OCT 26, 2017 12:00 PM PDT

WEBINAR: Overcoming Challenges in the Cellular Therapy Laboratory

  • Director, GMP for Immunotherapy Assistant Professor at Children's National and GWU
      Dr. Hanley is the director of the class 10,000 GMP facility at Children's National Health System, which is charged with manufacturing novel cellular therapies in the Program for Cell Enhancement and Technology for Immunotherapy (CETI) under IND applications, as well as processing standard-of-care stem cell transplant products. He is also responsible for follow-up and immune reconstitution testing performed on patients treated on CETI's protocols. For the past 10 years, he has investigated and helped to translate the following into more than 15 clinical trials:
      • Virus-specific T-cells for the prophylaxis and treatment of viral infections after transplant
      • Tumor-specific T-cells using endogenous receptors and chimeric antigen receptors
      • A GMP-compliant method of manufacturing MSCs using the Quantum® Cell Expansion System for patients after stroke, graft-versus-host disease and inflammatory bowel disease
      Dr. Hanley has been recognized as a developing expert in the field of cellular therapy and cellular therapy product manufacturing, and he has been granted the Excellence in Research award by the American Society of Gene and Cell Therapy in 2012 and the Young Investigator award by the Intl. Society for Cell Therapy (ISCT) in 2013 and 2016. In 2017, he was awarded the Be The Match/American Society of Blood and Marrow Transplantation (ASBMT) Amy Strelzer Manasevit award. He previously served on the trainee council of the American Society of Hematology, and he was selected for the prestigious American Society of Hematology/European Hematology Association Translational Research training program in 2013. In addition to translating cellular therapies from bench to clinic, Dr. Hanley is passionate about developing dedicated training programs for budding cellular therapists, particularly programs dedicated to training scientists in positions within the cellular therapy laboratory, such as laboratory facility management, quality assurance, manufacturing and quality control.


    DATE: October 26, 2017
    TIME: 12:00 PM PDT

    This presentation will focus on recent advances in cellular therapy—from mesenchymal stromal cells (MSCs) to tumor-specific T-cells. More specifically, we will discuss how these cells are made in our academic good manufacturing practice (GMP) facility, how we try to meet the demands of our investigators and what challenges we must overcome to expand these therapies.

    Who may this interest:

    • Clinicians, researchers, laboratory technologists
    • Cell therapy manufacturing professionals 
    • Gene and immunotherapy manufacturing professionals

    Learning Objective:
    Identify challenges associated with early-stage cell therapy manufacturing and potential solutions



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