New regenerative medicine reports detail current capability, capacity and clinical trials, future potential

Opportunities to foster growth in Australia’s regenerative medicine industry will be made clearer after the release of two research reports by the RM Catalyst consortium today, detailing the current state of manufacturing and clinical trials.

Australia’s Regenerative Medicine Manufacturing Capacity & Capability, the first of the two reports, identified seven TGA-licenced Good Manufacturing Practice facilities in the country, with a further five aspiring for licences. (RM treats injuries and illness using “the body’s own regenerative capabilities.”)

Globally, there is a bottleneck in the GMP manufacturing phase of product development in the fast-growing regenerative medicine industry. The sector attracted $US 19.9 billion in investment over 2020, despite the difficulties of the year. 

Consortium leader AusBiotech said in a statement on Thursday 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.”

On the importance of building local strength, it said, “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.”

The second report, Australia’s Regenerative Medicine Clinical Trials Database, “captures the portion of clinical trials in RM, and seeks to categorise them into type and phase.” 

The benchmarking would enable the local 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.”

The RM Catalyst Programme was announced in November 2020, and involves AusBiotech, Biointelect, Cell Therapies, Medicines Australia, MTPConnect, Novartis Australia and New Zealand, and Research Strategies Australia. 

The two reports can be accessed here.


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