Uploaded June 2025 | Updated September 2026, 2 weeks ago

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#datascience #dataanalysis #technology #pharmabrief #clinicaltrials #technologyinpharma #pharma #pharmanews

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: 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: fda.gov/news-events/press-announcements/fda-announces-completion-first-ai-assisted-scientific-review-pilot-and-aggressive-agency-wide-ai
BCG Report on AI Agents in Pharma: linkedin.com/posts/bcg-platinion_ai-agents-and-the-model-context-protocol-activity-7330864988070309891-zhCZ
Benchling + Claude Integration: anthropic.com/customers/benchling
AWS Life Sciences Symposium 2025 & Keynote: aws.amazon.com/blogs/industries/7th-annual-aws-life-sciences-symposium
youtube.com/watch?v=3hohXZF_3ys
FDA Request for Comments on CDISC Dataset-JSON: federalregister.gov/documents/2025/04/09/2025-06051/electronic-study-data-submission-data-standards-clinical-data-interchange-standards-consortium

Open Source Highlights:
{muttest} github.com/jakubsob/muttest
{mergen} bioinformatics.mdc-berlin.de/mergen
gptstudio & gpttools github.com/MichelNivard/gptstudio
{kuzco} github.com/frankiethull/kuzco
{cheetahR} 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 sessionize.com/rpharma-2025

You can follow Pharma Brief on LinkedIn: linkedin.com/newsletters/pharma-brief-7300489155535380480

Nat Chrzanowska
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
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