Twenty four member companies have attended invitation-only roundtables in the last fortnight to discuss action on clinical trials (CTs), in the first two events of a series of AusBiotech consultation meetings, to be held in each state across Australia.
AusBiotech is involved in advisory groups and projects to develop Australia’s capability, promote harmonisation, achieve consistent start-up times and promote Australia a key destination to conduct CTs. As the ecosystem is complex, involving many parts and stakeholders, these roundtables will focus on top-of-mind issues for companies, seeking to understand key considerations when contracting a CT, and help in developing policy positions and identifying areas for on-going attention.
The first roundtables, held in Sydney and Melbourne, were sponsored by Novotech and chaired by Chief Industry Affairs Officer, Lorraine Chiroiu, providing commentary on key issues and exploring policy issues.
For biotechnology and medical technology companies CTs are a critical part of the commercialisation process and have an important role to play in Australia’s economy, healthcare and social fabric, with benefits far beyond helping develop new treatments. They assist in the improvement of the healthcare system, providing early access to and information about unapproved treatments, as well as providing valuable economic activity and providing high-level Australian jobs in science and research.
The roundtables have been met with enthusiasm and interest from members. Key issues raised in the initial meetings included:
- Key elements of decision making around where to place trials;
- Recruitment in Australia;
- Regulation of CTs in new area of technology;
- TGA support/advice for SMEs
- Funding for trials and the importance of the R&D Tax Incentive;
- GST on comparator products;
- Requirement for diagnostics trials;
- Synchronisation of multi-centre CTs
- Issues in developing orphan therapeutics.
To express your interest in attending up-coming September roundtables in each state, please contact the Communications and Media, Kristen Goodgame at: firstname.lastname@example.org.