Inactive

Related Notices: Request for Information, Notice ID 75N95023R00004, Pharmacology Studies and Animal Model Development and Related Services for Drug Development, published November 7, 2022. Sources Sou... Related Notices: Request for Information, Notice ID 75N95023R00004, Pharmacology Studies and Animal Model Development and Related Services for Drug Development, published November 7, 2022. Sources Sought, Notice ID 75N95023R00004-SS, Pharmacology Studies and Animal Model Development and Related Services for Drug Development, published February 7, 2023. PURPOSE OF NOTICE This is a Research and Development (R&D) Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of Small Business sources to perform a potential R&D requirement. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. The Government will not entertain questions regarding the results of this market research. BACKGROUND The Therapeutic Development Branch (TDB) within 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 to support therapeutic development by moving small molecule and biologic drug candidates forward in the drug development pipeline. Upon reaching predetermined milestones, TDB hands off clinical candidates to external partners to bring these novel therapies to patients. In addition to developing new candidate drugs, TDB 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. The TDB 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, TDB will support studies up to human Phase IIb. TDB conducts drug development through collaborations, with therapeutic candidates originating from academia, industry, non-profit foundations, or internally from NCATS and other NIH institutes. TDB’s operational strategy is to combine the capabilities of in-house staff and collaborative partners with complementary support from contract research organizations (CROs). Each development program operates in a multi-disciplinary matrix team environment, with NCATS responsible for overall planning and execution. The NCATS has an existing single-award IDIQ contract for CRO Support for NCATS Efficacy and In Vivo Pharmacology Studies and Related Services. This potential procurement would be a re-competition of this existing contract with some technical and administrative updates. The incumbent is Lovelace Biomedical Research Institute, Contract No. 75N95019D00012. PURPOSE AND OBJECTIVES The purpose of this Small Business Sources Sought is to obtain information about Small Business capabilities to support Pharmacology Studies and Animal Model Development and Related Services for Drug Development. The objectives of this potential acquisition are to obtain information about the biological effects of test articles on cellular and organismal function during the drug discovery and development process; to provide expertise in designing, executing, interpreting, and reporting on such studies, including in support of regulatory filings; and to optimize or develop relevant in vivo animal models and/or in vitro / ex vivo animal model replacement systems that support preclinical drug development efforts. The test article/product formats may include small molecules, short oligomeric compounds, biological (large) molecules, quaternary molecular assemblies (homogenous or heterogenous), vectors for gene therapy, nanoparticles, and any of the above modified genetically, biologically, or chemically. Novel formats identified after this draft might also be needed. Formats could also include Devices or Combination Products. ANTICIPATED PERIOD OF PERFORMANCE The potential IDIQ contract(s) are expected to have a seven-year ordering period. Task orders issued under the IDIQ contract(s) will have their own periods of performance that are based on the specific requirement. PROJECT REQUIREMENTS The potential acquisition is anticipated to be a multiple-award Indefinite Delivery / Indefinite Quantity (IDIQ) contract. The anticipated IDIQ contract(s) would include one or more of three separate technical areas: Technical Area 1: In Vivo Pharmacology Services and Model Development in Small Animals Technical Area 2: In Vivo Pharmacology Services and Model Development in Large Animals Technical Area 3: In Vitro Pharmacology Studies in Ex Vivo Tissue-, Cell-Based, or Other Relevant Animal Replacement Models SEE ATTACHED SMALL BUSINESS SOURCES SOUGHT NOTICE FOR COMPLETE PROJECT REQUIREMENTS, RESPONSE INSTRUCTIONS, AND IMPORTANT NOTES.