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Session 3: Master Protocols With a Single Sponsor
Session Chair(s)
MaryAnn Morgan-Cox, PhD
Senior Director, Immunology Design Hub
Eli Lilly and Company, United States
Rui (Sammi) Tang
Vice President, Global Head of Biometrics
Servier Pharmaceuticals, United States
In contrast to traditional trial designs where a single drug is tested in a single disease population in one clinical trial, master protocols use a single infrastructure, trial design, and protocol to simultaneously evaluate multiple drugs and/or disease populations in multiple sub-studies, allowing for efficient and accelerated drug development. Although historically the master protocol concept has been utilized across multiple institutions or sponsors, master protocols are beginning to extend into single company sponsorship; this more discrete setting requires special attention with respect to operational, regulatory, and methodological considerations. This session invites industry experts who have identified and overcome trial complexities associated with simultaneous/concurrent evaluation within a single sponsor setting to share key learnings and best practices. We hope these case studies offer valuable information and support for companies that consider internal development of master protocols.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand value associated with master protocol utilization within the single sponsor setting
- Learn new clinical designs that can be executed within the single sponsor setting
- Explore regulatory feedback and insights related to master protocols designed for the single sponsor setting
Speaker(s)
Basket Trial for Rare Dermatological Disorders
MaryAnn Morgan-Cox, PhD
Eli Lilly and Company, United States
Senior Director, Immunology Design Hub
Innovative Approaches to Master Protocols in I/O
Rui (Sammi) Tang
Servier Pharmaceuticals, United States
Vice President, Global Head of Biometrics
![Nora Ku, MD](/_Images/member/Generic_Image_Missing-Profile.jpg)
Master Protocols in Practice: Tumor Agnostic Approvals
Nora Ku, MD
Loxo Oncology, Inc-A Wholly Owned Subsidiary of Eli Lilly and Company, United States
Executive Medical Director
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