FDA Cell Therapy Liaison Meeting - CTLM

ABOUT THE ISCT FDA CELL THERAPY LIAISON MEETING 

Since 2004, ISCT has hosted the FDA Cell Therapy Liaison Meeting (CTLM) bringing together over 20 invited stakeholder organizations in an annual meeting with the FDA. These closed meetings enable the cell and gene therapy community, and industry to inform the FDA of specific concerns, challenges and recent developments to advance the regulatory field. 

Host organization: ISCT (International Society for Cell & Gene Therapy)

Participating organizations include:

  • AABB (Association for the Advancement of Blood & Biotherapies)
  • ASFA (American Society for Apheresis)
  • ASTCT (American Society for Transplantation and Cellular Therapy)
  • CAP (College of American Pathologists)
  • CBA (Cord Blood Association)
  • FACT (Foundation for the Accreditation of Cellular Therapy)
  • FDA (Food and Drug Administration)
    • CBER (Center for Biologics Evaluation and Research)
    • OTP (Office of Therapeutic Products)
    • OCTHT (Office of Cellular Therapy and Human Tissues)
    • OGT (Office of Gene Therapy)
    • OCBQ (Office of Compliance and Biologics Quality)
    • OCOD (Office of Communication, Outreach and Development)
  • NHLBI (National Heart, Lung, and Blood Institute)
  • NMDP (National Marrow Donor Program)
  • SITC (Society for Immunotherapy of Cancer)
  • USP (United States Pharmacopeia)
  • WMDA (World Marrow Donor Association)

PREVIOUS MEETINGS

 2024 FDA Cell Therapy Liaison Meeting

On November 2024, ISCT hosted the 21st FDA CTLM with over 57 participants, comprised of representatives from AABB, ABC, ASFA, ASH, CBA, FACT, FDA (CBER/OTP/OCTHT/OGT/OCE/OCBQ/OBPV/ORO/OCOD), ICCBBA, NHLBI, NMDP, SITC, USP, WMDA, and NIST.

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

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Topics included:

  • 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 Manufacture of Human Stem Cells, HCT/Ps
  • Challenges with Moving Cell and Gene Therapies into the Commercial Space for Rare Diseases
    Full meeting summary and presentations will be available on January 15, 2024 on the ISCT website.

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Topics included: 

  • Developing Potency Assays for Cell Therapy Products
  • Considerations for increasing access to cord blood for cell therapy applications
  • Taking a Prospective, Risk-Based Approach to Genome Integrity
  • Development of a Sustainable Risk Mitigation Strategy: Standardization of Risk Evaluation and Mitigation Strategies and Sunsetting of REMS for CART-T Cell Therapies

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Topics included:

  • Roadmap to Address Potency for Complex Products
  • False Positive HIV Patient Results Post Receipt of Genetically Modified CT Products
  • Emerging Donor Testing Requirements
  • Use of Non-US Starting Materials 
  • Challenges with Sourcing Materials

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Topics included:

  • RMAT Program Update, Donor Adverse Events in Cellular Therapies
  • Infectious Disease Lookbacks Related to Blood Product Transfusions
  • Alternative BLA Pathway to Approved Genetically Modified Autologous HCT/Ps,
  • CMC Comparability of CGT
  • Framework for Use of Research Grade Materials in Manufacturing Cellular Therapies

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Topics included:

  • Maternal Donor Screening and Impact on Public Banking
  • RMAT Updates
  • Impact of Unproven Cellular Products in the Field

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Topics included:

  • Regulation of Biobanking Material
  • Collection of MNCs for Immune Effector Cells
  • Minimum Characterization Criteria for Clinical Grade iPSC Products
  • Early Interaction Mechanisms for Tool/Device Developers

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Topics included:

  • Comparability of iPSC Lines
  • Long Term Follow-Up of Recipients of Genetically Modified Cells
  • RMAT Designation Update
  • Licensing of CBUs for Indications other than Currently Approved
  • HPL Requirements for Cell Therapy Expansion

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