Search a title or topic

Over 20 million podcasts, powered by 

Player FM logo
Artwork

Content provided by Erin Harris. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Erin Harris or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.
Player FM - Podcast App
Go offline with the Player FM app!

Defining Product Roles and Navigating FDA Approval with Monika Swietlicka

38:30
 
Share
 

Manage episode 500410541 series 2945689
Content provided by Erin Harris. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Erin Harris or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

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 development, the different regulatory expectations based on disease context and patient population, and the crucial impact of unmet medical need on regulatory flexibility. Swietlicka emphasizes the necessity of a clear, scientifically sound regulatory narrative, especially when precedent is lacking, and advocates for early, robust investment in CMC to minimize risks. They also explore the complexities of using surrogate endpoints, planning for long-term patient follow-up under uncertainty, and the value of integrating commercial considerations from the outset. Swietlicka calls for cell and gene therapy developers to adopt a commercial mindset and proactive regulatory engagement to achieve clinical and commercial success.

Subscribe to the podcast!
Apple | Spotify | YouTube

Visit my website: Cell & Gene

Connect with me on LinkedIn

  continue reading

113 episodes

Artwork
iconShare
 
Manage episode 500410541 series 2945689
Content provided by Erin Harris. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Erin Harris or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

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 development, the different regulatory expectations based on disease context and patient population, and the crucial impact of unmet medical need on regulatory flexibility. Swietlicka emphasizes the necessity of a clear, scientifically sound regulatory narrative, especially when precedent is lacking, and advocates for early, robust investment in CMC to minimize risks. They also explore the complexities of using surrogate endpoints, planning for long-term patient follow-up under uncertainty, and the value of integrating commercial considerations from the outset. Swietlicka calls for cell and gene therapy developers to adopt a commercial mindset and proactive regulatory engagement to achieve clinical and commercial success.

Subscribe to the podcast!
Apple | Spotify | YouTube

Visit my website: Cell & Gene

Connect with me on LinkedIn

  continue reading

113 episodes

All episodes

×
 
Loading …

Welcome to Player FM!

Player FM is scanning the web for high-quality podcasts for you to enjoy right now. It's the best podcast app and works on Android, iPhone, and the web. Signup to sync subscriptions across devices.

 

Copyright 2025 | Privacy Policy | Terms of Service | | Copyright
Listen to this show while you explore
Play