CO-HOST

Amy Beres, PhD CABP, obtained her bachelor’s in biochemistry from the University of Wisconsin. She earned a PhD from the Medical College of Wisconsin and completed a postdoctoral fellowship at St. Jude’s Children’s Research Hospital. After more than a decade of bench research in cellular therapy, Dr. Beres transitioned to industry, where she gained experience in FDA regulations and cGMP manufacturing. She later transitioned to healthcare and served as director of regenerative medicine at Advocate Aurora Health, where she has overseen the Cell Processing Laboratory since 2016.

CO-HOST

Dr. Suzanne Thibodeaux is an Assistant Professor for the Division of Laboratory and Genomic Medicine, Department of Pathology and Immunology at Washington University St. Louis School of Medicine in St. Louis, MO. Dr. Thibodeaux completed her undergraduate and medical degrees at Tulane University in New Orleans, LA. She completed her Ph.D. and residency at the University of Texas Health Science Center in San Antonio, TX. Dr. Thibodeaux completed her fellowship with the Division of Transfusion Medicine and Therapeutic Pathology, Department of Pathology and Laboratory Medicine at the Hospital of the University of Pennsylvania, Philadelphia, PA. She is certified by the American Board of Pathology in Clinical Pathology, Blood Banking, and Transfusion Medicine. She also currently serves as the Assistant Medical Director for Transfusion Services, Laboratory Medical Director (Cellular Therapy Lab), Blood Bank Director, Laboratory Medical Director (Creve Cour), and Medical Director (Celluar Therapy Lab) at Barnes-Jewish Hospital, as well as Laboratory Director at CareSTL Health, all located in St. Louis, MO. Dr. Thibodeaux is also a course director, rotation supervisor, content expert, and thread leader for Washington University St. Louis School of Medicine, St. Louis, MO.

Ibrahim A. Ahmed, MD, DSc, is an accomplished physician and researcher specializing in pediatric hematology/oncology and bone marrow transplantation. He is the Director of Quality and Accreditation at Children's Mercy in Kansas City. Dr. Ahmed obtained his medical degree from the University of Cairo School of Medicine in Cairo, Egypt. Following graduation, he pursued his residency in pediatrics at Wayne State University School of Medicine/Children's Hospital of Michigan in Detroit, MI. He then completed pediatric bone marrow transplantation fellowships at Baylor University College of Medicine/Texas Children's Hospital in Houston, TX, and pediatric hematology/oncology at Wayne State University School of Medicine/Children's Hospital of Michigan in Detroit, MI. Dr. Ahmed serves as a member of the FACT Education Committee.

J. Wade Atkins is an MLS (ASCP) with a Specialty in Blood Banking, is credentialed as a Certified Advanced Biotherapies Professional, a certified Quality Auditor through the American Society for Quality, and holds a Master of Science in Health Care Administration. For 22 years, he has been associated with quality assurance and regulatory affairs for the Department of Transfusion Medicine (DTM) in the Clinical Center for the National Institutes of Health in Bethesda, Maryland. He is currently supervising a staff of 9 quality associates. He is responsible for ensuring compliance with standards and regulations for manufacturing high-quality products. He often speaks at local, national, and international meetings on quality and regulatory topics for blood and biological drug products.

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.

Priscilla Dasilva is the Senior Manager of TCT Regulatory/Quality Management at the City of Hope Hematopoietic Cell Transplantation Program. She has 16 years of experience in cellular therapy quality management and regulatory compliance in adult and pediatric transplant and cellular therapy clinical programs, marrow collection, apheresis collection, and processing facilities. Her experience extends into cellular therapy data management and blood product manufacturing. Currently, Priscilla DaSilva is the Senior Manager of the Transplant and Cellular Therapy Regulatory and Quality Management program at City of Hope in California. She is also a member of the Foundation for the Accreditation of Cellular Therapy (FACT) Quality Management Committee.

