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Session 7: Big Data
Session Chair(s)
Jeffrey N. Stuart, PhD
Associate Vice President, Global Regulatory Affairs
Merck Sharp & Dohme LLC , United States
Despite the rapid evolution in diagnostic multiplexing from systems with improving quality and standardization, only a fraction of the information generated is in use today for clinical decision-making. Scientists and regulators face significant challenges in deciding how to organize and utilize data that is being generated, and how to make optimize its use to benefit patients. The ability to extract knowledge and insights from large and complex data sets in the drug development and clinical care settings is vital to driving the next breakthrough in the field of precision medicine. This session will explore common regulatory, technical and clinical hurdles to knowledge extraction, and highlight some novel approaches to overcome them.
Speaker(s)
Use of Phenotypic and Genotypic Data in Support of Precision Medicine and Learning Health Care Systems Activities: Approach of the Department of Veteran’s Affairs
Louis Fiore, MD
VA Boston Healthcare System (MAVERIC), United States
Executive Director
Applications for Cognitive Computing, Big Data and Advanced Analytics in Precision Medicine - a Case Study Approach
John Piccone
IBM Watson Health, United States
Lead Partner Life Sciences Strategy and Analytics
High-performance Integrated Virtual Environment/HIVE: FDA's Solution for Next-Generation Sequencing Data Analysis in Research and Regulatory Domains
Vahan Simonyan, PhD
FDA, United States
Lead Scientist, HIVE Project Director, CBER
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