Grant Details

Drug/Device Development for Treatment of Mental/Substance Use/Alcohol Disorders

 
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    CFDA#

    93.242; 93.273; 93.279
     

    Funder Type

    Federal Government

    IT Classification

    B - Readily funds technology as part of an award

    Authority

    National Institutes of Health (NIH)

    Summary

    The objective of the National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental or Substance Use Disorders or Alcohol Disorder program is to establish NCDDG Groups to conduct innovative, high impact research focused on the discovery and testing of chemical entities for novel molecular targets, as well as novel devices for novel circuit/neural dynamic targets implicated in the pathophysiology of mental disorders, SUDs, or AUD. The NCDDG serves as a vehicle for pharmaceutical, biomedical device and academic scientists to pool intellectual and material resources for the translation of basic science findings into the conceptualization, discovery, and evaluation of new chemical entities and devices. Groups are encouraged to select molecular targets for drug discovery and circuit targets for device discovery based on recent findings in basic and clinical neuroscience, genetics, and proteomics relevant to the understanding of mental disorders, SUDs, or AUD.

    This Funding Opportunity Announcement (FOA) is to encourages applications from academic, biotechnology, biomedical device industry, or pharmaceutical industry investigators interested in participating with the National Institute of Mental Health (NIMH), the National Institute on Drug Abuse (NIDA), or the National Institute on Alcohol Abuse and Alcoholism (NIAAA) in a National Cooperative Drug/Device Discovery/Development Group (NCDDG) program. The objectives of this program are: to advance the discovery, preclinical development, early-stage human studies, and/or proof of concept testing of new, rationally based candidate agents or devices to treat mental disorders, substance use disorders (SUDs), or alcohol abuse disorder (AUD); and to develop novel ligands and novel brain circuit-modulatory technologies as tools to advance biological research on the function of genes, cells, biochemical pathways, distributed neural circuits, and neural oscillatory patterns implicated in the etiology and pathophysiology of mental disorders, SUDs or AUD, and as potential new therapeutics. Partnerships between academia and industry are strongly encouraged.

    Each NCDDG program should consist of a multi-disciplinary team of scientists with appropriate expertise to further the development and evaluation of novel compounds or proposed biomedical devices. Scientists from both academia and pharmaceutical industry are encouraged to participate within an NCDDG; scientists from foreign institutions and NIH Intramural laboratories may participate in some aspects. It is anticipated that the interaction of academic and non-profit research institutions with industry and NIH via the NCDDG model will:

    1) accelerate the discovery and development of new therapeutics for mental disorders, SUDs or AUD;

    2) increase the availability of pharmacologic and device-based research tools (including PET/SPECT imaging agents) for basic and clinical research;

    3) facilitate the development and validation of neurophysiological, pharmacokinetic (PK), and pharmacodynamic (PD) measures to evaluate novel therapeutics for mental disorders, SUDs, or AUD;

    4) increase the availability of new compounds, agents, and devices suitable for testing in humans;

    5) facilitate the development and validation of new clinical measures or biomarkers suitable for use in human PoC trials of novel therapeutics for mental disorders, SUDs or AUD; and/or

    6) develop and validate novel neurostimulation technologies and protocols for mental disorders.

    The goal of the NCDDG program is not to duplicate or compete with the private sector but to complement and accelerate the development of research tools for new molecular and circuit targets implicated in mental disorders, SUDs or AUD, and effective compounds, agents and devices for the prevention and treatment of psychiatric and addictive disorders, as well as core features of these illnesses, especially in areas of unmet medical need. NIMH encourages applications ranging from ligand discovery and testing in preclinical assays through human Phase I studies of novel agents. NIMH also encourages applications ranging from early-stage, pre-clinical, device development to FIH clinical trials.

