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Monday, June 28 • 4:00pm - 5:00pm
#153 SL: Regulatory, Industry, Patient, and Academic Perspectives on Machine Learning in Clinical Trials

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-557-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Stuart Michael Bailey, PhD


Industry Perspective
John Zhong, PhD

EMA Update on Machine Learning in Clinical Trials
Florence Butlen-Ducuing, MD, PhD, MS

Patient Perspective
Philip John Green

avatar for John Zhong

John Zhong

Vice President, Head of Biometrics, REGENXBIO, Inc., United States
Dr. Zhong is the Vice President of Biometrics at REGENXBIO. Prior to REGENXBIO, he was a Group Head at Biogen, accountable for Innovative Analytics, Rare Disease Statistics, and others. He has 20 years of industry experience successfully bringing the needed treatments to patients... Read More →

Stuart Bailey

Vice President, Head of Analytics and Data Sciences, Biogen, United States
Stuart leads the Analytics & Data Sciences team at Biogen supporting Research & Development of pioneering medicines for neuroscience patients. He holds a Doctorate in Mathematics from Sussex University, U.K. and is an expert in adaptive model-based dose-finding and Bayesian methods... Read More →

Florence Butlen-Ducuing

Senior Scientific Officer, Office of Therapies for Neurological and Psychiatric, European Medicines Agency, Netherlands
avatar for Philip Green

Philip Green

Steering Committee Patient Representative, CTTI, United States
Phil was diagnosed with ALS in August of 2018 and immediately dedicated himself to making a difference in the fight against ALS. Phil is active with multiple ALS organizations and institutions (Team Gleason, I AM ALS, Augie’s Quest, ALS TDI, ALS Cure Project, UW Medicine, ALSA... Read More →

Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Forum |   09: Regulatory, Forum