Public Health Emergency - Leading a Nation Prepared
WITHIN THE LAST TEN YEARS, THE UNITED STATES HAS experienced an intentional attack with a biological agent in the form of the anthrax letters as well as naturally emerging outbreaks of high-consequence infectious diseases, including pandemic influenza and SARS. These events represented national security threats and public health emergencies. The past decade has also witnessed the dramatic spread of antimicrobial resistance and community outbreaks of multidrug-resistant bacteria that had previously been confined to hospitals. Concerns persist about the potential use of chemical, biological, radiological and nuclear agents by terrorists. Effective medical countermeasures such as vaccines, antimicrobials, therapeutics, and diagnostics have the potential to reduce the impact of such threats and are a bulwark of our national defense and public health emergency preparedness.
The mission of the Biomedical Advanced Research and Development Authority (BARDA) is to develop and procure medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.
Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other products that are considered priorities for national health security. BARDA funding bridges the "valley of death" characterizing the late stages of product development. BARDA's support ensures continuity of funding at a critical point for medical countermeasures developed by industry or emerging from the basic research and preclinical development activities sponsored by the National Institutes of Health (NIH). In procuring medical countermeasures for the Strategic National Stockpile, BARDA enhances the capabilities of the Centers for Disease Control and Prevention (CDC) to organize an effective response.
BARDA is a core component of the Office of the Assistant Secretary for Preparedness and Response (ASPR) and as such contributes to the broader ASPR mission to "Lead the country in preparing for, responding to, and recovering from the adverse health effects of emergencies and disasters by supporting our communities' ability to withstand adversity, strengthening our health and response systems, and enhancing national health security."1
The first BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement (Draft) was published in July 2007. The specific goals of the 2007 Plan included aligning and coordinating BARDA goals and programs with key pandemic influenza and CBRN strategy documents; developing an HHS Public Health Emergency Medical Countermeasure Enterprise CBRN implementation plan; and establishing programs that promote innovation in MCM development.
The 2011 BARDA Strategic Plan builds on BARDA's successes in achieving those goals, defines BARDA's vision, and lays out a series of capability goals over the next five years (2011-2016). This Plan reflects the dynamic evolution of BARDA's mission and responsibilities, since its establishment in early 2007 and is informed by the National Health Security Strategy (NHSS; December 2009)2, The Public Health Emergency Medical Countermeasures Enterprise Review: Transforming the Enterprise to Meet Long-Range National Needs (PHEMCE Review; August 2010)3, and the many lessons learned from the 2009 H1N1 pandemic influenza response.
The Biomedical Advanced Research and Development Authority is the component of the Public Health Emergency Medical Countermeasures Enterprise that focuses on the advanced development, manufacturing and acquisition of medical countermeasures against chemical, biological, radiological and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases. BARDA's staff includes experts in the fields of physical, chemical and biological sciences, engineering, clinical medicine, public health, product development, regulatory affairs, and program management. The Pandemic and All-Hazards Preparedness Act (PAHPA) established BARDA in December 2006. BARDA oversees the Project BioShield program and Special Reserve Fund and is charged by statute with (1) promoting collaboration and communication between the U.S. Government and interested parties in the advanced development and licensure of needed medical countermeasures; (2) directing and coordinating the countermeasure and product advanced research and development activities of the U.S. Department of Health and Human Services (HHS); (3) facilitating medical countermeasure development by providing advice or directing interested parties to the relevant Centers of the U.S. Food and Drug Administration (FDA); and (4) supporting innovation through strategic initiatives and investment in technologies and research tools that facilitate countermeasure development.
PAHPA established a dual mandate for BARDA. BARDA is charged with coordinating the development of, and bridging the "valley of death" for, MCMs determined to be critical to the Nation's health security. It is important to note that many such MCMs lack meaningful commercial markets and without U.S. Government support would be unlikely candidates for development. In supporting their development, BARDA fills the gap between NIH, which supports basic and preclinical research, and CDC, which develops utilization plans and deploys MCMs during public health emergencies. BARDA fulfills its mission by supporting advanced research and development of needed medical countermeasures; working in collaboration with manufacturers, the NIH, the CDC, the FDA, and the Departments of Defense (DoD) and Homeland Security (DHS); supporting technology innovation through strategic initiatives; and overseeing Project BioShield acquisitions.
