Educational session instructors
Geoffrey Liu, MD FRCPC FISPE is a molecular pharmacoepidemiologist, the Alan B. Brown Chair and Professor of Medicine, Epidemiology, and Medical Biophysics at the University of Toronto, Canada. While practising as a medical oncologist at Princess Margaret Cancer Centre, Dr. Liu also runs a combined animal and human laboratory studying the use of novel drugs and biomarkers in the cancer setting, in addition to performing pharmacogenomic cohort and case-control studies, drug utilization, and knowledge translation studies. He also runs the multi-disciplinary COMBIEL (Cancer Outcomes, Medicine, Biostatatistics, Informatics, Epidemiology, and Laboratory) training program at the Ontario Cancer Institute, and teaches research methodology at the Faculties of Medicine and Pharmacy, and at the Dalla Lana School of Public Health.
Vincent Lo Re, M.D., M.S.C.E. is Associate Professor of Medicine (Infectious Diseases) and Epidemiology at the University of Pennsylvania, Senior Scholar in the Penn Center for Clinical Epidemiology and Biostatistics, and Senior Investigator in the Penn Center for Pharmacoepidemiology Research and Training. Dr. Lo Re leads a nationally recognized research program that examines the pharmacoepidemiology of drug-induced liver disease. He has conducted population-based and mechanistic studies that have helped to move the field of drug-induced liver disease, chronic viral hepatitis, and HIV/viral hepatitis coinfection forward in a unique way. Recent research has determined the impact that medications have on acute liver injury and progression of chronic viral hepatitis; assessed adherence and adverse effects of antiviral therapies of chronic hepatitis B and C; evaluated end-stage liver disease and liver cancer events among HIV/hepatitis C-coinfected patients; and examined how chronic viral hepatitis and HIV/viral hepatitis coinfection influence extra-hepatic outcomes, particularly metabolic bone disease. He has particular expertise in evaluating liver-related and other health outcomes within large electronic data sources, such as the Veterans Health Administration, Kaiser Permanente Northern California, US Medicaid, US Medicare, and Sentinel. His research has been funded by the National Institute of Allergy and Infectious Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Cancer Institute, Agency for Healthcare Research and Quality, Department of Veterans Affairs, and the US Food and Drug Administration. Additionally, Dr. Lo Re has been a standing member of FDA’s Antiviral Drug (now Anti-Infective) Advisory Committee since 2014 and co-chair of the Liver Core of the Veterans Aging Cohort Study since 2009. He has been an Associate Editor of Pharmacoepidemiology and Drug Safety since 2009 and will take over as Regional Editor for the Americas in 2018. He maintains an active clinical practice devoted to the care of patients with chronic viral hepatitis, particularly those coinfected with HIV.
Sallie Pearson is a health service researcher with more than 15 years experience conducting population-based research using routinely collected health data, particularly studies examining the use and impact of prescribed medicines in routine clinical care. Sallie heads the Medicines Policy Research Unit at the Centre for Big Data Research in Health, UNSW Australia. Sallie is also the Scientific Director of the Centre of Research Excellence in Medicines and Ageing. Sallie has also been actively involved in a number of Australian pharmaceutical policy and health data linkage committees and advisory groups including the Drug Utilisation Sub-Committee of the Pharmaceutical Benefits Advisory Committee, Commonwealth Department of Human Services Research Advisory Committee; NSW Population and Health Service Research Ethics Committee and NSW Ministry of Health Ethics and Data Linkage Working Group.
Chih-Ying (Natasha) Pratt, PhD, is an epidemiologist at the Division of Epidemiology II, Office of Pharmacovigillance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA)*. She supports the teams that oversee the anti-infective, antiviral, transplant and ophthalmology, anesthesia, analgesia, and addiction products. She provides expertise in the evaluation of safety data based upon post-marketing observational studies. She also provides consultation in the application of analytic epidemiologic principles and methods in post-marketing drug safety research. Dr. Pratt received her bachelor’s degree in Pharmacy from National Taiwan University, her Master degree in Health Administration from University of Pittsburgh, and her doctoral degree in Pharmacoepidemiology from University of Florida. She worked as a Research Fellow in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital before joining the FDA*.
*Dr. Pratt does not attend ACPE in her official capacity as an FDA employee.
