Symposium 1: Variability and generalizability of claimsbased algorithms in pharmacoepidemiologic research:Multinational perspectives
Moderators
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 School
and 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 inepidemiology 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 chronic
disease. 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.
Chieko Ishiguro, Pharmaceuticals and Medical Devices Agency (PMDA), JapanDr. Chieko Ishiguro is a senior epidemiologist in the Office of Medical
Epidemiology at the Pharmaceuticals and Medical Devices Agency(PMDA) in Japan. She has over 10 years' experience at PMDA. During
2009-2013, she established the team for epidemiological analysis andreview for drug safety assessment, through the Medical Information for
Risk Assessment Initiative (MIHARI Project). Since 2010, she has been
responsible for leading epidemiological studies using healthcare
information databases, including the National Claim Database and theelectronic medical record database named MID-NET®, and also forreviewing post-marketing study protocols submitted by pharmaceuticalindustries to PMDA.
She also has experience as a visiting scientist in the Office of Safety and Epidemiology in theFood and Drug Administration and the School of Public Health, at Boston University in
Massachusetts in 2010. She is the recipient of the Best Reviewer Award of
Pharmacoepidemiology and Drug Safety for 2016. She has been a board member of theInternational Society for Pharmacoepidemiology (ISPE) since 2018, and also a councilor ofthe Japanese Society for Pharmacoepidemiology (JSPE) since 2015.

Speakers
Brian Strom FISPE, Rutgers University, USA
Brian L. Strom, M.D., M.P.H. is the Inaugural Chancellor of Rutgers
Biomedical and Health Sciences (RBHS) and the Executive Vice
President for Health Affairs at Rutgers University. RBHS is comprised ofeight schools and seven major centers/institutes, and includes academic,patient care, and research facilities. Dr. Strom was formerly theExecutive Vice Dean of Institutional Affairs, Founding Chair of theDepartment of Biostatistics and Epidemiology, Founding Director of theCenter for Clinical Epidemiology and Biostatistics, and Founding Directorof the Graduate Program in Epidemiology and Biostatistics, all at thePerelman School of Medicine of the University of Pennsylvania (Penn).
Although Dr. Strom's interests span many areas of clinical epidemiology,
his major research interest is in the field of pharmacoepidemiology, i.e., the application ofepidemiologic methods to the study of drug use and effects. He is recognized as a founder ofthis field and for his pioneer work in using large automated databases for research.
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 in
Epidemiology from Columbia Mailman School of Public Health.
Benjamin Daniels, University of New South Wales, Australia
Dr. Benjamin Daniels is an early-career pharmacoepidemiologist,
specialising in the analysis of linked administrative health data tounderstand the use and outcomes of medicines, with a particular focus
on targeted cancer therapies. Ben has over 8 years of experience as abiostatistician and data analyst, leading analyses for multi-disciplinary
research teams spanning laboratory-based, epidemiology, and publichealth research at UNSW and the University of Sydney; and translating
findings to clinical and policy audiences. He is currently a Postdoctoral
Research Fellow within the Medicines Policy Research Unit at the
CBDRH.