SOURCES SOUGHT
A -- W911QY-12-S-0022 CBMS-MITS REQUEST FOR INFORMATION
- Notice Date
- 9/14/2012
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- ACC-APG - Natick (SPS), 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-12-S-0022
- Response Due
- 9/29/2012
- Archive Date
- 11/28/2012
- Point of Contact
- Richard Totten, 301-619-2446
- E-Mail Address
-
ACC-APG - Natick (SPS)
(richard.totten1@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- SYNOPSIS: This is a Request for Information (RFI) for planning purposes only, as defined in Federal Acquisition Regulation (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. BACKGROUND: Therapeutic pharmaceuticals against chemical, biological, radiological and nuclear (CBRN) warfare agents are required to support the joint forces across a range of military operations. As such, the Department of Defense (DoD) has a need for developing and fielding systems that provide treatment for exposure to CBRN agents. The Chemical Biological Medical Systems - Medical Identification and Treatment Systems (CBMS-MITS) Joint Product Management Office is responsible for the development, procurement, fielding, and sustaining of medical treatment and prophylactic capabilities against CBRN threats. The current CBMS-MITS portfolio includes therapeutics, pretreatments and prophylactics at varying stages of clinical development, including U.S. Food and Drug Administration (FDA)-approved drugs. CBMS-MITS is developing the Improved Nerve Agent Treatment System, (INATS), an enhanced regimen to treat nerve agent induced toxicity. PURPOSE AND OBJECTIVES: The objective of the INATS is to develop an improved nerve agent treatment regimen consisting of a broad spectrum oxime to replace the fielded oxime 2-pralidoxime chloride (2-PAM) and expand pretreatment indications for pyridostigmine bromide (PB). This development effort requires the study of an improved oxime to include but not limited to: formulation, stability and compatibility studies; non-clinical and clinical studies; manufacturing process development; large-scale manufacturing; and the preparation and submission of a New Drug Application (NDA). During the course of this development effort, studies will be conducted to expand the pretreatment indications for pyridostigmine bromide (PB). PB is currently FDA approved for use against the nerve agent soman. Obtaining new indications for PB will enhance INATS by allowing for pretreatment against exposure to additional nerve agents other than soman. The objective of issuing this RFI is to gather information that will assist in the identification of a potential therapeutic candidate(s) as well as in the determination of a suitable contract solution for the advanced development, FDA-approval, manufacture, and production of the INATS. 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) Description of your company's candidate therapeutic, 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. 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. 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. 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. Provide an assessment of candidate maturity, stage of development using the Technology Readiness Level (TRL) for Medical Product Development Appendix A. 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. (2) Description of your company's experience with the program management of technically complex efforts, to include: Existing capabilities to manage pharmaceutical product development efforts through FDA approval, to include assuming product sponsorship. a.Product(s) taken to FDA licensure/approval, including product type. Examples include small molecule therapeutics, large molecule therapeutics, vaccine, etc. b.Current products under development expected to achieve FDA licensure. Include explanation of product type and current stage of development. Examples include small molecule therapeutics, large molecule therapeutics, vaccine, etc. c.Experience with product development under 21 CFR 314 Subpart I or 601 Subpart H (i.e., the Animal Rule). Include any animal subject concerns. (3) Description of your company's technical expertise in pharmaceutical product development, to include: Ability to design and conduct non-Good Laboratory Practices (GLP) as well as GLP-compliant testing. a.Experience conducting the following types of research and development studies: efficacy studies; drug-drug interaction studies; genetic and reproduction toxicology studies; short-term and long-term toxicology studies; range-finding toxicology, toxicokinetic/pharmacokinetic studies; ADME studies; safety pharmacology analysis; mechanism of action studies. b.Experience with designing and developing well characterized animal models. Ability to manufacture current Good Manufacturing Practices (cGMP)-compliant clinical material to support Phase 1 and/or Phase 2 clinical studies. a.Experience with performing chemistry, manufacturing, and controls (CMC) studies and activities to include: standard characterization; assay development and validation; process development and validation; process scale-up assessments; preparation of technology transfer packages; formulation preparation and analysis; clinical trial formulation development; clinical dose delivery; container closure/extractables/leachables/compatability and sterilization. b.Estimate of small and/or large-scale cGMP-compliant manufacturing capability. c.Experience implementing International Conference of Harmonization (ICH) stability test programs to establish product shelf life, storage conditions and stability; experience conducting stability and compatibility testing of the pharmaceutical with the delivery device. Ability to manage and conduct clinical study activities, Phase 1 dose escalation/pharmacokinetic studies and Phase 2 expanded safety/drug-drug interaction studies, in accordance with FDA regulations and Good Clinical Practices (GCP) guidelines. a.Experience designing GCP-compliant clinical protocols, informed consent forms, and case report forms sufficient for submission to the U.S. Army Human Research Protection Office (HRPO). b.Experience managing day-to-day clinical study operations, to include study drug and study supplies inventory management, severe adverse event management, and safety monitoring board management. Experience with clinical study data management, archiving and final study report generation. c.Experience with the design and conduct of the bioanalytical and pharmacokinetic (BA/PK) aspects of human clinical trials as well as with the analysis and evaluation of BA/PK data from human clinical trials. d.Experience with statistical planning and analysis should include developing a detailed statistical analysis plan, developing a subject randomization scheme, conducting interim and final analyses, and preparing a final statistical report. e.Experience in designing clinical protocols to evaluate a multi-drug treatment regimen. (i.e., evaluate drug-drug interactions for concomitantly administered pharmaceuticals) Ability to evaluate and incorporate enabling technologies critical to enhance and/or prolong the drug product shelf life. a.Individual unique identification (IUID), other than syringe and needle administration, and stabilizing technologies to ensure stability across a wide range of temperatures. (4) Description of your company's experience with FDA regulatory interactions leading to product approval/licensure, to include: a.Ability to manage activities related to the development of an IND application and New Drug Application (NDA) submissions. Describe experience with submissions in an electronic Common Technical Document (eCTD) format. b.Engaging in meetings, Types A, B and C, with the FDA and preparation of pre-meeting information packets. c.Preparation and submission of Special Protocol Assessments. 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 fifteen (15) 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 the POC identified below; (3) be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; (4) include a single company point of contact with name, title, address, telephone and fax numbers, and e-mail address(es); and (5) 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. Material that is advertisement only in nature is not desired. The North American Industry Classification Systems (NAICS) for this notice is 541712, Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) with a size standard of 500 employees. Responders must identify their company's business size (based on the NAICS size standard), business status (i.e. small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned). Please include information regarding registration in System for Award Management (SAM), any prior experience with U.S. Government contracts, and favorable experience working with the FDA. Contracting Office Address: US Army, Army Contracting Command, Natick Contracting Division, Fort Detrick, ATTN: Richard Totten 1564 Freedman Drive, Fort Detrick, Maryland 21702. Point of Contact: Richard.w.totten2.civ@mail.mil
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/0933b20e696cd66e1f72c6b8cad2cedd)
- Place of Performance
- Address: ACC-APG - Natick (SPS) 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
- SN02884061-W 20120916/120915001215-0933b20e696cd66e1f72c6b8cad2cedd (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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