Significant Changes to the 13th Edition of Standards for Cellular Therapy Services (27EL-734)

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

• Topics: Accreditation, Adipose Tissues, Administration, Apheresis, Biotherapies, CLIA, Collection, Computers, Cord Blood, Donation, Donor Consent, Donor Eligibility, Donor Screening, FDA, Inventory, Marrow, Modifications, Operations, Outcomes/Engagement, Personnel, Processing, Quality, Quality Systems, Regulatory & Compliance, Release/Distribution, Standards, Storage, Transportation, Testing, Therapeutic Goals
• Intended Audience: Laboratory Professionals, Physicians, Research Scientists
• Teaching Level: Basic, Intermediate

• Director/Moderator: Christopher Bocquet, Senior Director, Standards Development and Quality Initiatives, AABB, Bethesda, MD
  Speakers:

  • Yvette Tanhehco, PhD, MD, MS, CABP, Associate Professor, Pathology and Cell Biology, Medical Director, Cellular Therapy Laboratory, Assistant Medical Director, Transfusion Medicine, Columbia University Irving Medical Center, New York Presbyterian Hospital, New York, NY
  • Kate Brown, PhD, Senior Director, Science, CooperSurgical, Tucson, AZ

• Program Description

  This program will introduce AABB's 13th Edition of Standards for Biotherapy Services. The speakers will summarize the new and revised requirements incorporated into the 13th Edition. In addition, the rationale for the changes will be reviewed and discussed.

  Learning Objectives

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

  • Explain the rationale for revised requirements.
  • Identify existing policies, processes and procedures that may need to be changed in order to conform to the 13th Edition of Standards.
  • Identify ways to implement the new and revised requirements.

  Registration

  Registration includes access to both the live and on-demand version of this eCast.

  If you are a facility interested in participating in this eCast, simply complete the Group Viewing registration form and AABB will provide detailed instructions to share with your team approximately one week prior to the live program (each team member to register for the program utilizing a promocode). For single viewers, simply click on the Register button below to register.

  Please note: registration for the live eCast will close 1 hour prior to the eCast start time. If you register after this time, you will receive access to the on-demand eCast when it is available.

  Single Viewer	Register
  Group Viewing	Register

  Continuing Education Credit

  This activity is eligible for one (1) continuing education credit/contact hour for California Nurses, 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.

  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: May 19, 2027; Credit Expiration Date: June 19, 2027
  • Enduring Activity Program Dates: May 19, 2027 – May 18, 2030; Credit Expiration Date: May 18, 2030

  Disclosure Declaration

  It is the policy of the Association for the Advancement of Blood & Biotherapies to ensure independence, balance, objectivity, and scientific rigor and integrity in all of its CE activities. Faculty must disclose to the participants any relationships with commercial companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. AABB has evaluated, identified, and mitigated any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process. The following information is for participant information only. It is not assumed that the presence of such relationships will have a negative impact on the presentations.

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

  Faculty Biographies

  Christopher Bocquet serves as the Senior Director for Standards and Quality Initiatives at AABB. In this role Christopher oversees all AABB Standards Committees as they work to create new editions of AABB Standards and associated Guidance documents.

  
  

  Dr. Kate Brown is the Senior Director of Science at Generate Life Sciences, a Cooper Surgical company. Dr. Brown earned her PhD in Molecular and Cell Biology from the University of California, Berkeley and her Bachelor’s degree from the University of Colorado, Boulder. Dr. Brown has been with Cord Blood Registry, an affiliate of Generate Life Sciences and the world’s largest private newborn stem cell bank, for more than a decade. In her current capacity, Dr. Brown is responsible for the scientific direction and tactical execution of Generate Life Science’s Research and Development portfolio to support the clinical translation of various perinatal stem cell populations and advancing a variety of Science and Technology projects throughout Generate Life Sciences.

  
  

  Dr. Yvette Tanhehco is Associate Professor of Pathology and Cell Biology at Columbia University Irving Medical Center/NewYork-Presbyterian Hospital. She has been a faculty member and attending physician in the Division of Transfusion Medicine and Cellular Therapy since 2012. She is the Director of the Cellular Therapy Laboratory and Assistant Director of Transfusion Medicine at NewYork-Presbyterian Hospital.

  She is board certified by the American Board of Pathology in both Clinical Pathology and Blood Banking/Transfusion Medicine. Dr. Tanhehco’s clinical and research interests focus on cellular and gene therapies for malignant and non-malignant disease particularly sickle cell disease. She is interested in strategies to optimize patients and procedures for apheresis collections of mononuclear cells and hematopoietic progenitor cells to minimize patient adverse events and improve cell yields for drug product manufacturing. She is also interested in methods to improve processing and cryopreservation of mononuclear cell and peripheral blood stem cell products. Dr. Tanhehco is an active member of several professional societies including the Association for the Advancement of Blood and Biotherapies, American Society for Apheresis, International Society for Cell and Gene Therapy, College of American Pathologists, and American Society for Clinical Pathology. She has authored over 50 peer-reviewed publications.