SPECIAL NOTICE
A -- Joint Project Manager for Medical Countermeasure Systems (JPM-MCS) Other Transaction Agreement Request for Letters of Intent
- Notice Date
- 11/10/2015
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of the Army, Army Contracting Command, ACC - New Jersey, BUILDING 10 PHIPPS RD, PICATINNY ARSENAL, New Jersey, 07806-5000, United States
- ZIP Code
- 07806-5000
- Solicitation Number
- W15QKN-16-Z-3188
- Point of Contact
- Kristen Kachur, Phone: 9737243217
- E-Mail Address
-
kristen.e.kachur.civ@mail.mil
(kristen.e.kachur.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- The Army Contracting Command - New Jersey (ACC-NJ), on behalf of the Joint Project Manager for Medical Countermeasure Systems (JPM-MCS) through the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) is releasing this special notice to inform interested parties about the Government's interest to establish an Other Transaction Agreement (OTA) under 10 U.S.C. §845 with an eligible entity or group of entities, to include industry, academic, non-profit, and not-for-profit partners, for advanced development efforts to support the Department of Defense's (DoD) medical pharmaceutical and diagnostic requirements as related to enhancing the mission effectiveness of military personnel. JPM-MCS provides U.S. military forces and the nation safe, effective, and innovative medical solutions to counter Chemical Biological Radiological and Nuclear (CBRN) threats. JPM-MCS accomplishes this mission through the development of products in four major areas: - Detection: Systems and devices to identify CBRN agents and assist in making medical decisions - Prevention: Prophylaxis, pretreatment, and post-exposure prophylaxis - Treatment: Therapeutics (post-exposure, post-symptomatic) - Chemical: Medical protection against use of chemical agents The Government is anticipating establishing a Section 845 Prototype Other Transaction Agreement (OTA) with a consortium that has significant non-traditional contractor participants. The Government in conjunction with a consortium shall perform a coordinated research and development program designed to develop non-traditional opportunities in support of the Joint Program Manager for Medical Countermeasure Systems (JPM-MCS) mission. Under this agreement and associated awards, the Government along with the consortium, shall perform coordinated planning and research and development prototype efforts designed to encompass the following as it relates to support of the Chemical and Biological Defense mission, in the advanced technical areas described below. JPM-MCS deters or mitigates the use of biological and chemical agents and the means to employ them by providing medical protection to the Warfighter through treatments and prevention. One approach is to develop one-threat-one-drug medical countermeasures (MCMs) for the most catastrophic threats. An example includes the smallpox vaccine to counter a biological threat. A variation on this traditional approach is to use innovative platform technologies that enable rapid development and FDA approval of new MCMs against specific threat agents using approaches analogous to annual influenza vaccines built on a common platform. Another approach is to pursue new technologies for broad-spectrum MCMs or many-threats-one-drug. The current program developing broad-spectrum capability against gram-negative bacteria is an example of this approach, and another is the Bioscavenger prophylactic for protection against chemical nerve agents. JPM-MCS also provides diagnostic devices and technologies to identify and characterize agents for appropriate treatment and other protective measures to improve outcomes against threats, including novel and previously unrecognized, naturally occurring emerging infectious diseases, as well as exposure to radiological and chemical threats: Medical Countermeasure Technology Objectives: JPM-MCS is interested in the establishment of a prototype Other Transactions Agreement (OTA), pursuant to §845 of P.L. 103-160 (10 U.S.C. §2371 note), with a consortium that has significant non-traditional defense contractor participants. JPM-MCS intends to use this prototype OTA to collaborate with industry partners for the advanced development of candidate medical countermeasures for chemical and biological defense. JPM-MCS would also like to use this vehicle to partner with the other agencies in the USG and DoD chemical and biological defense enterprise to collaborate with industry on applied research on candidate medical countermeasures and supporting technologies. The following goals/objectives will be pursued within the execution of this Agreement: (a) Accelerate the development of mission critical technologies in the areas of concern from applied research into advanced development. (b) Deliver therapeutic MCM prototypes targeting viral, bacterial, and biological toxin targets of interest to the DOD. MCM prototypes are drug products that have completed all or part of the activities required to support FDA licensure. This may include meeting warfighter requirements of protection against an aerosolized route of exposure. (c) Deliver enabling technologies that will support the development and regulatory review of MCM prototypes. The enabling technologies can include animal models of viral, bacterial or biological toxin disease and pathogenesis (multiple routes of exposure), assays, diagnostic technologies or other platform technologies applicable to development and regulatory review of MCM. (d) Develop prototype candidates for the prophylaxis, treatment and diagnosis of Chemical threats. This will include diagnosis of, and prophylaxis and treatment for, exposure to traditional and emerging chemical nerve agent threats, as well as other emerging chemical threat agents other than nerve agents. (e) Develop prototype candidates for the prophylaxis, treatment and diagnosis of Radiological and Nuclear threats. This will include prototype candidates for diagnosis of, and prophylaxis and treatment for Acute Radiation Syndrome. (f) Develop soldier-carried autoinjector delivery devices for single drug administration. Develop soldier-carried autoinjector delivery devices for administration of two or more drugs. (g) Develop vaccine-manufacturing platforms that offer early stage manufacturing flexibility and diversity using a deep knowledge of protein(s) expression in a biological system that is reproducible and scalable, and preferably with direct FDA