We look at the importance of finding suppliers able to develop and customise Process Intermediates to meet the rapidly-changing expectations of modern finished drug manufacturers, and the economic & logistic benefits of outsourcing Buffer manufacturing, especially with the rise of cell & gene therapy products.
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.