Regulatory

1. CRI's Response to NIH Cuts with Alicia Zhou, Ph.D. 4/22/2025

   In this episode of the Cell & Gene podcast, Host Erin Harris speaks with Alicia Zhou, Ph.D., CEO of the Cancer Research Institute (CRI), about CRI’s mission to advance cancer immunotherapy and the critical role of federal funding, particularly from the NIH, in supporting basic and translational cancer research.

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. Cell & Gene: The Podcast Presents: Better Biopharma's Editors' Roundtable — A Midyear Look at the 2026 Life Sciences Industry 6/15/2026

   For episode 131 of Cell & Gene: The Podcast, we’re sharing a recent "Better Biopharma" roundtable that Erin Harris had the opportunity to join alongside her Life Science Connect editorial colleagues.

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. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.