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Optimizing Life Sciences R&D. Ravinder Singh Oracle Health Sciences APAC Director Solutions Consulting. Safe Harbor Statement.
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OptimizingLife Sciences R&D Ravinder Singh Oracle Health Sciences APAC Director Solutions Consulting
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.
Escalating R&D Costs and Fewer New Drug Approvals R&D Spending ($B)2 New Drug Approvals (NMEs)1 Sources: (1) FDA CDER, “Is it true FDA is approving fewer new drugs lately?”, 2011 (2) PhRMA, “2011 Profile: Pharmaceutical Industry”, estimate for total Pharma industry R&D spending
Increased Complexity, Scale and Cost of Drug Development The number of new drugs in development continues to increase While the cost to develop a new drug has dramatically risen Additionally the number of adverse events reported to the FDA continues to increase 1 2 3 CAGR ‘08-’10: 20% CAGR 6% CAGR ‘00-’08: 9% 60% Sources: (1) PharmaProjects, “Pharma R&D Annual Review 2011” (2) PhRMA, “Biopharmaceuticals in Perspective”, 2011 (3) FDA web site, “Reports Received and Reports Entered into AERS by Year”, Dec 2011
Outsourcing of Drug Development and Growth of CRO Market Global trial volume and capacity constraints are primary drivers behind increased CRO usage Leading the majority of pharma companies to increase outsourcing Fueling continued rapid growth of the global CRO market 1 2 3 CAGR 13% Sources: (1) Applied Clinical Trials, “Successful Outsourcing: Tracking Global CRO Usage”, 2009 (2) William Blair & Company, “CRO Industry Update”, 2011 (3) GBI Research, “The Future of Contract Research Outsourcing – Market Forecasts to 2015, Geographical Landscape and Competitive Benchmarking”, 2009
Forces Transforming Clinical R&D CLINICAL INNOVATION REGULATORY SCRUTINY COMPETITIVE THREATS PERSONALIZED MEDICINE ECONOMIC CONSTRAINTS New technologies, 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 Source: Oracle Health Sciences Institute; Paul Keckley, Ph.D., “Health Reform Memo”, Deloitte CFO Journal, Wall Street Journal, April 29, 2013
“It is far more important to know what person the disease hasthan to know what disease the person has.” − Hippocratesc. 460−370 B.C.
Secondary Use of Health Data Is Growing • Healthcare Providers • Clinical quality initiatives and reporting • Operational efficiencies • Financial performance management • Pay-for-performance initiatives • Pharmaceutical / Biotechs • Comparative effectiveness • Adaptive trials to support personalized medicine • Consumer and physician engagement and decision support • Academic Medical Centers • Translational, clinical and comparative effectiveness research • Collaborative and extra-enterprise research • Public Health • Disease surveillance • Comparative effectiveness and clinical utility studies • Will you use secondary health data within the next two years?* • Provider 70% • Payer 54% • Pharma 61% * Source: PWC, “Transforming Healthcare Through Secondary Use of Health Data.”
Progress in Personalized Medicine 201050% 75% 200922% 50% 20084% 30% Clinical trials that collect patient DNA to aid in biomarker development2 Increase in personalized medicine investment over last 5 years3 U.S. hospitals with fully operational electronic health records1,2 U.S. population with medical information in some form of electronic health records3 Biopharmaceutical companies that require compounds to have biomarker1 Life Sciences Healthcare 1,2,3: Isaac S. Chan and Geoffrey S. Ginsburg “Personalized Medicine: Progress and Promise” Annual Review of Genomics and Human Genetics, Sept. 2011, Vol. 12:217-244
Integration and Collaboration Across Health Sciences Four distinct big data pools exist in the healthcare domain today with little overlap in ownership and limited integration • Pharmaceutical R&D Data • Owner: Pharmaceutical companies, academia • Example data sets: Clinical trials, high throughput screening (HTS libraries) • Clinical Data • Owner: Providers, Pharmacies, Labs • Example data sets: Electronic medical records, medical images Integration of Data Required to Create Significant Value • Patient Behavior and Sentiment Data • Owner: Various, including consumer stakeholders outside healthcare (e.g., retail, apparel) • Example data sets: Patient behaviors and preferences, retail purchase history, exercise data captured in running shoes • Activity (Claims) and Cost Data • Owner: Payers, providers • Example data sets: Utilization of care, cost estimates Source: McKinsey Global Institute Analysis
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 12
Holistic View of the Life Sciences and Healthcare EcosystemFrom Research to Population Health R&D Productivity TranslationalMedicine Quality& Safety PersonalizedCare Participatory& Preventive Care DiscoveryResearch DiagnosticsPharma/BiotechMedical Devices ClinicalResearch Care Delivery Care Management Population/Global Health Outcomes Insightand Collaboration improves care, lowers costs and delivers greater value Value-based healthcare
