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.