- Eric Nantz (Eli Lilly)
- HyeSoo Cho (FDA)
- Jizu Zhi (FDA)
- Joel Laxamana (Roche/Genentech)
- Joseph Rickert (R Consortium)
- Nan Xiao (Merck)
- Ning Leng (Roche/Genentech)
- Robert Devine (Johnson & Johnson)
- Saghir Bashir (Argenx)
- Yilong Zhang (Meta)
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The meeting was recorded and the video is available.
Pilot 2
Eric Nantz has made progress on addressing the issues identified with the Pilot 2 resubmission. Fixes include:
- User-friendly warnings when filters result in an empty data set
- Consistent footer and header notes in the tables titles that match the Pilot 1 output
The only outstanding issue that is still being worked on is the warning message that results from loading the teal package from GitHub because it is not yet on CRAN.
The Pilot 2 resubmission is now scheduled for 9AM PST on Wednesday July 19, 2023. Note that shortly after the meeting the date was confirmed with Beverly Chin and HyeSoo Cho.
Action JBR to schedule a zoom meeting and invite:
- HyeSoo Cho
- Beverly Chin
- Ning Leng
- Eric Nantz
Pilot 3
Joel Laxamana provide the status update on Pilot 3.
- The Pilot 3 team is developing the testing process and updating the ADRG to follow the process used in Pilots 1 and 2.
- Developing the testing process is taking longer than expected because they are attempting to develop a hybrid of the different process used in Pilot 1 and Pilot 2.
- The group is now targeting the first or second week of August for the Pilot 3 submission.
Action:
- Joel will confer with Eric and Nan at a separate meeting.
Pilot 4
Eric began the status update by thanking the team members from Appsilon who have set up a robust container environment for the Pilot.
- Saghir has been able to get the container and app running in his environment
- We must work with the FDA to determine the best method of transferring the container
- Team members from Posit are working with the the WebAssembly
- The major technical requirement is that the FDA reviewers will be able to run the Podman container environment
- Right now, we believe that the WebAssembly, if it works as advertised, would be preferred by the FDA
- It was noted that that FDA primarily works in a Windows environment
Action:
- JBR to discuss FDA constraints and preferences with Paul Schuette.
The next meeting of the working group will be at 9AM PST on Friday, August 4, 2023