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Session 1: Creating a Common Understanding of Master Protocols
Session Chair(s)
Daniel Millar, MBA
Senior Director, Strategic Business Transformation
Johnson & Johnson, United States
The list of publications on master protocols continues to expand, in parallel with expanding interest from diverse stakeholders, to utilize master protocols to reach the vision of patient-centric R&D and transform the model for drug development. With the expansion, diversity, and sometimes confusion can emerge with respect to terminology, priority objectives, and implications. This session will focus on explaining the fundaments, present findings from a landscape analysis, and present other original research which targets making design and implementation of master protocols easier.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Articulate common types of master protocols and identify situations where each could be applied in drug development
- Understand the history, current state of science, and trajectory for utilization of master protocols
- Identify sources for additional background information, tools, and methodologies
Speaker(s)
Creating a Common Understanding of Master Protocols
Kimberly Ann Fisher, MA
Clinical Trials Transformation Initiative (CTTI), United States
Project Manager for Master Protocol Project
Speaker
Nicholas Richardson, DO, MPH
FDA, United States
Clinical Team Leader, Division of Hematologic Malignancies 2, OND, CDER