Fachschaftsinitiative Biomedizin

Prof. Dr. Florian Gantner

Biomarkers: What they are and how they are used in Clinical Development

Institute: Translational Medicine & Clinical Pharmacology, Boehringer Ingelheim, Pharma GmbH & Co. KG, Biberach; Germany

A biomarker is a biological characteristic, which can be measured and evaluated objectively, and thus can act as an indicator of a normal or a pathogenic biological process. It further allows assessing the pharmacological response to a therapeutic intervention. Biomarkers can be molecular, anatomic, physiologic, behavioural, digital or biochemical in nature. They have become more and more valuable in recent years during the costly and lengthy process of drug discovery and development as they - if used appropriately and qualified accordingly - can give an early indication whether a new medicine might work or not, is safe enough, and which patient population might benefit most.

An overview of the biomarker field along with examples of biomarker-guided drug development will be presented.