1.0 NOTICE 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. 2371 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 three major areas: - Detection - systems and devices to identify CBRN agents and inform medical decisions. - Prevention - prophylaxis, pretreatment, post-exposure prophylaxis. - Treatment - therapeutics (post exposure, post symptomatic). JPM-MCS continues to leverage multiple vehicles as a holistic approach for effective and efficient execution of its capability development. Additional information about JPM-MCS and JPEO-CBD is available at http://www.jpeocbd.osd.mil/packs/Default.aspx?pg=220. The U.S. is in a race against enemies pursuing biological and chemical agents and the means to employ them. JPM-MCS deters or mitigates their use 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. Another approach is to pursue new technologies for broad-spectrum MCMs or many-bugs-one-drug. The current program developing broad-spectrum capability against gram-negative bacteria is an example of this approach 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. The Secretary of the Army (SA) is authorized to carry out prototype projects that are directly relevant to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the DoD, or to improvement of platforms, systems, components, or materials in use by the Armed Forces. See 845(a)(2) of the National Defense Authorization Act (NDAA) for Fiscal Year 1994, Public Law (P.L.) 103-160, as amended (Title 10 United States Code (U.S.C.) 2371 note). The Government is required to ensure that no official of an agency enters into an OTA for a prototype project under this authority unless there is significant non-traditional defense contractor(s) participation in the prototype project; or at least one third of the total cost of the prototype project is to be paid out of funds provided by parties to the transaction other than the Federal Government. More information regarding DoD use of OTA can be found at the following website: www.acq.osd.mil/dpap/Docs/otguide.doc. The Government is interested in gaining additional information regarding the establishment of a prototype OTA pursuant to 845 of P.L. 103-160 (10 U.S.C. 2371 note), with a new or existing consortium that has significant non-traditional contractor participants. At this time the Government is not ruling out the possibility of establishment of a prototype OTA pursuant to 845 of P.L. 103-160 (10 U.S.C. 2371 note) with a single entity that is not a consortium. However, more information is needed from industry to help the Government determine the appropriate course of action. The Government is interested in gaining additional information from industry such as: - Under what conditions/circumstances would industry participate in an OTA consortium? - What barriers does industry see in working with the DoD in an OTA consortium strategy? (e.g. legal, intellectual property rights, royalties, inclusion of DoD Advance Development & Manufacturing Capability, membership rules (Any company, university, or research organization should be eligible to join the consortium.), FAR applicability). - What incentives would industry like to see included as part of an OTA consortium strategy? (e.g. number and value of projects to be awarded within the consortium, time frame for the awards to be made and work to be accomplished, limited liability). 2.0 TECHNICAL OBJECTIVES Chemical agents of concern fall under the broad categories of nerve, blister, blood, and pulmonary agents. Biological agents of concern include bacterial, toxin and viral threat agents. Radiation threats result from nuclear detonations, nuclear accidents, or spread of radioactive materials through improvised radioactive explosive devices or other means of radioactive particulate dispersion, either intentional or accidental. The Government is seeking interested parties that are willing to join and/or establish a consortium with collective expertise in the following technology areas specifically related to the JPM-MCS Mission. A. DETECTION The DoD desires technologies that predict, detect and identify the clinical diagnosis of infection/illness caused by CBRN threats. Desired features of such systems include high sensitivity and specificity, ease of use (CLIA waiver), multiplexing capability, integrated sample preparation, and low logistics burden (size, weight, power requirements). Multiple technological approaches, such as molecular or protein-based detection would be considered to maximize diagnostics capability for the full spectrum of CBRN threats. A single system that could integrate multiple detection technologies is preferred. The Critical Reagents Program (CRP) performs a functional support role to a variety of MCM programs. The CRP's mission is to serve as the principal resource of high quality, validated, and standardized biological detection assays and reagents that meet the requirements. In addition, the CRP seeks to support the broader biological defense community by facilitating the transition of new technologies and coordinating their advanced development, efficient production, and timely distribution. CRP products include antibodies, antigens (inactivated organisms), genomic materials, electrochemiluminescence (ECL) assays, polymerase chain reaction assays (PCR), and lateral flow immunoassays (LFI). These products are available for sale to DoD and US Government customers and support biodefense missions throughout the Interagency. The CRP also sponsors the DoD's microbial strain repository (Unified Culture Collection, or UCC) as well as its derivative products (e.g., antibodies, antigenic and genomic materials). In FY14, the CRP launched a beta version of its microbial threat characterization data repository: CRP TIC (CRP (microbial) Threat Information Center). This data repository contains metadata on the strains housed in the UCC as well as corresponding genotypic and phenotypic characterization data on those strains. It also provides users with a link between the strains in the UCC and any related CRP products. CRP's specific needs include a variety of prototyping efforts that directly improve or augment the program's current product offerings. Prototypes are needed for new assays (both immuno- and molecular), significantly improved existing assays, and well-characterized reference materials that perform better when used in assays. B. PREVENTION Prevention is primarily concerned with the development of vaccines to counter the effects of biological warfare agents (BWA) and chemical warfare agents (CWA). These countermeasures include specialized medical materiel (e.g., vaccines and immunotherapeutics) as well as other biological products (e.g., immunoglobulins) designed to be effective as prophylaxis or, to treat rare but serious adverse events from other prophylaxis treatments. BWA of interest include various bacteria such as Francisella tularensis, Burkholderia, genetically altered, and multi drug resistant strains. Toxin threat agents of concern include the following Botulinum Neurotoxin (BoNT), Ricin, Staphylococcal Enterotoxins. Potential viral threat agents of concern include Alphaviruses and Filoviruses. MCMs must be FDA-approved to provide the US Military Forces from the debilitating and life threatening health threats of BWA or CWA prior to the appearance of symptoms. Overarching priorities of the prevention projects include: 1. Development of prophylaxis or pretreatment systems to protect Warfighters from the effects of BWA and CWA prior to the appearance of symptoms. Often vaccines are agent, and frequently subtype specific. For these reasons, there is particular interest in broad spectrum protection and multi-agent medical products. Development of safe and efficacious prophylaxis or pretreatments that have reduced logistical burden. 