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Steve GensPrincipal

Booz Allen HamiltonGens_stephen@BAH.com

267-614-0935

Special Libraries AssociationPharmaceutical and Health Technology Division

Las Vegas, NevadaApril 3rd – 5th, 2005

A Macro View:  External Forces Shaping Change in the Biopharmaceutical Environment

Drivers of Change in Information Management

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Table of Contents

Changing Industry Landscape

Information Management Dynamics

– Community Systems

– Health Information Technology

– Data Explosion & Complexity

– IT Labor Sourcing

Conclusions

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Drugs, Biologics, & Combinational Therapies

Drugs

Current Situation

New partnerships with external ‘owners’ and

miners of data

Increased IT Complexity

New approaches to regulatory interaction

Global Standards (ICH, CDISC etc.)

Local Standards

Pricing Pressures and Dwindling Pipelines

Double Digit Growth

Enterprise ArchitecturesFunctional Applications

Increased Regulatory Scrutiny (Safety, SOX, etc.)

General Regulatory Guidelines

Our industry is undergoing unprecedented change, we are only witnessing the tip of the iceberg

Billions in LawsuitsMillions in Lawsuits

Historical Situation Implications

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Information Managers are not excluded from this change and need to aggressively respond to several dynamics that are currently re-shaping the profession

Information and organizational systems that serve a community. Can be at a divisional, company, sector, industry, or country level.

Technology used to collect, store, retrieve, and transfer clinical, administrative, and financial health information electronically. Seen as a key enabler for reducing costs and improving quality, access and overall public health across the healthcare continuum

How Information Technology labor is sourced (on-shore, near-shore, off-shore).

The type, volume, and source of information through-out the information lifecycle (create, consume, manage, archive, and destruction)

Dynamic Description

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CommunitySystems

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Health Information Technology (HIT)

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Data Explosion & Complexity

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IT Labor Sourcing

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A new ‘community focused’ model is emerging as government, industry, and academia collaborate to solve the most pressing healthcare issues

Inward Focus… Community Focus…

Community Systems

Industry standards bodies and enabling knowledge workers are a critical part of this evolution

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Community Example: National Cancer Institute - Cancer Biomedical Informatics Grid (caBIG®) initiative.

caBIG® Program is:

A virtual web of interconnected data, individuals and organizations that redefines how research is conducted, care is provided and patients or participants interact with the biomedical research enterprise

A common, widely distributed infrastructure permitting cancer research community to focus on innovation

With shared vocabulary, data elements, data models facilitating information exchange

A collection of interoperable applications developed to common standards

That provides the availability of raw published cancer research data for mining and integration

Community Systems1

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To be successful, Information Managers utilize non-traditional skills to mobilize and run the caBIG® program

Community EnvironmentClassical Environment

Inside Out Decision Making

(Top Down )

Functional Data Modeling

1:1 Legacy Migration

Outside In Decision Making (grass roots

collaboration)

Abstract Data Modeling

Legacy Permutation

1. Negotiating standards in a community of diverse interest

2. Applying scenario’s in a grand scale

3. Legacy Data Migration and Archiving

Challenges

Organizational change, facilitation, and socialization skills are key success factors

Community Systems1

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Health Information Technology is made up of many varied components including data standards, infrastructure, architectures and processes.

Pharma

CDISC

Patient Safety

Initiatives

Adverse EventReporting

CPOE

NHII

ConsolidatedHealth

Informatics

HL7

IT Enterprise Initiatives

MedicareModernization

DecisionSupport

MobileComputing

RFID

Security

HLS Act(Bio-Terrorism)

Globalization

Outsourcing

ElectronicClinical Data

CaptureFederal Health

Architecture

PMA

PrescriptionDrug Marketing

Act HIPAA

HIT2

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Health Information Technology is enabling modernization across the healthcare value chain

Technology used to collect, store, retrieve, and transfer clinical, administrative, and financial health information electronically.

Goal: Improve care delivery at point of care/ service

Representative technologies:

– Clinical data repository

– Clinical documentation

– CPOE & e-Rx– Decision support– Digital content– EMR/ EHR/PHR– PACs

Goal: Streamline/ automate admin & financial processes

Representative technologies:

– Claims & remittance systems

– Eligibility verification– ERP– Predictive modeling

& data mining– Smart/ SwipeCards– Websites (incl.

Portals)

Goal: Monitor, analyze & improve public health

Representative technologies:

– Laboratory information exchange networks

– Outbreak alert & warning systems

– Epidemiological data repositories

R&D

Goal: Streamline R&D, clinical trials & product dev.

Representative technologies:

– Clinical trials data repositories

– Bioinformatics repositories & information grids

– Health outcomes evaluation systems

Clinical Administrative Public Health

Information Management professionals must service the nexus between pure technology and data and the delivery of healthcare (bench to bedside)

HIT2

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Information Managers are dealing with the complexity of integrating vast data sources and applications in a validated environment and….

