MODIFICATION
A -- Request for Information (RFI) Countermeasures for Multi-Drug Resistance-Bacterial (CMDR-B) program
- Notice Date
- 1/23/2015
- Notice Type
- Modification/Amendment
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- ACC-APG - Natick Installation, Directorate of Contracting, Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-15-S-0003
- Response Due
- 1/26/2015
- Archive Date
- 3/24/2015
- Point of Contact
- Jeremy D. michaels, 301-619-7421
- E-Mail Address
-
ACC-APG - Natick Installation
(jeremy.d.michaels.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Synopsis: The purpose of this Request for Information (RFI) is to conduct market research to determine the availability of medical countermeasures that mitigate the effects of multi-drug resistant bacterial infections by biological agents in DoD personnel. Respondents are invited to provide materials related to their capabilities to fulfill ALL or ANY of the requirements listed below. Respondents should provide whether their level of interest and current capability is to fulfill the entire scope of the effort, or a limited aspect of the effort, such as teaming as a subcontractor with another firm. If candidates are interested in teaming with other sources, please include in your response authorization to release your company's name, area of interest, and POC information to be made available on a public website. All proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. This is a Request for Information (RFI) for planning purposes only, as defined in FAR 15.201(e). This is not a solicitation for proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. Respondents are advised that the Government is under no obligation to acknowledge receipt. Background: The JPdM Biological Defense Therapeutics (BDTx) Medical Countermeasure Systems (MCS) Joint Project Management Office focuses on the advanced development of adaptable platform technologies and broad-spectrum medical countermeasures (MCMs) to counter emerging, genetically engineered, or unknown threats. JPdM BDTX 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 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. 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 (e.g., 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, JPdM BDTX 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 that have completed Quantitative Technology Readiness Level (QTRL) 6 or higher for a Public Health Indication and demonstrated activity against a BWA targets are to be included (see Attachment 1 QTRLs). Accordingly, using Attachment 1 QTRLs definitions for level 6 TRL provided on page 5-6, 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.Francisella tularensis b.Bacillus anthracis c.Brucella spp. d.Burkholderia mallei e.Burkholderia pseudomallei f.Yersinia pestis D. MCM effectiveness in disease models for aerosol and/or non-aerosol exposures (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: 1. Host immune modulation or disruption of bacterial immune evasion mechanisms. 2. Disruption of bacterial life cycle. 3. Disruption of common pathways of bacterial pathogenesis (through bacterial or host targets). 4. Mitigation of resistance to current therapeutic options. F. MCM utility as a post symptomatic treatment, with reported therapeutic window or post exposure prophylactic. Drugs with an intended pretreatment indication may be reported, but MUST also show in vivo efficacy as a 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 unique nature with respect to any known mechanisms conferring resistance to the compound. J. Novelty of the therapeutic target and unique nature with respect to 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). Contractor should discuss the proposed mechanism for response to new threat (e.g. tailoring the platform). M. Any associated intellectual property rights or patent coverage. Submission Instructions: All responses must be submitted electronically to jeremy.d.michaels.civ@mail.mil within fifteen (15) business days of issuance of this RFI. Address any question regarding this RFI, in writing, to the above. Submissions must: (1)Use 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 quote mark at the top, bottom, and sides; (2)Include 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 exceed ten single-sided pages in total (not including cover page and cover letter). 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 ten-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 ten-page response without any loss of understanding to the ten-page response. Material that is advertisement only in nature is not desired.. The respondent must also provide their DUNS number, organization name, address, point of contact, size and type of business (e.g. large business, small business, small disadvantaged business, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. The Government will retain comments and information received in response to this notice. Proprietary information should be identified as Company Proprietary. Do not use Government Security Classification markings. Any information provided to the U.S. Government in response to this sources sought notice is for planning purposes only and will not be used as a selection consideration factor in any U.S. Government contract competition. Should the U.S. Government elect to pursue the subject requirement, an official Request for Proposal will be released at a later date in accordance with FAR Part 5. Sources Sought Info: This Sources Sought Notice allows qualified sources for this requirement to self-identify. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for any information solicited. No solicitation document exists or is guaranteed to be issued as a result of this notice. Army Contracting Command - Aberdeen Proving Ground/Natick Division, Attn: Jeremy D. Michaels, 110 Thomas Johnson Drive, Suite 240, Frederick, Maryland 21702. Contracting Office Address: ACC-APG - Natick (SPS), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011 Place of Performance: ACC-APG - Natick (SPS) ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street Natick MA 01760-5011 US Point of Contact(s): Jeremy D. Michaels Jeremy.d.michaels.civ@mail.mil
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/71f97e952ea1199a0c55d1fdd93ed156)
- Place of Performance
- Address: ACC-APG - Natick Installation Directorate of Contracting, Building 1, Kansas Street Natick MA
- Zip Code: 01760-5011
- Zip Code: 01760-5011
- Record
- SN03624039-W 20150125/150123235312-71f97e952ea1199a0c55d1fdd93ed156 (fbodaily.com)
- Source
-
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