Inactive
Notice ID:75N95023R00029
INTRODUCTION PURSUANT TO FAR Subpart 5.2—Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT ACTION. The National Institute on Drug Abuse (NIDA), Office of ...
INTRODUCTION PURSUANT TO FAR Subpart 5.2—Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT ACTION. The National Institute on Drug Abuse (NIDA), Office of Acquistion (OA) on behalf of the National Center for Advancing Translational Sciences (NCATS) intends to award multiple indefinite-delivery, indefinite-quantity (IDIQ) type research and development (R&D) contracts for safety evaluation and toxicology studies and related services for drug development. EXTENT OF COMPETITION This acquisition is proposed to be solicited under full and open competition with no set-aside restrictions NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology); with a Size Standard of 1,000 employees. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2023-02 with effective date of March 16, 2023. This acquisition is conducted under the procedures as prescribed in FAR Subpart 15—Contracting by Negotiation at an amount exceeding the simplified acquisition threshold inclusive of options. DESCRIPTION OF REQUIREMENT Project Description 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 biologic 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). Purpose and Objectives Safety assessment of the therapeutics and diagnostics is an important component of the drug and device discovery and development efforts in DPI. These assessments play a pivotal role in determining and evaluating therapeutic targets; selecting and optimizing therapeutic lead candidates; and establishing first in human starting doses, dose limiting toxicities, safety/pharmacodynamic biomarkers and therapeutic indexes. To support safety assessments, DPI intends to award multiple contracts for the conduct of in vitro and in vivo exploratory and IND-directed toxicology studies. Contractors will be required to perform in vitro and in vivo safety studies for small and large molecules to support the submission of regulatory filings to the US Food and Drug Administration (FDA) or other regulatory bodies, such as Investigational New Drug (IND) applications, New Drug Applications (NDA) and Biologics License Applications (BLA). In addition, in vitro tests and in vivo exploratory studies will be carried out to aid therapeutic target evaluation, lead optimization, and compound selection processes on a case-by-case basis. Therapeutic modalities may include new and repurposed chemical entities and biological products (e.g., monoclonal antibodies, enzymes, gene vectors, etc.). Offerors will be required to propose on either Technical Area 1, Technical Area 2, or both Technical Areas. Project requirements: Technical Area 1: Exploratory and Genetic Toxicology In vitro toxicity testing (GLP and non-GLP) including but not limited to: mitochondrial toxicity, phospholipidosis and steatosis assay, hemolysis assay, lysosomal trapping assay (to assess the test article effect of lysosomotropism), membrane integrity assay, oxidative stress assay, apoptosis assay, hERG assay, Ames assay, mouse lymphoma assay, chromosome aberration assay; In vivo assays, including micronucleus assay and single cell gel electrophoresis (Comet Assay) in relevant species; and In vivo animal dosing studies, formulation and biological fluid analysis, clinical observations, clinical pathology, and histopathology evaluations in relevant species. Technical Area 2: In Vivo Toxicity and Pharmacology Testing In vivo toxicology studies (GLP and non-GLP) and or pharmacology studies in relevant species with datasets adhering to the Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data (SEND) guidelines; In vivo general toxicology and safety pharmacology studies via multiple routes of administration in support of IND/NDA/BLA-enabling toxicology packages including but not limited to: Non-GLP range finding studies; Formulation and biological fluid method development, validation, and analysis and defining pharmacokinetic/pharmacodynamic (PK/PD) relationships; Evaluating a range of endpoints and biomarkers in response to therapeutic candidates; GLP studies; GLP single-dose safety pharmacology studies; Reproductive toxicology studies; and Carcinogenesis studies. In vivo exploratory assays: Non-GLP exploratory toxicology studies in relevant species to aid therapeutic target evaluation, lead optimization, and compound selection. In vivo studies under this technical area will include, but not be limited to, animal dosing, formulation and biological fluid analysis, clinical observations, clinical pathology, and histopathology evaluations. Contractors shall also perform activities related to the overall administration of the contract including administrative reporting and deliverable requirements. Contractors shall have current certifications for conducting toxicology studies in accordance with appropriate regulatory guidelines and policies. Data and documentation from the above studies shall be prepared in a form acceptable to the Food and Drug administration (FDA) for inclusion in an IND application or New Drug Application and Biologic License Application. Contractors may be required to conduct any of the tests listed above to support the development of a therapeutic agent under development by DPI. Period of Performance The Government anticipates making multiple Indefinite Delivery, Indefinite Quantity (IDIQ) type contract awards with six-year ordering periods from April 21, 2024, through April 20, 2030, under the future solicitation. Projects will then be performed by contractors under individual task orders awarded under these IDIQ contracts. The Government anticipates awards will be made in the second quarter of FY 2024. CLOSING STATEMENT The solicitation will be issued on or about May 26, 2023, and bids or proposals will be tentatively due within 45 days after the solicitation release date. Potential offerors may request a copy of the solicitation from Contract Specialist Mark McNally electronically at mark.mcnally@nih.gov and must reference the solicitation number 75N95023R00029 on your electronic request. FAX requests are not accepted.
