October 9 th, 2015 Bethesda North Marriott TIES Cancer Research Network Y3 Face to Face Meeting U24 CA

Welcome to TCRN partners! Welcome to NCI Program! 2 Engaging Researchers Building Communities

Morning Welcome 8:00 – 8:30Goals for the Meeting; Overall Summary of Progress in Y2; Y3 Themes and Project Plan (Jacobson) Session 1 - Project Status from TCRN Partner Sites 8:30 – 9:00University of Pennsylvania Update (Feldman) 9:00 – 9:30Georgia Regents University (Bollag) 9:30 – 10:00Roswell Park Cancer Institute (Gaudioso) 10:00 – 10:15 Break Session 2 – Y3 Theme: Dissemination, Outreach and Training 10:15 – 10:30 TIES Dissemination Resources (Jacobson) 10:30 – 11:00Panel Discussion: Ideas for Disseminating TIES to Local Investigators (Feldman, Gaudioso, Bollag, Maihle )

Morning Session 3 – New Partner Introductions 11:00 – 11:20 Thomas Jefferson University Kimmel Cancer Center (Reber) 11:20 – 11:40Stony Brook University Cancer Center (Balasubramanian/Putney) Session 4 – Integrating TIES and TCRN with Tissue Banks and LIMS Systems 11:45 – 12:15 Panel Discussion (Bollag, Benkovich, Murphy, Feldman) 12:15 – 12:30 Break Session 5 – Working Lunch 12:30 – 1:00 Regulatory Update (Corrigan and Murphy) 1:00 – 1:30 Open Discussion of Ancillary Data (Especially Outcomes Data)

Afternoon Session 6 – User Stories – Completed, Current & Future Projects that Use TCRN 1:15 – 2:00Progress Reports (Gaudioso, Bollag and Feldman) 2:00 – 2:15Discussion: New Pilots; Opening Up Access to TCRN 2:15 – 2:30Break Session 7 – Year 3 Development Plan 2:30 – 2:45 Updates on Y2 Releases (Chavan) 2:45 – 3:30 Discuss Development Needs; Review Desired Features from Each Partner Site 3:30 – 4:00 Y2 Project Plan; Action Items and Wrap Up (Jacobson)

Goals for the Meeting 1.Review and discuss Y2 work – What worked and what didn’t? – What improvements can be made in any aspect of the project? 2.Discuss Y3 work and agree on basics of project plan – We will refine these further and present something more formal soon after meeting 3.Contribute to TIES development path to meet needs of institutions and investigators 4.Planning for Y3 manuscripts 6

U24 Specific Aims Specific Aim 1. Enhance the informatics technology to support inter-institutional “trust”, paraffin registry development, tissue microarray (TMA) development, and nondestructive tissue use. Specific Aim 2. Establish the TIES Cancer Research Network (TCRN) with four founding member institutions. Develop governance, network agreements, and policies for operating the TCRN. Specific Aim 3. Recruit and support pilot scientific collaborations across the network. Specific Aim 4. Disseminate the software and measure its impact.

8 Demonstration of Use of TIES across the TIES Cancer Research Network

Overall Progress in Y2 9 Complete Installation of nodes, data all sites Executed New Trust Agreements Policies and processes for operation Software releases (3) All data loaded and coded at every site QA ongoing Virtual Slide integration Structured data in TIES Deployment and Adoption Blueprints Dissemination materials Pending Complete QA at GRU Release of TIES 5.4 (planned for mid-October)

Overview of Y1 and Y2 Accomplishments Technical Accomplishments: -Release of TIES 5.0 5/14/14 -New TIES Project Website10/14/14 -All sites have operational nodes7/14/14 -All sites have processed reports8/14/14 -All sites are on the network10/14/14 -Release of TIES 5.11/15/15 -Release of TIES 5.36/1/15 -All sites have completed bulk document processing8/1/15 -Most sites have completed required QA4/22/15 -Sites start going live (available to investigators)9/1/15 10

Overview of Y1 and Y2 Accomplishments Process Development: ‐All sites have approved IRB protocols ‐All sites have signed new Network Agreement ‐All sites have portals with forms for account request ‐Policies and recommendations have been approved ‐de-identification QA, approval bodies, governance, verifying eligibility, study registration, auditing of users, incident reporting, joining of new members ‐Adoption and Deployment Blueprints available ‐Improving Dissemination materials for sites Pilot Projects: -Five pilot projects in various stages of completion -Many, many lessons learned -Repeated tweaking of policies, forms, education of personnel, engagement of stakeholders Publications: -Publication describing TCRN pending final acceptance at Cancer Research -Paper on NOBLE Coder under review at BMC Bioinformatics -Papers by users crediting TIES and TCRN (Yang Liu, Thaer Khoury) 11

TIES 5.3 released 12

A real federated network 13 Production level deployments at all four original members Disseminating to local users Pilot projects to exercise every part of our processes Potential new members are here (and others have been in touch)

New Network Agreement; Policies and Processes 14

Pending Cancer Research Manuscript 15 Jan 1 issue Online first before that Planning editorials and other efforts to get out the word

Y3 will be another pivotal year of this grant… 16 Releases to investigators at all sites New members Multiple new pilot projects with process adjustments; Open TCRN to investigators at all sites Technical improvements and new options for integration Engaging Researchers Building Communities

Plans for Y3 17 Work to complete TMA integration LIMS Integration LDAP integration Optional additional de-identifier Other goals Publications from users Dissemination at all sites Local TIES users at all sites Additional adoptions at other institutions Collaborations within ITCR (especially imaging and text)

Major challenges for Y3 All sites deployed to local users; increasing numbers of local users at each site Support systems in place at each site Prepare for opening up access to TCRN – We are forging new ground, be patient! – Y2 was the pivotal year ~ we paved the way for widespread use – Need more time and pilots to smooth out all of the kinks – Additions of new data types (e.g. outcomes data) provides important step forward, but will require additional processes and perhaps regulatory steps – Changes to the Common Rule will affect us Better integration (LIMS, DWs, CancerReg) 18

Progress on Cancer Deep Phenotyping U24 Significant progress with development of first pipeline for cancer phenotyping (Stage, TNM, Receptor status, metastasis) Deep Phe Information Models in FHIR (OWL) available at Two and four week sprints, encompassing annotations, method development, model development, rule development, packaged into distributable system Anticipating beta pipeline in Spring 2016, would like to ask all of your help in testing Eventually results of DeepPhe could be incorporated into TIES ‘structured data’ and annotations, enable greater diversity in genre of clinical reports we handle 19