Nonclinical Topics Working Group

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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.

2018 CSS Silver Spring Results

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

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

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.)

Completed Projects

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)

Conference Calls and Minutes


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,04/6/2018