DEVELOPMENT OF TRIPLE-CHAMBERED AUTOINJECTOR TECHNOLOGY

W911SR-23-S-3CAI REQUEST FOR INFORMATION development of TRIPLE-CHAMBERED AUTOINJECTOR TECHNOLOGY Objective: This is a Request for Information (RFI) for planning purposes only. 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. The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) and the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) is seeking information on the available capabilities and willingness of private entities (academic, non-profit, and commercial) to collaborate with the Government in the areas listed below. Background: JPM CBRN Medical is interested in developing the Consolidated Nerve Agent System (CNATS), an integrated and modernized triple-chambered autoinjector intended for use by the U.S. military and allies to counteract chemical and threats. The components of the program include the integration of chemical warfare nerve agent (CWNA) medical countermeasures (MCMs), to include an improved broad-spectrum oxime, in a modernized platform that is effective against current and emerging threats to supplement or replace fielded MCMs, thereby unencumbering the warfighter. ACC is seeking development of MCM prototypes for nerve agent exposure and to replace the government as regulatory sponsor with a contract research organization (CRO) sponsor to advance therapeutic prototypes. The performer will take the prototype/CNATS product through to FDA approval. Requirements: The Government is seeking white papers outlining novel approaches for a rapid acquisition plan with planned milestones to develop and deliver a triple-chambered autoinjector, using device manufacturing, preferably within 60 months. The purpose of this RFI is to solicit information on rough order magnitude (ROM) costs and the availability of companies with successful device manufacturing capabilities triple-chambered autoinjector technology that meet FDA cGMP and reliability requirements as well as MIL STD 810H standards. Performance Objectives: The triple-chambered autoinjector shall be designed for military use, and capable of being administered by self, medical, and non-medical individuals, in clinical and non-clinical (i.e., austere operational environment) settings, and maintain full functionality after prolonged exposure to an austere environment. A triple-chambered autoinjector prototype shall be capable of delivering three aqueous drug constituents via an intramuscular route through Mission Protective Posture (MOPP) Level 4 Personal Protective Equipment and Army Combat Uniform. A triple-chambered reconstitution autoinjector prototype shall be capable of delivering a single dose of a dry (lyophilized, spray dry, or combination) broad-spectrum oxime (i.e. HI-6, HLo-7) in one chamber via an intramuscular route through Mission Protective Posture (MOPP) Level 4 Personal Protective Equipment and Army Combat Uniform. A triple-chambered reconstitution autoinjector prototype shall be capable of delivering a combination of dry (lyophilized, spray dry, or combination) drug constituents and aqueous drug constituents via an intramuscular route through Mission Protective Posture (MOPP) Level 4 Personal Protective Equipment and Army Combat Uniform. To be consistent with the operation of other fielded military autoinjectors, a device with reconstitution capability should fully reconstitute the drug prior to administration, and not require additional user steps (such as shaking) to reconstitute. The triple-chambered autoinjector shall allow a warfighter wearing MOPP Level 4 Personal Protective Equipment and Army Combat Uniform, to identify this device from other current/developmental autoinjectors in use by the military, and be self-administered during periods of reduced visibility/dexterity and minimize the risk of inadvertent administration. The device design shall either; 1) utilize open-source technology that does not rely on protected intellectual property, or 2) use technology to which the Offeror has, or will obtain, sufficient intellectual property rights. Offeror's response must state with specificity how Offeror has adequate intellectual property rights to perform, addressing both the device and the drug. Identify sources of starting materials required for the manufacture of the autoinjector. Preference should be given for sourcing starting materials through U.S. based companies. Material sources manufactured in the U.S. are highly desired. Demonstrate capabilities to conduct or manage stability programs to support the development of the autoinjector. As the triple-chambered autoinjector program evolves through the phases toward licensure with the FDA, company to demonstrate capabilities to manufacture at scales necessary for the specific phases of the program and, as required, commercial scale production to meet market(s) requirements. Include discussion on how the manufacturing processes are validated. Demonstrate capability to confirm expected shelf life of the triple-chambered autoinjector. Demonstrate capabilities to develop and manufacture the autoinjector under cGMP guidelines to meet the needs of each clinical phase of the program and eventual commercial market(s) Develop a regulatory pathway to FDA approval including all required studies. Serve as the sponsor for Food and Drug Administration (FDA) correspondence and submissions of data packages to obtain FDA approval. The performer shall comply with Institution Animal Care & Use Committee (IACUC) review and U.S. Army Animal Care and Use Review Office (ACURO) review, approvals from the U.S. Army Medical Research and Materiel Command (USAMRMC) Human Research Protections Office (HRPO) and the study's central Institution Review Board (IRB), if required. Regulatory Objectives: FDA Compliance: The triple-chambered autoinjector shall meet or exceed the quality standards established by current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and FDA and/or International Conference on Harmonization (ICH) and International Organization for Standardization (ISO) standards, during the course of development The Respondents shall provide the following in reply to this RFI, not to exceed 7 pages in total: Company Description (2 page maximum). Provide a brief description of company history, alliances, and funding, emphasizing experience in device manufacturing Discuss any data rights assertions anticipated for the autoinjector development (Freedom to operate, patent application status, issued or licensed intellectual property) Triple-Chamber Autoinjector Technology Device Manufacturing Capability Description (5 page maximum). Please provide the following information for BOTH options. Three chambers, all liquid Three chambers, one with reconstitution technology for the broad-spectrum oxime Description and discussion of any or all of the capabilities described in the Performance Objectives section. Innovative approaches that address the overarching program goals that do not precisely match the above Performance Objectives can be included Provide a description of the design framework and design methods to be used in this effort Discussion of the maturity of the proposed approaches, including previous demonstrated use, and any relevant FDA regulatory exposure Provide a high-level development schedule Provide a Rough Order of Magnitude cost for triple-chambered autoinjector development with and without reconstitution technology, if applicable Provide approach to Cost of Goods analysis. Any associated intellectual property rights or patent coverage Administration: 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. All written responses must be received by COB on 26 May 2023. Responses should be sent by e-mail to: usarmy.detrick.jpeo-cbd.mbx.mcs-rfi@mail.mil, and usarmy.detrick.dod-jpeo-cbrnd.mbx.baa@army.mil, with Subject Line of Responding Organization and RFI Title. Material that is advertisement only in nature is not desired. If a solicitation is subsequently released based on the responses to this RFI the first choice for an acquisition vehicle, if appropriate, will be the Medical CBRN Defense Consortium (MCDC) Other Transaction Agreement (OTA). Respondents not already members of the consortium are encouraged to join at www.medcbrn.org. Respondents may also inquire about the MCDC at mcdc@ati.org and view the Medical Countermeasures Broad Agency Announcement (BAA) in SAM.gov, keywords MCS-BAA-17-01. For questions related to this RFI, please e-mail to: usarmy.detrick.jpeo-cbd.mbx.mcs-rfi@mail.mil, and usarmy.detrick.dod-jpeo-cbrnd.mbx.baa@army.mil. The Point of Contact for this RFI is Richard Totten at richard.w.totten2.civ@army.mil.