Information Management In Pharmaceutical Industry


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Pharmaceutical Industry Information Management Opportunities and Challenges in Research, Development, Clinical, Sales, Marketing, Managed Markets, Manufacturing, Supply Chain and Distribution

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Information Management In Pharmaceutical Industry

  2. 2. TOPICS• Challenges of Pharmaceutical R&D and Clinical, Sales and Marketing Productivity• Evolving Biopharma Value Chain• Information Management in Pharmaceutical R&D and Clinical Value Chain• Information Management in Pharmaceutical S&M and Managed Care• Information Management in Manufacturing and Distribution (Supply Chain Optimization)• Information Management to help IT Organization to run like a Business
  3. 3. PHARMACEUTICAL INDUSTRY IS AT A CROSS-ROAD. WHILE R&D PRODUCTIVITY SAGS, EMERGING MARKETS, RECESSIONS, HEALTHCARE REFORMS AND DEMOGRAPHICS ARE FUNDAMENTALLY CHANGING THE LANDSCAPE. Market and Industry Forces Impact• Rising demographic pressures as populations age. Mature • R&D countries large impact in 3-5 years, BRIC countries in 15-25 ― Focus on precision medicine to find segmented populations for years. line extensions, off-label and new specialty drug uses; the rise of disease management programs• Large scale entry of developing nations with adequate infrastructure leading to new market share opportunities ― Large scale pipeline renewal (process, organization, technology (>50% of growth from emerging markets). and therapeutic area focus) through R&D reorgs and M&A to refresh future funding sources. Shift R&D to developing nations• Research productivity dropped significantly while R&D and outsource to reduce costs and efficiencies expenses dramatically increased. Fewer blockbusters, more extensions; patent cliffs with generics; precision medicine. • Manufacturing and Supply Chain ― Reduce manufacturing footprint; outsource more manufacturing• The rise of biologics and genome-based therapies seen as new source of innovation but genome based research has ― Revitalize supply chain by adopting best of the breed not yet fulfilled its promise. manufacturing supply chain excellence such as lean manufacturing, demand forecasting and inventory optimization• Conflict of interest and fear of corporate influence driving new regulations affecting corporate-physician relationships. • Sales and Marketing• Recession and Healthcare Reform mandate require clear ― Differentiated sales and marketing strategies (segmentation) required to reach emerging markets, mature vs. novel products value prepositions of new molecular entities, new and therapeutic-specific patients; tailored communications by commercial business models and increased supply chain segment by channel agility. ― Socialized medicine cost pressures increase regulation in EMEA and developed countries; price controls drives unified approach to legal/safety, R&D and S&M ― Reduced access to Primary care as well as Specialty Physicians and Managed care in US markets requires new S&M approaches
  4. 4. HP’S VIEW OF FUTURE OF PHARMA VALUE CHAIN IN CORE MARKETS1 2 Development paradigm shifting to in-life monitoring Discovery shifting away from blockbuster • New clinical model, from adaptive trial to enrichment strategies to screen and select patients for targeted therapy will result in reduced costs and time needed for Phase III• Targeted treatment based on biomarker & Px trial• Focus on cure and prevention (convergence of Rx, Dx • Development Collaboration and offshoring: High % of development executed by CROs, and devices) and more development conducted in emerging markets• Research Collaboration and offshoring: High % of • Closer coupling with Providers, Payers, Government, Regulators to share clinical Research executed through biotech and academia; high % of research executed in emerging markets infrastructure• EHR data mining, convergence of informatics of • Collaboration between Regulatory Bodies and Industry on an expedited drug providers, payers and biopharma development pathway 3 Technical Operation modernizing • Increased complexity due to precision medicine, combination therapy, new delivery technologies • Personalized dosage, lean principles, supply chain analytics • New production sites and outsourcing to CMOs and offshoring in emerging markets • Continued emphasis on cGMP 4 Marketing transforming in core markets • Evidence-based medicine marketing, pay for performance pricing and reimbursement demanded by Managed Market • Investment focus on initial product launch and post marketing surveillance • Post launch marketing shifts from physician-centric to patient-centric • Collaboration with Providers, Payers and Government to improve patient outcomes 5 Sales transforming in core markets6 Distribution partnering in core markets • Sales model changes from product driven to disease-management driven • E-pedigree • Bundled selling model emerge which may include Rx, Dx, Devices and • Direct to pharmacy and newer channels supportive packages such as compliance monitoring and home delivery • Patient-outcome based payment changes financial model • Smaller but more specialized sales force; different sales model for mature and new products • Collaboration with whole sales, specialty distributors, PBM and pharmacies to increase patient adherence • Provides advisory, training and service roles4
  5. 5. PHARMA R&D AND CLINICAL • Business Processes • Paradigm Shift • Information Management Challenges and Maturity Model • Information Management Opportunities
  6. 6. Information Management and Knowledge Sharing along the Pharmaceutical R&D Value Chain Target ID Lead Identification Lead Preclinical Animal Non Clinical Clinical Validation (Assay Dev/Screening) Optimization Testing Development Support Genomics Compound Registration Tox LIMS Stability Clinical Trial Supply Proteomics Compound Inventory Bioanalytics LIMS Scale-up Clinical PK Bioinformatics Screening Databases Animal Pharmacology TotalChrom Manufacturing R&D Images Project Mart PK/PD LIMS Pathways Computational Chemistry Toxicogenomics Process Control Systems Biology Cheminformaitcs (e-ADME) Metabonomics CMC Strategies Rational Drug DesignBiology Therapeutic Centric DW IND SubmissionCorp R&D Knowledge Managment GLP/GMPCorp Compound Management Validation Part 11 CRF 21 Content Management DocumentumProject Portfolio ManagmentCollaboration, Portal, IP Management, CTI Data Governance, Data Integration, Information Management and Knowledge Sharing
