Interorganizational SEND Minutes 2014-09-29
From PHUSE Wiki
|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
- 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
- Create a "points to consider" list
- Nov: Refine the "points to consider" list
- 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