO of CropLife Australia.

“Biotechnology is also leading to crops with increased nutritional value. Innovations such as Golden Rice, an effective source of Vitamin A, and Cavendish bananas resistant to Panama Disease will generate more nutritious food for those that need it most.

“Food waste is also being tackled through biotechnology. Gene edited crops, like apples that reduce browning, will help tackle the widespread problem of food being thrown out when it’s actually fine to eat.”

There’s still time to register and delegates can utilise the day rate for Thursday 27 October, and soak up the insightful AgBiotech Summit sessions at AusBiotech 2022, and strengthen your networks through the day's social events and exhibition access opportunities.

Download the AusBiotech 2022 full programme, featuring the AgBiotech Summit on Thursday 27 October, here.

Study shows Patrys' PAT-DX3 cross blood brain barrier in healthy animals

Tue, 18 Oct 2022 00:00:00 +1100

ANDHealth CEO recognised with the 'Telstra Brilliant Women in Digital Health Award'

Tue, 18 Oct 2022 00:00:00 +1100

Health Canada approves Telix's Illuccix for prostate cancer imaging

Tue, 18 Oct 2022 00:00:00 +1100

Accelerating investment in Queensland’s early-stage companies

Thu, 13 Oct 2022 00:00:00 +1100

AusBiotech welcomes The Queensland Government’s $24 million Enterprise Acceleration Fund, which will aim to invest in innovative, early-stage Queensland companies, supporting increased access to investment capital and jobs growth.

The Enterprise Acceleration Fund builds on other Queensland investment funds managed by the Queensland Investment Corporation (QIC) that have previously invested $114.8 million in 65 Queensland companies, and created over 1,000 full-time equivalent jobs.

In a media statement, the Queensland Treasurer and Minister for Trade and Investment the Hon. Cameron Dick said the fund would invest from $500,000 up to $2.5 million in “innovative, early-stage” companies with a majority of their employees in Queensland.

Additionally, the Queensland Government suggests that the seed funding will grow over time as investments in other companies are realised and reinvested.

“There are great businesses right across Queensland that are developing new products and services right now,” the Treasurer said.

“This new $24 million fund will back those businesses and help them to grow their market share, [which] means more jobs for Queenslanders.

“And it means a positive return for Queenslanders, because the seed funding will grow over time as investments are realised and reinvested through this fund.”

Innovative Queensland companies across the State that are looking to grow can submit expressions of interest to the Enterprise Acceleration Fund, and view the fund’s investment criteria and guidelines.

Illumina and AstraZenca team up on AI-based research project

Thu, 13 Oct 2022 00:00:00 +1100

Botanix announces positive BTX 1702 clinical study outcome

Thu, 13 Oct 2022 00:00:00 +1100

International consultation on medicines and biologicals

Tue, 11 Oct 2022 00:00:00 +1100

AusBiotech is seeking contribution from affected members as it considers its response to the Therapeutic Goods Administration’s (TGA) consultation on the International Medical Device Regulators Forum (IMDRF)’s ‘Boundary and combination products - medicines, medical devices, and biologicals’.

The consultation is now open and the TGA is seeking comment on its draft guidance with the purpose to assist national and international sponsors and manufacturers in determining the status of therapeutic goods that may not fit clearly within existing definitions for medicines, biologicals, or medical devices. The draft guidance aims to provide clarity on which regulatory pathway is appropriate for therapeutic goods.

This draft guidance is intended to replace the existing guidance on boundary products, ‘Australian medical devices guidelines: 35. Device-medicine boundary products’, dated November 2005. The existing guidance is out of date and requires updating to reflect significant changes in the regulation of therapeutic goods since 2005, including the introduction of the biological regulatory framework and new requirements needed to appropriately regulate emerging types of products continually entering the market.

In this consultation, the TGA are seeking industry’s views on the following questions:

Does the draft guidance align with your understanding of what medicines, medical devices and biologicals are?
Are you aware of currently marketed products that are not in alignment with the definitions in this draft guidance, and if so, what are they?
Are special, interim arrangements required to ensure continued supply of products that have to date been represented and sold as a type of therapeutic good inconsistent with this guidance?
Are there any other issues that should be addressed in the draft guidance?

The International Medical Devices Regulatory Forum (IMDRF) is a voluntary group of medical device regulators that was formed in 2012 with the purpose of building on the strong foundational work of the Global Harmonization Task Force (GHTF) to promote a regulatory model that responds to emerging challenges while protecting and advancing public health and safety. Australia’s TGA is a current member of the Forum along with Brazil, Canada, China, the European Union, Japan, Russia, and the USA.

AusBiotech is currently consulting with its AusMedtech Regulatory Affairs Advisory Group to consider a submission in response to this consultation.

The public consultation is open until 20 November 2022 and AusBiotech encourages members to contact Karen Parr, Director Communications & Policy, by Friday 11 November 2022 to discuss how the draft guidance and/or consultation may affect their company.

IDT Australia announces new appointments to board of directors

Tue, 11 Oct 2022 00:00:00 +1100

BioNTech chooses Melbourne for its Asia-Pacific mRNA R&D centre

Tue, 11 Oct 2022 00:00:00 +1100

Industry responds to proposed regulatory changes for clinical trials of medical devices

Thu, 06 Oct 2022 00:00:00 +1100

Industry has united through the Research and Development Taskforce (RDTF) to respond to the Therapeutic Goods Administration’s (TGA) consultation on proposed changes for clinical trials of medical devices and make a joint submission on maintaining regulation commensurate with risk.

Industry came together through the RDTF, a multi-sector collaboration between AusBiotech, the Medical Technology Association of Australia and Medicines Australia, to thoroughly review the current design of clinical trials oversight, and highlighted in its submission that there is evidence demonstrating that Australia’s current process is safe and efficient for participants in first in human studies.

As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science sector.

Read the full submission now.

Second fast-track designation for Australian immunotherapy company

Thu, 06 Oct 2022 00:00:00 +1100

Move to expand Intellectual Property waiver presents concern

Tue, 04 Oct 2022 00:00:00 +1100

AusBiotech is backing global advocacy efforts as the World Trade Organization considers expanding its Trade-Related Aspects of Intellectual Property Rights Agreement to therapeutics and vaccines.

AusBiotech’s position is that while strongly supportive of equitable access to medicines globally, these waivers will not enable this - as proven by the vaccines waiver that has passed.

Dr Damian Slizys, Director of Intellectual Property at Telix Pharmaceuticals authored ‘The role of patents in drug development’ for the latest edition of Australasian Biotechnology (page 54) journal in collaboration with AusBiotech and its IP Advisory Group. Dr Slizys responded to the changes to the international TRIPS Agreement waiver for IP rights, which Telix suggests has highlighted a fundamental misunderstanding of the role of IP.

Expanding the IP waiver also presents risks to Australian home-made innovation and jobs – including the hundreds of SMEs developing health technologies – and their ability to compete globally.

This agreement has the potential to affect and harm small biotech companies the most as SMEs account for 307 of 357 COVID-19 therapeutics in development (86%), and most of these therapeutics potentially have other indications, which Biotechnology Innovation Organization (BIO) described in a letter to US President Joe Biden that it “may be their only path to financial viability and sustained investment to fund future R&D initiatives.”

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) which is responsible for representing research-based pharmaceutical companies and associations across the globe has launched a digital social media campaign on the value of IP. The hashtag - #IPMakesItHappen – coincided with the WIPO Standing Committee on Patents (26-30 September 2022) and the WTO Forum (27-30 September 2022). IFPMA rallied its online community to explain and showcase how IP makes breakthroughs happen and this can also demonstrate to innovation-supportive countries that industry is working hard to fly the flag.

For more information, visit BIO’s blog post for its position on the latest development in the TRIPS Waiver Agreement, here.

Australian biotechnology incubator Proto Axiom completes initial fundraising

Tue, 04 Oct 2022 00:00:00 +1100

New investor guide profiles biotech companies to watch

Thu, 29 Sep 2022 00:00:00 +1000

With AusBioInvest 2022 in four weeks on in Perth, WA on 27 October, Australian investment in biotechnology will be spotlighted and the recently released Health and Biotech Investor Guide from Stockhead and The Australian, profiles ten companies presenting at Australia’s largest life sciences investment conference.

AusBiotech CEO Lorraine Chiroiu was featured in the Health and Biotech Investor Guide and she spoke about the most significant and comprehensive strategy ever developed – Biotechnology Blueprint – for the Australian biotech industry, as well as profiles for ASX-listed companies, expert analysis, and even a few tips on which ones to watch.

“Industry leaders worked on the Blueprint and more than 300 organisations actively helped shape it,” Ms Chiroiu said.

“We’ve ended up with a high-level document of what the industry wants to achieve over the next decade and it also goes right down to targeted tactics and what we need to see happen.

“The COVID-19 pandemic has catapulted the sector into the global spotlight and given it a really strong boost.”

The ten companies to watch include: Patrys Limited (ASX:PAB), Prescient Therapeutics (ASX:PTX), Dimerix Limited (ASX:DXB), INOVIQ Ltd (ASX:IIQ), Emyria (ASX:EMD), Orthocell Ltd (ASX:OCC), LBT Innovations Ltd (ASX:LBT), Microba Life Sciences (ASX:MAP), Immuron (ASX:IMC), and Argenica Therapeutics (ASX:AGN).

Registrations remain open for AusBioInvest 2022, and the conference features global and local keynotes and panelists sharing insights to support informed investment decisions in a complex scientific field, and up to 30 public and private Australian biotechnology company presentations.

AusBioInvest 2022 is proudly sponsored by the WA Government and Business Events Perth.

Telix announces first patient enrolled in 'ProsACT TARGET' study

Thu, 29 Sep 2022 00:00:00 +1000

Agilex Biolabs expands capacity with the commissioning of new Brisbane facilty

Thu, 29 Sep 2022 00:00:00 +1000

CSL announces seven recipients of 'Global Research Acceleration Initiative' awards

Thu, 29 Sep 2022 00:00:00 +1000

Success stories featured in latest edition of Australasian Biotechnology journal

Tue, 27 Sep 2022 00:00:00 +1000

Australia’s captivating biotech sector has ‘come alive’ in the latest edition of Australasian Biotechnology, AusBiotech’s official journal, in anticipation of the upcoming AusBiotech 2022 and AusBioInvest 2022 conferences.

The global biotech industry presents significant opportunities for Australian companies to expand into new growth markets, and highlights of this edition of the journal offer insights into recognising the strides local and international companies have taken to provide public access to therapeutics treatments.

Providing a platform for education, the journal strengthens and grows industry knowledge of Australian capabilities and enablers through commentary from a diverse range of authors. This edition’s themes includes: Australian commercialisation successes, investment trends and ventures, and incubators and accelerators.

Read compelling insights from sector leaders, including What’s next in Australian investment by Scott Power, Research Analyst, Morgans Financial Limited, Australian innovation with global impact, by Dr Jackie Fairley, CEO, Starpharma and The secret sauce of biotech investor relations, by Jon Pilcher, CEO and Managing Director, Neuren Pharmaceuticals.

The journal toasts the successes of the industry today, including the AusMedtech 2022 Early-Stage Investment Forum winners, which showcases the emerging medtech stars who are tackling issues in the Australian community.

This edition also contains regular features, including the AusBiotech CEO Report, and AusBioStock – an exclusive report from James Fletcher, Evans & Partners. The journal welcomes new AusBiotech members, and holds a list of AusBiotech corporate members.

In-depth commentary on the Australian and global biotechnology sector will continue at AusBiotech 2022, from 26 - 28 October, and AusBioInvest 2022 on 27 October, live and in person in Perth. AusBiotech thanks the support of its Host State Partners, WA Government and Business Events Perth.

The next edition of Australasian Biotechnology will be released in April 2023 and will feature Australian and international medtech success stories. Contact admin@ausbioetch.org if you are interested in contributing, or to find out about advertising opportunities.

Australasian Biotechnology is published bi-annually in partnership with Executive Media. Download the Australasian Biotechnology journal today.

Grant to support cardiovascular study of Cynata Therapeutics' cell therapy

Tue, 27 Sep 2022 00:00:00 +1000

Alterity Therapeutics announces poster presentation from major study

Tue, 27 Sep 2022 00:00:00 +1000

Botanix Pharmaceuticals submits new drug application to FDA

Tue, 27 Sep 2022 00:00:00 +1000

Applications open for global female scholars award programme

Tue, 20 Sep 2022 00:00:00 +1000

Nominations are open for the 2023 Johnson & Johnson Scholars Award programme that aims to develop female leaders and feed the talent pipeline.

The $150,000 and three-year mentoring award sponsors women at critical points in their research careers, in each of the disciplines: Science, Technology, Engineering, Manufacturing, Math and Design (STEM2D).

Johnson & Johnson’s goal is to “fuel the research passion of the awarded women and inspire career paths in their respective STEM2D fields. Johnson & Johnson is looking to identify global women leading in both their research fields and leading as mentors, to be a vision for girls and other women in STEM2D.”

The global awards will fund one woman per discipline who has completed her advanced degree and is working at an accredited academic university, institution or design school, such as a non-tenured assistant professor, assistant professor or associate professor.

Australia’s leading scientists have been previously well-recognised, including:

Dr. Shayanti Mukherjee, Ph.D, Hudson Institute of Medical Research, won the 2021 engineering award for their work on advancing urogynaecological health using nanotechnology and 3D cellular bioprinting, helping to address unmet medical needs of up to 50 percent of childbearing women worldwide.
Veronica Garcia-Hansen, Ph.D, Queensland University of Technology won the design award for their research in hospital lighting design to help improve health outcomes for patients and overall energy efficiency.
Dr. Gayathri Naidu, Ph.D, University of Technology, Sydney, won the technology award, for their work researching off-grid solar membrane water treatment, which has the potential to convert sea water to fresh water and contribute to reducing carbon emissions.

The 2023 Johnson & Johnson WiSTEM2D Scholars Award is open for nominations until 30 September 2022.

FDA granted important designation to Radiopharm Theranostics' DUNP19 technology

Tue, 20 Sep 2022 00:00:00 +1000

Major milestone for PolyNovo for FDA clearance of wound care innovation

Tue, 20 Sep 2022 00:00:00 +1000

Medibio appoints experienced medical executive as new CEO

Tue, 20 Sep 2022 00:00:00 +1000

Noxopharm founder to depart board as part of 'natural evolution'

Tue, 20 Sep 2022 00:00:00 +1000

Linking biotech and investors: Stellar AusBioInvest 2022 programme launched

Thu, 15 Sep 2022 00:00:00 +1000

The programme for Australia’s largest life sciences investment conference, AusBioInvest 2022, has launched; engaging capital with health innovation it features global and local keynotes and panelists sharing insights to support informed investment decisions in a complex scientific field, and up to 30 public and private Australian biotechnology company presentations.

The event draws key decision makers from the investment community, including venture capitalists, private equity firms and investment bankers; as well as research analysts and representatives from pharmaceutical companies, and from governments. The event merges market intelligence with investment opportunities and acts as a guide to successful biotech investment.

The Hon Roger Cook MLA, Deputy Premier; Minister for State Development, Jobs and Trade; Tourism; Commerce; Science, Government of Western Australia will join AusBiotech CEO Lorraine Chiroiu for the event’s Welcome to Country and official opening, before the one-day programme focuses on why access to capital remains key amid biotech’s expanding industry.

Keynotes presentations include:

Inside the mind of a venture capitalist: how to build an innovative biotech company, Dr Nilay Thakar, Principal, ARCH Venture Partners, United States - one of the most respected and largest, most active and successful, VC funds in biotech – clinically and financially
Global trends in biotech and healthcare: leveraging US and Australian opportunities, Dr Daniel Getts, CEO and Co-Founder, Myeloid Therapeutics, United States
ASX Market Update on opportunities and headwinds for Australian life sciences, James Posnett, General Manager Listings, ASX Limited
Translating ground-breaking science into new medicines in the 21st Century: A VC’s perspective, Dr Arjun Goyal, Co-Founder and Managing Director, Vida Ventures, United States - a leading US-based life sciences venture capital firm with approximately US$1.7 billion in assets under management.

These presentations will be complemented with expert panel discussions on: Investor insights: New funds, emerging funding models and avenues for capital; and International investors unplugged, and includes heavy-weight investors such as Executive Chair Dr. Steve Burnell from Australia’s newest $250M healthtech investment fund Tenmile, backed by Tattarang - one of the largest diversified private investment groups in Australia that's owned by Andrew and Nicola Forrest.

Up to 30 C-suite of innovative biotech companies will present, including: Patrys (ASX:PAB), Prescient Therapeutics (ASX:PXT), Invion (ASX:IVX), Dimerix (ASX:DXB), Argenica Therapeutics (ASX:AGN), Emyria Limited (ASX:EMD), Orthocell Ltd (ASX:OCC), Noxopharm Limited (ASX:NOX), LBT Innovations (ASX:LBT), Microba (ASX:MPA), Immuron (ASX:IMC), Opyl (ASX:OPL), Living Cell Technologies (ASX:LCT), INOVIQ (ASX:IIQ), Carina Biotech, Cerecin, Tessara Therapeutics, FivepHusion, HaemaLogiX, Celosia Therapeutics, EpiAxis Therapeutics, Carpe Vitae Pharmaceuticals and Respirion Pharmaceuticals.

This premier event will lift the profile of the Australian biotechnology industry and create access to greater funding sources for local companies to develop world-class science into therapies, diagnostics and medical devices.

Download the AusBioInvest 2022 programme here, and register for the event here.

AusBioInvest 2022 is proudly sponsored by the WA Government and Business Events Perth.

EpiAxis Therapeutics announces collaboration with Canadian research hospital

Thu, 15 Sep 2022 00:00:00 +1000

Noxopharm reports promising results from pancreatic cancer study

Thu, 15 Sep 2022 00:00:00 +1000

Asia Pacific takes the lead in cell and gene clinical trials

Tue, 13 Sep 2022 00:00:00 +1000

The Asia Pacific region has taken in the lead in cell and gene clinical trials, accounting for the largest share of new trials during the first half of 2022, reveals the Alliance of Regenerative Medicine’s latest report mapping the sector’s progress.

The APAC region represents 42 per cent (61) of the 144 new clinical trials started this year, and includes a healthy number early in the pipeline (30); 26 in phase 2, and 5 in phase 3. The European pipeline has slowed “to a trickle” with 16 new clinical trials started in H1 2022, however, is the only region that is bottom-heavy.

By region, North America leads with 808 active clinical trials, followed by Asia Pacific with 640 trials, Europe with 329, and 88 active trials in all other regions.

Cell and gene therapies are a global activity, and the excitement around the opportunity to change the treatment paradigm was reflected in three new therapies approving in 2022, including: Legend Biotech & Janssen CAR-T therapy (US & EU); BioMarin Pharmaceutical gene therapy (EU); and PTC Therapeutics gene therapy (EU); as well as four therapies approved in new geographies or for new indications – including Novartis’ CAR-T therapy Kymriah, making it the only CAR-T therapy approved for both adult and pediatric settings. Read more about Kymriah in the case study, published in October 2021 and developed by the AusBiotech-led Regenerative Medicines Consortium Project.

It has already been a record year for the approval of new gene therapies to treat rare diseases, with more yet to come: four further regulatory decisions are anticipated in the final months of 2022, and 16 in 2023, including CSL Behring’s therapy to treat Hemophilia B.

To capitalise further on the opportunities that Australia’s burgeoning cell and gene sector can deliver to the Australian economy and society, AusBiotech, with support from the Australian Medtech Manufacturing Centre, is conducting detailed research to develop a ‘blueprint’ outlining implementation strategies for manufacturing cell and gene therapies medicines locally. This research will build on the work published in Australia’s Regenerative Medicines Manufacturing Capacity and Capability, and will work in harmony with Australia’s Cell and Gene Catalyst.

Building Australia’s sovereign manufacturing capability for complex and advanced cell and gene therapies offers the opportunity to offer equitable access to cutting-edge treatments for Australian patients and therefore reduce the burden of disease significantly, leading to better health outcomes for Australians and higher participation rates in the workforce, and additionally to create a new highly skilled workforce now and for the future, thereby cumulatively impacting the economy on a large scale. 

Read the Alliance of Regenerative Medicine’s 2022 H1 Report here.

Leading global health MD joins AusBiotech 2022 line-up

Thu, 08 Sep 2022 00:00:00 +1000

AusBiotech is delighted to announce Elizabeth Koff AM, Managing Director, Telstra Health will be delivering a keynote in-person at the industry’s national conference, AusBiotech 2022. The presentation titled global outlook on digital health will offer insights on how digital health is shaping Australian health systems.

In April 2022, Elizabeth was appointed Managing Director of Telstra Health, Australia’s largest digital health company and a subsidiary of Telstra Corporation.

Elizabeth was the former Secretary of NSW Health for a six-year term. As Secretary, Elizabeth was responsible for the management of the NSW Health system, the largest health system in Australia. Her achievements as Secretary include the implementation of value-based care across NSW, the progression of e-Health initiatives and a $2 billion per year capital infrastructure programme. Elizabeth led NSW Health through the COVID-19 pandemic and advised NSW crisis cabinet on the management of COVID-19 in NSW, and the subsequent vaccination rollout.

She was appointed a Member of the Order of Australia in the Queen’s Birthday 2022 Honours for her leadership in the health sector, service to public health administration and governance, and to professional organisations.

Hosting a keynote of Elizabeth’s calibre demonstrates the importance and profile of Australian life sciences within our global ecosystem, and how the AusBiotech 2022 national conference provides a platform for learning and networking, as AusBiotech continues to celebrate the Australian biotech industry and champion advocacy to facilitate the global growth.

Elizabeth’s keynote is one of 40 programme sessions across three days at AusBiotech 2022, in Perth WA, from 26-28 October 2022.

AusBiotech 2022 keynote speakers include:

Millis Oration keynote Professor Marvin Caruthers, Distinguished Professor, University of Colorado, Boulder: Biotechnology industry transformation through ground-breaking DNA synthesis chemistry;
Dr Lisa Haile, Partner, DLA Piper: The nexus of science and intellectual property and its impact on shaping the biotechnology sector globally;
Professor Fiona Wood AM, Director, Burns Service of WA & Director, Burn Injury Research Unit UWA: The story of spray-on skin cells; and
William F. McKeon, President and CEO, Texas Medical Center: Building the World’s Largest Life Science Cluster

AusPartnering, AusBiotech’s popular one-to-one business matching programme is expected to open on 21 September. Register now and purchase with a full conference pass to receive first access to booking your business meetings.

AusBiotech 2022, Australia’s annual flagship industry conference, and has been connecting the ecosystem for more than 35 years.

AusBiotech is proudly sponsored by the WA Government and Business Events Perth.

Victoria backs new ANDHealth-created innovation and commercialisation centre

Thu, 08 Sep 2022 00:00:00 +1000

New molecule chip changing the face of modern manufacturing

Thu, 08 Sep 2022 00:00:00 +1000

Antisense Therapeutics announces revised clinical development plan for ATL1102

Thu, 08 Sep 2022 00:00:00 +1000

Imugene doses first patient in nextHERIZON Phase 2 clinical trial

Thu, 08 Sep 2022 00:00:00 +1000

Framework released to facilitate university-industry partnerships

Tue, 06 Sep 2022 00:00:00 +1000

AusBiotech welcomes the release of the Department of Education’s voluntary Higher Education Research Commercialisation (HERC) Intellectual Property (IP) Framework to facilitate partnerships between universities and industry partners.

The Framework is recommended for universities and businesses to work together to develop new technologies and/or solve research problems, access technical services and equipment from a university, and for a business to license and buy IP from a university for internal or commercial use.

The Framework includes a voluntary set of standardised agreements, as well as education and guidance materials to assist users in navigating the research commercialisation process. The Department’s aim is that this Framework will enable future and ongoing industry and university collaboration and more research commercialisation opportunities will arise.

As part of the Department’s University Research Commercialisation Action Plan developed in 2021, AusBiotech supported a joint submission in collaboration with industry partners, including Research Australia, Medicines Australia and MTAA to contribute to the development of the Framework.

In its joint submission, the peak industry bodies that represent a significant proportion of the health R&D sector proposed that rather than making the Framework mandatory, it should be made available without restriction for all entities to use when its released.

The development of this Framework was informed by the Department of Education’s HERC IP Working Group and feedback from universities, industry, and government representatives across Australia.

To find out more, and access the Framework, click here.

Esfam Biotech receives $1 million for COVID-19 treatment discovery

Tue, 06 Sep 2022 00:00:00 +1000

QIMR Berghofer grants and license agreement for potential vaccine

Tue, 06 Sep 2022 00:00:00 +1000

Recce Pharmaceuticals announces appointment of executive chairman

Tue, 06 Sep 2022 00:00:00 +1000

AusBiotech 2022 programme launched

Thu, 01 Sep 2022 00:00:00 +1000

The AusBiotech 2022 programme has launched and profiles five keynotes and 40 engaging panel sessions highlighting the pressing and emerging topics facing the Australian and global biotech sector.

Marking the 20th anniversary of the 2002 Bali bombings, keynote Professor Fiona Wood AM, Director, Burns Service of WA & Director, Burn Injury Research Unit UWA will share The story of spray-on skin cells, and how it has contributed to her patients' lives and the global biotech industry.

This technology was produced from one of Professor Woods' early achievements, which was the development of a skin culture lab that she co-founded with scientist Marie Stoner in 1993; with support from a Telethon Kids Institute grant.

Opening AusBiotech 2022, Millis Orator Professor Marvin Caruthers, Distinguished Professor at the University of Colorado, Boulder will address Biotechnology industry transformation through ground-breaking DNA synthesis chemistry.

The Millis Oration is named in honour of Emeritus Professor Nancy Millis's contribution to the industry, and is held annually at the AusBiotech conference together with continuous support from CSL. The Oration is a focal point of the annual industry gathering and is appropriately named in honour of this pioneer of Australia’s biotechnology industry.

Keynote Dr Lisa Haile, Partner, DLA Piper, will present on The nexus of science and intellectual property and its impact on shaping the biotech sector globally. Dr Haile will address the global trends and implications of IP law on innovation, from the perspective of a world-leading expert in patent protection and strategy, who started as a microbiologist.

AusBiotech 2022 is run by industry, for industry; and for more than three decades it has created a forum to reflect on the sector’s achievements and exchange ideas to further advance the industry. This year's programme features an all-day ag-biotech summit, the Early-Stage Investment Forum, conference gala dinner, and plenty of informal networking opportunities.

Biotech’s biggest week also includes AusBioInvest 2022, Australia’s pre-eminent life science investment event, which will run concurrently on 27 October 2022. Australia’s biotech industry presents a compelling opportunity for investors and international partners, and it will encourage delegates to invest in health.

This independent conference is designed to engage capital with innovation and offers the opportunity for companies to a network of potential international partners and investors, including global pharma representatives. Qualified and pre-approved investors are invited to register free-of-charge now.

AusBiotech’s premier biotech conferences, AusBiotech 2022 AusBioInvest 2022, are proudly sponsored by the WA Government and Business Events Perth.

Join AusBiotech 2022 in-person to celebrate and connect with our thriving Australian and global biotechnology network. AusBiotech encourages delegates to take advantage of early-bird registrations before 14 September; register now.

Cynata Therapeutics appoints new non-executive director

Thu, 01 Sep 2022 00:00:00 +1000

Starpharma wins recognition for development of COVID-19 antiviral nasal spray

Thu, 01 Sep 2022 00:00:00 +1000

Rebranded AcuraBio acquired by major investors

Thu, 01 Sep 2022 00:00:00 +1000

Nominations open for AusBiotech Board

Tue, 30 Aug 2022 00:00:00 +1000

Nominations are open for the AusBiotech Board of Directors as it seeks to elect one new director.

The Directors are elected to provide strategic guidance and corporate management-related policies, and is comprised of up to nine members, including the CEO & MD.

Each Board member brings extensive experience of working in the Australian biotechnology industry, representing technical, commercial and policy expertise.

Members interested in joining the AusBiotech Board are invited to submit their nomination form together with a 350-word biography and photo by Friday 16 September 2022. AusBiotech warmly invites those interested in this position to have a confidential conversation with AusBiotech CEO, Lorraine Chiroiu, who can bring the role ‘to life’ and answer any questions you may have.

The election outcome will be announced at the 2022 Annual General Meeting of AusBiotech Ltd, which will be held virtually on Thursday 3 November at 1.00pm - 2.00pm (AEDT) – to which all members are invited to attend.

If an election is required, the on-line voting and access information will be emailed to eligible members on 26 September 2022.

Meet the current AusBiotech Board here.

University of Sydney announces landmark investment to create biomedical precinct

Tue, 30 Aug 2022 00:00:00 +1000

Monash University AI model could predict the best epilepsy medicine

Tue, 30 Aug 2022 00:00:00 +1000

Optiscan Imaging submits 510(k) application to the US FDA

Tue, 30 Aug 2022 00:00:00 +1000

Proposed regulatory changes for clinical trials of medical devices

Thu, 25 Aug 2022 00:00:00 +1000

Regulatory changes have been proposed by the Therapeutic Goods Administration (TGA) for clinical trials of medical devices, and AusBiotech is calling for feedback from affected members as it considers the impact on industry.

The proposed changes include:

Increased regulatory oversight of clinical trials of certain unapproved, high-risk medical devices.
Inclusion of all medical device clinical trials in Australia’s Good Clinical Practice (GCP) Inspection Program (to enable selected trials and documentation supporting these trials to be inspected).

All medical device trials in Australia have utilised the Clinical Trial Notification (CTN) pathway over the last five years (between 120-210 per year) and the TGA has received no Clinical Trial Approval (CTA) applications. While this may be appropriate in many instances, it allows novel permanently-implantable investigational medical devices to be used in humans without review by the TGA.

Over time, medtech has increased in complexity and some emerging medical devices are posing an increasingly higher risk to patient safety; whilst regulatory changes have been implemented affecting the regulation of devices with these innovations that are marketed, no oversight is currently mandated for these devices used in the context of clinical trials.

It is proposed that certain invasive or implantable medical devices that have not previously been used or studied in people would be required to obtain TGA approval through the CTA pathway – the CTN would no longer be an available option. It is estimated that this proposed change would impact less than ten-per-cent of medical device clinical trials would be affected by the proposal.

In addition to targeting certain unapproved, high-risk medical devices, the TGA is also proposing to include all medical devices in its Good Clinical Practice (GCP) Inspection Program. Clinical trials of medical devices are already legally required to comply with the medical device GCP standard, however the TGA does not currently conduct inspections of these sites, as they do for medicines and biologicals. This contrasts with regulators in comparable jurisdictions, such as the USA, UK, Canada and Japan.

The TGA’s proposed changes aim to assure the public that the rights, safety, and well-being of clinical trial participants are protected and that the trial data generated are credible.

As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science sector.

AusBiotech’s response to this consultation is being considered in collaboration with its AusMedtech Regulatory Affairs and Clinical Trials Advisory Groups.

To find out more on the consultation and to view the documents, click here.

Affected members are encouraged to contact Karen Parr, Director Communications & Policy at AusBiotech by Friday 16 September 2022.

Biotron announces phase 2 trial of BIT225 now fully recruited

Thu, 25 Aug 2022 00:00:00 +1000

Trajan reports strong sales and profit growth across the group

Thu, 25 Aug 2022 00:00:00 +1000

Prescient Therapeutics launches share purchase plan to raise $8 million

Thu, 25 Aug 2022 00:00:00 +1000

Alterity Therapeutics launches clinical trial in Europe

Thu, 25 Aug 2022 00:00:00 +1000

Positions vacant on key TGA statutory advisory committees

Tue, 23 Aug 2022 00:00:00 +1000

The Therapeutic Goods Administration (TGA) has recently commenced the recruitment process to welcome industry to apply for positions on its statutory advisory committees that will become vacant at the end of 2022.

The TGA is seeking applications from interested experienced professionals in relevant medical or scientific fields or consumer health issues to support the TGA’s function as a best practice regulator.

Successful applicants appointed to the committees will contribute significantly towards the TGA’s regulatory functions by providing independent expert advice relating to the regulation of medicines, devices, vaccines and other products and substances.

The positions available on the statutory advisory committee are:

Advisory Committee on Biologicals
Advisory Committee on Medicines
Advisory Committee on Vaccines
Advisory Committee on Complementary Medicines
Advisory Committee on Medical Devices
Advisory Committee on Chemicals Scheduling
Advisory Committee on Medicines Scheduling

Further information about the roles of the statutory advisory committees and the requirements for applying are available here. Applications will close 11.30pm AEST Sunday 4 September 2022.

Chroid plexus tissue shipped to Sydney as NTCELL research advances

Tue, 23 Aug 2022 00:00:00 +1000

Telix revenue soars after US commercialisation

Tue, 23 Aug 2022 00:00:00 +1000

Long COVID-19 study identifies novel blood markers as potential targets

Tue, 23 Aug 2022 00:00:00 +1000

Dimerix confirms CLARITY 2.0 COVID-19 study concludes recruitment

Tue, 23 Aug 2022 00:00:00 +1000

Accelerating biotech's future workforce needs

Thu, 18 Aug 2022 00:00:00 +1000

Contributing to the Federal Government’s Jobs and Skills Summit’s Employment White Paper, AusBiotech is seeking feedback from members on the key enablers and opportunities that will help us meet our industry’s future skill and workforce needs.

After participating in an invitation-only biotechnology roundtable discussion, led by Chief Scientist Dr Cathy Foley AO, AusBiotech is calling for feedback to inform the Employment White Paper that will map a comprehensive blueprint for Australia’s future labour market and recommend immediate actions and opportunities for medium and long-term reform.

The Jobs and Skills Summit, being led by the Prime Minister and Treasurer and supported by other key ministers including Industry and Science Minister Ed Husic, will take place on 1-2 September. The Summit will bring together industry, civil society, unions and governments, to focus on rebuilding sovereign manufacturing and maximising jobs and opportunities as we address our shared economic challenges. The Summit’s discussions will also inform Treasury’s Employment White Paper.

AusBiotech is considering its response and seeks to accelerate Australia’s biotechnology capability and workforce by understanding the challenges and opportunities being faced, and invites feedback to the following questions:

What is the one thing Government could do to make a difference?
What are the key enablers and opportunities that will help us meet biotech’s future skill and workforce needs?
How could we better support employers and employees to meet future skills needs?
How do we best attract global talent to support biotech’s workforce needs?
What are the opportunities for collaboration or partnerships to address workforce shortages, and boost innovation and productivity?

AusBiotech’s Biotechnology Sector Snapshot 2022 revealed that the number of employees in our industry has increased eight per cent since 2019, expanding from approximately 243,406 people to more than 263,693 in 2022. Increased innovation can lift productivity growth, however Australia needs to ensure the workforce has the right education and skills to meet these expanding needs.

AusBiotech maintains strong connections with government and encourages members to share their perspectives and insights by Wednesday 31 August 2022 by emailing Karen Parr, AusBiotech Communications & Policy Director.

CSL looking to strong post-pandemic growth

Thu, 18 Aug 2022 00:00:00 +1000

Cyclopharm reports strong revenue growth for six months to June

Thu, 18 Aug 2022 00:00:00 +1000

CSL starts planning to submit new antibody treatment

Thu, 18 Aug 2022 00:00:00 +1000

Best practice resource for life sciences to be updated

Tue, 16 Aug 2022 00:00:00 +1000

AusBiotech is seeking expressions of interest from expert members to assist with developing a new edition of The Code of Best Practice for Reporting by Life Sciences Companies (the Code) – a resource for Australian life sciences companies that encourages the adoption of high, consistent standards of communication and market disclosure, which in turn promotes investor confidence.

According to the Code’s rationale it: “has an important part to play in Australia because of the relatively high level of participation of retail investors in the life science sector.”

The Code emphasises the importance of appropriate terminology and context to announcements to help investors understand the commercial significance of what is being reported.

AusBiotech is currently bolstering its investment attraction programme and updating this important industry resource will assist the sector with incorporating international best practice in reporting, maintaining, and enhancing the reputation, integrity and credibility of the Australian life science sector.

While the predominant focus of the Code is on ASX-listed companies, there are many important considerations for private companies, and it will be an invaluable resource for representatives from Australian biotech company executives, company secretaries, Board Chairs and Non-Executive Directors, investors or fund managers, and legal or advisory firms across the sector.

AusBiotech wishes to acknowledge Dr Michael Hirshorn OAM’s contribution to the development of the Code’s first edition in 2005, as he convened a group of industry experts to deliver the resource. The review and second edition of the Code in 2013 was funded by the Victorian Government and supported by AusBiotech and the Australian Securities Exchange (ASX).

To read the Code’s second edition, click here.

AusBiotech members who are interested in supporting this review can submit their expression of interest by contacting AusBiotech's Director, Investment Lisa Renkin by 31 August 2022.

Major capital raise for Opthea as it prepares for commercialisation

Tue, 16 Aug 2022 00:00:00 +1000

Carina Biotech capital raise backed by new cornerstone investor

Tue, 16 Aug 2022 00:00:00 +1000

Microbio receives clearance to sell in vitro diagnostic test in the UK

Tue, 16 Aug 2022 00:00:00 +1000

EpiAxis Therapeutics and Peptilogics announce new collaboration

Tue, 16 Aug 2022 00:00:00 +1000

Notice of AusBiotech's AGM and forthcoming election 2022

Mon, 15 Aug 2022 00:00:00 +1000

Notice of AusBiotech AGM, Thursday 3 November 2022

To Members and other persons entitled to notice of Annual General Meetings (AGM) of AusBiotech Ltd, the 2022 AGM of AusBiotech Ltd will be held on a virtual platform and in accordance with the AusBiotech Constitution on Thursday 3 November at 1.00pm - 2.00pm (AEDT) to transact the following business:

1. ANNUAL ACCOUNTS

To consider the annual report, financial statements and report of the Directors and auditor for the year ended 30 June 2022.

2. RESULTS OF DIRECTOR APPOINTMENT/S

To note the Directors who return, and the appointment of the new Director/s in accordance with the Company’s Constitution.

3. OTHER BUSINESS

Any other business that may be brought forward at a general meeting in accordance with the Constitution.

Notice of Election to the AusBiotech Ltd Board of Directors

This notice relates to the Election for the Board of Directors of AusBiotech Ltd for 2022. The Board has determined that there is currently one (1) vacancy for a Director on the Board. The new Board will be announced at the AusBiotech AGM (details above).

Call for nominations will open today, Monday 15 August 2022. Please find the nomination form here.

Dates

15 August 2022 - Nominations open
16 September 2022 - Nominations close
26 September 2022 - If an election is required, on-line voting and access information is emailed to members
20 October 2022 - Closing date for on-line ballot

If you have any questions regarding the AGM please do not hesitate to contact the CEO, AusBiotech Ltd on 0437 126 843 or admin@ausbiotech.org.

By Order of the Chair

Geoffrey Kempler
Chair

Industry leaders to develop ESG framework

Thu, 11 Aug 2022 00:00:00 +1000

AusBiotech is seeking expressions of interest from senior members who are passionate about environmental, social and governance (ESG) reporting to join a working group, as part of AusBiotech’s expanded offering of investment attraction initiatives.

The development of a biotech industry-specific ESG resource will ensure it meets the needs of our diverse sector – especially companies in the early stages of their ESG journey.

AusBiotech understands that this responsible approach to doing business has long been a priority for the life sciences sector, with ethical considerations codified in many aspects of industry operation and regulation.

Explicit consideration of ESG issues has entered public and corporate narratives in recent years, where investors are increasingly evaluating opportunities using ESG criteria, and expectations have significantly increased for companies to clearly and publicly articulate approaches to ESG accountability.

While ESG reporting is not yet mandatory in Australia, there are varied approaches to mapping and responding to ESG issues. AusBiotech has identified an opportunity to proactively build capabilities within Australian biotech companies, develop some industry-specific guidelines and considerations, and ultimately position Australian companies as progressive, prepared, and highly-attractive to responsible investors.

The working group is seeking the following industry expertise:

Investors or funds with an interest in ESG
CEO or Board Chair of a listed or dual listed biotech, medtech and life sciences company
CEO or Executive Director of a pre-revenue company
Non-Executive Director of a medtech, pharma or biotech company
Peak industry bodies representing members from the investment community, superannuation funds, compliance, regulatory and legal sectors
Service providers with significant experience in developing ESG mapping or assessment tools, policies, strategies, reporting frameworks (e.g. preferably with clients in the life sciences and biotech sectors).

To submit an expression of interest to join AusBiotech’s ESG working group, please contact Lisa Renkin, Director of Investment by Thursday 1 September 2022.

CSIRO opens 'missing link' lab to developing Australian vaccine pipeline

Thu, 11 Aug 2022 00:00:00 +1000

Partrys' candidate in combination improves survival in brain cancer model

Thu, 11 Aug 2022 00:00:00 +1000

Starpharma announces new research agreement for DEP drug delivery platform

Thu, 11 Aug 2022 00:00:00 +1000

First patient enrolled in new trial of NovoSorb SynPath treatment

Thu, 11 Aug 2022 00:00:00 +1000

Email re: ‘AusBiotech 2022 contact lists’

Tue, 09 Aug 2022 00:00:00 +1000

It has come to our attention that a company is seeking to sell a contact list that is titled with AusBiotech’s name - in an unapproved manner.

Dear Exhibitor,

I’m glad to inform you that “AusBiotech 2022”Attendees/Visitors/Registrants list is available now.

Counts:1,500

26 - 28 Oct 2022 Perth, Australia

Key Benefits – Direct Email Marketing/ Email Campaign, Cold Calling, Network with Attendees etc.

Let me know if you are interested to acquire the list so that I can send you the cost and the additional details.

Awaiting your response.

Thanks & Regards,
Cendy Pacheco
Event Coordinator

AusBiotech does not share (or sell) the contact details of event attendees and maintains privacy of information according to its privacy policy (https://www.ausbiotech.org/privacy-policy).

Kind regards,

Lorraine Chiroiu
Chief Executive Officer
AusBiotech Ltd

Life sciences directory to connect the industry

Tue, 09 Aug 2022 00:00:00 +1000

AusBiotech’s innovative Australian Life Science Innovation Directory, is an engaging platform where members can check and update their details to connect with other members in Australia’s thriving life sciences sector.

The Australian Life Sciences Innovation Directory, sponsored by AusBiotech, is a fully searchable platform that offers access to information on biotechnology and life science companies and organisations in Australia and internationally.

It is integrated within the larger Biotechgate global life science database, which includes more than 50,000 company and organisation profiles, to help promote Australian biotechnology on a global scale.

As a membership benefit, AusBiotech members old and new can receive an exclusive profile that will help communicate each organisation’s valuable contribution to Australian biotechnology and life sciences, including:

An extended profile to display tailored company information;
A login to customise company information; and
An endorsement utilising the AusBiotech logo.

To use the Directory, select the directory or map feature of your choice.

The Life Sciences Innovation Directory can be searched by sector, indications, product phase and many other categories with the comprehensive search form and automated alerts.

To find out more, contact AusBiotech’s Director of Membership and Engagement, Tanya Daw.

Neuren commences enrolment new Phase 2 trials of NNZ-2591

Tue, 09 Aug 2022 00:00:00 +1000

Telix and UQ-led consortium awarded Australian Research Council grant

Tue, 09 Aug 2022 00:00:00 +1000

Dimerix announces new patient family for DMX-700

Tue, 09 Aug 2022 00:00:00 +1000

AusBiotech 2022 programme features top industry experts

Thu, 04 Aug 2022 00:00:00 +1000

AusBiotech is delighted to reveal a ‘sneak peek’ into the AusBiotech 2022 programme, which features global thought-leaders, and pressing and emerging topics to drive the Australian biotech sector forward.

Opening the largest annual biotech gathering for the Australian life science industry, Millis Orator keynote Professor Marvin Caruthers, Distinguished Professor at the University of Colorado, will address biotechnology industry transformation through ground-breaking DNA synthesis chemistry.

The Millis Oration is named in honour of Emeritus Professor Nancy Millis's contribution to the industry, and is held annually at the AusBiotech conference together with support from CSL. The Oration is a focal point of the annual industry gathering and is appropriately named in honour of this pioneer of Australia’s biotechnology industry.

Professor Caruthers has extensive industry experience as the co-founder of Amgen Pharmaceuticals and Applied Biosystems, and more recently, he is also a co-founder of Array BioPharma, miRagen Therapeutics and SynGenis Pty Ltd. The Oration will discuss how the supply of DNA/RNA is paramount to the biotechnology and life sciences sector for diagnostic, therapeutic, and research purposes.

Keynote Dr Lisa Haile, Partner, DLA Piper, will also present in-person on the nexus of science and intellectual property and its impact on shaping the biotechnology sector globally. With a career spanning 30 years that has included working with nine Nobel prize winners, Dr Haile will talk about the global trends and implications of IP law on innovation, from the perspective of a world-leading expert in patent protection and strategy, as a professional who started as a microbiologist.

Dr Haile is an awarded expert in patent protection and IP transactional matters and has special technical experience in molecular biology, immunology, cell biology, regenerative medicine, gene editing, immuno-oncology, diagnostics, therapeutics, and drug delivery systems.

The three-day programme is hosted in Perth, WA from 26-28 October 2022, and is packed with pressing, emerging, and engaging topics, designed to connect the Australian biotech sector.

Join us to celebrate and connect with our thriving Australian and global biotechnology network throughout the biggest week in biotech; engage and exchange ideas, pitch, partner and learn.

AusBiotech 2022 is run by industry, for industry; and for more than three decades it has created a forum to reflect on the sector’s achievements and exchange ideas to further advance the industry.

The premier event brings together industry leaders, investors, researchers, clinicians and regulatory representatives from across the globe. All benefits from the conference flow back into the sector to continue facilitating the industry’s growth and global development, as AusBiotech is a not-for-profit entity.

Biotech’s biggest week also includes AusBioInvest 2022, Australia’s preeminent life science investment event, which will run concurrently on 27 October 2022. Australia’s biotechnology industry presents a compelling opportunity for investors and international partners, and it will encourage delegates to invest in health.

This independent event is designed to engage capital with innovation and offers the opportunity for companies to present their technology and story to a network of potential international partners and investors, including global pharma representatives. Companies interested in presenting are invited to express their interest; qualified and pre-approved investors are invited to register their free-of-charge attendance now.

AusBiotech’s premier biotech conferences, AusBiotech 2022 AusBioInvest 2022, are proudly sponsored by the WA Government and Business Events Perth.

Come alive and take advantage of the AusBiotech 2022 early-bird registrations; register now.

Pfizer raises offer for Australian digital health company

Thu, 04 Aug 2022 00:00:00 +1000

Radiopharm Theranostics announces new agreements with Lantheus and NanoMab

Thu, 04 Aug 2022 00:00:00 +1000

Australia’s Cell and Gene Catalyst moves ahead

Tue, 02 Aug 2022 00:00:00 +1000

Australia’s Cell and Gene Catalyst will move ahead, establishing its inaugural Steering Group and opening recruitment, formally signalling the important next step in advancing cell and gene accessibility in Australia.

The Steering Group to lead the Cell and Gene Catalyst (the Catalyst) is comprised of AusBiotech, Medicines Australia, CSL Behring, Novartis, Pfizer, Therapeutic Innovation Australia and Cell Therapies. The Catalyst will bring to life the Regenerative Medicines in Australia: A Strategic Roadmap for the Regenerative Medicines Sector through leadership, advice and support, as the Catalyst seeks to create an end-to-end world-class value chain that can discover, develop, manufacture, and distribute cell and gene therapies to Australian patients, while creating jobs, commercialising research, and exporting Australian therapies to the world.

Leveraging the Regenerative Medicines Consortium Project’s exceptional foundation work throughout 2020-2021 that has cemented and benchmarked Australia’s place on the global RM map, the Catalyst, a joint venture between national peak industry bodies AusBiotech and Medicines Australia, will advance regenerative medicines policy, mobilise resources, build community engagement, establish shared measurement practices and support aligned activities.

To drive and deliver on the Catalyst’s national strategy, a General Manager is now being recruited for a two-year period.

The Catalyst is also being supported by the Victorian Government’s Australian Medtech Manufacturing Centre (AMMC) to help examine manufacturing barriers and explore new opportunities for growth to unlock the potential for cell and gene manufacturing in Australia.

A new role will be established for a dedicated ‘Project Manager, Cell and Gene Therapy Manufacturing’ to develop a ‘blueprint’ report to build on the work published in Australia’s Regenerative Medicines Manufacturing Capacity and Capability, to determine what is needed to manufacture more cell and gene products locally, and develop specific recommendations and a strategy document addressing: workforce skills development, attraction and retention; strengthened collaboration across the value chain; opportunities for secure long-term investment; and positioning Australian manufacturing capability in global markets.

This role will work in harmony with the Catalyst and its General Manager, which will drive the broader Strategic Roadmap.

-QUOTES -

AusBiotech CEO, Lorraine Chiroiu said: “Australia offers a wealth of opportunity in cell and gene therapies, and the formation of the Cell and Gene Catalyst’s Steering Group is a powerful step towards realising our national potential. The leadership and commitment demonstrated by this group is notable, and denotes the significant impact these treatments may have for Australia and Australians.”

Medicines Australia CEO, Elizabeth de Somer said: “Cell and gene therapies are at the forefront of innovation and have the potential to revolutionise how we treat serious diseases. The Cell and Gene Catalyst is a timely initiative that will bring together global companies with Australian SMEs to drive better healthcare outcomes and help build an Australian innovation-led economy fit for the 21st century. Medicines Australia is pleased to partner with key players in the Australian life sciences ecosystem to make this a reality.”

CSL Behring’s ANZ Executive Director and General Manger Loretta Croker said: “CSL Behring is proud to support the Catalyst in advancing access to cell and gene therapies in Australia. We look forward to collaborating with our partners and translating this effort to those people living with rare and serious diseases.”

Pfizer Rare Disease Lead, Developed Asia, Koray Koksal said: “The COVID-19 pandemic has shown us what can be achieved when we collaborate with a sense of urgency to solve health challenges. Cell and gene therapies hold vast potential to deliver breakthroughs that change patients’ lives across the country. To achieve this, we must continue to invest in innovation, improve the speed of access to new treatments, and solve affordability challenges. The Cell and Gene Catalyst will ensure we have a strong, coordinated voice to advance these issues and to reduce the burden of disease.”

Cell Therapies Pty Ltd CEO, Peter Giannopoulos, said: “Australia’s Cell & Gene Therapy ecosystem is burgeoning and now is the time for Australia to invest in building sovereign capabilities and capacity, from translation of basic research through to delivery of cutting-edge products to patients. We are delighted to be part of the CGT Catalyst Steering Group and look forward to contributing to the growth of an industry that can do so much for so many patients in need.

Victoria’s Minister for Industry Support and Recovery Ben Carroll said: "Our support for this programme will help advance our capabilities in cell and gene manufacturing – backing our medtech sector to be at the forefront of innovation for the benefit of all Victorians.”

-ENDS-
Media enquiries: Karen Parr, Director, Communications & Policy, AusBiotech,
kparr@ausbiotech.org / M: +61 (0) 420 729 123

About the cell and gene opportunities in Australia

Cell and gene therapies offer tremendous promise and hope, with some calling the therapies the most important discoveries of our future. To capitalise on the opportunities that the burgeoning cell and gene sector can deliver to the Australian economy and society, the Cell and Gene Catalyst has been established.

Globally, investment in cell and gene reached AU$32.8B (or US$22.7B) in financing in 2021, with over 1,220 clinical trials of RM being conducted worldwide. There is an opportunity for Australia to be a regional hub in the Asia Pacific region known for leading cell and gene research, clinical trials, translational know-how and manufacturing capabilities.

About the Cell and Gene Catalyst’s Steering Group

AusBiotech
AusBiotech is Australia’s biotechnology organisation, working on behalf of members for more than 35 years to provide representation and services to promote the global growth of Australian biotechnology. AusBiotech is a well-connected network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), food technology and agricultural sectors.

Medicines Australia
Medicines Australia represents the discovery‐driven pharmaceutical industry in Australia. Our member companies invent, manufacture and supply innovative medicines and vaccines to the Australian community, which keeps Australians out of hospitals, prevents disease and play a pivotal role in ensuring a productive and healthy community. Medicines Australia’s mission is to drive the creation and development of a predictable environment for the continued, sustainable growth of the innovative and researchbased prescription medicines industry.

Cell Therapies Pty Ltd
Cell Therapies Pty Ltd is an Australian-based, globally-active commercial contract development and manufacturing company, specialising in cell therapy, gene therapy, regenerative medicine, and cellular immunotherapy products. A leader in this groundbreaking field, our expert team and world-class facilities have been developing and manufacturing cutting edge treatments for cancer and rare diseases on behalf of local and international clients for nearly 20 years.

CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 25,000 people worldwide, and delivers its life-saving therapies to people in more than 100 countries. For inspiring stories about the promise of biotechnology, visit Vita CSLBehring.com/vita and follow us on Twitter.com/CSLBehring

Novartis Australia and New Zealand
Novartis is the largest Australian medicines company improving the lives of more than 2.8 million patients across Australia and New Zealand. From generics to gene therapy, we are committed to accelerating patient access to life saving treatments. We are reimagining medicine by using innovative science and technology to address challenging healthcare issues and our rich pipeline has 200+ projects in development and an industry leading clinical trial footprint in Australia. Our unbossed, curious and inspired culture unites our 700 employees, it is what unleashes the power of our people and is at the heart of the work we do each day.

Pfizer Australia
Breakthroughs That Change Patients’ Lives: At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. Find out more about Pfizer.

Therapeutic Innovation Australia
TIA is a network of 25 national translational research infrastructure facilities in biologics and vaccines, cell and gene therapies, and small molecule pharmaceuticals. We aim to provide Australian researchers with access to infrastructure that enables efficient translation of therapeutics to improve human health. Our investments ensure facilities are coordinated, comprehensive, accessible and responsive to the needs of the Australian translational research community. We work to strengthen links between academic researchers and the private sector to enrich the Australian medical innovation ecosystem.

About: Victorian Government’s Australian Medtech Manufacturing Centre (AMMC) is a $20 million initiative established to strengthen connections between manufacturers, researchers and innovators to grow Victoria’s medtech manufacturing sector.

Immutep reports new data from phase 2 TACTI-002 trial

Tue, 02 Aug 2022 00:00:00 +1000

Recruitment open for new study of lung disease

Tue, 02 Aug 2022 00:00:00 +1000

New study published demonstrating the utility of PromarkerD test

Tue, 02 Aug 2022 00:00:00 +1000

Nominations open to recognise sector leaders

Thu, 28 Jul 2022 00:00:00 +1000

Nominations for the 2022 AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards are now open and will recognise and celebrate life science leaders who are championing the sector and the Australian community.

These prestigious Awards recognise the leading lights of Australia’s world-class biotechnology and medical technology sectors, including researchers who successfully translate their discoveries into clinical practice and companies who pioneer the developments of new treatments, devices and reliable diagnostics.

Nominations for the awards are open until 16 September 2022 in the following categories:

Industry Leadership Award

This Award seeks candidates who have already made a significant difference to the industry and have an outstanding commitment to life sciences/biotechnology that often goes beyond the 'job description'. Candidates will be known for their passion, enthusiasm and commitment to the industry in Australia.

Previous winners include: David Blake, Sue MacLeman, Professor Andrew Wilks, and Dr Anna Lavelle.

Australian Company of the Year Award

The Australian Company of the Year will be awarded to a company that has demonstrated significant achievement(s), and may include any company working in biotechnology or life sciences, including but not limited to the medical diagnostics or devices, pharmaceutical and agricultural biotechnology sectors. Consideration of deals done, product pipeline, IP, company strategy and/or revenue is key, and nominations should address the significant achievements attained over the past 12 months.

Previous winners include: SpeeDx, PolyNovo, Medicines Development for Global Health.

Australian Emerging Company of the Year Award

The Australian Emerging Company of the Year Award will be based on the same criteria as the Australian Company of the Year, but is specific to companies under five years of age.

Previous winners include: oNKO-innate, OncoRes Medical, and Telix Pharmaceuticals.

The AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards 2022 will be presented in-person on Wednesday 27 October during AusBiotech 2022. Find out more and nominate a company or individual by Friday 16 September 2022.

MTPConnect launches next funding opportunity for medical device companies

Thu, 28 Jul 2022 00:00:00 +1000

Volpara Health announces outcomes of strategic review

Thu, 28 Jul 2022 00:00:00 +1000

Genetic Signatures completes recruitment in pivotal clinical trial

Thu, 28 Jul 2022 00:00:00 +1000

Immuron provides update on FDA review of IND application

Thu, 28 Jul 2022 00:00:00 +1000

Patent filings increase in new intellectual property report

Tue, 26 Jul 2022 00:00:00 +1000

Data from IP Australia’s recently released Australian Intellectual Property Report 2022 highlighted ‘a record high’ 32,397 standard patent applications filed in Australia in 2021, which demonstrated an 11 per cent increase on 2020 filings.

The top three technology classes – pharmaceuticals, medical technology, and biotechnology – created the increase in patents filed in 2021 around the need to develop novel coronavirus vaccines and treatments in Australia.

The report also noted an indication of ‘global innovation investments were more resilient during COVID-19 than during past global economic recessions.’

Patents filed in Australia were prominently featured in these sectors, and they saw a growth from 2020 filings with:

3,982 applications in the pharmaceuticals sector, increased by 27 per cent
3,912 applications in medical technology, rose by six per cent and;
3,120 applications in biotechnology, increased by nine per cent

The Australian Government’s IP Australia administers IP rights and legislation relating to patents, trademarks, designs, and plant breeder's rights. The government body contributes to the innovation system more broadly by using its skills and experience to advise government and Australian businesses to make the most of their IP.

AusBiotech is currently working with its Intellectual Property Advisory Group to showcase the importance of Australian life sciences companies and the relationship between IP and the sector’s ability to attract investment, create jobs and discover new innovations.

To download the Australian Intellectual Property Report, click here.

Industry responds to waiver with its own access declaration

Tue, 26 Jul 2022 00:00:00 +1000

ImpediMed announces departure of long-term chief executive

Tue, 26 Jul 2022 00:00:00 +1000

Adherium wins US clearance for GSK inhaler users to connect to new platform

Tue, 26 Jul 2022 00:00:00 +1000

Amplia Therapeutics' trial to be presented at major US conference

Tue, 26 Jul 2022 00:00:00 +1000

International consultation on medical device cybersecurity

Thu, 21 Jul 2022 00:00:00 +1000

AusBiotech is seeking contribution from affected members as it considers its response to the Therapeutic Goods Administration’s (TGA) consultation on the International Medical Device Regulators Forum (IMDRF)’s Medical Device Cybersecurity Guide (MDCG) Working Group.

The consultation is now open and it seeks comment on the proposed document Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity, which considers cybersecurity in the context of medical devices that either contain software, including firmware and programmable logic controllers (e.g., pacemakers, infusion pumps) or exist as software only (e.g., Software as a Medical device (SaMD)).

The scope of this guidance is limited to consideration of the potential for patient harm related to the regulated medical device. This includes, threats that could impact performance, negatively affect clinical operations, or result in diagnostic or therapeutic errors are considered in scope of this document. While other types of harm such as those associated with breaches of data privacy are important, they are not considered within the scope of this document.

AusBiotech is currently consulting with its AusMedtech Regulatory Affairs Advisory Group to consider a submission in response to this consultation.

The public consultation is open until 30 August 2022 and AusBiotech encourages members to contact Karen Parr, Director Communications & Policy, by Tuesday 23 August 2022 to discuss how the document and/or consultation may affect their company.

Neuren Pharmaceuticals company one step closer to major product launch

Thu, 21 Jul 2022 00:00:00 +1000

Australia's first national biotechnology incubator announces round one funding

Thu, 21 Jul 2022 00:00:00 +1000

ACCC clears Pfizer acquisition of Australian digital health company

Thu, 21 Jul 2022 00:00:00 +1000

The National Clinical Trials Governance Framework launched

Tue, 19 Jul 2022 00:00:00 +1000

AusBiotech welcomes the recent launch of The Australian Commission on Safety and Quality in Health Care (the Commission)’s National Clinical Trials Governance Framework.

The launch of the Governance Framework has provided the opportunity for the Commission to communicate the benefits of the Framework for the clinical trials sector and to the Australian community.

The Commission is updating the supporting resources to implement the Governance Framework and is working with accrediting agencies in preparation for assessment to the Governance Framework.

Assessments will likely commence in January 2023 under the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme and the process for accreditation will apply as either having met or not met the actions within the National Safety and Quality Health Service (NSQHS) Standards Clinical Governance Standard.

The Governance Framework is recognised as a significant reform for the Australian clinical trials sector. The Governance Framework embeds clinical trials into routine health service provision and strengthens the clinical and corporate governance arrangements for governments, hospital administrators, health services, private companies, trial sponsors and trial investigators that deliver clinical trials. Importantly, the Commission’s Governance Framework will make a concerted effort to reduce duplication and increase efficiency, cohesion and productivity across the clinical trials sector.

AusBiotech is currently collaborating with its Clinical Trials Advisory Group to advise relevant members on how the Governance Framework will continue to shape future clinical trial activities in the sector.

To find out more information on The Commission’s National Clinical Trials Governance Framework, click here.

AusBiotech's Lorraine Chiroiu: A 'hollow victory' and 'slap in the face'

Tue, 19 Jul 2022 00:00:00 +1000

Rhinomed announces Rhinoswab supply deal with SureScreen

Tue, 19 Jul 2022 00:00:00 +1000

Imugene appoints experienced executive as new chief financial officer

Tue, 19 Jul 2022 00:00:00 +1000

TGA’s new report on cell & gene therapy regulation

Thu, 14 Jul 2022 00:00:00 +1000

Therapeutics Goods Administration (TGA) has recently responded to stakeholder feedback on improving cell and gene regulation in Australia by releasing the ‘Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives’ report.

The report includes TGA’s responses to recommendations proposed by engagement with Australian stakeholders that wherever possible TGA will continue to align definitions and classifications with international regulators, will instigate a review of the Clinical Trial Approval (CTA) process, including the need for an education campaign to raise awareness and clarity of the timeframes and process, and increase guidance on Good Manufacturing Practice (GMP) requirements at various stages of cell and tissue therapy development.

Additionally, the report notes feedback that TGA and the Office of the Gene Technology Regulator (OGTR) have instigated a process to review their interactions around Genetically Modified Organisms (GMOs), including a revision of guidance material published on TGA’s website and the TGA has been working with Pharmaceutical Benefits Advisory Committee (PBAC) and Medical Services Advisory Committee (MSAC) that will increase collaboration and enable parallel processing and TGA Registration Pathways.

In response to feedback on TGA registration pathways, the TGA completed a consultation on the potential introduction of a Priority Pathway for biologicals, and a proposal is now before government. AusBiotech responded to that consultation in March 2022, citing that AusBiotech Members regularly utilise these expedited pathways internationally and the opportunity to introduce a priority pathway for biologics into Australia was warmly welcomed. TGA continues to offer a regulatory pathway that will enable patients with unmet clinical needs more timely access to innovative, novel technologies.

TGA commissioned MTPConnect in November 2021 to conduct a stakeholder engagement review, and it will now progress separate consultations on the items arising out of the recommendations, with implementation of any changes requiring approval by the Federal Government.

To download the report and read the recommendations, click here.

Neuren commences phase 2 trial of NNZ-2591 in Angelman syndrome

Thu, 14 Jul 2022 00:00:00 +1000

Cynata Therapeutics secures US patent for Use of the Cymerus MSCs in Asthma

Thu, 14 Jul 2022 00:00:00 +1000

Actinogen confirms Alzheimer's disease biomarker study timing and design

Thu, 14 Jul 2022 00:00:00 +1000

AusBiotech expands its investment attraction portfolio

Tue, 12 Jul 2022 00:00:00 +1000

AusBiotech is pleased to announce an expanded investment attraction offering has commenced in line with a new investment attraction strategy. This strategy was developed in response to feedback from members and industry stakeholders during the development of the Biotechnology Blueprint; A Decadal Strategy for the Australian Biotechnology Industry.

AusBiotech recognises that access to capital is one of the most significant drivers of growth and sustainability for Australia's life sciences sector. In the context of explosive growth in company numbers and a focus on commercialisation, the appetite for capital within our sector is accelerating.

As Australia's peak industry membership body, AusBiotech will continue to take a leadership role in promoting the sector to potential investors, building investment capability within the sector, and delivering a range of initiatives that aim to increase and diversify the flow of funding into the Australian life sciences sector.

To drive this expanded portfolio, Lisa Renkin has recently joined AusBiotech as Director, Investment. Lisa is well known to many in the sector and has worked collaboratively with AusBiotech and sector stakeholders over many years. Most recently Lisa was the Victorian Deputy Commissioner to China with responsibility for the investment attraction portfolio. Prior to that appointment she worked at the Burnet Institute, leading various commercialisation activities including the expansion of the Institute's China programme, and contributing to AusBiotech's global investment programme in an advisory capacity.

The investment programme will build on AusBiotech’s successful investment series that has brought together investors and Australian companies seeking capital over the past decade - and will bolster the evidence base and industry-level analysis available by refreshing and creating new resources.

The work will commence with the development of an environmental, social, and governance (ESG) framework to support reporting for the industry, as it is increasingly important to AusBiotech employees, members and industry stakeholders, including investors, and is strongly aligned with community expectations.

To continue this investment discussion, AusBiotech encourages you to register for AusBioInvest 2022 on 27 October 2022 in Perth, WA.

