Speakers
Florence Houn, MD, MPH, FACP
Consultant, Florence Houn MD MPH LLC, United States
Dr. Florence Houn is Vice President, Global Regulatory Policy, Intelligence and Strategy at Celgene. Previously, she served for 15 years in the US Food and Drug Administration (US FDA), most recently as Deputy Director for the Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research (CBER). Dr. Houn received her Bachelor of Arts degree from Harvard University and MD from the Albert Einstein College of Medicine. She completed her Cancer Prevention Fellowship at the National Cancer Institute and obtained a Masters of Public Health from the Johns Hopkins School of Hygiene and Public Health.
Zili Li, MD, MPH
Vice President, Head of Asia Pacific R&D, Janssen Research & Development, China
Zili oversees all R&D activities within Asia Pacific, leading over 1,400 science professionals dedicated to delivering transformational healthcare innovation across the region. Zili joined Janssen in June 2019 from the FDA where he served as Associate Director for Global Affairs at the Office of Generic Drugs. There he contributed significantly to the expansion of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to the field of generic drugs, playing a critical role in China’s National Medical Products Administration’s membership in ICH in 2017. Zili is a graduate of Peking Union Medical College and completed his residency training at Johns Hopkins in 2000.
Chi-Wan Chen, PhD
, Pfizer, Inc., United States
Dr. Chi-wan Chen is Executive Director in Global CMC, Pfizer, responsible for regulatory CMC policies and strategies with a focus on China and Asia Pacific. She has made numerous presentations on regulatory and CMC topics on China in these countries. Prior to joining Pfizer in 2008, Dr. Chen had served in the U.S. FDA for more than 21 years and held several management positions in the Center for Drug Evaluation and Research (CDER), including Deputy Director in the Office of New Drug Quality Assessment. She represented CDER on the ICH Q1AR, Q3AR/Q3BR, and Q8R Expert Working Groups between 1998 and 2008 and managed the CDER Quality-by-Design Pilot Program in 2005-08.
Bruce Close
, Celgene, United States
Mark Goldberger, MD, MPH
, Mark Goldberger MD MPH LLC, United States
David LIN, PhD
Senior Consultant, Biologics Consulting Group, Inc., United States
Gang Wang, PhD
, U.S.FDA China Office, China
Dylan YAO, MD, PhD
Senior Vice President and CSO, Joinn Laboratories, Inc., China
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