Navigating Clinical Trials - Quality Agreement Essentials for Cell Processing Facilities (24EL-416)

Please note: AABB reserves the right to make updates to this program.

Live Program Date: Wednesday, March 20, 2024 - On-Demand Available

Program Number: 24EL-416

  • Educational Track: Quality Education
  • Topic: Biotherapies
  • Intended Audience: CEOs, CFOs, Directors, Donor Recruitment Staff, Hospital Blood Banks, Hospitals, Laboratory Staff, Managers/Supervisors, Medical Directors, Nurses, Physicians, Research Scientists, Residents/Fellows, Scientists, Students (MD, MT, SBB), Technologists, Transfusion Safety Officers
  • Teaching Level: Advanced, Intermediate
  • Director/Moderator: Wanxing Cui, MD, PhD, CABP(H), Director, Cell Therapy Manufacturing Facility, MedStar Georgetown University Hospital, Washington, DC

    • Aisha Khan, PhD, Executive Director, Laboratory Operations, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL
    • Ronit Slotky, PhD, MSc, CABP, Director, Cell Therapies Manufacturing Facility, Hackensack University Medical Center; Professor of Oncology, Hackensack Meridian School of Medicine, Hackensack, NJ
    • Suzanne Thibodeaux, MD, PhD, CABP(H), Section Head, Blood Bank/Apheresis/CTL/HLA, Washington University School of Medicine St. Louis, St. Louis, MO
  • Program Description

    The rapidly evolving field of cell therapy has positioned clinical trials as the critical conduit to groundbreaking treatments, transforming the future of patient care. Within this intricate framework, quality agreements emerge as the cornerstone, ensuring that every facet of these trials adheres to the highest standards of safety, efficacy, and compliance. These agreements not only set the benchmarks but also act as the guiding compass, ensuring that all stakeholders, from researchers to cell processing facilities, navigate the clinical trial landscape with precision and expertise.

    This eCast delves into the heart of clinical trials, shedding light on the pivotal role of quality agreements. Through discussions, demonstrations, and case studies, attendees will gain insights into the structure and significance of these agreements. The program will explore how quality agreements influence the course of clinical trials and provide cell processing facilities with the tools and knowledge to stay at the forefront of best practices. By emphasizing the importance of these agreements in the broader context of cell therapy clinical trials, this program aims to equip attendees with a nuanced understanding, preparing them for the challenges and opportunities that lie ahead.

    Learning Objectives

    After participating in this educational activity, participants should be able to:

    • Describe the essence of quality agreements in clinical trials.
    • Discuss the components of quality agreements for clinical trials.
    • Optimize clinical trial navigation with quality agreements.
    • Enhance communication and collaboration through quality agreements.
    • Address clinical trial challenges using quality agreement frameworks.


    Please note: if you registered for the live eCast you do not need to register for the on-demand eCast (access to the on-demad eCast was included with the live eCast registration).

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    Continuing Education Credit

    This activity is eligible for one (1) continuing education credit/contact hour for Nurses (including California-based nursing professionals through CBRN), California Lab Personnel, Florida Lab Personnel and General Participation credit. AABB reserves the right to reduce or increase the number of credits granted based on the final activity duration. For more information on each credit type please visit our Continuing Education Credits webpage. Please note: This program is not eligible for continuing medical education credit for physicians.

    There is no financial support for this activity.

    Claiming Credit
    Live Activity - Upon completion of the live activity, you will receive instructions to complete your evaluation, which is necessary to claim credit and receive your certificate of attendance/completion (credit must be claimed by the date provided in the instructions). The evaluation can be found by logging into the AABB Education Platform.

    Enduring Activity - Once the enduring (on-demand) program is available, you will receive instructions to access the AABB Education Platform. Upon completion of viewing the enduring activity, you will need to complete the evaluation, which is necessary to claim credit and receive your certificate of completion (credit must be claimed by the date provided in the AABB Education Platform).

    Program & Credit Expiration Dates:

    • Live Activity Program Date: March 20, 2024; Credit Expiration Date: April 20, 2024
    • Enduring Activity Program Dates: March 20, 2024 – March 19, 2027; Credit Expiration Date: March 19, 2027

    Disclosure Declaration

    Disclosures for the planners of this event can be found here. Disclosures for the program faculty and peer reviewers are provided at the beginning of the program.

