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  • 1.  Transfer of sponsorship

    This message was posted by a user wishing to remain anonymous
    Posted 23-Feb-2021 12:35
    This message was posted by a user wishing to remain anonymous

    Dear community,

    My company is sponsor of an IND submission. But, as soon as the IND will be active, the IMP will be outlicenced to an other company and the Phase 1 will be sponsor by this new company.
    I would like to anticipe the administrative/regulatory  tasks that this transfer of sponsorship will induce.
    Can someone help me make a list ?
    Are you aware of a guidance document that could help me ?

    Thank you for your percious help !

    Best regards :-)


  • 2.  RE: Transfer of sponsorship

    Posted 24-Feb-2021 09:22

    Transferring Sponsor should provide the following:

     Signed FDA Form 1571: section 11, select 'other' and specify 'IND Transfer request'; section 10, check last 1571 submitted in order to determine correct serial number

     Signed Cover Letter including the following:

    • date new ownership will become effective
    • statement that all rights will be assigned or transferred to new Sponsor
    • statement that all responsible parties will be notified
    • assurance that a complete copy of files have been provided to new Sponsor

    New Sponsor should provide the following:

     Signed FDA Form 1571: section 11, select 'other' and specify 'IND Transfer'

     Signed Cover Letter including the following:

    • date new ownership will be effective
    • statement that all rights will be assigned or transferred to new Sponsor and that the new Sponsor will assume ownership
    • assurance that a complete copy of transferring Sponsor's files have been received
    • commitment to amend the IND within 60 days to cover all changes resulting from the transfer in accordance with IND regulations
    • a list of all active investigators or a statement that they are the same as currently listed in the IND
    • commitment to inform all active investigators of the change in sponsorship and to obtain from each an updated form FDA Form 1572
    • letters of authorization, as needed, naming the new Sponsor for referencing a DMF


      ------------------------------
      Glen Park PharmD
      Executive Director, Regulatory Affairs and Quality Assurance
      New York NY
      United States
      ------------------------------

      Original Message


    • 3.  RE: Transfer of sponsorship

      Posted 24-Feb-2021 11:39
      Pretty straightforward for an IND. Current Sponsor (your company) submits a letter of Transfer of Ownership of IND and listing the new company the IND will be transferred to and the effective date that ownership will be or was transferred. Also include a statement that all rights to the application have been transferred to the new owner and that the new owner will receive or has received the complete IND record. The new company then submits a letter to the IND accepting ownership of IND along with the new owner's commitment to agreements, promises, and conditions made by the former owner and contained in the application. This can be submitted on the same day or the next day.  I suggest the new sponsor include a copy of your company's cover letter in their submission.  Since the new sponsor will be taking over conduct of the clinical study, the new sponsor should include a list of all active investigators or a statement that they are the same as currently listed in the IND and a commitment to inform all active investigators of the change in sponsorship and to obtain from each an updated form FDA Form 1572.

      ------------------------------
      Tom Stothoff
      Senior Director, Regulatory Affairs CMC
      Chicago
      ------------------------------

      Original Message


    • 4.  RE: Transfer of sponsorship

      This message was posted by a user wishing to remain anonymous
      Posted 26-Feb-2021 08:56
      This message was posted by a user wishing to remain anonymous

      Very helpful, thank you very much !

      I was wondering when the transfer can be initiated ? when the IND is active ? or even after IND submission without waiting FDA reviewing ?
      Original Message


    • 5.  RE: Transfer of sponsorship

      Posted 26-Feb-2021 15:01
      If you are able, I would wait until the IND is active. If you need to transfer during the 30-day review period I would first contact the FDA project manager to confirm ok to do so.

      ------------------------------
      Tom Stothoff
      Senior Director, Regulatory Affairs CMC
      Chicago
      ------------------------------

      Original Message


    • 6.  RE: Transfer of sponsorship

      This message was posted by a user wishing to remain anonymous
      Posted 03-May-2021 19:01
      This message was posted by a user wishing to remain anonymous

      If we have 2 assets and are considering 'transfer' of each active IND to a different subsidiary with slightly different names for tax reasons (all entities are located in the US), can it be considered a name change or is it a change in sponsor? Do we need a DUNS number for each subsidiary?

      Thinking also about the effect on all our document templates and how to ensure changes are made to all affected documents including clinical/TMF documents.  I think we would have to phase in the use of the new name (aside from the updated 1571 and cover letter going in with each submission) but was curious about a comment in another thread about "A commitment to amend the IND within 60 days to cover all changes in the IND resulting from new ownership and to provide for subsequent changes by amendments in accordance with the IND regulations".   Can someone provide examples of these changes?  Why 60 days?
      Original Message


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