The Evolution of Data Platforms in IMI. Anthony Rowe, Janssen R&D IT 08 April 2016 Med-e-Tel Luxembourg

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1 The Evolution of Data Platforms in IMI Anthony Rowe, Janssen R&D IT 08 April 2016 Med-e-Tel Luxembourg

2 Three trends in technology today Ubiquity of the Internet

3 Three trends in technology today Ubiquity of the Internet Rise of the Post-PC Era

4 Three trends in technology today Ubiquity of the Internet Rise of the Post-PC Era The volume of data

5 Using Digital Technology for Research A voice based study for Parkinson's disease Create a database 10,000 recordings to build digital biomarkers of PD Accessible to 750,000,000 individuals A test for Parkinson's with a phone call Max Little, TEDGlobal 2012

6 IMI 2 Data Platforms in IMI

7 Data Platforms in IMI-1 Research Informatics Translational Informatics Medical Informatics (RWD)

8 IMI2 vision towards integrated healthcare solutions Addressing healthcare priorities identified by the WHO 2013 report Strategic Research Agenda aimed at progressing the vision of stratified medicines: prevention, treatment and health management Entire product cycle from discovery, through development to healthcare delivery and access models Collaboration across sectors to harness all knowledge and technologies which can contribute to IMI2 vision - diagnostics, imaging, IT, medical devices,

9 IMI 2 Strategic Governance Groups The Strategic Governing Groups (SGGs) Immunology Diabetes / metabolic disorders Neurodegeneration Translational safety Data and knowledge management Infections control Data And Knowledge Management SGG Leads: Janssen & Pfizer Representation from : Astellas, AstraZeneca, Bayer, Daiichi-Sankyo, Genzyme, GSK, Grünenthal, Janssen, MSD, Novo Nordisk, Roche, Sanofi, Servier, UCB European Commission

10 Data And Knowledge Management SGG 3 Priorities: Good Data Management Practices Data Sustainability Enabling Platforms

11 Good Data Management Practices We review topics to ensure that new IMI projects have considered appropriate issues such as: Appropriate Data Standards are used Appropriate Hosting and Data Management platforms are used Appropriate data privacy and security policies are developed and implemented

12 Data Sustainability IMI projects typically generate lots of data How do we sustain these datasets? Public archives are vertically integrated IMI projects are horizontally integrated How do we manage protected access? How do we ensure fair credit for investigators?

13 IMI 2 Data and Knowledge Management SGG Enabling Platforms Working Groups New project ideas: SGG Strategy or ad hoc proposals Research Informatics Translational Informatics Real World Data Adaptive Informatics Digital Patients IMI IMI-2 Life Science Networks RADAR Patient SMART BD4BO; DDN

14 Remote Assessment of Disease and Relapse (RADAR) Topic 1 - RADAR:CNS

15 Hypothesis: Digital Technologies can Improve Patient Outcomes Physician visits are time-limited evaluations based on subjective observations of both the patient and the physician or psychiatrist Changes in disease state for each of these diseases can occur on timescales much shorter than the interval between physician visits Through technological advances over the last decade it is now possible to objectively, remotely, and continuously measure aspects of patient physiology, behavior and symptoms

16 Objectives of the RADAR:CNS Topic The aim of RADAR:CNS topic is the characterisation and prediction of changes in disease state in central nervous system (CNS) disorders via non-invasive remote sensing. This topic is planned to be focused on the three diseases of unipolar depression, multiple sclerosis and epilepsy. For each disease it is proposed that a non-interventional/observational study of subjects is undertaken with three objectives: Characterisation of changes in disease state Characterisation of changes in disease state due to drug effects Prediction of change in disease state from remote sensing data

17 Suggested architecture of the project Cohort 1 Depression Cohort 2 Epilepsy Cohort 3 Multiple Sclerosis RADAR:CNS Remote Assessment Tools Sleep architecture Physical Activity Speech Cognition Project Management Social Connectivity Memory Of subjects of all of the target diseases Regulatory & Policy: How can biosignatures impact patients and care Data Management and Modelling Project Management RADAR:CNS

