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