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Spire

2018年11月08日 (木) 午後 12:45 - 2018年11月09日 (金) 午後 4:00

750 First Street NE, Washington, DC 20002

Master Protocol Workshop

Session 6: Operational Considerations

Session Chair(s)

Craig  Lipset, MPH

Craig Lipset, MPH

Co-Chair

Decentralized Trials & Research Alliance | Buffalo Initiative, United States

Daniel  Millar, MBA

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

Operational Considerations for Master Protocols: Experience in GBM AGILE

Meredith Buxton, PHD, MPH

Global Coalition For Adaptive Research, United States

Chief Executive Officer

Yichuan  Xia, PHD

Operational Considerations: Janssen’s Platform Trial in Evaluating Novel Compounds in Crohn’s Disease

Yichuan Xia, PHD

Johnson&Johnson, United States

Director

Daniel  Millar, MBA

Moderator

Daniel Millar, MBA

Johnson & Johnson, United States

Senior Director, Strategic Business Transformation

Victoria  Manax Rutson, MD

Panelist

Victoria Manax Rutson, MD

Pancreatic Cancer Action Network, United States

Chief Medical Officer

Lisa  LaVange, PHD

Panelist

Lisa LaVange, PHD

University of North Carolina at Chapel Hill, United States

Professor Emerita

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