Predictive Biomarkers in the Development of Oncology Drugs: A Therapeutic Industry Perspective

The codevelopment of predictive biomarkers along with therapeutic agents, particularly in oncology, is becoming increasingly important. This approach presents both substantial opportunities and challenges. We illustrate these by reviewing some specific recent examples relating to the development of anticancer drugs targeting the HER family of cell surface receptors. We argue that ultimate success may require significant changes to the current approach to drug development.