Research Veterinary Medical Officer US FDA Silver Spring, Maryland, United States
Biological therapeutics have provided significant advances in the treatment for oncologic and autoimmune indications.These drug products often target receptors or proteins that are integral to immune system function.As a result, the immunomodulatory effects designed to ameliorate disease can cause unwanted effects in other components of the immune system. These effects can range from immune stimulation observed with cytokine release syndrome to induction of autoimmune disease during or after cancer treatment.This presentation will review mechanisms associated with these adverse effects and discuss methodologies available for assessing these risks.