Enabling Risk Management: From Safety Signal to Risk/Benefit Management Subbaraju Sagi Senior Sales Consultant - APAC Orac...
Agenda <ul><li>Top 10 Healthcare Predictions </li></ul><ul><ul><li>How did 2009’s predictions do? </li></ul></ul><ul><ul><...
How Did 2009’s Predictions Do? Source: IDC Health Insights, 2009 A #10 -Best-of-breed e-clinical solutions will become the...
2010’s Top 10 Healthcare Predictions Source: IDC Health Insights, 2010 Jan 12th #10: Pharmaceutical IT Spending on Aggrega...
Trends in Pharmacovigilance <ul><li>Benefit-risk assessment is the ultimate driver for patient safety and not simply the f...
What is Risk Management? <ul><li>Risk Management = risk assessment + risk minimization  </li></ul><ul><li>Risk assessment:...
Requirement for Risk Management <ul><li>Pharmaceutical companies have a requirement to conduct continual signal analysis a...
Proactive Risk Management <ul><li>The Safety departments require multiple ways to interact with the safety data to ensure ...
Proactive Risk Management <ul><li>Automated alerts </li></ul><ul><ul><li>Safety system runs nightly queries to look for da...
RM by Regulators
Not all risk is equal <ul><li>2 types of risk (EMEA perspective):  </li></ul><ul><li>Identified risk  </li></ul><ul><ul><l...
The most common algorithms (80%) PRR Proportional Reporting Ratio Output = PRR + 95% C.I. In use at EMEA, FDA, MHRA X 2 Ch...
<ul><li>Single Case Processing, Expedited & Periodic Reporting </li></ul><ul><li>Case Versioning for Periodic Reports </li...
Argus Perceptive <ul><li>Features </li></ul><ul><ul><li>Assessors’ workflow separate from case processing  </li></ul></ul>...
Benefit-Risk Management Assess b:r  balance Develop/implement tools to minimize risk but preserve benefits  Adjust to impr...
The Safety Data Mart <ul><li>An Extract Transfer and Load (ETL) Engine populates the Data Warehouse </li></ul><ul><ul><li>...
Enterprise Risk Management Framework
Visualize Triggering
Oracle’s Clinical Development & Safety Portfolio  Oracle Argus Safety Suite/ Oracle Adverse Event Reporting System Term Cl...
© 2009 Oracle Corporation Proprietary and Confidential
 
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Enabling Risk Management: From Safety Signal to Risk/Benefit Management

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Enabling Risk Management: From Safety Signal to Risk/Benefit Management

  1. 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
  2. 3. Agenda <ul><li>Top 10 Healthcare Predictions </li></ul><ul><ul><li>How did 2009’s predictions do? </li></ul></ul><ul><ul><li>2010’s top 10 predictions </li></ul></ul><ul><li>Trends in Pharmacovigilance </li></ul><ul><li>Requirements for Risk Management </li></ul><ul><li>Benefit-Risk Management </li></ul><ul><li>A comprehensive Proactive Risk Management environment – Oracle Argus Perceptive </li></ul><ul><li>Questions </li></ul>
  3. 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
  4. 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
  5. 6. Trends in Pharmacovigilance <ul><li>Benefit-risk assessment is the ultimate driver for patient safety and not simply the frequency of adverse event types. </li></ul><ul><li>Risk evaluation and mitigation strategies (REMS) and risk management programs (RMPs). </li></ul><ul><li>Shift from “post-market” surveillance to full-spectrum monitoring of a drug. </li></ul><ul><li>Collect larger amount of data in order to identify patterns of safety-related issues. </li></ul>
  6. 7. What is Risk Management? <ul><li>Risk Management = risk assessment + risk minimization </li></ul><ul><li>Risk assessment: </li></ul><ul><ul><li>Assess known vs. previously unknown information </li></ul></ul><ul><ul><li>Identify & characterize nature/frequency/severity of drug risk </li></ul></ul><ul><ul><li>Risk should be quantified in different populations </li></ul></ul><ul><li>Risk minimization </li></ul><ul><ul><li>Minimize risk, preserve benefits </li></ul></ul>
  7. 8. Requirement for Risk Management <ul><li>Pharmaceutical companies have a requirement to conduct continual signal analysis as part of a Risk Management Plan </li></ul><ul><li>Requirement to identify risks starts in clinical development, and is especially important in the early years on the market </li></ul><ul><li>Risks can be seen as unusual adverse reactions and/or higher than expected adverse reaction counts </li></ul><ul><li>Risk Management covers many areas, but this presentation will focus on Safety Risks </li></ul>
  8. 9. Proactive Risk Management <ul><li>The Safety departments require multiple ways to interact with the safety data to ensure potential signals are not overlooked </li></ul><ul><ul><li>Automated alerts, based on preset triggers </li></ul></ul><ul><ul><ul><li>More than 3 cases of agranulocytosis </li></ul></ul></ul><ul><ul><li>Visualise information in multiple ways </li></ul></ul><ul><ul><ul><li>Cluster based on predictive factors </li></ul></ul></ul><ul><ul><li>Use a variety of statistical functions </li></ul></ul><ul><ul><li>Compare your drug’s adverse reaction profile vs. others in same class and therapeutic area </li></ul></ul><ul><li>These methods are documented as part of a risk management plan </li></ul>
  9. 10. Proactive Risk Management <ul><li>Automated alerts </li></ul><ul><ul><li>Safety system runs nightly queries to look for data that meet certain criteria </li></ul></ul><ul><ul><li>If condition met, then email sent to users with details of events for analysis </li></ul></ul><ul><li>Visualising data </li></ul><ul><ul><li>Run complex queries on your AE database </li></ul></ul><ul><ul><li>Store results for later analysis and historical purposes </li></ul></ul><ul><ul><li>Be able to run delta models on snapshots of data over time </li></ul></ul><ul><ul><li>Take resultant datasets to visualisation tools </li></ul></ul><ul><ul><li>Feed results back into system to incorporate into next PSUR </li></ul></ul><ul><li>Data Mining </li></ul><ul><ul><li>Statistical analysis </li></ul></ul><ul><ul><li>Comparison with external data </li></ul></ul><ul><ul><li>Weighting with factors </li></ul></ul>
  10. 11. RM by Regulators
  11. 12. Not all risk is equal <ul><li>2 types of risk (EMEA perspective): </li></ul><ul><li>Identified risk </li></ul><ul><ul><li>Adequate evidence to associate AE with product </li></ul></ul><ul><ul><li>Requires safety action plan in RMP (label changes, etc.) </li></ul></ul><ul><li>Potential risk </li></ul><ul><ul><li>Suspicion of an association of AE with product </li></ul></ul><ul><ul><li>Requires enhanced surveillance in different populations to see if it should be escalated to an identified risk </li></ul></ul>
  12. 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
  13. 14. <ul><li>Single Case Processing, Expedited & Periodic Reporting </li></ul><ul><li>Case Versioning for Periodic Reports </li></ul><ul><li>Integrated Case Management and Workflow </li></ul><ul><li>Web-based, high Performing, high availability System </li></ul><ul><li>Compliant with global safety Requirements </li></ul><ul><li>Flexible Configuration to model any Business Process </li></ul><ul><li>Structured Signal Management </li></ul><ul><li>Detailed Analytics and PV </li></ul><ul><li>Industry standard algorithms </li></ul><ul><li>Support for PV regulatory reporting </li></ul><ul><li>Coalesce data sources for complete signal detection </li></ul>Argus Solution Pyramid
  14. 15. Argus Perceptive <ul><li>Features </li></ul><ul><ul><li>Assessors’ workflow separate from case processing </li></ul></ul><ul><ul><li>Automated Signal Detection based on single cases or statistics, on in-house or external data </li></ul></ul><ul><ul><li>Analytical tools for signaling, and hypothesis testing & strengthening </li></ul></ul><ul><ul><li>Searchable knowledgebase and repository </li></ul></ul><ul><ul><li>Event Watch list Management </li></ul></ul><ul><ul><li>Signal Workup document preparation environment </li></ul></ul><ul><ul><li>Multiple levels of escalation and notifications </li></ul></ul><ul><ul><li>Adjudication management </li></ul></ul><ul><ul><li>Management monitoring tools and reports </li></ul></ul>Argus Perceptive is a state of the art web-based system designed to support Good Pharmacovigilance Practices (GPVP) and allow Good Post marketing Surveillance Practices (GPMSP)
  15. 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
  16. 17. The Safety Data Mart <ul><li>An Extract Transfer and Load (ETL) Engine populates the Data Warehouse </li></ul><ul><ul><li>From Argus </li></ul></ul><ul><ul><li>From other Sources </li></ul></ul><ul><li>Initial transfer is a full transfer </li></ul><ul><li>Subsequent transfers are only partial (delta) </li></ul>
  17. 18. Enterprise Risk Management Framework
  18. 19. Visualize Triggering
  19. 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)
  20. 21. © 2009 Oracle Corporation Proprietary and Confidential

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