SOLICITATION NOTICE
A -- Pharmacology Studies and Animal Model Development and Related Services for Drug Development
- Notice Date
- 6/13/2023 12:04:42 PM
- Notice Type
- Presolicitation
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NCATS BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95023R00004
- Response Due
- 6/28/2023 12:00:00 PM
- Archive Date
- 07/13/2023
- Point of Contact
- Kimberly Espinosa, Valerie Whipple
- E-Mail Address
-
kimberly.espinosa@nih.gov, valerie.whipple@nih.gov
(kimberly.espinosa@nih.gov, valerie.whipple@nih.gov)
- Description
- 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 Pharmacology Studies and Animal Model Development 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 and PRODUCT SERVICE CODE The intended procurement is classified under NAICS Code 541714 - Research and Development in Biotechnology (except Nanobiotechnology); with a Size Standard of 1,000 employees. The intended PSC Code is AN12 - Health R&D Services, Health care services, Applied Research. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular that is current at the time the solicitation is posted, which is currently (FAC) 2023-04 with effective date of June 2, 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. � 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 The purpose of this contract is to obtain pharmacology services related to the execution of in vivo and in vitro/ex vivo and related studies, including the optimization and/or development of animal models. The objectives 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. � There are three technical areas: Technical Area 1, Technical Area 2, and Technical Area 3. Offerors may propose on one or more Technical Areas. � Project requirements Technical Area 1: In Vivo Pharmacology Services and Model Development in Small Animals The Contractor shall provide services related to the conduct of in vivo studies with therapeutics under development. The studies under this technical area will be conducted using small animal models to support demonstration / verification of efficacy and further drug development activities. The Contractor also shall provide services related to the optimization / refinement of existing animal models or the development of novel models, including characterizing and validating such models to support drug development activities. Anticipated in vivo pharmacology services under this technical area include, but are not limited to: 1. Defining pharmacokinetic / pharmacodynamic (PK/PD) relationships from existing data or by independently establishing the PK parameters for therapeutic candidates. 2. Optimizing / refining or developing biomarkers and efficacy endpoints. 3. Determining correct route of administration (e.g., SC, IV, PO, IT, or ICV). 4. Determining appropriate dosing parameters. 5. Determining appropriate formulation(s) for administration. 6. Evaluating efficacy and biomarkers in response to treatment with test article. 7. Examination of preliminary toxicity and safety parameters. Anticipated model refinement / development services under this technical area may include, but are not limited to: 1. Developing novel or similarly existing genetically modified animals that are organ system-specific or whole-body targeted for stable or conditional knock-ins, knock-outs, knock-downs, overexpression, etc. using appropriate genomic techniques such as, but not limited to: � �a.�Generating targeting constructs per model requirement, including, plasmid DNA vector, single-stranded oligodeoxynucleotides� � �(ssODNs), and ribonucleic acid interference (RNAi) (e.g., silencing ribonucleic acid (siRNA) or short hairpin RNA (shRNA)). � �b.�Use of cre-lox or tetracycline-induced technology. � �c.�Use of random DNA transgenesis or optimization of other delivery / gene editing system (e.g., CRISPR/Cas9 or recombinant� � � � �adeno-associated viruses (rAAVs)-mediated or other applicable technology). � �d.�Transfection or electroporation of appropriate cells (e.g., skin fibroblasts (somatic) or embryonic stem (ES) cells) with targeting� � �construct with appropriate gene/editing delivery system(s). � �e.�Conducting somatic cell nuclear transfer (SCNT) into oocytes, transgene pronuclear microinjection or ES cell microinjection� � � � �into fertilized eggs for uterine implantation to generate required fetuses / harvest appropriate cells for downstream procedures as� � �necessary including genetic characterization. � �f.�Cryopreservation of embryos or sperm or harvested fibroblast for SCNT to resuscitate model as needed for future studies. 2. Chemically- or diet-induced models (e.g., CNS, respiratory or metabolic). 3. Physiologically- or procedure-induced models (e.g., anemic). 4. Mechanically-induced models. 5. Single or multiple genetic crossings / breeding. 6. Re-derivation, back-crossing, etc. as necessary to optimize or refine existing models, if feasible and cost-effective. 7. Production of live animals of the model. 8. Basic phenotypic characterization / validation of the model and/or definomg comprehensively the natural history of disease progression. � Technical Area 2: In Vivo Pharmacology Services and Model Development in Large Animals The Contractor shall provide services related to the conduct of in vivo studies with therapeutics under development. The studies under this technical area will be conducted using large animal models, inclusive of non-human primates, to support demonstration / verification of efficacy and further drug development activities. The Contractor also shall provide services related to the optimization / refinement of existing animal models or the development of novel models, including characterizing and validating such models to support drug development activities. Anticipated in vivo pharmacology services under this technical area include, but are not limited to: 1. Defining pharmacokinetic / pharmacodynamic (PK/PD) relationships from existing data or by independently establishing the PK parameters for therapeutic candidates. 