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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 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 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.

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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.