2018 CSS Nonclinical Topics Outcomes

From PHUSE Wiki
Revision as of 19:51, 16 April 2018 by SusanDeHaven (talk | contribs)
Jump to: navigation, search


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!

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

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