Nonclinical Topics Working Group
- 1 Latest News & Activities
- 2 Nonclinical Topics Working Group Vision
- 3 Current Projects
- 4 Completed Projects
- 5 Nonclinical Poster List
- 6 Core Team
- 7 Other Nonclinical Consortia of Interest
- 8 CSS Processes
- 9 Archive of Past Years' CSS Meetings
- 10 Disclaimer
- 11 Webinar Presentations
- 12 Meeting Minutes
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 Gretchen.e.Dean@pfizer.com and Michael.Wasko@pdslifesciences.com 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.
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:
Review the 2019 PHUSE Nonclinical Working Group Project Status Updates:
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|
Nonclinical Poster List
Click here to find our current and past posters: Nonclinical Topics Poster List
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.
|Lilliam Rosario||Sponsor||FDA||Lilliam.Rosario (at) fda.hhs.gov|
|Susan DeHaven||Working Group Co-Lead; Nonclinical Study Data Reviewers Guide||Sanofi||Susan.DeHaven (at) Sanofi.com|
|Patricia Brundage||Working Group Co-Lead||FDA||Patricia.Brundage (at) fda.hhs.gov|
|David Epstein||FDA Liaison||FDA||David.Epstein (at) fda.hhs.gov|
|Debra Oetzman||Nonclinical Study Data Reviewers Guide; SEND Implementation User Group||Instem||Debra.Oetzman (at) Instem.com|
|Troy Smyrnios||SEND Implementation User Group||Zoetis||troy.c.smyrnios (at) zoetis.com|
|Mike Wasko||Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies||PDS Life Sciences||michael.wasko (at) pdslifesciences.com|
|Gretchen Dean||Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies||Pfizer||gretchen.e.dean (at) pfizer.com|
|George Kahlbaugh||Industry SEND Progress Survey||Boehringer-Ingelheim||George.Kahlbaugh (at) boehringer-ingelheim.com|
|Lou Ann Kramer||CDISC SEND Team Liaison; Industry SEND Progress Survey||CDISC||lkramer (at) cdisc.org|
|Bob Friedman||Industry SEND Progress Survey||Xybion||bfriedman (at) xybion.com|
|Bill Houser||Nonclinical Script Assessment Project||Bristol-Myers Squibb||william.houser (at) bms.com|
|Kevin Snyder||Nonclinical Script Assessment Project||FDA||Kevin.Snyder (at) fda.hhs.gov|
|Fred Wood||Data Consistency: SEND Datasets and the Study Report||Accenture||fwood.dsc (at) gmail.com|
|Maria Francomacaro||Data Consistency: SEND Datasets and the Study Report||Merck||Maria_Francomacaro(at) merck.com|
|Kathy Brown||Sanofi||Kathryn.Brown (at) Sanofi.com|
|Jesse Anderson||SEND Dataset QC Best Practices||FDA|||
|Michael Rosentreter||SEND Dataset QC Best Practices||Bayer|||
Other Nonclinical Consortia of Interest
Here is a list of consortia that may from time to time have overlapping interests with this group.
- IQ Database Framework
- eTox (Innovative Medicines Initiative)
- NextGets (Innovative Medicines Initiative 2)
- RITA - Registry of Industrial Toxicology Animal data
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.
- Nonclinical Topics
- Nonclinical Topics PhUSE CSS 2017 Overview
- Nonclinical Topics Working Groups
- Nonclinical WG Overview
Last revision by Laurenwhite,06/16/2020
- Nonclinical All Team Meeting Minutes 12 NOV 2018
- Nonclinical All Team Meeting Minutes 15 OCT 2018
- Nonclinical All Team Meeting Minutes 23 JUL 2018
- Nonclinical All Team Meeting Minutes 25 JUN 2018
- Nonclinical All Team Meeting Minutes 14 MAY 2018
- Nonclinical All Team Meeting Minutes 30 APR 2018
- Nonclinical All Team Meeting Minutes 19 Mar 2018