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

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.

You can listen to Regulatory Flexibility in CGT: Key Shifts and Implications with Monika Swietlicka online on Radio and Podcast. Open the player on this page to stream the available audio.

Regulatory Flexibility in CGT: Key Shifts and Implications with Monika Swietlicka is an episode from Cell & Gene: The Podcast by Erin Harris.

This episode is 27:18 long.

This episode was published on Mar 26, 2026.

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