Portfolio of Solutions that Reflects the Industry’s Strategic Direction Post Marketing & Safety Surveillance Study Close Out & FDA Submission Study Conduct & AE Management Pre-Study Planning& Set Up Analytics • Subject Enrollment • Drug Supply Strategy • eCRF Design & Build • Site Training & Certification • Site Payments • Site Enrollment • Operational Study Management • Clinical Trial FinancialPlanning and Sourcing • Drug Supply Management • Drug Reconciliation • Drug Forecasting • Data Collection • Data Review • Data Management • Reporting & Analysis • Adverse Event Reporting • Clinical Trial Financial Sourcing and Tracking • FDA Submission Ready Reports • Final CRF Site Reports • Adverse Event Reporting • Site & Investigator Payment • Reconciliation • Clinical Trial Financial Reconciliation • Post-Marketing Safety Surveillance • Product Positioning & Enhancement • Quality of Life • Patient Reported Outcomes • Patient Advocacy & Recruitment Clinical Development from Planning to Post-Marketing Patient Safety Suite Data Warehousing Analytics Data Warehousing Safety Suite Predictive Clinical Development Real-time Healthcare Operational Translational Research Signal and Topic Management Case Management and Reporting Business Analytics and Intelligence Signal Detection and Analysis
Complete Capability from Planning to Surveillance Oracle Siebel CTMS Oracle Health Sciences Health Sciences Network Study Set Up Study Conduct & AE Management Study Close Out & FDA Submission Post Marketing & Safety Surveillance Pre-Study Planning Oracle Siebel CTMS Patient Oracle Health Sciences InForm GTM Oracle Health Sciences Interactive Response Technology Oracle Health Sciences ClearTrial Oracle Health Sciences Health Sciences Network Oracle Health Sciences ClearTrial Oracle Health Sciences Translational Research Center Oracle Health Sciences InForm GTM Oracle Siebel CTMS Oracle Health Sciences InForm GTM Oracle Health Sciences Interactive Response Technology • Biomarker Discovery • Protocol Validation • Study/Portfolio Cost, Timeline & FTE Scenario Planning • Study Operational Plan & Management • Sponsor/CRO Collaboration • Subject Enrollment • Drug Supply Strategy • eCRF Design & Build • Site Training & Certification • Site Enrollment & Payments • Financial & Project Performance Tracking • Patient Recruitment • Drug Supply Management • Data Collection, Review & Management • Reporting & Analysis • Adverse Event Reporting • FDA Submission Ready Reports • Final CRF Site Reports • Adverse Event Reporting • Site & Investigator Payment • Reconciliation • CDISC SDTM Validation &Safety Signal Detection • Cost & Performance Reporting • Post-Marketing Safety Surveillance • Product Positioning & Enhancement • Quality of Life • Patient Reported Outcomes • Patient Advocacy & Recruitment Oracle Health Sciences Interactive Response Technology Oracle Health Sciences Argus Safety Oracle Health Sciences OutcomeLogix Oracle Health Sciences Empirica Study Oracle Health Sciences Argus Safety Oracle Health Sciences Empirica Signal Oracle Health SciencesClearTrial Oracle Health SciencesClearTrial Life Sciences Warehouse Data Management Traceability Reporting & Analysis for Optimal Efficiency & Compliance
Oracle Health Sciences Cloud Strategy Oracle Cloud Clinical Trial Management Signal & TopicManagement TranslationalResearch Center Health Information Exchange Data Capture & Management Case Management & Reporting Business Analytics& Intelligence Randomization & Trial Supply Mgmt. Healthcare Analytics Healthcare Suite Safety Suite Clinical Suite Signal Detection& Analysis Late Phase & ePRO Coding / Thesaurus Management Phase I Clinic Automation Cloud Services enable greater flexibility, insight and lower cost
Oracle Health Sciences Cloud • Oracle Health Sciences Cloud Services • 4000+ hosted application instances (trials/studies) • 6000+ hosted trials for data collaboration • 700+ instances of hosted Oracle database • 100 million+ web pages served per month • 12 years of hosting services experience Hungary Romania Japan • Oracle Health Sciences Support • Helpdesk, Tier 2 and 3 for all HSGBU products • 177,000 helpdesk users • 45,000+ sites • 50,000+ tickets per month • 2400+ user management requests per day • 600+ calls per day • 900+ emails per day United Kingdom United States India • Oracle Health Sciences Application Managed Services (AMS) • 12 years of application implementation and support • HIPAA compliant • Fully integrated process framework with Oracle Health Sciences Cloud Services and Oracle Health Sciences Support • Integrated and dedicated AMS team as part of overall Oracle Health Sciences services team comprised of 800+ domain and product specialists Philippines
Oracle Health Sciences Cloud Global performance, scalability and security HIPAA certification Enables 21 CFR Part 11compliance Oracle Health Sciences Cloud Optimized for eachindividual trial/study Secure data andapplication managementacross organizationsand geographies Scale from smallest to largest enterprises Cloud services built for life sciences and healthcare applications
Oracle Health Sciences Network Secure HIPAA-Certified, Cloud-Based Collaboration for Clinical R&D De-Identified Data Protocols Alerts Life Sciences Participants Healthcare ProviderParticipants Near Real-Time Clinical Data Protocol Feasibility / Validation and Patient Recruitment
Lowering Costs and Speeding Time to Market • Near real-time datashared by participants • Protocol feasibility and validation results in seconds • Sponsors share protocols with provider and tie patients to sites/physicians instantaneously Operations Planning Site Selection Enrollment and Retention Protocol Feasibility and Refinement Timeframe Reduced from Months to Days Protocol Validation Patient Recruitment