Team Leader, Processing/Manufacturing, Heart Regeneration Program, University of Washington School of Medicine, United States
BIOGRAPHY
AUG 30, 2016 8:00 AM PDT
Transitioning to the clinic from proof of concept research: Challenges associated with converting research materials and methods to a clinical grade product
Presented at:
4th Annual 24 Hours of Stem Cells™ virtual event
Speaker
Abstract
Years of significant effort can go into generating key proof of concept data to support moving bench research to clinical development.Yet, much work remains in order to transition from POC to clinical trials for a cell therapy. Raw materials, processes, and cell banks may all require changes to meet regulatory guidances and more stringent specifications for treating a patient. We will discuss the practical aspects of developing a cell therapy to treat heart disease.
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