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Expanding Innovative Master Protocol Trial Designs to Cell and Gene Therapies for Rare Diseases
Session Chair(s)
Nancy Myers, JD
CEO and Founder
Catalyst Healthcare Consulting, United States
Master Protocols, including basket trials and umbrella trials, enable efficiencies in investigating multiple conditions or multiple treatments, respectively, under a single trial design. Applying Master Protocol trial designs to Cell & Gene therapies (CGTs) can streamline clinical and regulatory processes to speed the delivery of treatments to patients with rare diseases.
Learning Objective : Identify barriers to and solutions for leveraging Master Protocol clinical trial designs to study Cell & Gene Therapies for rare diseases.
Speaker(s)
Academic Perspective
Kiran Musunuru
University of Pennsylvania, United States
Professor of Medicine
Researcher Perspective
Jeff Allen, PhD
Friends of Cancer Research, United States
President and Chief Executive Officer
FDA Perspective
Representative Invited
FDA, United States
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