AusBiotech reveals landscape for regenerative medicine clinical trials and manufacturing

Biotech News: 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, Australia can become the clinical trials and manufacturing hub for the region and deliver potentially life-changing treatments to patients, both locally 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.

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.

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%) 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%) outnumbered non-industry sponsored trials in Australia and grew at a compound annual growth rate of 21% 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.

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.