Biography:
Zhaohua (Joe) Zhou, Ph.D., is a Research/Review Scientist at the Office of Biotechnology Products, CDER, US Food & Drug Administration. Dr. Zhou’s research interest is in the development of lab models to pinpoint and predict drug-induced acute allergic reactions. These methods are based upon and covering current understanding to the mechanisms of a clinical anaphylaxis, which, when using comprehensively, can quickly rule in and rule out drug quality related causes as well as predict patient sensitivity to therapeutics. Dr. Zhou’s regulatory expertise in the FDA includes biotherapeutics CMC assessment and immunogenicity method assessment.
Title : Mast cell degranulation links anti-PEG IgE to anaphylaxis caused by PEGylated drugs and PEG-contained LNP/mRNA COVID vaccines