Scientific Advisory Board

Continuous, close engagement with global stakeholders' expertise is critical to our success.

REPEAT prides itself on the involvement of an international Scientific Advisory Board. Our Scientific Advisory Board is comprised of representatives from regulatory and health technology assessment agencies, journal editors, payer organizations, large healthcare database networks, professional research societies, industry, and patients.

Sarah Priddy Alwardt, PhD | McKesson Specialty Health | Vice President Health Informatics and HEOR
Peter Arlett BSc, MBBS, MRCP, FFPM | European Medicines Agency | Head of Pharmacovigilance and Epidemiology Department
Andrew Bate, PhD | Pfizer | Senior Director, Analytics Team Lead in Epidemiology
Dorothee Bartels, MSc, PhD | UCB Pharma | Global Head of RWE
Alison Bourke, MSc, FRPharm.S | Quintiles IMS | Scientific Director at IMS Health Medical Research
Brian Bradbury, DSc | Amgen | Executive Director, Center for Observational Research
Troyen Brennan, MD, MPH | CVS Health | Executive Vice President and Chief Medical Officer
Jeffrey Brown, PhD | PCORnet, FDA’s Sentinel Program | Director of Scientific Operations
Karen K. Burnett, MBA, MS | Northwestern Memorial Hospital | Patient Advocate
K. Arnold Chan, MD, ScD | National Taiwan University | Director, Health Data Research Center
Nam-Kyong Choi B., PhD | Ehwa Woman's University | Assistant Professor
Hans Georg Eichler, MD, MSc | European Medicines Agency | Senior Medical Officer
Kristian Filion, PhD, FAHA | McGill University, Department of Medicine and of Epidemiology | Associate Professor
Lisa Freeman | Long term care-giver, PCORI reviewer
Jesper Hallas, MD, PhD | ISPE | President
Laura Happe, PharmD, MPH | Humana | Chief Pharmacy Officer
Sean Hennessy, PharmD, PhD | University of Pennsylvania Perelman School of Medicine | Professor of Epidemiology and of Systems Pharmacology and Translational Therapeutics
John Ioannidis, MD, DSc | Meta-Research Innovation Center at Stanford | Co-Director
Javier Jimenez, MD, MPH | Sanofi | VP Global Head RWE and Clinical Outcomes
Páll Jónsson, PhD, Mres | NICE | Associate Director, Research and Development
Kris Kahler, PhD | Novartis | Executive Director, Global Head of Outcomes Evidence & Analytics
Christine Laine, MD, MPH, FACP | Annals of Internal Medicine | Editor in Chief
Elizabeth Loder, MD, MPH | BMJ | Head of Research
Amr Makady, PharmD, MSc | Dutch National Healthcare Institute (ZIN) | Pharmacoeconomic & Policy Advisor
Michael Nguyen, MD | Food and Drug Administration (FDA) | FDA Sentinel Liaison
Brian Nosek, PhD | Center for Open Science | Executive Director
Richard Platt, MD, MSc | PCORnet, FDA’s Sentinel Program | Principal Investigator
Robert Platt, PhD | McGill University | Professor of Epidemiology, Biostastics, and Occupational Health and Pediatrics
John Seeger, PharmD, DrPH | Optum Epidemiology | Chief Scientific Officer
Will Shrank, MD | UPMC | Chief Medical Officer
Liam Smeeth, PhD | RECORD Guidelines, Wellcome Trust | Professor of Clinical Epidemiology
Henrik Toft Sørensen, MD, PhD | Clinical Epidemiology | Editor in Chief
Peter Tugwell, MSc, MD, FRCPC | Journal of Clinical Epidemiology | North American Editor
Yoshiaki Uyama, PhD | Pharmaceuticals and Medical Devices Agency | Director, Office of Medical Informatics and Epidemiology
Frank de Vries, PharmD, PhD | Dept. Clinical Pharmacy | Head of research, Maastricht UMC+, The Netherlands
Joanne Waldstreicher, MD | J & J | Chief Medical Officer
Richard Willke, PhD | ISPOR | Chief Scientific Officer
Wolfgang Winkelmayer, MD, MPH, ScD, FASN | Journal of the American Medical Association (JAMA) | Associate Editor
Deborah Zarin, MD | ClinicalTrials.gov, NIH | Director

Sarah Priddy Alwardt, PhD | McKesson Specialty Health | Vice President Health Informatics and HEOR
Sarah Alwardt, Vice President, leads the talented associates of McKesson Specialty Health’s Health Informatics and Heath Economics and Outcomes Research division. A highly accomplished leader with domestic and international experience in strategy development, research and development, operations and manufacturing support, technology development, analytics, and organizational design, Sarah has proven success in organizational transformation, strategic process/product gap analysis, associate engagement, and delivering data driven insights. Prior to joining McKesson, Sarah enjoyed ten years at Humana where she held increasingly responsible leadership roles in research, program, and process development. Sarah spent five years at Givaudan and four years at Brown-Forman. She also served two years as adjunct professor of chemical engineering at the University of Louisville. Sarah is an accomplished author and speaker, having published and presented several works in the international fine chemicals industry, specifically biofuels, flavors, and fragrances. In her current role, Sarah speaks frequently on the challenges and opportunities of research collaboration between Fortune 100 companies. Sarah is currently a member of the International Society for Pharmacoeconomics and Outcomes Research, American Institute of Chemical Engineers, Tau Beta Pi, and Sigma Xi. She also serves as an advisor on University of Louisville’s Chemical Engineering Board of Industrial Advisors. Sarah holds Bachelor’s, Master’s, and Doctoral degrees in Chemical Engineering and a Certificate in Environmental Engineering all from the University of Louisville’s Speed School of Engineering.

