Investigating Endpoint Modeling - Biomarkers

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Welcome to the site for the "Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping" 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

The question of, "Where does X type of data belong in a SEND dataset?" has been asked frequently. Some believe that there should be a "biomarker" domain or that immunophenotyping data should be separate from other lab data; the initial premise of our group is that most of these endpoints can be modeled within an existing domain. This group will attack the question, "What is the process for identifying whether a data endpoint is part of an existing domain or needs a separate domain?"

Project Scope

While there are many additional endpoints, such as pharmacodynamics, T-Dar, etc., we begin our investigation and exploration in Biomarkers, ADA (Anti-Drug Antibodies), and Immunophenotyping. The group will also research what the clinical side has done with regard to these endpoints to ensure alignment where possible.


To provide the community with methods to facilitate endpoint modeling using existing domains as opposed creating new or custom domains.



March 2015 - May 2015

  • Determine a refined scope

June 2015 - Dec 2015

  • TBD

Jan 2016 - March 2016

  • Publish


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


Poster presented at 2016 PhUSE CSS

File:Poster Incorporating Unmodeled Data.pdf

White Paper

Final White Paper Available here

File:White Paper Nonclinical Topics Biomarker Modeling.docx

Biomarker Modeling White paper comments

Participation Needs

The team was established at the PhUSE CSS March 2015.

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 ( and Debra Oetzman (

Work Group Participants


  • Debra Oetzman, Instem
  • Mike Wasko, PDS


  • Kathryn Brown, sanofi
  • Karolyn Forlenzo, Boehringer-Ingelheim
  • Pierre Jambaud, sanofi
  • George Kahlbaugh, Boehringer-Ingelheim
  • Catherine Roy, Merck
  • Troy Smyrnios, Zoetis
  • Audrey Walker, Charles River
  • Steven Ward, Eli Lilly
  • Craig Zwickl, Eli Lilly
  • Brian Argo, MPI
  • Christy Kubin, MPI

Conference Calls and Minutes

Our first telecon is scheduled for Thursday April 23rd, 2015 at 2:00 PM EST. Contact a co-lead for further details!

Investigating Endpoint Modeling - Biomarkers Minutes

Last revision by Mwasko79, 2017-05-26