James Chi & Jeff Clark - Grom Associates, Inc.                                          Ed Sullivan - EnteGreat, Inc.     ...
Key Learning Points                    Understand the business drivers for                    rapid commercialization in l...
Agenda                    Introduction                    Business Context and Success                    Strategies for R...
Company Overviews                                    GROM                                                                 ...
Rapid Commercialization               Business ContextReal Experience.Real Advantage. •                    Copyright © 200...
The Pharmaceutical Industry is Under a Great  Deal of Pressure         The pharmaceutical environment is becoming more and...
For Pharmaceutical R&D, These are Bittersweet    TimesCreating Safe and Effective New Medicines  The Potential Has Never B...
For Pharmaceutical R&D, These are Bittersweet  Times (Continued)Real Experience.Real Advantage. •                    Copyr...
For Pharmaceutical R&D, These are Bittersweet  Times (Continued)                                                          ...
Big Pharmaceutical Companies Are Undergoing     Significant Changes to Adapt                                           Sam...
Rapid Development & Commercialization   Bottom Line Contributions “…Drugs developed by thefastest companies enjoyed asmuch...
Rapid Development & Commercialization  Bottom Line Contributions (Continued) “…A one-day advantagetypically saves $37,000 ...
Rapid Commercialization                 Solution OverviewReal Experience.Real Advantage. •                    Copyright © ...
GROM Solution Portfolio for Life Sciences                                    Marketing &                                  ...
Solution Overview – Rapid CommercializationSolution                                                              Rapid Com...
Solutions Featured in Today’s Presentation                                                         Integrated Portfolio an...
Solution Review:     Integrated Portfolio and   Project Management (IPPM)Real Experience.Real Advantage. •                ...
Portfolio And Project Management:  Why This Is An Important Topic     Tufts CSDD Outlook 2007 Report on Globalization & Ou...
Portfolio And Project Management   Competitive Advantages To be Gained According to a benchmarkconducted by the AberdeenGr...
Portfolio And Project Management  Needed Capabilities and Enablers                   Before a company can expect the full ...
Integrated Portfolio & Project Mgt.    Solution Roadmap                       IPPM                      Maturity          ...
Project System Solution for R&D  Integrated Business Processes                    Standardized R&D project WBS template   ...
Pre-Configured R&D Project System Solution                    Pre-defined R&D project WBS template                    Inte...
Solution Review:                          Rapid Compliant                         CommercializationReal Experience.Real Ad...
Rapid Compliant Commercialization  Overall Business Objective• Shorten the time and reduce the cost to move from clinical ...
Rapid Compliant Commercialization  Capability Requirements           According to a cross-industry analysis performed by t...
Rapid Compliant Commercialization  The Business Benefits are Quantifiable             Areas of Average Business Improvemen...
Rapid Compliant Commercialization    Solution Roadmap              Program Maturity                 & Coverage            ...
Rapid Compliant Commercialization  Solution Architecture Overview            mySAP PLM                                    ...
Rapid Compliant Commercialization  Conceptual Architecture            mySAP PLM                                           ...
Rapid Compliant Commercialization  Conceptual Architecture            mySAP PLM                                           ...
Rapid Compliant Commercialization  Solution Architecture                                                                  ...
What is EnteGreat’s                                                                                   ?   Simply stated…  ...
Accelerated Solution for Rapid Compliant   Commercialization – Benefits of using CMF®By using the same Compliant Manufactu...
Schedule Acceleration: The                                                                                     AdvantageTy...
Schedule Acceleration: The                                                                                     AdvantageTy...
Schedule Acceleration: The                                                                                           Advan...
Rapid Compliant Commercialization  Business Benefits           Improved New Product Development & Introduction            ...
Questions                    We’ll gladly take additional questions                            after today’s session.     ...
Thank you for participating                                                                                         Please...
Supplementary Reference              Materials:      Pre-Configured PS Solution              In DetailsReal Experience.Rea...
Project System Solution for R&D  Integrated Business Processes                    Standardized R&D project WBS template   ...
Project System Solution for R&D  Integrated Business Processes                    Standardized R&D project WBS template   ...
Pre-Configured PS Solution for R&D  Standardized R&D Project WBS TemplateReal Experience.Real Advantage. •                ...
Pre-Configured PS Solution for R&D  Standardized R&D Project WBS Template                                                 ...
Pre-Configured PS Solution for R&D  Standardized R&D Project WBS Template    Tabular View                                 ...