Andrew Bate, PhD | Pfizer | Senior Director, Analytics Team Lead in Epidemiology
Andrew oversees the provision of methodological and analytic expertise to the Epidemiology group in support of drug development and safety evaluation activities worldwide. He previously led an enterprise-wide assessment of data and analytics needs associated with Real World Data. Prior to joining Pfizer in 2009, Andrew was at the WHO Collaborating Centre for International Drug Monitoring for more than 12 years, where he was responsible for Research. Andrew has an extensive research record focused on the development for methods and tools for the analysis of diverse types of Real World Data. He has over 50 publications in peer reviewed international journals, and is a regular invited presenter at international symposia. Andrew has contributed to several international initiatives and partnerships associated with medicinal safety including membership of the FDA Science Board Subcommittee on Pharmacovigilance, acting as an expert adviser to the Committee for Medicinal Products for Human Use (CHMP) of EMA and participated as a member of Council for International Organizations of Medical Sciences (CIOMS) Working Group VIII on signal detection of adverse effects of medicinal products. Andrew was on the Advisory Board of OMOP ((Observational Medical Outcomes Partnership), a US Foundation for the National Institutes of Health (FNIH) coordinated public-private partnership to help improve the monitoring of drugs for safety and was a co-PI for the IMEDS Evaluation Pilot, the first evaluative access and use of the FDA’s Sentinel Data Network by another entity. Andrew holds a Masters degree in Chemistry from Oxford University, and a PhD in Clinical Pharmacology from Umea University, Sweden.

Dorothee Bartels, MSc, PhD | Boehringer Ingelheim GmbH | Head of Global Epidemiology
Dorothee B. Bartels is Corporate Head of Global Epidemiology at Boehringer Ingelheim GmbH. She has a Master degree of Epidemiology from Harvard School of Public health and a PhD from Hannover Medical School. She also holds a Professorship of Epidemiology and Public Health at Hannover Medical School and is Adjunct Professor at McGill University, where she lectures in the course of Advanced Pharmacoepidemiology. She also lectures on a regular basis in the Advanced Pharmacoepidemiology course at Harvard School of Public Health and at the Peking University. She spent most of the year 2016 in the US interacting with various US healthcare stakeholders (provider, payer, patient organziation, academia) and doing fellowships. Her research is focused on secondary data use and data linkages, safety and effectiveness of newly marketed drugs and to provider a deeper understanding of targeted patient populations. She is also interested in innovative approaches, such as digital epidemiology.

Alison Bourke, MSc, FRPharm.S | Quintiles IMS | Scientific Director at IMS Health Medical Research
Alison is Scientific Director at the Center for Advanced Evidence Generation within the Real World Insights Group of QuintilesIMS. Here she is leading on innovative data and data analyses for med/sci research. With a pharmacy and IT background, Alison began her career developing pioneering primary care EMR research databases in the UK. As well as her QuintilesIMS role, Alison is 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.

Brian Bradbury, DSc | Amgen | Executive Director, Center for Observational Research
Brian D. Bradbury is Executive Director and Head of the Data & Analytic Center (DAC) within the Center for Observational Research (CfOR) at Amgen, Inc, and is an Adjunct Assistant Professor of Epidemiology at UCLA. He leads a team of epidemiologists, biostatisticians, data scientists and programmers who provide strategic support across the drug development lifecycle. Brian received his DSc in Epidemiology from Boston University and a MA in Education & Psychology from Pepperdine University. He has authored and co-authored peer-reviewed publications in the areas of pharmacoepidemiology, cancer and kidney disease epidemiology and methods for controlling confounding-by-indication in drug safety studies.

Troyen Brennan, MD, MPH | CVS Health | Executive Vice President and Chief Medical Officer
Troyen A. Brennan, M.D., M.P.H., is Executive Vice President and Chief Medical Officer of CVS Health. Prior to joining CVS Health, Dr. Brennan was Chief Medical Officer of Aetna Inc. In a previous academic career, he was Professor of Medicine at Harvard Medical School, and Professor of Law and Public Health at Harvard School of Public Health.

