The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Seeks Industry Collaborators for NAFLD, NASH & Cryptogenic Cirrhosis Clinical Studies
ID: NIH-NICHD-2020-DK-01Type: Special Notice
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NICHDBETHESDA, MD, 20817, USA
Timeline
    Description

    Special Notice: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) from the Department of Health and Human Services is seeking industry collaborators for NAFLD, NASH, and Cryptogenic Cirrhosis clinical studies. The NIDDK is looking for partners to collaborate on clinical studies related to these liver diseases. For more information, please refer to the attached Special Notice.

    Point(s) of Contact
    Averell H. Sherker, MD, FRCPC Scientific Advisor for Viral Hepatitis and Liver Diseases
    (301) 451-6207
    averell.sherker@nih.gov
    Similar Opportunities
    The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Seeks Industry Partners for Clinical Research Collaborations on Therapeutics, Diagnostics or Devices for Childhood Cholestatic Liver Diseases
    Active
    Health And Human Services, Department Of
    The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is seeking industry partners for clinical research collaborations focused on therapeutics, diagnostics, or devices for childhood cholestatic liver diseases. The initiative aims to engage collaborators in providing novel therapeutic agents and diagnostic tools for use in NIH-sponsored multi-center clinical trials targeting conditions such as biliary atresia and alpha-one antitrypsin deficiency, among others. This collaboration is critical for advancing research and improving clinical outcomes for children suffering from these rare liver diseases. Interested organizations must submit a Capability Statement detailing their proposed solutions and capabilities, with no funding provided by NIDDK for this opportunity. For inquiries, contact Edward Doo at dooe@niddk.nih.gov or Katrina Loh at katrina.loh@nih.gov.
    Industry Collaboration for the Kidney Precision Medicine Project (KPMP)
    Active
    Health And Human Services, Department Of
    Special Notice: HEALTH AND HUMAN SERVICES, DEPARTMENT OF is seeking Industry collaborators for the Kidney Precision Medicine Project (KPMP). This project aims to conduct multi-center clinical and molecular studies in individuals with Diabetic Kidney Disease, Hypertension-related Chronic Kidney Disease, or Acute Kidney Injury. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) of the Department of Health and Human Services (DHHS) is leading this initiative. Industry collaboration is sought to support the research and development efforts in these areas of kidney diseases.
    Vendor Collaboration - MULTI-CENTER CLINICAL TRIALS OF NOVEL THERAPIES FOR PATIENTS WITH WELL CHARACTERIZED GASTROPARESIS
    Active
    None
    Special Notice: Vendor Collaboration - MULTI-CENTER CLINICAL TRIALS OF NOVEL THERAPIES FOR PATIENTS WITH WELL CHARACTERIZED GASTROPARESIS This federal procurement notice is seeking vendors to collaborate on multi-center clinical trials of novel therapies for patients with well-characterized gastroparesis. Gastroparesis is a condition characterized by delayed emptying of the stomach, leading to symptoms such as nausea, vomiting, and abdominal pain. The purpose of this procurement is to find vendors who can contribute to the development and testing of new therapies for gastroparesis patients. The trials will involve multiple centers, allowing for a diverse patient population and a comprehensive evaluation of the effectiveness of the therapies. Vendors interested in this opportunity should refer to the uploaded document for collaboration details. For further information, please contact the primary contracting officer, Richard Bailey, at BaileyRichard@mail.nih.gov or 301-402-1139, or the secondary contracting officer, Marlene T. Mireles, at mirelesm@mail.nih.gov or 301-443-7795. By successfully fulfilling this procurement, you will not only contribute to the advancement of medical research but also make a positive impact on the lives of patients suffering from gastroparesis.
    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 solicitation number 75N95024R00003. The primary objective of this procurement is to acquire, analyze, create, and distribute a variety of drug compounds essential for drug abuse and addiction research, including controlled and uncontrolled substances, while ensuring compliance with DEA regulations. This contract, structured as an indefinite delivery, indefinite quantity (IDIQ) agreement for a five-year period, aims to enhance research capabilities in the field of drug abuse, with proposals due by November 15, 2024, at 1:00 PM (Eastern Time). Interested parties should contact Scott Duernberger at scott.duernberger@nih.gov or Josh Lazarus at josh.lazarus@nih.gov for further information.