  7. 7. Information Management Along the Pharmaceutical Clinical Operation, Regulatory Affairs and Post-marketing Surveillance Regulatory Phase I Phase II Phase III Phase IV NDA Submission Documentum Effectiveness of Medicine Web-based EDC in traditional phases and adaptive trials EDM Long-term Safety Design and Plan Document Life Cycle Life Cycle Management Start-up (Distribute Drug info, Site Selection) Management Patient Registry Recruiting Patients/Investigators eCTD Observational Trial Management and Monitoring E Submission Outcome Research Conduct, Reports and Closeout Sharepoint Pharmacoeconomics Global Registery CTDM CTMS Clinical Data Repository (SCE, eCDM) Clinical Data Warehouse Adverse Event Reporting SystemDocument Management, eCTD for IND/NDAGCP/CFR 21 Part 11 ValidationData Standards (HL7/CDISC/SPL/ICSR/RPSeClinical (trial data management, trial supplier managemnet, statisticsePRO, Clinical Trial Registry and Results Database Data Governance, Data Integration, Information Management and Knowledge Sharing
  8. 8. PHARMA R&D BUSINESS PROCESS: TWO TYPES OF R&D. TRANSLATIONAL IS THEINDUSTRY DIRECTION BUT PRESENTS THE GREATEST SET OF CHALLENGES. Discovery and Manufacture and Health Development Distribute Primary Management Clinical Care Basic Research Trials Payment Acute Extended Traditional R&D Translational R&D • Silos between disciplines and within and • Integrates traditional discovery processes between institutions with clinical practices • A number of different disciplines: Chemical, • Breaks down boundaries between silos and Biological, Clinical etc. organizations • In many ways has hit a wall in terms of • Closes the cycle between research and the efficiency and capacity for innovation clinic, and between different research • Rich history of many applications and data- disciplines providers • Requires collaborative infrastructures and data access • Process is circular (closed loop)8
  9. 9. VIRTUAL R&D, COLLABORATION AMONG ACADEMIC MEDICINE, PHARMACEUTICALCOMPANIES AND REGULATORY BODIES MANDATE EFFECTIVE INFORMATIONMANAGEMENT AND KNOWLEDGE MANAGEMENT Drug Discovery Disease Basic Science Development Management Clinical Informatics Clinical Care Research Payment Hypothesis generation Statisticians develop toolsIn vivo and in silico prospective to analyze and validate and retrospective biomarker biomarkers use in discovery Basic Statistics Science Informatician Biopharma Companies Clinical Care & Biospecimen collection, clinical conduct and develop Research diagnosis and treatment to putative new treatment assess biological activity and hypothesis Patient recruitment Prospective biomarker • Receive current standard therapy screening in new • On clinical trial of new therapy patients9
  10. 10. THE NEED FOR DEVELOPING A 360 VIEW OF BIOPHARMA PRECLINICAL ANDCLINICAL DEVELOPMENT ACTIVITIES – INFORMATION MANAGEMENT HUB ANDPHARMA R&D INTELLIGENCE SYSTEM •Patient recruitment •Site selection and monitoring •Investigator relationship management •Test sample logistics •EDC •Phase I safety study •POC Study •Animal Tox Studies •Clinical data reduction •Data to support phase 1 trials •DRA •Dosing stability studies •Tox analytical method development and validation •INC support •Clinical Supplies Manufacturing,QA/QC •Analytical development •CMC section of NDA •Pilot Manafacturing Clinical PK/PD •Dosage form Stability •Technology Transfer •Biomarker ID & Validation •Clinical Compendium Dx kits development •Phase I simulation, modeling and virtual patients •Clinical protocol development •IND Review •Phase I trial review
  11. 11. INFORMATION MANAGEMENT OPPORTUNITY - CLINICAL TRIAL PROCESS Design & Start-up Recruiting patients Closeout & ReportTrial Phases and Investigators, Planning managing trialKey Activities • Designing protocols • Distributing drug information • Monitoring progress & adverse • Entering & verifying databenefiting from events • Creating regulatory docs. • Setting up data collection • Processing clinical responseinformation • Managing drug supply formsmanagement • Planning, ordering drug • Selecting site supply • Tracking patient enrollment • Addressing and reconciling investigators’ queriesInformation Management • Tracking clinical-response forms1. Clinical Data Database of investigators and Standard interface to integrate Automated data checks to minimizeManagement their preferences to support third party pay systems quickly queries design of electronic forms and inexpensively2. Safety Data Real-time monitoring and analysis of study data to spot adverse reactions.Management3. Document Single repository of data with version control, work flow management.Management4. Clinical-Trials Modular design, construction System to convert study Electronic invoicing Report BuilderManagement of consent and case report designs to electronic forms and Automated drug supply work flow forms databases with minimal rework and manual effort Study planning and budgeting Patient Management5. Project & Standard data models to work Ability to track and analyze cost, quality and speedresource with third-party contractorsManagement
  12. 12. INFORMATION MANAGEMENT OPPORTUNITY - CLINICAL DATA REPOSITORY (CDR) BUSINESS CASES• New R&D model requires extracting and use data and metadata from all the transactional systems and aggregate them into a comprehensive clinical trial management environment.• Definition of a Clinical Data Repository: a centralized metadata repository fed by all the key systems (EDC, CTMS, IVRS, CDMS, Labs, Genomics, Resource and Planning) to allow for retrieving, combining, analyzing and reporting on operational data for multiple purposes.
