Sr. Principal Scientist
Merck & Co., Inc.
Dr. Honglue Shen is currently a Scientific Senior Director in the regulated bioanalytics at Merck, where she oversees bioanalytical and immunogenicity strategies for a wide range of therapeutic modalities through major milestones including IND, FIH, clinical phase 1-4, and regulatory filings. With over two years of experience in DMPK and Discovery Bioanalytics, Dr. Shen has been instrumental in shaping DMPK strategy and interpreting PK/PD data for multiple therapeutic areas. Prior to Merck, she spent 5 years in Specialty Biologics at Teva Pharmaceuticals, and over 10 years in QPS, where she held various roles of increasing responsibility in regulated bioanalytics, immunogenicity, and translational medicine.
Dr. Shen possesses a remarkable 20 years of experience spanning diverse modalities such as ASO and siRNA, ADCs, monoclonal and bispecific antibodies, and small molecules. Her invaluable expertise has supported successful IND, BLA, and MAA filings and secured FDA approval for over six BLA submissions. She is an active volunteer in AAPS, holding memberships in important leadership committees such as Bioanalytical, Immunogenicity, Biomarkers, and Precision Medicine. She holds multiple patents in the fields of prion-binding ligands and retinoids. She earned her PhD in Pharmacology from the Institute of Materia Medica, Chinese Academy of Medical Science, Beijing.