Nonclinical Topics Working Group

From PHUSE Wiki
Revision as of 08:27, 22 January 2019 by SusanDeHaven (talk | contribs)
Jump to: navigation, search


A collaboration working to improve nonclinical assessments and regulatory science by identifying key needs and challenges in the field and then establishing an innovative framework for addressing them in a collaborative manner through limited term projects.

Our focus is on using informatics approaches and standards for delivering ideas and solutions to nonclinical data challenges. Annually, at the Computational Sciences Symposium (CSS), we present our progress and achievements and develop new projects that further the value of nonclinical data.

   * Got a question about SEND?  Click Here to Ask in the Forum!

Latest News & Activities

TAKE THE SEND IMPLEMENTATION SURVEY!] Look for the email to All WG Members, sent from our listbox on Friday January 18. This is our 4th Annual Survey on Industry Send Implementation. The outcome will be presented at the PhUSE CSS in Silver Spring, June 9-11, 2019. Past Survey Results are available click here.

Every organisation can see where they are in relation to other organisations around the world that are striving to implement SEND solutions. No organisational identifiable data will be published from this survey.

This survey closes on February 26th 2019.

Publication News

The Visualization of Histopathology Data project is pleased to be able to share with you a recent publication from the Society of Toxicologic Pathology (STP) Working Group. Sean Troth and Brian Knight, co-authors of the paper, are members of the project team and have included references to the Histopathology Visualisation project in the publication. Congratulations on this excellent effort. Click the title to access their excellent article: Scientific and Regulatory Policy Committee Points to Consider: Data Visualization for Clinical and Anatomic Pathologists.

2018 CSS Silver Spring Results

VISIT our site: 2018 CSS Nonclinical Topics Outcomes for all the presentations.

Attendees to the Nonclinical Topics Working Group breakouts at CSS 2018 experienced 4 dynamic sessions at the Silver Spring Convention Center, Silver Spring, MD. Key topics of informative discussion were:

  • significant deliverables from our 8 ongoing projects, such as new approaches to visulization of histopathology data, white paper on how to handle differences between study report and SEND datasets and a list of Define file questions relevant to Nonclinical studies.
  • 2018 SEND Survey Results
  • Impact Panel: Pharma/CRO/Software vendor impacts of esubmission requirements - a very popular session!

  • Presentation of nonclinical data sharing initiatives in US and EU - Biocelerate and eTransafe

2018 Project Updates (March)

To view content from previous years' CSS events: Click here to reach the page for Past Nonclinical Topics CSS Activities

Current Projects

The current projects underway are listed below. We are always looking for participation in these projects as they move forward. Follow the links below for more information (e.g. background, tasks, milestones, and how to participate.)

Project Project leads Link to project page
Data Consistency Fred Wood, Maria Francomacaro Data Consistency: SEND Datasets and the Study Report
Data Visualization Alan P. Brown, Phil Drew Data Visualisation as an Enabler for Nonclinical Safety Signal Detection
Define.xml Jennifer Feldmann, Kathy Brown Demystifying Define.xml Codelists for Nonclinical Studies
SEND Survey Bob Friedman, Lou Ann Kramer Industry SEND Progress Survey
Anti-Drug Antibody Michael Wasko, Gretchen Dean, Thomas Gade Bjerregaard Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies
Nonclinical Scripts William Houser, Kevin Snyder Nonclinical Script Assessment Project
Nonclincial Study Data Reviewer's Guide Susan DeHaven, Debra.Oetzman Nonclinical Study Data Reviewers Guide
SEND Implementation User Group Troy Smyrnios, Debra Oetzman SEND Implementation User Group
Linked Data Drashtti Vasant, Thomas Gade Bjerregaard Understanding RDF/Linked Data for Potential Non-Clinical Use

Completed Projects

Project Deliverables/Output Link to project page
Roadmap Accomplishments Nonclinical Standardization Roadmap Team
Clinical Endpoint predictivity Activities completed NICE: Nonclinical data Interconnectivity for Clinical Endpoint predictivity
Historical Controls Completed tasks Nonclinical Historical Controls
Histopathology Visualization Deliverables Visualization of Group Related Differences in Histopatholgy Data
Interorganizational SEND Accomplishments Interorganizational SEND
Industry Discussion See project page for comments accumulated Nonclinical Working Group Industry Discussion Group
Emerging Technologies IG search tool (to add link) Emerging Technologies Collaboration
Test Submission Forum See page for discussion Test Submission Forum Group
Biomarkers Poster and white paper Investigating Endpoint Modeling - Biomarkers
SEND Data for Analysis Annotated examples Application of SEND Data for Analysis

