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

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===Project Scope===
 
===Project Scope===
 
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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===
 
===Vision===

Revision as of 13:26, 19 June 2017


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

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

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:

  • Mike Wasko, PDS
  • Gretchen Dean, Pfizer
  • Thomas Gade Bjerregaard

Participants:


Conference Calls and Minutes

Investigating Endpoint Modeling - ADA Minutes



Last revision by Mwasko79, 2017-06-19