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Regulatory, Industry, Patient, and Academic Perspectives on Machine Learning in Clinical Trials
Session Chair(s)
Stuart Michael Bailey, PHD
Vice President, Head of Analytics and Data Sciences, Biogen, United States
Machine / deep learning is being applied in an increasing number of industries, and biopharma is no exception. This session will examine regulator, patient, industry, and technical perspectives on machine learning applications in drug development
Learning Objective : Identify opportunities to prospectively integrate machine learning approaches and expertise within the modern drug development process; Evaluate challenges in the application of machine learning approaches in clinical trials and assessing benefit/risk; Distinguish between the use and value of historical, contextual, synthetic, and real-world data.
Speaker(s)
John Zhong, PHD
Vice President, Head of Biometrics, REGENXBIO, Inc., United States
Industry Perspective
Florence Butlen-Ducuing, MD, PHD, MS
Senior Scientific Officer, Office of Therapies for Neurological and Psychiatric , European Medicines Agency, Netherlands
EMA Update on Machine Learning in Clinical Trials
Philip John Green
Steering Committee Patient Representative, CTTI, United States
Patient Perspective
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