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San Diego Convention Center

Jun 23, 2019 9:00 AM - Jun 23, 2019 12:30 PM

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 A Dreyer, PhD, MPH, FISPE

Nancy A Dreyer, PhD, MPH, FISPE

Founder, Dreyer Strategies LLC, United States

Nancy Dreyer is Chief Scientific Advisor to Picnic Health and Adjunct Professor of Epidemiology at the University of North Carolina. Recently retired from full-time employment as Chief Scientific Officer at IQVIA Real World Solutions, she maintains an active career consulting, publishing and teaching for the International Society of Pharmacoepidemiology (ISPE). She is a Fellow of DIA and a member of DIA's Scientific and Policy Advisory Council, a Fellow of the International Society for Pharmacoepidemiology and a member of the ISPOR RWE leadership team. She has helped advance global use of real-world evidence by medicinal product regulators, with her work cited in guidelines in the US, Europe, and China.

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 80+ 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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