Virtualization of R&D Driving New Health IT Requirements

1. Virtualization of R&D Driving New Health IT Requirements Vijay Pillai, Director of Translational Medicine & Strategic Planning Presentation for The TRUST Autumn 2011 Conference November 2, 2011

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3. Health IT – What comes to mind? CONSENT PERSONAL HEALTH INFO (PHI) PRIVACY PERSONAL HEALTH RECORD HIPAA GOVERNANCE SECURITY DE-IDENTIFY ELECTRONIC MEDICALRECORD ENCRYPTION DOUBLE BLINDING

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5. 0 • Share • Print • Email • 0 • Share • Print • Email • 0 • Share • Print • Email • 0 • Share • Print • Email Electronic Medical Records are here to stay … but lot more to come Hospitals Laboratory Epidemiology Standards Employers Physician Office Pharmacy Pharma/ Medical Device Insurance A reality today … inside some hospitals A peek into the future

6. The “Big Data” challenge in healthcare is not very well known Medical Images – 10s of Terabytes to 1s of Petabytes Clinical Records – 100s of Gigabytes to 1s of Terabytes Security/Privacy Standards maturing Security/Privacy Standards well understood for structured data Genomic Data – 10s of Petabytes to 100s of Petabytes Security/Privacy Standards evolving

7. Bringing scale to research – Outsourced, integrating data and workflows Translational Research Center • Proactive consenting • Sample data access • Testing • Data management • Analytics/insights PATIENTS Clinical Data Data & Results PATIENT / DISEASESTRATIFICATION Sample Info SAMPLE COLLECTION Data & Results Best-Fit Treatment Options Report Sample Volumes NEW ADMITS ANALYTICS OMICs Data BIOREPOSITORY LABORATORY 7

8. Virtualization in R&D driving opportunities for security and cloud infrastructures Academia, CRO & Sponsor Sponsor Healthcare CRO CRO Discovery & Development Basic Research Point of Care Healthcare Sponsor Academia Source: adapted from DataMonitor 8

9. The collaboration in the cloud ENABLER (Enables Collaboration between Sponsors and Providers) CONSUMER (Pharma, MedDev, CROs, Payers, Govt.) SOURCE (Healthcare Providers) Hospital Networks Pharma Medical Device Academic Medical Center (AMC) R&D APPLICATIONS Biotech AMC AMC Pharma Biotech Hospital Medical Device Branded Networks Contract Research Organization (CRO) A collaborative network 9

10. Architecture considerations for the cloud • Data ownership • Access provisioning • Bound by HIPAA • Distributed architecture • De-identification/Double-blinding • “Push” technologies • Encrypted transport layer • Data Layer (Clinical, Image, OMICs) • Metadata management • 3rd party applications security • Infrastructure to support M-to-M • Data segregation – No co-mingling • Queries will run on cloud • No detailed row level access • Summary level • Bound by 21CFR Part 11 regulation • Workflow initiates provider alerts SOURCE ENABLER CONSUMER Hospital Networks Pharma Medical Device Academic Medical Center (AMC) Biotech AMC AMC Pharma Biotech Hospital Medical Device Branded Networks Contract Research Organization (CRO) Health Sciences Cloud 10

11. Yin Yang of health sciences PRIVACY COLLBORATE Seemingly contrary forces are interconnected and interdependent Make it possible by strong security and governance processes

12. Use of a Common Technology Platform Need for Common Data Model and Transformation Services Translational Research CLINCAL ALL HOSPITALS IMAGING HOW ? Portals LABORATORY AMC / LS OMICS CLINICAL TRIALS BIOBANK OPERATIONIONS 12

13. Clinical Research Fundamentals Common Healthcare Data Model and Transformation Services Master Data Management CLINCAL APPLICATIONS Healthcare Data Model ALL HOSPITALS IMAGING COHORT ID Data Integration SECURITY BIOMARKER ANALYTICS OMICs Data Model LABORATORY RULES PARTNER APPLICATIONS RULE ENG Statistical Computing Environment DI AMC / LS ETS TM OTHER EMPI OMICS DI ETS EMPI TM OTHER CLINICAL TRIALS BIOBANK TRANSFORMATION SERVICES OPERATIONIONS 13

14. Clouds enable people, applications, and data to collaborate and develop insights Provision Your Service. Set up a profile, get an Oracle SSO account, and configure service details. Get a Subscription. Predictable pricing, fixed monthly rates, no term obligation, and no hidden fees. Add Users. Add administrators, developers, and end users. Enrich with Content and Packaged Tools. Add third party content and packaged productivity apps. Operate. Scale, monitor, configure, upgrade, or diagnose. Use our tools or your own. Flex-Deploy. Use a hybrid lifecycle. Your end users and code can deploy on premise or in our cloud. Healthcare Payers BioPharma Diagnostics Medical Devices Patients & Families Healthcare Providers Government Payers Regulatory Agencies Open, standards based, flexible platforms that connect domain experts, data and applications in a regulatory-compliant framework 14

15. Taking algorithms to the data Need a powerful database with all capabilities embedded • Regular Expression, Semantic Web (RDF) • Naïve Bayes, ABN, SVM, NMF, K-Means, Decision Tree • Statistical capabilities • XML with table like functionality, Xquery/SQL • Consolidate spreadsheets and more; rapid web apps • Multi-Dimensional Cubes, drill-down • Manipulate images, Native support for DICOM • Store documents & access from anywhere/any platform • Virtual private databases • Advanced security • Advanced compression including hybrid columnar compression • In-memory analytics • Database machines: Exadata Appl. Express Secure Files

16. Q&A