🤖🧬 Where Technology Meets Science

#1 Pharma Brief: J&J Moves to Open Source, AI-powered Data Extraction, and Top Clinical Trials for 2025

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Pharma Brief delivers your monthly pulse on pharma’s evolving landscape. Stay ahead with curated insights on FDA/EMA updates, AI-driven trends, and must-attend global events. We unpack breakthroughs—from novel drug approvals to open-source tools like R/Shiny—and arm you with actionable resources to in tech transformations in clinical trials. Whether it’s GxP compliance strategies or clinico-genomic advancements, we’re here to sharpen your expertise.
You can follow it on LinkedIn: https://www.linkedin.com/newsletters/pharma-brief-7300489155535380480/  and now it’s available in the audio on all your favorite podcasting platforms.
Links from the episode:
  • The FDA draft guidance on AI: https://www.fda.gov/news-events/press-announcements/fda-proposes-framework-advance-credibility-ai-models-used-drug-and-biological-product-submissions
  • AWS re:Invent Talk about Natera’s AI-Powered Data Extraction: https://www.youtube.com/watch?v=csbfwFbg8zE
  • 2024 CDER Novel Drug Approvals: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024
  • 360i Kick off CDISC recording: https://www.cdisc.org/events/webinar/360i-program-kickoff-enabling-standards-driven-automation-study-design-through
  • The 360i Program is a transformative initiative designed to automate the entire clinical research data lifecycle. You can watch the recording here and the slide deck here.
  • Top clinical trials for 2025: https://www.nature.com/articles/s41591-024-03383-y/tables/1
  • A new study on personalized cancer treatment: https://www.nature.com/articles/s41467-024-55251-5
  • Generative Artificial Intelligence (AI) on AWS: https://aws.amazon.com/developer/generative-ai/?ref=dc&id=b2
  • You can now learn and build AI applications with Amazon Bedrock, SageMaker, and more.
  • Johnson & Johnson's Open Source Journey with R in Clinical Trials”: https://www.youtube.com/watch?v=IloY1jiDD_Y
  • About Pharmaverse: https://pharmaverse.org/
  • Overview of CDISC standards and their role in supporting clinical research: https://www.cdisc.org/standards
  • Recordings from the recent GxP Validation Summit: https://www.youtube.com/playlist?list=PLexAKolMzPcr5rd9bBF5HGoHdCznE2LcT
  • Contribute to the aNCA package GitHub: https://github.com/pharmaverse/aNCA


Events:
  • 35th Annual European Pharma Congress: 10 - 11 March, 2025  |  Rome, Italy
  • PHUSE Single Day Event: 13 March, 2025  |  Frankfurt, Germany
  • PHUSE US Connect 2025: 16 - 19 March, 2025  |  Orlando, US
  • PHUSE Single Day Event: 22 March, 2025  |  Pune, India
  • Real World Data Spring Event 2025: 9 - 10 April, 2025  |  Virtual
  • Pharma 2025: 9 - 11 April, 2025   |   Barcelona, Spain
  • PHUSE Single Day Event: 17 April, 2025  |   Utrecht, Netherlands

Nat Chrzanowskahttps://www.linkedin.com/in/nat-chrzanowska/ 
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🤖🧬 Where Technology Meets ScienceBy Appsilon