February 10, 2020 Meeting Notes

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Feb 10, 2020

Present First Name Last Name Affiliation
Yes Kevin Snyder FDA
Kevin Cahill EPL
Bill Varady Boehringer-Ingelheim
Bob Friedman Xybion
Stephen MacMannis Pfizer
Fred Mura PDS
Anthony Fata Altasciences
Hanming Tu Frontage
Yes Bill Houser Bristol-Myers Squibb
Atul Mishra Pfizer
Jared Slain MPI Research
Drashtti Vasant Bayer
Michael Muzyka MPI Research
Yes Eli Miller Covance
Yes Daniel Russo FDA

Notes from today:

  • Eli shared his enhancements to the SEND data factory
    • He created a diagram of the functions
    • During the discussion we concluded that the processing of LB which is slow, might be because the program is going through the config file without first filtering on the applicable species. Eli will check into this.
  • Kevin shared his Tox Summary app with the PhUSE nonclinical leadership. They liked it. Kevin, Dan, and Eli will consider converting it into a Javascript app.
  • Bill - has asked CDISC if we could permit full public access instead of making the script only useful to CDISC members who pay for Library access. He will continue to investigate getting access to CDISC Library

Notes from previous meetings:

  • Kevin is planning to add reference rages.
    • He will try to do unit conversions.
  • None of us understand how the files relate to each other nor a good understanding of the high level process. Some high level documentation in the readme would be helpful.
  • Kevin shared the Tox Summary app that he is creating.
  • Kevin will send out WebEx invitation to future meetings.
  • Kevin will share in the future their work at storing SEND data in a SQLite database.

Action Items:
LB - ranges to used

Bob -

  • Is there an argument in sourceline about reloading?
  • DUR_to_DAY function sometimes not loaded?
  • Why download button greyed out even after produce datasets selected?

to do

  • need assumption or configuration on how many days to create data for, for, LB, BW, PC, PP, etc.
  • Spelling fix: producting instead of producing
  • PCSPEC should have always PLASMA (as in configuration file)
  • PCSPEC should not be random


  • needed for sex, species, etc. for finding the appropriate values
  • general complete use of configuration files
  • Data Selections – does nothing it seems.
  • On produce dataset, shows “message” instead of a better text in progress bar, at first
  • Correlation between test results when generating test result data to allow a synthetic treatment effect to propagate among related test results.\
  • Synthetic time based changes for Body weights, adding in a body weight dose effect also useful.

Kevin -
collect OM ranges
historical control incidences for cl, ma
update LB ranges and add LB cat

also to do:
DD - not existing
cl,ma - assumes numeric, should be categorical, what observations?
mi -there is CT, should be used
DD - not existing

future: ts,tx,ta,te - OK for now? bw - seems not using the element lengths does it pass pinnacle validator?

Data Factory Use Cases

  • Demonstrating data visualization tools
  • Create datasets as standards are approaching finalization for testing data that receives data from the standard
  • Creating large enough data sets for testing visualization or data loading tools for capacity testing
  • As example code to show
    • R script creation of XPT files
    • R script reading of the standard (CDISC library to be done? Still require a login but program would ask for it when you run it?)
    • R script reading of CT files (xls version)