Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary

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 Discipline's 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. Introduction -- Characterizing The Implementation Science Landscape -- Regulatory Science Applications: Using Case Studies To Focus On Approaches To Advance The Discipline -- Regulatory Science Infrastructure And Workforce -- Challenges And Opportunities In Regulatory Science -- Appendix A: Bibliography -- Appendix B: Workshop Agenda -- Appendix C: Participant Biographies. Morgan L. Boname, Amanda Wagner Gee, And Anne B. Claiborne, Rapporteurs ; Forum On Drug Discovery, Development, And Translation, Board On Health Sciences Policy, Health And Medicine Division, National Academies Of Sciences, Engineering, And Medicine. Includes Bibliographical References. This Activity Was Supported By Abbvie, Inc.; The American Diabetes Association; American Society Of Microbiology; Amgen Inc. (contract No. Ghccops-csarf-63987); Association Of American Medical Colleges; Astrazeneca; Baxter Bioscience; Burroughs Wellcome Fund (contract No. 1015149); Critical Path Institute; Doris Duke Charitable Foundation (contract No. 2015103); Eli Lilly & Co.; Fastercures; Friends Of Cancer Research; Glaxosmithkline (contract No. 005319); Johnson & Johnson; Merck & Co., Inc. (contract No. Cmo-141224-000649); National Institutes Of Health (nih) (contract No. Hhsn263201200074i; Task Order Hhsn26300023): National Cancer Institute (nih), National Center For Advancing Translational Sciences (nih), National Institute Of Allergy And Infectious Diseases (nih), National Institute Of Mental Health (nih), And National Institute Of Neurological Disorders And Stroke (nih); New England Journal Of Medicine; Pfizer Inc.; Sanofi; Takeda Pharmaceuticals (contract No. 53108); And U.s. Food And Drug Administration (contract No. 1r13fd005496-01). Any Opinions, Findings, Conclusions, Or Recommendations Expressed In This Publication Do Not Necessarily Reflect The Views Of Any Organization Or Agency That Provided Support For The Project.