Difference between revisions of "Best Practices for Interactive Analyses for Decision Making & Submissions"

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|Matt Jones || Participant || Lilly || jones_matthew_robert@lilly.com
|Matt Jones || Participant || Lilly || jones_matthew_robert@lilly.com
|Mominul Islam || Participant || Sarepta ||MIslam@sarepta.com
|Wei Wang || Participant || Lilly || wang_wei_v@lilly.com
|Wei Wang || Participant || Lilly || wang_wei_v@lilly.com

Latest revision as of 03:00, 13 January 2020

Project Overview

Leverage Visual Analytics in our submission package to improve interactions between regulatory agencies and sponsors for a fast and effective review of submitted data and analyses.

Project Leads

Name Role Organization E-mail
Xiangyun 'Sharon' Wang Project Lead Genetech/Roche wang.xiangyun@gene.com
Zachary Skrivanek Project Lead Lilly skrivanek_zachary@lilly.com

Project Participants

Name Role Organization E-mail
Arlene Coleman Participant Pfizer Arlene.Coleman@pfizer.com
Ashok Gunuganti Participant Pfizer ashokvardhan.gunuganti@pfizer.com
Benjamin Devriendt Participant Business and Decision Life Sciences benjamin.devriendt@businessdecision.be
Catherine Xiao Participant Gilead catherine.xiao@gilead.com
Dana Soloff Participant Mandira Consulting LLC dsoloff@mandiraconsulting.com
Douglas Warfield Participant FDA Douglas.Warfield@fda.hhs.gov
Eric Herbel Participant Ireview Eherbel@ireview.com
Eunice Ndungu Participant Merck eunice_ndungu@merck.com
Gaoyang Li Participant Bayer gaoyang.li@bayer.com
Greg Ridge Participant Alexion Pharmaceuticals gregory.ridge@alexion.com
Hari J Vardhan Participant Chiltern hari.vardhan@chiltern.com
Ingeborg Holt Participant Commonwealth Inc iholt@commoninf.com
Iraj Mohebalian Participant Bayer iraj.mohebalian@bayer.com
Jatin Patel Participant Parexel jatin.patel@parexel.com
Josephine Fong Participant Genetech jfong@gene.com
Kishore Pothuri Participant Vita Data Sciences kpothuri@vitadatasciences.com
Karl Brand Participant Bayer Karl.brand@bayer.com
Ketan Dongre Participant Syneos Health ketan.dongre@syneoshealth.com
Paul Schuette Participant FDA Paul.Schuette@fda.hhs.gov
Peter Hu Participant Merck Peter_Hu@merck.com
Raj Kiran Boddu Participant Takeda Raj-kiran.Boddu@takeda.com
Rebeka Revis Participant Lilly rebeka_revis@lilly.com
Phil Bowsher Participant Rstudio phil@rstudio.com
Rinki Jajoo Participant Merck rinki_jajoo@merck.com
Shiva Katepilli Participant Sunovion Pharmaceuticals Shiva.Katepalli@sunovion.com
Sreekanth Gudapati Participant eclinical solutions sgudapati@eclinicalsol.com
Srinivas Veeragoni Participant Bayer srinivas.veeragoni@bayer.com
Maria Dalton Participant GSK maria.y.dalton@gsk.com
Mary Nilsson Participant Lilly nilsson_mary_e@lilly.com
Matt Jones Participant Lilly jones_matthew_robert@lilly.com
Mominul Islam Participant Sarepta MIslam@sarepta.com
Wei Wang Participant Lilly wang_wei_v@lilly.com

Project Updates

Date: Description of Update

Objectives and Timelines

List proposed project deliverables and timelines.

Objective Timeline
technical proof of concept with interactive data visualization display January, 2018
submission with interactive data visualization display March, 2019
white paper on best practices for interactive analyses for decision making & submissions June, 2019

Project Activities

Best Practices Notebook:

DevOps in Action, Containers@Bayer- Presentation by Karl Brand 21-03-19

Meeting Minutes

Activity Link to Materials
Group 1 Minutes 2017-07-18 2017-07-18
Group 1 Minutes 2017-08-18 2017-08-18
Group 1 Minutes 2017-09-06 2017-09-06
Group 1 Minutes 2017-10-31 2017-10-31
Group 1 Minutes 2017-12-13 2017-12-13
Group 1 Minutes 2018-01-22 2018-01-22
Group 1 Minutes 2018-02-14 2018-02-14
Group 1 Minutes 2018-3-28 2018-03-28
Group 1 Minutes 2018-4-18 2018-04-18
Group 1 Minutes 2018-16-05 2018-05-16
Group 1 Minutes 2018-20-07 2018-20-07
Group 1 Minutes 2018-15-08 2018-15-08
Group 1 Minutes 2018-18-09 2018-18-09
Group 1 Minutes 2018-17-10 2018-17-10
Group 1 Minutes 2018-18-12 2018-18-12

Archived Content