Available Online: Meeting Summary of the 21st Cell Therapy/FDA Liaison Meeting
Each year, FACT and several organizations regularly collaborate with the United States Food and Drug Administration (FDA) to identify and then discuss important topics in cellular therapies during the Cell Therapy/FDA Liaison Meetings (CTLM). These meetings provide important opportunities to express challenges and desired outcomes to the FDA.
The 21st CTLM, hosted by the International Society for Cell & Gene Therapy (ISCT), occurred on November 19, 2024. Topics included:
- Labeling of Cellular Therapy Starting Materials for Further Processing
- GxP Compliance for Phase 1 and Phase 2 Clinical Trial Manufacturing
- Manufacturing Cellular Products Using Viral Vectors
- FDA’s Current Views and Strategies on The Ban of Plasticizers (DEHP) Used in Manufacturing and Banking of Cord Blood and Blood Products
- Cord Blood as Starting Material for Adoptive Immunotherapies
- Cell Therapy Products: Framework for Relating Mechanism of Action, Potency & Efficacy
- Use of Research-grade Material for Manufacturing due to Source Material Constraints
The presentation slides and a meeting summary are available on the ISCT website after logging in or providing minimal demographic information. All are encouraged to read the information presented to the FDA. While on this webpage, see also summaries from past CTLMs!
