Keynote: When Your Process Equipment is a Raw Material and Your Raw Material is a Human: The Adaptation of Biotechnology CMC Skills to Cell Therapy

  • CMC/Operations disciplines have an important role in the commercialization of powerful new cell therapies
  • Well understood development principles can be applied, though there are challenges
  • It is important to identify when to draw on experience and when to adapt/grow to address gaps
  • Comparability is key in an emergent technology space, but may be limited by product understanding
  • Growing development skills to advance important new medicines

Alison Moore
Chief Technology Officer
Allogene Therapeutics

Dr. Alison Moore is Chief Technical Officer at Allogene Therapeutics. Prior to this role, Moore served as senior vice president, Process Development,in Amgen Operations. Moore was previously vice president, Process and Product Engineering (P&PE), where she was responsible for Process Development, Clinical Operations and Global Operations Planning. Moore served as vice president, Corporate Manufacturing, overseeing Supply Chain, Contract Manufacturing, Global Distribution, Manufacturing Technologies, and Operations Risk Management. Before taking on this position, she was vice president, Site Operations at Amgen’s Fremont, California, manufacturing facility (AFR).

Before heading up the AFR facility, Moore was a director in Chemistry, Manufacturing and Controls Regulatory Affairs at Genentech. Prior to her time at Genentech, Moore had previously spent nine years at Amgen in various positions of increasing responsibility within the Process Development organization.

Moore holds a Ph.D. in Cell Biology from Manchester University, England, and a bachelor’s in Pharmacology with Honors from Manchester University, England. Following her doctoral degree work at Manchester University, she was a Postdoctoral Research Fellow at the Medical University of Lübeck, Germany, and at Genentech.