Cell and Gene Regulatory

31. 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.

32. How The FDA's 2024 Draft Guidances Will Influence CGT Regulation In 2025 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Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) share why the FDA’s 2024 draft guidance documents are expected to shape regulatory standards for cell and gene therapy in 2025, with topics ranging from safety testing of allogeneic cells to manufacturing practices and the use of human and animal-derived materials.

33. How The New Administration Could Shape FDA Oversight, Compliance, And Guidance In 2025 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) share why the new administration may influence the regulatory landscape for cell and gene therapy, particularly regarding enforcement actions against unproven stem cell products and challenges to FDA authority at the state level.

34. 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.

35. Key Regulatory Challenges, Innovations, And Opportunities For CGT In 2025 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) detail how the regulatory landscape for cell and gene therapy in 2025 will continue to be shaped by advancements in science and manufacturing and evolving regulatory guidance.

36. 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.

37. Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements 4/8/2025

    Viral Disinfectant Efficacy Studies validate cleaning protocols in pharma facilities, ensuring regulatory compliance, reducing contamination risk, and supporting safe, effective disinfection with expert CRO guidance.

38. Unlocking The Full Potential Of AAV-Mediated Gene Delivery | Audience Q&A 4/7/2025

    In this final segment of the Cell & Gene Live, Unlocking the Full Potential of AAV-Mediated Gene Delivery, David Dismuke, Ph.D., Chief Technical Officer, Forge Biologics and Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO addressed audience questions on re-administration, stable producer cell lines, and manufacturing challenges, and more.

39. Addressing Regulatory Challenges Associated With AAVs 4/7/2025

    In this segment of the Cell & Gene Live, Unlocking the Full Potential of AAV-Mediated Gene Delivery, David Dismuke, Ph.D., Chief Technical Officer, Forge Biologics and Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO, the panelists cover the regulatory landscape, including working with regulatory agencies, addressing regulatory challenges for common diseases, long-term follow-up studies, beneficial regulatory pathways, establishing appropriate endpoints, vector shedding studies, anticipated regulatory guidance, and the cost burden of co-developing companion diagnostics.

40. 4 Key Solid Tumor Therapy Objectives iPSCs Can Help Achieve 4/4/2025

    Induced pluripotent stem cells offer some key biologic, technical, and financial advantages over more established PBMC-derived therapies.