Bioanalytical Community

Hello Lili,

All this will depend on the reagents you are using, if you have well characterized reagents and specific to the sponsor drug (Anti-IDs or affinity purified antibodies…), on our experience one assay for the sponsor drug will be enough with the assumption that you are testing the drug interference in your PK assay using the Co-med drug then for the ADA, assess your Co-med drug in the confirmatory stage to show any or no cross-reactivity of the ADA anti-sponsor drug toward the Co-med drug

Best, Cheikh

------------------------------
Cheikh Kane, PhD| Executive Director, BioPharma Services
Office: 913.248.3135 |Cell: 203-970 0189
[email protected] | kcasbio.com

IMPORTANT: The contents of this email and any attachments are confidential. They are intended for the named recipient(s) only. If you have received this email by mistake, please notify the sender immediately and do not disclose the contents to anyone or make copies thereof.
------------------------------

Original Message:
Sent: 07-28-2023 09:31
From: Lili Yang
Subject: Develop PK and ADA assays for a biologic Co-med in clinical trials (Phase 1-4)?

To BA community:

 

What is your experience when Co-med such as MAbs or other approved biologics being dosed together with Sponsor's drugs (also a biologic) for phase 1 to phase 4 clinical trials, in addition to the PK/ADA assays for the sponsor's drugs, do you also develop PK and ADA assays for the Co-med or this is not done?

 

 

 

 

 

 

The content of this email and of any files transmitted may contain confidential, proprietary or legally privileged information and is intended solely for the use of the person/s or entity/ies to whom it is addressed. If you have received this email in error you have no permission whatsoever to use, copy, disclose or forward all or any of its contents. Please immediately notify the sender and thereafter delete this email and any attachments.

Hello Lili,

All this will depend on the reagents you are using, if you have well characterized reagents and specific to the sponsor drug (Anti-IDs or affinity purified antibodies…), on our experience one assay for the sponsor drug will be enough with the assumption that you are assessing the drug interference in your PK assay using the Co-med drug then for the ADA, test your Co-med drug in the confirmatory stage to show any or no cross-reactivity of the ADA anti-sponsor drug toward the Co-med drug

------------------------------
Cheikh Kane, PhD| Executive Director, BioPharma Services
Office: 913.248.3135 |Cell: 203-970 0189
[email protected] | kcasbio.com
Connect with us | LinkedIn | Twitter
------------------------------

Original Message:
Sent: 07-28-2023 09:31
From: Lili Yang
Subject: Develop PK and ADA assays for a biologic Co-med in clinical trials (Phase 1-4)?

To BA community:

 

What is your experience when Co-med such as MAbs or other approved biologics being dosed together with Sponsor's drugs (also a biologic) for phase 1 to phase 4 clinical trials, in addition to the PK/ADA assays for the sponsor's drugs, do you also develop PK and ADA assays for the Co-med or this is not done?

 

 

 

 

 

 

The content of this email and of any files transmitted may contain confidential, proprietary or legally privileged information and is intended solely for the use of the person/s or entity/ies to whom it is addressed. If you have received this email in error you have no permission whatsoever to use, copy, disclose or forward all or any of its contents. Please immediately notify the sender and thereafter delete this email and any attachments.

If your drug is immunostimulatory, I see scientific value to understanding its impact on the comedication ADA seroconversion, particularly if positive ADA already known to impact safety or efficacy of that comedication. Not so much for the other direction of immunosuppression.
I'm not aware of any scientific reason to suspect changes in PK with co-administration of biologics, but if there is a reason to suspect, getting some steady-state PK may be warranted.

------------------------------
Joleen White Ph.D.
AAPS 2023 Global Health Community Past Chair
Bioanalytical 101 Course Development
Head of Bioassay Development
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: 07-28-2023 09:31
From: Lili Yang
Subject: Develop PK and ADA assays for a biologic Co-med in clinical trials (Phase 1-4)?

To BA community:

 

What is your experience when Co-med such as MAbs or other approved biologics being dosed together with Sponsor's drugs (also a biologic) for phase 1 to phase 4 clinical trials, in addition to the PK/ADA assays for the sponsor's drugs, do you also develop PK and ADA assays for the Co-med or this is not done?

 

 

 

 

 

 

The content of this email and of any files transmitted may contain confidential, proprietary or legally privileged information and is intended solely for the use of the person/s or entity/ies to whom it is addressed. If you have received this email in error you have no permission whatsoever to use, copy, disclose or forward all or any of its contents. Please immediately notify the sender and thereafter delete this email and any attachments.

Thank you for the feedback.

Best

Lili Yang

------------------------------
[email protected]

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

Original Message:
Sent: 08-07-2023 17:40
From: Joleen White
Subject: Develop PK and ADA assays for a biologic Co-med in clinical trials (Phase 1-4)?

If your drug is immunostimulatory, I see scientific value to understanding its impact on the comedication ADA seroconversion, particularly if positive ADA already known to impact safety or efficacy of that comedication. Not so much for the other direction of immunosuppression.
I'm not aware of any scientific reason to suspect changes in PK with co-administration of biologics, but if there is a reason to suspect, getting some steady-state PK may be warranted.

------------------------------
Joleen White Ph.D.
AAPS 2023 Global Health Community Past Chair
Bioanalytical 101 Course Development
Head of Bioassay Development
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: 07-28-2023 09:31
From: Lili Yang
Subject: Develop PK and ADA assays for a biologic Co-med in clinical trials (Phase 1-4)?

To BA community:

 

What is your experience when Co-med such as MAbs or other approved biologics being dosed together with Sponsor's drugs (also a biologic) for phase 1 to phase 4 clinical trials, in addition to the PK/ADA assays for the sponsor's drugs, do you also develop PK and ADA assays for the Co-med or this is not done?

 

 

 

 

 

 

The content of this email and of any files transmitted may contain confidential, proprietary or legally privileged information and is intended solely for the use of the person/s or entity/ies to whom it is addressed. If you have received this email in error you have no permission whatsoever to use, copy, disclose or forward all or any of its contents. Please immediately notify the sender and thereafter delete this email and any attachments.