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CHUCK WEBBER[ASUG INSTALLATION MEMBER MEMBER SINCE:2008
MALCOM POULIN[ASUG ASSOCIATE MEMBER MEMBER SINCE:1998
DENISE MISSONAK[SAP POINT OF CONTACT MEMBER SINCE: 1998
Rapid Commercialization Strategies for Pharmaceutical and Biotech
Companies
James Chi & Jeff Clark - Grom Associates, Inc.Ed Sullivan - EnteGreat, Inc.
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
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 commercialization
Real Experience. Real Advantage. •
Introduction
Business Context and Success Strategies for R&D / Commercialization
Rapid Commercialization Solution Overview
Integrated Portfolio and Project Management (IPPM)
Rapid Compliant Commercialization
Questions
Agenda
Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved.
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Founded in 2000 - Mgmt team has been working together since 1982Privately heldLeading provider of supply chain & manufacturing systems consulting and solution integration services
Extensive experience integrating SAP with plant environments since 1994
Fortune 500 customers in life sciences, consumer products, pulp & paper, and specialty chemicalsActive roles in industry groups such as: ISA, MESA, Supply Chain Council, World Batch Forum, and APICSSAP NetWeaver certificationIndependent and Unbiased
EnteGreat
Founded in 1982Privately heldLeading provider of strategy, integration, operation, and support services for complex business software solutions
Full off-shore capabilitiesFortune 2000 customers in life sciences & healthcare, consumer products, aerospace & defense, discrete manufacturing, and technology servicesSAP National Partner since 1994Other competencies include Oracle, Peoplesoft, JD Edwards, and Siebel.~350+ consultantsIndependent and Unbiased
GROM
Company Overviews
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Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Rapid CommercializationBusiness Context
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
The pharmaceutical environment is becoming more and more challenging. Pharmaceutical companies are pressured to
deliver revenue and earnings growth under tough conditions.
Rising commercialization costs. The average cost of developing a new drug is over $800MM.Declining R&D productivity. Number of FDA approvals have remained flat over past decade.Shorter product exclusivity due to increased competition from other branded and generic drugs.Increased regulatory stringency
Internal Industry Pressures
Ageing population will drive up utilization. The number of citizens over age 65 is expected to double over the next 40 years.Chronic diseases, such as diabetes, are projected to become more prevalent.Increasing payer Influence and role of government.Diminishing willingness to pay premium prices for branded pharmaceuticals. The share of generic drugs have tripled over the past two decades.
External Market Dynamics
The Pharmaceutical Industry is Under a Great Deal of Pressure
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Real Experience. Real Advantage. •
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Exciting scientific advances offer greater potential than ever before for discovering new, more effective ways to fight disease Wave of scientific advances and new technologies have begun to change how medicines are discovered.Growing knowledge of how diseases work at the genetic and molecular levels has opened up new drug targetsTreatments based on an individual’s 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)
Creating Safe and Effective New Medicines The Potential Has Never Been Greater
“…The next ten years will be seen as a signal point of transition in health care. Medicine will be transformed from an instinctive art of alleviating
symptoms to a science of personalized health care. The next
decade will be viewed by future generations as the time when
treatments became preventative, predictive, and personalized…”
Michael LeavittSecretary of Health and
Human Services
For Pharmaceutical R&D, These are Bittersweet Times
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Real Experience. Real Advantage. •
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For Pharmaceutical R&D, These are Bittersweet Times (Continued)
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Real Experience. Real Advantage. •
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Source: innovation.org
For Pharmaceutical R&D, These are Bittersweet Times (Continued)
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Real Experience. Real Advantage. •
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Focus on key therapeutic
areas
Financial
Customer
Internal Process
Capabilities
People & Culture
Growrevenue
Develop the capabilities to win
Patients
Develop transformational leaders
Create high performance culture
Sample Big Pharma Corporate Strategy MapMaximize shareholder value
Optimize cost Grow earnings Develop R&D pipeline value
Become the Leader in delivering value to customers
Payers Physicians BusinessPartners
Policy Stakeholders
Build effective and efficient business modelRethink the way we research and
develop new drugs
Rethink the way we commercialize
new drugs
Establish a efficient and adaptive
business model
Create a high performing organization
= Direct contribution by R&D= Indirect contribution by R&D
= Focus of today’s presentation
Big Pharmaceutical Companies Are Undergoing Significant Changes to Adapt
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Real Experience. Real Advantage. •
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“…Drugs developed by the fastest companies enjoyed as much as a 17-month speed advantage over average performers and a 28.5 monthmedian development cycle and a 7.1 month regulatory cycle advantage over those of the slowest companies…”
“…Fastest companies focus and prioritize resources better and kill projects sooner…Fastest companies terminated 56% of discontinued projects in Phase I versus 36% for slowest companies…” Tufts Center for the Study of Drug Development (CSDD),
Impact Report, Volume 8, Number 5, September/October 2006
Rapid Development & CommercializationBottom Line Contributions
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Real Experience. Real Advantage. •
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“…A one-day advantage typically saves $37,000 in out-of-pocket development costs and nets an additional $1.1 million in daily prescription revenue for an average performing drug…”
“…Drugs developed by the fastest companies saved $30 million in out-of-pocket development costs and gained $1.1 billion in incremental prescription revenue each, compared to those of the slowest companies…”
Tufts Center for the Study of Drug Development (CSDD), Impact Report, Volume 8, Number 5, September/October 2006
Rapid Development & CommercializationBottom Line Contributions (Continued)
Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved.
