Ed's extensive educational background and professional certifications testify to his qualifications. He holds a Bachelor’s in Biological Sciences from Glasgow Caledonian University, a master’s in biomedical sciences at Napier University in Edinburgh, UK, and a Certificate in Quality Management with distinction at the University of Manitoba. Ed's unwavering dedication to quality management is evident in his over 30 years of experience as a Medical Lab Technologist in Hematology, Transfusion, Microbiology, Clinical Biochemistry, Quality Management, Cord Blood, and Cellular Therapy. He has served in various technical and managerial roles in the UK and Canada. He is the Quality Manager for the Cellular Therapy & Transplantation Service at The Juravinski Hospital and Cancer Centre, Hamilton Health Sciences, Ontario, Canada.

Ed has continued to represent Quality in the Clinical Laboratory and Cellular Therapy space and has presented at international scientific conferences and webinars related to Quality Operations, Cord Blood, and Cellular Therapy. He is a member of the FACT HPC Standards and Quality Management Committee, the Canadian Society for Medical Lab Science, and the Canadian Standards Association (CSA). He actively participates in the BMT and Cellular Therapy Laboratory National Standards. Ed continues to advocate for quality and loves to share his passion for continuous quality improvement to enable facilities to meet International Regulatory and Accreditation Standards.

Jackie has been in the transplant and cellular therapy field for twenty years. She joined the Sarah Cannon Transplant and Cellular Therapy Network in early 2022, where her primary responsibilities include ensuring compliance with accreditation and regulatory standards through standardizing policies, developing quality tool templates, establishing, and analyzing actionable quality metrics, facilitating mock inspections, and mentoring the quality managers at each of the Network programs. Jackie is a current member of the FACT Quality Management Committee and the FACT-JACIE International Standards for HCT Ninth Edition Quality Management Subcommittee.

Karen Collum is Director of Nursing Quality at Memorial Sloan Kettering Cancer Center. As the Director, Karen oversees a team of Quality Management Nurses and Data Analysts who support the 4000+ nursing staff in monitoring patient outcomes, patient experience, and staff satisfaction through the tracking and reporting (internally and externally) of over 50 metrics. Karen also provides quality oversight to the transplant and cellular therapy programs and manages the organizational FACT accreditation. Karen has been a nurse for 21 years, with 15 years working in quality. Before her role as Director, Karen was the Nurse Leader for Nursing Quality & Transplant Services. Karen is a Felician University graduate with a Doctor of Nursing Practice degree in Nursing Executive Leadership.

Dr. Nicole Prokopishyn is currently serving as the Cellular Therapy Lab Director at the Alberta Blood and Marrow Transplant Program: Foothills Medical Centre, Alberta Children’s Hospital, Tom Baker Cancer Centre, and Calgary Laboratory Services. In this role, she oversees the provision of services for adult and pediatric transplants and cellular therapy. Nicole obtained her PhD in Biochemistry from the University of Saskatchewan. After completing her studies, she spent 10 years working abroad, with 5 years in Houston and 5 years in Philadelphia. During her time in these locations, she focused on the development of gene editing technologies in blood stem cells for the treatment of sickle cell disease and hemophilia. Nicole returned to Canada and accepted the director role at the Alberta Blood and Marrow Transplant Program, combining her expertise in quality assurance with a passion for treating patients through transplant and cellular therapy. Throughout her career, she has written numerous articles and presented her research findings internationally in the field of Cellular Therapy. Currently, she serves as the Chair of FACT's Standards Development Committee. In this role, she contributes to the development and enhancement of quality standards in this specialized field. Dr. Prokopishyn's extensive experience, dedication to improving patient outcomes, and commitment to advancing knowledge in the field make her one of the leading authorities in Cellular Therapy. Dr. Prokopishyn has been a FACT Inspector since 2013.

Dr. Phyllis Warkentin is a founding member of the Foundation for the Accreditation of Cellular Therapy (FACT), a member of the FACT Board of Directors, and the FACT Chief Medical Officer. She is a Pathology, Microbiology, Immunology, and Pediatrics professor at the University of Nebraska Medical Center, Omaha, NE, and the Medical Director of the Nebraska Medicine Blood and Marrow Transplant Marrow Collection Program. She has authored over one hundred scientific publications in transfusion, transplantation, and cellular therapy. She is a graduate of the University of Minnesota Medical School, Minneapolis, MN, board certified in pediatric hematology/oncology and transfusion medicine.

