Regulatory Guidance And Enabling Compliance

  1. Understanding AI And Machine Learning's Impact On CGT with Dr. Peter Marks and Dr. Nicole Verdun 1/30/2024

    During this segment, Dr. Peter Marks and Dr. Nicole Verdun share their take on how AI and machine learning will impact FDA regulation in 2024.

  2. Cell And Gene Therapy Innovations 5/19/2025

    This interview with a pharmaceutical analytics expert discusses key insights into advances in cell and gene therapy and the strategies used to support customers in improving their therapeutic development.

  3. 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.

  4. Innovative Contamination Control: Enabling Integrity And Efficiency 10/15/2024

    An integrated approach can enhance contamination control, boost process efficiency, and ensure the production of high-quality cell therapy products.

  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. 2024 Regulatory Outlook With Dr. Peter Marks And Dr. Nicole Verdun | Audience Q&A 1/30/2024

    Experts on the Cell & Gene Live event, 2024 Regulatory Outlook, answer questions about topics including pediatric development in rare diseases, diversity planning for ultra-rare disease, anticipated approvals by 2025, and more.

  7. Innovations In Mycoplasma And Sterility Testing For Biopharma 5/22/2025

    In this webinar, our expert speakers will discuss the types of analytical testing that can be effectively employed in the early stages of therapeutic development and subsequently scaled to meet production challenges.

  8. Collaborating with the FDA: Dr. Peter Marks and Dr. Nicole Verdun Share Advice For Small And Emerging Biotechs 1/30/2024

    In this segment, Dr. Peter Marks and Dr. Nicole Verdun share their advice and best practices for small and emerging biotechs when working with the FDA.

  9. Major Trends Impacting Allogeneic Cell Therapies For Oncology 5/6/2024

    We kicked off this Cell & Gene Live, Unlocking the Future of Allogeneic Cell Therapy for Oncology by discussing the major trends impacting allogeneic cell therapies for oncology.

  10. mRNA For Cancer Immunotherapy 2024 Outlook | Audience Q&A 1/29/2024

    During our Cell & Gene Live, mRNA For Cancer Immunotherapy 2024 Outlook, our expert panelists answered audience questions regarding patient safety, foreseeable challenges in mRNA cancer immunotherapy for solid tumors, and much more.