Regulations and Compliance

  1. Tackling Cell And Gene Therapies' Top 3 Regulatory Impediments: Audience Q&A 1/30/2023

    During each Cell & Gene Live, our audience has the opportunity to submit real-time questions for our expert panelists. Watch and listen as Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio provide detailed, insightful responses to our audience questions on everything from regulatory timelines to successful and unsuccessful strategies needed to convince the regulators that current regulation requirements are either inappropriate or alternatively excessively burdensome for cell and gene-based therapies.

  2. Dr. Peter Marks Talks a Standardized Playbook for Gene Therapy Manufacturing 1/30/2024

    In this segment, Dr. Peter Marks shares developments in CMC for advanced therapies in the near future.

  3. Navigating Global Regulations, Equity Challenges, And The Future Of Patient Access 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) continue the discussion to explore the complexities of expanded access programs (EAPs) in CGT, highlighting global regulatory differences, ethical concerns, and accessibility challenges.

  4. 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.

  5. 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.

  6. Master The 2-Point Calibration Process To Maintain Data Integrity 5/19/2025

    Ensure accurate sensor readings with an innovative software by mastering the 2-point calibration process. Learn more about how and why regular calibration supports data integrity and compliance.

  7. MilliporeSigma Bio-Expo Live February 2025: Upstream Bioprocessing 3/18/2025

    Review the benefits of implementing a closed and sterile sampling system, such as NovaSeptum®, to improve sampling procedures and meet regulatory expectations.

  8. Challenge #3: Lack Of Animal Models 1/30/2023

    Many cell and gene therapies are intended for diseases and conditions that primarily impact pediatric patients, requiring the prospect of direct benefit to individual subjects enrolled in the trial.  In the absence of good animal models, there may be challenges demonstrating the prospect of direct benefit.  During this segment of Cell & Gene Live, Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO discusses novel approaches to consider going forward.

  9. Regulatory And Biosafety Testing Expertise 3/31/2026

    Advancing biologics requires confidence in safety, quality, and compliance. Learn how integrated analytical and biosafety testing, backed by decades of expertise, helps reduce risk.

  10. Future Proof Process Design Through Risk-Focused Decisions, Automation Readiness, And Regulatory Pragmatism 10/29/2025

    In this segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene share that future proofing begins with deep process understanding.