FDA Pilots: Key Insights, Lessons Learned, and What’s Next for 2025 | Shiny Gathering

Join industry experts Ben Straub, Eric Nantz, and Sam Parmar for an insightful discussion on the latest developments in FDA Pilot programs. This session covers key takeaways, current challenges, and the evolving direction of regulatory innovation. Highlights include feedback from the FDA, the current status of Pilot 5, introduction of Pilot 5 and lessons learned from Pilots 1–3. You'll also get a look ahead at what’s planned for 2025 and how these initiatives are shaping the future of regulatory submissions using R. This project is part of the R Consortium R Submission Working Group, which supports R-based clinical trial regulatory submissions. Stay informed with expert insights into the next phase of regulatory science and data-driven submissions. Interested in learning more? Explore the additional resources: https://hubs.li/Q03knDL00 __________________ 00:00 - Introduction to the episode 05:50 - Summary of pilots 1 to 3 09:28 - Pilot 4 deep dive 12:48 - Pilot 5 introduction 15:39 - Key FDA feedback and challenges from pilot 4 34:26 - Discussion on hurdles for R adoption and open source risks 44:53 - Key FDA feedback on Shiny app interactivity and analysis integrity 59:28 - Closing remarks __________________ Looking for insights? Get them directly from a variety of industry leaders in our podcast, Where Technology Meets Science. Available here on YouTube and on all podcasting platforms. ► YouTube: https://www.youtube.com/playlist?list=PLexAKolMzPcpRNtpwdAwRO9fCxAdwDauo ► Spotify: https://open.spotify.com/show/6MckhYFZCwGU4Op6P09foR ► Apple Podcasts: https://apple.co/3CJDdVy