Jeffrey Brown, PhD | PCORnet, FDA’s Sentinel Program | Director of Scientific Operations
Jeffrey Brown, PhD is an Associate Professor in the Department of Population Medicine (DPM) at Harvard Medical School and the Harvard Pilgrim Health Care Institute. Within DPM, Dr. Brown serves as the Research Director of the Therapeutics Research and Infectious Disease Epidemiology program, overseeing a staff of over 75 scientists, analysts, and project managers. His primary research activities involve new approaches to facilitate large-scale multi-institutional research through the use of distributed health data networks to support a learning health system. This research esthablished the basis for several established research networks, including the FDA’s Sentinel System and PCORnet. He has leadership roles in FDA Sentinel, PCORnet, the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC), the Innovation in Medical Evidence and Development Surveillance (IMEDS) program, and the NIH Health Care Systems Research Collaboratory. In addition, Dr. Brown is the inventor and Chief Product Officer of PopMedNet, an open-source software platform that enables creation and operation of distributed health data networks. PopMedNet supports several multi-site research and surveillance projects.

Karen K. Burnett, MBA, MS | Northwestern Memorial Hospital | Patient Advocate
Marketing and advertising executive with expertise in marketing, strategic brand management and research experience in the healthcare industry. She began her career at Merck & Co. and was in several management roles including the Brand Manager of Prilosec when it was introduced in the U.S. She transitioned to professional and consumer communication and was responsible for the insulin brands, Axid and Evista for Eli Lilly & Co., Celebrex for Pfizer and Pharmacia, and other products as well as business development at Leo Burnett., U.S.A (no relation). Karen was instrumental in the development of the Patient and Family Advisory Council at the Northwestern Memorial Hospital and serves as a charter member for the past 10 years and sits on various improvement committees in the hospital. She holds a similar position as a patient advocate at Brigham and Women’s. Karen received a Master’s Degree in Business from Western Colorado State University and a Master’s Degree in Science from the Feinberg School of Medicine in Quality and Patient Safety. Karen serves her community by sitting on several not-for-profit boards and Friends of American Writers. The only thing more challenging that Direct-to-Consumer advertising and improving healthcare quality is playing golf on the team for Olympia Fields Country Club, which she does most of the summer.

K. Arnold Chan, MD, ScD | National Taiwan University | Director, Health Data Research Center
Dr. Chan is a physician epidemiologist with almost 30 years of global research experience in academia and private sector, with a primary focus on post-marketing evaluation of pharmaceutical agents and vaccines. He received medical training at National Taiwan University (MD-equivalent, 1987) and advanced 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 the Chief Scientist of the Epidemiology Unit at Optum. Dr. Chan returned to NTU in 2013 and is currently a professor at NTU College of Medicine, Director of the NTU Health Data Research Center, and Director of Medical Research Department at NTU Hospital. In addition to scientific research, he has provided consulting input to Taiwan Food and Drug Administration and related health authority for more than 20 years. Dr. Chan has authored or co-authored more than 100 peer-reviewed articles and co-edited one of the two widely used English textbook on pharmacoepidemiology.

Nam Kyong Choi, PhD | Ehwa Woman's University | Assistant Professor
Nam-Kyong Choi is an Assistant Professor of the Department of Health Convergence, College of Science & Industry Convergence at Ewha Womans University in Seoul, South Korea. Her research focuses on the development and application of epidemiologic and statistical methods for evaluating the safety and comparative effectiveness of medical products in large healthcare databases. She has been published more than 100 articles in peer reviewed journals and co-authored a Korean textbook of Pharmacoepidemiology. She received her B.S. in Pharmacy from Ewha Womans University and M.Sc. and Ph.D. in Pharmacoepidemiology from the Seoul National University College of Medicine. She worked as a Visiting Professor in the Division of Pharmacoepidemiology Pharmacoeconomics, within the Department of Medicine at Brigham and Women’s Hospital and Harvard Medical School from 2015 to 2017. She has been an Associate Editor of Pharmacoepidemiology and Drug Safety, the official journal of International Society for Pharmacoepidemiology (ISPE) since 2010, a Chair-elect of the Asian Pharmacoepidemiology Network (AsPEN), a Director of the International Cooperation Committee in Korean Society for Pharmacoepidemiology and Risk Management (2015-2020), and a Member of Editorial Board in Korean Academy of Social & Managed Care Pharmacy (2015-2018). She is an Advisory Committee Member of the Drug Safety Evaluation for the Korea Institute of Drug Safety and Risk Management (2017-2019). She received a Merit Award for activating post-marketing drug safety surveillance from the Korea Food and Drug Administration in 2012.

Hans Georg Eichler, MD, MSc | European Medicines Agency | Senior Medical Officer
Hans-Georg Eichler, M.D., M.Sc., is the Senior Medical Officer of the European Medicines Agency in London, United Kingdom, where he is responsible for coordinating activities between the Agency’s scientific committees and giving advice on scientific and public health issues. Prior to joining the European Medicines Agency, Dr. Eichler was at the Medical University of Vienna in Austria for 15 years. He was vice-rector for Research and International Relations since 2003, and professor and chair of the Department of Clinical Pharmacology since 1992. His other previous positions include president of the Vienna School of Clinical Research and co-chair of the Committee on Reimbursement of Drugs of the Austrian Social Security Association. His industry experience includes time spent at Ciba-Geigy Research Labs, U.K., and Outcomes Research at Merck & Co., in New Jersey. Dr. Eichler graduated with an M.D. from Vienna University Medical School and a Master of Science degree in Toxicology from the University of Surrey in Guildford, U.K. He trained in internal medicine and clinical pharmacology at the Vienna University Hospital as well as at Stanford University.

