The focus of this white paper is to highlight the rapidly evolving biomarker landscape in oncology from clinical development to regulatory uncertainties to commercial implications. It will focus on the key challenges and success factors involved in launching targeted therapies with biomarkers and/or in vitro diagnostics, outline how to navigate the complex realities of biomarkers and how the industry needs to adapt for targeted therapies to ultimately reach patients without creating too much of a burden on the healthcare system.