Difference between revisions of "Nonclinical Topics Working Group"

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    * Got a question about SEND?  [[SEND Implementation Forum|Click Here to Ask in the Forum]]!
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Got a question about SEND?  [[SEND Implementation Forum|Click Here to Ask in the Forum]]!
 
==Latest News & Activities==
 
==Latest News & Activities==
 
<br />
 
<br />
'''GET READY FOR NONCLINICAL TOPICS AT THE 2019 CSS!'''<br />
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'''''Deliverables in Review'''''<br />
  
'''PhUSE CSS in Silver Spring is coming up soon, June 9-11, 2019.'''
+
The Modeling Endpoints project team has published their White Paper for PhUSE Public Review:<br /><br />
 +
*[https://www.phusewiki.org/docs/WorkingGroups/Deliverables/PHUSE%20ADA%20WhitePaper%20Working%20Draft_15July2019%20Final%20Draft%20White%20Paper.pdf ''RECOMMENDATIONS FOR ADA MODELING IN SEND 3.0 AND 3.1''
 +
<br />
 +
Please provide review comments to Gretchen.e.Dean@pfizer.com and Michael.Wasko@pdslifesciences.com by August 12, 2019.<br />
 
<br />
 
<br />
  
We have prepared an active working agenda for breakout sessions that dive into SEND Data and Implementation Challenges, Communicate the 2019 SEND Survey Results and Collaborate with 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. 
+
'''''Feedback from FDA on Section 5 of the nSDRG - Data Conformance Issues'''''
<br /><br />
+
<br />
 
 
'''''Check out the AGENDA Here -''''' [[Media:Getting_Ready_for_2019_CSS_Nonclinical_Topics_Working_Group.pdf |2019 Agenda Preview and Prework Activities]]<br /><br />
 
 
 
'''''Review the 2019 PhUSE Nonclinical Working Group Project Status Updates:''''' <br /><br />
 
 
 
[[Media:2019_CSS_Modeling_ADA_in_Nonclinical_studies_Project_Status.pptx|Modeling ADA in Nonclinical Studies]]<br />
 
 
 
[[Media:Demystifying_Define.xml_Project_Status_2019.pptx|Demystifying Define Codelists]]<br />
 
 
 
[[Media:NSDRG_Project_Status_2019.pptx|Nonclinical Study Data Reviewers' Guide Maintenance]]<br />
 
  
[[Media:Data_Consistency_Project_Status_2019.pptx|SEND Data Consistency with Final Report ]]<br />
+
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 Implementation Wiki - FAQ|SEND FAQ]] page - see the subsection section on nSDRG.<br /><br />
 +
* [[Media:Questions_from_PhUSE_NSDRG_Team_on_Section_5_10May2019_-_FDA_Response.pdf|Improving the Reporting of Data Conformance Issues in the Nonclinical Study Data Reviewers' Guide]]<br />
  
 
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== Nonclinical Topics Working Group Vision ==
== 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.<br />
 
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.<br />
  
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<br />
 
<br />
 
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: [https://www.ncbi.nlm.nih.gov/pubmed/29843574 Scientific and Regulatory Policy Committee Points to Consider: Data Visualization for Clinical and Anatomic Pathologists.]
 
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: [https://www.ncbi.nlm.nih.gov/pubmed/29843574 Scientific and Regulatory Policy Committee Points to Consider: Data Visualization for Clinical and Anatomic Pathologists.]
 +
<br />
 +
 +
===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. 
 
<br /><br />
 
<br /><br />
 +
Presentations from Nonclinical Breakout Sessions and additional Posters provided:<br />
  
===2018 CSS Silver Spring Results===
+
[[Media:Nonclinical_Survey_Results_Slides_CSS_2019.pdf|Nonclinical SEND Implementation Survey 2019]]<br />
<br />
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[[Media:Challenges_of_SEND_Implementation_Status_List.xlsx|Five Perspectives on SEND Implementation Challenges 2019]]<br />
<big>''VISIT our site: [[2018 CSS Nonclinical Topics Outcomes]] for all the presentations.''</big>
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[[Media:PhUSE_CSS_2019_-_SEND_Workshop_-_BioCelerate_Presentation_Pack_vF.pdf|Cross-Study Analysis Workshop - BioCelerate and FDA]]
 
