Demystifying Cell And Gene Therapy Studies In Australia And The Broader APAC Region

By Dr. Jorgen Mould, Vice President, Global Scientific and Regulatory Affairs (APAC) at Avance Clinical and Dr. Jennifer Hollands, Government & Academic Liaison at Cell Therapies

The burgeoning field of cell and gene therapy (CGT) holds immense promise for treating a wide range of diseases. The Asia-Pacific (APAC) region, particularly Australia, has emerged as a strategic hub for CGT clinical trials, offering a unique blend of regulatory advantages, world-class research infrastructure, and a diverse patient population.

If you are unfamiliar with the unique landscape for CGT trials in Australia, there are a number of key considerations, including regulatory pathways, manufacturing capabilities, and patient access. The Australian Therapeutic Goods Administration (TGA) offers streamlined regulatory pathways, such as the Clinical Trial Notification (CTN) scheme, for certain types of CGT products. Additionally, Australia boasts a strong network of research institutions, experienced clinical trial sites, knowledgeable CROs, and advanced manufacturing facilities.

By leveraging the benefits of the APAC region, including its diverse patient population and cost-effective clinical trial operations, sponsors can accelerate the development and commercialization of their CGT therapies. Download the full article to read valuable insights for companies considering conducting CGT trials in Australia and the broader APAC region.