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

  • Ben Fryer, PhD

    Team Leader, Processing/Manufacturing, Heart Regeneration Program, University of Washington School of Medicine, United States

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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