<br /><br />
 
<br /><br />
  
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:
+
'''''Review the 2019 PHUSE Nonclinical Working Group Project Status Updates:''''' <br />
* 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
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[[Media:2019_CSS_Modeling_ADA_in_Nonclinical_studies_Project_Status.pptx|Modeling ADA in Nonclinical Studies]]<br />
* Impact Panel: Pharma/CRO/Software vendor impacts of esubmission requirements - ''a very popular session!
+
 
''
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[[Media:Demystifying_Define.xml_Project_Status_2019.pptx|Demystifying Define Codelists]]<br />
* Presentation of nonclinical data sharing initiatives in US and EU - Biocelerate and eTransafe<br />
 
  
==2018 Project Updates (March)==
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[[Media:NSDRG_Project_Status_2019.pptx|Nonclinical Study Data Reviewers' Guide]]<br />
*[[Media:NSDRG_Project_Status_2018.pptx|Project Status Update - nsdrg]]
 
*[[Media:Data_Consistency_Project_Status_2018.pptx|Project Status Update - Data Consistency between Datasets and Study Report]]
 
*[[Media:Demystifying_define.xml_Codelists_for_Nonclinical_Studies_Project_Status_2018.pptx|Project Status Update - Demystifying define.xml Codelists for Nonclinical Studies]]
 
*[[Media:Industry_SEND_Progress_Survey_Project_Status_2018.pptx|Project Status Update - Industry SEND Progress Survey]]
 
*[[Media:Modeling_Anti-Drug_Antibody_Data_in_Nonclinical_Studies_Project_Status_2018.pptx|Project Status Update - Modeling Anti-Drug Antibody Data in Nonclinical Studies]]
 
*[[Media:Nonclinical_Scripts_Project_Status_2018.pptx|Project Status Update - Nonclinical Scripts]]
 
*[[Media:SEND_Implementation_User_Group_Project_Status_2018.pptx|Project Status Update - SEND Implementation User Group]]
 
*[[Media:Visualization_of_Histopathology_Data_Project_Status_2018.pptx|Project Status Update - Visualization of Histopathology Data]]
 
  
 +
[[Media:Data_Consistency_Project_Status_2019.pptx|SEND Data Consistency with Final Report ]]<br />
  
To view content from previous years' CSS events: Click here to reach the page for [[Past Nonclinical Topics CSS Activities]]
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[[Media:SEND_Implementation_User_Group_Status_2019.pptx|SEND Implementation User Group]]<br />
  
 +
[[Media:Data_Visualization_Project_Status_2019.pptx ‎|Data Visualization as an Enabler for Safety Signal Detection]]<br />
  
 +
[[Media:Nonclinical_Scripts_Project_Status_2019.pptx‎|Nonclinical Scripts]]<br />
 +
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[[Media:SEND_Challenges_Breakout_Discussion.pptx|Evolution of SEND Implementation Challenges: Provided as Pre-read to Breakout 2]]<br />
  
 
== Current Projects ==
 
== Current Projects ==
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|-
 
|-
 
| '''Project''' || '''Project leads'''|| '''Link to project page'''
 
| '''Project''' || '''Project leads'''|| '''Link to project page'''
|-
 
| Data Consistency || Fred Wood, Maria Francomacaro || [[Data Consistency: SEND Datasets and the Study Report]]
 
|-
 
| Data Visualization || Alan P. Brown, Phil Drew  ||  [[Data Visualisation as an Enabler for Nonclinical Safety Signal Detection]]
 
|-
 
| Define.xml || Jennifer Feldmann, Kathy Brown || [[Demystifying_Define-XML_Codelist_Handling_for_Nonclinical_Studies|Demystifying Define.xml Codelists for Nonclinical Studies]]
 
 
|-
 
|-
 
| SEND Survey || Bob Friedman, Lou Ann Kramer ||  [[Industry SEND Progress Survey]]
 
| SEND Survey || Bob Friedman, Lou Ann Kramer ||  [[Industry SEND Progress Survey]]
|-
 