Emerging Australian company appoints industry research leader to head translation

Tue, 12 Jul 2022 00:00:00 +1000

Telix Pharmaceuticals announces major leadership appointment

Tue, 12 Jul 2022 00:00:00 +1000

Study identifies kids with cancer at risk of lethal infections

Tue, 12 Jul 2022 00:00:00 +1000

NeuroScientific Biopharmaceuticals seeks approval for phase 1 trial

Tue, 12 Jul 2022 00:00:00 +1000

AusBiotech and CSIRO partner to connect sector

Thu, 07 Jul 2022 00:00:00 +1000

AusBiotech is pleased to partner with Australia’s national industrial research agency CSIRO to deliver three BioCheers networking events across August in Melbourne, Sydney and Brisbane.

This partnership with CSIRO enables thousands of AusBiotech members to connect and engage with their respective state’s vibrant life sciences community, onsite at three CSIRO locations.

BioCheers brings together AusBiotech members and non-members in the life sciences, including therapeutics, medical technology (devices and diagnostics), digital health, and agri-biotech sectors to build relationships, make new and connect with members of AusBiotech’s State Branch Committees and national Advisory Groups.

AusBiotech welcomes you to register for our BioCheers at CSIRO, which includes:

VIC BioCheers at CSIRO: 4 August 2022
NSW BioCheers at CSIRO: 11 August 2022
QLD BioCheers at CSIRO: 25 August 2022

As the only national dedicated life sciences member network, AusBiotech is pleased to provide invaluable in-person opportunities for delegates to learn, strengthen and grow their industry knowledge.

Thanks to our host event partner CSIRO for sponsoring the BioCheers in August. To secure your place and for more information, register now.

Australian study uncovers a driving factor in the development of Alzheimer's disease

Thu, 07 Jul 2022 00:00:00 +1000

Patrys says PAT-DX1 engineering run successfully completed

Thu, 07 Jul 2022 00:00:00 +1000

Botanix Pharmaceuticals accelerates filing of NDA

Thu, 07 Jul 2022 00:00:00 +1000

ResApp Health extends agreement with Europe's Medgate

Thu, 07 Jul 2022 00:00:00 +1000

Funding programme increases support for WA researchers

Tue, 05 Jul 2022 00:00:00 +1000

The WA State Government recently announced an innovative programme – the Co-Funding Partnerships Program (Co-FFP) – that aims to provide an avenue for researchers or organisations to co-fund and support health and medical research programmes to improve the health and wellbeing of Western Australians.

The Co-FFP is an initiative of the WA State Government's Future Health Research and Innovation (FHRI) Fund, which provides funding to support health and medical research and innovation projects. Applicants can submit expressions of interest to the FHRI Fund for contributions between $500k to $1 million per annum, and the FHRI Fund contribution must be at least matched in cash by the applicant.

A key aim of the programme is to build and foster collaboration between the State Government and industry that will drive to increase the capacity and capability of WA health and medical researchers and innovators.

WA State Government Medical Research and Innovation and ICT Minister the Hon. Stephen Dawson MLC said: "We are looking to form strategic funding partnerships to help drive positive health outcomes for the Western Australian community. The program has been designed to provide a mechanism for funding partners to co-fund FHRI Fund research and innovation activities that are working toward common goals. The Co-Funding Partnership Program will increase the funding available for health and medical research and innovation of benefit to WA by enabling collaboration between partners with a shared vision."

Previous 2021/2022 AusBiotech member recipients of other programmes and initiatives under this Fund include, Linear Clinical Research, The University of Western Australia, Curtin University, and the Telethon Kids Institute.

The Co-FPP is continuously open so that new partnerships can be established at any time. To find out more information about the programme and eligibility criteria, click here.

Australian researchers identify new drug target for inflammatory lung disease

Tue, 05 Jul 2022 00:00:00 +1000

CSIRO supports CUREator with funding for health security stream

Tue, 05 Jul 2022 00:00:00 +1000

Dimerix updates with new and positive DMX-700 data

Tue, 05 Jul 2022 00:00:00 +1000

New leadership for medtech regulatory advisory group

Thu, 30 Jun 2022 00:00:00 +1000

AusBiotech has recently appointed Dr Darren Forrest, Director of Quality & Regulatory Affairs ANZ, Medtronic Australasia Pty Ltd as Chair of the national AusMedtech Regulatory Affairs Advisory Group.

Dr Forrest has been a contributor to the AusMedtech Regulatory Affairs Advisory Group since 2012. He brings an in-depth knowledge and experience regarding the implementation of European and Australian medical device regulations to the Advisory Group. Darren leads regulatory, quality and post market vigilance at Medtronic to ensure the best technology is available to Australian patients.

Members of the AusMedtech Regulatory Affairs Advisory Group include:

Rebecca Gaudin, Director of Regulatory Affairs, ANZ, Johnson & Johnson Medical
Dr Jeremy Paull, VP Development & Regulatory Affairs, Starphama Pty Ltd
Sarah Henderson, Regulatory Affairs Manager, Accelagen Pty Ltd
Veronica Lewis, Head of Regulatory Management and Trade Compliance - Australia & New Zealand, Merck Group Pty Ltd
Manuel Urena, Director Regulatory Affairs, APAC, Cochlear Ltd
Yervant Chijian, Director, Team Lead Medical Devices/IVD, Australia, PharmaLex Pty Ltd

The AusMedtech Regulatory Affairs Advisory Group represents members in the medical technology sector providing guidance and advice to AusBiotech on operational and policy-related regulatory matters regarding dealings with the Therapeutic Goods Administration (TGA). Advisory Group members represent AusBiotech at TGA’s RegTech Forums throughout the year to remain informed on major policy issues, which AusBiotech utilises to disseminate information to its membership.

AusBiotech would also like to thank Grant Bennett, Managing Director, PharmaLex for his time as Chair of the Advisory Group after four years of service. Grant remains involved as Chair of AusBiotech’s national AusMedtech Advisory Group.

NeuroScientific Biopharmaceuticals updates on early-stage trial

Thu, 30 Jun 2022 00:00:00 +1000

Novotech secures regional 'Best Biologics CRO' award

Thu, 30 Jun 2022 00:00:00 +1000

Starpharma's anti-viral nasal spray relaunched in the UK

Thu, 30 Jun 2022 00:00:00 +1000

Investment funds support university commercialisation

Tue, 28 Jun 2022 00:00:00 +1000

AusBiotech welcomes the announcement of two new university-specific investment funds, totalling $115 million, created in collaboration with Tanarra Capital, the University of Melbourne and Victorian State Government-funded Breakthrough Victoria.

The $100 million Tin Alley Ventures Fund led by Tanarra Capital, which the University of Melbourne is contributing $25 million, will invest in high-potential University of Melbourne-affiliated start-ups, provide support from the seed stage through to pre-IPO and engage the University’s alumni and supporters to help investee companies reach their full potential.

Breakthrough Victoria and Tanarra Capital will manage and contribute $7.5 million each to the second Fund, Genesis Pre-Seed. The $15 million Fund will support early-stage start-ups created by the University’s academics, students or alumni and will facilitate access to the University’s networks and mentoring to create seed-fund-ready companies.

The two Funds will embed dedicated venture capital into the University and enable start-ups’ pathway to commercialisation. Both Funds will be open to University of Melbourne students, University-affiliated organisations and alumni to accelerate their research innovation and commercialisation journeys.

Tanarra Capital founder and CEO John Wylie said: “Tanarra has a long track record in investing in venture capital. This is one of the most exciting things we’ve ever done and we’re so proud to be partnering with the University of Melbourne in doing this. We know the potential, the people and the smarts are there, so this is about lighting the match and making it really come to life.”

University of Melbourne Vice-Chancellor Professor Duncan Maskell said: “Universities have a social responsibility to make a difference in the world, and one way we do this is through translating our research into public good … Our two new Funds will play a critical role in supporting researchers to take more risks, to be creative in their thinking and accelerate the possibilities to take research discoveries from an idea to market.”

Breakthrough Victoria Chair John Brumby said: “The creation of the Genesis Pre-Seed Fund with the University of Melbourne will amplify and accelerate the support for commercialisation of important research from the University of Melbourne. The Genesis Pre-Seed Fund reinforces Breakthrough Victoria’s strategy to support investment so that research with strong commercial potential does not falter during the early stages.”

Expressions of interest for the University of Melbourne’s Genesis-Seed Fund are open and Tin Alley Ventures Fund will be open for applications in late 2022.

Orthocell announces new agreement with US-based BioHorizons

Tue, 28 Jun 2022 00:00:00 +1000

Starpharma signs expanded DEP research agreemnent with Genentech

Tue, 28 Jun 2022 00:00:00 +1000

Lumos Diagnostics secures authorisation for test in Canada

Tue, 28 Jun 2022 00:00:00 +1000

NSW & QLD Government investments into industry welcomed

Thu, 23 Jun 2022 00:00:00 +1000

AusBiotech has welcomed the investment into the life sciences industry through this week’s New South Wales and Queensland Budgets, as well as the recognition of biotech’s ability to “underpin the jobs, businesses and industries of the future”.

The NSW budget included a new $703.4 million Future Economy Fund, to drive growth in emerging high-value industries, including medtech, and digital technology, over four years.

Notably, included in this Fund is $342 million to boost commercialisation support, and to provide targeted support to research institutions, start-ups, scale-ups and SMEs.

The Fund will also invest $219 million to accelerate growth and investment in priority industry sectors, including modern manufacturing and medtech; and $142 million to drive R&D growth in sectors in which NSW has a natural competitive advantage, such as advance collaboration with the private sector, universities, and CSIRO.

Announcing the Budget, Treasurer Matt Kean highlighted the “power of medical science”, before revealing a number of additional investments into R&D facilities.

The Biomedical Accelerator Complex in Camperdown will receive $150 million over four years to become a state-of-the-art biomedical research hub enabling researchers and industry to collaborate together on solving critical health challenges.
The Viral Vector Manufacturing Facility at Westmead will see $50 million invested, to develop and test life-saving therapies for rare genetic diseases and cancers. This includes $26 million to continue providing highly specialised cell and gene therapies for patients with rare or late-stage diseases.
To translate RNA therapeutics research into clinical and commercial outcomes and ensure best use of the pilot manufacturing facility, $119 million will be invested over 10 years into RNA therapeutics manufacturing, research and development.
An Advanced Manufacturing Research Facility in the Bradfield City Centre will see $262 million invested, thereby aiming to support the creation of hundreds of high-value jobs and unlocking billions of dollars of real private sector investment by 2056.

The announcements align to the NSW Government’s 20-year roadmap for industry, which maps its long-term strategy for turning the state’s research and development capabilities into new world-leading industries and jobs.

AusBiotech also welcomed the Queensland Budget’s investment into the biotech sector, with the Hon. Cameron Dick MP, Treasurer and Minister for Trade and Investment, noting how advanced manufacturing and biomedical technology will deliver the well-paying, secure, highly skilled jobs of the future.

A $3.34 billion Queensland Jobs Fund has been announced to capture future opportunities in traditional and emerging industries. These will align to the government’s 10-year Industry Roadmaps and initiatives and aim to drive innovation-led jobs for the future.

The Queensland Jobs Fund includes a $350 million ‘Industry Partnership Program’ to unlock the State’s advanced manufacturing potential and to grow and create jobs across priority industry sectors, including in biomedicines.

A new facility to produce Vaxxas’ needle-free vaccines is an example of the Government’s support as it aims to make the state a globally-competitive Asia-Pacific biomedical hub. This facility is expected to employ up to 110 high-skilled biomedical experts once operating in early 2023.

In addition, $50 million is committed over two years to continue the Made in Queensland and Manufacturing Hubs Grant programmes. These support small and medium-sized manufacturers to increase their international competitiveness and build advanced manufacturing capability in Queensland’s regions.

The pre-Budget announcement of the Translational Research Institute’s expansion was also included in the Budget papers.

The announcements in the NSW and QLD State Budgets support core, critical areas of focus outlined in AusBiotech’s industry-developed Biotechnology Blueprint, a decadal strategy for biotech industry, including support for commercialisation, addressing capability and skills gaps, and building sovereign capabilities.

Read the NSW Budget papers here.

Read the QLD Budget papers here.

Victorian government to grant to Hudson Institute for collaboration with Noxopharm

Thu, 23 Jun 2022 00:00:00 +1000

Volpara Health in new collaboration with Microsoft

Thu, 23 Jun 2022 00:00:00 +1000

High appetite for biotech VC cited in new report

Tue, 21 Jun 2022 00:00:00 +1000

A recent report published by US-based firm McKinsey & Company has cited that venture capital (VC) investment in the biotech industry has boomed over the past three years.

The report noted that “from 2019 to 2021, VC companies invested more than $52 billion in therapeutic-based biotech companies globally. Two-thirds of that went to start-ups with platform technologies.”

According to the report, venture capitalists still have a strong interest and appetite in biotech, especially in emerging biotechs that are developing new innovations and therapies, with the report noting, “with substantial VC investment fuelling innovative therapies that address unmet needs, the biotech industry is poised to make lasting changes that can overcome the challenges it faces.”

The report also identified six technologies are generating significant investment in the biotech industry:

Cell therapy 2.0
Next-generation gene therapies
Precision medicine
Drug discovery enabled by machine-learning
Strategies for validated but undruggable targets
New delivery methods

AusBiotech’s recent strategic document Australian Biotechnology Sector Snapshot 2022 reveals data highlighting the support of investors into the Australian life sciences and biotech sectors. It notes, “annual data collected and reported by Bioshares shows that the capital raised by ASX-listed biotech companies in 2021 was a record high of $8 billion, of which $6.3 billion can be attributed to home-grown biotherapeutic multi-national giant CSL. This capital raising builds on the $1.7 billion in 2020, and the $1.08 billion raised the year prior.”

AusBiotech will present investment opportunities in-person at AusBioInvest 2022 in Perth, WA on 27 October 2022, with support from Host State Partners, Business Events Perth and the WA Government.

Life sciences industry says IP waiver an 'empty shell' and fact-free decision

Tue, 21 Jun 2022 00:00:00 +1000

New orphan drug designation for Kazia Therapeutics' paxalisib

Tue, 21 Jun 2022 00:00:00 +1000

Registrations are open to ‘come alive’ at AusBiotech 2022

Thu, 16 Jun 2022 00:00:00 +1000

The Australian biotech community will ‘come alive’ at AusBiotech 2022, Australia’s premier life science conference, and with early-bird registrations now open now is the time to plan to recharge and reconnect.

Under the sunny skies of its host state Perth, Western Australia, AusBiotech 2022 will bring the biotech industry together in-person at the Perth Convention and Exhibition Centre and breathe new life into the Australian biotech industry after two years of disruption and change.

There’s never been a more important time to reflect on what we have achieved and address the growing commercial opportunities for the national and global health and medical life sciences industry, including regenerative medicine, cell and gene therapies, biotech, precision medicine, clinical trials and agricultural biotech.

Delegates that register by Friday 29 July 2022 will save $250 by booking their early-bird registrations now.

A delegate pass to AusBiotech 2022, includes access to:

Fully refundable early registrations
Three-day interactive and cutting-edge programme
International and national keynote speakers
Expert panel discussions
The AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards 2022
Three days of in-person AusPartnering, AusBiotech's highly-popular business matching programme
Social and networking events including a welcome reception, conference gala dinner and closing ceremony
Early-Stage Investment Forum
An opportunity to connect with industry through our BioIndustry Exhibition
Satellite events.

Connecting the biotech community for more than three decades, the event is known and trusted as a very special part of AusBiotech’s broader work positioning Australia’s biotechnology industry for growth. As a leaders’ forum, it also presents a key opportunity to connect with potential partners and investors, to reflect on the sector’s achievements and to exchange ideas to further advance the sector’s standing both nationally and globally.

AusBiotech 2022 programme submissions are still open and we encourage you to help shape the programme with leading keynote and panel suggestions. Submissions close 24 June 2022, 5.00 pm AEST.

Last year’s AusBiotech conference was delivered virtually and brought together over 1,000 Australian and international biotech leaders and stakeholders that showcased the best and brightest in biotech.

AusBiotech 2022 is proudly supported by Host State Partners Business Events Perth and the WA State Government, from 26-28 October.

Major software acquisition for leading Australian company ResMed

Thu, 16 Jun 2022 00:00:00 +1000

NeuroScientific Biopharmaceuticals reports positive data from animal study

Thu, 16 Jun 2022 00:00:00 +1000

Significant growth symbolic of biotech sector’s sovereign value

Tue, 14 Jun 2022 00:00:00 +1000

The significant 40 per cent growth of Australia’s biotechnology industry in two years, revealed in AusBiotech’s new sector ‘snapshot’, is symbolic of the sector’s value to Australia and Australians.

The Australian Biotechnology Sector Snapshot (Snapshot) illuminates the sector’s 43 per cent growth since 2019 and 60 per cent growth since 2017; this research shows that 1,427 of the 2,654 organisations (54 per cent) are industry-based, with the number of companies undertaking biotech research and development having grown by 40% since 2019.

The number of employees behind our biotech companies has also expanded, increasing 21 per cent compared to 2019, from approximately 87,397 people in 2019 to more than 105,000 in 2022.

To determine how the Australian biotech sector is changing, the Snapshot is commissioned by AusBiotech to provide an updated and unique overview, in terms of organisation and employment numbers across the country, and gender distribution within the sector.

AusBiotech CEO, Ms Lorraine Chiroiu, said: “This Snapshot recognises the sovereign value of our Australian biotechnology sector, and its place as a significant economic and social driver for our country.”

“The substantial strength of the life sciences sector, shown in the Sector Snapshot 2022 through the substantially increasing numbers of organisations and the people employed within it, depicts an actively thriving ecosystem. This maturity is a key factor for the industry’s ability to attract and retain high-value jobs and backs its ability to compete on the world stage in a knowledge-based economy.”

There are currently 192 life sciences companies listed on the Australian Securities Exchange (ASX), increasing a notable 19 per cent from 2019’s 161 listed companies. Twenty-six of these companies have listed since 2020. Collectively, these ASX-listed biotech companies now represent a market capitalisation of approximately $233 Billion (compared to around $170B in 2019), demonstrating a substantive 27 per cent increase in value. This is one quantifiable measure of the life science sector’s contribution to the Australian economy. The proportion of biotech companies achieving market valuations greater than $100 million (36 per cent) also measures the industry’s ability to create companies of significant future value.

The biotech sector has grown year-on-year since AusBiotech’s Snapshot research was first commissioned: growing from 1,654 organisations in 2017, to 2,654 organisations in 2022. Over the four years, the sector has seen overall growth of 60 per cent. The high-value talent backing our Australian biotechnology sector has also increased, and there are now approximately 263,693 people employed.

New South Wales and Victoria is a critical life science hub, and supports 73 per cent of Australia’s life sciences sector; each state has grown 51 per cent and 34 per cent respectively. Queensland has seen an impressive 60 per cent growth, retaining the third largest number of life sciences organisations. Western Australia continues to steadily grow, increasing nine per cent in the past two years, and South Australia represents five per cent of the sector, growing 39 percent to 135 organisations.

The Snapshot report offers critical metrics that align to AusBiotech’s Biotechnology Blueprint, a strategic decadal framework developed by industry, for industry. The Blueprint metrics seek to track the maturity and vibrancy growth in our ecosystem, and to measure the Australian biotechnology industry’s global and local standing, and the industry’s positive contribution to Australian prosperity.

Download the Australian Sector Snapshot 2022 here.

EpiAxis Therapeutics says clinical trial validates targeting LSD1 inihibition

Tue, 14 Jun 2022 00:00:00 +1000

Telix and RefleXion expand partnership for prostate cancer treatment

Tue, 14 Jun 2022 00:00:00 +1000

Regeneus chief executive makes off-market investment in company

Tue, 14 Jun 2022 00:00:00 +1000

Strong Australian delegation to BIO 2022 marks biotech’s global resilience

Thu, 09 Jun 2022 00:00:00 +1000

This year’s annual Australian delegation to the largest biotech event in the world will return in-person next week, led by AusBiotech, and demonstrates a strong industry with participation bouncing back to pre-pandemic sizes.

The Australian delegation will see a number of state governments, the Australian Ambassador to the United States, State Ministers, over 170 companies and 300 delegates standing united.

AusBiotech leads the Australian contingent at the BIO International Convention 2022 in San Diego from 13-16 June, with the Australian Pavilion as the focal point. The delegation showcases Australian capabilities, promotes the strength of the Australian life sciences, and fosters global connections with its overseas counterparts.

The annual BIO International Convention hosted by the Biotechnology Innovation Organisation (BIO) and is the largest and most influential global event for the biotechnology industry. It draws more than 16,000 biotechnology and pharma leaders from over 3,000 companies and 67 countries and includes over 1,800 exhibitors and 800 speakers.

Lorraine Chiroiu, AusBiotech CEO will deliver a Global Innovation Hubs presentation on behalf of Australia, presenting Australia’s competitive advantage in the life sciences and sharing the top reasons to partner and invest in the Australian sector.

AusBiotech will host the Australian Wine Tasting Event this week, which continues to be a hallmark feature of the Australian Pavilion. The event draws BIO delegates from all corners of the exhibition hall and the globe to the national exhibit. The event has support from Agilex Biolabs and Medicines Australia.

The Pavilion features major supporters: MTPConnect, as well as state governments, including New South Wales Government and Investment NSW, South Australian Government, Victorian Government and Global Victoria, and Western Australian Government.

The mission to BIO continues to be closely aligned with AusBiotech’s strategic plan (2021-2024), which seeks to facilitate global engagement in strong established markets, including North America.

The Australian presence is one of the top ten largest international delegations, and it includes representatives from: 360Biolabs, Agilex Biolabs, Southern Star Research, Neuroscience Trials Australia, IQVIA, Medicines Australia, GenesisCare, Novotech, Avance, Clinials, Reece Pharmaceuticals, Alithia Life Sciences, Life Sciences Queensland, Greenlight Clinical, Evirma Technologies and CSIRO.

To find out more information on BIO 2022, click here.

Telix Pharmaceuticals reports significant RD tax refund

Thu, 09 Jun 2022 00:00:00 +1000

Dimerix enters agreement for new trial of DMX-200 in diabetic kidney disease

Thu, 09 Jun 2022 00:00:00 +1000

New blood test could spare patients from unnecessary chemotherapy

Thu, 09 Jun 2022 00:00:00 +1000

Early-stage medtech celebrated at AusMedtech 2022

Tue, 07 Jun 2022 00:00:00 +1000

The Australian medtech community celebrated and championed eight early-stage start-ups at the recent AusMedtech 2022 Early-Stage Investment Forum.

AusBiotech’s AusMedtech Early-Stage Investment Forum has empowered local research institutes, universities, hospitals and pre-series A companies with a boost on their pathways to commercialisation.

Dr Ricardo Garcia-Rosas, Co-founder and CEO of Virtetic was awarded first prize for the Best Translational Research project, which recognised their start-up’s game-based virtual reality therapeutics medical device for people living with limb loss. The company’s mission is to help people transition to life with a prosthesis and regain their function and independence faster.

The expert panel also gave a special mention to Mojtaba (MJ) Golzan from the University of Technology, Sydney for his medical device, A-Eye. The technology utilises a smartphone and is a smart and non-invasive alternative to brain and spinal cord injections. Its founder has secured a fast-tracked application into Medtech Actuator’s Origin accelerator.

Medtech Actuator’s Origin accelerator surrounds start-ups with the ecosystem support they need to bring their medtech, healthtech or biotech innovation to the patients and clinicians who need it most. Through intensive mentorship, industry collaboration, up to AUD$200K initial capital injection and capital raising support, founders can achieve in 12 months what can typically take three years or more.

Virtetic is an alumnus of Medtech Actuator’s Accelerator after completing the programme in 2021, which assisted the team to build their understanding of medical technology commercialisation and to develop a plan to do this for their technology.

The Forum presenters included:

Albert Chong, Triphasic Cardiac Pump: Physiological blood pump for open heart surgery
Wojciech Chrzanowski, The University of Sydney: EV-Phage Bio-bots
Dr Ricardo Garcia-Rosas, Virtetic: Game-based virtual reality therapeutics for people living with limb loss
Mojtaba (MJ) Golzan, University of Technology Sydney: A-Eye: a smart and non-invasive alternative to brain and spinal cord injections
Timothy Hughes, CSIRO: Injectable hydrogels for localised delivery of therapeutics
Nafiseh Mirabdolhosseini, Western Sydney University: A novel endoscopy system for early identification of abnormalities in the distal oesophagus
Chris Pymble, Graphics et al.: Graphics et al. - Simplify Complex Concepts
Lorace (Tianshu) Zhang, Vysum: A handheld eyedrop delivery device for improved glaucoma treatment

The Forum was supported by Davies Collison Cave and offered the early-stage projects and technologies the opportunity to gather feedback from an expert group of panelists. This included, Dr Emma Ball, Head of Illumina for Startups Australia, Dr Buzz Palmer, CEO, Medtech Actuator, Alistair Smith, Principal, Davies Collison Cave, Dr Amandeep Hansra, Managing Partner, Caligo Health and Kathy Connell, Senior Director, External Innovation Partnering, Johnson & Johnson Innovation.

Starpharma one of a number of Australian companies in the US for major oncology conference

Tue, 07 Jun 2022 00:00:00 +1000

Clarity secures US IND approval for phase 2 prostate cancer trial

Tue, 07 Jun 2022 00:00:00 +1000

Immutep reports positive overall response rate in lung cancer trial

Tue, 07 Jun 2022 00:00:00 +1000

One-stop shop for clinical trials enters its second phase

Thu, 02 Jun 2022 00:00:00 +1000

The Australian Commission on Safety and Quality in Health Care’s (The Commission) clinical trials ‘National One Stop Shop’ consultation has opened its second phase for health-related human research approvals.

In support of the work being undertaken by the Federal government, AusBiotech continues to champion industry’s voice as it works with its Clinical Trials Advisory Group and the R&D Taskforce throughout the consultation process. AusBiotech members are invited to unite and have their say as AusBiotech considers:

The proposed single national Site-Specific Assessment (SSA) core elements; and
A high-level interactive prototype of the single and nationally-focused health and human research approvals platform, which will be demonstrated and further tested through the second phase of consultations.

The goal of the National One Stop Shop and National Clinical Trials Front Door will improve coordination, and harmonisation across jurisdictions, and offer a single point of access to the sector. This will make it easier for industry, patients, researchers, to find, conduct, participate, and invest in Australia’s high-quality research. This consultation presents an exciting opportunity to make changes across the entire clinical trials landscape.

AusBiotech has supported the concepts of a National One Stop Shop and a National Clinical Trials Front Door since they were mooted more than two years ago, through national and international speaking opportunities, formal submissions, and through its ongoing discussions with Ministers and departmental staff.

AusBiotech is dedicated to promoting Australia globally as a key destination to conduct clinical trials, and a well-designed National One Stop Shop will be instrumental in supporting this mission. Its Biotechnology Blueprint outlines how ‘Australia has lots to boast about and our reputation is growing. From our reliable research sector to our world leading hospital system, and reliable clinical trials sector, to our R&D capabilities and notable expertise, the success of Australian biotechnology is an important story to share when demonstrating the value of companies from across the globe establishing in Australia.’

Clinical trials play a pivotal role in the economy of the future; already supporting more than 8,000 innovative Australian jobs, in 2019 clinical trials contributed more than $1.4 billion to the Australian economy – demonstrating its value in supporting the country’s transition from a post-mining boom.

AusBiotech members are encouraged to submit their feedback to Karen Parr by Friday 24 June 2022.

For more information on The National One Stop Shop consultation, click here.

Carina Biotech appoints Cell Therapies to manufacture LGR5 CAR-T cells

Thu, 02 Jun 2022 00:00:00 +1000

First patient recruited in Dimerix late-stage trial

Thu, 02 Jun 2022 00:00:00 +1000

New appointment to Imugene's scientific advisory board

Thu, 02 Jun 2022 00:00:00 +1000

Profile successes and add your voice

Tue, 31 May 2022 00:00:00 +1000

AusBiotech is calling for leadership articles to include in the September 2022 edition of the Australasian Biotechnology journal.

AusBiotech is welcoming abstracts from valued members on three set themes:

Australian commercialisation successes;
Investment trends and ventures;
Incubators and accelerators; who’s who and what’s the latest.

The journal will also feature a sneak peek into AusBiotech 2022 and AusBioInvest 2022, AusBiotech’s premier life sciences and investment conferences taking place on 26-28 October in Perth, WA, where key stakeholders of the Australian and international biotechnology and therapeutics sectors come together to engage and propel the sector.

Australasian Biotechnology is AusBiotech’s official bi-annual journal and published in April and September. Its contributions are by industry, for the industry.

With its informed and authoritative editorials, Australasian Biotechnology is a highly-effective communications vehicle for those wanting to reach out to stakeholders in the life sciences sector. The journal is mailed to over 3,000 AusBiotech members and investors, as well as published digitally. Readership includes companies, government and university departments, research institutes, biotechnology and professional services providers nationally, and in key overseas markets.

Two-hundred-word abstracts on your proposed topic, or questions, can be sent to the AusBiotech Communications team by 24 June 2022 (accepted articles due by 15 July 2022).

Download your copy of the April 2022 edition, here.

Channel Bio opens new state-of-the-art facility in Sydney

Tue, 31 May 2022 00:00:00 +1000

Cynata Therapeutics adds new site for MEND clinical trial

Tue, 31 May 2022 00:00:00 +1000

Adherium provides update on senior management

Tue, 31 May 2022 00:00:00 +1000

Thriving medtech community celebrated at record-breaking AusMedtech 2022

Thu, 26 May 2022 00:00:00 +1000

Demonstrating the buoyancy and growth of the sector, AusBiotech recorded its largest-ever face-to-face AusMedtech conference this week as the Australian medtech sector reunited and celebrated its achievements.

AusMedtech 2022’s theme ‘Medtech and Manufacturing: Building Global Capability’, reflected the industry’s international successes and aspirations, and drew more than 450 delegates and over 125 speakers from the Australian and international medical devices and diagnostics sector at the Melbourne Convention and Exhibition Centre.

The in-person two-day conference offered delegates over 25 cutting-edge conference sessions, and connections through one-to-one AusPartnering meetings and numerous informal networking opportunities.

AusBiotech thanks its AusMedtech 2022 Programme Committee led by Chair, Peter Bradley, LBT Innovations; and members, Rachel Hooke, FB Rice; Sue Dafnias, Atmo Biosciences; Peter Lewis AO, Hydrix; Bronwyn Le Grice, ANDHealth; and Tam Nguyen, St Vincent’s Hospital Melbourne.

Keynote speakers included:

Dr Vincent McCauley, Chief Medical Officer, Telstra Health on ‘The role of connectivity in transforming healthcare through COVID and beyond’;
Tamir Meiri, Director, Venture Investments, and Kathy Connell, Senior Director, Early Innovation Partnering ANZ, Johnson & Johnson Innovation, on ‘Medtech investment insights across Israel, USA and Australia: what’s comparable and what’s in contrast’;
Professor Nicolas Opie, Chief Technology Officer, Synchron on ‘Unlocking the brain’s roadmap for severely paralysed patients: accessing the brain’s natural neurological highways through ground-breaking implantable technology’;
Dr Amanda Caples, Lead Scientist, Department of Jobs, Precincts and Regions, Victorian Government on ‘Investing in innovation, discovering the next breakthrough’;
Adjunct Professor John Skerritt, Deputy Secretary, Health Products Regulation, Australian Department of Health on ‘Medical device regulation update’; and
Stuart Elliot, Co-CEO and Co-Founder, Planet Innovation on ‘Manufacturing led Innovation – insights into Australia’s role in the global manufacturing ecosystem’.

AusMedtech 2022 was proudly supported by the Victorian Government as the Host State Partner and was officially opened by David Latina, Deputy Secretary Jobs, Innovation and Business Engagement at the Department of Jobs, Precincts and Regions. 

As a highlight of the event, the Conference Dinner offered stakeholders, including those who were unable to attend the wider AusMedtech 2022 conference, an additional chance to reconnect. Guests heard from AusBiotech CEO, Lorraine Chiroiu; the Hon. Jaala Pulford MP, Victorian Government; Dr Samih Nabulsi, Cook Medical; and Microba Life Sciences' Co-Founders Professors Philip Hugenholtz and Gene Tyson, for a night that showcased our sector’s successes. The dinner was supported by Cook Medical and the Victorian Government.

In support of start-ups and SMEs, the AusMedtech 2022 programme featured a new ‘Lunch & Learn Reverse-Pitch’ event, supported by Illumina for Startups. This session offered an innovative approach to pitching with Australia’s leading medtech accelerators and incubators presenting to entrepreneurs, and advising on how to connect with the right programme at the right time.

AusBiotech’s Early-Stage Investment Forum, supported by Davies Collison Cave, offered eight early-stage projects and technologies the opportunity to gather feedback from an expert and investor group; advice that is essential when commercialising medtech technologies.

Brandon Capital backs New Zealand immunotherapy start-up

Thu, 26 May 2022 00:00:00 +1000

New clinical trial to test cancer drug in motor neuron disease

Thu, 26 May 2022 00:00:00 +1000

Archer Materials secures Australian patent for quantum computing chip

Thu, 26 May 2022 00:00:00 +1000

AusBiotech welcomes incoming Federal Government

Tue, 24 May 2022 00:00:00 +1000

AusBiotech welcomes the 31^st Federal Government of Australia, and extends its congratulations to incoming Ministers and elected members of Parliament.

AusBiotech has worked closely with key Labor Ministers on issues critical to biotech, including end-to-end tax incentives such as preserving the R&D Tax Incentive and introducing a Patent Box, and looks forward to meeting face-to-face after the full ministry has been sworn in, so together we can continue to advance Australian biotech.

Investment in ‘medical science’, innovation, and advanced manufacturing, as well as support to legislate the Australian Economic Accelerator as part of the University Research Commercialisation Action Plan, was announced by ALP during the lead-up to Election. The Party also pledged a $15 billion ‘National Reconstruction Fund’ to invest in our national sovereign capability, including a dedicated $1.5 billion Medical Manufacturing Fund.

With the final votes still being counted, ALP’s Ministerial line-up is still being confirmed, however, the significance of collaboration and partnerships cannot be understated with the cross-bench more than doubling in size. The increase to more than 15 independents and minor parties is unprecedented in Australian politics and demonstrates the importance of ongoing long-term and non-partisan support for biotechnology.

The biotechnology and life sciences sectors have enjoyed non-partisan, solid support from governments over many years, including Federal and State governments, and this ongoing support will be critical as industry seeks to successfully implement the Biotechnology Blueprint (Blueprint).

Achieving the Blueprint goals will require a partnership between governments and industry to create greater investment and funding opportunities, local infrastructure, translatable public sector science, workforce development, and the urgent sovereign capability Australia needs.

The Blueprint will be a critical tool during AusBiotech’s ongoing engagement with governments and will be a key ‘leave behind’ after meetings are held in-person. Tailored solutions-based tools are also being developed to assist understanding and alignment between industry’s goals and government programmes.

A shared understanding and strong relationships will be key to understand each other’s needs, and in obtaining agreement and meeting Blueprint recommendations in the short and longer term, including fulfilling Australia’s ability to meet sovereignty, innovation, technology, and manufacturing goals.

Living Cell Technologies announces new agreement to use AI in trial

Tue, 24 May 2022 00:00:00 +1000

Celebrating industry leaders on International Clinical Trials Day

Thu, 19 May 2022 00:00:00 +1000

AusBiotech is delighted to be presenting the inaugural Industry Partnership Award at the 2022 ACTA National Tribute and Awards Ceremony in Sydney, which coincides with the celebration of International Clinical Trials (CT) Day on 20 May.

The new Award will showcase the impactful outcomes that sector and industry partnerships can have on trials and better healthcare.

International Clinical Trials Day recognises Australia’s leadership and excellence in CTs and the important role it plays in Australia’s economy, healthcare and social fabric, with benefits far beyond helping develop new treatments.

International CT Day is celebrated around the world on 20 May to commemorate the day when James Lind commenced what is recognised as the first ever randomised CT in scurvy in 1747, laying the foundations for modern clinical research.

ACTA’s Ceremony will include announcement of the award winners for the ACTA Trial of the Year Award, the ACTA Consumer Involvement Award, the ACTA STInG Excellence in Trial Statistics Award, and the new ACTA Industry Partnership Award. Earlier this year, AusBiotech encouraged the CT sector to submit nominations for the 2022 Awards. For more information on the 2022 ACTA Awards, click here.

Australia offers a competitive and world class CT ecosystem, and AusBiotech has been promoting and advocating for over a decade to keep it in its principal position.

Actively participating in formal quorums and processes, AusBiotech sits on the Federal Government’s Clinical Trials Collaborative Forum which identifies issues, exchanges information and engages in collaborative problem solving, with a view to reducing duplication and improving the CT environment. AusBiotech has also engaged with its Clinical Trials Advisory Group on the Clinical Trials Governance Framework, which aims to improve quality, efficiency and timeliness of CT by reducing duplication and increasing efficiency, cohesion and productivity across the CT sector.

Australia’s global leadership in CTs is promoted by AusBiotech at international speaking opportunities, such as at JP Morgan, BioKorea, and BIO. Earlier this year, AusBiotech hosted a webcast during JP Morgan week, to demonstrate the value of Australia's CT and medical innovation advantages. Working in Australia offers a compelling opportunity for CT, and this webcast connected with international companies and showcased the country’s opportunities and capabilities that can be taken advantage of.

The conversation on clinical trials will continue during AusMedtech 2022, in-person from 24 – 26 May in Melbourne. Join the discussion, registrations remain open.

Immutep appoints leading oncologists to clinical advisory board

Thu, 19 May 2022 00:00:00 +1000

Starpharma says SPL7013 in VIRALEZE virucidal against influenza A and B

Thu, 19 May 2022 00:00:00 +1000

AnteoTech's updated COVID-19 RAT receives regulatory approval in Europe

Thu, 19 May 2022 00:00:00 +1000

FDA confirms a diagnostic method for Medibio’s final depression validation trial

Thu, 19 May 2022 00:00:00 +1000

Help the AusBiotech 2022 programme ‘Come Alive’

Tue, 17 May 2022 00:00:00 +1000

AusBiotech is calling for session proposals and speakers for Australia’s largest life sciences event of the year - AusBiotech 2022, to be held 26 - 28 October in Perth.

Running for over 35 years, Australia’s premier conference is developed by industry, for industry, and celebrates and champions our thriving sector.

Cutting-edge ideas and compelling stories or presentations on new, innovative or break-through research, projects or approaches to industry development, and inspirational session topics are encouraged to showcase to the global biotech industry. Thought-provoking session ideas should explore current trends, critical and emerging topics, breakthroughs, and stories from a range of areas that encourage creative conversations both locally and abroad.

AusBiotech 2022 will bring the global biotech industry back together, in person, for the first time in three years. This year’s theme is ‘Come Alive’ where the AusBiotech 2022 will be breathing new life into the biotech industry after years of disruption and change. The programme will give local and international industry leaders the opportunity to recharge, re-energise, refresh, and build relationships – old and new.

The annual flagship conference brings together more than 1,000 leading innovative thinkers and inventors across the Australian and international biotech sector. For more than three decades, the event has formed a very special part of AusBiotech’s broader work positioning Australia’s biotechnology industry for growth. As a leaders’ forum, it is also a key opportunity to connect with potential partners and investors, to reflect on the sector’s achievements and to exchange ideas to further advance the sector’s standing both nationally and globally.

AusBiotech is committed to diversity and inclusion, and submissions for panels must be gender diverse.

Applications close at 5.00 pm (AEST), 24 June 2022. Submit your proposal now.

Thanks to our Host State Partners, Business Events Perth and the WA State Government, for supporting AusBiotech 2022.

For more information, visit ausbiotechnc.org or contact events@ausbiotech.org.

Illumina's Susan Tousi on genomics and changing healthcare

Tue, 17 May 2022 00:00:00 +1000

Nyrada says European patent to be granted for cholesterol-lowering drug

Tue, 17 May 2022 00:00:00 +1000

Industry-backed plan to navigate Australian biotech into the future

Thu, 12 May 2022 00:00:00 +1000

For the first time in 20 years, Australia’s biotechnology sector has united to launch the Biotechnology Blueprint: A Decadal Strategy for the Australian Biotechnology Industry - a shared industry vision and ‘blueprint’ navigating the biotech ecosystem as it aspires to build solid companies, create more jobs, commercialise more biotechnologies, build sovereign capabilities, and deliver greater benefits and returns to Australia and all Australians.

With COVID-19 serving as an important reminder that Australia will need our biotech industry to help it face uncertain future threats, including the ongoing and increasingly common chronic health challenges, there has never been a more important time to proactively plan and shape the coming decade as a community and as an industry.

This valuable opportunity has been realised through the development of a clear decadal plan for the Australian biotechnology industry, as it strives to maximise on Australia’s vibrant and valuable sector, and identify the steps that should be taken in the near term to ensure that positive future is realised.

As the voice of Australia’s biotechnology industry, AusBiotech has led the development of the Biotechnology Blueprint (Blueprint) over the past two years, and it comprises of the contribution of almost 350 individuals and organisations, all working to realise the potential of biotechnology in our society.

AusBiotech CEO Lorraine Chiroiu said, “Australia has a wealth of innovative medicines, vaccines, and medical technologies being developed; to support them reaching Australian patients and improve and extend the quality of human life, we need to focus on creating the right environment for companies to innovate and grow, build dedicated research infrastructure, and enlist the Australian healthcare system as an active partner.”

“The Biotechnology Blueprint is, at its core, a ‘blueprint’ for societal good, and through its implementation, we can herald an era of Australian discovery, translation and innovation. It’s a chance to achieve great things for Australian biotech, Australia, and Australians.”

The Australian biotech industry’s vision is that over the coming decade it will: become a more mature, vibrant ecosystem; with a more established global and domestic standing; and be a stronger, more positive contributor to the Australian economy and its population.

The Blueprint includes many significant and detailed recommendations uncovered through thorough consultation and discussion, building upon AusBiotech’s existing knowledge from its more than 35 years operating as an industry leader. There are eight core, critical areas of focus:

Re-orient support for commercialisation to enable a dual focus on (academia and industry) commercialisation, through programmes and initiatives incentivising partnerships, addressing key gaps, building awareness of roles, value and capabilities, and supporting collaborative structures.
Deliver specific programmes aimed at transitioning small companies to medium-sized companies, and medium-sized to large, addressing capability and skills gaps, and ensuring access to a diverse capital base and incentives, to allow companies to retain value creation in Australia.
Increase the competitiveness of the Australian operating environment relative to its overseas peers, using a mix of government and industry led initiatives while remaining open and accessible for inward investment.
Build sovereign capabilities in the biotechnology sector, including manufacturing and scale-up, core drug/device/product development expertise, supported by a robust service industry enabling local sourcing and partnering
Increase the knowledge, awareness and understanding of the contribution made by the biotechnology sector, including delivery of aligned metrics and reporting on delivery progress of the Blueprint.
Investment and capital: build, diversify and address gaps in access to capital across the variety of industry organisations, to significantly increase the flow of capital to the biotechnology sector by $1 billion annually.
Talent: Address the gaps in access to appropriate skills and talent, using proactive and resourced initiatives that attract, build and retain core talent essential for the growth of the industry.
Metrics and accountabilities: Deliver consistent momentum on the Blueprint recommendations, using aligned metrics and evidence-based decision-making to guide changes and updates, with shared accountabilities.

Presenting a solutions-based approach, the Blueprint responds to well-articulated, stubborn issues that the industry has grappled with for years, including: access to capital to feed the need for commercialisation, clinical development and growth; growing companies through the commercialisation pathway and reaching market; gaps in technology transfer and commercialisation support; and incentives and structural supports along the pipeline.

The Blueprint aligns with the Federal Department of Health’s new ‘Biotechnology in Australia - Strategic Plan for Health and Medicine’, released as part of the 2022-23 Budget, and was first announced at AusBiotech’s CEO Forum in Canberra in 2019. These long-term commitments traversing election cycles are critical to structurally support Australia’s biotechnology sector and to deliver on the vision and the strategic investments that will solidify and strengthen Australia’s sovereignty and global standing in biotechnology.

Download AusBiotech’s Biotechnology Blueprint here.

Additional quotes from industry champions

In support the strategy’s development, industry champions from the Biotechnology Blueprint’s Expert Leadership Forum said:

Dr James Campbell, CEO, Patrys Ltd; AusBiotech Board member, said, “Tackling industry’s stubborn issues to develop a solutions-focused Blueprint has been a challenging and exacting process, and I offer my congratulations to the executive of AusBiotech for producing this visionary and extensive strategy for the coming decade. Lorraine and her team have done a great job of recognising and addressing the core value drivers, and have developed a strategy that should motivate and enthuse all of AusBiotech’s stakeholders. This process underscores the need for, and value of, AusBiotech as the peak body for biotechnology in the country.”

Michelle Burke, Ex-AusBiotech Chair, said, “This comprehensive Blueprint provides industry and associated stakeholders with a plan for growth and success. Given the wide consultation by AusBiotech in generating the report, it can be seen as being representative of industry views about what is needed to continue growth of the industry, which in turn can deliver health, social and economic outcomes.”

Dr Chris Davis, General Manager, Institute for Glycomics; Chair, AusBiotech QLD State Branch Committee; said, “Possibly the most significant and comprehensive strategic document ever developed through contributions of members of the Australian biotech industry, the AusBiotech Biotechnology Blueprint sets a roadmap for government, industry and research organisations to ensure robust and sustained growth of Australia's biotech industry over the next decade.”

Helen Fisher, Non Executive Director, Paradigm Biopharmaceuticals, said, "The Australian biotech industry is already one of the top employers and creators of wealth in Australia. The Biotechnology Blueprint looks at what can be done to accelerate the impact of the biotech industry on the wealth, health and wellbeing of Australians for the next 10 years. For the biotech industry to flourish, the issue of access to capital funding (especially, for the early to mid commercialisation companies) needs to be addressed. This document provides a clear direction and actionable recommendations to the government, industry participants and investors."

Marilyn Jones, Director, mexec, said, “Human capital growth, through multiple development strategies, is paramount for the future success of the Australian biotech industry. I believe the Biotechnology Blueprint is essential reading and lays out the foundations for a focused effort from the sector as a whole. It has been a privilege to be involved in the development of a plan that I now look forward to helping to implement.”

Julie Phillips, CEO, Biodiem, said, “Biotech sector voices have provided this plan for efforts to grow and sustain our industry’s important contribution to the Australian economy.”

Dr Siro Perez, Head of Life Sciences, IP Group Australia, said “We are honoured to have contributed to this pivotal document, and are confident that as we navigate this Blueprint we will see the Australian biotechnology sector continue to grow and become one of the key pillars of Australia’s future economy as it increasingly provides wide societal benefits.”

Warren Bingham, Managing Director, BioAnalytics Holdings Ltd, said, “It has been a privilege to contribute to the AusBiotech Biotechnology Blueprint. The Blueprint that is written by industry, for industry as one collaborative voice. The process of creating a shared vision for the industry that is underpinned with the core value of societal good is a powerful approach to uniting and focussing the entire ecosystem for the next 10 years, and aimed at improving clinical outcomes for patients
world-wide.”

-ENDS-
Media enquiries: Karen Parr, Director, Communications & Policy, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

About AusBiotech

Industry-backed plan to navigate Australian biotech into the future

Thu, 12 May 2022 00:00:00 +1000

Re-orient support for commercialisation to enable a dual focus on (academia and industry) commercialisation, through programmes and initiatives incentivising partnerships, addressing key gaps, building awareness of roles, value and capabilities, and supporting collaborative structures.
Deliver specific programmes aimed at transitioning small companies to medium-sized companies, and medium-sized to large, addressing capability and skills gaps, and ensuring access to a diverse capital base and incentives, to allow companies to retain value creation in Australia.
Increase the competitiveness of the Australian operating environment relative to its overseas peers, using a mix of government and industry led initiatives while remaining open and accessible for inward investment.
Build sovereign capabilities in the biotechnology sector, including manufacturing and scale-up, core drug/device/product development expertise, supported by a robust service industry enabling local sourcing and partnering
Increase the knowledge, awareness and understanding of the contribution made by the biotechnology sector, including delivery of aligned metrics and reporting on delivery progress of the Blueprint.
Investment and capital: build, diversify and address gaps in access to capital across the variety of industry organisations, to significantly increase the flow of capital to the biotechnology sector by $1 billion annually.
Talent: Address the gaps in access to appropriate skills and talent, using proactive and resourced initiatives that attract, build and retain core talent essential for the growth of the industry.
Metrics and accountabilities: Deliver consistent momentum on the Blueprint recommendations, using aligned metrics and evidence-based decision-making to guide changes and updates, with shared accountabilities.

Download AusBiotech’s Biotechnology Blueprint here.

ENA Respiratory joins initiative to boost development of nasal spray

Thu, 12 May 2022 00:00:00 +1000

Immuron partner submits IND application to US FDA for new therapeutic

Thu, 12 May 2022 00:00:00 +1000

NeuroScientific Biopharmaceuticals submits for approval of early-phase trial

Thu, 12 May 2022 00:00:00 +1000

NSW Government launches 20-year roadmap for industry

Tue, 10 May 2022 00:00:00 +1000

The New South Wales Government has released its NSW 20-Year R&D Roadmap, mapping its long-term strategy for turning the state’s research and development capabilities into new world-leading industries and jobs.

According to the NSW Government, the R&D Roadmap contains a 20-year vision for NSW ‘to produce more world-leading new technologies, products and services, and develop and sustain globally competitive advantages and future industries that improve productivity, standards of living, quality of life, and the natural environment’.

The NSW Government’s 20-Year Roadmap has identified four technology themes – biotechnology, digital, materials and chemistry, and energy – and 39 industry applications, which will inform and guide the NSW Government’s investment and activities in R&D over the next 20 years.

The NSW Government has developed ‘Action plans’ for each theme and application identified in the Roadmap, to accelerate research and technology commercialisation.

The R&D Roadmap is an outcome of the Accelerating R&D in NSW Action Plan, launched by Hon. Gabrielle Upton MP, Parliamentary Secretary to the Premier.

NSW Chief Scientist and Engineer Professor Hugh Durrant-Whyte said, “The Roadmap is the culmination of an extensive research and consultation process led by the Office of the NSW Chief Scientist & Engineer over the past six months.”

Download the NSW Government NSW 20-Year R&D Roadmap, here.

US FDA IND approval for Dimerix late-stage study

Tue, 10 May 2022 00:00:00 +1000

Imugene secures Australian ethics approval for HER-Vaxx trial

Tue, 10 May 2022 00:00:00 +1000

Prescient expands PTX-200 AML cohort following additional complete remission

Tue, 10 May 2022 00:00:00 +1000

AusBiotech welcomes Victorian Government industry investment

Thu, 05 May 2022 00:00:00 +1000

AusBiotech welcomes new funding announced in the Victorian Government’s 2022/23 budget, including a new $20 million Equity Investment Attraction Fund, providing funding in return for an equity stake.

The $20 million Equity Investment Attraction Fund is a Victorian Government pilot program to attract and retain high-growth and innovative companies by providing funding in return for an equity stake.

AusBiotech CEO Lorraine Chiroiu said, “as we accelerate the growth of Australian biotechnology, these major shifts in policy are welcomed and encouraged. With capital the lifeblood of the sector, directly investing in start-ups and SMEs will offer greater opportunities for growth and support, for more of our thriving biotech companies to be propelled onto the global stage.”

The 2022/23 Victorian Government budget, presented by the Victorian Treasurer Tim Pallas, is also investing more than $78 million in the state’s emerging manufacturing sector as well as further funding to attract international investment.

The Victorian Government’s outlined an additional $40 million for its International Investment Attraction Fund, as well as investing in a business case for the Murdoch Children’s Research Institute to expand stem cell research and translational regenerative medicine capabilities with a unique focuss on childhood conditions.

Treasurer Tim Pallas said, “International investment is so important for our economy, bringing new opportunities for trade and boosting local businesses – and that ultimately means more jobs for Victorians.”

“As our borders continue to open to the world, we’re getting out there and making sure everyone knows Victoria is the place to invest, innovate and grow your business.”

To read more about the Victorian Government’s 2022/23 budget, click here.

New senior appointments for Tessara Therapeutics

Thu, 05 May 2022 00:00:00 +1000

Botanix acquires rights to new dermatology product

Thu, 05 May 2022 00:00:00 +1000

Medtech featured in latest edition of Australasian Biotechnology journal

Tue, 03 May 2022 00:00:00 +1000

Australia’s compelling medtech sector is taking centre stage in the new edition of Australasian Biotechnology, AusBiotech’s official journal, in anticipation of the upcoming AusMedtech 2022 conference.

The global medtech industry presents significant opportunities for Australian companies to expand into new markets, and highlights of this edition of the journal offer insights into reimagining the future of medtech beyond our borders.

Providing a platform for education, the journal strengthens and grows industry knowledge of Australian capabilities and enablers through commentary from a diverse range of authors. This edition’s themes includes investment in medtech, a guide to pitching in the virtual world and improving the industry – university partnership.

Read compelling insights from sector leaders, including Building a dynamic ecosystem to help create, launch and grow genomics startups in Australia by Dr Emma Ball, Head of Illumina for Startups Australia and Dr Amanda Cashin, Co-Founder and Global Head, Illumina for Startups, and Grant Bennett, Managing Director, PharmaLex reveals how Australia is demonstrating global leadership on the global medtech stage.

The journal toasts the successes of the industry today, including the AusBiotech and Johnson and Johnson Industry Leadership Awards 2021 winners, which demonstrates the life sciences leaders who are championing the sector and the Australian life sciences community.

The new journal also contains regular features, including the AusBiotech CEO Report, and AusBioStock – an exclusive report from James Fletcher, Evans & Partners. The journal welcomes new AusBiotech members, and holds a list of AusBiotech corporate members.

In-depth commentary on the Australian and global medical technology sector will continue at AusMedtech 2022, from 24 - 26 May, live in Melbourne. AusBiotech thanks the support of its Host State Partner, Victorian Government. Registrations remain open.

The next edition of Australasian Biotechnology will be released in October. Please contact admin@ausbioetch.org if you are interested in contributing, or to find out about advertising opportunities.

Australasian Biotechnology is published bi-annually in partnership with Executive Media.

Download the journal now.

Biotron says BIT225 against SARS-CoV-2 infection effective in animals

Tue, 03 May 2022 00:00:00 +1000

INOViQ announces manufacturing agreement with MP Biomedicals

Tue, 03 May 2022 00:00:00 +1000

Industry dinner to reignite sector

Thu, 28 Apr 2022 00:00:00 +1000

The highly-popular AusMedtech 2022 industry dinner is a hallmark of the AusMedtech 2022 programme and it is back to reignite and reconnect the medtech sector on Wednesday 25 May, during AusBiotech’s premier medtech conference.

Australia’s premier medtech conference is returning to the Melbourne Convention Centre in-person from 24-26 May 2022 and brings together key stakeholders of the Australian and international medical devices and diagnostics sector to help prepare the industry sector for its changing landscape.

The must-attend three course conference dinner is the perfect opportunity to network with Australian and intetrnational industry leaders and meet new potential partners.

The dinner is open to AusMedtech 2022 delegates and non-delegates to join AusBiotech to celebrate the successes of the Australian and international medtech sector.

There is still time to register for AusMedtech 2022 in four weeks, with the programme bursting with a wide variety of Australian and global medtech leaders delivering keynotes, interactive expert panel discussions and pre-conference workshops throughout the AusMedtech 2022 week.

AusBiotech has an inspiring line-up of keynote speakers over three exciting days, including:

Tamir Meiri, Director Venture Investments for Johnson & Johnson Innovation, JJDC co-presenting with Kathy Connell, Senior Director, External Innovation Partnering ANZ, Johnson & Johnson Innovation on Thursday 26 May: ‘Medtech investment insights across Israel, USA and Australia: what’s comparable and what’s in contrast’
Dr Erica Kneipp, Research Director, Human Health, CSIRO on Thursday 26 May: ‘Accelerating Australia’s capabilities to future proof our nation’
Dr Amanda Caples, Lead Scientist, Department of Jobs, Precincts and Regions, Victorian Government on Wednesday 25 May: ‘Investing in innovation, discovering the next breakthrough’
Adjunct Professor John Skerritt, Deputy Secretary, Health Products Regulation, Australian Department of Health on Wednesday 25 May: ‘Medical device regulation update’
Stuart Elliott, Co-CEO and Co-Founder, Planet Innovation on Thursday 26 May: ‘Manufacturing led innovation – insights into Australia’s role in the global manufacturing ecosystem’
Professor Nicholas Opie, Chief Technology Officer, Synchron on Wednesday 25 May: ‘The Stentrode: Unlocking the brain for severely paralysed patients’
Dr Vincent McCauley, Chief Medical Officer, Telstra Health on Thursday 26 May: ‘The role of connectivity in transforming healthcare through COVID-19 and beyond’

AusBiotech thanks Cook Medical and the Victorian Government for their support in sponsoring the conference dinner at AusMedtech 2022.

AusBiotech encourages you to register today to secure your seat for the industry dinner.

Cochlear agrees to acquire Oticon Medical

Thu, 28 Apr 2022 00:00:00 +1000

First subjects randomised and dosed in Paradigm's late-stage trial

Thu, 28 Apr 2022 00:00:00 +1000

NSW Government seeks operator for RNA manufacturing

Tue, 26 Apr 2022 00:00:00 +1000

NSW Government has opened a registration of interest (ROI) process for an operator, to establish a commercial-scale GMP Pilot RNA manufacturing facility. This single site ecosystem has the ambition for leadership through manufacture across sRNA, mRNA and lipidnanoprotein encapsulation.

According to the NSW Government, it maintains its ‘strategic focus on health R&D and is committed to an investment of $96 million for an RNA Pilot Manufacturing Facility’. The centralised manufacturing facility will be focused on clinical trial-scale manufacture and will provide a home for the further development of local R&D success accelerating the translation of NSW’s research strengths into a sustainable commercial RNA therapeutics and products.

This investment will ‘further leverage this strength in NSW and aims to achieve the NSW Government’s ambition of being a global leader in RNA R&D’.

The NSW Government’s ROI will be used to identify suitable companies to progress to the expression of interest (EOI) phase, which will commence late May 2022.

The successful company that progresses through the ROI phase, will contribute to the growth of RNA R&D and manufacturing capability in NSW, and have:

The ability to run and operate an RNA facility at GMP and TGA level;
The commitment to building, and being part of, a thriving RNA R&D ecosystem;
The commitment to engaging with the RNA R&D ecosystem in building background IP, translating fundamental R&D to commercial and health outcomes for NSW – capitalising on the significant research expertise in NSW in RNA technologies and provide a path to further develop these products through the clinical trial process.

The ROI closes on 12 May 2022. To find more about the ROI, click here. The ROI is supported by Biointelect and the Centre for Biopharmaceutical Excellence (CBE), if you have any questions about the ROI please feel free to contact Leah Goodman, Senior Consultant at Biointelect.

Opthea announces the appointment of two new directors

Tue, 26 Apr 2022 00:00:00 +1000

Mission to BioKorea to strengthen ties

Thu, 21 Apr 2022 00:00:00 +1000

AusBiotech is pleased to support Austrade’s BioKorea 2022 delegation to strengthen reciprocal relationships and showcase Australia’s investment opportunities and life sciences capabilities.

AusBiotech CEO Lorraine Chiroiu will deliver an opening keynote ‘Australian biopharma industry and investment trends’ during the Australia-Korea Innovation Seminar at BioKorea on 11 May, promoting opportunities in Australia, and joining Julie Quinn, Senior Trade and Investment Commissioner, Austrade Seoul will speak on ‘investment opportunities in Australia’.

AusBiotech’s support of BioKorea 2022, which will be in-person from 11-13 May, is part of its global strategy, as it facilitates international opportunities for investment discussions, collaborations and partnerships, with a focus on the markets important to members.

AusBiotech is continuing to facilitate these ongoing investment opportunities, which is crucial for the growth of the Australian life sciences sector, and ultimately for continuing Australia’s position in the sector globally.

The organiser of BioKorea, Korea Health Industry Development Institute (KHIDI), has led large Korean delegations to AusBiotech for several years, demonstrating the strong interest Korean companies have in collaborating with Australia's biotech industry. KHIDI is a government agency affiliated to the Ministry of Health and Welfare that also supports KoBIA. AusBiotech is looking forward to welcoming another large Korean delegation to AusBiotech 2022 in Perth later this year. AusBiotech’s long-standing MoU with KHIDI will continue to make a solid platform for further international collaborations.

The Austrade Australian delegation provides plenty of opportunities for Australian companies to meet potential new partners, make international connections and explore investment opportunities.

On the trip, AusBiotech intends to sign a memorandum of understanding (MoU) with KoBIA (Korea Biomedicine Industry Association) at BioKorea 2022 to strengthen and generate collaboration opportunities between Australian and Korean biotech and pharmaceutical businesses. KoBIA is an industry association under the Ministry of Health and Welfare that represents over 140 bio and pharmaceutical companies, including vaccine developers. Its mission and roles can be found here.

AusBiotech also has an MoU with the Council for Advanced RM (CARM), Korea’s regenerative medicine industry association.

To find out more about BioKorea 2022, click here.

Arovella Therapeutics announces manufacturing agreement with Q-Gen

Thu, 21 Apr 2022 00:00:00 +1000

Kazia Therapeutics says phase 2 study of paxalisib

Thu, 21 Apr 2022 00:00:00 +1000

Medlab Clinical confirms northern hemisphere distribution

Thu, 21 Apr 2022 00:00:00 +1000

Volpara Health announces leadership and board changes

Thu, 21 Apr 2022 00:00:00 +1000

AusBiotech supports pre-Election statement on research

Tue, 19 Apr 2022 00:00:00 +1000

AusBiotech supports Research Australia’s pre-Election statement on behalf of the Australian health and medical research sector, calling for reforms to ensure research priorities better meet health system and population needs and maximises economic opportunities.

Research Australia is the national peak body for health and medical research and represents all stages of the sector. The statement is made on behalf of the broad cross section of researchers and innovators across the pipeline, including industry.

Research Australia CEO Nadia Levin said, “Australia must have a clearly articulated national approach to supporting a sustainable research ecosystem with a focus on excellence in fundamental and translational research and areas of global competitive advantage.”

“There are significant opportunities for real economic stimulus and jobs growth across Australia’s health and medical research pipeline. Short and long-term reforms are needed to harness the skills and talent that can help us realise the ambition of a world’s best health system.”

The statement presents four recommendations to seize the significant opportunities across Australia’s growing health and medical research sector.

A National HMR and innovation strategy that ensures research priorities better meet health system and population needs and maximises economic opportunities.
A national HMR Workforce Plan that attracts and supports a highly skilled, sustainable research workforce with circular mobility between academia and industry.
Consumers as co-designers of research to enable researchers and consumers to meaningfully engage in research co-design by ensuring they have the skills to improve research translation and Australians’ health.
Australia as a global health innovator to systematically build Australia’s capacity in medical commercialisation and medical manufacturing to meet local demand, grow industries and jobs, and build export markets for products and services.

To read Research Australia’s full pre-Election statement, click here.

UQ microbiopsy deal could change the way skin conditions are diagnosed

Tue, 19 Apr 2022 00:00:00 +1000

EpiAxis Therapeutics appoints new chief science officer

Tue, 19 Apr 2022 00:00:00 +1000

Zelria Therapeutics executes acquisition of Health House

Tue, 19 Apr 2022 00:00:00 +1000

Workforce and Capacity Summit White Paper released

Thu, 14 Apr 2022 00:00:00 +1000

AusBiotech supports call for the Federal Government to develop a National Competency Framework for Australia, endorsing the ARCS Australia Workforce & Capacity Summit White Paper (the Paper).

ARCS Australia has recently released its Paper after consultation with industry partners, to identify strategies to enhance industry qualifications, training and experience in Australia’s high-performing biotech and medtech sector. The Paper outlines the important opportunity for the sector to ensure the best standard of patient care, through skills that support sovereign manufacturing capacity, capability, and innovation, to drive growth creating jobs and exports.

In the Paper’s Foreword, ARCS Australia CEO Dr Shanny Dyer said, “There is an immense opportunity to capture the fruits of that innovation in a vibrant, research–based manufacturing industry with growing exports. This will bring opportunities for substantial, skilled employment and retain more of the value of the nation’s innovative research and development.”

ARCS Australia presents four recommendations in the Paper to enhance Australia’s biotech and medtech sector:

Overwhelmingly, the participants called for the establishment of robust and comprehensive national competency standards for the key professions that service the industry. These standards should align with those already established in Australia and overseas and provide the elements of nationally consistent training programs.
As the peak professional body for the research sector, industry endorsed ARCS Australia to lead the development of a national training curriculum for the key professions, linked to the competency frameworks, and to engage with all stakeholders to facilitate its adoption.
The industry sector should develop a stronger and more coordinated outreach via its peak bodies to tertiary institutions to increase awareness of the sector and the existing and emerging career opportunities. Furthermore, this outreach should extend to the provision of training (including micro–credentialling) that will facilitate the development of ‘job–ready’ entrants.
ARCS Australia and its industry partners should take a more active role to engage with government policy in order to realise the economic development and employment opportunities identified by this summit in the areas of:
1. Targeted manufacturing support specifically for mRNA, pharmaceutical ingredients and commercial fill and finish;
2. A range of ecosystem support policies including: tax incentives, workforce and training policy and visa and immigration policy.

To download ARCS Australia’s Workforce & Capacity Summit White Paper, click here.

