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Platform for Translational Medicine:Oracle ExamplesRaghbir Bains PhDBusiness Develipment Director, Life Sciences,EMEA

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Agenda

• Industry Challenges

• Translational Medicine Enablers

• Oracle Examples

• Summary

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Industry ChallengesDecreasing R&D Efficiency

Capitalized Costs Increased 481%

8454 214

104

336

466

0

100

200

300

400

500

600

700

800

900

MIL

LIO

NS

OF

2000

DO

LLA

RS

1970s Approvals 1980s Approvals 1990s Approvals

Non-Clinical Costs Clinical Costs

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Industry ChallengesIncrease R&D Spending; All Time Low for New Drugs

26 2522

28

53

39

30

35

2724

17

21

16

11

$11.50$12.70 $13.40

$15.20$16.90

$19.00$21.00

$26.00

$29.80$32.10 $33.20

$38.80 $39.40

$22.70

0

10

20

30

40

50

60

1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Num

ber N

ME

's

$0.00

$5.00

$10.00

$15.00

$20.00

$25.00

$30.00

$35.00

$40.00

$45.00

$ B

illion

s

New Drug Approvals (NMEs)

R&D Spending

Innovation Gap

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The Case for Change to TranslationalMedicine

“Translational Medicine”FDA Critical Path

Declining R&DProductivityPatent ExpirationPatient SafetyGeneric ErosionValue Based Pricing

PharmaDrivers

Life Science &Healthcare

Systems UnderPressure

NOTSUSTAINABLE

BusinessDriversRising Health CostsIncrease in ChronicDiseaseCost of ChronicDiseaseAgeing PopulationsPatient Safety

HealthcareDrivers

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Agenda

• Industry Challenges

• Translational Medicine Enablers

• Oracle Examples

• Summary

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Translational Medicine

Translational Medicine Enablers

Enablers

2. ‘omic Data2. ‘omic Data

4. Clinical Trials4. Clinical Trials

5. Investigators5. Investigators

PotentialBenefits

- Better diagnoses

- Earlier inter-ventions

- More effective therapies

- Improved health outcomes

- Increased cost-effectiveness

1. BioBanking1. BioBanking

3. Electronic Health Records3. Electronic Health Records Bench Bedside

Integrated on a Secure, Scalable, Reliable IT InfrastructureIntegrated on a Secure, Scalable, Reliable IT Infrastructure

Will be detailed out on the following slides

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Agenda

• Industry Challenges

• Translational Medicine Enablers

• Oracle Examples

• Summary

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• BioBankingUK BioBank

Aim• 500,000 people (age 40-69)

Invited to participate• Recruitment Clinic

• Explicit broad consent• Detailed Lifestyle & Health

questionnaire• Physical Measurements &

Sample Collection• Follow up

• Participants health for 20-30 yrs• Information

• Environmental• Lifestyle• Linking to Medical Records &

Biological Samples

Challenges• Build a secure repository

• Protect the confidential medical,health, and lifestyle data collected

• Ensure access to it is restricted toauthorized parties

• Create a single, consistentelectronic record for eachindividual

• Complies with the Health Level 7Version 3 (HL7v3) protocol for theformat, content, and exchange ofdata

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The UK Biobank Resource UK BioBank

UK BiobankAssessment Centre

UK

Biobank Lab &

Archive

NHS Records

GP Health RecordSymptomsDiagnosesReferralsMedicationsProcedures

Hospital RecordsIn & Day PatientsICD-10/ICD-9(Diagnoses)OPCS4 (procedure)Primary DiagnosisMain Operation

Questionnaire e.g.DietCircumstancesFamily HistoryEmploymentSmokingAlcoholLifestyleMedicationsCognitive FunctionHealth

Measurements e.g.HeightWeightRespiratory FunctionSightHearingBlood Pressure

ResultsBiochemistryHaematologyAdvanced testing

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RecruitmentServices

Invitation

Partcipant Liaison & Booking

Assessment Centre

External Data(Clinical)

External Data(Non Clinical)

Middlew

are/Messaging M

anagement/P

seudonymisation

Clinical Repository

LIMS Biological Repository

Data W

arehouses

Health Record Repository

User Portal

Query Tools

Research Com

munity

UK Biobank Core

Systems

Standards Oracle HTB

Overall Systems ArchitectureUK BioBank

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1. BioBankingWindber Research Institute, USA