Shadya George is the program quality manager over UofL Health Brown Cancer Center’s Blood Cancers, Cellular Therapeutics and Transplant Program (BCT) at the University of Louisville in Kentucky, where she provides quality oversight to apheresis, processing, and clinical departments for adult and pediatrics. She promotes FACT accreditation and regulatory compliance, including providing education, corrective action and process improvement, quality indicator development and trends, data analysis, process validation and qualification, and development of structures to promote integration and achievement of program goals. She has previously participated in the startup of the University of Louisville GMP facility, providing quality management and manufacturing development and translation for regenerative cell therapy phase I clinical trials to include MSCs, cardiac stem cells, and autologous Islets. She is a licensed Medical Technology Supervisor in the State of TN. She completed her master's degree in quality assurance in healthcare and manufacturing in 2018 and is a volunteer FACT processing inspector. She has over 20 years of experience in clinical laboratory and quality, serving 15 years dedicated to cell therapy and transplant.

Debe has 30 years of experience in cellular therapy and laboratory science, including minimally and more-than-minimally manipulated products. Deborah has been a FACT inspector for over a decade and has performed almost 20 external inspections. In addition, she was responsible for the FACT inspections of three independently accredited facilities at UPMC, the adult hematopoietic stem cell lab, the pediatric hematopoietic stem cell lab, and a dendritic cell vaccine production facility, and successfully led them through 10 inspections. She is an active member of the FACT Quality Committee in FACT. Deborah was formerly the Chair of the ISCT North America Legal and Regulatory Committee and Editor of the Telegraft. She was formerly the Director of Quality Management for Cell Therapies of the Cell Therapies Facility at Moffitt Cancer Center in Tampa, FL, USA.

Dr. Koepsell is a Pathology, Microbiology, and Immunology Professor at the University of Nebraska Medical Center. He is the medical director for the Biologic Production Facility and Apheresis Services at Nebraska Medicine.

Dr. Nadim Mahmud is a Professor in the Department of Medicine in the Division of Hematology and Oncology at the University of Illinois College of Medicine, Chicago. He is also the Clinical Stem Cell Laboratory Director for UI Hospital Blood & Marrow Transplant Program. He has more than 22 years of experience in hematopoietic stem cell biology and stem cell transplantation. He also has extensive experience in studies of hematopoietic stem cell biology and blood cell regeneration, both in human and animal models, which includes bone marrow failure following myeloablative radiation or chemotherapy. Dr. Mahmud has a broad background in medicine, stem cell biology, and transplantation and is currently serving as PI or co-investigator on several university and NIH-funded grants. His clinical laboratory is responsible for processing, storing, and releasing stem cell grafts for administration to patients undergoing bone marrow transplantation or other cell-based therapy. Dr. Mahmud’s laboratory has pioneered a novel way to augment the number of transplantable blood-forming stem cells present in an umbilical cord blood graft by using chromatin-modifying agents and has been awarded a US patent for this work. Dr. Mahmud’s research lab has the expertise in developing leukemia patient-derived xenografts (PDX) to test the in vivo function of efficacy of isoform-selective HDAC inhibitors in leukemia. Dr. Mahmud also serves as the principal investigator for the UIC Hembank, a repository of banked hematologic malignancy samples with detailed clinical and molecular annotation. Dr. Mahmud serves on the FACT (accreditation body) Board of Directors and the FACT Global Affairs Committee chair. He is also a FACT Executive Committee member and serves on the editorial board of the premier cell therapy journal Cytotherapy.

As Quality Assurance Manager, Heather works with the Hemapheresis Unit, Stem Cell Lab, and Adult and Pediatric Clinical Transplant Program. Since 2015, she has collaborated with all areas to ensure regulatory compliance is incorporated into all aspects of the program. Most recently, she has served as operational lead, implementing all FDA-approved CAR-T therapies within the Hematologic Malignancy/Stem Cell Transplant (HM/SCT) Program. Throughout her career, Heather has worked within the bone marrow transplant field. She began as a donor coordinator for 4 years at BeTheMatch, guiding unrelated donors through donation. In 2010, she joined UCLA as a CIBMTR Coordinator. While reviewing and reporting patient status to the CIBMTR registry, she learned critical elements fundamental to the success of the HM/SCT program. Heather transitioned her donor and patient experience into the QA Manager role, providing a cohesive understanding of the entire program.