Neuroscientfic Biopharmaceuticals reports on preclinical program

Thu, 14 Apr 2022 00:00:00 +1000

Botanix confirms presentation of data at upcoming congress

Thu, 14 Apr 2022 00:00:00 +1000

Imugene says first cohort two patient dose in phase 1 clinical trial

Thu, 14 Apr 2022 00:00:00 +1000

Australian Pavilion returns in-person to BIO 2022

Tue, 12 Apr 2022 00:00:00 +1000

AusBiotech is delighted to lead the Australian Pavilion at BIO 2022, as the world’s largest biotechnology congress returns in person to San Diego from 13-16 June 2022.

AusBiotech would like to invite the biotechnology community to join the Australian delegation and Pavilion and explore the opportunities available at BIO 2022.

As the industry’s independent voice, AusBiotech has led the Australian delegation to BIO for over a decade, and Australia’s strong presence will continue to be felt as the Pavilion will showcase Australian capabilities and promote the strength of the national life sciences sector, to foster global connections.

Hosted by the Biotechnology Innovation Organisation (BIO), the congress is the largest and most influential global event for the biotechnology industry.

AusBiotech invites its members to register for a USD$200 discount code to unlock ‘general and premier access partnering’ during the conference. To learn more about the opportunity, click here.

To bolster international profile, AusBiotech encourages member companies to exhibit at the Australian Pavilion, with a few remaining spaces.

Produced by AusBiotech and available at the highly-popular Australian Pavilion, members and non-members are invited to promote their presence to a global audience in the Access Australia: Exhibitor & Australian Biotech Directory, from AUD$1,210 for members.

AusBiotech CEO Lorraine Chiroiu is leading the Australian Delegation in-person and will deliver a Global Innovation Hub presentation on the ‘Strengths of the Australian Bio-Economy’.

The popular Australian Wine Tasting Event, hosted by AusBiotech, returns at BIO 2022 and is accessible to delegates as part of the Exhibitor Hospitality Reception.

There are plenty of opportunities to network at BIO 2022, with the one-on-one partnering now open. This is the one of the most efficient ways to do business with the global biotechnology and pharmaceutical industries.

AusBiotech gratefully acknowledges the support of MTPConnect, Victorian State Government, Global Victoria, New South Wales Government, Investment NSW, Government of South Australia and Government of Western Australia, and industry sponsor companies. For further information, please contact events@ausbiotech.org.

Pfizer announces acquisition of Australian digital health company

Tue, 12 Apr 2022 00:00:00 +1000

Microbio is a step closer to launching its InfectID-BSI tests in Europe

Tue, 12 Apr 2022 00:00:00 +1000

Rhonomed completes institutional component of capital raise

Tue, 12 Apr 2022 00:00:00 +1000

Consultation opens on reforming research block grants, to boost collaboration

Thu, 07 Apr 2022 00:00:00 +1000

A new consultation reforming the research block grant funding framework, to increase collaboration between universities and industry, is open under the Department of Education, Skills and Employment.

The proposed reforms are seeking to break down barriers to collaboration, differences in skill sets, regulation and intellectual property, and it is designed so that universities and industry can access valuable benefits of engagement and partnering.

RBGs form a critical part of Australia’s research funding system by ensuring the research pipeline, from basic research to innovation, is supported. It ensures that universities receive support for basic research, feeding high-quality and innovative research into the research pipeline. Because RBG funding is flexible, it can be invested in the translational and commercialisation phases of R&D.

The research block grant funding framework reform is one element of the Federal Government’s $2.2 billion University Research Commericalisation (URC) Action Plan, released in February 2022

The consultation paper outlines the proposed implementation approach, transitional arrangements and discussion questions. The Department seeks to understand from industry:

How industry decides which universities to engage with for research and development and what metrics or rankings play a role in this decision-making process;
If industry is more likely to collaborate with a university that ranks highly in research quality;
Indicators, such as ERA rankings;
Additional metrics, rankings or data that would be useful for industry in deciding which universities to engage with;
If the proposed ‘government’ and ‘industry’ funding drivers and changes to the RBG funding framework have the effect of increasing universities' collaboration with organisations.

AusBiotech is seeking member feedback to admin@ausbiotech.org by 5:00pm AEST on 6 May 2022.

Agilex Biolabs appoints a new chief scientific officer

Thu, 07 Apr 2022 00:00:00 +1000

MTPConnect announces support for major new resilience projects

Thu, 07 Apr 2022 00:00:00 +1000

Race receives human ethics approval for new trial

Thu, 07 Apr 2022 00:00:00 +1000

RDTI Determination published

Tue, 05 Apr 2022 00:00:00 +1000

Australia’s first Research & Development Tax Incentive (RDTI) Determination has been approved, offering certainty and transparency when claiming clinical trials activities.

The RDTI is the most critical policy available to life sciences companies and the new Determination provides clarity on the types of clinical trials that will be accepted as core R&D activities, and thereby offers certainty in eligibility and aims to reduce companies’ regulatory burden.

It is a welcome and positive step in cementing certainty to a programme that has been incentivising investment into the sector for over 10 years.

The clinical trial sector already contributes around $1.4 billion to the economy each year; it is a highly-regulated environment and industry has become familiar with eligibility over the past 10 years. This Determination acts as a formal indicator to the national and international life sciences ecosystem that clinical trials are a recognised and eligible core activity under the RDTI, and will enhance Australia as a globally-preferred location for clinical trials.

New guidance has been released to accompany the legislative tool, and notes that the Determination may also “be used by companies applying for advance or overseas findings if [they are] seeking certainty about whether their activities are core R&D activities or if conducting or planning to conduct activities overseas.”

“The Determination can only be used if all parts of the core R&D activity are occurring solely in Australia. If any part of the activity occurs overseas; e.g., if the evaluation or conclusions are sent to a parent company overseas, then the activity will not be deemed to be an Australian core activity.”

The guidance also offers suggested wording for applicants to indicate their intention to utilise the Determination.

Through the consultation process, the definitions of the Determination have been strengthened and extended, and the legislative tool is now suitable for development pathways of medicines as well as medical technologies (devices and diagnostics) and gives greater detail of the objectives included under each phase. This has been reflected in the Determination’s new name: Industry Research and Development (clinical trials, phase 0, I, II, III, pre-market pilot stage, pre-market pivotal stage, for an unapproved therapeutic good) Determination 2022.

This is the first determination released and has been done so under the RDTI reforms announced in the 2020-21 Budget. It was developed by the Department of Industry, Science, Energy and Resources and in consultation with the Australian Taxation Office and Department of Health.

AusBiotech’s response was developed together with the AusBiotech Clinical Trial Advisory Group, which provides guidance and advice on clinical trials policy, and AusBiotech members that are tax experts.

AusBiotech champions advocacy, and its submission was quoted in the Determination’s launch, demonstrating that it is recognised as a persuasive, credible and collaborative voice of leadership for Australia’s life sciences industry. Read AusBiotech’s policy submissions here.

Read the Determination legislation here, and the Government’s guidance here.

Australian healthcare investor urges greater support from peers

Tue, 05 Apr 2022 00:00:00 +1000

Government launches biotechnology - strategic plan for health and medicine

Thu, 31 Mar 2022 00:00:00 +1100

The federal Department of Health has launched a new ‘Biotechnology in Australia - Strategic Plan for Health and Medicine’ as part of the 2022-23 Budget.

The Plan sets out three pillars of Government support for life sciences, and signals how its current initiatives align:

Pillar 1: Supporting world-class research and development by strategically investing in areas of need and driving strong partnerships between academia, government science organisations, industry, health services, and consumers.
Pillar 2: Facilitating high-quality and secure clinical development that attracts global interest by continuously improving research capabilities, processes, and infrastructure thus ensuring they remain or become globally competitive.
Pillar 3: Accelerating commercialisation through partnerships and collaborations between academics, government science organisations, and industry; regulation that is fit-for-purpose; and by supporting the development of advanced manufacturing capabilities for biopharma and med-tech products.

It also “provides a framework to coordinate future commitments that identify and address gaps as they emerge across investments, infrastructures, skills and capabilities.”

Lorraine Chiroiu, CEO, AusBiotech, said: “As the peak industry organisation for biotechnology, we are delighted to see the Government recognise the opportunity that biotechnology presents for Australian society and its economy.”

“AusBiotech supports this commitment to taking a long-term approach that looks beyond election cycles, that structurally supports the Australia’s biotechnology sector to thrive, and that builds on and complements AusBiotech’s Biotechnology Blueprint that has been developed by industry over the past two years.”

Read the Australian Government's long-term plan for health and medical biotechnology here.

The Biotechnology Blueprint outlines goals, which have helped to define objectives, steer strategies and craft tactics that will drive and shape the biotechnology industry’s growth through to 2032 and beyond.

The Government’s vision for Australian biotechnology is to create a vibrant and thriving ecosystem; AusBiotech looks forward to working closely with the Department of Health to deliver on this vision, and on the strategic investments that will solidify and strengthen Australia’s sovereignty and global standing in biotechnology.

NTCELL to be produced in Australia under UTS research agreement

Thu, 31 Mar 2022 00:00:00 +1100

Avecho reports positive results for Phase 2 topical CBD osteoarthritis study

Thu, 31 Mar 2022 00:00:00 +1100

Launching AusBioNSW: promoting and strengthening state’s capabilities

Tue, 29 Mar 2022 00:00:00 +1100

AusBiotech is launching AusBioNSW, a new peak industry membership body for NSW, to represent, connect, and promote NSW organisations doing business in and with the local, national and global life sciences economy.

The prosperous NSW community of medtech and biotech companies is now supported by a dedicated local body to foster local connection, and ensure it is structurally connected to national and global happenings, and supported to capitalise on growth opportunities and on new technologies.

AusBioNSW is backed by AusBiotech’s national representation on advocacy activities, membership services, events and networks – and for AusBiotech members in NSW, no additional membership subscription is required.

AusBiotech’s CEO Lorraine Chiroiu said, “AusBiotech has been working closely with its NSW members and the NSW Government for many years, and AusBioNSW will take this support to the next level so that the NSW life sciences industry is structurally supported to capitalise on growth opportunities and on new technologies.”

AusBioNSW Chair, Graham McLean, will provide leadership for NSW and its Committee. This support is already being felt, with active meetings and activities to accelerate R&D investment and development in NSW. Graham McLean, Non-Executive Director, Universal Biosensors is a highly-experienced healthcare senior executive leader with extensive service in the medical technology industry in Australia, Asia and US. He has recently returned to Sydney after a successful 16-year career at Stryker, where he was most recently President Asia Pacific, reporting to the global CEO and sitting on Stryker’s global executive leadership team.

Graham McLean said, “I am delighted to support the launch of AusBioNSW a new AusBiotech initiative. NSW has a strong reputation of a thriving biotech and medtech sector, and we plan to accelerate the opportunities for growth, collaboration and job creation with our partners and State government across NSW. As Chair of the NSW Leadership Committee, I look forward to contributing to enhancing AusBiotech’s national capabilities.”

AusBiotech is bolstering its capabilities in-state, with a re-energised NSW Leadership Committee; consisting of ten diverse members of life science executives representing the breadth of biotech, and with a passion for NSW life sciences growth. This initiative will also build on the existing strengths of AusBiotech and grow the NSW team, as AusBiotech searches for a General Manager, to steer AusBioNSW and to support and promote initiatives and actions to bolster the NSW industry.

AusBioNSW will promote and showcase local capabilities and facilitate connections and networks. In addition to a strategic workplan, a calendar of events is underway to build relationships, grow skills, and share ideas. This includes:

500 delegates attended the in-person NSW Women in Life Sciences Luncheon 2022, co-hosted by AusBiotech and Medicines Australia, and ‘amplified her voice’ in celebration of International Women’s Day earlier this month.
Register now for our upcoming NSW BioCheers networking event on 2 June 2022, in partnership with Children's Medical Research Institute. Open to AusBiotech members and non-members, these informal networking events are held regularly throughout the year and are an opportunity to connect with NSW’s vibrant biotechnology community.
This year AusBiotech partnered with and profiled NSW Government and leading biotech companies internationally during JP Morgan week 2022; and we’re looking forward to uniting again through AusBiotech’s strong ‘Team Australia’ delegation to BIO 2022.

Launching AusBioNSW: promoting and strengthening state’s capabilities

Tue, 29 Mar 2022 00:00:00 +1100

The prosperous NSW community of medtech and biotech companies is now supported by a dedicated local body to foster local connection, and ensure it is structurally connected to national and global happenings, and supported to capitalise on growth opportunities and on new technologies.

500 delegates attended the in-person NSW Women in Life Sciences Luncheon 2022, co-hosted by AusBiotech and Medicines Australia, and ‘amplified her voice’ in celebration of International Women’s Day earlier this month.

Register now for our upcoming NSW BioCheers networking event on 2 June 2022, in partnership with Children's Medical Research Institute. Open to AusBiotech members and non-members, these informal networking events are held regularly throughout the year and are an opportunity to connect with NSW’s vibrant biotechnology community.

This year AusBiotech partnered with and profiled NSW Government and leading biotech companies internationally during JP Morgan week 2022; and we’re looking forward to uniting again through AusBiotech’s strong ‘Team Australia’ delegation to BIO 2022.

Hexima presents data on new topical treatment

Tue, 29 Mar 2022 00:00:00 +1100

Dimerix receives R&D tax rebate for last financial year

Tue, 29 Mar 2022 00:00:00 +1100

Neuren receives FDA approval for Pitt Hopkins IND and Phase 2 trial

Tue, 29 Mar 2022 00:00:00 +1100

Industry concerned by leaked COVID-19 vaccine IP waiver text

Thu, 24 Mar 2022 00:00:00 +1100

AusBiotech joins global biotechnology peak industry bodies in their concern of the leaked ‘compromise text’ by World Trade Organization in negotiations on a proposed IP waiver for COVID-19 vaccines.

The leaked text indicates a compromise had been reached by four (quad) WTO members: USA, Europe, India, and South Africa.

The text of the proposed WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver would see, under certain circumstances, member countries set aside patent rights for a vaccine in response to COVID-19, and for COVID-19 therapeutics and diagnostics in the future.

Industry notes a misguided understanding of equitable access remains and the proposal to waive IP protection that is before the WTO will not overcome the real barriers, despite voluntary global agreements and unparalleled R&D efforts and levels of cooperation that have taken place, including 371 collaborations on vaccines manufacturing and 155 for therapeutics.

The ‘compromise text' proposes to waive several patents in one notification thereby removing the requirement to grant compulsory licenses for individual patents, which are considered on ‘individual merits’. Instead, a single compulsory license could be granted, if these are necessary for the production of a COVID-19 vaccine. There is concern that this could capture IP only used tangentially in a COVID vaccine, and force the transfer of significant technology with value in other applications.

The proposal also seeks to broaden its scope to therapeutics and diagnostics, which risks impacting antibody and antiviral investment, where first generation products are starting to show promising clinical results.

Steve Bates, Chair of International Council of Biotechnology Associations (ICBA) said, “The leaked QUAD proposal of a waiver on intellectual property rights for COVID vaccines would, if agreed, have a chilling impact on investment into the small companies that have been at the heart of the solutions to COVID-19. It would do nothing to solve the challenges we face in 2022 and make it far harder for small companies pioneering in this space in future.”

“… This proposal directly threatens this innovative ecosystem’s ability to attract the capital needed to develop next generation of vaccines whilst doing nothing to solve the access challenges we have in 2022.

“Weakening IP rights does nothing to facilitate the distribution of these manufactured vaccines to people around the world who most need them – rather prioritising addressing healthcare infrastructure and vaccine hesitancy in the developing world would lead to more shots in arms.”

AusBiotech is a member of the ICBA, a coalition of non-profit, national biotechnology trade associations formed to promote public understanding of, and to advocate for, public policies that support the growth of the innovative biotechnology industries.

If agreed, the proposal would undermine the global, innovative ecosystem of SMEs, with countries no longer needing to obtain prior approval from the IP rights-holders – this means that companies may not be informed of compulsory licensing approaches that are being adopted in countries, which could lead to manufacturing inefficiency as manufacturers try to follow the recipe ‘blind’.

WTO negotiations are lengthy due to their requirement to reach consensus-based decision making and due to the complexity of the challenges being faced. To achieve greater vaccine access, focus is best applied to addressing hurdles such as the bottlenecks and shortages in global supply chains, vaccine hestitancy, and strained health-care systems in low-and middle-income countries.

BioScience Managers welcomes FDA approval of Saluda technology

Thu, 24 Mar 2022 00:00:00 +1100

Large molecule facility doubles size of leading bioanalytical laboratory

Thu, 24 Mar 2022 00:00:00 +1100

Access savings by registering early for AusMedtech 2022

Tue, 22 Mar 2022 00:00:00 +1100

The AusMedtech 2022 programme has launched, and delegates have until 28 March to register for early-bird registrations and access savings and the thought-provoking list of keynotes and panel sessions during Australia’s biggest week in medtech.

Australia’s premier medtech conference is returning to Melbourne Convention Centre in-person from 24-26 May 2022 and brings together key stakeholders of the Australian and international medical devices and diagnostics sector to help prepare the industry sector for its changing landscape.

Registration to AusBiotech’s AusMedtech 2022 will enable delegates to access all conference sessions, AusPartnering, our successful one-to-one business matching programme, the welcome function and closing ceremony, Exhibition Hall and all networking opportunities. Group discounts are available for five or more event registration passes.

The AusMedtech conference dinner is also back and offers stakeholders, including those unable to attend the wider AusMedtech 2022 conference, the chance to reconnect over charged glasses, devour a three-course dinner, and celebrate the successes of the Australian medtech sector in style.

AusBiotech has an inspiring line-up of keynote speakers over three exciting days, including:

Tamir Meiri, Director, Venture Investments, co-presenting with Kathy Connell, Senior Director, Early Innovation Partnering ANZ, Johnson & Johnson Innovation, on ‘Medtech investment insights across Israel, USA and Australia: what’s comparable and what’s in contrast’
Erica Kneipp, Research Director, Human Health, CSIRO on ‘Accelerating Australia’s capabilities to future proof our nation’
Prof. Nicolas Opie, Chief Technology Officer, Synchron on ‘Unlocking the brain’s roadmap for severely paralysed patients: accessing the brain’s natural neurological highways through ground-breaking implantable technology’
Dr Amanda Caples, Lead Scientist, Department of Jobs, Precincts and Regions, Victorian Government on ‘Investing in innovation, discovering the next breakthrough’
Adjunct Professor John Skerritt, Deputy Secretary, Health Products Regulation, Australian Department of Health on ‘Medical device regulation update’ and;
Stuart Elliot, Co-CEO and Co-Founder, Planet Innovation on ‘Manufacturing led Innovation – insights into Australia’s role in the global manufacturing ecosystem’

AusMedtech 2022 is proudly supported by the Victorian Government as the Host State Partner.

Early-bird registrations are available until 28 March; save up to $300 by registering now to connect with like-minded leaders growing the Australian and global medtech industry.

TGA approval for Orthocell's Remplir peripheral nerve repair device

Tue, 22 Mar 2022 00:00:00 +1100

US FDA grants new orphan designation to Noxopharm's Veyonda

Tue, 22 Mar 2022 00:00:00 +1100

Biotron updates on pre-clinical study of BIT225 in COVID-19

Tue, 22 Mar 2022 00:00:00 +1100

First Participants dosed in ENA Respiratory's phase 2a study

Thu, 17 Mar 2022 00:00:00 +1100

WA funding programmes open

Thu, 17 Mar 2022 00:00:00 +1100

The West Australian State Government is offering a boost to life science companies, with start-ups and SMEs given the opportunity to apply for funding from two new programmes.

Invest & Trade WA’s Investment Attraction is a new $100 million fund, with applications available for up to 50 per cent of funding, to a maximum of $5 million each. The fund will leverage WA’s existing strengths and priority sectors, including health and medical life sciences, to attract and incentivise national and foreign investment.

The programme seeks to create sustainable local jobs and is encouraging expressions of interest from companies that are interested in establishing and growing their WA operations and that will improve WA’s productivity, including in supply chain development, advanced manufacturing, science, innovation and technology, and environmental, social and governance (ESG) frameworks.

Expression of interest for the Investment Attraction Fund close at 3.00 pm (AWST), 4 May 2022. To learn more and apply, visit the IAF page here.

The Innovation Booster initiative, previously known as the Innovation Voucher Program, has $20,000 grants available to WA start-ups and SMEs to access professional skills, services or knowledge, enabling the advancement in an innovative idea, project or commercial activity. Successful grant recipients will be required to contribute 20 per cent funding. Support will be provided to research and development, product development, technology transfer and intellectual property, and commercialisation support services.

Applications for the Innovation Booster Grants close at 11:00 am (AWST), 20 April 2022. To learn more and apply, visit the IBG page here.

The Australian life sciences sector considers access to capital as one of the most pressing issues for the nation; and AusBiotech’s Biotechnology Blueprint decadal strategy notes that, “Access to capital to feed the need for commercialisation, clinical development and growth remains key amid an expanding industry, and the diversity of investment sources is a pressing issue.”

The strategy continues, “With capital the lifeblood of the sector, increasing start-up and spinout company numbers, and a dearth of venture capital in Australia compared to other major countries, the thirst for capital is key.”

These WA Government funding programmes are a positive step forward for companies and supports their abilities to accelerate their technology through to commercialisation.

Paradigm secures UK approvals for PARA_OA_002 clinical trial

Thu, 17 Mar 2022 00:00:00 +1100

‘Gold standard’ commercialisation for biotech

Tue, 15 Mar 2022 00:00:00 +1100

An Australian-first ‘gold standard’ framework has been developed to ensure health and medical discoveries can be fast-tracked to commercialisation, through a partnership between AusBiotech, the University of Sydney’s Faculty of Medicine and Health, and the University of Sydney Business School.

Ten recommendations and two proposals have been developed to encourage the translation of health and medical research, and overcome collaboration barriers. Transcending individual companies and institutions, the opportunities outlined in the new Accelerating Health and Medical Research Commercialisation in Australia report (the framework) offer an opportunity to improve industry-university partnerships in the post-COVID period.

The framework includes short and long-term recommendations that focus on identifying positive changes that would enable industry to access emerging intellectual property, evaluate its commercial potential, strengthen collaborations and grow a skilled workforce.

Launching the framework, Professor Robyn Ward AM, Executive Dean and Pro Vice-Chancellor Medicine and Health at University of Sydney said, “Our vision is to establish a hub for the health and medical industry that transforms Australia’s research and commercialisation capabilities by developing a gold-standard in which the private sector and universities co-design and co-invest.”

“Our universities are already contributing billions of dollars to the national economy and growing the health workforce, further collaboration between our leading researchers and prominent industry players will strengthen this and fast-track medical discoveries that could make a huge difference in people’s lives.”

The recommendations align with AusBiotech’s Biotechnology Blueprint: A Decadal Strategy for the Australian Biotechnology Industry, the decadal plan that has been written by industry, for industry. Currently open for sector-wide consultation, the strategy charts an aspirational pathway to how the biotech industry can help solve problems and generate the long-term economic growth and social capital that will be needed as we emerge from the current pandemic.

AusBiotech’s CEO Lorraine Chiroiu said “The Biotechnology Blueprint has clearly articulated that creating strong and effective partnerships between the Australia’s biotechnology industry and universities will significantly contribute to commercialising high-quality ideas, and to creating a better connected and more vibrant community.”

“This industry-academia framework is an important step towards that, as it identifies opportunities for the entire community – from bench to bedside – and aims to nurture an agile, nimble and interconnected environment that is able to consistently create and grow high-value biotech companies.”

To develop the ‘gold standard’ framework, wide consultation brought together cross-disciplinary expertise, with almost 100 industry leaders, and government and academic stakeholders engaged, and coupled with benchmarking international institutions that successfully co-located with researchers, start-ups and business incubators to deliver rapid innovation through the convergence of skills, perspectives and resources.

Explore the recommendations and read the full report here.

Neuren receives ethics approval for Angelman Phase 2 trial

Tue, 15 Mar 2022 00:00:00 +1100

Partnership encourages innovation in how Australian universities and industry collaborate

Mon, 14 Mar 2022 00:00:00 +1100

Creating a ‘gold standard’ approach to the translation of health and medical research

Embargo: 5.45am, Monday, 14 March 2022

Australian universities could be at the global forefront of research translation and commercialisation in health and medicine if barriers to collaboration are overcome and best practice models explored, according to a new University of Sydney and AusBiotech report.

The University of Sydney's Faculty of Medicine and Health and University of Sydney Business School explore the development of an Australian-first gold standard framework to ensure health and medical discoveries are more accessible to industry and can be fast-tracked to commercialisation opportunities.

The partnership focused on wide consultation with industry leaders coupled with benchmarking international institutions that successfully co-located with researchers, start-ups and business incubators to deliver rapid innovation through the convergence of skills, perspectives and resources.

The result is 10 recommendations that reflect what industry and university partners would like to see for successful collaboration.

They include strategies such as growing opportunities for proof-of-concept funding and career incentives, and secondments and training and development opportunities for academics and professional staff involved in commercialisation pathways. Up-skilling industry in academic processes, and publishing needs and streamlining the way commercialisation is negotiated and tracked are also discussed.

“This helpful report reinforces the need for Australia to take a holistic and eco-system approach to research commercialisation – universities, industry, governments and consumers all have a crucial role to play in working collectively to get our best research out into the world making a positive difference,” said Professor Duncan Ivison, Deputy Vice-Chancellor (Research) at the University of Sydney.

"Our Vision is to establish a hub for the health and medical industry that transforms Australia’s research and commercialisation capabilities by developing a gold-standard in which the private sector and universities co-design and co-invest,’ said Professor Robyn Ward AM, Executive Dean and Pro Vice-Chancellor Medicine and Health at University of Sydney.

The recommendations will also be incorporated into AusBiotech’s ‘Biotechnology Blueprint: A Decadal Strategy for the Australian Biotechnology Industry’ as part of their decadal plan that builds both a thriving ecosystem and develops a sovereign capability for Australia.

AusBiotech’s CEO Lorraine Chiroiu said “The Biotechnology Blueprint has clearly articulated that creating strong and effective partnerships between the Australian biotechnology industry and universities will significantly contribute to commercialising high-quality ideas, and to creating a better connected and more vibrant community.”

“This industry-academia collaboration framework is an important step towards that, as it identifies opportunities for the entire community – from bench to bedside – and aims to nurture an agile, nimble and interconnected environment that is able to consistently create and grow high-value biotech companies.”

The consultation process

The consultation included one-on-one interviews and a virtual roundtable, with total input from almost 100 high profile industry, government and academic stakeholders. Out of this grew the ten recommendations for mutually beneficial partnerships between the Australian biotech industry, universities and health sectors.

The overwhelming majority of stakeholders represented industry, including biotechnology, pharmaceutical, consulting, investment, and venture capital.

Recommendations:

Proof of Concept Funding: Create a national University PoC scheme to support both clinical and commercial proof of concept activities.
Incentivise: Adjust standard career progression metrics for academics who are seeking to explore the commercialisation of their research.
Global placements: Industry fellowships should consider global placements in order to access international R&D infrastructure and maximise learning opportunities.
Upskill: Improved training and professional development opportunities for commercialisation offices within universities.
Commercialisation institute: Partner with AusBiotech on an Australian Commercialisation Institute (ACI) to leverage expertise by forming strategic partnerships to access sophisticated insights into the commercial potential of university research.
Secondments into industry: Secondments for professional staff involved in technology transfer within private equity/venture capital firms to understand their approach to valuing pre-clinical invention disclosures/intellectual property.
Track commercialisation: Further develop metrics to assist in tracking commercialisation progress, complemented by standard term sheets outlining baseline terms and conditions to streamline the negotiation of licence, option or assignment.
Integrate business know how: Additional clarity on technology transfer offices (TTO) contracts, contacts and processes and make available information on baseline terms and conditions for standard commercial agreements, and general information on approaches to IP and equity structuring.
Attract the right talent: Access the global pipeline of TTO talent by creating opportunities commensurate with those in the US and UK.
Freedom to publish: Industry should ensure publication requirements can be accommodated as part of industry-funded research.

View an overview of the ten recommendations or access the full report.

More information

We welcome your input and feedback. For more information contact fmh.stratent@sydney.edu.au

Media enquiries

Michelle Blowes, Media and PR Adviser (Medicine and Health), University of Sydney, 0478 303 173, michelle.blowes@sydney.edu.au

Karen Parr, Director, Communications, AusBiotech, 0420 729 123, kparr@ausbiotech.org

Victoria’s Medtech Manufacturing Capability Programme opens

Thu, 10 Mar 2022 00:00:00 +1100

A Victorian Medtech Manufacturing Capability Program (MMCP) supporting the growth of its medtech and manufacturing sectors has opened.

The Australian Medtech Manufacturing Centre (AMMC)’s $3 million programme is offering SMEs matched-funding grants of up to $500,000, as it aims to build greater capacity and capability across the State and to strengthen Victoria’s long-term global competitiveness.

The AMMC notes that the four-week application timeline reflects the programme’s target of “ready-to-go” medtech projects that can be delivered over the next 12 months, and that it’s designed to “service the industry’s needs of today, increasing medtech manufacturing capability leading to new job creation and business growth.”

Building long-term sovereign manufacturing capability is important for the nation, and AusBiotech’s Biotechnology Blueprint strategy notes that, “In 2020, Australia ranked last in the OECD list for manufacturing self-sufficiency, a ranking that means Australia has the most underdeveloped manufacturing sector, and the greatest sovereign risk of any industrial country in the world. But while manufacturing now comprises just eight percent of the Australian economy, manufacturing remains one of Australia’s major sources of innovation, responsible for a quarter of all investment in R&D.”

Victoria’s funding programme is a positive step to bolster local capacity and supports Australia to become a manufacturing destination of choice.

The AMMC is holding an information session for applicants at 1.00 pm, Wednesday, 16 March. Applicants are invited to register here.

Applications for the MMCP closes at 5.00 pm, 5 April 2022. To learn more and apply, visit the AMMC program page here.

Telix's ZIRCON late-stage kidney cancer imaging study completes enrolment

Thu, 10 Mar 2022 00:00:00 +1100

Rebrand for Australia's largest life sciences venture fund

Thu, 10 Mar 2022 00:00:00 +1100

International Women’s Day: AusBiotech ‘moving the dial’ on gender equity

Tue, 08 Mar 2022 00:00:00 +1100

In celebration of International Women’s Day, AusBiotech is offering practical and tangible opportunities to support gender equity of life sciences and supporting emerging female leaders via the ‘Big Sisters/Little Sisters’ programme and the ‘Women in Life Sciences (WILS) Luncheon’ in Sydney this week.

International Women's Day is annually held on March 8 to “celebrate women's achievements throughout history and across nations”, and AusBiotech is ‘moving the dial’ for emerging sector leaders during its sell-out WILS Luncheon, co-hosted by AusBiotech and Medicines Australia.

The 2022 Luncheon will focus on ‘amplifying her voice’, uniting almost 500 delegates. Whether it’s in healthcare, politics, workplaces, relationships, boardrooms or life sciences, the voice of women is gaining significant traction. Since the last Women’s Luncheon, when the ‘Me Too’ movement had acted as a global lightning rod for women’s inequality, the past year has seen a reckoning for Australian women and the voice of many, thankfully, come to fore.

Profiling Executives, Founders, and leaders that span bench to bedside, the Luncheon also offers a tangible and practical way that leaders in the life sciences can provide support and encouragement to women in the early stages of their career via the ‘Big Sisters/Little Sisters’ programme.

The programme invites women advanced in their careers in the sector to sponsor a student to attend the event, meet their network during the Luncheon, and to receive an annual AusBiotech membership.

The quality of applications was excellent and comments from ‘Little Sister’ applicants showed enormous vision and commitment to the area.

One Little Sister said, “As a woman in STEM, I stand on the shoulders of giants. I want to become an exemplar role model for young girls who are considering a career in STEM. To show that we are important to the industry and we can make an impact. Even from the short time since I undertook my undergraduate degree in engineering, we have taken great strides towards diversity and equity.”

Another emerging leader noted, “Life sciences is key to understanding the world around us and creating equitable, sustainable and innovative solutions to the problems that we face... I am a young adult with hopefully many years ahead and I want a better future not just for me, but also for generations that come long after I'm gone. We cannot continue as we have, and novel solutions must be found to ensure the longevity of life on earth.”

AusBiotech’s Sector Snapshot 2022 report, to be launched later this month, has found that women form 51 per cent of the workforce across the life sciences sector, retaining consistent equality since 2017 (50 per cent).

Female representation in senior positions (executive, board, CEO/founder), however, was mostly under 50 per cent across the sector - except in government and regulatory organisations and support services. Inequality as seniority increases is well recognised, and it was pleasing to see the ‘dial’ shifting in some areas, with an increase in the percentage of women in life sciences board positions overall (35 per cent) and within industry (17 per cent), when compared to 2019 (31 and 15 per cent respectively).

This year's WILS Luncheon speaking programme includes keynote Nirelle Tolstoshev, Managing Director, Organon ANZ - the largest biopharmaceutical company dedicated to women’s health, and a panel of leaders to discuss the importance of ‘voice’ and how we can amplify that of women in Australian life sciences. Our speakers will share their experiences throughout their careers and discuss the ways they have amplified women's voices in their respective workplaces.

Panellists include:

Anne Harris, Managing Director, Pfizer Australia
Prof. Alison Todd, Co-Founder & Chief Scientific Officer, SpeeDx
Chris Stemple, Vice President & General Manager, Abbvie ANZ
Dr Samantha Wade, NSW Young Woman of the Year 2022, Associate Research Fellow, University of Wollongong
Dr Clara Tuck Meng Soo, Public Health Advocate & Practice Principal, Hobart Place General Practice & East Canberra General Practice
Fiona Clark, General Manager, Sanofi, Australia and New Zealand

Read more about the ‘Big Sisters/Little Sisters’ programme, the sell-out event and our esteemed speakers here.

Recognition for Vetter in CMO Leadership Awards

Tue, 08 Mar 2022 00:00:00 +1100

Chimeric Therapeutics announces final results from Phase 1 trial of CORE NK Platform

Tue, 08 Mar 2022 00:00:00 +1100

New expedited regulatory pathway proposed for novel biologicals

Thu, 03 Mar 2022 00:00:00 +1100

A new regulatory priority pathway has been proposed for novel biologicals, including human cell and tissue therapies, and AusBiotech is calling for feedback from affected members as it considers responding to the Therapeutic Goods Administration (TGA)’s consultation.

The proposed expedited pathway is for the assessment of certain novel and life-saving biologicals to enable patients with life-threatening diseases or seriously debilitating conditions to access these treatments quicker.

The ‘Priority Review’ pathway has been developed in recognition of the number of late-stage clinical and commercial products that industry is preparing to deliver for conditions with high unmet need, and has been designed to accommodate emerging and novel technologies.

The proposed pathway will be aligned with the pathway for medicines, and will increase alignment with other overseas regulators offering accelerated assessment processes.

There is currently no formal mechanism to expedite the assessment and inclusion of biologicals in the ARTG. The new ‘Priority Review’ pathway aims to provide a predictable and transparent mechanism to formalise processes for sponsors and the TGA.

The TGA is seeking feedback on:

Support for the introduction of a priority pathway for biologicals
the proposed eligibility criteria
the proposed ‘determination process’ for whether a biological application meets the eligibility criteria.

As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science industry.

The public consultation is open until 28 March 2022, and Members are encouraged to contact Karen Parr, Communications Director, by Friday 18 March to discuss how the proposal may impact their company.

The TGA’s consultation papers can be read here.

Active agent in Australian-developed nasal spray highly active against 'Omicron'

Thu, 03 Mar 2022 00:00:00 +1100

Antisense Therapeutics confirms ATL1102 poster presentation

Thu, 03 Mar 2022 00:00:00 +1100

AusBiotech highlights clarity and transparency is key in recent submissions

Tue, 01 Mar 2022 00:00:00 +1100

Clarity and transparency are highlighted in AusBiotech’s recent submissions, as it responds to the Department of Industry, Science, Energy and Resources’ R&D Tax Incentive Determination and the Department of Health’s Prostheses List (PL) Reform consultations.

As the national voice of the biotechnology industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science industry. Read AusBiotech’s submissions here.

R&D Tax Incentive Determination

The Research and Development Tax Incentive (RDTI) is the most critical programme in supporting the Government’s stated policy objective – to improve Australia’s performance when it comes to the commercialisation of medical research; and the new Determination will offer certainty to the clinical trial sector, which already contributes around $1.4 billion to the economy each year, and enhance Australia as a globally-preferred location for clinical trials.

The Determination is a new instrument seeking to provide clarity on the types of clinical trials that will be accepted as core R&D activities, and thereby offer certainty in eligibility and reduce regulatory burden.

Clinical trials work in a highly-regulated environment and industry has become familiar with eligibility over the past 10 years; this Determination offers eligibility certainty and consistency and acts as a formal indicator to the national and international life sciences ecosystem that clinical trials are a recognised and eligible core activity under the RDTI.

AusBiotech was supportive of the Determination, and recommended improvements for even greater certainty, including that definitions be added to the instrument and that guidance be released simultaneously and detailing what activities are included under each clinical trial phase and how decisions are made.

Prostheses List Reforms - A modernised fit-for-purpose listing process

AusBiotech has welcomed the opportunity to engage with the Department of Health on the redesign of the PL reforms’ listing pathways, and has proposed five key principles to ensure improvements are in line with the Australian Government’s whole-of-government approach to innovation.

These guiding principles include: Clarity and transparency; Maintaining safety and efficacy; Streamlining and efficiency; Rewarding innovation and effort; and Timeliness. While the consultation paper outlines pathway improvements that are aligned to these principles, AusBiotech’s response recommends opportunities to ensure that the proposals do not lead to unintended consequences, particularly for small and medium-sized Australian companies.

The Department has proposed a new three-tiered approach to listing pathways:

(New) Tier 1: Abbreviated pathway: where the device is medium or lower-risk, is a well-established technology, and is substantially similar in characteristics, intended use and clinical effectiveness to other devices listed on PL in the existing grouping with the benefit set up based on the reference pricing; assessments are largely undertaken by the Department with the relevant expertise and knowledge in medical devices
Tier 2: Clinical/Focused health technology assessment (HTA) Pathway
Tier 3: Full HTA Pathway (MSAC)

As an integral part of the PL Reform, the listing pathways must ensure fit-for-purpose processes to ensure timely access for private health insurance members to medical device innovation.

As well as containing cost, the PL Reform is an opportunity to reflect the Australian Government’s objectives to drive domestic innovation and effort in the medical device sector and to address the ongoing shortcomings of PL listing medical devices under private health insurance.

AusBiotech’s recommendations include:

Retain a standing consultative stakeholder mediating body, like the current Prostheses List Advisory Committee, to ensure a balance of interests for final decision making in all three proposed listing pathways by providing consistent and coherent PL listing advice to the Minister.
Implement parallel process of TGA approval and PL submission assessment for all three listing pathways.
Remove the requirement for all Class III devices to go through a focused HTA, and determine the appropriate listing pathway based on the type of clinical and economic claims rather than TGA device classification.
Consistent with other Government policies and programs, reward local innovation by reducing or refunding cost recovery fees of all three listing pathways for PL applications of medical devices backed with Australian innovation.
Ensure process is predictable through clear and mutually exclusive listing pathway criteria and guidelines for applications, as well as pre-listing consultations.
Increase transparency around listing decisions by publishing application summary documents.
Manage post-listing monitoring and PL de-listings via clear and transparent criteria.
Timelines and milestones for all three listing pathways must be clearly defined, predictable and reflective of the varying complexity of the three pathways to PL listing.

Lucy Turnbull AO rejoins the board of Immutep

Tue, 01 Mar 2022 00:00:00 +1100

Patrys selects stable cell line for the production of PAT-DX3

Tue, 01 Mar 2022 00:00:00 +1100

Approval for Neuren Pharmaceuticals' Phase 2 trial in Angelman syndrome

Tue, 01 Mar 2022 00:00:00 +1100

New award recognises industry’s role in clinical trials

Thu, 24 Feb 2022 00:00:00 +1100

In recognition of the important role that industry plays in Australian clinical trials, a new Australian Clinical trials Alliance (ACTA) Industry Partnership Award has been launched.

At a time when the spotlight is firmly on clinical trials across the globe, this is an opportunity to tell the success stories of the ground-breaking work happening in the Australian clinical trials sector.

Open to Members and non-members, the Industry Partnership Award will celebrate a significant collaboration between an industry company and a team of academic investigators uniting to conduct a high-impact clinical trial.

To coincide with International Clinical Trials Day, the winner will be publicly announced at ACTA’s National Tribute and Awards Ceremony, which will be held in Sydney on 20 May 2022.

The annual awards honour Australians advancing our health system by designing, conducting, or participating in ground-breaking clinical trials and promote the importance of clinical trials and the expertise and complexity of the work involving trial teams, industry partners and consumers.

In 2022, there nominations are being accepted for four award categories:

· ACTA Industry Partnership Award

· ACTA Trial of the Year Award

· ACTA STInG Excellence in Trial Statistics Award

· ACTA Consumer Involvement Award

Assessment of the Industry Partnership Award applications will be around the nature of the partnership; however, award judges will also be asked to confirm that the research undertaken in the trial in question was outstanding quality.

AusBiotech encourages you to learn more about the Awards and to make your nomination by midnight, Sunday 6 March 2022.

Kazia Therapeutics to be 'transformed' by pipeline progress

Thu, 24 Feb 2022 00:00:00 +1100

Important support programme oversubscribed

Tue, 22 Feb 2022 00:00:00 +1100

The impacts of the reforms made to the Export Market Development Grants (EMDG) programme are now being felt, with grant amounts unexpectedly and significantly reduced.

With the changes in the eligibility criteria, an explosion of applications has resulted in the funding being thinly spread. One biotech company has had their approved $450,000 three-year grant unexpectedly reduced to $105,000, at most, due to this unprecedented demand.

The EMDG scheme is a key Government financial assistance programme to help aspiring and current exporters grow their business overseas.

AusBiotech CEO Lorraine Chiroiu said, “The Australian life sciences industry is global in nature and relies on international trade and investment for success, and the EMDG has been an important opportunity to support the early stages of their global export mission.”

“The explosion in applications demonstrates the strong need for the programme. This is the first year of the reform implementation and the Government needs to ensure the support remains so that Australian biotech can continue to shine on the world stage.”

The life sciences industry is characterised by a large number of micro and small business in growth phases. While these small and emerging innovative businesses are beneficial for Australia’s economic growth, it also provides challenges for the companies themselves in accessing global markets.

A press release from the Minister for Trade, Tourism and Investment, the Hon Dan Tehan MP, notes on 23 December that exporter demand for EMDG grants had soared in 2021.

“This year Austrade received more than 5,300 applications [up from 4,000, the year prior] for the reformed EMDG grants - the highest number in the history of the program – demonstrating strong business support for the new, forward looking EMDG program.”

“The much higher number of grant recipients will see the fixed funding pool spread across more businesses with all eligible businesses receiving a payment.”

Following the reforms, three tiers of funding are now available:

Tier 1: first time exporters, for a maximum of $40,000/financial year
Tier 2: Businesses currently exporting and expanding activities, for a maximum of $80,000/financial year
Tier 3: Businesses currently exporting, expanding and making a strategic shift, including new markets or customer types, for a maximum of $150,000/financial year.

With the significant uptick in eligible companies, individuals’ grant sizes have been significantly reduced.

Biotech companies impacted by this change are asked to share their concerns with AusBiotech, by contacting admin@ausbiotech.org.

Arovella Therapeutics closes over-subscribed share purchase plan

Tue, 22 Feb 2022 00:00:00 +1100

Engage early on reimbursement and regulation strategies

Thu, 17 Feb 2022 00:00:00 +1100

Australian start-ups and early-stage companies developing US/European regulatory and reimbursement strategies are encouraged to engage in AusBiotech’s newest BiotechTalk webcast, and to learn about the processes that are essential for commercial success in Australia and internationally.

The webcast, Regulatory and Reimbursement 101: the pathway to commercialisation, offers an opportunity to navigate product development through to international access strategy, including exploring how to take an idea from a prototype, through planning for manufacture, collaborating with “Big Medtech”, and taking your product to commericalisation.

Medical technology (device and diagnostics) reimbursements are an extremely important consideration for any medtech early-stage company or emerging SME. Fuelled by a value-driven healthcare environment, the reimbursement landscape can certainly present a wide spectrum of challenges.

Developed in collaboration with AusBiotech’s AusMedtech Advisory Group and AusMedtech Regulatory Affairs Advsiory Group, this platform offers a chance to meet esteemed and experienced speakers.

The seminar includes: Grant Bennett, Managing Director, PharmaLex Pty Ltd, and Chair, AusMedtech & Regulatory Affairs Advisory Groups; Rebecca Gaudin, Director of Regulatory Affairs, ANZ, Johnson and Johnson Innovation and Member, AusMedtech Regulatory Affairs Advisory Group; Sarah Griffin, Director, Medtechnique Consulting and Member, AusMedtech Advisory Group; Dr Greg Roger, Founder & Chief Executive Officer, Vestech Medical and Member, AusMedtech Advisory Group; and Ferando Gonzalo, VP Global Market Access, Cochlear, and AusBiotech Member.

The webcast will take place on Thursday 31 March 2022 via Zoom and is available free of charge to AusBiotech members and $75 for non-members. Register for Regulatory and Reimbursement 101: the pathway to commercialisation now.

BiotechTalks is AusBiotech’s webcasting platform, and enables the Australian biotechnology industry to stay connected, present ideas, projects and updates, and exchange knowledge.

The conversation of regulating medtech will continue at Australia’s premier medical technology conference, AusMedtech 2022, on 24-26 May, where an engaging line up of keynote speakers and knowledgeable panellists will share their expertise and insights to further advance the sector nationally and globally.

Amplia says new report 'paves the way' for its phase 2 trial

Thu, 17 Feb 2022 00:00:00 +1100

New Prostheses List pathways proposed

Tue, 15 Feb 2022 00:00:00 +1100

Feedback from AusBiotech’s medtech members is sought as the Department of Health proposes an ‘Abbreviated pathway’ within its newly proposed three-tiered approach to the assessment of Prostheses List (PL) applications.

The Department of Health’s “Prostheses List Reforms – Consultation Paper No 3” outlines the three-tiered approach as:

New: Tier 1: Abbreviated pathway: where the device is medium or lower-risk, is a well-established technology, and is substantially similar in characteristics, intended use and clinical effectiveness to other devices listed on PL in the existing grouping with the benefit set up based on the reference pricing; assessments are largely undertaken by the Department with the relevant expertise and knowledge in medical devices
Tier 2: Clinical/Focused health technology assessment (HTA) Pathway
Tier 3: Full HTA Pathway (MSAC)

As an integral part of the broader multi-year HTA processes, the PL listing pathways must ensure fit-for-purpose processes to ensure timely access for private health insurance members to medical device innovation.

The PL is one policy lever that Government uses to encourage innovation within the medtech sector, particularly from Australian medical device companies. In place since 1985, the PL has been subject to numerous reforms, however, pathways to list an item have not evolved at the same pace as broader changes for assessing medical technologies in other Australian Government HTA processes.

This consultation reflects the ‘design’ stage of the reforms to the listing process and puts forward ideas to establish three separate pathways to list existing technology, a variation or upgrade to existing technology, and novel technology.

In response, AusBiotech’s key recommendations include:

Remove the requirement for all Class III devices to go through a focused HTA, and determine the appropriate listing pathway based on the type of clinical and economic claims rather than TGA device classification
Implement parallel process of TGA approval and PL submission assessment for all three listing pathways
Retain the Prostheses List Advisory Committee, to ensure a balance of interests for final decision making in all three proposed listing pathways by providing consistent and coherent PL listing advice to the Minister
Consistent with other Government policies and programmes, reward local innovation by reducing or refunding cost recovery fees of all three listing pathways for PL applications of medical devices backed with Australian innovation
Ensure processes are predictable through clear and mutually exclusive listing pathway criteria and guidelines for applications, as well as pre-listing consultations
Increase transparency around listing decisions by publishing application summary documents
Manage post-listing monitoring and PL de-listings via clear and transparent criteria, and
Timelines and milestones for all three listing pathways must be clearly defined, predictable and reflective of the varying complexity of the three pathways to PL listing.

It is expected that implementation of the new pathways will commence from July 2022. Prior to that, we expect to see another consultation paper detailing the scope, criteria, governance arrangements, timelines and cost-recovery fees.

AusBiotech members are invited to give feedback on its draft response by Monday 21 February; request a copy by emailing Karen Parr, AusBiotech Communications Director. Read the full Department of Health consultation papers here.

AusBiotech has previously submitted responses to the Prostheses List reform, accepting that some reform may be needed to the PL, it that it was but small in nature. It was pleased to see that the Department has maintained the PL, and the benefits and the value it brings to innovators and patients. Read AusBiotech’s submissions here.

Fuelled by a value-driven healthcare environment, the medtech (devices and diagnostics) reimbursement landscape can certainly present a wide spectrum of challenges for early-stage and emerging SMEs. Join a panel of experts at AusBiotech’s BiotechTalks: Regulatory and Reimbursement 101: the pathway to commercialisation, to learn about the processes that are essential for commercial success in Australia and internationally, and to ask your questions on how these reforms may impact the sector. Free of charge for AusBiotech members, register now for this webcast on 31 March 2022.

New chair for the Agricultural Biotechnology Council of Australia

Tue, 15 Feb 2022 00:00:00 +1100

Vaccine developer Sementis appoints chief operating officer

Tue, 15 Feb 2022 00:00:00 +1100

AusBiotech greets the patent box legislation

Thu, 10 Feb 2022 00:00:00 +1100

The national voice of the biotechnology industry, AusBiotech, has welcomed the patent box legislation that was introduced to the Australian Parliament today - to provide a tax incentive for Australian medical innovations.

AusBiotech CEO, Lorraine Chiroiu, said, “AusBiotech notes the progression of the patent box legislation as a positive first step.”

“AusBiotech looks forward to the establishment of an expert working group, with industry representation, to support the implementation of the patent box scheme – in order for Australia to realise the benefits of this important incentive.”

“This tax concession, from AusBiotech’s perspective, aims to support Australian medical innovators to be globally competitive, retain value creation from home-grown research and IP, and to support sovereign capability. Its purpose is to make it more genuinely viable for businesses to retain this value creation and manufacturing in Australia, including providing an incentive to industry to locate the associated high-value jobs at home.”

A well-designed patent box will support Australian manufacturers to remain competitive on an international scale by bridging the gap between R&D and commercialisation.

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

About AusBiotech

Senate Inquiry into sovereign manufacturing report released

Thu, 10 Feb 2022 00:00:00 +1100

The needs of biotech manufacturing have been reflected in the recommendations outlined in the Economics References Committee’s Inquiry into the Australian Manufacturing Industry’s report that was released this week.

Acknowledging the evolution in manufacturing, from heavy industrial to high-technology goods such as “sophisticated health-care equipment”, the majority report offers 19 recommendations to strengthen Australia's manufacturing capacity and capabilities.

While the view that the manufacturing sector is important to Australia was shared, the dissenting report by the Liberal senators disagreed with a number of the recommendations, demonstrating that Australia’s sovereign manufacturing is becoming a key election issue as campaigning begins ahead of the upcoming Federal elections.

The Senate Inquiry has considered the Australian manufacturing industry, including: current and future economic growth drivers, capacity, national resilience, new areas Australia can establish itself as a global leader, and the role that government can play in assisting our domestic manufacturing industry, including R&D, attracting investment, supply chain support, government procurement, trade policy, and skills and training.

Through written submission and verbal evidence, Australia’s opportunity to harness the important and emerging cell and gene therapies, or regenerative medicines (RM), sector was promoted through the joint submission of AusBiotech, Cell Therapies Ltd, Research Strategies Australia, and MTPConnect.

The Inquiry report noted these emerging opportunities that are disrupting the manufacturing industry, and the work that is still required for Australia to harness them, specifically the training and skills needed to develop the talent pipeline.

The substantial growth in the RM sector has revealed a significant manufacturing capacity shortage. Right now, global manufacturing capacity is not meeting demand and it is approximated that five-times the current capacity is required.

Building Australia’s sovereign manufacturing capability for complex and advanced RM Therapies will ensure equitable access to cutting-edge treatments for Australian patients, create new jobs now and for the future, and develop a highly skilled workforce.

The joint submission utilised insights from and promoted the work of the AusBiotech-led Consortium project that has been developing resources to build the foundations of RM in Australia.

The Senate Inquiry recommendations included:

Periodic reviews of R&D, commercialisation, and investment incentives and tax arrangements to ensure they facilitate the growth of Australia's manufacturing industry and investment
Establishment of a Manufacturing Industry Fund to provide a range of co-investment incentives to the manufacturing industry in conjunction with the private sector.
Significant increases to manufacturing R&D and commercialisation support to improve international competitiveness and stimulate the development of self-sustaining manufacturing ecosystems, including the establishment of an expert working group, with industry representation, to support the design and implementation of the patent box scheme; and through the establishment of a Research Translation Fund to fund large projects which encourage R&D and the commercialisation of innovative products, processes, and services.
That Government tenders preference bidders who have sustainable supply chains that maximise the use of local suppliers, manufacturers, and service providers and which are committed to developing the domestic manufacturing industry, and that are sustainable.
Federal and State Governments adopt procurement policies which maximise both domestic production and the provision of local jobs, and that the Commonwealth take on a more active role in facilitating national coordination in industry development, so as to ensure that multiple states are not all trying to replicate identical outcomes when a differentiated result which leverages each state’s existing strengths and assets may be more preferable.
Establish a working group with representatives from both employers and unions to examine policy options to secure and strengthen domestic pharmaceutical supply chains.

As the national voice of the biotech industry, AusBiotech champions advocacy and regularly submits responses to policy consultations on behalf of the sector. Read AusBiotech’s submissions here.

Read the complete Senate Inquiry report here.

Tessara Therapeutics announces key senior appointments

Thu, 10 Feb 2022 00:00:00 +1100

CSL campaign challenging stereotypes about people working in science

Thu, 10 Feb 2022 00:00:00 +1100

Applications for Bridge Programme 2022 open

Tue, 08 Feb 2022 00:00:00 +1100

Applications for Bridge Programme 2022 open

The Bridge Program has opened its doors for 2022 applications, as it provides 100 mid-career professionals tailored training on the scientific, legal, financial, clinical, regulatory and reimbursement disciplines that are essential to pharmaceutical commercialisation.

Using industry-led biotech and venture capital expertise, the programme empowers speakers and participants to share specific, detailed and practical translation know-how. Those involved will gain confidence and create networks and opportunities in all areas of the commercialisation pathway.

The programme is unique as it has been crafted and developed in collaboration with industry partners and with leaders in key global organisations in the biotech sector.

Applications are encouraged from mid-career professionals in the sector, including: entrepreneurs, researchers, scientists, legal practitioners (IP & patents), clinicians, venture capitalists, business development personnel, and staff from regulatory and government agencies. A background in pharma biotech, and demonstrated interest in a commercialisation career is essential.

Selection into the programme offers participants an exclusive opportunity to enter its annual video Pitch Competition, critiqued by industry partners. The winning pitches are awarded a US tour to visit the headquarters of major pharmaceutical companies to expand industry connections and discuss collaboration, travel permitting.

Biotech is a growing sector of high-value jobs, and skills and talent attraction will become a significant need for its future. The Bridge Program is one positive step in addressing this gap by upskilling our workforce, and enabling Australia to more effectively capitalise on its world-class medical research sector.

Launched in 2017, this programme has an alumni of over 700 and is fully supported by industry and government; there is no course fee. The Bridge Program is convened and administered by Queensland University of Technology, and match-funded through MTPConnect’s Project Fund Program and the Medical Research Future Fund’s Biomedical Translation Bridge Program.

The programme’s hybrid model offers online and in-person elements to increase accessibility across Australia.

Applications are open until 21 February 2022 via the online form here.

NeuroScientific Biopharmaceuticals reports outcomes of pre-clinical studies

Tue, 08 Feb 2022 00:00:00 +1100

Medlab Clinical updates on progress towards phase 3 trial

Tue, 08 Feb 2022 00:00:00 +1100

Changes proposed to TGA fees and charges

Thu, 03 Feb 2022 00:00:00 +1100

Feedback is sought on the annual Therapeutics Goods Administration (TGA) fees and charges consultation, as AusBiotech considers its response on behalf of the biotech industry.

The TGA is proposing an increase of 2.6 percent, which is consistent with its long-established practice. This would also see fees and charges rounded to the nearest $10 for items less than $10,000 and to the nearest $100 for items $10,000 and above. If implemented, this would take effect from 1 July 2022.

Working through a 96 percent cost recoverable model, the TGA reviews its fees and charges annually to ensure they’re set at the appropriate level and that cost recovery for each therapeutic industry sector is also appropriate.

This increase will also support the TGA to continue providing an increasing number of activities for the public good, which cannot be appropriately cost recovered from industry. These services include providing timely access to unapproved medicines (including medicinal cannabis, cell and tissue therapies and medical devices) to patients under the Special Access Scheme, the Authorised Prescriber Scheme and the Orphan Drug Program.

In addition, it is proposed that fees for clinical trial variations are amended.

2020 legislation amendments now allow variations to previously approved Clinical Trial Approvals (CTA) for medicines, biologicals and medical devices, however, also require that the change requests be accompanied by the fees prescribed in the regulations. Currently no such fees are prescribed in the regulations. Based on the staff effort required for variation applications, it is proposed to implement the variation application fees with effect from 1 July 2022, subject to approved indexation for 2022-23. The proposed fees equate to 28% of a new CTA application fee.

AusBiotech is working with its AusMedtech Regulatory Affairs Advisory Group as it considers its response to this consultation.

Members are invited to read the consultation paper here, and to contact AusBiotech’s Director, Communications, Karen Parr, with your feedback by 18 February 2021.

Action Plan to promote research-industry commercialisation

Thu, 03 Feb 2022 00:00:00 +1100

Cytiva announces winner of Australia-NZ BioChallenge

Thu, 03 Feb 2022 00:00:00 +1100

Certainty offered for RDTI clinical trial activities

Tue, 01 Feb 2022 00:00:00 +1100

Certainty and clarity are being offered for clinical trial activities under the R&D Tax Incentive, and AusBiotech is calling for Member feedback as it develops its response to the first draft determination released by the Department of Industry, Science, Energy and Resources.

The determination seeks to provide clarity on the types of clinical trials that will be accepted as core R&D activities, and thereby offer certainty in eligibility and reduce regulatory burden. This is the first determination released that will touch on activity eligibility matters and is being done under the reforms to the RDTI announced in the 2020-21 Budget.

The scope of the draft determination currently states that Phase 0-III clinical trials will qualify as core activities for the purposes of the R&D Tax Incentive; Phase IV and generics clinical trials currently excluded, however, will still be capable of meeting the definition of core R&D activities in particular circumstances.

Ensuring certainty and clarity for clinical trials, which are conducted within rigorous regulatory frameworks, will support the development process of bringing new therapies, devices and diagnostics to patients.

The draft determination has been developed in consultation with the Australian Taxation Office and Department of Health. Following consultation, it will then be approved by Industry Innovation and Science Australia, or its delegate.

AusBiotech is working with its Clinical Trials Advisory Group and a number of tax experts in its membership to develop a response, and encourages its members to submit their feedback to Karen Parr, Communications Director, by Friday 11 February 2022.

The consultation papers can be read here.

Exopharm announces new agreement with Astellas Institute for Regenerative Medicine

Tue, 01 Feb 2022 00:00:00 +1100

New trial underway of Pharmaxis' first-in-class LOX inhibitor

Tue, 01 Feb 2022 00:00:00 +1100

Keynote announced for NSW Women in Life Sciences Luncheon

Thu, 27 Jan 2022 00:00:00 +1100

Nirelle Tolsoshev, Managing Director for women’s health company Organon ANZ, has been announced as the keynote speaker for the Women in Life Sciences Luncheon in Sydney on 11 March 2022. Organon is the largest biopharmaceutical company dedicated to women’s health globally, and will share her experiences and insights into ‘amplifying her voice’.

Starting her career in cancer research, Ms Tolsoshev has since held commercial roles across most therapeutic areas in the pharmaceutical industry. She holds a Bachelor of Science with Honours in Gene Therapy, an MBA, and also completed the Company Directors course through the Australian Institute of Company Directors in 2021.

The Women in Life Sciences Luncheon 2022 will focus on ‘amplifying her voice’. Whether it’s in healthcare, politics, workplaces, relationships, boardrooms or life sciences, the voice of women is gaining significant traction. Since the last Women’s Luncheon, when the ‘Me Too’ movement had acted as a global lightning rod for women’s inequality, the past year has seen a reckoning for Australian women and the voice of many, thankfully, come to fore.

Ms Tolsoshev will be joined by a panel of leaders to discuss the importance of ‘voice’ and how we can amplify that of women in Australian life sciences.

Event details

When: Friday 11 March 2021

Where: Doltone House, Darling Island Wharf, Sydney

Time: 12.00pm - 3.30pm

The NSW Women in Life Sciences Luncheon 2022 will celebrate leadership at all levels. Leaders that nurture female ambition, elevate and inspire others to achieve their aspirations, and ultimately influence and drive new benchmarks in support of greater diversity in senior leadership positions.

Become a Big Sister

AusBiotech values their partnership with Medicine Australia, and the opportunity to demonstrate change in action around policies of equality and inclusion. Joining forces, this luncheon brings stakeholders together to further galvanise the diversity required within life sciences. For this diversity is the underpinning to building a successful sector – a position supported regardless of gender.

Applications to be a Little Sisters are also being received.

First patient dosed in Telix ‘ProstACT’ therapeutic program

Thu, 27 Jan 2022 00:00:00 +1100

New partnership between BiomeBank and Hudson Institute

Thu, 27 Jan 2022 00:00:00 +1100

Global biomanufacturing report seeks Australian voice

Tue, 25 Jan 2022 00:00:00 +1100

Australian biotechnology manufacturers are invited to contribute to global benchmarking, with the 19th Annual Biopharmaceutical Manufacturing global survey underway.

The work is benchmarking advances in global and regional bioprocessing, new technologies, and emerging trends, including new questions that reflect current industry trends.

BioPlan Associates collects more than 280 responses from biopharma manufacturers, contract manufacturing organisations (CMOs), and service providers across 28 countries. The white paper developed from the survey will highlight the top trends in biopharma manufacturing, ensuring that the report continues to reflect critical changes and trends across the global sector.

This survey includes questions on: new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, trends and budgets in disposables, trends in downstream purification, quality management, hiring issues, and employment. The quantitative trend analysis provides details and comparisons of production by biotherapeutic developers and CMOs. It also evaluates trends over time, and assesses differences across the globe.

For each completed survey, BioPlan Associates will either send a USD $25 Amazon e-gift card or donate up to $3,000 to global health charities.

AusBiotech encourages the industry to contribute their voice to the global biomanufacturing industry’s benchmarking. Each survey takes between 15-25 minutes and responses are aggregated and confidential. Participants will receive a free copy of the white paper.

The survey is open until 15 February; complete it now.

Significant capital raise for emerging Australian company

Tue, 25 Jan 2022 00:00:00 +1100

Technovalia announces interim safety results from vaccine phase 1 trial

Tue, 25 Jan 2022 00:00:00 +1100

Have your say on our industry’s decadal strategy

Thu, 20 Jan 2022 00:00:00 +1100

There is still time to have your say on the sector’s draft Biotechnology Blueprint: A Decadal Strategy for the Australian Biotechnology Industry – a plan by the industry for the industry.

AusBiotech will host roundtables in February, and warmly invites expressions of interest from C-suite across the membership as it seeks to finalise this critical plan. The invitation roundtables will ‘deep dive’ into topics raised in the Biotechnology Blueprint’s development. Specifically:

Commercialisation: 9 February 10.00 – 12.00 (two part: early and late. Includes proof of concept fund)
Capital and growth: 16 February 9.30 – 11.00am
Sovereign Capability: 22 February 10.00 – 11.00am

In addition, AusBiotech seeks feedback from the entire sector on any part of the Blueprint, and has also posed specific consultation questions, regarding:

The scope of the Blueprint: accuracy and appropriateness
Capital and growth: VC, superannuation, tactics to lift commercialisation, international models
Sovereign capability: increasing domestic toxicology capability, manufacturing, talent and skills development.
Metrics and data: importance, appropriateness, and priority
Agricultural biotechnology: suitability of approach
Sustainability: sector-wide sustainability framework (Environmental, Social and Governance framework)
Proof of concept fund: effectiveness, size, and global examples

More than 200 stakeholders and organisations have contributed to the plan’s development to date, which charts an ambitious pathway to how the biotech industry can help solve problems and generate the long-term economic growth and social capital that will be needed as we emerge from the current pandemic.

For the first time in 20 years, we have created a shared industry-developed vision for the next decade. The plan includes three goals, each with two sub-goals, which have helped define the substantive strategies, objectives, and ‘drills down’ to specific tactics that will drive and shape the biotechnology industry’s growth through to 2032 and beyond. The Blueprint responds to well-articulated, stubborn issues that the industry has grappled with for years, and presents a solutions-based approach.

The entire biotech sector is warmly invited to comment by 7 February 2022. The draft Blueprint and consultation paper can be found here.

To submit feedback on the draft Biotechnology Blueprint, or to request a Word version for tracking, please contact AusBiotech (admin@ausbiotech.org/ 03 9828 1400). To express your interest in the member roundtables email communications@ausbiotech.org.

