. Author manuscript; available in PMC: 2010 Aug 8.

Published in final edited form as: Neuropsychopharmacology. 2008 Sep 17;34(1):229–243. doi: 10.1038/npp.2008.125

Table 1.

Selected examples of NIMH and NIH programs and initiatives to support psychiatric drug discovery and development. See text for further description of programs and initiatives listed here.

Drug Discovery and Development Pipeline	NIMH or NIH Programs or Initiatives
Early stage research and discovery
• Target discovery and validation: genes, drug targets, preclinical models, research tools	Investigator initiated research Selected Resources: Chemical Synthesis and Drug Supply Program GAIN, GEI KOMP Mouse Models (PAR-08-158) PET Imaging (PA-06-463) Psychoactive Drug Screening Program SBIR (PA-08-142, PA-08-137, PA-06-016, PA-06-375)
• Assays	Assay Development (PAR-08-024) HTS Assay (PAR-08-035) Fast Track Process (NOT-RM-07-012) SBIR (PA-08-142, PA-08-001)
• HTS	MLSCN, MLPCN NIH Clinical Collection SBIR/STTR (PA-08-001, PA-08-002)
• Hit to lead
◦ Hit generation, chemical optimization, computational chemistry, SAR, in vitro functional assays, data mining	Drug Discovery for Nervous System Disorders (PAR-07-048; PAR-07-049) MLSCN, MLPCN NCDDG, NCDDDG (PAR-07-159) PubChem SBIR (PA-08-142, PA-07-424)
◦ Selectivity testing	Psychoactive Drug Screening Program SBIR (PA-08-142)
Preclinical development
• Continuation of lead optimization to IND filing
◦ Medicinal chemistry, SAR, biology, preclinical testing, proof of mechanism, back up compounds	Chemical Synthesis and Drug Supply Program MLSCN, MLPC NNCDDG/NCDDDG (PAR-07-159) SBIR (PA-08-142)
◦ Scale up synthesis and bulk supply	NIH-RAID SBIR (PA-08-142)
◦ GMP synthesis	Chemical Synthesis and Drug Supply Program NIH-RAID SBIR (PA-08-142)
◦ Pharmacokinetics, bioanalytical assays	NIH-RAID SBIR (PA-08-142)
◦ GLP toxicology studies supporting IND ◦ Safety pharmacology studies	NCDDG/NCDDDG (PAR-07-159) NIH-RAID SBIR (PA-08-142) Toxicological Evaluation of Novel Ligands Program
◦ Formulation	NIH-RAID SBIR (PA-08-142)
Clinical development
Phase I – safety: dose selection, pharmacokinetics, exploratory biomarkers	Autism Consortium/STAART Biomarkers Consortium CNTRICS NCDDG, NCDDDG (PAR-07-159) NIH Toolbox SBIR TURNS
Phase I/II – efficacy: proof of concept, exploratory biomarkers	Autism Consortium/STAART Biomarkers Consortium CNTRICS CDDG, NCDDDG (PAR-07-159) MATRICS Consensus Cognitive Battery MATRICS CT PROMIS SBIR (PA-08-142, PA-08-137, PA-06-016, PA-06-079) TURNS

Abbreviations. CDDG, Cooperative Drug Development Group; CNTRICS, Cognitive Neuroscience Approaches to Treatment Development for Impaired cognition in Schizophrenia; GAIN, Genetic Association Information Network; GEI, Genes, Environment and Health Initiative; KOMP, Knock Out Mouse Project; HTS, High throughput screen; MATRICS, Measurement and Treatment Research to Improve Cognition in Schizophrenia; MLSCN/MLPCN, Molecular Libraries Screening Centers Network/Molecular Libraries Probe Production Centers Network; NCDDG, National Cooperative Drug Discovery Group; NCDDDG, National Cooperative Drug Discovery and Development Group; PROMIS, Patient-Reported Outcomes Measurement Information System; SBIR, Small Business Innovation Research; NIH-RAID, NIH-Rapid Access to Interventional Development; STAART, Studies to Advance Autism Research and Treatment; TURNS, Treatment Units for Research on Neurocognition and Schizophrenia;