Human responses to drugs vary widely depending on the combination of multiple factors affecting both efficacy and risk of adverse effects. Human population variability is shaped by differences in sex, age, genetic background, lifestyle, underlying diseases and environmental factors. To represent human variability, currently standard factors are still applied. Therefore, there is a need to characterize the degree of variability between individuals of adverse drug responses and have a definition of data-driven variability factors to represent true human variability. Furthermore, the identification of genetic polymorphisms in critical drug response genes as key drivers of variability allows for genetic screening and tailoring treatment strategies for each patient. This session will highlight recent work in the characterization of human diversity in drug responses thereby driving towards precision medicine.