HARMONY: European Network of Excellence for Big Data in Hematology

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1 European Network of Excellence for Big Data in Hematology, consisting of 51 partners from 11 countries. HARMONY: European Network of Excellence for Big Data in Hematology Barcelona, 5 de marzo de 2018 Jesús M. Hernández HARMONY Coordinator Institute of Biomedical Research of Salamanca (IBSAL) Funded by

2 What is HARMONY?

3 IMI: Innovative Medicines Initiative Europe s largest public-private partnership in healthcare to speed up development of and patient access to new medicines BD4BO: Big Data for Better Outcomes Initiative within IMI seeking to leverage big data to improve outcomes Initiatives in different disease areas IMI projects addressing BD4BO's key enablers in different therapeutic areas 1.6 B funding for public partners 3.3 B Partnership B in-kind (data, capabilities, FTEs) During first phase ( ), IMI budget of 2 billion, half of which came from the EU's FP7, and half of which came from in kind contributions by EFPIA companies 4 key enablers Design sets of standard outcomes and demonstrate value Increase access to high quality outcomes data Use data to improve value of HC delivery Increase patient engagement through digital solutions HARMONY is a key initiative within IMI Funded by

4 "Big data for better outcomes" Goal: Support the evolution towards outcomes-focused and sustainable healthcare systems, exploiting the opportunities offered by large data sets from variable sources DO-IT COORDINATION AND SUPPORT ACTION (CSA) (Launched) EUROPEAN DISTRIBUTED DATA NETWORK Design sets of standard outcomes and demonstrate value Increase access to high quality outcomes data HARMONY: HEMATOLOGIC MALIGNANCIES ROADMAP: ALZHEIMER'S DISEASE (Launched) BIGDATA@HEART: CARDIOVASCULAR (Launched) PIONEER: PROSTATE CANCER (Consortium formed) HEALTH OUTCOMES IN MULTIMORBID PATIENTS Use data to improve value of HC delivery Increase patient engagement through digital solutions PLANNED PROJECTS Future topic proposals, e.g. respiratory, oncology and ophthalmology Under the "BD4BO" umbrella, HMs is currently the largest program Funded by

5 WP1 Project management (IBSAL, NOVARTIS, CELGENE, HULAFE, SYNAPSE) All Partners Specific questions by disease Involvement of KOLs and collaborative Working Groups Molecular and Clinical Data MM AML ALL CLL NHL MDS Sonneveld San Miguel Boccadoro WP5 Ossenkoppele Huntly Lo Coco WP3 WP4 Gökbuget Dombret Ribera Ghia Pospisilova Bosch Salles Dreyling Montoto Data access (GMV, JANSSEN, BAYER) Data platform (ELN, JANSSEN) Fenaux Kuendgen Santini Child HM Moorman Reinhardt Locatelli Data analytics for therapies valuation (UNIBO, MENARINI, JANSSEN) WP2 Outcomes definition (UULM, BAYER, TAKEDA) WP6 HTA, EMA, patients integration (LeukaNET, CELGENE, JANSSEN) WP7 Dissemination & Communication (EHA, NOVARTIS, TAKEDA) Legal, Ethics & Expert Governance Advisory (MUW, Panel AMGEN, BAYER) WP8 8 Work Packages across 7 diseases Funded by

6 organisations from 11 european countries, including 8 pharmaceutical companies Funded by

7 Ethics Hematologists Pharma Industry Economists Policy makers Regulators Bioinformaticians, data scientists & ICT HTAs Involving every stakeholder group is necessary to meet patients' needs Funded by

8 Data Sharing

9 Data intake and storage Harmonisation Analysis Data Sources Honest Broker Data preparation Data Brokerage CNAF OMOP Our database is ready to work Funded by

10 Source Data Data Preparation Data Brokerage Data Harmonization BigData Storage Data Intake Harmonized Data Storage Data Analysis and Visualization Data Source Trusted Third Party Harmony Platform.. Data Pipeline Funded by

11 Data Privacy And Protection: Legal And Ethical Implications

12 Objectives of the data management process Make the data available in a format that optimally addresses the research questions while respecting the applicable legal and regulatory requirements. De Facto Anonymization Definition Data for which attributing the individual data to the relevant individual concerned requires unreasonable effort in terms of time, cost and manpower. Funded by

13 Privacy and Security HARMONY Platform protection VPN (Virtual Private Network) Firewall with two levels Audit: WHO, WHEN, WHERE, WHAT, HOW Risk analysis Named access Roles' segregation Data governance: nobody has access to the data Physical Layer Applying controls and security to 4 layers Network Layer Host Layer Application / Services Layer The platform is hosted on CNAF Hosting with ISO Funded by

14 Technical anonymisation Data Access Restrictions Organizational security Supression Generalisation Perturbation Policies Processes Contracts Green light for data intake: de-facto anonymization Funded by

15 Research Projects: Standard Operational Procedure

16 START Project proposal Submission HARMONY Coordination Office - Research Project (RP) Submission & Evaluation Admission Scientific Assessment Evaluation Clearance CLARIFICATIONS EXECUTION Coordinator & WP2 Leaders Yes No WP2 HM Pillar KOLs WP6 HTAs, Payers, and Patients, Evaluation WP4&5 Data Analytics WP8 Legal and Ethics Compliance No Yes Yes Yes Yes If RP has scientific merit APPROVAL ASSESMENT WP6 INPUT Report WP4&5 INPUT Report ETHICS Report REVIEW MATERIALS PROVIDED No

17 WP2 Outcomes definition (UULM, BAYER, TAKEDA) Public KOLs EFPIA Disease Contacts HTA, EMA, patients integration (LeukaNET, CELGENE, JANSSEN) WP6 ALL Gökbuget Dombret Ribera Jens Hasskarl, Celgene Marieke Schoonen, AMGEN Zack Pemberton Whiteley Data analytics for therapies valuation (UNIBO, MENARINI, JANSSEN) WP4 WP3 Data access (GMV, JANSSEN, BAYER) Data platform (ELN, JANSSEN) AML CLL NHL MDS MM Ossenkoppele Huntly Lo Coco Ghia Pospisilova Bosch Salles Dreyling Montoto Fenaux Kuendgen Santini Sonneveld San Miguel Boccadoro Christina Loefgren Alberto Vasconcelos, Celgene Rory Goodbody, AbbVie Christina Loefgren, Janssen Sante Cundari, Celgene Christina Pelizon, Abbvie Anne I. Merlat-Guitard, Novartis Sushant Hardikar, Abbvie Christina Loefgren, Janssen Bruno Costa, Celgene Bianca Witting, Abbvie Zack Pemberton Whiteley Nick York TBD Sophie Wintrich Kate Morgan WP5 Child HM Moorman Reinhardt Locatelli TBD Anita Kienesberger 8 Work Packages across 7 diseases Funded by

18 Thank you!

19 Any Questions?

20 This material is developed by the HARMONY Alliance Disclaimer This presentation is of scientific nature and has been produced by the HARMONY Alliance. The HARMONY Alliance makes no warranties or representations of any kind as to the content's accuracy, currency or completeness, neither the Alliance nor any party involved in creating, producing or delivering this document shall be liable for any damages, including without limitation, direct, incidental, consequential, indirect or punitive damages, arising out of access to, use of or inability to use this document, or any errors or omissions in the content thereof. This material may not be used for commercial purposes. Remixing is not permitted except for private use. Acknowledgement This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under HARMONY Grant Agreement n This Joint Undertaking receives support from the European Union s Horizon 2020 Research and Innovation Programme and EFPIA.