Karen Moniz, MHA, MT(ASCP)SBB, is the Technical Director at ICCBBA. This international non-profit manages, develops, and licenses ISBT 128, the international information standard for terminology, coding, and labeling medical products of human origin (MPHO). She leads the ISBT 128 Standard's technical development to meet MPHO's global traceability needs. She studied medical technology at the University of Kentucky, immunohematology at Johns Hopkins Hospital, and healthcare administration at George Washington University. Karen spent decades managing blood donor centers, transfusion services, and biomedical information technology. An early advocate of the ISBT 128 Standard, she remains enthusiastic about the evolution of the ISBT 128 Standard to continue contributing to MPHO traceability, biovigilance, harmonization of terminology, and electronic data transfer.

Mary has over 25 years of experience in cellular therapy and transfusion service medicine. She earned her Bachelor of Science in Medical Technology from Rush University and her Bachelor of Arts in Liberal Arts from Monmouth College. Mary later completed the Specialist in Blood Banking program at Barnes Washington University. Mary started at Stanford Health Care in 1994 and has had various roles, starting as a Cell Therapy Technologist. Mary’s experience includes cellular therapy product collection, processing, cryopreservation, regulatory compliance, labeling, process improvement, audits, and quality management oversight. Mary is active with FACT, ISCT, and AABB organizations.

Nancy Hegdahl is currently a Quality Manager at NMDP. Nancy and her team focus on Quality Systems that support Operational functions. She has held a range of roles in Quality Assurance and Quality Control throughout her career. She has held Quality management roles in regulated industries for the last ten years, overseeing quality systems governed by EPA or FDA regulations in GMP, GLP, and GTP. 

William leads Autolus’ Patient and Cell Management Team with a dual remit of Patient Scheduling and “Apheresis and Infusion Operations.” He has worked in cancer immunotherapy drug development for the past 20 years and, immediately before joining Autolus, led the technical onboarding of UK hospitals for Novartis’ Kymriah launch program.  Previously, he led the global clinical supply chain at Immunocore Limited (a T cell receptor-focused biotech) and held various clinical and drug development positions. Before this, William was the Principal Scientist in the clinical immunology group at Oxford BioMedica, focusing on their therapeutic cancer vaccine program.  In June 2018, William obtained an MBA with distinction from the University of Oxford, Säid Business School. He had previously gained his PhD studying apoptosis, cancer, and immunology at the University of Nottingham and the University of Edinburgh. He also holds a BSc in Biochemistry and Genetics from the University of Nottingham.

Dr. Nicole Aqui is an Associate Professor of Clinical Pathology and Laboratory Medicine at the University of Pennsylvania. She is also the attending Pathologist, Section Chief, and Apheresis Services for the division of Transfusion Medicine, Department of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania. Dr. Aqui is also the Director of the Clinical Service Center, Department of Pathology and Laboratory Medicine. Dr. Aqui is an Ambulatory EMR Operations Committee member, Residency Program Director, and Vice Chair of the Inclusion, Diversity, and Equity Committee. She completed her undergraduate degree in Cellular And Molecular Biology at the University Of Maryland College Park and her medical degree at the University of Pennsylvania School of Medicine.  She is an expert in transfusion medicine, apheresis, blood banking, hematopoietic stem cell and immune effector cell collection/processing, and sickle cell disease. Dr. Aqui has numerous publications and research.

HOST

Tracy is responsible for assessing, analyzing, and recommending quality and clinical performance improvement processes. She collaborates with clinical service groups to provide division guidance to ensure the cancer service line is in compliance with regulatory and accreditation bodies. Dodd is a senior consultant for the Foundation for the Accreditation of Cellular Therapy (FACT) Consulting Services, a FACT Quality Inspection Auditor. Tracy previously served as the Quality Improvement Director for the Sarah Cannon Transplant and Cellular Therapy Network and, before that, as the Quality Improvement Committee Chair for the Medical College of Wisconsin BMT Program and as the Blood and Marrow Transplant Manager at Children’s Hospital of Wisconsin. Tracy has over 35 years of healthcare quality and accreditation/regulatory compliance experience, 25 years specific to adult and pediatric BMT Programs, and 25 years of transplant and cellular therapy management experience. She earned her diploma in nursing at Columbia Hospital School of Nursing and her MBA at the Keller Graduate School of Management.