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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

Subscribe on LinkedIn: https://www.linkedin.com/newsletters/pharma-brief-7300489155535380480/ 

Nat Chrzanowska 
https://www.linkedin.com/in/nat-chrzanowska/
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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 
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