Key Dates

NOT-MH-22-221 - Notice of Intent to Publish a Funding Opportunity Announcement for National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders or Alcohol Use Disorder (U19 Clinical Trial Optional)

PAR-20-118 - National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental or Substance Use Disorders or Alcohol Disorder (U01 Clinical Trial Optional)

National Institute of Mental Health (NIMH)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

The National Institute of Mental Health (NIMH) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) intend to publish a Funding Opportunity Announcement (FOA) to solicit applications to accelerate innovative drug and device therapies translation from discovery to early human studies as part of the National Cooperative Drug/Device Discovery/Development Group (NCDDG) program. This FOA will be a reissue of PAR-20-118.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects to this reissue.

The FOA is expected to be published in Spring 2022 with an expected first application due date of June 27, 2022

This FOA will utilize the U01 activity code. Details of the planned FOA are provided below.

Consistent with the objectives of PAR-20-118, 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. The FOA will encourage 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 U19 FOA (see NOT-MH-22-221; reissue of PAR-20-119).

The 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).

The objective of the FOA 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, or AUD. The NCDDG serves as a vehicle for pharmaceutical, biomedical devices 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, or AUD.

The identification of lead compounds/candidate agents/devices and refining them for target validation and medication development are important goals of this initiative.

It is anticipated that the interaction of academic and non-profit research institutions with NIH and pharmaceutical industry will facilitate timely evaluation and development of preclinical and clinical research tools, models, and novel therapeutics. The FOA will support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies.

Each NCDDG program should consist of a multi-disciplinary team of scientists with appropriate expertise to further the development and evaluation of novel candidate agents 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 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 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 or AUD; and/or 6) develop and validate novel neurostimulation technologies and protocols for mental disorders.

TBD

Applications are not being solicited at this time.

Please direct all inquiries to:

Enrique Michelotti, Ph.D.
National Institute of Mental Health (NIMH)
301-443-5415
[email protected]

For Applications to the National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Mark Egli
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-594-6382
E-mail: [email protected]