A--Drug Manufacturing and Formulation Program (DMFP)

etwork (BPN). The goal of this DMFP requirement is to initiate and complete active pharmaceutical ingredient (API) scale-up and manufacturing to enable candidate molecules to enter clinical stage development. The Contractor in their own facilities and/or through subcontract shall conduct chemical synthesis and development of active pharmaceutical ingredients (API) and manufacture dosage forms of small molecule drug candidates rendering them suitable for administration in preclinical efficacy studies, Investigational New Drug (IND) enabling studies, and clinical trials. The Contractor in its own facilities and/or through subcontract shall also conduct process development and preparation of APIs, pre-formulation and formulation studies, analytical method development and validation, stability studies, API/drug product manufacturing, packaging, storage, and distribution. The Contractor shall also prepare data and documentation for all chemistry, manufacturing and controls (CMC) regulatory documents in a format acceptable to the U.S. Food and Drug Administration (FDA) for inclusion in a Drug Master File (DMF), IND or New Drug Application (NDA). All work must be conducted in accordance with current Good Manufacturing Practices (cGMP) regulations as required, and as appropriate Good Laboratory Practice (GLP) regulations. The ultimate goal of the BPN and DMFP is to bring new therapeutic drugs to market. To facilitate this, resultant contract(s) for this requirement will include a Determination of Exceptional Circumstances (DEC) to the Federal Acquisition Regulation (FAR). The DEC will enable the Contributors to retain control of the intellectual property for investigational agents evaluated through the DMFP. The Contractor shall be required to demonstrate its capability of performing all activities under Performance Activity 2A and Performance Activity 2B (summarized below). Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed, to conduct services in the following Performance Activities: Performance Activity 2A: Work under this performance activity will require the principal investigator/ project manager to consult with the project COR on a weekly basis, attend and participate in all meetings and teleconferences, and review and approve all contract deliverables. As part of Performance Activity 2A, the project manager/ principal investigator of the Contractor shall also provide general administration, coordination, and management of contract activities; participate in Lead Development Team (LDT) meetings, ad hoc meetings and teleconferences such as pre-IND meetings, IND meetings; prepare and submit reports as required by the terms of the contract. Performance Activity 2B: Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities as needed to successfully perform Performance Activity 2B, which includes all technical activities related to API scale up and manufacturing, formulation and dosage form manufacturing, analytical methods development, and stability testing. Technical activities falling under Performance Activity 2B will include the following three, major campaigns: 1. Campaign #1 Feasibility Studies: Campaign #1 shall include but is not limited to the following activities: chemistry technology transfer, route familiarization and process development, chemical synthesis of demonstration batch, analytical method development and qualification, salt polymorph screen, characterization of API and related substances, synthesis of labeled reference standards, annual certification of reference standards, and supply chain management. 2. Campaign #2 Clinical Trial Readiness: Campaign #2 shall include but is not limited to the following services to be provided by the Contractor: chemical synthesis and scale-up of toxicology batches, ICH stability on toxicology batches, analytical methods development, pre-formulation studies, formulation development studies, and supply chain management of toxicology batches. 3. Campaign #3 Clinical Trial Material: Campaign #3 shall include but is not limited to the following services to be provided by the Contractor: manufacturing of API under cGMP regulations; stability testing of API under cGMP regulations; preparation of drug products, analytical methods development, stability testing of drug products, storage of drug products, labeling of drug products, and distribution of drug products. A multiple-award Indefinite Delivery Indefinite Quantity (IDIQ) type contract program is anticipated for this requirement. Resultant contracts will have a ten-year ordering period to allow for the issuance of task order request for proposals (TORFP) for each DMFP project. All IDIQ contract holders will have an opportunity to submit their proposal in response to the TORFP. The NINDS program officials will evaluate the submitted proposals and award a level-of-effort and completion type, cost-reimbursement task order to an offeror. It is anticipated that the IDIQ contract awards will be issued in January 2025. Offerors are required to be registered and active in the System for Award Management (SAM) when submitting a proposal and shall continue to be registered until time of award, throughout performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from a solicitation. Processing time should be taken into consideration when registering. Offerors who are not registered in SAM should consider applying for registration immediately upon receipt of this pre-solicitation. See FAR 52.204-7 System for Award Management (Oct 2018) and https://www.sam.gov for registration information. This is NOT a Request for Proposals (RFP). Request for Proposals (RFP) No. 75N95024R00077 will be available electronically and may be accessed through the SAM website (URL: https://www.sam.gov) 30 or more calendar days after the issuance of this synopsis. THIS SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THE SAM WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED. All responsible sources may submit a proposal, which shall be considered by the agency.