Request for Information - Improved Nerve Agent System - Scopolamine

REQUEST FOR INFORMATION IMPROVED NERVE AGENT TREATMENT SYSTEM (INATS) - SCOPOLAMINE DEPARTMENT OF DEFENSE SOLUTION TO DEVELOP AN ADVANCED ANTICHOLINERGIC WITH INCREASED EFFICACY AGAINST NERVE AGENTS 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 Product Manager for Chemical Defense Pharmaceuticals (JPdM CDP) at the Joint Program Executive Office for Chemical and Biological Defense (JPEO CBD) Medical Countermeasures Systems (MCS) is seeking information on the capabilities and willingness of private entities (non-profit and commercial) in the areas listed below. Background: Therapeutic pharmaceuticals against chemical, biological, radiological and nuclear (CBRN) warfare agents are required to support the Joint Forces across a range of military operations. As such, the DoD has a need for developing and fielding systems that provide treatment for exposure to CBRN agents. The JPdM CDP is responsible for the development, procurement, fielding, and sustaining of medical treatment and prophylactic capabilities against chemical, radiological and nuclear threats. The current MCS-CDP portfolio includes nerve agent therapeutics, pretreatments and prophylactics at varying stages of clinical development, including FDA-approved drugs. The DoD is repurposing scopolamine hydrobromide trihydrate as a centrally-acting adjunct therapy that would be administered in conjunction with the ATNAA upon exposure of an individual to nerve agent. Scopolamine readily crosses the blood brain barrier and acts as a competitive antagonist at muscarinic acetylcholine receptors. It is intended to improve survivability and medical treatment outcomes against the central symptoms of current and emerging nerve agent threats. If successful, scopolamine will supplement existing medical countermeasures in a single chambered autoinjector similar to the Atropen. Requirements: One objective of the INATS is to develop an improved nerve agent treatment regimen consisting of a centrally-acting anticholinergic to treat the central symptoms of nerve agent poisoning. This development effort requires the repurposing of scopolamine to include but not limited to: formulation, stability and compatibility studies; non-clinical and clinical studies; manufacturing process development; large-scale manufacturing; and the preparation and submission of a New Drug Application (NDA). The objective of issuing this RFI is to gather information that will assist in the determination of a suitable solution for the advanced development of the oxime. The Government requests that potential performers provide an up to 5 page response containing the following information on current capabilities with potential to meet ANY of the following criteria, IN WHOLE OR IN PART: (1) Description of your company's experience with the program management of technically complex efforts, to include: - Existing capabilities to manage pharmaceutical product development efforts through FDA approval, to include assuming product sponsorship. a. Product(s) taken to FDA licensure/approval, including product type. Examples include small molecule therapeutics, large molecule therapeutics, vaccine, etc. b. Current products under development expected to achieve FDA licensure. Include explanation of product type and current stage of development. Examples include small molecule therapeutics, large molecule therapeutics, vaccine, etc. c. Experience with product development under 21 CFR 314 Subpart I or 601 Subpart H (i.e., the Animal Rule). Include any animal subject concerns. (2) Description of your company's technical expertise in pharmaceutical product development, to include: - Ability to manufacture current Good Manufacturing Practices (cGMP)-compliant clinical material to support Phase 1 and/or Phase 2 clinical studies. a. Experience with performing chemistry, manufacturing, and controls (CMC) studies and activities to include: standard characterization; assay development and validation; process development and validation; process scale-up assessments; preparation of technology transfer packages; formulation preparation and analysis; clinical trial formulation development; clinical dose delivery; container closure/extractables/leachables/compatability and sterilization. b. Estimate of small and/or large-scale cGMP-compliant manufacturing capability, to include experience with successful scale-up activities to full scale. c. Experience implementing International Conference of Harmonization (ICH) stability test programs to establish product shelf life, storage conditions and stability; experience conducting stability and compatibility testing of the pharmaceutical with the delivery device. - Ability to manage and conduct clinical study activities, Phase 1 dose escalation/pharmacokinetic studies and Phase 2 expanded safety/drug-drug interaction studies, in accordance with FDA regulations and Good Clinical Practices (GCP) guidelines. a. Experience designing GCP-compliant clinical protocols, informed consent forms, and case report forms sufficient for submission to the U.S. Army Human Research Protection Office (HRPO). b. Experience managing day-to-day clinical study operations, to include study drug and study supplies inventory management, severe adverse event management, and safety monitoring board management. Experience with clinical study data management, archiving and final study report generation. c. Experience with the design and conduct of the bioanalytical and pharmacokinetic (BA/PK) aspects of human clinical trials as well as with the analysis and evaluation of BA/PK data from human clinical trials. d. Experience with statistical planning and analysis should include developing a detailed statistical analysis plan, developing a subject randomization scheme, conducting interim and final analyses, and preparing a final statistical report. e. Experience in designing clinical protocols to evaluate a multi-drug treatment regimen. (i.e., evaluate drug-drug interactions for concomitantly administered pharmaceuticals) f. Experience with determination of human equivalent dose based on animal efficacy data, and a description of the methodology used. (3) Description of your company's experience with FDA regulatory interactions leading to product approval/licensure, to include: a. Ability to manage activities related to the development of an IND application and New Drug Application (NDA) submissions. Describe experience with submissions in an electronic Common Technical Document (eCTD) format. b. Engaging in meetings, Types A, B and C, with the FDA and preparation of pre-meeting information packets. c. Preparation and submission of Special Protocol Assessments. 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 November 2017. Responses should be sent by e-mail to: contracts.mcdc@ati.org with Subject Line of Responding Organization and RFI Title (INATS- SCOPOLIMINE). Material that is advertisement only in nature is not desired. This RFI is being released to the general public via the Federal Business Opportunities web site for market research purposes only. All capable providers, particularly members of the Medical Countermeasures Defense Consortium are encouraged to respond. Respondents not already members of the consortium are encouraged to join at www.medcbrn.org.