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  • 1.  CDx regulatory guidance

    Posted 10-06-2025 16:29

    Dear Regulatory Sciences Community 

    I am interested in gaining a greater understanding of the CDx regulatory landscape as it applies to development, validation, as well as implementation into the clinical sample analysis.  Primarily interested in implementation around biomarkers and in the cell & gene therapy space across an array of therapeutic areas.  I would like to gauge interest in starting a repository of applicable regulatory documents for companion diagnostics, as well as white papers, and meeting regularly to discuss.  Thank you! 



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    Wendy Adamowicz, M.S.
    Principal Scientist
    PPD Clinical Research, Thermo Fisher Scientific
    [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: CDx regulatory guidance

    Posted 10-08-2025 11:47

    Hi Wendy,

    I saw your post and wanted to invite you to a discussion group that we have within the Biomarkers and Precision Medicine group and the Gene and Cell Therapy Products communities. We have been discussing the latest in CDx, IDE and IVDR regulations for biomarkers used in patient enrollment. Would you be interested in joining this group? I'm happy to send you the meeting invitation. We meet on the fourth Wednesday of every month from 11-12pm EST (Our next meeting is October 22nd).



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    Amanda Hays Ph.D.
    Scientific Officer
    BioAgilytix
    Overland Park KS
    [email protected]

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