Kristian Filion, PhD, FAHA | McGill University, Department of Medicine and of Epidemiology, Biostatistics, and Occupational Health | Associate Professor
Dr. Filion a tenured Associate Professor jointly appointed in the Departments of Medicine and of Epidemiology, Biostatistics, and Occupational Health at McGill University, an Investigator at the Center for Clinical Epidemiology of the Lady Davis Institute of the Jewish General Hospital, and an Investigator at the McGill Pharmacoepidemiology Research Unit. He is a Steering Committee member and the Co-Lead of the Clinical Practice Research Datalink (CPRD) Team of the Canadian Network for Observational Drug Effect Studies (CNODES), a pan-Canadian drug safety network funded by the Canadian Institutes of Health Research that addresses emerging questions of drug safety and effectiveness posed by key government stakeholders such as Health Canada. He leads an independent research program focused on pharmacoepidemiology and the use of large, population-based databases to study the effectiveness, safety, and utilization of prescription drugs in real-world settings. The primary substantive area of his pharmacoepidemiologic research is cardiometabolic conditions (heart disease and diabetes). Dr. Filion was elected as a Fellow of the American Heart Association. He is a member of the Permanent Scientific Committee for the Evaluation of Medications of the Institut national d'excellence en santé et en services sociaux (INESSS; Quebec’s health technology assessment agency), which helps inform policy regarding which drugs should be included in Quebec’s provincial drug formulary.

Lisa Freeman | Long term care-giver, PCORI reviewer
Lisa Freeman is the Executive Director of the Connecticut Center for Patient Safety. She is faculty at the Academy of Emerging Leaders in Patient Safety, and other organizations focusing on Patient Safety and Person Engaged Care. She also holds a public seat on the Connecticut Board of Examiners for Nursing. Lisa participates on several PFAC's including the Planetree International PFAC, and a Brigham & Women’s PFAC, and is involved in patient-centered research and policy through a number of national organizations and agencies including PCORI, NQF and the PQA Alliance. Through representing the patient voice, making sure that the patient perspective is part of all health care conversations, and by working together with all stakeholders, Lisa is committed to moving the bar and improving patient safety across the board.

Jesper Hallas, MD, PhD | ISPE | President
JH established a pharmacoepidemiologic research line in the late 1980s at the University of Southern Denmark. A breakthrough came in 1990 with the advent of the Odense University Pharmacoepidemiologic Database (OPED). It has complete capture of all computerised prescriptions in Region of Southern Denmark (population 1.2 million) which allows a detailed account of how drugs are distributed among different users and - by linkage to other data resources - the experience of the drug users in terms of adverse events. Among the research interests are studies of rational prescribing, neurological diseases caused by drug treatment, interventions to improve prescribing among GPs, development of indices to characterise patterns of prescribing and management of dyspepsia. Among the collaborators are the General Practice Research Unit, the Research Unit of Demographics and Statistics and a number of clinical research units at Odense University Hospital. There are international collaborators in among other places Oslo, Dundee, Barcelona, Stockholm, Boston and Chapel Hill, North Carolina. From 2017-18, JH has been elected President of International Society of Pharmacoepidemiology.

Laura Happe, PharmD, MPH | Humana | Chief Pharmacy Officer
Laura E. Happe, PharmD, MPH is the Chief Pharmacy Officer of Humana, where she is responsible for advancing the clinical pharmacy acumen and integration into the company’s integrated care delivery model. During her time at Humana, she has advanced the research program, contributing to more than 70 peer-reviewed published manuscripts. In addition to this role, she also serves as the Editor-in-Chief of the Journal of Managed Care and Specialty Pharmacy, a peer-reviewed journal with a circulation of over 30,000. Laura earned her Doctorate of Pharmacy degree from Creighton University and is a licensed pharmacist in both Florida and Arizona. She also holds a Master’s of Public Health degree with an emphasis in epidemiology from the University of South Florida and is fellowship trained in pharmacoeconomics and outcomes research.