BiomeBank appoints new chair to accelerate commercialisation strategy

Thu, 20 Jan 2022 00:00:00 +1100

Recharged with resolutions for 2022

Tue, 18 Jan 2022 00:00:00 +1100

With the beginning of 2022, the pace picking up after the summer break, and the realities of our respective New Year’s resolutions settling upon us, AusBiotech starts the year with a recharged focus on leadership in policy and a resolution to continue committed advocacy for innovation in life sciences.

The time is right to list AusBiotech’s New Year’s resolutions, which will buoy and grow the Australian biotechnology industry, support your success and ensure the year ahead is biotech’s best one yet.

New Year’s resolution one: Championing advocacy. AusBiotech will champion advocacy and be recognised as a persuasive, credible and collaborative voice of leadership for Australia’s life sciences industry.

On the radar for Q1:

Federal Election: This year Australia will see a Federal Election taking place; whatever the outcome, with a new Health Minister on the horizon after 2021’s announcement that the Hon. Greg Hunt will not seek reelection.
Clinical trials ‘One Stop Shop’ consultation – AusBiotech and its Clinical Trials Advisory Group and the joint Medicines Australia, AusBiotech and MTAA R&D Task Force committees met with the Australian Commission on Safety and Quality in Healthcare in December 2021 to contribute to phase one of the long-awaited consultation. Phase two is expected to kick off in Q1 2022, and AusBiotech looks forward to continuing to be the voice of industry.
TRIPS Waiver on IP related to vaccines – A new date has yet to be set for the WTO’s Ministerial Conference, after the Omicron strain of COVID-19 led several governments to impose travel restrictions that would have prevented many ministers from reaching Geneva last November. AusBiotech does not support the proposed patent waiver, which is a form of forced technology transfer or compulsory acquisition of intellectual property that would undermine the global vaccination effort rather than strengthen it. As the global discussions continue, AusBiotech continues to represent Australia at a global level on the International Council of Biotechnology Associations, and collaborate with Medicines Australia on this important policy issue, and remains connected with DFAT and IP Australia.
Patent Box – no news has been published on the progress of the Australian Patent Box since the consualtion of August 2021. The policy was announced in the May 2021 Federal Budget. AusBiotech continues to promote the benefit of end-to-end tax incentives, and looks forward to working with Treasury on the design of the incentive, which will be critical if the incentive is to achieve its full potential and enable industry to locate high-value jobs, manufacturing, exports and economic benefits in Australia, rather than sending the benefits of innovative to more competitive jurisdictions.

New Year’s resolution two: Focusing on growth. Save the dates in your diary for AusBiotech’s key events .

Coinciding with the virtual JP Morgan 2022 week, AusBiotech reached out to the world and delivered two great events to connect Australian innovation with the global market. Attended by industry and investors, AusBiotech illustrated the globally-recognised strength of the Australian life sciences sector. The distinct perspectives highlight State initiatives and programmes, and Australia's cross-border relationships, investment opportunities, and research, clinical trial and regulatory capabilities. Re-watch on demand here.

In an always-busy week, these dedicated events were an important opportunity to engage with global life science decision makers, for collaboration and partnerships, and for investment discussions.

AusBiotech’s 2022 events programme is being developed, and includes in person and virtual event opportunities. Save the dates below, and keep an eye on the AusBiotech website as the year progresses.

Watch two great events that took place during JP Morgan 2022 week and connected international biotech with Australia's thriving biotechnology community: Watch on demand: Australian showcase: Clinical trials and medical innovation advantages, and AusBiotech Pitch.
Biotechnology Blueprint roundtables: February 2022. Express your interest to join us as we deep dive into commercialisation (early and late, including proof of concept fund); capital and growth; and/or sovereign capability.
BioCheers: kicking off from February and March 2022.
NSW Women in Life Sciences Luncheon: 11 March 2022. Register now.
BiotechTalks: Regulatory and reimbursement 101: the pathway to commercialisation: 31 March 2022; save the date.
BiotechPitch: late March 2022. Details coming soon.
AusMedtech 2022: 24-26 May, Melbourne. Register now.
BIO 2022: 13 – 16 June, San Diego, USA. Announcement coming soon…
The biggest week in biotech: Australia Biotech Invest & Partnering 2022 & AusBiotech 2022: 26 – 28 October, Perth, Western Australia. Save the date.

New Year’s resolution three: Launching the industry’s decadal plan

After more than two years of development and engaging with more than 200 stakeholders, AusBiotech is finalising the Biotechnology Blueprint: A Decadal Strategy for the Australian Biotechnology Industry, and preparing to launch in March.

The plan charts an ambitious pathway to how the biotech industry can help solve problems and generate the long-term economic growth and social capital that will be needed as we emerge from the current pandemic. It is the first industry strategy in more than 20 years, and it presents a shared industry-developed vision for the next decade. The Biotechnology Blueprint responds to well-articulated, stubborn issues that the industry has grappled with for years, and presents a solutions-based approach.

There’s still time to have your say, and AusBiotech invites sector-wide feedback on the plan with the consultation open until 7 February; read more about the plan and have your say here.

With so much going on, it’s bound to be an exciting year. Your industry body looks forward to a successful year as it continues to work with you and on your behalf to make it a year to be celebrated.

Pharmaxis welcomes government research grants for new study collaborations

Tue, 18 Jan 2022 00:00:00 +1100

Patients dosed in Dimerix's DMX-200 COVID-19 late-stage study in India

Tue, 18 Jan 2022 00:00:00 +1100

Australia’s health security audit closing with the year

Thu, 16 Dec 2021 00:00:00 +1100

To compile an accurate and truly national picture of the capability and capacity of Australia’s health security ecosystem, including end-to-end supply chains and workforce, the Australian biotech industry is invited to contribute to the National Health Security Resilience Assessment (NHSRA), that is closing with the year.

The online assessment will examine Australia’s capability and capacity for research, development, manufacturing, supply chain resilience and distribution of priority products and solutions that contribute to national health security. Health Security Systems Australia, a division of DMTC Limited, is conducting the assessment.

The NHSRA will consider sovereign capability across six critical sectors, including medical countermeasures, medical devices and CBR-related personal protective equipment (PPE), modelling and simulation, hazard management, and sensing systems.

The information from the assessment will feed a database, and provide support to Governments and partners on Australia’s national health security capacity and capability, in order to inform future investment and enhance Australia’s prevention, preparedness, response and recovery ecosystem for future pandemic or emerging disease threats.

Detailed analysis of responses submitted by the end of 2021 will allow for a comprehensive report will be published in 2022.

The activity is being conducted by an expert team led by Dr Leigh Farrell, Head Health Security for DMTC, and Dr Felicia Pradera, General Manager – Health Security and Program Leader for the Medical Countermeasures initiative at DMTC.

Complete the online Assessment tool by 31 December 2021.

Uniting to progress biotech in the year ahead

Thu, 16 Dec 2021 00:00:00 +1100

The year has seen the biotech sector unite to progress and deliver, as it is recognised as an invaluable industry that continues to exhibit its strength in innovation and leadership. As the country and world has navigated ‘Covid-normal’ life, life sciences has gained great recognition for its health, economic and social value, as it focuses on the potential health products and services of tomorrow.

As the national voice of the biotech industry, AusBiotech’s achievements this year reflect our loyal and committed Australian life sciences community. It too has continued to unite the ecosystem and to consciously lay the groundwork for our industry’s future success.

AusBiotech invites EOIs for member roundtables

Over the past 18 months AusBiotech has been leading the development of the Biotechnology Blueprint, a decadal strategy for the Australian Biotechnology Industry, together 200 stakeholders. Currently open for consultation until February, AusBiotech will host roundtables in the New Year and warmly invites expressions of interest from C-suite across the membership as it seeks to finalise this critical plan. The invitation roundtables will ‘deep dive’ into topics raised in the Blueprint’s development, for further detailed development.

Commercialisation: 9 February 10.00 – 12.00 (two part: early and late. Includes proof of concept fund)
Capital and growth: 16 February 9.30 – 11.00am
Sovereign Capability: 22 February 10.00 – 11.00am

For biotech to fulfil its potential, a shared sense of purpose through an industry strategic plan, developed by the industry, is critical. It has been an opportunity to create a shared vision for Australian biotechnology, to raise our ambitions as a sector and share the returns, and, through its implementation in the years ahead, we can herald in an era of Australian research, translation, commercialisation and innovation.

The entire biotech sector is warmly invited to comment on the draft strategic plan by 7 February 2022. Read the plan and download the consultation paper here.

Save the dates for 2022 events

Australian showcase: Clinical trials and medical innovation advantages; during JP Morgan week: 11 January 2022 (PST)/12 January 2022 (AEDT). Register now.
Biotechnology Blueprint roundtables: February 2022. Express your interest now.
BioCheers: kicking off from February and March 2022.
NSW Women in Life Sciences Luncheon: 11 March 2022. Register now.
BiotechTalks: Regulatory and reimbursement 101: the pathway to commercialisation: 31 March 2022; save the date.
BiotechPitch: late March 2022. Details coming soon.
AusMedtech 2022: 24-26 May, Melbourne. Register now.
BIO 2022: 13 – 16 June, San Diego, USA. Announcement coming soon…
The biggest week in biotech: Australia Biotech Invest & Partnering 2022 & AusBiotech 2022: 26 – 28 October, Perth, Western Australia. Save the date.

Summer break office closure

The AusBiotech office will be closed over the holiday period from Thursday, 23 December 2021 until Monday 17 January 2022. Biotech Dispatch will resume on Tuesday 18 January 2022.

More than 35 years of AusBiotech and Australian biotechnology: 31 December 2021 marks the end of AusBiotech’s 35 year anniversary. From humble beginnings with less than 100 members in 1986, AusBiotech has grown to become a strong well-connected, 3,000+ member community representing the entire value chain of biotechnology development.

AusBiotech thanks its members from across the years for their ongoing support, wishes them a happy and safe festive period, and looks forward to working together during 2022.

CSL completes $6.3 billion placement to support Vifor acquisition

Thu, 16 Dec 2021 00:00:00 +1100

QIMR Berghofer attracts up to $63M for potential new multiple sclerosis treatment

Thu, 16 Dec 2021 00:00:00 +1100

Stem cell advocacy highly commended

Tue, 14 Dec 2021 00:00:00 +1100

Research Australia’s 18th Health and Medical Research Awards have been announced, and AusBiotech congratulates Professor Megan Munsie, Melbourne University, who was recognised for her ongoing advocacy work in stem cells.

The ‘Advocacy Award’ at the Awards ceremony recognises the champions of health and medical research who are raising community awareness and understanding about the importance of health and medical research.

Prof. Munsie has worked in stem cell research for more than 20 years, is an AusBiotech member and a member of the AusBiotech Regenerative Medicine Advisory Group.

Research Australia’s annual black-tie awards are the pinnacle of health and medical research achievement in Australia, and celebrate the outstanding efforts and achievements of individuals and teams who drive and support the opportunities that health and medical innovation bring to each and every one of our lives.

For his work on personalised medicine, Dr Qing Zhong, Children's Medical Research Institute, received a highly commended for the Data Innovation Award by presenter by Gabrielle Upton MP, Parliamentary Secretary to the NSW Premier. This award recognises innovative methods of gathering, making available, processing or interpreting data in a way that advances the sector.

Dr John Parker, Saluda Medical, took out the Frontiers Award, which recognises bold leadership and game-changing innovation. Saluda Medical is a global medical company seeking to transform the neuromodulation industry through pain relief optimisation, by measuring and recording each patient’s unique response to stimulation, and then making millions of real-time adjustments per day to maintain a consistent level of therapy. Saluda Medical contributed to AusBiotech’s joint submission to the Medical Manufacturing Roadmap Consultation, under the coalition of ‘Australian Medical Manufacturing Exporters Coalition’.

Starpharma announces early orders following Vietnam distribution agreement

Tue, 14 Dec 2021 00:00:00 +1100

Save the date: NSW Women in Life Sciences Luncheon announced

Thu, 09 Dec 2021 00:00:00 +1100

AusBiotech and Medicines Australia are thrilled to announce the annual NSW Women in Life Sciences Luncheon will be held in Sydney on Friday, 11 March 2022 in celebration of International Women’s Day, on 8 March.

The annual Luncheon brings together up to 550 leaders and future leaders, and is focused on connecting the community to encourage, support, and further develop women in the life sciences sector in order to achieve a more equal standing in the biotech, pharma and medtech workplace.

Event details
When:      Friday 11 March 2021
Where:    Doltone House, Darling Island Wharf, Sydney
Time:        12.00pm - 3.30pm

The Luncheon will showcase outstanding women in biotech, including women in industry who are still under represented (32 per cent), according to AusBiotech’s Sector Snapshot 2019. The research shows that female representation is very close to or over 50 per cent in funding bodies, government and regulatory organisations, research institutions and support service companies.

Become a Big Sister
Make a commitment: The successful ‘Big Sisters’ programme will again invite women advanced in their careers in the sector to sponsor a student to attend the event and facilitate their networking during the Luncheon. Up to 30 women students will be sponsored to attend the event and receive a one-year membership of AusBiotech.

Sponsorship of a sister is for the Luncheon only, and a practical and tangible way that leaders in the life sciences can provide support and encouragement to a woman in early stages of her career in life sciences. Each sponsored place can be secured for $275. Sponsors will be recognised at the event and the sponsored sister seated at the same table. To include this sponsorship please select the checkbox during the registration process.

AusBiotech values their partnership with Medicine Australia, and the opportunity to demonstrate change in action around policies of equality and inclusion. Joining forces, this luncheon brings stakeholders together to further galvanise the diversity required within life sciences. For this diversity is the underpinning to building a successful sector – a position supported regardless of gender.

Save the date and register as an individual or table now.

Applications for Little Sisters will open in the New Year.

Recce Pharmaceuticals update on clinical trial of burn wound infections

Thu, 09 Dec 2021 00:00:00 +1100

2021 Brilliant Women in Digital Health

Tue, 07 Dec 2021 00:00:00 +1100

AusBiotech congratulates Kate Quirke, CEO of Alcidion, who has been awarded a winner of the inaugural 2021 Brilliant Women in Digital Health. Kate Quirke is an AusBiotech member, was an AusMedtech 2021 keynote speaker, and is one of 25 women that have been recognised and celebrated for their outstanding achievements through the Telstra Health initiative.

Kate Quirke has been recognised for her contributions to leading Alcidion through rapid transformation and growth, identifying the significant potential to use smart informatics, artificial intelligence and machine learning to create new solutions for clinical staff to improve the quality of care delivered, and for improving health outcomes using digital health.

Under Kate’s leadership, the number of healthcare organisations assisted by Alcidion has grown across Australia, New Zealand and, increasingly, the UK. As at March 2021, they had 68,000 users and captured more than 1 billion observations at the 50,000 hospital beds.

When asked about her hope for the potential of digital health, Ms Quirke replied, “While digital health can deliver multiple benefits, the timeline for adoption is incredibly lengthy. A positive outcome of the pandemic has been the relatively rapid and agile adoption of digital health solutions to support virtual care and remote patient monitoring.”

“I hope this more dynamic approach will flow through to other areas that can benefit from the adoption of digital health solutions; for all healthcare organisations to be supported by smart technology aligned with their clinical and business requirements and deployed with true interoperability to ensure that patients receive optimal care as clinicians have access to information when and where it is needed.”

Read Kate Quirke’s editorial on accessing global markets in AusBiotech’s April 2021 edition of the Australasian Biotechnology journal (page 9), featured in advance of her keynote address at the annual AusMedtech 2021 conference.

Read the 2021 Brilliant Women in Digital Health report celebrating all 25 winners.

Australian-produced eucalyptus compound effective at treating lung damage in sheep mode

Tue, 07 Dec 2021 00:00:00 +1100

Positive late-stage trial results for Neuren Pharmaceuticals' trofinetide

Tue, 07 Dec 2021 00:00:00 +1100

Call for Australasian Biotechnology journal abstracts

Thu, 02 Dec 2021 00:00:00 +1100

AusBiotech is calling for thought leadership articles on innovative approaches, contributions or analyses to include in the April 2022 edition of the Australasian Biotechnology journal.

AusBiotech is welcoming abstracts from valued members on set themes, including investing in medical technology (devices and diagnostics), robotics, mRNA, and medtech regulation.

The journal will also feature a sneak peek into the AusMedtech 2022, AusBiotech’s premier medtech conference taking place on 24-26 May, where key stakeholders of the Australian and international devices and diagnostics sector engage and challenge the status quo as they drive the sector forward.

Australasian Biotechnology is AusBiotech’s official biannual journal, and published in April and October. Its contributions are written by the sector, for the sector.

With its informed and authoritative editorials, Australasian Biotechnology is a highly-effective communications vehicle for those wanting to reach out to stakeholders in the life sciences sector. The journal is mailed on a name-and-title basis to over 3,000 AusBiotech members and investors, as well as published digitally. Readership includes companies, government and university departments, research institutes, biotechnology and professional services providers nationally, and in key overseas markets.

Two-hundred word abstracts on your proposed topic can be sent to the AusBiotech Communications team by 17 December 2021.

If your abstract is accepted, the full article will be required on or before 4 February 2022. Article lengths are approximately 500 words (1 page) or 1,000 words (2 pages). High resolution photos to accompany articles are encouraged.

Articles are a member-benefit, however there is limited space and so are not guaranteed to be included. Abstracts are welcomed on research, business news, and sector trends for consideration at any time of the year.

New discoveries make steps toward lipoedema diagnosis and treatment

Thu, 02 Dec 2021 00:00:00 +1100

US FDA grants new fast designation for Bionomics' BNC210

Thu, 02 Dec 2021 00:00:00 +1100

AusBiotech welcomes Parliamentary Inquiry report

Tue, 30 Nov 2021 00:00:00 +1100

AusBiotech has welcomed The New Frontier - Delivering better health for all Australians – the final report delivered by the Parliamentary Inquiry into approval processes for new drugs and novel medical technologies in Australia.

AusBiotech was one of more than 200 submitters that enthusiastically engaged with the Parliamentary Committee, and through written submission and in-person presentation it highlighted the long-term and stable biotech policy incentives needed to support and sustain R&D for treating rare diseases and conditions, where there is high and unmet clinical need.

Keeping Australian patients front-of-mind, this 400-page report examines opportunities to deliver better health care for Australians through our regulatory and reimbursement processes for medicines and technologies. The 31 Recommendations and additional and numerous sub-recommendations span the pipeline of development, and covers the ecosystem of stakeholders involved in getting medicines and technologies to patients.

AusBiotech CEO, Lorraine Chiroiu, said, “This report includes key recommendations on processes that industry has been challenged by for many years, and offers an opportunity to both reduce the existing red tape and to roll out the red carpet as we prepare for new technologies that are on Australia’s horizon.”

AusBiotech proudly advocates on behalf of our national biotech sector; it is pleased to see many of the issues that are included in the key recommendations, having long-advocated for them. These include:

Protecting existing and designing new tax incentives that create end-to-end motivation, and bridge over extensive investments. Keeping the benefits of home grown, often publicly funded IP in Australia will enable Australia to economically and societally benefit and will also incentivise the associated manufacturing to stay here and boost our sovereign capability
Supporting new therapies to address Antimicrobial Resistance by reviewing and assessing existing funding, and considering implementation of a national reimbursement system
Supporting equitable access to blood products
Valuable initiatives that position Australia as the premier destination for international clinical trials, including e-consents, a National One Stop Shop, and a National Front Door.
International harmonisation of regulatory guidelines and priority tracks around approvals, especially in emerging areas
Increasing the TGA’s education campaigns, including health literacy and building a better understanding of the benefits and impacts of emerging medicines and technologies for patients, governments and industry. AusBiotech believes the TGA should be appropriately resourced through non industry-recovered funding to accomplish this necessary activity.

The significance of the biotech sector, what it has delivered (particularly over the past 18 months), and its potential for the future was noted, with The New Frontier unanimously adopted by the entire bipartisan Committee. The report has been tabled, and is under consideration by the Federal Government.

Tackling the regulatory and reimbursement challenges in the sector, many of the Parliamentary Inquiry’s recommendations also align to the draft Biotechnology Blueprint, industry’s decadal strategy that has been led by AusBiotech, and designed by industry. The Biotechnology Blueprint offers a pathway to shift the horizon of possibility, and reach industry’s ambitions for the coming decade. The draft strategy is an opportunity to speak as one voice and includes key priorities for the ecosystem to work together to improve our business environment and deliver better results for the patients and the sector. The Biotechnology Blueprint is currently open for consultation and the sector is warmly encouraged to submit its feedback.

Read The New Frontier - Delivering better health for all Australians report here.

ResApp receives first regulatory approvals for cough counter smartphone application

Tue, 30 Nov 2021 00:00:00 +1100

Victoria produces Australia’s first mRNA COVID-19 vaccine candidate

Tue, 30 Nov 2021 00:00:00 +1100

New BARD1 exosome liquid biopsy agreement with Griffith University

Tue, 30 Nov 2021 00:00:00 +1100

Nominations open for Prime Minister’s science prizes

Thu, 25 Nov 2021 00:00:00 +1100

Nominations have opened for the Prime Minister’s Prizes for Science, Australia’s most prestigious awards for outstanding achievements in scientific research and research-based innovation. The Science Prizes range between $50,000 - $250,000.

The Science Prizes are an opportunity for the biotech community to showcase their achievements and illustrate the value that biotech offers Australia economically and socially.

The 2022 Prime Minister’s Prizes for Science include:

Prime Minister's Prize for Innovation
Prime Minister’s Prize for Science
Frank Fenner Prize for Life Scientist of the Year
Prize for New Innovators.

AusBiotech congratulated The University of Sydney’s Professor Anthony (Tony) Weiss AM, who was presented with the $250,000 Prime Minister’s Prize for Innovation 2021 earlier this month. One of AusBiotech’s original members, Prof. Weiss has been recognised for his trailblazing research into accelerating and improving the repair of human tissue.

In 2008, Prof. Weiss founded the Australian spin-out company Elastagen to commercialise his research and inventions. The company raised $35 million in venture capital and grant funding, completed clinical trials and scaled-up production. Ten years later, Elastagen was sold for $334 million to Allergan, one of the world’s 20 largest biopharmaceutical companies, in one of the largest transactions ever completed in the Australian life science sector.

Nominations close on 10 February, and can be made here.

Biotron's BIT225 effective against COVID-19 in animal study

Thu, 25 Nov 2021 00:00:00 +1100

Member feedback sought on mandatory reporting of adverse events

Tue, 23 Nov 2021 00:00:00 +1100

AusBiotech is seeking feedback from Members that may be impacted by potential TGA regulation changes on Mandatory Reporting of Medical Device Adverse Events by Healthcare Facilities in Australia.

The Government is exploring whether it should be mandatory for healthcare facilities to report adverse events with medicines and medical devices to the TGA; and removing some existing exemptions to require more timely and improved reporting of adverse events by industry to the TGA.

In Australia, mandatory adverse event reporting requirements exist only for device manufacturers and sponsors. Healthcare facilities, health professionals, and consumers are strongly encouraged to report adverse events, however, this is voluntary.

A number of reviews have highlighted the need for improving the monitoring of medical devices’ safety and performance once supplied on the market, including how adverse events are reported to the TGA.

Areas of interest include:

· Feasibility of mandatory reporting of medical device adverse events in healthcare facilities

· Included or excluded facilities

· Included or excluded device types

· Reporting logistics and avoiding data duplication

· Quality assurance of systems used, and

· Accountability.

Targeted discussions between the TGA and Australian stakeholders and international regulators occurred in early 2021, and insights and feedback from these have informed its Discussion Paper.

The proposed changes are part of the Government’s broader action plan, launched in 2019, for ensuring timely access to information and strengthening post-market medical device monitoring.

A globally thriving medtech ecosystem means that the number, range, and complexity of medical devices will increase over time. As the national voice of the life sciences industry, including medical technology (devices and diagnostics), AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science industry.

Members are invited to read the consultation paper here, and to contact AusBiotech’s Director, Communications, Karen Parr, with your feedback by 3 December 2021.

CSL's new headquarters will be home to biotech incubator

Tue, 23 Nov 2021 00:00:00 +1100

Call for AusMedtech 2022 session submissions

Thu, 18 Nov 2021 00:00:00 +1100

AusBiotech is inviting session proposals for AusMedtech 2022, Australia’s premier medtech conference, to be held in person on 24 – 26 May next year. AusBiotech invites proposals for inspirational, cutting-edge session topics that will be at the forefront of the global medtech industry, including keynote presentations, discussion panels, and workshops.

This is your opportunity to have a say and lead discussions, bringing new and diverse topics to the forefront of the medtech industry.

Thrilled to be back in person for the first time in two years, AusMedtech 2022 is being supported by Host State Partner Victoria Government at the Melbourne Conference Centre, and will feature a cutting-edge three-day programme, industry exhibition, Early-Stage Investment Forum, a welcome function (24 May) and a conference dinner (25 May).

AusBiotech, together with the Programme Committee, is looking for topical session submissions that explore current trends, critical and emerging topics, breakthroughs and stories that are thought provoking and encourage discussion on topics that matter to medtech locally and abroad.

AusMedtech 2022 aims to leverage our diverse membership base to present an engaging line up of keynote speakers and knowledgeable panellists who will share their expertise, insight and commentary on a range of topics that are practical, forward thinking and inspirational, with a core focus on increasing the knowledge and understanding across the sector of the future of medtech innovation beyond current technologies and trends.

Preference will be given to completed submissions that include strong rationale; clear links to developments in technology, clinical practice and commercialisation; and interesting and diverse speakers. Please note that AusBiotech is committed to gender diversity, and submissions for panels will only be considered if they meet a 50 per cent gender balance.

Run by industry, for industry, AusMedtech is an annual conference held by AusBiotech. Read about “The power of reconnection at AusMedtech 2021” in the October 2021 edition of the Australasian Biotechnology journal, where where almost 400 national and international members of the Australian medtech community gathered.

Submit your programme ideas by 31 December 2021.

Early bird registrations will be opened imminently.

AusBiotech highlights cell and gene therapy opportunity to Senate Inquiry

Tue, 16 Nov 2021 00:00:00 +1100

Jointly delivering evidence to the Senate Inquiry on the Australian manufacturing industry last week, AusBiotech and Cell Therapies Ltd promoted Australia’s opportunity to harness the emerging regenerative medicine (RM), or cell and gene therapy, sector.

This followed AusBiotech’s written and joint submission with Cell Therapies Ltd, Research Strategies Australia, and MTPConnect.

AusBiotech CEO, Lorraine Chiroiu, explained, “These treatments are approved and reimbursed in Australia and are changing the lives of patients with cancer in an unprecedented way, however they are individualised and complex, and there is an obvious and significant opportunity to maximise the health investment in generating each treatment, by ensuring sovereign manufacturing capacity.”

“Sophisticated advanced manufacturing is required to generate these products, including expensive credentialled facilities, specialised equipment and technologies, high levels of quality assurance and quality control, and a highly-skilled workforce working in this new and emerging industry … [These necessary requirements] currently limit the ability of manufacturers to take advantage of scale-up efficiencies with proven track records of meeting global standards, despite the need for scale to be able to treat greater numbers of patients and make the facilities commercially viable.”

The opportunity for regenerative medicine is great and Australia is well positioned to capture the high-value opportunities that will exist in the future. However, there is intense regional competition in Asia for their jurisdictions to be the future location of this developing industry to supply the region.

If Australia is to realise this opportunity, a regenerative medicine industry must be fostered at all levels and in a sophisticated way. To support and coordinate this, AusBiotech and Medicines Australia are co-leading a national Cell and Gene Therapy Catalyst which will drive the delivery of its Strategic Roadmap.

AusBiotech has been leading the Regenerative Medicine Consortium Project, a consortium of seven partners, that over the past 12 months has developed a plethora of resources offering new knowledge and benchmarking, purpose, and a firm, unified direction for the Australian industry’s future. These resources offer a solid ‘foundation’ for the new Cell and Gene Therapy Catalyst to drive benefits to Australia’s economy and the health of its people.

The Senate Inquiry is considering current and future economic growth drivers, capacity, new areas Australia can establish itself as a global leader, national resilience, and the role that government can play in assisting our domestic manufacturing industry, including R&D, attracting investment, supply chain support, government procurement, trade policy, and skills and training.

Telix Pharmaceuticals says first Australian patient doses in global study

Tue, 16 Nov 2021 00:00:00 +1100

AusBiotech calls for feedback on National One Stop Shop for clinical trials

Thu, 11 Nov 2021 00:00:00 +1100

AusBiotech is calling for member feedback as it develops its response to the Australian Commission on Safety and Quality in Health Care’s clinical trials ‘National One Stop Shop’ consultation. Feedback will support the development of a single and nationally-focused health and human research approvals platform – the National One Stop Shop.

The consultation notes that a single national and interconnected approvals platform offers a significant opportunity for Australia to:

· address long-standing challenges with duplication, delays, navigation and fragmentation as a result of different research ethical approval and local site authorisation systems in the jurisdictions; separate processes for Therapeutic Goods Administration (TGA) notifications; a separate process for registration on the Australian and New Zealand Clinical Trials Registry; separate processes for other jurisdiction-specific and therapy-specific approvals and authorisations and, the absence of individualised and fragmented operational monitoring and reporting approaches

· enhance patient access to state-of-the-art treatments

· improve health outcomes

· contribute to the innovation economy and a self-improving health system

· strengthen Australia’s global positioning in health and human research.

Options for improving research participation through a related community volunteer recruitment portal, the National Clinical Trials Front Door will also be considered through this consultation process, including mechanisms that facilitate access to third party participant recruitment providers.

AusBiotech has supported the concepts of a National One Stop Shop and a National Clinical Trials Front Door since they were mooted more than two years ago, through national speaking opportunities, formal submissions, and through its ongoing discussions with Ministers and departmental staff. Health Minister Greg Hunt has previously acknowledged these as a “golden” opportunity for Australian clinical trials.

AusBiotech is working with its Clinical Trials Advisory Group to develop a response, and encourages its members to submit their feedback to Lorraine Chiroiu by Friday 10 December 2021.

Access the consultation survey here.

New incubator to support the translation of local innovation

Thu, 11 Nov 2021 00:00:00 +1100

Nirtek begins R&D collaboration with TTRA funding support

Thu, 11 Nov 2021 00:00:00 +1100

Winner of 2021’s Prime Minister’s Prize for Innovation congratulated

Tue, 09 Nov 2021 00:00:00 +1100

AusBiotech congratulates The University of Sydney’s Professor Anthony (Tony) Weiss AM, who has been presented with the $250,000 Prime Minister’s Prize for Innovation 2021. One of AusBiotech’s original members, Prof. Weiss has been recognised for his trailblazing research into accelerating and improving the repair of human tissue.

The Prime Minister’s Prizes for Science are Australia’s most prestigious awards for outstanding achievements in scientific research, research-based innovation and excellence in science, mathematics or technology teaching.

Accepting the Award, Prof. Weiss said, “This award means so much to me. It's been wonderful to go down the path of commercialising the products of science and technology. And it's incredibly invigorating to put products on shelves in hospitals and elsewhere to make the world a better place.”

Minister for Science and Technology Melissa Price said research-based innovation leading to commercialisation demonstrated the value and importance of the work of Australian scientists.

Further prizes presented on the night included:

Prime Minister’s Prize for Science: Professor Edward C. Holmes, University of Sydney. An evolutionary biologist and virologist who played a transformative role in the global scientific response to COVID-19, Prof. Holmes received the $250,000 prize for almost 30 years of pioneering research on genome sequencing data, providing invaluable insights into diseases such as HIV, Ebola, SARS and most recently, COVID-19. Last year Professor Holmes was the first person in the world to publicly share the COVID-19 virus’ genome sequence. This crucial data enabled scientists to start vaccine design within days.
Frank Fenner Prize for Life Scientist of the Year: Prof. Sherene Loi, Medical Oncologist and Head of the Translational Breast Cancer Laboratory at Peter MacCallum Cancer Centre was awarded the $50,000 Prize for her work to translate scientific findings into innovative treatments that can improve the survival of breast cancer patients in Australia and around the world.
Prize for New Innovators: A/Prof. Michael Bowen, co-founder and Chief Scientific Officer for Kinoxis Therapeutics and from the University of Sydney’s Brain and Mind Centre was presented the $50,000 prize for his work to drive scientific discoveries relating to serious brain disorders (such as opioid use disorder) that lack effective treatments.

Watch a video about Prof. Weiss’ work, as well as his acceptance speech, here.

Microbiome discovery could help save kids' hearing

Tue, 09 Nov 2021 00:00:00 +1100

Mr Geoffrey Kempler announced as new AusBiotech Chair

Mon, 08 Nov 2021 00:00:00 +1100

AusBiotech is pleased to announce that experienced biotechnology Chair and director, Mr Geoffrey Kempler, has been appointed as non-executive director of AusBiotech and will lead the Board as its incoming Chair.

Mr Geoffrey Kempler is a highly-experienced chair, company director and CEO in the global biotechnology industry. His wealth of experience in working across markets in Australia, Asia, US, and Europe will support and advance AusBiotech’s vision of being the leading Australian industry body representing and advocating for organisations doing business in and with the global life sciences economy.

Mr Geoffrey Kempler said: “The Australian biotechnology sector is a vibrant and active community that continues to positively impact on global healthcare, having played a role in developing new diagnostics, pharmaceuticals, and life science products.

“The global COVID-19 pandemic has demonstrated the power of healthcare innovation in its response, and the Australian biotechnology industry has been centre stage with its early work in mRNA, rapid diagnostic tests, and prophylactics.

“It’s an incredible opportunity and privilege to lead the next phase of AusBiotech’s maturation.”

Mr Kempler has previously held roles as Chairman and non-executive director of Opthea Limited (ASX: OPT) from December 2015 until October 2020. Opthea is a global healthcare company that specialises in developing novel treatments for chronic eye diseases. Mr Kempler led Opthea’s strategic growth plan leading up to its NASDAQ listing.

Mr Kempler was a founder and leader of Alterity Therapeutics (ASX:ATH) (formerly Prana Biotechnology) for nearly 20 years. Alterity is a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative conditions. Mr Kempler led the company’s commercialisation programme, partnering with the world’s leading clinicians, scientists and patient advocacy groups and was responsible for the company’s listing on both the ASX and NASDAQ. Mr Kempler remains with the company as its Chairman.

Mr Kempler’s substantial experience in investment markets includes a strong domestic and international network of specialist and sophisticated investors.

The announcement was made after Ms Michelle Burke retired as Chair and from the Board of AusBiotech, having completed a nine-year tenure as non-executive director, the maximum possible under the AusBiotech Constitution. Ms Burke has significantly and successfully contributed to the AusBiotech Board, organisation, and industry, and the Board sincerely thanks her for her generous commitment and leadership over the years.

AusBiotech’s CEO & MD, Lorraine Chiroiu, said, “The calibre and generosity of the AusBiotech Board, past and present, is inspiring, and its effectiveness is the result of the acumen, drive and dedication of the individuals on the Board and within the organisation. AusBiotech is an active champion of our sector, and intimately understands the new opportunities ahead of us; I welcome and look forward to working with Geoffrey as we seize these: emerging from the pandemic we will begin implementing the new Biotechnology Blueprint decadal strategy, and launch a refreshed AusBiotech strategy. The future is bright.”

Mr Kempler also sits on the Industry Advisory Board of the Monash Institute of Cognitive and Clinical Neurosciences, bringing together world-class researchers with cutting-edge research infrastructure from a range of disciplines and faculties. Geoffrey is a qualified psychologist and holds a B.Sc. degree in science from Monash University and Grad. Dip. App. Soc. Psych. degree from Swinburne University.

Mr Kempler will be supported by AusBiotech’s Deputy Chair Dr Megan Baldwin, CEO & MD, Opthea Ltd; Lorraine Chiroiu, CEO & MD, AusBiotech; Serg Duchini, Director, AusBiotech; Dr Jan Tennent, Founder & Principal, ConnectBio; Dr Dean Moss, CEO, UniQuest Pty Ltd; Dr Serge Scrofani, Vice President, Strategy & Corporate Development, CSL Ltd; Linda Peterson, COO and Company Secretary, BioCurate; and Dr James Campbell, CEO, Patrys Ltd.

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

About AusBiotech

Decadal Biotech Blueprint opens for sector-wide consultation

Thu, 04 Nov 2021 00:00:00 +1100

AusBiotech is inviting sector-wide feedback after releasing the draft Biotechnology Blueprint: A Decadal Strategy for the Australian Biotechnology Industry – a plan by the industry for the industry.

AusBiotech CEO, Lorraine Chiroiu, said, “AusBiotech is delighted to have led this work, on behalf of the biotechnology industry and acknowledges that the plan is much bigger than one organisation. There has never been a more important or opportune time to plan for the coming decade as an industry and the Blueprint is a shared vision for the biotechnology sector’s future. I invite the whole sector to support this endeavour, as a goal without a (shared) plan is but a wish.”

“We have harnessed this opportunity to put forward a clear and ambitious plan for our industry, contemplating what a vibrant and valuable Australian biotechnology industry could look like over the coming decade, and identifying the steps that should be taken in the near term to ensure that positive future is realised. Through its implementation, we can herald an era of enhanced Australian discovery, translation and innovation.”

For the first time in 20 years, the Biotechnology Blueprint (the Blueprint) presents a shared industry-developed vision for the next decade. The plan includes three goals, each with two sub-goals, which have helped define the substantive strategies, objectives, and ‘drills down’ to specific tactics that will drive and shape the biotechnology industry’s growth through to 2032 and beyond. The Blueprint responds to well-articulated, stubborn issues that the industry has grappled with for years, and presents a solutions-based approach.

AusBiotech seeks feedback on any part of the Blueprint, but has also posed specific consultation questions, regarding:

The scope of the Blueprint: accuracy and appropriateness
Capital and growth: VC, superannuation, tactics to lift commercialisation, international models
Sovereign capability: increasing domestic toxicology capability, manufacturing, talent and skills development.
Metrics and data: importance, appropriateness, and priority
Agricultural biotechnology: suitability of approach
Sustainability: sector-wide sustainability framework (Environmental, Social and Governance framework)
Proof of concept fund: effectiveness, size, and global examples

The draft Blueprint and consultation paper can be found here. To submit feedback on the draft Biotechnology Blueprint, or to request a Word version for tracking, please contact AusBiotech (admin@ausbiotech.org/ 03 9828 1400). Consultation meetings are available on request.

The entire biotech sector is warmly invited to comment by 7 February 2022

TGA approves Telix Pharmaceuticals' Illuccix for prostate cancer

Thu, 04 Nov 2021 00:00:00 +1100

AusBiotech to farewell Chair who has contributed so much for so long

Tue, 02 Nov 2021 00:00:00 +1100

AusBiotech extends its enormous thanks to its Chair, Michelle Burke, as she retires from the board having successfully completed her nine-year tenure as Non-Executive Director, the maximum possible under the AusBiotech Constitution. AusBiotech and the Australian biotechnology sector has benefited enormously from Ms Burke’s years of leadership, generosity, and ongoing commitment to seeing Australian biotech companies flourish through global development.

Over the past nine years Ms Burke has significantly and successfully contributed to the AusBiotech Board, organisation, and industry, having held positions as Chair, Deputy Chair, Chair of Remuneration and Nomination Committee, member of the Risk and Audit Committee.

AusBiotech CEO, Lorraine Chiroiu, said, “The combination of Michelle’s vision, expertise, considered and strategic approach, and dedicated support is rare; she has been an invaluable and inspiring leader and role model to the AusBiotech team and the sector, and will always remain a cherished member of the AusBiotech ‘family’.”

Michelle Burke reflected, “It is a great honour to serve this industry through AusBiotech. Not only have I continued to learn from our amazing membership, I have also had the pleasure of working alongside highly engaged past and present CEOs and Non-executive directors. I hope and intend to continue my strong relationship and association with AusBiotech.”

During her time on the Board, Ms Burke has supported and steered AusBiotech through the appointment of two CEOs, and two Chair changes. Appointed as the AusBiotech Board Chair in February 2020, Michelle’s extraordinary response and support throughout the COVID-19 pandemic, a most difficult period of AusBiotech’s history, has been unparalleled.

Above and beyond her Board duties, Ms Burke has significantly contributed her knowledge and experience; for example she has recently actively participated at roundtables with Federal and State MPs and Government representatives, delivered evidence on behalf of industry at the Parliamentary Inquiry into approval processes for new drugs and novel medical technologies in Australia, presented at AusBiotech national events, and been present from day one of the Biotechnology Blueprint’s development.

AusBiotech will officially farewell Ms Burke at the AusBiotech Virtual AGM on 5 November 2021, where Members will be able to listen to Michelle’s Chair Address and where she will announce the new Chair. AusBiotech members are invited to register by 12.00pm AEDT, 4 November.

Ms Burke is a Non-Executive Director of Cell Therapies Pty Ltd, a member of the Pharmaceutical Benefits Advisory Committee and the Strategic Advisory Group of the Australian Brain Cancer Mission. She also leads Indigo Advisory, an independent advisory consultancy serving companies, academia and government.

Biotron commences two new clinical trials of BIT225

Tue, 02 Nov 2021 00:00:00 +1100

Antisense Therapeutics advances development with capital raise

Tue, 02 Nov 2021 00:00:00 +1100

A goal without a plan is but a wish: Decadal Biotech Blueprint opens for sector-wide consultation

Mon, 01 Nov 2021 00:00:00 +1100

AusBiotech invites sector-wide feedback after releasing the draft Biotechnology Blueprint: A Decadal Strategy for the Australian Biotechnology Industry – a plan by the industry for the industry.

AusBiotech CEO, Lorraine Chiroiu, said, “AusBiotech is delighted to have led this work, on behalf of the biotechnology industry and acknowledges that the plan is much bigger than one organisation. There has never been a more important, or opportune, time to plan for the coming decade as an industry and the Blueprint is a shared vison for the biotechnology sector’s future. I invite the whole sector to support this endeavour, as a goal without a (shared) plan is but a wish.”

AusBiotech seeks feedback on any part of the Blueprint, but has also posed specific consultation questions, regarding:

The scope of the Blueprint: accuracy and appropriateness
Capital and growth: VC, superannuation, tactics to lift commercialisation, international models
Sovereign capability: increasing domestic toxicology capability, manufacturing, talent and skills development.
Metrics and data: importance, appropriateness, and priority
Agricultural biotechnology: suitability of approach
Sustainability: sector-wide sustainability framework (Environmental, Social and Governance framework)
Proof of concept fund: effectiveness, size, and global examples

The entire biotech sector is warmly invited to comment by 7 February 2022. The draft Blueprint and consultation paper can be found at ausbiotech.org. To submit feedback on the draft Biotechnology Blueprint, or to request a Word version for tracking, please contact AusBiotech (admin@ausbiotech.org/ 03 9828 1400). Consultation meetings are available on request.

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

About AusBiotech

AusBiotech to farewell Chair who has contributed so much for so long

Mon, 01 Nov 2021 00:00:00 +1100

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

About AusBiotech

Life sciences’ highest achievers awarded with prestigious Industry Excellence Awards

Thu, 28 Oct 2021 00:00:00 +1100

Australian Company of the Year: SpeeDx
Australian Emerging Company of the Year: oNKo-innate
Industry Leadership Award: David Blake, Editor and Publisher, Bioshares

In recognition of the highest achievers in the Australian life sciences sector, the prestigious Industry Excellence Awards were announced today at the AusBiotech 2021 national conference, during Australia’s biggest week of biotech.

The AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards celebrate life science leaders who are championing the sector throughout Australia and the global community. From researchers who successfully translate their discoveries to clinical practice, to companies who pioneer the developments of new treatments and reliable diagnostics, these illustrious Awards recognise the leading lights of Australia’s world-class biotechnology, medical technology and healthcare sectors.

AusBiotech’s Chief Executive Officer, Lorraine Chiroiu, said: “Congratulations to the recipients of the 2021 AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards, who represent the leading success stories of Australian biotechnology and act as a celebration of the innovation excellence happening across the country. The companies and individuals recognised have made an invaluable contribution to the sector and Australia over the years, are driven by passion for innovation and technical excellence in biotechnology, and demonstrate what can be achieved when vision and commitment unite.”

Ms Kathy Connell, Senior Director Early Innovation Partnering, ANZ, Johnson & Johnson Innovation, who announced the Awards, said: “These inspiring award recipients are undertaking an incredibly important mission, aiming to improve the health of people across the globe. We are delighted to sponsor these awards for the ninth consecutive year, and to help recognise the innovative and outstanding approaches to science and business, and the meaningful contributions these biotechnology leaders have made to the Australian life sciences ecosystem.”

About the 2021 winners

Australian Company of the Year: SpeeDx
Already experiencing strong growth, NSW-based molecular diagnostics company SpeeDx has demonstrated agility throughout the COVID19 pandemic – almost doubling its staff and increasing manufacturing capabilities by over 500 per cent to meet demand for production of COVID-related products, namely tests for detecting the causative agent and/or for genotyping variants of concern.

SpeeDx has pioneered an innovative approach to molecular diagnostics that supports data-driven treatment pathways in key areas of healthcare. The home-grown company, supported by key investors Northpond Ventures and Platinum International Health Care Fund, specialises in diagnostics that offer comprehensive information for improved infectious disease testing, and personalised treatment practices in oncology. SpeeDx sells over 45 products across multiple regions and regulatory jurisdictions based on over 80 patents protected globally. @speedx.

Australian Emerging Company of the Year: oNKo-innate
oNKo-innate (oNKo) is a discovery-stage biotechnology company dedicated to how the immune system might be better harnessed to treat cancer. oNKo aims to be the first to master Natural Killer cell biology and therapeutically harness the cancer-fighting abilities of these remarkable white blood cells. Founded in 2017, oNKo’s capabilities have already received international recognition, and it has formed a partnership in 2020 with two global biopharmaceutical companies, Gilead Sciences Inc and Kite Pharma, to discover novel therapies in immuno-oncology and cell therapy. oNKo also partnered with Monash University, to base its operations within Monash Biomedicine Discovery Institute, Clayton, Victoria.

The Australian company has grown from a humble team of two founders in 2019 to team of 32 scientists in 2021, with even more ambitious plans for expansion over the coming years. As a privately-owned company, it demonstrates a unique model of funding and building an early-stage venture locally through discovery research partnership with global biopharmaceutical companies, it is a true exemplar of a university-industry partnership success. @oNKo_innate.

Industry Leadership Award: David Blake, Editor and Publisher, Bioshares
As Co-Founder, Editor and Publisher of industry publication Bioshares, David Blake has been instrumental in growing and maintaining investors’ knowledge of and confidence in the Australian life sciences sector. Delivering weekly independent investment research, analysis and opinion to stockbrokers, analysts, fund managers, and investors, David has created considerable profile of and value for the Australian life sciences sector and investors.

David’s commitment to seeing the sector flourish is at the heart of his authentic, independent and clear leadership. Through the annual BioShares Investor Conference, a unique, trusted, and comfortable learning space has been created for leaders to network and share experiences, and between the sessions build great friendships and strengthen the social bonds that are central to the fabric of the life sciences sector, adding to the cluster-effect that is essential in driving innovation ecosystems. Blake Industry and Market Analysis Pty Ltd was founded in 1998 by Mark Pachacz and David Blake.

Rhinomed announces details of new trial for Rhinoswab

Thu, 28 Oct 2021 00:00:00 +1100

Life sciences’ highest achievers awarded with prestigious Industry Excellence Awards

Wed, 27 Oct 2021 00:00:00 +1100

Australian Company of the Year: SpeeDx
Australian Emerging Company of the Year: oNKo-innate
Industry Leadership Award: David Blake, Editor and Publisher, Bioshares

About the 2021 winners

Australian Company of the Year: SpeeDx
Already experiencing strong growth, NSW-based molecular diagnostics company SpeeDx has demonstrated agility throughout the COVID19 pandemic – almost doubling its staff and increasing manufacturing capabilities by over 500 per cent to meet demand for production of COVID-related products, namely tests for detecting the causative agent and/or for genotyping variants of concern.
SpeeDx has pioneered an innovative approach to molecular diagnostics that supports data-driven treatment pathways in key areas of healthcare. The home-grown company, supported by key investors Northpond Ventures and Platinum International Health Care Fund, specialises in diagnostics that offer comprehensive information for improved infectious disease testing, and personalised treatment practices in oncology. SpeeDx sells over 45 products across multiple regions and regulatory jurisdictions based on over 80 patents protected globally. @speedx.
Australian Emerging Company of the Year: oNKo-innate
oNKo-innate (oNKo) is a discovery-stage biotechnology company dedicated to how the immune system might be better harnessed to treat cancer. oNKo aims to be the first to master Natural Killer cell biology and therapeutically harness the cancer-fighting abilities of these remarkable white blood cells. Founded in 2017, oNKo’s capabilities have already received international recognition, and it has formed a partnership in 2020 with two global biopharmaceutical companies, Gilead Sciences Inc and Kite Pharma, to discover novel therapies in immuno-oncology and cell therapy. oNKo also partnered with Monash University, to base its operations within Monash Biomedicine Discovery Institute, Clayton, Victoria.
The Australian company has grown from a humble team of two founders in 2019 to a team of 32 scientists in 2021, with even more ambitious plans for expansion over the coming years. As a privately-owned company, it demonstrates a unique model of funding and building an early-stage venture locally through discovery research partnership with global biopharmaceutical companies, it is a true exemplar of a university-industry partnership success. @oNKo_innate.
Industry Leadership Award: David Blake, Editor and Publisher, Bioshares
As Co-Founder, Editor and Publisher of industry publication Bioshares, David Blake has been instrumental in growing and maintaining investors’ knowledge of and confidence in the Australian life sciences sector. Delivering weekly independent investment research, analysis and opinion to stockbrokers, analysts, fund managers, and investors, David has created considerable profile of and value for the Australian life sciences sector and investors.
David’s commitment to seeing the sector flourish is at the heart of his authentic, independent and clear leadership. Through the annual BioShares Investor Conference, a unique, trusted, and comfortable learning space has been created for leaders to network and share experiences, and between the sessions build great friendships and strengthen the social bonds that are central to the fabric of the life sciences sector, adding to the cluster-effect that is essential in driving innovation ecosystems. Blake Industry and Market Analysis Pty Ltd was founded in 1998 by Mark Pachacz and David Blake.

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

About AusBiotech

Event details
AusBiotech 2021
Date: 25 – 29 October 2021
Venue: Online, and on demand
Website: www.ausbiotechnc.org
Programme: www.ausbiotechnc.org/programme

Australia’s premier life sciences conferences celebrate and champion the sector

Tue, 26 Oct 2021 00:00:00 +1100

More than 900 Australian and global life science leaders are uniting virtually this week to celebrate, champion, and further the sector at AusBiotech 2021 and Australia Biotech Invest & Partnering 2021, Australia’s premier life science conferences, commencing 26 October 2021.

Australia’s biggest week in biotech features the events of the year that the sector has known and trusted for over 35 years, and attracts industry leaders, investors, researchers and regulatory and government representatives.

The two conferences will lift the profile of the Australian biotechnology industry, share new and ground-breaking knowledge, connect companies, and create access to greater funding sources for companies to develop world-class science into therapies, diagnostics and medical devices.

AusBiotech 2021’s programme has been developed by industry for industry; online and on demand, the five days are packed with more than 100 inspiring thought leaders from across 25 countries, in almost 30 sessions. Delegates will be engaging, their way, as they pitch, partner, exchange ideas and remain engaged with our national and international biotech community.

Keynote speakers bringing their expertise to AusBiotech 2021 include:

Dr Barney Graham, Former Deputy Director of the US NIAID Vaccine Research Center, one of the ‘brains trust’ behind the design of Moderna’s COVID-19 vaccine, voted one of the world’s most influential individuals of 2021 by Time Magazine, and a multi award-winning US immunologist, virologist, and clinical trials physician;
Dr Paul Stoffels, Executive Vice President, Chief Scientific Officer, Johnson & Johnson;
Millis Oration keynote Professor Sharon Lewin, Director, Doherty Institute;
Howard Sachs, Siemens Pharmaceutical Vertical Manager, Siemens Ltd;
Dr Niels Emmerich, Vice President and Global Head of Technology Search & Evaluation, AbbVie Inc;
Professor Philip Hugenholtz, Co-Founder, Microba; and
Dr Victoria Gordon, Managing Director and CEO, QBiotics Group.

The AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards 2021 will recognise and celebrate life science leaders who are championing the sector and the Australian community, returning to the categories: Industry Leadership, Company of the Year and Emerging Company of the Year.

The ‘foundation stones’ for Australia’s regenerative medicine (RM) future will be completed with the launch of three resources offering new knowledge and benchmarking, purpose, and a firm, unified direction for the industry’s future. Join the Catalysing regenerative medicine in Australia panel discussion as industry leaders offer extensive insights and experience on the breadth of opportunity present in the Australian RM sector.

AusBiotech’s Biotechnology Blueprint, the sector’s decadal framework, will be launched and sector-wide feedback sought. The strategy charts an ambitious pathway to how the biotech industry can help solve problems and generate the long-term economic growth and social capital that will be needed as we emerge from the current pandemic

For fourth consecutive year, the national conference will feature the Early-Stage Investment Forum, featuring quick-pitch presentations on early-stage technologies and projects. Offering each presenter feedback which is critical for commercialisation, the expert investor panel will include international big pharma representatives as well as corporate VCs and early-stage investors.

Engaging capital with innovation, Australia Biotech Invest & Partnering 2021 is taking place on Tuesday 26 October and remains the preeminent opportunity for companies to present their technology and story to a network of potential international partners and investors. The full-day programme features five keynote speakers and over 20 public and private companies, showcasing the potential of life sciences.

The Hon. Tim Pallas MP, Treasurer, Victorian Government, will join Lorraine Chiroiu, CEO, AusBiotech to open the conference, before keynotes, company pitches, and Q&A sessions with experienced investors take to the virtual stage.

Australia Biotech Invest & Partnering 2021 keynote speakers include:

William F. McKeon, President & CEO, Texas Medical Center (USA);
Stacy Feld, Head, Johnson & Johnson Innovation, West North America, Australia & New Zealand (USA);
Victor Windeyer, Portfolio Manager, Australian Unity Future of Healthcare Fund;
Kate Galpin, Business Development Manager, Listings, ASX Limited; and
David Weir, CEO and Co-Founder, Radium Capital.

AusBiotech 2021 and Australia Biotech Invest & Partnering 2021 are proudly supported by their Host State Partner, the Victorian Government.

Registrations remain open, and the programmes are available on demand throughout November.

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

About AusBiotech

Final ‘foundation stones’ set for future of Australian regenerative medicine

Tue, 26 Oct 2021 00:00:00 +1100

The ‘foundation stones’ for Australia’s regenerative medicine (RM) future are now complete, with the publication of three resources offering new knowledge and benchmarking, purpose, and a firm, unified direction for the industry’s future.

Benchmarking the investment in the sector in Australia in 2019 and 2020, Australia’s Regenerative Medicine Investments Database reveals the extent of private funding and active interest that has been invested into the sector. Investment increased by 113 per cent between 2019 and 2020, and with $394.1 million invested into RM in 2020, this accounts for approximately 23 per cent of the overall capital invested into the Australian biotech sector. In addition, a group of four industry case studies demonstrates the breadth of cell and gene technology development present in Australia and its potential for addressing and managing patients’ unmet needs; and the Strategic Roadmap for the Regenerative Medicine Sector is charting the way ahead with priorities identified to support the sector’s growth.

The Regenerative Medicine Consortium has delivered the final ‘capstones’ in its 12-month project, which collectively demonstrate the breadth of opportunity present in the Australian RM sector.

New resource: Strategic Roadmap for the Regenerative Medicine Sector

To support Australian patients accessing world-class RM therapies that are sustained by a thriving Australian RM industry, a strategic roadmap for the Australian RM sector has been released.

The first strategy of its kind, it seeks to create an end-to-end world-class value chain that can discover, develop, and distribute RM, while creating jobs, commercialising research, exporting Australian therapies to the world, and attracting global therapies for Australian patients.

The roadmap articulates the objectives and priority actions, backed by a detailed discussion of the key barriers facing the RM sector. The five key strategic goals include: capabilities/workforce; collaboration; funding; regulation and policy; and infrastructure.

Developing and sustaining the necessary capacity and capability requires a coordinated approach across the public and private sectors, and the uniqueness of RM in both opportunity and in challenges is why Australia requires a unified, catalyst body led by industry and supported by governments championing the cause. As such, Australia’s new Cell and Gene Therapy Catalyst, co-led by AusBiotech and Medicines Australia, is committed to implementing this new strategy.

Included within the Strategic Roadmap is a sub-report that further investigates the skills and talent specific to the sector, and forms a plan to attract long term investment in the sector and the role of Australian biotech companies partnering with global companies.

Download the Strategic Roadmap for the Regenerative Medicine Sector here.

New resource: Australia’s Regenerative Medicine Investments Database

Investment in Australian RM companies grew with a 113 per cent increase in private funding over the period between 2019 and 2020, reveals the newly-published Australia’s Regenerative Medicine Investments Database report. With $394.1 million invested into RM in 2020, this accounts for approximately 23 per cent of the overall capital invested into the Australian biotech sector in 2020.

As a burgeoning sector working in a global environment, the report quantifies Australia’s position and reveals that while the country holds just 0.32 per cent of the global population, in 2020 it accounted for 1.5 percent of global RM investment (AU$26.3B in 2020).

The report breaks down the types of financing and shows that, compared with global norms, Australia is highly dependent (2020: 94 per cent, $371 million) on placements as a form of raising capital. This reveals the importance of institutional investors to the current Australian RM sector, and that Australian RM companies have little access to venture capital funding.

Continued investment pattern tracking for the sector will be important in understanding and supporting the growth of the Australian RM sector.

Download the Australia’s Regenerative Medicine Investments Database here.

New resource: Four Case Studies: Cell, Gene, Gene Modified Cell and Tissue Engineered Products

Four case studies demonstrating a depth of information on cell and gene technology development and their potential for addressing and managing unmet needs, has been released.

RM is a multidisciplinary field that seeks to develop the science and tools that can help repair, augment, replace, or regenerate damaged or diseased human cells, tissues, genes, organs, or metabolic processes, to restore normal function. It is a complex field addressing complex conditions, and the case studies are an important tool for increasing understanding of the science and the opportunities available.

The four case studies each focus on a different aspect of cell and gene technology: Cell therapy (Mesoblast), Gene therapy (Pfizer), Gene Modified Cell (Novartis) and Tissue Engineered Products (Orthocell).

The plain English report reveals the array of real-world applications for RM: a freak fall while mountain biking with friends in the Perth hills resulted in C6 quadriplegia; mild lymphoma that transformed into large B-cell lymphoma, a much more aggressive cancer that can be fatal within months if left untreated; a man’s 10 and three-year-old sons who were diagnosed with Duchenne muscular dystrophy – a rare disease occurring primarily in boys that typically results in losing the ability to walk when they reach eight to 12 years of age; and patients that prove unresponsive to corticosteroids when treating acute graft-versus-host-disease.

Read the Case Studies here.

The three new knowledge and resources for RM add to the resources previously released:

About the RM Consortium Project

The RM Consortium’s seven partners hold extensive insight and experience in the life science and regenerative medicines landscape in Australia. Led by AusBiotech, partners include Medicines Australia, Cell Therapies Pty Ltd, Novartis Australia and New Zealand, Biointelect Pty Ltd, Research Strategies Australia, and MTPConnect.

The RM Consortium has received matched funding through MTPConnect’s Growth Centre Project Fund Program, an Australian Government initiative supported by the Department of Industry, Science, Energy and Resources. It is a competitive matched funding program that aims to invest in ideas to boost the innovation, productivity and competitiveness of Australia’s MTP sector.

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

About AusBiotech
AusBiotech is Australia’s biotechnology organisation, working on behalf of members for more than 35 years to provide representation and services to promote the global growth of Australian biotechnology. AusBiotech is a well-connected network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), and agricultural biotechnology sectors.

About Biointelect
Biointelect provides a range of services for biopharmaceutical and medical device companies streamlining path to market to support the commercialisation of new technologies across the globe. Biointelect operates across the entire product development pathway with expertise and services including commercialisation of early-stage technologies, strategic R&D project management, health policy and industry engagement, as well as supporting clients growth strategies, including new product planning, regulatory, clinical and market access strategies.

About Cell Therapies Pty Ltd
Cell Therapies Pty Ltd is an Australian-based, globally-active commercial contract development and manufacturing company, specialising in cell therapy, gene therapy, regenerative medicine, and cellular immunotherapy products. A leader in this groundbreaking field, our expert team and world-class facilities have been developing and manufacturing cutting edge treatments for cancer and rare diseases on behalf of local and international clients for more than 15 years.

About Medicines Australia
Medicines Australia represents the discovery‐driven pharmaceutical industry in Australia. Our member companies invent, manufacture and supply innovative medicines and vaccines to the Australian community, which keeps Australians out of hospitals, prevents disease and play a pivotal role in ensuring a productive and healthy community. Medicines Australia’s mission is to drive the creation and development of a predictable environment for the continued, sustainable growth of the innovative and researchbased prescription medicines industry.

About MTPConnect
Established by the Federal Government in 2015 as an independent, not-for-profit organisation, MTPConnect is Australia’s Medical Technologies and Pharmaceuticals (MTP) Industry Growth Centre, championing the growth of Australia’s vibrant MTP ecosystem.

About Novartis Australia and New Zealand
Novartis is the largest Australian medicines company improving the lives of more than 2.8 million patients across Australia and New Zealand. From generics to gene therapy, we are committed to accelerating patient access to life saving treatments. We are reimagining medicine by using innovative science and technology to address challenging healthcare issues and our rich pipeline has 200+ projects in development and an industry leading clinical trial footprint in Australia. Our unbossed, curious and inspired culture unites our 700 employees, it is what unleashes the power of our people and is at the heart of the work we do each day.

About Research Strategies Australia
Research Strategies Australia is a consulting firm with the mission of maximising the benefits of publicly funded research. We work with government, universities non-profits and the private sector to plan, manage and monitor research investments.

Australia’s biggest week in biotech begins

Tue, 26 Oct 2021 00:00:00 +1100

The AusBiotech 2021 programme has been developed by industry for industry; online and on demand, the five days are packed with more than 100 inspiring thought leaders from across 25 countries, in almost 30 sessions. Delegates will be engaging, their way, as they pitch, partner, exchange ideas and remain engaged with our national and international biotech community.

Australia Biotech Invest & Partnering 2021 remains the preeminent opportunity for companies to present their technology and story to a network of potential international partners and investors. The full-day programme features five keynote speakers and over 20 public and private companies, showcasing the potential of life sciences.

The ‘foundation stones’ for Australia’s regenerative medicine (RM) future will be complete, with the publication of three resources offering new knowledge and benchmarking, purpose, and a firm, unified direction for the industry’s future, during the AusBiotech 2021 Catalysing regenerative medicine in Australia panel discussion today.

Benchmarking the investment in the sector in Australia in 2019 and 2020, Australia’s Regenerative Medicine Investments Database reveals the extent of private funding and active interest that has been invested into the sector. Investment increased by 113 per cent between 2019 and 2020, and with $394.1 million invested into RM in 2020, this accounts for approximately 23 per cent of the overall capital invested into the Australian biotech sector. The group of four case studies demonstrates the breadth of cell and gene technology development present in Australia and its potential for addressing and managing patients’ unmet needs; and the Strategic Roadmap for the Regenerative Medicine Sector is charting the way ahead with priorities identified to support the sector’s growth.

The Regenerative Medicine Consortium will deliver the final ‘capstones’ in its 12-month project, and collectively, these demonstrate the breadth of opportunity present in the Australian RM sector.

AusBiotech 2021 and Australia Biotech Invest & Partnering 2021 are proudly supported by their Host State Partner, the Victorian Government.

Registrations remain open, and the programmes are available on demand throughout November.

Chimeric Therapeutics achieves manufacturing milestone for CAR-T

Tue, 26 Oct 2021 00:00:00 +1100

Noxopharm announces patents and launch of new trial

Tue, 26 Oct 2021 00:00:00 +1100

Proposal to amend definitions of GM for food classifications

Thu, 21 Oct 2021 00:00:00 +1100

Food Standards Australia New Zealand is calling for feedback on its proposal to amend the definitions for gene technology and new breeding techniques, for clarity and to accommodate food produced by existing, emerging and future genetic technologies.

New definitions for 'food produced using gene technology' and 'gene technology' have not yet been developed, and changes will be informed by the first of two rounds of consultation. The first round is currently open.

The definitions in the Australia New Zealand Food Standards Code (the Code) determine what foods are classed as genetically modified (GM) food. Currently, all GM food available for sale in Australia and New Zealand must have been assessed for safety by Food Standards Australia New Zealand and be permitted and listed in the Code.

This proposed definition changes are in response to Food Standards Australia New Zealand’s 2020 Review of food derived using new breeding techniques.

Consultation for round one will close on 3 December 2021. Read more and submit your views here.

Hearing company Hemideina completes successful capital raise

Thu, 21 Oct 2021 00:00:00 +1100

Australian businesses invited to advance the future of healthcare technologies in Medtronic challenge

Thu, 21 Oct 2021 00:00:00 +1100

Voluntary standardised IP framework supported

Tue, 19 Oct 2021 00:00:00 +1100

A newly-proposed standardised IP Framework is a long-supported idea, but should be voluntary, recommended a joint submission by Research Australia, AusBiotech, Medicines Australia and MTAA to the Department of Education, Skills and Employment’s recent consultation.

