ISCT Publishes Summary of Cell Therapy/FDA Liaison Meeting

The International Society for Cell and Gene Therapy (ISCT) recently published a summary of the 21st FDA Cell Therapy Liaison Meeting (CTLM), which took place Nov. 19. This closed forum provides a platform for the cell and gene therapy community, including AABB, and the Food and Drug Administration to discuss regulatory challenges, emerging issues and recent advancements in the field.

Discussions from the meeting included the labeling of cellular therapy starting materials, compliance considerations for early-phase clinical trial manufacturing and the use of viral vectors in cellular product development. Carl G. Simon, Jr., PhD, presented on AABB’s proposed topic, a framework for relating mechanisms of action, potency and efficacy in cell therapy products. The forum also explored FDA’s approach to eliminating di(2-ethylhexyl) phthalate (DEHP) in blood and cord blood product manufacturing, as well as the potential role of cord blood as starting material for adoptive immunotherapies.

AABB encourages members to review the full summary on the AABB website.