BARDA is comprised currently of the Office of the Director and seven functional divisions that oversee BARDA's programmatic activities. These divisions include
Additionally, to address issues relating to countermeasure development that cut across divisional boundaries, BARDA operates collaboratively in "matrix teams" in the areas of vaccines, biological therapeutics, small molecule therapeutics, and diagnostics. These matrix teams help knit the BARDA organization together and facilitate sharing of information and best practices.
BARDA is committed to improving its workforce, increasing the expertise and skills of BARDA personnel, and helping to prepare the pharmaceutical industry to meet the challenges of the 21st Century. The investment BARDA makes now in developing needed infrastructure, capabilities, processes, and human resources will pay off in the long run by enhancing national preparedness to meet the public health threats of the future. Continually looking forward, scanning the horizon for new technologies, and striving to develop a fast, flexible and efficient armamentarium of medical countermeasure capabilities and products will be key contributing factors to BARDA's success in addressing medical countermeasure requirements for the nation. BARDA will address these current and evolving requirements, aggressively seek out and support promising technology and platforms, and facilitate collaboration across HHS and other Federal Departments and agencies participating in medical countermeasure research and development while striving continually for greater overall transparency.
The BARDA strategic plan is guided by the priorities of the Administration and of ASPR and BARDA leadership, and by other guidance including the U.S. Department of Health and Human Services Strategic Plan, governing legislation, Presidential Policy Directives, the 2009 NHSS, the 2010 PHEMCE Review, and the 2011 HHS Assistant Secretary for Preparedness and Response Strategic Plan 2011-2015 (ASPR Strategic Plan). The NHSS establishes a framework for national efforts, to promote health security and encompasses BARDA's mission. National health security is a state in which the nation and its people are prepared for, protected from and resilient in the face of health threats or incidents with potentially negative health consequences. All elements of this strategic plan align with and support the BARDA role in contributing to national health security under the NHSS and, as specified in PAHPA, the BARDA Strategic Plan is considered to be incorporated as part of the NHSS.
This strategic plan sets the direction for BARDA over the next five years. Five strategic goals define the highest level aims of BARDA, each one is supported by strategies for accomplishing that goal. These goals are interrelated and derive from the mission outlined in the PHEMCE Review that "Our nation must have the nimble, flexible capacity to produce medical countermeasures rapidly in the face of any attack or threat, known or unknown, including a novel, previously unrecognized, naturally occurring emerging infectious disease."
A number of themes cut across one or more of the strategic goals. Cultivating public-private partnerships, for example, is a critical element in almost every aspect of BARDA's work. Developing tools and processes to facilitate systematic portfolio management and program and project evaluation is an important priority for BARDA, given BARDA's broad mandate and foreseeable budgetary constraints. In pursuing its mandate to develop medical countermeasures to protect civilian populations, BARDA must also address the needs of vulnerable populations such as children, pregnant women, persons with compromised immune systems, and the elderly. These and other cross-cutting issues have been considered as each one of the five strategic goals was developed and are reflected in the guiding principles.
BARDA will implement this strategic plan with full involvement of its leadership and a firm commitment to turning strategy into action, tracking progress, and correcting course when needed. The strategic plan maps out a broad five-year strategic direction. More detailed actions for accomplishing the goals and strategies as well performance measures and milestones will be developed and annually reviewed by BARDA staff and leadership. All BARDA employees are critical to the organization's success, and should see themselves and their work directly in one or more of the goals and strategies. BARDA divisions and program teams may develop even more granular action plans, and budgets will be formulated and executed in line with strategic priorities.
Like the HHS and ASPR strategic plans, the BARDA strategic plan will be published online and updated periodically to reflect evolving activities and progress toward goals. BARDA's partners and the public will be able to see the latest information on priorities and accomplishments, reinforcing the plan's purpose as an evolving, living tool for guiding decision making and action.
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