AUG 30, 2016 08:00 AM PDT

Transitioning to the clinic from proof of concept research: Challenges associated with converting research materials and methods to a clinical grade product

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  • Team Leader, Processing/Manufacturing, Heart Regeneration Program, University of Washington School of Medicine, United States
      Ben Fryer is the team leader for CMC-Cell Manufacturing and Processing at the University of Washington School of Medicine's Heart Regeneration Program (HRP). Ben joined the HRP in January 2015. The program was started by Chuck Murry and is currently in pre-clinical development of a therapy to treat heart disease using cardiomyocytes generated from hES cells.

      Prior to joining HRP, Ben worked at Janssen R&D's internal diabetes venture (BetaLogics) from 2006 to 2014. BetaLogics' mission was to treat insulin-dependent diabetes with a combination islet-like tissue product generated from hES cells and delivered via an immune-isolation device. Ben managed an internal research team and several external partnerships dedicated to finding a defined and scalable method to manufacture pancreatic beta islets for the treatment and cure of diabetes.

      Ben earned a BA from Colorado College and his PhD in pharmacology from the University of Pennsylvania. As a post-doc he studied Hypoxia Inducible Factor in cancer and stem cell development in the Howard Hughes Laboratory of M. Celeste Simon at the University of Pennsylvania. Prior to graduate school he worked for several small biotech/pharmaceutical firms in the Denver-Boulder area supporting discovery research and pre-clinical and clinical development of small and large molecule therapies for cancer.

      Ben is an inventor on several pending patents for Janssen/Johnson&Johnson, including stirred tank bioreactor based suspension expansion and differentiation processes and a product currently marketed by Thermo-Fisher™ as Nunc™ Nunclon™Vita.

    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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