Advanced Therapeutics for Treating Neutropenia Resulting from Acute Exposure to Ionizing Radiation

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), provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDAs mission includes managing the advanced research and development of medical countermeasures (MCM) for chemical, biological, radiological, and nuclear agents (CBRN).



As part of its CBRN medical countermeasure development and preparedness mission, BARDA contemplates a five year Cost Reimbursement, multiple award contract for the advanced development and manufacturing of therapeutics on the path to licensure or market approval (i.e., BLA or NDA, respectively) for the indication of treating neutropenia arising from acute exposure to ionizing radiation, (Acute Radiation Syndrome, ARS). This solicitation supports ARS product development activities on the path to obtaining a New Drug Application (NDA) or a Biologic License Application (BLA).





NOTE: This solicitation does not acquire product for delivery to the Strategic National Stockpile.



This requirement was synopsized under HHS-BARDA-09-33 "Advanced Therapeutics for Treating Neutropenia Resulting from Acute Exposure to Ionizing Radiation" posted on January 16, 2009.