18

19 BIG Data For Better Outcomes Distributed Data Network

20 The Big Data for Better Outcomes programme at a glance "Big data for better outcomes" Goal: Support the evolution towards outcomes-focused and sustainable healthcare systems, exploiting the opportunities offered by big and deep data sources Design sets of standard outcomes and demonstrate value COORDINATION AND SUPPORT ACTION (CSA) published in Dec 2015 EUROPEAN DISTRIBUTED DATA NETWORK Increase access to high quality outcomes data Use data to improve value of HC delivery Increase patient engagement through digital solutions Coordination and operational topics Themes / Enablers ROADS: ALZHEIMER'S DISEASE published in Oct 2015 HEMATOLOGIC MALIGNANCIES - published in Oct 2015 CARDIOVASCULAR published in Dec 2015 PATIENTS' MULTI-COMORBIDITIES RARE CANCERS Diseasespecific topics PROSTATE CANCERS MULTIPLE SCLEROSIS Future topic proposals

21 Therapeutic area projects are expected to coordinate with the CSA and the DDN throughout the duration of the project CSA (Coordination and Support Action) DDN (Distributed Data Network) Disease-specific projects Consistency & quality policy/direction, objectives, call texts facilitate interactions and learnings between projects Standards for data and knowledge Contribute to Data Standards Define TA specific Data Standards Implementation Knowledge integration Policy principles (programme level) Gap analysis and recommendations for projects TA specific recommendations Knowledge repository/platform Processes for collection, use and exploitation of knowledge and active process management Repository infrastructure Generate and manage TA specific contents Engagement with HC stakeholders & communication Branding (templates, guidance) Programme comms material Programme website Stakeholders engagement Recommendations on data formats and standards TA specific interactions with stakeholders (+reporting to CSA) Communication (project level) Data protection & integrity Legal & ethical standards Code of practice Common ethics Board Templates/guidance Technical data security and privacy solutions Common minimum data standards Operational interactions with competent authorities Data sustainability & growth of networks Data sustainability mechanisms (including quality of data and adequate use)

22 Back ups Backups

23 Model Based Drug Development Clinical Trial Simulator - Prototype v.2 Adaptive Optimal Designs prototype V.1

24 Compound Target Pathway Disease data Created the Open PHACTS Discovery Platform linking information and facts from multiple public databases Created an API for drug discovery with an ecosystem of apps Methodology for delivery business-relevant solutions Use by bench and computational scientists Established itself as a a unique forum for partners the Open PHACTS Foundation support the existing infrastructure and widen scientific scope

25 Efforts to Automate clinical research 1 DESIGN Feasibility Study Protocol (CDISC PRM SDM) 2 EXECUTION Patient Recruitment 3 EXECUTION Data Collection Case Report Form (CDISC ODM) FDA-EMA SUBMISSION Regulators XML XML XML Trial Registry Document Management System Clinical Trial Management System (CTMS) Clinical Data Management System (CDMS) XML

26 EMIF European Medical Information Framework Research topics provide focus Platform Make data available for browsing and analysis in multiple ways Alzheimers Disease Identification and validation of markers that predict Alzheimer s progression Metabolics Discovery of predictors of the metabolic complications of adult and paediatric obesity

27 European Translational and Knowledge Management Services Supports collaborative projects Analysis needs of translational data Deploys open-source transmart Service with public data Abirisk Oncotrack UBIOPRED Predict-TB RA-MAP... studies including omics images clinical assessment data Ethics / data protection 22 translational, 1400 gene expression studies Standards research transmart Foundation o 35 transmart implementations o multiple development teams o commercial services J&J etriks TraIT TheHyve IDBS Sanofi Pfizer Takeda RecombinantbyDeloitte Thomson Reuters Michigan Harvard

28 WEB-RADR: Mobile and Social Technology for Pharmacovigilance English, French and German or Spanish language analysed Consortium keen for global applicability What else can social media tell us - Abuse? - Misuse? - Counterfeit? Geo pharmacovigilance a possibility?

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