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OSD on Overview of the Draft PSG guidance : solicitation of feedback from the Industry

  • 1.  OSD on Overview of the Draft PSG guidance : solicitation of feedback from the Industry

    Community Leadership
    Posted 13 days ago

    Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Translational and Clinical Sciences Community on September 8, 12 pm – 1 pm EST on the following topic:

     

    Overview of the draft PSG guidance : solicitation of feedback from the Industry 

    Join us for an open scientific discussion to:

    • Solicit community feedback on FDA's July 2026 draft PSGs for peptide drug products to inform a consolidated response to FDA.
    • Discuss areas requiring greater clarity, including ANDA/comparability expectations, higher-order structure, biological activity, peptide impurities, and immunogenicity assessment.
    • Identify science- and risk-based recommendations, including fit-for-purpose analytical, in silico, and human cell-based/NAM approaches, that can be incorporated into constructive FDA comments.
    • Discuss whether the intrinsic immunogenic risk of a peptide should be considered when establishing guidelines.

    We welcome perspectives across regulatory science, CMC/analytics, peptide development, and immunogenicity to help shape the AAPS response.

    Moderators:

    ·         Dr Daniela Verthelyi, Thimmus, LLC  [email protected] and Vibha Jawa, Epivax  [email protected]

    Organizers:  

    ·         Vibha Jawa (Epivax), Karen Quadrini (Prothena Biosciences), and Carmen Fernández-Metzler (PharmaCadence) 

    When:  Tuesday, Sep 8, 2026 at 12 pm – 1 pm EST    We start at 12:00 EST sharp.  

    Where:  Free registration at https://science360.aaps.org/science360/2026/webinars/4236465

    This OSD is open to all the scientific community and hosted through Science 360.  The link above will take AAPS members directly to the OSD page.  For non-members, the link will allow you to create a free account in order to join the OSD.  There will be the possibility to ask questions live and submit questions.

    Please feel free to share with everyone who may be interested in this topic.

      

    Thanks,

    On Behalf of The AAPS Translational and Clinical Biosciences Community Programming and Science Exchange Activity Team



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    Carmen Fernandez-Metzler Ph.D.
    President
    PharmaCadence Analytical Services, LLC
    Hatfield 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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