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 Prime Systems RFI, W9113M-RFI-090001. Responses are requested regardless of whether a response to the previous RFI 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 has a requirement for a capability to rapidly treat the effects of nerve agent poisoning in the central nervous system. The Centrally-Acting Nerve Agent Treatment System, (CANATS), will encompass the development and addition of a centrally-acting therapeutic to the existing therapy, atropine/oxime/anti-convulsant, as well as to future treatment regimens in order to improve the efficacy of these countermeasures against traditional and non-traditional nerve agents. Current treatment options do not easily cross the blood-brain barrier to counteract the central symptoms of nerve agent poisoning. Research indicates that the addition of such centrally-acting compounds increases survival, reduces morbidity, decreases neurological damage to the brain and improves other treatment outcomes in animal models. The new treatment must provide broad spectrum protection against nerve agent exposure. The objective of issuing this RFI is to gather information that will assist in the identification of a potential centrally-acting therapeutic candidate(s). 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 treatment requirement specified above, including information to support its centrally-acting potential. (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 ALL OR ANY of the requirements specified above. 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. The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. Questions regarding this RFI should be forwarded to the CBMS e-mail address listed below within five (5) days after RFI release. SUBMISSION INSTRUCTIONS: All written responses must be received within fifteen (15) days of issuance of this RFI. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to
[email protected]; (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 10 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 US Army Research, Development and Engineering Command, ATTN: Leo Fratis, 64 Thomas Johnson Drive, Frederick, Maryland 21702. Material that is advertisement only in nature is not desired.