Prepare to move your biologic (or biosimilar) drug to a First-in-Human study. Hear from leading preclinical and Phase I investigators on how to identify safety risks and plan to mitigate them.

Learning Objectives:
Describe safety-related differences between biologics and small molecules, with implications for determining FIH dose, preparations for adverse event recognition and management, safety review, and dose escalation
Discuss factors of biosimilar versus small molecule drug development.