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San Diego Convention Center

23 jun 2019 1:30 p.m. - 23 jun 2019 5:00 p.m.

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

#36: A Novel Interactive Safety Graphic to Evaluate Potential Drug-Induced Hepatotoxicity

Instructors

James  Buchanan, PharmD

James Buchanan, PharmD

President, Covilance LLC, United States

Dr. James Buchanan is presently an independent drug safety consultant. Dr. Buchanan began his industry career at Genentech where he worked for 9 years in the areas of medical information and drug safety. He subsequently established the drug safety departments at Gilead, Tularik and Nuvelo. Dr. Buchanan next served at BioSoteria as the head of the medical and safety consulting group. Dr. Buchanan is currently president of Covilance, LLC, a drug safety consulting service. He is also a co-lead of the American Statistical Association Biopharmaceutical Safety Working Group Interactive Safety Graphics taskforce that is developing novel, open-source interactive graphical tools to identify and evaluate safety issues during drug development.

Jeremy  Wildfire, MSc

Jeremy Wildfire, MSc

Director, Biostatistics, Gilead Sciences, United States

Jeremy is a Data Scientist focused on creating open source tools that improve the clinical trials analysis pipeline. Jeremy’s team has created over a dozen web-based data visualizations focusing on different domains of clinical trial research including study safety, lab monitoring, data cleaning and study operations. All of these tools are free to use and modify, with code and examples available on GitHub. Jeremy has served as the technical lead for the Interactive Safety Graphics (ISG) sub-team of the ASA Biopharm-DIA Safety Working Group since early 2018.

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