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Oracles Health Sciences Vision and Strategy

Neil de Crescenzo
Senior Vice President and General Manager Oracle Health Sciences Global Business Unit (HSGBU)

Agenda

Industry Trends and Implications Oracles Industry Leadership Oracles Health Sciences Industry
Strategy

Next Generation Product Demonstration

Key Trends Emerging for the Health Sciences Industry

Factors driving innovation in Health Sciences Market Trends
Patients are becoming better informed Cost to patients is increasing Increasing demand for personalized medicine Patients want cures, not treatments Increasing importance of emerging markets

Healthcare Trends
Costs of chronic disease is soaring Treatment protocols increasingly used by healthcare payers Pay-for-performance is on the rise Blurring boundaries between different forms of care Increasing financial constraints on payers

Research Trends
R&D is becoming more virtualized The research base is shifting to Asia Remote monitoring is improving rapidly The volume of data is exploding due to imaging and omics technologies

(Source: Oracle research, PriceWaterhouseCoopers, Pharma2020 Challenging Business Models)

Implications for the Health Sciences Industry

Shaping the future business model for Health Sciences Health Sciences Industry
Outcomes will drive health policy and reimbursement R&D is becoming increasingly virtualized, in addition to its current global scope Chronic care costs rising due to demographics and lifestyles Payors, providers, pharma and regulators will become closely linked Increasing demand for personalized medicine and translational research

Oracle
Integrated analytics that spans broad spectrum of care Software and data stores that support end-to-end R&D processes across partners Care management systems to support disease management Enterprise software that supports collaboration across the Health Sciences ecosystem Integrated software to support evolving models of R&D linked to patient care

The New Healthcare Paradigm

Built Around a Personalized Healthcare Ecosystem
Translational Research Ecosystem

Development Partnerships

Building the Infrastructure for Personalized Medicine and Translational Research

Health Information Services Agreement Clinical & Operational Benefit

Patient Health Information Gathered Patient Health Information Aggregated for Normalization

Transform and Normalize Health Information

Authenticate Requester

Health Information Request

Clinical Innovations

Transformed into Information Service Format

Fulfill Health Information Request

Building the Infrastructure for Personalized Medicine and Translational Research

Health Information Services Agreement Clinical & Operational Benefit

Patient Health Information Gathered Patient Health Information Aggregated for Normalization

Clinical Information Systems Personal Health Records

Health Information Request Clinical Innovations

HTB Identity and Access Management

Authenticate and Business Process Automation Requester Normalize
Health Information Transform

Fusion MW Database Security

Web 2.0 Enterprise Healthcare Analytics

Fulfill Health Information Request

Transformed into Information Service Format

Portals
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Agenda

Industry Trends and Implications Oracles Industry Leadership Oracles Health Sciences Industry
Strategy

Next Generation Product Demonstration

Oracles Leadership in Health Sciences

10 of the Top 10 Healthcare Organizations 10 of the Top 10 Research Universities 20 of the Top 20 Pharmaceutical Companies 8 of the Top 10 Contract Research Organizations 9 of the Top 10 Medical Device Companies
Use Oracle Applications to Run Their Business

Use Oracle Applications to Run Their Business Use Oracle Applications to Run Their Business Use Oracle Applications to Run Their Business Use Oracle Applications to Run Their Business

Industry Global Business Units Drive Growth

Best-in-class operational applications in key industries
2005 2006 2007 2008 2009

Apr05

Jul05

Jan06

Sep08

Nov05

Oct06

Sept06

Dec06

Sep07

May08(re-organization)

Nov06

Jun07

Jun08 Aug08

FORMED INTERNALLY
Jun08

* Pending

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IDC #1 Report
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ORACLE #1 in Life Sciences

Health Sciences Insights, IDC June 2009

Oracle easily topped the chart, with nearly $60 million more than the second-place SAP. While our internal estimates show that Oracle and SAP were virtually tied five years ago, Oracle's fast-paced acquisition strategy, coupled with its increased commitment and focus on the life sciences via its new Health Sciences Global Business Unit, has paid big dividends, which have helped to drive its success in the life science industry.

