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Session 6: Operational Considerations
Session Chair(s)
Craig Lipset, MPH
Co-Chair, Digital Trials and Research Alliance, United States
Daniel Millar, MBA
Senior Director, Strategic Business Transformation, Johnson & Johnson, United States
Getting a master protocol trial started may seem daunting. How do you go from an impressive theoretical design to a tangible trial? And how do you convince internal stakeholders that it will be operationally feasible within your constraints? This session will explore best practices for master protocol operationalization. Experienced industry colleagues will share their insights on setting up and operating master protocols, including assessment of internal capabilities and practical approaches to resolving common problems. An interactive expert panel and time for question and answer will round out the session.
Speaker(s)
Meredith Buxton, PhD, MPH
Chief Executive Officer, Global Coalition For Adaptive Research, United States
Operational Considerations for Master Protocols: Experience in GBM AGILE
Yichuan Xia, PhD
Director, Johnson&Johnson, United States
Operational Considerations: Janssen’s Platform Trial in Evaluating Novel Compounds in Crohn’s Disease
Daniel Millar, MBA
Senior Director, Strategic Business Transformation, Johnson & Johnson, United States
Moderator
Victoria Manax Rutson, MD
Chief Medical Officer, Pancreatic Cancer Action Network, United States
Panelist
Lisa LaVange, PhD
Professor Emerita, University of North Carolina at Chapel Hill, United States
Panelist
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