  13. 13. INFORMATION MANAGEMENT OPPORTUNITY – COMPREHENSIVEPHARMACOVIGILANCE SYSTEM BUSINESS CASES FOR DRUG SAFETYAND POST MARKET SURVEILLANCE SYSTEM • Traditionally, Pharmacovigilance seen as drug adverse-event case processing, relatedness assessment and regulatory compliance reporting. • Public safety concern and new R&D and commercial models require a comprehensive benefit-risk analysis on drug development and drug life cycle management. • New bars on drug safety and post market surveillance require a comprehensive pharmacovigilance system • Definition of a comprehensive pharmacovigilance system: possess ability to process safety data, to detect safety signals, to assess preclinical and clinical potential safety concerns/risks. The goal of the system is to enhance safety monitoring, to communicate identified safety risks, to provide strategies for implementing risk minimization
  14. 14. BUSINESS INTELLIGENCE: TRADITIONAL CORPORATE BI VS. PHARMA R&D BI Traditional Corporate  R&D BI BI Predictive Models Number ERP Text CRM Visualization Images R&D DW Corp DW Reports Gene MRP Interactive Reports Structured DB SFA Compound Structure • Heterogeneous data • Structured texts • Out-of-dated data • Clear business rules • Unstructured and structured • Data residing in various dbs • Data resides internally and externally
  15. 15. DO YOU LEVERAGE YOUR INFORMATION ASSETS? ASSESSMENT OF INFORMATION MANAGEMENT MATURITY IN PHARMACEUTICAL R&D (1) DATA INTEGRATION MATURITY P3 P4 P10 P5 P8 P11 P7 P6 P2 P9 P12 No Minimally Integrated, Federated Querying, Full Discovery Full Integration IntegrationIntegration in Pilot Programs on EDC, within research (Targets to including with Discovery, loosely harmanization discipline (Genomics, leads) Research, Commercial standalone between CTDM and Medicinal Chemistry) Preclinical (Tox, Preclinical and (EBM, LIMS, paper- AERS, separate and clinical (EDC, DMPK) and clinical data Personalized based CRF research databases CTDM, CTMS and Clinical Medicine) within therapeutic area AERS) as stop-gap Lifecycle solutions Integration
  16. 16. DO YOU LEVERAGE YOUR INFORMATION ASSETS? ASSESSMENT OF INFORMATION MANAGEMENT MATURITY IN PHARMACEUTICAL R&D (2) DATA MINING AND ANALYTICS MATURITY P3 P4 P10 P5 P8 P11 P7 P6 P2 P9 P12 No data Some data mining and Data repository Information Enterprise mining and analytics capabilities, environment for Analytics Data Analytics analytics SAS in biostatistics, informatics and environment and capabilities. various loosely- analytics developed no longer InformationHeavy use of coupled informatics in discovery, specific to Workbench Excel tools implemented in preclinical and single withspreadsheets discovery, preclinical clinical. Analytic application customized mostly associated results still and databases. dashboards siloed applications application and Some and some signal database specific. dashboards detection in safety Siebel analytics capabilities reports CRM reach of frequency but not marketing analytics
  17. 17. DO YOU LEVERAGE YOUR INFORMATION ASSETS? ASSESSMENT OF INFORMATION MANAGEMENT MATURITY IN PHARMACEUTICAL R&D (3) INFORMATION ARCHITECTURE AND DELIVERY CAPABILITIES P3 P4 P10 P5 P8 P11 P7 P6 P2 P9 P12No information Information Siloed IT initiated Enterprise MDM Enterprise architecture architecture built integration based on initiatives about MDM delivered consideration. mostly based on SOA and portal. targets, on-demand.Ad-hoc queries vendor supplied Example: Discovery compounds, Well thought- as needed for standards. Siloed IT gene/compound products, out SOA in groups develop databases integrated customers, place and single with project suppliers and enterprise web application. SQL/database queries patients along Manual review strategies based on portfolios. Clinical services the R&D+M of multiple employee skillsets. data warehouses value chains. groups in queries to Information delivery being built to SOA and web place.answer a single via window/Mac/web integrate EDC, CDMS services Information question interfaces as needed based on industry adopted delivery based standards customized portal and access control
  18. 18. DO YOU LEVERAGE YOUR INFORMATION ASSETS? ASSESSMENT OF INFORMATION MANAGEMENT MATURITY IN PHARMACEUTICAL R&D (4) LEVERAGING EXTERNAL INFORMATION/COLLABORATION CAPABILITIES P3 P4 P10 P5 P8 P11 P7 P6 P2 P9 P12 No external Access external Third party project Fully leverage collaboration information via ftp, management tools industryand no need to internet and VPN chosen. R&D and standards ofaccess external eROOM, sharepoints, Clinical implemented information and document life cycle apply semantic information – stand alone EDC, strategies. webs and non existent large scale R&D and ontology clinical project Documentum and standards. management based other content External on MS projects and management tools information visios chosen for integrated on- information demand and archiving and based on regulatory business needs submissions
  19. 19. PHARMA SALES, MARKETING ANDMANAGED CARE • Business Challenges • Evolving Business Models • Information Management Opportunities
