1. Emerging Technologies Semantic Web and Data Integration 12 April 2013

2. Team logistics Meeting schedule Communication Membership/Outreach Optimal organization How to organize ourselves to best handle parallel activities? Ensure that we have consensus on the basic project scope What do you expect to gain from participating in this project group? Do we have a clear definition of the problem(s)? Agree on near term deliverables and timeline Meeting Objectives 2

3. Expectations: Hands-on experience with semantic technologies Establish consistent (CDISC, data integration) standards based on W3C semantic standards Key Problems for the Project to Address: Support the development of therapeutic area content development including standards Representation and management of CDISC standards Execute experiments to better understand the value of representing clinical trial data in RDF Pre-Meeting Q&A 2

4. Team Communication Employ the PhUSE Wiki as the primary communication tool Overall plan and deliverables Meeting minutes (how soon after a meeting and who will post?) Discussions Post materials/project artifacts to Wiki ListBox for group communications 3

5. Leadership Team Industry Co-Lead: Frederik Malfait FDA Co-Lead: Mitra Rocca Project Manager: Michael Brennan Project Communication: Scott Bahlavooni 5

6. Team Logistics Meeting Schedule Weekly the end of April, then propose that we meet as a group every 2 weeks Fridays at 11 AM EDT/8:00 PDT/5:00 PM CEST Initial focus would be on curriculum develop – getting everyone on the same page and developing a catalog of use cases After this initial phase, break into sub-teams? Focus on specific sub-projects Alignment with other organizations How to best co-ordinate efforts and keep everyone informed? 5

7. Membership/Outreach Presently we have ~25 people signed up for this project We plan to actively reach to folks not involved in the meeting to participate in this project What skills, background should we target? Best way of getting awareness of our group outside of PhUSE. 6

8. Project Scope Document Three key areas of focus Educate Develop a core curriculum Develop a basic core slide deck/”elevator speech” that can be used internally to make the case for semantic technology Influence Call awareness to the work of this group – beyond PhUSE Alignment with other groups working in this area NCI, BRIDG, CDISC-SHARE, W3C Deliver/Experiment Define a catalog of use cases Represent CDISC Standards in RDF Plan and implement 3 pilots 7

9. Initial Areas of Focus CDISC2RDF as a starting point Conformance checks in RDF Turn attention to CDASH and ADaM Link CDISC standards to other data sources like MedDRA, NCI Thesaurus, HGNC etc. to RDF Development of clinical data Standards for the Therapeutic areas on CDER/CBER’s plan 8

10. Timeline 9

11. Some Questions What should be the expected level of time commitment to this project (given that we have “day jobs”)? Are the proposed objectives and timelines reasonable What are the key product that we will deliver as a team? 10