Request for Information; Regulation of Host Response as a Medical Countermeasure Approach

The Defense Threat Reduction Agency (DTRA) is seeking medical countermeasures that (1) enhance innate and adaptive immunity for pre- and post-exposure prophylaxis, or (2) attenuate final common pathways of pathogenesis to reduce the severity of disease, in support of the Transformational Medical Technologies Initiative (TMTI) program. The TMTI mission is to protect the Warfighter from potent known, naturally emerging and genetically engineered threats by providing a capability that includes rapid response and the development of Food and Drug Administration (FDA) approved medical countermeasures. High priority organisms include hemorrhagic fever viruses and intracellular bacteria on the Centers for Disease Control and Prevention (CDC) Category A and B high priority pathogen list. Information Sought: Specifically, the program is interested in the discovery and development of pre- and post-exposure prophylaxis that enhance innate and adaptive immunity, effectively priming the immune system to safely respond to unknown, emerging or bioengineered threats. The program is also interested in medical interventions that target host pathways constituting final common pathways of pathogenesis, e.g., attenuation of inflammatory and coagulation cascades to enhance survival. The intended use may be administration as a stand alone or adjunctive therapy. An alternative approach may be the development of supportive therapies to prevent or treat end-organ failure complicating septic shock or vascular endothelial dysfunction, or prevention or treatment of end-organ damage due to diverse etiologies (e.g., trauma, shock, ischemia, radiation; e.g. - shock liver, myocardial or cerebral infarction). Solutions from domains outside of biodefense related-research (e.g. HIV, cancer, sepsis, and trauma) are encouraged. Approaches may include new discoveries or repurposing of FDA approved treatments or candidates in late development. Instructions to Responders: Sources having the capability and/or concept to meet these requirements are invited to respond to this RFI. Responses should be limited to five (5) pages for any given concept, not including cover page, cover letter and table of contents. Any proprietary concepts of information should be clearly identified as such. Submitted data and information will not be returned. Input on technical aspects of the responses may be solicited by DTRA from non-government consultants/experts who are bound by appropriate non-disclosure requirements. For all RFI responses, an additional, non proprietary cover page is also requested identifying your company name, technical point of contact, and contact information. This is a Sources Sought Synopsis/ Request for Information (RFI). There is no solicitation available at this time. Requests for Solicitation and inquiries related to same will not receive a response. This RFI is published for market research purposes only, and in no way obligates the Government to issue a solicitation or otherwise make a contract award. Any and all information submitted in response to this synopsis is strictly voluntary. The Government will not pay for any information submitted in response to this RFI. Only electronic submissions of information provided to the email address specified will be accepted. RFI responses should be sent to the following email address: contact@example.gov. All emails should include in the subject line the RFI number and the submitting organization's name. Responses should be submitted electronically not later than 5:00 p.m. EST on 01/15/2010.