Seeking to incentivise and increase partnerships between companies and universities, the Department released a sector-agnostic consultation paper: the Higher Education Research Commercialisation (HERC) IP Framework.

The aim of the framework is to “provide standardised IP licensing and contractual agreements to establish a strong foundation for negotiating and managing successful university-industry collaboration and partnerships.” IP includes rights such as patents, designs, trade marks, plant breeder’s rights and copyright, as well as trade secrets.

In its joint submission, the peak industry bodies that represent a significant proportion of the health R&D sector agrees that an IP Framework is a good idea, however, proposed that rather than making it mandatory, it should be made available without restriction for all entities to use from the date of its release.

If mandatory, the Framework has the very real potential to stifle innovation in Australia, both in the types of commercial agreements that can be reached and even in the format the contracts can take. It will also make it more difficult to adapt the Framework to accommodate new innovation and approaches in IP Framework development, commercial negotiation, dispute resolution and contract execution.

Despite the intention to the contrary, mandatory contracts may well deter some large businesses and SMEs. Where one of the parties is an international organisation, there may be a preference to adopt an international jurisdiction for the agreement. Large and multinational companies are also likely to have their own global standard agreements and terms they prefer to use, particularly for lower value investments and transactions. These factors will prevent engagement between universities and businesses in some circumstances.

A formal pilot of the new IP Framework was recommended, including collecting performance metrics during its first few years to support its continuous improvement.

The peak industry bodies welcome working with the Department on the further development and implementation of this pilot, and – given the technology-agnostic nature of the consultation – strongly encouraged the Department first organise a series of sector-specific workshops to explore the unique issues faced by a standardised IP Framework.

Read the joint submission here.

Microbio moves to Brisbane’s Translational Research Institute

Tue, 19 Oct 2021 00:00:00 +1100

Late-stage trial for Dimerix's investigative COVID-19 treatment

Tue, 19 Oct 2021 00:00:00 +1100

Bright ideas sought to keep our country disease and pest free

Thu, 14 Oct 2021 00:00:00 +1100

Bright ideas are wanted as the Biosecurity Innovation Program opens its expressions of interest, and seeks innovative technologies and approaches to keep Australia disease and pest free.

Now in its fourth year, the Federal Government’s $5.6 million annual programme is seeking bright ideas on diagnostics, screening and surveillance, automation, data and intelligence, risk analysis, and communication and collaboration, to enhance the capacity of our national biosecurity system.

The programme is open to industry, including start-ups, innovators, research institutes, and the Australian community, and industry.

“Australia exports food, fibre and forestry products to markets all over the world, but our ability to reach these markets hinges on our country remaining disease and pest free,” said Minister David Littleproud, Minister for Agriculture and Northern Australia.

Technologies previously invested in include: developing a risk assessment model for avian influenza; DNA testing in cows to address anti microbial resistance; high-throughput sequencing to expand our diagnostic capability and deliver faster, more accurate results for plant viruses; and implementation of human health reporting digitisation and mobile passport reader projects in Australian airports.

Submit your idea to the Department of Agriculture, Water and the Environment by 3 December 2021.

IDT announces deal with Monash to produce mRNA vaccine for trial

Thu, 14 Oct 2021 00:00:00 +1100

CV-19 vaccine designer joins AusBiotech 2021 line-up

Tue, 12 Oct 2021 00:00:00 +1100

In less than two weeks, global keynote Dr Barney Graham will join Australia’s biggest week in biotech to share his lessons learnt during the COVID-19 pandemic and offer insights on the future of vaccinology.

One of the ‘brains trust’ behind the design of Moderna’s COVID-19 vaccine, voted one of the world’s most influential individuals of 2021 by Time Magazine, and a multi award-winning US immunologist, virologist, and clinical trials physician, Dr Graham is the Former Deputy Director of the US NIAID Vaccine Research Center and a global thought leader on emerging viral diseases and pandemic preparedness.

Hosting a keynote of Dr Graham’s calibre demonstrates the importance and profile of Australian life sciences within our global ecosystem, and how the AusBiotech 2021 national conference provides a platform for learning and networking as we continue to celebrate our industry and champion advocacy in our mission to facilitate the global growth of our industry.

Dr Barney Graham is one of more than 100 national and international thought leaders delivering almost 30 sessions across five days at AusBiotech 2021, Australia's premier life sciences conference.

AusBiotech 2021 keynote speakers include:

Dr Paul Stoffels, Executive Vice President, Chief Scientific officer, Johnson & Johnson: Past, Present and Future – a 10 year retrospective of Johnson & Johnson Innovation in Australia and a view to the next 10 years;
Millis Oration keynote Professor Sharon Lewin AO, The Peter Doherty Institute for Infection and Immunity: HIV to COVID-19: what history has taught us about our response to pandemics;
Howard Sachs, Siemens Ltd: Pharma 4.0: fast tracking discovery through to commercialisation;
Dr Niels Emmerich, Vice President and Global Head of Technology Search & Evaluation, AbbVie Inc: Current pharma models for accessing novel technologies: opportunities and challenges for biotechs and universities;
Professor Philip Hugenholtz, Co-Founder, Microba: The human health and microbiome connection – advances in methods to controlling human health and disease;
Dr Victoria Gordon, Managing Director and CEO, QBiotics: Changing the pace: Raising capital to accelerate programmes.

AusBiotech 2021 is dedicated to consolidating the sector’s growth, and the conference will once again present issues critical to industry; engage our strong network through the one-to-one business matching programme, an ‘Engage Hub’ to meet potential partners, and informal networking lounges; celebrate our life science leaders through the AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards 2021; and connect innovation with capital, with delegates also receiving access to Australia’s preeminent life science investment event Australia Biotech Invest & Partnering 2021.

The annual event brings together Australian and international biotech leaders and stakeholders. For more than three decades the national event has created a forum to reflect on the sector’s achievements and exchange ideas to further advance the sector’s standing both nationally and globally.

Secure your registration now and save up to $150; Late Registration rates begin on 14 October 2021.

Pitch, partner, engage and exchange - no matter where you are, as we unite to celebrate and champion Australia’s life sciences sector. AusBiotech 2021 is proudly sponsored by the Victorian Government.

NSW's first trade statement aims to double exports by 2031

Thu, 07 Oct 2021 00:00:00 +1100

The NSW Government has released its inaugural NSW Trade Statement, seeking to double exports to $200 billion by 2031, create more jobs, and support the State’s economic recovery. In order to reach its ambitious goals, 10 priority sectors have been identified, including health, biotech and medtech.

NSW Government currently values its exports at $96 billion, making up 15 percent of its overall economy and supporting one in five jobs across Australia. Its first milestone of reaching $130 billion in exports is anticipated to be reached by 2024.

Strategies to support the growth and outlined in the NSW Trade Statement include:

Helping SMEs to compete internationally
Harnessing NSW’s competitive advantages
Facilitating new export growth opportunities
Promoting NSW as a world-leading knowledge opportunity, including funding R&D and clinical trials to “turbocharge" industry commercialisation, and
Strengthening international partnerships at all levels.

Work is already underway on achieving the targets, with the establishment of the NSW Trade and Industry Advisory Committee (TIAC) earlier this year. The TIAC has been formed to support NSW as it seeks to harness its competitive advantages, and the group delivers expert advice to the Government on effectively managing the evolving global trade industry, including current trends and emerging export growth opportunities.

AusBiotech CEO Lorraine Chiroiu, who was appointed to the NSW TIAC earlier this year, said, “AusBiotech looks forward to supporting and promoting strategic initiatives and actions to bolster the industry. We were pleased to partner with NSW earlier this year, and to profile the State as an important pillar in our strong ‘Team Australia’ delegation at BIO Digital 2021. Local capabilities were proudly showcased, and global connections fostered, and we look forward to continuing to unite on this important mission.”

Read the NSW Trade Statement 2021 here.

Global Pipeline Tracker provides view of global pipeline and possible cell and gene therapies for Australia

Tue, 05 Oct 2021 00:00:00 +1100

The globe is anticipating an avalanche of new and novel regenerative medicine (RM) treatments, reveals Australia’s Regenerative Medicine Global Pipeline Tracker, and Australia may share in access to some.

The inaugural report, released by the Regenerative Medicine Catalyst Project Consortium, horizon-scanned the global pipeline of products in this emerging field of medicine, and postulates which might come to Australia for patient access.

While there are currently six RM therapies already approved in Australia [1], the new data shows a rich pipeline with 140 therapies in late-stage development globally in multiple therapeutic areas, and up to nine may reach Australian patients in the next five years.

The growth seen in RM is driven by an increasing prevalence of chronic diseases, genetic disorders, and cancer, coupled with increasing investments and collaboration with the medical research sector to develop therapies that will treat a variety of diseases across multiple therapeutic areas.

Analysis of the global pipeline includes therapies that are already registered overseas as well as those that are likely to get to market through global clinical development pipelines, and subsequently to the Australian market.

The cell and gene therapies (CGT) pipeline comprises cell therapies, gene therapies, and gene-modified cell therapies, and the Global Pipeline Tracker discovered that around 70 percent of products in this pipeline are in phase III of development, 11 percent of products are already undergoing regulatory review (mostly in major developed markets, such as the US and EU), and that Phase II/III accounted for 16 percent of the pipeline.

The analysis of CGT products, looks at the pipeline and determines those most likely to enter the Australian market in the next five years and the timelines for entry. Likelihood to enter the Australian market was based on estimates of the likelihood of approval, companies’ current presence in Australia and clinical trials of the product in Australia. Timelines for entry were based on RM approved products average timings of phase III completion, phase III to regulatory filing, filing to approval and average approval gap US vs Australia.

Based on these estimates the following products were considered to be the most likely to enter the Australian market:

Cell Therapy: StrataGraft® (Mallinckrodt Plc) and RVT-802 (Enzyvant Sciences Ltd) in 2023; Omidubicel (Gamida Cell Ltd) and Stapuldencel-T (Sotio AS) in 2024;
Gene Therapy: Vutrisiran (Alnylam Pharmaceuticals Inc) in 2023; Fitusiran (Sanofi) and Etranacogene dezaparvovec (UniQure NV) in 2025; and
Gene Modified Cell Therapy: Lisocabtagene maraleucel (Juno Therapeutics Inc) in 2023; Ciltacabtagene autoleucel (Legend Biotech Corp) in 2024.

Tissue engineered products make up 43 of the 140 products in development globally, and are typically approved through a medical device regulatory pathway. Musculoskeletal disorders are the leading therapy area for these products, followed by dermatology and cardiovascular diseases.

The future of RM is bright: given the quantity of early-stage clinical trials already underway it is expected that the number of late-stage pipeline products will also continue to rise, ultimately meaning that even more RM treatments are expected to be approved in the future. The opportunity of regenerative medicine technology is being recognised and with a greater number of smaller biotech companies entering into this space, even more options will become available. As the RM market becomes more established, both small biotech companies and multinational pharma firms are seeking to get a larger share of the market, and so are entering into strategic alliances or acquiring small- to mid-size players or products.

Download the Australia’s Regenerative Medicine Global Pipeline Tracker report here.

About the RM Catalyst Project

The RM Catalyst’s seven partners hold extensive insight and experience in the life science and regenerative medicines landscape in Australia. Led by AusBiotech, partners include Medicines Australia, Cell Therapies Pty Ltd, Novartis Australia and New Zealand, Biointelect Pty Ltd, Research Strategies Australia, and MTPConnect.

The RM Catalyst has received matched funding through MTPConnect’s Growth Centre Project Fund Program, an Australian Government initiative supported by the Department of Industry, Science, Energy and Resources. It is a competitive matched funding program that aims to invest in ideas to boost the innovation, productivity and competitiveness of Australia’s MTP sector.

The project is developing nine reports to create the foundations for an RM future for Australia, these include:

The comprehensive Regenerative Medicine Value Chain report considers the chain of activities involved in RM therapy development;
Australia’s Regenerative Medicine Clinical Trials Database benchmarks Australia’s clinical trials and captures the portion in RM, and seeks to categorise them into type and phase;
Australia’s Regenerative Medicine Manufacturing Capacity & Capability provides a new evidence base and model against which to map, build and strengthen our sovereign GMP manufacturing position over time; and
Australia’s Regenerative Medicine Catalyst Body Funding & Model Structure provides a recommendation for a funding and model structure for the Regenerative Medicine (RM) sector ‘catalyst’ collaboration body, with a scope that includes industry as a key component within a broader sector.

Read the other reports and more about the Regenerative Medicine Catalyst Project here.

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

[1] Australia’s Regenerative Medicine Clinical Trials Database, August 2021.

Standardised agreements proposed to support commercialisation

Thu, 30 Sep 2021 00:00:00 +1000

AusBiotech seeks Member feedback on the proposed standardised commercialisation agreements outlined in the Department of Education, Skills and Employment’s sector-agnostic consultation paper seeking to incentivise and increase partnerships between companies and universities.

The Higher Education Research Commercialisation (HERC) IP Framework will “provide standardised IP licensing and contractual agreements to establish a strong foundation for negotiating and managing successful university-industry collaboration and partnerships.” IP includes rights such as patents, designs, trade marks, plant breeder’s rights and copyright, as well as trade secrets.

AusBiotech’s CEO Lorraine Chiroiu notes “AusBiotech remains strongly supportive of greater industry-university collaboration, however, the mechanisms in which we offer this needs to be considered in the broader innovation ecosystem, and co-supported with commercialisation skills development.

“Our previous submission into April 2021’s University Research Commercialisation consultation encouraged the development of a broader ‘commercialisation toolkit’, which included an IP toolkit to support efficiencies in reaching an agreement. However, these commercialisation agreements must be optional to best support researchers through the development process.

“Strong and effective partnerships between Australian universities and industry are the foundations for a robust biotechnology industry that works ‘hand in glove’ with Australia’s research sector. We are renown for ‘punching above our weight’ in biotech research, however, in order for local and multi-national companies to partner with Australia’s early-stage technologies, flexibility in mutual agreements must be retained in order to foster and encourage enduring collaboration-to-commercialisation partnerships.

“A lack of resources and a comprehensive understanding about the commercialisation process within many Australian universities has also contributed Australia’s commercialisation weakness and so AusBiotech recommends that the optional standardised agreements are paired with additional tech-transfer office resourcing to improve commercialisation performance and to deliver greater economic and social benefits.”

Download the Department’s consultation paper here.

Feedback is being sought on the Framework’s scope, target audiences, tools, and implementation, and AusBiotech members are encouraged to submit their feedback to Lorraine Chiroiu by COB Wednesday 13 October 2021.

Submissions on the HREC IP Framework consultation paper close at 10.00 am AEST 18 October 2021.

EOI sought for new Cell and Gene Catalyst

Tue, 28 Sep 2021 00:00:00 +1000

A new Cell and Gene Catalyst (the Catalyst) is being established to capitalise on the opportunities that the burgeoning cell and gene sector can deliver to the Australian economy and society, and co-leads AusBiotech and Medicines Australia are seeking expressions of interest from industry partners interested in contributing to and supporting it.

The two national peak industry bodies are seeking:

Financial contributors willing to provide funding support to the Catalyst to enable the expansion of work, including the employment of a General Manager over a two-year period;
In-kind contributors willing to contribute to the Catalyst (i.e. advice, personnel, assistance in organising, minute-taking, scientific advice); and
Other parties interested in participating in or staying informed on the activities of the Catalyst.

Leveraging the exceptional foundational work over the past 12 months that has cemented and benchmarked Australia on the global RM map, it is envisaged that the Catalyst will guide the vision and strategy of the new body, advance regenerative medicines policy, mobilise resources, build community engagement, establish shared measurement practices and support aligned activities.

The Catalyst’s ambition is to bring a dedicated General Manager on-board to drive its work and ensure meaningful outcomes are delivered over the next two years. Significant financial contributors will have the opportunity to join an oversight body and to be involved in the Catalyst's development.

Financial and in-kind contributors are sought to support this important industry-led work that will be guided by its goals of increasing access to life-changing RM therapies through greater reimbursement and/or registration in the Australian health landscape. The Catalyst will focus on the process from the point of translation onwards, while aiming to cover the entire value chain, from discovery through to patients.

The Cell and Gene Catalyst will build on and progress the work that has been developed over the past 12 months through the Regenerative Medicine Catalyst Project. AusBiotech has been leading the fixed-term project to 'deep-dive' into the RM sector, which sought to identify and establish a national RM sector ‘catalyst’ collaboration body, and address priority action areas including: workforce capabilities, collaboration, funding, regulation and policy infrastructure, and Australian manufacturing capability. Read more about the project and its major reports here.

Interested partners are warmly invited to contact Karen Parr, Director, Communications, AusBiotech for an exploratory discussion or to express their interest by 1 October 2021.

Indian regulator approves study of Dimerix's DMX-200 in COVID-19

Tue, 28 Sep 2021 00:00:00 +1000

Cynata Therapeutics announces publication of new paper

Tue, 28 Sep 2021 00:00:00 +1000

Manufacturing opportunities in cell and gene therapies highlighted in Inquiry submission

Thu, 23 Sep 2021 00:00:00 +1000

Responding to the Economics References Committee’s Inquiry into the Australian Manufacturing Industry Australia’s opportunity to harness the important and emerging cell and gene therapies, or regenerative medicines (RM), sector was promoted through the joint submission of AusBiotech, Cell Therapies Ltd, Research Strategies Australia, and MTPConnect.

The submission highlighted that whilst complex and nuanced, unique cell and gene therapies have the potential to reduce the burden of disease significantly, leading to better health outcomes for Australians, higher participation rates in the workforce, and to impact the economy on a large scale.

The Senate Inquiry is considering the Australian manufacturing industry; specific regard includes: current and future economic growth drivers, capacity, national resilience, new areas Australia can establish itself as a global leader, and the role that government can play in assisting our domestic manufacturing industry, including R&D, attracting investment, supply chain support, government procurement, trade policy, and skills and training.

Commercially-scaled resources will also build new export markets and deflect the prevailing trend of establishing advanced manufacturing in lower-cost markets. By leveraging Australia’s reputation for delivering high-quality, complex, and safe medical products, as well as our highly-skilled workforce, we can become the manufacturing hub for the region and deliver potentially life-changing treatments to patients, both in Australia, and the broader Asia Pacific region.

The joint submission utilised insights from and promoted the work of the AusBiotech-led Consortium project that has been developing resources to build the foundations of RM in Australia.

The Senate referred the matter of the Australian manufacturing industry to the Economics References Committee for inquiry and report by 24 November 2021.

Read AusBiotech’s joint submission here.

Japanese patent for Imugene's HER-Vaxx immunotherapy

Thu, 23 Sep 2021 00:00:00 +1000

New research shows drug repurposing is no 'quick-fix' in race to treat COVID-19

Thu, 23 Sep 2021 00:00:00 +1000

Feedback sought on Review of the National Medicines Policy

Tue, 21 Sep 2021 00:00:00 +1000

AusBiotech is seeking member feedback as it responds to the Department of Health’s Review of the National Medicines Policy (NMP).

This Review will support a refresh of the NMP as a high-level policy framework, rather than reviewing the activities and programmes aimed at delivering the policy, to ensure that the changes in the health system environment are addressed, and where applicable, the policy updated to take account of these changes. It aims to deliver positive health outcomes for all Australians through their access to, and appropriate use of, medicines.

AusBiotech members are invited to share their views and discuss the Review in an informal zoom conversation with AusBiotech CEO Lorraine Chiroiu at 3.00 pm, Tuesday 28 September.

Commissioned by the Minister for Health, the Hon. Greg Hunt MP, the review is in recognition of the substantial changes to the health landscape since the policy was published in 2000, including expanding innovation technologies, improved health outcomes, digital transformations, and a more coordinated patient voice.

The terms of reference include:

evaluation of the current NMP objectives and determining whether these should be modified or additional objectives included;
considering the definition of medicines and whether the NMP needs to be expanded to include health technologies;
assessing the NMP’s utility in the context of rapidly evolving treatments options, population changes, interconnected relationships and system-wide capacities;
identifying options to improve the NMP’s governance; communications, implementation (including enablers) and evaluation;
reviewing the NMP partners and provide options for building greater accountability including addressing conflicts of interest.

Read the Department of Health’s discussion paper.

The consultation closes on Friday 8 October 2021; AusBiotech members are invited to RSVP for the informal zoom with Lorraine Chiroiu here.

Certa Therapeutics announces new clinical trial of investigative candidate

Tue, 21 Sep 2021 00:00:00 +1000

Bionomics expands clinical trial plan for BNC210

Tue, 21 Sep 2021 00:00:00 +1000

Email re: 'AusBiotech 2021 lists'

Mon, 20 Sep 2021 00:00:00 +1000

It has come to our attention that a company is seeking to sell a contact list that is titled with AusBiotech’s name - in an unapproved manner. We wish to advise that this activity is not associated with AusBiotech in any way, and that our database remains secure. We cannot verify the quality of the list and note that proceeds are not being returned to support the industry.

Please see below for an example. Many different marketing executives’ names and domains are seeking to sell exactly the same product and we believe this is emanating from the same source.

AusBiotech does not share (or sell) the contact details of event attendees and maintains privacy of information according to its privacy policy (https://www.ausbiotech.org/privacy-policy).

Kind regards

Lorraine Chiroiu
Chief Executive Officer
AusBiotech Ltd

___________________________________________________________

Hi,

I am following up to confirm if you ([your company name]) are interested in acquiring the Visitors/Registrants List.

AusBiotech
25 - 29 Oct 2021
Melbourne, Australia
Registrants Counts:3,000+

Each record of the list contains: Contact Name, Email Address, Company Name, URL/Website, Phone No, Title/Designation.

Currently the best way to grow your business is through digital. This list will help you pass information about your organization and products directly and digitally to the buyer. This list will help you to acquire many potential clients / leads.

If you are interested in acquiring the list, we can provide you the cost and additional details.

I look forward to hearing from you.

Thanks & Regards,

Shawn - Business Analyst

COVID-19 vaccine patent waiver will not speed up global vaccination say AusBiotech and Medicines Australia

Thu, 16 Sep 2021 00:00:00 +1000

AusBiotech and Medicines Australia released a joint statement urging the Australian Government to not support a proposed patent waiver for COVID-19 vaccines and therapies, as it will not help global vaccination.

The proposed patent waiver at the World Trade Organization (WTO), also known as the TRIPS waiver (Trade-Related Aspects of Intellectual Property Rights waiver), is a form of forced technology transfer or compulsory acquisition of intellectual property that would undermine the global vaccination effort rather than strengthen it.

The comments made by Trade Minister Dan Tehan last week were part of a continuing discussion held on that day and do not appear to indicate a change in the Government’s position. Medicines Australia and AusBiotech acknowledge the Australian Government’s determination to play a constructive role in resolution of this issue, including their recognition that the multilateral intellectual property system critically supports innovation and that patents are not the barrier to vaccine availability.

Lorraine Chiroiu, CEO of AusBiotech, and Elizabeth de Somer, CEO of Medicines Australia, have both consistently stated the importance of upholding strong intellectual property protections as the key to innovative vaccines and treatments against COVID-19 and future pandemics. In a joint statement, they both said:

“If a compulsory acquisition of patents are put into place, there will be serious, long-term impacts, which will dampen the drive for investment into medical research and innovation, placing us in a worse position to tackle new COVID-19 variants and preparation for future health crises.”

“The only way to solve this is through continuing to build robust partnerships backed by a reliable international intellectual property system. Rather than causing more bottlenecks and delays by supporting the TRIPS waiver, we hope that the Australian Government will engage in a pragmatic and constructive dialogue with industry focused on the real barriers to global vaccination.”

Read the entire joint statement here.

Co-hosting a BiotechTalk in August, to engage members on Australia’s international engagement on global IP negotiations, AusBiotech and Medicines Australia were joined by representatives from IP Australia, the Department of Foreign Affairs and Trade, and AusBiotech’s IP Advisory Group. The shifting global IP landscape was explored, misreported ‘facts’ were debunked, and the impact that current negotiations may have on future technology development were considered. AusBiotech Members can rewatch the webcast in AusBiotech’s online BiotechTalks Library.

Australian company's COVID-19 tests approved in Europe

Thu, 16 Sep 2021 00:00:00 +1000

Joint statement supports Australian Patent Box

Tue, 14 Sep 2021 00:00:00 +1000

Australia’s health innovators have united to release a statement supporting the introduction of a patent box, and welcoming the important initiative by the Australian Government. The collective statement made by Research Australia, AusBiotech, Medicines Australia, and the BioMelbourne Network asserts that with the right policy settings, a patent box will ensure Australian discoveries in health are developed here, ensuring Australia captures the opportunity for new industries and jobs in health innovation.

This alliance demonstrates the alignment and strong interdependencies from bench to bedside within the biotechnology and medical products sectors, and strengthens our sector positioning. Each national peak industry body submitted individual responses to Treasury’s initial patent box design discussion box, with many having advocated for the initiative for many years.

The supportive recommendations include a call for the Government to establish an expert working group with industry representation to support the design and implementation of the patent box; and to look to tested regimes in comparable ecosystems when considering the key design elements – such as the UK Patent Box.

Read the joint statement of support for an Australian Patent Box here.

AusBiotech continues to warmly welcome the Australian Patent Box policy development that will apply to the medical and biotechnology sector, however, implores that getting the policy’s design right is tantamount to its future success.

An Australian Patent Box incentive would work ‘hand in glove’ with the R&D Tax incentive (RDTI) to keep more of the value creation and its benefits in Australia, for longer.

It is estimated that 86 percent of the approximate 1,852 organisations in the Australian life sciences sector is in the SME category, the majority of which is yet to reach commercialisation or earn revenue. While most companies will not be eligible for some years, the Patent Box is intended as an incentive for long-term decision-making and creating long-term value for Australia.

It is well accepted that as a product reaches commercialisation, the benefits of the much-valued RDTI diminish, the development of highly-portable IP may (and does) move the associated benefits offshore, where other countries benefit.

A well designed, accessible, and effective Australian Patent Box will incentivise and support companies to keep the development of their IP and the value they create from it in Australia, to the economic and social benefit of all Australians.

Read AusBiotech’s call for a workable patent box design here.

Rhinomed announces deal with Victorian government

Tue, 14 Sep 2021 00:00:00 +1000

RDTI administration model review

Thu, 09 Sep 2021 00:00:00 +1000

The R&D Tax Incentive (RDTI)’s administration model is being reviewed by the Board of Taxation (Board), a non-statutory Government advisory body, to identify opportunities for reducing duplication between the RDTI’s two administrators, to simplify administrative processes, and to reduce the compliance costs for applicants.

Changes to the RDTI’s broader policy settings, such as eligibility requirements or rates of support, are not being considered.

The RDTI is currently jointly administered by the Australian Taxation Office (ATO), which is responsible for the administration and processing of R&D tax offset claims, and Industry Innovation and Science Australia (IISA), which is responsible for registering companies' R&D activities. AusIndustry sits within the Department of Industry, Science, Energy and Resources and delivers the programme on behalf of IISA.

The consultation paper notes that, “The Board may make recommendations to modify the [RDTI’s] administrative model or to streamline existing administrative functions or processes. If the Board finds that taxpayers experience difficulty in understanding the different roles and responsibilities of the two administrators, the Board should consider whether education programs or communications would assist.

Importantly, the review being co-led by biotech veteran Neville Mitchell, who brings strong industry experience to the table. Mr Mitchell is the former Chief Financial Officer and Company Secretary of ASX-listed Cochlear Limited, and current NED of privately-owned and publicly-listed Australian life sciences companies, including AusBiotech member Q’Biotics Group.

A consultation paper has been developed in order to understand stakeholders’ experiences during the registration and claiming processes. The Board is accepting written submissions until 15 September 2021.

The Board will submit its report to Government by 30 November 2021. This review will fulfil a 2020‑21 Budget commitment.

WEHI collaborates with MSD on researcher exchange

Thu, 09 Sep 2021 00:00:00 +1000

Telix Japanese prostate cancer imaging study completes enrolment

Thu, 09 Sep 2021 00:00:00 +1000

Global female scholars award opens for 2022

Tue, 07 Sep 2021 00:00:00 +1000

Nominations are open for the Johnson & Johnson Scholars Award programme that aims to develop female leaders, and feed the talent pipeline. The $150,000 award sponsors women at critical points in their careers, in each of the disciplines: Science, Technology, Engineering Manufacturing, Math and Design (STEM2D).

The global awards will fund one woman per discipline who has completed her advanced degree, is working as an assistant professor (or global equivalent faculty position) and who is not yet tenured at an accredited university, institution or design school.

Australia’s leading scientists have been previously well-recognised, with three winners in the past two years.

Dr. Shayanti Mukherjee, Ph.D, Hudson Institute of Medical Research, won the 2021 engineering award for their work on advancing urogynaecological health using nanotechnology and 3D cellular bioprinting, helping to address unmet medical needs of up to 50 percent of childbearing women worldwide.

Veronica Garcia-Hansen, Ph.D, Queensland University of Technology won the 2020 design award for their research in hospital lighting design to help improve health outcomes for patients and overall energy efficiency.

Dr. Gayathri Naidu, Ph.D, University of Technology, Sydney, won the 2020 technology award, for their work researching off-grid solar membrane water treatment, which has the potential to convert sea water to fresh water and contribute to reducing carbon emissions.

The 2022 Johnson & Johnson WiSTEM2D Scholars Award is open for nominations until 27 September 2021.

Orthocell welcomes new patents for CelGro collagen medical device

Tue, 07 Sep 2021 00:00:00 +1000

Australia’s regenerative medicine clinical trials and manufacturing landscapes revealed

Thu, 02 Sep 2021 00:00:00 +1000

The opportunity for Australia to be a global regenerative medicine (RM) leader has been revealed as its clinical trials and manufacturing landscapes are benchmarked in two new reports, published by the RM Catalyst, a consortium of seven partners.

Each report provides a new evidence base and model against which to map, build and strengthen our clinical trials and sovereign GMP manufacturing position over time. By leveraging Australia’s reputation for delivering high-quality, complex, and safe medical products, as well as our highly-skilled workforce, we can become the clinical trials and manufacturing hub for the region and deliver potentially life-changing treatments to patients, both in Australia, and the broader Asia Pacific region.

Despite the COVID-19 pandemic, in 2020 alone the global RM sector attracted USD$19.9B in investment. The FDA predicts that by 2025, 10 to 20 products will be approved each year in the USA; global companies are turning their attention to the RM sector and we are seeing more gene and cell therapies being brought to Australia.

Australia’s Regenerative Medicine Manufacturing Capacity & Capability (Manufacturing Report)

The inaugural Australia’s Regenerative Medicine Manufacturing Capacity & Capability (Manufacturing Report) highlights how Australia has RM manufacturing sites from East to West, with seven TGA-licenced Good Manufacturing Practice (GMP) sites and five non-TGA licenced sites. Being TGA-licenced means that the manufacturing facility and quality systems have been approved by the local regulatory authority and products manufactured by these facilities meet global regulatory standards such as US (FDA), Europe (EMA), Japan and other jurisdictions. Those sites not yet TGA licenced are aspiring to be, so that they can extend their manufacturing capability to late-stage clinical trials and commercial supply.

RM therapies require highly-specialised GMP capabilities and infrastructure, a highly-skilled workforce, and complex supply chains. The increasing demand for RM therapy manufacturers is growing and a major bottleneck exists at the GMP manufacturing phase of product development, both in Australia and globally. This progressive direction demonstrates that Australia’s capabilities are growing and greater opportunities are available for the sector if further investment is pledged. Investing in and building Australia’s sovereign manufacturing capability for complex and advanced RM therapies will ensure faster access to cutting-edge treatments for Australian patients, create new jobs now and for the future, and develop a highly skilled workforce.

There are significant benefits to having manufacturing facilities located onshore in Australia, for patients as well as RM therapy developers: local manufacturing will build resilience for the sector and ensure faster access to cutting-edge therapies for all Australians. Sovereign capability facilitates access not only to early phase trials for Australian patients for locally developed products, but also supports access to innovative and cutting-edge international trials.

Download Australia’s Regenerative Medicine Manufacturing Capacity & Capability here.

Australia’s Regenerative Medicine Clinical Trials Database (CT Database)

Australia is an active, globally-popular, and internationally-competitive destination for clinical trials with a bountiful pipeline of RM therapies seeking to join the six regenerative medicines already approved in Australia.

Delivering clarity of the development landscape, the inaugural CT Database captures the portion of clinical trials in RM, and seeks to categorise them into type and phase. This benchmarking is important as the sector prepares to thrive, and enables the ecosystem to develop in a way that capitalises on the opportunities that present now and in the future.

In 2021, there were over 1,220 ongoing clinical trials investigating RM globally; of these, 130 (11 per cent) were ongoing and investigating RM in Australia, and two were in progress and being conducted by Australian companies overseas.

Australia’s industry is thriving and companies developing RM therapies include both small biotechs and larger pharma companies. Industry-sponsored trials (~80 percent) outnumbered non-industry sponsored trials in Australia and grew at a compound annual growth rate of 21 percent from 2016-2020, which was seven times higher than non-industry sponsored trials for the same period. Over the study period, the highest number of new trials were recorded in 2019 and 2020 both for industry and non-industry sponsors.

Download Australia’s Regenerative Medicine Clinical Trials Database here.

Regenerative Medicine Catalyst Project

The project is developing a total of nine reports, to create the foundations for an RM future for Australia.

The comprehensive Regenerative Medicine Value Chain report, released in August, considers the chain of activities involved in RM therapy development, including: research capabilities - workforce and infrastructure; supporting Australian research and small and medium-sized enterprises: funding, investment and partnerships; attracting investment in clinical trials; streamlined approvals and incentives; clear pathways to patient delivery: healthcare system preparedness; and data-driven approaches across the value chain.

Read more about the Regenerative Medicine Catalyst Project here.

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

Notice of AusBiotech's virtual AGM, Friday 5 November 2021

Thu, 02 Sep 2021 00:00:00 +1000

To Members and other persons entitled to notice of Annual General Meetings (AGM) of AusBiotech Ltd, the 2021 AGM of AusBiotech Ltd will be held virtually and according to the AusBiotech Constitution on Friday 5 November 2021 at 12.30 pm - 1.30 pm AEDT to transact the following business:

Ordinary Business

1. ANNUAL ACCOUNTS

To consider the annual report, financial statements and report of the Directors and auditor for the year ended 30 June 2021.

2. RESULTS OF DIRECTOR APPOINTMENT/S

To note the Directors who return, and the appointment of the new Director/s in accordance with the Company’s Constitution.

3. OTHER BUSINESS

Any other business that may be brought forward at a general meeting in accordance with the Constitution.

Members are invited to register their attendance.

Note: A Member who is entitled to vote at the meeting has a right to appoint a proxy and should use the proxy form available on request from AusBiotech Ltd on (03) 9828 1400 or election@ausbiotech.org.

The proxy form must be signed and dated by the Member or the Member’s attorney. Proxy forms and the original or a certified copy of the power of attorney (if the proxy form is signed by an attorney) must be received no later than 1.00 pm AEDT Wednesday 3 November 2021 by email to election@ausbiotech.org.

Neuren's US partner launches new Rett syndrome clinical trial for young girls

Thu, 02 Sep 2021 00:00:00 +1000

MRFF grant criteria expanded

Tue, 31 Aug 2021 00:00:00 +1000

Providing greater access to the upcoming Medical Research Future Fund (MRFF) Missions’ grant opportunities, the criteria to become an Eligible Organisation has been expanded to include public and private companies.

If approved to be an MRFF Eligible Organisation, an organisation may then apply for MRFF grant opportunities, which are administered by the National Health and Medical Research Council (NHMRC).

Previously, only NHMRC ‘Administering Institutions’ - universities, hospitals and medical research institutes - could apply for MRFF grants administered by the NHMRC. Now, the following types of organisations can apply:

Australian public companies, Australian private companies, and other incorporated entities
Medical research institutes
Universities
Commonwealth entities that are bodies corporate.

More detail on MRFF Eligible Organisations, including the approval process, can be found on the NHMRC website.

Guidance on MRFF incubator and accelerator grants has also been updated.

Incubator grants: small scale (up to $1 million) and short-term (6 - 24 months) funding that supports early-stage research projects that create new solutions for significant health challenges.
Accelerator grants: large scale (up to $5 million) and long-term (up to five years) funding that supports researchers to translate knowledge into practice to improve health practice and/or policy.

Pharmaxis wound and scar treatment clears phase one trial

Tue, 31 Aug 2021 00:00:00 +1000

Nominations open in recognition and celebration of life science leaders

Thu, 26 Aug 2021 00:00:00 +1000

Nominations for the 2021 AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards are open, and will recognise and celebrate life science leaders who are championing the sector and the Australian community.

Nominations for the awards are open until Friday 9 September 2021 in the following categories:

Industry Leadership Award

Previous winners include: Sue MacLeman, Professor Andrew Wilks, Dr Anna Lavelle, and Dr Chris Nave.

Australian Company of the Year

The Australian Company of the Year will be awarded to a company that has demonstrated significant achievement/s, and may include any company working in biotechnology or life sciences, including but not limited to the medical diagnostics or devices, pharmaceutical and agricultural biotechnology sectors. Consideration of deals done, product pipeline, IP, company strategy and/or revenue is key, and nominations should address the significant achievements attained over the past 12 months.

Previous winners include: PolyNovo, Medicines Development for Global Health, and Planet Innovation.

Australian Emerging Company of the Year

The Australian Emerging Company of the Year Award will be based on the same criteria as the Australian Company of the Year, but is specific to companies under five years of age.

Previous winners include: OncoRes Medical, Telix Pharmaceuticals, and Microba.

The AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards 2021 will be presented on Wednesday 27 October during AusBiotech 2021. Find out more and nominate a company or individual by Friday 9 September 2021.

Anatara clinical trial to leverage precision microbiome analysis

Thu, 26 Aug 2021 00:00:00 +1000

CSIRO report reveals potential of synthetic biology ecosystem

Thu, 26 Aug 2021 00:00:00 +1000

New Nasdaq rule encourages diversity

Tue, 24 Aug 2021 00:00:00 +1000

A new Nasdaq Board Diversity Rule encouraging minimum board diversity has been approved by the U.S. Securities and Exchange Commission. Board diversity is well-recognised as making good business sense and this Rule is another important example of efforts to foster an inclusive industry culture, and an opportunity for biotech to attract the best and brightest talent from diverse backgrounds.

Nasdaq’s disclosure requires all companies that are listed on Nasdaq’s U.S. exchange to publicly disclose their Board of Directors’ diversity composition statistics through consistent and comparable reports.

The rules require Nasdaq-listed companies to have—or explain why they don’t have—at least two diverse directors, including one who self-identifies as female and one who self-identifies as either an underrepresented minority or LGBTQ+. Flexibility is offered to foreign issuers and smaller reporting companies.

Following the new Board Diversity Rule is thoroughly encouraged, however it is not mandated. Nasdaq will verify that each company has provided an explanation but will not assess the explanation’s merits. There is no right or wrong reason that a company may give for not having at least two directors.

Read What Nasdaq-listed companies should know.

To continue this important discussion and engage on how to ‘build your board as you grow’, register for the AusBiotech 2021 conference. A dedicated session will feature a panel of experienced directors, and cover elements of building and operating as an effective board from an early stage to IPO and beyond.

AusBiotech has re-commissioned its biennial research into the shape and size of the life sciences industry, including tracking Australian biotech’s gender diversity landscape across the levels of leadership. This research will also be released at AusBiotech 2021.

The 2019 research found that women form 51 per cent of the workforce across the life sciences sector, however, women in industry are still under-represented (32 per cent). This decreases as seniority increases, with executive-level women representing 25 per cent and female board members representing 15 percent. The Sector Snapshot 2019 research can be read here.

AdAlta and Carina in new collaboration focused on CAR-T candidates

Tue, 24 Aug 2021 00:00:00 +1000

FDA approves early-stage trial for Chimeric CAR-T

Tue, 24 Aug 2021 00:00:00 +1000

Impact of investors’ tax concessions reviewed

Thu, 19 Aug 2021 00:00:00 +1000

The impact of three tax concessions aimed at increasing venture capital investment in Australia and upskilling venture capital fund managers are being evaluated by the Australian Government, after being announced five years ago.

Three venture capital fund programmes are in-scope for review: the Early-Stage Venture Capital Limited Partnership (ESVCLP); Venture Capital Limited Partnership (VCLP); and the Australian Venture Capital Fund of Funds (AFOF); as well as investments made directly by foreign residents registered under Part 3 of the Venture Capital Act 2002.

To evaluate how the programmes are working in practice and to understand if they are meeting their intended objectives, quantitative and qualitative evidence is sought, together with feedback on how the concessions work in practice.

The primary focus of ESVCLP is encouraging investments in early-stage start-ups seeking to commercialise; the VCLP aims to attract foreign investment to the Australian venture capital sector; and the AFOF seeks to provide diversification and flexibility for the fund and its investors.

These tax concessions were implemented as part of the Turnbull Government’s 2016 National Innovation and Sciences Agenda.

The five-year review is part of the Government’s Digital Economy Strategy and is being undertaken jointly by Treasury and Industry, Innovation and Science Australia: an independent statutory board that advises the Australian Government on innovation, research, and science matters. The final report will be delivered to the Treasurer before the end of 2021, and will be subsequently tabled in Parliament.

As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science industry.

Biotech investors and AusBiotech Members are invited to read the consultation paper here, and to contact Hayley Laing, Manager, Global Investment Programme, with feedback by 31 August 2021.

Telix Pharmaceuticals updates on new collaborations and studies

Thu, 19 Aug 2021 00:00:00 +1000

AusBiotech calls for Chair successor

Tue, 17 Aug 2021 00:00:00 +1000

AusBiotech is calling on its Membership as it searches for an experienced and influential successor as its next non-executive Chair.

The Board of Directors supports AusBiotech to deliver on its vision to be the leading Australian industry body representing and advocating for organisations doing business in and with the global life sciences economy.

AusBiotech is a not-for-profit limited by guarantee company governed by a collegial Board comprising a maximum of nine Directors, including the Chair and the CEO. The Board provides strategic guidance to the organisation and ensures good corporate governance. Each Director brings to the Board extensive knowledge and experience of working in the Australian and international biotechnology industry, with collective expertise in technical, commercial and policy domains. As a national body, AusBiotech strives for diversity of representation across demographics, geography and expertise.

Alongside performing the standard role of a Non-Executive Director, the Chair will be expected to:

lead the Board and facilitate constructive contributions by all Directors;
establish a beneficial working relationship with the CEO of AusBiotech;
chair Board meetings to ensure effectiveness and efficiency; and
represent AusBiotech to key stakeholders as required.

You will be readily identified as an experienced and effective Board Chair with demonstrated strengths in organisational strategy. A persuasive communicator with a passionate interest in the life sciences sector, you will have the time and capacity to dedicate to the role, ideally for a term of 3 – 5 years. You will have access to a broad network of relevant stakeholders, including Government, a reputation of achievement in the biotechnology, life science or other related sector, and be willing to influence and advocate on behalf of AusBiotech and its members.

AusBiotech’s current Chair, Michelle Burke, will retire from the AusBiotech Board having successfully completed her tenure. It is expected that the newly appointed Chair will take up the role at the Board meeting following the AusBiotech AGM on 5 November 2021.

A copy of the position profile can be requested via recruitment@ausbiotech.org.

Applications close at 11am on Wednesday 8 September 2021.

For more information, call Jan Tennent on 0418 637 613 or Michelle Burke on 0411 267 023, in confidence.

About AusBiotech

AusBiotech is Australia’s life sciences organisation, working on behalf of members for more than 35 years to provide representation and services to promote the global growth, development and prosperity of the Australian life sciences industry. AusBiotech is a well-connected network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), digital health, and agri-biotech sectors.

It has representation in each major Australian state, providing a national network to support members and promote the commercialisation of Australian life science in national and international marketplaces.

AusBiotech calls for workable patent box design

Tue, 17 Aug 2021 00:00:00 +1000

Through its submission to Treasury, AusBiotech has called for a patent box design that works for the very industry it is intended to incentivise, and takes account of the unique characteristics of medical and biotechnology development.

An enthusiastically-supportive voice for an Australian patent box, AusBiotech makes numerous recommendations, including an industry panel to support the design and implementation of the policy - with the current design unworkable if it wishes to achieve the goals of both government and industry.

CEO of AusBiotech, Lorraine Chiroiu, explained, for example, that “…it is critical that the Treasury note that the companies eligible for the incentive at its start date, under the current design, will be nil, and access in the forward estimates is near impossible.”

Australia’s Patent Box should look to a tested regime in a comparable ecosystem, when considering key design elements. Notably the UK Patent Box should be seen as an exemplar for design elements, such as (but not limited to) the competitive tax rate of 10 percent, transitional or introductory arrangements, a government-industry working group and eligible patents.

AusBiotech warmly welcomed the Australian patent policy announcement that will apply to the medical and biotechnology sector, however, implored that getting the policy’s design right is tantamount to its future success.

The policy is intended as an incentive for companies to make long-term decisions and create long-term value for Australia, but due to biotech’s unique characteristics, most target companies will not be eligible anytime soon. It is estimated that it would take some three to five years for the first handful of companies to be eligible and up to 10 years to see any meaningful additionality created.

A well designed, accessible, and effective Australian patent box will support companies to keep the development of their IP and the value they create from it in Australia, to the economic and social benefit of all Australians.

Following broad and deep consultation with industry, AusBiotech has submitted its response to Treasury’s Australian patent box policy design discussion paper.

As the national peak industry body and voice of the life sciences industry, AusBiotech developed its submission in consultation with its Members, AusBiotech advisory groups, and through an information webcast that gathered and engaged more than 100 stakeholders.

Read AusBiotech’s final submission here.

TGA approval for SpeeDx COVID-19 diagnostic test

Tue, 17 Aug 2021 00:00:00 +1000

Dimerix capital raise to progress late-stage trial

Tue, 17 Aug 2021 00:00:00 +1000

Women in STEM leadership program to go national

Tue, 17 Aug 2021 00:00:00 +1000

Strengthening Australia’s regenerative medicine value chain

Thu, 12 Aug 2021 00:00:00 +1000

With new thinking and approaches necessitated by emerging, transformative and disruptive regenerative medicine (RM) therapies, a new report has been launched by the RM Catalyst, a consortium of seven partners, considering how to best strengthen the Australian value chain of research, development, regulation, advanced manufacturing capabilities, reimbursement, and patient delivery.

The Australian biotech sector is actively considering how it can support greater access to ground-breaking therapies for Australians, as RM challenges the traditional biopharmaceutical value chains and business models. Complex development approaches, limited access to raw materials, and personalised therapeutic approaches are difficult to scale, but they are surmountable.

Pathways have been forged across the Australian value chain, however, further advances are required to support Australia’s position in this rapidly growing sector and enable Australian patients to access these innovative therapies that offer enormous potential to save lives and enhance quality of life.

The Regenerative Medicine Value Chain report considers the chain of activities involved in RM therapy development, including: research capabilities - workforce and infrastructure; supporting Australian research and small and medium-sized enterprises: funding, investment and partnerships; attracting investment in clinical trials; streamlined approvals and incentives; clear pathways to patient delivery: healthcare system preparedness; and data-driven approaches across the value chain.

The comprehensive report highlights that by addressing multiple ‘links’ in the ‘chain’, cumulative value will be delivered; for example, building research capability attracts investment in clinical trials, which in turn facilitates pathways to market access and implementation of RM therapies in the Australian healthcare system.

The RM development pathway is iterative, combining approaches from the biomedical and bioengineering sciences, and involving many stakeholders. A coordinated, national approach for Australia that includes engaging with regional and international collaborators will support the country’s position in the global sector.

Advancing RM in Australia offers patients timely access to cutting-edge and potentially life-saving RM therapies by promoting a thriving domestic RM sector and ensuring that Australia remains a priority market for global developers. While the global RM sector remains nascent, the pace of innovation and investment is accelerating rapidly.

Australia holds a strong and vibrant RM industry ecosystem with an internationally-recognised clinical trials framework, translational research, and clinical centres. With more than 60 companies in Australia developing products and over 130 clinical trials in progress, Australia is internationally-competitive in this space.

Globally, the RM sector has more than 1,200 clinical trials in progress, and in 2020 alone it attracted USD$19.9B. Global companies are also turning their attention to the RM sector and we are seeing more gene and cell therapies being brought to Australia.

Read more about the broader Regenerative Medicine Catalyst Project here.

Download the Regenerative Medicine Value Chain report here.

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

Rhinomed announces first government order for new nasal swab

Thu, 12 Aug 2021 00:00:00 +1000

Proteomics International contracts Biotem to manufacture PromarkerD test kits

Thu, 12 Aug 2021 00:00:00 +1000

Employee Share Scheme consultation open

Tue, 10 Aug 2021 00:00:00 +1000

Consultation on the Treasury’s draft legislation for further reforms of Australia’s Employee Share Scheme (ESS) has opened, and AusBiotech is seeking feedback from Members that may be impacted.

The reforms have been welcomed by AusBiotech as they will make it easier for companies – particularly biotech start-up and SMEs – to offer an improved ESS to their employees. It will cut red tape and remove the ‘cessation of employment’ taxing point, as well as other reforms. ESS enables companies to complement cash remuneration and make salary packaging appear more substantive and attractive.

This is an important opportunity for Australia to attract the best and brightest employees within an industry that works in a global community and where competition is fierce; it is an area that AusBiotech has advocated in for more than eight years.

While the changes to the ESS were first announced in 2018, the legislation was never moved and therefore the reform was never implemented. The 2020-2021 Federal Budget demonstrated further commitment through its forward estimates, and consultation has now opened.

AusBiotech welcomed the Budget announcement, given the advantages of ESSs is amplified in the life science sector, where the pre-revenue phase is typically extended by the need to clear regulatory hurdles before revenue can be earned, which can exceed a decade. To support the growth of Australian innovation, it is essential to encourage start-ups and implement beneficial taxation provisions.

Treasury noted that “Currently, employees are taxed on their shares issued under an ESS as soon as they leave the company, often forcing them to sell them to meet the tax liability. Once the reforms are implemented, employees will instead be taxed at the earlier of the remaining deferred taxation points.”

As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science industry. It has made numerous submissions and representations on ESS since 2009.

Members are invited to read the consultation papers here, and to contact AusBiotech’s Director, Industry Policy and Advocacy, Khaled Chakli, with your feedback by 20 August 2021.

Noxopharm announces collaboration with the US National Institutes of Health

Tue, 10 Aug 2021 00:00:00 +1000

Opthea announces patient recruitment open in Canadian trial

Tue, 10 Aug 2021 00:00:00 +1000

Feedback sought on recommendations for Australia’s proposed patent box design

Thu, 05 Aug 2021 00:00:00 +1000

AusBiotech calls for feedback on its six key recommendations in response to the Treasury discussion paper on the Australian patent box policy design.

While Treasury’s consultation paper is limited in scope, important questions have been asked to help frame and target future discussion and legislation appropriately. AusBiotech has developed six key recommendations in response to these.

Bridging the gap between R&D and commercialisation is core to ensuring that Australian medical and biotechnology researchers, companies, and manufacturers remain internationally competitive by making it genuinely more viable for Australian businesses to utilise, develop and create value from Australian IP in Australia. The incentive would work ‘hand in glove’ with the R&D Tax Incentive to keep the value creation in Australia.

Treasury’s discussion paper outlines four key design features for feedback:

Definition of medical and biotechnology – how these sectors or patents will be clearly identified.
Eligible IP - only inventions claimed in standard patents granted by IP Australia, which have a priority date on/after 11 May 2021.
Eligible profits/revenues – types of patent-related revenue that’s eligible for the patent box.
Majority of R&D must be conducted in Australia - complicit with OECD Nexus requirements.

AusBiotech’s draft recommendations:

Australia’s patent box should look to a tested regime in a comparable ecosystem when considering key design elements. Notably the UK Patent Box should be seen as an exemplar for design elements such as (but not limited to) the competitive tax rate of 10 percent, transitional or introductory arrangements, and eligible patents.
As the key consideration should be patent-ownership and point of taxation, provide eligibility to patents registered by Australian companies in jurisdictions of comparable quality for patent granting as Australia.
Look to an already-legislated definition such as the definition of a therapeutic good as shown Section 3(1) of the Therapeutic Goods Administration Act 1989; do not use the International Patent Classification or Cooperative Patent Classification systems’ classification of a patent to deem if a patent is ‘medical or biotechnology’. Instead target the definition to enable the intended recipients to access to the programme.
Given the Australian environment where many forms of R&D are unavailable or unworkable, apply an arrangement for research conducted overseas, where a substantive proportion or majority must be done in Australia, when assessing patent box claimants’ substantial activity requirement. The RDTI provides a framework that could be applied.
Rather than assessing eligibility on a patent-by-patent basis, simplify the approach by acknowledging a ‘whole of product’ approach. This would mean that once a product has an eligible patent, the product would be eligible. Also, noting the time between first patent application and first revenue is when the majority of the R&D in the process occurs, the patent box design needs in to take account the common and typical circumstances of medial and biotechnology development, where R&D may be preceded or followed by multiple patent filings of varying types on the one product or platform.
To ensure some companies will be eligible to access the patent box in the next three to five years, create a transition arrangement such as that used by the UK, or simply ensure that all eligible patents granted as at the start date of the regime (i.e. patents in existence at 1 July 2022) should be eligible patents for patent box purposes. Additionality would be created as there would be an incentive to keep the value creation related to the IP in Australia.

As the national peak industry body, AusBiotech developed its draft submission in consultation with its Members, AusBiotech advisory groups, and through an information webcast that gathered and engaged more than 100 stakeholders.

AusBiotech encourages Members to read AusBiotech’s complete draft response here, and to engage with Khaled Chakli, Director, Industry Policy and Advocacy, with feedback by 13 August 2021.

As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science industry.

Neuren says Rett syndrome Phase 3 trial enrolment successfully completed

Thu, 05 Aug 2021 00:00:00 +1000

Immutep reports dosing of first patient in INSIGHT-003 study

Thu, 05 Aug 2021 00:00:00 +1000

AusBiotech 2021 programme released

Tue, 03 Aug 2021 00:00:00 +1000

The AusBiotech 2021 programme has been released, and features global thought-leaders, and pressing and emerging topics to drive the Australian biotech sector forward. Opening the largest annual biotech gathering for the Australian life science industry, Millis Oration keynote Professor Sharon Lewin AO, Director, The Peter Doherty Institute for Infection and Immunity, will address HIV to COVID-19: what history has taught us about our response to pandemics.

Prof. Lewin has spent her career researching infectious diseases and the body’s reaction and notes that there are some parallels of the body’s response to fighting HIV and COVID-19 that has informed Australia’s response to this pandemic. The Millis Oration, proudly supported by CSL, will discuss how the history of the HIV pandemic has emerged with new investment and collaboration to combat and treat COVID-19.

Keynote Howard Sachs, Siemens Pharmaceutical Vertical Manager, Siemens Ltd, will also present live in-person and online, presenting on Pharma 4.0: fast tracking discovery through to commercialisation. With an industry and government deeply focused on innovation and supply chain sovereignty, the calls for faster, leaner and quality processes across all areas of business to shorten the time-to-market, has never been more of a hot topic for our nation. Howard will present on Pharma 4.0 concepts, provide insights, including on onshoring mRNA and digital twinning, and will touch on what’s occurring both here and overseas in accelerating discoveries through to commercialisation

The four-day programme is packed with pressing, emerging, and engaging topics, designed to drive the Australian biotech sector forward. Topics include clinical trials, manufacturing, regenerative medicines, IP, early-stage commercialisation, digital health, therapeutics and personalised medicines. More keynotes and speakers will be revealed over the upcoming weeks.

Join us to celebrate and connect with our thriving Australian and global biotechnology network throughout the biggest week in biotech; engage and exchange ideas, pitch, partner and learn.

AusBiotech 2021 is run by industry, for industry; and for more than three decades it has created a forum to reflect on the sector’s achievements and exchange ideas to further advance the industry. The premier event brings together industry leaders, investors, researchers, clinicians and regulatory representatives from across the globe. All benefits from the conference flow back into the sector to continue facilitating the industry’s growth and global development, as AusBiotech is a not-for-profit entity.

Biotech’s biggest week also sees the return of Australia Biotech Invest & Partnering 2021, Australia’s preeminent life science investment event, which will run concurrently on 26 October 2021. Australia’s biotechnology industry presents a compelling opportunity for investors and international partners, and this independent event is designed to engage capital with innovation, and offers the opportunity for companies to present their technology and story to a network of potential international partners and investors, including global pharma representatives. Companies interested in presenting are invited to express their interest; qualified and pre-approved investors are invited to register their free-of-charge attendance at the online and/or in-person event now.

AusBiotech’s premier events, AusBiotech 2021 and Australia Biotech Invest & Partnering 2021, are proudly sponsored by the Victorian Government.

Engage, your way, and take advantage of the AusBiotech 2021 early bird registrations available until 27 August 2021; register now.

COVID-19 study incorporating Dimerix's DMX-200 adds more sites

Tue, 03 Aug 2021 00:00:00 +1000

Faecal transplants to help treat symptoms of Parkinson’s

Tue, 03 Aug 2021 00:00:00 +1000

Bionomics announces plans for US initial public offering

Tue, 03 Aug 2021 00:00:00 +1000

Draft roadmap for Australian regenerative medicine released for comment

Thu, 29 Jul 2021 00:00:00 +1000

A draft strategic roadmap has been released for a new regenerative medicine (RM) Catalyst, and sector feedback is sought from those interested in the future of RM in Australia.

The Catalysing Regenerative Medicine in Australia, Strategic Roadmap (Strategic Roadmap) provides the strategic goals, objectives and priority actions for a national RM sector Catalyst. It includes an outline of the mission and vision; strategic goals, objectives, and priority actions; and detailed discussion of the major issues informing the strategic roadmap.

The Strategic Roadmap has been developed as a key part of the RM Catalyst Project. The project has been supported by a consortium of seven members that hold extensive insight and experience in the life sciences and RM landscape in Australia: AusBiotech, Medicines Australia, Cell Therapies Pty Ltd, Novartis Pharmaceuticals Australia Pty Ltd, Biointelect Pty Ltd, Research Strategies Australia and Australia’s Industry Growth Centre, MTPConnect.

The uniqueness of RM, in both opportunity and in challenges, drives Australia’s need for a unified, national RM sector ‘catalyst’ collaboration body championing its cause. Many of the issues discussed in the Strategic Roadmap can be partially addressed through greater coordination and collaboration in Australia across the RM development pathway.

Developing and sustaining the necessary capacity and capability requires a coordinated approach across the public and private sectors. This needs to be led by industry and supported by government.

The Catalyst’s proposed vision is that Australian patients have access to world-class RM therapies sustained by a thriving Australian RM industry. Its proposed mission is to create an end-to-end world-leading value chain that can discover, develop, and distribute RM, while creating jobs, commercialising research, and exporting Australian therapies to the world.

The Strategic Roadmap has been developed based on extensive consultation with stakeholders across the RM value chain in Australia, together with desktop research into the Australian and global RM sectors. Together, these activities revealed key issues facing the sector and informed the strategic goals, objectives and priority actions developed.

The Strategic Roadmap is one of the deliverables that the 12-month RM Catalyst Project was formed to develop. Further priority action areas include: workforce capabilities, collaboration, funding, regulation and policy infrastructure, and Australian manufacturing capability.

Australia has an opportunity to harness and leverage a growing and active global RM industry. If we get this right, success could be worth at least $6 billion in annual revenue, 6,000 new jobs for Australia by 2035 and earlier access to ground-breaking therapies for Australian patients.

The Project received matched funding through MTPConnect’s Growth Centre Project Fund Program, an Australian Government initiative supported by the Department of Industry, Science, Energy and Resources. It is a competitive matched funding program that aims to invest in ideas to boost the innovation, productivity and competitiveness of Australia’s MTP sector. Read more about the broader RM Catalyst Project here.

The sector is invited to download the draft Strategic Roadmap here, and to send feedback to Camille Shanahan, National Projects Manager – Regenerative Medicine, by Friday 13 August 2021.

Chimeric Therapeutics licenses CAR-T therapy from the University of Pennsylvania

Thu, 29 Jul 2021 00:00:00 +1000

Feedback sought on proposed changes to medical devices that are substances

Tue, 27 Jul 2021 00:00:00 +1000

AusBiotech is seeking feedback from Members that may be impacted by proposed TGA regulation changes through the Proposed refinements to the regulation of medical devices that are substances introduced into the human body via a body orifice or applied to the skin.

The TGA is committed to aligning Australian medical device regulations with the EU framework – where possible and appropriate. The AusBiotech AusMedtech Regulatory Affairs Advisory Group is considering responding to the consultation, and seeks to better understand how this proposed rule deviation will effect AusBiotech members, given the overlap in the medicine and medical device regulatory frameworks for some products.

Following a public consultation, the TGA amended the regulations for medical devices by introducing new classification rules for medical devices that are substances intended to go into the human body through an orifice or be applied to the skin, and are absorbed or dispersed. The new rules take effect on 25 November 2021. This consultation seeks to further refine this regulation.

As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science industry.

Members are invited to read the consultation paper here, and to contact AusBiotech’s Director, Industry Policy and Advocacy, Khaled Chakli, with your feedback by 2 August 2021.

CTxONE rebrands as Oncology One

Tue, 27 Jul 2021 00:00:00 +1000

Patrys announces preclinical data for PAT-DX1 in pancreatic cancer

Tue, 27 Jul 2021 00:00:00 +1000

Digital health state of the industry survey open

Thu, 22 Jul 2021 00:00:00 +1000

ANDHealth’s annual digital health survey is open, and input from digital health innovators and companies is being called for to help identify gaps, challenges and opportunities in digital health commercialisation.

Insights from the survey are anonymous and data will be aggregated and analysed before being included in its State of the Industry report, that provides key insights into the strengths, weaknesses, opportunities and challenges faced by Australian digital health innovators.

Last year’s report Digital Health: The Sleeping Giant of Australia’s Health Technology Industry was used by industry and government stakeholders to benchmark the state of the industry and identify needed reforms to strengthen the sector. It demonstrated Australia’s potential to become a global destination for digital health development, commercialisation, clinical trials and implementation.

ANDHealth was established to transform the digital health sector in Australia, and as Australia’s only dedicated provider of digital health commercialisation support. ANDHealth is a not-for-profit company that was established in 2017 by a consortium of industry partners, including AusBiotech.

Complete the survey before it closes 31 July 2021.

Funding opening for large-scale life science manufacturers

Tue, 20 Jul 2021 00:00:00 +1000

Large-scale medical product manufacturers in Australia are being invited to apply for Federal funding through its “Manufacturing Collaboration” stream, under the Modern Manufacturing Initiative (MMI). Co-funded grants from $20 million to $200 million are available, from a total funding pool of $800 million.

The funding aims to support long-term transformation creation, and projects are being sought that feature, or will create and facilitate, business-to-business or business-to-research collaboration at their core.

Applications are invited from companies, including those:

with a minimum of $60.6 million in eligible project expenditure;
where no more than 50% of your project is funded from Commonwealth funding sources;
where no more than 65% of your project is funded from all government sources (including Commonwealth, State and Territory and local);
where your project shows the potential to expand or promote interstate or international trade.

AusBiotech CEO, Lorraine Chiroiu, said, “The support through MMI continues to signify the Government’s endorsement of the potential of the Australian biotechnology industry. Our companies need a supportive system throughout the entire pipeline in order to commercialise, manufacture and deliver new technologies for patients in Australia and across the globe. Supporting Australia’s medical product manufacturing means supporting biotech’s innovative industry, its research expertise, and its highly-skilled workforce. It is a ‘salute’ to the impact that Australian biotechnology has in improving health and wellbeing, and for Australia’s economy.”

The Government’s objectives for this funding is to increase investment in Australian manufacturing, particularly in high value-added activities; increase manufacturing capability, business acumen, knowledge diffusion and expertise; support long-term job creation and a more highly skilled workforce in the Australian manufacturing sector and to foster collaboration.

The Manufacturing Collaboration stream is an aspect of the Modern Manufacturing Initiative, part of the Australian Government’s Modern Manufacturing Strategy announced during the October 2020 Federal Budget, that will invest a total of $1.3 billion over five years and across six priority areas, including medical products. This stream is independent of the Translation and Integration funding streams that were opened in May 2021.

Interested companies can begin preparing their application using the sample application form available on the Government portal website, and can lodge complete submissions between 11 August 2021 and 9 September 2021.

Read more information and download the documents here.

An information session hosted by the Department of Industry, Science, Energy and Resources is being held on 21 July, 2.00 - 3:30 pm (AEST). It is anticipated that the information session recording will be made available on its website for those unable to attend a live session.

J&J Innovation extends innovation partnering office at Monash University

Tue, 20 Jul 2021 00:00:00 +1000

Nominations open for Australian Export & Investment Awards

Thu, 15 Jul 2021 00:00:00 +1000

Nominations are being called for Austrade’s 59th Australian Export & Investment Awards, in recognition and celebration of businesses achieving export success.

This year the prestigious and long-running business awards programme has 13 national categories, including ‘International health’. Companies with outstanding international success in medical, healthcare, biotechnology fields for products, technology, equipment or services, including e-health, digital health, and medtech, are being asked to self-nominate.

Nominations are welcomed from small, medium and large companies, no matter your export experience. This is an opportunity to shine the light on your company, and illustrate your achievements and the Australian life science sector’s social and economic contributions.

