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Episode

Regulatory Flexibility in CGT: Key Shifts and Implications with Monika Swietlicka

Podcast
Cell & Gene: The Podcast
Published
Mar 26, 2026
Duration seconds
1638
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Summary

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...