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eTRIKS at Pharma IT 2017, London

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eTRIKS: Successes, Surprises and Lessons on the Verge of Completing the Largest General Translational Informatics Public Private Partnership to Date

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eTRIKS at Pharma IT 2017, London

  1. 1. European Translational Research Information and Knowledge Management Service http://www.etriks.org p.agapow@imperial.ac.uk, jay.m.bergeron@pfizer.com eTRIKS: Successes, Surprises and Lessons on the Verge of Completing the Largest General Translational Informatics Public Private Partnership to Date Pharmaceutical IT Congress, London September 2017
  2. 2. Enable translational research by: • Common open source platform • Multi-study data harmonisation • Developing best practices • Providing support for translational research projects • Sustainability
  3. 3. Program Goals
  4. 4. Open Source Translational Data Warehouse q Developed by J&J (Janssen) q Based on I2B2 q Cloud Hosted (Amazon EC2) q Open Source q Management of Clinical/Molecular Data q Repository, User Interface, ETL Tools
  5. 5. Integrated and explorable data are valuable data! www.etriks.org Application to Platform Cohort Creation Hypothesis Analysis/Export
  6. 6. Integrated and explorable data are valuable data! www.etriks.org Curation Services • Grounded by the Standards Starter Pack • Combination of modification for consistency and harmonization to established standards • Implemented using the “ICE” tool and/or ad hoc scripting Application to Platform
  7. 7. Integrated and explorable data are valuable data! www.etriks.org eTRIKS Research Application to Platform eTRIKS Labs eTRIKS Operations eTRIKS Harmonization Service (eHS) eTRIKS Analytical Environment EAE SmartR Supplemental Tools Branded as the eTRIKS Labs
  8. 8. Integrated and explorable data are valuable data! www.etriks.org HiDome Similarity Network Fusion Integrated Visualizations Application to Platform eTRIKS Labs Disease Networks/Maps
  9. 9. Integrated and explorable data are valuable data! www.etriks.org Application to Platform eTRIKS Labs
  10. 10. What We Have Done, What We Do In less than 30 months eTRIKS has created an open access information platform and accompanying services to bolster collaborative engagements by speeding and democratizing access to translational research results “Knowledge Management in U-BIOPRED without eTRIKS would have been like running a clinical trial without GCP.” Professor Peter Sterk of the University of Amsterdam “eTRIKS provides gel without which we would be floating in pool of excess data with no direction.” Professor Ian Adcock of Imperial College London PostgreSQL
  11. 11. Integrated and explorable data are valuable data! www.etriks.org At Project Mid Point Deliveries Compute Infrastructure • Established, two projects hosted Base Open Platform • Created/Integrated/Released Applicable Standards • Assessed and Codified Curation • Services applied to multiple projects Sustainability • eTRIKS Network proposal Engagement • 13 Projects supported Ethics/Security • Guidelines for reuse of patient data Challenges • Support for 40 projects unlikely • Legal issues impeding/preventing • Hosting strategy • Federation • Multi-tenancy • Project desires preventing • Multi-tenancy • Provision of integrated data sets • EFPIA partner under-commitment • Reorganization • Loss of key personnel • Lack of adoption of the platform • MTAs/CDAs • Extremely problematic to close • Academic publications
  12. 12. Integrated and explorable data are valuable data! www.etriks.org Outreach Patients and Projects 0 20 40 60 80 100 120 0 20 40 60 80 100 120 Days since document sent % eTRIKS Signatures outstanding for ABIRISK agreement ABI-RISK (Materials Transfer MTA) Oncotrack (Data Processing DPA)
  13. 13. Integrated and explorable data are valuable data! www.etriks.org Confidential Disclosure Agreements • Created an “Mandate” • Allowed the Coordinator (AZ) to sign CDAs on behalf of the collaboration given GA approval Materials Transfer Agreements • Created a general template Data Processing Agreements Outreach Patients and Projects Guidance for Project/Project Interaction Use agreements that only cover those organisations that are directly involved in the joint activities. Ensure that new grant and project agreements include a mandated CDA • when possible, an MTA template for data processing is agreed as part of the project agreement
