The Role of Artificial Intelligence in Cellular Therapy Laboratory Quality Assurance

ABOUT THE WEBINAR

In this day and age, almost everything involves artificial intelligence (AI). While AI is becoming more popular, human decision-making can sometimes be inconsistent and time consuming. This session focuses on how AI can be used in quality assurance (QA) for cellular therapy laboratories. 

In this session, speakers will begin with explaining basic concepts like machine learning and large language models, and also open vs. closed systems, and AI prompt writing. In addition, speakers will also highlight: how AI can be used as a support tool/assistant with human experts reviewing the output; comparing different AI tools based on how accurate, transparent, and useful they are for QA work; and discussing how AI can help with everyday QA tasks such as writing SOPs, creating forms, performing risk assessments, root cause analysis (RCA), CAPA planning, validation protocols, training materials, audit preparation, and literature reviews; addressing concerns like incorrect AI outputs (hallucinations), bias, and ethical risks; and managing risks, such as using approved platforms, involving subject matter experts (SMEs), and following institutional AI policies. 

Are you a QA professional? Register today and join the session to explore how you can make smarter and better data-driven decisions in the interest of strengthening quality systems while maintaining patient safety and regulatory compliance.

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KEY LEARNING OBJECTIVES

  • Discuss potential applications of artificial intelligence (AI) in cellular therapy laboratory (CTL) quality assurance (QA) operations.
  • Compare and contrast different AI platforms.
  • Provide a practical example of how to use and validate the AI workflow to improve the CTL’s quality management program.
 WEBINAR CHAIRS

Yvette Tanhehco, PhD, MD, MS, CABP(AABB)
Medical Director of Cellular Therapy Laboratory
New York-Presbyterian Hospital/Columbia University Irving Medical Center
United States

Dr. Yvette C. Tanhehco is an Associate Professor of Pathology and Cell Biology at Columbia University Irving Medical Center (CUIMC) and the Director of the Cellular Therapy Laboratory and Assistant Director of Transfusion Medicine at NewYork-Presbyterian Hospital/CUIMC. Dr. Tanhehco received her Bachelor of Arts degree in Microbiology and Molecular and Cell Biology from Cornell University in Ithaca, NY. She then received her Doctor of Philosophy degree in viral oncology from Johns Hopkins University prior to obtaining a medical degree from the University of Pittsburgh. She completed her residency training in Clinical Pathology followed by fellowship training in Blood Banking/Transfusion Medicine at the Hospital of the University of Pennsylvania. In addition, she obtained a Master of Science degree in Translational Research from the University of Pennsylvania. Dr. Tanhehco’s clinical and research interests focus on cellular and gene therapies for sickle cell disease. She is particularly interested in strategies to optimize patients and procedures for apheresis collections of hematopoietic progenitor cells and mononuclear cells to minimize patient adverse events and improve cell yields for drug product manufacturing.

 WEBINAR SPEAKERS

Ashita Chauhan
Compliance Technical Specialist
Beth Israel Deaconess Medical Center
United States

Ashita Chauhan works as a Compliance technical specialist (QA) professional specializing in cellular therapy manufacturing and regulatory compliance in BIDMC. With more than 6 years of experience in GMP operations, and quality systems, she plays a key role in ensuring product safety, process integrity, and adherence to FACT and FDA standards. She is interested in integrating artificial intelligence into QA processes to enhance efficiency, consistency, and data-driven decision-making in cell therapy. Passionate about continuous improvement, she is actively involved in developing innovative approaches for the application of AI in Quality management system.

Wanxing Cui, MD, PhD, CABP(H)
Director of Cell Therapy Manufacturing Facility
Medstar Georgetown University Hospital
United States

Dr. Wanxing Cui is Director of the Cell Therapy Manufacturing Facility at MedStar Georgetown University Hospital, an FDA-registered operation accredited by the Association for the Advancement of Blood & Biotherapies (AABB) and the Foundation for the Accreditation of Cellular Therapy (FACT). He leads manufacturing for the hospital's Pancreatic Islets, Stem Cell Transplant, and Cellular Immunotherapy programs. With over 30 years of expertise in pancreatic islet transplantation, Dr. Cui has authored more than 70 peer-reviewed publications and holds numerous biotechnology patents. He serves on the AABB Cellular Therapies Section Coordinating Committee, and as an AABB assessor and FACT inspector. Within ISCT, he contributes to the iPSC Joint and Lab Practice Committees. Dr. Cui is also a member of the International Pancreas and Islet Transplantation Association (IPITA) Advocacy Committee (since 2024) and Co-Chair of the NMDP Cell Therapy Lab Alliance (since March 2025). He mentors emerging professionals through ISCT's Professional Education Program (PEP) and AABB's Early Stage Professionals (ESP) programs.

Stephan Kadauke, MD, PhD
Associate Director of Cell Based Therapy Laboratory, Medical Director of Cell and Gene Therapy Informatics
Children’s Hospital of Philadelphia
United States

Stephan Kadauke, MD, PhD, is Associate Professor of Pathology and Laboratory Medicine at the University of Pennsylvania Perelman School of Medicine and Medical Director of Cell and Gene Therapy Informatics at the Children's Hospital of Philadelphia. His work focuses on cellular therapy manufacturing, clinical informatics, and the application of AI to cell and gene therapy operations. He co-leads CHOP's huCART19 point-of-care CAR-T program and works on practical uses of large language models to support quality activities such as SOP authoring, deviation review, and validation — always with human subject-matter experts in the loop. He is particularly interested in how academic centers can adopt AI safely under existing regulatory frameworks.