Using humanized mouse models of NNMT and SULT1A1 for follow-up efficacy studies
ID: 75N95024Q00586Type: Combined Synopsis/Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NCATSBETHESDA, MD, 20892, USA

NAICS

Testing Laboratories and Services (541380)

PSC

SPECIAL STUDIES/ANALYSIS- CHEMICAL/BIOLOGICAL (B504)

Original Source

https://sam.gov/opp/aebbc9acf55d46b28e50e849ce611d55/view
Timeline
    Description

    The Department of Health and Human Services, through the National Institutes of Health (NIH) and its National Center for Advancing Translational Sciences (NCATS), intends to award a sole-source contract to GemPharmatech, LLC for follow-up efficacy studies utilizing humanized mouse models of NNMT and SULT1A1. The primary objective of this procurement is to conduct a series of studies, including a Maximum Tolerated Dose (MTD) study, a pharmacokinetic (PK) study, and an efficacy study, to evaluate small molecule inhibitors developed by NCATS, necessitating the creation of mouse models that express human versions of the enzymes involved. This research is critical for advancing the development of therapeutics targeting various human diseases, and the project is expected to span 12 months. Interested parties may submit their capabilities by September 17, 2024, to Michelle Cecilia at michelle.cecilia@nih.gov, with the contract value and specific funding details not disclosed in the announcement.

