FACT Cellular Therapy Accreditation Workshop, Tandem 2024

FACT Accreditation Workshop Presenters

Nicole Aqui

Joseph Schwartz, MD, MPH (HOST)
Director of Transfusion Services at H. Lee Moffitt Cancer Center & Research Institute Blood and Marrow Transplant Program

Dr. Joseph Schwartz is the Director of Transfusion Medicine Services at the Moffitt Cancer Center in Tampa, FL. Dr. Schwartz is the Chair of the FACT Technology Committee and Co-Chair of the FACT Cellular Therapy Accreditation & Cord Blood Bank Accreditation Committees. In addition, he is a member of the FACT Standards Steering, and Education committees. In The past, he had served on the FACT Board of Directors. Dr. Schwartz has participated as an Apheresis and Marrow Collection, Cord Blood Banking, and Cord Blood Collection Inspector since 2006.

Suzanne Birnley

Kimberly Kasow, DO
Director of Pediatric Bone Marrow Transplant at University of North Carolina

Dr. Kim Kasow is the Director of Pediatric Bone Marrow Transplant at UNC with a primary clinical research interest in providing hematopoietic cell transplantation to patients with sickle cell disease. She is the Associate Director of Quality Initiatives for the UNC BMTCTP adult and pediatric program and the Associate Director of Quality for the UNC Advanced Cellular Therapeutics Facility.

She is a current member of the FACT Board of Directors, serving as the Treasurer, the Chair of the FACT Finance and Quality Management Committees, and Vice-chair of the FACT Technology Committee. Dr. Kasow is also a member of the Cellular Therapy Accreditation Committee. Dr. Kasow has served as a Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy, and Marrow Collection FACT inspector since 2006.

Charles Branson

Michele Sugrue, MS, MT(ASCP)SBB
FACT Inspectorate

Michele Sugrue was most recently the Coordinator of Research Programs and Services, Division of Hematology/Oncology at the University of Florida – UFHealth, following a career in cellular therapy product collection and processing.  She participated in various investigative projects, provided regulatory guidance, and collaborated with professionals in the Bone Marrow/Stem Cell Transplant Program. She now enjoys a simpler life in retirement.  

She continues to serve on several committees including as Co-Chair of the FACT-JACIE HCT Cellular Therapy Collections Subcommittee, member of the FACT-JACIE HCT Steering Committee, FACT Education Committee, and the FACT Inspector Development Committee. She has presented at numerous cellular therapy related audioconferences and workshops, and published guidance documents, book chapters, and peer-reviewed manuscripts. Since 1998, Michele has continued participating as a FACT Apheresis Collection and Processing Inspector.

Paul Eldridge

Nic Prokopishyn, PhD
Cellular Therapy Lab Director for the Alberta Blood and Marrow Transplant Program

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.

Liz Ferraro

Patrick Hanley, PhD
Chief & Director of the Cellular Therapy Program at Children’s National

Patrick Hanley, Ph.D., serves as the chief and director of the Cellular Therapy Program at Children's National, holding the position of associate professor of pediatrics at the Children’s National Research Institute. Additionally, he is a member of the Center for Cancer and Blood Disorders and the Division of Blood and Marrow Transplantation. In his role, Dr. Hanley collaborates with investigators to discover, optimize, and manufacture novel cell and gene therapies, emphasizing safety and efficacy through post-infusion immune system evaluations. With a focus on improving existing cellular therapies, he has overseen the production of over 300 cellular therapy products.

Dr. Hanley's leadership extends to roles such as vice president-elect of North America and co-chair of the immuno-gene therapy committee at the International Society for Cell and Gene Therapy (ISCT), Commissioning Editor of the journal Cytotherapy, and a member of the Board of Directors of the Foundation for the Accreditation of Cellular Therapy (FACT), solidifying his position as a distinguished immunotherapist, immunologist, and expert in Good Manufacturing Practice (GMP) regulations for cell and gene therapies.

Sara Murray

Phyllis I. Warkentin, MD
FACT Chief Medical Officer

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 serves as Chair of Cellular Therapy and Cord Blood Accreditation Committees and FACT-CIBMTR Data Audit Committee, and is a member of numerous other FACT committees.

Dr. Warkentin has authored over one hundred scientific publications in the field of transfusion, transplantation, and cellular therapy. She is a graduate of the University of Minnesota Medical School, Minneapolis, MN, and is Board certified in Pediatric Hematology/Oncology and Transfusion Medicine.

Joseph Schwartz, MD, MPH

Premal Lulla MD, MBBS
Assistant Professor of Medicine at Baylor College of Medicine, Stem Cell Transplant Program, Texas Children's Hospital and Houston Methodist Hospital

Dr. Premal Lulla is a transplant and cell therapy physician-scientist at the Center for Cell and Gene Therapy at Baylor College of Medicine. His translational research centers on improving outcomes for cancer patients with immune-based cellular therapies such as novel CAR-T cells, virus, or tumor-specific T cells. Additionally, he is committed to ensuring high-quality care for cell therapy recipients and thus serves as an inspector for FACT as well as a member of their Educational and Clinical Outcomes Committees.

Joan Sevcik

Suzanne Birnley MS, MBA
FACT Director of Operations

Suzanne is passionate about immunology and her research thesis focused on T-cell homeostatis and interleukin-2. She managed an academic research lab for a decade prior to joining the FACT team in Accreditation Services as a Coordinator, then served as the Accreditation Services Manager, and most recently join the executive team as the Director of Operations. She has served as the staff liasion for multiple FACT standing committees and also participated in multiple editions of Standards review.