Jan 19, 2017 Meeting Notes

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Meeting minutes of Nonclinical_Script_Assessment_Project

Jan 19, 2017

Present First Name Last Name Affiliation
Yes Kevin Snyder FDA
Yes 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
Yes Anthony Fata PDS
Yes Hanming Tu Accenture
Yes Bill Houser Bristol-Myers Squibb
Carol Gleason Bristol-Myers Squibb
Atul Mishra Pfizer
Peter Scaefer Validated Cloud Applications

Action Items from previous meetings:

  • Hanming volunteered to integrate a parameter file (using .yml format) into one of the scripts.
  • Hanming will contribute the script he wrote to load data into Oracle including a reference to the article that guided him.* 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. The team felt this would be useful to be shared even if the exact layout of the pdf table is not widely used. Elaine thought it would be great to have a discussion of the timing variables to show a good example for the industry.

Meeting Notes:

Priorities for next meetings:

  • Finalize Poster
  • Bill's SAS scripts
  • Kevin's Krona's script