Conference updates & feedback, FDA quartely meeting, CAMIS-ONCO workshop

Published

September 11, 2023

Attendees

attendees 11_sep_2023
Aiming Yang No
Ben Arancibia No
Brian Varney Yes
Christina Fillmore No
Chelsea Dickens Yes
Chi Zhang No
Clara Beck No
Aditee Dani Yes
Doug Kelkoff No
Dhvani Patel Yes
Filip Kabaj No
Harshal Khanolkar Yes
Iris Wu No
Jayashree Vedanayagam No
Joe Rickert No
Kyle Lee No
Leon Shi No
Lily Hsieh Yes
Lyn Taylor Yes
Martin Brown Yes
Mia Qi No
Michael Kane No
Michael Rimler No
Mike Stackhouse No
Min-Hua Jen No
Molly MacDiarmid Yes
Mona Mehraj Yes
Paula Rowley No
Soma Sekhar Sriadibhatla Yes
Vandana Yadav No
Vidya Gopal Yes
Vikash Jain Yes
Wilmar Igl No
Orla Doyle No

Agenda

PHUSE SDE: Missisauga: June 8th feedback: Jayashreee not available today so see if any feedback at next meeting

PHUSE FDA CSS Poster acceptance, white paper planning, PHUSE US Connect planning & CAMIS ONCO update: Soma Sekhar / Vikash Jain

Poster presentation is next week. Harshil will advertise on social media.
Submitted a abstract for poster & presentation/workshop for US Connect 2024. White paper ongoing. Python code for CAMIS-ONCO being created. Workshop for PHUSE CSS 2024 will need planning. DVOST subgroup ½ day workshop ACTION Soma/Vikash work on the CSS workshop For 2024 .

Vikash was at the PHUSE SDE Boston last week. Met Michael Rimler and he’s introduced CAMIS to the board so they are aware of it.

RSS conference feedback - Lyn Suggestions were to get more academics, university representatives involved with the project as it also makes for nice disseration projects for BSc/MScs.

IBS CEN2023 conference - Feedback from Chi IBS CEN2023 conference (biometric society central Europe network held in Basel), CAMIS was mentioned along with other R working groups in a talk. The talk was about software engineering working group, the one that developed MMRM. Quite encouraging!

Social Media update : Harshal
Call for volunteers.

  1. Software Engineering Working Group –

    1. WG goals are:

      1. Collaborate to engineer selected R-packages which will fill in gaps in the open-source statistical software landscape, and to promote software tools designed by the working group through publications, conference presentations, workshops, training courses, and others.

      2. Develop best practices for engineering high-quality statistical software, and promote the use of best practices in the broader Biostatistics community via public training materials.

      3. Communicate and collaborate with other R software initiatives.

    2. Working group HomePage - https://rconsortium.github.io/asa-biop-swe-wg/

    3. Co-chairs - Daniel Sabanes Bove and Ya Wang.

  1. Statistical Methods in Oncology Scientific Working Group – WG goals are:

    1. Encourage increased use of systematic oncology assessment approaches and selection of best methods through training and education

      1. Gain clear understanding of current regulatory environments in oncology

      2. Prepare a library of recommended methods including innovative methods

      3. Understand commonly used and innovative methods

      4. Collect and share experiences on using innovative designs

      5. Put together points to consider for oncology innovative designs’ implementation

      6. Develop new methods if needed

    2. Educate the broader statistical community to understand and contribute to this important area

    3. Increase statisticians’ leadership roles in cross-functional collaboration

    4. Communicate statistical perspectives to larger clinical trial community

    5. Co-chairs - qjiang@seagen.com and olga.marchenko@bayer.com

Adittee volunteered to join the Stats methods in oncology Scientific working group to represent us. ACTION: Aditee to reach out to co-chairs and ask to join, then feedback at our meetings on if there are opportunities to collaborate.
Also looking for volunteers to work on the Software Engineering WG & CAMIS ONCO- white paper, Harshil will work with Vikash & Soma to request that PHUSE share to advertise what we are looking for in a linkedIn post.

Preparation for PHUSE FDA Quarterly meeting 27th sept: Slides / Survey questions : Lyn / harshil Tomorrow we can get the data back from questionnaire.   ACTION : Lyn/Harshil to meet, summarize survey & prepare slides.   Friday.

Website Christina/ Chi / Jayashree

  • Currently, needs fixing pending RENV issue. So will be slight delay on getting content on the website

  • Content curation lead items - Chi / Jayashree Made a great start to close discussions & address actions which have questions on them.

  • MMRM update - No update ACTION: Lyn to follow up.

  • github training plan (R/Pharma workshop & PSI training course) - ongoing prep for workshop & course through PSI AIMS team.

  • Agnieszka (PAREXEL) and Chi – working on Wilcoxon test content for paired & unpaired data.

Upcoming conference planning

  • PHUSE SDE New York: Oct 16th : Aiming

  • PHUSE US Connect: Soma/Vikash

  • R/Pharma – Christina?

  • SESUG (South East SAS user group) late october 2023, Brian will present on CAMIS.

  • North Carolina - SDE if anyone wants to volunteer to attend let us know.

AOB - None.