2. Enabling Risk Management: From Safety Signal to Risk/Benefit Management Subbaraju Sagi Senior Sales Consultant - APAC Oracle Health Sciences Email: subbaraju.sagi@oracle.com

4. How Did 2009’s Predictions Do? Source: IDC Health Insights, 2009 A #10 -Best-of-breed e-clinical solutions will become the mainstream approach to performance of clinical trials B #9 -Revenue leakage awareness drives pharmaceutical companies to undergo mass reevaluation of installed software C #8 -IT outsourcing of software/hardware maintenance and support continues its growth, while companies reduce IT service spend on 3rdparty consulting services A #7 -Medical Home concept pilots will emerge in 2009 but evolve slowly A #6 -Business Intelligence differentiation focuses on driving better outcomes A #5 -Cleaning Up the Core: Investment in foundational technologies is prioritized to improve return on Health 2.0 and related technologies investment B #4 -New products give Remote Patient Monitoring new life B #3 -Consumers will heal each other with Health 2.0 technology A #2 -The Obama Administration will compel cost control and quality improvements A #1 -Healthcare IT spending continues to grow in spite of the down turn

5. 2010’s Top 10 Healthcare Predictions Source: IDC Health Insights, 2010 Jan 12th #10: Pharmaceutical IT Spending on Aggregate Promotional Spend Compliance Will Surge #9: Major Pharmaceutical Companies Will Move Significant Amounts of Their Discovery Research IT Infrastructure to the Cloud #8: Value in the Drug Access and Pricing Equation Will Begin to Significantly Impact Drug Makers in the United States in 2010 #7: Medical Home Best Practices Will Emerge #6: Meaningful Use Requirements Will Fuel Investment in HIE Technologies #5: 2010 Will Be the Year of the EMR #4: Following the Hype Will Be Over –Return on Investment and Value Leads Selection Criteria Priorities #3: Legislative and Regulatory Compliance Initiatives Will Be Among the Top 3 Technology Investment Categories in 2010 #2 –Actionable Advice Will Lead Business Intelligence Priorities and Investment #1 –Business Intelligence is the Number One Technology Investment Category

11. RM by Regulators

13. The most common algorithms (80%) PRR Proportional Reporting Ratio Output = PRR + 95% C.I. In use at EMEA, FDA, MHRA X 2 Chi-Squared Test of independence of variables Often calculated with PRR Case Scoring Case Scoring Pre-defined case criteria pass threshold and trigger alert BCPNN Bayesian Confidence Propagation Neural Network WHO (UMC) MGPS Multi-item gamma Poisson shrinker

16. Benefit-Risk Management Assess b:r balance Develop/implement tools to minimize risk but preserve benefits Adjust to improve b:r profile Evaluate tool effectiveness and reassess b:r profile 1. Signal detection 2. Signal mgmt 3. Signal workup Risk Evaluation Risk Minimization Risk Identification Risk Communication

18. Enterprise Risk Management Framework

19. Visualize Triggering

20. Oracle’s Clinical Development & Safety Portfolio Oracle Argus Safety Suite/ Oracle Adverse Event Reporting System Term Classification / Dictionary Management (Oracle Thesaurus Management System) R&D Data Integration/Interoperability (Oracle Life Sciences Data Hub) Clinical Data Management System (Oracle Clinical) Clinical Trial Management System (Siebel Clinical) Electronic Data Capture (Oracle Remote Data Capture) Patient Care Data Integration/Interoperability Healthcare Transaction Base Analytics (Clinical Data Analytics)

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