Symposium 6: Japan In Real Life: Data, evidence and anevolving regulatory framework for Pharmacovigilance
Moderator
Robert Reynolds FISPE, GSK R&D, USADr. Reynolds is Vice President, Epidemiology in GSK’s Value, Evidence
and Outcomes organization, part of Research and Development. He is
also an Adjunct Associate Professor of Epidemiology at Tulane Schoolof Public Health and Tropical Medicine. He is a Fellow and former Board
member of the International Society for Pharmacoepidemiology. Priorto joining the GSK, he was Vice President, Epidemiology at Pfizer in theWorldwide Regulatory and Safety organization for twenty years. Heholds a BA in Biology from Bard College and a MSc in Epidemiology
and ScD in Population and International Health from the Harvard
School of Public Health.

Speakers
Robert Reynolds FISPE, GSK R&D, USA
Dr. Reynolds is Vice President, Epidemiology in GSK’s Value, Evidence
and Outcomes organization, part of Research and Development. He is
also an Adjunct Associate Professor of Epidemiology at Tulane Schoolof Public Health and Tropical Medicine. He is a Fellow and former Board
member of the International Society for Pharmacoepidemiology. Priorto joining the GSK, he was Vice President, Epidemiology at Pfizer in theWorldwide Regulatory and Safety organization for twenty years. Heholds a BA in Biology from Bard College and a MSc in Epidemiology
and ScD in Population and International Health from the Harvard
School of Public Health.
Masato Takeuchi, Kyoto University, Japan
Masato Takeuchi received MD degree from Nagoya City University,
MPH and PhD degree from The University of Tokyo. He is currently
working as an associate
professor at
Department ofPharmacoepidemiology, Graduate School of Medicine and PublicHealth,
KyotoUniversity.
Hisresearchinterestsare
Pharmacoepidemiology/Clinical Epidemiology and Machine Learning.

Takashi Ando, Pharmaceuticals and Medical Devices Agency, JapanMr. Takashi Ando is an epidemiologist in Division of Epidemiology,
Office of Medical Informatics and Epidemiology, Pharmaceuticals andMedical Devices Agency (PMDA) in Japan. He joined PMDA in 2014and he was assigned to the team for epidemiological analysis andreview for drug safety assessments, through the Medical Information
for Risk Assessment Initiative (MIHARI Project). Since 2014, also as amember of MID-NET® project to provide electronic medical record
database for drug safety assessments in Japan, he has contributed toverification of MID-NET® system reliability and utilized MID-NET® forpost-marketing drug safety assessments.
Cynthia de Luise, Pfizer, USA
Cynthia de Luise, MPH, PhD, PA, is a senior pharmacopidemiologist in
the Worldwide Medical and Safety organization at Pfizer with over 25
years of experience in pharmaceutical drug safety research and clinicalmedicine. Prior to joining Pfizer in 2001 she had a successful career asa physician assistant in surgical critical care. At Pfizer she supports
products across multiple therapeutic areas and drug safety issues andhas significant expertise using real world data for safety, effectiveness,
drug utilization and validation studies. Over the last several years she
has led a long-term initiative to develop pharmacoepidemiologic
capabilities in Japan, which has included hospital-based validation
studies of claims data and scientific oversight of the first post-marketing
safety study using the Japan MID-NET. Her product support includes
Pfizer’s first in class CDK 4/6 inhibitor, Ibrance for which she developed novel predictivemodels to identify early and advanced ER+/HER2- breast cancer in administrative claims data,
the meningitis B vaccine, Trumenba, and Pfizer’s biosimilar oncology portfolio. Cynthia is an
Adjunct Associate Professor of Epidemiology at Rutgers School of Public Health and received
her PhD in Public Health/Epidemiology from Rutgers School of Public Health and a MPH inEpidemiology from Columbia Mailman School of Public Health.

Soko Setoguchi FISPE, Rutgers University, USA
Soko Setoguchi, MD, DrPH, FISPE, a cardiologist by training, US boardcertified internist, and pharmacoepidemiologist, is Associate Professorof Medicine and Epidemiology, Director of Clinical Research Education,
Department of Medicine, Rutgers Robert Wood Johnson Medical Schooland Co-Director of the Master of Science in Clinical and Translational
Science at Rutgers School of Graduate Studies. After her medical school
and Cardiology training in Japan, she completed her doctoral training in
epidemiology at the Harvard School of Public Health. Dr. Setoguchi isrecognized as an international leader in the field ofpharmacoepidemiology. She has authored more than 120 peer-reviewed
papers, and has successfully obtained federal and non-federal grants forher pharmacoepidemiology research program. Her research uses realworld data to perform health services/outcomes research and comparative effectivenessresearch for medications and implantable medical devices in patients with chronic disease.
She has produced critical insights to improve the health outcomes of patients with chronicdisease. Her work is internationally regarded for its methodological rigor and creativity. As shetackled important research questions, she used, promoted, and developed/tested various
methods to conduct valid studies including 1) data linkage, 2) design-based and analytic
methods for pharmacoepidemiologic studies, and 3) validation studies.