Gene And Cell Therapy Products Community

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  • 1.  Upcoming Open Scientific Discussion on IMG strategy for Cell Therapy and clinical application; Please sign up June 27 ; 12-1 pm

    Community Leadership
    Posted 06-19-2022 13:35

    Sponsored by the AAPS GCTPs Bioanalysis and Biomarker Subteam

    Monday, June 27, Noon to 1 pm EST

    Open Scientific Panel Discussion: IMG strategy for Cell Therapy and clinical application

      • How IMG study results were used and what are the value in approved products?
      • Timing of monitoring/sample collection for cellular responses
      • Identify our current limitations
      • Better practice in future studies, any changes?
      • New modality/generation of CART IMG assessment
      • Current IMG draft guidance (FDA and EMA) for cell therapy


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    Vibha Jawa
    Executive Director
    Nonclinical Disposition and Bioanalysis
    Bristol-Myers Squibb
    Princeton,NJ
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 2.  RE: Upcoming Open Scientific Discussion on IMG strategy for Cell Therapy and clinical application; Please sign up June 27 ; 12-1 pm

    Community Leadership
    Posted 06-21-2022 08:59
    Thank you for posting @Vibha Jawa I am looking forward to this discussion! Information to join Monday, June 27Noon to 1 pm EST is below.


    Moderators: @Vibha Jawa @Yanmei Lu Yanmei Lu (Sangamo)

    Panelists:  @Robert Dodge  @Dale Miles Tong Yuan (JnJ)

    ________________________________________________________________________________

    Microsoft Teams meeting

    Join on your computer or mobile app

    Click here to join the meeting

    ​​​​​​​​​

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    Allison Radwick Ph.D.
    Associate Medical Director
    Symbiotix
    New York NY
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 3.  RE: Upcoming Open Scientific Discussion on IMG strategy for Cell Therapy and clinical application; Please sign up June 27 ; 12-1 pm

    Community Leadership
    Posted 06-27-2022 08:05
      |   view attached
    Today from noon to 1 pm EST is our Open Scientific Discussion about IMG Strategy for Cell Therapy and Clinical Application.  Attached is the IQ presentation from April: Bioanalytical Considerations and Challenges for Cell Therapies & Immunogenicity Risk Assessment.

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    Allison Radwick Ph.D.
    Associate Medical Director
    Symbiotix
    New York NY
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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    Attachment(s)



  • 4.  RE: Upcoming Open Scientific Discussion on IMG strategy for Cell Therapy and clinical application; Please sign up June 27 ; 12-1 pm

    Community Leadership
    Posted 06-21-2022 10:24
    Look forward to it!

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    Yan Ni
    Senior Director
    Passage Bio
    Philadelphia PA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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