Early Drug Discovery and Development Guidelines: For Academic Researchers, Collaborators, and Start- up Companies

Published by EATRIS

Drug RepurposingTarget Validation Drug DevelopmentNCATSNIHResearch and Drug DevelopmentDrug Discovery GuidelineSmall Molecule

This manual contains guidelines to develop therapeutic hypotheses, target and pathway validation, proof of concept criteria and generalized cost analyses at various stages of early drug discovery. Various decision points in developing a New Chemical Entity (NCE), description of the exploratory Investigational New Drug (IND) and orphan drug designation, Drug Repurposing and drug delivery technologies are also described and geared toward those who intend to develop new drug discovery and development programs.

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Assay Development and Screening Technology (ADST)

Published by NCATS

Small MoleculeNCATSHigh Throughput Screening

One of the first steps in the drug development process is creating test systems — called assays — on which researchers assess the effects of chemical compounds on cellular, molecular or biochemical processes of interest. At NCATS, the experts in the Assay Development and Screening Technology (ADST) program work to optimize assays requested or submitted by the biomedical research community for high-throughput small-molecule screening

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Functional Genomics Lab

Published by NCATS

NCATSTarget IdentificationRNAi Screening

NCATS’ Functional Genomics Lab is designed to develop and improve RNAi Screening approaches to better understand gene function and identify treatment targets. Gene silencing through RNAi has emerged as a powerful tool for understanding gene function. Over the past several years, high-throughput RNAi screens have illuminated a wide variety of biological processes, ranging from genes that affect the activity of therapeutic agents to novel components of signaling pathways.

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Rare Diseases Clinical Research Network (RDCRN)

Published by NCATS

NCATSRDCRNClinical DevelopmentNetwork

The RDCRN program is designed to advance medical research on rare diseases by providing support for clinical studies and facilitating collaboration, study enrollment and data sharing. Through the RDCRN consortia, physician scientists and their multidisciplinary teams work together with patient advocacy groups to study more than 200 rare diseases at sites across the nation.

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NCATS, in collaboration with other NIH Institutes and Centers and the Food and Drug Administration (FDA), is leading the Tissue Chip for Drug Screening program to develop human tissue chips that accurately model the structure and function of human organs — such as the lungs, liver and heart — to help predict drug Safety in humans more rapidly and effectively

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Discovering New Therapeutics Uses for Existing Molecules (NTU) program, National Center for Advancing Translational Sciences (NCATS)

Published by IRDiRC

Orphan DrugDrug RepurposingNCATSResearch and Drug DiscoveryNTU-NCATSFunding

The NTU program aims to improve the process of developing new treatments for diseases by finding new uses for existing therapies that already have cleared several key steps along the development path. Existing or partially developed therapeutic candidates can be repurposed for use in new disease indications

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the Biomedical Data Translator

Published by NCATS

NCATSDatabase

NCATS launched the Biomedical Data Translator (Translator) program to accelerate biomedical translation for the research community. Through this program, NCATS will integrate multiple types of existing data sources and reveal potential relationships across the spectrum of data types.

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