SOURCES SOUGHT
A -- Development of Therapeutics to Defeat Antibacterial Resistant Bacteria - Appendix 1
- Notice Date
- 3/4/2013
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Other Defense Agencies, Defense Threat Reduction Agency, Defense Threat Reduction Agency (Headquarters), DTRA Annex, 8725 John J. Kingman Road, MSC 6201, Fort Belvoir, Virginia, 22060-6201
- ZIP Code
- 22060-6201
- Solicitation Number
- HDTRA1-RFI-TMT01
- Archive Date
- 5/1/2013
- Point of Contact
- Victor E. Cramer, Phone: 7037678769, Malissa Smith,
- E-Mail Address
-
usarmy.belvoir.jpeo-cbd.mbx.communications-email-and-calendar@mail.mil, usarmy.belvoir.jpeo-cbd.mbx.communications-email-and-calendar@mail.mil
(usarmy.belvoir.jpeo-cbd.mbx.communications-email-and-calendar@mail.mil, usarmy.belvoir.jpeo-cbd.mbx.communications-email-and-calendar@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Technology Readiness Levels (TRLs) for Medical Countermeasure (MCM) Product Definitions 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 Joint Project Manager Transformational Medical Technologies (JPM-TMT) focuses on the advanced development of adaptable platform technologies and broad-spectrum medical countermeasures (MCMs) to counter emerging, genetically engineered, or unknown threats. JPM-TMT's Countermeasures for Multi-Drug Resistance-Bacterial (CMDR-B) program develops therapeutics for Biological Warfare Agents (BWAs) that cannot be mitigated by existing MCMs. To ensure Warfighter capability-in the face of the continuing emergence of multi-drug resistant bacteria and advancements in biotechnology that enable development of genetically engineered, drug resistant bacteria-there is a need to identify new chemical classes of antibacterial compounds and new bacterial targets. Accordingly, the goal of the CMDR-B program is to develop long-term, broad-spectrum therapeutic solutions to defeat antibiotic resistant BWAs. Purpose and Objectives: The CMDR-B program is considering development of a therapeutic for antibacterial resistance mitigation with potential solutions including development of combinations of existing FDA-approved therapeutics that act synergistically to overcome antibacterial resistance; development of adjunctive molecules which interfere with antibiotic resistance mechanisms; and development of novel therapeutics (i.e., novel chemical entities) for which there is no known bacterial resistance. Interested parties should fully describe their medical countermeasure (therapeutic) and provide all available information with respect to criteria A-M below. If an MCM candidate meets only some of the criteria, a portion of a criterion, or otherwise has capabilities not specifically called out by the criteria, JPM-TMT still strongly encourages a response to this RFI so that a more complete understanding of the state-of-the-art may be obtained. MCMs developed by the commercial sector, academia, the United States Government, and international entities are acceptable. A. Antimicrobial MCMs that either directly or indirectly prevent or treat disease caused by pathogenic bacteria (either gram positive or gram negative). MCMs should be either FDA-approved or currently in development and could include novel combinations of FDA-approved drugs. For this purpose, drugs can be defined as: • two or more antibiotics • an antibiotic with a molecule that augments the activity of the antibiotic • a novel single molecule. The chemical entity for the MCM should be identified as well as its relationship to existing FDA-approved drugs, if applicable (e.g., fluoroquinolone, 4th generation cephalosporin). Only those MCMs at Technology Readiness Level (TRL) 3 or higher are to be included (see below for MCM TRL definitions). Accordingly, using the MCM TRL definitions provided below, specify the maturity of the MCM and discuss the TRL steps that have been completed. B. MCM in vivo activity against all bacterial species for which data is available, and provide a brief summary of the approach of the analysis. C. MCM activity (in vitro and/or in vivo) against one or more of the following biothreat agents: a. Bacillus anthracis b. Yersinia pestis c. Brucella spp. d. Burkholderia mallei e. Francisella tularensis f. Burkholderia pseudomallei D. MCM effectiveness in disease models for septicemia and/or inhalation (in vitro and/or in vivo) with endpoint used in the study for efficacy identified (e.g., increased survival rate and/or ability to stop/minimize/reverse the progression of signs and symptoms of infection, as compared with controls). E. MCM mechanism of action: a. Host immune modulation or disruption of bacterial immune evasion mechanisms. b. Disruption of bacterial life cycle. c. Disruption of common pathways of bacterial pathogenesis (through bacterial or host targets). d. Mitigation of resistance to current therapeutic options. F. MCM utility as a post‐exposure prophylactic, or post‐symptomatic treatment, with reported therapeutic window. Drugs with an intended pretreatment indication may be reported, but MUST also show in vivo efficacy as a post-exposure prophylactic or post-symptomatic treatment. G. MCM potential utility against multi-drug resistant bacteria. H. For adjunctive molecules, MCM ability and mode of action to abrogate a specific mechanism of antibiotic resistance. I. Novelty of the compound class and any known mechanisms conferring resistance to the compound. J. Novelty of the therapeutic target and any known mechanisms conferring resistance to the compound. K. Route of administration. L. Suitability as a platform technology adaptable to other MCM discovery applications (e.g., a chemical scaffold that is rapidly adaptable to multiple pathogenic threats and which could be tailored to generate a therapeutic solution for a new pathogenic threat once that threat has been characterized). M. Any associated intellectual property rights or patent coverage. Response Requirements: Sources having a potential therapeutic solution in line with the CMDR-B 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-M 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 JPM-TMT 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: Malissa Smith at usarmy.belvoir.jpeo-cbd.mbx.communications-email-and-calendar@mail.mil no later than April 30, 2013 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 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. JPM-TMT 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/ODA/DTRA/DTRA01/HDTRA1-RFI-TMT01/listing.html)
- Record
- SN03002903-W 20130306/130305114402-82eb6921a9f79138afb46ba6cee88234 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |