A participatory discussion with key exosome stakeholders and the regulatory requirements for exosome therapies.
The Centre for Commercialization of Regenerative Medicine (CCRM) Australia is organising a series of annual regulatory workshops to increase interactions between industry stakeholders to improve the ability to navigate the regulatory framework and discuss existing and emerging challenges related to translation commercialisation of regenerative medicine.
This session will focus on extracellular vesicles and exosomes. Recent years have seen an ever-increasing investigation of exosomes in potential therapeutics and a viable alternative for cellular therapies. However, the lack of well-established manufacturing protocols, high manufacturing cost, and regulation concerns, amongst others, are known
challenges on the commercialisation pathway.
The workshop will cover themes based upon questions and concerns provided to CCRM Australia by biotech companies, academia, clinicians and other stakeholders.
The Exosome Regulatory Workshop will adopt an online format via Zoom and held on 23rd July 2021 at 9 am (AEDT) and facilitated by Dr Sowmya Viswanathan, Cell Therapy Stakeholder Group Co-chair 2015 – 2020 (Cellular Manufacturing and Clinical Trials)
Guest speakers include:
- Prof Andrew Hill, Associate Provost (Research and Industry Engagement), La Trobe University. Former ISEV President
- Prof Luis Ortiz, MD, Clinical and Translational Science Institute, University of Pittsburgh. ISCT Exosome Committee Member
Topics to be discussed include:
- EVs/exosome therapies, regulatory concerns
- Requirements for adventitious agents/safety/potency testing and
- CMC considerations for manufacturing scalable quantities of EVs/exosomes
To register your interest in participating and contributing to the discussion, please contact: CCRM Australia: Dr Chih Wei Teng at firstname.lastname@example.org
2021 CCRM Australia Regulatory Workshop: Exosome Spotlight Flyer.