The High Price of Success

The company is showcasing new development solutions and advanced digital technologies including its new OSD Express and Steriles Express solutions for drug development.

Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.

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.