Biomarker play an important role in modern pharmaceutical development because they allow a treatment adjusted for the patient’s individual circumstances. Recommendation for specific therapies for example based on the patient’s very own gene mutation profile (keyword “Precision Medicine”) take the place of the predominant “one-size-fits-all” approach.

This presentation starts with an introduction to the field of precision medicine and biomarker and discusses their relevance. The different roles of biomarker (prognostic, predicative) are illustrated with the help examples from oncology. Afterwards, statistical procedures for identification and biomarker validation are introduced.