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Amgen IS and POQ IS Overview Keith Brown June 2006

Amgen IS and POQ IS Overview Keith Brown June 2006. 2006 POQ IS Key Messages “Every Patient, Every Time”. Critical focus areas requiring IS leadership Aggressive action on single points of failure in IS infrastructure, processes, and systems to sustain our manufacturing network

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Amgen IS and POQ IS Overview Keith Brown June 2006

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  1. Amgen IS and POQ IS OverviewKeith BrownJune 2006

  2. 2006 POQ IS Key Messages“Every Patient, Every Time” Critical focus areas requiring IS leadership • Aggressive action on single points of failure in IS infrastructure, processes, and systems to sustain our manufacturing network • Establishing sustained governance and roadmaps for business processes • Proactive integration of IS and automation system on all manufacturing expansion projects • Deployment of key functional business processes in POQ prior to ERP • Prepare POQ business functions for ERP implementation

  3. Agenda • Amgen IS Framework and Strategy • Amgen IS Goals and Roadmaps • Amgen IS Organization • POQ IS Accomplishments and Projects

  4. Amgen Operating Framework Mission, Aspiration, Values, Strategy, and Goals

  5. Amgen Strategy Our aspiration is to become the best human therapeutics company • Focus solely on the human therapeutics business • Invest heavily in the pipeline to prepare for the future • Pursue primarily organic growth supplemented by investments in and partnerships with biotechnology companies • Pursue multiple therapeutic modalities in our current therapeutic areas and expand our therapeutic area footprint opportunistically We will strive to consistently achieve operational and financial excellence • Focus our operations geographically in the US and EU, and pursue organic growth in Japan • Optimize our operational locations, capacity, and processes • Become the leading franchise in every therapeutic area we commercially serve • Effectively create and tenaciously defend our intellectual property • Put our patients first • Foster a high-performing, motivated, diverse workforce grounded in our values • Provide growth opportunities for and reward staff based on impact, consistent with our values • Remain independent by delivering superior value to shareholders We will preserve and enhance our patient focused, value-based organization

  6. Amgen Strategy and Goals DriveInformation Systems’ Strategy • Intellectual capital is the dominant competitive advantage • Manage data assets • Transform data to information to knowledge • Amgen is a single integrated business unit • Support sharing and integration both across the company and with partners • Effective business operations allow us to devote more resources where it makes a difference • Support effective cross-functional business process • Operate an effective and cost-efficient operation

  7. Focus Areas for the Next Three to Five YearsMeet Local Needs While Optimizing Amgen • Reveal common behaviors, relationships, & synergies • Enable prediction, optimization, design, control, & scaling Info Science & Applied Mathematics Establish &Support BusinessProcesses • Laboratory operations • Commercial practices • Contracts & reimbursement • Data stewardship • ERP • COTS systems consistent with our architecture & strategic direction • Integrate using our services-based organization & framework Provide ApplicationServices Provide the Information Utility • Secure, reliable, & manageable infrastructure • Common processes, services, & objects • Multi-dimensional people • RUP by 2007 • Change Control by 2006 • Leverage common capabilities IS People, Processes, & Policies

  8. Manage Amgen’s Intellectual CapitalTransform Data to Information to Insight Modelingand ScenarioPlanning “What if” analysis Analysisand DecisionSupport Reporting and dashboards;filtering and clustering DataCapture andOrganization Extract electronic information from multiple sources. Structure to facilitate access and analysis.

  9. Enable a Single, Integrated Business UnitThrough Shared Processes and DataEnabling the Commercialization Process Develop Discover Manufacture Sell Output Patents Publications NDA Clinical Protocol Registration Filing Package Insert Adverse Events Report ProductInformation Med Ed Clinical Supply Product Input Raw Material Supplies Data Enterprise solutions, local delivery

  10. Information Systems StrategyManaging Amgen’s Data Assets • People are the foundation of our success • Highly competent, multidimensional people • Effective structure and process • Provide the information utility • Ubiquitous, cost-effective, a competitive business • Over time services must migrate into the utility • Enable effective business processes • Articulate and deliver solutions that are commensurate with measurable business results • Demonstrate how local processes are a component of an Amgen operation; “systems approach” • Enable sharing of common data and processes • Modify the business process rather than the software • Accelerate understanding of systems and data

