Regulatory Guidance And Enabling Compliance

  1. 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.

  2. Challenge #2: Rare Or Ultra-Rare Study Design Considerations And Use Of Existing Data 1/30/2023

    There are more than 7,000 unique, rare diseases recognized in the United States, and 300 million people worldwide living with a rare disease; patients often experience a long journey to receive their diagnosis. Our expert panelists, Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio, examine the regulatory requirements for safety and efficacy demonstration and identify the gaps in regulatory oversight that require clearer guidance.

  3. How Past Gene Therapy Approvals Are Shaping the Future with Dr. Peter Marks 1/30/2024

    In this segment of Cell & Gene Live, Dr. Peter Marks shared what he and his team have learned from current gene therapy approvals to accelerate future approvals.

  4. Successful Microbial Testing And Identification 5/27/2025

    In this presentation, one of our industry-leading customers discusses how they've successfully implemented the Applied Biosystems MicroSEQ Microbial Identification System in their laboratory testing.

  5. 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.

  6. 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.

  7. Race To The Regulatory Finish Line: Dr. Nicole Verdun Talks Efficiencies In Platform Technologies 1/30/2024

    Could a platform approach help certain therapies make their way over the regulatory finish line more efficiently?

  8. Maximize Quality Assurance Through Rapid Sterility Testing 9/10/2024

    This webinar explores mitigating the risk of product loss, and production delays, as well as the critical role rapid sterility testing plays in ensuring the quality and safety of cell therapy products.

  9. 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.

  10. Dr. Peter Marks on the Adoption of Novel Precision Analytics 1/30/2024

    Hear advice for developers who are worried that the FDA will not accept changes in their process that include a new analytical method.