Feb 16, 2017 Meeting Notes

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Meeting minutes of Nonclinical_Script_Assessment_Project

Feb 16, 2017

Present First Name Last Name Affiliation
Kevin Snyder FDA
Elaine Thompson FDA
Kevin Cahill EPL
Bill Varady Boehringer-Ingelheim
Bob Dorsam FDA
Bob Friedman Xybion
Chris Eley Pfizer
Stephen MacMannis Pfizer
Fred Mura PDS
Yes 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

The minutes from our previous meeting (Feb 2) was lost Action Items from previous meetings:

  • Hanming volunteered to integrate a parameter file (using .yml format) into one of the scripts. This has turned out to be more work that was expected.
  • Hanming will contributed the script he wrote to load data into Oracle including a reference to the article that guided him.
  • Hanming also supplied instructions to install R Oracle: https://github.com/phuse-org/phuse-scripts/edit/master/contributed/Nonclinical/R/Install%20ROracle
  • Peter will consider the possibility of generating test data sets for toxicokinetics data in accordance with the SEND standard with the goal of identifying all of the different ways that this data could be "correctly" encoded and determining whether a universal analysis routine could be performed successfully across all possible interpretations of the standard.
  • Bill will ask Gitte if the "Application of SEND Data for Analysis" has an report that would be useful for the scripting group to create from SEND. - no response yet.
  • Bill created a script to prepare PC and PP from a PDF report and shared it with the team Feb 2.
  • Kevin uploaded the krona tool to the github repository. Bill H. and Bob F. tried running it with their own data and it
  • We looked at the poster Tony prepared.
    • We agreed that the font size was appropriate when viewed at 100%.
    • He'll notify Bob Friedman that it is ready to submit as final.
    • The final version needs to be submitted by Feb 24.
  • Bill shared the SEND3.0-print script
  • He also demonstrated running the SEND3.0-to-Excel script but the location of the output was not clear.

Priorities for next meetings:

  • Finalize Poster
  • Bill's SAS scripts
  • Kevin's Krona's script
  • Elaine thought it would be great to have a discussion of the timing variables to show a good example for the industry.