| Anti-Drug Antibody ||Michael Wasko, Gretchen Dean||  [[Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies]]
 
 
|-
 
|-
 
| Nonclinical Scripts  || William Houser, Kevin Snyder ||  [[Nonclinical Script Assessment Project]]
 
| Nonclinical Scripts  || William Houser, Kevin Snyder ||  [[Nonclinical Script Assessment Project]]
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| SEND Implementation User Group ||Troy Smyrnios, Debra Oetzman ||  [[SEND Implementation User Group]]
 
| 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]]
 
|}
 
|}
  
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|-
 
|-
 
||Roadmap  || [[WG6_Nonclinical_-_Standardization_Roadmap#Accomplishments|Accomplishments]] || [[WG6_Nonclinical_-_Standardization_Roadmap|Nonclinical Standardization Roadmap Team]]
 
||Roadmap  || [[WG6_Nonclinical_-_Standardization_Roadmap#Accomplishments|Accomplishments]] || [[WG6_Nonclinical_-_Standardization_Roadmap|Nonclinical Standardization Roadmap Team]]
 +
|-
 +
||Define.xml Code List Handling ||[[SEND_Implementation_Wiki_-_FAQ#Define_File|SEND FAQ - DEFINE.XML section]] || [[Demystifying_Define-XML_Codelist_Handling_for_Nonclinical_Studies|Demystifying Define.xml Codelists for Nonclinical Studies]]
 
|-
 
|-
 
||Clinical Endpoint predictivity  || [[NICE#Project_Activities_Completed_in_2014|Activities completed]] || [[NICE|NICE: Nonclinical data Interconnectivity for Clinical Endpoint predictivity]]
 
||Clinical Endpoint predictivity  || [[NICE#Project_Activities_Completed_in_2014|Activities completed]] || [[NICE|NICE: Nonclinical data Interconnectivity for Clinical Endpoint predictivity]]
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|-
 
|-
 
|| SEND Data for Analysis || [[Application_of_SEND_Data_for_Analysis#SEND_Variable_Annotation_Examples|Annotated examples]] || [[Application of SEND Data for Analysis]]
 
|| SEND Data for Analysis || [[Application_of_SEND_Data_for_Analysis#SEND_Variable_Annotation_Examples|Annotated examples]] || [[Application of SEND Data for Analysis]]
 +
|-
 +
||Data Visualization ||[https://www.phusewiki.org/docs/2019_CSS/Presentations_Posters/CSS%20Posters/PP07.pdf CSS 2019 Poster] ||  [[Data Visualisation as an Enabler for Nonclinical Safety Signal Detection]]
 +
|-
 
|-
 
|-
 
|}
 
|}
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|-
 
|-
 
| Gretchen Dean|| Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies || Pfizer||[mailto:gretchen.e.dean@pfizer.com gretchen.e.dean (at) pfizer.com]
 
| Gretchen Dean|| Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies || Pfizer||[mailto:gretchen.e.dean@pfizer.com gretchen.e.dean (at) pfizer.com]
|-
 
| Phil Drew|| Visualization of Group Related Differences in Histopathology Data|| PDS Consultants||[mailto:philip.drew@pds-consultants.co.uk philip.drew (at) pds-consultants.co.uk]
 
|-
 
|Alan Brown|| Visualization of Group Related Differences in Histopathology Data|| Novartis||[mailto:alan_p.brown@novartis.com alan_p.brown(at)novartis.com]
 
 
|-
 
|-
 
|George Kahlbaugh|| Industry SEND Progress Survey|| Boehringer-Ingelheim||[mailto:George.Kahlbaugh@boehringer-ingelheim.com George.Kahlbaugh (at) boehringer-ingelheim.com]
 
|George Kahlbaugh|| Industry SEND Progress Survey|| Boehringer-Ingelheim||[mailto:George.Kahlbaugh@boehringer-ingelheim.com George.Kahlbaugh (at) boehringer-ingelheim.com]
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| Maria Francomacaro|| Data Consistency: SEND Datasets and the Study Report|| Merck||[mailto:Maria_Francomacaro@merck.com Maria_Francomacaro(at) merck.com]
 
