Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-05-07

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<< Go back to the Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes Page When: 2015-05-07, 14:00-15:00 EST
Place: Telecon



Participant Attended
Mike Wasko X
Debra Oetzman
Kathy Brown X
Donna Danduone
Jennifer Feldmann
Karolyn Forlenzo
Pierre Jambaud X
George Kahlbaugh
Catherine Roy
Troy Smyrnios
Audrey Walker
Steven Ward
Craig Zwickl


Next meeting: May 21, 2015 at 14:00 to 15:00 EST

Meetings: 2 week schedule



The meeting was very brief, with only 3 attendees. Wiki pages have been updated. We have 2 new members, Pierre Jambaud from Sanofi and Troy Smyrnios from Zoetis. Rather than put the scanned document from the first meeting, and other references for team not needed to be as visible, the information and/or links are present on the Minutes page. Currently only 3 organizations have submitted a top 20 Biomarkers, and are listed on the minutes page. Mike will change the format to be a table to track the number of incidence. Currently there are no repeats.

We hope to see everyone on May 21st at 14:00 EST. Please remember to inquire at your organizations about Biomarkers and forward them to Mike.


Identified Need/Challenge
-Discussed and attendees agreed current passage is acceptable.

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.

-Formulate a broad definition of what biomarkers are, and provide guideline when custom domains are needed or when exisiting domains can or should be used. -Some definitions discussed. See the Charter for CDISC SDS Biomarker Subteam and will be used as the definition.

-To suggest methods to facilitate endpoint modeling using existing domains as opposed creating new or custom domains. Answer the question of "What is the process for identifying whether a data endpoint should go into an existing domain or a custom domain"


Action Items

Responsible Task Timeframe
Mike Update Wiki Next few days
Group Take question back to prospective organizations what a Biomarker is By next meeting
Debra Email Jerry Salyers about CDISC Biomarker team and their findings By next meeting
Mike Upload the Scanned sheets of the group intent from Phuse CSS Meeting also CDISC definition of Biomarker Next few days - Completed.
Group Approach organizations to ask top 10 or 20 endpoints and a few odd balls in the biomarker arena and email to group By next meeting
Mike Tabulate top 10 or 20 biomarkers from group By next meeting - continue

Last revision by Mwasko79, 2015-05-7