SEND Implementation User Group Minutes 2018-08-27

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For other minutes, see the SEND Implementation User Group Minutes page.



Meetings occur every 4 weeks, at 10-11am EDT.


Participant Attended
Troy Smyrnios X
Debra Oetzman
Audrey Walker X
Bill Houser
Brett Coupland
Brian Argo
Carrie Neeley
Cheryl Sloan
Christy Kubin X
Dan Potenta
Donna Danduone
Frederic Mura
Jamie Megna
Jennifer Feldmann
Jeff Foy
Kathy Powers
Kev Martin
Linda Hunt
Lou Ann Kramer
Louis Norton
Lynda Sands
Mike Wasko
Pam Hills-Perry
Peggy Zorn
Sarah Obbers
Sue DeHaven
Wenxian Wang




Review Forum

Current Issues

  • Bone marrow smear here
    • Answered
  • Interim datasets here
    • Answered

Open Issues

Review News Page

SEND Implementation News

  • Nothing


  • SEND FAQ - 3.1 Updates
    • Will SEND be developed to cover genetic tox studies?
      • Updated
    • Are Anti-drug Antibody (ADA) and Flow Cytometry Expected?
      • Split
    • Is Anti-drug Antibody (ADA) expected?
      • Created (split from above)
      • Updated
    • Is Flow Cytometry expected?
      • Created (split from above)
    • Are other endpoints being developed?
      • Updated
    • How Do I Handle PK Data or Analysis with CROs/External Labs?
      • reference link to Debra/Audrey document
      • Christy/Brian review link to Template to Facilitate Creating Pharmacokinetic SEND Datasets
    • Is DART / Repro Tox included in SEND?
      • Audrey to ask mary jo about wording for juvenile tox (e.g., noting that it should be excluded)


  • SEND between Organizations [[[SEND Implementation Wiki - SEND between Organizations|SEND between Organizations]]
    • Review this
  • PC/PP Template ([Template to Facilitate Creating Pharmacokinetic SEND Datasets])
    • Review this
  • LEFT OFF AT What software is used by reviewers to visualize and review SEND data?
    • Need to update, agnosticize if possible. Somewhere else there is a list of providers, use that instead.
  • Google-izing
    • Standout icon/box things
      • Super stand-out of FAQ on main and some other pages
    • Main page - link overload
      • Fundamentals - reorg under send fundamentals
      • Entry points for brand new user are SEND Fundamentals and Getting SEND-ready
    • FAQ - first glimpse into page is crazy
      • maybe expand first sentence - say what TOC is, idea of search, etc.
      • reduce/remove all links in favor of template links
      • Basics - remove header
    • News not pretty or obvious - make it stand out as not the forum
      • To initiate, confusing what this is
        • needs better header to make it more clear what it is (specifically not the forum)
        • Example of nice version:
        • currently resource constrained
        • Next step #1: PhUSE core team item to evaluate news status quo vs future - get attendee list
        • Next step #2: header
        • Next step #3: email how to use reminder
    • ACTION: Troy to draft text for FAQ and Forum links

Action Items

Responsible Task Timeframe
Troy Simplify home page Next meeting

Last revision by Troy.smyrnios, 2018-08-27