  11. Amgen Information Systems Organization DesignIS Integrates Across the Business and Across IS; Meeting Local Needs While Optimizing Amgen Client-facing IS Organizations Amgen Client Organizations The Customer Shared IS Capabilities Enterprise Customer Services Enterprise Shared Infrastructure Enterprise Program Management Informatics Architecture Regulated Systems People, Process,& Policies Research IS Research & Preclinical Development Development IS Development Patients GCO IS Global Commercial Operations POQ IS Process Devel, Operations, Quality Business IS HR, Finance, Legal The IS supply chain starts and ends with the business

  12. 2010 IS ArchitectureEnabling Cross-functional Results ThroughShared Data and Common Services Access Services Portal Reporting/Dashboard Web Services Functional Services Research Clinical Dev POQ GCO Finance HR Legal Management Security ESB (Enterprise Service Bus) Enterprise Services ERP Analytics ETL,Cleansing Shared Objects Workflow DataMarts B2B, EDI LMS EDM Infrastructure Svcs IDManagement DesktopComputing CollaborationServices DataManagement ComputingFacilities Networks Functional Build Functional Buy Enterprise Services ERP

  13. 2010 POQ IS ArchitectureMature COTS; Enable Scale and Compliance Access Services Portal Reporting/Dashboard Web Services Functional Services Management Security ESB (Enterprise Service Bus) Functional Build Functional Buy Enterprise Services ERP Clin Dev Process Development, Operations, Quality Rsch GCO Fin HR Legal • Recipes/Specifications Development • Manufacturing Execution • Samples & Result Data Management • Preventive Maintenance • Quality Tracking • POQ Metrics • Process Development Analysis • Learning Management • Document Collaboration • Quality Document Management • Supply Chain Planning • Production Planning • Material & Inventory Management • Product Routing • Quality Assurance • Product Shipping

  14. 2010 POQ IS (Platforms) Access Services Portal Reporting/Dashboard Web Services Functional Services Management Security ESB (Enterprise Service Bus) Functional Build Functional Buy Enterprise Services ERP Clin Dev Process Development, Operations, Quality Rsch GCO Fin HR Legal • Recipes/Specifications Development (Livelink -> Documentum) • Manufacturing Execution (Paper -> Werum) • Samples & Result Data Management (SQL*LIMS -> SampleManager) • Preventive Maintenance (Maximo) • Quality Tracking (Trackwise) • POQ Metrics (Cognos) • Process Development Analysis (Cognos) • Learning Management (SumTotal) • Document Collaboration (Paper -> Documentum) • Quality Document Management (Livelink -> Documentum) • Supply Chain Planning (Excel -> SAP) • Production Planning (JDE -> SAP) • Material & Inventory Management (JDE -> SAP) • Product Routing (JDE -> SAP) • Quality Assurance (JDE -> SAP) • Product Shipping (JDE -> SAP)

  15. Week Day Global Business Process Information Network Hour Minute Second Within a Plant The ANSI /ISA S95 Architecture model to develop a comprehensive & complete framework

  16. POQ IS architecture: Right info for the right people at the right time ISA95 Level 4 Enterprise Res. Planning (ERP) Product Lifecycle Mgmt Business Intelligence • Plan to Ship • Supply Chain Planning • Production Planning • Mat’l and Inventory Mgmt • Routing Mgmt • Quality Assurance • Shipping • Master Data Mgmt • Requisition to Pay • Order to Cash • Financials Mgmt • HR Mgmt • Capacity and Projects Mgmt Deviation & Change Mgmt (QMTS, CCMS) Document Mgmt (EDM) Learning Mgmt (LMS) ISA95 Level 3 • Manufacturing Execution(MES) • Production Finite • Scheduling • Process Monitoring • Recipe Management • Production Coordination Laboratory Info Mgmt (LIMS) • Mfg Process Data & Analysis (Process DW) • Process Modeling & Optimization • Electronic Batch Record • Data Historian • Trending / SPC Management Security ESB (Enterprise Service Bus for Application Integration) • Batch Result Recording • Equipment Management • Material Flow Control • Weigh & Dispensing • WIP tracking Enterprise Asset Mgmt (CMMS) ISA95 Level 2/1 Process Control Systems (DCS, PCS) Environment & Building Monitoring (EMS, BMS) Chromatographic Data Systems (CDS)

