New Frontiers in Personalized Medicine

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New Frontiers in Personalized Medicine Oracle Open World Shanghai 2013 Neil de Crescenzo SVP and GM 1

Safe Harbor Statement The following is intended to outline our general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functionality described for Oracle s products remains at the sole discretion of Oracle. 2

Oracle's Investment in Innovation and Integration $24B IN R&D SINCE 2004 Figures in GAAP 3

Five Forces Transforming Healthcare CLINICAL INNOVATION REGULATORY SCRUTINY COMPETITIVE THREATS PERSONALIZED MEDICINE ECONOMIC CONSTRAINTS New technologies, devices, medicines, treatment methods, and delivery models New rules, new agencies, increased compliance risk, and global complexity Innovators in adjacent sectors are forcing incumbents to rethink value propositions New expectations of quality, service, and affordability; ever increasing appetite for data Cost constraints that threaten margins, drive consolidation, and reward efficiency and scale 4 Source: Oracle Health Sciences Institute; Paul Keckley, Ph.D., Health Reform Memo, Deloitte CFO Journal, Wall Street Journal, April 29, 2013

We believe in a more predictive, preventive, personalized and participatory system to improve human health We believe that Oracle can help enable personalized medicine through data and insights Why: Oracle Health Sciences exists to enable people to live healthier lives How: Oracle Health Sciences enables companies and institutions to help improve human health through information technology innovation What: Oracle Health Sciences provides cloud-based solutions to improve human health 5

Maximizing the Benefits from Innovation Disseminate Innovations Test New Ideas Rethink Processes 71% of companies say that innovation is the #1 factor in competitiveness Leading companies use IT to empower their people to drive innovation and change However, 70-90% of companies do not use IT to its potential 6

IT Spending Distribution 66% 50% RUN THE BUSINESS 20% 25% GROW THE BUSINESS 14% 25% TRANSFORM THE BUSINESS Source: IT Metrics: IT Spending and Staffing Report, 2011, Gartner Research, 2011 7

Integration and Collaboration Across Health Sciences Four distinct big data pools exist in the healthcare and life sciences domain today with little overlap in ownership and limited integration Pharma/Med Device R&D Data Owner: Life sciences companies, academia Example data sets: Clinical trial data, high throughput screening (HTS libraries) Activity (Claims) and Cost Data Owner: Payers, providers Example data sets: Utilization of care, care patterns, cost estimates Integration of Data Required to Create Significant Value Clinical Data Owner: Providers, Pharmacies, Labs Example data sets: Electronic medical records, medical images, patient family histories Patient Behavior and Sentiment Data Owner: Various, including consumer stakeholders outside healthcare (e.g., retail, home electronics) Example data sets: Patient behaviors and preferences, retail purchase history, exercise data, diet, family history/geneology Source: McKinsey Global Institute Analysis 8

Oracle s Health Sciences Data Management Suite Supports Four Solution Areas For Secondary Use Of Healthcare Data Enterprise Healthcare Analytics (Hospitals, Clinics, IDNs, Payers) Quality and safety Clinical analytics Revenue cycle Clinician performance Decision support Patient Engagement* (Pharma, Medical Devices, Providers, Payers) Analytics and Health Information Exchange Translational Research Center (Academic Medical Centers, Research Organizations & Pharma) Patient Cohort Identification and Selection Statistical & Scientific Analysis Biomarker Research Health Sciences Network (Pharma, AMC, CROs, Payers) Outcomes-based reimbursement Care and Disease management Utilization management Healthcare Pay-for-Performance Mgt * Medication Adherence application expected to be Generally Available in FY14 Clinical Trial Optimization Protocol Validation, Recruitment, Late Phase monitoring Safety & Pharmacovigilance Biomarker Discovery Comparative Effectiveness Research 9

Opportunities for Translational Medicine Utilizing Genomic Advances in the Delivery of Health Care Aggregate & Integrate High-quality standardized clinical data with appropriate levels of security and access control Integration and analysis of cross-platform omics data agnostic to scientific approach & technology Normalize & Annotate Analysis of internal datasets in the context of ever-increasing large public domain data sets Using public domain reference datasets, provides powerful out of the box biological context ready for immediate query Represent & Visualize Biomarker identification and validation through a single integrated analysis-ready view of clinical and omics data 10

