San Diego Convention Center

2019年6月23日 (日) 午前 9:00 - 2019年6月23日 (日) 午後 12:30

111 W Harbor Drive, , San Diego, CA 92101 , USA

#20: Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know?

Instructors

Nancy  Dreyer, PhD, MPH, FISPE

Nancy Dreyer, PhD, MPH, FISPE

Founder, Dreyer Strategies LLC, United States

Nancy Dreyer is Chief of the Scientific Advisory Board at OM1, and brings her experience having served as Chief Scientific Officer at IQVIA Real World Solutions, Global Chief of Scientific Affairs at Outcome Sciences and Quintiles, and CEO of Epidemiology Resources Inc. Her expertise includes patient-generated information, electronic health records, health insurance claims, and data linkage, including collaboration with regulators and HTA. Widely published, she is a Science and Policy Advisor to DIA and a member of the Real-World Evidence Leadership Team for ISPOR. She is a Fellow of ISPE and DIA, an Adjunct Professor of Epidemiology at University of North Carolina at Chapel Hill and a Trustee of Brandeis University.

Brian  Bradbury, DrSc, MA

Brian Bradbury, DrSc, MA

Vice President, Center for Observational Research, Amgen, United States

Brian D. Bradbury is Vice President and Head of the Center for Observational Research (CfOR) at Amgen, Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) to support the development and continuous benefit:risk assessment of Amgen's medicines. Brian also holds an Adjunct Professor of Epidemiology appointment at the University of California, Los Angeles. He received his DSc in Epidemiology from Boston University and a MA in Education and Psychology from Pepperdine University. He has authored/co-authored 90+ peer-reviewed publications in the areas of pharmacoepidemiology, cancer, kidney, cardiovascular and bone disease.

Paul  Muntner, MHS, PhD

Paul Muntner, MHS, PhD

Professor of Epidemiology and Associate Dean for Research , University of Alabama at Birmingham , United States

Paul Muntner is Associate Dean for Research and Professor of Epidemiology at the University of Alabama at Birmingham. He earned a Master’s degree in biostatistics and a doctorate degree in epidemiology from the Johns Hopkins University. Since 2014, he has served as Co-Director of the University of Alabama at Birmingham Pharmacoepidemiology and Economics Research group. Also, Dr. Muntner is the director for an American Heart Association Strategically Focused Research Network hypertension center and he is the principal investigator on grants from the National Heart Lung and Blood Institute. From 2015 to 2018, he was Vice-Chair of the Statistics Committee for the American Heart Association. He has published > 450 peer-reviewed articles.

Jessica  Franklin, PhD

Jessica Franklin, PhD

Principal Consultant, Epidemiology and Real-World Evidence , Optum, United States

Jessica M. Franklin joined Optum in 2020 after 10 years as faculty in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School, where she remains affiliated as a Visiting Scientist. Dr. Franklin has extensive experience in designing and leading studies of the effectiveness, safety, and utilization of medications from large healthcare databases, including health insurance claims and electronic health records. She led the development and application of a wide range of novel methods in pharmacoepidemiology and co-founded the FDA and NIH-funded RCT DUPLICATE project focused on producing an empirical evidence base for the validity of real-world evidence on medications.

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