FDA quartely meeting, FDA CSS, SDEs, website & conference plans

Published

August 21, 2023

Attendees

attendees 21_aug_2023
Aiming Yang No
Ben Arancibia No
Brian Varney Yes
Christina Fillmore Yes
Chelsea Dickens Yes
Chi Zhang Yes
Clara Beck No
Aditee Dani Yes
Doug Kelkoff No
Dhvani Patel No
Filip Kabaj Yes
Harshal Khanolkar Yes
Iris Wu No
Jayashree Vedanayagam Yes
Joe Rickert No
Kyle Lee No
Leon Shi No
Lily Hsieh Yes
Lyn Taylor Yes
Martin Brown Yes
Mia Qi Yes
Michael Kane No
Michael Rimler No
Mike Stackhouse No
Min-Hua Jen No
Molly MacDiarmid Yes
Mona Mehraj No
Paula Rowley No
Soma Sekhar Sriadibhatla Yes
Vandana Yadav Yes
Vidya Gopal No
Vikash Jain Yes
Wilmar Igl Yes
Orla Doyle No

Agenda

PHUSE FDA CSS Poster acceptance & white paper planning: Soma Sekhar

Social Media update : Harshal

PHUSE SDEs: Missisauga: June 8th feedback: Jayashreee

Preparation for PHUSE FDA Quarterly meeting 13th sept:  Questions/Slides feedback: Lyn

Website Christina/ All

  • New Role: “Content curation lead”

    • We have been missing some posts when added to issues/discussion pages on website

    • This role will Monitor the  “Discussion” and “Issues” pages of the repo, and help to raise at each meeting where we need volunteers to answer questions/ add to discussion.
      We will add a Standard agenda item lead by the “Content curation lead” to go through issues, & assign to people / close down issues/ discussions.
      If you would like to volunteer please let Lyn / Christina know.

  • How can we encourage creation of more content?

  • What areas are key for us to focus on

  • MMRM update

  • github training plan (R/Pharma workshop & PSI training course)

Upcoming conference planning.

  • RSS 7th Sept: Lyn presentation

  • POSIT Conf: Lyn to reach out to Juliane / Doug to ask to include slide for CAMIS

  • PHUSE SDE New York: Oct 16th :  Aiming

Meeting minutes

Review of Action log

Action Assigned to Status

Welcome to new members: Chi Zhang & Filip Kabaj

PHUSE SDEs: Missisauga: June 8th feedback: Jayashreee

GPT chat & machine learning for oncology presentations, needs for guidelines on how to use next level tools were discussed. Jayashree presented on behalf of CAMIS but on a Shiny App & got good questions including highlighting that for Endpoint /efficacy analysis they may require very specific standards so not easy to be generic/default. Chris Hurley (PHUSE SDE) also mentioned CAMIS which is great exposure for us.

Preparation for PHUSE FDA Quarterly meeting 27th sept:  Questions/Slides feedback: Lyn/ Harshal

Meeting was postponed by 4 weeks so we have time to prepare a short survey and send out on social media. Harshal went through the proposed questionnaire. Filip suggested Q2 to refer to frequency more specifically. Harshal to update & distribute

Social Media update : Harshal

Harshal has posted the PSI poster post to social media. Going forward the proposal is to run a series of posts to focus on the content on the website - perhaps a short post just to say have you seen this new content and provide links.

RE: Workshop - FDA CSS event (5-7 June): could run a comparison of SAS vs R workshop. Could focus on a set of issues & work though them make content & resolve issues. Could turn to linkedIn to ask wider community to vote for the biggest issue outstanding that they’d like to look into and select these for resolving at the workshop. See item below, as can discuss with Soma following this years FDA CSS event.

Website Christina/ All

  • Thank you ALL!! Much content has been recenly pushed to the website.

  • New Role needed for a “Content curation lead”

    • We have been missing some posts when added to issues/discussion pages on website

      This role will Monitor the  “Discussion” and “Issues” pages of the repo, and help to raise at each meeting where we need volunteers to answer questions/ add to discussion.
      We will add a Standard agenda item lead by the “Content curation lead” to go through issues, & assign to people / close down issues/ discussions.

      Jayashree & Chi volunteered to take on the role & to help monitor the repo activity. Lyn & Christina can put together guidance of what’s needed. Currently it’s just the issues & discussion, as pull requests are currently Ok being approved by Lyn & Christina as it’s a bit tricky to make sure it fits in with the repo and doens’t break anything!

      Chi suggested that Christina check out projects to see if that would help to monitor whose doing what - may not work if can only be accessed by those already with granted access as we want anyone to be able to assign themselves. ACTION Christina to: Change the readme to say how to assign yourselves to content tasks.

  • How can we encourage creation of more content? / What areas are key for us to focus on

    • Great increase in content pre-meeting so Ok to grow organically for now.

    • MMRM update : Christina to add link to MMRM website to cross reference.

  • github training plan (R/Pharma workshop - free to attend in end October & PSI training course - series of session each week for x weeks, & PSI Conference Amsterdam - workshop 1.5 hrs.)

PHUSE FDA CSS Poster acceptance (sept 20th) & white paper planning/ CAMIS ONCO: Soma Sekhar

Soma demonstrated the poster which he’ll present with Vikash at CSS. Focused on Solid tumors OS/PFS but could broaden CAMIS ONCO with time to include other cancer.

Longer term plan to create a white paper and to load survival analysis in python to repo.

Soma to work with Harshil & others, to plan a sub team to work on CSS workshop for June 2023.

Lyn asked if there is demand for packages to be written that do standard stats analysis? The difficulty with this is how to standardise the programming and what it adds in addition to existing packages. It may not be worthwhile as options need to be considered so can’t automate.

Upcoming conference planning.

  • RSS 7th Sept: Lyn presentation

  • POSIT Conf: Lyn to reach out to Juliane / Doug to ask to include slide for CAMIS

  • PHUSE SDE New York: Oct 16th :  Aiming

  • R/Pharma - Christina submitted presentation

AOQ/AOB - None.