    Faculty Biographies

    Wanxing Cui, MD, PhD, CABP(H) is the director of the Cell Therapy Manufacturing Facility at Medstar Georgetown University Hospital. Dr. Cui received medical training in Shenyang, China, and practiced general surgery as a resident surgeon for three years. He earned his PhD degree at Kyoto University, Japan, in 2001 with research on bioartificial pancreas development. Since then, Dr. Cui has been working on pancreatic islet transplantation at Emory University, the University of Alabama at Birmingham, and Georgetown University for more than twenty years. His research covers a wide spectrum from basic studies with rodent islets and preclinical studies with non-human primate islets to clinical trials with human islets, using a multidisciplinary translational approach. Dr. Cui has published 58 scientific papers and possesses five islet and bioengineering-related patents currently. Dr. Cui has been a standing International Pancreas and Islet Transplant Association (IPITA) member for more than 20 years. At present, Dr. Cui is an active committee member of the Association for the Advancement of Blood & Biotherapies (AABB) cellular therapies section.

    Aisha Khan, PhD serves as the Executive Director of Laboratory Operations at the University of Miami’s Interdisciplinary Stem Cell Institute in Miami, Florida. Dr. Khan has over twenty years of professional experience in developing cellular therapy products, expertise in mesenchymal stem cell, cardiac progenitor stem cell development, and manufacturing of various types of cells and vaccines. Manage all aspects of cutting-edge medical research labs that are focused on developing various types of stem cells and manufacturing a wide variety of cellular products. Serve as a subject matter expert and consultant for many U.S. and international organizations in the arena of cell processing, development, and manufacturing. Possess extensive experience in developing standard operating procedures to establish top quality laboratory operations in order to maintain quality assurance and compliance with all regulatory requirements of FDA, FACT, CLIA, AABB and other organizations. Fifteen years of hands-on experience in setting-up and managing GMP labs at world-class research facilities in the United States and abroad.

    Ronit Slotky, PhD, MSc, CABP is a professor of oncology at Hackensack Median Health School of Medicine and the Director of the Cell Therapies Manufacturing Facility at the Hackensack University Medical Center. She earned her PhD at the Technion, Israel Institute of Technology in Israel, and completed her post doctorate at Columbia University Medical Center studying proteins’ structure and function, as well her MSc in Biostatistics at Columbia University Mailman School of Public Health in New York. Dr. Slotky has been working in the cellular therapy field for over 15 years and has published numerous scientific articles in the field of cell processing. She is the chair of the AABB Cellular Therapy Section Coordinating Committee and a member of the FACT Quality Management Standards Committee. Her current work and research efforts focus on improving cell processing methods and patients’ outcomes and providing education opportunities for clinicians and researchers.

    Suzanne Thibodeaux, MD, PhD, CABP(H) is an associate professor of pathology and immunology and Co-Section Head of Transfusion Medicine/Blood Bank/HLA at Washington University School of Medicine. She serves as medical and laboratory director of the Cellular Therapy Laboratory, medical director of apheresis, and associate medical director of transfusion and blood banking medicine at Barnes-Jewish Hospital in Saint Louis. She also serves as the Program Director for Blood Banking and Transfusion Medicine Fellowship. Thibodeaux received a bachelor of science degree in cellular and molecular biology from Tulane University. She then earned her doctor of philosophy degree and doctor of medicine degree from the University of Texas Health Science Center in San Antonio. Thibodeaux completed residency in clinical pathology in 2016, during which time she served as chief resident, followed by a fellowship in blood banking and transfusion medicine, both at the Hospital of the University of Pennsylvania. After completing training, Thibodeaux joined the faculty in the Department of Pathology and Immunology at Washington University School of Medicine in St. Louis. Thibodeaux is actively involved in multidisciplinary and collaborative approaches to patient care, education, and clinical and translational research as it relates to cellular therapy and transfusion medicine, demonstrated by her multiple publications, presentations and scholarly pursuits in these areas. Thibodeaux has been an active member of AABB since joining as a trainee. She served on the Cellular Therapy Education Committee and contributed to AABB’s Flow Cytometry Educational Module and the Certified Advanced Biotherapies Professional (CABP) examination. She has contributed to the 10th edition of the AABB Standards for Cellular Therapies and is currently contributing to the 11th edition. As an elected member of the Cellular Therapy Section Coordinating Committee, she helps to lead the Quality, Regulatory and Management (QRM) subsection. She aligns her efforts in AABB and other organizations with her personal and professional goals of helping to advance cellular therapies, transfusion medicine and education, particularly where clinical, research and regulatory aspects of the field meets.