Educating For The Future

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Project Overview

Methodologies and technologies utilized in the clinical development process have been largely unchanged since 2005. Externally, there have been immense advancements in technology and mindsets related to working with data that have had little impact in our industry. This Working Group sees this as a risk. The risks breakdown into 3 categories:

1) There is a risk of advancement happening outside of our domain that may expose us to threats that we are unable to protect ourselves against.

2) There is a risk that our skill sets and capabilities become outdated and external forces strongly influence the Industry without us having a say

3) There is a risk that we are missing opportunities to become more efficient and to use these advancements to deliver better value for patients

The goal of this Working Group is to develop frameworks by which to educate the PhUSE community at large. The frameworks will be designed to educate the community on the importance of topics where we feel we have gaps, the details of the topics themselves, and how they can be used to drive innovation in the industry.

We have now established 3 sub teams:

Machine Learning / Artificial Intelligence

Design Thinking

Data Engineering

Project Leads

Ian Fleming Working Group Lead Medidata Ian.Fleming@phuse.eu
James McDermott Working Group Lead Ab Tartarus mc_dermotts@me.com
Wendy Dobson Project Co-ordinator PhUSE wendy@phuse.eu

Project Participants

Name Role Organisation Email
Amy Gillespie Participant Merck amy_gillespie@merck.com
Dirk Spruck Participant Clinipace dspruck@clinipace.com
Kevin Kyosun Lee Participant Industry Kevin.Kyosun.Lee@gmail.com
Adrienne_Bonwick Participant Eisai Adrienne_Bonwick@eisai.net
Chris Price Participant Roche Chris.Price.CP1@roche.com
Paul Schuette Participant FDA Paul.Schuette@fda.hhs.gov
Paul Slagle Participant Inventivhealth Paul.Slagle@inventivhealth.com
Crystal Allard Participant FDA Crystal.Allard@fda.hhs.gov
David Pressley Participant Clear Creek Analytics dpressley@clearcreekanalytics.com
Simon Walsh Participant Novartis Simon.Walsh@novartis.com
Josephine Fong Participant Genentech jfong@gene.com
Jacques Lanoue Participant Novartis Jacques.Lanoue@novartis.com
Jen Nash Participant Prothena Jen.Nash@prothena.com
Vijay Pasapula Participant Gilead Vijay.Pasapula@gilead.com
Janette Garner Participant Gilead Janette.Garner@gilead.com
Regina Zopf Participant FDA Regina.Zopf@fda.hhs.gov
Amanda Demontjoie Participant Assero aj@s-cubed.co.uk
Nicolas Dupuis Particant Novartis nicolas.dupuis@novartis.com
Dante Di Tommaso Participant Novartis dante.di_tommaso@novartis.com
Guy Garrett Participant Achieve Intelligence guy.garrett@achieveintelligence.com
Kris Lauwers Participant JNJ Klauwer2@its.jnj.com
Scott Bahlavooni Participant d-Wise Scott.Bahlavooni@phuse.eu
Julia Popova Participant Novartis Julia.Popova@novartis.com
Amit Jain Participant Iconplc Amit.Jain@iconplc.com
Jagdev Bhogal Participant BCU Jagdev.Bhogal@bcu.ac.uk
Sascha Ahrweiler Participant Bayer sascha.ahrweiler@phuse.eu
Karl Brand Participant Bayer Karl.Brand@bayer.com
Vishnu Kollisetti Participant PPDI Vishnu.Kollisetti@ppdi.com
Vince Marinelli Participant Medidata Vince.Marinelli@mdsol.com
Karnika Dalal Participant Bayer Karnika.Dalal@bayer.com
Prasanna Murugesan Participant Independent Prasanna.Murugesan@gmail.com
Mike Carniello Participant Astellas michael.carniello@astellas.com
Paul Slagle Participant Inventiv Health Paul.Slagle@inventivhealth.com
Alisa Khomyanina Participant IBM khomyanina@us.ibm.com
Steve Wilson Participant FDA steve.wilson.fda@gmail.com
Caitlin Anderson Participant IBM cmanders@us.ibm.com
Josephine Fong Participant Gene jfong@gene.com
Kathryn Matto Participant IBM kathryn.matto@us.ibm.com
Mark Bynens Participant JNJ Mbynens@its.jnj.com
Tania Walton Participant Independent Tee_Walton@yahoo.com
Beate Hientzsch Participant HMS Beate.Hientzsch@analytical-software.de
Shaaz Ansari Participant Gene Ansari.Shaaz@gene.com

Working Group Updates

Presentation - All Team Meeting 11.12.17
Presentation - All Team Meeting 16.01.18

Objectives and Timelines

List proposed project deliverables and timelines.

Objective Timeline
Selection of Repository Q22018
Logistics and Communications Q22018
Position Paper TBD

Project Activities

This section can document project activities or serve as a jumping off point to other pages in the project.

Project Minutes

All Team Meeting 11.12.17

Archived Content

References

References