U.S. Department of Health and Human ServicesHHS National Institutes of HealthNIH National Center for Advancing Translational SciencesNCATS

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Understand Translational Research Tools

Overview

Your patient group can help accelerate the discovery stage of therapy development for your disease by working with patients, scientists, and industry partners to develop translational research tools. Translational research and development is the process of turning observations from the laboratory, clinic, and patient community into therapies that improve the health of the patients. Translational research tools are needed to bridge the gap from understanding the disease process to identifying therapeutic targets and testing potential therapies in preparation for clinical research in humans. These tools include biological assays (bioassays), biomarkers, cell and animal models, and biorepositories.

Resources

Bioassays
Assay Guidance Manual National Center for Advancing Translational Sciences (NCATS) (link)
Biomarkers
CDER Biomarker Qualification Program U. S. Food and Drug Administration (FDA) (link)
BEST (Biomarkers, EndpointS, and other Tools) Resource) FDA-NIH Biomarker Working Group (link)
Developing and Validating Biomarkers Global Genes (link)
Cell and Animal Models
Animal Model Qualification Program U. S. Food and Drug Administration (FDA) (link)
Biorepository
NCI Best Practices for Biospecimen Resources National Cancer Institute (NCI) (link)