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The commercialization of cell and gene therapies: regulatory challenges

Despite a promising global demand and clinical potential, a number of regulatory challenges are impeding the translation of cellular based therapeutics from “bench to bedside”.

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May 02, 2017

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Go to the profile of James L. Sherley, M.D., Ph.D.

Pettitt and Brindley have presented an excellent summary of how recent and ongoing developments in the cell therapy trials and commercialization market space are entwined in ineffective and compromising regulatory policies. Their article is a seminal contribution to recognizing and introducing the concept that crucial advances for cell therapy development will require divestiture from the canonical pharmaceutical and biopharmaceutical clinical trial paradigm. Bringing about the needed changes in philosophy, practice, and vision will require a new creative spirit of collaboration among entrepreneurial cell therapists and leaders of government regulatory agencies.

James L. Sherley, M.D., Ph.D.
Asymmetrex, LLC