Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear Forum-

Recently, my company bought an asset from a company that went bankrupt, and this company does not exist now.  How should the IND transfer be handled?  I was thinking it was a transfer and we would accept, but there is not anyone to transfer the IND to us.  Could it be handled as a Change in Sponsor without having an official transfer?

Any advice would be greatly appreciated.

Thank you for your time.

Hi Anon,

Change in Sponsor/Transfer of IND are similar terms, My opinion in this case you have to submit the Change in Sponsor with company acquisition information including all active INDs. 

Once the changes informed to USFDA,

•  A complete copy of the former sponsor's files is provided to new Sponsor.
• The IND will be amended within 60 days to cover all changes resulting from the sponsorship transfer and you will provide for subsequent changes via amendments in accordance with the IND regulations.
• All active investigators will be informed of the change in sponsorship and an updated Form FDA 1572 with commitments to you will be obtained from each investigator.
• An updated investigator list will be submitted to the IND if there are any changes in investigators.

Regards
Pragnesh Donga
+91 9925262377



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PragneshDonga
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Original Message:
Sent: 22-Jun-2021 14:21
From: Anonymous Member
Subject: IND Transfer/Acceptance vs. Change in Sponsor

This message was posted by a user wishing to remain anonymous

Dear Forum-

Recently, my company bought an asset from a company that went bankrupt, and this company does not exist now.  How should the IND transfer be handled?  I was thinking it was a transfer and we would accept, but there is not anyone to transfer the IND to us.  Could it be handled as a Change in Sponsor without having an official transfer?

Any advice would be greatly appreciated.

Thank you for your time.

I think you need something in writing from the original IND holder.  What rights do you have to the IND and data?  Information in an IND is considered confidential, so why should FDA transfer it to you without some proof you are entitled to access the information.  You will need a letter or something from a former Executive of the company or their bankruptcy attorney acknowledging your right to the IND.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States
------------------------------

Original Message:
Sent: 22-Jun-2021 14:21
From: Anonymous Member
Subject: IND Transfer/Acceptance vs. Change in Sponsor

This message was posted by a user wishing to remain anonymous

Dear Forum-

Recently, my company bought an asset from a company that went bankrupt, and this company does not exist now.  How should the IND transfer be handled?  I was thinking it was a transfer and we would accept, but there is not anyone to transfer the IND to us.  Could it be handled as a Change in Sponsor without having an official transfer?

Any advice would be greatly appreciated.

Thank you for your time.

Dear Anonymous,

To my knowledge the only way to transfer an IND is for the company owning the IND initiate the transfer by FDA notification. In the absence of that, the sale of the asset to your company must have some documentation of what was actually transferred and presaged the idea that IND ownership would also need to be transferred.  There must be a legal entity that was responsible for the sale of the asset and dissolution of the company that could notify FDA of the sale of the asset to your company and transfer of the IND. That is where I would start because in FDAs files that company still owns the IND whether they "exist" in reality or not.  Even with a so-called Change in Sponsor, i.e., assumption of Sponsor responsibilities, that change has to be authorized by the "current" Sponsor.

In the extreme I might also explore the possibility of opening a new IND, assuming that all of the information from the previous Sponsor's IND was transferred to you. In the absence of any other actions on the part of the bankrupt company, FDA will eventually inactivate their IND due to inactivity.

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

Original Message:
Sent: 22-Jun-2021 14:21
From: Anonymous Member
Subject: IND Transfer/Acceptance vs. Change in Sponsor

This message was posted by a user wishing to remain anonymous

Dear Forum-

Recently, my company bought an asset from a company that went bankrupt, and this company does not exist now.  How should the IND transfer be handled?  I was thinking it was a transfer and we would accept, but there is not anyone to transfer the IND to us.  Could it be handled as a Change in Sponsor without having an official transfer?

Any advice would be greatly appreciated.

Thank you for your time.

This message was posted by a user wishing to remain anonymous

This is a simple thing, please do not over complicate! You purchased the asset, PERIOD! There is no transfer of IND! You just submit an amendment to the active IND or INDs and notify the FDA review division that you are the new owner/sponsor and commit to comply with all the IND regulations, etc etc...........
Original Message:
Sent: 22-Jun-2021 14:21
From: Anonymous Member
Subject: IND Transfer/Acceptance vs. Change in Sponsor

This message was posted by a user wishing to remain anonymous

Dear Forum-

Recently, my company bought an asset from a company that went bankrupt, and this company does not exist now.  How should the IND transfer be handled?  I was thinking it was a transfer and we would accept, but there is not anyone to transfer the IND to us.  Could it be handled as a Change in Sponsor without having an official transfer?

Any advice would be greatly appreciated.

Thank you for your time.

Your reply is incorrect.  The owner of the IND must notify FDA that the asset has been transferred.  They will not just take your word for it.  see 21 CFR 314.72 - Change in ownership of application...

