2016年4月27日（周三）上午9：00-12：00在302-2208教室，研究生高级毒理学课程邀请了苏州药明康德总经理金毅博士和毒理服务部郑成恩主任及一般毒理课题负责人潘磊博士。三位专家将从药物安全评价角度给大家做150分钟的讲座。时间安排如下：
Topic: Drug Safety Evaluation:
1. General discussion of drug safety evaluation ( 50 min, Yi Jin).
2. Guidance of nonclinical safety data to clinical trials (50 min, Charlie).
3.Drug safety evaluation on biologics (50 min, Leo).
Yi Jin (金毅), PhD, DABT
Dr. Jin is Vice President of WuXi AppTec Toxicology Services and Chief Scientific Toxicologist for the GLP toxicology facility at Suzhou. Prior to joining WuXi, Dr. Jin was Director of Preclinical Safety at Novartis Pharmaceutical Company and worked for 13 years in drug safety evaluation. He contributed to various drug discovery and development projects including drugs for hypertension, osteoporosis, hepatitis C, and cancers.?Before Novartis, he was employed at Schering-Plough Pharmaceuticals Corp as a genetic and molecular toxicologist. Dr. Jin obtained his B.S. degree in Biology from East China Normal University in 1982 and received his M.S. and Ph.D. degrees in Environmental Health Science-Toxicology from New York University in 1992 and 1994, respectively. Dr. Jin completed his postdoctoral training at the Institute of Cancer Research of Columbia University and at the Haskell Laboratories of Industrial Toxicology of DuPont Company. He has been a Diplomate of the American Board Toxicology (DABT) since 2002. He was President of American Association of Chinese in Toxicology (AACT) in 2014-15. He also served Executive Committee member for Sino-American Pharmaceutical Professionals Association (SAPA) in 2012-13.
Chen-En Cheng （郑成恩）, MS, DABT
Mr. Chen-En Cheng currently serves as senior director of Toxicology at WuXi AppTec Co Ltd from 2014, and is responsible for the toxicology program at the Wuxi Suzhou site. Mr. Cheng holds B.S. degree from Chung Hsing University and Mater degree from Taiwan University, majoring in Veterinary Medicine. Mr. Cheng has extended experience in both Toxicology and Veterinary Medicine. His expertise includes safety evaluation of pharmaceuticals, medical device biocompatibility, chemicals and food additives.?And he is a certificated toxicologist of the American Board of Toxicology. Before joining Wuxi, Mr. Cheng was Manager and study director at Level Biotechnology Inc. for 7 years, where he led the CRO group responsible for safety evaluation of pharmaceuticals, medical device biocompatibility, chemicals and food additives.Currently, Mr. Cheng is the Institutional Animal Care and Use Committee Chair of the Wuxi Suzhou facility and also ad hoc specialist of AAALAC International.
Lei Pan （潘磊）, PhD
Lei Pan is a Study Director for general toxicology and also leads one of the two SD team of toxicology, WuXi AppTec (Suzhou). He holds a PhD degree in developmental biology and has been worked in chemical/drug safety evaluation since graduation in Year 2008. Before joining WuXi, he worked at Intertek as a study director for reproductive toxicity testing of chemicals. He was involved in a wide range of preclinical programs for pharmaceuticals, some of which have been submitted to FDA, CFDA, and other regulatory agencies for IND/NDA. In the past few years, he managed several programs of biologics including antibodies, vaccines, and ADCs.