Regulatory
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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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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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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.
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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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Globalization's Impact on Patient Access with ARM's COO, Rita Johnson-Greene
11/20/2024
Rita Johnson-Greene, COO at Alliance for Regenerative Medicine (ARM) joined Cell & Gene: The Podcast Host, Erin Harris, on-site during the 2024 Meeting on the Mesa to record their discussion. Johnson-Greene shared information about the Joint Clinical Assessment (JCA) in Europe and its potential impact on cell and gene therapies, how globalization impacts patient access, an update on ARM's Grow Internship Program, as well as a few key takeaways from the event that sector professionals can anticipate impacting the CGTs in the next 12 months and beyond.
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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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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.
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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.