| Maria Francomacaro|| Data Consistency: SEND Datasets and the Study Report|| Merck||[mailto:Maria_Francomacaro@merck.com Maria_Francomacaro(at) merck.com]
 
|-
 
|-
| Jennifer Feldmann|| Demystifying Define-XML Codelist Handling for Nonclinical Studies || Epreda|| [mailto:jennifer.feldmann@epreda.com jennifer.feldmann (at) epreda.com]
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| Kathy Brown|| || Sanofi || [mailto:Kathryn.Brown@sanofi.com Kathryn.Brown (at) Sanofi.com]
 
|-
 
|-
| Kathy Brown|| Demystifying Define-XML Codelist Handling for Nonclinical Studies || Sanofi || [mailto:Kathryn.Brown@sanofi.com Kathryn.Brown (at) Sanofi.com]
+
| Jesse Anderson|| SEND Dataset QC Best Practices || FDA || [mailto:jesse.anderson@fda.hhs.gov]
 
|-
 
|-
 +
| Michael Rosentreter|| SEND Dataset QC Best Practices || Bayer || [mailto:michae.rosentreter@bayer.com]
 +
|-
 +
 
|}
 
|}
  
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==Archive of Past Years' CSS Meetings==
 
==Archive of Past Years' CSS Meetings==
'''2012'''<br />
 
[[File: FDA_PhUSE_WG6_Needs_Challenges_2012CSS.xlsx‎]]<br />
 
[[CSS 2012 WG6 WhitePaper]]<br />
 
[[WG6 30Mar2012]]<br />
 
 
'''2013'''<br />
 
[[File:PhUSE WG6 NonClinical Update Mar 2013 final.pdf]]<br />
 
[[Nonclinical Working Group Minutes 20Dec2013]]
 
 
'''2014'''<br />
 
[[media:Nonclinical WG update to PhUSE CSS March 2014.pdf|Highlights and Outcomes of the CSS2014 Nonclinical WG breakouts]]<br />
 
[http://www.phuse.eu/CSS-2014-Presentations.aspx all presentations or posters from CSS2014]<br />
 
 
'''2016'''<br />
 
[[File:CSS_2016_Agenda_-_NC_-_20160218.xls|Nonclinical Working Group CSS Agenda - 2016]]<br />
 
[[File:Detailed_Breakout_Plan_2016.docx|Detailed Breakout Descriptions - Times and Facilitators]]<br />
 
Click here to reach the page for [[2016 EU CSS]]
 
  
'''2017'''<br />
+
To view content from previous years' CSS events: Click here to reach the page for [[Past Nonclinical Topics CSS Activities]]<br />
*[[Media:2017_CSS_NCT_Breakout_Plan.pptx|Nonclinical Topics WG Breakout Agenda]]
 
*[[Nonclinical Topics Breakout Presentations]]
 
'''Project Updates'''
 
*[[Media:2017_UPDATE_Endpoint_Modeling.ppt|Project Status Update - Endpoint Modeling]] - Now completed.
 
*[[Media:2017_UPDATE_nSDRG.ppt|Project Status Update - Nonclinical SDRG]]
 
*[[Media:2017_UPDATE_Test_Submission_Forum_2.ppt|Project Status Update - Test Submission Forum]] - Now completed.
 
*[[Media:2017_UPDATE_Visualization_of_Histopath_Data.ppt|Project Status Update - Visualization of Histopathology Data]]
 
*[[Media:2017_UPDATE_Nonclinical_Script_Assessment.ppt|Project Status Update - Nonclinical Scripts Assessment]]
 
*[[Media:2017_UPDATE_Data_Consistency_to_Reports.ppt|Project Status Update - Data Consistency between Datasets and Study Report]]
 
  
 
==Disclaimer==
 
==Disclaimer==
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'''Deliverables Disclaimer''' : <br />
 
'''Deliverables Disclaimer''' : <br />
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.
+
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.
 
<br />
 
<br />
  

Latest revision as of 09:00, 16 June 2020


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.

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) 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 [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

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 Laurenwhite,06/16/2020

Meeting Minutes