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Virtual Event

Jun 14, 2020 9:00 AM - Jun 14, 2020 12:30 PM

(US Eastern Standard Time)

Horsham, PA 19044

#21: Real World Evidence: The Evolving Landscape of Regulators, Data and Integrated Use

Instructors

Gillis  Carrigan, PhD, MS

Gillis Carrigan, PhD, MS

Director, Center for Observational Research, Amgen, United States

Dr. Carrigan has over 20 years of experience in observational studies with a focus on study design and methodology. He is experienced with the use of electronic medical records (EMR), administrative claims data, and registry data. He has worked with observational data in a number of settings and therapeutic areas including oncology, neuroscience, respiratory disease, and vaccine safety. In recent years, he has focused on applying epidemiological methods to real-world oncology data to augment evidence from clinical trials.

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.

Matthew  Reynolds, PhD, FISPE

Matthew Reynolds, PhD, FISPE

Vice President, Real World Evidence, IQVIA, United States

Dr. Reynolds is a member of the Center for Advanced Evidence Generation, Real World Solutions at IQVIA. He designs innovative solutions for real world evidence on effectiveness and safety. Dr. Reynolds brings more than 20 years of diverse experience in non-interventional research and has a deep expertise in the usage of real world data to address questions of effectiveness, safety, and value of pharmaceutical products. He founded and led the successful Database Special Interest Group for the International Society of Pharmacoepidemiology where he served as an elected executive leader. Dr. Reynolds earned his graduate and doctoral degrees in epidemiology and preventive medicine from the University of Maryland at Baltimore in January 2000.

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