Development of Oral Form of Diethylenetriaminepentaacetate (DTPA) for Use in Radionuclide Decorporation - Radiological Emergency

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 improved forms of Diethylenetriaminepentaacetate (DTPA), in particular orally available formulations, 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 Broad Agency Announcement, entitled "Development of an Oral Form of Diethylenetriaminepentaacetate (DTPA) for Use in Radionuclide Decorporation in Radiological Emergencies", is to solicit proposals for research and development programs that focus on the further development of improved forms of DTPA. Specifically, NIH seeks to acquire developed medical countermeasures that will be clinically useful in a civilian medical emergency situation that results from or involves exposure of a large population to the effects of a nuclear detonation, RDD (such as a "dirty bomb"), or exposure to radioactive material. It is anticipated that research and development studies awarded from this BAA will advance therapeutic products toward eventual approval from the Food and Drug Administration (FDA) for treatment of internal radionuclide contamination and that some may progress sufficiently to allow BARDA the opportunity to acquire such products as medical countermeasures. Offerors are invited to submit proposals that request funding to advance the development of lead candidate products of improved forms of DTPA, conduct translational research and development, and provide additional information and data toward U.S. Food and Drug Administration (FDA) licensure of an Investigational New Drug (IND) under a New Drug Application (NDA). The lead candidates that will be supported must be orally bioavailable, be able to decorporate transuranic radionuclides (e.g., Am, Pu, 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 lead candidate and have preliminary data on an orally available lead candidate that will decorporate the radionuclides of interest (e.g., Am, Pu, Cm). Offerors will be evaluated on the feasibility of their Product Development Work Plan based on existing efficacy and safety data for their lead candidate as described in the Product Profile, and the studies described in their Product Development Work Plan. Pursuant to the need for manufacturing of the product, the organization 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.