  20. 20. HARNESSING INFORMATION MANAGEMENTFOR PHARMACEUTICAL S&MBusiness Challenges Information Management Opportunities • Global IM approach provides better insights and added value • Emerging Market from core and emerging markets • Global shared services allow robust integration of data sources • Cost Containment and systems to drive efficiencies, support quality decisions and • Generic Market reduce costs • Consistent, and consolidated data improves performance • Specialty Products and measurement such as launch success rate, product Biologics penetration rate across regions, globally and therapeutics areas. • Managed Care • Integration of pharma, hospitals and payers data help realize • New Distribution Channels the vision of EBM • Integration of pharma, hospital, retails, PBM provide a more • Evidence based medicine intelligent, integrated market view across national market, and (EBM) alternative distribution channels • DTC/Online Marketing • Comprehensive dashboards drive optimal brand management at the global level and increase brand growth through • eDetailing performance measurement • Precision Medicine • Integration of marketing analytics allow for better measurement of effectiveness of DTC and online marketing • Consolidated reporting strategies reduce market research reporting costs,
  21. 21. REFERENCE ARCHITECTURE FRAMEWORK FOR A TYPICAL PHARMACEUTICAL SALES, MARKETING AND MANAGED CARE ORGANIZATION as influence field operations yields insights that drive strategy and direction as well Analysis performed on information from the field Decision Support and Analytics (Bus Intelligence/Scenario Planning/Predictive Analytics)Information from the field is captured, filtered upward,and used to make operational and strategic decisions Managed Markets Sales Territory Alignment/ Marketing Segmentation Formulary Strategy Management & Targeting Primary Market Research / Professional/Organization Key Account Management Incentive Compensation Expense Management Contract Management Campaign Management Literature Fulfillment Sample Management Competitive Intelligence Key Opinion Leader Speaker Programs Regulatory Compliance E-Channels Detailing Governance HEOR Master Data Management (Customer, Product, Organization) Data Warehousing/Information Management Infrastructure
  22. 22. UNDERSTAND ANALYTICAL NEEDS: WHAT BUSINESS QUESTIONS SALES AND MARKETING EXECUTIVES ASK LEAD TO DESIGN STRATEGY OF INFORMATION MANAGEMENT Entities • Addresses • Market HierarchyS&M Analytical Areas: Groupings of KBQs into Analytical Areas to facilitate needs • Affiliations • Patientanalysis. Analytical KBQ Areas • Brand Hierarchy • People (Employees, etc.) • Market Performance • What is segment script writing behavior by region, by brand, by geography? • Compound – The analysis of Client’s position in the marketplace These Analytical Areas volume? How do customers in various segments compare on scriptallow us to analyze • Physical Assets over time against competitors.• current challenges and issues associated with • Customers • Customer Segmentation • Which customers within a therapeutic classansweringmost per product robustly have the KBQ’s that are similar in (Individual/ Org) • Product – The analysis of Customer behavior using groupings with similar it? market share and what is ways such as: characteristics that allow Client to Whattheir communication • tailor is the brand adaptability by graduation date or specific school? and investments in an optimal fashion. • Data Capture. • Identifier • Product Hierarchy • Data not captured in Client How do we track segmentation of non-physician prescribers? systems • Sales Tracking and Analysis • consistently. May point to process, application What products have reached their saturation threshold with specific • Financial • Promotion – The analysis of Script behavior across Customers and or organization issues or data does not exist. customers both now and forecasted? associated Sales Force activity and effectiveness. • • practice and what are the demographics How many patients are in a doctors Data Integration • Healthcare Provider • Lifecycle Management Data exists across multiple systems, e.g. over time? KOLs kept on multiple lists. (HCP) – The analysis and between the drugs in various stages and Customer behaviors. • Which doctors influence the purchasing of which institutional entities for example, nursing homes? • Information Access • Event Analysis No direct access or Analytical tools available. • What is the retention time of a prescriber towards Client over time by – The analysis of the impact and effectiveness of Customer product? • Data Quality Event activities and other communication touchpoints. • Patient Outcome Analysis • Issues include sufficiency, completeness, How much does a customer cost to pursue and is there a significant accuracy. Product variance in this by segment or region? – The analysis of patient adherence to product • How do we utilize segments at the household level for a practice entity? prescription/regimen and the rate of outcome achieved. May include comparisons to results expected from relationship between patient adherence and customer script Other Vendor IMS • Is there a clinical