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

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

Latest revision as of 06:09, 30 June 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
Catherine Xiao Participant Gilead catherine.xiao@gilead.com
Douglas Warfield Participant FDA Douglas.Warfield@fda.hhs.gov
Eric Herbel Participant Ireview Eherbel@ireview.com
Gaoyang Li Participant Bayer gaoyang.li@bayer.com
Hari J Vardhan Participant Chiltern hari.vardhan@chiltern.com
Iraj Mohebalian Participant Bayer iraj.mohebalian@bayer.com
Karl Brand Participant Bayer Karl.brand@bayer.com
Paul Schuette Participant FDA Paul.Schuette@fda.hhs.gov
Raj Kiran Boddu Participant Takeda Raj-kiran.Boddu@takeda.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
Maria Dalton Participant GSK maria.y.dalton@gsk.com
Mary Nilsson Participant Lilly nilsson_mary_e@lilly.com
Mominul Islam Participant Sarepta MIslam@sarepta.com
Wei Wang Participant Lilly wang_wei_v@lilly.com
Vishal Shah Participant Sunvion Vishal.Shah@sunovion.com
Yang Yu Participant Sunovion Yu.Yang@sunovion.com
Nagadip Rao Participant Elissen NRao@eliassen.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