Regulatory

  1. Globalization's Impact on Patient Access with ARM's COO, Rita Johnson-Greene 11/20/2024

    Rita Johnson-Greene, COO at Alliance for Regenerative Medicine (ARM) joined Cell & Gene: The Podcast Host, Erin Harris, on-site during the 2024 Meeting on the Mesa to record their discussion. Johnson-Greene shared information about the Joint Clinical Assessment (JCA) in Europe and its potential impact on cell and gene therapies, how globalization impacts patient access, an update on ARM's Grow Internship Program, as well as a few key takeaways from the event that sector professionals can anticipate impacting the CGTs in the next 12 months and beyond.

  2. The Current State of the Global Regulatory Landscape with ISCT's Dr. Bambi Grilley 5/28/2024

    Dr. Bambi Grilley is Professor of Pediatrics and the Director of Clinical Research and Early Product Development for the Center of Cell and Gene Therapy (CAGT) at Baylor College of Medicine AND she is Chief Regulatory Officer at ISCT. Dr. Grilley talks to us about her role as CRO at ISCT and the global regulatory landscape for cell and gene therapies.

  3. FDA Fridays: Advancing Communication and Consistency in CGT Regulation with Kaye Spratt 8/7/2025

    This is Episode 1 of a special series of Cell & Gene: The Podcast, "FDA Fridays." This first episode features Host, Erin Harris' conversation with Kaye Spratt, Strategic and Non-Clinical Regulatory Consultant at Spratt Advanced Cell & Gene Therapy Regulatory Consulting.

  4. Defining Product Roles and Navigating FDA Approval with Monika Swietlicka 8/13/2025

    In Episode 2 of FDA Fridays, the special series from Cell & Gene: The Podcast, Host Erin Harris talks to regulatory expert Monika Swietlicka, Principal, Regulatory Strategy, Halloran Consulting Group to discuss key strategies and challenges in navigating FDA regulation for cell and gene therapies.

  5. CGT Regulatory Update and Outlook with Dark Horse Consulting's Kimberly Benton, Ph.D. 8/14/2024

    Dark Horse Consulting Group (DHC)'s Kimberly Benton, Ph.D. joins Erin Harris to discuss Biologics License Applications (BLAs) of recent approvals as well as those currently under review. Benton shares information about FDA Draft Guidances, including Platform Technology Designation Program for Drug Development: Guidance for Industry.

  6. What Changes to FDA and CBER Mean for the Future of CGT with Daniela Drago 8/27/2025

    This is Episode 4 of "FDA Fridays," a special series from Cell & Gene: The Podcast, Chief Editor Erin Harris speaks with regulatory affairs expert Daniela Drago, Partner, NDA Partners, about how shifting FDA and CBER priorities under the current administration could influence the trajectory of cell and gene therapy development.

  7. Barriers, Breakthroughs, and Building Access in Pediatric CGTs with Bambi Grilley, Ph.D. 8/21/2025

    This is Episode 3 of "FDA Fridays," a 4-week special series from Cell & Gene: The Podcast. Host Erin Harris talks to Bambi Grilley, Ph.D., Professor of Pediatrics and the Director of Clinical Research and Early Product Development for the Center of Cell and Gene Therapy (CAGT) at Baylor College of Medicine and Chief Regulatory Officer for ISCT, a leading expert at the forefront of pediatric cell and gene therapy.

  8. The Editors' Roundtable: A 2025 Retrospective of the Life Sciences Industry 1/8/2026

    We’re sharing this episode on Cell & Gene: The Podcast because Better Biopharma is a sister podcast within the Life Science Connect family. This conversation speaks directly to the challenges and opportunities our Cell & Gene: The Podcast audience is navigating right now.

  9. Inside Genome Editing With CBER's Dr. Peter Marks 9/12/2023

    The FDA's Center for Biologics Evaluation and Research (CBER)'s Dr. Peter Marks makes his second appearance on Cell & Gene: The Podcast. This time Dr. Marks talks to Host, Erin Harris, about base editing and prime editing and their potential to meet unmet medical need. They discuss what clinical holds say about the FDA’s views on gene editing. They also discuss heritable genome editing.

  10. How AI and ML Drive iPSC Quality with Aspen Neuroscience's Thorsten Gorba, Ph.D. 10/7/2025

    In Episode 113 of Cell & Gene: The Podcast, Host Erin Harris is joined by Thorsten Gorba, Ph.D., of Aspen Neuroscience to explore how the company is advancing the field of cell therapy manufacturing.