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: https://www.linkedin.com/newsletters/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-announcements/fda-announces-completion-first-ai-assisted-scientific-review-pilot-and-aggressive-agency-wide-aiBCG
Report on AI Agents in Pharma: https://www.linkedin.com/posts/bcg-platinion_ai-agents-and-the-model-context-protocol-activity-7330864988070309891-zhCZ
Benchling + Claude Integration: https://www.anthropic.com/customers/benchling
AWS Life Sciences Symposium 2025 & Keynote: https://aws.amazon.com/blogs/industries/7th-annual-aws-life-sciences-symposium/
https://www.youtube.com/watch?v=3hohXZF_3ys
FDA Request for Comments on CDISC Dataset-JSON: https://www.federalregister.gov/documents/2025/04/09/2025-06051/electronic-study-data-submission-data-standards-clinical-data-interchange-standards-consortium
Open Source Highlights:
{muttest} https://github.com/jakubsob/muttest
{mergen} https://bioinformatics.mdc-berlin.de/mergen/
gptstudio & gpttools https://github.com/MichelNivard/gptstudio
{kuzco} https://github.com/frankiethull/kuzco
{cheetahR} https://githu
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