Pre-Configured PS Solution for R&D  Progress Analysis Report                                                      Actual  ...
Pre-Configured PS Solution for R&D  Progress Analysis Report – Export to ExcelReal Experience.Real Advantage. •           ...
Project System Solution for R&D  Integrated Business Processes                    Standardized R&D project WBS template   ...
Pre-Configured PS Solution for R&D  Labor Activity Processing  Labor Assignment & Planning                                ...
Pre-Configured PS Solution for R&D  Labor Activity Processing  Time Entry Through CATS                        Actual Work ...
Pre-Configured PS Solution for R&D  Labor Activity Processing  Time Entry Approval    Approved Work HoursReal Experience.R...
Pre-Configured PS Solution for R&D   Labor Activity Processing   Booking of Actual Labor Hours to ProjectApproved Work Hou...
Pre-Configured PS Solution for R&D  Labor Activity Processing  Plan vs Actual Labor Hour & Cost Reporting                 ...
Project System Solution for R&D  Integrated Business Processes                    Standardized R&D project WBS template   ...
Experimental Manufacturing Activity Processing  BOM Assigned To Project Activity                                          ...
Experimental Manufacturing Activity Processing  Planned Order to Process Order Conversion                                 ...
Experimental Manufacturing Activity Processing  Assignment of WBS Number to Process Order                                 ...
Project System Solution for R&D  Integrated Business Processes                    Standardized R&D project WBS template   ...
Consumption & Procurement Activity Processing  Material Planning                                                          ...
Consumption & Procurement Activity Processing  Material ConsumptionReal Experience.Real Advantage. •                    Co...
Consumption & Procurement Activity Processing  Booking of Material Costs to Project                                       ...
Consumption & Procurement Activity Processing      Planned vs Actual Material Cost Analysis      Across Projects          ...
Consumption & Procurement Activity Processing  External Service Order Planning                                            ...
Consumption & Procurement Activity Processing  Service Acceptance Through Entry SheetsReal Experience.Real Advantage. •   ...
Consumption & Procurement Activity Processing  Booking of External Services to Project                                    ...
Consumption & Procurement Activity Processing  External Services Analysis                                                 ...
Project System Solution for R&D  Integrated Business Processes                    Standardized R&D project WBS template   ...
Document Processing  With e-Signature Approval                                                                            ...
Document Processing  With e-Signature Approval                                                                            ...
Project System Solution for R&D  Integrated Business Processes                    Standardized R&D project WBS template   ...
Cost Allocation  Manual Cost Apportionment to Project                                                                     ...
Cost Allocation  Booking of Apportioned Costs to Project                                                                  ...
Project System Solution for R&D  Integrated Business Processes                    Standardized R&D project WBS template   ...
Financial Analysis  Planned vs Actual Costs Analysis  Hierarchical View                                                   ...
Financial Analysis  Planned vs Actual Costs Analysis  Cost Element View                                                   ...
Project System Solution for R&D  Integrated Business Processes                    Standardized R&D project WBS template   ...
Budget Control  Allocation of Budget to Project  WBS Element View                                                         ...
Budget Control  Allocation of Budget to Project  Fiscal Period View                                                       ...
Budget Control  Message When Budget is Exceeded                                                                           ...
Budget Control  Budget vs Actual Cost Analysis                                                                            ...
Project System Solution for R&D  Integrated Business Processes                    Standardized R&D project WBS template   ...
Capacity Evaluation & Leveling  Resource Capacity Analysis                                                                ...
Upcoming SlideShare
Loading in …5
×

Session 4400 - Rapid Commercialization Strategies For Pharmaceutical And Biotech Companies - Presentation

2,821 views

Published on

0 Comments
2 Likes
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
2,821
On SlideShare
0
From Embeds
0
Number of Embeds
12
Actions
Shares
0
Downloads
162
Comments
0
Likes
2
Embeds 0
No embeds

No notes for slide

Session 4400 - Rapid Commercialization Strategies For Pharmaceutical And Biotech Companies - Presentation

  1. 1. James Chi & Jeff Clark - Grom Associates, Inc. Ed Sullivan - EnteGreat, Inc. Rapid Commercialization Strategies for Pharmaceutical and Biotech Companies[ DENISE MISSONAK SAP POINT OF CONTACT MEMBER SINCE: 1998 [ CHUCK WEBBER ASUG INSTALLATION MEMBER MEMBER SINCE:2008 [ MALCOM POULIN ASUG ASSOCIATE MEMBER MEMBER SINCE:1998
  2. 2. Key Learning Points Understand the business drivers for rapid commercialization in life science Understand the benefits which rapid commercialization provides for life science companies Develop insight into the challenges of achieving rapid commercialization Understand the proven pre-configured solutions which Grom and Entegreat have built to accelerate rapid commercializationReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  3. 3. Agenda Introduction Business Context and Success Strategies for R&D / Commercialization Rapid Commercialization Solution Overview Integrated Portfolio and Project Management (IPPM) Rapid Compliant Commercialization QuestionsReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved.
