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

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(Participation Needs)
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==Participation Needs==  
 
==Participation Needs==  
  
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Call For Participants for Nonclinical Topics Working Group “Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies” Project
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The team was established at the PhUSE CSS March 2017.
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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.
  
'''Call for participation!'''<br />
+
Who are we looking for to participate?
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SEND Core, Preclinical CROs/Bioanalytical labs, Industry (Pharma and biotechnology for preclinical), SEND software vendors, and SEND service vendors.
  
'''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) and Debra Oetzman (debra.oetzman@instem.com)
+
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==
 
==Work Group Participants==

Revision as of 14:23, 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

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