Jan 5, 2017 Meeting Notes

From PHUSE Wiki
Jump to: navigation, search

Meeting minutes of Nonclinical_Script_Assessment_Project

Jan 5, 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
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:

  • All should try to the TK analysis script with our private data to see what we can learn.
  • We should each try the script on our own data and share the results
    • Stephen tried and encountered an error reading the xpt file. There are multiple analytes in his data, but the data frame only had one analyte.
    • Kevin has successfully used it on a study with multiple analytes.
    • Stephen will try some more.
  • Kevin showed the Krona plotting tool for browsing hierarchical data: https://github.com/marbl/Krona/wiki
  • Hanming volunteered to integrate a parameter file (using .yml format) into one of the scripts.
  • 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.
  • Hanming will contribute the script he wrote to load data into Oracle including a reference to the article that guided him.

Meeting Notes:

  • Bill contributed some SAS scripts that he previously wrote
    • SEND3.0-to-xls 0.3.sas for creating an excel representation of SEND datasets.
    • Example template for Excel to SEND script "empty SENDIGv3 Excel.xls"
  • 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.
  • Kevin shared the Krona data view and asked if there was any concern from the participating vendors with making this available. No concern was raised. The Histopathology visualization team would like to collaborate on this and possibly other visualizations.

Action Items:

  • Posters for PhUSE - abstract is due Jan 13, Poster draft needed Feb 9. Bob Freedman will prepare the abstract.
    • Focus on TS script. Possibly show ideal list (SSPONSOR, TRT, SPECIES, SSTYP, DOSDUR, TRTCAS, STSTDTC) or just the required STSTDTC.
    • Bill Varady and Anthony volunteered to help Bob with the layout of the poster
    • Mention that our team is also working on other scripts and possibly mention these:
      • functions that make processes simpler.
      • Convert excel files to SEND *.xpt files

Priorities for next meetings:

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