How The FDA Strengthens Industry Collaboration

Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) explain why the FDA is signaling a stronger commitment to dialogue with sponsors and advancing cell and gene therapies, particularly through early-stage engagement and regulatory guidance. Key initiatives include enhanced pre-IND meetings, increased guidance document cross-referencing, and a focus on addressing potency challenges.