Regulatory Guidance And Enabling Compliance

  1. 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.

  2. Microbial Identification Via DNA-Seq 6/9/2025

    Learn how DNA sequencing-based microbial identification supports regulatory compliance and enhances contamination control in critical environments.

  3. A Successful Journey To Cell Therapy Manufacturing 5/29/2025

    Learn about the three main areas to consider when you're preparing to commercialize a cell therapy, including starting/raw material, the controlled manufacturing process, as well as testing safety and quality.

  4. 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.

  5. 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.

  6. Leveraging dPCR r Techniques To Quantitate Lentivirus Particles 5/28/2025

    Discover how digital PCR can streamline lentiviral vector characterization to reduce variability and improve analytical sensitivity. Learn how this approach can help you comply with regulatory guidance.

  7. 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.

  8. Key Considerations For Rapid Microbial Methods For Mycoplasma Detection 5/29/2025

    Learn the importance of demonstrating product specific suitability, defining representative sample, consistent sampling protocols, accommodating volume and turnaround time constraints, and the need to establish equivalence.

  9. Defining The CMC / Clinical Relationship For Allogeneic Cell Therapies 5/6/2024

    During this segment, Nguyen and Wagner define why the relationship between CMC and Clinical is so critical, and they also explain what a mutually beneficial partnership between CMC and Clinical looks like.

  10. 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.