experience. The goal is to manufacture and test identified protective molecule(s) and target molecule(s) (along with associated reagents and standards) in multiple scalable, flexible manufacturing platforms encompassing a diverse array of manufacturing systems (e.g., insect, mammalian, live viral, plant, E.coli, yeast, etc.) for use in appropriate animal model(s) and in Phase 1 trials. (h) Pharmaceutical development will address the FDA Animal Rule, as appropriate. (i) Utilize adjuvants and excipients supporting the ability to develop up to 300,000 equivalent doses within 60 days at clinical quality. (j) Support a family of systems diagnostic approach that increases the speed, accuracy, and confidence of agent identification and disease diagnosis. Diagnostic areas include those for organisms that circulate freely and at relatively high numbers at or near the onset of symptoms, organisms that circulate in low numbers early in infection but then integrate with host cells, organisms that have significant genomic diversity from strain to strain, and non-BW agents such as toxins/chemical agents/radiological agents that do not replicate and require low quantities to cause illness. (k) Support the Critical Reagents Program, the principal DoD resource of high quality, validated, and standardized biological reference materials, reagents, and assays, as necessary. (l) DoD Advanced Development and Manufacturing Capabilities: The DoD awarded a contract to Nanotherapeutics, Inc. to establish the DoD Advanced Development and Manufacturing (ADM) capabilities. The primary capability will be a BSL-3 capable, multiproduct, cGMP compliant manufacturing facility for biologic products. The ADM, through the prime contractor and teaming partners, will also provide additional product development support, such as clinical research, assay development, small molecule development and manufacturing, and regulatory support, necessary for successful FDA approval/licensure/clearance of medical countermeasures. The facility design employs single use technologies, but will also maintain traditional stainless steel capability. The JPEO-CBD and JPM MCS requires the successful OTA Consortium to include the ADM contractor, Nanotherapeutics, as a member. Further, to facilitate lessons learned and to ensure DoD MCM product development schedules are not impacted, the consortium will consider the ADM contractor for biologics manufacturing activities for monoclonal antibodies, vaccines, and recombinant proteins utilize the DoD funded facility. (m) Pursue collaborative research with non-traditional technology providers in a manner that enables effective transition of technologies to Government prototyping programs during any phase of life cycle support (affordability, manufacturability, sustainment, etc.). The Government requests submission of formal Letters of Intent in response to this announcement from new or existing interested Consortia. Responses can be sent to Ms. Kristen Kachur, Contract Specialist, via email at Kristen.e.kachur.civ@mail.mil no later than 4:00 PM EST 24 November 2015. NO TELEPHONE INQUIRIES WILL BE ACCEPTED. Electronic responses are to be in Adobe PDF or Microsoft Word format using a size 12 font with one inch margins. Adobe PDF format is preferred. The Letter of Intent should include the following: 1. A cover page labeled with the heading, in quotation marks, "Medical Countermeasure Systems", name of consortium, name of corporate point of contact (POC), name of technical POC, telephone number for each POC, full mailing address, e-mail addresses for each POC, and any other pertinent information. 2. The consortium's vision, mission statement, goals, membership (indicating traditional and non-traditional defense contractors including corporate locations), IP plan, ability to support rolling membership/maximum flexibilities, proposed interactions between DoD and members, plan to get widest dissemination of tasks for best capabilities and performers, management framework, articles of collaboration/by-laws, Consortium Member Agreement (CMA), accounting practices, fee structure, and other information which the respondent considers important. Responses should also contain the interested parties' experience and capability, linking capabilities to scope and objectives IAW paragraph 3 below, and demonstrate how consortium capabilities and experiences meet requirements. Most importantly, responses should include relevant FDA experience and capabilities of members, and examples of FDA experiences and demonstrated success at all levels of development. 3. No more than twenty (20) pages of technical information including: (a) Narrative describing how the specified technical objectives will be addressed and fulfilled (b) Corporate competencies and past performance experience with regard to development and modification of systems including relevant history of ability to develop and integrate similar technologies. (c) Describe ability to comply with quality assurance. (d) Describe use of regulatory programs to accelerate the pace of development (including but not limited to priority review vouchers and fast-track status) and ability to work with JPM-MCS through provision of FDA submissions to MCS (e) Describe preferred level of interaction/oversight desired with JPM-MCS. (f) Describe ability to work with USG Labs. (g) Describe experience with Quantitative Technology Readiness Levels (QTRLs). (h) Describe systems providing insight into Cost/Schedule/Performance of effort (e.g., EVMS or other systems). Please submit all pages as a single (.doc or.pdf) file. Proprietary information, if any, should be minimized and MUST BE CLEARLY MARKED. Please be advised that all submissions become Government property and will not be returned. All information is to be submitted at no cost or obligation to the Government. The U.S. Government is not obligated to notify respondents of the results of this announcement. The U.S. Government reserves the right to reject, in whole or in part, any private sector input, as a result of this announcement. If a formal solicitation is generated at a later date, a separate solicitation notice will be published. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. No sensitive or classified information will be discussed. Foreign-owned, controlled, or influenced firms are advised that security restrictions may apply that may preclude their participation in these efforts.
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