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  • 1.  GLP Tox to IND timelines

    This message was posted by a user wishing to remain anonymous
    Posted 19-Jan-2017 14:56
    This message was posted by a user wishing to remain anonymous

    Hi all,
    I'm gathering data points for a start-up company seeking to develop internal base-case timelines.  For an initial small-molecule IND, how many business days does it take your company to file an IND following receipt of the 28-day toxicology study unaudited draft report (excluding publishing time)?
    Thank you for the information!


  • 2.  RE: GLP Tox to IND timelines

    Posted 20-Jan-2017 07:57
    Hi,

    It depends, if your package is ready and waiting for the last GLP Tox report, I would estimate 20 working days to submission. However if you are waiting to start document preparation after the GLP Tox report is available I would estimate 90 working days.

    Thanks
    Harriet

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    Harriet Kamendi RAC
    Gaithersburg MD
    United States
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    Original Message


  • 3.  RE: GLP Tox to IND timelines

    Posted 20-Jan-2017 11:06
    Please also understand that to file a new IND, you also need other regulatory documents such as CMC section, phase 1 FIH protocol etc... I am assuming that all these other reports are already available and ready to file and your question is specific to one individual pending Tox report. Harriet's proposed timelines is reasonable in this case.

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    GRSAOnline (WWW.GRSAONLINE.COM)
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    Original Message


  • 4.  RE: GLP Tox to IND timelines

    Posted 20-Jan-2017 11:50

    My experience is for biologics, but I would expect it to be similar.  I plan approximately 3 months for authoring/submission (includes 1 week for publishing).  However, this is flexible – often some info gets dropped in during the last month of authoring, right before final review and publishing.  At a minimum, I would expect it to take 2 months after the tox report is available (although heroic measures are always possible).

     

    Best regards,

     

    Cathy

     

    ​​​​​

    Catherine M Anderson, PhD, RAC

    Senior Manager, Regulatory Affairs CMC




    Original Message


  • 5.  RE: GLP Tox to IND timelines

    This message was posted by a user wishing to remain anonymous
    Posted 23-Jan-2017 09:42
    This message was posted by a user wishing to remain anonymous

    Thanks for the feedback, all- much appreciated.
    Original Message


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