Скачать или смотреть Pharma Brief: Generative AI Advances at FDA, Pharma’s Autonomous Agents, and Open-Source Tools

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Pharma Brief’s fourth edition spotlights generative AI’s rapid expansion across pharma and regulatory landscapes. This issue covers the FDA’s planned rollout of generative AI tools across all centers, including the launch of Elsa to streamline reviews and inspections. We explore Anthropic’s Model Context Protocol as a new standard for context-aware AI, plus pharma’s growing use of autonomous agents in clinical operations and medical writing, with insights from BCG’s latest report.

Benchling’s integration of Claude into biotech R&D workflows highlights significant time savings and smarter data management. Catch a recap of the AWS Life Sciences Symposium keynote and FDA’s public call for comments on the CDISC Dataset-JSON standard, which could reshape study data exchange.

Open-source tools like {mergen}, {kuzco}, and {cheetahR} are featured to empower your R workflows with AI, computer vision, and blazing-fast data rendering.

You can follow Pharma Brief on LinkedIn:   / pharma-brief-7300489155535380480  
Now also available in audio on your favorite podcast platforms.

Links from the episode:
FDA’s Generative AI Rollout: https://www.fda.gov/news-events/press...
BCG Report on AI Agents in Pharma:   / bcg-platinion_ai-agents-and-the-model-cont...  
Benchling + Claude Integration: https://www.anthropic.com/customers/b...
AWS Life Sciences Symposium 2025 & Keynote: https://aws.amazon.com/blogs/industri...
   • AWS Life Sciences Symposium 2025: Keynote ...  
FDA Request for Comments on CDISC Dataset-JSON: https://www.federalregister.gov/docum...

Open Source Highlights:
{muttest} https://github.com/jakubsob/muttest
{mergen} https://bioinformatics.mdc-berlin.de/...
gptstudio & gpttools https://github.com/MichelNivard/gptst...
{kuzco} https://github.com/frankiethull/kuzco
{cheetahR} https://github.com/cynkra/cheetahR

Upcoming Events:
AI and SaMD in Healthcare Webinar | 18 June 2025 | Virtual
PHUSE Single Day Event | 21 June 2025 | Hyderabad, India
COSA Spotlight Q2 2025 | 24 June 2025 | Virtual
Value-Driven Clinical Data Review Webinar | 26 June 2025 | Virtual
PSI/PHUSE Change Management Event | 3 July 2025 | Cambridge, UK
PSI Webinar on iRISE Consortium Results | 24 July 2025 | Virtual

Open Call for Papers:
R/Pharma 2025 https://sessionize.com/rpharma-2025

You can follow Pharma Brief on LinkedIn:   / pharma-brief-7300489155535380480  

Nat Chrzanowska
  / nat-chrzanowska  
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