# NIH/NIMH Therapeutics Discovery Research

NIMH supports early-stage therapeutic discovery and development, through first-in-human and early efficacy trials for mental disorders. This web page details the range of NIMH programs and resources related to therapeutic discovery and development, as well as complementary programs available through broader NIH efforts.

## Genes to biology

### Target identification

Identification of a possible biological target and elucidating its role in disease. A target is a biochemical entity (a protein, RNA, or gene) to which a drug can bind and elicit a physiological change.

## Biology to Therapeutics

### Lead Identification/ Target validation

Confirms that a molecular target is directly involved in a disease mechanism and that modulation of the target has a therapeutic effect.

## Biology to Therapeutics

### Hit-to-Lead

Confirming structure-activity relationship (SAR) exists within several hit series for the biological target. In addition, an early assessment of in-vitro ADMET properties to help select the most promising leads for optimization.

#### Lead Optimization/Preclinical Development

The process of discovering a lead compound and progressing it towards a safe and efficacious drug therapy and successful commercialization into the market.

## Small (Pilot) Clinical Trial

### Preclinical Development

Process that links drug discovery in the lab to initiation of human clinical trials. Preclinical studies include, Process Development (select best synthetic route), new drug scale-up; select the best formulation, frequency, and duration of exposure; and support the intended clinical trial design.

## Strategic Plan

                  - NIMH 2020 Strategic Plan for Research : Outlines the Institute’s research goals and priorities over the next five years.

## Extramural Divisions Supporting Therapeutics Research and Trials

                  - Division of Neuroscience and Basic Behavioral Science (DNBBS)
                  - Division of Translational Research (DTR)
                  - Division of AIDS Research (DAR)
                  - Division of Services and Intervention Research (DSIR)

## Information Relevant to Therapeutics Discovery FOAs

                  - From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illnesses : Report of the National Advisory Mental Health Council's Workgroup on the next generation of interventions for mental disorders.
                  - Report of the National Advisory Mental Health Council Workgroup on Genomics : Guidance for applicants following the Report of the National Advisory Mental Health Council Workgroup on Genomics.
                  - Rigor and Reproducibility ** : Information to assist the extramural community in addressing rigor and transparency in NIH grant applications and progress reports.
                  - Research Domain Criteria (RDoC) Project : A description of the RDoC project, workshop proceedings, current Requests for Applications (RFAs), and additional information.
                  - NIMH NOT-MH-19-053 ** : Notice of NIMH’s Considerations Regarding the Use of Animal Neurobehavioral Approaches in Basic and Pre-clinical Studies.
                  - Central Nervous System (CNS) Radiotracer Table : A table of CNS radiotracers that have been advanced for use in human studies.
                  - Lead Compound Report Card : Use this form to summarize the characteristics of a lead compound you are studying and the desired characteristics of a therapeutic candidate, to track progress through the lead optimization process.
                  - Sample Drug Development Testing Funnel : A graphical illustration of the comprehensive series of assays used for lead optimization and candidate selection.