Regulatory
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.