What are biomarkers?

Biomarkers are biological molecules found in the body that help discern some aspect about the pathophysiology of a disease. Biomarkers can be useful in helping understand which patients might do best on certain therapies (especially targeted therapies). Sometimes, development programs focus specifically on patients who meet a certain biomarker requirement (such as PDL1 expression above a certain thresold in solid tumors or existence of a specific genetic mutation)- examples such as this might be considered “precision medicine”.

Some companies may have a function which is responsible for identification and analysis of biomarker data from company-run trials. This is especially common in the oncology space given the high (and increasing) number of tumor biomarkers.