SOURCES SOUGHT
A -- Identification of a Prophylactic Bioscavenger
- Notice Date
- 2/18/2011
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- RDECOM Contracting Center - Natick R&D (RDECOM-CC), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-11-RFI-0001
- Response Due
- 4/1/2011
- Archive Date
- 5/31/2011
- Point of Contact
- Drake Russell, 301-619-8472
- E-Mail Address
-
RDECOM Contracting Center - Natick R&D (RDECOM-CC)
(drake.russell@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- REQUEST FOR INFORMATION Request for Information: W911QY-11-RFI-0001 Identification of a Prophylactic Bioscavenger as a Nerve Agent Countermeasure SYNOPSIS: This is a Request for Information (RFI) for planning purposes only, as defined in Federal Acquisition Register (FAR) 15.201e. This is not a solicitation or request for competitive 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 of the information received or provide feedback to respondents with respect to any information submitted. (Note: this RFI is separate from the previously released Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasures SSN, W911QY-10-S-0003. Responses are requested regardless of whether a response to the previous SSN was submitted). BACKGROUND: The Chemical Biological Medical Systems (CBMS) Medical Identification and Treatment Systems (MITS) Joint Project Management Office (JPMO) is responsible for the development, procurement, fielding, and sustaining of medical treatment and prophylactic capabilities against chemical, biological, radiological and nuclear agents. The current CBMS-MITS portfolio includes therapeutics, pretreatments and prophylactics at varying stages of clinical development, including FDA-approved drugs. PURPOSE AND OBJECTIVES: The Department of Defense (DoD) has a requirement for providing a prophylactic regimen that will protect the warfighter from incapacitation and death caused by organophosphorus (OP) nerve agents. The concept is to provide effective pre-exposure prophylaxis as appropriate to protect the force from a nerve agent attack and allow the force to complete its mission in a non-linear, dispersed battle space. A prophylactic that requires minimal or no medical intervention after exposure to nerve agents would represent a significant advance in protection of warfighters against lethal agents. Such a prophylactic would bind or degrade nerve agents before they inhibit acetylcholinesterase (AChE), an enzyme essential to normal nerve system function, and cause toxic effects. The Bioscavenger program will pursue the development and of a suitable prophylactic candidate that will provide broad-spectrum protection against nerve agents, and work in concert with existing pretreatments and therapeutic countermeasures to offer optimal protection to the Warfighter. To date, CBMS MITS has evaluated multiple candidates, and has determined human plasma derived butyrylcholinesterase (huBChE) to be its most promising candidate. CBMS MITS has animal safety and efficacy study data and Phase 1 clinical human safety study data on multiple candidates. The most promising candidates are at a Technology Readiness Level of 6. The objective of issuing this RFI is to gather information that will assist in the identification of a potential Bioscavenger candidate(s). The DoD is interested in information pertaining to huBChE as a candidate, or any other possible candidate that meets or exceeds the capabilities demonstrated by huBChE. As such, CBMS-MITS is seeking information on current industry capabilities from interested entities with potential to meet ANY of the following criteria, IN WHOLE OR IN PART: (1)Describe your company's candidate currently under development, to include general background information, pertinent research efforts, proposed indication(s) and proposed human dose and route of administration. Specifically, identify the candidate's capabilities to fulfill the prophylactic requirement specified above, including information to support its ability to bind or degrade the nerve agent. (2)Provide a status of in vitro and/or animal model development (i.e., small animal species, large animal species, route of exposure). Include any proprietary information and limitations, if any, on sharing of animal models or testing paradigms with the government and its contractors. (3)Provide a summary of any pertinent data resulting from efficacy studies (i.e., route of challenge, animal model); genetic and reproduction toxicology studies; short-term and long-term toxicology studies; range-finding toxicology, toxicokinetic/pharmacokinetic studies; absorption, distribution, metabolism and excretion (ADME) studies; safety pharmacology analysis; mechanism of action studies. (4)Describe formulation development efforts, the candidate's proposed formulation and any relevant chemical, physical, and immunological characteristics. Summarize any efforts related to manufacturing process development, to include assay qualification and validation, production qualification and validation, process scale-up. Provide any available information on candidate stability, shelf-life and storage conditions. (5)Provide an assessment of candidate maturity, stage of development using the Technology Readiness Level (TRL) for Medical Product Development in Appendix A. (6)Describe any intellectual property concerns to include your company's rights and ability to sell or license any intellectual property as well as your company's interest in selling or licensing the intellectual property. Proprietary information should be marked as described in the paragraph below. Respondents are invited to provide materials related to their capabilities to fulfill ANY OR ALL of the requirements specified above. Respondents should provide responses 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. The Government will retain comments and information received in response to this RFI. Proprietary information should be clearly identified as Company Proprietary if you choose to submit this information. Do not use Government Security classification markings. Questions regarding this RFI should be forwarded to the CBMS e-mail address listed below within ten (10) days after RFI release. SUBMISSION INSTRUCTIONS: All written responses must be received Friday April 1, 2011. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to Mr. Drake Russell, EMAIL ADDRESS: drake.russell@us.army.mil; (3) be minimum 11 font on 8.5" X 11" paper; (4) be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; (5) include a single company point of contact with name, title, address, telephone and fax numbers, and e-mail address(es); and (6) not exceed 12 single sided pages in total (not including cover page and cover letter). Other media types (i.e. CD, printed technical information) that meet the submission criteria above will be accepted and should be sent to the and should be sent to the address below. Material that is advertisement only in nature is not desired. 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 organization's 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 the 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 which may be published in the future. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. Contacting Office Address: JPEO - CBMS - MITS Natick, RDE - COM Contracting Office 64 Thomas Johnson Drive Frederick, MD 21702 Point of Contact: Mr. Drake Russell, Contract Specialists, JPEO CBD, email address: drake.russell@us.army.mil
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/fd2d0910350bb25630fd0b61c00c4e84)
- Place of Performance
- Address: RDECOM Contracting Center - Natick R&D (RDECOM-CC) ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street Natick MA
- Zip Code: 01760-5011
- Zip Code: 01760-5011
- Record
- SN02383611-W 20110220/110218234143-fd2d0910350bb25630fd0b61c00c4e84 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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