发布时间:
2018
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12
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04
点击次数:
0
Positions：
Chief Consultant and Partner ; Former FDA Senior Reviewer
Company：
Humphries Pharmaceutical Consulting Inc.
个人简介：
Dr. Tao (Tom) Du is currently working as the Chief Consultant of Humphries Pharmaceutical Consulting, which is a global pharmaceutical consulting firm. Dr. Du is a physician and also a scientist. He graduated from Tianjin Medical University (TMU). He got his training in medicine at TMU and in pathology at McGill University, Montreal. Before joining the US Food and Drug Administration (FDA) as a reviewing officer in 1994, he had two years of fellowship training at Harvard University. When he worked at the FDA, Dr. Du worked in the Division of Pulmonary, Allergy and Rheumatology Products, and then worked in the Division of Oncology Products. He reviewed more than one hundred INDs and NDAs. Since leaving the FDA in 2000, he has held several important positions in the pharmaceutical industry. He worked as Senior Director, Clinical and Regulatory Affairs, Hutchison Whampoa Company based in Hong Kong. He served as Acting Managing Director, China operations, and then worked as Senior Director, Global Regulatory Affairs at Ingenix Pharmaceutical Services, an UnitedHealth Group Company. Dr. Du has extensive experience in drug development and has held regulatory responsibilities in various therapeutic areas including oncology, pulmonary/allergy, gastrointestinal, and inflammatory, cardiovascular, and lipid-lowering indications. He has been working as either project leader or project team member to help various American, European, and Asian drug makers develop their drug products and medical devices in the United States and China. Du’s team has participated in more than 100 IND, NDA, BLA, ANDA, PMA and 510(k) submissions in the United States during the past 10 years. Dr. Du has also worked as a consultant for the American financial industry to evaluate the investment/business potentials of small pharmaceutical companies. He has served as a board member for three publicly listed biopharmaceutical companies in the North America. He worked as a consultant involved in the acquisitions of several pharmaceutical or medical device companies in the past ten years. Dr. Du has published 19 articles on peer-reviewed scientific journals in the United States and Europe. Dr. Du was a member of FDA committees for Botanical Drug Products and Clinical Pathology. He has received several awards from the FDA and pharmaceutical industry. He is also a frequently requested speaker for major international forums. In recent years, he organized and/or participated in symposia on drug development and evaluation in China, Hong Kong, and the United States. Dr. Du has given several lectures to the Chinese CFDA officers in a training program held by the North Carolina State University from 2011 to 2015. Dr. Du is an expert in botanical drug development in the United States. He was a reviewer of three botanical drug INDs when he was with the FDA. After he joined the pharmaceutical industry, he has helped more than 20 Chinese drug companies to submit ANDA or IND and initiate clinical trials for the development of herbal, biological, generic, and new chemical drugs in the United States. Dr. Du was selected in 2011 as a member of “1000 Talent Plan”, which is the highest honor awarded to oversea Chinese scholars by Chinese government.