REQUEST FOR INFORMATION (RFI) Chikungunya Virus (CHIKV) prophylaxis or therapeutic

REQUEST FOR INFORMATION REQUEST FOR INFORMATION (RFI) NO: CHIKUNGUNYA-HK-2019-5-16 1.0 RFI TITLE: Chikungunya Virus (CHIKV) prophylaxis or therapeutic 2.0 AGENCY: U.S. Army Medical Materiel Development Activity (USAMMDA), Ft Detrick, Maryland 3.0 OFFICE: Pharmaceutical Systems Project Management Office (PSPMO) 4.0 LOCATION: N/A 5.0 SUBJECT: The PSPMO, USAMMDA is conducting market research to determine whether a commercial solution can be provided to meet requirements for a U.S. Food and Drug Administration (FDA) Chikungunya prophylaxis or therapeutic. This market research may also assist with the further development and/or refinement of the requirements. 6.0 DISCLAIMER: : In accordance with Federal Acquisition Regulation (FAR) 15.201 "Exchange with industry before receipt of proposals," this RFI is for information and planning purposes only at this time, and shall not be construed as a solicitation or as an obligation on the part of the USAMRMC, or collaborative Department of Defense (DoD) activities. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained. 7.0 DESCRIPTION: The PSPMO, USAMMDA has a requirement to identify biopharmaceutical businesses capable of supporting human clinical trials, non-clinical studies, manufacturing, and FDA regulatory compliance to meet the U.S. Army objective of providing an FDA-licensed/approved chikungunya prophylaxis or therapeutic. The FDA-licensed/approved chikungunya prophylaxis or therapeutic will support deploying and deployed U.S. Army forces to areas of concern. 8.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must demonstrate the firm's ability, capability, and responsibility to provide the research and development efforts to supply an FDA-licensed/approved prophylaxis or therapeutic. Responses to this RFI will be in the form of a White Paper, not to exceed 10 pages. Respondents are urged to limit marketing material in order to provide more substantive information in their response. All information is to be submitted in Microsoft Word via email. Information provided will not be returned. All responses shall be in the English language. The subject header of the email for submission of questions and/or the RFI response shall be: Chikungunya prophylaxis or therapeutic. All information regarding capabilities statements or any other proprietary information relative to this RFI shall be marked appropriately. Submission should include the following information: 8.1 The USAMMDA requires a biopharmaceutical company capable of supporting innovative advanced development efforts to meet the U.S. Army objective of providing an FDA-licensed/ approved chikungunya prophylaxis or therapeutic. Preference is for a company capable of serving as the Sponsor to the FDA for all development and license/approval requirements with a potential candidate meeting at least the Technology Readiness Level (TRL) 5 criteria in accordance with the attached TRL definitions. USAMMDA is contemplating the award of either a FAR-based contract, Other Transaction (OTA), or Cooperative Research and Development Agreements (CRADA) to accomplish the objective. The level of technical maturity and possible industry cost-sharing opportunities to meet the objective will help inform the strategy for the award. 8.2 Respondents are requested to provide their capabilities and previous experience to meet FDA regulations and guidelines for the following activities: - a) Conduct or contract for required current Good Manufacturing Practices (cGMP) to meet clinical scale - b) Conduct clinical trials in accordance with Good Clinical Practices (GCP) - c) Conduct or contract for required Good Laboratory Practices (GLP) for non-clinical studies - d) Devise regulatory development and approval strategies The initial project phase scope is anticipated to include all research, development, manufacturing, nonclinical, Investigative New Drug (IND) submission, and human clinical trial activities. The government's desire is to identify industry candidates that have demonstrated in an appropriate animal model an initial proof of concept that the candidate is efficacious against a CHIKV exposure, a favorable safety profile in humans, and a GMP manufacturing process. Therefore, respondents are requested to provide information for the following by demonstrating the technical maturity of their potential candidate for continued development to licensure/approval: - a) Proof of concept protection or treatment in relevant animal model(s) against CHIKV - b) Scalable manufacturing process that provides cGMP material in quantities sufficient to support human clinical trials - c) Documentation required to file an Investigational New Drug (IND) application with the FDA, including Chemistry, Manufacturing and Controls (CMC), nonclinical, and clinical data - d) Current product stability, storage parameters, and anticipated efficacy based on data generated to date, and anticipated dosing schedule - e) CHIKV prophylaxis/therapeutic clinical development plan that clearly describes how safety and efficacy will be established to satisfy FDA licensure requirements - f) Freedom to operate (i.e., ownership of intellectual property or licensing agreements) 8.3 The government desires a solution that either has demonstrated or is anticipated to meet the following performance criteria: - a) 80% Efficacy - b) 18 months of protection - c) Less than three months to achieve protection (i.e., vaccination series is 3 months or less) - d) Shelf life at least two years - e) Storage temperature in standard 2 - 8 C refrigeration. 9.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Herbert "Caj" Keen and Rebecca Foster at herbert.e.keen.civ@mail.mil and rebecca.d.foster4.civ@mail.mil no later than the close of business 28 June 2019. Telephonic communication will not be considered as submission nor receive response. Responses shall be limited to 10 pages, answer the questions posed in Section 8 and submitted via e-mail only. The font shall be Times New Roman, size 12, single space. Electronic files shall not exceed 3 MB. All submissions become Government property and will not be returned. 10.0 REQUIRED INFORMATION: Fill in the below table when responding to this RFI. Question Answer RFI Number Company Name Company Address Point of Contact Phone Number E-mail Address Tax Identification Number (TIN) CAGE Code DUNS Number Company Web Page Company Location(s) Company is / is not a Small Business Company is / is not SAM Registered Other Socio-Economic Classifications (e.g. 8(a), HUB Zone, Woman-Owned, Veteran-Owned, Service- Disabled Veteran-Owned) If 8(a), date that the company graduates from the program