Sean Hennessy, PharmD, PhD | University of Pennsylvania Perelman School of Medicine | Professor of Epidemiology and of Systems Pharmacology and Translational Therapeutics
Dr. Hennessy conducts research in the field of pharmacoepidemiology, which is the study of the health effects of drugs and other medical products in populations. His team identified a survival benefit of potassium supplementation in users of loop diuretics, and studied serious health consequences of drug-drug interactions involving high-risk drugs including anticoagulants, antidiabetic agents and antiplatelet agents. His research has produced crucial knowledge about the cardiovascular safety of many widely-used drugs for mental health conditions in including ADHD, depression, and schizophrenia. He also evaluated an early approach to using medical insurance data to improve prescribing, finding it ineffective despite its federal mandate. This contributed to the omission of a requirement for drug utilization review programs in Medicare Part D. He co-led a pair of studies demonstrating the effectiveness and safety of the SA14-14-2 vaccine for Japanese encephalitis (JE), which subsequently led to the immunization of millions of children per year in populous countries including Cambodia, India, Malaysia, Nepal, Sri Lanka, and Thailand. Use of that vaccine has been credited with reducing the incidence of JE. He co-developed the trend-in-trend research design for studying the effects of rapidly increasing or declining exposures. He was the senior author of one of two citizen petitions to the US Food and Drug Administration that led to re-labeling of metformin, the best-proven oral drug for diabetes, to permit its use in persons with mild to moderate renal insufficiency.

John Ioannidis, MD, DSc | Meta-Research Innovation Center at Stanford | Co-Director
John Ioannidis is a Professor of Medicine, Health Research and Policy, and Biomedical Data Science at Stanford University School of Medicine and a Professor of Statistics at Stanford University School of Humanities and Sciences. He is the C.F. Rehnborg chair in Disease Prevention at Stanford, and co-director, along with Steven N. Goodman, of the Meta-Research Innovation Center at Stanford (METRICS). He was chairman at the Department of Hygiene and Epidemiology, University of Ioannina School of Medicine as well as adjunct professor at Tufts University School of Medicine. He is best known for his research and published papers on scientific studies, particularly the 2005 PLoS Medicine paper "Why Most Published Research Findings Are False". Ioannidis is one of the most-cited scientists across the scientific literature, especially in the fields of clinical medicine and social sciences, according to Thomson Reuters' Highly Cited Researchers 2015. He was inducted in the Association of American Physicians in 2009, the European Academy of Cancer Sciences in 2010, the American Epidemiological Society in 2015, and the European Academy of Sciences and Arts in 2015. He completed his undergraduate studies at Athens University, received his Medical Degree from National University of Athens, and trained in internal medicine and infectious diseases at Harvard and Tufts.

Páll Jónsson, PhD, Mres | NICE | Associate Director, Research and Development
Dr. Páll Jónsson is Associate Director for Research and Development at UK’s National Institute for Health and Care Excellence (NICE). He leads NICE's contribution to a portfolio of research projects which support NICE in adapting to policy developments in health and social care delivery. Páll Jónsson has a doctorate degree in biochemistry and bioinformatics from University College London and has expertise in health technology assessments of drugs and diagnostics gained through his work at NICE. Before joining NICE he gained research experience in academia, the not-for-profit sector and the pharmaceutical industry.

Kris Kahler, PhD | Novartis | Executive Director, Global Head of Outcomes Evidence & Analytics
Kristijan (Kris) Kahler is Executive Director, and the Global Head of Outcomes Evidence & Analytics group within the Real World Evidence Center of Excellence at Novartis Pharmaceuticals. In this role he leads a team of RWE Scientific Leads responsible for real world evidence generation across the organization; largely conducting non-interventional studies with secondary data sources. Kris has been with Novartis since January 2001, and prior to his current role, was responsible for the development and implementation of health economics and outcomes research strategies for both marketed and developmental products for various therapeutic areas in the US organization. Kris has a Pharmacy degree from the University of Rhode Island, a Masters in Epidemiology from the Harvard School of Public Health, and received his Ph.D. in Epidemiology from the UMDNJ School of Public Health.

Elizabeth Loder, MD, MPH | BMJ | Head of Research
Elizabeth Loder is a Professor of Neurology at Harvard Medical School. She is the head of research for The British Medical Journal and Chief of the Division of Headache in the Department of Neurology at the Brigham and Women’s Hospital in Boston. Dr. Loder joined the Brigham and Women’s Hospital in 2006 following service as the Director of the Inpatient Pain Management and Outpatient Headache Management Programs at the Spaulding Rehabilitation Hospital in Boston. Dr. Loder earned an AB from Harvard College, a medical degree from the University of North Dakota Medical School, and a master’s degree in Public Health from the University of Massachusetts, Amherst. She trained in internal medicine at the Faulkner Hospital in Boston and did a headache fellowship at the Graham Headache Center in Boston. She is board certified in Internal Medicine and is certified in Headache Medicine by the United Council for Neurologic Subspecialties. Dr. Loder is the immediate past president of the American Headache Society, has served on the Board of Directors of the International Headache Society, and was a member of the Institute of Medicine Committee on Advancing Pain Research, Care and Education. She has been a clinical investigator in numerous trials of medications for the treatment of migraine and other headache disorders. Dr. Loder has published many articles, chapters, and editorials in peer-reviewed publications and books relating to clinical aspects of headache and pain evaluation and treatment. She speaks regularly at regional, national and international medical meetings on topics related to pain and headache as well as publication practices and ethics.