    Point(s) of Contact
    Michelle Cecilia
    (301) 827-7199
    michelle.cecilia@nih.gov
    Files
    Title
    Posted
    SOW_GemPharmatech follow up_2024 FINAL.pdf
    The Statement of Work (SOW) outlines a research project involving the evaluation of humanized mouse models for NNMT and SULT1A1 by the National Center for Advancing Translational Sciences (NCATS). The primary objective is to conduct efficacy studies to assess small molecule inhibitors developed by NCATS, necessitating the creation of mouse models that express human versions of the enzymes involved. The study comprises two phases: a Maximum Tolerated Dose (MTD) study and a pharmacokinetic (PK) study, followed by an efficacy study on high-fat diet (HFD) models. The MTD study involves serial oral administration of test articles to determine safe dosage levels, while the PK study entails plasma analysis using established methods. The efficacy study will assess the impact of treatments on body weight, blood metrics, and liver pathology in both humanized and control mouse strains. The project spans 12 months, with a structured methodology for administering treatments and a strict timeline for deliverables and reporting. Additionally, confidentiality and publication guidelines are established, ensuring the NCATS retains ownership of data and governs any disclosures. This document reflects a formal agreement and delineates the responsibilities of both NCATS and the contractor, GemPharmatech, LLC, reinforcing the collaborative nature of government-funded biomedical research.
    Lifecycle
    Title
    Type
    Using humanized mouse models of NNMT and SULT1A1 for follow-up efficacy studies
    Currently viewing
    Combined Synopsis/Solicitation
    Similar Opportunities
    A--Request for Proposals - Phase I Clinical Trials
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is seeking proposals for Phase I clinical trials aimed at developing small molecule and biologics therapeutics, as outlined in RFP No. 75N95024R00086. The selected contractor will be responsible for comprehensive services including protocol development, trial management, and reporting to regulatory agencies, with a focus on safety, tolerability, and pharmacokinetics of the investigational therapeutics. This initiative is crucial for advancing therapeutic development in the field of neurology, ensuring compliance with FDA and ICH GCP standards throughout the trial process. Proposals are due by October 3, 2024, with a contract performance period from April 1, 2025, to March 31, 2035, and a maximum contract value of $233,227,446. Interested parties can contact Evan C. Feely at evan.feely@nih.gov or +1 301 827 5301 for further information.
    Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is seeking proposals for Chemistry, Manufacturing, and Controls (CMC) services related to the development of drug substances. The primary objective is to ensure the Division of Preclinical Innovation (DPI) receives drug substances of adequate quality and quantity to support preclinical and Investigational New Drug (IND)-enabling studies, adhering to current Good Manufacturing Practice (cGMP) standards. This procurement is crucial for advancing therapeutics from preclinical stages to market readiness, emphasizing a multidisciplinary approach and compliance with regulatory requirements throughout the drug development pipeline. The Request for Proposals (RFP) is expected to be released on or about October 4, 2024, with contract awards anticipated in the second quarter of FY2025. Interested parties may contact Samson Shifaraw at samson.shifaraw@nih.gov for further information.
    Service/maintenance agreement for Discover 2.0 and Liberty Blue HT12/Razor systems
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Center for Advancing Translational Sciences (NCATS), is seeking to award a non-competitive contract for a service and maintenance agreement for the Discover 2.0 and Liberty Blue HT12/Razor systems. This procurement aims to ensure the full functionality of these critical laboratory instruments, which are essential for NCATS's research in developing innovative diagnostics and therapeutics. The service agreement will include unlimited service visits, preventative maintenance, and support from OEM-trained engineers, ensuring the continuity and standardization of NCATS research efforts. Interested parties must submit their capability statements to Rhanda Lopez at rhanda.lopez@nih.gov by September 20, 2024, at 2:30 PM Eastern Standard Time, referencing solicitation number 75N95C24P00096.
    Good Manufacturing Practice (GMP)-manufactured Monoclonal Antibody
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), intends to award a sole source contract for the procurement of Good Manufacturing Practice (GMP)-manufactured Monoclonal Antibody UB-421, with a requirement of 100 liters. This procurement is critical for an ongoing clinical trial aimed at treating patients with multidrug-resistant HIV-1 infection, utilizing UB-421, which is exclusively manufactured by United BioPharma, Inc., the sole patent holder and provider of the necessary cell line for production. Interested parties who believe they can meet the specifications must submit a capability statement to the primary contact, Hershea Vance, by 3:00 PM EST on September 20, 2024, as the contract is expected to be awarded within 19 days of this notice, with a performance period from September 23, 2024, to September 24, 2025.
    A--BPCA Pediatric Trials Network
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is soliciting proposals for an Indefinite Quantity Contract to establish and manage the Best Pharmaceuticals for Children Act (BPCA) Pediatric Trials Network. This initiative aims to create a robust infrastructure for conducting pediatric clinical trials, emphasizing compliance with federal regulations and ethical standards in research practices. The contract, which has a performance period from May 19, 2025, to May 18, 2033, offers a minimum compensation of $2,500 and a maximum potential value of $149 million, contingent on successful performance. Proposals are due by November 4, 2024, and interested parties can contact Elizabeth J. Osinski at eo43m@nih.gov or 240-550-5028 for further information.
    PREPARATION AND DISTRIBUTION OF RESEARCH DRUG PRODUCTS
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute on Drug Abuse (NIDA), is seeking proposals for the preparation and distribution of research drug products under a presolicitation notice. The contract will involve acquiring, importing, and exporting drugs and chemical compounds, as well as developing and analyzing various drug dosage forms, including marijuana and nicotine research cigarettes, to support drug abuse and addiction research. This contract is critical for maintaining a reliable supply of authentic controlled and uncontrolled drug compounds for the research community, with an anticipated award of one indefinite delivery, indefinite quantity (IDIQ) contract over a five-year period. Interested parties must possess a current DEA registration and comply with FDA’s current Good Manufacturing Practices, with proposals due approximately 45 days after the release of the RFP, expected on or about September 20, 2024. For further inquiries, contact Scott Duernberger at scott.duernberger@nih.gov or 301-594-0670.
    High-content, Multiomic Imaging System for Spatial Biology Research
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), is seeking quotes for a high-content, multiomic imaging system to enhance spatial biology research focused on tick-borne infectious diseases. The procurement requires a comprehensive multiomics platform, including a widefield epifluorescence microscope, a scientific CMOS high-resolution camera, a liquid handling station, and associated software, along with installation and training services. This acquisition is crucial for advancing research methodologies in public health and will be processed under Simplified Acquisition Procedures, with a firm-fixed-price purchase order anticipated. Interested offerors must submit their quotes by September 20, 2024, and can direct inquiries to Seth Schaffer at seth.schaffer@nih.gov or Tamara McDermott at tamara.mcdermott@nih.gov.
    Surveys and Cognitive Tasks
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute on Drug Abuse (NIDA) and the National Institute of Mental Health (NIMH), is seeking a vendor for a non-competitive contract to provide account management, planning, and maintenance for online crowd-sourced surveys and cognitive tasks related to depression and anxiety. The primary objective is to facilitate participation in these surveys for individuals both with and without mental health conditions, thereby supporting research efforts in this critical area. This procurement falls under NAICS code 541910, with a contract period of one year, and is scheduled for award on or around September 23, 2024. Interested parties must submit their capability statements and proposals by September 23, 2024, at 9:00 a.m. Eastern Standard Time, to Robin Knightly at Robin.Knightly@nih.gov.
    Hitachi HT7800 Transmission Electron Microscope
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH) through the National Institute of Allergy and Infectious Diseases (NIAID), is seeking quotes for the procurement of a Hitachi HT7800 Transmission Electron Microscope. This acquisition aims to support the development of antibody therapeutics and the design of vaccines and antivirals, which are critical for ongoing research at the Vaccine Research Center (VRC). The procurement is governed by FAR Simplified Acquisition Procedures, and the selected vendor will be required to deliver the microscope within 30 days of award, with installation and training to be completed by March 25, 2024. Interested vendors must submit their quotes by 12:00 PM EST on September 23, 2024, to Hershea Vance at hershea.vance@nih.gov, and ensure compliance with all specified requirements and clauses outlined in the solicitation.
    Amendment No. 1 -Notice of Intent to Award a Sole Source Contract – Radiation Protection Advancing Patient Safety
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), intends to award a Sole Source contract to the National Council on Radiation Protection and Measurements (NCRP) for the project titled "Radiation Protection Advancing Patient Safety." The primary objective of this procurement is to obtain up to six well-sourced scientific analyses, reports, and recommendations on radiation safety, which will inform regulatory decision-making and policy development related to radiological medical devices and radiation-emitting electronic products. This initiative is crucial for enhancing patient safety by ensuring that radiation exposure is minimized and that the quality of patient care is improved. Interested parties must submit their capability statements to Bernice Nelson by September 19, 2024, with the contract being executed under simplified acquisition procedures and the NAICS code 541720, which has a small business size standard of $28 million.