Lesson Description
The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) hosted a virtual scientific public workshop on February 25, 2025, titled “Cell Therapies and Tissue-based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development.” The purpose of the workshop was to identify and discuss the current state of the science, development, and regulation for cellular therapies and tissue-based products.
In this session, presentations on “Cell Therapies for Niche Indications: Clinical Insights and Future Directions”:
“Biologics and Other ‘Stuff’ that Gets Injected in Sports Medicine and Orthopedics”
- Blake Boggess, DO, Professor, Duke University School of Medicine; Duke Sports Medicine Team Physician
“Emerging Treatments: Cell Therapy and Synthetic Grafts for Corneal Endothelial Dysfunction”
- Ellen Koo, MD, Associate Professor of Clinical Ophthalmology, Bascom Palmer Eye Institute, University of Miami Health System
“Cell Therapy for Heart Disease”
- Eduardo Marbán, MD, PhD, Executive Director, Smidt Heart Institute, Mark S. Siegel Family Foundation Distinguished Professor