Excerpt

At the request of the U.S. Food and Drug Administration (FDA), the Institute of Medicine’s (IOM’s) Forum on Drug Discovery, Development, and Translation and the IOM’s Forum on Medical and Public Health Preparedness for Catastrophic Events jointly convened a workshop on March 29–30, 2011. The workshop, titled Advancing Regulatory Science for Medical Countermeasure Development, was designed to (1) examine ways to advance regulatory science for medical countermeasure (MCM) development and regulatory evaluation; (2) identify scientific opportunities to improve, simplify, or speed MCM development; and (3) identify tools and methods to improve the predictability and success rate of candidate MCMs.

Contents

• The National Academies
• Planning Committee for the Workshop on Advancing Regulatory Science for Medical Countermeasure Development
• Forum on Drug Discovery, Development, and Translation
• Forum on Medical and Public Health Preparedness for Catastrophic Events
• Reviewers
• Acronyms
• 1. Introduction
  • DEFINING REGULATORY SCIENCE
  • CHARGE TO THE WORKSHOP PARTICIPANTS
  • IMPLEMENTING THE 2010 PHEMCE REVIEW
  • OVERVIEW OF THE FDA MCM INITIATIVE
  • SUMMARY OF KEY WORKSHOP THEMES
• 2. MCM Enterprise and Stakeholder Perspectives
  • FDA REGULATORY SCIENCE RESEARCH NEEDS
  • ENTERPRISE PARTNER AND STAKEHOLDER PERSPECTIVES
• 3. Cutting-Edge Efforts to Advance MCM Regulatory Science
  • NONCLINICAL APPROACHES TO ASSESSING EFFICACY
  • SAFETY AND REAL-TIME MONITORING
  • ANTIMICROBIALS
  • VACCINES AND ADJUVANTS
  • SYNTHETIC AND COMPUTATIONAL BIOLOGY AND PLATFORM TECHNOLOGIES
  • DIAGNOSTICS
  • STATISTICAL TECHNIQUES
• 4. MCM Regulatory Science Needs for At-Risk Populations
  • CHILDREN
  • PREGNANT WOMEN
• 5. Crosscutting Themes and Future Directions
  • ADVANCING REGULATORY SCIENCE
  • BENEFIT AND RISK
  • PLATFORMS, PROCESSES, AND TOOLS
  • COLLABORATION, PARTNERSHIPS, AND DATA SHARING
  • FDA RESOURCES AND INFRASTRUCTURE ISSUES AFFECTING REGULATORY SCIENCE
  • A FRAMEWORK FOR DEFINING REGULATORY SCIENCE NEEDS
• 6. Closing Remarks
• References
• Appendixes
  • A Workshop Agenda
  • B Participant Biographies

Rapporteurs: Theresa Wizemann, Bruce M. Altevogt, and Anne B. Claiborne

This project 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, HHSF223001003T, HHSF22301022T TO #24, N01-OD-4-2139 TO #198, HHSP233200900680P, HH5P23320042509X1, and HHSP233200800498P), the American Diabetes Association, the American Society for Microbiology, Amgen Inc., the Association of American Medical Colleges, Bristol-Myers Squibb, the Burroughs Wellcome Fund, Celtic Therapeutics, LLLP, the Critical Path Institute, the Doris Duke Charitable Foundation, Eli Lilly & Co., Faster-Cures, the Foundation for the NIH, Friends of Cancer Research, GlaxoSmithKline, Howard Hughes Medical Institute, Johnson & Johnson, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Pfizer, Inc, the American College of Emergency Physicians, the American Hospital Association, the American Medical Association, the American Nurses Association, the Association of State and Territorial Health Officials, the Centers for Disease Control and Prevention (Contract No. 200-2005-13434 TO #6), the Department of the Army (Contract No. W81XWH-08-P-0934), the Department of Homeland Security’s Office of Health Affairs (Contract No. HSHQDC-07-C-00097), the Department of Homeland Security, Federal Emergency Management Agency (Contract No. HSFEHQ-08-P-1800), the Department of Transportation’s National Highway Traffic Safety Administration (DTNH22-10-H-00287) the Department of Veterans Affairs (Contract No. V101(93)P-2136 TO #10), the Emergency Nurses Association, the National Association of Chain Drug Stores, the National Association of County and City Health Officials, the National Association of Emergency Medical Technicians, the Pharmaceutical Research and Manufacturers of America, The Robert Wood Johnson Foundation, and the United Health Foundation.

Suggested citation:

IOM (Institute of Medicine). 2011. Advancing Regulatory Science for Medical Countermeasure 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.