  4. 4. Company Overviews GROM EnteGreat Founded in 1982 Founded in 2000 - Mgmt team has Privately held been working together since 1982 Leading provider of strategy, Privately held integration, operation, and support Leading provider of supply chain & services for complex business manufacturing systems consulting and software solutions solution integration services Full off-shore capabilities Extensive experience integrating Fortune 2000 customers in life SAP with plant environments since sciences & healthcare, consumer 1994 products, aerospace & defense, Fortune 500 customers in life discrete manufacturing, and sciences, consumer products, pulp & technology services paper, and specialty chemicals SAP National Partner since 1994 Active roles in industry groups such Other competencies include Oracle, as: ISA, MESA, Supply Chain Council, Peoplesoft, JD Edwards, and Siebel. World Batch Forum, and APICS ~350+ consultants SAP NetWeaver certification Independent and Unbiased Independent and UnbiasedReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  5. 5. Rapid Commercialization Business ContextReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  6. 6. The Pharmaceutical Industry is Under a Great Deal of Pressure The pharmaceutical environment is becoming more and more challenging. Pharmaceutical companies are pressured to deliver revenue and earnings growth under tough conditions. External Market Dynamics Internal Industry Pressures Ageing population will drive up Rising commercialization costs. The utilization. The number of citizens over average cost of developing a new drug age 65 is expected to double over the is over $800MM. next 40 years. Declining R&D productivity. Number of Chronic diseases, such as diabetes, are FDA approvals have remained flat over projected to become more prevalent. past decade. Increasing payer Influence and role of Shorter product exclusivity due to government. increased competition from other Diminishing willingness to pay premium branded and generic drugs. prices for branded pharmaceuticals. Increased regulatory stringency The share of generic drugs have tripled over the past two decades.Real Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  7. 7. For Pharmaceutical R&D, These are Bittersweet TimesCreating Safe and Effective New Medicines The Potential Has Never Been Greater Exciting scientific advances offer greater potential than ever before for discovering “…The next ten years will be seen as a signal point of transition in health new, more effective ways to fight disease care. Medicine will be transformed from an instinctive art of alleviating Wave of scientific advances and new symptoms to a science of technologies have begun to change how personalized health care. The next decade will be viewed by future medicines are discovered. generations as the time when treatments became preventative, Growing knowledge of how diseases work predictive, and personalized…” at the genetic and molecular levels has opened up new drug targets Michael Leavitt Secretary of Health and Treatments based on an individual’s Human Services genetic make-up show great promise to improve health care Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Profile 2007 (Washington, DC: PhRMA, March 2007) Real Experience. Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  8. 8. For Pharmaceutical R&D, These are Bittersweet Times (Continued)Real Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  9. 9. For Pharmaceutical R&D, These are Bittersweet Times (Continued) Source: innovation.orgReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  10. 10. Big Pharmaceutical Companies Are Undergoing Significant Changes to Adapt Sample Big Pharma Corporate Strategy Map Maximize shareholder value Grow Develop R&D Optimize cost Grow earnings Financial revenue pipeline value Become the Leader in delivering value to customers Business Policy Patients Payers PhysiciansCustomer Partners Stakeholders Build effective and efficient business model Internal Focus on key Rethink the way Rethink the way Establish a efficient Process therapeutic we research and we commercialize and adaptiveCapabilities areas develop new drugs new drugs business model Create a high performing organization People & Create high performance Develop transformational Develop the Culture culture leaders capabilities to win = Direct contribution by R&D = Focus of today’s = Indirect contribution by R&D presentation Real Experience. Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  11. 11. Rapid Development & Commercialization Bottom Line Contributions “…Drugs developed by thefastest companies enjoyed asmuch as a 17-month speedadvantage over averageperformers and a 28.5 monthmedian development cycle anda 7.1 month regulatory cycleadvantage over those of theslowest companies…” “…Fastest companies focus andprioritize resources better and killprojects sooner…Fastestcompanies terminated 56% ofdiscontinued projects in Phase Iversus 36% for slowestcompanies…” Tufts Center for the Study of Drug Development (CSDD), Impact Report, Volume 8, Number 5, September/October 2006 Real Experience. Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  12. 