FACT Cellular Therapy Processing Inspector Training

Facilitators

   
Suzanne Birnley, MS, MBA
Manager of Accreditation Services

Foundation for the Accreditation of Cellular Therapy

Suzanne is passionate about immunology and her research thesis focused on T-cell homeostasis and interleukin-2. She managed an academic research lab for a decade prior to joining the FACT team in Accreditation Services as a Coordinator, and now as the Accreditation Services Manager. She is the former FACT Staff Liaison for the Cellular Therapy Accreditation Committee, and participated as a staff member in the Seventh Edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration. Suzanne is in the process of developing a training program for new FACT Coordinators.

   
Phyllis I. Warkentin, MD
FACT Chief Medical Officer

University of Nebraska Medical Center

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 Professor of Pathology/Microbiology and Pediatrics at the University of Nebraska Medical Center, Omaha, NE, and the Medical Director of the Nebraska Medicine Biologics Production Facility. She 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.

Paul Eldridge, PhD
Research Professor/Laboratory Director
Levine Cancer Institute Transplant and Cellular Therapy Program

Dr. Eldridge is past chair of the Standards Committee and former member of the FACT Board of Directors. He serves as Co-chair of the Common Standards Committee and on the Accreditation Committee. He is FACT representative to the WBMT.

Dr. Eldridge serves as a FACT Inspector for Processing: Minimal manipulation of HPC, and Processing: More than minimal manipulation of any cell type.

Alex Babic, MD, PhD
Director of Cellular Therapy Laboratory and Collections
Saint Louis University Blood and Marrow Transplant Program

Dr. Alex Babic is an Associate Professor of Internal Medicine at St Louis University Medical School. He is the Director of the Cellular Therapy Laboratory and Collections at St Louis University Medical Center. From 2013 until 2018 he was also the Medical Director of St Louis Cord Blood Bank. Since 2016, he has served as FACT Inspector and since 2019, as a member of FACT Education Committee. In 2020, he became a member of FACT Accreditation Committee. His focus is on evaluation and optimization of outcomes of cell collection and processing.

Nicole Prokopishyn, PhD
Cellular Therapy Lab Director
Alberta Blood and Marrow Transplant Program

Dr. Nicole Prokopishyn received her PhD in Biochemistry and Cell Biology from the University of Saskatchewan with a specific interest in the spread of colon cancer cells, and then moved to the USA working first in Houston, TX and then Philadelphia, PA to work in the fields of gene repair/editing and blood stem cell gene therapy. In 2007, Nic returned to Canada to take up the position as processing facilities director (Cellular Therapy Lab (CTL) at Alberta Precision Labs) for the Alberta Cellular Therapy and Transplant Program. In CTL, focused on providing innovative, novel cellular therapy products for clinical use in our transplant patients. Including, participation in the first blood stem cell gene therapy clinical trial in Canada which treated patients with Fabry’s disease, generating the first alphabeta depleted T cell transplant product for clinical use in Canada, and generation of Alberta made CAR-T cells for a clinical trial to treat lymphoma and leukemia. Dr. Nic holds appointments as clinical assistant professor in the Department of Hematology and the Department of Pathology/Laboratory Medicine. Dr. Nic is the Standards Chair for the Foundation of Accreditation of Cellular Therapy (FACT) and the Director at Large for Regulatory & Quality for Cell Therapy and Transplant Canada (CTTC).

   
Wanxing Cui, MD, PhD
Director of Cell Therapy Manufacturing Facility

Medstar Georgetown University Hospital Cell Therapy Manufacturing Facility

Dr. Wanxing Cui is the director of the Cell Therapy Manufacturing Facility at MedStar Georgetown University Hospital. He received medical training in surgery and completed postdoctoral training in islet cell transplantation. Dr. Cui has exceptional experience in the cell therapy field from bench to bedside, including cGMP cell product manufacturing. Dr. Cui is an editorial board member for the Journal Cytotherapy under the International Society for Cell and Gene Therapy (ISCT) and a FACT Board of Directors member as an ISCT representative. Dr. Cui has been a FACT cell therapy processing inspector for both minimal and more minimal manipulation for four years.