The Public Health Emergency Medical Countermeasures Enterprise Innovative Strategies to Enhance Products from Discovery Through Approval Workshop Summary 1st Edition by Institute Of Medicine, Theresa Wizemann, Clare Stroud, Bruce Altevogt, Forum on Medical and Public Health Preparedness for Catastrophic Events, Translation Forum on Drug Discovery, Development ISBN 978-0309150248 0309150248

The Public Health Emergency Medical Countermeasures Enterprise Innovative Strategies to Enhance Products from Discovery Through Approval Workshop Summary 1st Edition by Institute Of Medicine, Theresa Wizemann, Clare Stroud, Bruce M. Altevogt, Forum on Medical and Public Health Preparedness for Catastrophic Events, Translation Forum on Drug Discovery, Development – Ebook PDF Instant Download/Delivery: 978-0309150248, 0309150248
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Product details: 

ISBN 10:  0309150248

ISBN 13: 978-0309150248

Author: Institute Of Medicine, Theresa Wizemann, Clare Stroud, Bruce M. Altevogt, Forum on Medical and Public Health Preparedness for Catastrophic Events, Translation Forum on Drug Discovery, Development

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.

Table of contents: 

1. INTRODUCTION
   About This Summary
   Charge to Workshop Participants
2. BACKGROUND
   The Public Health Perspective on Medical Countermeasure Development, Acquisition, and Use
   The FDA Perspective on the Countermeasures Enterprise: Moving Forward
   Government Procurement of Science
3. 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
4. EXAMPLES OF SUCCESSFUL COUNTERMEASURES DEVELOPMENT AND DEPLOYMENT
   Features of Successful Government Countermeasures Efforts
   Countermeasures Development in Industry
5. 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
6. ENGAGING INDUSTRY
   Incentives: Push vs. Pull
   Incentives Not Needed?: Making a Strong Business Case
7. 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
8. 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
9. CONCLUSION
10. APPENDIXES
    References
    Workshop Agenda
    Registered Workshop Attendees
    Case Studies of HHS Chemical, Biological, Radiological, and Nuclear Medical Countermeasure Development Programs, Executive Summary
    Synthesis of Business Models and Economic and Market Incentives for Vaccines and Therapeutics

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