Regulatory Guidance And Enabling Compliance

  1. Leveraging Rapid Sterility Testing To Advance Cell Therapy Production 6/23/2025

    Explore the crucial role of rapid sterility testing in cell therapy manufacturing. This presentation delves into the benefits of swift, accurate detection for product quality and patient safety.

  2. ResDNASEQ Workflow Solution 5/22/2025

    Explore the Applied Biosystems resDNASEQ workflow solutions. Starting with the sample preparation kit, to purification, quantitating residual host-cell DNA, and analyzing resDNASEQ assays.

  3. 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.

  4. CAR-T Innovation: Balancing Allogeneic And Autologous Cell Therapy 6/30/2025

    Join experts as they discuss strategies for optimizing allogeneic and autologous therapies, aiming for balanced development and wider patient accessibility by 2030.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Explore The Analytics Knowledge Hub 5/22/2025

    Discover smarter solutions with the new Analytics Knowledge Hub that provides articles, webinars, e-books, and infographics designed to enhance and streamline your bioprocess workflow.

  10. Implementing Rapid Microbial Identification In Biotherapy Manufacutring 5/27/2025

    Learn about rapid microbial identification strategies that enhance environmental monitoring and compliance with regulatory requirements for your manufacturing processes.