Amr Makady, PharmD, MSc | Dutch National Healthcare Institute (ZIN) | Pharmacoeconomic & Policy Advisor
Amr is a pharmacist by training, having completed his Bachelor’s degree in Egypt before moving to the Netherlands to pursue his Master’s studies at Utrecht University in the field of pharmaceutical policy. Throughout his Master’s studies, Amr has conducted research on various areas, including: counterfeit in drugs (RIVM), corruption in healthcare (University of Toronto) and risk-assessment modelling of generic drug quality (CBG-MEB). Currently, Amr works as a pharmacoeconomic assessor and policy advisor at the Dutch National Health Care Institute (ZIN) within the team of complex elderly care. Simultaneously, Amr is a PhD candidate at Utrecht University whereby his thesis focuses on the use of Real-World Evidence (RWE) in HTA practice. Examples of research he has performed in this area relates to RWE definitions, HTA agency policies on RWE and experiences gained from the implementation of conditional reimbursement schemes in the Dutch setting. Within this context, he is involved in a number of international projects related to RWE generation and use in decision-making, namely: IMI-GetReal, IMI-ROADMAP, EUnetHTA JA3 and NEWDIGS.

Michael Nguyen, MD | Food and Drug Administration (FDA) | FDA Sentinel Liason
Michael D. Nguyen, MD is the FDA Sentinel Program Lead in the Office of Surveillance and Epidemiology at the Center for Drug Evaluation and Research (CDER). He oversees the day to day management of the Sentinel Program for the Agency and coordinates scientific operations, routine safety analyses, and data infrastructure development. He previously served as the Acting Director and Deputy Director of the Division of Epidemiology in the Center for Biologics Evaluation and Research (CBER), where he led CBER’s Sentinel Program and was involved in postmarketing safety surveillance of vaccines, blood components, and blood-derived products. Prior to working at the FDA, he completed his training in pediatrics at Washington University in St. Louis, and served as an officer in the Epidemic Intelligence Service at the Centers for Disease Control and Prevention.

Brian Nosek, PhD | Center for Open Science | Executive Director
Brian Nosek is co-Founder and Executive Director of the Center for Open Science (http://cos.io/) that operates the Open Science Framework (http://osf.io/). COS is enabling open and reproducible research practices worldwide. Brian is also a Professor in the Department of Psychology at the University of Virginia. He received his Ph.D. from Yale University in 2002. He co-founded Project Implicit ( http://projectimplicit.net/ ), a multi-university collaboration for research and education investigating implicit cognition--thoughts and feelings that occur outside of awareness or control. Brian investigates the gap between values and practices, such as when behavior is influenced by factors other than one's intentions and goals. Research applications of this interest include implicit bias, decision-making, attitudes, ideology, morality, innovation, barriers to change, open science, and reproducibility. In 2015, he was named one of Nature's 10 and to the Chronicle for Higher Education Influence list.

Richard Platt, MD, MSc | PCORnet, FDA’s Sentinel Program | Principal Investigator
Richard Platt, MD, MSc, is Professor and Chair of the Harvard Medical School Department of Population Medicine and Executive Director of the Harvard Pilgrim Health Care Institute. He is Principal Investigator of the FDA Sentinel System. He led the development, with the Massachusetts Department of Public Health, of ESPnet, a system for doing real time EHR-based surveillance for both syndromes of interest and individually notifiable conditions. He is also co-Principal Investigator of the National Patient Centered Clinical Research Network (PCORnet) Coordinating Center, which is developing standard methods for extracting and using EHR data for multiple uses. Dr. Platt also co-leads the coordinating center of the NIH Health Care System Research Collaboratory and leads a CDC Prevention Epicenter. He co-chairs the CER Innovation Collaborative of the National Academy of Medicine's Leadership Consortium for a Value & Science-Driven Health System, and is a member of the American Medical Colleges Advisory Panel on Research.

Robert Platt, MD, MSc | McGill University | Professor, Departments of Epidemiology, Biostatistics and Occupational Health and of Pediatrics
Albert Boehringer I Chair in Pharmacoepidemiology
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. Dr. Platt is the executive co-lead of the Canadian Network for Observational Drug Effect Studies (CNODES); CNODES is a network of over 100 researchers, policy-makers, and trainees across Canada that provides high-quality evidence to support Canadian decision-makers on drug safety queries. 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’s 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.

