Jun 16 2021 Full Team Meeting

[mli1]

Attendees

• @jwildfire @xni7 @JimBuchanan @PHayashi @MelvinSMunsaka @wal615 @mli1 @anzianorj @sunnyman101
• & Asli Memisoglu, Yu-yi Hsu, Greg Ball, Mike Colopy, Gabrielle Murashova, Danae Williams, Scott Wong and Bo Wang

Agenda/Notes

1. Agenda item V0.1.0 #1: Alpha testing deadline is this Friday Jun 18 2021. It looks good so far. Some areas for improvement were identified.

Beta testing is still in planning, however the goal is to roll it out by mid Jul, and to get it done by Aug so we can release V2.0 in early Sep.

Xiao suggested if we want to do advertisement for beta testing among different companies? Jeremy agreed that It would be great to start with a list of names of companies. Also would be good to get some feedback from FDA as well. Team agreed it would be a good idea to reach out to the folks who were involved in the beta testing for V1.0. Skip will reach out to a liaison person in FDA who can speak to technical team and clinical team. By Jul 21, team will develop a plan for beta testing, and with names to be reached out. Jeremy will sort out the FDA colleagues’ names who worked on this before and share those with Skip.

2. Agenda item Warning appears in R console when widget renders #2: Subgroup update:

• AE volcano plot subgroup update: No update so far. Mengchun mentioned Safety Graphics Consortium where it was noticed that PHUSE did “an interactive volcano plot proof-of-concept and pilot completed”. We can take a look of what they have done see if there could be any features we can add in the future version. Post meeting note: Greg suggested Zak is the right person to reach out. Mengchun sent out a mail to Zak with AE volcano subgroup copied (Dennis, Xiao, Asli and Scott).
• QT subgroup update: An educational event is planned on Jun 24, with key speakers from CSRC (and Rich from ISG, about his QT graphics on CTSPedia, Yeah!!!). Purpose of the meeting is to ensure ISG is on the same page with CSRC (or at least to get to know the basics of QT topic). The entire ISG team is invited to join. Another discussion session is scheduled a week after (Jun 30) but will be with limited seats (closed door session). The goal of the two sessions is to align the objectives and goals before we jump into the details/deliverables.
• Safety Graphics Consortium: Greg updated the team that on Jun 11 a kick-off meeting was held where several working group members attended. ISG joined the session, Jim/Jeremy made a wonderful presentation. This forum is for networking and sharing purpose since different working groups may have tried to address the same question. Also good opportunities to work together and to be more efficient. For ISG, it is also good to increase our visibility. Ambassadors are encouraged across groups. The next meeting is in Sep. Will keep the entire team posted.
• Product Launch readiness subgroup--- not yet discussed at leadership council meeting.

3. Agenda item Decide on capitalization of package/function name #3: PCI and R in Pharma meetings. No updates on PCI event, but for R in Pharma, the nomination process is just finished today and we will be waiting for the final voting result. If our topic is picked up, the event would be in Oct.

4. Agenda item Widget does not appear in RStudio viewer in windows #4: Small company IND safety reporting survey. A small group (special taskforce) is working on a survey to better understand the current practice of small company's IND safety reporting per FDA's Final Rule. The purpose is to understand what are the challenges small companies are facing, if we can understand things better, we can help to provide some suggestions. We will also get FDA's input of the survey design, and we can also help FDA to understand the current situation better. Team members who are working for small companies (defined as employee number is less than 500) are highly encouraged to participant.

5. Agenda item Implement JS settings in htmlwidget #5: Github user name and access. All the team members are encouraged to create a Github account. Please reach out to Mengchun/Jim/Jeremy/Xiao if there is any question. Also, everyone is encouraged to reply to this note so we can easily identify each of the members.

Action Items

• Jeremy to sort out FDA colleagues' names (those who were involved in V1 beta testing) and share Skip the name list by 21 Jul.
• Jeremy/Xiao to work out a list of companies where beta testing can be conducted. A detailed plan is to be followed.
• Team members to ensure access to Github and to announce themselves with their username (Make Mengchun aware your username so she can @ you )