Oracles Life Sciences Footprint

Business Intelligence Enterprise Performance Operations
Clinical Development and Safety Clinical Data and Trial Management Electronic Data Capture Data Repository and Warehouse Drug Safety Risk Management Supply Chain Warehouse Transportation Rev, Trade Mgmt Distribution SCP, Forecasts S&OP ePedigree Returns Manufacturing PLM Process Devpmt Equipment Process Mfg MES Mat. Mgmt LIMS QA, QC, RA Sales E-Detailing Acct Mgmt Terr. Mgmt Inc Comp Samples Call Mgmt Contracts Collaboration Portfolio Loyalty Clinical Corporate Scorecard Safety Planning and Budgeting Mfg Marketing Sales

Oracle ISV Partners Regulatory

Profitability

Consolidation

Business Simulations

Marketing Campaigns Literature Events MRM Loyalty E-Mail Portals Segmentation

Administration
GRC Indirect Procurement Financials Projects Human Resources Compensation Real Estate Helpdesk HR IT

Infrastructure
Master Data Management Integration Framework Content Management Middleware & Database
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Oracles Healthcare Provider Footprint

Business Intelligence
Clinical Compliance Operations Human Resources

Oracle ISV Partners

Financials/Supply Chain

Operations
ADT Clinical Departments Patient Accounting Patient Scheduling Resource Scheduling Decision Support Care Management Health Information Management EHR Clinician Management

Clinical Research Patient Relations

Administration
Compensation Facilities Management Financials Projects Human Resources Supply Chain Helpdesk HR IT

Infrastructure
Master Data Management Integration Framework Content Management Middleware & Database

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Oracles Healthcare Payer Footprint

Business Intelligence
Customer Insight Channel Insight Operational Insight Profitability HR Analytics

Oracle ISV Partners

Exec Analytics

Operations
Product Dev & Marketing Product Design Pricing Consumer & Channel Mktg Corporate Marketing Events Sales & Underwriting Sales Planning Direct Sales Channel Mgmt Channel Sales Compensation Mgmt Rating & Underwriting Membership & Benefits Application Processing Policy Issuance Member Enrollment Benefits Administration Reinsurance Medical Management Networks Network Development Contract Management Application Processing Performance Assessment Service Premium Billing Member Services Provider Services Self-Service Claims Claims Adjudication Fraud & Abuse Claims Service Self-Service Appeal & Grievance Mgmt Referrals & Authorizations Care Management

Administration
Planning & Forecasting Quality Assurance Regulatory Compliance Finance & Treasury Risk Management Human Resources

Infrastructure
Master Data Management Integration Framework Content Management Middleware & Database

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Agenda

Industry Trends and Implications Oracles Industry Leadership Oracles Health Sciences Industry Strategy Next Generation Product Demonstration

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Oracles Strategy for Industry Leadership

Complete. Open. Integrated.

Complete

Open

Integrated

Comprehensive Industry Portfolio

Standards-Based Architecture

Designed to Work Together

More Value Less Complexity

More Choice Less Risk

More Flexibility Less Cost

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Oracles Strategy Reflects the Interdependence Among Stakeholders in Health Sciences

Bio-marker discovery Personalized medicine

Pharma/ Biotech

Adaptive Clinical Trials

Healthcare institutions
Research Networks Care Delivery Clinical Research

Labs & Bio-banks

Submissions

Safety and Pharmacovigilance

Oracles Health Sciences Industry Strategy

Delivering Innovation in Health Sciences
Requirement
Improve operational efficiencies and outcomes in clinical trials Reduce supply chain risk via process validation and compliance Improve pharmaceutical marketing, sales and service effectiveness Ensure quality of care and patient safety

Oracle Capability
Clinical Data and Trial Management , Life Sciences Hub Product Lifecycle Management, ePedigree, SCM Oracle CRM Solutions for Pharma Oracle Safety and PV Solutions, HTB, LSH

The Oracle Difference

Leading provider of applications to support clinical trials end-to-end Suite of applications to fully support lifecycle supply chain management and quality Innovative solutions to support transformational CRM for customer centricity Supports patient and safety data across clinical, post-market and patient care Solutions to enable secure access of clinical Information End-to-end analytics and BI solutions across the value chain

Provide accurate and secure clinical Oracles HIE information across collaborative Solutions networks Deliver better insights on data across the health sciences value chain Analytics and Business Intelligence Solutions

Oracles Clinical Development & Safety Suite

Supporting Clinical Development through Patient Care
Health Sciences
Life Sciences and Healthcare Analytics
Life Sciences Healthcare
Oracle Safety, Pharmacovigilance and Risk Management
Oracle Clinical Oracle Clinical Trial Mgmt Oracle Remote Data Capture Oracle Thesaurus Management Oracle Interoperability Data Repository Data Acquisition and Integration

