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 “Tissue- and Cell-Derived Therapies”:
Introduction of the three presenters by Elizabeth Lessey-Morillon, PhD, Office of Cellular Therapy and Human Tissue CMC (OCTHT), OTP, CBER, FDA
“Development of a Biologic for Osteoarthritis”
- Katie Mowry, PhD, Vice President of Research and Development, Organogenesis
“Clinical Use of Cord Blood and Blood Cord Mesenchymal Stem Cells (MSCs) and MSC-Exosomes”
- Amanda Olson, MD, Associate Professor of Medicine, MD Anderson Cancer Center
“Neural Stem Cell Derived Biologic: Cleared IND”
- Steven Stice, PhD, Co-Founder and Chief Scientific Officer, Aruna Bio, Inc.