U.S. Food and Drug Administration (FDA) Licensed Countermeasure for Botulinum Neurotoxin Exposure

The U.S. Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division, Ft. Detrick, on behalf of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), Joint Project Manager (JPM) CBRN - Medical is issuing this Request for Information (RFI) for Market Research purposes. This is not a solicitation or request for competitive proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. 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. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The Government will NOT pay for information and materials received in response to this RFI and is no way obligated by the information received. This notice is for market research purposes only to obtain information regarding (1) the availability and capability of all qualified performer sources, (2) including small businesses; HUB Zone small businesses; service-disabled small businesses; veteran-owned small businesses; woman-owned small businesses; small disadvantaged businesses; and universities and educational institutions, (3) their size classification relative to the North American Industry Classification System (NAICS) Code for the proposed acquisition. The applicable NAICS Code is 541714 Research and Development in the Physical, Engineering and Life Sciences (except Biotechnology). OBJECTIVES The Government requires the advancement of a medical countermeasure (MCM) against exposure to botulinum neurotoxin (BoNT) A and B serotypes to obtain Food and Drug Administration (FDA) licensure within five years for a prophylactic indication. The prospective MCM shall have submitted an Investigational New Drug (IND) application to the FDA for the indication and initiated subject enrollment for a Phase 1 clinical trial. The respondent must include all necessary studies to obtain FDA licensure fully compliant to all FDA regulations, including go/no-go decisions points between development phases. The respondent must provide data to substantiate that it has the capacity to produce a maximum quantities of 75,000 doses to be delivered over five (5) years following FDA-licensure. RESPONDENTS MUST PROVIDE EVIDENCE IN THEIR RESPONSE SHOWING THAT THEY HAVE THE REQUISITE ABILITY/EXPERTISE AND CURRENT EXPERIENCED PERSONNEL ON STAFF TO PERFORM THE REQUIREMENTS IN ALL AREAS AS INDICATED BELOW. MOST SPECIFICALLY RESPONDENTS MUST HAVE SUBMITTED AN IND PACKAGE FOR PREVENTION (PRE-EXPOSURE) AND REDUCTION OF INCIDENCE OR PROGRESSION OF DISEASE FOLLOWING EXPOSURE TO BoNT A AND B SEROTYPES, ESTABLISHED PHASE-APPROPRIATE TARGET PRODUCT PROFILE (TPP), OBTAINED - YOU MAY PROCEED LETTER FROM FDA, AND BEGUN SUBJECT ENROLLMENT FOR A PHASE I CLINICAL TRIAL. THE RESPONDENT SHALL OBTAIN FDA LICENSURE WITHIN FIVE YEARS FROM AWARD, AND MCM MUST PROVIDE PROTECTION TO THE WARFIGHTER IN THE FIELD. The proponent must have the ability/expertise to develop the product for FDA licensure under the - Animal Rule, and provide all documentation required for FDA submissions. The proponent must have the ability to provide all Chemistry, Manufacturing and Controls (CMC) processes, as well as clinical and nonclinical studies required for licensure. The proponent must have the ability/expertise to advance the proposed MCM through to FDA licensure by accomplishing the following objectives: Provide a prototype suitable for licensure by meeting the 21 Code of Federal Regulations (CFR) regulatory requirements, applicable International Code Harmonization(s) (ICH) and FDA communicated requirements. A Regulatory Strategy and Target Product Profile (TPP) to incorporate feedback from formal FDA communications or issues identified by the DOD for the proposed product. Take advantage of all opportunities to expedite licensure, such as Priority Review and Fast Track. A Product Development Plan (PDP) to include risk assessment of proposed MCM developmental path to licensure, in accordance with feedback from the FDA and DOD. Complete Process Performance Qualification (PPQ) for Drug Substance (DS) and Drug Product (DP) manufacturing in accordance with FDA regulations and ICH guidelines (e.g. ICH Q8(R2) and obtain FDA concurrence for manufacturing process validation. Complete method qualification/validation of all DS and DP release, stability, and in-process assays according to FDA regulations and ICH guidelines (e.g. ICH Q2R1)). Complete method qualification/validation and obtain FDA concurrence for use of Pharmacokinetic (PK) methods to assess clinical (human) and nonclinical (large and small animal) samples in support of pivotal endpoints. Develop a plan to submit an Emergency Use Authorization (EUA) request and subsequently execute an Emergency Use Authorization (EUA) or Expanded Access (EA) protocol, and implement it at the direction of the DOD. Generate adequate DP to support nonclinical studies, Phase II and III clinical trial(s), and either an EUA or EA protocol as proposed. Conduct all required clinical planning and execute Phase II and III clinical trial(s) in compliance with regulatory requirements towards licensure. Address and resolve identified manufacturing concerns Conduct non-Good Laboratory Practices (GLP) and GLP nonclinical studies and dose modeling analysis to support prototype licensure as specified in the FDA - Guidance for Industry: Product Development under the Animal Rule. Define immunobridging (between humans and selected animal models) strategy, address and resolve identified issues with animal efficacy study design and assays required to test for efficacy under the FDA - Animal Rule. Provide storage facilities for regulatory compliance documents, clinical specimens, and DP, in agreement with regulatory requirements until final disposal or transfer. Monitor in-process inventory, including retains and assay testing plans, to include DS and DP stability reports Submit a Biologics License Application (BLA) to the FDA, and complete all regulatory touch points along the development and approval pathway (such as End-of-Phase I and II meetings (EOP1, EOP2), pre-BLA, pre-approval inspection (PAI), and others as necessary). DISCLAIMER AND IMPORTANT NOTES The Government will not pay for any information submitted in response hereto. Responders are solely responsible for all expenses associated with responding to this RFI. This notice does not obligate the Government to issue a solicitation or to award a contract. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to the respondents with respect to any information submitted. Submission Instructions: Responses shall be submitted and received via Email to lee.a.hess.civ@mail.mil no later than 2:00PM EST December 16, 2020. Documents shall be no more than 15 pages total, electronic in Microsoft Word, Excel, Power Point, and/or Adobe Portable Document Format (PDF) and provided as attachments to the Email. No telephonic responses to this RFI will be considered. All information received in response to this RFI that is marked proprietary will be handled accordingly. Responses to the RFI will not be returned. Responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Responders must include information on their organization (not counted towards page limitations shown above): Company Name, Address and Single Point of Contact with Name, Title, Telephone Number and E-mail Address. DUNS Number and Cage Code Confirmation of Current Active Registration in System for Award Management (SAM), SAM registration information may be found at the following website: https://www.sam.gov/portal/public/SAM Primary NAICS Code(s) and Business Size (i.e., small/large)