Fireside Chat: Leveraging FDA Platform Technology Designation Program Learnings to Accelerate Multi-Program Development & Reduce Redundant Studies
10:00 am - Wednesday 24th February 2027
- Understanding regulatory interactions and data package requirements for platform designation applications, positioning companies to benefit from streamlined review processes and reduced filing burdens
- Sharing knowledge from companies that have successfully obtained platform designation to reduce redundant development, saving years of process characterization work and millions in development costs
- Navigating applicability of platform approaches for small companies with single assets versus large multi-program portfolios, determining when platform investment delivers meaningful return
