Harnessing the power of the immune system has revolutionized the treatment options for patients with serious illnesses in fields such as oncology and autoimmune disease. However there are concerns about unwanted immune responses leading to serious adverse events. Regulatory agencies throughout the world require a thorough assessment of a biotherapeutic’s potential to trigger these unwanted responses, a requirement complicated by the fact that “traditional” animal studies may not be highly predictive in this area. Assessing the potential for immunogenicity and immunotoxicity early in candidate selection helps you make better decisions, evaluate safety and can accelerate development time. This presentation will focus on solutions to address the potential for unwanted immune responses both in early candidate selection as well as for improving existing drugs.