Difference between revisions of "Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies"

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This page describes high-level project management details on the group, including purpose, milestones, attendees, and so on.
 
This page describes high-level project management details on the group, including purpose, milestones, attendees, and so on.
We are part of the FDA/PhUSE Computational Sciences Nonclinical Working Group.  
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We are part of the FDA/PHUSE Computational Sciences Nonclinical Working Group.  
 
Learn more about the larger working group at [[Non-Clinical Road-map and Impacts on Implementation]].
 
Learn more about the larger working group at [[Non-Clinical Road-map and Impacts on Implementation]].
  
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- Poster
 
- Poster
 
- Scope of Poster - SENDIG v3.0 recommendation and then provisional recommendation for SENDIG v3.1
 
- Scope of Poster - SENDIG v3.0 recommendation and then provisional recommendation for SENDIG v3.1
- January 12th draft, abstract with summary due
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- Final poster presented at PHUSE CSS 2018
- Final poster presented at PhUSE CSS 2018
 
  
[http://www.phusewiki.org/wiki/images/1/11/PP_-_Modelling_of_ADA_in_SEND_-_PhUSE_CSS_18_final.pdf]
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[http://www.phusewiki.org/wiki/images/1/11/PP_-_Modelling_of_ADA_in_SEND_-_PhUSE_CSS_18_final.pdf PhUSE 2018 CSS ADA team poster]
  
- White Paper to follow
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- Final White Paper
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[https://www.phusewiki.org/wiki/images/9/97/22317_PHUSE_Deliverables_Nov_2019_%E2%80%93_Recommendations_for_ADA_Modeling_in_SENDIG_A4_v3.pdf Final ADA modeling White Paper]
  
 
==Participation Needs==  
 
==Participation Needs==  
  
 
Call For Participants for Nonclinical Topics Working Group “Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies” Project
 
Call For Participants for Nonclinical Topics Working Group “Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies” Project
The team was established at the PhUSE CSS March 2017.
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The team was established at the PHUSE CSS March 2017.
 
What is the Goal/Focus?
 
What is the Goal/Focus?
 
To provide recommendations for modeling Anti-Drug Antibody utilizing SENDIG V3.0 and SENDIG V3.1 Domains and variables.  Create a landscape of possible solutions and provide recommendations.  Consider appropriateness for visualization for ADA at a high level.  This will included investigating what clinical is doing and/or recommending and how this can be harmonized into SEND datasets.
 
To provide recommendations for modeling Anti-Drug Antibody utilizing SENDIG V3.0 and SENDIG V3.1 Domains and variables.  Create a landscape of possible solutions and provide recommendations.  Consider appropriateness for visualization for ADA at a high level.  This will included investigating what clinical is doing and/or recommending and how this can be harmonized into SEND datasets.
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* Michael Wasko - michael.wasko@pdslifesciences.com
 
* Michael Wasko - michael.wasko@pdslifesciences.com
 
* Gretchen Dean - gretchen.e.dean@pfizer.com  
 
* Gretchen Dean - gretchen.e.dean@pfizer.com  
* Thomas Gade Bjerregaard -  tgb@novonordisk.com
 
  
  
 
Participants:
 
Participants:
* Thomas Gade Bjerregaard, Novo Nordisk
 
 
* Alan Brown, Novartis
 
* Alan Brown, Novartis
* Kathy Brown, Sanofi
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* Anna Pron-Zwick, AstraZeneca
* Christine Connolly, EMD Serono
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* Anthony Fata, SNBL
 +
* Christy Kubin, MPI Research
 +
* Dennis Stocker, Bristol-Myers Squibb
 
* Gretchen Dean, Pfizer
 
* Gretchen Dean, Pfizer
 +
* Jason Rogers, Envigo
 +
* Janessa Pierce, Merck
 
* Jennifer Emenegger, Merck
 
* Jennifer Emenegger, Merck
* Anthony Fata, SNBL
+
* Jordan Li, National Institutes of Health
 +
* Joleen White, Gates MRI
 
* Joyce Ford, Janssen
 
* Joyce Ford, Janssen
 +
* Kathy Brown, Sanofi
 +
* Kennan Marsh, Abbvie
 +
* Lauren White, PHUSE
 +
* Leslie Lorello, Pfizer
 +
* Virginie ORY - Ipsen
 +
* Ralf Loebbert, Abbvie
 +
* Rihab Kordane, Charles River Laboratories
 +
* Susan Steen, Bristol-Myers Squibb
 +
* Thomas Gade Bjerregaard, Novo Nordisk
 +
* Trina Jiao, Janssen
 +
* Virginie Ory, Ipsen
 
* Wendy Freeburn, Bristol-Myers Squibb
 
* Wendy Freeburn, Bristol-Myers Squibb
 
* William Houser, Bristol-Myers Squibb
 
* William Houser, Bristol-Myers Squibb
* Trina Jiao, Janssen
 
* Rihab Kordane, Charles River Laboratories
 
* Christy Kubin, MPI Research
 
* Jordan Li, National Institutes of Health
 
* Ralf Loebbert, Abbvie
 
* Leslie Lorello, Pfizer
 
* Stephen MacMannis, Pfizer
 
* Kennan Marsh, Abbvie
 
* Janessa Pierce, Merck
 
* Anna Pron-Zwick, AstraZeneca
 
* Jason Rogers, Envigo
 
* Susan Steen, Bristol-Myers Squibb
 
* Dennis Stocker, Bristol-Myers Squibb 
 
* Joleen White, EMD Serono
 
* Lauren White, PhUSE
 
  
 
== Conference Calls and Minutes ==
 
== Conference Calls and Minutes ==
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<br>
 
