Understand Translational Research Tools


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.


Assay Guidance Manual National Center for Advancing Translational Sciences (NCATS) (link)
CDER Biomarker Qualification Program U. S. Food and Drug Administration (FDA) (link)
Cell and Animal Models
Animal Model Qualification Program U. S. Food and Drug Administration (FDA) (link)
NCI Best Practices for Biospecimen Resources National Cancer Institute (NCI) (link)