Allogeneic cell therapies have a potential to revolutionize life-saving Cell and Gene therapy (CGT) field by removing the bottlenecks created by long scheduling delays, lengthy manufacturing times and potential product failures of autologous cell therapies. Despite some early data showing promising clinical results, allogeneic cell therapies have not yet achieved the clinical benchmark set by their predecessors. Some of the challenges unique to allogeneic cell therapies include limited understanding of donor characterization and variability, diminished persistence of allogeneic cells in patients, rapidly evolving need for novel techniques such as gene-editing approaches, and lack of suitable analytical techniques. As already seen in the first generation of autologous cell therapies, the Achilles heel of the commercialization of allogeneic cell therapies remains the CMC challenges. While the industry and regulators have collaborated immensely to advance the CGT field by bringing a number of autologous cell therapy products to the market, similar efforts are warranted for allogeneic cell therapies as the industry is experiencing a shift towards an allogeneic approach.

In this session, we will hear from the industry stakeholders and regulators on the challenges and opportunities in allogeneic cell therapies. Speaker presentations will be followed by a panel discussion and live Q&A with panel members representing both industry and regulators.

Session Speakers:

Donor Qualification and Procurement of Allogeneic Cellular Starting Material: A Global Regulatory Perspective

Jared Schuster, National Marrow Donor Program

Allogenic Cell and Gene Therapy Production, Opportunities and Challenges in the Use of iPSCs

Francois Gianelli, TreeFrog Therapeutics

CMC Considerations for Manufacturing Allogeneic CAR T Products

Athena Wong, Sana Biotechnology

Additional Panelists:

Pankaj Mandal, CBER, FDA

Kevin Okimura

Appearances