Advance Development of a broad spectrum Medical Countermeasure (MCM)

Synopsis: This is a Request for Information (RFI) issued for planning purposes, as defined in Federal Acquisition Regulation (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 Joint Product Manager Biological Defense-Therapeutics (JPdM BD-Tx), part of the Joint Project Manager Medical Countermeasures Systems (JPM-MCS) which is part of the Joint Program Executive Office for Chemical and Biological Defense, focuses on the advanced development of adaptable platform technology and broad-spectrum medical countermeasures (MCMs). JPdM BD-Tx's Emerging Infectious Diseases Therapeutics (EID Tx) program mission is to deliver a U.S. Food and Drug Administration (FDA)-approved, broad-spectrum medical countermeasure to the Warfighter for protection against naturally occurring or biologically engineered viruses. To ensure Warfighter capability, the EID Tx program seeks to identify potential candidates of mature technical nature to meet mission objectives. If an MCM candidate meets only some or portion of the criteria, or otherwise has capabilities not specifically called out by the criteria as stated in Purposes and Objectives (A through L) below, EID Tx still strongly encourages a response to this RFI so that a more complete understanding of the state-of-the-art may be obtained. Purpose and Objectives: The EID Tx program is seeking to develop a broad spectrum medical countermeasure (MCM) effective against naturally occurring or biologically engineered viruses. Interested parties should fully describe their medical countermeasure and provide all available information. At a minimum the following areas should be addressed: A. Efficacy data against any virus (non-human primates, other species, in vitro) B. Route of administration (oral, intramuscular, inhalation, other) C. Clinical trials completed for any indication or Investigational New Drug (IND) D. Shelf life of drug product in years supported by current Good Manufacturing Practice (cGMP) stability studies E. Number and type of pharmacologically relevant animal models in agents targeted F. Storage requirements as demonstrated by cGMP studies (room temperature, refrigerated, frozen) G. Number of treatment courses produced in a single manufacturing run H. Estimated cost per treatment course I. Therapeutic index in species in which efficacy testing for virus was carried out J. Estimated number of months before New Drug Application (NDA) for any indication K. Estimated number of months until IND can be submitted for any virus indication L. Any associated intellectual property rights or patent coverage Response Requirements: Sources having a potential therapeutic solution in line with the EID Tx program objectives 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-L 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. Input on technical aspects of the responses may be solicited by JPdM BD-Tx 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: jay.y.wang.civ@mail.mil no later than May 5, 2014 at 2:00PM EST. Any questions should also be directed to Jay Y Wang at email above. 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 to 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 solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation that may be published in the future. JPdM BD-Tx representatives may or may not choose to meet 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).