Regulations and Compliance

  1. Mitigate Clinical Risk In Cell Therapy Development With A GMP Compliant Process 4/21/2025

    Help shape the future of medicine by building better, safer cell therapies. See how expertise in scalable, GMP-compliant cell engineering can effectively mitigate clinical development risks.

  2. Focal Points for 2024: Dr. Verdun and Dr. Marks Talk Regulatory Challenges for Cell-Based Therapies 1/30/2024

    Dr. Verdun and Dr. Marks provide detailed feedback on the regulatory challenges facing cell therapy and explain the Agency’s most important focal points for 2024, patient accessibility, and more.

  3. CGT's Main Opportunities To Meet Regulatory Requirements 1/30/2023

    Host and Moderator, Erin Harris, Chief Editor of Cell & Gene, began this Cell & Gene Live, Tackling Cell and Gene Therapies’ Top 3 Regulatory Impediments, featuring Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio, by asking the experts to highlight the main opportunities where the cell and gene therapy industry is working to meet regulatory requirements. They cover accelerated and expedited designation of regenerative medicines, navigating the regulatory requirements around the root causes of genetic disease by repairing or replacing a patient’s genes, and much more.

  4. Congruence And Divergence In Global Regulatory Approvals 4/8/2025

    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 how regulatory standards for cell and gene therapy approvals are largely consistent across regions, with North America typically leading in approvals, followed by Europe and then Asia.

  5. Other CGT Regulatory Challenges 1/30/2023

    During this segment of Cell & Gene Live, Tackling Cell and Gene Therapies’ Top 3 Regulatory Impediments, Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio detail their own experiences with roadblocks with regulators and how they and their teams worked to overcome them.

  6. Patient Data's Impact On CMC Robustness 1/30/2024

    When CGT products demonstrate dramatic improvements with minimal safety concerns in a Phase 2 study, sponsors may want to modify the protocol mid-study to increase patient enrollment.

  7. Strategies To Reduce Regulatory Risks In Gene Therapy 5/15/2020

    Learn how to mitigate regulatory risk for your gene therapy process.

  8. How The FDA Strengthens Industry Collaboration 4/8/2025

    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.

  9. Challenge #1: The Changing Regulatory Landscape 1/30/2023

    By 2030, 60 CGTs are expected to reach regulatory approval. One of the biopharmaceutical industry's most closely watched regulatory developments is the FDA’s reauthorization of the Prescription Drug User Fee Act (PDUFA) or PDUFA VII, as it provides resources for the FDA and CBER to have the capacity to provide feedback on development and review submitted applications, among other critical activities. During our Cell & Gene Live, Tackling Cell and Gene Therapies’ Top 3 Regulatory Impediments, Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio break down how PDUFA VII, Fiscal Year 2023 Omnibus Appropriations Bill, and more will impact the cell and gene therapy field in the next few years.

  10. Why Clinical Requirements Change: Dr. Peter Marks on Pre-IND Meeting Pathways 1/30/2024

    Learn how clinical requirements change after the FDA and a company agree on a pathway during a pre-IND meeting and how the company might recover as a result.