and Medicine Engineering National Academies of Sciences, Health and Medicine Division, Board on Health Sciences Policy, and Translation Development Forum on Drug Discovery, Anne B. Claiborne (EDT), Amanda Wagner Gee (EDT), Morgan L. Boname (EDT) Advancing the Discipline of Regulatory Science for Medical Product Development

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The field of endeavors known as regulatory science has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline.In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the disciplines success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop.