Regulatory Open Forum

Would you please describe how you would manage M2 summaries if you have a parent IND, but new data is available when you are submitting additional initial INDs for the same product that will be cross referencing the parent.  Would you update the parent M2 and cross ref, or write new sections for the new IND?  Or write a summary of just the new info for the new IND and still cross ref to the parent?  Trying to find a logical plan that does not create more issues down the road!  

Thank you!

"write a summary of just the new info for the new IND and still cross ref to the parent" this should suffice!

Would you please describe how you would manage M2 summaries if you have a parent IND, but new data is available when you are submitting additional initial INDs for the same product that will be cross referencing the parent.  Would you update the parent M2 and cross ref, or write new sections for the new IND?  Or write a summary of just the new info for the new IND and still cross ref to the parent?  Trying to find a logical plan that does not create more issues down the road!  

Thank you!

In regards to the summary sections, what would you do for the summaries if you then have a third IND for the same product?  If you have some early information in the parent, cross referenced that for the 2nd IND but also added some newly available information, how do you handle IND #3?.  Would you then cross refer to both of the previous INDs?  What is the best practice when you anticipate one parent and many additional indications with their own INDs?  It seems there is a lot of potential for this to get very messy.  Looking for best practices. Many thanks!

"write a summary of just the new info for the new IND and still cross ref to the parent" this should suffice!

Would you please describe how you would manage M2 summaries if you have a parent IND, but new data is available when you are submitting additional initial INDs for the same product that will be cross referencing the parent.  Would you update the parent M2 and cross ref, or write new sections for the new IND?  Or write a summary of just the new info for the new IND and still cross ref to the parent?  Trying to find a logical plan that does not create more issues down the road!  

Thank you!

Can you specify which M2 summaries you're referring to?

In regards to the summary sections, what would you do for the summaries if you then have a third IND for the same product?  If you have some early information in the parent, cross referenced that for the 2nd IND but also added some newly available information, how do you handle IND #3?.  Would you then cross refer to both of the previous INDs?  What is the best practice when you anticipate one parent and many additional indications with their own INDs?  It seems there is a lot of potential for this to get very messy.  Looking for best practices. Many thanks!

"write a summary of just the new info for the new IND and still cross ref to the parent" this should suffice!

Would you please describe how you would manage M2 summaries if you have a parent IND, but new data is available when you are submitting additional initial INDs for the same product that will be cross referencing the parent.  Would you update the parent M2 and cross ref, or write new sections for the new IND?  Or write a summary of just the new info for the new IND and still cross ref to the parent?  Trying to find a logical plan that does not create more issues down the road!  

Thank you!

Just looking for general advice for planning, as of now we have 2 INDs for the same product but I anticipate there may be many more, so just thinking ahead for some best practices for cross referencing.  I know the summaries are generally not updated until filing a marketing app, but is it not possible some might have new information that should be included when submitting a new IND?  Then what do you do about IND #3 or #4?  

Thank you

Can you specify which M2 summaries you're referring to?

In regards to the summary sections, what would you do for the summaries if you then have a third IND for the same product?  If you have some early information in the parent, cross referenced that for the 2nd IND but also added some newly available information, how do you handle IND #3?.  Would you then cross refer to both of the previous INDs?  What is the best practice when you anticipate one parent and many additional indications with their own INDs?  It seems there is a lot of potential for this to get very messy.  Looking for best practices. Many thanks!

"write a summary of just the new info for the new IND and still cross ref to the parent" this should suffice!

Would you please describe how you would manage M2 summaries if you have a parent IND, but new data is available when you are submitting additional initial INDs for the same product that will be cross referencing the parent.  Would you update the parent M2 and cross ref, or write new sections for the new IND?  Or write a summary of just the new info for the new IND and still cross ref to the parent?  Trying to find a logical plan that does not create more issues down the road!  

Thank you!

Hi

Full transparency: I would like developers and others to advocate for clarity that submitting CMC information to Module 2.3 is not mandatory for a US IND. (But is an option if desired by an applicant). It is something that I feel adds little value. With the exception of an initial submission (when it is stated as a requirement in e.g. the gene therapy IND guidance) I personally would not advise any client to lifecycle it. I completely agree with the comment that it adds workload - and as far as I am concerned also adds ambiguity to compliance activities since from my perspective it is not "registered detail".

And to add! I would not advise clients to provide more than the Module 3 headings for the CMC content of an IMPD (with the exception of a couple of IMP specific quirks!).

That's just my opinion!

Alexis

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Alexis Cockroft
Lex Regulatory Ltd
Royston
United Kingdom

Original Message:
Sent: 16-Mar-2019 05:30
From: Rachel Thornton
Subject: IND Module 2 Updates

​Just sharing our practice:

We do not submit Module 2.3 to the IND; we submit all Quality information under Module 3 in the eCTD. This was not always the case, and we have some older INDs where a Module 2 was submitted with the initial IND, but we have not updated it since then as CMC development has progressed. FDA (CDER, OPQ) has had no issue with this.

For the IMPD, we also only submit Module 3, though I can see a benefit to including a Module 2 if the information starts to get lengthy and/or complicated.

The only country where we routinely submit Module 2.3 is to Canada, but then Canada actually dictates that the Quality information is supposed to go first in Module 2.3, with supplemental information in Module 3.

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Rachel Thornton
Associate Director
Smyrna GA
United States

Original Message:
Sent: 15-Mar-2019 09:03
From: Jingdong Zhu
Subject: IND Module 2 Updates

I agree with Glen that US IND module 2 is typically not needed or greatly simplified by simply referring to M3. However, for EU IMPD, there might still be some value to include M2. As the original question was asked on IND only, the practice of IMPD may be out of picture and out of context unless a harmonized IMPD is also considered simultaneously.
Thanks for sharing your thoughts.

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Gene Zhu
Independent Consultant
Basking Ridge NJ
USA

Original Message:
Sent: 14-Mar-2019 09:07
From: Rajnish Kumar
Subject: IND Module 2 Updates

Thanks Glen for update. The rationale behind my sharing is that QoS is a comprehensive overview of all the information's in the dossier. If any specific information is updated in the dossier, it should also sync with QoS, otherwise, we might get into situation of two different sets of information. Additionally, I also encountered this requirement from some of the EU member states in the past.

Best Regards

Rajnish

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Rajnish Kumar
Founder
Delft
Netherlands

Original Message:
Sent: 14-Mar-2019 08:40
From: Glen Park
Subject: IND Module 2 Updates

Rajnish - that is interesting comment. I and others that I have spoken to, including at FDA, do not consider it necessary to include a QOS in Module 2 for an IND. It is double the work and provides no additional value. May I ask why you consider it necessary to have a QOS and to update all of the Module 2 summaries? From you comment, I assume you do it every time you submit a nonclinical or clinical report to the IND?

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

Original Message:
Sent: 14-Mar-2019 00:43
From: Rajnish Kumar
Subject: IND Module 2 Updates

Module requires update everytime, you make a change, specifically in the CMC part of the IND

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Rajnish Kumar
Founder
Delft
Netherlands

Original Message:
Sent: 12-Mar-2019 14:33
From: Marissa Berry
Subject: IND Module 2 Updates

Hi all,

How often do you recommend updating Module 2 summaries once an IND has been opened?  In practice, do you ever update them once the IND is active?

Thanks!

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Marissa Berry, Ph.D., RAC
Manager, Global Regulatory Affairs
Durham, NC
United States
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