Symposium 7: Real World Evidence to support new drug
approval and label expansion
Moderator
K. Arnold Chan FISPE, National Taiwan University, Taiwan
Dr. Chan is a physician epidemiologist with more than 30 years of global
research experience in academia and private sector, with a primary focus
on post-marketing evaluation of medical products. He received medical
training at National Taiwan University (MD-equivalent, 1987) andadvanced training in epidemiology at Harvard School of Public Health(Doctor of Science, 1992). He has served on the faculty at National
Taiwan University (NTU) and Harvard School of Public Health and joined
the private industry in 2005, subsequently became Chief Scientist of theEpidemiology Unit at Optum.
Dr. Chan returned to NTU in 2013 and is currently a professor at NTU College of Medicine
and Director of the NTU Health Data Research Center. In addition to scientific research, hehas provided consultation for Taiwan Food and Drug Administration and related healthauthority for more than 20 years. Dr. Chan has authored or co-authored more than 100 peerreviewed articles and co-edited one of the two widely used English textbook onpharmacoepidemiology.

Speakers
Jeff Lange, Amgen Inc., USA
Jeff is an epidemiologist within Amgen’s Center for Observational
Research. He received his PhD from the University of Iowa. During his 8years at Amgen, he has been applying the use of observational researchfor both clinical development and regulatory decision-making within thetherapeutic areas of oncology and general medicine. Currently, Jeff is
supporting further development of organizational capabilities within Asia.

Yuki Ando, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yuki Ando is a Senior Scientist for Biostatistics of the Pharmaceuticals
and Medical Devices Agency (PMDA), Japan. She received a master’s
degree in Engineering from Tokyo Science University, and PhD in Health
Science from Osaka University. In 1997, she joined the Pharmaceuticals
and Medical Devices Evaluation Center (PMDEC), which was establishedthat year and subsequently transformed into the current PMDA.
Currently she is responsible for the biostatistics review and consultationin the new drug and device review offices in PMDA. Additionally, sheworks for Office of Advanced Evaluation with Electronic Data, the office
which is responsible for the use of patient level electronic study data that are submitted withnew drug applications. She is responsible for promoting implementation of data standards andthe use of submitted electronic study data in PMDA.

Wei Zhou FISPE, Wei Zhou, Merck Research Laboratories, USA
Wei Zhou, MD, Ph.D., is currently Executive Director and head forOncology, Pharmacoepidemiology, Center for Observational and Realworld Evidence (CORE) at Merck Research Laboratories. Before that, hewas the Executive Director at CORE Product Line, Regional Director andHead of Epidemiology Asia Pacific Unit at Merck, Director of MolecularEpidemiology at Pfizer Oncology, and Senior Epidemiologist at Merck.
Wei was a Research Fellow/Research Associate/ Research Scientist atHarvard School of Public Health between June 1999 and December,
2007, where he had contributed to a number of projects on geneenvironment interactions in the development and prognosis of different
chronic diseases including cancers. Wei is a Fellow of the International
Society of Pharmacoepidemiology (ISPE).
Wei received his MD from West China University of Medical Sciences in 1994 and Ph.D ofEnvironmental Health from Shanghai Medical University in 1998. He was the recipient of theJohn E. Fogarty International Training and Research Program. He has published more than
80 peer-reviewed manuscripts and book chapters, and served as a reviewer for various
international journals. Wei has given numerous presentations and served as chair/co-chair atdifferent international conferences and symposiums.
K. Arnold Chan FISPE, National Taiwan University, Taiwan
Dr. Chan is a physician epidemiologist with more than 30 years of global
research experience in academia and private sector, with a primary focus
on post-marketing evaluation of medical products. He received medical
training at National Taiwan University (MD-equivalent, 1987) andadvanced training in epidemiology at Harvard School of Public Health(Doctor of Science, 1992). He has served on the faculty at National
Taiwan University (NTU) and Harvard School of Public Health and joined
the private industry in 2005, subsequently became Chief Scientist of theEpidemiology Unit at Optum.
Dr. Chan returned to NTU in 2013 and is currently a professor at NTU College of Medicineand Director of the NTU Health Data Research Center. In addition to scientific research, hehas provided consultation for Taiwan Food and Drug Administration and related healthauthority for more than 20 years. Dr. Chan has authored or co-authored more than 100 peerreviewed articles and co-edited one of the two widely used English textbook on
pharmacoepidemiology.