WELCOME! Nonclinical Topics Working Group CSS Breakout Plan

Date/Time Monday 11-12 Nonclinical Topics Working Group intro session, chaired by Sue DeHaven and Patty Brundage Welcome – 10 min Remarks (30-40 min) Mission and Principles Preview upcoming activities Working Group Keynote Speaker: Lilliam Rosario, FDA 12-1 Lunch 1-2:30 – Breakout 1 Fit for Use: Industry Feedback Panel Discussion – chaired by Kathy Brown, Maria Francomacaro Sponsor Panel to present experiences from Fit For use Pilot Data Consistency Challenges Discussion forum on ways to improve SEND implementations 2:30-3 (estimated) Break 3-4:30 – Breakout 2 “Functionalizing” Data Visualizations via Scripts – chaired by Alan Brown, William Houser Opportunities with different tools Discussion on General Session FDA presentation as relevant to visualization Some contingency time 5-6:30 Poster Session

Tuesday Date/Time 8:30-10 – Breakout 3 PhUSE and CDISC Collaboration – We’re Not Silos! – chaired by Lou Ann Kramer, Chris Decker Joint discussion of nonclinical standards development “hot topics” and related implementation support opportunities Results Presentation of 2017 SEND Readiness Survey – chaired by George Kahlbaugh, Lou Ann Kramer How far has industry advanced since last year Surface ideas for ways PhUSE can support implementation challenges 10-10:30 Break 10:30 -12 – Breakout 4 Update on Industry Consortiums: (*may be moved to Tues, pending schedule) Transcelerate/Biocelerate – William Houser IMIeTox/NextGets – Phil Drew Project Reviews and Selections for upcoming year – chaired by Sue DeHaven, Patty Brundage Past year Project updates with decisions on continue or close Analysis and decision on new project ideas 12-1 Lunch 1-2 – Working Group Wrap up