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The Next Frontier: Autoimmune Cell and Gene Therapy, Regulation, and Patient Access
Session Chair(s)
Samantha Roberts, PHD
Senior Director, Regulatory Intelligence
AstraZeneca, United States
This panel will explore how patient advocacy can shape regulatory strategy, trial design, and access planning for autoimmune cell and gene therapies as they move toward future approvals.
Learning Objective : Identify how patient advocacy can shape regulatory strategy and access for future autoimmune CGTs; Describe approaches to incorporating patient priorities such as quality of life and treatment burden into trial design; Discuss strategies to ensure equitable and sustainable patient access.
Speaker(s)
Perspectives from the Myositis Community
Paula Eichenbrenner, MBA
The Myositis Association, United States
Executive Director
Patient Perspective
Joy Buie, PHD
Lupus Foundation of America, United States
Vice President of Research
Patient advocacy perspective
Brian Kennedy
Global Alliance for Patient Access, United States
Executive Director
FDA perspective
Vijay Kumar
FDA, United States
Acting Director OTP/CBER
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