• Focus on Women’s Health, Cardiovascular Disease, Aging• The most highly annotated BioBank in the US

• Patient annotation (580+data fields)• > 43,000 samples (tissue, serum, lymph nodes)• Image Repository contains:

• Mammograms (film & digital), 4D-ultrasound, PET/CT ,3T MRI,digitized pathology images

• Complementary analysis at WRI• Genomics

• Sequencing, SNP’s, CGH, LOH, expression• Proteomics

• Protein Separation, Protein Identification

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1. BioBankingErasmus MC, Netherlands• Focus on cardiovascular diseases, oncology, pediatrics, genetics and cell biology,

human reproduction, endocrinology, virology and aging

• Highly annotated population/genetics cohorts• ERGO (15.000 cohort)• Generation R (12.000 cohort)• ERF (2.500 cohort)

• Linking genomics data with clinical data

• Image Repository contains:• Mammograms (film & digital), 4D-ultrasound, PET/CT ,3T MRI, digitized pathology and

radiology images

• Complementary research at Erasmus MC• Genomics Sequencing, SNP’s, CGH, LOH, expression• Proteomics Protein Separation, Protein Identification• Forensic Molecular Biology SNP analysis• Functional Genomics Mouse models• Clinical trials CRO efforts

Valk et al, 2004

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2. ‘omic Data HandlingThe Sanger Centre, UK

Challenges• Convert cumbersome & error prone

flat-file based data store into afaster, more flexible databasesystem

• Store and analyse over 400TB ofgenomic data, whilst receiving up2TB of new data per week

• Develop applications faster and in amore integrated way in order toleverage information from thedatabase

• High availability when data is beingtransferred from flat-files to RDBMS

• Web-site is currently taking 8-10million hits per week, and increasing

SolutionTechnical solution of Middleware,Database and RACUnique licensing model to enableunlimited deployment

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3. Electronic Health RecordsStockholm County, Sweden

Every Day• 22,000 people visit a doctor• 7,000 are admitted to hospital• 60 babies are born• 500 undergo an operation• 11 heart attacks are treated• 6,000 are treated by the Public Dental• Services (free service for under 19s)

Stockholms läns landsting

Stockholm County• 1.8 million inhabitants

• Geographical area includes 26municipalities

• 6,500 km2

Melior BMS Swedestar Take Care

Obstetrix ProfDoc Medidoc

InfoMedix Pasett VAS PVS Alfa Biosis

Cambio Sigma m.fl.

EHR16 Different Systems

Islands of DataOracle HTB

Semantic Interoperability EHR

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4. Clinical TrialsQuintiles

Background• Most experienced and largest

contract provider of this tool inthe industry, in production since1996

• Over 320,000 patients and6,130,000 pages have beenprocessed by Quintiles’ datamanagement

• 730+ studies, 555 completed,175 active

• 251 Oracle clinical studies inNorth America

• 305 Oracle clinical outside NorthAmerica

Case Study• Phase III Study

• 10,000 patients• ~1,000 sites in 33 countries• Fast recruitment (18 months)• 3 year project• Hybrid Process – Electronic

Data Capture & Paper

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4. Clinical TrialsQuintiles

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4. Clinical TrialsTrial Coordination Centre at UMCG, Netherlands

Clinical Trial Directive 001/20/EU

100%100%100%Total

......…..

20%15%11%Data validation5%8%6%

Databasemanagement

12%12%14%Data entry6%2%1%On-site monitoring

22%19%18%Management......…..

6%5%4%Administration......…..

200420032003

Selection criteria• Pharma industry proven• Experience and vision of software

company in health sciences• Scalable• Implementation time• Access, transformation, integration,

distribution• Test environment• Presence of a user group• 21 CFR 11 compliant• EDC; single application• Manage clinical trials

Clinical Trials in an Academic Clinical Research Environment,optimizing cost-effectiveness of clinical research

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4. Clinical TrialsTrial Coordination Centre at UMCG, Netherlands

Benefits• Significant reduction in

workload Paper`based vsRDC (200 pts study)

• Data entry 300 -> 0 hrs• Monitoring 730 -> 730 hrs• Validation 250 -> 100 hrs

• New feature in services(hosting)

