Regulatory
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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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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.
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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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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.
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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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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 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.
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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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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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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.