  17. POQ IS Design Principles • A manufacturing site is the fundamental element of POQ • When a site has people, material and equipment it must be able to make product • Company business information systems must support Enterprise business processes (L4) • Reliability & consistency are primary business drivers • Site information & control systems must support site production capability (L3) • Resiliency (fault tolerance) & risk management are primary business drivers • Company business systems & site systems are connected asynchronously • Adoption of S95 as the primary systems integration framework and use of market leading COTS are critical success factors • Amgen is not in the software development or integration business • Use COTS for their intended and demonstrated use within the framework • Vendor commitment to the life science industry and long term position are critical • Manufacturing process simplification, data integration with information & control architecture simplicity is the objective • Business needs must drive information & control solutions (level of Automation, Sequence of implementation) • Data & functional integration is our primary target, not functionality itself • Limit the number of solution providers

  18. Information Systems 2006 Priorities Are Aligned With Functional Priorities; Focused on Scalability • Integrated BiologicalMaterials Mgmt • Cross-functional,GxP Compliant Sys • Global AnalyticalData Integration • Core TA Systems • Core CBSS Systems • Sustain Supply • Expansion Projects • Automation Sys • Lab Management • Contract Mfg • Quality Systems • Data Analysis • “Filing” Capability • Dev Phase Pipeline • Geographic Growth • Forecast Capacity • Patient Safety • Strategic KOL Mgmt • Reimbursement Payor • Government Pricing • Medicaid Claims • Health Care Compliance • Global Gov Affairs • Prepare for AMG 162 & Panitumumab Launch Clinical Development Global Commercial Operations Research POQ Business Operations • Human Capital Implementation • SAP to Non-SAP Integration • Contracts Mgmt Expansion • Records Retention Program • Link Contract Mgmt to Financial Sys • Litigation Support • Corporate Compliance Support Shared Services • SAP Implementation • Learning Mgmt – POQ • B2B & Collaboration • Change/Config/Asset Mgmt • Regulated Systems • Global EDM Deployment • Collaboration Capabilities • Risk Mitigation • Messaging/Desktop Upgrade • Site Additions/Expansions • Common Compliance Processes • Network (WAN) & Telephony Upgrade People & Competencies – IS Competencies • PMO • IS Business Ops Council

  19. Agenda • Amgen IS Framework and Strategy • Amgen IS Goals and Roadmaps • Amgen IS Organization • POQ IS Accomplishments and Projects • ERP Program Overview

  20. 2006 Amgen Goals

  21. 2006 Amgen IS Goals

  22. 2006 POQ Goals tie to Corporate Goals Specific Goal Score Owner POQ Goals Corporate Goals

  23. POQ IS 2006 GoalsAligned with POQ Business Goals

  24. POQ IS Goal: Eliminate Single Points of FailureEach of these areas have identified actions • Server operations • Server spares, maintenance contracts • Backup and Recovery • Daily off sites (complete) • Improve approach (e.g. 53 hours to restore from large tape) • Service Desk • Call routing, prioritization • Application Support across time zones, 7 x 24 • On call processes, notifications, rotation • Network segmentation • Protect lab and plant systems from business network events • IS root cause analysis, NC/CAPA • Problem mgmt used too sparingly, additional follow through • Disaster Recovery • ATO failover, ACO DR, and contracted DR sites