Nicole Pratt is an Associate Professor in Biostatistics and Pharmacoepidemiology at the Quality Use of Medicines and Pharmacy Research Centre, Sansom Institute, University of South Australia. She is a chief investigator on the Medicines and Device Surveillance Centre of Research Excellence and is responsible for evaluating the quality use of medicines program: Veterans’ Medicines Advice and Therapeutics Education Service (Veterans’ MATES). Veterans’ MATES uses administrative claims data to develop and evaluate interventions to improve use of medicines in the veteran population in Australia.
Krishna Undela, M.Pharm had graduated in Pharmacy from Jawaharlal Nehru Technological University (JNTU), Anantapur in 2010 and completed M.Pharm (Pharmacy Practice) from National Institute of Pharmaceutical Education and Research (NIPER), Mohali in 2012. Thereafter he started working at JSS College of Pharmacy, Mysuru where he currently holds a position as a Lecturer in Department of Pharmacy Practice. He is an instructor for Pharmacoepidemiology and Pharmacoeconomics subjects for Pharm.D. and Post Graduate courses. Krishna Undela is having an experience in conducting various Pharmacoepidemiological studies in hospital setting. He received scholarship from International Society for Pharmacoepidemiology (ISPE) to attend ISPE conferences held at Hong Kong (in 2013), Taiwan (in 2014), Thailand (in 2015), Ireland (in 2016) and Canada (in 2017). He received 2015 Endeavour Executive Fellowship from Department of Education, Australian Government to undertake three months training on “Advanced Pharmacoepidemiology and Quality Use of Medicines” at University of South Australia, Adelaide, Australia. Krishna Undela is also having an expertise in conducting Systematic reviews and Meta-analyses and published papers in various peer reviewed reputed journals, which were cited well. He presented one of his meta-analysis on ‘Statin use and risk of Parkinson’s disease’ at XX World Congress on Parkinson’s Disease and Related Disorders held at Geneva, Switzerland in December, 2013. Currently there are 42 scientific publications in his credit. Total citations of his publications were 361 with h-index 7 and i10-index 6.
Wei Zhou, MD, Ph.D., is currently Executive Director, Center for Observational and Real-world Evidence at Merck Research Laboratories. Before that, he was the Regional Director and Head of Epidemiology Asia Pacific Unit at Merck, Director of Molecular Epidemiology at Pfizer Oncology, and Senior Epidemiologist at Merck. Dr. Zhou was a Research Fellow/Research Associate/ Research Scientist at Harvard School of Public Health between June 1999 and December, 2007. He has served as the Principal Investigator and Co-investigator for a number of projects on gene-environment interactions in the development and prognosis of different chronic diseases including cancers. Dr. Zhou is the current ISPE (International Society of Pharmacoepidemiology) Board of Director representing Industry and Service Provider from Asia (till August, 2017). Dr. Zhou received his MD from West China University of Medical Sciences in 1994 and Ph.D of Environmental Health from Shanghai Medical University in 1998. He was the recipient of the John E. Fogarty International Training and Research Program. He has published more than 70 peer-reviewed manuscripts and book chapters, and served as a reviewer for various international journals. Dr. Zhou has given numerous presentations and served as chair/co-chair at different international conferences and symposiums.
Alison Bourke is Scientific Director in the Center for Advanced Evidence Generatiion within QuintilesIMS. She is also Deputy Chair of PRIMM (Prescribing and Research in Medicines Management – UK and Ireland, a multi-disciplinary organisation devoted to the study of medicine use in society) and has recently been elected to serve as President of the International Society of Pharmacoepidemiology (ISPE) from August 2018. Alison has over 30 years experience in medical data collection and research, with proven leadership skills involving managing, developing and motivating teams, as well as external thought leadership. Alison has expertise in analysis, study design, together with financial and strategic planning, and has been instrumental in promoting the role of Real World Data for research in epidemiology and to inform the drug development cycle particularly in the areas of drug safety and outcomes research.
