Accelerated Pathways: Strategies to Manage and Maximize Across the Development Cycle
Summary: While accelerated development programs are intense by design, few have a similar regulatory experience鈥攑articularly when it comes to Breakthrough Therapy Designation (BTD). In this executive summary, industry experts from Alnylam庐 Pharmaceuticals, Mirum Pharmaceuticals, sa国际传媒官网网页入口Biologics and UroGen庐 Pharma share case studies of how they鈥檝e adapted to increasingly expedited regulatory reviews.