W
Hello, I'm Winston.
Your senior counsel on global drug development.
Suggested starting points
FDA PathwayHow should I design my dose-optimisation study under FDA's Project Optimus framework for an oral TKI programme?
Accelerated ApprovalWhat does 'reasonably likely to predict clinical benefit' actually come down to for Accelerated Approval today?
EndpointWhat endpoint is defensible for a first-in-class ADC in gastric cancer: ORR, PFS, or OS? What does precedent say?