Development of Oral Radionuclide Decorporation Agents for Use in Radionuclide Decorporation in Radiological Emergencies

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of Allergy, Immunology and Transplantation has a requirement for novel decorporation agents to remove a range of radionuclides from the body, and for the development of formulations that are stable and easier to dispense and use in a mass casualty, radiological emergency and supporting research and development efforts to make them available for acquisition through the Biomedical Advanced Research and Development Authority (BARDA). The purpose of this BAA, entitled "Development of a Radionuclide Decorporation Agent for Use in Radiological Emergencies", is to solicit proposals to further advance the development of novel medical countermeasures for the treatment of large affected populations who are acutely exposed to radionuclide contamination as a result of a nuclear detonation, radiological dispersive device (RDD; such as a "dirty bomb"), or other radiological mechanisms, including deliberate contamination. This BAA provides development funding opportunities with the hope that some decorporating agents may progress sufficiently to allow BARDA the opportunity to acquire such products as medical countermeasures once approved by the Food and Drug Administration (FDA) to treat specific medical conditions resulting from internal contamination with radionuclides. It is therefore anticipated that research and development studies awarded from this BAA will advance therapeutic products toward eventual approval from the FDA for treatment of internal radionuclide contamination. Offerors are invited to submit proposals that request funding to advance the development of lead candidate products that directly address the elimination of a range of radionuclides and physicochemical forms of radionuclides that are relevant to accidental or nonaccidental radioactive contamination and exposure. The goals are to advance the development of novel decorporation agents, conduct translational research and development, and provide additional information and data toward FDA licensure. Because of the needs resulting from a mass casualty situation, the lead candidates that will be supported must be suitable for a mass casualty situation (e.g., orally available) and be able to decorporate radionuclides of interest, such as, but not limited to (listed by increasing atomic number, not priority), Co, Sr, Cs, Ce, Ir, Po, U, Pu, Am, and Cm in physicochemical forms that would be encountered in an actual exposure, and administered by inhalation, ingestion, or transdermal absorption through wounds. It is anticipated that organizations selected under this BAA will have identified a promising product and already have preliminary data on a lead candidate that will decorporate one or more of the radionuclides of interest (e.g., Co, Sr, Cs, Ce, Ir, Po, U, Pu, Am, and Cm) and that is suitable for a mass casualty situation. Offerors shall propose a Product Profile and a Product Development Work Plan that will incorporate non-clinical research and development including IND or NDA enabling studies as well as manufacturing of the proposed decorporation agent. Pursuant to the need for manufacturing of the product, the Offeror is expected to be capable of manufacturing the product under cGMP conditions or work with a partner that can manufacture the product under cGMP conditions. The Offeror must have a facility or arranged to have access to a facility that is licensed by Federal, State and/or local agencies for in vivo radionuclide experiments. It is anticipated that two cost reimbursement, completion type contracts will be awarded for a three-year period of performance beginning on or about 6/30/10 utilizing special contracting methods, FAR Subpart 17.1-Multi-year Contracting. It is estimated that the provision of FTEs will be approximately 3.0 FTEs/year. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about 9/08/09, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.