Mar 16, 2017 Meeting Notes

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Meeting minutes of Nonclinical_Script_Assessment_Project

March 16, 2017

Present First Name Last Name Affiliation
Yes Kevin Snyder FDA
Elaine Thompson FDA
Kevin Cahill EPL
Yes Bill Varady Boehringer-Ingelheim
Bob Dorsam FDA
Yes Bob Friedman Xybion
Chris Eley Pfizer
Yes Stephen MacMannis Pfizer
Fred Mura PDS
Anthony Fata PDS
Yes Hanming Tu Accenture
Yes Bill Houser Bristol-Myers Squibb
Carol Gleason Bristol-Myers Squibb
Yes Atul Mishra Pfizer
Peter Scaefer Validated Cloud Applications
Yes Mark Pinches Lhasa

Summary of Status of Nonclinical Script Assessment Projects:

  • Kevin shared a draft slide showing the progress of our Team for the year. We updated some details.
  • Mark has permission to share
  • Kevin shared the tool

Potential New Projects:

  • Further development on existing projects.
  • Tool to allow FDA reviewers to look at body weight gain data so that Sponsor's do not have to submit this data to the FDA.
    • Questions/concerns regarding this project:
      • Should the output be .pdf or an .html graphical view?
      • What language/platform should be used?
        • Something like javascript/html may provide the necessary portability for use by FDA reviewers, but the team does not currently possess much expertise in this area.
      • Kevin will talk to Elaine Thompson to gain clarity regarding whether this project will be worth pursuing and if so, what the best approach might be.
  • Interaction/collaboration with other nonclinical PhUSE groups
    • Histopathology Visualization Project
      • Kevin is currently collaborating on Krona tool with this group
    • SEND Data Analysis Project
      • We will touch base with them at CSS

General Notes:

  • We should be mindful not to spread ourselves too thin across too many programming languages.
    • R is the preferred language to in-depth meeting discussions as most of the team is interested in learning to program better in R.
    • Other languages like SAS, perl, and python may be useful too, but it is not currently a priority of the group to delve deeper into these languages for purely educational purposes.
  • Of this meeting's attendee's, Tony Fata, Bill Houser, Bill Varady, Hanming Tu, Bob Freidman, and Kevin Snyder plan on attending the March 2017 CSS in Silver Spring, MD.