Rethinking the Regulatory Infrastructure for Human Gene Transfer Clinical Trials

Affiliations

• ¹ WCG Biosafety, WIRB-Copernicus Group, Princeton, New Jersey, USA.
• ² Inovio Pharmaceuticals, Plymouth Meeting, Pennsylvania, USA.
• ³ Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
• ⁴ Institute for Advanced Study, The Simons Center for Systems Biology, Princeton, New Jersey, USA.
• ⁵ Therapeutic Development, Sangamo BioSciences, Inc., Richmond, California, USA.
• ⁶ Department of Pathology and Laboratory Medicine and Center for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
• ⁷ Department of Medicine, University of California San Diego Health, La Jolla, California, USA.
• ⁸ WCG Biosafety, WIRB-Copernicus Group, Puyallup, Washington, USA.