Since the 2014 Ebola outbreak many public- and private-sector leaders have seen a need for improved management of global public health emergencies. The effects of the Ebola epidemic go well beyond the three hardest-hit countries and beyond the health sector. Education, child protection, commerce, transportation, and human rights have all suffered. The consequences and lethality of Ebola have increased interest in coordinated global response to infectious threats, many of which could disrupt global health and commerce far more than the recent outbreak.

In order to explore the potential for improving international management and response to outbreaks the National Academy of Medicine agreed to manage an international, independent, evidence-based, authoritative, multistakeholder expert commission. As part of this effort, the Institute of Medicine convened four workshops in summer of 2015 to inform the commission report. The presentations and discussions from the Workshop on Research and Development of Medical Products are summarized in this report.

Contents

• The National Academies of SCIENCES • ENGINEERING • MEDICINE
• PLANNING COMMITTEE ON GLOBAL HEALTH RISK FRAMEWORK: A WORKSHOP ON RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS
• BOARD ON HEALTH SCIENCES POLICY
• Reviewers
• Acknowledgments
• Acronyms and Abbreviations
• 1. Introduction
  • THE GLOBAL HEALTH RISK FRAMEWORK INITIATIVE
  • THE WORKSHOP ON RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS
  • WHO PERSPECTIVE ON THE GLOBAL HEALTH RISK FRAMEWORK
• 2. Models and Incentives for Engagement
  • PUBLIC–PRIVATE PARTNERSHIPS AS THE ESSENTIAL OPERATING MODEL
  • CREATING A BLEND OF INCENTIVES FOR ENGAGEMENT OF PARTNERS
  • ELEMENTS OF SUCCESS
  • CHALLENGES
• 3. Discovery Research
  • ADVANCING THE SCIENCE OF DISCOVERY
  • INTELLECTUAL PROPERTY AND SHARING OF DATA AND REAGENTS
  • LIABILITY
• 4. Development
  • ETHICAL PRINCIPLES AND METHODOLOGICAL FRAMEWORK FOR CLINICAL TRIAL DESIGNS
  • METHODOLOGICAL DESIGN CONSIDERATIONS
  • ETHICAL REVIEW
  • REGULATORY PERSPECTIVE
  • PRACTICAL CONSIDERATIONS AND COMMUNITY ENGAGEMENT
• 5. Convergence of Regulatory Expectations, Review, and Approval
  • COORDINATION, HARMONIZATION, AND CONVERGENCE
• 6. Manufacturing, Stockpiling, and Distribution
  • POLICY PERSPECTIVE
  • MANUFACTURING CAPACITY
  • STOCKPILING LOGISTICS
  • SUPPLY CHAIN AND DISTRIBUTION
  • FORECASTING DEMAND
• 7. Critical Considerations for Facilitating Medical Product Research and Development
  • DEFINING THE PRIORITIES FOR RESEARCH AND DEVELOPMENT
  • INCENTIVES
  • DISCOVERY
  • DEVELOPMENT
  • REGULATIONS
  • MANUFACTURING
  • DISTRIBUTION
• 8. Crosscutting Themes and Closing Remarks
  • CLOSING REMARKS
• APPENDIXES
  • A. References
  • B. Workshop Statement of Task
  • C. Workshop Agenda
  • D. Workshop Speaker Biographies

Rapporteurs: Theresa Wizemann, Michelle A. Mancher, and Anne B. Claiborne.

Suggested citation:

National Academies of Sciences, Engineering, and Medicine. 2016. Global health risk framework: Research and development of medical products: Workshop summary. Washington, DC: The National Academies Press. doi: 10.17226/21853.