Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)
ID: 347499Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Award Range

$0 - $275K

Eligible Applicants

Others

Funding Category

Income Security and Social Services

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The National Institutes of Health (NIH) is offering a funding opportunity titled "Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes" under the R21 Exploratory/Developmental Research Grant initiative. This grant aims to support projects that address critical barriers to clinical trial readiness for rare diseases, which are defined as conditions affecting fewer than 200,000 individuals in the U.S., by developing and validating biomarkers, clinical outcome measures, and understanding disease natural history. The initiative is crucial for enhancing the progression of therapeutics toward clinical trials, addressing significant public health concerns related to the limited treatment options available for rare diseases. Eligible applicants can receive up to $275,000 for a two-year project, with applications due by October 17, 2024. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov or visit the opportunity's webpage at https://grants.nih.gov/grants/guide/pa-files/PAR-23-159.html.

    Point(s) of Contact
    Files
    Title
    Posted
    The Department of Health and Human Services announces a funding opportunity through the NIH to enhance clinical trial readiness for rare diseases through the R21 Exploratory/Developmental Research Grant initiative. This request for proposals invites researchers to submit applications aimed at addressing barriers to effective clinical trials for rare diseases, defined as those affecting fewer than 200,000 individuals in the U.S. Key areas of focus include developing and validating biomarkers and clinical outcome assessment measures, understanding disease natural history, and fostering partnerships among stakeholders such as academic entities, industry, and patient groups. Applications are expected to leverage existing research resources and must not propose clinical trials themselves. Eligible organizations include higher education institutions, nonprofits, and government entities. Budgets can reach up to $275,000 for a two-year project, with the goal of facilitating the progression of therapeutics toward clinical trials. The initiative operates under rigorous guidelines to ensure compliance with NIH policies. The urgency for clinical trial readiness is underscored, addressing critical public health concerns associated with rare diseases—acknowledging the significant unmet medical needs and the limited treatments available.
    Similar Opportunities
    Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R03 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity through the R03 Small Grant Program to enhance clinical trial readiness for rare diseases, disorders, and syndromes. This initiative aims to support research that identifies critical needs for advancing therapeutics or diagnostics in rare diseases, which are defined as affecting fewer than 200,000 individuals in the U.S., by developing better biomarkers, clinical outcome measures, and insights into the natural history of these conditions. The program emphasizes the importance of partnerships among researchers, industry, and patient advocacy groups to optimize clinical trial designs, while explicitly stating that applications should not propose clinical trials directly but focus on pre-trial research activities. The maximum funding available for each project is $100,000 over a two-year period, with applications due by October 17, 2024. Interested applicants can find more information and submit inquiries via email at grantsinfo@nih.gov or visit the official announcement at https://grants.nih.gov/grants/guide/pa-files/PAR-23-160.html.
    Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)" aimed at supporting preclinical efficacy studies for therapeutic agents targeting rare diseases. This initiative seeks to fund projects that demonstrate the effectiveness of proposed treatments in established rare disease models, along with necessary pharmacodynamic and pharmacokinetic studies, to facilitate further development towards Investigational New Drug (IND) applications or clinical trials. With a total funding budget of up to $1.2 million, the NIH anticipates awarding 3-5 grants, each with a maximum budget of $275,000 over a two-year project period. Interested applicants must submit letters of intent by May 1, 2024, with full applications due by May 3, 2024, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required) to support innovative research projects at the preliminary or conceptual stage, particularly those with the potential to advance biomedical, behavioral, or clinical research. Applicants must include at least one clinical trial in their proposals, focusing on mechanistic studies that align with the scientific missions of participating NIH Institutes and Centers. This funding opportunity is crucial for stimulating novel research that challenges conventional methods and improves clinical practices, with a maximum budget of $275,000 available for a two-year project, and no more than $200,000 allocated in any single year. Interested applicants should adhere to strict submission guidelines and can contact the NIH OER Webmaster at FBOWebmaster@OD.NIH.GOV for assistance; the application deadline is January 7, 2025.
    Translational Efforts to Advance Gene-based Therapies for Ultra-Rare Neurological and Neuromuscular Disorders (U01 - Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Translational Efforts to Advance Gene-based Therapies for Ultra-Rare Neurological and Neuromuscular Disorders" (U01), aimed at supporting Investigational New Drug (IND)-enabling studies and clinical trial planning for innovative gene-based therapeutics targeting ultra-rare diseases affecting fewer than 6,000 individuals. The program seeks to advance promising therapeutic candidates through robust proof-of-concept data and facilitate the submission of IND applications to the FDA, thereby addressing significant unmet medical needs within the ultra-rare disease community. Eligible applicants include higher education institutions, nonprofits, and governmental agencies, with a project period not exceeding two years and application deadlines ranging from October 2023 to February 2025. For further inquiries, interested parties can contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov, and additional details can be found at the provided NIH link.
    NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed) to support innovative biomedical and clinical research projects. This grant aims to foster exploratory research that may involve significant risks but has the potential for breakthroughs or the development of novel methodologies in health-related fields. The program is crucial for advancing research that addresses pressing health challenges and encourages applications that present new scientific ideas distinct from traditional R01 projects. Eligible applicants include a wide range of institutions, including higher education institutions, nonprofits, and for-profit organizations, both domestic and foreign, with a budget limit of $275,000 over two years and a maximum request of $200,000 in any single year. Interested parties should submit their applications electronically by January 7, 2025, and can contact the NIH OER Webmaster at FBOWebmaster@OD.NIH.GOV for further assistance.
    Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R21 - Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity for innovative research aimed at developing screening approaches and therapies for screenable disorders in newborns, designated as R21 - Clinical Trial Optional. This initiative encourages projects that focus on creating novel screening techniques and therapeutic interventions for potentially fatal or disabling conditions identified through newborn screening, particularly emphasizing early diagnosis and treatment to improve health outcomes. The program is part of NIH's commitment to advancing public health and reducing health disparities, with a funding ceiling of $275,000 available over a two-year period. Interested applicants, including a diverse range of institutions and organizations, must submit their proposals by November 16, 2024, and can reach out to the NIH OER Webmaster at OERWebmaster03@od.nih.gov for further inquiries.
    Ultra-Rare Gene-based Therapy (URGenT) Network Resource Access (X01, Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through its National Institute of Neurological Disorders and Stroke (NINDS), has announced a funding opportunity titled "Ultra-Rare Gene-based Therapy (URGenT) Network Resource Access" (X01), aimed at facilitating research in gene-based therapies for ultra-rare neurological disorders affecting fewer than 6,000 individuals in the U.S. This initiative provides investigators with access to contract research organizations (CROs) and subject matter experts to assist in planning, manufacturing, and nonclinical therapeutic development, specifically for the preparation of Investigational New Drug (IND) applications without involving clinical trials. The program emphasizes collaboration and strategic planning to address the unmet medical needs of patients with ultra-rare diseases, encouraging multidisciplinary project teams to outline development plans and regulatory considerations. Interested applicants must submit their proposals by January 24, 2025, and can direct inquiries to the NIH OER Webmaster at OERWebmaster03@od.nih.gov. Additional information can be found at http://grants.nih.gov/grants/guide/pa-files/PAR-22-028.html.
    NCI Clinical and Translational Exploratory/Developmental Studies (R21 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity through the R21 Clinical Trial Optional mechanism, aimed at supporting exploratory and developmental research in cancer diagnosis, treatment, imaging, symptom management, and prevention. This grant is designed to encourage innovative studies that challenge existing paradigms and address critical barriers in cancer research, particularly focusing on reducing disparities among underserved populations. Eligible applicants include a wide range of organizations, such as historically black colleges, tribal governments, and faith-based organizations, with a maximum funding amount of $275,000 available over a two-year period. Interested parties can find more information and application details at the provided link, with a submission deadline of July 1, 2025, and inquiries directed to the NIH OER Webmaster at OERWebmaster03@od.nih.gov.
    Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R21 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity for research on Alzheimer's Disease (AD) and its related dementias (ADRD) through the R21 Clinical Trial Optional grant. This grant aims to support innovative research methods and tools that advance understanding and treatment of AD/ADRD, particularly focusing on interdisciplinary studies that require preliminary data for broader application in the field. Given the increasing prevalence of AD and the associated public health concerns, this funding opportunity is crucial for fostering new approaches to address the complexities of the disease and its impact on diverse populations. Interested applicants can apply for up to $275,000 over a two-year period, with the application deadline set for November 12, 2024. For further inquiries, applicants may contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov or visit the additional information link at http://grants.nih.gov/grants/guide/pa-files/PAR-22-094.html.
    Development of Biomarkers or Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Development of Biomarkers or Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33 Clinical Trial Optional)." This initiative aims to promote the discovery and early evaluation of candidate biomarkers that can facilitate the clinical development of neurotherapeutics and their application in clinical practice, focusing on both animal studies and preliminary human evaluations. The funding is structured as a phased R61/R33 award, where the R61 phase emphasizes proof-of-concept studies using human samples, while the R33 phase focuses on clinical validation for specified uses. Interested applicants, including various educational and community organizations, must submit their proposals by May 7, 2025, and can find additional details and application guidelines at the provided NIH link. For inquiries, applicants can contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov.