AABB Cellular Starting Material Forum (23EL-808) - Free for everyone!

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

Live Program Date: Friday, February 24, 2023 - On-Demand Available

Program Number: 23EL-808


This on-demand forum is complimentary to all, but registration is required. After signing up on GoToWebinar, the video will immediately begin to play.

  • Program Description

    The AABB Cellular Starting Material (CSM) Forum connects organizations involved in providing or procuring CSM for research and manufacturing of advanced therapies. CSM is used for a variety of novel biotherapies including cellular therapy, gene and cell therapy, and regenerative medicines. The CSM Forum explores standards development, industry, and regulatory perspectives as well as strengthening the capacity for cell collection organizations to meet current and future demand for qualification to collect CSM.

    Agenda & Faculty

    Program Chair: Linda S. Barnes, DrPH, MHA, RAC, CABP(H), AABB

    Introductory Remarks
    Standardization Perspectives

    • Development of the Site Qualification and Risk Assessment Tool: Presentation of the proposed approach to reduce inspection burden in the biotherapies sector.
      • Kelly Poon, Deloitte Industry Working Group for Gene and Cell Therapies
      • Jennifer Rabin, RN, Next Generation Therapies Consultant, Deloitte
      • Tracey Hlucky, CMQ/OE, CQA, Kite Pharma, Co-Chair of the BSR/PDA Standard 08-202x -Apheresis Collection for Cell and Gene Therapy Products
      • Christopher Bocquet, Senior Director, Standards Development and Quality Initiatives, AABB

    Cell Collector Perspectives

    • AABB Cellular Starting Material Qualification
      • Susan Noone, MPH, CQA(ASQ), Vitalant
      • Suzanne Thibodeaux, MD, PhD, CABP(H), Washington University School of Medicine
      • Vasiliki Kalidomou, PhD, MSc, CABP(H), Research and Regenerative Medicine, IASO Maternity & Research Hospital

    Industry Perspectives

      • Jean Stanton, Johnson & Johnson/Janssen
      • Anh Jones, GentiBio
      • Christina Anderson, AvroBio

    Audience Questions
    Closing Remarks

    Learning Objectives

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

    • Discuss the recent developments in the biotherapies ecosystem for standardization of Cellular Starting Material (CSM).
    • Explore the perspectives of CSM providers and the biotherapies industry.
    • Explain current and future tools and resources available to AABB members.

    Continuing Education Credit

    Continuing education credit will not be offered for this program.