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

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"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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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autores Corporativos: 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
Otros Autores: Wizemann, Theresa M., Stroud, Clare, Altevogt, Bruce M.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington : National Academies Press, ©2010.
Colección:The national academies
Temas:
Emergency management > United States > Congresses.
Public health > United States > Congresses.
Emergency management > Congresses.
Emergency medical services.
Medical emergencies.
Public health.
Disaster Medicine
Emergency Medical Services
Program Development
Emergencies
Public Health
Santé publique > États-Unis > Congrès.
Services des urgences médicales.
Urgences médicales.
Santé publique.
emergency medical centers.
public health.
POLITICAL SCIENCE > Government > State & Provincial.
Medical emergencies
Emergency medical services
Emergency management
Public health
United States
Electronic books.
Congress
proceedings (reports)
Conference papers and proceedings
Conference papers and proceedings.
Actes de congrès.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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.

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