SPONSORSHIP AND DEVELOPMENT OF MANUFACTURING CAPABILITY FOR HI-6 DRUG PRODUCT

The below has been corrected to reflect 30 Apr 2023. ***************************************************************************************************************************************************** W911SR-23-S-MHI6 REQUEST FOR INFORMATION SPONSORSHIP AND development of manufacturing capability for HI-6 DRUG PRODUCT 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) under 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 Reactivator Nerve Agent Treatment System (RNATS), an improved broad-spectrum vialed oxime intended for use by the U.S. military and allies to counteract chemical threats. The components of the program include the development of an improved oxime, HI-6, that is effective against current and emerging threats to supplement the fielded oxime, 2-pralidoxime chloride (2-PAM). JPM CBRN Medical is seeking a performer with the capabilities for development of medical countermeasure prototypes for nerve agent exposure and to act as regulatory sponsor to take the prototype/RNATS drug 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 HI-6 drug product in a vial, preferably within 60 months. The purpose of this RFI is to solicit information on the availability of companies with successful manufacturing capabilities that meet cGMP requirements. Performance Objectives: The performer shall have demonstrated capabilities to develop and manufacture drug products in a vial under cGMP guidelines to meet the needs of each phase of the program and eventual commercial market(s). The performer shall have demonstrated capability to develop, qualify, and validate analytical methods for the characterization, release, and stability analysis of formulated drug products. The performer shall have demonstrated capabilities to conduct or manage stability programs to support the development and manufacturing of drug products. Regulatory Objectives: The performer shall develop a regulatory pathway to Food and Drug Administration (FDA) approval including all required studies. The performer should be familiar with the Animal Rule regulatory pathway. The performer shall serve as the regulatory sponsor for the RNATS product. FDA Compliance: The HI-6 drug product 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. FDA Communications: The performer shall have the ability to manage and coordinate all regulatory communications, documentation, and submissions with the agency including in person meetings, teleconferences, and email communications. Quality: The Awardee shall have the ability to prepare cGMP formulated Drug Product in a vial that can be used in Clinical/Preclinical studies, achieve FDA approval, and meet commercial market needs. 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) Office of Human Research Oversight (OHRO) and the study's central Institution Review Board (IRB), if required. 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 and partnerships, emphasizing experience in Drug Product manufacturing to cGMP standards. Provide a brief description of company experience in delivering FDA approved products. Provide a brief description of supply chain utilized for raw material procurement including location. Product Development Plan (9 page maximum) Provide a description and discussion of any or all 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. Discuss batch size capabilities including minimum, scale, and surge capabilities. Discuss 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. Provide approach to Cost of Goods analysis. Discuss any data rights assertions anticipated for the drug formulation process (Freedom to operate, patent application status, issued or licensed intellectual property). 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 30 Apr 2023 1600 EDST. Responses should be sent by email to: contact@example.gov, AND contact@example.gov, with Subject Line denoting the 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 an Other Transaction Agreement (OTA) issued either bilaterally via publicly posted Request for Prototype Proposal (RPP), and/or an RPP issued either under the Medical CBRN Defense Consortium (MCDC). Respondents not already members of the MCDC are encouraged to join at www.medcbrn.org. In addition, respondents are encouraged to view the Chemical Biological Radiological and Nuclear Defense (CBRND) Broad Agency Announcement (BAA) in SAM.gov, keywords - CBRND BAA. For questions related to this RFI, please e-mail to: contact@example.gov, AND contact@example.gov. The Points of Contact for this RFI are Richard Totten, at contact@example.gov and Lee Hess, at contact@example.gov.