Meeting Overview:
The purpose of the meeting was to explore and develop strategies to address common challenges related to the design and implementation of master protocols, including:

• Mapping the pre-planning, planning, and execution processes of a master protocol trial.
• Strategizing solutions to common roadblocks related to the pre-planning, planning, and execution of a master protocol study.  
• Identifying and prioritizing the creation of tools to support the adoption of emerging best practices outlined by CTTI’s roadmap.

Meeting Materials:

Meeting Agenda

Meeting Summary

Roadmap

Participant List

Full Presentation Set - Day 1

Full Presentation Set - Day 2

Welcoming Remarks & Meeting Overview

• Introduction to the Clinical Trials Transformation Initiative (CTTI) - Annemarie Forrest, CTTI
• VeloCTTI Master Protocol Project Overview - Kimberly Fisher, CTTI

Session I: Landscape Review

• Landscape Review Findings - Nicholas Richardson, FDA, CDER
• Multi-Stakeholder, Cross-Institutional Strategies for Change - Daniel Millar, Janssen Pharmaceuticals
• Leveraging Master Protocols to Build Local Infrastructure & Technical Capacity for Low & Middle-Income Countries - Jay Park, MTEK Sciences

Session II: Building Capacity for Innovation

• I-ACT for Children Overview - Ed Connor, I-ACT for Children
• xCures Overview - Mika Newton, xCures

Session III: Small Group Breakout Sessions

• Pre-Planning - Jane Perlmutter & Annemarie Forrest, CTTI
• Planning - Marianne Chase, Massachusetts General Hospital & Kimberly Fisher, CTTI
• Execution - Roger J. Lewis, Berry Consultants, LLC & Laura Shannon, CTTI
• Large Group Discussion

Session IV: Tool Identification

• Roadmap Strategy Session Instructions - Kimberly Fisher, CTTI
• Breakout Session Facilitators
  • Pre-Planning - Karen Dimick, Genentech & Annemarie Forrest
  • CTTI Planning - Gene Vinson, Syneos Health & Kimberly Fisher
  • CTTI Execution - Rajeshwari Sridhara, FDA, CDER, & Laura Shannon, CTTI
• Large Group Strategy Session - Facilitator/Moderator: Nicholas Richardson, FDA, CDER

Session V: Next Steps & Closing Comments