Will Shrank, MD | UPMC | Chief Medical Officer
Dr. William Shrank joined UPMC’s Health Plan Division in June 2016 as the company’s new Chief Medical Officer. In this role, Dr. Shrank focuses on the design and implementation of new payment and delivery models to promote improved population health and further advance UPMC’s integrated clinical business strategies. Prior to joining UPMC, Dr. Shrank served as Senior Vice President, Chief Scientific Officer and Chief Medical Officer of Provider Innovation for CVS Health. Prior to joining CVS, Dr. Shrank served as the inaugural Director, Research and Rapid-Cycle Evaluation for the Center for Medicare & Medicaid Innovation at the Centers for Medicare & Medicaid Services (CMS). Dr. Shrank began his career as an Assistant Professor at Harvard Medical School, where his research focused on improving the quality of prescribing and the use of chronic medications and he published nearly 200 papers on these topics. Dr. Shrank received his Medical Degree from Cornell University Medical College, served his residency in Internal Medicine at Georgetown University and was a Fellow in Health Policy Research at UCLA, RAND. He earned his Master of Science degree in Health Services from the University of California at Los Angeles and his Bachelor’s Degree from Brown University. Dr. Shrank has served on various national committees and advisory boards, such as the National Advisory Committee for FDA, CMS, White House (Networking Information, Technology Research and Development Program), DHHS and AHRQ. He also was the recipient of the Robert Wood Johnson Pioneer Award to evaluate the effect of innovative prescription label design on adherence to chronic medication and health outcomes.

Liam Smeeth, PhD | RECORD Guidelines, Wellcome Trust | Professor of Clinical Epidemiology
Liam Smeeth is professor of clinical epidemiology and Head of the Department of Non-Communicable Disease Epidemiology at the London School of Hygiene and Tropical Medicine. He also undertakes clinical work as a general practitioner in London and is involved in a range of activities for the National Health Service more widely. Much of his research is based on making better use of computerised clinical data for research, and he leads a large group at LSHTM (http://ehr.lshtm.ac.uk/). He holds a Wellcome Senior Fellowship in Clinical Science, is a Trustee of the British Heart Foundation, and is an elected Fellow of the Academy of Medical Sciences. His broad interests include disease aetiology, drug effects, genetics and non-communicable diseases in low income settings.

Peter Tugwell, MSc, MD, FRCPC | Journal of Clinical Epidemiology | North American Editor
Dr. Peter Tugwell is Professor of Medicine and Epidemiology & Community Medicine at the University of Ottawa and is a practicing rheumatologist at the Ottawa Hospital. In 2001, he became Director for the Centre for Global Health at the University of Ottawa. He has built a research program and multidisciplinary team around his Canada Research Chair in Health Equity. Dr. Tugwell was Founding Director of the International Clinical Epidemiology Network Training Centre at McMaster University [1982-91] and currently serves as Secretary General to INCLEN's North American group (CanUSAClen). Dr. Tugwell is co-director of a WHO Collaborating Centre for Knowledge Translation & Health Technology Assessment in Equity. Dr. Tugwell is Coordinating Editor of the Cochrane Musculoskeletal Review Group and is Founding Co-convenor of the Cochrane Health Equity Field/Campbell Equity Methods Group and serves on the Steering Committee of the Campbell Collaboration. In 2002 he was appointed the North American Editor for the Journal of Clinical Epidemiology. In 2013, His Excellency the Right Honourable David Johnston, Governor General of Canada appointed Dr Tugwell to the rank of Officer of the Order of Canada, the second-highest ranking conferred by Canada. Dr Tugwell was recognized for his contributions as an epidemiologist reducing global disparities in health care access. Dr. Tugwell's publication record includes over 600 journal articles, monographs, and book chapters.

Yoshiaki Uyama, PhD | Pharmaceuticals and Medical Devices Agency | Director, Office of Medical Informatics and Epidemiology
Yoshiaki Uyama is currently Office Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan, where he is responsible for all epidemiological activities in PMDA including the projects of MIHARI(Medical Information for risk assessment initiative) and MID-NETⓇ(Medical Information Database Network). He has many experiences in regulatory science of benefit/risk assessment of a new drug, including the role in ICH as ICH Technical Coordinator (2004-2009), the topic leader of ICH E15 and E16, Rapporteur of ICH E17 Expert Working Group (2014-). He is also served as the visiting professor in Nagoya University (Graduate School of Medicine) and Chiba University (Graduate School of Medicine).

Frank de Vries, PharmD, PhD | Dept. Clinical Pharmacy | Head of research, Maastricht UMC+, The Netherlands
Dr. Frank de Vries started a PhD in pharmacoepidemiology at Utrecht University in 2002 on side effects of use of inhaled corticosteroids. Since then, he has worked for the Medicine and Healthcare products Regulatory Agency. He has obtained several research grants and prizes, including the Swierenga award for respiratory disease, an 'NWO Veni' fellowship and the Kohn prize from the UK National Osteoporosis Foundation. His work has been published in various journals including JAMA, the NEJM & BMJ. He currently works as a hospital pharmacist in the Maastricht University Medical Centre+. He is a member of the Clinical Epidemiology program at School CAPHRI in Maastricht and is on secondmend at the Utrecht Institute for Pharmaceutical Sciences, The Netherlands. He is a visiting scientist at the MRC Lifecourse Epidemiology Unit in Southampton, UK.

