Public Health Emergency - Leading a Nation Prepared
BARDA will pursue its strategic goals through an approach comprised of the following core principles.
The PHEMCE Review highlighted the critical role of public-private partnerships in addressing the challenges that arise throughout the product development process and in rapidly adapting to new technologies and changing needs. BARDA's commitment to public-private partnerships is deep-rooted and extends across its entire portfolio.
Where vaccine and biological therapeutics manufacturing capacity is concerned, BARDA will continue to enter into public-private partnerships with manufacturers to build and/or retrofit medical countermeasure production facilities within the U.S., increasing domestic access to medical countermeasures. Internationally, BARDA will maintain its financial and technical support of the WHO Global Action Plan, working in concert with the Developing Countries Vaccine Manufacturers Network and other partners to expand influenza vaccine manufacturing capacity in developing countries.
BARDA will establish its Centers of Innovation for Advanced Development and Manufacturing as partnerships in which the U.S. Government and private sector partners share facility construction costs, collaboratively facilitate medical countermeasure product development, and jointly ensure domestic vaccine manufacturing surge capacity. These Centers will provide advanced development and manufacturing capabilities for medical countermeasures to address both national security and public health needs on a cost-effective, reliable, and sustainable basis. In order to minimize delays in the availability of critical medical countermeasures during public health emergencies, BARDA will establish a network of providers to formulate, fill, and finish bulk vaccine product provided by primary manufacturers in the event that the primary manufacturers lack sufficient surge capacity of their own.
BARDA is supporting the development of novel platform technologies that provide flexible systems for the production of medical countermeasures against a variety of threats. BARDA will also leverage established programs to maximize the value of current investments in technological innovations. Strategic support for platform technologies will greatly enhance the value provided by BARDA investments and position the U.S. Government to respond more effectively to the unknown threats of the future.
As an illustration, adjuvants, which can be used to increase the supply of pandemic influenza vaccine, may have the potential to enhance the efficacy of vaccines against biological threats or emerging diseases and may be essential components of next-generation recombinant protein influenza vaccines. By supporting the development and use of adjuvant "platforms" to enhance the efficacy of currently licensed vaccines, BARDA is also supporting the establishment of a regulatory pathway for other vaccines that exploit adjuvant technology – a critical step in speeding the availability of new vaccines against a broad array of threats.
BARDA is committed, where feasible, to developing products that demonstrate efficacy against a wide range of specified threats and will seek out products with such potential through its Strategic Science and Technology program. Investing in multi-use products such as broad-spectrum therapeutics and diagnostic platforms that can find durable and well-defined commercial markets and leverage market forces will greatly facilitate the development of medical countermeasures for use in public health emergencies and enhance long-term sustainability for the PHEMCE.
BARDA's Broad Spectrum Antimicrobial Program was established in January 2010 and is focused on developing novel antibacterial and antiviral drugs for the treatment or prevention of disease caused by currently defined and future biological threats. Recognizing the immediate value of new antimicrobials in addressing the increasingly prevalent public health threat of antibiotic resistance, as well as the likelihood that antimicrobial resistance will complicate primary treatment of a wide array of threats, BARDA is supporting the development of public-private partnerships for the development of novel antimicrobials. Through these partnerships, BARDA will support the development of candidate antimicrobials for their commercial, clinically prevalent infectious disease indications, as long as our private sector partners concomitantly support the development of these products for biodefense threat agent indications. By adopting this approach, BARDA will support the development of new classes of antimicrobials, increase the number of antimicrobial drugs in the developmental pipeline, address the important and immediate threat of antimicrobial resistance, and prepare the nation for the predictable threat of biological terrorism and the unpredictable threat of emerging infectious diseases.
Many other BARDA projects demonstrate the variety of ways in which "dual utility" and multi-use value can be achieved. For example, next-generation, low-cost, easy-to-use ventilators and improved respiratory protective devices all have applications against a wide array of threats. BARDA will continue to seek out multipurpose products and support their development in order to enhance our Nation's ability to respond effectively to the broad array of threats we face.
The PHEMCE Review requested by the Secretary of HHS included recommendations to adopt a new, more intensive approach ("case management") to program and project management. Under case management, BARDA leads the effort to ensure that intra-and inter-agency stakeholders are kept abreast of product development progress and issues in the identified programs. BARDA is adopting a rigorous approach to project, program, and portfolio management that will establish cost and schedule metrics for each phase of product development, and allow the identification of best practices and earlier interventions in troubled programs. In Process Review of program contracts occur on a regular basis by a team of experts from HHS and PHEMCE partners who provide critical input on key decisions in program development and guidance on issues that may arise during product development.
When challenges with product development arise, BARDA employs a case management approach of intensive support and guidance to private sector partners, which also entails appropriate input and expertise from relevant federal agencies (BARDA, CDC, DoD, FDA, and NIH). Case management of BARDA programs is essential to the proper stewardship of the funding provided for these endeavors and will ensure that all U.S. Government stakeholders are aware of products being developed and the long-term budgetary impact those products may have on other agencies through the course of their life cycle.
BARDA has adopted a matrix-like organizational structure that makes the specialized capabilities of its different components available to project managers throughout the organization. This matrix-like organizational structure will maximize efficiency and collaboration across BARDA, promote a culture of continual process improvement, and facilitate the ultimate application of case management to all supported programs.
In addition to the management of specific programs under the effort highlighted above, BARDA, in collaboration with its HHS and DoD partners, has adopted an integrated approach to co-managing the nation's aggregate portfolio of medical countermeasure development programs for CBRN threats. The overall goal is to optimize the use of resources to address the broad range of common threats and requirements with greater efficiency and effectiveness. Although DoD and HHS each have certain unique requirements due to their different missions and focus, there are many areas of convergent requirements for products or capabilities where resources and information will be appropriately shared to optimize investments and preclude unnecessary redundancies. This integrated approach will ensure balance and completeness across all agencies funding the research, development, and procurement of medical countermeasures for CBRN threats.
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