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.

TOPIC: Key to Compliance Application Success (w/Activity: Evaluating Compliance)

Topic: What to Expect During an Inspection

Vicki is the Laboratory Director of the Blood Transplant and Cell Therapies Laboratory at Westmead Hospital, which is the largest laboratory in Sydney, preparing more than 380 products each year for infusions and performing over 1000 laboratory procedures for adult and pediatric patients undergoing transplantation and cell therapies to four Sydney BMT Hospitals. The laboratory also performs complex and specialized procedures involving extensive manipulation. The laboratory also receives and releases Immune Effector Cells, including CAR T cells. Vicki is also involved and responsible for all the administrative and scientific aspects of cellular cell processing and manipulation for HPCs and IEC, including compliance with national and international standards. She has been in this role for over 30 years at Westmead Hospital and has developed strong collaborations with national and international colleagues. Her interests have always been improving, teaching, and advancing all cell processing procedures for blood transplantation and cellular therapy. Her input and commitment to FACT and ISCT continue to grow. Vicki has been an active FACT inspector for cell processing laboratories for more than 12 years. 

Topic: Correction of Deficiencies

Jessica Sue is the Quality Manager at the Sydney Cord Blood Bank, a FACT-accredited and TGA-licensed public cord blood bank. Jessica has gained industry knowledge in the regulatory requirements of cellular therapy organizations through her involvement in the FACT Quality Management Committee and ISCT ANZ Legal and Regulatory Affairs Committee, as a trainee FACT Inspector, and at various FACT Accreditation and Training Workshops. Jessica is also a founding co-chair of the ISCT ANZ Early Stage Professional (ESP) Subcommittee and holds a position with the global ESP Committee.   

Topic: Program Perspectives - Achieving Outcomes

For 30 years, Cheryl has been the Laboratory Director of the Cellular Therapy Laboratory, Cancer Care Services at the Royal Brisbane & Women’s Hospital, the first haemopoietic progenitor cell transplant program accredited by FACT in Australia. The Cellular Therapy Laboratory is a large processing facility for the haemopoietic progenitor cell transplant and immune effector cell programs at the Royal Brisbane & Women’s Hospital and Queensland Children’s Hospital. As part of the HPCT program, the laboratory performs complex processing procedures such as CD34+ cell selection, TCRαβ depletion, or CD45RA depletion. As part of the CAR-T cell program, the laboratory has developed point-of-care production of CAR-T cells to provide treatment options for patients ineligible for government-funded commercial CAR-T cell therapies. 

Topic: Maintaining FACT Readiness