Data Visualisation as an Enabler for Nonclinical Safety Signal Detection

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Project Overview

The overall objective is to explore how data visualization can be used as a means for enabling safety signal detection within the scope of nonclinical data. To augment this, algorithms for assisting in the identification of safety signals will be identified in the literature (and from the public domain) and considered for investigation as case examples using suitable data, such as may be available from research databases. As an example, analyses of clinical trial safety data have utilized eDISH plots of serum ALT activity and total bilirubin levels for signal identification of hepatotoxicity (based on Hy’s Law). Could this and similar approaches be translated to nonclinical data? The intent is for the project to utilize existing software visualization tools (including HistoGraphic which was developed in the team’s preceding project) to demonstrate potential safety signal detection using the identified algorithms or visual cues. The project will not expand into the development and/or evaluation of visualization software. A key project deliverable will be to reinforce the importance of promoting standardized nonclinical safety data in SEND format (e.g. LB, MI & MA domain data) as a signal alert enabler. The project will use non-confidential, nonclinical data from the IMI eTOX/eTRANSAFE Consortia (in the European Union) for real-world evaluation of cross-domain algorithms which may identify safety signals in nonclinical studies. Project communication and documentation will be managed via a PhUSE wiki-page, consistent with prior related projects.

The project concluded following presentation of a poster at the June 2019 FDA PhUSE Computational Sciences Symposium. The poster summarizes key presentations and discussions held during project team teleconferences. A copy of the poster can be accessed on this wiki page under "Project Updates" (see below).

Project Leads

Name Role Organization E-mail
Alan P. Brown Co-lead Novartis
Phil Drew Co-lead PDS Consultants

Project Updates

Objectives and Timelines

List proposed project deliverables and timelines.

Objective Timeline
Project endorsement from PhUSE July 2018
Formalize project core team, define initial project deliverables (example: eDISH plots from toxicology data) and create project wiki page July – Aug 2018
Invite project membership to those on the Histopathology Visualization project email distribution list and establish project team Aug - Sept 2018
Kick off project Sept 2018
Present project poster at 2019 FDA PhUSE CSS June 2019

Project Members

Name Organisation Email
Alan P. Brown Novartis
Anisa Scott SAS
BeLinda Hayes FDA
Benjamin Sefing Merck
Bettina Lawrenz Bayer AG
Bill Houser Bristol-Myers Squibb
Bill Varady Boehringer Ingelheim
Brian Johnson Boehringer Ingelheim
Brian Knight Boehringer Ingelheim
Daniel Lee Potenta PDS Lifesciences
Eli Miller Covance
Elyse Hoffmann Boehringer Ingelheim
Jean-Pierre Kieffer Roche
Joyce Zandee INDS
Karen Porter PointCross Life Sciences
Kevin Snyder FDA
Kuno Wuersch Novartis
Laura Kaufman Eagle
Linda Hunt Merck
Mark Carfagna Lilly
Matthew Hayes Genentec
Mikayla Simons Covance
Montserrat Cases Synapse
Nidhi Khurana Nalawade Gilead
Patricia Brundage FDA
Patrick Villiger Roche
Phil Drew PDS Consultants
Philippe Marc Novartis
Raja Ramesh Tummala PointCross Life Sciences
Robert Stull Novartis
Sagar Jain Gilead
Sean Troth Merck
Sree Rayavarapu FDA
Steven Polley GlazoSmithKline
Stephen Thomson FDA
Suresh Madhavan PointCross Life Sciences

Meeting Minutes

21 September 2018 Meeting Minutes
19 October 2018 Meeting Minutes
30 November 2018 Meeting Minutes
11 January 2019 Meeting Minutes
8 February 2019 Meeting Minutes
18 February 2019 Meeting Minutes
29 March 2019 Meeting Minutes
26 April 2019 Meeting Minutes
1 July 2019 Meeting Minutes

Archived Content

Project team questionnaire/survey_November 2018

GSK iNCAS Safety Visualization Tool

Published Reference Materials

Reference Materials