Contemporary Advances and Challenges in Drug Safety Assessment

Delivering safe and effective drugs remains a major challenge in biomedical science. To address this important challenge, the Drug Safety GRC program is designed to span safety science across the development pipeline from target selection and complex systems biology through the patient experience. The session themes bring together basic and applied science focused on improving drug safety with a specific goal of creating interactions among drug safety scientists and experts from other disciplines. The daily themes are complemented by a closing lecture illustrating where safety can be addresses with new approaches and where advances are needed. The opening sessions focus on computational approaches to modeling drug effect in complex systems and the challenges inherent in extrapolating safety signals across species to understand human risk. The focus then shifts to tissue engineering and stem cell strategies to re-creating complex human biology in tractable in vitro microphysiological test systems to improve safety and efficacy screening. With that background, the topics transition to current safety challenges associated with immunomodulation, an emerging area in clinical testing of novel agents with the first wave of molecules on the market. The meeting wraps up with a focus on pharmacovigilance and real world evidence then closes with a keynote address that highlights the impact of drug safety science on patients. Finally, attendee participation is enhanced through the poster session with daily short talks drawn from submitted posters.