2. Development of enabling technologies that support, facilitate, or accelerate the development or licensure of MCMs. It is anticipated that FDA approval will be achieved under the animal rule. Development efforts may involve identification of correlates of protection, and development/characterization of relevant animal models. C. TREATMENT Therapeutic pharmaceuticals are non-vaccine pharmacological or biological products used to treat patients exposed to either CWA or BWA. Overarching goals of the treatment projects include: 1. Development of systems that support maintenance or restoration of pre-CWA or pre- BWA exposure health and that allow Warfighters to complete their mission. This includes CWA or BWA MCMs that prevent, reverse, or significantly mitigate the effects and negative operational impact of CWA or BWA. MCMs may block, stop or reverse the direct effects of these agents, or prevent or treat the pathology and symptoms of these agents. 2. Development of MCMs that provide broad-spectrum treatment for classes of CWA or BWA and a range of exposure routes. The products should be flexible enough to respond to a wide range of warfare agents, including traditional and emerging agents. 3. Evaluate and leverage enabling technologies to enhance/prolong the shelf life of CWA MCMs currently in the military arsenal. Areas of focus include developing new container-closure systems, single- and dual-chamber auto-injectors, wet-dry auto-injectors and any needed formulation development. 4. Development of enabling technologies that support, facilitate, or accelerate the development or licensure of MCMs. It is anticipated that FDA approval will be achieved under the animal rule. Development efforts may involve identification of correlates of protection, and development/characterization of relevant animal models. 3.0 INDUSTRY DAY An industry day is planned to occur June 15, 2015 in Philadelphia, PA. This event will provide industry/academia the opportunity to obtain further details and engage in discussion of Government requirements with the Government sponsors. The industry day will also provide another venue for discussion of the barriers and incentives associated with the establishment and use of an OTA consortium to meet JPM-MCS mission requirements. Additional details of the industry day will be provided in a forthcoming notice. This industry day will serve as an initial opportunity for interested members of industry and academia to meet and discuss details with the key Army stakeholders. 4.0 REQUEST FOR INFORMATION In preparation for the industry day, the Government requests submissions from interested parties. An eligible party or group of parties, may include; industry, academic, non-profit, and not-for-profit partners, for research and development efforts to support JPM-MCS mission technical objectives. Responses can be sent to: Ms. Kristen Kachur (
[email protected]) NO TELEPHONE INQUIRIES WILL BE ACCEPTED. Responses should contain the interested parties' experience and capability information. 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. Responses should include a cover letter and at a minimum, provide the following: 1. A cover letter 2. A cover page labeled with the heading, in quotation marks, quote mark MCS OTA RESPONSE quote mark quote mark , name of company, 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, CAGE Code, and any other pertinent information. 3. No more than twenty (20) pages including: (a) Responses to the questions - Under what conditions/circumstances would industry participate in an OTA consortium? - What barriers does industry see in working with the DoD in an OTA consortium strategy? (e.g. legal, intellectual property rights, royalties, inclusion of DoD Advance Development & Manufacturing Capability, membership rules (Any company, university, or research organization should be eligible to join the consortium.), FAR applicability, Government expectation of use of ADM). - What incentives would industry like to see included as part of an OTA consortium strategy? (e.g. number and value of projects to be awarded within the consortium, time frame for the awards to be made and work to be accomplished, limited liability). (b) Questions to be answered/discussed at the industry day. (ALL QUESTIONS AND ANSWERS WILL BE PUBLISHED) (c) Narrative describing capability (past and present) with respect to technical objectives listed in this notice. 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. 5.0 ADDITIONAL INFORMATION This Special Notice is for information and planning purposes only, shall not be construed as an invitation for bid, request for quotation, request for proposal, or a commitment by the U.S. Government. The U.S. Government does not intend to award a contract on the basis of this announcement. 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. In March 2013 the DoD awarded a contract to Nanotherapeutics, Inc. (NANO-ADM) to establish a capability containing two Current Good Manufacturing Practices (cGMP) manufacturing suites capable of manufacturing at Bio Safety Level (BSL) 3. The capability will also include laboratory space for process development, pilot scale manufacturing, and quality control (QC) testing. The DoD has made a significant investment with the intent of full utilization of this capability to support the advanced development of CBRN MCM. The JPM-MCS expects NANO-ADM will be invited to join any consortium formed in response to a future request from the JPM-MCS On February 9, 2015 the U.S. Army Medical Research and Material Command (USAMRMC) released an open solicitation requesting proposals to organize and operate the Medical Technology Enterprise Consortium (MTEC), a consortium of industrial, academic and other organizations operating as a 501(c)(3) corporation. The Consortium will engage in: 1. biomedical research and prototyping; 2. capitalization of private sector technology opportunities; 3. technology transfer; 4. commercialization of Government intellectual property; and 5. follow-on production for the U.S. Army Medical Research Acquisition Activity, on behalf of the U.S. Army Medical Research and Materiel Command. Proposals were solicited to address the Consortium organization, operation, capitalization, research, technology transfer, and commercialization requirements. The JPM-MCS does not intend to utilize nor compete with the MTEC once established as there is a significant difference between the USAMRMC and JPM-MCS missions.