Interorganizational SEND Minutes 2014-04-21
From PHUSE Wiki
|Pranav Agnihotri, PointCross|
|Kenjie Amemiya, Genentech|
|Kathryn Brown, Sanofi|
|Susan DeHaven, Sanofi|
|Steven Denham, MPI Research|
|Jennifer Feldmann, Instem|
|Jeff Foy, Celgene|
|Geoff Ganem, Genentech|
|Erika Gigante, Amgen|
|Nancy Gongliewski, Novartis|
|Elizabeth (Liz) Graham, MPI Research|
|Pam Hills-Perry, Pfizer|
|William Houser, Bristol-Myers Squibb||x|
|Jyotsna Kasturi, Johnson & Johnson|
|Laura Kaufman, Preclinical Data Systems||x|
|Lou Ann Kramer, Eli Lilly|
|Christy Kubin, MPI Research|
|Wayne Kung, Genentech|
|Connie Marvel, Bristol-Myers Squibb||x|
|Carolyn McGary, Bristol-Myers Squibb||x|
|Jamie Megna, MPI Research||x|
|Shree Nath, PointCross|
|Louis Norton, Covance|
|Debra Oetzman, Covance|
|Daniel Potenta, Novartis|
|Kathy Powers, Pfizer|
|Gerard Randolph, Roche|
|Maureen Rossi, Roche||x|
|Lynda Sands, GlaxoSmithKline||x|
|Paul Sidney, Charles River Laboratory||x|
|Jared Slain, MPI Research|
|Troy Smyrnios, Zoetis|
|Eric Sun, Sanofi|
|Nathan VanSweden, MPI Research|
|Audrey Walker, Charles River Laboratory|
|Heather Williamson, PointCross|
|Peggy Zorn, INDS|
Discussed this meeting
- Develop template for creating PC and PP (and RELREC) for legacy data?
- Third-party has the data, but that party doesn't have SEND export for the historical study.
- Objectives of team:
- The template
- Determine resulting template format: *.csv, *.xpt?
- Points to consider list
- Animal numbers
- Sample collection times and formats
- Common Challenges
- Review workflow in scenario 3 and propose adjustments
- Team Members should include users of each system (Xybion, Instem, PDS, Watson, Pharsite) , scientific knowledge, SEND knowledge.
- Minor players
- Identify the most pominent data sources that are outside our primary tox systems, e.g. PC&PP, infusion pumps, ECG
- Identify the key vendors supplying data collection software.
- Identify the format(s) that are useful to receive.
- Objectives of team:
- Prepare an appraoch for consistent interactions across the vendors.
- Approach each vedor as PhUSE non-clinical representatives.
- Help the vendors identify an approach to facilitate the creation of SEND data (perhaps a *.csv report file.)
- Report the responses and plans of the vendors.
- Team Members should include knowledge of the data coming from each minor players and how this is represented in SEND.
- Learn about ODM to determine if it would be useful for non-clinical studies?
- Laura Kaufman will begin researching.
Additional Ideas for our work for next year which we weren't able to discuss in detail today:
- standard approach to transfer raw data records - CDISC?
- Improve existing scenarios:
- Are there other scenarios that we should map?
- lower level steps, greater details?
- Survey of CROs: State of the industry
Not for this year for our group:
- Consider if there is a need for something like CDASH for non-clinical
- We don't see a strong need in non-clinical within a single study.
- This may be useful to make cross-study analysis for a submission simpler.
- Cross study analysis - develop scenarios, pain points, propose solutions.
- This is much broader than just cross-organizational issues. We may contribute if another group takes this on.
Other topics discussed
- See what Gitte finds in a month and revisit after the April 7 European meeting:
- International submissions - reach out to see if there will be an adoption or another standard will be adopted by other major authorities. Get involved with ICH?
- Are there learnings from Clinical CDISC that would be applicable to SEND?
- Last meeting, Jeff mentioned that he heard Pharsight’s WinNonlin will support SEND beginning with release this summer.
- Jeff will ask if they will support both PC and PP.