Synopsis: This is a Request for Information (RFI) issued for planning purposes, as defined in FAR 15.201(e). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The Department of Defense (DoD) is not seeking proposals at this time and will not accept unsolicited proposals. This notice is open to all sources. Background and Mission: The mission of DTRA-Research and Development Enterprise (RD)-Chemical and Biological Directorate Technologies Directorate (CB) (DTRA-RD-CB), is to develop scientific knowledge, technical solutions and deliver Medical Counter Measures to reduce the chemical and biological threat to the military and the Nation. As part of this mission DTRA CB/JSTO seeks to initiate programs and deliver "Medical Counter Measures" (MCMs) against tier 1 infectious threat pathogens. Tier 1 list includes bacterial threat pathogens (natural or engineered) for which effective MCMs are required for preparedness. Purpose and Objectives: The objective of this RFI is to identify candidate Small organic Molecules Inhibitors (SMI) that have the potential to potently and specifically inhibit multiple drug resistance (MDR) bacterial pathogens including tier-1 CDC/DoD listed bacterial. The DoD is interested in exploring availability of SMIs that possess new mechanism of action(s) and are bactericidal against broad MDR bacterial infectious pathogens. DoD welcomes engagement of all sources that have reached at an advanced Phase I clinical studies or completed this clinical Phase. Interested parties should fully describe their technology and provide all available information with respect to criteria listed below. Responders can be from the commercial sector, academia, the United States Government, and international entities. General Guidelines: The SMIs of interest need to have supporting information for a unique, novel mechanism of action that does not substantially overlap with marketed anti-bacterial pathogens for which multiple drug resistance (MDR) strains have been identified. The compound of interest should have commenced Phase I clinical studies for safety, tolerability, and PK, and advanced through Single Ascending Dosing (SAD) regimens with promising data that support utility against civilian infectious diseases (including MDR pathogens below. Data supporting safety and tolerability of compound administered via systemic or oral routes for at least 10 consecutive days are of special interest to the DoD. In this latter respect, it is an advantage for the compound to be delivered as a single dose or twice a day dosing regimen in either the oral or systemic (intravenous) injections. It is also assumed that the compound(s) of interest have completed 3 month Toxicokinetic studies in 2 species for the duration of 1-3 months with acceptable profile supporting the IND filing. Furthermore, it is expected that no major issues regarding CMC, acceptable shelf life, and formulation needed to support viable civilian indication have been identified. Specific requirements: A. DTRA CB/JSTO will screen against threat bacterial pathogens will seek in vitro screen of the company compound to establish MIC50/90 sets of the strains of interest. B. DTRA CB/JSTO will seek small animal proof of concept (POC) studies using animal models where ‘natural disease' profile acceptable to the FDA has been established. Where needed, complementary PK studies and modeling will be performed. C. DTRA CB/JSTO will seek single efficacy study for treatment efficacy as per FDA guidance. D. DTRA CB/JSTO will seek "animal rule" studies as guided by the FDA for respective threat pathogens. E. DTRA CB/JSTO will require company to submit data generated in "animal rule" studies as sIND and eventually sNDA along with NDA submission for civilian indications. F. DTRA CB/JSTO will seek the establishing of joint teams working in collaboration towards accelerated development path in tandem with all regulatory requirements. G. It is also expected that the company intention in regards to compound development such as CAP (Community Attracted Pneumonia), UTI (Urinary Tract Infection), skin abscess etc. Response Requirements: Sources having a potential SMI in line with what is described above are invited to respond to this RFI. Responses shall be limited to five (5) pages, including diagrams but not including the cover page, the cover letter (not to exceed one (1) page) and the table of contents. Responses shall be organized to provide concise information to respond directly to the points given in the A-F criteria (as listed above) in the order shown. Respondents may include additional information, such as supporting test reports or pertinent journal articles as desired. However, the five-page response shall stand-alone from the additional information, and shall describe the technology without reference to the additional information. The additional information, if any, shall be separately labeled from the response, and removable from the five- page response without any loss of understanding to the five-page response. Any and all information submitted in response to this notice is strictly voluntary and in no way obligates the Government or otherwise to make a contract award. Proprietary information, if any, should be minimized and must be clearly marked. To aid the Government, please segregate proprietary information. Submitted data and information will not be returned. Reviews/Input on technical aspects of the responses may be solicited by DTRA-RD-CB from non-government consultants/experts who are bound by appropriate non-disclosure requirements. For all responses, the additional, non-proprietary cover page is required, identifying the company name, technical point of contact, and contact information including respondents DUNS number, organization name and address, administrative point of contact, size and type of business. Submission Instructions: Respondents shall provide responses: (1) using Microsoft Word or Adobe PDF (text searchable format) using single-space, 12-point font and printable on 8.5 x 11 size white paper, with margins no less than 1" at the top, bottom, and sides; (2) including technical and administrative points of contact, with names, titles, addresses, telephone and fax numbers, and e-mail addresses in the cover page; and (3) not exceeding five single-sided pages in total (not including cover page, cover letter, table of contents, and any additional information separately provided, as described above) sent via email to the following inbox:
[email protected],
[email protected], and
[email protected] no later than March 26, 2014 at 11:59 PM EST. Disclaimer and Important Notes: The Government will not pay for any information submitted in response hereto. This notice does not obligate the Government to issue a solicitation or to award a contract. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organizations qualifications that perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and/or a solicitation may be published in Federal Business Opportunities if the government determines to pursue a contract. However, responses to this notice will not be considered adequate responses to a solicitation that may be published in the future. DTRA-RD-CB representatives may or may not choose to communicate with respondents. Such discussions would only be intended to get further clarification of potential capability to meet the requirements, especially any development and certification risks. Confidentiality: No classified or sensitive information should be included in your response. The Government reserves the right to use the non-proprietary technical information in any resultant solicitation(s).