Regulatory Sciences Community

This message was posted by a user wishing to remain anonymous

Hi Friends

We have a registrational trial at hand however this is our first BLA.  Has anyone gone through this process before?  Where can I find information on how to submit PK and PD data?  Is there a template?  Greatly appreciate any guidance on how this process looks like.

Best

Hello

If you need help with regulatory submission of PK and PD data, I have substantial experience with this kind of work as a part of Regulatory Consulting CRO and now as freelance consultant. Please feel free to reach at [email protected].
Checkout my LinkedIn profile.
Thank you,

Galina Bernstein

------------------------------
Galina Bernstein Ph.D.
Senior Director of Clinical Pharmacology
AzureDelta Consulting
Thornhill ON
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------

Original Message:
Sent: 12-02-2022 08:59
From: Anonymous Member
Subject: BLA submission process for PK and PD data

This message was posted by a user wishing to remain anonymous

Hi Friends

We have a registrational trial at hand however this is our first BLA.  Has anyone gone through this process before?  Where can I find information on how to submit PK and PD data?  Is there a template?  Greatly appreciate any guidance on how this process looks like.

Best

Thank you, Galina!  Will follow up with you!


Original Message:
Sent: 12-05-2022 09:54
From: Galina Bernstein
Subject: BLA submission process for PK and PD data

Hello

If you need help with regulatory submission of PK and PD data, I have substantial experience with this kind of work as a part of Regulatory Consulting CRO and now as freelance consultant. Please feel free to reach at [email protected].
Checkout my LinkedIn profile.
Thank you,

Galina Bernstein

------------------------------
Galina Bernstein Ph.D.
Senior Director of Clinical Pharmacology
AzureDelta Consulting
Thornhill ON
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.

Original Message:
Sent: 12-02-2022 08:59
From: Anonymous Member
Subject: BLA submission process for PK and PD data

This message was posted by a user wishing to remain anonymous

Hi Friends

We have a registrational trial at hand however this is our first BLA.  Has anyone gone through this process before?  Where can I find information on how to submit PK and PD data?  Is there a template?  Greatly appreciate any guidance on how this process looks like.

Best

There are sample analysis report templates now available from the Bioanalytical Community. I would also suggest that you avail yourself of the opportunity to get copies of Module 2 documents from approved molecules in EU, since they publish redacted module 5. You have to register on EMA website to request access, and your regulatory group can do that. Modules 2.7.1 and 2.7.2 will be your primary locations for these types of data.

I agree that a good consultant in this area is worth more than their weight in gold to help you navigate the format. You want to be brief in the summary documents while maintaining transparency about what was actually done. This is significantly more challenging than the longer source documents where there is lots of information with a ToC.

If you wish for additional consultants to interview, please contact me privately. I am not a consultant but happy to share some additional names for comparative purposes.  I do not like to advocate for individuals publicly because I have not worked with everyone and don't want to exclude good people just because I have no personal experience.

------------------------------
Joleen White Ph.D.
AAPS 2022 Global Health Community Chair
AAPS 2022 Bioanalytical Community Past Chair
Head of Bioassay Development and Operations
Gates Medical Research Institute
Cambridge MA
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------

Original Message:
Sent: 12-02-2022 08:59
From: Anonymous Member
Subject: BLA submission process for PK and PD data

This message was posted by a user wishing to remain anonymous

Hi Friends

We have a registrational trial at hand however this is our first BLA.  Has anyone gone through this process before?  Where can I find information on how to submit PK and PD data?  Is there a template?  Greatly appreciate any guidance on how this process looks like.

Best

This message was posted by a user wishing to remain anonymous

Thank you, Joleen.  This is helpful.  I will browse through the BioA community for the template.

Best
Faith
Original Message:
Sent: 12-07-2022 08:48
From: Joleen White
Subject: BLA submission process for PK and PD data

There are sample analysis report templates now available from the Bioanalytical Community. I would also suggest that you avail yourself of the opportunity to get copies of Module 2 documents from approved molecules in EU, since they publish redacted module 5. You have to register on EMA website to request access, and your regulatory group can do that. Modules 2.7.1 and 2.7.2 will be your primary locations for these types of data.

I agree that a good consultant in this area is worth more than their weight in gold to help you navigate the format. You want to be brief in the summary documents while maintaining transparency about what was actually done. This is significantly more challenging than the longer source documents where there is lots of information with a ToC.

If you wish for additional consultants to interview, please contact me privately. I am not a consultant but happy to share some additional names for comparative purposes.  I do not like to advocate for individuals publicly because I have not worked with everyone and don't want to exclude good people just because I have no personal experience.

------------------------------
Joleen White Ph.D.
AAPS 2022 Global Health Community Chair
AAPS 2022 Bioanalytical Community Past Chair
Head of Bioassay Development and Operations
Gates Medical Research Institute
Cambridge MA
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.

Original Message:
Sent: 12-02-2022 08:59
From: Anonymous Member
Subject: BLA submission process for PK and PD data

This message was posted by a user wishing to remain anonymous

Hi Friends

We have a registrational trial at hand however this is our first BLA.  Has anyone gone through this process before?  Where can I find information on how to submit PK and PD data?  Is there a template?  Greatly appreciate any guidance on how this process looks like.

Best

I believe it was published rather than in the community library. Hoping @Chad Briscoe and @Robert Dodge (current chairs), can help point you towards the citation. I haven't used the new template since I no longer have an internal lab so use our CRO's templates.​​​

------------------------------
Joleen White Ph.D.
AAPS 2022 Global Health Community Chair
AAPS 2022 Bioanalytical Community Past Chair
Head of Bioassay Development and Operations
Gates Medical Research Institute
Cambridge MA
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------

Original Message:
Sent: 12-07-2022 08:55
From: Anonymous Member
Subject: BLA submission process for PK and PD data

This message was posted by a user wishing to remain anonymous

Thank you, Joleen.  This is helpful.  I will browse through the BioA community for the template.

Best
Faith
Original Message:
Sent: 12-07-2022 08:48
From: Joleen White
Subject: BLA submission process for PK and PD data

There are sample analysis report templates now available from the Bioanalytical Community. I would also suggest that you avail yourself of the opportunity to get copies of Module 2 documents from approved molecules in EU, since they publish redacted module 5. You have to register on EMA website to request access, and your regulatory group can do that. Modules 2.7.1 and 2.7.2 will be your primary locations for these types of data.

I agree that a good consultant in this area is worth more than their weight in gold to help you navigate the format. You want to be brief in the summary documents while maintaining transparency about what was actually done. This is significantly more challenging than the longer source documents where there is lots of information with a ToC.

If you wish for additional consultants to interview, please contact me privately. I am not a consultant but happy to share some additional names for comparative purposes.  I do not like to advocate for individuals publicly because I have not worked with everyone and don't want to exclude good people just because I have no personal experience.

------------------------------
Joleen White Ph.D.
AAPS 2022 Global Health Community Chair
AAPS 2022 Bioanalytical Community Past Chair
Head of Bioassay Development and Operations
Gates Medical Research Institute
Cambridge MA
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.

Original Message:
Sent: 12-02-2022 08:59
From: Anonymous Member
Subject: BLA submission process for PK and PD data

This message was posted by a user wishing to remain anonymous

Hi Friends

We have a registrational trial at hand however this is our first BLA.  Has anyone gone through this process before?  Where can I find information on how to submit PK and PD data?  Is there a template?  Greatly appreciate any guidance on how this process looks like.

Best