The Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan 2011-2016 is a national cross-sectoral strategic plan of the United States of America. BARDA’S overarching vision is of a nation with the capability to respond quickly and effectively to deliberate, natural, and emerging threats so as to minimize their impact and recover promptly. A critical enabling factor for the realization of this vision is the existence of a robust domestic pharmaceutical and biotechnology sector that actively collaborates with the U.S. Government to address unmet medical countermeasure and public health requirements. BARDA’s mission is to develop and procure needed medical countermeasures, including vaccines, therapeutics, diagnostics, and non-pharmaceutical countermeasures, against a broad array of public health threats, whether natural or intentional in origin. BARDA was created to address gaps in the U.S. Government medical countermeasure development and procurement process and to bridge the “valley of death” that separates candidates identified in early research from potential Food and Drug Administration (FDA) licensure/approval by providing funding, technical support and services necessary to advance candidate products through the developmental pipeline. In order to increase the resilience of livelihoods to disasters, the strategic plan provides for five main goals – Goal 1: An advanced development pipeline replete with medical countermeasures and platforms to address unmet public health needs, emphasizing innovation, flexibility, multipurpose and broad spectrum application, and long-term sustainability; Goal 2: A capability base to provide enabling core services to medical countermeasure innovators; Goal 3: Agile, robust and sustainable U.S. manufacturing infrastructure capable of rapidly producing vaccines and other biologics against pandemic influenza and other emerging threats; Goal 4: Responsive and nimble programs and capabilities to address novel and emerging threats; and Goal 5: A ready capability to develop, manufacture and facilitate distribution of medical countermeasures during public health emergencies. The strategic plan further provides to refine BARDA planning and readiness capabilities by drawing on the many lessons learned during the pandemic; in concert with the Assistant Secretary for Preparedness and Response (ASPR) Office of Preparedness and Emergency Operations and in close coordination with the Centers for Disease Control and Prevention (CDC), FDA, and other U.S. Government departments and agencies, develop comprehensive plans that will facilitate the response to future pandemics, chemical, biological, radiological, and nuclear (CBRN) events, and emerging epidemics by establishing mechanisms for interfacing with medical countermeasure manufacturers and distributors during a public health emergency; establishing mechanisms for positioning BARDA medical countermeasure production subject matter experts in manufacturing plants as needed; providing a framework for developing and validating emergency funding requests; facilitating the prompt evaluation of investigational products for emergency use authorization as warranted; and exercise these readiness capabilities plans to ensure that they are fully consistent with existing ASPR and Health and Human Services (HHS) response plans as well as the overarching National Response Framework. Among others, the strategic plan concerns antimicrobial resistance and provides for establishing a program to support the development of platforms and countermeasures to address the threats of emerging infectious diseases and antimicrobial resistance; expanding BARDA’s Broad Spectrum Antimicrobials and Innovations programs to develop a robust portfolio of countermeasures to address an array of known and unknown threats; expanding BARDA’s Broad Spectrum Antimicrobials and Innovations programs; and combatting the growing problem of antimicrobial resistance through development of new antimicrobials and innovative therapeutics by pursuing new classes of drugs and innovative antimicrobial therapies that will be less susceptible to drug resistance. 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.
United States of America · 2011-10-04