  25. 2006 Amgen IS:Enterprise Shared Services Goals • Develop and implement Infrastructure upgrades • WAN – ATM/FR network with MPLS • Network segmentation • Global telephone dialing plan and voice mail • Upgrade EDM for global use • Develop tiered storage strategy • Improve collaboration environment • Implement standard conference configuration • Implement AVTC • Improve desktop sharing • Complete application remediation for identity management • Implement phase 1 of PKI • Messaging/Desktop 2003 • Re-architect and upgrade entire messaging backend • Upgrade all desktops in the enterprise • Develop high performance computing strategy • Develop and implement strategy and roadmap for shared objects with explicit definition including ERP subset

  26. Today, POQ information needs are often supported by unique local applications

  27. In future, POQ information needs will be met with scalable common applications

  28. POQ IS RoadmapEnabling Scale While Improving Quality and Reliability FinishKey Verticals Rollout ERP FullyDeploy MES Capability 2006 2007 2008 2009 2010 Provide On-time, Integrated & Global Operations Information Establish Data Analysis & Metrics Dashboard Implement POQ Commercialization Product Lifecycle Mgmt Improve Existing Systems Reliability Implement ERP Scale Common and Effective Global Systems Complete Rollout of Key Apps (LIMS, EDM, LMS, Weigh/Dispense) Retire Legacy Applications Design Automation Into New Plants; Improve Existing Plant Systems; Fully Deploy MES Enhance Plant Automation & Data Sharing Standardize & Integrate Key Shared Data

  29. POQIS RoadmapMajor Rollouts 2006 2007 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 POQ Global ACM ACO AML ARI ATO AWA ELC ERP APO, HR, ELC POQ NA Plants EDM AWA ACO ARI ATO AML ELC LMS ELC AWA ARI ATO ACO AML AWA QAL LIMS ATO ACO LIMS PD LIMS AML AWA Weigh & Dispense Mfg Data Mgmt ARI W/D ACO ATO AML ACO (AMPS Replacement) AML ATO Pilot Plant (B30, B23?) AWA CMMS MAXIMO5.2 ELC

  30. 2006 2007 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 GO GO GO GO GO GO POQIS AML Roadmap — Major Rollouts ERP POQ NA Plants APO, HR, ELC AMOS(2008) CoreDB, etc EDM Quality Ver 1.1 AML Version 6.5 Configuration LMS AML LIMS AML?? Weigh Dispense Mfg Data AML PI Improvements CMMS CMMS2.0 CMMS2.1 Feasibility POQ Global ACM ACO AML ARI ATO AWA ELC Go-Live EBR AWA Pilot Plant

  31. Example: AWA Systems Roadmap 2006 2007 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 POQ Metrics 3.0 POQ Metrics 2.0 TR TR TR TR TR GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO WS WS WS WS WS WS WS HR Quality 1.1 Quality 1.2 Auditing LMS Pilot Plant EBR PI PI Alignment TR Media Buffer LIMS CDS PDW LIMS LIMS EH&S Mgmt Sys CMMS CMMS CMMS R2 Workshop Training Go-Live

  32. ECS Will Continue to Drive Its StrategyOver the Next Twenty Four Months Submissions DM e-CTD Eliminate Single Points of Failure Vista (ACE 2.0) Launch (new systems) Retire Livelink Endeavor Doc Records Retention Self-serve Vista Upgrades Available Promotional Materials Retire LiveLink GMP Distributed PortalInfrastructure Global Architecture Office Upgrade Launch Office Upgrade Pilot LMS Enterprise Enhancements Vista (ACE 2.0) App Testing Service Pack Upgrade UsabilityImprovements Clinical Trials Formal SLAs POQ Deploy 1, 2, 3 Quality 1.0.2 POQ Deploy 4,5,6 CommunityRemediation SMS 4.0 Upgrade PT 6.0 Eval HR Go Live SAP Integration ESS / MSS Pilot IM Launch Teams 1.1 Retire OnTrack GRA 3.0 Upgrade WebEx Launch LMS 8.0 PT 6.0 GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO GO 2007 2006 Q2 Q3 Q4 Q1 Q2 Q1 Q3 Q4 Q4

