Difference between revisions of "2017-Aug-11 BiWeekly PhUSE Nonclinical ADA Endpoint Modeling"

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(Attendance)
(Minutes)
 
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==Minutes==
 
==Minutes==
1) Introductions
 
 
2) Usage of PhUSE Wiki:
 
http://www.phusewiki.org/wiki/index.php?title=Modeling_Endpoints:_How_to_Model_Anti-Drug_Antibody_Data_in_Nonclinical_Studies
 
 
3) Reviewed charter
 
 
4) Discussions:
 
Mike shared feedback received from PhUSE Steering Committee was to make sure we are not introducing new/conflicting methodology as to what clinical is doing.  Can we model using existing domains in SEND 3.0?
 
 
Bill Question: Is there someone from clinical team that could join?
 
 
Thomas shared Novo Nordisk approach: shared usage of LB domain which was rejected by CDISC as terminology to be used in  the LB code list and recommended it be used in IS.  IS domain is used in clinical – where they intend to use as measurement for immunogenicity.  Problem is IS domain is not available in SEND 3.0.  ADA is compound specific and generic terms need to work together.  Concern about hijacking the subcat used in clinical.
 
 
ADA reporting: positive/negative result as well as titer or RLU (e.g., magnitude of response)
 
 
Company to company variability in how assay methodology is applied (screen vs titre), neutralizing and cross reactivity, so needs to be flexible.  Some companies may do binding and neutralizing.  Methods can also be developed for cross reactivity (e.g. against administered compound and endogenous target).
 
 
Remit: guidance on SEND and future implementations and address how we should approach under SEND3.0.
 
 
FDA won’t expect dataset in standardized format until standard is defined and pilots have been conducted.
 
 
 
===General===
 
Types of expertise on the team:
 
 
Scientific representation – Nonclinical.  Can we add someone from Clinical?
 
 
CDISC Controlled terminology team (Virology) – Jordan Li
 
 
SDTM IS representation – Craig ?
 
 
FDA rep -for expectations in nonclinical
 
 
 
 
  
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Minutes Courtesy of Gretchen Dean
  
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Given the discussion today I thought it might be nice to include an article with background on ADA testing.  I think this Covance white paper is a nice summary.  Testing is discussed on page 3:  http://www.covance.com/content/dam/covance/assetLibrary/whitepapers/adawhitepaperpdf.pdf
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I took down the following notes:
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A summary of the interchange discussion was shared.  Notes from this meeting can be found here:  https://wiki.cdisc.org/display/TER/Anti-Drug-Antibodies+Modeling+Page  Mike will also provide a PDF for those who cannot access. MRC= Modelling Review Committee
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It was generally agreed that for now:  the LB domain can be used with SENDIG 3.0 to model ADA data. Some companies may not have an IT solution in place that will allow them to model this data in IS domain (which was generally agreed to be the long term solution for this data). The other option mentioned was a custom domain could be considered.
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Participants discussed various scenarios for ADA testing strategies and endpoints. We reviewed the IS example on the wiki.  General agreement that “agent” would be sufficient to describe what the ADA method was specific toward and a nonstd variable is not needed (NSV).
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Thomas will reach out to Craig Zwicki about using “function definition” (epitopes and cross reactivity). Not sure I captured this right
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Action: All to  review controlled terminology for  “ISMETHOD”
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Next meeting is 8/25.  Mike will not be able to attend, but will have the go to meeting activated.  Next meeting we will review some examples of data (Thomas and Leslie has previously volunteered).
  
 
==Action Items==
 
==Action Items==

Latest revision as of 14:06, 16 August 2017



<< Go back to the Investigating Endpoint Modeling - ADA Minutes Page When: 2017-08-11, 09:00-10:00 EDT
Place: Telecon

Logistics

Attendance

Participant Attended
Mike Wasko X
Gretchen Dean X
Thomas Bjerregaard X
Alan Brown
Christy Kubin
Janessa Pierce
Jennifer Emeneggee
Joleen White X
Joyce Ford
Kennan Marsh
Leslie Lorello X
Rihab Kordane X
Stephen MacMannis X
Trina Jiao
Wendy Freeburn X
William Houser X
Susan Steen X
Anna Pron-Zwick X
Dennis Stocker X
Jordan Li X


Meetings

Next meeting: Aug 25, 2017 at 09:00 to 10:00 EDT

Meetings: 2 week schedule

Minutes

Minutes Courtesy of Gretchen Dean

Given the discussion today I thought it might be nice to include an article with background on ADA testing. I think this Covance white paper is a nice summary. Testing is discussed on page 3: http://www.covance.com/content/dam/covance/assetLibrary/whitepapers/adawhitepaperpdf.pdf

I took down the following notes:

A summary of the interchange discussion was shared. Notes from this meeting can be found here: https://wiki.cdisc.org/display/TER/Anti-Drug-Antibodies+Modeling+Page Mike will also provide a PDF for those who cannot access. MRC= Modelling Review Committee

It was generally agreed that for now: the LB domain can be used with SENDIG 3.0 to model ADA data. Some companies may not have an IT solution in place that will allow them to model this data in IS domain (which was generally agreed to be the long term solution for this data). The other option mentioned was a custom domain could be considered.

Participants discussed various scenarios for ADA testing strategies and endpoints. We reviewed the IS example on the wiki. General agreement that “agent” would be sufficient to describe what the ADA method was specific toward and a nonstd variable is not needed (NSV).

Thomas will reach out to Craig Zwicki about using “function definition” (epitopes and cross reactivity). Not sure I captured this right

Action: All to review controlled terminology for “ISMETHOD”

Next meeting is 8/25. Mike will not be able to attend, but will have the go to meeting activated. Next meeting we will review some examples of data (Thomas and Leslie has previously volunteered).

Action Items

Responsible Task Timeframe
Mike Update Wiki Next few days
Group Each member to track down an example of data set used in submission for clinical (SDTM). Will likely need to reach out to clinical data management function within your organization (target 1 month) By next meeting
Group Future meeting – share example of anonymized/mock data (Leslie and Thomas – 8/11 & 25) Can be shared in excel format. By next meeting



Last revision by Mwasko79, 2017-08-16