The Future of Personalized Medicine: Powered by Real World Data. Kris Joshi, PhD Global Vice President

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1 The Future of Personalized Medicine: Powered by Real World Data Kris Joshi, PhD Global Vice President

2 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.

3 Disclosures Oracle Employee Oracle Shareholder

4 Life Expectancy Today s babies are likely to live to 100, doctors predict The Guardian, October 2009

5 Convergence Between Healthcare and Life Sciences Driving to Personalized Healthcare Personalized Healthcare Translational Med DNA chemistry and advanced technology Targeted Therapies Patient Care and Disease Mgmt Retrospective and Prospective Analytics Precision Healthcare Evidence Based Healthcare Increased regulation and efficacy standards Pharmacovigilance and Risk Mgmt Safety at Point of Care Managed Healthcare Blockbusters and mass-production of novel drugs Electronic Data Capture Paper based Records Electronic Medical Records Paper based Systems Trial and Error Healthcare LIFE LIFE SCIENCES HEALTHCARE

6 The Transformation of R&D Will be Driven by the Evolution of the Entire Healthcare Value Chain R&D Productivity Translational Medicine Quality & Safety Personalized Care Participatory & Preventive Care Discovery Research Diagnostics Pharma/Biotech Medical Devices Clinical Research Care Delivery Care Management Population/ Global Health Outcomes Value-based healthcare Collaborating across the life sciences and healthcare industries improves care, lowers costs and delivers greater value

7 Collaboration Insight & Innovation Patient-Centric, Value-Based

8 Value Personalized Healthcare Requires a 360 View of the Individual Diet, Electronic Genetics Lifestyle Environment and Omics Therapy Exercise Data Adherence Health Information Individual Time

9 Silos Kill Insight & Stifle Collaboration

10 Healthcare s Critical Data Management Priorities are Integration and Collaboration Four distinct big data pools exist in healthcare 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) Clinical Data Owner: Providers, Pharmacies, Labs Example data sets: Electronic medical records, medical images, laboratory results data Integration of Data Required to Create Significant Value Activity (Claims) and Cost Data Owner: Payers, providers Example data sets: Utilization of care, care patterns, cost estimates 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/genealogy Source: McKinsey Global Institute Analysis

11 One of the Great Challenges in Leveraging Real World Data is Data Integration Integration of Data Clinical Admin Financial Omics

12 A Comprehensive Healthcare Platform Must Support Both, Primary and Secondary Uses of Data Enterprise Analytics Clinical Financial Revenue Cycle Care Management Meaningful Use Patient Engagement Care Gap Analysis Accountable Care Tele-monitoring Medical Adherence Enterprise Platform + Global Network Translational Research Patient Stratification and Cohort Studies Statistical & Scientific Analysis Biomarker Research Health Sciences Network Protocol Validation & Recruitment Safety & Pharmacovigilance Biomarker Discovery Comparative Effectiveness Research

13 Researchers and Clinicians Want Frictionless Access to Big Data Oracle s Enterprise Healthcare Analytics Platform Clinical App Exchange Financial Oracle Apps Cohort Explorer Operational EHA Data Integration & Validation Healthcare Data Model (HDM) Omics Data Bank (ODB) Partner Apps Omics Explorer Mobile Dashboards Predictive Clinician/ Researcher Omics Interface tables ETLs from Interface tables to HDM Rules and metadata for data validation Custom/ Open Source apps Visualization, Algorithms, etc. Public Domain Term. Service MPI Unit of Measure NLP Master Data Management & Other Services De identification

14 Molecular Data and Public Domain Reference Data: Changing the Game EMBL gene_id transcript_id CpG site intron exon promoter splice site etc. dbsnp & COSMIC SNP_id rs_id begin end reference etc. HUGO chromosome HGNC_ID ENTREZ_gene_id synomyms Approved_dt status MGI_id etc. SwissProt protein_name accession component_type component_desc start/end etc. Pathway Commons pathwy_name gene_symbol frequency etc. Polyphen/ SIFT prediction_score Prediction variant_id transcript_id etc. Reference Data Result Data Simple Variant (SNP & Indel) SNP_id chromosome position variant _type replace_tag zygosity QC_score etc. Expression Study probeset_id probeset_annot hybridization intensity P_value call etc. Copy Number Variant Analysis chromosome position normalized_cvg gc_corrected_cvg call_ploidy ploidy_score etc. RNA Seq raw_counts median_length RPKM chromosome position etc.

15 Translational Research Requires a Community Supporting the Transformation of Healthcare Discovery Diagnosis Therapy Wellness Accelerate bio-marker discovery Extend Analytics into care delivery & daily life Strategic Development Partners Strategic Development Partners? 2012 Oracle Corporation Proprietary and Confidential 15

16 Enabling Rapid Patient Stratification Across Clinical and Genomic Data

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18 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.

