2018 CSS Nonclinical Topics Outcomes
||A big THANKS to attendees and their companies for investing in attendance to the 2018 CSS this year.|
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
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|
|Monday – Breakout 1 – Project Recognition||Nonclinical Topics Delivering Over the Past Year||• Data consistency|
|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 |
|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
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