Principal Scientist, Regulated Bioanalytics
Merck & Co., Inc.
Collegeville, Pennsylvania
Karen Liao is a Principal Scientist in Regulated Bioanalysis group at Merck. In this role, Karen manages ADA and PK deliverables for biologic clinical programs from assay development, assay validation and sample testing, to data reporting and regulatory submission. Karen has participated in several BLA submissions, including the recent FDA approved Winrevair, with responsibilities of leading and authoring bioanalytical method and immunogenicity sections and addressing related regulatory responses. Prior to joining Merck, Karen was an investigator and GSK Associate Fellow at GSK. In the time at GSK, Karen established and implemented in vitro CD4 T and DC activation immunogenicity risk prediction platforms supporting early-stage biologic programs. Karen has nearly 30 years of experience in pharmaceutical and biotechnology industry and 20 years of that was in immunogenicity and bioanalytical field. Karen has published a handful research papers on immunogenicity in recent years. Karen’s research interests include clinical relevant immunogenicity, regulatory submission, and immunogenicity risk prediction. Karen obtained a medical doctor degree and a master’s degree of Immunology in China and received a master’s degree of QARA (quality assurance & regulatory affairs) from Temple university.
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Impact of Soluble Target on Clinical ADA Assessment
Tuesday, July 23, 2024
9:35 AM – 10:05 AM CST