Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2016-10-20

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<< Go back to the Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes Page When: 2016-10-20, 14:00-15:00 EST
Place: Telecon



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


Next meeting: 03 NOV, 2016 at 11:30 to 12:30 EST

Meetings: 2 week schedule



-Proceeded through White Paper comments and FDA BEST paper pertaining to white paper. -Debra to create a sentence to adde to end of recommendation section lines 228-231 per Bill Houser's comments -Approx 2/3 through the review of paper comments. -Thank you all who provided feedback

Updates on white paper review

-Review period over -White paper review complete. Team considers paper final -Mike to initiate final publication process -Only have a meeting if necessary. Mike and/or Debra will inform the team.

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been asked by PhUSE leadership to continue with the new guidances, ADA, and Immunophenotyping -White paper probably be outdated before long, no PhUSE method for updating white papers -Does team want to close or keep going?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, 2016-12-15

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