Interorganizational SEND Minutes 2014-04-21

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Participant Attended
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.