Symposium 2: Data science and Pharmacoepidemiology inthe next 10 Years
Moderator
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 Molecular
Epidemiology at Pfizer Oncology, and Senior Epidemiologist at Merck.
Wei was a Research Fellow/Research Associate/ Research Scientist at
Harvard 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.

Speakers
Almut G. Winterstein FISPE, University of Florida, USA
Almut Winterstein is professor and chair of pharmaceutical outcomesand policy and director of the Center for Drug Evaluation and Safety, bothat the University of Florida. She received her pharmacy degree from theFriedrich Wilhelm University in Bonn, Germany and her PhD in
Pharmacoepidemiology from the Charité Humboldt University in Berlin,
Germany. As recognized expert in drug safety, she has chaired the Foodand Drug Administration’s Drug Safety and Risk Management Advisory
Committee from 2012-2018. Recognizing her contributions to the field ofpharmacoepidemiology, Dr. Winterstein was inducted as a fellow of theInternational Society of Pharmacoepidemiology (IPSE) in 2013 and as president-elect of thesociety in 2018. In 2017, she was named the Dr. Robert and Barbara Crisafi Chair forMedication Safety in recognition of her research on drug safety and on assessing and devising
ways to improve medication use. Her work in this area has resulted in more than 300 peerreviewed publications and 21 PhD graduates in pharmacoepidemiology.

Nancy Santanello FISPE, Consultant, USA
Nancy Santanello is a physician-epidemiologist trained in Emergency
Medicine and Preventive Medicine with a MS in Epidemiology. Dr.
Santanello was a Medical Officer with the National Heart, Lung, andBlood Institute (NHLBI) Prevention and Demonstration Research Branchof the Division of Epidemiology and Clinical Applications (1987-1991)
conducting clinical trials, epidemiology studies and developing physician
training and patient education materials. She joined Merck & Co. Inc.
(MSD) where she became the Vice President and Head of theEpidemiology Department (2003-2015).
Dr. Santanello consults in drug and vaccine pharmacoepidemiology (safety andeffectiveness), clinical outcome assessments, and the development and validation of patientreported outcome (PRO) measures for use in clinical trials, trial and observational study
design. She is a Past President of the International Society for Pharmacoepidemiology (ISPE)
and is a Fellow of ISPE (FISPE). Dr. Santanello is the current Chair of the PhRMA Foundation
Health Outcomes Advisory Committee.
Currently, Dr. Santanello is co-leading an ISPE working group of researchers from FDA, EMA,
pharmaceutical companies and academia in an effort to incorporate real-world data in clinical
trial programs as external controls.
Koji Kawakami, Kyoto University, Japan
Koji Kawakami, MD, PhD is Professor and Chair of Department ofPharmacoepidemiology, Graduate School of Medicine and Public Health,
Kyoto University. After the residency training in head and neck surgery
and emergency medicine, Dr. Kawakami served as postdoc and later
promoted to clinical trial IND reviewer at the US-FDA during 1999-2004.
From 2006, Dr. Kawakami moved to Kyoto University, where he isconducting various clinical epidemiology and pharmacoepidemiology
research programs. He is also focusing on the development of the EMRderived clinical real world data database (currently 1.9M patients from 170
hospitals) and the health checkup database of 0-14 years old (currentlyfrom 135 local governments) in Japan.