Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies
- 1 Working Group Overview
- 2 Plans
- 3 Deliverables
- 4 Participation Needs
- 5 Work Group Participants
- 6 Conference Calls and Minutes
- 7 Webinar Presentations
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
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.
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.
- Determine endpoints
- Call for Participants
- Maintain wiki (ongoing)
- Research CDISC ADA
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 (firstname.lastname@example.org), Gretchen Dean (email@example.com) and/or Thomas Gade Bjerregaard (firstname.lastname@example.org).
Work Group Participants
- Michael Wasko - email@example.com
- Gretchen Dean - firstname.lastname@example.org
- Thomas Gade Bjerregaard - email@example.com
- 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
Conference Calls and Minutes
CDISC Cross Collaboration with CDISC Microbiology Team in regards to ADA
Last revision by Mwasko79, 2017-11-1