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!
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 |
|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 - 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