DEVELOPMENT OF AN ALTERNATIVE ATROPINE AND 2-PAM AUTOINJECTOR

W911SR-22-S-ALTAI REQUEST FOR INFORMATION Development of an Alternative Atropine and 2-PAM Autoinjector 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 expanding the industrial base for fielded nerve agent treatment systems to reduce risk and expand manufacturing capabilities. JPM CBRN Medical is seeking information from private entities interested in the advanced development through Food and Drug Administration (FDA) approval of a novel concept delivery device suitable for intramuscular administration of pralidoxime chloride (2-PAM) and atropine. Candidates should be an autoinjector or other similar device and could potentially augment the currently fielded Antidote Treatment Nerve Agent, Autoinjector (ATNAA) device. The final end product of this work will be an FDA approved device capable of delivering 600 mg 2-PAM and 2.1 mg atropine via self-aid or buddy-aid. Requirements: The Government is seeking white papers outlining approaches for a 36 month rapid acquisition plan with planned milestones to develop and deliver an FDA approved combination product capable of delivering two drugs (2-PAM and atropine) from a single device employing military self-aid, or buddy-aid, or administered by a civilian first responder. The purpose of this RFI is to solicit information on the availability of autoinjectors capable of delivering two drugs, as an additional source for an autoinjector supplier to augment ATNAA inventory. The autoinjector should only require minor development rework to meet DOD user requirements, MIL STD 810H standards, and FDA approval. Performance Objectives: The autoinjector shall be designed for military use, and capable of being administered by self, medical, and non-medical individuals, in austere operational environment settings, and maintain full functionality after prolonged exposure to an austere environment. The delivery device shall be capable of supplying a single dose, up to 2 mL, of 2.1 mg of atropine and 600 mg of 2-PAM via an intramuscular route of administration through Mission Protective Posture (MOPP) Level 4 Personal Protective Equipment and Service Combat Uniform. The autoinjector shall allow a warfighter wearing MOPP Level 4 Personal Protective Equipment and Service Combat Uniform, to identify this device from other current auto-injectors in use by the military, to facilitate self-administer 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 contractor 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. The device shall have the ability to meet requirements for an FDA approved combination product and emergency-use injector. Regulatory Objectives: FDA Compliance: The prototype 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, and for establishing safety, efficacy, and device reliability of the product. FDA Approval The Awardee shall: Assume regulatory sponsorship of this Medical Countermeasure (MCM) Take the autoinjector through all required non-clinical and clinical trials. Develop a device that meets FDA reliability requirements [as evidenced by deliverables from Critical Parameter Development & Management (CPD&M)], and all other Chemistry, Manufacturing, and Controls (CMC) requirements. The Respondents shall provide the following in reply to this RFI, not to exceed 11 pages in total: Company Description (2 page maximum). Provide a brief description of company history, alliances and funding emphasizing experience in autoinjector development. Discuss any data rights assertions anticipated for the autoinjector development (Freedom to operate, patent application status, issued or licensed intellectual property). Autoinjector Development Capability Description (5 page maximum) 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 methods to be used in this effort. Provide a regulatory strategy. Discussion of the maturity of the proposed approaches, including previous demonstrated use, and any relevant FDA regulatory exposure. Provide a high level development schedule, to include NDA submission and approval. Provide a Rough Order of Magnitude cost. 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 20 September 2022. Responses should be sent by e-mail to: contact@example.gov, and contact@example.gov, with Subject Line of Responding Organization and RFI Title. Material that is advertisement only in nature is not desired. Respondents not already members of the Medical CBRN Defense Consortium (MCDC) are encouraged to join at www.medcbrn.org. Respondents may also inquire about the MCDC at contact@example.gov. JPM Medical also manages a Broad Agency Announcement (BAA), which may be viewed on SAM.gov, keywords W911SR-22-R-CBRND at https://sam.gov/opp/66870bda25274773b3e5fa7cfd3c0e11/view. For questions related to this RFI, please e-mail to: contact@example.gov, and contact@example.gov. The Point of Contact for this RFI is Richard Totten, at contact@example.gov.