trial systems. growth? If so, what is it? • Market Group • Who are the Key Opinion Leaders (KOL) by therapeutic area, by • Market • Market geography? • Which customers are most profitable by segment, by region? © Copyright 2007 HP • Subclass • Sub Market • How can the best segment based opportunities be identified? • Sub Market a • What is the lifetime value of a doctor? • Franchise • Sub Market b • What is the brand switching behavior of products by customer, by segment, by therapeutic class, by time, by geography? • Brand • Brand • How can Client distinguish between brand switching and new scripting habits • Strength when there are steep changes in market share (e.g. significant decrease • Product within a short time period)? • How does segmented customer level market share compare to competitors • Strength within a product class? 22 • Packaging
  23. 23. THE TYPICAL MASTER DATA ENVIRONMENT IN THE INDUSTRY IS DIVERSE. ATHOUGHTFUL APPROACH IS NEEDED TO RATIONALIZE MDM WHILE STILLMAINTAINING BUY-IN FROM USERS Illustrative Pharma Mastering Environment Customer Mastering Product Mastering Siebel SFA Customer Master Storage is in Visage. Production Hierarchy: Siebel Compact and slowly No history. Client In-house Developed System. IBM SAP ECC changing. WebSphere QualityStage for Customer List standardization and miscellaneous tools for matching. Client No true Product mastering Customer List IMS WKH process is in place External ??? Manual especially for competitor Data Resolution for and switching analysis IMS WKH more granular than Rejects External therapeutic class. Data Future Needs: Future Needs: Data vendor with competitor products. Their data may be sourced at a moreBelieved to drop • Internal Client Customer Lists, Medical granular level than today (today, at anCustomers for non- Affairs, KOLs, etc. aggregated and used at therapeutic class level).core products, even • Track affiliations e.g. nurses withcompetitor data. patients. • Data vendor Customer level. Geography/Territory Mastering Employee Mastering Contains • Lacks all Client In-house Developed System contractors not Reps in field. Siebel Custom in PeopleSoft. Siebel PeopleSoft • Alignments have • Manages Alignment hierarchies for different hierarchies e.g. for Specialty, General HR purposes. Siebel may both filter Custom Practitioner and Primary and transform CA • Geography: State, FSA, Alignment data. postal groups etc.
  24. 24. PHARMACEUTICAL SALES, MARKETING AND DISTRIBUTIONMODEL IS EVOLVING It was It is or will be•Large sales forces •Smaller sales force per geography•Captive sales forces •Fewer drugs in the bag, more targeted patient groups --•Product focused all are equally important•Broad detailing; often manual and push oriented •Contract sales forces that ramp up and down quickly•Primary product with multiple other products •Specialist and clinical scientists focused, fewer products to discuss, but deeper disease stage•Single or few channels for product or disease discussions information •Multiple channels/contact points; tiered contacts e.g.•Single relationship based MSLs, nurses, reps; Web, TV, wikis, physician and•One size fits all consumer portals, social media•Simple channels: Offices; educational seminars, •Disease management focused hospitals •Insight-led, Information based touchpoints e.g. knowing•Physician or influence individual focus outcomes and safety issues•Single company sales • Develop customer and prospect segmentation•Direct to Consumer (DTC) nascent strategies that enable effective differentiation and•Substantial sales force overhead time targeting of offerings. •Empowered managed care account manager for payer account management •eDetailing, pull oriented, physician pull •Collaborative sales; joint sales with multiple companies •Sophisticated DTC to all demographics •Reduced Rep overhead time
  25. 25. TO MEET EVOLVING BUSINESS NEEDS, INFORMATION MANAGEMENT MATURITY LEVEL WILL NEED TO BE INCREASED AS WELL Customer Centric View Patient Centric View 360 Degree of All Customers and Patients limited IM maturity Intermediate IM maturity Future IM Maturity• Start global • Integrated SFA and • Syndicated, global data • Support for flexible sales • Longitudinal patient mastering with CRM feeds hubs force structures as # centric predictive models local customer realignments increases. to predict outcomes • Start to develop • Simplified Information masters integrated architecture and • Establish new • Electronic medical• Start data quality marketing channels framework; standardized compensation plans records with integrated programs and consolidated. genomic profiles. • Start to develop • Automatic, integrated• Start integration eDetailing POCs • Physician spend data safety reporting with maps with integration with tight single point of data entry • Real-time S&M standard • Gather new linkages to ERP systems. (e.g. harmonized effectiveness and ROI definitions channel information vocabularies for clinical analytics • Limited real-time S&M• Start MDM to measure data) data. effectiveness. • Real-time analytics aids shared service • Implement integrated organizations • Larger amounts of diverse faster and frequent eDetailing data integration; data territory coverage fusion; unstructured and • Off-the-label activities remaps structured. completely automated • Integrated data mining and tracked assists in pharma- • Global master data management systems as a • Region based IM covigilance and exploit in value-add shared service. outcome based research • Highly centralized and standardized
