Excerpt

[T]he Forum (Forum on Drug Discovery, Development, and Translation) convened a workshop on September 20-21, 2011, entitled “Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development.” This workshop provided a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and infrastructure as articulated in the 2010 workshop on regulatory science. The broad objectives of the workshop were (1) to consider opportunities and needs for advancing innovation in the discipline of regulatory science for therapeutics development through an interdisciplinary regulatory science workforce and (2) to examine specific strategies for developing a discipline of innovative regulatory science through development of a robust workforce within academia and industry and at FDA (Food and Drug Administration).

Specific objectives included the following:

• Define and discuss the current regulatory science workforce, with particular attention to the disciplines involved, professional training opportunities, and gaps in the essential components of this workforce.
• Consider workforce development needs in areas identified as key components of a robust discipline of innovative regulatory science in therapeutics development.
• Examine the application and advantages of collaborative (multisector and multidisciplinary) approaches for strengthening the national regulatory science workforce.
• Explore the resources and stakeholder engagement needed, not only within FDA and other federal agencies but throughout the extramural sector, to build the discipline and establish career paths in regulatory science for therapeutics development.

Contents

• THE NATIONAL ACADEMIES
• PLANNING COMMITTEE FOR THE WORKSHOP ON STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE IN THERAPEUTICS DEVELOPMENT
• FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION
• Reviewers
• Acronyms
• 1. Introduction
  • SCOPE OF THE WORKSHOP AND ORGANIZATION OF THE SUMMARY
• 2. The Importance of Innovative Regulatory Science
  • PERSPECTIVE FROM THE FOOD AND DRUG ADMINISTRATION
  • PERSPECTIVE FROM THE NATIONAL INSTITUTES OF HEALTH
  • PERSPECTIVE FROM THE PHARMACEUTICAL INDUSTRY
  • PERSPECTIVE FROM ACADEMIA
  • PATIENT PERSPECTIVE
  • PRINCIPLES AND THEMES
• 3. Defining a Discipline of Regulatory Science and Core Competencies for Its Workforce
  • DEFINING REGULATORY SCIENCE THROUGH THE LENS OF TRANSLATIONAL SCIENCE
  • DEFINING REGULATORY SCIENCE AS SCIENCE OF EVALUATION OF REGULATIONS
  • CASE STUDIES: REGULATORY SCIENCE IN PRACTICE
  • CORE COMPETENCIES OF REGULATORY SCIENCE
  • DEFINING REGULATORY SCIENCE
• 4. Education and Training of a Regulatory Science Workforce
  • AN OVERVIEW OF EXISTING TRAINING PROGRAMS
  • DEVELOPING EDUCATION AND TRAINING PROGRAMS IN REGULATORY SCIENCE
  • MODELS FOR EDUCATION AND TRAINING
  • FELLOWSHIPS AND EXCHANGE PROGRAMS
• 5. Career Paths Within Academia and Industry
  • CAREER PATHS IN ACADEMIA
  • CAREER PATHS IN INDUSTRY
• 6. International Applications of Regulatory Science
  • MAINTAINING A ROBUST GLOBAL THERAPEUTICS PIPELINE
  • THERAPEUTICS DEVELOPMENT FOR GLOBAL NEGLECTED DISEASES
• 7. Collaborative Models and New Paradigms for Supporting Regulatory Science Research and Practice
  • CREATING A COLLABORATIVE ENVIRONMENT IN AN ACADEMIC SETTING
  • A COLLABORATIVE MODEL FOR RESEARCH, TRAINING, AND BUSINESS DEVELOPMENT
  • REGULATORY SCIENCE: SOLVING FOR A LARGER CONTEXT
  • CLOSING PANEL
• References
• APPENDIXES
  • Appendix A Workshop Agenda
  • Appendix B Participant Biographies

Rapporteurs: Steve Olson, Anne B. Claiborne

This study was supported by contracts between the National Academy of Sciences and Department of Health and Human Services (Contract Nos. N01-OD-4-2139 TO #158 and HHSF223001003T), American Society for Microbiology, Amgen Inc., Association of American Medical Colleges, Bristol-Myers Squibb, Burroughs Wellcome Fund, Celtic Therapeutics, LLLP, Critical Path Institute, Doris Duke Charitable Foundation, Eli Lilly & Co., FasterCures, Foundation for the NIH, Friends of Cancer Research, GlaxoSmithKline, Johnson & Johnson, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, and Pfizer Inc.

Suggested citation:

IOM (Institute of Medicine). 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press.

Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.