In the Spotlight May 2004

NVIDIA’s $250M, five-year compute donation funds UK agentic AI safety research, with implications for how GMP teams validate and govern autonomous AI.

MASH and cardiomyopathy AI collaboration: AstraZeneca pays insitro $40M upfront for target discovery, then leads clinical development and CMC planning.

Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.

Jaenisch, Muraru, and Pandey join PharmTech's Cole to discuss FDA's generative AI paper, ARPA-H's SURPASS trials, and AI accountability.

Richard Jaenisch explains what FDA's real-world use case database means for CMC and quality teams navigating NAMs.

This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating manufacturing systems, centralized data management, Industrial Internet of Things connectivity, electronic batch production records, and AI-driven analytics.

PharmTech AI Pulse Check panelists explain why attribution, audit trails, and sign-off matter more than AI watermark detection for GxP quality teams.

Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.