Karen Edward has over 25 years experience working in clinical laboratories, 15 years of which have been in cellular therapy laboratories in industry, hospital-based, and academic settings. Her expertise includes cellular processing in GTP and GMP facilities, process development, training, setting up and managing facilities, project management, development and maintenance of quality systems, regulatory compliance, inspections and audits. Most recently, Ms. Edward was Quality Assurance Manager for Controlled Cellular Production at the Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance, one of the largest and most active cellular therapy programs in the world. She has served as Cellular Therapy Laboratory Manager, also at the FHCRC-SCCA, as Director of Laboratory Operations and Laboratory Network Manager at Progenitor Cell Therapy, and as Bone Marrow Transplant Supervisor, Stanford University Hospital. Ms. Edward serves on the advisory board, laboratory practices committee, and legal and regulatory committees of the International Society of Cellular Therapy. In addition she is a member of the Organization of Regulatory and Clinical Associates, and has conducted inspections for the Foundation for the Accreditation of Cellular Therapy (FACT) and AABB. She has led multidisciplinary project teams developing and improving quality systems to enable compliance with FDA cell therapy regulations, as well as FACT and AABB accreditation standards. As a consultant, Ms. Edward works closely with laboratory and collection personnel to assess existing operational and quality systems, and offers practical, targeted solutions to enable regulatory compliance and effective operations.