  26. 26. PHARMACEUTICAL COMPANY IS CHANGING FASTER THAN BEFORE. MOST COMPANIESLACK THE INFORMATION MANAGEMENT (IM) INFRASTRUCTURE TO SUPPORT CHANGEAND ACCOMMODATE LOCAL COUNTRY NEEDS Illustrative Informatics Value Stack • Global platform and tools, local/regional • Standard tools typically used such as BO, Cognos. Other Customer and Patient implementation tools not proven globally, e.g. Siebel Analytics, embedded Analytics & Reporting • Master data and DI offers new analytic reporting apps. possibilities • Different lens created regionally, globally and different • Specialty data mining more outsourced. functional areas e.g. R&D and S&M. • Governance is local and regional, very few global • Programming labor outsourced.Data Integration, Quality • Quality rules are being standardized at local • Standard tools, may be some regional and Governance level, but local variations will remain • Volume demands different approach to infrastructure for • Good master data and reference maps speed-up global scalability data integrations • Different lens created for different groups is key • DI and DQ are implemented as shared services; functionality; forced standardization has not worked well success varies overall • S&M Transaction data is configured regionally • Local data services are offered due to local regulations Data • Master Data is implemented regionally and • Efforts underway to standardize data for global analytics, locally, some opportunities for global master primarily around disease data • Maintenance is outsourced, not the content/quality • Shared services model where possible (Master • Some definitions are being standardized Data, analytics data, external data), some regional and some global • Regionally centralized; master data hubs • Uniform hardware and software, few regional/local IT Infrastructure • Generally infrastructure not outsourced but variations changing • Apps and db maintenance often out-sourced. • Shared services oriented • Standard tools and platforms • Some applications may be offered in SAAS model for some countries
  27. 27. BRIDGING THE GAP BETWEEN PHARMACEUTICAL MANUFACTURERS AND HEALTHCARE PROVIDERS, PAYERS AND GOVERNMENT• Healthcare Economics and Outcome Research (HEOR)• Quality Index of Medical Care and Evidence based Medicine mandated by Center for Medicare and Medicaid and the Healthcare Reform Act• Pay for Performance Reimbursement Model by Healthcare Payers• Superior clinical benefits and longitudinal impact demanded by Healthcare Providers
  28. 28. PHARMACEUTICAL MANUFACTURING AND DRUG SUPPLY CHAIN• Manufacturing Process and Challenges• Drug Supply Chain Process and Challenges• Federal and State Pedigree Legislation• Information Management Opportunities
  29. 29. PHARMACEUTICAL MANUFACTURING (GMP) Pharmaceutical Technology Commercial Product Development Transfer Manufacturing Discontinuation Investigational Products cGMP Quality Assurance (QA) and Quality Control (QA) System Corrective Action/Preventive Action (CAPA) System Knowledge Management and Information Management 29
  30. 30. PHARMACEUTICAL SUPPLY CHAIN PROCESS Product Forward Reverse Shipments Returns / Recalls Returns / RecallsPharmaceutical Co Shipments Return Resale Returns Chargeback Shipments Returns / Recalls Credit Wholesaler Order Payment Order Payment Returns / Recalls Credit Pharmacy Payment Rebate PBM Financial Forward Reverse 30
  31. 31. PHARMACEUTICAL SUPPLY CHAIN CHALLENGES Counterfeiting / The level of pharmaceutical counterfeiting is approximately 5-10% of world trade. This represents a Product Diversion direct revenue loss of $24-$49B for the industry Several states (California, Florida,etc) have state Regulatory legislation on drug pedigree. Federal Government (FDA) is considering adoption of track & trace technologies. Compliance Customers are beginning to apply the technologies for product recalls Supply Chain Pharma experiences $2B in returns annually. The Management estimated typical percentage of a facility’s total monthly and Visibility Rx volume returned by customers is 4% for distributors and 2% for manufacturers. Improving Increasing FDA concern on contaminated or ineffective Quality of Care products. 60% of counterfeits did not contain any active ingredients; 19% contained a wrong dosage and 16% contained inappropriate agents. 31
  32. 32. INFORMATION MANAGEMENT OPPORTUNITIESManufacturer Wholesaler RetailProduction DC DC Chain DC Retail Store Pedigree Pedigree Pedigree Pedigree Drug ID Info Drug ID Info Drug Id Info Drug ID Info Manufacturer MFR Pedigree MFRPedigree Manufacturer Wholesaler Wholesaler Wholesaler Re-packaging Hospitals/Doctor’s Office Pedigree Pedigree Pedigree Pedigree Drug ID Info Drug ID Info Drug ID Info Drug ID Info Manufacturer Manufacturer MFR Pedigree MFR Pedigree Re-packaging MFR Pedigree MFR Pedigree Re-packaging Repacker TRACKING DRUG SUPPLY CHAIN DATA FLOW 32
