With the news of Cell Therapies' regenerative medicine (RM) manufacturing capabilities expanding, the mapping of Australia's RM manufacturing capability that the AusBiotech-led RM Catalyst Project is doing is highlighted.
The consortium is mapping and benchmarking RM's GMP manufacturing capability and capacity, as part of its work establishing annual data points and information resources.
These data points will be able to be tracked over time and demonstrate advancement, such as the Cell Therapies' licence approval. Until now this advanced manufacturing process was conducted in the USA, or other approved overseas facility, and so it marks an important milestone as Australia strives to bring innovative cell and gene therapies to Australian patients.
Globally, the RM sector has more than 1,200 clinical trials in progress, including 152 trials currently in phase 3, and has attracted $25.7 billion (US$19.9 billion) in financing during 2020 alone. Global therapeutic companies have turned their attention to the RM sector and more gene and cell therapies are being brought to Australia for patient access.
To prepare for Australia's RM future, AusBiotech is leading a consortium of seven partners, including Cell Therapies, that will enable the regenerative medicine industry to thrive and drive benefits to Australia's economy and health of its people.
The project will identify and establish a national RM sector 'catalyst' collaboration body, and address priority action areas including: workforce capabilities, collaboration, funding, regulation and policy infrastructure, and Australian manufacturing capability.
Major outcomes of the project include:
- Establishing annual data points and information resources to: map/benchmark GMP manufacturing capability and capacity; establish a model for an annual clinical trial database; and capture investments in Australian RM;
- A researched, strategic roadmap for the RM sector's development in Australia, including sub-reports on skill and talent specific to the sector; determining a plan to attract patient venture capital investment and the role of Australian biotech companies partnering with global companies; and case studies;
- Determining a sustainable funding and model structure for an RM sector 'catalyst' collaboration body;
- A regulatory white paper;
- Mapping the pathway for a typical product from early research to market, and patients receiving a therapy; and
- Mapping the global pipeline of gene and cell therapy products on the horizon.