    NIAID CLINICAL PRODUCTS CENTER (CPC)
    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 proposals for a contract to provide pharmacy and pharmaceutical oversight for clinical trials, both nationally and internationally. The primary objective of this contract is to ensure the integrity of study products, participant safety, and compliance with pharmacy and pharmaceutical regulations throughout various NIH-funded clinical trials. This opportunity is critical for maintaining high standards in public health research, as it encompasses a wide range of services including product management, regulatory document maintenance, and clinical laboratory testing. Proposals are due by January 17, 2025, with the contract expected to commence on April 1, 2026, and run through March 31, 2027, potentially extending through 2033. Interested parties can contact Deborah Blyveis at blyveisd@niaid.nih.gov or Emily Bannister at emily.bannister@nih.gov for further information.
    CRO Support for NCATS Bioanalytical Method Development for Biologics
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified contractors to provide support for bioanalytical method development for biologics under a Sources Sought notice. The primary objective is to identify capable organizations that can develop and validate bioanalytical methods for quantitative analyses of novel therapeutic biologics and anti-drug antibodies in various biological matrices, as well as manage project administration and quality assurance. This initiative is crucial for advancing drug development processes and ensuring compliance with regulatory standards, ultimately facilitating the transition of therapeutic candidates to clinical trials. Interested parties must submit their capability statements and relevant information by November 8, 2024, to Nick Niefeld at nick.niefeld@nih.gov.
    2026 NIAID DMID Omnibus Broad Agency Announcement
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH) and specifically the National Institute of Allergy and Infectious Diseases (NIAID), is soliciting proposals for the 2026 NIAID DMID Omnibus Broad Agency Announcement (BAA) aimed at advancing medical countermeasures against infectious diseases. This opportunity encompasses two primary research areas: the development of therapeutics, vaccines, and diagnostics for antimicrobial-resistant pathogens, and the creation of direct acting antivirals targeting viruses with pandemic potential. The initiative is critical for enhancing public health responses to emerging infectious threats and includes funding estimates of up to $8.5 million for Research Area 001 and $20 million for Research Area 002, with proposals due to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) platform, starting around November 22, 2024. For further inquiries, interested parties may contact Swee L. Teo at teosl@niaid.nih.gov or Brian Madgey at brian.madgey@nih.gov.
    SOURCES SOUGHT: Long read sequencing services
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified small businesses to provide long read sequencing services as part of the Global Parkinson’s Genetics Program (GP2). The objective is to genotype over 150,000 individuals worldwide to enhance understanding of genetic risk factors associated with Parkinson’s Disease, requiring the contractor to perform long read sequencing on 500 human genomic DNA samples with a minimum coverage of 25X per sample, alongside ancillary services such as DNA fragmentation, library preparation, and bioinformatics support. Interested parties must submit their capability statements by November 15, 2024, at 9:00 AM Eastern Time, to Rashiid Cummins at rashiid.cummins@nih.gov, ensuring compliance with the specified guidelines and format.
    Deep Tissue Imaging
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking information from institutions and companies with expertise in deep tissue optical imaging technologies. The objective is to gather insights on capabilities related to overcoming the limitations of light penetration in tissue, which affects the applications of optical imaging in biomedical and clinical research. This initiative is crucial for advancing non-invasive optical approaches for biological systems, with a focus on technologies such as adaptive optics, wavefront shaping, and biophotonics. Interested parties are encouraged to contact Jonathan Pollock at jpollock@mail.nih.gov or Robert Bailey at rob.bailey@nih.gov for further details and to describe their organizational capabilities.
    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 soliciting proposals for Chemistry, Manufacturing, and Control (CMC) services related to the development of drug substances under RFP number 75N95024R00094. The primary objective is to secure high-quality drug substances to support preclinical and Investigational New Drug (IND)-enabling studies, ensuring compliance with current Good Manufacturing Practices (cGMP) and federal regulations. This initiative is crucial for advancing therapeutic innovations and facilitating collaborations in drug development, with a total funding amount of up to $49.7 million over the contract period from September 1, 2025, to May 14, 2031. Interested parties must submit their proposals by December 3, 2024, and can direct inquiries to primary contact Samson Shifaraw at samson.shifaraw@nih.gov or secondary contact Valerie Whipple at valerie.whipple@nih.gov.