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National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders or Alcohol Use Disorder (U01 Clinical Trial Optional)

National Institutes of Health

The purpose of this Funding Opportunity Announcement (FOA) is to accelerate innovative drug and device therapies translation from discovery to early human studies. Studies appropriate for this FOA will develop pharmacologic and neuromodulatory tools for basic and clinical research on mental health disorders or alcohol use disorder (AUD); develop and validate tools (pharmacologic or neurostimulation) in support of experimental therapeutic studies of innovative candidates for mental disorders or AUD; and support early-stage human studies to rapidly assess the safety, tolerability, and pharmacodynamics of promising drug candidates/devices and new indications for novel Investigational New Drug (IND)-ready agents or Investigational Device Exemption (IDE)-ready devices for the treatment of mental disorders or AUD. This FOA encourages applications to advance the discovery, preclinical development, and proof of concept (PoC) testing of new, rationally based candidate agents and neurostimulation approaches to treat mental disorders or AUD, and to develop novel ligands and circuit-engagement devices as tools to further characterize existing or to validate new drug/device targets. Partnerships between academia and industry are strongly encouraged. Projects seeking support for a research program of multiple projects directed toward a specific major objective, basic theme or program goal, requiring a broadly based, multidisciplinary and often long-term approach should consider the companion FOA ( PAR-22-144 )

This FOA will also support applications proposing preclinical discovery of biotechnology products and biologics with potential as candidate therapeutics including, but not limited to, large biologic macromolecules, (e.g., proteins, antibodies, and peptides), gene-based therapies (i.e., oligonucleotide- and viral vector-based), cell therapies, and novel emerging therapies (e.g., microbial and microbiome therapies).

This FOA supports a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies.

Deadlines:

Letter of Intent Due Date: 30 days before the application due date
Application Due Date(s): June 27, 2022; Oct 25, 2022; Feb 24, 2023; June 26, 2023; Oct 26, 2023; Feb 27, 2024; June 25, 2024; Oct 25, 2024; Feb 24, 2025

PAR-22-143 Expiration Date February 25, 2025

Specialties

Engineering and Physical Sciences

Interdisciplinary

Medical - Basic Science

Medical - Translational

Environmental & Life Sciences

Medical

Medical - Clinical Science

Eligibility Requirements

The PD/PI will be expected to devote at least 1.8 person months of effort to the NCDDG program. If MPI application, each MPI is expected to devote at least 1.8 person months of effort to the NCDDG program.