2020’s awards pivoted to recognise just eight Australian businesses, and to promote stories of resilience and perseverance in the face of COVID-19. AusBiotech member Epichem Pty Ltd, based in Western Australia, featured in the 2020 National Recognition Program for their dedication to ‘keeping Australians safe through science’ and how they responded to the challenges that the pandemic caused them. Read the Epichem story here.

Applications will close on Friday 6 August. Nominate here.

Planet Innovation opens new 'cleanroom' in Melbourne

Thu, 15 Jul 2021 00:00:00 +1000

PolyNovo stars in new, global BBC biotech series

Tue, 13 Jul 2021 00:00:00 +1000

Australian regenerative medicine company PolyNovo stars in a new, global BBC biotech series as one of just 27 companies chosen worldwide, and the only Australian company. The video is an important indication of Australia’s position in the strong international biotech community.

This riveting new six-minute vignette series demonstrates how biotechnology is bringing solutions to global challenges, and making a real impact along the way. It uncovers stories of innovation that are changing the world every day by harnessing the power of nature, and highlights some of the most pioneering and innovative organisations in our sector.

The PolyNovo story follows John, an international winemaking consultant that was left with burns to 75 per cent of his skin after a serious accident; it shows how dermal regeneration supported the rebuilding of his damaged skin tissue, and his life.

Launched at BIO Digital 2021, the ‘Nature’s Building Blocks’ series traverses health, industrial and agri-biotech applications.

This web-series aims to challenge viewers’ perceptions and bring more understanding to biotech. Biotech plays a central role in solving complex problems and improving the health of humankind and the planet. This series seeks to effectively communicate the industry’s contributions and bring the solutions to screen through a series of short videos.

The new biotech series has been produced by BBC StoryWorks in partnership with the International Council of Biotechnology Associations (ICBA), of which AusBiotech is a member. AusBiotech increases opportunities for members to offer their views and case studies, illustrating industry achievements and issues.

ICBA is a coalition of not-for-profit, national biotechnology trade associations formed to promote public understanding of, and to advocate for, public policies that support the growth of the innovative biotechnology industries. ICBA represents the global voice of the industry in international fora, with the goal of promoting continued innovation in the human health, agriculture, and industrial and environmental sectors.

PolyNovo was chosen after a world-wide call for submissions, and is part of a global communications programme being developed through ICBA. Selected organisations, including PolyNovo, contributed to the production costs of their mini documentary.

Watch PolyNovo’s video ‘Rebuilding skin tissue and lives’ here.

UniQuest partners with CSL to develop potential new therapy

Tue, 13 Jul 2021 00:00:00 +1000

Patrys' full-size PAT-DX3 able to cross the blood brain barrier

Tue, 13 Jul 2021 00:00:00 +1000

Access to GM crop innovation now available to all mainland Australian states

Thu, 08 Jul 2021 00:00:00 +1000

Agri-biotech companies across all mainland Australian States now stand in-line with their global competitors, after the expiration of the NSW Government’s 18-year moratorium on genetically-modified crop innovations commenced this month.

Having long-lasting and certainty of access to current and future GM crops approved for commercialisation will encourage stronger research and innovation, and support the sector’s abilities to reach the growing population’s needs.

Access will be maintained to all GM crops that have been approved through the Office of the Gene Technology Regulator’s robust assessments.

An increasing number of Australian farms are R&D driven, technologically advanced, capital intensive, and entrepreneurial. The agritech industry strives to enhance seeds and crops, improve diet and provide functional foods for preventative health.

Chief Executive Officer of CropLife Australia, the national peak industry organisation for the plant science sector, Mr Matthew Cossey, said “Having access to GM crops is only going to become more important as farmers continue to face periods of drought and increasingly harsher conditions in a changing climate.

“The importance of food security highlighted by the pandemic is a prime example of the continuous need for exploration and development of agricultural innovations via both conventional systems and modern approaches, such as genetic modification, gene editing and in chemical and biological crop protection.

“A major strength of biotechnology is that it does so much more than boost agricultural yields. Biotechnology has strong environmental and industrial credentials and presents substantial possibilities in medicine and healthcare for the diagnosis, treatment and prevention of serious illness and disease.”

Treasury opens patent box design consultation

Tue, 06 Jul 2021 00:00:00 +1000

Consultation on the design of the Australian patent box has been opened by Treasury, after the Federal Treasurer announced the policy for the medical and biotechnology sectors during the 2021 Federal Budget.

Following discussion with industry bodies, and critical in determining the policy’s design, Treasury has clarified the aim of the Government’s policy:

To encourage companies to base their medical and biotechnology research and development (R&D) operations, and commercialise innovation, in Australia. R&D investment is mobile and a range of factors influence companies’ decisions. While it usually takes a number of years for innovations to become profitable in the medical and biotechnology sectors, a concessional tax rate on those profits will create an additional incentive to locate R&D in Australia.
To retain the ownership of eligible patented inventions in Australia.

The consultation’s discussion paper outlines four key design features for feedback:

Definition of medical and biotechnology – how these sectors or patents will be clearly identified.
Eligible IP - only inventions claimed in standard patents granted by IP Australia, which have a priority date on/after 11 May 2021.
Eligible profits/revenues – types of patent-related revenue that’s eligible for the patent box.
Majority of R&D must be conducted in Australia - complicit with OECD Nexus requirements.

A well-designed patent box will help bridge the gap to commercialisation, and support companies to keep the development of their IP and the value they create from it - especially by manufacturing locally - in Australia to benefit Australians. It will offer sound, long-term structural policy that will benefit the country.

AusBiotech will be running information sessions on the proposed policy, and will imminently release webcast details as it gathers its members together. It is preparing its response by 16 August 2021 with support from its members, and encourages them to connect with Khaled Chakli, Director, Industry Policy and Advocacy, with their feedback by 30 July 2021.

As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science industry.

Download the consultation paper here.

FDA fast track designation for Opthea’s OPT-302

Tue, 06 Jul 2021 00:00:00 +1000

Tessara Therapeutics announces new collaboration with the Florey Institute

Tue, 06 Jul 2021 00:00:00 +1000

ResApp: Publication of COPD data and new commercial agreement

Tue, 06 Jul 2021 00:00:00 +1000

Preserving biotech’s IP rights

Thu, 01 Jul 2021 00:00:00 +1000

AusBiotech has joined BIO, the UK BioIndustry Association, and more than 290 other global biotech company leaders as they unite in their concern of the ongoing risk to international IP protection that is before the World Trade Organization (WTO).

As currently experienced across Australia, accessing COVID-19 vaccines and essential treatments is being hampered by manufacturing abilities and supply chains, rather than due to access to the IP that backs them.

Despite voluntary global agreements and more collaboration and partnerships in biotech than ever before, a misguided understanding of equitable access remains and the proposal to waive IP protection that is before the WTO will not overcome the real barriers.

Bottlenecks and shortages in global supply chains for vaccine production need to be urgently addressed. Strained health-care systems in low-and middle-income countries, particularly, need significant support to ensure vaccines get to people.

The WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver would see, under certain circumstances, member countries set aside patent rights for a medicine or vaccine in response to a public health emergency.

AusBiotech members represent a wide range of biotech firms that rely on IP to fund their research, turning ideas into products, and a platform to partner globally. Allowing international governments to waive IP rights would undermine the global collaboration that has led to more than 11 billion doses of COVID vaccines in 2021, and significantly more in the first part of 2022, being developed by existing global vaccine manufacturers.

AusBiotech was invited to sign the letter through its International Council of Biotechnology Associations (ICBA) membership. ICBA is a coalition of not-for-profit, national biotechnology trade associations formed to promote public understanding of, and to advocate for, public policies that support the growth of the innovative biotechnology industries. ICBA represents the global voice of the industry in international fora, with the goal of promoting continued innovation in the human health, agriculture, and industrial and environmental sectors.

Read the open declaration here.

SpeeDx and MolGen announce partnership for COVID-19 test solution

Thu, 01 Jul 2021 00:00:00 +1000

BiomeBank submits for market authorisation of world-first microbial therapy

Thu, 01 Jul 2021 00:00:00 +1000

Call for nominations: Victoria Prize for Science & Innovation

Tue, 29 Jun 2021 00:00:00 +1000

The Victorian Government is calling for nominations for Victoria's prestigious science research awards.

In celebration of the achievements, leadership, determination and creativity of Victorian Innovators, Entrepreneurs, Scientists and Researchers, a call for nominations is open for the 2021 Victoria Prize for Science and Innovation.

These prestigious awards support the promotion of Australia’s globally-competitive biotech talent, connects the innovation community and demonstrate the internationally-significant research and development happening within Australia.

Each prize is worth $50,000, and is awarded for a scientific discovery or technological innovation, or a series of such achievements, that significantly advances knowledge. The clear potential to produce a commercial outcome or other substantial benefit to the community will be highly regarded.

The Victoria Prize for Science and Innovation is typically awarded to an individual. It is recognised, however, that outstanding achievement is often the result of long-term collaboration between individuals making equivalent and complementary contributions. The Prize, therefore, may be awarded to a maximum of two individuals in each category, if the outstanding achievement can be clearly shown to be the outcome of a long-term collaboration.

Make your nomination by 5.00pm (AEST) 19 July 2021.

QBiotics completes successful $85 million capital raise

Tue, 29 Jun 2021 00:00:00 +1000

New collaboration between Antisense Therapeutics and MCRI

Tue, 29 Jun 2021 00:00:00 +1000

Expressions of interest: mRNA Victoria Industry Panel

Thu, 24 Jun 2021 00:00:00 +1000

mRNA Victoria, in collaboration with AusBiotech and BioMelbourne Network, is seeking Victorian-based companies with relevant experience in mRNA or RNA-related manufacture, supply chain and systems support to submit their expression of interest (EOI) for its Industry Panel.

The Industry Panel will meet as required and support mRNA Victoria, including the Scientific Advisory Group, and provide advice to mRNA Victoria on mRNA manufacturing capability and related technologies.

mRNA Victoria is a newly-established initiative, and is responsible for the Victorian Government’s commitment to establish a world-class Victorian mRNA and RNA industry by supporting supply chain and R&D for pre and clinical research, commercialisation and manufacturing investments.

mRNA Victoria identifies key capabilities, gaps and opportunities and leads the engagement and partnership with domestic and international companies, researchers and stakeholders on behalf of the Victorian Government, to build RNA capability and supply chain through a suite of investments and programmes.

Alongside providing grants and international market-entry support, it will facilitate and enter into research agreements and partnerships, and deliver programmes to support the development and commercialisation of mRNA research products.

In performing these functions, mRNA Victoria is advised by a Scientific Advisory Group made up of world leading experts from the medical research sector and is also staffed with experts in medical research and pharmaceutical manufacturing.

Registrants may be contacted and asked to provide further information once the initial EOI has been submitted.

Opal Biosciences seeking partners to establish precinct

Thu, 24 Jun 2021 00:00:00 +1000

New international guidelines for stem cell research

Tue, 22 Jun 2021 00:00:00 +1000

Responding to advances in science, revised Guidelines for Stem Cell Research and Clinical Translation have been published by the International Society for Stem Cell Research.

Stem cell research is an emerging and innovative field, and the guidelines were updated to “encompass a broader and more expansive scope of research and clinical endeavour while maintaining the fundamental principles of the research and application”. New recommendations address recent scientific advances involving embryos, stem cell-based embryo models, chimeras, organoids, and genome editing.

The Guidelines were revised with the support of a comprehensive Task Force. Australia was represented in the working group by Professor Megan Munsie, University of Melbourne, and Head -Education, Ethics, Law & Community Awareness Unit, Stem Cells Australia; Prof. Munsie is also an active contributor to AusBiotech’s Regenerative Medicine Advisory Group.

The primary goals of stem cell research are to advance scientific understanding, to generate evidence for addressing unmet medical and public health needs, and to develop safe and efficacious therapies for patients.

As the field advances, it is important to balance the excitement over the growing number of clinical trials for serious diseases with the requirement to rigorously evaluate the safety and effectiveness of each potential new intervention. The Guidelines offers a number of recommendations, and is built on a set of widely-shared ethical principles, and complement existing legal frameworks.

Stem cell therapies are part of the broader regenerative medicine (RM) ecosystem. Australia holds a strong and vibrant RM industry ecosystem with an internationally-recognised translational research, clinical trials framework and clinical centres. With more than 30 companies in Australia developing products and over 30 clinical trials in progress, Australia is globally competitive in this space.

Globally, the RM sector has more than 1,000 clinical trials in progress, and in 2020 alone it attracted USD$19.9B, doubling from the previous year. Global companies are also turning their attention to the RM sector and we are seeing more gene and cell therapies being brought to Australia for patient access.

Download and read the ISSCR Guidelines here.

New Australian R&D collaboration for Pfizer’s Centers for Therapeutic Innovation

Tue, 22 Jun 2021 00:00:00 +1000

SUDA licenses iNKT cell therapy platform from Imperial College London

Tue, 22 Jun 2021 00:00:00 +1000

Team Australia pavilion in top four on global stage

Thu, 17 Jun 2021 00:00:00 +1000

The AusBiotech-led Team Australia delegation featured in the top four largest pavilions present at BIO Digital 2021 this week, where it proudly flew the virtual Australian flag and showcased Australia’s capabilities to a global audience.

As the industry’s independent voice, AusBiotech has led the Australian delegation to BIO for more than a decade. Its 60 company-strong digital delegation, with strong Victorian and New South Wales partnerships profiled, showcased Australian capabilities, promoted the strength of the Australian life sciences, and fostered global connections with its overseas counterparts.

Delivered digitally for the second year, the conference moved to a two-week format, with a new Global Marketplace and Innovation Stage taking place on 10-11 June (US), and an interactive education week on 14-18 June (US).

Promoting Australia’s competitive advantage in life sciences and sharing the top reasons to partner and invest in our Australian sector, AusBiotech CEO Lorraine Chiroiu delivered a Global Marketplace presentation on behalf of the country. The Global Marketplace was coupled with an Innovation Stage that featured fast-paced presentations, and digital networking, allowing delegates to identify prospective partners.

Hosted by the Biotechnology Innovation Organisation (BIO), the annual conference is the largest and most influential global event for the biotechnology industry.

With the vaccine rollout underway across the globe, AusBiotech is enthusiastic to reconvene in-person next year and to continue leading the Team Australia delegation in person, and to host the Australian pavilion. The pavilion showcases Australian companies, promotes the strength of the Australian life sciences, and fosters the global connections with its overseas counterparts.

Orthocell announces new patents in China and NZ

Thu, 17 Jun 2021 00:00:00 +1000

Progress welcome on national front door for clinical trials

Tue, 15 Jun 2021 00:00:00 +1000

AusBiotech has welcomed the first step towards a national front door for clinical trials, as the Australian Commission on Safety and Quality in Health Care announces scoping is underway on a national one-stop-shop and consequently, a ‘National Clinical Trials Front Door’.

AusBiotech has been supportive of the concept of a national front door, since it was mooted more than two years ago, through national speaking opportunities, formal submissions, and through its ongoing discussions with Ministers and departmental staff. Health Minister Greg Hunt has previously acknowledged it as a “golden” opportunity for Australian clinical trials.

The proposed national online portal for all health and medical research seeks to make it easier for researchers, industry and sponsors to find, conduct, participate and invest in research in Australia.

AusBiotech CEO, Lorraine Chiroiu, said, “We’re supportive of the compelling opportunity of the one-stop-shop and a national front door for clinical trials. Australia offers a globally-competitive environment and by reducing the administration and supporting every stage of research – from application to approval and reporting – it will support us to cut the red tape, and roll out the red carpet, as Australian clinical trials remain open for business.”

Consultation is underway to develop a national, interconnected, rapid and streamlined approvals platform that will:

include a cross-jurisdictional ethics and governance approvals platform that incorporates key application, notification and approval systems;
incorporate the Clinical Trials Notification and Clinical Trials Approval schemes administered by the Therapeutic Goods Administration;
include an embedded and automated next-generation national clinical trials registry;
provide sophisticated monitoring and reporting functionality for different users.

Options for improving patient recruitment through a related National Clinical Trials Front Door, will also be considered.

As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science industry.

AusBiotech, together with its Clinical Trials Advisory Group, will be actively engaged in this consultation. To register your interest with the Australian Commission on Safety and Quality in Health Care in being involved in the upcoming consultation, click here.

Starpharma's Viraleze registered for sale in India

Tue, 15 Jun 2021 00:00:00 +1000

Engage on upcoming UDI system changes

Thu, 10 Jun 2021 00:00:00 +1000

Medtech stakeholders can be kept abreast of how the establishment of a new Australian Unique Device Identification (UDI) system will effect their companies through the Therapeutic Goods Administration’s upcoming webcast series.

The introduction of the UDI system offers manufacturers and sponsors, and procurement and supply chain functions, improved abilities to: manage inventory through its ability to automatically capture production information by scanning a label, and to automatically capture device information, reducing time and risk of data errors and inconsistencies. It also offers improved post-market surveillance due to the ability to unambiguously identify models of devices on a national, regional, and global basis.

Many manufacturers supply to multiple markets and are preparing to meet the new European Union (EU) regulations; the TGA is not planning to implement before the EU dates. The TGA is in its early planning stages for the Australian implementation and has not yet defined the new regulations, regulatory dates or the transition approach. The webcast series will keep stakeholders informed on its progress.

Through its AusMedtech Regulatory Affairs Advisory Group, AusBiotech has been responding to TGA consultations on implementing a UDI system in Australia for more than two years. The Advisory Group also regularly participates through the TGA’s Regulatory & Technical Consultative (RegTech) Forum. This ongoing engagement has supported the TGA in its planning and design of the Australian UDI system.

Previous submissions, most recently in November 2020, support the idea of a UDI system, on the proviso that Australia adopts a globally harmonised system that is consistent with that of the US and EU. This includes ensuring alignment with international coding standards of UDI issuing agencies designated in the US and accredited in the US.

Monthly webinars are being held by TGA. The first webinar is on 11.30 – 12.30 pm (EST), Tuesday, 15 June 2021, and will cover the background to the UDI in Australia and progress to date, and allow time for questions and answers. Register here.

Sessions will also be recorded and available on the TGA website.

Proteomics International announces new executive appointments

Thu, 10 Jun 2021 00:00:00 +1000

Taking action against IP protection threats

Tue, 08 Jun 2021 00:00:00 +1000

AusBiotech is inviting its Members to join it in signing a global, open letter in opposition to the ongoing risk to international IP protection that is before the World Trade Organization (WTO).

An open letter from members of the world’s biotechnology ecosystem regarding COVID-19, intellectual property and access to vaccines and other essential treatments, is being developed through the International Council Biotechnology Association (ICBA), and AusBiotech and its members have been invited to back this critical message.

The global biotech industry is united in its drive for equitable access to COVID-19 vaccines, but the proposal to waive IP protection that is before the WTO will not overcome the barriers preventing access.

AusBiotech members represent a wide range of biotech firms that rely on IP to fund their research, turning ideas into products, and a platform to partner globally. Allowing international governments to waive IP rights would undermine the global collaboration that has led to more than one billion vaccine doses being administered in 188 countries so far.

The letter outlines how “more must be done to ensure global access to the vaccines, therapeutics and diagnostics that have been developed by our sector. We strongly believe we must address access issues in a way that not only ensures that we are able to save more lives during the current pandemic, but also helps make certain that we are better prepared, and better positioned, to respond to the next one.”

Uniting the pipeline, AusBiotech is joined by Medicines Australia in co-signing the letter. The two organisations, and its memberships, have a strong relationship and collaborate together to foster and support the biotech and medicines industry.

AusBiotech was invited to sign the letter through its ICBA membership. ICBA is a coalition of not-for-profit, national biotechnology trade associations formed to promote public understanding of, and to advocate for, public policies that support the growth of the innovative biotechnology industries. ICBA represents the global voice of the industry in international fora, with the goal of promoting continued innovation in the human health, agriculture, and industrial and environmental sectors.

AusBiotech members are invited to contact Karen Parr, Director Communications, for a copy of the letter and to co-sign it.

Telix and ATS awarded 'Eurostars’ grant for alpha therapy

Tue, 08 Jun 2021 00:00:00 +1000

2022 sees biggest week in biotech heading to WA

Thu, 03 Jun 2021 00:00:00 +1000

Two of Australia’s premier life science industry events are heading to Western Australia in 2022, for the first time in more than 15 years. AusBiotech 2022 and Australia Biotech Invest & Partnering 2022 will showcase Australian life sciences, and deliver the biggest week in biotech for the year.

Lorraine Chiroiu, CEO of AusBiotech said, “AusBiotech is thrilled to be partnering with Business Events Perth and the WA Government to bring two of Australia’s premier life science events to Perth in 2022, for the first time in more than 15 years. The mature sector continues to flourish and deliver social and economic benefits to the country, and these platforms offer critical opportunities for industry to engage with each other and with potential investors and partners.”

It is expected that the two conferences will attract more than 1,000 Australian and global researchers, investors and industry stakeholders from across the life sciences pipeline to Perth, WA.

The annual AusBiotech conference is Australia’s largest life sciences conference and has been delivered for industry, by industry, for more than 35 years. A world-class programme of forward-thinking, diverse, and engaging topics and speakers will drive meaningful discussion, and celebrate and champion the sector. The premier event unites companies and leaders, and offers the chance to engage, profile, partner, and build networks.

Engaging capital with innovation, AusBiotech’s annual Australia Biotech Invest & Partnering event remains the preeminent opportunity for companies to present their technology and story to a network of potential international partners and investors. AusBiotech is passionate about growing the event that has been successfully established for more than a decade into a ‘mini JP Morgan’.

Science and Medical Research Minister Roger Cook said, "The annual AusBiotech conference is an exciting opportunity for our medical and life science community to showcase its competitive advantages, build networks and secure new partnerships.

"Life sciences is a rapidly growing industry in WA, so it's more than fitting that AusBiotech 2022 is held right here in Perth. Medical technology that has the potential to improve lives internationally is being developed right here in Western Australia, and we look forward to sharing our industry knowledge and success with the world."

AusBiotech’s Sector Snapshot 2019 revealed the Western Australia life sciences industry had notably increasing, with the number of organisations increasing from 119 in 2017 to 179 in 2019. Overall, the Australian life sciences sector has a substantial 1,800 organisations and employs around 240,000 people.

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

About AusBiotech

2022 sees biggest week in biotech heading to WA

Thu, 03 Jun 2021 00:00:00 +1000

It is expected that the two conferences will attract more than 1,000 Australian and global researchers, investors and industry stakeholders from across the life sciences pipeline to Perth, WA.

First patient dosed in combination trial of QBiotics and MSD therapies

Thu, 03 Jun 2021 00:00:00 +1000

Help shape the AusBiotech 2021 programme

Tue, 01 Jun 2021 00:00:00 +1000

AusBiotech is calling for session proposals and speakers for Australia’s largest life sciences event of the year: AusBiotech 2021, to be held 25 - 29 October. Running for more than 35 years, Australia’s premier conference is developed by industry, for industry, and celebrates and champions our sector.

AusBiotech 2021 will enable you to engage, your way, with current and future biotech leaders to pitch, partner, and exchange - no matter where you are. The thriving Australian and global biotechnology community will connect through a week of live and on-demand virtual sessions, and in-person functions.

AusBiotech is seeking speakers who are forward-thinking, diverse, engaging and who drive meaningful discussion about the business of biotech. Thought-provoking session ideas should explore current trends, critical and emerging topics, breakthroughs, and stories from a range of areas that encourage creative conversations both locally and abroad.

The annual AusBiotech conference brings together more than 1,000 leading innovative thinkers and inventors across the Australian and international biotech sector. For more than three decades, the event has formed a very special part of AusBiotech’s broader work positioning Australia’s biotechnology industry for growth. As a leaders’ forum, it is also a key opportunity to connect with potential partners and investors, to reflect on the sector’s achievements and to exchange ideas to further advance the sector’s standing both nationally and globally.

AusBiotech is committed to diversity and inclusion, and submissions for panels must be gender diverse.

Applications close at 5.00 pm (AEST), 23 June 2021. Submit your proposal now.

For more information see ausbiotechnc.org or contact events@ausbiotech.org.

Neuren to proceed with INDs for three trials after FDA meeting

Tue, 01 Jun 2021 00:00:00 +1000

Testing shows Starpharma's Viraleze highly active against UK COVID strain

Tue, 01 Jun 2021 00:00:00 +1000

AusBiotech bolsters advocacy capabilities

Thu, 27 May 2021 00:00:00 +1000

AusBiotech is bolstering its capabilities, appointing two new members to its team: Director, Industry Policy and Advocacy: and Industry Communications Coordinator. These roles are critical for AusBiotech as it drives the sector forward during a time when biotech is being recognised for the economic and social benefits it delivers.

AusBiotech is delighted to announce Mr Khaled Chakli will join the team next week, where he will apply his strong policy and scientific skills and knowledge as he champions the organisation’s policy and advocacy work.

Employing his expertise in policy development, strategic communications and stakeholder relations in government, business, and in the non-profit sector, Khaled’s initial focus will be working with industry on the development of the decadal strategic framework, the Biotech Blueprint. The Blueprint is an important opportunity for industry to unite to reflect what a vibrant and valuable Australian biotech industry could and should look like a decade from now, and for the industry to speak with one voice to governments.

Khaled’s background includes working as an advisor to members of parliaments; Manager of Policy and Advocacy for the Australian Academy of Science; and the former Executive Director of the Australian Brain Alliance - a national body for brain research institutes and neurotechnology organisations. Khaled is an MBA candidate at the University of Melbourne, has an academic background in arts/psychology, and has studied in biomedical science.

Ms Shannan Osrin has also been warmly welcomed into AusBiotech’s Communications Team as its new Industry Communications Coordinator. This role centres around membership engagement, and enhancing the reputation and positioning of the Australian life sciences industry. As well as increasing opportunities for members to offer their views and achievements, Shannan will be supporting its Advisory Groups and Committees, who provide advice and guidance on current and emerging trends.

Shannan has spent the past four years supporting external and internal communication activities at MTPConnect, including connecting with industry leaders as she produced, and sometimes hosted, podcasts, and sharing sector news through its social media platforms. Shannan holds a double degree with a Bachelor of Communications and a Bachelor of Arts from Edith Cowan University in Perth, where she majored in journalism and writing.

As the national voice of the Australian biotechnology industry, AusBiotech continues to champion advocacy and to be recognised as a persuasive, credible and collaborative voice of leadership for Australia’s life sciences industry. Telling industry’s story, working with governments, and facilitating sector investments, AusBiotech will ensure industry’s rightful place as a key and growing economic and social driver.

New collagen rope patent for CelGro platform technology

Thu, 27 May 2021 00:00:00 +1000

Nutromics wins best early-stage project award

Tue, 25 May 2021 00:00:00 +1000

Nutromics took home the coveted ‘Best Translational Research’ award at AusMedtech 2021’s Early-Stage Investment Forum, after winning the pitching event judged by an expert investment panel.

Nutromics’ Head of Commercial and Intellectual Property Ms Rosie Stramandinoli presented the company’s wearable Continuous Molecular Monitoring (CMM) platform which can measure a wide array of molecular targets continuously and in real time, including drugs, hormones, metabolites, and proteins. This platform technology enables clinicians to receive continuous real-time molecular data to accurately dose a patient and keep them within a narrow therapeutic range. Nutromics’ vision is to create a world with zero preventable deaths due to the lack of timely, molecular-level data.

Commenting on her win Rosie said “I was honoured to present Nutromics’ vision at the Early-Stage Investment Forum and thrilled that the technology resonated with the judges. Nutromics will be closing a funding round soon and this win, along with the one-on-one mentoring with Medtronic ANZ, will go a long way in helping us turn our vision into reality.”

Partnering with AusBiotech to deliver the Early-Stage Investment Forum, Medtronic ANZ’s Business Development & Strategy Manager Jamie Platt will mentor Nutromics for six months, includes in-depth and personalised pitch analysis, expert insight into future planning, and access to key industry contacts to help with preparation, negotiating, growth, and closure.

AusBiotech also extends its thanks to the expert panellists who generously shared their insights and experience with the 15 presenters during the Forum: Sarah Meibusch, Principal, One Ventures; Steven Suchting, Investment Director, IP Group PLC; Kathy Connell, Senior Director, New Ventures, Australia & New Zealand, Johnson & Johnson Innovation; and Jamie Platt, Business Development and Strategy Manager, Medtronic.

The successful initiative offers feedback essential for commercialising early-stage projects and technologies, and is one aspect of AusBiotech’s work in empowering start-ups and SMEs during their commercialisation journey.

Featured at the annual AusBiotech conference since 2018, this was the first time the Forum was held at AusMedtech 2021, Australia’s premier medtech event. A strong number of applications were received for the initiative, demonstrating the healthy research pipeline that Australia fosters.

The Forum featured rapid-fire rounds of quick-pitch presentations from early-stage technologies and projects from local research institutes, universities, hospitals and pre-series A companies in the areas of medical devices and diagnostics, digital health and enabling technologies.

AusMedtech 2021: Reimagine and reconnect offered a week of inclusive half-day virtual sessions that represented Australia’s medtech industry. Reconnect with a network of resilient and innovative leaders, and reimagine the future of medtech beyond our borders.

Run by industry, for industry, AusMedtech week featured a mix of cutting edge leading keynotes, expert panel discussions, and Q&A, bringing together key stakeholders of the Australian and international medical devices and diagnostics sector to help prepare the industry sector for its changing landscape.

AusMedtech 2021 was supported by the Victorian Government as the Host State Partner.

Registered delegates can rewatch content on-demand until 21 June 2021.

Chimeric Therapeutics updates on CAR T clinical trial

Tue, 25 May 2021 00:00:00 +1000

Microba Life Sciences and Illumina partner to accelerate microbiome research

Tue, 25 May 2021 00:00:00 +1000

Celebrating International Clinical Trials Day

Thu, 20 May 2021 00:00:00 +1000

AusBiotech is celebrating International Clinical Trials (CT) Day today, 20 May, recognising Australia’s leadership and excellence in CTs and the important role it plays in Australia’s economy, healthcare and social fabric, with benefits far beyond helping develop new treatments.

Australia’s first rate facilities and quality of medical research are internationally recognised. Commencing over 1,000 CT annually, they represent a AU$1 billion industry investment. Australia’s proximity to Asia, combined with our diverse population and robust regulations, brings a strong advantage in this competitive market.

Australia offers a world class CT ecosystem, and AusBiotech has been promoting and advocating for more than a decade to keep it in its principal position.

Bristol Myers Squibb’s (BMS) recently commissioned research from Evaluate (2021) ‘Pathways to deliver harmonisation of clinical trial approvals in Australia’ offered insights into enhancing Australia’s attractiveness for CT even further, and the benefits this would garner, including: increased patient access, building local capacity, upskilling talent, economic growth through a relief to PBS and other parts of the health system, and direct revenue to the Australian industry. Introducing the suggested changes could deliver a return on investment of $5.80 for every dollar invested.

As one of the company’s top six countries for CT investment globally, Australia attracted $33M of BMS’ investment in 2017. The same year, BMS partnered with over 100 local academic research institutes and support service organisations to conduct 65 clinical studies with nearly 1,300 Australian patients participating. This is a clear demonstration of the additionality offered through a thriving biotechnology ecosystem.

Acknowledged as a “golden” opportunity for CTs by Health Minister Greg Hunt, AusBiotech has been advocating for the development of a ‘national front door’ for CT. The BMS report also found this to be a clear action that would add a lot of value: “Multiple state-based online information systems and portals still exist, meaning that investigators and sponsors need to provide different data and forms across different jurisdictions. [This] adds to the complexity for those trying to establish new clinical trials. Harmonisation of these systems would support trial sponsors to maintain and build on their current activities.”

Actively participating in formal quorums and processes, AusBiotech sits on the Federal Government’s Clinical Trials Collaborative Forum which identifies issues, exchanges information and engages in collaborative problem solving, with a view to reducing duplication and improving the CT environment. AusBiotech has also engaged with on the Clinical Trials Governance Framework which aims to improve quality, efficiency and timeliness of CT by reducing duplication and increasing efficiency, cohesion and productivity across the CT sector.

Australia’s global leadership in CTs is promoted by AusBiotech at international speaking opportunities, such as at Biotech Showcase at JP Morgan, BioKorea, and BIO. Earlier this year, AusBiotech hosted a webcast during JP Morgan week, to demonstrate the value of Australia's CT and medical innovation advantages. Working in Australia offers a compelling opportunity for CT, and this webcast connected with international companies and showcased the country’s opportunities and capabilities that can be taken advantage of.

During this week’s AusMedtech 2021: reconnect and reimagine – AusBiotech’s premier medtech conference happening this week – industry leaders have discussed the barriers for conducting CTs, and provided insights and solutions to overcome these challenges.

Challenging and driving the sector forward, panels considered how technology advancement offering increased opportunities for hospitals and researchers to develop devices that meet patient needs and taking products to the global market, as well as the recent and swift changing CT landscape in response to COVID-19 - from telehealth to at-home diagnostics, from remote patient care to vaccines. These sessions are available to registered delegates on-demand for 30 more days.

International CT Day is celebrated around the world on or near the 20 May to commemorate the day when James Lind commenced what is recognised as the first ever randomised CT in scurvy in 1747, laying the foundations for modern clinical research.

Recce Pharmaceuticals progresses R327 in SARS-CoV-2 screening program

Thu, 20 May 2021 00:00:00 +1000

AusBiotech presents at Parliamentary Inquiry

Tue, 18 May 2021 00:00:00 +1000

AusBiotech presented today at the Parliamentary Inquiry into approval processes for new drugs and novel medical technologies in Australia, highlighting the long-term and stable biotech policy incentives needed to support and sustain R&D for treating rare diseases and conditions, where there is high and unmet clinical need.

Biotechnology innovation occurs in a unique environment and faces highly complex challenges, and AusBiotech highlighted the necessary enablers to commercialise research. Ms Lorraine Chiroiu, CEO, AusBiotech, underscored the long-term bipartisan support for the R&D Tax Incentive, and how the design of the patent box – announced in the Federal Budget last week – will be key to unlocking further economic and social benefits.

Lorraine Chiroiu, CEO, AusBiotech said, “… we would like to see our pre-revenue companies mature and earn revenue, because that indicates that a treatment, vaccine, device or diagnostic has reached a patient. It indicates that research has been commercialised or translated, and it then creates value. It is reliant on all parts of the pathway being open and healthy, as gaps and blockages impede our progress.

“Every researcher with a promising technology, university or MRI tech transfer office, spin-out, start-up or SME must have a clear, reliable, consistent view to the point of commercialisation, market and patient access – if we, the Australian community, are ultimately to benefit. … If we wish to have access to these new and novel technologies then we need to ensure the pathway is fit for purpose and the structures welcome, rather than block, our progress.”

AusBiotech was pleased to make a submission in October 2021 to the House of Representatives Standing Committee on Health, Aged Care and Sport, chaired by Coalition MP Trent Zimmerman, in response to the Inquiry. The Inquiry follows a referral from the Minister for Health, the Hon Greg Hunt MP.

AusBiotech’s submission and comments directly addressed the Inquiry’s Terms of Reference and outlined key areas where Australia can respond to emerging global trends and be well positioned to access new drugs and novel medical technologies in a timely manner. It also identified:

areas of innovation and opportunities in relation to new therapeutic and medical interventions
policy levers to incentivise research, development and commercialisation of products in the biotechnology sector
the importance of clinical trials in the development process of bringing new therapies, devices and diagnostics to patients, and
enhancements to Australia’s regulatory and reimbursement frameworks for cell and gene therapies, across areas of innovation such as digital health, precision medicines as well as rapid diagnostics.

BioCurate and Monash University launch oncology startup company

Tue, 18 May 2021 00:00:00 +1000

Sanofi and GSK advance COVID-19 vaccine to late-stage trial

Tue, 18 May 2021 00:00:00 +1000

2021 Federal Budget backs biotech

Thu, 13 May 2021 00:00:00 +1000

Announcements in the 2021 Federal Budget are backing biotech and demonstrating the Government’s ongoing recognition of biotechnology as a long-term social and economic driver that will enhance Australia’s competitiveness, and keep us at the cutting edge of science and innovation.

Following the October budget’s support of pre-revenue companies through the RDTI, this budget offers further support of biotech manufacturing and the talent behind the companies and products.

Research and innovation are central to Australia’s international competitiveness and the newly announced patent box will help bridge the gap to commercialisation, and support companies to keep the development of their IP and the value they create from it - especially by manufacturing locally - in Australia to benefit Australians.

Only patents applied for after the Budget announcement will be eligible, which means that the benefits will not be seen for some years, however AusBiotech is pleased that the patent box will offer sound long-term structural policy that will benefit the country. Advocacy interest in the incentive commenced in 2013, and AusBiotech commends the Government whole-heartedly for this announcement for medical and biotechnology innovations. The Government has pledged to work closely with industry on its design, and AusBiotech looks forward to continuing this work together.

The budget also included support for building sovereign manufacturing capability by way of developing onshore mRNA vaccine manufacturing capability in Australia; employee share schemes reform; clinical trials support, scholarships for women in STEM, in partnership with industry; and retaining the prostheses list.

As the national voice of the biotechnology sector for more than 35 years, AusBiotech remains committed to amplifying opportunities and communicating the industry’s concerns to reduce barriers. It is pleased to deliver a wrap-up of announcements for life sciences that will work to support the capability and capacity of our sector and enable it to thrive long-term as a global leader.

Approval for Telix's phase three prostate cancer trial

Thu, 13 May 2021 00:00:00 +1000

NSW government backs expansion of SpeeDx and Baxter

Thu, 13 May 2021 00:00:00 +1000

International IP protection at risk for COVID-19 vaccines

Tue, 11 May 2021 00:00:00 +1000

The global biotech industry is united in its drive for equitable access to COVID-19 vaccines, but the proposal to waiver IP protection that is before the World Trade Organization (WTO) will not overcome the barriers preventing access.

Vaccine production is complicated and few organisations around the world can do it at scale, at low cost, and in compliance with the strict standards and public expectations of manufacturing safety. Supply chain and distribution challenges, regrettably, are preventing increased vaccine output and delivery.

The Biden Government backflipped last week on its support of the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver, followed by other countries, including Australia. The waiver would see, under certain circumstances, member countries set aside patent rights for a medicine or vaccine in response to a public health emergency.

While it typically takes many years to develop biotech IP, once approved it requires safe and approved manufacturing facilities, a stable and expeditious supply chain, and a sizable and trained workforce to deliver them. Waiving IP rights would jeopardise the existing quality control systems in place, and make it far more difficult to distinguish genuine vaccine products from ‘knock-offs’ that may target vulnerable communities. It would also not address the workforce challenges.

AusBiotech members represent a wide range of biotech firms that rely on IP to fund their research, turning ideas into products, and a platform to partner globally. Allowing international governments to waive IP rights would undermine the global collaboration that has led to more than one billion vaccine doses being administered in 188 countries so far.

AusBiotech CEO, Lorraine Chiroiu, said, “The impacts being felt in countries hard-hit by COVID-19 is tragic, but highlights the importance of the biotech sector and the IP it relies upon to deliver new vaccines.

“The best way to end the COVID-19 pandemic is to immunise individuals across the globe, and the answers don’t not lie in removing our innovators’ IP rights through the TRIPS waiver. It will not address the current access barriers being faced in the developing world, and the changes could cause long-term detrimental effects to our global development of vaccines and therapies.

“Weakening IP protection and disincentivising investment into biotech companies must be considered with extreme caution. Fostering these technologies is essential, and we must retain the protection and sustainability of the critical research and innovation behind the industry’s life-saving technologies, and avoid setting precedents. Disincentivising investment could result in less technologies available and less willingness to engage in global collaborations when we face the next, inevitable, pandemic.”

AusBiotech’s IP Advisory Group Chair, Declan McKeveney, Senior Counsel, FB Rice, added, “The WTO TRIPs waiver may have well-intentioned support but it overlooks key aspects of the current innovation system and it is by no means clear that its implementation would solve the problems it purports to address.

“No clear evidence has been provided as to IP rights being a barrier to COVID-19 vaccine access. It would appear that a more significant challenge relates to manufacturing bottlenecks and it is not clear how the waiver proposal would address these in any way. Holding up IP rights as a barrier to faster vaccine production and distribution also ignores the significant time challenge presented to any country in scaling up vaccine production while maintaining essential regulatory approval standards to ensure safe and efficacious vaccine production.

“Importantly, the waiver proposal also ignores the already significant waiving of patent enforcement rights; provision of key manufacturing information and data; and wide-spread collaboration exhibited by a number of the key biotechnology players who have enabled the successful design and production of a number of efficacious vaccines. The dissemination of the necessary technology can, and is, being achieved by existing technology transfer means including licensing arrangements and large numbers of vaccine doses are already being produced with capacity increasing all of the time.

“It is key to acknowledge that the incredible speed with which this has been achieved has been based, for example in the case of the mRNA vaccines, on technology which was incentivised and developed over many years under existing IP regimes by biotechnology companies spending significant amounts of resources in addressing challenging technological problems and accepting all of the uncertainty, both scientific and financial, that goes with the development of new therapeutics.”

WTO negotiations typically take time to reach consensus-based decision making, and due to the complexity of the challenges being faced. Scaling up manufacturing also takes time – and it is the distribution of vaccines, rather than the IP behind them, that countries need to remain focused on to achieve greater access.

Prescient signs CAR-T agreement with Peter Mac Cancer Centre

Tue, 11 May 2021 00:00:00 +1000

Bionomics expands study of BNC210 to include social anxiety disorder

Tue, 11 May 2021 00:00:00 +1000

Budget delivers for biotech manufacturing

Tue, 11 May 2021 00:00:00 +1000

AusBiotech welcomes the support for biotech manufacturing as the Federal Treasurer announces a new patent box during tonight’s Federal Budget.

The announcement demonstrates the Government’s ongoing recognition of biotechnology as a long-term social and economic driver, will enhance Australia’s competitiveness and keep us at the cutting edge of science and innovation.

A new “patent box” incentive will tax corporate profits from Australian developed and patented medical and biotechnology innovations at a concessional 17 per cent effective corporate tax rate. An internationally competitive tax regime for patents will help encourage companies to develop their research and development innovations into profitable businesses in Australia.

AusBiotech CEO, Lorraine Chiroiu, said: “We commend whole-heartedly the patent box announced in tonight’s Budget for medical and biotechnology innovations.

“Research and innovation are central to Australia’s international competitiveness and the patent box will help bridge the gap to commercialisation, and support companies to keep the development of their IP and the value they create from it - especially by manufacturing locally - in Australia to benefit Australians.

“This approach as it is central to helping ensure that Australian manufacturers remain competitive on an international scale by bridging the gap between R&D and commercialisation.

“This tax incentive will address the gap that leaves our IP vulnerable, retain home-grown IP, and support Australian innovators and manufacturers. It will make the commercialisation of IP and manufacturing in Australia more genuinely viable for businesses.”

The patent box’s purpose would be to encourage the manufacturing and commercialisation phase of innovation by providing an incentive to industry to locate high-value jobs associated with the development, manufacture and exploitation of IP in Australia.

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

About AusBiotech

Emails re: AusBiotech conference lists

Mon, 10 May 2021 00:00:00 +1000

It has come to our attention that a company, such as ACE B2B Global Marketing Inc, is seeking to sell a contact list that is titled with AusBiotech’s name and logo - in an unapproved manner.

We wish to advise that this activity is not associated with AusBiotech in any way, and that our database remains secure. We cannot verify the quality of the list and note that proceeds are not being returned to support the industry.

AusBiotech does not share (or sell) the contact details of its stakeholders and maintains privacy of information according to its privacy policy (https://www.ausbiotech.org/privacy-policy).

Please see below for an example. Different marketing executives’ names and domains are seeking to sell exactly the same product and we believe this is emanating from the same source.

Kind regards

Lorraine Chiroiu
Chief Executive Officer
AusBiotech Ltd

___________________________________________________________

Good Day,

I am glad to inform you the Australia's Biotechnology Organisation 2021 registered E-mail Contact list is available now.

Information fields include: Contact name, Company name, Job Title, Company Mailing, Verified E-mails, Contact number and more.

Shall I send you Counts and Cost details for full database.? Please let me know.

Awaiting for your reply

Regards,
Avery Daniel
Head of Sales and Marketing

Last chance to register for AusMedtech 2021

Thu, 06 May 2021 00:00:00 +1000

In less than two weeks hundreds will gather for Australia’s premier medical technology conference, which will reconnect key stakeholders of the Australian devices and diagnostics sector to help reimagine the industry during a changing landscape. Business partnering will open in less than one week.

Five keynotes and a plethora of panels will traverse the medtech innovation pipeline through a week of virtual half-day sessions that represent Australia’s medtech industry. Over 65 speakers unite to celebrate the successes and impacts our industry has made, and engage on the reimagined future of medtech. On-demand programming will also be accessible for a further 30 days post AusMedtech 2021.

Run by industry, for industry, the programme features a mix of cutting-edge leading keynotes, expert panel discussions, and Q&A. Keynotes include:

Reimagining MedTech through partnership, real world innovation and ingenuity – a fireside chat with Tim Schmid, Company Group Chairman, Johnson & Johnson Medical Devices, Asia Pacific;
Ellume: An Australian success story – Dr Sean Parsons, Managing Director and Co-Founder, Ellume
EU medical device regulation, implications for the TGA and Australia – Adjunct Professor John Skerritt, Deputy Secretary, Health Products Regulation, Australian Department of Health
Accelerating the commercialisation journey through partnering with big medtech – the Epi-Minder story – Dr Rohan Hoare, Chief Executive Officer, Epi-Minder
Accessing the global market – Kate Quirke, Group Managing Director & CEO, Alcidion.

AusPartnering, AusBiotech’s highly popular business matching programme, opens on Monday, 10 May, and offers registered delegates the opportunity to schedule one-on-one private meetings with other conference attendees and participants.

In an exciting new development, AusBiotech’s Early-Stage Investment Forum is being held for the first time at AusMedtech 2021, and offers 15 early-stage projects and technologies the opportunity to gather feedback from an expert and investor group; advice that is essential when commercialising biotech technologies.

AusMedtech 2021 is supported by the Victorian Government as the Host State Partner.

Nyrada announces to new cholesterol-lowering drug candidates

Thu, 06 May 2021 00:00:00 +1000

Companies sought for AusBiotech’s new pitching series

Tue, 04 May 2021 00:00:00 +1000

AusBiotech is inviting expressions of interest from its corporate members for its new virtual pitching series, BiotechPitch. Its new platform will profile Australian companies to investors internationally, and will feature expert industry speakers and commentators offering capital insights and market updates.

Overcoming border closures, the series provides access to local and international investors, and will also be available to the broader and interested biotech community.

Each BiotechPitch will highlight innovative companies in an industry sub-sector, such as regenerative medicine (including cell therapies and immunotherapy), digital health, and diagnostics, and will feature up to five investment opportunities.

Expert speakers will share the virtual stage, providing insights on current investment trends, including sourcing capital, preparing for capital raising, understanding the priorities of investors, and the challenges and opportunities in the COVID-19 era.

The series has been developed as a free-of-charge opportunity for AusBiotech’s corporate members, and is part of AusBiotech’s broader Investment Programme. AusBiotech helps Australian life science companies connect with international capital markets and empowers them to be competitive on a global scale. The Programme leads companies to global investment hubs; arranges access to opportunities for collaboration and partnerships; and provides investor support and education, both domestically and internationally.

The BiotechPitch series will be scheduled over the coming months, and AusBiotech invites its corporate members to check their eligibility and express their interest now.

Providing further support to the sector, AusBiotech has developed a range of resources for investors and companies that is specific to the life sciences sector, including:

Guide to Life Science Investing – to overcome investor hesitancy, the Guide aims to build an improved understanding of the unique life sciences sector to increase the quantity and quality of investment in life sciences companies.
Roadmap to a successful IPO for life sciences companies - the Roadmap aims to provide life sciences companies with independent, non-proprietary information about becoming an ASX–listed company.
Code of Best Practice for Reporting by Life Science Companies - ASX and AusBiotech strongly encourage companies in the life science sector to adopt best practice in reporting events to investors.
Guide for Life Science Company Directors - to support and enhance the performance of boards of directors leading public and private life science companies.

See AusBiotech’s investment resources here.

Recce Pharmaceuticals' R327 shows promise against pathogens

Tue, 04 May 2021 00:00:00 +1000

Australian drug discovery to be studied in the US

Tue, 04 May 2021 00:00:00 +1000

Medtech featured in April’s Australasian Biotechnology journal

Thu, 29 Apr 2021 00:00:00 +1000

Australia’s dynamic medtech sector is taking centre stage in the May edition of Australasian Biotechnology, AusBiotech’s official journal, in anticipation of the upcoming AusMedtech 2021 conference.

Providing a platform for education, the journal strengthens and grows industry knowledge of Australian capabilities and enablers through commentary from a diverse range of authors. This edition’s themes include cutting-edge discussions at AusMedtech 2021; global medtech opportunities; intellectual property: positioning with purpose, and how timing is everything when mastering the protection and commercialisation.

AusBiotech is also celebrating 35 years of providing advocacy and national representation for Australian biotechnology. The journal toasts the successes of the industry today, how far the dial has shifted since the organisation was first incorporated, and the strong leaders upon whose shoulders we stand. AusBiotech and Johnson and Johnson Industry Leadership Awards 2020 winners are profiled, demonstrating the life sciences leaders who are championing the sector and the Australian community through the worst pandemic and the greatest collaboration seen in the industry.

The April journal also contains regular features, including the AusBiotech Chair and CEO Report, and AusBioStock – an exclusive report from James Fletcher, Evans & Partners. The journal welcomes new AusBiotech members, and holds a list of AusBiotech corporate members. AusBiotech members that are located in Australia and have opted in will shortly receive a print copy of the journal in the mail.

In-depth commentary on the Australian and global medical technology sector will continue at AusMedtech 2021, being held 17 - 21 May, live online and on-demand. AusBiotech thanks the support its Host State Partner, Victoria Government. Registrations remain open.

The next edition of Australasian Biotechnology will be released in October. Please contact Karen Parr, Director, Communications at AusBiotech if you are interested in contributing, or to find out about advertising opportunities.

Australasian Biotechnology is published bi-annually in partnership with Executive Media.

Download the journal now.

Artificial super stool to bring hope for people with chronic gut disease

Thu, 29 Apr 2021 00:00:00 +1000

Orthocell says study results open US market opportunity

Thu, 29 Apr 2021 00:00:00 +1000

Report shows life sciences’ economic contribution

Tue, 27 Apr 2021 00:00:00 +1000

The impact of Victorian Government’s investment in health and medical research has been revealed through its newly released report ‘Creating a healthy future.’

The report dives into how successive Victorian Governments have invested in the health and medical research system over the past twenty years, and the impact these investments have had.

The primary findings demonstrate life sciences’ economic contribution, with every dollar of Victorian Government funding invested to support the health and medical technologies and pharmaceuticals sectors has generated an additional Gross State Product (GSP) of $3.66 and additional income of $4.54 in Victoria.

Dr Amanda Caples says, “We have an opportunity to build on the evidence base presented in this report to inform a new 10-year investment framework that continues to stimulate and sustain a strategic economic asset that has demonstrated its value in rising to urgent health challenges.”

The report highlights how Victorian medtech and pharmaceutical companies spend just under $1 billion a year on research and development, and their exports are worth over $2.4 billion each year.

Biotechnology offers high-worth jobs. Medical research institutes (MRIs) in Victoria employ almost 5,000 people and, in 2018-2019, spent $365 million on research activities, ran almost 600 clinical trials, spun out five start-up companies and received $223 million in competitive grant income from government and philanthropic organisations.

To further demonstrate the impact of the sector, 11 case studies spanning the biotech pipeline are presented. These illustrate the diversity, strategic intent, and impacts over time, and include AusBiotech members: Bio21 Institute; Walter and Eliza Hill Institute of Medical Research; Australian Regenerative Medicine Institute; Murdoch Children’s Research Institute; CSL; Burnet Institute, and the BioMelbourne Network.

The value of AusBiotech, and its drive to facilitate local, national and international networks, was acknowledged as a feature of Victoria’s approach to developing the health and medical research and biotechnology industry sectors. AusBiotech thanks the Victorian Government for its ongoing support in premier conferences, including AusMedtech 2021, and to BIO: the industry’s largest international conference.

The research was commissioned by Victoria’s Lead Scientist, Dr Amanda Caples, and the Victorian Department of Jobs, Precincts and Regions (DJPR). It draws on a number of data sets, including AusBiotech’s Sector Snapshot 2019, which maps the growth of the Australian biotechnology ecosystem.

New manufacturing agreement for Telix Pharmaceuticals

Tue, 27 Apr 2021 00:00:00 +1000

AusBiotech promotes Australian capabilities at BioKorea 2021

Thu, 22 Apr 2021 00:00:00 +1000

AusBiotech is fostering its international connections with biotech and medtech companies and demonstrating why Australia is a global leader within the sector, through its support of the Australian delegation and pavilion at BioKorea 2021.

The hybrid conference is running in person 9 – 11 June and online 9 – 21 June 2021. Partnering with Austrade, it will feature Team Australia, and showcase its investment opportunities and the Australian life sciences capabilities.

A dedicated session on Wednesday 9 June will focus on the cooperation strategy between Korean and Australian biotech industries. It will consider current trends and examples of successful open innovation cases in key pharmaceutical value chains of the two countries. A networking event will also provide a platform for the two countries to connect.

The organiser of BioKorea, The Korea Health Industry Development Institute (KHIDI), has led large Korean delegations to AusBiotech for several years, demonstrating the strong interest Korean companies have in collaborating with Australia's biotech industry. AusBiotech is looking forward to welcoming another large Korean delegation to AusBiotech 2021, 25 – 29 October.

AusBiotech’s support of BioKorea 2021 is part of its global strategy, as it facilitates international opportunities for investment discussions, collaborations and partnerships, with a focus on the markets important to members, notably the US and growth markets in Asia.

Continuing to facilitate these ongoing investment opportunities is crucial for the growth of the Australian life sciences sector, and ultimately for continuing Australia’s position in the sector globally.

Companies interested in attending BioKorea are invited to contact Tanya Daw, AusBiotech’s Director Membership & Engagement.

Kazia licenses global rights to potential first-in-class oncology drug

Thu, 22 Apr 2021 00:00:00 +1000

AusBiotech appoints new director, Dr James Campbell

Tue, 20 Apr 2021 00:00:00 +1000

AusBiotech announced today the appointment of Dr James Campbell as an AusBiotech Director, contributing strong commercialisation and capital-raising expertise to the Board.

Dr James Campbell is the CEO of Patrys Limited, an ASX-listed biotech company developing novel antibody therapeutics for cancer. As a senior biotechnology executive, Dr Campbell’s successful career in biotech includes bench research, academic technology transfer, establishment of early-stage start-ups, leading private and public companies, and making hundred million-dollar deals.

AusBiotech Chair, Michelle Burke, has welcomed his appointment and said, “The Board welcomes Dr Campbell to his new role on the AusBiotech Board. As the CEO of a home-grown biotech company, and with previous success in developing and commercialising novel health treatments, he represents the heart of AusBiotech’s membership. His global skills and expertise will be invaluable as AusBiotech drives and promotes the growth of the sector.”

Dr James Campbell said, “It is a great privilege to join respected leaders in the biotechnology sector as an appointed AusBiotech Director, to further the capabilities and reach of Australia’s vibrant and globally-recognised ecosystem of research and development. AusBiotech represents a credible and united voice for a variety of stakeholders, and I look forward to contributing to combined advocacy efforts that support research, development, and investment activity in this space.”

With more than 25 years’ experience in research, research management, consulting and venture capital in Australia and internationally, Dr Campbell has a unique set of skills that enable him to identify and monetise future trends in the biotech and pharmaceutical industries.

After being a researcher with CSIRO, Dr Campbell was appointed to the investment committee of Uniseed, where he evaluated and oversaw the spin-out of numerous ventures from the University of Melbourne, including Hatchtech. Dr Campbell then moved to ChemGenex Pharmaceuticals as COO, helping guide the company to its eventual $230M acquisition by Cephalon in 2011, which at the time was the largest sale of an Australian biotech company by enterprise value.

Dr Campbell co-founded Gemini Biotechnology, where he advised Australian and international life science companies on fundraising, M&A, partnering and corporate strategy. Clients ranged from ASX-listed biotech companies through to U.S. university spin-outs. This included time on the small executive team at Evolve Biosystems, a private microbiome/probiotics company, where he helped develop the strategy and business plan that grew the company from a US$150k seed round to a US$300M company, with product on market.

Dr Campbell sits on the Board of Directors of ASX-listed biotech company Prescient Therapeutics, and has previously served on the Advisory Board for the Centre for Innovation in Mental and Physical Health and Clinical Treatment at Deakin University, the IP and Commercialisation Committee of the Cooperative Research Centre for Mental Health and several government advisory panels.

Holding a PhD in plant biochemistry, Dr Campbell completed a MBA at the Melbourne Business School, and is a Graduate of the Australian Institute of Company Directors. He is the author of more than 15 peer-reviewed papers in fields ranging from plant biochemistry to bioinformatics and antibody development, and is a named inventor for the therapeutic antibody candidate PAT-DX1.

The current Board members include:

Michelle Burke, Chair, AusBiotech & Principal and Director, Indigo Advisory
Dr Megan Baldwin, Deputy Chair, AusBiotech & Managing Director and CEO, Opthea Limited
Lorraine Chiroiu, CEO and Managing Director, AusBiotech
Serg Duchini, Senior Partner Deloitte Asia Pacific. Director, Deloitte Tax Services Pty Ltd
Dr Jan Tennent, FTSE FASM GAICD, Founder & Principal, ConnectBio
Dr Dean Moss, CEO, UniQuest Pty Ltd
Dr Serge Scrofani, Vice President, Strategy & Corporate Development, CSL Ltd
Linda Peterson, Chief Operating Officer and Company Secretary, BioCurate
Dr James Campbell, CEO & Managing Director, Patrys Ltd

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

About AusBiotech

AusBiotech appoints new director, Dr James Campbell

Tue, 20 Apr 2021 00:00:00 +1000

AusBiotech announced today the appointment of Dr James Campbell as an AusBiotech Director, contributing strong commercialisation and capital-raising expertise to the Board.

The current Board members include:

Michelle Burke, Chair, AusBiotech & Principal and Director, Indigo Advisory
Dr Megan Baldwin, Deputy Chair, AusBiotech & Managing Director and CEO, Opthea Limited
Lorraine Chiroiu, CEO and Managing Director, AusBiotech
Serg Duchini, Senior Partner Deloitte Asia Pacific. Director, Deloitte Tax Services Pty Ltd
Dr Jan Tennent, FTSE FASM GAICD, Founder & Principal, ConnectBio
Dr Dean Moss, CEO, UniQuest Pty Ltd
Dr Serge Scrofani, Vice President, Strategy & Corporate Development, CSL Ltd
Linda Peterson, Chief Operating Officer and Company Secretary, BioCurate
Dr James Campbell, CEO & Managing Director, Patrys Ltd

Australian medtech consultancy merges with international leader

Tue, 20 Apr 2021 00:00:00 +1000

Exopharm completes $12 million capital raise

Tue, 20 Apr 2021 00:00:00 +1000

CSL’s Plasma Protein Purification Challenge opens

Thu, 15 Apr 2021 00:00:00 +1000

CSL Behring and Cicada Innovations’ new Plasma Protein Purification Challenge seeks to tackle some of the biggest challenges in plasma protein production, and to save and improve lives.

As the world’s biggest plasma producer, CSL Behring is looking for innovative new ideas and ways to help meet the growing global demand for plasma-derived Human Immunoglobulin G (IgG). IgG is an antibody that contributes to the body’s immune response.

CSL stated, “There is a global shortage of plasma-derived IgG, leaving many patients unable to access essential treatments. The demand for life-saving IgG therapies continues to grow rapidly in parallel to our global population, making its production a matter of life or death for many.”

Two cash prizes are available, with first place being awarded AUD$40,000 and the runner up being awarded $15,000; both winners will receive mentorship from CSL Behring and Cicada Innovations and a direct pathway to one of the world’s leading global biotech companies.

The global challenge is open to entrepreneurs, researchers, engineers and academics. The ambitious and innovative ideas sought will be assessed by a panel of judges on:

Innovation: impact and uniqueness of solution
Technical feasibility: conceptually and technically sound
Commercial feasibility: scalable and cost-efficient
Team: credibility and capabilities

Applications close 25 May 2021. Apply here.

Amplia completes dosing in phase one study of AMP945

Thu, 15 Apr 2021 00:00:00 +1000

Pharmaxis sells Bronchitol rights in Russia and completes placement

Thu, 15 Apr 2021 00:00:00 +1000

AusBiotech responds to university research commercialisation consultation

Tue, 13 Apr 2021 00:00:00 +1000

AusBiotech united voices across the biotech pipeline as it responded to the University Research Commercialisation (URC) consultation and provided views on how any new scheme must be set in the context of a strategic long-term national objective.

The capability and capacity gaps directly impact the early investment required for biotechnologies to reach market and flourish. A united approach that aims at long term, sustainable solutions will aid in steering the sector to a more sustainable growth and better return on investment. As such, any commercialisation strategy in this space should form part of a long term (10+ years) plan, which provides space for the cultivation of these critical skills.

The Department of Education, Skills and Employment’s consultation paper explored possible mechanisms to incentivise and increase partnerships between businesses and universities. AusBiotech highlighted how it is vital that potential solutions to gaps in Australia’s commercialisation landscape are considered within the unique context associated with the biotechnology sector.

Existing support (programs, advice, funds, information, education, experience) available for researchers is disjointed, inconsistent, often hidden and unequitable in terms of access. Despite the range of varied support available across Australia, finding and accessing this is dependent on geography, the university and its expertise/programs and other barriers. Equally, within the Federal Government, there are at least four portfolios that have key responsibilities for this sector and yet there is no “whole of government approach”.

Any new scheme should be at scale nationally, accessible to all researchers translating and commercialising, that meet a set assessable bar, with a single ‘front door’, and set in the context of a strategic long‐term national objective.

Australia holds world-class research; however, it is recognised that the existing paradigm needs to shift to encourage and accelerate universities’ commercialisation outcomes.

AusBiotech members joined a virtual roundtable and one-to-one meetings with Lorraine Chiroiu, CEO, as it developed its response. Drawing upon global examples of how private-public partnerships have been successfully supported in other jurisdictions, AusBiotech responded to key elements outlined in the consultation paper, including:

mission-driven research;
stage-gated design;
incentives for participation;
industry-university collaboration;
governance.

Australia’s medical and health research ecosystem is the funnel into the industry’s pipeline so if world-class research residing in academia cannot be commercialised, it cannot reach the ultimate beneficiaries: the patients. Australia’s biotech innovation is critically important to the long-term social and economic success of our nation, but particularly in the short to medium term COVID-19 recovery. Focusing URC efforts will boost the economy and optimise community benefit from public investment in medical research.

The Department is developing a scoping study that will outline options for a new model for URC. The scoping study will be presented to the Government later in the year for consideration and decisions on the next steps of implementation. AusBiotech looks forward to being involved in future discussions on improving the commercialisation of research in Australia.

Read the full AusBiotech’s submission here.

Approval to start trial of new Australian COVID-19 vaccine

Tue, 13 Apr 2021 00:00:00 +1000

European approval for AnteoTech's COVID-19 test

Tue, 13 Apr 2021 00:00:00 +1000

Australian-led discovery could speed up bone implant recovery

Tue, 13 Apr 2021 00:00:00 +1000

Opportunity to join Team Australia at BIO

Thu, 08 Apr 2021 00:00:00 +1000

AusBiotech is inviting companies to be prominently profiled at its Team Australia digital pavilion at BIO Digital 2021. As the industry’s independent voice, AusBiotech has led the Australian delegation to BIO for more than a decade, and Australia’s strong presence will continue to be felt at BIO Digital 2021.

AusBiotech’s digital delegation showcases Australian capabilities, promotes the strength of the Australian life sciences, and fosters global connections with its overseas counterparts.

The strength of the Australian life sciences will be present, with strong Victorian and New South Wales partnerships profiled. Companies have the opportunity to align with these profiles or to take an overarching national presence.

Joining the Team Australia pavilion offers companies: national presence to a global audience; access to networking opportunities; access to premier partnering during the fortnight and up to 12 months following the event; detailed company profile; registration, with the opportunity of discounted rates for further registrations; featuring in AusBiotech’s Global Showcase presentation.

This year the conference will span two weeks: with a new Global Marketplace and Innovation Stage happening on 10-11 June US/11-12 June AU, and an interactive education week occurring on 14-18 June US/15-19 June AU.

The Global Marketplace and Innovation Stage will feature fast-paced presentations, coupled with live, face-to-face networking allowing delegates to identify prospective partners. Lorraine Chiroiu, AusBiotech CEO, will deliver a Global Marketplace presentation on behalf of Australia highlighting Australia’s competitive advantage in life sciences and sharing the top reasons to partner and invest in our Australian sector.

The global event features biotech leaders, such as Dr. Anthony Fauci, Director, National Institute of Allergies and Infectious Diseases, National Institutes of Health, with more than 50 interactive and on-demand sessions across six days. Topics will cover a variety of therapeutic areas, business development, digital health, patient advocacy, public policy, next-generation biotherapeutics, and the latest updates from industry experts on COVID-19 and the vaccine.

Hosted by the Biotechnology Innovation Organisation (BIO), the conference is the largest and most influential global event for the biotechnology industry.

With the vaccine rollout underway across the globe, AusBiotech is enthusiastic and optimistic to reconvene in-person next year as it continues to lead the Team Australia delegation and to host the Australian pavilion.

