The International Society for Cell & Gene Therapy, ISCT, hosted the 21st FDA Cell Therapy Liaison Meeting (CTLM) on November 19, 2024. Led by Olive Sturtevant, MHP, MT(ASCP)SBB, SLS, CQA(ASQ) from the ISCT North America Legal and Regulatory Affairs (NA LRA Committee), this meeting brought together over 60 participants from various stakeholder organizations including the US Food and Drug Administration (FDA).
Participating Organizations
- Association for the Advancement of Blood & Biotherapies (AABB)
- American’s Blood Centers (ABC)
- American Society for Apheresis (ASFA)
- American Society of Hematology (ASH)
- Cord Blood Association (CBA)
- Foundation for the Accreditation of Cellular Therapy (FACT)
- FDA Center for Biologics Evaluation and Research (CBER):
- Office of the Center Director
- Super Office of Therapeutic Products (OTP)
- Office of Cellular Therapy and Human Tissue CMC (OCTHT)
- Office of Gene Therapy CMC (OGT)
- Office of Clinical Evaluation (OCE)
- Office of Compliance and Biologics Quality (OCBQ)
- Office of Biostatistics and Pharmacovigilance (OBPV)
- Office of Regulatory Operations (ORO)
- Office of Communication, Outreach and Development (OCOD)
- International Society for Cell & Gene Therapy (ISCT)
- National Heart, Lung & Blood Institute (NHLBI)
- National Institute of Standards & Technology (NIST)
- National Marrow and Donor Program (NMDP)
- Society for Immunotherapy of Cancer (SITC)
- United States Pharmacopoeia (USP)
- World Marrow Donor Association (WMDA)
Topics of Discussion
During the two-hour virtual meeting, 7 topics were presented and discussed with the Agency. These topics and their presenters were:
- Labeling of Cellular Therapy Starting Materials for Further Processing presented by Huy P. Pham, MD, MPH (National Marrow and Donor Program, NMDP)
- GxP Compliance for Phase 1 and Phase 2 Clinical Trial Manufacturing presented by Joanne Kurtzberg, MD (Duke University)
- Manufacturing Cellular Products Using Viral Vectors presented by Kevin Bosse, PhD, RAC-US, CABP(H) (Nationwide Children’s Hospital)
- FDA’s Current Views and Strategies on The Ban of Plasticizers (DEHP) Used in Manufacturing and Banking of Cord Blood and Blood Products presented by Wouter Van’t Hof, PhD (Cleveland Cord Blood Center)
- Cord Blood as Starting Material for Adoptive Immunotherapies presented by Rob Tressler, PhD (Excellos)
- Cell Therapy Products: Framework for Relating Mechanism of Action, Potency & Efficacy presented by Carl G. Simon, Jr., PhD (National Institute of Standards & Technology, NIST)
- Use of Research-grade Material for Manufacturing due to Source Material Constraints presented by Rob Tressler, PhD (Excellos)
This meeting was concluded with closing remarks by the Director of FDA Center for Biologics Evaluation and Research (CBER), Peter Marks, MD, PhD.
The meeting summary, providing a comprehensive overview of the discussions and expected outcomes, is currently under development and will be made available online in January 2025.
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