12. Rapid Development & Commercialization Bottom Line Contributions (Continued) “…A one-day advantagetypically saves $37,000 in out-of-pocket development costs andnets an additional $1.1 million indaily prescription revenue for anaverage performing drug…” “…Drugs developed by thefastest companies saved $30million in out-of-pocketdevelopment costs and gained$1.1 billion in incrementalprescription revenue each, Tufts Center for the Study of Drug Development (CSDD),compared to those of the slowest Impact Report, Volume 8, Number 5, September/October 2006companies…”Real Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  13. 13. Rapid Commercialization Solution OverviewReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  14. 14. GROM Solution Portfolio for Life Sciences Marketing & Rapid Compliant Solutions Industry Field Sales Commercialization Manufacturing Channel Supply Chain Lean Manufacturing Management Optimization Validation and Quality Assurance Industry Threads Specific Regulatory Compliance Data Migration and Data Governance Methodology Base GEMReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  15. 15. Solution Overview – Rapid CommercializationSolution Rapid Commercialization Portfolio R&D Project Specification Recipe Electronic Management Management Management Management FilingComponents Integrated Inventory And Internal Product Manufacturing Production Warehouse Production Development Execution Planning Management Ramp-up Manufacturing Contract Mfg. Clinical Trial Electronic Quality Performance Production Supply Chain Batch Record Management Analysis Ramp-upValue Levers Faster Increased Personnel Lower NPDI Increased Revenue Lower IT Costs Time-to-Market Productivity Costs Improved Capital Established Improved Plant Increased Market Architecture Planning and Process & Change Utilization Share Simplification Investment Control = Areas with accelerated solutions Real Experience. Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  16. 16. Solutions Featured in Today’s Presentation Integrated Portfolio and Project Management Rapid Compliant CommercializationReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  17. 17. Solution Review: Integrated Portfolio and Project Management (IPPM)Real Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  18. 18. Portfolio And Project Management: Why This Is An Important Topic Tufts CSDD Outlook 2007 Report on Globalization & Outsourcing “…The industry is stepping up itsuse of global outsourcing practicesto speed development and reduceassociated costs...” “…Growing clinical trials volume andscope, are prompting drug sponsors toincrease their reliance on foreignbased investigators and patients…” “…Many top pharmaceuticalcompanies project that, within two tothree years, up to 65% of their FDA-regulated clinical trials will beconducted abroad…” “…Demand for CRO services isexpected to grow by 16% annuallyover the next five years…” Managing R&D activities across diverse and widely dispersed teams is becoming an exceptionally difficult proposition…Real Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  19. 19. Portfolio And Project Management Competitive Advantages To be Gained According to a benchmarkconducted by the AberdeenGroup, Best-in-Classperformers enjoy significantperformance advantagesover their competitors,including: 28% more likely to meet product development cost targets than the Industry Average and over three-times as likely as Laggard companies 52% more likely to hit target launch dates than the Industry Average and 3.3- executed, it can provide …But when well times as likely asa Laggards competitive advantage significant to hit these targets Real Experience. Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  20. 20. Portfolio And Project Management Needed Capabilities and Enablers Before a company can expect the full benefits of globalization and outsourcing, it must develop the necessary capabilities to enable global R&D collaboration. Key Business Capabilities Key Technology Enablers Standardized processes across global Integrated project, program, and R&D chain for both internal and external resource management tools resources Real-time, web-enabled, interactive Centralized and secure access to collaboration tools development data Product Lifecycle Management (PLM) Formal project and program Product Data Management (PDM) management methodologies Formal review process that includes external parties throughout development process Design performance / metrics formally measured across global R&D chainReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  21. 21. Integrated Portfolio & Project Mgt. Solution Roadmap IPPM Maturity Level xRPM OPTIMIZE Portfolio Portfolio Resource Management Evaluations Management PLMMANAGE ANDCOLLABORATE Recipe cProjects cFolders Management Project System Activity & Material Financial Milestone Mgt Planning Planning Pre-Configured Solution Document Procurement Time Management Activities Recording Offering CONTROL Capacity Production Budget Evaluation Activities Control Real Experience. Real Advantage. • Time Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  22. 22. Project System Solution for R&D Integrated Business Processes Standardized R&D project WBS template Labor activity processing – time entry through CATS Experimental manufacturing activity processing – integrated with existing planning processes Consumption & procurement activity processing Materials Contract services Document processing (with e-signature approval) Cost Allocation Automatic postings Manually apportioned Financial analysis Budget control Capacity evaluation & leveling Please refer to the “supplementary reference materials” sectionReal Experience.Real Advantage. • towards the back of this presentation for additional details Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  23. 