Cynthia de Luise is a Senior Director of Epidemiology in Worldwide Safety and Regulatory at Pfizer, and has over 16 years of experience in pharmaceutical drug safety research. At Pfizer she has supported products across multiple therapeutic areas in all phases of drug development, and has significant content expertise with the use of large administrative databases across North America and Europe. Her current focus includes leading a long-term initiative to develop pharmacoepidemiologic capabilities in Japan, her support of Ibrance, the novel kinase 4/6 inhibitor for advanced ER+/HER2- breast cancer and Pfizer’s Biosimilars portfolio in the areas of inflammation and oncology. She has presented and published her work at scientific congresses and in peer reviewed journals. 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.
Jesper Hallas graduated as an MD from University of Copenhagen in 1984. He has a background in clinical medicine as a specialist in internal medicine, medical gastroenterology and clinical pharmacology. Jesper established the first pharmacoepidemiological prescription database in Denmark, OPED, based on reimbursed prescriptions from Funen County in Denmark (1990 and onwards). He was one of the co-founders of the Danish Society of Pharmacoepidemiology and became its first president in 1994. Since 2004, Jesper has been a professor of clinical pharmacology at University of Southern Denmark, the first four years also filling a position as consultant in internal medicine at Odense University Hospital. He has been an ISPE member for about 20 years and has served ISPE in a number of ways, among others as program chair for the annual meeting in Copenhagen in 2008, as chair of the Public Policy Committee in 2011-14 and as president 2017-18. Jesper has used the OPED database for developing a variety of analytic templates and principles, such as the symmetry analysis, the waiting time distribution and the principles underlying the individual-level drug use statistics He has more than 270 publications within the fields of clinical medicine, clinical epidemiology and pharmacoepidemiology.
Dr Judith Jones is a clinical pharmacologist, pharmacoepidemiologist, and geriatrician/internist with a long-standing interest in the study of adverse drug reactions, drug utilization, and drug development and regulation.
Dr Jones received her medical training at Baylor College of Medicine in Houston, Texas, followed by clinical training, a fellowship in clinical pharmacology and a PhD in developmental pharmacology at University of California at San Francisco. In 1978, she became Director of the FDA’s Division of Drug Experience (now the Office of Safety & Epidemiology) and stayed at FDA until 1985. She then went to Georgetown U. School of Medicine to practice geriatrics and internal medicine, but continued focusing primarily on special projects in pharmaco-epidemiology.
In 1988, Jones founded The Degge Group, Ltd., a consulting company for issues relating to drug safety, medical product epidemiology, natural histories of diseases, FDA and international regulations, and research. In 1989 Dr. Jones began the nonprofit Pharmaceutical Education and Research Institute (PERI, Inc, www.peri.org) that educates personnel in the pharmaceutical and other medical products industries on the appropriate development, regulatory management, marketing and postmarketing surveillance of medical products, and in 1996, she founded DGI-BridgeToData (www.bridgetodata.org), a nonprofit online resource describing population databases globally. In addition to these credentials, Dr. Jones is affiliated with many scientific committees and has published over 100 peer-reviewed articles relating to adverse reactions, post-marketing surveillance of drugs, risk management in pharmaceuticals, use of drugs by special populations (e.g., geriatric, pediatric), and drug information.
Adrian R Levy is Professor and Head of the Department of Epidemiology and Community Health at Dalhousie University and a District Chief in the Nova Scotia Health Authority. He is the nominated principal investigator for the Maritime Strategy for Patient Oriented Research SUPPORT Unit and the co-principal investigator and Nova Scotia Database team leader on the Canadian Network of Observational Drug Effect Studies. He is author of over 135 peer reviewed publications and is the co-editor on the Springer Handbook of Health Services Research volumes on Comparative Effectiveness Research and on Data and Measures. His academic interests lie in health services research including measurement and valuation, health technology assessment, pharmacoepidemiology, quality of life, and access to care.
Professor Yola Moride has a strong track record of methodological expertise in pharmacoepidemiology and therapeutic risk management. She is Full Professor at Université de Montréal and President of YOLARX Consultants. She received a PhD in Epidemiology from McGill University, and a Post-doctoral Fellowship in Pharmacovigilance from the University of Bordeaux. With more than 20 years of experience in the conduct of drug safety and effectiveness studies, she serves on the Steering Group of the European Network of Centres of Pharmacoepidemiology and Pharmacovigilance (ENCePP) at the European Medicines Agency (EMA). She is Past President of the International Society for Pharmacoepidemiology (ISPE) and Past Vice-President of the International Society of Pharmacovigilance (ISoP). She was a member of CIOMS Working Group IX on «Practical Approaches for Risk Minimisation for Medicinal Products».
