Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2015-05-23

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<< Go back to the Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes Page When: 2015-04-06, 10:00am-11:00am EST
Place: Telecon



Participant Attended
Mike Wasko X
Debra Oetzman X
Audrey Walker X
Bill Houser X
Cheryl Sloan X
Dan Potenta X
Debra Oetzman X
Donna Danduone
Frederic Mura
Jennifer Feldmann
Jeff Foy X
Kathy Powers
Kev Martin
Linda Hunt
Lou Ann Kramer
Louis Norton
Marc Ellison X
Mike Wasko
Pam Hills-Perry X
Peggy Zorn
Sarah Obbers
Tom Ratcliffe
Wenxian Wang


Next meeting: 2015-05-04 10-11am EST

Meetings: 4 week schedule



    • Team will continue indefinitely
    • Positive feedback from FDA
  • FDA Questions
    • Laura Kaufman took minutes - to be published soon
    • Some opportunity to incorporate results into FAQ, in particular:
      • QA pieces
      • Statement that data have been checked / systems in place, etc. - "Datasets were verified and accurately reflect the final report" (to be in updated of the conformance guide - more frequent updates)
      • If not raw data, then not GLP/CFR Part 11-bound, but there is expectation that it is validated
      • Which study types, etc. are/aren't covered
    • ECG telemetry data - just what is submitted (e.g., summarized per time point)



Broadcasting presence of forum capability

  • Additional outlets for socializing forum:
    • (Jeff) ACT
      • 2015-04-06: ACT previously posted to website
    • (Jeff) SOT
      • 2015-04-06: Calling it
    • (Donna) The IQ group (htp:// cold call
      • 2015-04-06: Calling it

Review Forum

  • "QC type data - where a lab collects followup or checks on previous steps (e.g., micro confirmation of observations - no place for the "no microscopic correlate" entry)
    • Suggestion is to use comments - not ideal, but then something of an operational edge case (not critical to regulatory submissions)
    • Comment on the spec for the MA but no MI case?
    • Need to be submitted - no?
    • MA to MI handling is inconsistent with CL to MA (which has a CLSF test)
    • Core item - Troy to submit
      • 2015-04-06: Still to be discussed
  • FDA question-related (to be covered when we incorporate FDA questions summary):
    • Question on data not in report
    • Question on STUDYID (sponsor's or CRO's)
    • Question on applicability of GLP to SEND datasets
  • Question on multiple test articles
    • Answered - answer is to use SEE PROTOCOL
    • Action item: Jeff to submit CCT item to have better solution
  • Question on bone marrow data
    • Answer: in LB as different CAT, SCAT, or METHOD
    • Action item: Bill to respond

Review News Page

SEND Implementation News

  • Action item: Audrey to add news item for technical conformance guide update


  • Getting SEND-ready
    • Briefly reviewed new roles section
      • Action item: Team to review this
    • Added sponsor responsibilities section (to cover things the sponsor can't offload to CRO)
      • Action item: Team to review this
      • Action item: Audrey to look up FDA reference on sponsor responsibilities

Action Items

Responsible Task Timeframe
Jeff Submit CCT item for SEE PROTOCOL on TX's TRTDOS Next meeting
Bill Answer question on bone marrow smear data Next meeting
Audrey Add news item for technical conformance guide update Next meeting
Audrey Look up FDA reference on sponsor responsibilities to put on Getting SEND-ready page Next meeting
Team Review Getting SEND-ready page for the sponsor responsibilities and roles sections Next meeting

Last revision by Mwasko79, 2015-04-21