Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,
is it correct that I have to file a new IND if I want to extend the product that already has an approved IND for a new subpopulation - or would that be possible as protocol amendment?

In general, if the indication is the same or similar and your are adding a new subpopulation, a new IND would not be needed. If the change is to an ongoing protocol, an amendment to the protocol would be appropriate.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 15-Apr-2019 17:49
From: Anonymous Member
Subject: new population - new IND?

This message was posted by a user wishing to remain anonymous

Hello,
is it correct that I have to file a new IND if I want to extend the product that already has an approved IND for a new subpopulation - or would that be possible as protocol amendment?

This message was posted by a user wishing to remain anonymous

Thanks Glen. I appreciate your active participation on this forum. We as a regulatory community benefit from your insight. 

Follow up on this old thread: what if the sponsor is amending an ongoing Phase 1 FIH protocol to add a new genetic sub-population?

Context: for a molecularly targeted drug in the oncology space the sponsor has opened an IND for solid tumors with specific molecular target/biomarker.  The IND-opening study is a traditional dose escalation + dose expansion study design, with multiple tumor types with the same molecular target/biomarker being further evaluated at the same dose in the expansion cohorts.

Proposal:  If the sponsor wants to amend the same Phase 1 protocol to add a new molecularly targeted patient population, is this possible, or will FDA require a separate protocol and separate IND since it's a different molecular target/biomarker that the IND is active for? 

Best,
RA
Original Message:
Sent: 16-Apr-2019 08:40
From: Glen Park
Subject: new population - new IND?

In general, if the indication is the same or similar and your are adding a new subpopulation, a new IND would not be needed. If the change is to an ongoing protocol, an amendment to the protocol would be appropriate.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 15-Apr-2019 17:49
From: Anonymous Member
Subject: new population - new IND?

This message was posted by a user wishing to remain anonymous

Hello,
is it correct that I have to file a new IND if I want to extend the product that already has an approved IND for a new subpopulation - or would that be possible as protocol amendment?

Dear Anonymous,

Based on the general concept, I do not think a new IND will be required. You could ask the Project Manager, or just submit a protocol amendment. If FDA wants a new IND they will tell you. It should be simple enough to then just cross-reference the existing IND. Of course, the caveat is that if the indication is quite different there could be additional dosing and/or safety information that might be required.

Best regards,

Glen

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

Original Message:
Sent: 28-Jul-2021 17:37
From: Anonymous Member
Subject: new population - new IND?

This message was posted by a user wishing to remain anonymous

Thanks Glen. I appreciate your active participation on this forum. We as a regulatory community benefit from your insight.

Follow up on this old thread: what if the sponsor is amending an ongoing Phase 1 FIH protocol to add a new genetic sub-population?

Context: for a molecularly targeted drug in the oncology space the sponsor has opened an IND for solid tumors with specific molecular target/biomarker.  The IND-opening study is a traditional dose escalation + dose expansion study design, with multiple tumor types with the same molecular target/biomarker being further evaluated at the same dose in the expansion cohorts.

Proposal:  If the sponsor wants to amend the same Phase 1 protocol to add a new molecularly targeted patient population, is this possible, or will FDA require a separate protocol and separate IND since it's a different molecular target/biomarker that the IND is active for?

Best,
RA
Original Message:
Sent: 16-Apr-2019 08:40
From: Glen Park
Subject: new population - new IND?

In general, if the indication is the same or similar and your are adding a new subpopulation, a new IND would not be needed. If the change is to an ongoing protocol, an amendment to the protocol would be appropriate.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 15-Apr-2019 17:49
From: Anonymous Member
Subject: new population - new IND?

This message was posted by a user wishing to remain anonymous

Hello,
is it correct that I have to file a new IND if I want to extend the product that already has an approved IND for a new subpopulation - or would that be possible as protocol amendment?

Let me clarify, a new molecularly targeted patient population for the same solid tumor (including the line i.e. salvage population) as the original IND protocol, can be done under the same IND i.e. amending the current protocol with an addition of a cohort of patients with new mutation, provided that the dosage form with the same API is same as in the original IND and original FIH population.

The above underlined and bold is very critical in order to use the same protocol under the same IND. This would be considered an exploratory cohort as long as the same solid tumor and line of patient population is used with the same dosage form/API.

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

Original Message:
Sent: 28-Jul-2021 17:37
From: Anonymous Member
Subject: new population - new IND?

This message was posted by a user wishing to remain anonymous

Thanks Glen. I appreciate your active participation on this forum. We as a regulatory community benefit from your insight.

Follow up on this old thread: what if the sponsor is amending an ongoing Phase 1 FIH protocol to add a new genetic sub-population?

Context: for a molecularly targeted drug in the oncology space the sponsor has opened an IND for solid tumors with specific molecular target/biomarker.  The IND-opening study is a traditional dose escalation + dose expansion study design, with multiple tumor types with the same molecular target/biomarker being further evaluated at the same dose in the expansion cohorts.

Proposal:  If the sponsor wants to amend the same Phase 1 protocol to add a new molecularly targeted patient population, is this possible, or will FDA require a separate protocol and separate IND since it's a different molecular target/biomarker that the IND is active for?

Best,
RA
Original Message:
Sent: 16-Apr-2019 08:40
From: Glen Park
Subject: new population - new IND?

In general, if the indication is the same or similar and your are adding a new subpopulation, a new IND would not be needed. If the change is to an ongoing protocol, an amendment to the protocol would be appropriate.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 15-Apr-2019 17:49
From: Anonymous Member
Subject: new population - new IND?

This message was posted by a user wishing to remain anonymous

Hello,
is it correct that I have to file a new IND if I want to extend the product that already has an approved IND for a new subpopulation - or would that be possible as protocol amendment?

I think it would depend on what the new indication is and how closely related it is to the current indication being studied.  If it is closely related then you can probably submit to the same IND.  I suggest you email your FDA Project Manager if you have justification to submit to same IND.

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

Original Message:
Sent: 15-Apr-2019 17:49
From: Anonymous Member
Subject: new population - new IND?

This message was posted by a user wishing to remain anonymous

Hello,
is it correct that I have to file a new IND if I want to extend the product that already has an approved IND for a new subpopulation - or would that be possible as protocol amendment?

Let me give you an example:

If your original IND filing is for Parkinson disease  in general, and now you wish to target a sub-population of Parkinson disease like MSA indication (Orphan indication), you don't need a separate IND. You just submit a new protocol to the same IND. This is only subject to the original dosage form, say capsules, is same for this new indication also. For a different strength of capsules, you need to submit a CMC amendment to go along with the new protocol to the same IND. If you are developing a new dosage form for this indication, then its a different story.
Hope this is clear!

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

Original Message:
Sent: 15-Apr-2019 17:49
From: Anonymous Member
Subject: new population - new IND?

This message was posted by a user wishing to remain anonymous

Hello,
is it correct that I have to file a new IND if I want to extend the product that already has an approved IND for a new subpopulation - or would that be possible as protocol amendment?