Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, was established to aid in securing our nation from chemical, biological, radiological, and nuclear (CBRN) threats, as well as from pandemic influenza (PI) and emerging infectious diseases (EID). BARDA supports the transition of medical countermeasures such as vaccines, drugs, and diagnostics from research through advanced development towards consideration for approval by the FDA and inclusion into the Strategic National Stockpile.

BARDA’s support includes funding, technical assistance and core services, ranging from a clinical research organization network to Centers for Innovation in Advanced Development and Manufacturing, and a fill-finish manufacturing network. To-date, BARDA has supported 42 FDA approvals for products addressing CBRN, PI, and EID threats.

The BARDA Strategic Plan 2011-2016 emphasizes five goals BARDA will use to accomplish its mission:

• Goal 1:  An advanced development pipeline replete with medical countermeasures and platforms to address unmet public health needs, emphasizing innovation, flexibility, multi-purpose 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
• Goal 5: A ready capability to develop, manufacture and facilitate distribution of medical countermeasures during public health emergencies