Regulatory

1. 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.

2. Bridging Development and Regulation in CGT with Halloran Consulting Group's Monika Swietlicka 6/3/2025

   On this episode of Cell & Gene: The Podcast, Host Erin Harris welcomes Monika Swietlicka, Principal, Regulatory Strategy at Halloran Consulting Group to discuss the key regulatory challenges facing cell and gene therapy companies.

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. 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.

5. 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.

6. 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.

7. 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.

8. Dr. Usman "Oz" Azam Discusses The State Cell And Gene Therapy Space 6/6/2023

   Cell and gene therapy expert Dr. Usman "Oz" Azam provides his valuable perspective on the therapy space and answers questions about the FDA, solid tumor cancer treatment, and much more.

9. 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.

10. 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.