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Virtual Event

Oct 08, 2020 10:15 AM - Oct 09, 2020 2:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

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


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

Washington University School of Medicine, United States

Charles F. and Joanne Knight Distinguished Professor of Neurology

Scott  Berry, PhD

DIAN Platform Trial: Statistical Design

Scott Berry, PhD

Berry Consultants LLC, United States

President and Senior Statistical Scientist

Susan  Mills

DIAN-TU Platform: Operational Complexities and Considerations

Susan Mills

Washington University School of Medicine, DIAN Trials Unit, United States

Senior Director, Clinical Operations

Tina  Gislimberti, MA

IQVIA Perspective

Tina Gislimberti, MA

IQVIA, United States

CNS Project Management

Phyllis Barkman Ferrell, MBA

Perspective from Lilly

Phyllis Barkman Ferrell, MBA

Eli Lilly and Company, United States

Global Head, External Engagement, Alzheimer's Disease and Neurodegeneration

Geoffrey  Kerchner, MD, PhD

Perspective from Roche

Geoffrey Kerchner, MD, PhD

F. Hoffmann-La Roche, Ltd., Switzerland

Global Development Leader

Vivek  Subbiah, MD


Vivek Subbiah, MD

UT MD Anderson Cancer Center , United States

Executive Director, Cancer Medicine Research

Kert  Viele, PhD

Statistical Aspects of the ROAR Basket Trial

Kert Viele, PhD

Berry Consultants, United States

Director of Research. Senior Statistical Scientist

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