#250: Open-Label, Long-Term Extension Studies: Study Designs and Ethics
Chair LK
Senior Statistical Science Director, AstraZeneca
Lisa Kammerman, PhD is a Senior Statistical Director in Oncology at AstraZeneca. She consults on PRO projects and regulatory submissions. She developed AZ's PRO guidance document and led AZ's missing data project. After 24 years of public service, she retired from the FDA, where she...
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Speakers SA
Principal Research Scientist, Eli Lilly and Company
Scott has been a statistician designing and analyzing neuroscience clinical trials for nearly 20 years. While most of his research has focused on depression and schizophrenia disease states, Scott has spent the last five years working on Alzheimer's Disease. In 2015, Scott co-authored...
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Vice President and Global Head of Epidemiology, Johnson & Johnson
Jesse Berlin is Vice President of Epidemiology at Johnson & Johnson, with responsibility for pharmaceuticals, devices and consumer products. He joined J&J over 11 years ago after spending 15 years at University of Pennsylvania, where he was a Professor of Biostatistics. He has authored...
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Deputy Director & Senior Pediatric Ethicist, Ofc of Pediatric Therapeutics, OC, FDA
Robert “Skip” Nelson, M.D., M.Div., Ph.D. is currently the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics, Office of the Commissioner at the U.S. Food and Drug Administration. Prior to joining FDA full-time in 2009, he was Professor of Anesthesiology...
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Tuesday June 28, 2016 2:00pm - 3:15pm EDT
201A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA