Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2016-08-11

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<< Go back to the Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes Page When: 2016-08-11, 14:00-15:00 EST
Place: Telecon



Participant Attended
Mike Wasko X
Debra Oetzman X
Brian Argo
Kathy Brown
Donna Danduone
Jennifer Feldmann
Karolyn Forlenzo
Pierre Jambaud
George Kahlbaugh X
Christy Kubin
Catherine Roy X
Audrey Walker
Steven Ward
Craig Zwickl
Fred Wood X


Next meeting: Aug 25, 2016 at 11:30 to 12:30 EST

Meetings: 2 week schedule



-Thank you everyone for flexibility and patience

Updates on white paper review

-Still waiting for paper to be posted -Debra emailing Sue, Bob and Scott to see if we need anything from team -Review period saying 2 weeks from newsletter publication date -Feedback provided via email and a wikipage -Distribute in monthly mailshot (if possible), as well as various wiki pages and DISQUS -Mike to set up wiki feedback page and be collector of email comments.

Future of team

-Team has been asked by PhUSE leadership to continue with the new guidances, ADA, and Immunophenotyping -White paper probably be outdated before long, no PhUSE method for updating white papers -Does team want to close or keep going? -Keeping updated seems useful, but is a lot of work -ADA question reflects to more modeling by CDISC -Group votes to end team once final white paper completed due to waiting on other teams to make decisions that would feed into an update -Meetings canceled but invite/calendar open until done. Have meetings when feedback or updates available -Mike to make deadline for meeting decision 2pm day before meeting. So team can plan their day.

Action Items

Last revision by Mwasko79, 2016-10-20

Responsible Task Timeframe
Mike SEND final of white paper to PhUSE leadership as well as CDISC SEND leadership and FDA Completed
Mike Ask George for copy of the Visio image - visio file Completed
Mike Distribute draft to team for extra review Completed
Craig Take a shot at a second draft Completed
Mike Update Wiki Next few days
Debra Distribute Biomarker literature to group Completed
Debra Provide Phuse Leadership with the update from our working group Debra provided
Group Take question back to prospective organizations what a Biomarker is Completed
Debra Email Jerry Salyers about CDISC Biomarker team and their findings Completed, received email back from Jerry
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 Almost Complete
Mike Tabulate top 10 or 20 biomarkers from group By next meeting - continue
Audrey Get permission for many people from team to join Clinical Lab Team Next meeting
Mike Add Biomarker definition from FDA page. Completed
Debra Look into SDTM to see what other grouping qualifiers available Completed