MI2026 – Juhao Yang

Title:
Leveraging non-clinical immunogenicity assays for clinical candidate selection

Abstract:
While George Box famously noted that “all models are wrong, but some are useful,” this principle is especially resonant in preclinical immunogenicity assessment. In vitro tools like DC/T-cell and MAPPs assays offer critical mechanistic insights, yet their cost and complexity often challenge project timelines and budgets. Drawing from personal experience, I would like to discusses how to implement these assays by moving away from “checking every box” toward a risk-based, cost-of-goods approach.

Biography:
Juhao Yang is the Lead of the non-clinical department at Sanegenebio. He brings extensive expertise in drug safety and immunology, having previously served as a Toxicology Project Leader at the Roche Innovation Center Shanghai. In that role, he was instrumental in developing immunogenicity strategies for large molecule programs. Dr. Yang also managed the design, monitoring, and reporting of non-clinical toxicology studies.