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) within the National Institutes of Health (NIH) 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.
Contract research organizations (CROs) and contract manufacturing organizations (CMOs) provide DPI with manufacturing, pharmacology, toxicology, regulatory, and clinical operations services to assist with drug development. Planning and execution of each individual drug development program includes identification of scientific areas best suited for utilization of CROs and CMOs to conduct some or all parts of a given drug development program.
Information Requested
The Government seeks to obtain information about industry capabilities to support the DPI drug development programs by providing pharmacology studies and animal model development and related services for drug development. This requires novel, re-developed, optimized, or use of existing, validated animal models to conduct in vivo pharmacology studies, often for rare disorders and neglected diseases. These models are not able to be pre-determined as needs change depending on the disease; as such, access to both small (e.g., mice, rat) and large (e.g., dog, cat, monkey, pig) models are needed. In addition, therapies can cover a wide range of modalities such as, small molecules, and biologics (e.g. antibody, proteins, and cell and gene therapy).
Specifically, the Government seeks to determine industry capability in the following five areas:
1. In Vivo Pharmacology Services in Small Animal Models
2. In Vivo Pharmacology Services in Large, Non-Traditional Animal Models Including Non-Human Primates
3. Small Animal Models Acquisition, Optimization/Refinement, and Development
4. Large, Non-Traditional Animal Models Acquisition, Optimization/Refinement, and Development
5. In Vitro Pharmacology Studies in Ex-Vivo Tissue, Cell-Based or Other Relevant Animal Replacement Models including Acquisition, Optimization/Refinement, or Development of Such Relevant Experimental Model Systems
The specific information requested is in the attached Word document titled Vendor Response Form . This document provides the required format for responses and 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 document. Vendors may submit this document as a Word document or a PDF. This response document is intended to minimize the effort of the respondent and structure the responses for ease of review by the Government. Use of this document is REQUIRED for all responses.
Responses must be emailed to Kimberly Espinosa, Contracting Officer, at kimberly.espinosa@nih.gov. 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 at kimberly.espinosa@nih.gov no later than 12:00pm Eastern Time on Monday, November 14, 2022. 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 to 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 solicitations 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 proposals 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 review of information obtained from this notice will be announced to the public in the System for Award Management (SAM.gov), in accordance with the FAR Part 5. However, responses to this notice will not be considered adequate responses to any resulting solicitation.