  14. 14. Integrated and explorable data are valuable data! www.etriks.org Outreach Patients and Projects 41 Rules consistent with the Eu Directive The Directive “on the protection of individuals with regard to the processing of personal data and on the free movement of such data” (95/46/EC, 24 October 1995) The General Data Protection Regulation REGULATION (EU) 2016/679 “on the protection of natural persons with regard to the processing of personal data and on the free movement of such data • A single set of harmonized rules binding for all EU member states • Replace the directive, increased personal protection • Came into force on 24th May 2016, will be law as of 25th May 2018
  15. 15. Willingness to share data Results of a public survey – 2.000 people in the UK 35% Did not trust the NHS with their data 56% Would not allow their data to be shared 22% Personal data had been shared without their consent Integrated and explorable data are valuable data! www.etriks.org
  16. 16. Integrated and explorable data are valuable data! www.etriks.org Outreach Patients and Projects Value of data sharing and reuse Discussion game Finding convergence Concrete actionSmall groups Interviews Canvas
  17. 17. Integrated and explorable data are valuable data! www.etriks.org Outreach Patients and Projects • A Strategy – Enable bilateral engagements across projects • Contract templates • Best practices to facilitate working engagements – Enable productive interactions with data owners • Understand personal data policies and guidelines • Build trust with data providers, researchers and patients through ethical behavior and legal constructs – Enable productive interactions with the public • Raise awareness to the healthcare benefits of data reuse
  18. 18. Integrated and explorable data are valuable data! www.etriks.org Best Practices
  19. 19. Integrated and explorable data are valuable data! www.etriks.org Comprehensive Engagements (6) End Collaboration Prep (2) Multi-Study Programs (16) Specialty Development (2) OPTIMISE Enabling Engagements: Platform, Consulting, Training, Catalog (32) RA-MAP PREPARE RASP Tech 4 Strat Meds 60 Supported Projects CF-MAP Athero-MAP Anaphylaxis-MAP PD-MAPLCDM ACIM ACSN MS-MAP And Counting Chart Target
  20. 20. Integrated and explorable data are valuable data! www.etriks.org RA MAP eHS eTRIKS v1 eTRIKS v2 eTRIKS v3 eTRIKS v4 eTRIKS v5 CDAs MTAs Public Server Best Practices
  21. 21. Integrated and explorable data are valuable data! www.etriks.org Sustainability Assets Distributed to the Individual Academic Partners Imperial College London (Y. Guo) • eTRIKS Platform elements to Imperial College, (with noted exceptions) • eHS, EAE and platform elements associated with eTRIKSv5 • eTRIKS Website U of Luxembourg (R. Schneider) • Public Server and project data residing on eTRIKS infrastructure • SmartR, Data Catalog • Service Portal European Institute for Systems Biology and Medicine • Disease Networks/Maps Biosci Consulting • Patient Input Plan U of Oxford (S. Sansone) • Standards Starter Pack
  22. 22. Integrated and explorable data are valuable data! www.etriks.org Sustainability Commercial Spin Off from the U of Luxembourg • Offering curation, disease map and other services Program Management • Large Scale PPP services: contracting, consulting, business development, collaboration Commercial Sustainability Model Training Material and Patient Input Plan considered project IP Platform elements open licensed under GPLv3 or Apache 2
  23. 23. Integrated and explorable data are valuable data! www.etriks.org Synopsis Meeting the Target KPI - priceless Meeting All Deliverables Favorable Academic Outcomes Commercial Sustainability Plan But Pharma direct benefits slim (substantially underspent) Is the PPP the right model for information technology projects? Enhancements difficult to apply broadly, integration is hard There’s standards & standards tranSMART needs refactoring & repurposing Curation still arduous
  24. 24. Integrated and explorable data are valuable data! www.etriks.org
  25. 25. Integrated and explorable data are valuable data! www.etriks.org Backup
  26. 26. Initial Clients Unbiased biomarkers for the prediction of respiratory disease outcomes Anti-Biopharmaceutical Immunization: prediction and analysis of clinical relevance to minimize the RISK Methods for systematic next generation oncology biomarker development
  27. 27. eTRIKS PLATFORM Founded on tranSMART GPL v3 Open Source Translational Data Warehouse Building upon Janssen’s Award Winning Translational Informatics System Demonstrated Success with the U-BIOPRED IMI Project

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