23. Pre-Configured R&D Project System Solution Pre-defined R&D project WBS template Integrated process design with materials management, procurement, manufacturing, and finance Pre-defined work centers roles Baseline PS Module Configuration Baseline SAP DMS Configuration (with e-signature activation) Baseline SAP CATS Configuration Baseline SAP PP Configuration (work center capacity management) Pre-defined SAP security profiles Pre-Configured Solution Project Documentation Business process flows User / functional requirements specifications Business process procedures Unit / integration test scripts End-user training materialssystem solution can save a Our pre-configured R&D projectReal Experience. typical project up to 3 months in design and implementationReal Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  24. 24. Solution Review: Rapid Compliant CommercializationReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  25. 25. Rapid Compliant Commercialization Overall Business Objective• Shorten the time and reduce the cost to move from clinical supply manufacturing to scaled-up commercial manufacturing Rapid Compliant Commercialization Accelerate• Eliminate the “toss it over the wall” syndrome after approval Early Late Over Early Improved R&D Clinical Clinical The Commercial Commercial Supply Supply Wall Supply Supply ?Real Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  26. 26. Rapid Compliant Commercialization Capability Requirements According to a cross-industry analysis performed by the Aberdeen Group*, the characteristics of a winning formula- based product development strategy include: Key Business Capabilities Integrated Product Data Architecture - To support both production scaling and regulatory requirements Detailed Audit Trail – Throughout the entire material flow Integration with Value Chain Participants – To enable quick and complete reporting on all product and ingredient sourcing and distribution data Demonstrated Regulatory Compliance – Proactive management brand integrity and risks, fines, and fees associated with non-compliance. Inspire confidence with regulatory agencies and speed up regulatory review cycles. Speed and Access to all Relevant Product Data – Provide direct and immediate access to regulatory compliance information to both production and product development personnel.Real Experience. * = “Formula-Based Product Development: Recipes for Compliance and Success”, Aberdeen Group, Nov. 2004Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  27. 27. Rapid Compliant Commercialization The Business Benefits are Quantifiable Areas of Average Business Improvement Across MaturitiesIMPROVEMENT AREA BEST-IN-CLASSReduction in Product Costs 17.5%Reduction in Engineering Change Orders Cycle Time 75%Reduction in Design Cycles 25% - 35%Reduction in Time-to-Volume Cycles 10% - 15%Reduce Search Times / Improve Engineering 15% - 20%ProductivityNew Product Revenue as a % of Total Revenue 28%Counterfeiting, Grey Market Cost Reduction 31%New Product Costs as a % of Planned Product Costs 69% Source: “The Design for Compliance Benchmark Report”, AberdeenGroup, September 2004Real Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  28. 28. Rapid Compliant Commercialization Solution Roadmap Program Maturity & Coverage Leverage Infrastructure DEPLOY and Accelerate Process PROGRAM Late Stage Inline Mfg. Contract Mfg. Clinical Mfg. Site Site Site Deployment Deployment Deployment Integrated Supply Chain Execution & Visibility Implement PLM &REALIZE AND ERP Solution Pilot STABILIZE ISA-88 Recipe Electronic Enforced Manufacturing Management Batch Record Compliance Electronic Integrated CAPA / NCR Planning and Product Data Analytics ManagementSTANDARDIZE Establish Foundational Capabilities Modular & Configurable ISA-88-based Automated Solution Offering Recipe ISA-95-based Compliance Modeling Interoperability Processes Standard Internal Mfg. External Mfg. Solution Architecture Architecture Architecture Assessment Assessment Real Experience. Time Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  29. 29. Rapid Compliant Commercialization Solution Architecture Overview mySAP PLM Definition (in Late Stage Clinical & Commercialization) SAP ERP Material Personnel Equipment Sequence of Work Requirements Requirements Requirements Operations Procedures SAP ERP 3rd Party Execution (in Late Stage Clinical & Commercialization) Applications Electronic Shop Floor Material Personnel Equipment SequenceNetWeaver Work Systems Qualification Qualification Qualification Enforcement Portal Instructions SAP ERP Documentation Optimization NetWeaver Portal Electronic Process Analytics KPIs SAP xMII Batch RecordReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  30. 30. Rapid Compliant Commercialization Conceptual Architecture mySAP PLM Definition (in Late Stage Clinical & Commercialization) SAP ERP Material Personnel Equipment Sequence of Work Requirements Requirements Requirements Operations Procedures Manufacturing Assets & Procedures Models Using ISA-88 SAP ERP 3rd Party Execution (in Late Stage Clinical & Commercialization) Applications Electronic Shop Floor Material Personnel Equipment SequenceNetWeaver Work Systems Qualification Qualification Qualification Enforcement Portal Instructions Segmentation Of Manufacturing Resource and Activity Models Into Standard Formats Enables Application of Uniform Policies and Procedures SAP ERP Documentation Optimization NetWeaver Portal Electronic Process Analytics KPIs SAP xMII Batch RecordReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  31. 