Gene And Cell Therapy Products Community

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Leadership

Chair: Hardik Mody | Vice Chair: Yanmei Lu | Past Chair: Yan Ni | Secretary: Nagendra Chemuturi | Learning Opportunities Managers: Dale Miles, Yan Ni, Yun Liu, Allison Radwick, Vibha Jawa, Oeystein Brekk, Lalit Kumar, Saleem Shaik | Member Engagement Managers: Steven Louie, Dale Miles, Hiroshi Sugimoto, Vibha Jawa, Ami Patel, Nicholas Buss, Prathap Nagaraja Shastri | Scientific Advisory Committee Regulatory Response Subcommittee Members: Yan Ni

2025 Goals for the Gene and Cell Therapy Products Community (PDF)

Community email address: aaps-[email protected]

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Latest Discussion Posts

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Announcements

  • Open Scientific Discussion Next Month!

    Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Gene and Cell Therapy Products (GCTPs) Community on October 14, 2025, 12 pm – 1 pm EDT on the following topic:
     
    Low Blood Volume Alternatives for Immune Monitoring in Clinical Trials
    Low-volume blood collection methods are transforming immune monitoring by reducing patient burden and enabling more frequent, longitudinal sampling. 
    Join our excellent panel of speakers/discussion leaders to engage on the following topics:
    • Shivshankar Balasubramaniam (ImmunitasBio): Low Blood Volume Alternative for Monitoring COVID-Specific T-Cell Immunity 
    • Kirk Hofman ( SUNY Buffalo):  An Accessible Truculture based Whole-Blood Assay for CAR-T Recall Response: Simplified Workflow with Multiplexed Immunological Readouts
    • Yanshan Dai (Avantia Labs): RT-ddPCR-based Cellular Immunity Assessment
     
    The Whole-Blood CAR-T Recall Assay offers a simplified workflow with multiplexed readouts for real-time CAR-T monitoring, while the Low-Volume COVID T-Cell Test tracks protective immunity from just a minimal blood draw, ensuring reliable and accessible insights. Complementing these approaches, the RT-ddPCR Immunity Platform delivers transcript-level precision with ultra-sensitive and reproducible detection of immune activation. Together, these innovations make immune monitoring in clinical trials more practical, scalable, and patient-friendly.
     
    Discussion Leaders:
    Vibha Jawa (Epivax Inc.)
     
    Organized by:  
    @Yan Ni (Passage Bio), @Yanmei Lu (Sangamo Therapeutics), Dale Miles (Genentech)
     
    We start at 12:00 PM EDT sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts.
    (Please remain on mute unless asking questions)
     
    When:  October 14, 2025; 12:00pm – 1:00 pm EDT
    Where: Please join from your computer, tablet or smartphone using Microsoft Teams at this LINK or use the meeting ID and passcode.
     
    Meeting ID: 252 931 396 163 8
    Passcode: eK9AT3bP
     
    Please feel free to share with colleagues who may be interested in this topic.
    Thank you,
    The Leadership Teams of the AAPS BPM and GCTPs Communities
    More

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