  33. 33. PHARMACEUTICAL IT MANAGEMENT• CIO Challenges• Metrics that demonstrates aligns IT values to business priorities• IT Innovation Metrics that tied to biopharmceutical companies• Information Management Opportunities to help IT organization run like a business
  34. 34. CIOS FACE A BALANCING ACT: CONTAIN IT COSTS, DELIVER HIGHERQUALITY SERVICES AND APPLICATIONS AND LEAD INNOVATION IN AFAST-PACED BUSINESS ENVIRONMENT. Run IT ‘AS’ a business Run IT ‘FOR’ the business Speed Cost Quality Average IT operational spending growing at 3x other systems costs. $200 New server spending (USM$) 3% CAGR 30 minutes 5 seconds Trading analytics Cost of mgmt. & admin. 10% CAGR 20 minutes 30 seconds Airline operations $180 8 hours 10 seconds Call center inquiries $160 1 day 5 minutes Track financial position $140 1 day 15 minutes Supply chain updates $120 3 days 30 seconds Mail/ express/ fax/ e-mail $100 3 days 45 seconds Document transfer $80 3 days 3 minutes Phone activation $60 1 month 1 hour Refresh data warehouse $40 5 days 1 day Trade settlement $20 6 weeks 24 hours Build-to-order PC $0 10 7 10 6 10 5 10 4 1,000 100 10 1 Seconds ’96 ’97 98 ’99 ’00 ’01 ’02 ’03 ’04 ’05 ’06 ’07 ’08 Your Average IT Operational spending WW Spending (US$B) growing at 3x other systems costs
  35. 35. ILLUSTRATIVE METRICS: AN INTEGRATED SET IS NEEDED TO UNDERSTAND IT VALUE. IT Value Proposition Starts with: Objective Metrics Actual Target InitiativesIT Mission/Value – Optimize the return on IT – % of revenue spent on IT investment – % of IT budget spent on new 1.2% 15% 2% 50% – Value mgmt. program – Program mgmt. • Aligning IT objectives to – Contribute value to investments – IT opinion survey/satisfaction N/A 75% – Infrastructure 2007 relevant business units goals business processes ratingIT Customers – Optimize use of enterprise services – Infrastructure alignment index – Post-acceptance satisfaction 0.85 2.5 2.0 4.0 – Program mgmt. – Value mgmt. program • Developing metrics to track – Streamline business unit services score – Application alignment index 0.50 2.0 – Program mgmt. progressInternal ITProcesses – Technology migration – Establish value focus – % of facilities at company standards – % of projects coming through 75% 50% 95% 100% – Infrastructure 2007 – Value mgmt. program • Launching key IT initiatives to – Faster application dev. value process – On-time delivery 30% 90% – Infrastructure 2007 support those goalsEnabling – Improve moves, adds and – % of SLA requests to install met 70% 100% – Infrastructure 2007Technologies changes (MAC) – No. of versions installed at same N/A <3 – Infrastructure 2007 management time – No. of software releases and N/A max. 2 – Infrastructure 2007 dist. methods per platformIT – Leverage ESP – % of noncore positions 25% 95% – Infrastructure 2007Organizational – Attract and retain staff outsourcedEnablers with appropriate skills for – Attrition rate improvement -2% per 10% per – Employee development services offered year year program IT Value Proposition Targeted to Cost Containment Goals IT Value Proposition Oriented towards Innovation and Growth Objective Metrics Actual Target Initiatives Objective Metrics Actual Target InitiativesIT – Reduce IT Cost – % of reduction in CAPEX 1.5% 5% – 2006 “to the bone” IT – Support new sales – % of sales through new 9% 15% – Web/kiosk initiativeMission/Value – Maximize ESP – Cost of service comparison N/A +/- 8% – Vendor management Mission/Value channels channel Performance – Weighted % (by importance/ 75% 85% program – Improve time to market – % of project delivery on time N/A 90% – New products cost) of contractual and on budget program achievementIT Customers – Sustain appropriate cust. – IT opinion survey/satisfaction 3.25 3.5 – IT customer sat. IT Customers – Better customer business – No. of IT-driven improvement 2 10 per – Value management sat. levels through 2004 rating survey processes opportunities identified year program – Provide a secure IT – % of compliance to policy 80% 100% – Enterprise security – No. of identified opportunities 1 8 per – Value management environment – No. of monthly incidents 2 per <4 per program realized year program month month – Technology consolidation – No. of departmental servers 143 400 – 2006 “to the bone” Internal IT – Increase use of – % of projects using coll. tools 60% 90% – New productsInternal IT eliminated – Infrastructure 2007 Processes collaborative tools programProcesses – % of two-screen desks 9% 0% – Infrastructure 2007 – Contribute to business – % of projects with IT 70% 100% – Value management – Standardization of – Change in IT development N/A -5% – Infrastructure 2007 case development contribution development costs as proportion of total – Technology refresh – Time spent vs. planned N/A +/-5% – Value managementEnabling – Thin-client simplification – % of conversion of possible 45% 95% – Infrastructure 2007 Enabling – % of desktops >3 years old 25% <5% – Infrastructure 2007 Technologies – Reduce app. dev. time – % of new projects using RAD 20% 80% – Development 2006Technologies desktops methods – Personal – Better business – No. of bus. edu. forums N/A 10 per – Bus. education forumIT – Keep and attract staff – % of staff with important N/A <15% development program IT understanding yearOrganizational training needs not addressed – employee Organizational – Faster recruitment – Time to fill job requests 90 days 45 days – Employee dev. planEnablers – Improve hiring and – % of open requests unfilled in 15% 20% development plan Enablers – Provide integrated – % of staff with business 10% 75% – Personal dev. plan promotions >10 weeks – employee performance criteria initiative measures in review – No. of key positions with no 1 2 criteria successor ready in < 6 months development plan
