Regulatory Open Forum

 View Only

  • 1.  IND holder and trial sponsor

    This message was posted by a user wishing to remain anonymous
    Posted 22-Feb-2022 13:22
    This message was posted by a user wishing to remain anonymous

    colleagues, suppose a trial is ongoing in the US under Company A sponsorship (Company A is the GCP sponsor and the IND holder). Company B acquires the asset. Would it be possible that the Company B becomes the IND holder while Compnay A would remain the sponsor of the trial (from a GCP perspective). Thanks for your thoughts.


  • 2.  RE: IND holder and trial sponsor

    Posted 22-Feb-2022 14:15
    Yes! I am not sure what GCP have to do with being a Sponsor?
    TORO would be a tool for assigning who does what! B can also have a GCP responsibility if you want it that way. Every responsibility can be described in TORO and submit to your 'B' IND (i.e. acquired by B)
    Good luck!

    ------------------------------
    GRSAOnline
    ------------------------------

    Original Message


  • 3.  RE: IND holder and trial sponsor

    Posted 22-Feb-2022 15:57
    If you are suggesting that Company A continues to conduct the trial for Company B, then yes that works. 21 CFR 312.52 indicates that a Sponsor can transfer IND obligations to a contract research organization. While Company A may not be constituted as a CRO an appropriate contract between Company A and Company B to transfer obligations would seem legitimate. But, I emphasize that there should be a written agreement to that effect. Check your terminology though. Company A would not be the Sponsor from ANY perspective.

    ------------------------------
    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
    ------------------------------

    Original Message


  • 4.  RE: IND holder and trial sponsor

    This message was posted by a user wishing to remain anonymous
    Posted 23-Feb-2022 10:43
    This message was posted by a user wishing to remain anonymous

    Yes, Company A can have GCP oversight without being the IND holder, if that's what you mean! As pointed out earlier, TORO would be your tool (who does what)to submit to the B acquired IND. This is from FDA and regulatory perspective for IND. I am assuming you are not asking from business/legal agreement perspective which is probably handled separately by your company! Company A can be a sponsor from funding, drug supply, API supply etc.. perspective! These are all 'non regulatory/FDA', business/legal agreements that your other groups probably handling! If company B wish to be IND holder, after acquiring the asset, then make sure you submit a transfer of IND ownership to the FDA from company A to company B.
    Original Message


Related Content