Workshops seek to encourage dialogue between different stakeholders in research, commercial, clinical and the regulatory ecosystem on regulatory issues impacting the translation and introduction of advanced therapies into the market. Each facilitated workshop builds upon the experience generated from previous workshops and involves internationally recognised subject matter experts engaging in discussion with workshop participants in themes relevant to regenerative medicine and other advanced therapies. Discussion themes can range from manufacturing issues, regulatory issues, quality control aspects, clinical issues to other sector-specific related matters.

In our first workshop, we will be focusing on exosomes/extracellular vesicles. The workshop will be conducted by Dr Sowmya Viswanathan, former co-Chair, Cellular Manufacturing and Clinical Trials at the Canadian Cell Therapy Stakeholder Group. The workshop will also involve guests Prof Andrew Hill, Associate Provost (Research and Industry Engagement) at La Trobe University and Former ISEV President together with Prof Luis Ortiz MD, Clinical and Translational Science Institute, University of Pittsburgh and current ISCT Exosome Committee Member.

Key discussion topics include manufacturing, regulatory, quality control, and clinical concerns of exosome/extracellular vesicles therapies.

CCRM Australia welcomes attendees to the workshop and invites suggestions for discussion items in addition to those listed above.

The first workshop was hosted on 23rd July 2021, visit the 2021 CCRM Australia Regulatory Workshop: Exosome Spotlight page for more details. Minutes of the workshop is available to download here.