Overview

The webinar highlights five perspectives on the ISBT 128 Split-Label. Each presenter delivers a 10-minute presentation and a collective round table discussion. The session ends with a dedicated period during which presenters respond to questions from the audience. 

Speaker(s)

Phyllis I. Warkentin, MD (Moderator)

Chief Medical Officer

FACT

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.

No Disclosures

Karen Moniz, MHA, MT(ASCB)SBB

Technical Director

ICCBBA

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.

Nothing to disclose.

Mary Grable McLeod, MLS(ASCP)cm SBBcm, SSGB (ASQ), CABP(H)

Quality Manager – Blood and Marrow Transplant Cellular Therapy Facility

Stanford Health Care

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.

 

Nothing to disclose.

Nancy Hegdahl

Quality Manager-Operations Support

Be The Match BioTherapies

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. 

Nothing to disclose.

William Shingler, PhD MBA

Senior Director, Patient and Cell Management

Autolus Limited

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.

Nothing to disclose.

  • Register
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    • Committee Member - $100
    • Consultant - Free!
    • FACT Staff - Free!
    • Inspector - Free!
    • Inspector Trainee - Free!
    • Non-member - $100
    • Industry Representative - $200
    • Fellow - $50

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2024 GEN Webinar: ISBT-128 Hybrid (Split) Label Registration
The webinar will highlight five perspectives on the ISBT 128 Split-Label. Each presenter will deliver a 10-minute presentation and a collective roundtable discussion. The session will end with a dedicated period during which presenters will respond to questions from the audience. You must register to access.
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