Current Regulatory and cGMP Compliance Trends for Cellular Therapeutics and the Challenges in Translation to Late-Stage Commercial-Ready Manufacturing

WuXi AppTec
Vice President, Testing and Cell Services
Mr. Moore has more than thirty years’ experience in the contract manufacturing and testing of biopharmaceutical products. Prior to joining WuXi AppTec in 2011, he was Executive Vice President and Chief Business officer for Althea Technologies, a biological product CMO.

Mr. Moore served as a senior regulatory advisor at Genzyme Corporation and interacted with FDA on investigational products such as patient-specific vaccines for B-cell lymphoma, and licensed cell therapies such as Carticel® and Epicel®, including participation in FDA Advisory Committee meetings.

Mr. Moore had management responsibility for the facility producing CTM for Phase III clinical trials and for the contract manufacture of recombinant protein products in Genzyme’s Rockville, Maryland facility. Mr. Moore directed the Biotechnology Services group at Bioreliance after advancing from the laboratory and quality unit during his sixteen year tenure.