2018 CSS Nonclinical Topics Outcomes

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WELCOME

A big THANKS to attendees and their companies for investing in attendance to the 2018 CSS this year.


The Nonclinical Topics Working Group had the biggest turnout ever (>70), filling up the big conference space.

With all that brain power, experience and enthusiasm, the experience was truly valuable!

Click the links below to see the presentations of each breakout session. If you'd like to learn more about the NCT WG, or find a project to join <Go to Nonclinical Topics Working Group Wiki site.>

AGENDA and Presentations

Session Title Presentation Links

Sunday - Eve Workshop

Maintaining the SDRG: Clinical and Nonclinical Workshop File:SDRG Workshop Outcomes 5Mar2018.pptx
Monday - NCT WG Intro session Working Group Keynote Speaker: Lilliam Rosario, FDA

Bringing It All Together
Outcome of Lilliam’s question: What can we do to help?

Monday – Breakout 1 – Project Recognition Nonclinical Topics Delivering Over the Past Year Data consistency

Nonclinical scripts BW gain presentation
Project status presentations
2017 SEND Implementation Survey

Monday – Breakout 2 – Industry Impact Perspectives Industry Impacts of e-data implementation –experience and expectations

• Impact Panel: Pharma/CRO/Software vendor impacts of esubmission requirements.

Discussion outcomes: Pharma-CRO-Regulatory-Vendor-Consultants
Tuesday - Breakout 3 – Future Ways of Working Solving nonclinical data challenge of Toxicology data sharing initiatives eTransafe presentation and Visualization of Group Related Differences in Histopathology Data

Biocelerate presentation
Improving the NCT WIKI - discussion outcome

Tuesday - Breakout 4 – Future Value

What is on the horizon for implementation challenges?

CDISC SEND Development Status CSS2018
CSS Outcomes New Projects - agreed proposal List • Improving the NCT WIKI

• Linked Data Education

• Modeling Flow Cytometry in SEND

(project requests to be created)

Nonclinical Posters

PP15 - CSS Industry Poster Award Winner! BioCelerate Toxicology Data Sharing Initiative: Development of a Centralized Searchable Preclinical by Thomas Bjerregaard, Novo Nordisk & William Houser, Bristol-Myers Squibb

PP02 - Results of the Third Annual SEND Industry Readiness Survey by George Kahlbaugh, Boehringer Ingelheim, Lou Ann Kramer, CDISC & Bob Friedman, Xybion

PP03 - Modeling of Anti-Drug Antibodies in SEND by Leslie Lorello & Gretchen Dean, Pfizer

PP04 - Ensuring Consistency of SEND Datasets with Study Reports, Using Machine Learning Algorithms by Suresh Madhavan, Kurien Abraham & Venkatesh Krishnan, PointCross

PP06 - Data Consistency: SEND Datasets and the Study Report by Maria Francomacaro, Merck, Wenxian Wang, Xybion & Michael Rosentreter, Bayer

PP13 - Body Weight Gain Analysis Based on the BW Domain Using an R Shiny Application by Bob Friedman, Xybion & Anthony Fata, SNBL USA

PP18 - Evaluation of a Novel Graphical Display Tool for Visualizing and Analyzing Histopathology Data from Multiple Toxicology Studies by Alan Brown, Novartis, Kevin Snyder, FDA & Philip Drew, PDS Consultants

PP32 - eTRANSAFE: A New Player in the Translational Safety Assessment by William Drewe, Lhasa Limited, Thomas Steger-Hartmann, Bayer & Montserrat Cases, Synapse Research Management Partners