Nonclinical Topics Working Group
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
The Nonclinical Topics Working Group is looking forward to a dynamic 2018 US Computational Sciences Symposium March 4-6, at the Silver Spring Convention Center, Silver Spring, MD. In addition to updates on our 8 ongoing projects, we are gathering topics now for our highly informative and interactive breakout sessions with a strong agenda in the works. Of course, your ideas are still welcome! Contact email@example.com if you have questions or would like to engage in the CSS activities in any way.
Attention all Nonclinical Topics Project Teams: POSTERS at the CSS are a great way to release your deliverables into the wild! Click here for information about CSS abstract & poster information.
To view content from previous years' CSS events: Click here to reach the page for Past Nonclinical Topics CSS Activities
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.)
- Demystifying Define.xml Codelists for Nonclinical Studies
- Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies
- Nonclinical Study Data Reviewers Guide
- SEND Implementation User Group
- Visualization of Group Related Differences in Histopatholgy Data
- Industry SEND Progress Survey
- Nonclinical Script Assessment Project
- Data Consistency: SEND Datasets and the Study Report
- Nonclinical Standardization Roadmap Team
- NICE: Nonclinical data Interconnectivity for Clinical Endpoint predictivity
- Nonclinical Historical Controls
- Interorganizational SEND
- Nonclinical Working Group Industry Discussion Group
- Emerging Technologies Collaboration
- Test Submission Forum Group
- Investigating Endpoint Modeling - Biomarkers
- Application of SEND Data for 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|
|Thomas Gade Bjerregaard||Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies||Novo Nordisk||tgb (at) novonordisk.com|
|Phil Drew||Visualization of Group Related Differences in Histopathology Data||PDS Consultants||philip.drew (at) pds-consultants.co.uk|
|Alan Brown||Visualization of Group Related Differences in Histopathology Data||Novartis||alan_p.brown(at)novartis.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||f.wood (at) accenture.com|
|Maria Francomacaro||Data Consistency: SEND Datasets and the Study Report||Merck||Maria_Francomacaro(at) merck.com|
|Jennifer Feldmann||Demystifying Define-XML Codelist Handling for Nonclinical Studies||Epreda||jennifer.feldmann (at) epreda.com|
|Kathy Brown||Demystifying Define-XML Codelist Handling for Nonclinical Studies||Sanofi||Kathryn.Brown (at) Sanofi.com|
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.
- 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
- Project Status Update - Endpoint Modeling - Now completed.
- Project Status Update - Nonclinical SDRG
- Project Status Update - Test Submission Forum - Now completed.
- Project Status Update - Visualization of Histopathology Data
- Project Status Update - Nonclinical Scripts Assessment
- Project Status Update - Data Consistency between Datasets and Study Report
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 Pbrundage,11/15/2017