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Zhaoyang Li

Director Clinical Pharmacology at Sanofi , USA

Biography

Dr. Li is Director of Translational Medicine & Clinical Pharmacology at Sanofi.  She received her B.S. in Chemistry from Peking University (China) and a Ph.D. in Pharmaceutics from the Ohio State University (USA).  She has over 17 years of industry experiences in clinical pharmacology and drug development of both small molecules, RNA based therapies and monoclonal antibodies. She is also a clinical study director for Phase 1 clinical pharmacology studies, responsible for design, execution and reporting of the trials.  Dr. Li has accumulated extensive experience in regulatory interactions and submissions, and was the clinical pharmacology lead for the approvals of Kynamro (for a rare disease, HoFH), Lemtrada (for MS) and Dupixent (for atopic dermatitis).  Her interests have included traditional clinical pharmacology topics (e.g. PK/PD, metabolism, drug-drug interactions and special populations), patient focused medicines development and Biosimilar.  Dr. Li serves as a member on a variety of working groups and councils in Sanofi, including Immunogenicity Council, PK Working Group, Patient-Centered Integrated System Design Working Group and Patient Engagement Task Force. 

Abstract

Abstract : Practical considerations in clinical strategy to support the development of biologics device combination products