Advancing Translational Science and Regulatory Science Synergistically

Co-Chairs: Tina Morrison, Director, Office of Regulatory Science and Innovation, US FDA, Guigen Zhang, Professor and Halcomb Chair, University of Kentucky, SFB President

Speakers: Klaus Romero, PhD, Chief Science Officer, Critical Path Institute, Susan C. Winckler, RPh, Chief Executive Officer, Reagan-Udall Foundation for the FDA, and Xiaoming Xu, PhD, FDA

In this workshop, thought leaders from government agencies, academia, industry, and relevant consultancies gathered to discuss and identify efficient ways to integrate translational science and regulatory science toward developing better regulatory tools and facilitating effective regulatory processes to accelerate medical technology innovation. Three key areas were addressed: 1) showcasing Success Stories on Regulatory Science Collaborations that involved industry, academia, and FDA; 2) unpacking the lifecycle from the perspective of the stakeholder; and 3) heeding the needs of regulatory agency, industry/users for reducing regulatory friction