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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.

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.

Read more about the broader Regenerative Medicine Catalyst Project here.

Download the Regenerative Medicine Value Chain report 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.