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Renewal of the National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental or Substance Use Disorders or Alcohol Addiction

NAMHC Concept Clearance

Presenter:

Linda Brady, Ph.D., Enrique Michelotti, Ph.D.
Division of Neuroscience and Basic Behavioral Science

Goal:

The goal of the NCDDG Program is to advance the discovery, preclinical development, and early proof of concept testing in humans of new pharmacologic and neuromodulatory approaches to treat mental disorders, substance use disorders (SUDs), or alcohol addiction, and to develop novel ligands and circuit-engagement devices as tools to further characterize existing or to validate new drug/device targets.

Rationale:

Significant advances in neuroscience, genetics and related omics, behavioral neuroscience, together with technological developments (structural biology, in silico and high throughput screening, in vivo imaging methods), provide a rich knowledge base for understanding pathophysiology, identifying new molecular targets for drug discovery, new circuit/oscillatory targets for device development, and developing rational pharmacotherapies and neuromodulation interventions for the treatment of psychiatric disorders, SUDs and alcohol addiction. Taking advantage of the wealth of potential new targets, the NCDDG Program aims to accelerate the process of target validation and medication discovery to advance novel and effective treatments for mental disorders, SUDs or alcohol addiction by supporting innovative, multidisciplinary approaches to the discovery of new treatments and research tools. The initiative will take full advantage of available intellectual and material resources to accelerate the discovery, lead optimization, model development, and clinical testing of chemical identities or devices for novel molecular targets related to brain disorders. As such, it is anticipated that the NCDDG model will:

  • Accelerate the discovery and development of new therapeutics for brain disorders.
  • Increase the availability of pharmacologic research tools (including imaging agents) for basic and clinical research.
  • Facilitate the development and validation of models and pharmacodynamic measures to evaluate novel therapeutics.
  • Increase the availability of new Investigational New Drug (IND)-ready compounds and agents suitable for testing in humans.
  • Facilitate the development and validation of new clinical measures or biomarkers suitable for use in human proof of concept trials of novel therapeutics for mental disorders.
  • Accelerate the development of novel neurostimulation technologies.
  • Perform first in human and early stage pharmacokinetic/pharmacodynamic trials of experimental agents to define CNS dosing for subsequent trials.

The intent 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 alcohol addiction, 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.