Background and Objectives
The National Academies Forum on Drug Discovery, Development, and Translation conducted a workshop that explored issues related to Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development. More specifically, the workshop: (1) considered opportunities and needs for advancing innovation in the discipline of regulatory science for therapeutics development through an interdisciplinary regulatory science workforce; and (2) examined specific strategies for developing a discipline of innovative regulatory science through development of a robust workforce within academia and industry and at FDA.
Subject matter experts were invited to participate in the workshop to discuss and help explore models to advance the discipline of innovative regulatory science for therapeutics development through workforce and career development. The workshop considered the necessary components of an academic discipline of and infrastructure for regulatory science that fosters innovation in therapeutics development methodologies. The workshop also focused on regulatory science workforce issues related to scientific innovation in the process of therapeutics development, with attention to the entire development lifecycle, including post-market safety monitoring.
Objectives
The workshop featured invited presentations and discussions to:
- Define and discuss the current regulatory science workforce, with particular attention to discussion of the disciplines involved and professional training opportunities.
- Identify gaps between the essential components of a workforce that will produce innovation in regulatory science and the current reality.
- Consider workforce development needs in areas identified as key components of a robust discipline of innovative regulatory science in therapeutics development.
- Examine application and advantages of collaborative (multisector and multidisciplinary) approaches for strengthening of a robust national regulatory science workforce.
- Identify and discuss specific opportunities for enhancing collaboration and coordination – among relevant federal programs and between FDA and the extramural community – to strengthen a regulatory science workforce supporting innovation in therapeutics development.
- Identify barriers to implementation of collaborative models, and discuss potential solutions to address those identified barriers.
- Explore the resources and stakeholder engagement needed, not only within FDA and other federal agencies, but also throughout the extramural sector, to build the discipline and establish career paths in the area of regulatory science innovation for therapeutics development.
Planning Committee
Barry S. Coller (Co-Chair), The Rockefeller University
Elaine K. Gallin (Co-Chair), QE Philantrophic Advisors
Gail H. Cassel, Harvard Medical School
Garret A. Fitzgerald, University of Pennylsvanie School of Medicine
Jesse L. Goodman, U.S. Food and Drug Administration
Harry B. Greenberg, Stanford University School of Medicine
Stephen Groft, National Institutes of Health
Sharon Hesterlee, Parent Project Muscular Dystrophe
Petra Kaufmann, National Institutes of Neurological Disorders and Stroke
Jack D. Keene, Duke University Medical Center
Freda Lewis-Hall, Pfizer, Inc.
Michael E. Mendelsohn, Merck & Co., Inc.
Amy Patterson, National Institutes of Health
Carl Peck, University of California, San Francisco
Nancy Sung, Burroughs Welleome Fund
Leslie D. Wheelock, U.S. Food and Drug Administration
Janet Woodcock, U.S. Food and Drug Administration
Below are materials for the workshop, including an agenda and presentations.
For additional information on the workshop, including the planning committee and sponsors, please visit our project page.