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Master Protocol Workshop


Session 2: Lessons Learned from Completed and Ongoing Master Protocols

Session Chair(s)

Michelle  Detry, PhD

Michelle Detry, PhD

  • Director, Adaptive Trial Execution & Senior Statistical Scientist
  • Berry Consultants LLC, United States
AnnCatherine M. Downing, PharmD

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)

Randall J. Bateman, MD

DIAN-TU Platform Trial: Lessons Learned *this presentation will only be available live and not on demand

Randall J. Bateman, MD

  • Charles F. and Joanne Knight Distinguished Professor of Neurology
  • Washington University School of Medicine, United States
Scott M Berry, PhD

DIAN Platform Trial: Statistical Design

Scott M Berry, PhD

  • President and Senior Statistical Scientist
  • Berry Consultants LLC, United States
Susan  Mills

DIAN-TU Platform: Operational Complexities and Considerations

Susan Mills

  • Senior Director, Clinical Operations
  • Washington University School of Medicine, DIAN Trials Unit, United States
Tina  Gislimberti, MA

IQVIA Perspective

Tina Gislimberti, MA

  • CNS Project Management
  • IQVIA, United States
Phyllis Barkman Ferrell, MBA

Perspective from Lilly

Phyllis Barkman Ferrell, MBA

  • Global Head, External Engagement, Alzheimer's Disease and Neurodegeneration
  • Eli Lilly and Company, United States
Geoffrey  Kerchner, MD, PhD

Perspective from Roche

Geoffrey Kerchner, MD, PhD

  • Global Development Leader
  • F. Hoffmann-La Roche, Ltd., Switzerland
Vivek  Subbiah, MD

Speaker

Vivek Subbiah, MD

  • Executive Director, Cancer Medicine Research
  • UT MD Anderson Cancer Center , United States
Kert  Viele, PhD

Statistical Aspects of the ROAR Basket Trial

Kert Viele, PhD

  • Director and Senior Statistical Scientist
  • Berry Consultants, United States