• Erasmus MC, UMCG,Xendo

Investment• Significant set-up time

investment:• Implementation and system

validation > 850 hrs• Documentation, modification

and implementing QMS > 400hrs

• Training > 350 hrs• Study initiation

• Maintenance

Future’s Clinical Research -> e-Clinical Research;managing data, not paper

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5. InvestigatorsChallenge: Current Process Does Not Provide CRA WithComplete Investigator Information For Site Selection

CRA 1 conducts astudy with a site

and has poorexperience withinvestigator and

site staff

CRA 2 selects thesame site for a newstudy because theinvestigator meetsspecialty and boardcertification criteria

Investigator’s pastperformance andhistorical informationincludingresponsiveness,adherence to GCPs,etc. are not part ofnew site evaluationcriteria

Problem:Problem:

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5. InvestigatorsAmgen, USA

CUSTOMER PERSPECTIVE“If the protocol is not working, I don’t want towait two months to find out. Now I know withindays or hours if there is a problem”

Hassan Movahhed, Senior Director for ClinicalAffairs

COMPANY OVERVIEW• A biotech company since 1980, Amgen was one of the first

companies to realize the new science’s promise by bringingnovel medicines from lab, to manufacturer plan, to patient.Amgen therapeutics has changed the practice of medicine,helping millions of people in the fight against cancer, kidneydiseases, rheumatoid arthritis and other serious illness. With abroad and deep pipeline of potential medicines, Amgen remainscommitted to advancing sciences to dramatically improvepeople’s lives

CHALLENGES/OPPORTUNITIESLack of comprehensive view of valued customers--physicianinvestigators and prescribersScattered information leads to delay and escalating costsProtocol non-compliance impacts trial qualityManual, labor-intensive, error-prone payments process adds trialcosts and impacts investigators satisfaction

SOLUTIONSOracle Siebel Clinical

RESULTSReduced time spent on costsreconciliation by 80%Reduced monitoring visits by 10-20%due to better data visibilityBetter trial experiences and improvedinvestigator relationshipsReal time trial information leading toearly recognition of issues and quickand better decision makingCuts down wasted payments on workthat is never done

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Adverse Event Reporting/Adverse Event Reporting/PharmacovigilancePharmacovigilance

(Oracle AERS)(Oracle AERS)

Term Classification / Dictionary Management (TMS)Term Classification / Dictionary Management (TMS)

Clinical Integration/Reporting (Life Sciences Data Hub)Clinical Integration/Reporting (Life Sciences Data Hub)

Clinical DataClinical DataManagement SystemManagement System

(Oracle Clinical)(Oracle Clinical)

Clinical Trials Management System (Siebel Clinical)Clinical Trials Management System (Siebel Clinical)

Oracle Life Sciences (OLS) Applications

Remote Data Capture (RDC)Remote Data Capture (RDC)

Clinical A

nalyticsC

linical Analytics

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Integrated Clinical DevelopmentMoving from data compilation to scientific decision

Clinical DataManagement

MedicalTerm

Coding

ReportingTools

Clinical TrialManagement

StatisticalAnalysis

Trial DataCapture

PatientDiaries

Documentand Image

Management

Outsourcedand Managed

Drug Supply

Lab Data

Central View ofInformation

Intranet

SecureInternet

This slide courtesy of IBM BCS

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What is LSH?

• LSH is an application that supports all the necessary functions for:

• Integrating, Loading, Transforming, Analyzing, Viewing, and Reportingon……

Clinical and Non-clinical data, both within and across studies.

• Oracle and SAS tools supported• Designed for regulatory compliance• Designed to be managed by business users• Maximizes reuse and standardization as well as allows for ad-hoc

development

Write Once Validate Once Use Many

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Clinical Integration

Clinical Research Organizations

RDC / CDMS

IVRS

Pharmacoeconomics

LSH

Regulatory CompliantIntegration & Reporting

Environment

CTMS

Financials

Clinical TrialsProgress Review

Data Marts,Reports and

Outputs

BusinessProcess

Automation withWorkflow

Central Labs

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Medical Image ManagementOracle 10g Intermedia

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Agenda

• Industry Challenges

• Translational Medicine Enablers

• Oracle Examples

• Summary

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Summary

• Translational Medicine Vision shows great potential

• Many Enablers are required for an effective WorldClass Clinical Research Platform

• Oracle is committed to help deliver this vision