Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

Our product is currently running clinical trials in the EU for Phase 1 and we intend to open a US IND for the Phase 2 studies. We plan to hold a pre-IND meeting with the FDA to discuss the Phase 2 protocol (synopsis) and our development plan with the product. However, following the pre-IND meeting, we may file the Phase 1 protocol to open US sites (but we don't discuss the Phase 1 protocol at all during our pre-IND meeting).

Do you see any challenges with this approach?

Thanks in advance for your feedback!
Anon

The biggest challenge I would see is that FDA may not be willing to answer all questions regarding a Phase 2 protocol without Phase 1 information and based on a synopsis only. In my experience FDA is reluctant to talk about details of study design and conduct without a full protocol to review. Without knowing what the questions are regarding the Phase 2 protocol or the type of product you have, it is difficult to be very concrete. I think providing the information on the Phase 1 study is more likely to get you useful feedback from FDA.

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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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Original Message:
Sent: 14-Aug-2019 10:51
From: Anonymous Member
Subject: pre-IND meeting

This message was posted by a user wishing to remain anonymous

Hello,

Our product is currently running clinical trials in the EU for Phase 1 and we intend to open a US IND for the Phase 2 studies. We plan to hold a pre-IND meeting with the FDA to discuss the Phase 2 protocol (synopsis) and our development plan with the product. However, following the pre-IND meeting, we may file the Phase 1 protocol to open US sites (but we don't discuss the Phase 1 protocol at all during our pre-IND meeting).

Do you see any challenges with this approach?

Thanks in advance for your feedback!
Anon

Original Message------

The biggest challenge I would see is that FDA may not be willing to answer all questions regarding a Phase 2 protocol without Phase 1 information and based on a synopsis only. In my experience FDA is reluctant to talk about details of study design and conduct without a full protocol to review. Without knowing what the questions are regarding the Phase 2 protocol or the type of product you have, it is difficult to be very concrete. I think providing the information on the Phase 1 study is more likely to get you useful feedback from FDA.

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

I agree with Glen! You won't be getting answers for Phase 2 when your package does not contain the information for Phase 2 .

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Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States
------------------------------

Original Message:
Sent: 14-Aug-2019 10:51
From: Anonymous Member
Subject: pre-IND meeting

This message was posted by a user wishing to remain anonymous

Hello,

Our product is currently running clinical trials in the EU for Phase 1 and we intend to open a US IND for the Phase 2 studies. We plan to hold a pre-IND meeting with the FDA to discuss the Phase 2 protocol (synopsis) and our development plan with the product. However, following the pre-IND meeting, we may file the Phase 1 protocol to open US sites (but we don't discuss the Phase 1 protocol at all during our pre-IND meeting).

Do you see any challenges with this approach?

Thanks in advance for your feedback!
Anon