In the Spotlight - May 2005

Ishani Maharaj of Univar Solutions explains how to stabilize GLP-1 multi-agonists, weigh delivery formats, and qualify novel excipients and suppliers.

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

Boyang Wang, Immortal Dragons, discusses how the FDA’s Expedited IND Pilot must prove efficiency as sponsors chase the fastest route to valid first-in-human data.

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.

The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors, CDMOs, and quality teams.

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

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.