Sr. Principal Scientist Boehringer Ingelheim Ridgefield, Connecticut
As therapeutic modalities and mechanisms of action continue to diversify, traditional neutralizing antibody assessment strategies are increasingly strained by scientific complexity and operational burden. This session moves beyond one-size fits all templates to explore flexible, risk-based approaches to neutralizing antibody assessment across clinical development. Attendees will gain a historical perspective on neutralizing antibody assays followed by a critical discussion of when the data are truly needed to inform safety, efficacy, and regulatory decisions. Through practical examples, the session will highlight how immunogenicity risk, homology to endogenous targets, and clinical context should guide assay design, sample pretreatment, and testing intensity. We will examine how tiered testing strategies and surrogate pharmacodynamic markers can reduce late-stage burden without compromising scientific rigor. Real world case studies will illustrate how different strategic choices shape immunogenicity programs. Participants will leave with a decision-focused framework to right-size neutralizing antibody assessments in an era of complex biologics.
Learning Objectives:
Understand the scientific and strategic rationale for conducting neutralizing antibody assays and evaluate when neutralizing antibody assessment is critical for safety and or efficacy decision making.
Apply a risk based, tiered approach to neutralizing antibody assay implementation across development phases, including criteria for reducing or eliminating neutralizing antibody testing in late stage or registrational studies.
Explore how surrogate pharmacodynamic markers and comparative case studies can inform alternative strategies to standalone neutralizing antibody assays while maintaining regulatory and clinical confidence.
