Carlos R. Bachier, MD, is a board-certified Hematologist/Oncologist with the Sarah Cannon Transplant & Cellular Therapy Program at Methodist Hospital in San Antonio, Texas. He is also the Medical Director of Research and Cellular Therapy. While growing up, Dr. Bachier spent summers working at the clinic of his uncle, a pediatric endocrinologist. It was there he became interested in the field of medicine, as it combined his love of science with "detective work," or finding out what is wrong with someone.

After completing a Bachelor of Science in Chemistry from Tulane University in New Orleans, LA, Dr. Bachier received his medical degree at the University of Puerto Rico School of Medicine in San Juan, Puerto Rico. While in Puerto Rico, one of his mentors showed him how fascinating oncology treatment was. Dr. Bachier found oncology interesting because of the science of it, and it was the beginning of DNA abnormalities being discovered that would help determine future therapies.

After completing both his Residency in Internal Medicine and Fellowship in Hematology in San Juan, he came to the University of Texas Health Science Center in San Antonio for a Fellowship in Hematology and Medical Oncology. He worked at the MD Anderson Cancer Center after completing his fellowship. In the late 1990s, he returned to San Antonio and worked at the Texas Transplant Institute, where he eventually became program director. Dr. Bachier was then recruited to the Sarah Cannon Center for Blood Cancer as program director and as Director of Cellular Therapy Research at Sarah Cannon Research Institute. After six years as the Program Director at the Sarah Cannon Center for Blood Cancer in Nashville, Tennessee, he returned to Methodist Hospital in San Antonio.

He is a member of numerous professional associations, including the American Society of Hematology, the American Society of Clinical Oncology, and the American Society for Blood and Marrow Transplantation. He is also a member of the Sarah Cannon Blood Cancer Network, leading its Cellular Therapy Working Group.

Lisa Cantwell is a certified Professional in Healthcare Quality (CPHQ). Twenty years of healthcare service management experience, including employee supervision, financial management, project management, budgeting, marketing, policy development, program development, quality assurance, and regulatory compliance. Lisa is the Senior Director of Authorized Treatment Center Operations at Iovance Biotherapeutics, Inc.

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.

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.

Topic: Overview of the FACT Accreditation Process

Dr. Phyllis I. Warkentin is a founding member of FACT and has been serving as a board member and chief medical officer since the organization’s inception. In addition to her work with FACT, Dr. Warkentin has been the director of the unrelated bone marrow transplantation program at the University of Nebraska Medical Center since 1988 and a professor of pediatrics and pathology/microbiology at the University of Nebraska Medical Center since 1994. She attended medical school at the University of Minnesota, where she subsequently completed a residency in pediatrics and fellowships in pediatric hematology/oncology and blood banking.

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.

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Harminder Kaur-Singh is an accomplished professional with over 15 years of experience in regulatory compliance and quality improvement in the field of cell therapy. Harminder is a certified LEAN Green Belt and CPHQ, with extensive experience leading regulatory compliance and improvement efforts as both an employee and a consultant. As Quality Advisor for the Stem Cell transplant program at CHU Sainte-Justine in Montréal, Quebec, she works with all cell therapy sectors to ensure regulatory compliance and quality improvement efforts. Harminder serves as the Director-at-Large for Quality for the CTTC (Cell Therapy Transplant Canada) and co-chairs the Quality & Regulatory Committee for the CTTC.  Harminder is also a member of the ASTCT Quality Committee as well as being a member of the FACT Education Committee.

Susie Joron serves as the Operations Manager at Hema-Quebec in Montreal, QC, where she has significantly contributed since 2013, particularly in developing stem cell donor and cord blood services. She holds a BSc in Microbiology and is pursuing an Executive MBA from Laval University in Quebec City, QC. Her areas of expertise include process development, strategic planning, quality & regulations, and operational efficiency.

With over 15 years of experience in cellular therapy, Susie has also held key roles in stem cell transplant programs across Canada. Her responsibilities have encompassed the management of activities such as stem cell donor selection, recruitment, eligibility, and collection, as well as the importation of stem cell products. She has established international partnerships with the World Marrow Donor Association (WMDA) and its members. Recently, she became an inspector for the Foundation for the Accreditation of Cellular Therapy (FACT). Additionally, Susie is an active Swab The World Foundation board member.