  33. Agenda • Amgen IS Framework and Strategy • Amgen IS Goals and Roadmaps • Amgen IS Organization • POQ IS Accomplishments and Projects

  34. Amgen Information Systems Organization DesignIS Integrates Across the Business and Across IS; Meeting Local Needs While Optimizing Amgen Client-facing IS Organizations Amgen Client Organizations The Customer Shared IS Capabilities Enterprise Customer Services Enterprise Shared Infrastructure Enterprise Program Management Informatics Architecture Regulated Systems People, Process,& Policies Research IS Research & Preclinical Development Development IS Development Patients GCO IS Global Commercial Operations POQ IS Process Devel, Operations, Quality Business IS HR, Finance, Legal The IS supply chain starts and ends with the business

  35. IS Leadership Team (ISLT) Diana McKenzie Sr Director, Development IS BS Computer Technology, Purdue Yrs at Amgen: 1.5 Yrs Experience: 18+ Radboud Wijnen Sr Director, Europe IS BS Informatics Enschede BBA, Newport Univ Yrs at Amgen: 5 Yrs Experience: 18+ • Michael Hughes • Sr Director, GCO IS • MS Industrial & Systems Eng, USC • MBA Information Systems, USC • BS Industrial Eng, System EngConcentration • Yrs at Amgen: 8 • Yrs Experience: 27+ Client-facing David Balaban VP, Research Informatics BA, MA, PhD Applied Math, UC Berkeley Yrs at Amgen: 2 Yrs Experience: 30+ Keith Brown Sr Director, POQ IS & Regulated IS BS Computer Science, NC State Univ Yrs at Amgen: 2 Yrs Experience: 20+ Allan Doe Sr Director, Business IS (BIS) MBA Finance, Babson College BA Political Science, Univ of Alabama Yrs at Amgen: 3 Yrs Experience: 30+

  36. IS Leadership Team (ISLT) Common Services Global ERP Samir Abed Sr Director, Enterprise Security & Architecture MBA, Duke BS Electrical Engineering, Bucknell Yrs at Amgen: 2 Yrs Experience: 25+ Gloria Samuels Sr Director, Global ERPSystems and Tech BS MIS & Marketing, SUNY Yrs at Amgen: 2 Yrs Experience: 20+ Tom Flanagan VP, Bus Transformation Officer MS, Massachusetts Inst of Tech BS, US Naval Academy Yrs at Amgen: 1.5 Yrs Experience: 30+ Allan Doe Sr Director, Enterprise Customer Services (ECS)MBA Finance, Babson College BA Political Science, Univ of Alabama Yrs at Amgen: 3 Yrs Experience: 30+ Ole Mikkelsen Sr Director, Enterprise Shared Infrastructure (ESI) MBA Finance, UCLA BA International Economics, UCLA Yrs at Amgen: 11.5 Yrs Experience: 20+

  37. Operations Dennis Fenton IS Support By Keith Brown's Team Facilities & Eng. Process Development Manufacturing Business Intelligence Shared Services Quality Rob Westberg Geoff Slaff Fabrizio Bonanni POQ IS POQ IS Dave Tillett IS Support By IS Support By IS Support By IS Support By IS Support By IS Support By John Scott's Team Denis Zerr's Team Pam May's Team Vikram Jhala's Team John Scott's Team Ed Maliski's Team Corporate Engineering EH&S Supply Chain IS Support for IS Support for POQ PD IS POQ PD IS Andy Skibo Joe Halcomb Laurel Junk (Ed Maliski's Team) (Ed Maliski's Team) IS Support By IS Support By IS Support By Denis Zerr's Team John Scott's Team John Scott's Team IS Support for IS Support for POQ Manufacturing IS POQ Manufacturing IS (Denis Zerr's Team) (Denis Zerr's Team) Operations Planning Bob Baltera IS Support for IS Support for POQ Ops & Quality IS POQ Ops & Quality IS IS Support By (John Scott's Team) (John Scott's Team) John Scott's Team ATO ACO ARI AML AWA IS Support By IS Support By IS Support By IS Support By IS Support By Robert McInerney's Team Cole Gauger's Team John Bent's Team Justo Moreno's Team Lisa Brown’s Team Amgen Information Systems Organization DesignPOQ IS Aligns With and Integrates Across POQ Shared Services Corp. Client Teams Site Teams

