2015 CSS Nonclinical Working Group Breakout Agenda

From PHUSE Wiki
Jump to: navigation, search

Venue: "Silver Spring Civic Center"

Sunday March 15

Working Group Meet and Greet - 5:00 pm - 7:00 pm
Come introduce yourself to the Working Group!

Monday March 16

Working Group Kick-Off, 11am-12pm

  • Welcome remarks - Nonclinical WG Co-leads (Bob Dorsam, Sue DeHaven)
  • Remarks from Tim Kropp, Associate Director for Innovation, Office of Computational Science, CDER/FDA
  • Re-iterate 8 Jan webinar topic: areas for collaboration on data challenges
  • Refresh on CSS project missions (finite, impactful…)
  • Set mindset of group for new project selection

Breakout Session 1, 1:30-3pm

  • Past Year Project deliverable presentations from each project
  • NICE: Nonclinical data Interconnectivity for Clinical Endpoint predictivity
  • Nonclinical Study Data Reviewers Guide
  • Nonclinical Historical Controls
  • Interorganizational SEND
  • SEND Implementation User Group
  • Nonclinical Standardization Roadmap Team
  • Nonclinical Working Group Industry Discussion Group
  • Emerging Technologies Collaboration
  • Outcome decision – close or keep project open for 2015-2016 CSS year.

Breakout 2, 3:30-5pm:

  • New Project Candidates Presentations
  • Present collated list
  • Clarify understanding and “vet” proposals
  • Derive “best” of list
  • Explain methodology for project selection for coming year

Tuesday Mar 17

Breakout Session 3, 8:30-10am:

  • New project prioritization and selection
  • Selected project refinement and team building

Breakout 4, 10:30am-12pm

  • Team Time
  • Closing Remarks:
  • Plan for 2015-2016 – Team by Team verbal report out on Team plans
  • Meeting accomplishment presentation compilation
  • Meeting Wrap up
  • Coming year communication plans