Zhaoyang Megan Li | Senior Director, Clinical Pharmacology
Shire

Dr. Li is a Senior Director of Clinical Pharmacology at Shire.  She has nearly 20 years of industrial experience in clinical development for small molecules, RNA based therapies and biologics, including monoclonal antibodies and enzyme replacement therapies.  Prior to joining Shire in June 2018, Dr. Li worked at Sanofi as a Director of Translational Medicine & Clinical Pharmacology for 8 years and Biogen for 11 years. She received her B.S. in Chemistry from Peking University in China and a Ph.D. in Pharmaceutics from the Ohio State University in the US. During her career, Dr. Li also acted as a Clinical Study Director for early phase clinical studies, responsible for the design, execution and reporting of the trials.  Dr. Li has extensive experience in global regulatory interactions and submissions, and was the global clinical pharmacology lead for the submission and marketing approvals of Kynamro (for a rare disease, HoFH), Lemtrada (for MS) and Dupixent (for atopic dermatitis).  Her interests include traditional clinical pharmacology topics (e.g. PK/PD, metabolism, drug-drug interactions and special populations) as well as patient focused clinical development of therapeutics and biosimilar.  Dr. Li was a member of a variety of working groups and councils in Sanofi, including Immunogenicity Council, PK Working Group, Patient-Centric Integrated System Design Working Group and Patient Engagement Task Force.  She has been the Chair for the Biosimilar Task Force at American Association of Pharmaceutical Scientists (AAPS) since July 2017.