Member Exclusive

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”.

Go to the profile of RegMedNet
May 02, 2017

Please sign in or register for FREE

Register to RegMedNet

RegMedNet is a free content and networking hub promoting global connection, knowledge-sharing and collaboration between all members of the regenerative medicine field.



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