Therapeutic for treatment of Thrombocytopenia arising from H-ARS   2

Background
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to use Project BioShield (PBS) to procure a U.S. Food and Drug Administration (FDA) approved thrombopoietin receptor agonist, for use as a Medical Countermeasure (MCM) that can treat thrombocytopenia arising as a pathology of acute exposure to ionizing radiation that may be a consequence of a radiological/nuclear mass casualty event. The procured therapeutic will be delivered to the ASPR/Strategic National Stockpile and maintained as vendor managed inventory. The USG seeks therapeutics that meet specific mandatory criteria.

Work Details
BARDA is seeking a medical countermeasure (MCM) to treat thrombocytopenia arising from the Hematopoietic subsyndrome of Acute Radiation Syndrome (H-ARS) to augment the United States Government (USG) response capabilities in response to a radiological/nuclear incident. The therapeutic will be delivered to the ASPR/Strategic National Stockpile and maintained as vendor managed inventory. The USG seeks therapeutics that meet specific mandatory criteria: 1) The approved label indication shall be to increase survival in adults and in pediatric patients acutely exposed to myelosuppressive doses of radiation H-ARS, 2) The approved label shall state the drug’s mechanism of action is through stimulation of thrombopoiesis and/or treatment of thrombocytopenia resulting in a statistically significant increase in platelet counts, and 3) The MCM is effective when administered at 24-hours or more post-radiation exposure.

Period of Performance
The contract will have an initial base period of 60-months with an option for up to 120-months.

Place of Performance
The contract will be performed at the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness & Response (ASPR), located at 200 C St. SW, Washington, District of Columbia 20024.