Nonclinical Poster List

Click here to find our current and past posters: Nonclinical Topics Poster List

Core Team

The Nonclinical Working Group Core Team is the leadership from each of our ongoing projects. This membership has the responsibility to steer the overall activities of the Working Group, review new project proposals and to provide communication transversely across the projects and between the core team and their projects. The Core Team is chaired by the the Working Group Co-Leads and meets approximately monthly.

Name Role Organization E-mail
Lilliam Rosario Sponsor FDA Lilliam.Rosario (at)
Susan DeHaven Working Group Co-Lead; Nonclinical Study Data Reviewers Guide Sanofi Susan.DeHaven (at)
Patricia Brundage Working Group Co-Lead FDA Patricia.Brundage (at)
David Epstein FDA Liaison FDA David.Epstein (at)
Debra Oetzman Nonclinical Study Data Reviewers Guide; SEND Implementation User Group Instem Debra.Oetzman (at)
Troy Smyrnios SEND Implementation User Group Zoetis troy.c.smyrnios (at)
Mike Wasko Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies PDS Life Sciences michael.wasko (at)
Gretchen Dean Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies Pfizer gretchen.e.dean (at)
Thomas Gade Bjerregaard Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies Novo Nordisk tgb (at)
Phil Drew Visualization of Group Related Differences in Histopathology Data PDS Consultants philip.drew (at)
Alan Brown Visualization of Group Related Differences in Histopathology Data Novartis alan_p.brown(at)
George Kahlbaugh Industry SEND Progress Survey Boehringer-Ingelheim George.Kahlbaugh (at)
Lou Ann Kramer CDISC SEND Team Liaison; Industry SEND Progress Survey CDISC lkramer (at)
Bob Friedman Industry SEND Progress Survey Xybion bfriedman (at)
Bill Houser Nonclinical Script Assessment Project Bristol-Myers Squibb william.houser (at)
Kevin Snyder Nonclinical Script Assessment Project FDA Kevin.Snyder (at)
Fred Wood Data Consistency: SEND Datasets and the Study Report Accenture fwood.dsc (at)
Maria Francomacaro Data Consistency: SEND Datasets and the Study Report Merck Maria_Francomacaro(at)
Jennifer Feldmann Demystifying Define-XML Codelist Handling for Nonclinical Studies Epreda jennifer.feldmann (at)
Kathy Brown Demystifying Define-XML Codelist Handling for Nonclinical Studies Sanofi Kathryn.Brown (at)

Other Nonclinical Consortia of Interest

Here is a list of consortia that may from time to time have overlapping interests with this group.

CSS Processes

For those developing our new projects, please use the New Project Template as a guide.

Archive of Past Years' CSS Meetings

File:FDA PhUSE WG6 Needs Challenges 2012CSS.xlsx
CSS 2012 WG6 WhitePaper
WG6 30Mar2012

File:PhUSE WG6 NonClinical Update Mar 2013 final.pdf
Nonclinical Working Group Minutes 20Dec2013

Highlights and Outcomes of the CSS2014 Nonclinical WG breakouts
all presentations or posters from CSS2014

File:CSS 2016 Agenda - NC - 20160218.xls
File:Detailed Breakout Plan 2016.docx
Click here to reach the page for 2016 EU CSS


Project Updates


FDA comments are an informal communication and represent the individual's best judgment. These comments do not bind or obligate FDA. The contents of this wiki are from the individual contributors and do not necessarily reflect the view and/or policies of the Food and Drug Administration, the employers of the individuals involved or any of their staff.

Deliverables Disclaimer :
The opinions expressed in this document are those of the authors and do not necessarily represent the opinions of PhUSE, members' respective companies or organizations, or regulatory authorities. The content in this document should not be interpreted as a data standard and/or information required by regulatory authorities.

Webinar Presentations

Last revision by SusanDeHaven,01/22/2019

Meeting Minutes