AusBiotech is encouraging all companies that are interested in a national presence or to be connected to the VIC or NSW State partnerships to contact Natalia Cikorska, Senior Events Manager by 16 April 2021.

Recce Pharmaceuticals: Patient response encouraging

Thu, 08 Apr 2021 00:00:00 +1000

Grant open for Boosting Female Founders Initiative – round 2

Tue, 06 Apr 2021 00:00:00 +1000

Grants between $25,000 and $480,000 for female founded start-ups are being provided to expand into domestic and global businesses.

The Boosting Female Founders Initiative (the Initiative) – Round 2 will help female entrepreneurs overcome the disadvantages they face in getting access to finance and support, to grow their start-ups, and seeks to boost the economy through increasing the diversity of start-up founders.

Round 2 offers $11.6 million in grant funding, and is a significant increase on round 1’s $6 million available. The total initiative provides $52.2 million over five years from 2020-21 to 2024-25.

Eligible activities include (but are not limited to): product development and marketing; launching and scaling products; expansion to other markets; developing software and apps; purchase of equipment to enable growth; access to independent management (for example, C-suite and advisory boards); and access to relevant professional development.

AusBiotech responded to the Department of Industry, Science, Energy and Resources’ Female Founders consultation in October 2019. Read the submission here.

The Female Founders Initiative – Round 2 grant applications close at 5.00 pm (AEST) on 22 April 2021.

The grant opportunity will be delivered through a two-stage competitive selection process due to the expected high demand for this programme.

Check the eligibility criteria and apply here.

Noxopharm applies to patent Veyonda in septic shock treatment

Tue, 06 Apr 2021 00:00:00 +1000

Investment support for early-stage translation

Thu, 01 Apr 2021 00:00:00 +1100

Feedback essential for commercialising early-stage projects and technologies is being offered by an expert and investor group at AusMedtech’s Early Stage Investment Forum. Early-stage projects are invited to apply for the AusMedtech 2021 Early Stage Investment Forum, with submissions due 9 April 2021.

The Forum offers six-minute virtual quick-pitches to an expert investor panel that will include international big pharma representatives, corporate VCs and early-stage investors. Each presentation will be followed by direct feedback that will be valuable during translation and commercialisation.

In an exciting new development, the Forum is being held for the first time at AusMedtech 2021, Australia’s premier medtech event, and will be supported by Medtronic. The Forum will take place on Friday 21 May.

Early-stage technologies and projects are being sought from across Australia from research institutes, universities, hospitals and pre-series A companies in the areas of medical devices and diagnostics, digital health and enabling technologies.

AusBiotech is dedicated to the development, growth and prosperity of the Australian biotechnology industry and facilitates opportunities for investment discussions, collaborations and partnerships. To encourage, recognise and reward early-stage technology and projects, an award for Best Translational Research will also be up for grabs.

AusMedtech 2021: Reimagine and reconnect offers a week of inclusive half-day virtual sessions that represent Australia’s medtech industry. Reconnect with a network of resilient and innovative leaders, and reimagine the future of medtech beyond our borders.

Run by industry, for industry, AusMedtech week features a mix of cutting edge leading keynotes, expert panel discussions, and Q&A, bringing together key stakeholders of the Australian and international medical devices and diagnostics sector to help prepare the industry sector for its changing landscape.

AusMedtech 2021 is supported by the Victorian Government as the Host State Partner.

Submit your application for the AusMedtech 2021 Early Stage Investment Forum by 9 April.

Companies outside of the early-stage criteria are encouraged to contact Hayley Laing, AusBiotech’s Manager, Global Investment Programme, to explore other opportunities to connect with capital.

World-first trial for Australian company Pharmaxis

Thu, 01 Apr 2021 00:00:00 +1100

UK launch for Starpharma's COVID-19 nasal spray

Thu, 01 Apr 2021 00:00:00 +1100

AusMedtech 2021: best value registration available for few more days

Tue, 30 Mar 2021 00:00:00 +1100

As plans are being finalised for the medtech week of the year, early bird registrations are still open until 3 April for AusMedtech 2021.

Australia’s premier medtech conference, which will be delivered virtually during 17 – 21 May 2021, has been timed to be inclusive of states around the country to make this a truly national event, including Western Australia.

AusMedtech 2021: Reimagine and reconnect provides an opportunity for the whole Australian medtech community to unite through an accessible week of virtual half-day sessions. Reconnect with a network of resilient and innovative leaders and reimagine the future of medtech beyond our borders.

AusBiotech's premier medtech conference brings together key stakeholders of the Australian and international medical devices and diagnostics sector to help prepare the industry sector for its changing landscape. More than 350 delegates are expected to attend the event that is run by industry, for industry.

An inspiring line-up of Australian and global keynotes and panels has been announced, including keynote speakers Dr Sean Parsons, Founder and Chief Executive Officer, who will share insights on Ellume, the Australian success story; and Kate Quirke, Managing Director and Chief Executive, who will present on how Alcidion’s built their business through accessing the global market.

The five days will traverse the medtech pipeline, with themes across the week including:

· Product development, idea generation, feasibility prototyping and manufacturing

· Regulation, clinical trials and reimbursement

· Investment, investor relations, partnering and grants

· Marketing, distribution and partnering for market access

· Early Stage Investment Forum.

AusMedtech 2021 is supported by the Victorian Government as the Host State Partner.

Early bird registrations are available until 3 April; register now to connect with like-minded leaders growing the Australian and global medtech industry.

Pfizer hosts stakeholder roundtable on the future of Australian life sciences

Tue, 30 Mar 2021 00:00:00 +1100

Encouraging university research commercialisation

Thu, 25 Mar 2021 00:00:00 +1100

A new model to encourage university research commercialisation (URC) is being developed, and Members are invited to an AusBiotech virtual roundtable as it develops its response. The Department of Education, Skills and Employment’s consultation paper explores possible mechanisms to incentivise and increase partnerships between businesses and universities.

Australia holds world-class research, however, it is recognised that the existing paradigm needs to shift to encourage and accelerate universities’ commercialisation outcomes.

Drawing upon global examples of how private-public partnerships have been successfully supported in other jurisdictions, the consultation paper seeks feedback on key elements across the model, including:

mission-driven research;
stage-gated design;
incentives for participation;
industry-university collaboration;
governance.

It is well-recognised across industry that the technology transfer and commercialisation support gap needs attention. The capability and capacity shortage directly impacts the early investment required for biotech SMEs to flourish. Australia’s medical and health research ecosystem is the funnel into the industry’s pipeline so if world-class research residing in academia cannot be commercialised, it cannot reach the ultimate beneficiaries: the patients. Australia’s biotech innovation is critically important to the long-term social and economic success of our nation, but particularly in the short to medium term COVID-19 recovery. Focusing URC efforts will boost the economy and optimise community benefit from public investment in medical research.

During his virtual address to the Business Council of Australia AGM, November 2020, the Hon Scott Morrison MP, Prime Minister said, “We want to provide a platform and a pathway for our talented researchers to partner with you, with businesses all around the country and to apply their intellectual firepower as research entrepreneurs.”

Submissions and input from numerous stakeholders will feed into a scoping study that will outline options for a new model for URC. The scoping study will be presented to the Government later in the year for consideration and decisions on the next steps of implementation.

Members are invited to a virtual roundtable with Lorraine Chiroiu, CEO, AusBiotech, to be held on Wednesday 7 April. Members can register their interest in attending the roundtable, and can also send initial thoughts, ideas and considerations, to Karen Parr, Director, Communications, by Tuesday 6 April.

Modernising and future-proofing the Gene Technology Scheme

Tue, 23 Mar 2021 00:00:00 +1100

AusBiotech has responded to changes proposed by the Office of the Gene Technology Regulator (OGTR) to the Gene Technology Scheme, that seek to modernise and future-proof the risk-management framework.

An enhanced risk-tiered model was recommended as suitable for all regulated communities and sectors in Australia and to ensure the Scheme remains flexible, fit for purpose and futureproof. It would reduce the cost of regulation and enhance the competitiveness of the Australian biotech industry, without compromising the object of the Gene Technology Act. This would prove critical for both agricultural and medical research and for Australia in general, as this would ensure the benefits from new innovations reach Australian and global communities.

The early consideration of how a framework that was originally designed on biotech’s agricultural application could accommodate emerging gene technology fields, such as gene therapies, that do not fit into the current system, was welcomed by AusBiotech.

The submission highlighted that work needed to build on the progress to date. It is important that the proposed changes are effective and do not present unnecessary barriers for the progress of biotech research and development, including clinical trials, which contribute to the wellbeing of the community and the environment.

The proposed changes seek to: update existing definitions in the Gene Technology Act to clarify the scope of regulation in light of on-going technological advances; introduce a new risk-tiering framework that ensures regulation remains commensurate with risk; and reduce regulatory burden through streamlining processes and current regulatory requirements, where appropriate.

Critically, for medicines, AusBiotech recommended that any developments undertaken must be done in coordination with TGA requirements. The TGA is globally-recognised, with well-established processes and regulations governing these activities for safety and efficacy in Australia. Leveraging required and existing risk management measures would reduce overlap on applications and thereby improve review timeliness, and reduce unnecessary duplication of effort and regulatory burden.

As the nation’s peak industry body, AusBiotech holds a unique position as the voice of industry in both agritech and emerging medical developments, such as regenerative medicine. AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian industry.

The Final Report on the Third Review of the Scheme was released in October 2018 and included 27 recommendations. These proposed changes addressed four of the 27 recommendations. Stakeholder feedback on this consultation will inform the development of a Decision Regulatory Impact Statement, which will underpin legislative changes to give effect to Review recommendations.

AusBiotech has actively engaged on consultations on the Scheme throughout its Third Review, and seeks to build on the strong work accomplished to date while supporting its ability to prepare for Australia’s gene technology future.

Read AusBiotech’s full response to the consultation here, and all AusBiotech submissions here.

Nyrada raises $11 million in new placement

Tue, 23 Mar 2021 00:00:00 +1100

Novartis oncology leader joins board of local biotech

Tue, 23 Mar 2021 00:00:00 +1100

NSW ensures access to GM crop innovation

Thu, 18 Mar 2021 00:00:00 +1100

The NSW Government has announced access will continue for approved genetically modified crop innovations, as it will not seek to continue an 18-year moratorium that is due to expire on 1 July 2021.

The decision will align NSW with all other major States, ensuring that innovators and farmers are not disadvantaged in the future.

The moratorium expiring will encourage stronger research and innovation and ensure easier access to current and future GM crops approved for commercialisation. Access will be maintained to all GM crops that have been approved through the Office of the Gene Technology Regulator’s robust assessments.

With the global population expected to reach 9.7 billion by 2050, agricultural technologists and food science researchers must develop tools to reach growing population’s needs. An increasing number of Australian farms are R&D driven, technologically advanced, capital intensive, and entrepreneurial. The agritech industry strives to enhance seeds and crops, improve diet and provide functional foods for preventative health.

The fourth edition of the Official Australian Reference Guide to Agricultural Biotechnology and GM Crops was published in October by the Agricultural Biotechnology Council of Australia (ABCA). It considers developments in agritech with a focus on the role of gene-editing, and includes regulation requirements across the country, and how consumer attitudes have evolved, in Australia and globally. AusBiotech is a founding member of ABCA. Download the Guide here.

New plans for Australia’s biggest biotech industry gathering

Tue, 16 Mar 2021 00:00:00 +1100

The biggest gathering of Australia’s biotech industry, AusBiotech 2021, will now be offered through a predominantly virtual format, after AusBiotech shifted its plans and support to bring the planned in-person event to Brisbane moving to October 2023.

Due to the ongoing public health response and pandemic-related border closures nationally and internationally, AusBiotech 2021 will now be delivered through a predominantly virtual format, with some face-to-face components as restrictions allow. Australia’s premier biotech conference will unite and engage the Australian and global industry virtually by bringing the industry’s leaders together to further the sector.

Lorraine Chiroiu, CEO, AusBiotech, said, “As the pandemic continues to challenge us, this is a good outcome to ensure that AusBiotech, as always, offers opportunities to continue connecting the pipeline, providing access to local and global thought-leaders, with certainty, to celebrate the sector and facilitate its global development.”

“We look forward to bringing the biggest biotech industry gathering to Brisbane in 2023, and in the meantime offering a predominately virtual event for 2021,” she said.

No matter the year, Australia’s biggest week in biotech will remain the feature event that the sector has known and trusted for more than 35 years, and is developed by the industry for the industry.

AusBiotech remains committed to providing a valuable, flexible and accessible forum to pitch, partner, exchange and engage, no matter where you are.

Further details on the new plans will be available in due course, including sponsorship opportunities. Continue to save the date for AusBiotech’s national conference, 25 – 29 October 2021.

New collaboration between Immutep and MSD

Tue, 16 Mar 2021 00:00:00 +1100

Opthea launches late-stage study of eye therapy

Tue, 16 Mar 2021 00:00:00 +1100

Expert Leadership Forum announced to drive industry’s Biotech Blueprint strategy

Thu, 11 Mar 2021 00:00:00 +1100

A new expert Leadership Forum to drive the development of the industry’s Biotech Blueprint, the sector’s decadal framework, has been announced. The Leadership Forum includes key industry leaders that represent industry’s various facets and will use their experience and knowledge to identify solutions and ensure a valuable, visionary and dynamic strategy.

The sector’s plan is an opportunity for the industry to speak with one voice to governments, identifying key policy priorities that can deliver benefits both for the industry and for the nation as a whole. As the national voice of the Australian biotech industry, AusBiotech is leading the development of the strategy.

AusBiotech sincerely thanks the Biotech Blueprint Leadership Forum for supporting the development of the Strategy.

Dr Andrew Nash - CSL
Dr Mary-Beth Brinson – Cochlear Ltd
Julie Phillips – BioDiem Ltd
Dr Glenn Begley – BioCurate Pty Ltd
Dr Siro Perez - IP Group Australia
Silvio Tiziani – Australian Regenerative Medicine Institute
Dr Ryan Parlett – Patheon Biologics Australia Pty Ltd
Michelle Burke – Indigo Advisory
Helen Fisher – Paradigm Biopharmaceuticals Ltd
Marilyn Jones – MeXec
Professor Trent Munro - Australian Institute for Bioengineering and Nanotechnology, University of Queensland
Warren Bingham - BioAnalytics Holdings Pty Ltd
Dr James Campbell – Patrys Ltd
Dr Chris Davis – Institute for Glycomics, Griffith University

The first task for the Leadership Forum is to confirm the six goals that will underpin and drive industry growth through to 2030, and the metrics that will tell us how we are progressing; these were drafted following broad industry consultation during 2020.

As the plan is progressed through 2021, AusBiotech and its Biotech Blueprint Leadership Forum will inform the strategic plan with solutions. Steps will be identified that should be taken in the near-term to ensure that biotech’s positive future is realised, and to reflect what a vibrant and valuable Australian biotech industry could and should look like a decade from now. The growth of the industry is critical for supporting Australian and global citizens’ health and economic wellbeing.

Playing a critical role in the pandemic response, biotech is at the forefront and there has never been a more important time to plan for the future. This is, therefore, a valuable opportunity for the industry to put forward a clear and ambitious plan for the future. If Australia is to build on the critical mass that has been established to date, strong alignment between industry and government over the coming decade will be key.

New plans for Australia’s biggest biotech industry gathering

Thu, 11 Mar 2021 00:00:00 +1100

AusBiotech has shifted its plans for AusBiotech 2021, the biggest gathering of Australia’s biotech industry, and will now offer a predominantly virtual format, with the support to bring the event to Brisbane moving to 2023.

Due to the ongoing public health response and pandemic-related border closures nationally and internationally, the backing for AusBiotech 2021 as a Brisbane-based event has shifted to support the planned in-person event in October 2023 instead.

AusBiotech 2021 will now be delivered through a predominantly virtual format, with some face-to-face components as restrictions allow. Australia’s premier biotech conference will unite and engage the Australian and global industry virtually by bringing the industry’s leaders together to further the sector.

“We look forward to bringing the biggest biotech industry gathering to Brisbane in 2023, and in the meantime offering a predominately virtual event for 2021,” she said.

No matter the year, Australia’s biggest week in biotech will remain the feature event that the sector has known and trusted for more than 35 years and is developed by the industry for the industry.

AusBiotech remains committed to providing a valuable, flexible and accessible forum to pitch, partner, exchange and engage, no matter where you are.

Further details on the new plans will be available in due course, including sponsorship opportunities. Continue to save the date for AusBiotech’s national conference, 25 – 29 October 2021.

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

About AusBiotech

Neuren completes drug substance manufacturing for NNZ-2591 trials

Thu, 11 Mar 2021 00:00:00 +1100

NSW responds to industry opportunities

Tue, 09 Mar 2021 00:00:00 +1100

The NSW government has launched its Accelerating R&D in NSW Action Plan, with key themes aligning to the industry needs highlighted in an AusBiotech NSW roundtable last year.

The Action Plan, developed with the Hon. Gabrielle Upton MP, Parliamentary Secretary to the Premier, who has been tasked with accelerating R&D investment in NSW, recommends five Priority Actions and 16 Supporting Actions that seek to accelerate the rate at which ideas are translated into new industries, jobs, products and services. The recommendations in the Action Plan aim to make NSW an Australian R&D leader and a world-class contributor.

During the development of the Action Plan, AusBiotech hosted Ms Upton at a policy roundtable to discuss opportunities in NSW with almost 20 Member companies. AusBiotech also outlined opportunities through a submission in the formal consultation process.

Implemented advice includes: strengthening facilitation, collaboration and communication platforms through connecting innovators on an online matchmaking platform; demonstrating commitment to translation and commercialisation with appropriate funding initiatives; and encouraging a greater culture of collaboration between industry and academia.

The five recommended Priority Actions in the Action Plan are:

Launch a Small Business Innovation Research (SBIR) programme – provide competitive grants for small and medium-sized enterprises (SMEs) to find and commercialise innovative solutions to well-defined problems for NSW Government agencies.
Boost open data – release new government datasets so businesses can make better decisions, entrepreneurs can build new businesses and the government can solve complex challenges.
Turbocharge precincts – develop precincts to attract national and global technology industries and investment, and drive collaboration between universities, research organisations, start-ups, scale-ups and SMEs, to commercialise R&D.
Target strategic support for NSW universities – collaborate on research that drives future NSW strategic growth industries and research-led industry attraction, and better leverage Commonwealth Government research funding.
Establish an R&D matchmaking platform – better connect research ‘sellers’ and ‘buyers’ and link researchers to research infrastructure and expertise.

NSW continues its ongoing commitment to the biotechnology industry, as it drives economic growth and leads to improved patient wellbeing. AusBiotech has a strong relationship with the State Government and looks forward to supporting and promoting initiatives and actions to bolster the industry.

Read the Action Plan here.

Noxopharm launches second part of NOXCOVID-1 clinical trial

Tue, 09 Mar 2021 00:00:00 +1100

The three women leading emerging Australian biotech

Tue, 09 Mar 2021 00:00:00 +1100

AusMedtech 2021 programme launched

Thu, 04 Mar 2021 00:00:00 +1100

An inspiring line-up of Australian and global keynotes and panels has been revealed as the AusMedtech 2021 conference programme is launched. AusMedtech 2021: Reimagine and reconnect provides virtual half-day sessions across five days, 17 – 21 May, that represent Australia’s medtech industry.

Keynote speakers include Dr Sean Parsons, Found and Chief Executive Officer, who will share insights on the Australian success story: Ellume; and Kate Quirke, Managing Director and Chief Executive, who will present on how Alicidion’s built their business through accessing the global market.

Digital diagnostics company Ellume caught attention around the globe last month with a $231.8 million agreement with the US Departments of Defense and Health and Human Services, to accelerate domestic US production of its COVID-19 home tests. The breathtaking deal was a stand-alone achievement, but for Ellume and its founder Sean Parsons, it marked a spate of good news that has positioned the company as a global contender and Australian success story.

Alcidion is providing clinicians with real time data via mobile devices to enhance decision making. Currently in 307 hospitals across the UK, Australia and New Zealand, they have 68,000 users and have captured more than 1 billion observations at the 50,000 hospital beds.

The five-day AusMedtech 2021 programme will traverse the medtech pipeline, with themes across the week including: product development, idea generation, feasibility prototyping and manufacturing; regulation, clinical trials and reimbursement; investment, investor relations, partnering and grants; marketing, distribution and partnering for market access; and AusMedtech’s inaugural Early Stage Investment Forum.

More keynotes and speakers will be revealed over the upcoming weeks.

AusMedtech 2021 is Australia’s premier medical technology conference. It is developed by AusBiotech and industry, for industry, and brings together key stakeholders of the Australian and international devices and diagnostics sector to help prepare the industry sector for its changing landscape.

Download the full programme, and register now to connect with like-minded leaders growing the Australian and global medtech industry. Secure your early bird rates by 3 April to save.

AusMedtech 2021 is supported by the Victorian Government as the Host State Partner.

Orthocell confirms Australian reimbursement for CelGro

Thu, 04 Mar 2021 00:00:00 +1100

Kazia Therapeutics signs global agreement for lead candidate

Thu, 04 Mar 2021 00:00:00 +1100

Funding opens for advanced bio-manufacturing

Tue, 02 Mar 2021 00:00:00 +1100

AusBiotech welcomes the Government’s support of the biotech industry as it opens the first round of funding for bio-manufacturing and launches its Medical Products’ National Manufacturing Priority road map.

The first round of funding includes $140 million across two streams (Translation and Integration) for the six priority areas; co-funding grants are available of between $1 million to $20 million, of up to 50 per cent of the eligible project expenditure. Applications are open and will close on 29 March 2021.

Read more about the Medical Products road map here.

The road map and concomitant funding are aimed at helping Australian companies build long-term business collaboration at scale, translating research into commercial outcomes and bringing new products to market, and integrating local firms to deliver products and services into global value chains.

AusBiotech has worked with the Department of Industry, Science, Energy and Resources as the road map was being developed. As the national voice of the biotechnology sector for 35 years, AusBiotech remains committed to amplifying opportunities, reducing barriers, and communicating the industry’s concerns. It welcomed the opening of the first round of funding, having actively advocated for policy to complement the RDTI and directly incentivise advanced manufacturing for more than 10 years.

Lorraine Chiroiu, CEO, AusBiotech said, “This support continues to signify the Government’s endorsement of the potential of the Australian biotechnology industry. Our companies need a supportive system throughout the entire pipeline in order to commercialise, manufacture and deliver new technologies for patients in Australia and across the globe. Supporting Australia’s medical product manufacturing means supporting biotech’s innovative industry, its research expertise, and its highly-skilled workforce. It is a ‘salute’ to the impact that Australian biotechnology has in improving health and wellbeing, and for Australia’s economy.

“This is not a ‘standing start’; it is supporting Australia’s existing and strong life science foundations upon which, as a smart nation, we can leverage and accelerate, taking industry to the next level.

“Investment in this sector is not only is important for recovering from the COVID-19 recession and for building our economy for the future, but also can provide critical defence against some of the health impacts arising from this and future pandemics.”

The sector has access to the funding that was announced during the October 2020 Federal Budget, where the Modern Manufacturing Initiative (MMI), part of the Australian Government’s Modern Manufacturing Strategy, will invest a total of $1.3 billion over five years and across six priority areas, including medical products.

The Department’s new road map outlines measurable success factors for advanced bio-manufacturing, which will dovetail into AusBiotech’s broader Biotech Blueprint: the decadal framework for the sector. AusBiotech’s Biotech Blueprint is an opportunity for the industry to speak with one voice to governments, identifying key policy priorities that can deliver benefits both for the industry and for the nation. This includes the steps to be taken in the near-term to ensure that biotech’s positive future is realised, and to reflect what a vibrant and valuable Australian biotech industry could and should look like a decade from now.

Cynata Therapeutics announces new study of cell therapy

Tue, 02 Mar 2021 00:00:00 +1100

Botanix expands its management team

Tue, 02 Mar 2021 00:00:00 +1100

Feedback sought on gene technology changes

Thu, 25 Feb 2021 00:00:00 +1100

AusBiotech is seeking feedback from Members on proposed changes to the Gene Technology Scheme (the Scheme) that may impact companies and early research working with GMOs. While the Scheme has previously focused on biotech’s agricultural application, attention is now turning to managing risk in emerging technologies, such as gene therapies, with proposed changes related to definitions, risk-proportionate regulation, and streamlining regulation.

The Office of the Gene Technology Regulator has recognised three policy problems that have the potential to unnecessarily slow down the progression of a medical product on the path to market, which is detrimental to industry and its international competitiveness.

The proposed changes seek to: update existing definitions in the Gene Technology (GT) Act to clarify the scope of regulation in light of on-going technological advances; introduce a new risk-tiering framework that ensures regulation remains commensurate with risk; and reduce regulatory burden through streamlining processes and current regulatory requirements, where appropriate.

More recently, different types of GMOs are being developed for medical and industrial purposes, and these do not necessarily fit into a system that was originally designed for GMO plants. There is a growing trend that licences under the GT Act are being granted for medical and other uses, with 92 per cent of licences granted in 2019–20 related to medical uses. This trend is expected to continue into the future, as the Australian government recognises and is investing in promoting Australia as a leader in clinical trials and medical research.

Therefore, it is important that the proposed changes are effective and do not present unnecessary barriers for the progress of biotech research and development, including clinical trials, which contribute to the wellbeing of the community and the environment.

The consultation offers three regulatory reform options: no change; a risk-tiering model, where dealings with GMOs would be categorised according to their indicative risk; or a matrix model, where the nature of the dealing with the GMO would be the determinative factor for categorisation.

Twenty years of experience in regulating trials and commercial releases of GM crops and GM therapeutics supports the creation of new streamlined authorisation pathways for dealings that are low risk and where effective management conditions are known. This would reduce the cost of regulation and enhance the competitiveness of the Australian biotech industry, without compromising the object of the GT Act.

Members are encouraged to contact Karen Parr, Communications Director, by 4 March to discuss how these changes may impact their companies.

Feedback on the current consultation will inform the development of a Decision Regulatory Impact Statement, which will underpin legislative changes to give effect to Review recommendations.

AusBiotech has previously responded to the third review of the Scheme that was conducted by all Australian governments in 2017-18. The Final Report on the third review was released in October 2018 and included 27 recommendations. These currently proposed changes address four of the 27 recommendations.

Telix Pharmaceuticals secures clearance for Japanese trial

Thu, 25 Feb 2021 00:00:00 +1100

CSIRO secures licence to develop medicinal cannabis

Thu, 25 Feb 2021 00:00:00 +1100

FDA approval for new Cochlear sound processor

Thu, 25 Feb 2021 00:00:00 +1100

Applications open for Bridge Program

Tue, 23 Feb 2021 00:00:00 +1100

The Bridge Program is currently accepting applications for its next cohort, and provides specific training on the scientific, legal, financial, clinical, regulatory and reimbursement disciplines that are essential to pharmaceutical commercialisation.

The programme is unique as it has been crafted and developed in collaboration with industry partners and with leaders in key global organisations in the biotech sector.

Launched in 2017, this programme is fully supported by industry and government; there is no course fee. The Bridge Program is convened and administered by Queensland University of Technology, and match-funded through MTPConnect’s Project Fund Program and the Medical Research Future Fund’s Biomedical Translation Bridge Program.

This year a hybrid model is being implemented, with a blend of online and in-person elements to increase accessibility across Australia.

Applications are open until 21 March 2021 via the online form here.

Pharmaxis launches new trial of potential cancer therapy

Tue, 23 Feb 2021 00:00:00 +1100

Starpharma secures European and UK approval of Viraleze

Tue, 23 Feb 2021 00:00:00 +1100

Maintaining access to innovation through the Prostheses List

Thu, 18 Feb 2021 00:00:00 +1100

AusBiotech has submitted comment on the Department of Health’s Prostheses List (PL) consultation on behalf of members, advocating for maintained access to new innovation in order to achieve good outcomes for patients through timely access to the medical devices they need.

While AusBiotech accepts that some reform may be needed to the PL, it is but small in nature. It has encouraged the Department to maintain the PL, and the benefits and the value it brings to innovators and patients. The consultation paper offered two options for consideration: major reform, or completely changing the system.

Lorraine Chiroiu, CEO, AusBiotech, said, “Medtech innovators are the engine of the healthcare system, and they need a supportive system throughout the entire pipeline to be able to deliver new technologies for patients and surgeons. If a well-constructed and considered reform is not achieved then the development of Australian research and industry in the medtech sector will be collateral damage in the pursuit of minimising cost.”

Through its submission to the Department, AusBiotech demonstrated how the proposed Diagnosis Related Groups (DRGs) model would erode value, choice and access to innovation and novel technologies. DRGs would implement a simple accounting methodology that does not account for the health benefits that protheses offer.

Rather, healthcare should be approached with an all-of-government perspective. Implementing DRGs will damage the research and development ecosystem with the proposed changes further disincentivising manufacturing during a time we are looking to strengthen it. COVID-19 has not only brought life sciences’ social and economic contributions to the fore, it has also highlighted Australia’s sovereign capabilities, and the Australian Government has backed six key national priorities, including medical products, with its $1.3 billion Modern Manufacturing Initiative. Implementing DRGs would be wasting the benefit of the local innovations/innovators present in Australia’s thriving sector.

A ‘win/win’ opportunity for the Australian Government to build on its support and become a global contender was offered. AusBiotech’s submission details how, through the creation of a ‘sandbox’ environment, Australian medtech companies would be able to realise their full potential. This environment would enable the small companies a chance to be reimbursed, while maintaining the necessary rigorous regulatory and safety requirements but, importantly, truncating the ‘dead’ time it can take to access the prostheses benefits.

As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science industry.

Read AusBiotech’s full response to the PL consultation here, and all AusBiotech submissions here.

Australia’s RM manufacturing capabilities expanding

Tue, 16 Feb 2021 00:00:00 +1100

With the news of Cell Therapies’ regenerative medicine (RM) manufacturing capabilities expanding, the mapping of Australia’s RM manufacturing capability that the AusBiotech-led RM Catalyst Project is doing is highlighted.

The consortium is mapping and benchmarking RM’s GMP manufacturing capability and capacity, as part of its work establishing annual data points and information resources.

These data points will be able to be tracked over time and demonstrate advancement, such as the Cell Therapies’ licence approval. Until now this advanced manufacturing process was conducted in the USA, or other approved overseas facility, and so it marks an important milestone as Australia strives to bring innovative cell and gene therapies to Australian patients.

Globally, the RM sector has more than 1,200 clinical trials in progress, including 152 trials currently in phase 3, and has attracted $25.7 billion (US$19.9 billion) in financing during 2020 alone. Global therapeutic companies have turned their attention to the RM sector and more gene and cell therapies are being brought to Australia for patient access.

To prepare for Australia’s RM future, AusBiotech is leading a consortium of seven partners, including Cell Therapies, that will enable the regenerative medicine industry to thrive and drive benefits to Australia’s economy and health of its people.

The project will identify and establish a national RM sector ‘catalyst’ collaboration body, and address priority action areas including: workforce capabilities, collaboration, funding, regulation and policy infrastructure, and Australian manufacturing capability.

Major outcomes of the project include:

Establishing annual data points and information resources to: map/benchmark GMP manufacturing capability and capacity; establish a model for an annual clinical trial database; and capture investments in Australian RM;
A researched, strategic roadmap for the RM sector’s development in Australia, including sub-reports on skill and talent specific to the sector; determining a plan to attract patient venture capital investment and the role of Australian biotech companies partnering with global companies; and case studies;
Determining a sustainable funding and model structure for an RM sector ‘catalyst’ collaboration body;
A regulatory white paper;
Mapping the pathway for a typical product from early research to market, and patients receiving a therapy; and
Mapping the global pipeline of gene and cell therapy products on the horizon.

For more information on the project please contact Lorraine Chiroiu, CEO, AusBiotech.

Read more about the AusBiotech-led RM Catalyst Project here.

The consortium project is funded through MTPConnect’s Growth Centre Project Fund Program, an Australian Government initiative supported by the Department of Industry, Science, Energy and Resources. It is a competitive matched funding program that aims to invest in ideas to boost the innovation, productivity and competitiveness of Australia’s MTP sector. Consortia members are providing matched funding.

TGA approves first Australian commercial CAR-T manufacturing site

Tue, 16 Feb 2021 00:00:00 +1100

Neuren Pharmaceuticals updates on phase one trial

Tue, 16 Feb 2021 00:00:00 +1100

Biotech boards’ gender diversity moving forward

Thu, 11 Feb 2021 00:00:00 +1100

Gender diversity on biotech boards has increased, with a recent review of ASX-listed biotech companies revealing an average representation of 26 per cent for FY20. AusBiotech is encouraged that this is a step in the right direction as equality becomes a reality, however more work is required if biotech boards are to meet the AICD goal of 30 per cent.

Wexford Hayes’ review of 83 ASX-listed biotech and healthcare companies noted that the overall average was impacted by lower representation in the smaller capitalised segment of the market. The report samples companies across a broad range of market capitalisation.

The AICD recommends all boards adopt a 30 per cent target and to regularly report on their progress towards it. As at 31 December 2020, overall representation of women on Australia’s top ASX-200 Boards, sat at 32.4 per cent. While two boards in the ASX-200 do not have any women, it is notable that 76 of the boards that are yet to reach the 30 per cent target are just one more woman shy of the target.

The Wexford Hayes’ review noted that biotech and healthcare companies with a market capitalisation of more than $1 billion had an average Board size of seven, with 32 per cent female Board members. Companies with a market cap of $100-$999 million had an average Board size of four members, of which 24 per cent female; thirty-three per cent had no female representation on their Board. Biotech companies with a market cap of less than $100 million also had an average Board size of four members however, only nine per cent female representation and 63 per cent of companies had no female representation at all.

This data is aligned to AusBiotech’s Sector Snapshot which show that, on average, women represent 50 per cent of the workforce across the entire sector; however women are under-represented in industry, representing only 32 per cent of the workforce. And this figure dwindles as seniority levels increases.

The Australian figures are above the 18 per cent of female board members indicated in BIO’s Measuring Diversity in the Biotech Industry: Building an Inclusive Workforce report, but AusBiotech encourages companies to continue their drive to achieve gender diversity, so that the industry can realise it full potential.

AusBiotech is committed to diversity and inclusion. In 2018, it launched its Diversity and Inclusion Statement; it follows these principles and encourages industry to follow too.

AusBiotech believes that diversity in all aspects of business operations will optimise the continued growth and success of the life sciences industry.
AusBiotech will champion diversity and inclusion as a way to attract, develop and retain the employee talent pool within the globally competitive industry.
AusBiotech will lead by example and be outward-facing in its diversity efforts, and will incorporate diversity and inclusion into all aspects of operations: in communications and membership engagement, at events through programming and education, and in the composition of the Board of Directors and its committees.
AusBiotech will engage with external partners to broaden the reach and incorporation of diversity throughout the biotechnology ecosystem.

Global biotech executive to boost microbiome drug development for Asia Pacific

Thu, 11 Feb 2021 00:00:00 +1100

New research cooperation agreement for Telix Pharmaceuticals

Thu, 11 Feb 2021 00:00:00 +1100

Member feedback sought on Protheses List consultation

Tue, 09 Feb 2021 00:00:00 +1100

AusBiotech is seeking comment from members affected by the Department of Health’s Prostheses List consultation paper: Options for reforms and improvements to the Prostheses List (PL).

AusBiotech is asking for comments on its response to the PL consultation paper. Its key themes, comments and issues include: facilitating access to new innovation; maintaining good outcomes for patients by protecting access to the devices they need; maintaining surgeon choice of prostheses; and improving administration of the PL.

The paper offers two options for consideration: major reform, or completely changing the system. AusBiotech is advocating against a complete change; it accepts that some reform may be needed to the PL, but that it is but small in stature.

AusBiotech supports Federal and State systems and processes that reward Australian innovation, with timely access to healthcare products for Australian patients through value-based principles.

The current reform considerations were initiated in 2017, when the Australian Government entered into a Strategic Agreement with the Medical Technology Association of Australia. AusBiotech has been actively involved in an Industry Working Group that has been considering options for reforms to the PL for the past two years.

The PL specifies a set benefit amount for listed prostheses. While the PL is often thought to be applicable only to multinational companies, AusBiotech members are typically SMEs locally developing new technologies, many of which will be destined for inclusion on the PL. Many of these companies have one or a few devices in development, and some are manufacturing in Australia too.

As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science industry.

For more information on the consultation, please email or call (03 9828 1405) Karen Parr, Communications Director, AusBiotech, with your views and comments by Friday 12 February 2021.

BioCurate says it eyes next phase of growth with appointment of acting CEO

Tue, 09 Feb 2021 00:00:00 +1100

First export to the US triggers milestone payment for Pharmaxis

Tue, 09 Feb 2021 00:00:00 +1100

Early bird registrations open for AusMedtech 2021

Thu, 04 Feb 2021 00:00:00 +1100

Early bird registrations have opened today for AusMedtech 2021, Australia’s premier medtech conference, that will be delivered virtually during 17 – 21 May 2021.

AusMedtech 2021: Reimagine and reconnect provides a week of virtual half-day sessions to reconnect with a network of resilient and innovative leaders and reimagine the future of medtech beyond our borders.

AusBiotech's annual conference brings together key stakeholders of the Australian and international medical devices and diagnostics sector to help prepare the industry sector for its changing landscape. More than 350 delegates are expected to attend the event that is run by industry, for industry.

The five days will traverse the medtech pipeline, with themes across the week including:

Product development, idea generation, feasibility prototyping and manufacturing
Regulation, clinical trials and reimbursement
Investment, investor relations, partnering and grants
Marketing, distribution and partnering for market access
Early stage investment forum.

The programme is being finalised now, and will represent Australia’s medtech industry; celebrate the successes and impacts our industry has made, and engage on the reimagined future of medtech.

AusMedtech 2021 is supported by the Victorian Government as the Host State Partner.

Positive study result for Botanix's BTX 1801 in golden staph

Thu, 04 Feb 2021 00:00:00 +1100

Australian-developed COVID nasal spray set to land in Europe

Thu, 04 Feb 2021 00:00:00 +1100

Industry leaders sought to drive decadal strategy for sector

Tue, 02 Feb 2021 00:00:00 +1100

Expressions of interest from industry leaders are sought to join AusBiotech’s new expert forum to drive the development of the industry’s Biotech Blueprint, the sector’s decadal framework.

As the national voice of the Australian biotech industry, AusBiotech is leading the development of the strategy, and is seeking key industry leaders that are representative of its various facets, to share their experience and knowledge to ensure a valuable, visionary and dynamic plan.

AusBiotech’s Biotech Blueprint is an opportunity for the industry to speak with one voice to governments, identifying key policy priorities that can deliver benefits both for the industry and for the nation as a whole.

The six draft goals that will underpin and drive industry growth through to 2030, and the metrics that will tell us how we are progressing, are being finalised after broad consultation in 2020. As the plan is progressed through 2021, AusBiotech aims to provoke discussion and debate in the steps that should be taken in the near-term to ensure that biotech’s positive future is realised, and to reflect what a vibrant and valuable Australian biotech industry could and should look like a decade from now.

Playing a critical role in the pandemic response, biotech is at the forefront and there has never been a more important time to plan for the future. This is, therefore, a valuable opportunity for the Industry to put forward a clear and ambitious plan for the future. If Australia is to build on the critical mass that has been established to date, strong alignment between industry and government over the coming decade will be key.

The Expert Forum will meet on an ‘as needed’ basis. Expressions of interest from AusBiotech Members can be sent to Lorraine Chiroiu, CEO, AusBiotech.

Ellume announces new agreement to scale-up US production

Tue, 02 Feb 2021 00:00:00 +1100

Orthocell updates on world-first case report for its tendon repair treatment

Tue, 02 Feb 2021 00:00:00 +1100

Help shape Australian health security policy

Thu, 28 Jan 2021 00:00:00 +1100

The National Medical Countermeasures Initiative has invited the life sciences industry to help shape the future of Australian health security policy. The Initiative is developing a comprehensive national picture of Australia’s capability and capacity to conduct research, development, manufacturing and distribution of products and services that are essential to the nation’s health security.

The National Health Security Resilience Assessment (Assessment) will build on and extend beyond previous audits of Australia’s medical countermeasures capability to include end-to-end research, development, manufacturing and distribution in six critical sectors including medical countermeasures, medical devices, personal protective equipment (PPE), modelling and simulation, hazard management and sensing systems.

The current COVID-19 environment highlights the need for Australia’s health security to be underpinned by a nationally coordinated approach to sovereign preparedness, prevention, response, and recovery (PPRR). With a strong focus on supply chain resilience and in-country manufacturing capacity, the Assessment will assess the strengths and vulnerabilities of Australia’s PPRR ecosystem.

The Assessment is led by DMTC (Defence Materials Technology Centre). Multiple government agency stakeholders were consulted in the development of the assessment and will gain strategic insight and direction from the results including: Department of Industry, Science, Energy, and Resources; Department of Health; Commonwealth Scientific & Industrial Research Organisation (CSIRO), Department of Foreign Affairs and Trade; Department of Defence; and Department of Home Affairs.

The Assessment is open until 31 May 2021. It is expected to take 15 – 60 minutes, depending on the sectors your organisation is involved in.

To participate in the Assessment, register as a user here, then complete the surveys of relevance to your company.

Further information on the Assessment and its stakeholders can be found on DMTC’s website.

AusBiotech renews agreements with international industry bodies

Thu, 21 Jan 2021 00:00:00 +1100

AusBiotech’s international partnerships have been extended, with new Memorandums of Understanding (MoU) signed with major international industry associations to support collaboration efforts.

The agreements have been re-signed with FIRM, Japan’s peak regenerative medicine industry body, and Biocom California, the largest, most experienced leader and advocate for California’s life science sector.

These alliances will strengthen Australia’s sector positioning and offer international opportunities for investment discussions, collaborations and partnerships, with a focus on a key market (US) and technologies, that are important to members.

AusBiotech’s renewed agreement with Biocom California enables stronger connections and greater collaboration between the associations and their respective regions, with both AusBiotech and Biocom representing a combined 1,400 entities in the global life sciences sector.

The partnership will support knowledge and idea sharing between Associations, their respective Boards and members; create joint agendas in areas of common strategic focus; and maximise member services and benefits through collaboration.

AusBiotech has also renewed the MoU with Japan’s peak regenerative medicine body, Forum for Innovative Regenerative Medicine (FIRM), under the MoU between the Australian Trade Commission (Austrade) and FIRM, in relation to the collaboration in advancing regenerative medicine and cell and gene therapies within Australia, Japan and worldwide.

FIRM is a Japanese general incorporated association with a mission to accelerate research and commercialisation of regenerative medicine in Japan. FIRM was formed in 2011 and has more than 250 members of Japanese companies from various fields with diverse expertise in such as pharmaceutical, biotechnology, manufacturing, transportation, insurance and related supporting areas for regenerative medicine.

AusBiotech and FIRM will collaborate to advance their individual and common missions by sharing information encompassing technology, policy, laws etc., and assist each other in co-sponsoring meetings or through other cooperation based on common concerns.

In particular, AusBiotech sees FIRM as an important international partner and the representative of the regenerative medicine industry in Japan, and FIRM sees AusBiotech as an important international partner and the representative of the regenerative medicine industry in Australia.

AusBiotech has a long and valued relationship with Austrade, partnering for many years to promote Australian biotechnology around the world, with particular focus on regenerative medicine, clinical trials, medical devices and diagnostics, biotechnology and pharmaceutical sectors.

Joe Panetta, President and CEO, Biocom; Lorraine Chiroiu, CEO, AusBiotech; Lisa Haile, Partner, DLA Piper; and Jennifer Landress, Senior Vice President and Chief Operating Officer, Biocom; progressing opportunities between the Australian and Californian biotech industries at BIO 2019.

Queensland research institute in new cell therapy trial

Thu, 21 Jan 2021 00:00:00 +1100

Capital raising hits new high

Tue, 19 Jan 2021 00:00:00 +1100

As we enter a new year and reflect on the past 12 months, the metrics show a positive and resilient outcome for the industry with the highest capital raising for life science companies on record.

Annual data collected and reported by Bioshares shows that the capital raised by ASX-listed biotech companies in calendar year 2020 was $1.7 billion, building on the $1.08 billion raised the year prior.

While the impact of COVID-19 is yet to be realised, the result is looking better than first anticipated for Australian life science companies seeking to commercialise health and medical research.

David Blake, Editor/Analyst & Co-founder of Bioshares, said, “Rising share prices are one of the key drivers of capital raisings. Compared to the first quarter of 2019, the Bioshares Index was up 62 per cent at the end of 2020.

“Shares prices move when companies hit milestones, such as Opthea successfully marching through a Phase IIb study in 2019, and even begin to pay dividends, as seen with Clinuvel Pharmaceuticals for example.

“But 2020 was different. While the June quarter saw raisings of buffer capital (about $600 million), investors, probably many of whom were newly minted day traders stuck at home, got on the biotech-is-actually-good-for-something bandwagon… an opportunity presented itself for some companies to position themselves in front of new investors.”

Scott Power, Analyst for Morgans and committee member of the AusBiotech Investor Advisory Group, said, “At the start of the pandemic, Australia saw a short period where companies and investors were cautious of where and when to put their money to get the best return on income. Through low interest rates and government incentives we’ve seen a flood of money being pumped into the sector since April – particularly in health and life sciences, including diagnostics.

“It’s been an absolute bumper year, not just in terms of the dollar figure, but also the number of transactions. Around 25 per cent of the listed companies in life sciences don’t need to raise money, they’re profitable. Many outside of the top 100 ASX-listed companies have a large appetite for capital. Around 60 per cent of those came to market and successfully raised money, resulting in the extraordinary numbers that have come through.”

Less than 12 months ago, Australia was facing the potential risk of losing a generation of mid-to-late stage biotech companies, and the talent behind them. Typically taking more than a decade for a product to get to market, this would have been detrimental to Australia’s future.

Instead, Australia has been amongst the globe’s lesser COVID-19-impacted countries, providing the opportunity to start and continue medical research and clinical trials through the pandemic. Overall, clinical trials in Australia have progressed as they were pre-lockdown; and in some therapeutic areas the number of trials being conducted has increased. COVID-19 has reiterated the vibrant industry’s health and economic benefits, and its opportunity to be a major contributor to the country’s economic recovery.

Scott Power predicted that 2021 will continue this momentum; while not at the same rate. “Many companies have raised more than what they need, which will see them through for a considerable period. While there may not be the same opportunity as in 2020, there will still be plenty of capital available in 2021.”

AusBiotech is committed to fostering relationships between life science companies and investors, in connecting with innovative, Australian companies that offer high-value return-on-investment.

Members invited to Industry and state government updates

Thu, 14 Jan 2021 00:00:00 +1100

Completing the ‘Update online roadshow’ AusBiotech members from Queensland and Western Australian are invited to hear the latest information from their State Government representative at AusBiotech’s Industry Update, which aims to grow and support the biotech industry.

Facilitated by Michelle Burke, Chair, AusBiotech, Members are invited to join Mark Tierney, Executive Director, Industry Development – QLD Department of State Development, Tourism and Innovation on 20 January; and Dr Debra Cousins, Executive Director, WA Department of Jobs, Tourism, Science and Innovation on 10 February, for a live industry update.

Lorraine Chiroiu, CEO, AusBiotech will discuss national policy advocacy for the sector during these tailored events.

These events are delivered as part of AusBiotech’s virtual Industry Update roadshow, and are limited to AusBiotech members only, which includes SMEs, multinational organisations, support services, universities, and research institutes.

The Victorian Industry Update, delivered late last year and available to members in the BiotechTalks Library for a limited time, included an update on the State Budget that was announced a week prior to the event. Chris Barrett, CEO, Invest Victoria, and Paul Stagg, Director, Trade, Global Victoria, Department of Jobs, Precincts and Regions (DJPR), joined Michelle Burke and Lorraine Chiroiu.

Initiatives discussed included:

Significant investment through the newly announced $2bn Breakthrough Victoria Fund, to drive investment in research innovation and the next great breakthroughs over the next 10 years, including how the fund is being set up, and next steps.
To better access and engage with international markets, the ecommerce programme is broadening, including promotional activities, market and sector insights, and creating digital collateral.
Advocacy for VIC interests for the Commonwealth International Freight assistance programme that connects exporters with key markets and is in place until June 2021.
A new $15.7m Export Recovery Package: to establish new export channels, adapt existing export strategies, and remain connected to key markets through key activities, e.g. virtual trade missions.
One-off grants of up to $50,000 available through VIC’s Global Gateway Programme, for companies to pivot to stabilise their export activity or adapt their export strategy to mitigate barriers caused by COVID-19. Grants are expected to subsidise 80 per cent of project costs.
Update on the new International Investment Strategy, launched in March 2020, that covers digital technology, advanced manufacturing, health and life sciences, and agri-food.
Highlighting the new four pillars of the ‘Jobs Plan’, that aims to create 200,000 jobs by 2022 and 400,000 jobs by 2025.
$20m to champion, develop and identify new opportunities for VIC’s medtech manufacturing and innovation sector, and $50m to focus on manufacturing and industry development, including sovereign manufacturing and industry supply capability in Victoria.
$210m to support research organisations and institutes, including the Australian Institute for Infectious Disease.
Funds to address access to capital challenges.
Supporting regenerative medicine as emerging technologies, and how a roadmap and sustainable body will drive it forward for the future of Australia.
What the latest significant RDTI announcements means to Australian biotech companies.

Read more about the upcoming QLD/WA webcasts and their speakers, and register here.

Already have a burning question or an issue you want an update on from Lorraine or your State Government representative? Pre-submitted questions will take precedence so ask AusBiotech now; as many as possible will be covered in the presentation and Q+A.

Noxopharm says study advancing after clinical review

Thu, 14 Jan 2021 00:00:00 +1100

ARTMS and Telix Pharmaceuticals announce successful production of 68Ga PSMA-11

Thu, 14 Jan 2021 00:00:00 +1100

New Year resolutions demonstrating commitment to growth

Tue, 12 Jan 2021 00:00:00 +1100

As the country returns after the festive break and the realities of ‘COVID-normal’ and the respective New Year’s resolutions settle on us, AusBiotech starts the year focused on leadership in policy, and a resolution to continue committed advocacy for innovation in life sciences.

With the life sciences industry under the spotlight and being recognised as it never has before, now is the time to be ambitious about how the biotechnology industry cannot just help solve problems, but also generate the long-term economic growth and social capital that will be needed as we emerge from the current pandemic.

Resolution one: Help us write the Biotech Blueprint - Australia's life science industry's decadal framework.
If Australia is to build on the critical mass that has been established to date, strong alignment between industry and government over the coming decade will be key.

AusBiotech is developing and leading this important plan. The plan will be valuable, visionary, and dynamic and, as the national voice of Australia’s life science industry, AusBiotech’s Biotech Blueprint is an opportunity for the industry to speak with one voice to governments, identifying key policy priorities that can deliver benefits both for the industry and for the nation as a whole.

The six draft goals that will underpin and drive industry growth through to 2030 are being finalised, following consultation in 2020. As the plan is progressed through 2021, AusBiotech aims to provoke discussion and debate, and to reflect what a vibrant and valuable Australian biotechnology industry could look like in another decade from now.

Resolution two: engage through major Australian life science events
Continuing to facilitate opportunities for investment discussions, collaborations and partnerships is crucial for the growth of Australian life sciences sector and ultimately for continuing Australia’s position in the life sciences sector globally.

AusBiotech’s 2021 events programme is already underway, connecting with international companies virtually during JP Morgan week to demonstrate the value of Australia's clinical trial and medical innovation advantages. Working in Australia offers a compelling opportunity for clinical trials, and this webcast will showcase the country’s opportunities and capabilities that can be taken advantage of.

Save the dates below for more key industry events.

Australia showcase: clinical trials and medical innovation advantages: JP Morgan week – 14 Jan (PST)/15 Jan (AEDT), online live
Industry Update – QLD: 20 January, online live
Industry Update – WA: 10 February, online live
BioCheers: kicking off from March 2021
AusMedtech 2021, 17-21 May, online live
BIO Digital 2021: 14 – 17 June - watch this space for more information!
Australia Biotech Invest & Partnering, 26 October, online live
AusBiotech 2021, 27 – 29 October, Brisbane

AusBiotech’s events are run by the industry for the industry. As a not-for-profit organisation, all event registrations are reinvested into driving the industry forward towards its short and long-term goals.

Resolution three: Blow the candles out as we celebrate 35 years
This year marks an important anniversary: your industry organisation has been providing more than 35 years of national representation and advocacy of Australian biotechnology. From humble beginnings with less than 100 members in 1986, AusBiotech has grown to become a strong well-connected, 3,000+ member community representing the entire value chain of biotechnology development.

AusBiotech has representation in each Australian state providing a national network to support members and promote the commercialisation of Australian bioscience in the national and international marketplaces.

Throughout 2021, AusBiotech will celebrate the milestone, the work that we have accomplished together, and the opportunities available to industry to drive the sector forward.

This year is already shaping up to be an exciting year with much to celebrate. Your industry body looks forward to a successful year as it continues to work with you and on your behalf as it facilitates the international growth of the sector.

Pharmaxis receives milestone payment from US partner

Tue, 12 Jan 2021 00:00:00 +1100

2020: an unforgettable year

Tue, 22 Dec 2020 00:00:00 +1100

2020 has been an unforgettable year, with the biotech community’s strong contribution to the global healthcare system and to Australia’s economy shining brightly through the many challenges being faced professionally and personally.

While times have been testing, there has been giant strides for Australian life sciences. Most critically for our industry, after more than four years of advocacy, certainty was delivered after the majority of the proposed changes to the Research and Development Tax Incentive (RDTI) were dropped; Australia embraced telehealth as a standard consultation method, thereby increasing accessibility to healthcare; the sector engaged enthusiastically through AusBiotech’s virtual platforms and first virtual conference: AusBiotech + Invest 2020; goals for the Biotech Blueprint, the sector’s decadal framework, were developed; and the AusBiotech-led Regenerative Medicine (RM) Catalyst Project has begun preparing for Australia’s RM future.

AusBiotech truly is for the industry, by the industry, and COVID-19 has highlighted the collective strength in collaborating and uniting together to deliver in strides. The extraordinary innovation, resilience and dedication of the life sciences industry is humbling, and something that Australia can be proud of.

More than 35 years of AusBiotech and Australian biotechnology: 31 December 2020 marks AusBiotech’s birthday. From humble beginnings with less than 100 members in 1986, AusBiotech has grown to become a strong well-connected, 3,000+ member community representing the entire value chain of biotechnology development.

Throughout 2021, AusBiotech will celebrate the milestone, the work that we have accomplished together, and the opportunities available to industry to drive the sector forward.

2020 by the numbers

AusBiotech is the national voice of more than 3,000 AusBiotech members
After more than four years of proposed changes, certainty was delivered on the R&D Tax Incentive (RDTI) Bill
More than 700 delegates joined AusBiotech’s first virtual conference: AusBiotech + Invest 2020
BiotechTalks webcasts, AusBiotech’s virtual platform, was launched to connect the pipeline and ensure linkages and knowledge sharing.
Almost 3,000 attendees attended 22 AusBiotech events throughout the year
AusBiotech’s social media communities connects more than 18,000 people
11 submissions were made on behalf of members
11 committees regularly met, with more than 95 experts from almost 80 companies
New policy update webcasts were launched for Members
Four new Industry Excellence Awards were announced, celebrating the innovation excellence happening across the country
Six goals developed for the Biotech Blueprint: Australia’s life science industry’s decadal framework, that will underpin and drive industry growth through to 2030
Launched the Regenerative Medicine Catalyst Project, to establish a national RM sector ‘catalyst’ collaboration body, and address priority action areas.

Save the dates for 2021 events

AusBiotech’s 2021 events programme is being developed. Save the dates below, and keep an eye on the AusBiotech website as the year progresses:

Australia showcase: clinical trials and medical innovation advantages: JP Morgan week – 14 Jan (PST)/15 Jan (AEDT), online live
Industry Update – QLD: 20 January, online live
Industry Update – WA: 10 February, online live
BioCheers: kicking off from March 2021
AusMedtech 2021, 17-21 May, online live
BIO Digital 2021: 14 – 17 June, - watch this space for more information!
Australia Biotech Invest & Partnering: 26 October, Melbourne
AusBiotech 2021: 27 – 29 October, Brisbane

Championing advocacy

We have sought to deliver strength in advocacy on the issues and opportunities that matter to our stakeholders, and we have an unashamedly aspirational agenda for growth across the industry.

AusBiotech passionately advocated for its members throughout the year by attending more than 30 meetings and consultations, and crafting 11 submissions.

Significant RDTI win: AusBiotech congratulated the Government as through the Federal Budget, the Federal Treasurer delivered significant news on the Research and Development Tax Incentive (RDTI).
A critical industry mission for AusBiotech has been the preservation of the R&D Tax Incentive, which has remained the number one public policy issue within the industry. It was thrilled that the change of position on the RDTI will support and incentivise growth in R&D and manufacturing as Australia recovers from the pandemic.

While the calculations for companies will be dependent on the applicable corporate tax rate, the announcement signified an important and positive shift in the appreciation of the benefits brought by R&D.

Roadmap of recommendations: Throughout Australia’s ‘first wave’ of COVID-19, AusBiotech engaged with the sector and advocated for its needs. This included developing a roadmap of recommendations to minimise and mitigate the COVID-19 impacts on the biotechnology industry, and to facilitate the fastest recovery possible. It highlighted the sector’s sensitivity to policy settings around investment attraction, research funding along the value creation ‘pipeline’, and the taxation environment, in the context of global enterprise where Australian comparative advantage is key. This was submitted by AusBiotech to the National COVID-19 Coordination Commission (NCCC).

Clinical trials: With Australia becoming one of the globe’s lesser COVID-19-impacted countries, AusBiotech developed a policy statement together with the AusBiotech Clinical Trials Advisory Group in support of clinical trial activity in Australia. It highlights how the country’s position, in combination with its well-developed clinical trials sector, gives Australia an opportunity to attract new medical research, technology and clinical trials.

Biotech Blueprint: Australia’s life science industry’s decadal framework: 2020 has been a pivotal year in many ways, and so now is the time to be ambitious about how the biotechnology industry cannot just help solve problems, but also generate the long-term economic growth and social capital that will be needed as we emerge from the current pandemic. AusBiotech is developing and leading this important plan, and has consulted on six draft goals that will underpin and drive industry growth through to 2030. The plan will be progressed through 2021, and will reflect what a vibrant and valuable Australian biotechnology industry could look like in another decade from now.

Regenerative medicine: A new consortium preparing for Australia’s regenerative medicine (RM) future was announced at AusBiotech + Invest 2020. AusBiotech is leading the consortium of seven partners as industry prepares to thrive and drive benefits to Australia’s economy and the health of its people.

Focusing on growth

AusBiotech + Invest 2020: A new level of global insight and perspective was offered at AusBiotech + Invest 2020, Australia’s largest life sciences conference that assembled virtually for biotech’s biggest week of the year.

The premier event - run by industry, for industry – brought together more than 700 industry leaders, investors, researchers, clinicians and regulatory representatives from 21 countries to hear more than 100 inspiring thought leaders from across the globe, in 40 sessions, over three days. More than 2,200 one-to-one meetings were facilitated through our AusPartnering app.

AusBiotech continues to deliver on and foster an inclusive industry, presenting a gender-diverse line-up of speakers and Chairs across the programme. The impactful Student Scholarship Programme, in partnership with AbbVie, also supports diversity and inclusion and this year 42 future leaders were awarded scholarships to participate, learn, exchange and engage.

Industry Excellence Award winners: The prestigious Industry Excellence Awards were announced at the AusBiotech + Invest 2020 national conference, during the biggest week in biotech. The AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards recognise and celebrate life science leaders who are championing the sector and the Australian community through the worst pandemic and greatest collaboration seen in the sector.

Congratulations to 2020’s winners: COVID-19 Life Science Sector Innovation Award: Ellume; Dual COVID-19 Life Science Sector Collaboration Award: University of Queensland; and the Medicines Manufacturing Innovation Centre; Dual COVID-19 Communication Leaders Award: Dr Rob Grenfell, Health and Biosecurity Director, CSIRO; and Professor Sharon Lewin AO, Director, Doherty Institute; Industry’s Choice Award: University of Queensland. Read more about the 2020 winners and their work.

AusBiotech Board

Previous Deputy Chair, Michelle Burke, took up the role of Chair in February, after long-serving Chair Julie Phillips stepped away following an active tenure. Dr Megan Baldwin, CEO and Managing Director of Opthea Limited was named as the new Deputy Chair. During AusBiotech’s first virtual AGM, the election of Linda Peterson as an AusBiotech Director was announced. Read AusBiotech’s 2020 Annual Report, including the annual Chair report, here.

Summer break office closure

The AusBiotech office will be closed over the holiday period from Wednesday 23 December 2020 until 9.00 am, 11 January 2021. Biotech Dispatch will resume on Tuesday 12 January 2021. AusBiotech thanks its members again for their support throughout this unforgettable year, wishes them a happy and safe festive period, and looks forward to working together during 2021.

NSW Medical Devices Fund opens

Thu, 17 Dec 2020 00:00:00 +1100

Applications are open for round 9 of the NSW Government’s Medical Devices Fund (the Fund). More than $8 million in competitive funding is available to support investment in the development and commercialisation of medical devices, and related technologies.

The Fund will support products across a range of applications, throughout the medical device product life-cycle.

The Fund aims to provide support to companies, medical research institutes, universities, individuals, public and private hospitals, and the medical devices industry to take local innovation to market. It also seeks to increase the uptake of NSW medical devices by the health system where they are cost effective and contribute to improved patient outcomes.

Funding can be used for proof-of-concept, prototyping and piloting studies; manufacturing samples for product trials; conducting market and product assessments; engaging a consultant to locate other national and international trials and research relevant to the product under development; and conducting clinical assessments.

Since its launch in 2013, the Fund has provided over $55 million to 35 technologies; some past recipients have later gained high-profile investors. The technologies have now treated over 47,000 patients and are delivering better patient outcomes for NSW.

An online webinar for the Fund will be held in late February 2021, with further webinar details and registrations opening in the new year.

Applications are called for once a year, and there is a two-stage application process. Preliminary applications close on Monday 1 March 2021 at 5.00 pm.

Read more the eligibility and selection criteria, and apply here.

US FDA grants emergency authorisation to Ellume's COVID-19 test

Thu, 17 Dec 2020 00:00:00 +1100

SUDA Pharmaceuticals announces 'firm commitments' on capital raise

Thu, 17 Dec 2020 00:00:00 +1100

Save the date: AusMedtech 2021

Tue, 15 Dec 2020 00:00:00 +1100

Save the date for AusMedtech 2021, Australia’s premier medtech conference, that will be delivered virtually during 17 – 21 May 2021.

AusMedtech 2021 will present a full week of half-day sessions where cutting edge keynotes, expert panel discussions, and Q&A sessions will engage industry on policy, science and technological trends, and their growth potential.

Run by industry, for industry, AusMedtech is an annual conference held by AusBiotech; more than 350 delegates are expected to attend the event, which brings together key stakeholders of the Australian and international medical devices and diagnostics sector to help prepare the industry sector for its changing landscape.

The five days will feature:

Product development, idea generation, feasibility prototyping and manufacturing
Regulation, clinical trials and reimbursement
Investment, investor relations, partnering and grants
Marketing, distribution and partnering for market access
Early stage investment forum.

AusBiotech thanks its programme committee for their support and commitment as they develop 2021’s innovative programme: Chair: Peter Bradley, Vice President Global Business Development - LBT Innovations; Ann Damien, New Technology Associate, New Ventures at Cook Medical; Rachel Hooke, Partner, FB Rice; and Bronwyn Le Grice, Managing Director, ANDHealth; and Grace Lethlean, Chief Operating Officer, ANDHealth.

AusMedtech 2021 is supported by the Victorian Government as the Host State Partner.

Early bird registrations will open in the new year.

Europe grants Antisense's ATL1102 orphan designation

Tue, 15 Dec 2020 00:00:00 +1100

Shaping the industry’s future starts with goals

Thu, 10 Dec 2020 00:00:00 +1100

AusBiotech is calling for feedback on the draft goals of the Biotech Blueprint: Australia’s life science industry’s decadal framework. These goals will set the structures for the broader strategy that will underpin and drive industry growth through to 2030.

AusBiotech welcomes feedback on the specific opportunities identified, as well as any others that should be highlighted. Engagement is important, as AusBiotech sets the foundations of a clear and ambitious plan for the future of our industry.

This plan will be progressed through 2021, and it is critical to ensure these initial pillars reflect what a vibrant and valuable Australian biotechnology industry could look like in another decade from now.

The six draft goals consider what success looks like for the biotech industry in 2030, and what metrics should be determined and tracked against, in order to identify the steps that should be taken in the near-term to realise industry’s positive future.

The goals have been developed taking into account the current state of the industry and future opportunities, global megatrends, and feedback from AusBiotech + Invest 2020’s panel session and from a number of key opinion leaders.

2020 has been a pivotal year in many ways, and so now is the time to be ambitious about how the biotechnology industry cannot just help solve problems, but also generate the long-term economic growth and social capital that will be needed as we emerge from the current pandemic.

AusBiotech is focused on delivery of members’ and industry’s needs, and is committed to growing the industry. The Biotech Blueprint is a powerful long-term approach to healthcare, and will ensure that the pipeline of innovative technologies being developed and manufactured in Australia continues to bring crucial life-enhancing and enriching benefits directly to patients.