Simplifies the collection,

monitoring and analysis of data across the clinical development and safety process Improves collaboration across clinical, postmarket surveillance and patient care Reduces total cost of ownership Aids in alignment of business operations across departments

Healthcare

Applications
Terminology Management Privacy and Security Oracle Life Sciences Data Hub

Oracle CRM Oracle ERP Middleware and Collaboration Database

Oracles Safety & Pharmacovigilance Solution

End-to-end Support of Safety and Risk Management Processes Provides visibility of strategic data across the enterprise Uncovers key, statistically significant data using signal detection and other methods to manage the risk-benefit profiles of drugs Supports key decision making by compiling and analyzing data for executives and end-users Enables regulatory compliance and improves case management processing Facilitates the exchange of core data between systems

Oracle for Product Lifecycle Management

Research Early Development Late Development Commercial

Comprehensive solution from Drug Design, Development to Commercialization

Product Lifecycle Management (PLM)

New Product Development (NPD)

ERP
Discovery Tools Lab Note Book

Design Experiments
Material mgmt Experiment tracking Results tracking eDR Electronic Dev. Record

Formulation & Recipe Development

Tracking blend, formula and recipes Specification details BOM and Bill of Substance

Product spec for packaging and labels Equipment Model Process instructions including global eBR Electronic Batch variations; Regulatory control record

Process Development and Batch Mgmt

Packaging & Label Mgmt

SCM MES LIMS

Packaging and Label Mgmt

TQM - Quality Assurance /CAPA Doc Mgmt

Clinical Trial

Oracle

Conformia

Regulatory Submissions

05/05/12

Oracle Pedigree & Serialization Manager

Single Interoperable Solution for Serialization and Pedigree Management
1 6
Returns Reconciliation Serialization

Unit and case mass serialization Multi-site provisioning Serial import and export Contract manufacturing serial data exchange Custom serial algorithms

Packaging

Import returned serials Reconcile serials against sales orders Assess and authorize valid returns Serial disposition

Web services integration to packaging systems Packaging hierarchy maintenance UI and services Serial and packaging inquiry

Comply, Track, Trace, Protect

Receiving

Track & Trace

3 4
Inbound ePedigree management BI dashboard drilldown into receipt and serial details

Shipping

Portal for customer and consumer serial verification Mobile access Flag counterfeit serials Protect public health

Outbound ePedigree management Shipment and serial analytics Export product data to regulatory database(s)

Oracle CRM for Life Sciences

Transforms Sales and Marketing for a New Era
Analyze Effectiveness of Strategies Sales Force Sales Campaign Design & Planning Email Physician

Patients & Consumers MultiChannel Response Healthcare Practitioner Scientific Leadership Multi Channel Delivery Key Opinion Leaders Provider & Payer Accounts, Hospitals, Government

Medical Affairs Brand Manager Customer Service Account Managers Segmentation and Target Audience

Web

Call Center Direct Mail TV/ Print Advertising

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Oracles Life Sciences CRM Solution

Complete CRM - Supporting the Pharma Sales User Experience
Siebel CRM CRM On Demand Social CRM

Integration (Fusions Application Integration Architecture)

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Oracles Health Information Exchange (HIE)

Healthcare Portal / MPI / Knowledge Bases (ISV Partners) Security, Access & Identity Management Business Intelligence Source Systems Pharmacy Labs CIS Knowledge Bases Clinics MD Office Message Services Healthcare specific services architecture Standards-based (meaningful clinical data) Web access for patient centered care Person Services Security & Auditing

Improve the Accuracy and Availability of Secure Clinical Information

FMW / SOA Suite Message Normalization

(HL7V2.X V3.0)

Healthcare Transaction Base Terminology Normalization Normalized Clinical Data Repository

DW / SOA Suite / FMW Clinical Information Reuse Clinical Data Warehouse Clinical Decision Support Handheld Support Regional Health Networks Custom or 3rd Party Applications

Transform Messages into a Common Format & Route

Translate Disparate Vocabularies & Concepts

Data Model

Oracles Health Sciences Analytics

Analytics to support the entire Health Sciences value chain
1 Integrates Data for Analysis and Reporting Pre-built integration of data from Oracle Health Sciences solutions and other sources into an integrated data warehouse optimized for analysis Provides User-Friendly Analytic Model of Enterprise Information and Metrics Embedded best practice calculations, metrics, and KPIs Easy for business people to access, analyze, and use the information Delivers Personalized Performance Dashboards by role Pre-built dashboards, reports, and alerts by business function and role Extensible by customers to meet their specific and unique needs 1
2 3

