At Charles River, we understand that biomarkers are critical tools in the discovery and development of new drugs and therapies. They are typically developed first in preclinical animal models of disease with translation to the clinic, and their measurements support target validation and proof of target, mechanism and efficacy. Biomarkers are being applied clinically to identify patients at risk for disease, predict potential treatment responders or adverse event occurrences and forecast favorable clinical outcomes. We offer biomarker services as part of our specialty pathology program, which involves protein localization in tissues using immunohistochemistry with comprehensive histopathologic interpretation.
It is important to note that for clinical trials, the clinicians conducting the studies are responsible for diagnosis and assessing outcome for “go/no go” decisions. We provide correlative studies that are designed as an adjunct to the clinical trial. These studies assist in determining whether a drug is reaching the intended target and whether the drug works the same way in humans as it has in animals.
Our pathologists and scientists will work closely with you to identify which markers to assess, design a scientifically rigorous approach to sample testing and provide a bridge between preclinical and clinical biomarker development.
For more information about our clinical pathology servcies, please contact us at 1.877.CRIVER.1 or askcharlesriver@crl.com.