Biomarkers and surrogate endpoints have been increasingly used in clinical trials for many different purposes, such as patient management and efficacy evaluation. They would allow individualization of treatment to mitigate risk and to increase efficacy for each patient and faster and more feasible efficacy determination. Statistical methods for validating these measures have evolved over the last 20 years and are still being actively developed. In this talk I will review the use of biomarkers and surrogate endpoints in the regulatory setting and discuss how different needs and scenarios may require different considerations and pathways for validation.