Translational Medicine Use Cases Find patients that are poor responders for drug Y and have a mutation in the promoter region of Gene X. What is the expression level of TP53 mutants by cancer tissue? How many patients have disease Z, responded to treatment, have a chromosome 18 deletion and have blood samples in the biobank? Do mutations in the coding sequence of Gene X perturbs its expression across all projects? Show HER+ cell lines that have ERBB2 copy number gains. Filter the gene variants found in chromosome region X by quality score and read depth. Take only the exome portion of the whole genome and do a statistical association analysis with phenotype Z and then prioritise the genes based on their variant type (e.g. non-syn SNPs), annotations (e.g. growth factors) and membership to known pathways. 11

Key Components of a Hospital Analytics and Translational Medicine Solution EHA Platform EHA App Exchange Cohort Explorer Biobanks Oracle Analytic Apps Omics Explorer Exec Clinical Systems Financial Systems Administrative Systems Term. Service Oracle Healthcare Analytics Data Integration Omics Loaders MPI Unit of Measure NLP Master Data Management & Other Services Healthcare Data Model Omics Data Bank De id Partner Apps Custom Apps Operating Room Analytics Provider Supply Chain Analytics Registries Quality Reporting Revenue Cycle Administrator Clinician Staff Research Systems INFA Oracle Data Integrator Oracle Database Pharmacovigilance Researcher Data Integration Enterprise Data Warehouse / Data Model Analytics & Reporting 12

Translational Medicine Leaders Use Oracle MD Anderson goes big on analytics Initiative aimed at reducing cancer deaths, driving care innovation HOUSTON February 1, 2013 As we focus on the next-generation of treatments including our Moon Shots Program we require a powerful analytical infrastructure that can yield new insight from the unprecedented volume of data available today, said John Frenzel, MD, chief medical information officer, MD Anderson. Frenzel added that Oracle s applications and technology stack would help provide one of the robust foundations that we need to accelerate deployment, and ultimately, discovery of life-saving treatments, The new platform will bring together clinical, genomic, financial, administrative and operational information from internal and external sources to yield insights that drive care innovation and optimize operational efficiency. Leveraging data and information to drive more effective resource utilization, improve operational efficiency, and level patient volumes across the days of the week is becoming increasingly more important, said Craig Owen, director of clinical analytics and informatics at MD Anderson. 13

The Opportunity to Improve Medication Adherence 25-50% of clinical trial participants do not take medications as prescribed 14

Ingestible Monitors and Sensor-based Data Proteus Digital Health solutions for medication adherence and continuous patient monitoring Ingestible Monitor Wearable Sensor Mobile Applications Therapeutic Information Medication Dose Timing Adherence Supply Chain Physiologic Information Heart Rate Respiration Activity Posture Gait Sleep Stress Temperature Mobile Information Sociability Engagement Cognitive Assessment Environment Location Context Subjective Information Side Effect Symptoms QOL Mood Emotion 15 See press release: http://www.oracle.com/us/corporate/press/1941306

Complex, Scalable System Invisible to User Information not Data, Automatically Web/Mobile Apps Patient/Caregiver Networks Patch attached to user and paired to phone, data uploaded periodic and automatically Ingestible sensor activated upon fluid contact Phone receives data from patch, forwards to Oracle Health Sciences Cloud. Analytics sent to customers from the Oracle Health Science Cloud. Analytics Clinician analytics and Clinical Trial tools 16

Oracle Health Sciences Big Data Architecture Data Sources Public and Private Data Integration Data Federation Data Virtualization 10g DATA SERVICE INTEGRATOR 12c DATA VIRTUALIZATION Data Visualization BUSINESS INTELLIGENCE 12c Secure Multi-tenant ADF (custom views) EVENT PROCESSING INPUT ESSBASE HSGBU Virtual Data Models OUTPUT REAL-TIME DECISIONS Sense, Respond & Decide Hadoop / HDFS Open (3 rd party views) Acquire Organize & Analyze Decide 17

Integrated Data Providing a 360 View of Your Identified and De-Identified Data Powering Behavioral Insights and Management Health Holistic Longitudinal Individual Data and Insights Federated Data Access using Virtual Data Models Identified 360 View of the Individual De-identified Personal Data Institutional Data Behavioral Management Social Graph Data Integration SPI (SDK/API) Behavior Graph Physical Graph (Device Data) Customer Data 3 rd Party Apps and 3 rd Party Data Oracle Apps Data Device Data 18

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