Interorganizational SEND Minutes 2014-09-29

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Participant Attended
Pranav Agnihotri, PointCross
Brian Argo , MPI Research
Kenjie Amemiya, Genentech x
Kathryn Brown, Sanofi x
Rich Buchanan, Preclinical Data Systems
Susan DeHaven, Sanofi
Steven Denham, MPI Research
Jennifer Feldmann, Instem
Jeff Foy, Celgene
Geoff Ganem, Genentech
Nancy Gongliewski, Novartis
Pam Hills-Perry, Pfizer x
William Houser, Bristol-Myers Squibb x
Laura Kaufman, Preclinical Data Systems x
Rihab Kordane, Charles River Laboratory x
Lou Ann Kramer, Eli Lilly
Christy Kubin, MPI Research x
Wayne Kung, Genentech
Connie Marvel, Bristol-Myers Squibb x
Carolyn McGary, Bristol-Myers Squibb
Jamie Megna, MPI Research x
Shree Nath, PointCross
Louis Norton, Covance
Debra Oetzman, Covance
Daniel Potenta, Novartis x
Kathy Powers, Pfizer
Gerard Randolph, Roche
Maureen Rossi, Roche
Lynda Sands, GlaxoSmithKline
Paul Sidney, Charles River Laboratory x
Jared Slain, MPI Research
Troy Smyrnios, Zoetis
Eric Sun, Sanofi
Kevin Trimm, Charles River Laboratory
Audrey Walker, Charles River Laboratory
Heather Williamson, PointCross
Peggy Zorn, INDS x

Discussed Sep 29, 2014

  • The CSS 2015 dates have been set (March 15-17) and the planning committee has begun meeting. Registration will open the beginning of November.
  • The FDA is interested in ideas/feedback on what industry wants to hear so they provide valuable information to the attendees.
  • Rich demonstrated the spreadsheet he drafted to facilitate creating SEND PC and PP domains
  • Should this tool produce a full PC and PP SEND compliant domain?
  • Laura and Peggy thought this would be very helpful.
  • Some information is missing to enable this (e.g. animal reference start date to determine PCDY, VISITDY)
  • Maybe we need another tab to list the samples being provided to the lab that includes the missing information
  • Objectives for this exercise is also to determine what is needed to successfully exchange this data and hint at what is needed to automate this.
  • A smaller group will meet this same time next week to make progress on the spreadsheet.
  • Rich Buchanan
  • Brian Argo
  • Christy Kubin
  • Laura Kaufman
  • Troy Smyrnios
  • Bill Houser

Action Items

  • All to ask what is done to exchange PC and PP data.
  • Rich to create GoTo Meeting for subgroup to work on the spreadsheet.

Timeline for creating and piloting a PC/PP template

  • July-Sept: Prepare a package for pilot use
  • Nov:
  • Pilot
  • Create a "points to consider" list
  • Nov: Refine the "points to consider" list
  • Dec-Jan:
  • Adjust the package for production use
  • Publish the results on the PhUSE SEND Wiki
  • Draft poster
  • Feb: Finalize poster and Publish the results at 2015 PhUSE CSS
  • While we are waiting for the pilot work to complete (Nov) we can work on
  • Answering how other CDISC standards are applicable or not applicable to nonclinical research.
  • Reach out to "Minor Players" contributing to SEND