31. Rapid Compliant Commercialization Conceptual Architecture mySAP PLM Definition (in Late Stage Clinical & Commercialization) SAP ERP Material Personnel Equipment Sequence of Work Requirements Requirements Requirements Operations Procedures 21 CFR 211 21 CFR 58 21 CFR 600/610 (Pharmaceutical) (Labs) (Biological) SAP ERP 3rd Party Execution (in Late Stage Clinical & Commercialization) Applications The Regulator’s Motivation and Intent As Expressed in ElectronicNetWeaver Shop Floor Law, Additional Guidance, andSequence Material Personnel Equipment Work Qualification Qualification Qualification Enforcement Portal Systems Actual Assessments and Judgments Instructions SAP ERP Documentation Optimization NetWeaver Electronic Portal Process Analytics KPIs SAP xMII Batch RecordReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  32. 32. Rapid Compliant Commercialization Solution Architecture SAP NetWeaver PLM APO BI HR QM PM MM PP-PI EBR ERP XI xMII ODA ISA-95 Documents (B2MML + Evolving Part 4) OPC 3rd Party 3rd Party 3rd Party 3rd Party DCS / Historian / HR LIMS EAM MES Batch SCADAReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  33. 33. What is EnteGreat’s ? Simply stated… Compliant Manufacturing Framework® is a library of proven best practices accelerators for executing regulated manufacturing using SAP Proven templates for defining manufacturing objects and activities in a cGMP environment using industry standards such as ISA-88 and ISA-95 Proven templates and examples for configuring and implementing cGMP manufacturing applications Proven content for US FDA/GAMP CSV documentation Proven content for training and system documentationCMF® provides materials that accelerate the development of an SAP- based cGMP shop floor manufacturing execution environmentReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  34. 34. Accelerated Solution for Rapid Compliant Commercialization – Benefits of using CMF®By using the same Compliant Manufacturing Framework for late stage clinical supply manufacturing that supports commercial manufacturing, companies can achieve these added benefits: Seamless transition for manufacturing systems Instant integration into the supply chain Eliminates re-engineering or revalidation Ready to begin compliance work in commercial production CSVs and most documentation already in place Facilitates efficient processing of post-approval changes Increases clinical supply manufacturing efficiency Rapid access to data for bi-directional exchange, analysis, and continuous improvement Real Experience. Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  35. 35. Schedule Acceleration: The AdvantageTypical Project Timeline Without CMF-based Prototyping Proof Of Concept Pilot Initial Implementation Deployment / Roll-OutReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  36. 36. Schedule Acceleration: The AdvantageTypical Project Timeline Without CMF-based Prototyping Proof Of Concept Schedule Pilot Compression Opportunities Initial Implementation Deployment / Roll-OutReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  37. 37. Schedule Acceleration: The Advantage Project Timeline With CMF-based Prototyping Proof Of Concept Overall Schedule Pilot Reduction and Quicker Payback Initial Implementation Deployment / Roll-OutReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  38. 38. Rapid Compliant Commercialization Business Benefits Improved New Product Development & Introduction • Faster product-to-market • Standardized mechanism for product definition / data architecture from Development to Commercialization Improved Supply Chain Performance • Increased responsiveness and flexibility • Improved manufacturing reliability and performance against plan Reduced Labor (Operations & Quality) • Reduced effort to transform Clinical product definition data for Commercialization Improved Batch Review / Dispositioning & Product Release • Elimination of “clerical” batch record errors via Electronic Batch Record • Exception-based electronic batch record review Improved Quality and Compliance • Compliant First-Time • Supports top-down quality management (QSIT) Drives Continuous Improvement • Timely access to accurate, current, and complete mfg data • Feedback from Commercialization to Development • Direct bi-directional transfer of product / production dataReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  39. 39. Questions We’ll gladly take additional questions after today’s session. Just stop by booth 1787 !!Real Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  40. 40. Thank you for participating Please remember to complete and return your evaluation form following this session. For ongoing education on this area of focus, visit the Year-Round Community page at www.asug.com/yrc James Chi Grom Associates 908-483-2000 x253 jchi@grom.com Jeff Clark 908-483-2000 x256 [SESSION CODE: 4400 jclark@grom.com Edward Sullivan EnteGreat, Inc. 412-523-2723 ed_sullivan@entegreat.comReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved. EnteGreat, Inc. All rights reserved.
