June 23, 2016 Meeting Notes

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Meeting minutes of Nonclinical_Script_Assessment_Project

June 23 2016

Present First Name Last Name Affiliation
Yes Kevin Snyder FDA
Elaine Thompson FDA
Kevin Cahill EPL
Yes Bill Varady Boehringer-Ingelheim
Bob Dorsam FDA
Bob Friedman Xybion
Chris Eley Pfizer
Yes Stephen MacMannis Pfizer
Yes Fred Mura PDS
Hanming Tu Accenture
Yes Bill Houser Bristol-Myers Squibb
Yes Carol Gleason Bristol-Myers Squibb

Specially Invited Vendors that don't have representatives on the team:

Present First Name Last Name Affiliation
Yes Mohit Matthew PointCross
Yes Joyce Zandee INDS
Yes Peter Schaefer Validated Cloud Application
Yes Jen Feldman Instem

What are the concerns you have with this group’s existence? How can we tailor our group to promote SEND solutions?

  • Peter Schaefer has started a company to implement solutions that leverage the specifications and scripts that are publically available to create commercial solutions that are easy to use and supported.
  • Joyce: INDS uses internal experts to create their requirements and views this as a competitive advantage.
  • Fred: PDS sees the same concerns as Joyce.
  • Jen: Instem also sees the concerns of Joyce and Fred.
  • Concerns
    • If the script group creates scripts for the best visualizations across the industry, this will discourage vendors from creating cutting-edge visualizations.
    • If this group has the “backing of the FDA” and could its output may be perceived as having the blessing of the FDA.
      • The group could make a script that duplicates commercial software’s capability making it free undercutting the business because potential customers might then not make a purchase.
      • The results might be more easily incorporated in vendor A’s tools than in vendor B’s tool. – We need to be vendor neutral.
  • Goals that would be helpful for us to focus on
    • Stay at the forefront of the scientific and business processes
    • Work on the mainstream issues especially new ones.
    • Communicate the current needs of scientists, reviewers, and data handling (script requirements) (I'm not sure all vendors agreed to this since some vendors view their knowledge of what the industry wants as a competitive advantage.)
  • Capability of the group
    • Limited to scripts, not validated programs

Proposed solution:

  • Create a list of potential script topics and ask if any vendor objects to any of them. (We ran out of time to fully discuss this.)