Advances in Models, New Modalities and Clinical Considerations for Drug Safety

Drug safety describes the potential for adverse effects that are related to the administration of drugs. Key challenges in drug discovery and development are identifying and solving potential safety problems as early as possible in the nonclinical or clinical setting. Advancements in the approaches used to characterize toxicities have resulted in identification of safety biomarkers and clear opportunities to aid in understanding mechanisms of clinically-important adverse drug reactions. The unique goal of the science applied to drug safety is to improve the benefit-risk ratio of investigational drugs and ultimately, improve the safety profiles and tolerability of therapies. The session themes will highlight various concepts and approaches that are addressing the key challenges in drug safety. A unique attribute of the Drug Safety GRC is the specific intent to create science-based partnerships among drug safety scientists and experts from many disciplines.