If you have read any review about biomarkers, you have most likely encountered the following definition put forth by the FDA via the Critical Path Institute:
"A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention."
While this definition is scientifically accurate, it lacks a key element: an intent. In my mind, this definition should be revised to include the following phrase: "...designed to drive decisions in drug development and/or patient treatment"
Thus, biomarkers are first and foremost decision tools that need to produce reliable predictions about the the biological process of interest in order to make informed decision about a drug or a patient treatment.
Thierry Sornasse for Integrated Biomarker Strategy
Over the past two decades, the promise of accelerated drug development and personalized medicine have brought heighten attention to the field of biomarker. But do you really know what biomarker are, how they are developed, and how they are used? Here, I'll share over 15 years of experience in the fields of biomarker development and translational research to try to answer some of these questions.
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