The public health emergency medical countermeasures enterprise : innovative strategies to enhance products from discovery through approval : workshop 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 Countermeasu...

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Bibliographic Details
Corporate Authors:	Institute of Medicine (U.S.). Forum on Medical and Public Health Preparedness for Catastrophic Events, Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation, National Academies Press (U.S.)
Other Authors:	Wizemann, Theresa M., Stroud, Clare, Altevogt, Bruce M.
Format:	Book
Language:	English
Published:	Washington : National Academies Press, [2010]
Subjects:	Emergency management > Planning > United States. Public health > United States. Emergency management. Congresses. Emergency Medical Services. Public Health. Program Development. United States.

Table of Contents:

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
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,a nd 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.