2. Optimizing / refining or developing biomarkers and efficacy endpoints. 3. Determining correct route of administration (e.g., SC, IV, PO, IT, or ICV). 4. Determining appropriate dosing parameters. 5. Determining appropriate formulation(s) for administration. 6. Evaluating efficacy and biomarkers in response to treatment with test article. 7. Examination of preliminary toxicity and safety parameters. � Anticipated model refinement / development services under this technical area may include, but are not limited to: 1. Developing novel or similarly existing genetically modified animals that are organ system specific or whole-body targeted for stable or conditional knock-ins, knockouts, knock-downs, overexpression, etc. using appropriate genomic techniques such as, but not limited to: � �a. Generating targeting constructs per model requirement (e.g., plasmid DNA vector, single-stranded oligodeoxynucleotides� � � � � � �(ssODNs), and ribonucleic acid interference (RNAi) (e.g., silencing ribonucleic acid (siRNA) or short hairpin RNA (shRNA)). � �b.�Use of cre-lox or tetracycline-induced technology. � �c.�Use of random DNA transgenesis or optimization of other delivery / gene editing system (e.g., CRISPR/Cas9 or recombinant� � � � �adeno-associated viruses (rAAVs)-mediated or other applicable technology). � �d.�Transfection or electroporation of appropriate cells (e.g., skin fibroblasts (somatic) or embryonic stem (ES) cells) with targeting� � �construct with appropriate gene/editing delivery system(s). � �e.�Conducting somatic cell nuclear transfer (SCNT) into oocytes, transgene pronuclear microinjection or ES cell microinjection� � � � �into fertilized eggs for uterine implantation to generate required fetuses / harvest appropriate cells for downstream procedures as� � �necessary including genetic characterization. � �f.�Cryopreservation of embryos or sperm or harvested fibroblast for SCNT to resuscitate model as needed for future studies. 2. Chemically- or diet-induced models (e.g., CNS, respiratory or metabolic). 3. Physiologically- or procedure-induced models (e.g., anemic). 4. Mechanically-induced models. 5. Single or multiple genetic crossings / breeding. 6. Re-derivation, back-crossing etc. as necessary to optimize or refine existing models, if feasible and cost-effective. 7. Production of live animals of the model. 8. Basic phenotypic characterization / validation of the model and/or defining comprehensively the natural history of disease progression. Technical Area 3: In Vitro Pharmacology Studies in Ex Vivo Tissue-, Cell-Based, or Other Relevant Animal Replacement Models The Contractor shall conduct in vitro pharmacology studies to establish biomarkers and efficacy endpoints, and to test the efficacy and toxicity of therapeutics in existing, optimized / refined, or newly developed in vitro / ex vivo cell- or tissue-based models of disease or other relevant animal replacement models, including those derived from human samples. The Contractor shall provide services related to the optimization / refinement of existing alternative animal replacement models or the development of such novel alternative animal replacement models. The Contractor shall characterize and validate such models to support drug development activities. Anticipated in vitro / ex vivo models under this technical area include, but are not limited to: 1. Stably (immortalized) or transiently transfected genetically modified cell lines (e.g., knock-in, knock-down, knock-out, overexpressing transgene). 2. Unaffected or affected donor-derived cells (e.g., induced pluripotent stem cells (iPSCs) or progenitor or primary cells from human patients or animal models). 3. Tissue-chip technology (e.g., single or interconnected organ systems). 4. 3D cell- or tissue-based models (e.g., skin, liver, neuronal architecture). 5. Freshly harvested cells / tissues. Anticipated in vitro / ex vivo study activities under this technical area include, but are not limited to: 1. Optimizing conditions / performing cell or tissue culture maintenance. 2. Optimizing / refining or developing biomarkers and efficacy endpoints. 3. Treatment with test articles, collection of samples (e.g., cells, tissues, fluids) and performance of relevant assays (e.g., protein concentration, imaging). 4. Performing relevant biomarker and/or efficacy assays. 5. Assessment of cell viability / toxicity. Contractors shall also perform activities related to the overall administration of the contract including administrative reporting and deliverable requirements. Mandatory Qualification Criteria All offerors must acknowledge the terms and conditions of the Determination of Exceptional Circumstances by signing and including the RFP Attachment titled FAR Clause Deviation Acknowledgement Form as part of their proposal. In addition - Technical Areas 1 and 2: Offerors proposing on Technical Area 1 and/or Technical Area 2 must have an approved Animal Welfare Assurance from the Office of Extramural Research (OER), Office of Laboratory Animal Welfare (OLAW) (https://olaw.nih.gov/home.htm), Office of the Director, NIH, as required by the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals. There must be an approved Assurance for each contractor and subcontractor facility proposed to conduct work involving live vertebrate animals. Offerors and proposed subcontractors must also have an active accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). Period of Performance The Government anticipates making multiple Indefinite Delivery, Indefinite Quantity (IDIQ) type contract awards with six-year ordering periods from July 1, 2024, through June 20, 2030, resulting 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 on or around June 1, 2024. � Closing Statement Solicitation No. 75N95023R00004 is anticipated to be issued on or about June 28, 2023. Proposals will be tentatively due within 45 days after the solicitation release date. This presolicitation notice does not commit the Government to award a contract.
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