The Biomedical Advanced Research and Development Authority Special Projects

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The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), supports advanced development and availability of medical countermeasures (MCMs) for chemical, biological, radiological and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases through advanced product development, stockpile acquisition, building manufacturing infrastructure, and product innovation. BARDA establishes and maintains business collaborations by means of grants, cooperative agreements, contracts, and other transactions with the public and private sectors, domestically and internationally. BARDA has grown significantly since inception, acquiring new capabilities and employing new business approaches leading to unprecedented success in the development and acquisition of MCMs. Twenty-one products supported by BARDA have received FDA approval, licensure or clearance against the threats within BARDA’s purview and twelve products have been procured under Project BioShield for the Strategic National Stockpile. BARDA has also played a key role in responding to newly emerging threats, including most prominently the 2009-H1N1 influenza pandemic as well as the ongoing Ebola epidemic in West Africa. The National Strategy for Combating Antibiotic Resistant Bacteria (2014) identifies BARDA as having a key role in the nation’s response to the more slowly, but inexorably emerging threat of antimicrobial resistance (AMR). By their unpredictability and potentially explosive nature, emerging threats present unique challenges, particularly with respect to the development of MCMs, which normally takes years, requires substantial investment, and is associated with high rates of attrition. Many of the challenges are technical; some are economic. The problem of AMR presents special hurdles in that the discovery of novel drug targets unique to the resistant pathogens has proved increasingly difficult. Having a mechanism in place to engage external subject matter experts and develop far-reaching, but focused, technical reports that provide recommendations on how to address such challenges would facilitate progress in the development of MCMs against these national health security threats.

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