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FDA CBER-OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products

  • 1.  FDA CBER-OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products

    Community Leadership
    Posted 07-25-2023 08:44

    Greetings All,

    This may be relevant those working in the Preclinical/Nonclinical Gene and Cell Therapy research areas including VACCINES.

    Please review the FDA OTP town hall information below.

    Cheers,

    Steven-

    The FDA's Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting its next virtual town hall on Wednesday, August 30, 2023 to answer stakeholder questions related to nonclinical assessment of cell and gene therapy products. Experts from OTP's Office of Pharmacology/Toxicology will be on-hand to answer questions.

    Focus for This Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products

    Nonclinical studies are an important part of medical product development and inform regulatory decisions. The data from nonclinical studies provide information on the safety and activity profile of an investigational product and guide the design of early-phase clinical trials. For more information, see the 2013 FDA guidance document for recommendations on the substance and scope of nonclinical information needed to support clinical trials for investigational cellular therapies, gene therapies, therapeutic vaccines, xenotransplantation, and certain biologic-device combination products. 

    Meeting Logistics

    • Date: Wednesday, August 30, 2023
    • Time: 11:30 a.m.–1:00 p.m. ET
    • Location: The webinar will be held via Zoom.
    • Registration: Registration is required. Please register for the event now.

    Submit a Question

    Questions can be submitted during the registration processExternal Link Disclaimer. Please submit questions by July 21, 2023. Attendees will also be able to submit questions during the live event.

    Please note, the FDA is not able to comment on or answer questions regarding specific investigational products or drug applications during the town hall. Further, questions considered inappropriate or out of scope for the event will not be addressed.



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    Steven Louie M.S.
    Sr. Principal Scientist
    Novartis
    Cambridge MA
    [email protected]

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