Joanne Waldstreicher, MD | J & J | Chief Medical Officer
Joanne Waldstreicher, M.D., is Chief Medical Officer, Johnson & Johnson. In this role, she has oversight across pharmaceuticals, devices and consumer products for safety, epidemiology, clinical and regulatory operations transformation, internal and external partnerships and collaborations supporting development of the ethical science, technology and R&D policies, including those related to clinical trial transparency and compassionate access. Joanne also chairs the Pharmaceuticals (Janssen) R&D Development Committee and supports the Device and Consumer Development Committees, which review late stage development programs in the pipeline. She also holds an appointment as a Faculty Affiliate of the Division of Medical Ethics, Department of Population Health, New York University School of Medicine. Among her prior roles in Janssen, the pharmaceutical sector of Johnson & Johnson, Joanne was responsible for late-stage development spanning the areas of neuroscience, cardiovascular and metabolism. Before joining Johnson & Johnson in 2002, Joanne was head of the Endocrinology and Metabolism clinical research group at Merck Research Laboratories. During that time, she received numerous awards and distinctions, including the Merck Research Laboratory Key Innovator Award. Joanne received both the Jonas Salk and Belle Zeller scholarships from the City University of New York and graduated Summa Cum Laude from Brooklyn College. Joanne graduated Cum Laude from Harvard Medical School in 1987, and completed her internship and residency at Beth Israel Hospital, and her endocrinology fellowship at MGH. She has won numerous awards and scholarships, and has authored numerous papers and abstracts. In December, 2016, Joanne was named Healthcare Champion of the Year for Women by the National Association of Female Executives. Joanne combines broad experience in science and medicine along with a passion for advancing transparency and ethics with the goal of improving the lives of patients and consumers around the world.

Richard Willke, PhD | ISPOR | Chief Scientific Officer
Dick became ISPOR’s first Chief Scientific Officer in April 2016, following his retirement from Pfizer after 25 years in the pharmaceutical industry with Pfizer and its legacy companies. In his CSO role at ISPOR, Dick’s responsibilities are to develop, lead, support and direct strategic initiatives related to research, scientific, and content priorities to accomplish the organization’s mission to promote health economics and outcomes research (HEOR) excellence to improve decision making for health globally. While with Pfizer his final position was Vice President, Outcomes & Evidence, lead for Cardiovascular/Metabolic, Inflammation & Immunology, the last in a succession of HEOR group lead roles. He received a Ph.D. in economics from Johns Hopkins University in 1982, concentrating in econometrics and labor economics. Prior to joining Pfizer’s legacy company Upjohn in 1991, he was a member of the economics faculty at Ohio State University as well as a senior economist at the American Medical Association Center for Health Policy Research. Dick has served on the ISPOR Board of Directors (2007-09), was Chair of the ISPOR Institutional Council in 2010, and was co-chair of the ISPOR Good Research Practices Task Force on Cost-Effectiveness Analysis in Randomized Clinical Trials in 2003-2005 as well as its 2014-15 reprise to revise and update that Report. He was also a member of the Health Outcomes Committee of PhRMA from 1998-2009, having been its chair from 2002-2004. He has served as a co-editor for Value in Health, on the editorial board for Farmeconomia, on AHRQ, NIH, and PCORI project review study sections, and is a member of the Ohio State University Economics Advisory Board. He has over 90 peer-reviewed journal articles, book chapters, monographs and other professional publications.

Wolfgang Winkelmayer, MD, MPH, ScD, FASN | Journal of the American Medical Association (JAMA) | Associate Editor
Wolfgang C. Winkelmayer, MD, MPH, ScD, is the Gordon A. Cain Chair of Nephrology and a Professor of Medicine at Baylor College of Medicine in Houston, Texas. Dr. Winkelmayer received his medical degree (1990) from the University of Vienna, Austria, and later earned a Master of Public Health degree in Health Care Management (1999) and a Doctor of Science degree in Health Policy (2001) from Harvard University. He then spent 8 years on the faculty of Brigham and Women’s Hospital and Harvard Medical School where he established himself as a prolific investigator and leader in the discipline of comparative-effectiveness research as it pertains to patients with kidney disease. From 2009 to 2014, he was the Director of Clinical Research in the Division of Nephrology at Stanford University School of Medicine, Palo Alto, California. He assumed his current position as Chief of Nephrology at Baylor College of Medicine in September 2014. His main areas of research interest include comparative effectiveness and safety research among treatment strategies of anemia as well as among various interventions for cardiovascular disease in patients with kidney disease. His clinical passion lies in providing quality kidney care to the predominantly disadvantaged and un(der)insured population in the public safety net health system of Harris County, Texas. Dr. Winkelmayer has authored over 280 peer-reviewed publications and he has a particular interest in medical publishing. He currently serves as an Associate Editor for JAMA, The Journal of the American Medical Association and was a Co-Editor of the American Journal of Kidney Disease from 2007-2016, and has been appointed to several other editorial boards of leading nephrology and epidemiology journals. He also volunteers his time towards important initiatives of the American Society of Nephrology (e.g., Public Policy Board) and as the Co-Chair of Kidney Disease: Improving Global Outcomes (KDIGO), the leader in global clinical practice guidelines in kidney health care.