Implementation of risk assessment outputs to drive clinical immunogenicity strategy and regulatory filing-related activities

Vibha discusses a proactive risk based approach to assessing immunogenicity in early development. She describes a suite of in silico risk assessment tools in combination with in vitro methods to evaluate immunogenicity or product attributes and how, when used in combination, those methods can reduce false positive identification. The stages of when to implement and report the data from the risk assessment tools is described as well as the current challenges the FDA reviewers face when evaluating the data package.