On December 8, 2023, ISCT hosted the landmark 20th FDA Cell Therapy Liaison Meeting (CTLM), a closed forum strategically designed to facilitate knowledge sharing and discussions between the cell and gene therapy (CGT) community and FDA, with the objective of informing the Agency of specific concerns, challenges and recent developments to advance the regulatory field.
Discussions at the 2023 CTLM covered topics including:
- Cellular and tissue material as raw “starting” material for iPSC clinical products and other cell banks
- Changing the definition of starting material
- QC testing for point of care (POC) manufacturing
- Request for guidance document clarifying which entities are required to register with FDA for the manufacture of human stem cells, HCT/Ps
- Challenges with moving cell and gene therapies into the commercial space for rare diseases
FACT encourages readers to review the entire summary of the meeting and also view the presentation slides. This information is available on the ISCT website at https://www.isctglobal.org/publications/regulatory-quality-initiatives/fda-ctlm.