  38. POQ IS Leadership TeamHalf the Team Is New in 2005 • John Scott • Director, Operations & Quality • MBA Campbell Univ • BS Computer Info Systems, E Carolina Univ • Yrs at Amgen: <1 • Yrs Experience: 21 • Denis Zerr • Director, Manufacturing • MA Info Systems, Inst Natl of Telecom (Paris, France) • MBA, Paris Dauphine France • Yrs at Amgen: <1 • Yrs Experience: 17 • Vikram Jhala • Assoc Dir, Shared Services • MBA MIS, Cal Lutheran Univ • BS Electronics & Communication;Karnataka Univ, India • Yrs at Amgen: 14 • Yrs Experience: 29 • Ed Maliski • Assoc Dir, Corp Quality • PhD Chemistry, Univ of Portsmouth  • Yrs at Amgen: 6 • Yrs Experience: 25 • Jamie Kiguchi • Assoc Dir, Regulated IS • BS Computer Science • BA Experimental Psych • Yrs at Amgen: 11 • Yrs Experience: 21 • Pam May • Assoc Dir, Business Intelligence • BS, E Carolina Univ   • MS Information Mgmt, Marymount Univ • Years at Amgen: <1 • Years Experience: 15

  39. POQ IS Site HeadsThink Globally, Act Locally • Robert McInerney • Sr Manager, ATO IS • BS Computer Science, So. Illinois Univ. • BS Business Management, Cal. Lutheran Univ. • Yrs at Amgen: 3 • Years Experience: 15 John Bent Director, ARI IS • MBA Intl Economics, Univ of Detroit • BS Business Mgmt, Northeastern Univ • Yrs at Amgen: 7 • Yrs Experience: 30+ • Lisa Brown • Assoc Dir, AWA IS • MS, PhD Biophys Sci, Univ of Minnesota • BS Elec Eng, So Illinois Univ, Edwardsville • Yrs at Amgen: 8.5 (Immunex/Amgen) • Yrs Experience: 20+ Justo Moreno Assoc Dir, AML IS • B Business Admin. , Univ. of Puerto Rico • Accounting Major, IS Minor • Yrs at Amgen: <1 • Yrs Experience: 26 Cole Gauger Assoc Dir, ACO IS • MBA, Anderson School at UCLA • BA Biochemistry, UCSB • Yrs at Amgen: 19 • Yrs Experience: 19

  40. POQ IS – Operations & Quality

  41. Process Development IS

  42. Manufacturing Information Systems Provides IS services supporting Amgen Contract Manufacturing. Executes projects in existing facilities regarding MES and automation. Manages interface development between L3L4 systems and interface development between L3L2 systems. Same as MIS Projects role but for new capital construction. Provides vendor management & internal project consulting regarding key Amgen platforms. Develops & applies MIS data & analysis tools supporting shop floor execution.

  43. POQ IS Shared Services

  44. ACO IS (Dept. 2710)

  45. ARI IS Org

  46. ATO POQ IS

  47. Regulated IS Staff

  48. Agenda • Amgen IS Framework and Strategy • Amgen IS Goals and Roadmaps • Amgen IS Organization • POQ IS Accomplishments and Projects

  49. 2005 POQ IS Accomplishments:POQ Operations & Quality • POQ • Deployed EDM Teams (Endeavor Migration and Retirement) • Implemented manufacturing metrics dashboard (AMDB) • Operations Planning • POQ Training & Development GMP Assessment of Amgen LMS • POQ IS Assessment of POQ LMS platforms (IsoTrain(s), 4D) • resulting in agreement for 2006 project “POQ on Amgen LMS” • Environmental Health and Safety • Initial client alignment and business system assessment • EH&S Assessment of ERP-SAP • resulting in agreement of SAP EH&S selected for ERP Phase2 • resulting in agreement for 2006 “interim” projects

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