Cell & Gene: The Podcast

Author: Erin Harris

Cell & Gene, the most valuable online resource for delivering in-depth content from authoritative authors and sources to professionals in the CGT sector, introduces Cell & Gene: The Podcast. In each episode, Cell & Gene Chief Editor, Erin Harris, will talk to industry and academic leaders about their current initiatives and how they are moving the sector forward.
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Language: en

Genres: Life Sciences, Science

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Regulatory Flexibility in CGT: Key Shifts and Implications with Monika Swietlicka
Thursday, 26 March, 2026

We love to hear from our listeners. Send us a message.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. They also explore what this means for developers, from platform strategies and global regulatory divergence to the growing role of patient advocacy and the need for early, integrated planning.Subscribe to the podcast!Apple | Spotify | YouTubeVisit my website: Cell & GeneConnect with me on LinkedIn