Nonclinical Topics Working Group

From PHUSE Wiki
Jump to: navigation, search

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

Latest News & Activities

Deliverables in Review

The Modeling Endpoints project team has published their White Paper for PhUSE Public Review:

Please provide review comments to and by August 12, 2019.

Feedback from FDA on Section 5 of the nSDRG - Data Conformance Issues

Read the feedback gathered by the nSDRG team, based on a questionnaire proposing the team's questions about the usefulness and effectiveness of this important section of the nsdrg. Each question and answer combination has been added to the SEND FAQ page - see the subsection section on nSDRG.

Nonclinical Topics Working Group Vision

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.

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.

2019 CSS Silver Spring Results

We a great turnout and strong engagement for breakout sessions that explored SEND Implementation Data Challenges and collaborated with FDA and Biocelerate on SEND for Cross-Study Analysis, followed by PHUSE Project Development to ensure we can help drive solutions and innovations addressing nonclinical data topics.

Presentations from Nonclinical Breakout Sessions and additional Posters provided:

Nonclinical SEND Implementation Survey 2019
Five Perspectives on SEND Implementation Challenges 2019
Cross-Study Analysis Workshop - BioCelerate and FDA

Review the 2019 PHUSE Nonclinical Working Group Project Status Updates:

Modeling ADA in Nonclinical Studies

Demystifying Define Codelists

Nonclinical Study Data Reviewers' Guide

SEND Data Consistency with Final Report

SEND Implementation User Group

Data Visualization as an Enabler for Safety Signal Detection

Nonclinical Scripts

Evolution of SEND Implementation Challenges: Provided as Pre-read to Breakout 2

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
SEND Survey Bob Friedman, Lou Ann Kramer Industry SEND Progress Survey
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
SEND QC Best Practices Jesse Anderson, Michael Rosentreter SEND Dataset QC Best Practices
Harmonization of SEND Implementation to Enable Historical Control Data Analysis Kevin Snyder, Mark Carfagna Harmonization of SEND Implementation to Enable Historical Control Data Analysis

Completed Projects

Project Deliverables/Output Link to project page
Roadmap Accomplishments Nonclinical Standardization Roadmap Team
Define.xml Code List Handling SEND FAQ - DEFINE.XML section Demystifying Define.xml Codelists for Nonclinical Studies
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
Data Visualization CSS 2019 Poster Data Visualisation as an Enabler for Nonclinical Safety Signal Detection

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)
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)
Kathy Brown Sanofi Kathryn.Brown (at)
Jesse Anderson SEND Dataset QC Best Practices FDA [1]
Michael Rosentreter SEND Dataset QC Best Practices Bayer [2]

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

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


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 Laurenwhite,06/16/2020

Meeting Minutes