On December 8, 2023, ISCT successfully hosted the landmark 20th FDA Cell Therapy Liaison Meeting (CTLM), a closed gathering strategically designed to facilitate discussions between the cell and gene therapy (CGT) community and the FDA. The primary goal of the CTLM is to address specific concerns, navigate challenges, and delve into recent developments, all aimed at advancing the regulatory landscape in the CGT field.
The meeting commenced with insightful opening remarks delivered by Olive Sturtevant, MHP, MT(ASCP)SBB, SLS, CQA(ASQ), and the ISCT North America Legal and Regulatory Committee Designate. Along with remarks from Dr. Peter Marks, MD, PhD, the Director of the FDA Center for Biologics Evaluation and Research (CBER).
In attendance were 45 invited representatives, comprising international regulatory bodies such as the Association for the Advancement of Blood & Biotherapies (AABB), American Society for Apheresis (ASFA), American Society for Apheresis (ASTCT), College of American Pathologists (CAP), Cord Blood Association (CBA), Foundation for the Accreditation of Cellular Therapy (FACT), Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP), Office of Cellular Therapy and Human Tissues (OCTHT), Office of Gene Therapy (OGT), Office of Compliance and Biologics Quality (OCBQ), Office of Communication, Outreach and Development (OCOD), National Heart, Lung, and Blood Institute (NHLBI), National Marrow Donor Program (NMDP), Society for Immunotherapy of Cancer (SITC), United States Pharmacopeia (USP), and World Marrow Donor Association (WMDA).
Read the Full Summary Report Now
#Regulatory