Regulatory

  1. 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.

  2. Redefining Heart Failure Treatment with Precision Autologous Cell Therapy with BioCardia's Peter Altman, Ph.D. 5/6/2025

    In this episode of Cell & Gene: The Podcast, Host Erin Harris sits down with Peter Altman, Ph.D., CEO of BioCardia, to discuss the company’s evolution from a cardiac biotherapeutic delivery firm to a developer of autologous and allogeneic cell therapies for cardiovascular and pulmonary diseases.

  3. 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.

  4. 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.

  5. Regulatory Flexibility in CGT: Key Shifts and Implications with Monika Swietlicka 3/24/2026

    On episode 125 of Cell & Gene: The Podcast, Host Erin Harris talks to Halloran Consulting Group's Monika Swietlicka to discuss how the FDA is increasing flexibility in cell and gene therapy development without lowering evidentiary standards, emphasizing a risk-based, holistic approach.

  6. Inside a Breakthrough HER2 Immunotherapy for PMO with OS Therapies' Paul Romness 2/10/2026

    In episode 122 of Cell & Gene: The Podcast, Host Erin Harris talks to Paul Romness, CEO of OS Therapies, to learn the company’s mission to address the severe unmet need in pulmonary metastatic osteosarcoma (PMO), a rare pediatric cancer with no established standard of care once it metastasizes.

  7. Extracellular Vesicle Breakthroughs with Aegle Therapeutics' Dr. Gloria Matthews 6/17/2025

    In this episode of Cell & Gene: The Podcast, Host Erin Harris interviews Dr. Gloria Matthews, Chief Medical Officer of Aegle Therapeutics, a clinical-stage regenerative medicine company focused on developing therapies for rare and severe dermatologic and immunologic disorders.