Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We are transferring ownership of an IND as a new sponsor to a CV product. The previous sponsor has has conducted initial ph 1 single and multiple ascending dose PK/PD studies in healthy subjects over 6 years ago and reports finalized and submitted these reports under this IND (IND still active) . As a new sponsor, our intent is to go for a different indication than was originally shared with the FDA by the previous sponsor. The studies/intact IND still apply to the new indication and we plan to request a FDA mtg to discuss plans for a phase 2 protocol. Is a new IND application required first, however?  All the previous data would apply as is and would be the same package previously submitted to the existing IND. Our briefing package would summarize it.  Should we just pose the question that we believe the current IND is still "valid" as is?
Or, Should I try to network ahead of time with the division (one IND is fully transferred)?
Thanks for you input.
Norma

This message was posted by a user wishing to remain anonymous

What was your original indication in the first initial IND?
Original Message:
Sent: 02-Mar-2021 11:34
From: Anonymous Member
Subject: New IND needed? Cardiovascular Division

This message was posted by a user wishing to remain anonymous

We are transferring ownership of an IND as a new sponsor to a CV product. The previous sponsor has has conducted initial ph 1 single and multiple ascending dose PK/PD studies in healthy subjects over 6 years ago and reports finalized and submitted these reports under this IND (IND still active) . As a new sponsor, our intent is to go for a different indication than was originally shared with the FDA by the previous sponsor. The studies/intact IND still apply to the new indication and we plan to request a FDA mtg to discuss plans for a phase 2 protocol. Is a new IND application required first, however?  All the previous data would apply as is and would be the same package previously submitted to the existing IND. Our briefing package would summarize it.  Should we just pose the question that we believe the current IND is still "valid" as is?
Or, Should I try to network ahead of time with the division (one IND is fully transferred)?
Thanks for you input.
Norma

This message was posted by a user wishing to remain anonymous

If the initial or Original IND indication is in an entirely different therapeutic area (different from CV) then yes you need a new IND but you could cross refer few of the modules depending on the API used and dosage form used!
Original Message:
Sent: 02-Mar-2021 11:34
From: Anonymous Member
Subject: New IND needed? Cardiovascular Division

This message was posted by a user wishing to remain anonymous

We are transferring ownership of an IND as a new sponsor to a CV product. The previous sponsor has has conducted initial ph 1 single and multiple ascending dose PK/PD studies in healthy subjects over 6 years ago and reports finalized and submitted these reports under this IND (IND still active) . As a new sponsor, our intent is to go for a different indication than was originally shared with the FDA by the previous sponsor. The studies/intact IND still apply to the new indication and we plan to request a FDA mtg to discuss plans for a phase 2 protocol. Is a new IND application required first, however?  All the previous data would apply as is and would be the same package previously submitted to the existing IND. Our briefing package would summarize it.  Should we just pose the question that we believe the current IND is still "valid" as is?
Or, Should I try to network ahead of time with the division (one IND is fully transferred)?
Thanks for you input.
Norma

I would not file a new IND until I knew that one was required. You can request an end of Phase 1 meeting with the Division under the current IND and discuss your plans for the new indication. One of the questions would be whether administratively they will require a new IND. Since only Phase 1 study has been completed and all previous data is relevant for the new indication, I would assume that you will not need a new IND.

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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 02-Mar-2021 11:34
From: Anonymous Member
Subject: New IND needed? Cardiovascular Division

This message was posted by a user wishing to remain anonymous

We are transferring ownership of an IND as a new sponsor to a CV product. The previous sponsor has has conducted initial ph 1 single and multiple ascending dose PK/PD studies in healthy subjects over 6 years ago and reports finalized and submitted these reports under this IND (IND still active) . As a new sponsor, our intent is to go for a different indication than was originally shared with the FDA by the previous sponsor. The studies/intact IND still apply to the new indication and we plan to request a FDA mtg to discuss plans for a phase 2 protocol. Is a new IND application required first, however?  All the previous data would apply as is and would be the same package previously submitted to the existing IND. Our briefing package would summarize it.  Should we just pose the question that we believe the current IND is still "valid" as is?
Or, Should I try to network ahead of time with the division (one IND is fully transferred)?
Thanks for you input.
Norma