National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Health Disorders

Presenter

Yael Mandelblat-Cerf, 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, and to develop novel ligands and circuit-engagement devices as tools to further characterize existing or to validate new drug and device targets.

Rationale

Significant advances in neuroscience, genetics and related omics, and 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 biological targets for drug and device development, and developing evidence-based pharmacotherapies and neuromodulation interventions for the treatment of mental disorders. 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, by supporting innovative, multidisciplinary approaches to the discovery of new treatments and research tools. The concept takes 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 mental disorders. As such, it is anticipated that the NCDDG Program would continue to:

• Accelerate the discovery and development of new therapeutic drugs and devices for mental 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 Investigational Device Exemption (IDE)-ready devices 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.
• Perform first-in-human (FIH) trials of therapeutic drug candidates to test safety, pharmacokinetics/pharmacodynamics, and define central nervous system dosing for subsequent trials.
• Perform FIH trials of therapeutic devices such as neurostimulatory, neuromodulatory and closed-loop systems to test safety and efficacy.