SIG: Cell and Gene Therapy

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ISPE CGT Community Meeting Minutes Sept 25

  • 1.  ISPE CGT Community Meeting Minutes Sept 25

    Posted 09-25-2025 20:19
      |   view attached

    Thank you to everyone for attending the CGT SIG meeting today.

    We were lucky to have Diogo Almeida, a PhD student at University of Lisbon studying pharmacoepidemiology and regulatory science, to discuss his recent manuscript. The slides that he discussed are attached.

    We also discussed the newly released FDA guidances that were released for review: Federal Register :: Postapproval Methods To Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry; Availability & Guidance for Industry

    Our next meeting in November will focus on patient patient-centric approaches to cell and gene therapy research and we'll be joined by Jamie's colleague from the patient engagement function at Novartis.

    As always, additional speakers and topics are always welcome.

    Best,

    Jamie, Lourens, and Kristen



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    Kristen Hahn MPH, PhD
    PicnicHealth
    Old Lyme CT
    +1 (860) 575-3411
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    Attachment(s)

    pdf
    ATMPS_ISPE_SIG.pdf   2.74 MB 1 version