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Clinical Development Analytics (CDA)

Insight into Clinical Trial Data to Improve Performance
Clinical Data Management
Provides Clinical Data Manager insight into the completeness and cleanliness of clinical data, whether paper or EDC, to ensure early database lock

Clinical Operations
Provides Clinical Project Managers and CRAs the ability to analyze and gain insight into Study Enrollment performance, Patient Status tracking, Visit and Trip Report monitoring, Data Completeness & Cleanliness, and Financial performance across multiple Sites and Regions, and by Study

Clinical Site
Provides Site Investigators and Study Coordinators insight into their specific Sites enrollment performance, Patient Status tracking, and Financials

Clinical Executive
Provides Finance and Executive Management insight and analysis of a studys budgetary performance through the tracking of planned, forecast and actual payments over time.

Enterprise Healthcare Analytics (EHA)

Insight gained from Clinical, Operational and Financial Data to Improve Performance Multi-Dimensional Data Warehousing
Disease

Flexible Analytics and Data Mining

View aggregated,
normalized information across configurable dimensions

Organization Procedure

Easily browse and drill into

details via Star Schema

Facility

Restrict access to all or

Healthcare Transaction Base
Outcomes

Department

portions of opt out patient health data to support compliance requirements (e.g., HIPAA)

Oracle Health Sciences Reference Architecture

Applications

SOA Services

Interfaces

System and Application Services

Storage

Oracle Health Sciences Reference Architecture

Applications
Analytics

Applications Composite
Applications

Domain Applications

SOA Adapters

SOA Services
Standardization / Normalization Security Translation

SOA Services

Routing

Business Process Management Complex Event Processing

Transformation

Orchestration

Interfaces

Interfaces

ETL

System and Application Services

System Services
Identity & Security Master Data Management Consent and Application Services System Management Translational De-Identification Terminology Healthcare

Application Services
Medicine and Research Life Sciences

Enterprise Master Person Index Record Locator

Auditing / Logging

Legacy Adapters

Storage
Transactional Repositories

Storage
Enterprise Data Warehouse

Integrated Data Repositories

Agenda

Industry Trends and Implications Oracles Industry Leadership Oracles Health Sciences Industry Strategy Next Generation Product Demonstration

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Transforming Health Sciences

Improved Value from Oracles Technology and Applications

Next Generation ADAPTABILITY

Native service-oriented architecture and open standards support customization, rapid change and interoperability

Next Generation PRODUCTIVITY

Embedded intelligence, rich user experience, and instant collaboration to improve decision making and efficiency

Next Generation MANAGEABILITY

Reduced work for IT administration through improved user setup, flexible upgrades, and centralized security

Oracles Clinical Development and Safety Strategy

Three Horizons
Health Sciences Suite
NEXT GEN FULLY INTEGRATED APPS

Integration & Analytics Current Applications

INITIAL FOCUS: ANALYTICS APPLICATION INTEGRATION ARCHTECTURE, ANALYTICS

eu a V l

PARTIALLY INTEGRATED APPS ADDRESS EXISTING BUSINESS PROCESS CUSTOMERS & ATTRACT INTEGRATION NEW CUSTOMERS FEATURE SET FOR ISOLATED BUSINESS PROCESSES INSIGHT & ANALYTICS

INTEGRATED, FLEXIBLE, COLLABORATIVE BUSINESS PROCESS

(v1 - Oracle Protocol Manager)

Time
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Oracles Health Sciences Suite

Developing an integrated, open, standards-based global suite for Health Sciences

Oracles Health Sciences Suite

Oracle Protocol Manager (Collaborative Development w/Industry)

Presented by Ed Dougherty Oracle HSGBU Sales Consultant

Oracle Health Sciences

A Comprehensive Software Portfolio based on Open Standards

Provides the capabilities to enable health

sciences companies to address current and future challenges and opportunities

Delivers an application portfolio supporting

end-to-end processes, based on open standards and interoperable with other industry solutions

Promotes the continued focused

development and delivery of innovative, industry-leading software solutions

Enables collaboration across functions and

organizations for better decision making

Reduces total cost of ownership Backed by world class service and support
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