Regulations and Compliance

  1. Regulatory Challenges And Future Outlook For iPSC Therapies 5/23/2025

    In this part of our discussion during the Cell & Gene Live, Unlocking the Potential of iPSC Therapies in Regenerative Medicine, Julie Allickson, Ph.D., Chief Technology Officer at Mayo Clinic's Center for Regenerative Biotherapeutics and Erin Kimbrel, Ph.D., Head of Cell & Gene Therapy Research at Astellas discussed key regulatory challenges for iPSC-based therapies, including donor cell sourcing, genetic modification risks, and long-term safety concerns like tumorigenicity.

  2. Making USP Guidance Actionable For CGT Materials 4/1/2026

    In this segment of Cell & Gene Live, Anthony Blaszczyk, Ph.D., Senior Scientist at the U.S. Pharmacopeia, and Basak Clements, Ph.D., Founder and Senior Advisor at biomatria, were joined by Cell & Gene Chief Editor Erin Harris to discuss USP’s Cell & Gene Therapy Expert Committee, which is working to make existing guidance, such as USP 1043, more practical and actionable, while developing updated frameworks that clarify roles across the supply chain and strengthen risk-based control of raw materials.

  3. 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.

  4. 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.

  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. Future Proof Process Design Through Risk-Focused Decisions, Automation Readiness, And Regulatory Pragmatism 10/29/2025

    In this segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene share that future proofing begins with deep process understanding.

  7. Challenge #3: Lack Of Animal Models 1/30/2023

    Many cell and gene therapies are intended for diseases and conditions that primarily impact pediatric patients, requiring the prospect of direct benefit to individual subjects enrolled in the trial.  In the absence of good animal models, there may be challenges demonstrating the prospect of direct benefit.  During this segment of Cell & Gene Live, Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO discusses novel approaches to consider going forward.

  8. Bridging Analytical Gaps To Ensure CGT Material Quality 4/1/2026

    In this segment of Cell & Gene Live, "Materials Matter: Ensuring Quality of CGT Materials," Cell & Gene Chief Editor Erin Harris was joined by Anthony Blaszczyk, Ph.D., Senior Scientist at the U.S. Pharmacopeia, and Basak Clements, Ph.D., Founder and Senior Advisor at biomatria, to discuss why analytical gaps remain a major challenge in cell and gene therapy.

  9. Inside The Phased, Risk-Based Approach For CGT Materials 4/1/2026

    In this segment of Cell & Gene Live, Anthony Blaszczyk, Ph.D., Senior Scientist at the U.S. Pharmacopeia, and Basak Clements, Ph.D., Founder and Senior Advisor at biomatria, were joined by Cell & Gene Chief Editor Erin Harris to discuss the efforts that are underway to close the gap in particulate guidance for cell and gene therapy by developing new best practices and fostering cross-industry collaboration, recognizing that particulates remain a complex, unsolved challenge.

  10. CGT's Main Opportunities To Meet Regulatory Requirements 1/30/2023

    Host and Moderator, Erin Harris, Chief Editor of Cell & Gene, began this Cell & Gene Live, Tackling Cell and Gene Therapies’ Top 3 Regulatory Impediments, featuring Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio, by asking the experts to highlight the main opportunities where the cell and gene therapy industry is working to meet regulatory requirements. They cover accelerated and expedited designation of regenerative medicines, navigating the regulatory requirements around the root causes of genetic disease by repairing or replacing a patient’s genes, and much more.