  41. 41. Supplementary Reference Materials: Pre-Configured PS Solution In DetailsReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  42. 42. Project System Solution for R&D Integrated Business Processes Standardized R&D project WBS template Labor activity processing – time entry through CATS Experimental manufacturing activity processing – integrated with existing planning processes Consumption & procurement activity processing Materials Contract services Document processing (with e-signature approval) Cost Allocation Automatic postings Manually apportioned Financial analysisReal Experience.Real Advantage. • Budget control Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  43. 43. Project System Solution for R&D Integrated Business Processes Standardized R&D project WBS template Labor activity processing – time entry through CATS Experimental manufacturing activity processing – integrated with existing planning processes Consumption & procurement activity processing Materials Contract services Document processing (with e-signature approval) Cost Allocation Automatic postings Manually apportioned Financial analysisReal Experience.Real Advantage. • Budget control Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  44. 44. Pre-Configured PS Solution for R&D Standardized R&D Project WBS TemplateReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  45. 45. Pre-Configured PS Solution for R&D Standardized R&D Project WBS Template Project Structure Area Details Area Work list and Template AreaReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  46. 46. Pre-Configured PS Solution for R&D Standardized R&D Project WBS Template Tabular View Gantt ChartReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  47. 47. Pre-Configured PS Solution for R&D Progress Analysis Report Actual Remaining Planned Delay Work Work WorkReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  48. 48. Pre-Configured PS Solution for R&D Progress Analysis Report – Export to ExcelReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  49. 49. Project System Solution for R&D Integrated Business Processes Standardized R&D project WBS template Labor activity processing – time entry through CATS Experimental manufacturing activity processing – integrated with existing planning processes Consumption & procurement activity processing Materials Contract services Document processing (with e-signature approval) Cost Allocation Automatic postings Manually apportioned Financial analysisReal Experience.Real Advantage. • Budget control Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  50. 50. Pre-Configured PS Solution for R&D Labor Activity Processing Labor Assignment & Planning Personnel assignmentReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  51. 51. Pre-Configured PS Solution for R&D Labor Activity Processing Time Entry Through CATS Actual Work (Time)Real Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  52. 52. Pre-Configured PS Solution for R&D Labor Activity Processing Time Entry Approval Approved Work HoursReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  53. 53. Pre-Configured PS Solution for R&D Labor Activity Processing Booking of Actual Labor Hours to ProjectApproved Work HoursTransferred to Project Real Experience. Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  54. 54. Pre-Configured PS Solution for R&D Labor Activity Processing Plan vs Actual Labor Hour & Cost Reporting CostsR&D Personnel Actual Plan assigned toInternal ActivityReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  55. 55. Project System Solution for R&D Integrated Business Processes Standardized R&D project WBS template Labor activity processing – time entry through CATS Experimental manufacturing activity processing – integrated with existing planning processes Consumption & procurement activity processing Materials Contract services Document processing (with e-signature approval) Cost Allocation Automatic postings Manually apportioned Financial analysisReal Experience.Real Advantage. • Budget control Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  56. 56. Experimental Manufacturing Activity Processing BOM Assigned To Project Activity BOM assigned to Project ActivityReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  57. 57. Experimental Manufacturing Activity Processing Planned Order to Process Order Conversion MRP result Convert Planned Order to Process OrderReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  58. 58. Experimental Manufacturing Activity Processing Assignment of WBS Number to Process Order Costs Plan Actual Variance Process OrderReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  59. 59. Project System Solution for R&D Integrated Business Processes Standardized R&D project WBS template Labor activity processing – time entry through CATS Experimental manufacturing activity processing – integrated with existing planning processes Consumption & procurement activity processing Materials Contract services Document processing (with e-signature approval) Cost Allocation Automatic postings Manually apportioned Financial analysisReal Experience.Real Advantage. • Budget control Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  60. 60. Consumption & Procurement Activity Processing Material Planning Reservation Material QuantityReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  61. 61. Consumption & Procurement Activity Processing Material ConsumptionReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  62. 62. Consumption & Procurement Activity Processing Booking of Material Costs to Project Costs Plan Actual VarianceReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  63. 