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Session 2: Lessons Learned from Completed and Ongoing Master Protocols
Session Chair(s)
Michelle A Detry, PHD
Director, Adaptive Trial Execution & Senior Statistical Scientist
Berry Consultants, LLC, United States
AnnCatherine M. Downing, PHARMD
Chief Operating Officer - Lilly Research Laboratories
Eli Lilly and Company, United States
This session will highlight lessons learned from multiple stakeholders across design, implementation, and data readout for a consortia-driven platform study. An ongoing, single-pharma sponsor basket trial will highlight lessons learned in building a business case, operational challenges, and planning for dissemination of results.
Learning Objective : At the conclusion of this session, participants should be able to:
- Explain key considerations for master protocols across the lifecycle of the protocol
- Articulate differences between consortia-driven and single-sponsor master protocols
- Relate multiple stakeholder perspectives within different master protocol structures
Speaker(s)
DIAN-TU Platform Trial: Lessons Learned *this presentation will only be available live and not on demand
Randall J. Bateman, MD
Washington University School of Medicine, United States
Charles F. and Joanne Knight Distinguished Professor of Neurology
DIAN Platform Trial: Statistical Design
Scott Berry, PHD
Berry Consultants LLC, United States
President and Senior Statistical Scientist
DIAN-TU Platform: Operational Complexities and Considerations
Susan Mills
Washington University School of Medicine, DIAN Trials Unit, United States
Senior Director, Clinical Operations
IQVIA Perspective
Tina Gislimberti, MA
IQVIA, United States
CNS Project Management
Perspective from Lilly
Phyllis Barkman Ferrell, MBA
Eli Lilly and Company, United States
Global Head, External Engagement, Alzheimer's Disease and Neurodegeneration
Perspective from Roche
Geoffrey Kerchner, MD, PHD
F. Hoffmann-La Roche, Ltd., Switzerland
Global Development Leader
Speaker
Vivek Subbiah, MD
UT MD Anderson Cancer Center , United States
Executive Director, Cancer Medicine Research
Statistical Aspects of the ROAR Basket Trial
Kert Viele, PHD
Berry Consultants, United States
Director of Research. Senior Statistical Scientist