The goals of this new conference are to stimulate discussion of contemporary approaches to assessing drug safety, and to bridge the divide that exists between individuals working in pre-clinical and clinical drug safety research. An additional objective is to catalyze discussions among drug safety experts in academia and industry, so as to create opportunities for collaboration and to strengthen the valuable relationship between basic and applied research in the field of drug safety. Academic and industry scientists attempt to understand and predict drug safety issues using computer-based models, in vitro tests, toxicology studies in animals, and clinical trials. In spite of these efforts, drug toxicity continues to occur in patients at all stages of drug development, and has forced withdrawal from the market dozens of medications in the past 20 years. To help this field make progress, we propose this conference to discuss data, experimental strategies, and new technologies that are being used to answer basic and applied questions: What are the most important drug safety issues for which we need additional research? What approaches are effective, which approaches have failed, and why? For which drug safety issues are animals successful predictors of human drug safety issues, and for which are they inadequate, and why? Are human stem cells superior models for predicting human drug safety, for which types of toxicity, and why? How can we share our data from pre-clinical and clinical safety studies more effectively, to enable model development and hypothesis-testing by academic and industry scientists in the Drug Safety community? How can we best leverage human genetic data to improve the design and interpretation of drug safety studies in humans? What do we currently know, and what do we suspect, are the contributions of genetic polymorphisms to drug safety issues in humans? How could this knowledge improve the design of clinical trials and guide the safe use of marketed compounds? Our target audience is an equal mix of academic and industry scientists striving to improve drug safety. Participants from industry will be expected to have an active publication record, and to make presentations that reflect open disclosure of current activities in their labs. We expect them to make strong contributions related to applications of new technologies in pre-clinical and clinical drug development, describe successes and failures of using novel blood-based safety biomarkers in veterinary species and in man, and share quantitative models of drug safety response in animals and in clinical trials. In a related sense, we expect participation by academic scientists who have a track record not only of publications but also of tackling challenging problems that improve our ability to assess the safety of new and existing medications. Academic progress in the field include computer modeling of biological processes at the biochemical and cellular level, trial simulations exploring the role of genetic variation on patient outcome at the individual and population levels, and applications of adaptive trial design and Bayesian methods in clinical research. We strongly believe this mix of academic and industry scientists will create a dynamic environment where the ideas and resources of both types of organizations will advance the field, lead to valuable research collaborations, and strengthen the community that becomes our Drug Safety GRC. Noteworthy is the observation that chemical space and drug targets have evolved over the years, and with this evolution there has been a significant shift in the types of drug toxicities being observed. Sharing of this type of information should be very interesting to academic scientists, and create opportunities for research collaborations. In addition, there is broad recognition that a deeper association can be made between compound-induced toxicities and human genetic variants. We believe such questions are likely to be solved more successfully through collaborations between academia and industry than operating independently. This conference intentionally seeks to create such connections by drawing experts from both academia and industry into active dialogue of contemporary drug safety issues. We also want a small number of scientists from regulatory agencies (e.g., FDA, EMA), who can offer their perspective on challenging drug safety issues, and who can become informed about contemporary advances and challenges in this field by leaders in academia and industry. The structure of the conference builds momentum in a way that parallels the drug development process itself. We open with an articulation of the ambitious objective of alleviating human disease, proceed through computer-based modeling of protein-protein networks underlying pharmacological and toxicological processes and structure-based predictions of compound toxicity. Next we examine the strengths and limitations of empirical, lab-based pre-clinical safety assessments, beginning with in vitro technologies including human stem cells, and move progressively through safety studies in veterinary species, to early phase human clinical trials. We then examine contemporary strategies of experimental design for Phase 3 studies, including adaptive trial design and Bayesian methods that are rarely used by drug developers but have been demonstrated to have clear advantages in academic research. Finally, we examine what additional information is learned about drugs after they’ve been approved, and to what extent these drug safety findings might be made earlier through use of pharmacogenetics and novel clinical trial designs.