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.

Contents

• The National Academies of SCIENCES • ENGINEERING • MEDICINE
• COMMITTEE ON ADVANCING THE DISCIPLINE OF REGULATORY SCIENCE FOR MEDICAL PRODUCT DEVELOPMENT: AN UPDATE ON PROGRESS AND A FORWARD-LOOKING AGENDA
• FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION
• Reviewers
• Acronyms and Abbreviations
• 1. Introduction
  • ORGANIZATION OF THIS REPORT
• 2. Characterizing the Regulatory Science Landscape
  • INNOVATIVE SCIENCE AT FDA
  • THE ROLE OF DATA SCIENCE IN REGULATORY SCIENCE: A CASE STUDY IN COLLABORATION
• 3. Regulatory Science Applications: Using Case Studies to Focus on Approaches to Advance the Discipline
  • IDENTIFICATION AND DEVELOPMENT OF MEANINGFUL BIOMARKERS
  • INTEGRATING CLINICAL TRIAL DATA
  • NEXT-GENERATION SURVEILLANCE
  • INNOVATIVE MODELING FOR INTEGRATING DATA
• 4. Regulatory Science Infrastructure and Workforce
  • CHARACTERIZING THE DISCIPLINE OF REGULATORY SCIENCE
  • TRAINING THE NEXT-GENERATION REGULATORY SCIENTIST
  • INCENTIVIZING AND FUNDING REGULATORY SCIENCE
• 5. Challenges and Opportunities in Regulatory Science
  • REGULATORY SCIENCE LANDSCAPE CONSIDERATIONS
  • CONSIDERATIONS FOR APPLICATIONS OF REGULATORY SCIENCE
  • INFRASTRUCTURE AND WORKFORCE CONSIDERATIONS
• APPENDIXES
  • Appendix A. Bibliography
  • Appendix B. Workshop Agenda
  • Appendix C. Participant Biographies

Rapporteurs: Morgan L. Boname, Amanda Wagner Gee, and Anne B. Claiborne.

Suggested citation:

National Academies of Sciences, Engineering, and Medicine. 2016. Advancing the discipline of regulatory science for medical product development: An update on progress and a forward-looking agenda: Workshop summary. Washington, DC: The National Academies Press. doi: 10.17226/23438.