The drug development process is currently being hindered by non-optimal prediction of toxicity. Advances in molecular profiling approaches, such as transcriptomics, proteomics and metabolomics, offer the potential to provide a more comprehensive insight into toxicological effects than hitherto possible. These new technologies present their own challenges, however, particularly in relation to standardization and assessment. The focus of this article is on describing the current trends concerning the application of omic approaches in drug safety assessment, with specific emphasis on the role of public-private partnerships in advancing this emerging arena.