# Regulatory Flexibility in CGT: Key Shifts and Implications with Monika Swietlicka Page: https://stenobird.com/podcast/cell-gene-the-podcast-4048431/regulatory-flexibility-in-cgt-key-shifts-and-implications-with-monika-swietlicka Text version: https://stenobird.com/podcast/cell-gene-the-podcast-4048431/regulatory-flexibility-in-cgt-key-shifts-and-implications-with-monika-swietlicka.md Podcast: [Cell & Gene: The Podcast](https://stenobird.com/podcast/cell-gene-the-podcast-4048431) Published: 2026-03-26T09:00:00+00:00 Episode link: https://www.buzzsprout.com/1810482/episodes/18898974-regulatory-flexibility-in-cgt-key-shifts-and-implications-with-monika-swietlicka.mp3 Audio file: https://www.buzzsprout.com/1810482/episodes/18898974-regulatory-flexibility-in-cgt-key-shifts-and-implications-with-monika-swietlicka.mp3 Processing state: not_requested JSON: https://stenobird.com/v1/public/podcasts/cell-gene-the-podcast-4048431/episodes/regulatory-flexibility-in-cgt-key-shifts-and-implications-with-monika-swietlicka Duration seconds: 1638 ## Resource 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... ## Actions - request_transcript: `POST https://stenobird.com/v1/public/podcasts/cell-gene-the-podcast-4048431/episodes/regulatory-flexibility-in-cgt-key-shifts-and-implications-with-monika-swietlicka/transcription-requests` — Idempotently request low-priority transcript generation for this episode. - read_markdown: `GET https://stenobird.com/podcast/cell-gene-the-podcast-4048431/regulatory-flexibility-in-cgt-key-shifts-and-implications-with-monika-swietlicka.md` — Read the agent-friendly Markdown representation of this episode resource. A page view does not enqueue transcription. Agents should invoke `request_transcript` explicitly when they need this episode processed. ## Transcript Full transcripts are not published on public pages unless there is a clear rights basis.