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Drug Development for Ocular Disease, New Therapies, Regulations, and Patient Perspectives
Session Chair(s)
Nita Ichhpurani, PMP
Consultant To Daiichi Sankyo, Inc.
Phase One Forward, Consultant, Canada
This session will highlight recent advances and review challenges and opportunities in rare disease ocular therapies. New therapeutic approaches have emerged including promising gene and cell-based therapies in retinal diseases. Relevant case studies and special considerations will be discussed. We will explore the regulatory and scientific issues with experts to provide insights from the FDA and different sponsors.
Learning Objective : Identify recent advances in in ocular drug development therapies; Discuss the existing regulatory framework; Describe challenges and opportunities in ocular rare disease drug development highlighting what has been done and what might be done in the future.
Speaker(s)
Gene Therapy for Inherited Retinal Diseases
Melissa Shiao Hui Liew, MD
Novartis Institutes of Biomedical Research, United States
Global Head of Translational Medicine-Opthamology
FDA/CBER Perspective on the Development of Gene Therapy Products for Retinal Disorders
Wei Liang, PhD
FDA, United States
Pharmacologist, OTAT, CBER
Changing What it Means to be Blind: We're All in This Together
Kristin Smedley
Curing Retinal Blindness Foundation, United States
President
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