Robert Platt is Professor in the departments of Pediatrics and of Epidemiology, Biostatistics, and Occupational Health at McGill University. He holds the Albert Boehringer I endowed chair in Pharmacoepidemiology. Since December 2016, Dr. Platt is the executive co-lead of the Canadian Network for Observational Drug Effect Studies (CNODES); he has led the methods team of CNODES since its inception. In this role he has led a methods research and training program for CNODES, and has participated as senior methodologist in several CNODES studies. Dr. Platt received his PhD in Biostatistics from the University of Washington in 1996, and has been on faculty at McGill since then. His research interests are in statistical methods and applications for administrative-data pharmacoepidemiology, and in methods for causal inference from epidemiologic studies. His methodologic interests are in marginal structural models for analyses of large administrative-data cohorts, in particular with regard to specification and optimization of the propensity score and inverse probability weights.
Soko Setoguchi, MD, DrPH, FISPE, a pharmacoepidemiologist and physician, is an adjunct associate professor of epidemiology at Rutgers School of Public Health and an associate professor of medicine at Rutgers Robert Wood Johnson Medical School (pending appointment). She works primarily in Center for Pharmacoepidemiology and Therapeutic Sciences (PETS) at Rutgers University. Combining clinical background and advanced training in Epidemiology and Biostatistics, she published widely in her research areas, comparative safety and effectiveness of medications and devices in patients with chronic diseases using large databases and registries in US and other countries. Her methodological research includes (1) conducting data linkage and evaluating linkage methods for pharmacoepidemiology and (2) evaluating design-based and analytic methods for pharmacoepidemiologic studies. Dr. Setoguchi is a Fellow of the International Society of Pharmacoepidemiology (FISPE) and has taught basic, practical, and advanced courses in pharmacoepidemiology in courses at Harvard School of Public Health, and Duke University and at national and international conferences (including ICPE and ACPE) and seminars.
Dr. Stephen B. Soumerai is Professor of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute, where he focuses on pharmaceutical outcomes, quality of health care studies and health policy. He also co-chaired the Statistics and Evaluative Sciences concentration within Harvard University’s health policy Ph.D. program for over 20 years, and continues as an active faculty member in the concentration. Dr. Soumerai has led or been a member of numerous NIH and international peer review committees. Dr. Soumerai is the recipient of many honors including numerous article of the year awards from national and international scientific societies, named lectureships, and the Everett Mendelsohn Excellence in Mentoring Award from Harvard University.
Dr. Soumerai has published more than 250 original scientific articles in leading scientific journals, such as the New England Journal of Medicine and the Journal of the American Medical Association. He is well known for his work on the impacts of health policies and methods to improve the quality of medical practice. His recent research has focused on cost-related underuse of medications; as well as the impacts of drug coverage, FDA warnings and cost-containment policies on access to effective medications, quality and costs of care and clinical outcomes among vulnerable populations. He frequently advises Congress, state legislatures, and federal and international agencies on drug cost containment, coverage and quality-of-care policies, and evidence-based health policy. His research has been used extensively to support expanded economic access to medications in Medicaid and Medicare.
Dr. Soumerai’s work also focuses on common biases in research designs, the unreliability of health research, and improving the evidence base for health policies. Dr. Soumerai has published numerous op-eds in leading news outlets, including Vox News, The Wall Street Journal, The Washington Post, Newsweek, The Huffington Post, and Stat News on subjects including elimination of coverage gaps in the Medicare drug benefit, adverse consequences of rushed nationwide implementation of health IT, undertreatment of pain, required drug coverage in Massachusetts health reform plans, state censorship of health research, poor efficacy of pay-for-performance policies, and arbitrary economic penalties for hospital readmissions.
Prof. Ian C. K. Wong is Professor of Pharmacy of the UCL School of Pharmacy and Honorary Professor of Pediatrics of University of Hong Kong. His research focuses on the application of large databases for phamacoepidemiology and drug safety research. He also has special interest in medicines for children research.