<br>
 
* [http://www.phusewiki.org/wiki/index.php?title=File:ADA_Modelling_proposal_06Oct2017.pdf Working Slide deck of proposal]
 
* [http://www.phusewiki.org/wiki/index.php?title=File:ADA_Modelling_proposal_06Oct2017.pdf Working Slide deck of proposal]
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 +
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'''Interested in attending a webinar where the White Paper for ADA modelling will be presented, Then attend the PHUSE Webinar below:'''
 +
 +
Here is the information to share for those wishing to join as a general attendee.
 +
 +
 +
'''Please register for Webinar Wednesday - 25th March, 2020 3:00 PM GMT at:'''
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 +
https://attendee.gotowebinar.com/register/4722240118418764812
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 +
After registering, you will receive a confirmation email containing information about joining the webinar.
 +
 +
  
 
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Last revision by {{REVISIONUSER}}, {{REVISIONYEAR}}-{{REVISIONMONTH}}-{{REVISIONDAY}}

Latest revision as of 06:38, 2 March 2020


Welcome to the site for the "Investigating Endpoint Modeling - How to Model Anti-Drug Antibody Data in Nonclinical Studies" project group.

This page describes high-level project management details on the group, including purpose, milestones, attendees, and so on. We are part of the FDA/PHUSE Computational Sciences Nonclinical Working Group. Learn more about the larger working group at Non-Clinical Road-map and Impacts on Implementation.

Working Group Overview

Identified Need/Challenge

Withing the SEND Model, SENDIG version 3.0 and SENDIG version 3.1, the model does not dictate a clear methodology for reporting and tabulating Anti-Drug Antibody Data in Nonclinical Studies.

As the model develops, these considerations are taken into account, but prior recommendations and possible solutions are needed.

Project Scope

To provide recommendations for modeling Anti-Drug Antibody utilizing SENDIG V3.0 and SENDIG V3.1 Domains and variables. Create a landscape of possible solutions and provide recommendations. Consider appropriateness for visualization for ADA at a high level. Investigate the current SDTM practices and recommendations.

Vision

Plans

Milestones

Tasks

  • Determine endpoints
  • Call for Participants
  • Maintain wiki (ongoing)
  • Research CDISC ADA


Deliverables

- Poster - Scope of Poster - SENDIG v3.0 recommendation and then provisional recommendation for SENDIG v3.1 - Final poster presented at PHUSE CSS 2018

PhUSE 2018 CSS ADA team poster


- Final White Paper

Final ADA modeling White Paper

Participation Needs

Call For Participants for Nonclinical Topics Working Group “Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies” Project The team was established at the PHUSE CSS March 2017. What is the Goal/Focus? To provide recommendations for modeling Anti-Drug Antibody utilizing SENDIG V3.0 and SENDIG V3.1 Domains and variables. Create a landscape of possible solutions and provide recommendations. Consider appropriateness for visualization for ADA at a high level. This will included investigating what clinical is doing and/or recommending and how this can be harmonized into SEND datasets.

Who are we looking for to participate? SEND Core, Preclinical CROs/Bioanalytical labs, Industry (Pharma and biotechnology for preclinical), SEND software vendors, and SEND service vendors.


Call for participation! What is the commitment?  Time (minimum of 1 hour every two weeks for team meetings, up to 3 hours / month)  Expected to contribute, not just be a spectator  Contribution of viewpoints and content  Wiki - creating/reviewing page content If you would like to participate, please contact the co-leads for this group: Mike Wasko (michael.wasko@pdslifesciences.com), Gretchen Dean (gretchen.e.dean@pfizer.com) and/or Thomas Gade Bjerregaard (tgb@novonordisk.com).

Work Group Participants

Co-leads:

  • Michael Wasko - michael.wasko@pdslifesciences.com
  • Gretchen Dean - gretchen.e.dean@pfizer.com


Participants:

  • Alan Brown, Novartis
  • Anna Pron-Zwick, AstraZeneca
  • Anthony Fata, SNBL
  • Christy Kubin, MPI Research
  • Dennis Stocker, Bristol-Myers Squibb
  • Gretchen Dean, Pfizer
  • Jason Rogers, Envigo
  • Janessa Pierce, Merck
  • Jennifer Emenegger, Merck
  • Jordan Li, National Institutes of Health
  • Joleen White, Gates MRI
  • Joyce Ford, Janssen
  • Kathy Brown, Sanofi
  • Kennan Marsh, Abbvie
  • Lauren White, PHUSE
  • Leslie Lorello, Pfizer
  • Virginie ORY - Ipsen
  • Ralf Loebbert, Abbvie
  • Rihab Kordane, Charles River Laboratories
  • Susan Steen, Bristol-Myers Squibb
  • Thomas Gade Bjerregaard, Novo Nordisk
  • Trina Jiao, Janssen
  • Virginie Ory, Ipsen
  • Wendy Freeburn, Bristol-Myers Squibb
  • William Houser, Bristol-Myers Squibb

Conference Calls and Minutes

Investigating Endpoint Modeling - ADA Minutes


CDISC Cross Collaboration with CDISC Microbiology Team in regards to ADA

https://wiki.cdisc.org/display/TER/Anti-Drug-Antibodies+Modeling+Page

Webinar Presentations



Interested in attending a webinar where the White Paper for ADA modelling will be presented, Then attend the PHUSE Webinar below:

Here is the information to share for those wishing to join as a general attendee.


Please register for Webinar Wednesday - 25th March, 2020 3:00 PM GMT at:

https://attendee.gotowebinar.com/register/4722240118418764812

After registering, you will receive a confirmation email containing information about joining the webinar.



Last revision by Laurenwhite, 2020-03-2