Translational and Personalized Medicine The goal of personalized medicine is to deliver the right drug to the right person at the right dose in an effort to reduce the cost of high-quality health care and minimize human suffering due to adverse events. As an example of the former, it has been estimated that hospitalization due to adverse drug reactions in Britain alone cost US$847 million per year. New tools are required to improve decision-making during drug development and in the clinic. To achieve this goal, biomarkers are needed to improve preclinical detection of human adverse events for enhanced selection of new drug candidates, detect an individual patient’s sensitivity to a particular compound before systemic drug administration, and identify earlier signs of adverse events to better manage patients’ reactions after exposure. This session will provide insight into technological advancements spurring the discovery of new biomarkers in areas such as genes (i.e., pharmacogenetics, pharmacogenomics, and toxicogenomics), proteins (i.e., proteomics), and metabolites (i.e., metabolomics). Translational (animal to human and vice versa) approaches to biomarker identification and qualification for use will be presented. Experiences with human clinical trials that implement pharmacogenetic (gene variant) biomarkers of safety and efficacy will be described.