Our in-house experts, along with Cecile Bellamy from Pfizer, deep dive into the factors that are influencing our industry today and look at what trends are likely to impact us in the future. We cover topics including regulatory compliance, manufacturer flexibility & supply chain risk and debate the supplier vs partner relationship and the importance of collaboration as we face a challenging future.
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.