Sunday, September 24
Keynote Lecture: 
Regulatory Science: Evolution of a Discipline
Issam Zineh, Office of Clinical Pharmacology, U.S. Food and Drug Administration, CDER, Silver Spring, MD
Regulatory agencies, such as the US Food and Drug Administration (FDA), have a mission to protect and promote public health. Development and incorporation of leading edge science into regulatory evaluation of new drugs is critical to advancing this core responsibility. As such, there has been a fairly recent global movement to define and foster “regulatory science” on the part of many stakeholders. The FDA defines regulatory science as “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.”

This talk will provide an overview of the evolving discipline of regulatory science. Specifically, discussion will focus on some of FDA’s efforts to: 

  • Support regulatory science efforts through research, focusing resources on priority areas
  • Integrate new science into regulatory review processes, policies, guidances, and standards
  • Support collaborations, consortia, and proactive sharing of pre-competitive data

Examples will include efforts and initiatives by the FDA’s Center for Drug Evaluation and Research, Office of Translational Sciences, and Office of Clinical Pharmacology intended to advance scientific priority areas across the drug development, regulation, and therapeutic use spectrum.