  36. 36. INNOVATION METRICS ARE PARTICULARLY IMPORTANT TO PHARMACEUTICAL CIOAS MORE COMPANIES ARE FACING PATENT CLIFF AND REVENUE SHRINKAGEInnovation Number of New Lag A measure indicating the uptake of new technologies (such Percent measure. For a given time period, the number new development projects using "strategic technologies" (as defined), Technology Applications as RFID and so on, depending on the enterprises divided by the total number of new development projects, expressed as a percent requirement) Usually expressed as a proportion of projects underway, there is a definitional issue that must be resolved: to what extent does a new technology have to be part of the project before it can be counted? 1% of budget? 10% of budget...Innovation # Of patents and other Lead Measure of the level of innovation exercised by the IT group Value measure over time. Every time a patent is rewarded or an award is received, this measure is incremented by one and awards the date recordedInnovation % new projects using Lead An architectural target measure charting the adoption rate of Percent measure. For a given time period, the number projects using Rapid Application Development tools and approaches RAD Methods Rapid Application Development, an interactive prototyping (as defined), divided by the sum of projects using RAD tools plus projects not using RAD tools, expressed as a percent approach to application developmentInnovation % of new development Lead Measure of the degree to which IT budget can be directed Percent measure. For a given time period, the new development budget (for the month, for the quarter and year-to-date) budget for strategic into new - and strategic or high pay off - projects allocated to strategic projects (as defined), divided by the total new development budget for the same period projectsInnovation Average age of hardware Lead An aggregate measure of the age of hardware assets, Measure of age. For all assets, the sum of the number of days since each asset was first used (or purchased for unused usually divided into categories (mainframe, servers, assets), divided by the number of assets whose age is being counted, expressed in days, months or years, depending on the desktops). This measure is useful if demonstrating the asset type impending need to replace assets or for planning asset refresh cyclesInnovation Extent to which an Lead A measure that attempts to quantify the almost Percent measure. For a given period, during an employee satisfaction survey, the number of full-time equivalents giving a environment is in place unquantifable. The only meaningful way of applying this score of high and very high to the question regarding This is a place that encourages innovation" , divided by the total number which encourages measure is to seek the opinion of a competent authority and of full-time-employees completing the survey innovation use this opinion to show the degree to which the environment encourages innovationInnovation Knowledge Sharing & Lead A (qualitative) measure of knowledge sharing - usually a Year to date measure. The total number of "learning events" held Learning Events Held survey or surrogate measure such as documents referenced or designs reused - scaled by the number of learning events: meetings, teleconferences and so on, to gauge how effective these learning events areInnovation Level of activity in Lead A measure that attempts to quantify how much innovation is Percent measure. For a given time period, the new development budget (for the month, for the quarter and year-to-date) innovation work. taking place. Since this is a notoriously difficult factor to allocated to strategic projects (as defined), divided by the total new development budget for the same period manage, surrogate measures are usual: number of patents, number of invitations to speak at conferences, number of publications in peer reviewed journals.Innovation Percentage of effort on Lag Effort normally gets split between Maintenance, Percent measure. Cumulative Project Workdays spent on new projects, divided by the Total number of workdays available, new projects Enhancement, operations and new projects. Infrastructure, expressed as a percentage M&E spending is largely non-discretionary and mostly not value creating in the same way as new projects are. The significance of this measure the larger the proportion I&M&E spending is of the IT budget, the less proportionately there is for new projects.