Research Catalog

Title

The public health emergency medical countermeasures enterprise : innovative strategies to enhance products from discovery through approval : workshop summary / Theresa Wizemann, Clare Stroud, and Bruce M. Altevogt, rapporteurs ; Forum on Medical and Public Health Preparedness for Catastrophic Events ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies.

Publication

Washington : National Academies Press, c2010.

Items in the Library & Off-site

Details

Additional Authors

• Altevogt, Bruce M.
• Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation.
• Institute of Medicine (U.S.). Forum on Medical and Public Health Preparedness for Catastrophic Events.
• National Academies Press (U.S.)
• Stroud, Clare.
• Wizemann, Theresa M.

Description

xiv, 179 p. : col. ill.; 23 cm.

Summary

"During public health emergencies such as pandemic influenza outbreaks or terrorist attacks, effective vaccines, drugs, diagnostics, and other medical countermeasures are essential to protecting national security and the public's well-being. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE--a partnership among federal, state, and local governments; industry; and academia) is at the forefront of the effort to develop and manufacture these countermeasures. However, despite the PHEMCE's many successes, there are still serious challenges to overcome. Government-funded medical research is not always focused on countermeasures for the most serious potential threats, and it is difficult to engage pharmaceutical and biotechnology companies to develop and manufacture medical countermeasures that have a limited commercial market. At the request of the Secretary of the U.S. Department of Health and Human Services and the Assistant Secretary for Preparedness and Response, the IOM held a workshop February 22-24, 2010, to address challenges facing the PHEMCE. Workshop participants discussed federal policies and procedures affecting the research, development, and approval of medical countermeasures and explored opportunities to improve the process and protect Americans' safety and health."

Subject

• Emergency Medical Services
• Emergency management > Planning > United States
• Emergency management
• Program Development
• Public Health
• Public health > United States
• United States

Genre/Form

• Congress.
• Congresses

Bibliography (note)

• Includes bibliographical references.

Additional Formats (note)

• Also available in print

Contents

About This Summary -- Charge to Workshop Participants -- The Public Health Perspective on Medical Countermeasure Development, Acquisition, and Use -- The FDA Perspective on the Countermeasures Enterprise: Moving Forward -- Government Procurement of Science -- Partners in a Single Mission, Diverse Concerns and Challenges -- The Growing Threat of Bioweapons -- Gaps and Barriers to International Collaboration -- Issues for Federal Agencies Engaged in Countermeasures Development -- Challenges Facing the Innovative Biopharmaceutical Industry -- Research Infrastructure and Resources -- Liability -- End Users: Challenges for Public Health and Providers -- Examples of Successful Countermeasures Development and Deployment -- Features of Successful Government Countermeasures Efforts -- Countermeasures Development in Industry -- Partnerships and Alternative Business Models -- Venture Philanthropy and Orphan Product Development Models -- Pharmaceutical Shared-Risk Approaches -- Planning for Failure -- Open Innovation Business Strategies -- Public-Private Partnerships -- Independent Third-Party Facilitation of Collaboration -- Strategic Investor Model -- Engaging Industry -- Incentives: Push vs. Pull -- Incentives not Needed?: Making a Strong Business Case -- New Paradigms, Strategies, and Tactics for Enhancing the Countermeasures Development Enterprise -- Outsourcing Program Management -- Government as a Strategic Partner -- Platform Technologies -- Revised PHEMCE Implementation Plan -- Existing Regulatory Tools and Approaches that can be Applied to Advance Countermeasures Development -- Opportunities for Accelerating Approval of Medical Countermeasures: Evolving the Regulatory Framework -- The Way Forward: Themes from the Workshop -- CONCLUSION -- APPENDIXES -- A. References -- B. Workshop Agenda -- C. Registered Workshop Attendees -- D. Case Studies of HHS Chemical, Biological, Radiological, and Nuclear Medical Countermeasure Development Programs, Executive Summary -- E. Synthesis of Business Models and Economic and Market Incentives for Vaccines and Therapeutics.

ISBN

• 0309150248
• 9780309150248

Owning Institutions

Columbia University Libraries