Tune in for the FDA Pilots: Key Insights, Lessons Learned, and What’s Next for 2025 session! @appsilon

Uploaded June 2025 | Updated September 2026, 2 weeks ago

We welcomed Ben Straub, Eric Nantz, and Sam Parmar who shared valuable insights from the FDA pilot programs and discussed what’s next in the world of regulatory submissions using R.

If you missed the live session, the recording is now available! 🌟 Tune in for an great conversation on the progress of Pilots 1-3, a review of Pilot 4, an introduction to Pilot 5, and key FDA feedback and challenges.

#ShinyGathering #FDApilots #regulatoryinnovation #rstats #webinar

Tune in for the FDA Pilots: Key Insights, Lessons Learned, and What’s Next for 2025 session!

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$Pharma Brief: FDAs Animal Testing Phase-Out, AI in Clinical Development, and Open-Source News #datascience #dataanalysis #technology #pharmabrief #clinicaltrials #technologyinpharma #pharma #pharmanews Pharma Brief is back with its third edition, packed with essential industry insights and the latest developments in pharma and biotech. This issue covers the FDA’s plan to phase out animal testing for monoclonal antibodies in favor of AI models and NAMs, insights from Stanford’s AI Index 2025 and McKinsey’s analysis of AI in clinical development, plus new tools like CDISC Dataset Generator, scMultiSim, open-source releases from Novo Nordisk and Genentech and more! You can follow Pharma Brief on LinkedIn: https://www.linkedin.com/newsletters/pharma-brief-7300489155535380480/ And now it’s available in audio on all your favorite podcasting platforms. Links from the episode: FDA’s New Plan for Phasing Out Animal Testing: https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs Stanford’s AI Index Report 2025: https://hai-production.s3.amazonaws.com/files/hai_ai_index_report_2025.pdf Summary & takeaways: https://hai.stanford.edu/ai-index/2025-ai-index-report McKinsey & Company’s article on clinical development with AI & ML: https://www.mckinsey.com/industries/life-sciences/our-insights/unlocking-peak-operational-performance-in-clinical-development-with-artificial-intelligence CDISC Dataset Generator for Synthetic Data: https://cdiscdataset.com/ scMultiSim for Omics Data Simulation: https://www.nature.com/articles/s41592-025-02651-0 Revolutionising Participant Safety Monitoring with Advanced Solutions (Risk Based Quality Management PHUSE Working Group): https://phuse.s3.eu-central-1.amazonaws.com/Archive/2025/Webinar/Worldwide/Virtual/REC_CF12.mp4 Slides: https://phuse.s3.eu-central-1.amazonaws.com/Advance/Community+Forums+/Revolutionizing+Participant+Safety+Monitoring+with+Advanced+Solutions.pdf Clinical Data Analysis: Open Source in Pharma (Free eBook): https://hubs.li/Q03kf2Pk0 FDA Pilots Session (ShinyGatherings): https://youtu.be/zZMGFq57wnE Open-Source packages: Novo Nordisk’s {connector} Package: https://novonordisk-opensource.github.io/connector/ Genentech’s BRAID Foundation Models: https://github.com/Genentech/BRAID bslib v0.9.0 is on CRAN: https://rstudio.github.io/bslib/news/index.html?_gl=1*125lu4v*_ga*NzczNzkyMTAxLjE3Mzc1NTYwMzA.*_ga_8QJS108GF1*MTc0NTkzMzIzMy4xLjAuMTc0NTkzMzIzOC4wLjAuMA..*_ga_2C0WZ1JHG0*MTc0NTkzMzIzMy45LjAuMTc0NTkzMzIzOC4wLjAuMA..#bslib-090 Chores package: https://simonpcouch.github.io/chores/ Upcoming Events: Domino RevX Life Science Edition | 20 May 2025 | Philadelphia (PA), United States PHUSE Computational Science Symposium 2025 | 20-21 May 2025 | Utrecht, Netherlands ShinyGatherings x Pharmaverse: Presenting aNCA: From Idea to Clinical Impact | 27 May 2025 | Virtual PharmaSUG US Conference | 1-4 June 2025 | San Diego (CA), United States Veeva Summit | 4-5 June 2025 | Madrid, Spain PSI 2025 | 8-11 June 2025 | London, United Kingdom PHUSE Single Day Event | 11 June 2025 | Boston (MA), United States You can follow Pharma Brief on LinkedIn: https://www.linkedin.com/newsletters/pharma-brief-7300489155535380480/ Nat Chrzanowska https://www.linkedin.com/in/nat-chrzanowska/ Appsilon empowers pharmaceutical and life sciences companies to leverage open-source technology for faster, data-driven decision-making in regulated environments. Schedule a free consultation with our expert ► https://www.appsilon.com/contact-us We design scalable and user-friendly Shiny dashboards to help you make data-driven decisions. ► https://www.appsilon.com/services/data-dashboards We design and implement Statistical Computing Environment for R and Python for efficient data analysis: ► https://www.appsilon.com/services/sce We design, implement, and optimise data analysis environments so you can focus focus on insights and innovation. ► https://www.appsilon.com/services/platform Where Technology Meets Science podcast is available on all podcasting platforms: ► Spotify: https://open.spotify.com/show/6MckhYFZCwGU4Op6P09foR ► Apple Podcasts: https://apple.co/3CJDdVy For more insights about how technology helps scientists push the boundaries of data analysis and reporting check out our blog: ► http://appsilon.com/blog LinkedIn: https://www.linkedin.com/company/appsilon/$