Data Explosion and Complexity3

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SWISS-PROTSWISS-PROTPROSITEPROSITE

InterProInterProBLOCKSBLOCKSDOMODOMO

PfamPfamPRINTSPRINTSProDomProDomPROTOMAPPROTOMAP

SBASESBASEKabatKabatPMDPMD

DIPDIPINTERACTINTERACTProNetProNet

BiocartaBiocartaPDBPDBBioMagResBankBioMagResBankCATHCATHSCOPSCOPReLiBaseReLiBaseHistoneHistoneTRANSFACTRANSFACGlycoSuiteDBGlycoSuiteDB

CCDCCCDCHSSPHSSP

EMBLEMBLGenBankGenBankDDBJDDBJGSDBGSDBdbESTdbESTdbSTSdbSTS

NDBNDBAsDbAsDbACUTSACUTSEPDEPDHOVERGENHOVERGENIMGTIMGTISISISISRDPRDPgRNAs dbgRNAs dbPLACEPLACEPlantCAREPlantCAREsRNA dbsRNA dbssu rRNAssu rRNAHotMolecBaseHotMolecBaseTreeBASETreeBASEDPDDPD

Nat Rx DBNat Rx DBADAMADAMSnoMedSnoMedUMLSUMLSFDA StandardFDA StandardEMR taskforceEMR taskforce

lsu rRNAlsu rRNA5S RNA5S RNAtmRDBtmRDBuRNADBuRNADBRNAmod dbRNAmod dbSOS-DGBDSOS-DGBDTelDBTelDBTRADATTRADATSubviral RNA dbSubviral RNA dbVectorDBVectorDBCarbBankCarbBankGlycoSuiteDBGlycoSuiteDBTCNTCNFCCAFCCACARBHYDCARBHYD

OMIMOMIMGENATLASGENATLASGeneClinicsGeneClinics

GDBGDB

GeneCardsGeneCardsUDBUDBIntegrinsIntegrinsICNICN

PubMedPubMedRainbowRainbowICD-CMICD-CM

EnsemblEnsembl

TIGR HGITIGR HGI

UniGeneUniGeneSTACKSTACKAllgenes.orgAllgenes.orgGenLinkGenLinkGENOTKGENOTKHUGEHUGE

CGAPCGAPSCDbSCDbIXDBIXDBOMIAOMIA

MGIMGIRatMAPRatMAPPiGBASEPiGBASEFuguFuguGOBASEGOBASEMitoDatMitoDatMITOMAPMITOMAPHvrBaseHvrBaseMitBASEMitBASESPADSPADCSNDBCSNDB

GOGO

FlyBaseFlyBaseGadFlyGadFlyGIFTSGIFTSFlyNetsFlyNets

WormBaseWormBaseACeDbACeDbWormPepWormPepWormPDWormPD

MaizeDbMaizeDbBeanGenesBeanGenesChlamyDBChlamyDBCottonDBCottonDBRGPRGPRiceGenesRiceGenesSorghumDBSorghumDB

SGDSGD

YPDYPDFGRFGRYTPdbYTPdbMDBMDBEcoWebEcoWeb

MedlineMedlineSRPDBSRPDB

RefSeqRefSeq

SubtiListSubtiList

EcoCycEcoCycHIVHIVHPVHPV

HGMDHGMDSVDSVDHGBASEHGBASE

dbSNPdbSNPADBADBPrionPrionTSCTSCTGDBTGDBBCGDBCGDBRENDABRENDACANSITECANSITEENZYMEENZYMEepoDBepoDBGCRDbGCRDbGPCRDBGPCRDBORDBORDBGRAPGRAPGRRGRR

GENESEQGENESEQ

HUGOHUGO

maintaining corporate security as knowledge workers need to access third party data sources and collaborate with partners seamlessly

Enterprise and Information Architecture skills are critical to achieving the vision of R&D Knowledge Management

Data Explosion and Complexity3

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Information Technology organizations are using a variety of labor methods to build capabilities and leverage global suppliers to reduce operational cost

Right-shoring

Outsourcing

Offshoring Transferring work from within client organization to an international service provider (India, Vietnam)

Transferring work from within client organization to a domestic service provider

Leveraging client’s global footprint to access labor in local low-cost geographies

In–sourcing Transferring work from an existing service provider to be performed within client organization

Type Explanation

Automation Leveraging available and proven new technology to

reduce labor input

As commodity skills are increasingly sourced globally, the effort and competency to manage global development has often been underestimated

IT Labor Sourcing4

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So, what do all these dynamics mean to those who serve the industry?

Business leaders expect us to be business savvy with good change management skills!

We need to understand the dynamics and complexity of managing globally with multiple partners (culture, time-zones, decision rights etc.)

We must remain current with ever changing regulatory requirements and understand our company’s interpretation

Community systems and HIT requires us to participate and advise on key standards bodies

Our executives expect real-time information, we must play the advisor/ educator to the value of Enterprise Information Management Architectures

And finally, we must except that change is the only thing that is constant!