The public health emergency medical countermeasures enterprise (PHEMCE) provides an essential interagency coordinating and integrating framework to enable the provision of needed medical products – such as vaccines, therapeutics, diagnostics, and non-pharmaceutical countermeasures - to protect or treat the U.S. population in public health emergencies arising from naturally occurring events, such as pandemic influenza or emerging infectious diseases, as well as chemical, biological, radiological, and nuclear threats. This requires a host of complex and interdependent efforts, including early detection of emerging diseases, developing and stockpiling medical products for potential threats, distributing and administering countermeasures to an affected population, and evaluating the effectiveness of the countermeasures. The ultimate national goal is a flexible and modern countermeasures enterprise that quickly delivers safe and effective products to the population in need.
The ASPR role includes a policy coordinating responsibility for the medical countermeasures enterprise, including development of national policy and requirements; an operational responsibility for the advanced development and acquisition of products that address civilian requirements; and an operations coordinating responsibility to assure that medical countermeasures can be effectively provided and administered when needed. ASPR’s activities depend upon and are conducted in close partnership with other HHS agencies and offices, Federal departments, State and local governments, national public health partners, health care providers, and private industry. ASPR’s Biomedical Advanced Research and Development Authority (BARDA) oversees and manages the development and acquisition of medical countermeasures, working with our industry partners to facilitate the transition of promising medical countermeasure candidates from early research through advanced development to potential licensure.
Strategies
- Review and revise medical countermeasure requirements in light of full life cycle costs and budgetary constraints
- Promote development and acquisition of medical countermeasures with an emphasis on innovation, flexibility, and broad spectrum application by
- Providing core advanced development and manufacturing services to medical countermeasure innovators
- Promoting the establishment of a medical countermeasures Strategic Investor that will pursue the strategic objectives of the PHEMCE while acting as, and providing all the services and benefits of, a venture capital firm
- Establishing a program to support the development of platforms and countermeasures to address the threats of emerging infectious diseases and antimicrobial resistance
- Enhancing investments in host-directed therapeutics, such as immunomodulators, anti-inflammatories, and other countermeasures that aren’t pathogen-specific
- Improving processes governing the solicitation, review, and award of medical countermeasure contracts
- Improve management and administration of the PHEMCE by
- Examining investment priorities and completing annual portfolio reviews, including making course corrections where necessary
- Supporting the development of pandemic influenza vaccines, other medical countermeasures, and vaccine manufacturing infrastructure and addressing gaps identified in the PCAST Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza
- Developing a five-year budget for policy and requirements development and response, and for medical countermeasure development, acquisition, and stockpiling or other methods of provision, with flexibility for emergency needs
- Instituting improvements in the functions, structure, and scope of working groups and Integrated Program Teams
- Implementing end-to-end project management teams to coordinate development activities
- Support partners in their activities to improve regulatory science, translational research, concepts of operation, and dispensing medical countermeasures by
- Contributing to the development and implementation of a regulatory science agenda as it applies to the advanced development of medical countermeasures
- Promoting the development of a precompetitive collaboration space within the PHEMCE to address cross-cutting problems of medical countermeasure development, including regulatory science
- Assuring coordination between the development of products and the policies for rapid distribution and use of medical countermeasures
- Integrating ASPR responsibilities and planning for medical countermeasure development, manufacturing and acquisition during a response with other response elements while addressing the capabilities and needs of end-users
- Completing the development and acquisition of products designed to provide maximal flexibility and responsiveness at the federal, state and local and community levels
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