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ISCT hosted the 21st FDA Cell Therapy Liaison Meeting (CTLM) on November 19, 2024 - a closed forum dedicated to fostering knowledge exchange and dialogue between the cell and gene therapy (CGT) community and the FDA to address concerns, challenges, and recent advancements to drive progress in the regulatory landscape. Since 2004, ISCT has led a stakeholder consortium of over 20+ organizations in the cell therapy field to develop this forum, playing a crucial role in helping to shape regulatory frameworks and accelerating the field.

The 2025 CBER Guidance Agenda published earlier this year includes upcoming draft guidance on donor eligibility for HCT/Ps and non-DEHP blood collection and storage devices, two key topics addressed during recent CTLMs, underscoring the impact of these discussions to our sector.

Read the Summary Report to explore all the topics addressed at the most recent CTLM:

• 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

Stakeholders in Attendance: ISCT, AABB, ASFA, ASH, CBA, FACT, NHLBI, NMDP, SITC, USP, WMDA, and key FDA representatives from CBER, OTP, OCTHT, OGT, OCE, OCBQ, OBPV, ORO, and OCOD. Full detailed list available in meeting report

Read the Report Now