Cell & Gene: The Podcast
Cell & Gene: The Podcast
Erin Harris
Defining Product Roles and Navigating FDA Approval with Monika Swietlicka
38 minutes Posted Aug 15, 2025 at 10:00 am.
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Show notes
We love to hear from our listeners. Send us a message. Episode 2 of FDA Fridays, the special series from Cell & Gene: The Podcast, features Host Erin Harris' discussion with regulatory expert Monika Swietlicka, Principal, Regulatory Strategy, Halloran Consulting Group about the key strategies and challenges in navigating FDA regulation for cell and gene therapies. Their conversation covers the importance of defining a therapy’s intended role (curative, chronic, or adjunctive) early in dev...