63. Consumption & Procurement Activity Processing Planned vs Actual Material Cost Analysis Across Projects For All Selected Project Costs Actual Plan VariancePROJE Raw Material ConsumptionCT Real Experience. Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  64. 64. Consumption & Procurement Activity Processing External Service Order Planning Purchase Requisition Service ActivityReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  65. 65. Consumption & Procurement Activity Processing Service Acceptance Through Entry SheetsReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  66. 66. Consumption & Procurement Activity Processing Booking of External Services to Project Costs Plan Actual VarianceReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  67. 67. Consumption & Procurement Activity Processing External Services Analysis Status IndicatorReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  68. 68. Project System Solution for R&D Integrated Business Processes Standardized R&D project WBS template Labor activity processing – time entry through CATS Experimental manufacturing activity processing – integrated with existing planning processes Consumption & procurement activity processing Materials Contract services Document processing (with e-signature approval) Cost Allocation Automatic postings Manually apportioned Financial analysisReal Experience.Real Advantage. • Budget control Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  69. 69. Document Processing With e-Signature Approval Document Status Digital SignatureReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  70. 70. Document Processing With e-Signature Approval Document attached to Project ActivityReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  71. 71. Project System Solution for R&D Integrated Business Processes Standardized R&D project WBS template Labor activity processing – time entry through CATS Experimental manufacturing activity processing – integrated with existing planning processes Consumption & procurement activity processing Materials Contract services Document processing (with e-signature approval) Cost Allocation Automatic postings Manually apportioned Financial analysisReal Experience.Real Advantage. • Budget control Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  72. 72. Cost Allocation Manual Cost Apportionment to Project Amount ‘R&D Generics’ ‘Travel & Enter…’ Project Root WBS Cost Center Cost Element - Element 612000Real Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  73. 73. Cost Allocation Booking of Apportioned Costs to Project Costs Actual Plan Variance 612000 – Travel & EntertainmentReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  74. 74. Project System Solution for R&D Integrated Business Processes Standardized R&D project WBS template Labor activity processing – time entry through CATS Experimental manufacturing activity processing – integrated with existing planning processes Consumption & procurement activity processing Materials Contract services Document processing (with e-signature approval) Cost Allocation Automatic postings Manually apportioned Financial analysisReal Experience.Real Advantage. • Budget control Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  75. 75. Financial Analysis Planned vs Actual Costs Analysis Hierarchical View Costs Plan Actual VarianceReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  76. 76. Financial Analysis Planned vs Actual Costs Analysis Cost Element View For Selected Project Costs Actual Plan VarianceReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  77. 77. Project System Solution for R&D Integrated Business Processes Standardized R&D project WBS template Labor activity processing – time entry through CATS Experimental manufacturing activity processing – integrated with existing planning processes Consumption & procurement activity processing Materials Contract services Document processing (with e-signature approval) Cost Allocation Automatic postings Manually apportioned Financial analysisReal Experience.Real Advantage. • Budget control Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  78. 78. Budget Control Allocation of Budget to Project WBS Element View Planned Costs of Project Budget allocatedWBS ElementReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  79. 79. Budget Control Allocation of Budget to Project Fiscal Period View Budget allocatedPeriod Planned Costs of ProjectReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  80. 80. Budget Control Message When Budget is Exceeded Control Message When Project Costs Exceeds Allocated BudgetReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  81. 81. Budget Control Budget vs Actual Cost Analysis Costs Budget Actual Variance For Selected Project Summary – Year wiseReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  82. 82. Project System Solution for R&D Integrated Business Processes Standardized R&D project WBS template Labor activity processing – time entry through CATS Experimental manufacturing activity processing – integrated with existing planning processes Consumption & procurement activity processing Materials Contract services Document processing (with e-signature approval) Cost Allocation Automatic postings Manually apportioned Financial analysisReal Experience.Real Advantage. • Budget control Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
  83. 83. Capacity Evaluation & Leveling Resource Capacity Analysis Capacity Planning Overload Capacity EvaluationReal Experience.Real Advantage. • Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.

×