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Boston Convention and Exhibition Center

Jun 24, 2018 8:30 AM - Jun 24, 2018 12:00 PM

415 Summer Street, , Boston, MA 02210 , 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 served as Chief Scientific Officer at IQVIA Real World Solutions, Global Chief of Scientific Affairs at Outcome Sciences Inc and Quintiles, and CEO of Epidemiology Resources Inc. prior to her recent switch to consultancy. She maintains an active practice, working with the pharmaceutical industry, serving as Chief, Scientific Advisory Board at OM1, and participating on the Real-World Evidence Leadership Team for the Intl Society of Pharmacoeconomics and Outcomes Research, as a Science and Policy Advisor to DIA, teaching and publishing. She is a Fellow of both ISPE and DIA, an Adjunct Professor of Epidemiology at University of North Carlina at Chapel Hill and a Trustee of Brandeis University.

Mary Jane  Geiger

Mary Jane Geiger

Vice President and TA Lead, Drug Development Services, ICON, United States

MJ Geiger is VP & CV lead for ICON’s Drug Development Services providing scientific, operational and therapeutic expertise spanning the development continuum from concept through development to post-approval activities. She is involved in the Cardiac Safety Research Consortium, serving as Co-Chair of the Scientific Oversight Committee and Program Chair of a Real World Evidence CV Safety Think Tank.

Alan  Brookhart

Alan Brookhart

Professor, Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, United States

M. Alan Brookhart is a Professor of Epidemiology at UNC Chapel Hill. His research is focused primarily on the development and application of statistical and epidemiologic methods for studies of prescription medications, vaccines, and other exposures using large clinical and healthcare utilization databases. In this area, he has made contributions to the development of quasi-experimental approaches that can be used to estimate causal effects in the presence of unmeasured or poorly recorded confounding variables. He has also been involved with the development of propensity score and marginal structural model methodology and has also developed new epidemiologic approaches for studying patterns of use medications and healthcare services.

Norman  Stockbridge, MD, PhD

Norman Stockbridge, MD, PhD

Director, Division of Cardiology and Nephrology, OND, CDER, FDA, United States

Norman Stockbridge, MD, PhD has been in FDA/CDER's Division of Cardiovascular and Renal Products since 1991 and has been its Director since 2004.

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