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22 Mayo Clinic Center for Individualized Medicine (CIM) Working with Oracle as a strategic development partner Deploying Oracle platform to manage trillions of unique genetic variants To support Mayo s translational programs, the platform will: Integrate enormous amounts of patient derived genomic data with associated clinical data from a heterogeneous array of source systems to support both the discovery and application of biomarkers Manage genomic variants for multiplexed panels, whole exome and whole genome testing Overall goal is to develop a single infrastructure spanning research and clinical practice that can support individualized medicine

23 Real Time Querying of Big Data is No Longer a Dream Oracle Omics Data Bank Performance 100k Genomes, 100 Concurrent Users % of Use Cases Response Time 56 < 1 Second Seconds Seconds Seconds Seconds.

24 Enabling New Models of Care Patient Stratification / Cohort Identification Omics Oracle EHA Data Warehouse Genotype Drive New Guidelines via Analytics at the Point of Care Phenotype Enterprise Healthcare Analytics Biomarker Identification Translational Research Center Correlate Cost Impact to New Guidelines Predictive Analytics/ Hypothesis Testing New Evidence-based Care Guideline

25 Building a Learning Health System

26 Bridging the clinical and research divide Breast Cancer Pilot Study Re-identify 140 tumors submitted to TCGA Perform a retrospective integrative analysis of the 140 cancers by extracting clinical information (path, med onc, surg onc, rad, and rad onc), including omics profiling, tumor size, stage, treatment, outcome etc. Interrogate relationship between -omics and outcomes Investigate pre- and post menopausal breast cancer differences

27 Answering key questions

28 Investigate relationship between new and old tests Comparison of gene expression profiles vs. IHC based testing for ER/PR/Her2

29 Patients Like Mine Analysis Application of the Oracle personalized medicine solution at UPMC s Tumor Board. The UPMC multidisciplinary oncology team will include informaticist support and have real time access to the rich clinical and omics data during tumor board meetings.

30 Cancer Research UK Background: Cancer Research UK's Stratified Medicine Programme is a significant step in making targeted therapies available for people with cancer. Working together with AstraZeneca, Pfizer and the UK government's Technology Strategy Board, the Program aims to establish the foundation for a national service that will ensure standardized, high quality, costeffective genetic testing of tumors. Part of the program is to build a national database of tumor genetic information, treatments and outcomes that will help researchers design more effective cancer treatments in future. Strategic Value / Rationale: Provide a scalable platform to capture standardized, high-quality and cost-effective genetic testing data linked to clinical data. This system has already tested two thousand tumors from patients across 24 clinical sites, and set up data capture covering diagnostics, genetics, treatment and outcomes. Enable clinicians and researchers an easy to use interface for stratifying patients based on clinical and molecular characteristics. Our new analytical platform, which we are building with Oracle Health Sciences Translational Research Center, is an exciting addition to the future of our Stratified Medicine Program and its goal of combining genetic testing of tumors with clinical data capture to determine more effective treatment. - Monica Jones, Enterprise Architect and Informatics Lead, Cancer Research UK s Stratified Medicine Programme 30 Copyright 2013, Oracle and/or its affiliates. All rights reserved.

31 Stratified Medicine Programme Central Repository DB Compiled Clinical Data Extract Anonymised Data Oracle TRC Accessed by Researchers Partners NHS Clinical Hubs Leed s Man Edin Glas Camb Card RM H Birm Delivery Research Cancer Patients XML Genetic Results Sample + XML Test Request Cardiff Birm ICR Genetic Technology Hubs

32 Intuition Behavior Analytics Genetics Statistics Omics Insight & Collaboration Drive Innovation Technology Social Connections

33 Oracle Health Sciences Network Secure, Global, Cloud-Based Collaboration Life Sciences Participants Studies Protocols Healthcare Provider and Payer Participants Near Real-Time Clinical Data Protocol design Safety Monitoring Disease and Patient Registries

34 Value proposition Lowering costs and speeding time to market Protocol Feasibility & Refinement Operations Planning Site Selection Enrollment & Retention Significant Impact on Timelines Efficiency/Accuracy Protocol Validator Patient Recruiter Near real-time data shared by participants Protocol feasibility and validation results in seconds Sponsors share protocols with provider and tie patients to sites/physicians instantaneously

35 Oracle Health Sciences Network Global Collaboration with Confidence and Control Provides participants full control over their data Protects institutional IP Respects patient consent Enables real-time collaboration Cloud-Based HIPAA Certified Provider A Clinical System / EMR Provider C Clinical System / EMR Provider B Clinical System / EMR

36 Acknowledgements MD Anderson Dr. John Frenzel Keith Perry Craig Owen Mayo Clinic Jean-Pierre Kocher, PhD UPMC Dr. Adrian Lee Lisa Khorey

37 From the beginning, Oracle has demonstrated the value of a true partnership. Thank You Mark Hulse CIO & VP for Information Technology Moffitt Cancer Center