Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies

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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 - January 12th draft, abstract with summary due - Final poster due Feb 9th

- White Paper to follow

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
  • Thomas Gade Bjerregaard - tgb@novonordisk.com


Participants:

  • Alan Brown
  • Christy Kubin
  • Janessa Pierce
  • Jennifer Emeneggee
  • Joleen White
  • Joyce Ford
  • Kennan Marsh
  • Leslie Lorello
  • Rihab Kordane
  • Stephen MacMannis
  • Trina Jiao
  • Wendy Freeburn
  • William Houser
  • Susan Steen
  • Anna Pron-Zwick
  • Dennis Stocker
  • Jordan Li
  • Christine Connolly
  • Jason Rogers
  • Anthony Fata

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



Last revision by Mwasko79, 2017-12-1