Inactive

This is a REQUEST FOR INFORMATION (RFI). This RFI is for market research purposes only to formulate a procurement strategy. It does not constitute a Request for Proposal (RFP) or a promise to issue an... This is a REQUEST FOR INFORMATION (RFI). This RFI is for market research purposes only to formulate a procurement strategy. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. Background The Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) conducts translational research on human therapeutics development by moving small molecule and biologic drug candidates forward in the drug development pipeline. Upon reaching predetermined milestones, DPI hands off clinical candidates to external partners to bring these novel therapies to patients. In addition to developing new candidate drugs, DPI seeks to advance the entire field of drug discovery and development by encouraging scientific and technological innovations aimed at improving success rates in the crucial preclinical stage of drug development. DPI’s model is to operate as a comprehensive small molecule and biologics drug development organization, moving therapeutic candidates through each phase of the preclinical development process until an Investigational New Drug (IND) application is filed with the US Food and Drug Administration (FDA). For certain drug development campaigns, DPI will support studies up to human Phase IIb. DPI conducts drug development through collaborations, with therapeutic candidates originating from academia, industry, non-profit foundations, or internally from NCATS and other NIH institutes. DPI’s operational strategy is to combine the capabilities of in-house staff and collaborative partners, who may be the drug originators, with complementary support from contract research organizations (CROs). Each development program operates in a multi-disciplinary matrix team environment, with a DPI project officer (PO) responsible for overall planning, execution, and reporting. Information Requested The Government seeks to obtain information about industry capabilities to support the DPI drug development programs by providing Chemistry, Manufacturing, and Control (CMC) services. The goal of these support services is to ensure DPI receives Drug Substance (DS) and formulated Drug Product (DP) of sufficient quality and quantity to support preclinical, IND-enabling, and clinical studies. Product formats may include small molecules, short- oligomeric compounds, biological (large) molecules, quaternary molecular assemblies (homogenous or heterogenous), and any of the above modified genetically, biologically, or chemically. The Chemistry, Manufacturing, and Control (CMC) services may include a broad range of preclinical services required for the design, development, manufacture, and release of DP as Clinical Trial Material (CTM), including precursors, preliminary states, DS standards and all required testing. Ancillary products (e.g., placebos, diluents, adjuvants, master cell banks, testing standards, reference materials) and other materials manufactured or purchased to support clinical trials or CMC activities may also be needed. All activities preliminary to manufacturing in accordance with current Good Manufacturing Practice (cGMP) may be required (e.g., process development, development or engineering lots, formulation studies), even without an associated cGMP manufacturing task. All activities required to maintain material in a usable state, including storage, shipping, testing (in process, release, stability, and quality actions), and preparation of documents to support regulatory submissions may also be needed. Specifically, the Government seeks to determine industry capability around Drug Substance (scale-up production of active pharmaceutical ingredients / drug substances) and Drug Product (Formulation and manufacture of drug product intended for administration to humans) in the following three areas: 1. Process Development, Manufacture and Analysis of Small Molecules 2. Process Development, Manufacture and Analysis of Synthetic Peptides, Oligonucleotides, and Related Substances 3. Process Development, Manufacture and Analysis of Biopharmaceuticals The specific information requested is in the attached Word document titled “Vendor Response Form”. This document provides specific questions and the required format for responses. This document is REQUIRED for all responses. Additional information may be provided along with this document if the respondent wishes to do so. There is no page limit on additional information but the Government may or may not review any or all of the additional information provided. Submission Instructions Submissions MUST include the attached Word document. This response document is intended to minimize the effort of the respondent and structure the responses for ease of analysis by the Government. Use of this document is REQUIRED for all responses. Responses must be emailed to Kimberly Espinosa, Contract Specialist, at kimberly.espinosa@nih.gov. Responses must be received by 12:00pm Eastern Time on Monday, May 17, 2021. The Government will make every attempt to acknowledge receipt but is not obligated to do so. Questions Questions regarding this RFI shall be submitted via email to Kimberly.espinosa@nih.gov no later than 3:00pm Eastern Time on Thursday, May 13, 2021. Verbal questions will not be accepted. The Government will attempt but does not guarantee to answer questions submitted. Any answers will be provided in writing. Additional Information This RFI is not a Request for Proposal (RFP) or an obligation on the part of the Federal Government and the NIH. The Government will not formally evaluate or provide feedback to responses received for this RFI. The Government does not intend to award a contract based on this RFI or to otherwise pay for the information solicited. All exchanges between the Government and outside entities, including responses to this RFI, may guide the NIH in drafting future contracts at an undetermined time. There is no solicitation available at this time; no basis for claims against NIH shall arise as a result of this RFI, responses thereto, or the NIH’s use of such information as either part of its evaluation process or in developing specifications for any subsequent requirement. Responses to this RFI are voluntary. This RFI is for planning purposes only and should not be construed as a solicitation for applications or an obligation on the part of the Federal Government, the National Institutes of Health, or individual NIH Institutes or Centers. The Government will not pay for the preparation of any information submitted or for the Government’s use of that information. The information provided will not be considered confidential. The NIH will use the information submitted in response to this RFI at its discretion; the submitted information will be reviewed by the NIH and shared with the NIH Institutes and Centers that have an interest in this matter. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s), policies or procedures; responses to the RFI may be reflected in future funding opportunity announcements. Any solicitation resulting from the analysis of information obtained from this notice will be announced to the public in Federal Business Opportunities, at FBO.gov, in accordance with the FAR Part 5. However, responses to this notice will not be considered adequate responses to any resulting solicitation.