    In summary, the NCDDG Program will support broad, innovative, multidisciplinary approaches to the discovery of new, rationally based treatments and research tools for mental disorders, SUDs or AUD. Since the creative talents in the required scientific disciplines are rarely available in a single institution, a multi-institutional, group approach involving academic, nonprofit, commercial, and/or industrial institutions is envisioned. Academic, pharmaceutical and biomedical technology scientists are strongly encouraged to form partnerships that take full advantage of their combined intellectual and material resources for drug discovery, lead optimization, model development, and clinical testing. Further, the interaction of academic and non-profit research institutions with pharmaceutical and biomedical device industry and NIH is expected to facilitate subsequent development and marketing of new pharmacologic and device treatments, although these latter activities are not within the scope of this FOA. Molecular targets for drug/device discovery, and the sources and types of chemical/circuit entities to be investigated will be selected by the applying group. Both novel mechanism of action and disease-oriented approaches are of interest.

     

    History of Funding

    None available.

    Additional Information

    Accepting applications that either propose or do not propose clinical trial(s).

    Prior to submission of an application, applicants are strongly encouraged to contact the relevant Scientific/Research Contact of this FOA to determine if the proposed Research Project would be considered a priority for NIMH, NIDA or NIAAA.

    The NIMH strongly encourages an experimental medicine approach to therapeutic development. This FOA will support up through First-in-Human (FIH) for devices or Phase Ia or Ib trials for pharmacological agents. For these trials, studies are expected to assess the agent/device for:

    1) safety and tolerability,

    2) target engagement, and

    3) pharmacodynamic effects on relevant circuits or systems.

    Data resulting from Phase I trials in healthy controls and in the target patient population are expected to determine optimal clinical dosing and to establish feasibility for further testing in PoC and efficacy trials. Agents/devices should be sufficiently potent and selective for critical evaluation of target engagement and brain exposure. The agent/indication (if successful) should have a major, not merely incremental, impact on unmet medical need in psychiatric disorders. In support of this effort, NIMH recognizes the need for the timely development of new PET tracers for targets that are of interest for assessing target engagement/dose selection for clinical trials of novel therapeutics and for studies of the pathophysiology of psychiatric disorders.

    Contacts

    Tanya Ramey M.D., Ph.D.

    Tanya Ramey M.D., Ph.D.
    National Institute on Drug Abuse
    9000 Rockville Pike
    Bethesda, MD 20892
    301-827-5944

    Nick Gaiano

    Nick Gaiano

    ,
    (301) 827-3420

    RV Srinivas, Ph.D

    RV Srinivas, Ph.D
    301-451-2067
    9000 Rockville Pike
    Bethesda, MD 20892
    301-451-2067

    Linda Brady Ph.D

    Linda Brady Ph.D
    National Institute of Mental Health
    9000 Rockville Pike
    Bethesda, MD 20892
    301-443-3563

    Mark Egli, Ph.D

    Mark Egli, Ph.D
    National Institute on Alcohol Abuse and Alcoholism
    9000 Rockville Pike
    Bethesda, MD 20892
    301-594-6382

    Dharmendar Rathore, PhD

    Dharmendar Rathore, PhD
    National Institute on Drug Abuse
    9000 Rockville Pike
    Bethesda, MD 20892
    301-402-6965
     

  • Eligibility Details

    Eligible applicants:

    • Higher Education Institutions
    • Public/State Controlled Institutions of Higher Education
    • Private Institutions of Higher Education

    The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

    • Hispanic-serving Institutions
    • Historically Black Colleges and Universities (HBCUs)
    • Tribally Controlled Colleges and Universities (TCCUs)
    • Alaska Native and Native Hawaiian Serving Institutions
    • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

    • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
    • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

    For-Profit Organizations

    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations

    Foreign Institutions

    • Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    • Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
    • Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

    Deadline Details

    Applications are due on the following dates: June 27, 2022; October 25, 2022; February 24, 2023; June 26, 2023; October 26, 2023; February 27, 2024; June 25, 2024; October 25, 2024; February 24, 2025.

    Award Details

    The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited but need to reflect the actual needs of the proposed project. The total project period may not exceed five years. No cost-sharing is required.

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