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1 Steve Gens Principal Booz Allen Hamilton 267-614-0935 Special Libraries Association Pharmaceutical and Health Technology Division.

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Presentation on theme: "1 Steve Gens Principal Booz Allen Hamilton 267-614-0935 Special Libraries Association Pharmaceutical and Health Technology Division."— Presentation transcript:

1 1 Steve Gens Principal Booz Allen Hamilton 267-614-0935 Special Libraries Association Pharmaceutical and Health Technology Division Las Vegas, Nevada April 3 rd – 5 th, 2005 A Macro View: External Forces Shaping Change in the Biopharmaceutical Environment Drivers of Change in Information Management

2 2 Table of Contents Changing Industry Landscape Information Management Dynamics –Community Systems –Health Information Technology –Data Explosion & Complexity –IT Labor Sourcing Conclusions

3 3 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 Architectures Functional 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 Lawsuits Millions in Lawsuits Historical SituationImplications

4 4 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 1 Community Systems 2 Health Information Technology (HIT) 3 Data Explosion & Complexity 4 IT Labor Sourcing

5 5 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 1

6 6 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 Systems 1

7 7 To be successful, Information Managers utilize non-traditional skills to mobilize and run the caBIG ® program Community Environment Classical 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 scenarios in a grand scale 3.Legacy Data Migration and Archiving Challenges Organizational change, facilitation, and socialization skills are key success factors Community Systems 1

8 8 Health Information Technology is made up of many varied components including data standards, infrastructure, architectures and processes. Pharma CDISC Patient Safety Initiatives Adverse Event Reporting CPOE NHII Consolidated Health Informatics HL7 IT Enterprise Initiatives Medicare Modernization Decision Support Mobile Computing RFID Security HLS Act (Bio-Terrorism) Globalization Outsourcing Electronic Clinical Data Capture Federal Health Architecture PMA Prescription Drug Marketing Act HIPAA HIT 2

9 9 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 ClinicalAdministrativePublic Health Information Management professionals must service the nexus between pure technology and data and the delivery of healthcare (bench to bedside) HIT 2

10 10 Information Managers are dealing with the complexity of integrating vast data sources and applications in a validated environment and…. Data Explosion and Complexity 3

11 11SWISS-PROTPROSITEInterProBLOCKSDOMOPfamPRINTSProDomPROTOMAPSBASEKabatPMDDIPINTERACTProNetBiocartaPDBBioMagResBankCATHSCOPReLiBaseHistoneTRANSFACGlycoSuiteDBCCDCHSSPEMBLGenBankDDBJGSDBdbESTdbSTSNDBAsDbACUTSEPDHOVERGENIMGTISISRDP gRNAs db PLACEPlantCARE sRNA db ssu rRNA HotMolecBaseTreeBASEDPD Nat Rx DB ADAMSnoMedUMLS FDA Standard EMR taskforce lsu rRNA 5S RNA tmRDBuRNADB RNAmod db SOS-DGBDTelDBTRADAT Subviral RNA db VectorDBCarbBankGlycoSuiteDBTCNFCCACARBHYDOMIMGENATLASGeneClinicsGDBGeneCardsUDBIntegrinsICNPubMedRainbowICD-CM Ensembl TIGR HGI UniGeneSTACKAllgenes.orgGenLinkGENOTKHUGECGAPSCDbIXDBOMIAMGIRatMAPPiGBASEFuguGOBASEMitoDatMITOMAPHvrBaseMitBASESPADCSNDBGO FlyBaseGadFlyGIFTSFlyNetsWormBaseACeDbWormPepWormPDMaizeDbBeanGenesChlamyDBCottonDBRGPRiceGenesSorghumDBSGDYPDFGRYTPdbMDBEcoWebMedlineSRPDBRefSeq SubtiListEcoCycHIVHPVHGMDSVDHGBASEdbSNPADBPrionTSCTGDBBCGDBRENDACANSITEENZYMEepoDBGCRDbGPCRDBORDBGRAPGRRGENESEQHUGO 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 Complexity 3

12 12 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 clients 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 TypeExplanation 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 Sourcing 4

13 13 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 companys 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!

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