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—particularly when it comes to Breakthrough Therapy Designation (BTD). In this executive summary, industry experts from Alnylam® Pharmaceuticals, Mirum Pharmaceuticals, 91Ï㽶ÊÓƵ Biologics and UroGen® Pharma share case studies of how they’ve adapted to increasingly expedited regulatory reviews.