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States
------------------------------

Original Message:
Sent: 23-Jun-2021 09:53
From: Anonymous Member
Subject: IND Transfer/Acceptance vs. Change in Sponsor

This message was posted by a user wishing to remain anonymous

This is a simple thing, please do not over complicate! You purchased the asset, PERIOD! There is no transfer of IND! You just submit an amendment to the active IND or INDs and notify the FDA review division that you are the new owner/sponsor and commit to comply with all the IND regulations, etc etc...........
Original Message:
Sent: 22-Jun-2021 14:21
From: Anonymous Member
Subject: IND Transfer/Acceptance vs. Change in Sponsor

This message was posted by a user wishing to remain anonymous

Dear Forum-

Recently, my company bought an asset from a company that went bankrupt, and this company does not exist now.  How should the IND transfer be handled?  I was thinking it was a transfer and we would accept, but there is not anyone to transfer the IND to us.  Could it be handled as a Change in Sponsor without having an official transfer?

Any advice would be greatly appreciated.

Thank you for your time.

314.72 applies to marketed product application not INDs. I agree with the Anon regarding the bankrupt opioid manufacturers with the INDs transfer (i.e. ownership change) process.

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

Original Message:
Sent: 24-Jun-2021 00:12
From: Michael Hamrell
Subject: IND Transfer/Acceptance vs. Change in Sponsor

Your reply is incorrect.  The owner of the IND must notify FDA that the asset has been transferred.  They will not just take your word for it.  see 21 CFR 314.72 - Change in ownership of application...

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States

Original Message:
Sent: 23-Jun-2021 09:53
From: Anonymous Member
Subject: IND Transfer/Acceptance vs. Change in Sponsor

This message was posted by a user wishing to remain anonymous

This is a simple thing, please do not over complicate! You purchased the asset, PERIOD! There is no transfer of IND! You just submit an amendment to the active IND or INDs and notify the FDA review division that you are the new owner/sponsor and commit to comply with all the IND regulations, etc etc...........
Original Message:
Sent: 22-Jun-2021 14:21
From: Anonymous Member
Subject: IND Transfer/Acceptance vs. Change in Sponsor

This message was posted by a user wishing to remain anonymous

Dear Forum-

Recently, my company bought an asset from a company that went bankrupt, and this company does not exist now.  How should the IND transfer be handled?  I was thinking it was a transfer and we would accept, but there is not anyone to transfer the IND to us.  Could it be handled as a Change in Sponsor without having an official transfer?

Any advice would be greatly appreciated.

Thank you for your time.

The devil is in the details in how the acquisition was made.

If only the asset itself was purchased and not the bankrupt company, I agree with Michael that the IND needs to be formally transferred for FDA to accept your submissions to that IND.  The bankrupt company likely still exists as an entity under a legal or financial caretaker who could initiate the transfer.  If it's the asset itself that was purchased and not formally transferred, formally FDA would not be able to accept your submission to that IND.  If there really is no entity any longer, even if as a shadow organization, then I'd suggest contacting the project manager at FDA and identifying what information they many need to administratively transfer the IND to your company.  I would expect they encounter this situation quite frequently and have a process for this scenario.

If your company purchased the bankrupt entity as a whole, then no IND transfer is required.  You may want to include a copy of the press release or some such public document in your first submission to the IND so that FDA has a record of the change in sponsor name.

Hope this helps.

Mark


------------------------------
Mark A De Rosch, PhD, FRAPS
Chief Operating Officer
Aura Biosciences
Cambridge, MA
United States
------------------------------

Original Message:
Sent: 24-Jun-2021 00:12
From: Michael Hamrell
Subject: IND Transfer/Acceptance vs. Change in Sponsor

Your reply is incorrect.  The owner of the IND must notify FDA that the asset has been transferred.  They will not just take your word for it.  see 21 CFR 314.72 - Change in ownership of application...

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States

Original Message:
Sent: 23-Jun-2021 09:53
From: Anonymous Member
Subject: IND Transfer/Acceptance vs. Change in Sponsor

This message was posted by a user wishing to remain anonymous

This is a simple thing, please do not over complicate! You purchased the asset, PERIOD! There is no transfer of IND! You just submit an amendment to the active IND or INDs and notify the FDA review division that you are the new owner/sponsor and commit to comply with all the IND regulations, etc etc...........
Original Message:
Sent: 22-Jun-2021 14:21
From: Anonymous Member
Subject: IND Transfer/Acceptance vs. Change in Sponsor

This message was posted by a user wishing to remain anonymous

Dear Forum-

Recently, my company bought an asset from a company that went bankrupt, and this company does not exist now.  How should the IND transfer be handled?  I was thinking it was a transfer and we would accept, but there is not anyone to transfer the IND to us.  Could it be handled as a Change in Sponsor without having an official transfer?

Any advice would be greatly appreciated.

Thank you for your time.

This message was posted by a user wishing to remain anonymous

Just submit a change in sponsor to the active IND and indicate that the company previous owner no longer exists due to bankrupt! Recently several opioid companies went bankrupt and the few owners are in  jail! As the above anon indicated, please you don't have to overcomplicate as others are suggesting! The above simple process is well accepted!!!
Original Message:
Sent: 22-Jun-2021 14:21
From: Anonymous Member
Subject: IND Transfer/Acceptance vs. Change in Sponsor

This message was posted by a user wishing to remain anonymous

Dear Forum-

Recently, my company bought an asset from a company that went bankrupt, and this company does not exist now.  How should the IND transfer be handled?  I was thinking it was a transfer and we would accept, but there is not anyone to transfer the IND to us.  Could it be handled as a Change in Sponsor without having an official transfer?

Any advice would be greatly appreciated.

Thank you for your time.