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OSD Oct 15 from noon 1pm EDT: From Parallel Paths to Intersection: Bioanalytical Sciences and CMC Analytical Development

  • 1.  OSD Oct 15 from noon 1pm EDT: From Parallel Paths to Intersection: Bioanalytical Sciences and CMC Analytical Development

    Community Leadership
    Posted 10-01-2024 16:03

    Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Gene and Cell Therapy Product (GCTP) Community on Tuesday October 15 from 12 pm – 1 pm EDT on the following topic:

    From Parallel Paths to Intersection: Bioanalytical Sciences and CMC Analytical Development

    •         What are the roles and responsibilities of Bioanalytical Sciences in R&D vs. CMC Analytical Development?
    • What strategies can be employed to create synergy between these two functions, particularly in advancing gene and cell therapy drug development?
    • What are the key differences in approaches to assay development/qualification and relevant regulatory requirements between these two areas?

    Discussion Leaders:

    @Yanmei Lu, PhD (Sangamo Therapeutics)

    @Savita Nair, PhD (Sangamo Therapeutics)

    Mark Galbraith, PhD (Transposon Consulting)

    Organized by:  

    @Allison Radwick (USP), Ami Patel (Boyds), @Yanmei Lu (Sangamo)

    We start at 12:00 EDT sharp. To avoid interruptions, please dial in before noon and mute yourself until the Q&A starts.

    (Please remain on mute unless asking questions) 

    When: Tuesday, October 15, 2024, 12 pm – 1 pm EDT

    WherePlease join from your computer, tablet or smartphone.
    https://meet.goto.com/505947717

    You can also dial in using your phone.
    United States: 
    +1 (646) 749-3122
    Access Code: 505-947-717

    Join from a video-conferencing room or system.
    Dial in or type: 
    67.217.95.2 or inroomlink.goto.com
    Meeting ID: 505-947-717
    Or dial directly
    [email protected] or 67.217.95.2##505947717

    New to GoToMeeting? Get the app now and be ready when your first meeting starts:
    https://meet.goto.com/install

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

    Thank you,

    The Leadership Team of the AAPS GCTP Community



    ------------------------------
    Allison Radwick Ph.D.
    Sr Regulatory & Policy Comms Mgr
    USP
    East Fallowfield PA
    [email protected]

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



  • 2.  RE: OSD Oct 15 from noon 1pm EDT: From Parallel Paths to Intersection: Bioanalytical Sciences and CMC Analytical Development

    This message was posted by a user wishing to remain anonymous
    Posted 10-01-2024 16:22
    This message was posted by a user wishing to remain anonymous

    Looking forward to this!