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Master Protocol Workshop


Welcome, Opening Remarks and Session 1: Master Protocols: Where Have We Been? How Far Have We Come?

Session Chair(s)

Abby  Bronson, MBA

Abby Bronson, MBA

  • Vice President, Patient Advocacy and External Innovation
  • Edgewise Therapeutics, United States
This session will build on the keynote and present the overall arc of master protocols, where we are in the trajectory of master protocols becoming mainstream and some of the key metrics that show their success. Starting with the early oncology trials and continuing with some of the newer rare disease trials, how and why master protocols are becoming more widely used will be discussed. The session will also cover master protocol adoption from the lens of patient advocacy as the drivers and beneficiaries of these innovative designs. A “glossary” of concepts and terms will be presented to foster a common language for master protocols and also to exemplify the importance of internal and external communication in planning and executing a master protocol.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Discuss the history of master protocols, their adoption, and why they make sense
  • Describe the role patient advocacy has had in the spread of master protocols and why they benefit patients
  • Identify a set of common terms to use in internal and external communications

Speaker(s)

Scott M Berry, PhD

History of Master Protocols and Where We Are

Scott M Berry, PhD

  • President and Senior Statistical Scientist
  • Berry Consultants LLC, United States
Jane  Perlmutter

From the Lens of Patient Advocacy

Jane Perlmutter

  • Patient Advocate, United States
Cecile  Spiertz, MSc

A Glossary of Master Protocol Terms: What They Are and Why They Are Important

Cecile Spiertz, MSc

  • Senior Director, External Innovation Clinical Trial Platforms
  • Janssen, Netherlands