Distinguished Scientist-Toxicologist Genentech, Inc.
Immunosuppression refers to the weakening, delay, or less efficient function of the immune system and its ability to fight infections or other diseases and has been a major focus of immunotoxicologists for several decades. In the context of pharmaceuticals, immunosuppression may be part of the intended mechanism of action (MOA) or a result of unintended effects on the immune system. Dedicated assays and assessments may be warranted to characterize the effects of the pharmaceutical on the immune system, which component is suppressed, the extent of suppression, reversibility, and potential functional consequences. Immunosuppression evaluations are generally conducted in an integrated manner using a weight-of-evidence (WOE) approach to inform further assessments. This presentation will outline the considerations as well as strategies and tools to assess immunosuppressive potential of pharmaceuticals during the course of drug development.
