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 “Nonclinical Considerations for Cell Therapy Product Development”:
Introduction of the presenters by Maria Torruella Suarez, PhD, Office of Pharmacology/Toxicology, OTP, CBER, FDA
“Autologous Dopamine Neuron Replacement for Parkinson’s Disease”
- Jeanne Loring, PhD, Co-Founder, Aspen Neuroscience and Professor Emeritus, Scripps Research
“A Cell Based Therapy Trial for Huntington’s Disease”
- Leslie Thompson, PhD, Professor, University of California, Irvine
“Translating Retinal Pigment Epithelium (RPE) Biology into Disease Treatments Using Induced Pluripotent Stem (iPS) Cells”
- Kapil Bharti, PhD, Senior Investigator and Scientific Director, National Eye Institute, National Institutes of Health