Nonclinical Topics Working Group

From PhUSE Wiki
Jump to: navigation, search


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.

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.)

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) 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 fwood.dsc (at) gmail.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

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

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

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

2014
Highlights and Outcomes of the CSS2014 Nonclinical WG breakouts
all presentations or posters from CSS2014

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

2017

Project Updates

Disclaimer

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,04/18/2018