The survey should take up to 10 minutes to complete.

Help shape the Biotech Blueprint; have your say by taking the survey now.

Queensland government back Ellume manufacturing expansion

Thu, 10 Dec 2020 00:00:00 +1100

Immutep updates on AIPAC breast cancer study and announces new trial

Thu, 10 Dec 2020 00:00:00 +1100

New guidance on regulatory changes for custom-made medical devices

Tue, 08 Dec 2020 00:00:00 +1100

New guidance on personalised medical devices (PMD), including 3D printed devices, has been released by the TGA. New regulatory requirements will apply under the framework from 25 February 2021.

The new rules are applicable to manufacturers, sponsors or suppliers of devices that are, or can be, personalised to address the particular needs of an individual. Actions to comply with the amended regulations will depend on whether or not the device is currently included in the Australian Register of Therapeutic Goods (ARTG).

Custom-made medical devices are currently exempt from being included in the ARTG. New definitions are being introduced will effect the majority of devices under this pathway; the new regulations will impact differently depending on which of the PMD definitions are met.

This includes:

custom-made medical devices
patient-matched medical devices
medical device production systems
diagnostic images, and
anatomical models.

The concept of a Medical Device Production System (MDPS) will be introduced, together with a framework for regulating these systems, to enable healthcare providers to produce PMD for treating their patients without the need for manufacturing certification.

The new guidance document includes a decision tree to help manufacturers and sponsors determine which new definition the PMD will be regulated under; case study examples, check lists to action, and a statement template.

AusBiotech’s AusMedtech Regulatory Affairs Advisory Group fed into the framework consultation through its participation the TGA’s RegTech Forum. Alongside consulting with industry on the new framework, the TGA also consulted with global regulators.

Download the guidance document on the TGA’s website here.

TGA grants priority review for Telix Pharmaceuticals' TLX591-CDx

Tue, 08 Dec 2020 00:00:00 +1100

Global manufacturing survey invites Australia’s views

Thu, 03 Dec 2020 00:00:00 +1100

Australian manufacturers invited to contribute to global benchmarking, with the 18th Annual Biopharmaceutical Manufacturing global survey underway.

The work is benchmarking advances in global and regional bioprocessing, new technologies, and emerging trends. including new questions that reflect current industry trends.

BioPlan Associates collects more than 280 responses from biopharma manufacturers, contract manufacturing organisations (CMOs), and service providers across 28 countries. The white paper developed from the survey will highlight the top 15 trends in biopharma manufacturing, ensuring that the report continues to reflect critical changes and trends across the global sector.

For each completed survey, BioPlan Associates will will either send a USD $25 Amazon e-gift card or donate up to $3,000 to global health charities.

The survey is open until mid-January, complete it now.

Noxopharm completes $23m share placement

Thu, 03 Dec 2020 00:00:00 +1100

AusBiotech showcases Australia’s clinical trials advantages during JP Morgan

Tue, 01 Dec 2020 00:00:00 +1100

AusBiotech is set to showcase the globally-recognised strength of the Australian clinical trials sector during JP Morgan week in January 2021.

The annual event is an important opportunity for investors and industry to engage with each other across the globe, and AusBiotech’s virtual showcase will highlight the advantages of partnering with Australian life science companies.

Australia’s clinical trials sector is open for research. The robust regulatory environment combined with incentives for research and development, strong networks and excellent engagement with clinicians/researchers, access to established and proven pathways of obtaining high quality clinical data recognised by US and European regulators, and other global institutions, and the speed with which trials can be initiated, makes Australia an attractive place to do business.

The showcase will also highlight how Australia’s R&D Tax Incentive, a cornerstone for innovation, actively supports innovative local companies with their R&D and offers an attractive environment for companies from around the world to develop their intellectual property to Australia.

The distinct perspectives across the programme highlight Australia's cross-border relationships, investment opportunities, and research and regulatory capabilities. The programme includes:

Capitalising on the strengths of the Australian bio-economy, Lorraine Chiroiu, CEO, AusBiotech
Opportunities in Australia’s healthcare sector, Nicola Watkinson, General Manager, The Americas, Austrade
Australia as a destination for clinical trials – capabilities and infrastructure, Professor Megan Robertson, Group Chief Research Officer, St Vincent's Health Australia and Chair, AusBiotech Clinical Trials Advisory Group
Conducting clinical trials in Australia – ethics, approvals and lead times, Kylie Sproston, Chief Executive Officer, Bellberry
How state government is supporting clinical trials, Anne O’Neill, Director Enterprise and International Partnerships, NSW Office for Health and Medical Research, Ministry of Health
How Australia supports research and development, Hank Sciberras, Partner, Global Investment and Innovation Incentives, Deloitte Tax Services
Why Australia should be a priority market for medical innovation – Brandwood CKC
Clinical trials in action, a case study.

Australia has been amongst the globe’s lesser COVID-19-impacted countries, providing the opportunity to start and continue clinical trials and medical research through the pandemic. Through careful management of the pandemic, clinical trials are not only giving Australian patients access to new therapies, vaccines and medical devices, but also giving the country a comparative advantage as a destination for clinical trials from around the globe.

Intended for international audiences, the showcase is free of charge, and will be broadcast live on Thursday, 14th January, 3:00pm – 5:00pm (San Francisco/PST)/ Friday, 15th January, 10:00am – 12:00pm (Melbourne/AEDT).

Interested parties are encouraged to share with their networks and/or register for the Australian Showcase here.

Dimerix announces a new COVID-19 study for DMX-200

Tue, 01 Dec 2020 00:00:00 +1100

Telix Pharmaceuticals acquires Swiss-German counterpart

Tue, 01 Dec 2020 00:00:00 +1100

Industry update highlights SA opportunities

Thu, 26 Nov 2020 00:00:00 +1100

Clinical trials, immediate initiatives and long-term strategies to support life sciences at a State and national level were highlighted at AusBiotech’s SA Industry Update.

AusBiotech’s virtual Industry Update roadshow is engaging members on Federal and state-specific issues facing our sector, discussing recently announced opportunities and programmes from state governments, and enabling Members to connect with AusBiotech and their local life sciences community.

Facilitated by AusBiotech Chair, Michelle Burke, Members were invited to join AusBiotech CEO, Lorraine Chiroiu, and Dirk Beelen, Director, Health and Medical Industries - Department for Trade and Investment, for the South Australian Industry Update.

Initiatives discussed included:

What South Australia’s recently released Hi-Tech Sector Plan 2030 means for life sciences, and how the State is planning to grow the sector from A$2.3b to $5b by 2030.
The new health and medical initiative that will better connect companies and promote local capabilities and contact details. The database is based on the national Industry Capability Network.
Supporting clinical trials: global promotion that Australia’s clinical trials are open for business; creating a single point of entry for private and public care; initiatives to address workforce training; and considering how clinical trials will change and what they’ll look like in the future.
How the RDTI Federal Budget announcement will support our leading sector by giving companies and investors the certainty they need to commercialise and deliver new, innovative treatments to Australian patients.
The three key goals AusBiotech urges Government to focus on to maximise the sector’s export and investment attraction potential, and its capacity to improve lives.

Members can view the SA Industry Update in our BiotechTalks Library until 2 December.

These intimate events are delivered as part of AusBiotech’s virtual Industry Update roadshow, and are limited to AusBiotech members only, which includes SMEs, multinational organisations, support services, universities, and research institutes.

The next AusBiotech Industry Update on 2 December will focus on Victoria and include an update on its recently announced State Budget. Michelle Burke and Lorraine Chiroiu will be joined by Chris Barrett, CEO, Invest Victoria, and Paul Stagg, Director, Trade, Global Victoria, Department of Jobs, Precincts and Regions (DJPR).

Date: Wednesday 2 December
Time: 9:30am - 10:30am (AEDT)
Cost: Free for AusBiotech members

Read more about the speakers and register here.

Telix submits prostate cancer imaging product to FDA

Thu, 26 Nov 2020 00:00:00 +1100

Stem cell news 'the most unexpected result of my career’

Thu, 26 Nov 2020 00:00:00 +1100

Have your say: Biotech Blueprint goals

Tue, 24 Nov 2020 00:00:00 +1100

AusBiotech is preparing for Australia's life science industry’s future, and the sector is invited to have their say on the draft goals that will underpin and drive its decadal strategy: the Biotech Blueprint.

The six draft goals consider what success looks like for the biotech industry in 2030, and what metrics progress should be determined and tracked against. The goals have been developed taking into account the current state of the industry and future opportunities, global megatrends, and feedback from AusBiotech + Invest 2020’s panel session, and from a number of key opinion leaders.

AusBiotech welcomes feedback on the specific opportunities identified, as well as any others that should be highlighted, and is important as AusBiotech sets the foundations of a clear and ambitious plan for the future of our industry.

COVID-19 is a reminder that Australia will need its biotech industry to help it face uncertain future threats. It is therefore a good time to contemplate what a vibrant and valuable Australian biotechnology industry could look like another decade from now, and identify the steps that should be taken in the near term to ensure that positive future is realised.

The survey should take up to 10 minutes to complete, and closes 30 November 2020.

Take the survey now.

Monash to leverage MRFF funds in AMR fight

Tue, 24 Nov 2020 00:00:00 +1100

Carina Biotech teams up with Bionomics on CAR-T

Tue, 24 Nov 2020 00:00:00 +1100

Australia’s role in addressing AMR

Thu, 19 Nov 2020 00:00:00 +1100

During World Antimicrobial Awareness Week, AusBiotech celebrates the leading work of the Australian life sciences industry as it prepares for the role it may take in addressing antimicrobial resistance (AMR), and the opportunities and barriers ahead of us.

With no new classes of antibiotics approved globally in more than 15 years and resistance rates to some drugs in the 95 per cent range – the time is ticking to get on top of this global health emergency.

CEO of BioDiem Ltd, Julie Phillips, said “Australia has a chance to look at what policies are working in the US, Europe and UK to mimic successful strategies in incentivising antibiotic research and development.”

“AMR is a lot like climate change. The scientists have been warning about it since at least the 1970s, yet an understanding of the consequences and policies to drive action have only really been more evident in the last decade.” said Ms Philips.

“Industry needs to be included in AMR strategy-setting and I am hopeful this will start to happen. Given the response of Australian companies to the COVID-19 pandemic, it is clear that we have a role in problem-solving, including in AMR,” said Ms Philips.

BioDiem and its subsidiary company, Opal Biosciences, are targeting unmet needs in infectious diseases. BioDiem owns the technology for an intranasal flu vaccine, which has been licensed to the WHO for developing countries, targeting both seasonal and pandemic flu (e.g. swine or bird flu), while Opal is separately developing treatments targeting antibiotic-resistant infections.

Recce Pharmaceuticals is an Australian company pioneering a new class of synthetic anti-infectives to address the urgent global health threat posed by superbugs and emerging viral pathogens. Its lead candidate RECCE 327 will be trialled in a Phase I human clinical trial study soon.

“RECCE® 327 is a broad-spectrum synthetic antibiotic formulated using synthetic polymer technology to treat blood infections and sepsis – a life threatening inflammatory response to infection that has spread in the body, and the most expensive condition in US hospitals.” said Recce Pharmaceuticals Executive Director, James Graham.

“By introducing RECCE® 327 as a new treatment option that can reduce the use of traditional antibiotics, it could lower the selective pressure on bacteria that leads to the development of resistance.”

One of the biggest legacies of the current coronavirus (COVID-19) pandemic is that broader society is now acutely aware of the interconnectedness of our health, and attention is now turning to AMR. Life sciences leaders around the world are now increasingly focused on research and development for new antibiotics, spurred on by a sense of urgency.

Botanix Pharmaceuticals is another Australian company working against the superbugs. It recently diversified its dermatology research portfolio to include antimicrobials.

“Australia’s biotech community is beginning to respond, but its size and access to international talent and marketplaces is a challenge. That’s why we’ve taken the approach of splitting our R&D capabilities across Australia and the US, and engaged some of the world’s leading drug developers to assist our clinical development,” said Botanix President and Executive Chairman, Vince Ippolito.

Botanix recently announced it is bringing its first in-human Phase II trial for a product called BTX 1801 home to Perth. This nasal medication, containing synthetic cannabidiol, will be tested for its ability to eradicate Staphylococcus aureus and methicillin-resistant S.aureus (MRSA) from the nose of individuals known to carry the bacterium in their nasal cavity.

Strategic planning and market research firm, Biointelect, identified a need to coordinate an industry position on antimicrobial resistance. In partnership with Medicines Australia, AusBiotech, CSIRO, Pfizer and MSD they convened a workshop and developed an AMR industry position paper.

Australia has specific strengths and capabilities in science and research related to immunity and infectious diseases, as well as some unique pathogens of concern to Australia and the neighbours in our region. To combat AMR successfully, the whole life science eco-system should be aligned and work together on a coordinated national AMR research programme, and ensure industry perspectives, capability and contribution are communicated in the development of the next National AMR strategy.

World Antimicrobial Awareness Week takes place on 18 – 24 November, and aims to increase awareness of global antimicrobial resistance (AMR) and to encourage best practices among the general public, health workers and policy makers to avoid the further emergence and spread of drug-resistant infections.

Read the full feature on page 52 in the Australasian Biotechnology journal, here.

FDA approval for QBiotics' canine cancer treatment

Thu, 19 Nov 2020 00:00:00 +1100

Clinical Trial Exemption (CTX) scheme renamed

Tue, 17 Nov 2020 00:00:00 +1100

The Clinical Trial Exemption (CTX) scheme - one of the two avenues available for trials of unapproved therapeutic goods in Australia - has been renamed as the Clinical Trial Approval (CTA) scheme.

The TGA had recently made the change to more accurately reflect the scheme’s purpose. The accompanying Clinical Trial Notification (CTN) scheme remains unchanged.

The overall decision as to whether a CTA or CTN is required is the responsibility of the trial sponsor, and further guidance is available on the TGA’s website (https://www.tga.gov.au/resource/australian-clinical-trial-handbook). Consultation with a Human Research Ethics Committee that will approve the trial protocol may assist in this decision.

The TGA’s website, applications forms and the Australian clinical trial handbook have been updated with the name change.

AusBiotech is dedicated to promoting Australia as a key destination to conduct clinical trials. It is a globally-competitive location, and are worth around $1 billion to the Australian economy annually, including around $650 million of foreign investment, with Australia attracting trials from around the world. They are a critical component in the development process of bringing new therapies, devices and diagnostics to patients.

Patents Accessibility Review submission

Thu, 12 Nov 2020 00:00:00 +1100

AusBiotech has used its submission on the Department of Industry, Science, Energy and Resources’ Patents Accessibility Review to support efforts that ensure the patent system represents an accessible and useful resource for SMEs.

The review is part of the Australian Government’s commitment to ensuring IP frameworks support the needs of SMEs and protects their inventions in Australia and overseas. It included reviewing costs, processing times, advice and SME awareness levels; and options to improve access and support.

AusBiotech promoted the value of providing skills and raising awareness on the value and importance of IP within SMEs, and is engaging with the Department to support these efforts.

Its recommendations included the development of targeted information to enhance SME IP literacy and understanding of the patent system; government funding programmes and/or tax incentives that prioritise the commercialisation end of the research pipeline and assistance to encourage Australian SMEs to register, insure and promote eligible IP, including patents; and the development of ‘IP Audit Check lists’ for each stage of the commercialisation process.

Australia’s mature and thriving life sciences industry operates in a globally competitive market that demands we create and maintain the business conditions that maximise our competitiveness. AusBiotech’s response noted that when making any changes to the IP framework or patent system the Australian Government should be conscious of the nature of this market.

The Patents Accessibility Review relates to 2019 consultations, including Commercialising Business Ideas discussion paper, conducted by the Department, with the intent of better understanding the needs of innovative SMEs.

This response was led by AusBiotech’s Intellectual Property Advisory Group (IPAG), which provides advice to AusBiotech on intellectual property issues from across the life sciences industry. AusBiotech extends its sincerest thanks to Dr Brett Lunn, Patent Attorney & Managing Partner, FB Rice, who is stepping down as Chair of IPAG.

Lorraine Chiroiu, CEO, AusBiotech, said: “On behalf of the sector, I wish to thank Brett for his seven years of generous commitment to the Intellectual Property Advisory Group. His Chairmanship has driven strategic and proactive advocacy decisions, and we look forward to continuing to working with him through the AusMedtech Advisory Group.” The new Chair of the IPAG is yet to be appointed.

Read the AusBiotech response to the Patents Accessibility Review here.
Read all AusBiotech submissions here.

Botanix Pharmaceuticals updates on meeting with FDA

Thu, 12 Nov 2020 00:00:00 +1100

Antisense Therapeutics' ATL1102 moving towards orphan designation in Europe

Thu, 12 Nov 2020 00:00:00 +1100

AusBiotech welcomes new Chief Scientist

Tue, 10 Nov 2020 00:00:00 +1100

AusBiotech welcomes and congratulates Dr Cathy Foley, as Australia’s newly-appointed Chief Scientist.

Currently CSIRO’s Chief Scientist, Dr Foley has championed emerging and future areas of science research and capability within CSIRO, been an inspiring advocate for science and STEM careers, and has led the development of a Quantum Technology Roadmap for Australia.

Lorraine Chiroiu, CEO, AusBiotech, says: “I am delighted to congratulate Dr Foley on her new role. CSIRO and AusBiotech have a strong relationship, and I look forward to continuing to working closely with Dr Foley in her new role too.”

“Life sciences in Australia is globally competitive; together, we can continue sharing its strengths internationally, and to advance translational locally to ensure it realises its nationally-important economic potential.”

Prime Minister Scott Morrison highlighted the importance of the role, noting: “Dr Foley has a big task ahead to drive collaboration between industry and the science and research community, as we look to create jobs for the COVID-19 recovery and for the future.”

Dr Foley will take the role following Dr Alan Finkel’s five-year tenure. Dr Foley is the second woman to be named Australia’s Chief Scientist, after Professor Penny Sackett, who held the role from 2008-2011. Dr Foley’s three-year appointment begins in January 2021.

Noxopharm announces Veyonda to be studied in new immunotherapy trial

Tue, 10 Nov 2020 00:00:00 +1100

New consortium prepares for Australia’s regenerative medicine future

Thu, 05 Nov 2020 00:00:00 +1100

A new consortium preparing for Australia’s regenerative medicine (RM) future has been announced at AusBiotech + Invest 2020. AusBiotech will lead the consortium of seven partners as industry prepares to thrive and drive benefits to Australia’s economy and the health of its people, after it received funding through MTPConnect’s Project Fund Program.

The seven consortium partners hold extensive insight and experience in the life science and regenerative medicines landscape in Australia: AusBiotech, Medicines Australia, Cell Therapies Pty Ltd, Novartis Pharmaceuticals Australia Pty Ltd, Biointelect Pty Ltd, Research Strategies Australia, and MTPConnect. The partners will match the funding from MTPConnect to deliver the project.

Lorraine Chiroiu, CEO, AusBiotech, said: “AusBiotech is delighted to be joining with a high-quality consortium of organisations to further build the foundations for regenerative medicine in Australia.

“The potential health benefits of a surging regenerative medicine sector, were until quite recently more likely to be considered science fiction than reality, but the evidence is mounting; the outcomes stunning – and the excitement for the sector’s future is too good to ignore.

“However, Australia is underprepared to capitalise on the opportunities gene and cell therapies can deliver. This project will bring together, for the first time, the entire ecosystem, and focus our efforts for best effect. From SME to multinational, investor to manufacturer, patient to employee, this project will prepare us for the road ahead.”

The 12-month project will build on Australia’s expertise and achievements in the RM industry - an emerging area of health technology that targets the body’s own regenerative capabilities. RM includes gene therapies, cell therapies (such as CAR-T), and tissue-engineered products intended to regenerate or replace injured, diseased, or defective cells, tissues, or organs to restore or establish function and structure.

Major outcomes of the project include:

A researched, strategic roadmap for the RM sector’s development in Australia;
Determining a sustainable funding and model structure for an RM sector ‘catalyst’ collaboration body;
A regulatory white paper;
Establishing annual data points and information resources;
Mapping the pathway for a typical product from early research to market, and patients receiving a therapy; and
Mapping the global pipeline of gene and cell therapy products on the horizon.

AusBiotech remains committed to identifying opportunities to further enhance Australia's regenerative medicine ecosystem and life sciences sector.

Read the media release with further project details here.

New report looks to remove barriers to 'innovation adoption'

Thu, 05 Nov 2020 00:00:00 +1100

Life science leading lights celebrated with Industry Excellence Awards

Tue, 03 Nov 2020 00:00:00 +1100

The prestigious Industry Excellence Awards were announced at the AusBiotech + Invest 2020 national conference, during the biggest week in biotech. The AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards recognise and celebrate life science leaders who are championing the sector and the Australian community through the worst pandemic and greatest collaboration seen in the sector.

Congratulations to 2020’s winners: COVID-19 Life Science Sector Innovation Award: Ellume; Dual COVID-19 Life Science Sector Collaboration Award: University of Queensland; and the Medicines Manufacturing Innovation Centre; Dual COVID-19 Communication Leaders Award: Dr Rob Grenfell, Health and Biosecurity Director, CSIRO; and Professor Sharon Lewin AO, Director, Doherty Institute.

AusBiotech + Invest 2020 delegates voted for the Industry’s Choice Award; this was awarded during the conference closing - congratulations to the University of Queensland for being awarded the winner.

Lorraine Chiroiu, CEO, AusBiotech, said: “We received a phenomenal number of high-quality nominations, and it made the decisions incredibly difficult. The extraordinary achievements that these individuals and companies have delivered in response to COVID-19, has been a truly remarkable illumination of the importance of our sector to the health, well-being and economic security of all Australians within a very difficult year. The Awards act as a celebration of the innovation excellence happening across the country.”

Ms Kathy Connell, Senior Director New Ventures, ANZ, Johnson & Johnson Innovation, who announced the Awards, said: “Johnson & Johnson Innovation is delighted to sponsor these Awards for the eighth consecutive year. This year the Industry Excellence Awards recognise the unsung heroes who are making meaningful contributions to, or whose achievements or response has significantly impacted patient improvements, Australian public health, or the Australian biotechnology industry. We are incredibly proud of Australia’s contribution.”

More on the 2020 winners

COVID-19 Life Science Sector Innovation Award: Ellume
Ellume's point-of-care COVID-19 test provides rapid and accurate identification of the virus, making it an effective tool in the global management of the pandemic.

Ellume is a Queensland-based digital diagnostics company that has created a high-performance COVID-19 antigen test capable of delivering results in less than 15 minutes. Their technology will be game-changing as the world moves into a ‘COVID-normal’ way of living; it enables rapid detection of the virus and provides real-time reporting of positive test results for efficient contact tracing. Taking 10 years to develop the core technology, the company pivoted to develop the test within four months.

In October 2020, Ellume was awarded US$30m funding by the US National Institutes of Health (NIH) to support the accelerated clinical testing and manufacturing scale-up of the company’s COVID-19 antigen tests. It has already shipped the first batch to the US for clinical trials, where the virus is widespread in the community. View footage of Ellume’s labs here.

Dual COVID-19 Life Science Sector Collaboration Award: University of Queensland; and the Medicines Manufacturing Innovation Centre.

University of Queensland
The University of Queensland (UQ) sits at the centre of dozens of global collaborations and enabling agreements, mobilising quickly in their fight against COVID-19. Its partnering response across academic and industry partners – aided by Uniquest - includes CEPI, CSL, Doherty Institute, WHO Collaborating Centre, ANU, CSIRO, Hong Kong University, TetraQ, Patheon, Cytiva, Sypharma, Nucleus Network, GSK, Dynavax, Lonza, Life Technologies, Viroclinics Xplore, Syneos and Berkeley Lights. It has also been working closely with Federal and Queensland governments, philanthropists and donors. These partnerships aim to rapidly translate and develop the COVID-19 vaccine candidate.

Researchers have worked tirelessly to take the vaccine successfully through Phase 1 trials and into CSL’s preparation for Phase 2B/3 trials planned for December 2020. Research, clinical, and product development work that would normally take years has been accelerated into weeks and months, and planning that would typically take place sequentially is occurring simultaneously. This Australian and international research collaboration has already been extraordinary, and has the potential to be world changing.

An additional collaboration involving QUT, WEHI and UQ used a first-in-Australia approach to identify a genetic signature specific to patients with severe COVID-19, where excessive inflammation in the lungs can be deadly. While validation is required, this is likely to represent a prognostic signature to identify those most at risk among seriously ill patients – potentially saving lives.

Monash University, Medicines Manufacturing Innovation Centre
In response to the pandemic, the Medicines Manufacturing Innovation Centre (MMIC) prioritised resource allocation to COVID-19 related projects and provided formulation development support to Victorian biotechnology companies, research institutes and companies beyond Victoria in response to the global pandemic.

MMIC has provided assistance to numerous COVID-19 therapies in various stages of development by Australian biotechnology companies, including with early-stage development of intranasal formulations and a sizeable collaborative programme between The Peter Doherty Institute, University of Melbourne, Monash University, Certara, CSIRO, Murdoch Children’s Research Institute and clinicians from Royal Melbourne Hospital, Northern Health, St Vincent’s Hospital to investigate the potential to repurpose an existing medication to reduce the spread and severity of COVID-19 infections.

Dual COVID-19 Communication Leaders’ Award winners: Dr Rob Grenfell, Health and Biosecurity Director, CSIRO; and Professor Sharon Lewin AO, Director, Doherty Institute

Dr Rob Grenfell, Health and Biosecurity Director, CSIRO
Dr Rob Grenfell, CSIRO’s Health and Biosecurity Director, has emerged as a trusted voice on the pandemic public health measures and the race to find a vaccine, engaging Government, businesses, and medical and NGO communities. As the primary COVID-19 spokesperson for CSIRO, and drawing on 30 years’ experience as a general practitioner and in public health, he has provided a trusted and evidence-based voice to keep the Australian public informed on the latest developments on COVID-19, from vaccines to the public health response.

Since January 2020, Dr Grenfell has engaged on complex and evolving subject matter, and in more than a hundred media interviews, resulting in more than 4,000 news stories (including syndications) reaching at least 64.8 million people in Australia alone.

Professor Sharon Lewin AO, Director, Doherty Institute
Prof. Lewin has worked tirelessly at the helm of the Doherty Institute, and was recently appointed a member of the Victorian COVID Advisory Group, providing advice to the Victorian Treasurer on safely easing COVID-19 restrictions for various industries.

Prof. Lewin has given a huge number of Australian and international media interviews during the pandemic, offering measured, clear, concise explanations of complex virological, immunological and epidemiology concepts. She has ensured the public health messaging is helpful, easy-to understand and in line with global evidence about COVID-19.

The Institute has hosted high profile visits and information sessions for politicians, and records video messages offering Doherty Institute staff advice, comfort and information on lockdown messages.

See previous Industry Excellence Award winners here.

Pharmaxis joins elite Australian club with US approval

Tue, 03 Nov 2020 00:00:00 +1100

Telix announces major deal for its products in China market

Tue, 03 Nov 2020 00:00:00 +1100

Immutep announces new collaboration with US-based LabCorp

Tue, 03 Nov 2020 00:00:00 +1100

UQ awarded Industry’s Choice Award

Fri, 30 Oct 2020 00:00:00 +1100

The University of Queensland (UQ) has been awarded the Industry’s Choice Award, the final AusBiotech and Johnson & Johnson Innovation Industry Excellence Award for 2020. The prestigious Industry Excellence Awards were announced at the AusBiotech + Invest 2020 national conference, during the biggest week in biotech.

The AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards recognise and celebrate life science leaders who are championing the sector and the Australian community through the worst pandemic and greatest collaboration seen in the sector.

The Awards celebrate those who have played a critical role guiding and inspiring us locally, and shining a light on Australia globally as a leader in the response to COVID-19. Behind these critical and timely responses are people and companies that inspire their workforce, their State, and their nation.

Industry’s Choice Award: University of Queensland
COVID-19 Life Science Sector Innovation Award: Ellume
Dual COVID-19 Life Science Sector Collaboration Award: University of Queensland; the Medicines Manufacturing Innovation Centre.
Dual COVID-19 Communication Leaders Award: Dr Rob Grenfell, Health and Biosecurity Director, CSIRO; Professor Sharon Lewin AO, Director, Doherty Institute

Life science leading lights celebrated with Industry Excellence Awards

Thu, 29 Oct 2020 00:00:00 +1100

COVID-19 Life Science Sector Innovation Award: Ellume
Dual COVID-19 Life Science Sector Collaboration Award: University of Queensland; the Medicines Manufacturing Innovation Centre.
Dual COVID-19 Communication Leaders Award: Dr Rob Grenfell, Health and Biosecurity Director, CSIRO; Professor Sharon Lewin AO, Director, Doherty Institute

The prestigious Industry Excellence Awards were announced today at the AusBiotech + Invest 2020 national conference, during the biggest week in biotech. The AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards recognise and celebrate life science leaders who are championing the sector and the Australian community through the worst pandemic and greatest collaboration seen in the sector.

AusBiotech’s Chief Executive Officer, Lorraine Chiroiu, said: “We have received a phenomenal number of high-quality nominations, and it made the decisions incredibly difficult. The extraordinary achievements that these individuals and companies have delivered in response to COVID-19, has been a truly remarkable illumination of the importance of our sector to the health, well-being and economic security of all Australians within a very difficult year. The Awards act as a celebration of the innovation excellence happening across the country.”

Ms Kathy Connell[1], Senior Director New Ventures, ANZ, Johnson & Johnson Innovation, who announced the Awards, said: “Johnson & Johnson Innovation is delighted to sponsor these Awards for the eighth consecutive year. This year the Industry Excellence Awards recognise the unsung heroes who are making meaningful contributions, or whose achievements or response has significantly impacted patient improvements, to Australian public health and the Australian biotechnology industry’s response to the COVID-19 pandemic. We are incredibly proud of Australia’s biotech and scientific contributions.”

Voting is also open to AusBiotech + Invest 2020 delegates to have their say on the Industry’s Choice Award, from the five winners listed below.

More on the 2020 winners

Dual COVID-19 Life Science Sector Collaboration Award: University of Queensland; and the Medicines Manufacturing Innovation Centre.

Dual COVID-19 Communication Leaders’ Award winners: Dr Rob Grenfell, Health and Biosecurity Director, CSIRO; and Professor Sharon Lewin AO, Director, Doherty Institute

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

Ellume enquiries: Patrick Condren, Media and Government Relations, Ellume
patrick.condren@ellumehealth.com / P: +61 (0)7 3393 1448 / M: +61 (0) 405 186 630

About AusBiotech

Event details

AusBiotech + Invest 2020
Date: 28 – 30 October 2020
Venue: Online, and on demand
Website: www.ausbiotechnc.org
Programme: www.ausbiotechnc.org/programme

New Board member elected for AusBiotech

Thu, 29 Oct 2020 00:00:00 +1100

AusBiotech announced the election of Linda Peterson as a Director at its Annual General Meeting yesterday – an addition that will bring 30 years’ experience from across the breadth and depth of the sector.

Linda Peterson is Chief Operating Officer and Company Secretary of BioCurate, a joint initiative between Monash University and the University of Melbourne, with Victorian State Government support, that works to translate medical research outputs into high quality pre-clinical candidates for the bio-pharmaceutical industry.

Linda holds experience across academic, translational research, start-up and the commercial life sciences sector, and has held positions in medical research, industry R&D services, business management, and C-Suite executive leadership.

Her scientific training, extensive management experience at all levels, together with her long-held passion for the sector and strong people skills, enables Linda to provide the critical ‘interface’ for effective cross collaboration and delivery of challenging research and business goals.

AusBiotech Chair, Michelle Burke, said, “On behalf of the AusBiotech Board, we warmly welcome Linda to her new role. She brings an experienced perspective from across the life sciences pipeline, and together with her strong network and commercialisation experience, will be a valuable contribution to the team’s strategic leadership.”

Newly elected AusBiotech Director Linda Peterson said, “Working alongside people with the shared goal of building the life sciences sector and delivering real world impact has always been my passion – so I’m delighted to have the opportunity to join the AusBiotech Board and contribute to their important work.”

As the first (and sole) staff member of BioCurate, Linda led and project managed the initial set-up of all aspects of the company’s operations. With its foundations in place, Linda’s role shifted to responsibility for recruiting the BioCurate team and ensuring operations, financial management and governance of the Company were effective and continually adapted to the changing requirements of the business.

Prior to joining BioCurate in 2016, Linda was the Executive Manager of Bionics Institute and CEO of Bionic Enterprises.

The Board of Directors are elected as representatives of AusBiotech to provide strategic guidance and corporate management-related policies. Learn more about the AusBiotech Board here.

Cancer trials collaborative celebrates patient milestone

Thu, 29 Oct 2020 00:00:00 +1100

BioCurate inks new MoU with AbbVie

Thu, 29 Oct 2020 00:00:00 +1100

New Board member elected for AusBiotech

Wed, 28 Oct 2020 00:00:00 +1100

AusBiotech announced the election of Linda Peterson as a Director at today’s Annual General Meeting – an addition that will bring 30 years’ experience from across the breadth and depth of the sector.

Prior to joining BioCurate in 2016, Linda was the Executive Manager of Bionics Institute and CEO of Bionic Enterprises.

Current AusBiotech Board members include:

Michelle Burke, Chair, AusBiotech & Principal and Director, Indigo Advisory
Dr Megan Baldwin, Deputy Chair, AusBiotech & Managing Director and CEO, Opthea Limited
Lorraine Chiroiu, CEO & Managing Director, AusBiotech
Serg Duchini, Partner Global Investment and Innovation Incentives (Gi³)/Co. Director, Deloitte Tax Services Pty Ltd
Dr Jan Tennent, FTSE FASM GAICD, Founder & Principal, ConnectBio
Dr Dean Moss, CEO, UniQuest Pty Ltd
Dr Serge Scrofani, Vice President, Strategy & Corporate Development, CSL Ltd
Linda Peterson, Chief Operations Officer, BioCurate

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

About AusBiotech

AusBiotech is Australia’s biotechnology organisation, working on behalf of members for 35 years to provide representation and services to promote the global growth of Australian biotechnology. AusBiotech is the voice a well-connected network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), food technology and agricultural sectors.

New consortium prepares for Australia’s regenerative medicine future

Wed, 28 Oct 2020 00:00:00 +1100

AusBiotech will lead a consortium of seven partners as the Australian regenerative medicine (RM) industry prepares to thrive and drive benefits to Australia’s economy and the health of its people, after it received funding through MTPConnect’s Project Fund Program.

Australia has a strong and active RM industry eco-system with internationally-recognised basic and translational research, clinical trials framework and clinical centres, with more than 30 companies in Australia developing products and more than 30 clinical trials in progress.

Globally, the sector has more than 1,000 clinical trials in progress, and attracted USD $9.8billion in financing in 2019 alone. Global therapeutics companies are turning their attention to the RM sector and we are seeing more gene and cell therapies being brought to Australia for patient access.

The significance and need for this project was highlighted in a national, sector-wide report that assessed the current state of the Australian RM sector and made recommendations on the priorities and goals, see Regenerative medicine: Opportunities for Australia (MTPConnect, LEK, 2018).

Major outcomes of the project include:

A researched, strategic roadmap for the RM sector’s development in Australia, including sub-reports on skill and talent specific to the sector; determining a plan to attract patient venture capital investment and the role of Australian biotech companies partnering with global companies; and case studies;
Determining a sustainable funding and model structure for an RM sector ‘catalyst’ collaboration body;
A regulatory white paper;
Establishing annual data points and information resources to: map/benchmark GMP manufacturing capability and capacity; establish a model for an annual clinical trial database; and capture investments in Australian RM;
Mapping the pathway for a typical product from early research to market, and patients receiving a therapy; and
Mapping the global pipeline of gene and cell therapy products on the horizon.

The new consortium project will receive $300,000 funding through MTPConnect’s Growth Centre Project Fund Program, an Australian Government initiative supported by the Department of Industry, Science, Energy and Resources. Consortia members are providing $300,000 in matched funding. It is a competitive matched funding program that aims to invest in ideas to boost the innovation, productivity and competitiveness of Australia’s MTP sector.

- QUOTES FROM CONSORTIUM –

AusBiotech CEO, Lorraine Chiroiu said: “AusBiotech is delighted to be joining with a high-quality consortium of organisations to further build the foundations for regenerative medicine in Australia.

Biointelect Managing Director, Jennifer Herz, said, “Biointelect is committed to the commercialisation of cell and gene therapies in Australia. In our day-to-day work with promising researchers and companies in early stage development, we see a real need to support commercialisation locally. We also work with late stage biopharma companies and see a broad range of challenges in supply chain, logistics, health service implementation, funding and reimbursement ahead. Biointelect is excited to be involved in the Catalyst Project as the foundation for a world-leading Australian regenerative medicine industry, helping to ensure that Australians patients have access to cutting edge therapies.”

Cell Therapies Pty Ltd CEO, Dawn Driscoll, said, “Australia’s regenerative medicine ecosystem has so many positive attributes and so much going for it: from excellent basic research through to an innovative commercial scene, and underpinned by a robust and rational regulatory framework. Now is absolutely the right time for AusBiotech to oversee a Consortium to move this industry forward and maximize the many opportunities regenerative medicine presents. I am thrilled to be part of it, and look forward to contributing to the further expansion of an industry that can do so much for so many patients in need.”

Medicines Australia CEO, Elizabeth de Somer, said, “Medicines Australia is pleased to be a member of the consortium, as we consider it is vital to modernise regulatory and reimbursement pathways to keep pace with the rapid advancements in therapies such as cell and gene therapies.

“There are around 360 novel cell and gene therapies in early to late stages of clinical development and one third of these are in development for rare diseases. These therapies have the potential to revolutionise treatment options. It will be necessary to ensure the regulatory and reimbursement processes in Australia allow Australian patients to benefit from them as quickly and efficiently as possible.”

MTPConnect Managing Director and CEO Dr Dan Grant said, “MTPConnect’s Growth Centre funding awarded to AusBiotech and consortia members over the next twelve months will help to deliver this important growth initiative for the regenerative medicine sector in Australia.

“Australia has a strong and active regenerative medicine industry eco-system and if we get this right, success could be worth $6 billion in annual revenue and 6,000 new jobs for Australia by 2035. Setting up Australia’s first Regenerative Medicine Catalyst body will now make this a possibility, helping to elevate and drive growth of this emerging industry sector in Australia. Congratulations to AusBiotech and consortia members on securing this funding.”

Novartis Oncology, Australia and New Zealand General Manager, Cheryl Maley, said “More than one year after the first Australian patient received government funded Kymriah®, and with over 100 patients infused since the first local trial patient, we continue to strive to bring innovative cell and gene therapies to Australian patients. Novartis is excited to join this Regenerative Medicines (RM) consortium as we hope that by sharing some of our experiences, and share our successes we can help map the path for local RM companies to bring their developments to Australian patients in a similar way.”

About Kymriah^® (tisagenlecleucel)
Kymriah is an immunocellular therapy, a one-time treatment manufactured individually for each patient using their own T cells, genetically reengineered and programmed to recognise and destroy cancer cells. More information about Kymriah can be found at https://www.novartis.com.au/products/consumer-information/products. Healthcare professionals should see approved Product Information before prescribing. Approved Product Information available on request. For the most up to date Product Information go to https://www.novartis.com.au/products/healthcare-professionals

Warning: Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving KYMRIAH. Do not administer KYMRIAH to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab as per the CRS management algorithm.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Cytokine release syndrome; Neurological events; Infections and febrile neutropenia; Prolonged cytopenias; Secondary malignancies; Hypogammaglobulinemia; Live vaccines; Tumour lysis syndrome; Blood, organ, tissue and cell donation; Active central nervous system (CNS) leukaemia or lymphoma; Concomitant disease such as patients with a history of active CNS disorder or inadequate renal, pulmonary or cardiac function; Prior bone marrow transplant; HIV, Hepatitis B, Hepatitis C and viral reactivation; Prior treatment with an anti-CD19 therapy; Effects on laboratory tests; Use in the elderly and paediatric use; Reasons to delay treatment such as Unresolved serious adverse reactions, Active uncontrolled infection; active chronic GVHD, Significant clinical worsening of leukaemia burden or rapid progression of lymphoma with unstable clinical presentation following lymphodepleting chemotherapy; Patient information regarding adverse event symptoms.

Research Strategies Australia Managing Director, Tim Cahill said, “Research Strategies Australia is very excited to be part of this project which aligns with our mission to maximise the benefits of publicly funded research. Developing a body to catalyse and grow the regenerative medicine industry in Australia is needed to translate our excellent health and medical research capability into improved health outcomes for Australians and those living across our region. By linking the different parts of the regenerative medicine value chain we can speed up the pathway from benchtop to bedside and grow the benefits from our public investment in research.”

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

About AusBiotech
AusBiotech is Australia’s biotechnology organisation, working on behalf of members for more than 30 years to provide representation and services to promote the global growth of Australian biotechnology. AusBiotech is the voice of a well-connected network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), food technology and agricultural sectors.

About Biointelect
Biointelect provides a range of services for biopharmaceutical and medical device companies seeking to commercialise new technologies globally. We conduct detailed market evaluations and we define optimum clinical, regulatory, reimbursement and market-entry strategies.

About Cell Therapies
Cell Therapies Pty Ltd (CTPL) is an Australian-based, globally-active commercial contract development and manufacturing company, specialising in cell therapy, gene therapy, regenerative medicine, and cellular immunotherapy products. A leader in this groundbreaking field, our expert team and world-class facilities have been developing and manufacturing cutting edge treatments for cancer and rare diseases on behalf of local and international clients for more than 15 years.

About MTPConnect
MTPConnect was formed in December 2015 as part of the Federal Government’s Industry Growth Centres Initiative. It aims to accelerate the rate of growth of the medical technologies, biotechnologies and pharmaceuticals sector to increase commercialisation, collaboration and establish Australia as an Asia-Pacific hub for MTP companies.

2020’s biggest week in biotech arrives

Tue, 27 Oct 2020 00:00:00 +1100

A new level of global insight and perspective will be offered this week at AusBiotech + Invest 2020, as Australia’s largest life sciences conference assembles virtually for biotech’s biggest week of the year.

The premier event - run by industry, for industry – is bringing together more than 650 industry leaders, investors, researchers, clinicians and regulatory representatives from 20 countries to hear more than 100 inspiring thought leaders from across the globe, in 40 sessions, at the largest annual biotech gatherings for the Australian life science industry.

Global speakers include: Dr Michelle McMurry-Heath, President & CEO, Biotechnology Innovation Organisation (BIO), United States; Janet Lynch Lambert, CEO, Alliance for Regenerative Medicine (ARM) United States; Dr Reza Halse, President, MRL Ventures Fund, United States; Dr Niels Emmerich, Vice President and Global Head, Search and Evaluation, AbbVie, Inc, United States; Dr Barbara Sosnowski, VP and Global Head of Emerging Science and Innovation Leads, Pfizer Worldwide R&D, United States; and Alison Finger, Chief Commercial Officer, bluebird bio, United States.

Recognising, celebrating and advancing Australian innovation, national speakers include: Professor Paul Young, Professor of Virology and Head of School, School of Chemistry and Molecular Biosciences, University of Queensland; Paul Brennan, Managing Director, PolyNovo Limited; Dr Jackie Fairley AO, Chair, Invest Victoria & Chief Executive Officer, Starpharma Holdings; Dr Craig Rayner, President, Integrated Drug Development, Certara; Professor Tanya Monro, Chief Defence Scientist, Department of Defence Science and Technology, Australian Government; Dr Rob Grenfell, Health Director, Health & Biosecurity, CSIRO; and Professor Sharon Lewin AO, Director, The Peter Doherty Institute for Infection and Immunity.

Keynotes, panel discussions and key themes will cover: The global biotech response to COVID-19; Australia’s life sciences industry uniting through COVID-19; medtech and digital health; clinical trials; global pharma talks: search, evaluation and venture investment; the business of biotech; regenerative medicine and cell therapies; therapeutics and personalised medicine; regulatory innovation; and health meets agriculture.

The AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards 2020 will recognise and celebrate life science leaders who are championing the sector and the Australian community through the worst pandemic and greatest collaboration seen in the sector, with four new Award categories: COVID19 life science sector innovation award; COVID19 life science sector collaboration award; COVID19 communication leaders’ award; and the Industry’s choice award. The winners of the Awards will be announced on Thursday, with delegates then voting for their choice; the Industry’s Choice Award will be announced at the conference closing on Friday.

Despite the volatility and challenging market brought upon us by the pandemic, Australia’s biotechnology industry presents a compelling opportunity for investors and international partners. AusBiotech + Invest 2020 will include an investment showcase, including its leading Australia Biotech Invest & Partnering annual event, and an Early Stage Investment Forum.

Private and publicly-funded companies will take centre-stage and present to an audience of investors to make meaningful connections, and early stage projects will receive direct feedback on their pitches from an expert panel of investors.

Company spotlights include Australian private and publicly listed companies: Prescient Therapeutics (ASX:PTX); AdAlta (ASX:1AD); Anatara Lifescienes (ASX:ANR); Noxopharm Limited (ASX:NOX); NeuroScientific Biopharmaceuticals (ASX:NSB); OncoSil Medical (ASX:OSL); Optiscan Imaging (ASX:OIL); LBT Innovations (ASX:LBT); ResApp Health (ASX:RAP); TruScreen Ltd (NSX:TRU); Microba; Nirtek; HalleyAssist; Macuject; Bondi Bio; Carina Biotech; HaemaLogiX Pty., Ltd; Nutritional Growth Solutions; and Tekcyte. A Korean Biotech Company Showcase will also feature 10 companies and their technologies.

Driving our industry strongly forward, the virtual conference includes a live and interactive three-day multi-stream AusBiotech + Invest 2020 programme, one-to-one partnering, and online exhibition. On demand access also allows delegates to return and view conference programme sessions, exhibition, sponsors and retrieve notes taken during AusBiotech + Invest 2020.

The event that has been known and trusted for 35 years will lift the profile of the Australian biotechnology industry, share new and ground-breaking knowledge, connect companies, and create access to greater funding sources for companies to develop world-class science into therapies, diagnostics and medical devices.

AusBiotech + Invest 2020 is supported by the Victorian Government as State Host Partner.

Engage, no matter where you are. Register for AusBiotech + Invest 2020 here.

Immutep partners for 'efti' COVID-19 trial

Tue, 27 Oct 2020 00:00:00 +1100

Dimerix updates on the development of DMX-200 for kidney disease

Tue, 27 Oct 2020 00:00:00 +1100

$2.5 million CSL Centenary Fellowship winners announced

Thu, 22 Oct 2020 00:00:00 +1100

CSL have announced the winners of their two five-year $1.25 million fellowships, with research investigating new ways to combat health challenges of global significance: cancer and infectious diseases.

The Centenary Fellowships are for early-mid career medical researchers. The fellowships are high-value awards available to Australians who wish to continue a career in medical research in Australia.

CSL announced that Dr Alisa Glukhova, biologist at the Walter and Eliza Hall Institute of Medical Research in Melbourne, is investigating a fundamental cell communication system that guides the growth of embryos. When it goes wrong, the system can contribute to cancer and other diseases. By determining the structure and shape of a signal receptor in this system, known as the Frizzled protein, she hopes to create a path to new kinds of cancer drugs. Little is known about how Frizzled proteins and cell signalling systems work – a gap in knowledge that Alisa hopes to close.

Professor Si Ming Man is investigating disease-fighting proteins produced by the immune system and how they might be harnessed to fight infectious diseases. The answers could lead to alternatives to over-used and increasingly ineffective antibiotics, providing new ways to combat multidrug-resistant microbes. Professor Man is an infectious diseases researcher at the John Curtin School of Medical Research, Australian National University, in Canberra.

CSL Chief Scientific Officer Dr Andrew Nash said “Alisa’s and Si Ming’s work epitomises the ethos of the CSL Centenary Fellowships. They are each seeking a deeper understanding of key proteins—vital molecules for all living systems—that could transform how we fight infectious diseases and cancer.”

Established in 2016, CSL’s centenary year, the fellowships pay tribute to the company’s origins by supporting Australia’s scientific community. The awards support Australian scientists to pursue world-class research, thereby fostering excellence within the Australian medical research sector.

Two competitively selected, five-year fellowships are awarded each calendar year to early-mid-career (4-10 years post doctoral) medical researchers. The total value of each award is $1.25 million, and provides for a full-time salary plus research costs and/or a post-doctoral research assistant.

CSL also continues to support the AusBiotech + Invest 2020 conference, where Dr Nash will Chair the Millis Oration. This year’s keynote features Professor Paul Young, Professor of Virology and Head of School, School of Chemistry and Molecular Biosciences, University of Queensland, who present on his world-leading work fighting against COVID-19. The Millis Oration will be presented at 9.30 am, Thursday, 29 October. Registrations remain open.

Biosceptre collaboration to progress CAR-T research in Sydney

Thu, 22 Oct 2020 00:00:00 +1100

Microbio announces development of replicating SARS-CoV-2 virus test

Thu, 22 Oct 2020 00:00:00 +1100

AnteoTech looking to clinical trial after receiving results of validation study

Thu, 22 Oct 2020 00:00:00 +1100

AusBiotech seeks feedback on medical device consultations

Tue, 20 Oct 2020 00:00:00 +1100

AusBiotech is seeking comment from affected members on two TGA consultations on medical devices: options for introducing a UDI system, and enhancing reporting of adverse effects.

As the national voice of the life sciences industry, AusBiotech champions advocacy and regularly submits commentary on behalf of its members and the Australian life science industry. It is developing responses to the two consultations below.

Consultation One - Exploring options for the introduction of an Australian Unique Device Identification (UDI) System

The TGA is running a series of consultations to inform the planning and design of the potential Australian implementation of a UDI system for medical technology. It is intended that this consultation will consider characteristics unique to the Australian environment, while acknowledging the benefits of a globally aligned UDI System, and will inform the policy decisions.

AusBiotech seeks Members views on:

The benefits of an Australian UDI System across the broader health system
Whether the first phase of an Australian implementation should be limited to a small number of high-risk devices
What the impact will be should Australian implementation fully align with the International Medical Device Regulators Forum guidance
What mechanisms should be considered for submitting the UDI data to the TGA
The benefits for implementing the EU Basic UDI-Device Idenfier in Australia
The benefits of the Global Medical Device Nomenclature and how is it being used.

AusBiotech supported an earlier TGA consultation on whether to implement a UDI system in Australia, on the proviso Australia adopts a globally harmonised UDI system consistent with that of the US and EU. This includes ensuring alignment with international coding standards of UDI issuing agencies designated in the US and accredited in the US. Read AusBiotech’s full 2019 consultation response here.

Consultation 2 - Proposed enhancements to adverse event reporting for medical devices

The regulatory framework for medical devices in Australia strong and covers the technologies before and after they enter the market, with continuous monitoring and reporting once they enter the market. However, the TGA have identified that more can be done, and proposes enhancements to adverse event reporting and to improve communication with medical device consumers.

AusBiotech seeks feedback on five proposals that aim to enhance the adverse event reporting system and improve access to safety information related to medical devices.

Proposal 1 – make changes to the current adverse event reporting exemptions
Proposal 2 - strengthen reporting requirements for medical device adverse events
Proposal 3 - implement a programme of TGA inspections and audits of sponsor activities and premises to validate how they conduct their post market surveillance obligations
Proposal 4 - review post-market definitions in the Medical Device Regulations, and
Proposal 5 – find ways to enhance communication between the TGA and the consumers of medical devices.

Proteomics signs deal for distribution of PromarkerD in Italy

Tue, 20 Oct 2020 00:00:00 +1100

Amplia Therapeutics takes Australian cancer discovery into trials

Tue, 20 Oct 2020 00:00:00 +1100

Life sciences skills gap report released

Thu, 15 Oct 2020 00:00:00 +1100

A new cross-industry report has been released today, delivering a better understanding of the life sciences sector’s workforce needs and skills gaps.

The Report, A Survey of Workforce Skills and Capacity in the Medical Technology, Biotechnology, Pharmaceutical and Digital Health (MTP) Sector, is seeking a clearer view of current, emerging and future needs.

Results showed great concern for ‘global experience’ (65% rated as major concern or concern), and, a common theme was concern for both business and commercialisation expertise. The identified concerns were mostly related to mid- and senior level recruits, rather than entry level. More than half of respondents worked in SMEs.

Industry-specific skills and experience, and talent attraction and retention continues to be a significant issue for industry and the report works to identify where these gaps are located. Managers with hiring responsibilities and HR professionals were invited to complete the survey.

Analysis was undertaken on the quantity and quantity of candidates, and their level, across a multitude of areas:

Business skills and commercialisation expertise
Regulation and quality
Clinical (including trials)
Biological sciences and technologies
Informatics, computation, mathematical and statistics and;
Chemical science

Many thanks to the AusBiotech members that took the time to provide valuable feedback.

A part of AusBiotech’s strategic plan, the significance of the work was initially prompted by the sudden and damaging tightening of skilled migration visas in April 2017, when the issue came into the spotlight as a widely-used tool to fill the skills gaps that exists in Australia.

Highly skilled and globally-connected talent is at the heart of Australian innovation and success in our medtech, pharma, biotech and digital health sectors. People are the underlying foundation of success and by addressing the current and emerging gaps in our workforce enables the sector to plan for its future growth, to advocate for pathways to address them, and ultimately to continue to strengthen and grow the industry so that Australia remains a world-leading location for health innovation.

The cross-industry project, led by MTPConnect, included AusBiotech, Medicines Australia, MTAA and ANDHealth.

Download the report.

Funding for Brisbane-based clinical trial manufacturing facility

Thu, 15 Oct 2020 00:00:00 +1100

Promoting science and evidence in Agritech’s gene technology debate

Tue, 13 Oct 2020 00:00:00 +1100

The fourth edition of the Official Australian Reference Guide to Agricultural Biotechnology and GM Crops (the Guide) has been launched by the Agricultural Biotechnology Council of Australia (ABCA).

The Guide considers the latests developments in agritech, with a focus on the role of gene-editing. It also includes regulation requirements across the country, and how consumer attitudes have evolved, in Australia and globally.

ABCA said, the Guide “provides credible, balanced, science-based information on agricultural biotechnology to allow for informed decisions about the application, uses and future of agricultural biotechnology in Australia, and a better understanding of its benefits and safety.”

Chairman of ABCA, Ken Matthews AO, said, “In an increasingly alarming world of fake news, alternative facts, disinformation, disdain for experts, suspicion of science, opinions trumping evidence, and blindly partisan position-taking, we need more reliable, accessible, and factual inputs to public debate on matters of science.

“This is the agriculture industry that exists and must be promoted. Just as people concerned about climate change urge us to listen to the science, so too should the science and evidence be front and centre in the gene technology debate.”

With the global population expected to reach 9.7 billion by 2050, agricultural technologists and food science researchers must develop tools to reach growing population’s needs. An increasing number of Australian farms are R&D driven, technologically advanced, capital intensive, and entrepreneurial. The agritech and foodtech industry strives to enhance seeds and crops, improve diet and provide functional foods for preventative health.

AusBiotech is a founding member of ABCA. ABCA aims to ensure that the Australian farming sector can appropriately access and adopt biotechnology for the benefit of national and global food security, the nation’s farming sector, and the environment, thus helping to deliver a more sustainable and prosperous future for Australian agriculture.

Download and read the Guide here.

LBT Innovations confirms sale of APAS Independence to German company

Tue, 13 Oct 2020 00:00:00 +1100

Opthea launches US initial public offering

Tue, 13 Oct 2020 00:00:00 +1100

New guidance released for FMT products

Thu, 08 Oct 2020 00:00:00 +1100

New guidance on faecal microbiota transplant (FMT) products has been released by the TGA. The two documents include a FMT product Standard that specifies the minimal requirements for donor and product screening; and specific guidance on manufacturing requirements.

The guidance has been released following regulatory changes in late 2019. The new model seeks to strike a balance between ensuring appropriate safety levels for the Australian public and maintaining patient access to the products.

FMT products are used to repopulate the bacterial micro-environment in a recipient's bowel with healthy microorganisms. All FMT products are regulated as biologicals.

Guidance on TGO 105: Standards for faecal microbiota transplant (FMT) products

Therapeutics Goods Order (TGO) 105 specifies the minimum criteria donor and product screening to minimise the risk of infectious transmission during the manufacture of FMT products. The guidance has a a commencement date of 1 July 2021, enabling a transition period for sponsors to meet the requirements.

Read the guidance on TGA 105 here.

Interpretative and technical guidance on GMP requirements

This guidance is for sponsors, manufacturers and providers of faecal microbiota transplant (FMT) products and provides information on TGA manufacturing license requirements; and TGA interpretation and expectations for compliance. It includes specific sections of the GMP for human blood and blood components, human tissues and human cellular therapy products.

Read the guidance on GMP requirements here.

US government agency backs accelerated development of Ellume diagnostic

Thu, 08 Oct 2020 00:00:00 +1100

$12M digital transformation for TGA

Tue, 06 Oct 2020 00:00:00 +1100

AusBiotech applauds Minister for Health, Greg Hunt’s announcement of $12 million to ‘digitise, transform and modernise’ the TGA’s business systems and infrastructure.

The Minister announced the four-year measure will yield a significant reduction in red tape, cutting costs for the life sciences industry, better connecting services to get medicines and devices to patients sooner. It will also position Australia to more quickly access emerging and new health technologies in the international market.

Lorraine Chiroiu, CEO, AusBiotech, says, “We welcome the announcement: reduced red tape, efficiency, and getting products to patients more quickly without comprising safety, are areas that AusBiotech has extensively advocated for the mature Australian life sciences sector.

“Industry is a key driver of better health outcomes in our health system, and so utilising technology that better supports emerging and cutting-edge technologies is essential. We look forward to continuing to work closely with the TGA as these new systems are rolled out.”

The new digital processes aim to deliver simpler, faster and more secure interactions between industry and government to apply for, track, pay, and manage listings for regulated and subsidised health related products and services. It will result in earlier approvals of medical products, reduced administrative effort, and timelier decision-making by the TGA.

Cyber security will also be bolstered to ensure the protection of commercial-in-confidence information from industry.

The TGA noted it receives 15,000 adverse drug reaction reports on patient safety per year which are entered manually through PDF rather than through a central database. With these reforms, medical companies will now be able to use an electronic database to report these patients’ safety events with automatic data transfer.

Kazia Therapeutics completes first stage of capital raise

Tue, 06 Oct 2020 00:00:00 +1100

Budget delivers significant news for R&D

Tue, 06 Oct 2020 00:00:00 +1100

AusBiotech congratulates the Government as tonight’s Federal Treasurer delivered significant news on the Research and Development Tax Incentive (RDTI).

The announcement demonstrates the Government understands how Australia’s post-COVID-19 recovery will be supported by business expenditure for research and development (BERD) and has provided a welcome change of position on the RDTI that will support and incentivise growth in R&D and manufacturing as we recover from the pandemic.

Lorraine Chiroiu, CEO, AusBiotech, said, “This is excellent news for our industry, and will preserve the highly-skilled STEM-based jobs in Australia. Tonight’s RDTI announcement, together with the support for medical manufacturing, is a recognition of the economic and social value research and development in life sciences delivers to Australia, particularly in response to the current pandemic.

“While the calculations for companies will be dependent on the applicable corporate tax rate, the announcement tonight signifies is an importance and positive shift in the appreciation of the benefits brought by R&D.”

Support for the refundable component of the RDTI has been increased 5 percentage points from the earlier 2019 Bill before the Senate. The $4 million cap proposed on annual cash refunds will not proceed and the complex intensity threshold measure that was planned has been reduced from three tiers to two, with support increased. An increase in the R&D expenditure threshold from $100 million to $150 million, unchanged from the 2019 Bill.

Compared to the reforms before the Senate, the Government is investing a further $2 billion in the RDTI over the forward estimates, that’s $240 million over the forward estimates compared to current policy settings.

“As the most critical policy for the industry, the announcements tonight will support our leading sector by giving companies and investors the certainty they need to commercialise and deliver new, innovative treatments to Australian patients,” said Chiroiu.

“As long-time supporter of the Incentive, AusBiotech has been committed to the RDTI’s preservation and ensuring that it continues to deliver benefits to the Australian economy, the development of new medical products and to the creation of highly-skilled jobs.

“Government support through the RDTI for this sector can provide critical defence against some of the health impacts arising from this and future pandemics. Decade-long investment into the industry has prepared these companies to act swiftly in response to the pandemic, pivoting to fast track COVID-19 vaccines, treatments, diagnostics and digital health solutions.”

The 2020-21 Budget also includes an investment of $1.5 billion over four years for the Modern Manufacturing Strategy (MMS). Minister for Industry, Science and Technology, Karen Andrews, said the investments highlight the Government’s commitment to making science and technology work for industry.

“A resilient and competitive manufacturing sector should be at the heart of a modern Australian economy and this Strategy will create jobs, drive our economy forward and make Australia more secure.”

The centrepiece of the MMS is the $1.3 billion Modern Manufacturing Initiative, which will see the Government strategically invest in projects that help manufacturers to scale up and create jobs.

“We are putting our money where our mouth is, to galvanise investment in Australian manufacturing,” Minister Andrews said.

As biotechnology is a long-term activity that requires large investment, with products typically taking 10 to 15 years to market, policy certainty builds business confidence and encourages investment and growth across the sector.

The key announcements in tonight’s Budget:

No cap on cash refunds;
An increase in the R&D expenditure threshold from $100 million to $150 million, unchanged from the 2019 Bill;
An 18.5 per cent refundable R&D tax offset above the prevailing company tax rate for small and medium entities (SMEs);
A generous 2-tiered R&D intensity measure providing a base rate (intensity < 2 per cent) of 8.5 per cent above the company tax rate and an enhanced rate (intensity > 2 per cent) of 16.5 per cent above the prevailing company tax rate for large companies.
Measures to improve the administration, transparency and integrity of the program, unchanged from the 2019 Bill.
The package retains the current generous level of support for SMEs to provide them certainty and the confidence to invest for the future.
Larger companies will be well-rewarded for raising their R&D investments beyond 2 per cent of their expenses, supporting the key policy objective of incentivising additional R&D beyond ‘business as usual’ investment.
The reform package would commence on 1 July 2021.

-ENDS-
Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123

About AusBiotech
AusBiotech is Australia’s national biotechnology organisation, working on behalf of members for more than 30 years to provide representation and services to promote the global growth of Australian biotechnology. AusBiotech is a well-connected network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), food technology and agricultural sectors.

Medical manufacturing to feature in recovery plans

Thu, 01 Oct 2020 00:00:00 +1000

AusBiotech welcomes support for medical manufacturing as the Prime Minister, Scott Morrison, announces its manufacturing plan ahead of next week’s Federal Budget. However, the industry advocate remains concerned that overall support will be reduced if the Bill to cut the R&D Tax Incentive (RDTI) moves ahead.

AusBiotech has been actively advocating for policy to complement the RDTI and directly incentivise advanced manufacturing, for more than 10 years - most recently in its pre-Budget submission.

The “modern manufacturing initiative” funding will be focused on six priority areas, including “medical products”, and was announced at a Press Club pre-budget speech today. It will invest in projects to help manufacturers “scale up” and create jobs.

More than $107 million has been identified for “supply chain resilience” within the national sovereignty aspect of the manufacturing plan.

Lorraine Chiroiu, CEO, AusBiotech, says, “We are pleased to see that advanced manufacturing in life sciences is being recognised for the economic and social value it delivers Australia, and we welcome more details of the announced Initiative. This is not a ‘standing start’; Australia already has strong life science foundations upon which to grow, which as a smart nation we can leverage and accelerate.

“AusBiotech is the national voice of more than 3,000 life science members for 35 years. We engage with parties across the sector, including governments, investors, and our scientific and research community. We facilitate the growth of the sector by enabling the ecosystem to collaborate, translate, and integrate, and we ensure that we are ‘pulling in the one direction’.”

In order to identify growth opportunities, barriers to scale and what is needed along the value chain in each area, AusBiotech has already begun advancing the sector-wide decadal framework ‘Biotech Blueprint: a vision for biotech beyond COVID-19’.

The map will articulate a shared vision and agreed actions as a guide to continue to grow and strengthen Australia’s biotech sector through its recovery and beyond. Looking to the future, the plan will address research and development, investment, jobs, and regulation for the Australian biotechnology industry and discuss opportunities and barriers within the sector to achieve the best growth when delivering improved health and economic outcomes for all Australians.

Maximising the Australian manufacturing sector, as it relates to R&D of “medical products”, will also largely depends on the existing RDTI being complemented with a tax regime that can secure Australia’s competitiveness for the future.

AusBiotech continues to urge the Government to revisit plans to reduce the RDTI, and remains concerned around the proposed ‘intensity measure’ and its impact on bio-medical manufacturing.

Larger companies in the sector are grappling with the impacts of the suggested intensity measure that will see a reduction in support for almost every claimant, particularly those who are undertaking manufacturing in Australia, and a significant layer of complexity and uncertainly about eligibility added.

AusBiotech contends that the calculation will disadvantage companies that have expenditure (and invest in) advanced manufacturing in Australia. This expenditure should be encouraged, rather than discouraged – and AusBiotech finds it another unwelcome consequence of the proposed intensity measure.

AusBiotech actively advocates on behalf of the life sciences sector, and believes that Australia needs a business tax regime to support the innovation ecosystem, both at start-up phase and throughout the lifetime of a company, to retain international competitiveness. Read AusBiotech submissions here.