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Rapid CommercializationSolution Overview
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Bas
e G
EM
Met
hodo
logy
Indu
stry
Spe
cifi
cT
hrea
ds
Indu
stry
Sol
utio
ns
Validation and Quality Assurance
Regulatory Compliance
Data Migration and Data Governance
ChannelManagement
Marketing &Field Sales
CompliantManufacturing
Lean ManufacturingSupply ChainOptimization
RapidCommercialization
GROM Solution Portfolio for Life Sciences
Copyright © 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved.
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Com
pone
nts
Val
ue L
ever
sS
olut
ion
R&D ProjectManagement
Rapid Commercialization
QualityManagement
SpecificationManagement
RecipeManagement
PortfolioManagement
ManufacturingPerformance
Analysis
IntegratedProductionPlanning
ManufacturingExecution
Inventory And Warehouse
Management
= Areas with accelerated solutions
Increased PersonnelProductivity
FasterTime-to-Market
Lower NPDICosts Increased Revenue Lower IT Costs
Improved PlantUtilization
Improved CapitalPlanning andInvestment
Established Process & Change
Control
Increased MarketShare
ArchitectureSimplification
ElectronicBatch Record
ProductDevelopment
InternalProductionRamp-up
Contract Mfg.ProductionRamp-up
ElectronicFiling
Clinical TrialSupply Chain
Solution Overview – Rapid Commercialization
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Real Experience. Real Advantage. •
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Integrated Portfolio and Project Management
Rapid Compliant Commercialization
Solutions Featured in Today’s Presentation
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Real Experience. Real Advantage. •
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Solution Review:Integrated Portfolio and
Project Management (IPPM)
Real Experience. Real Advantage. •
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“…The industry is stepping up its use of global outsourcing practicesto speed development and reduce associated costs...”“…Growing clinical trials volume and
scope, are prompting drug sponsors to increase their reliance on foreign based investigators and patients…”“…Many top pharmaceutical
companies project that, within two to three years, up to 65% of their FDA-regulated clinical trials will be conducted abroad…”“…Demand for CRO services is
expected to grow by 16% annually over the next five years…”
Tufts CSDD Outlook 2007 Report on Globalization & Outsourcing
Managing R&D activities across diverse and widely dispersed teams is becoming an exceptionally difficult proposition…
Portfolio And Project Management:Why This Is An Important Topic
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Real Experience. Real Advantage. •
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According to a benchmark conducted by the Aberdeen Group, Best-in-Class performers enjoy significant performance advantages over 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-times as likely as Laggards to hit these targets
…But when well executed, it can provide a significant competitive advantage
Portfolio And Project ManagementCompetitive Advantages To be Gained
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Real Experience. Real Advantage. •
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Before a company can expect the full benefits of globalization and outsourcing, it must develop the
necessary capabilities to enable global R&D collaboration.
Integrated project, program, and resource management toolsReal-time, web-enabled, interactive collaboration toolsProduct Lifecycle Management (PLM) Product Data Management (PDM)
Key Technology Enablers
Standardized processes across global R&D chain for both internal and external resourcesCentralized and secure access to development data Formal project and program management methodologies Formal review process that includes external parties throughout development processDesign performance / metrics formally measured across global R&D chain
Key Business Capabilities
Portfolio And Project Management Needed Capabilities and Enablers
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Real Experience. Real Advantage. •
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IPPMMaturity
Level
Time
CONTROL
MANAGE AND COLLABORATE
OPTIMIZE
Project SystemActivity &
Milestone Mgt
DocumentManagement
CapacityEvaluation
MaterialPlanning
ProcurementActivities
ProductionActivities
FinancialPlanning
TimeRecording
BudgetControl
PLM
cProjects cFolders RecipeManagement
xRPMPortfolio
ManagementPortfolio
EvaluationsResource
Management
Pre-ConfiguredSolutionOffering
Integrated Portfolio & Project Mgt.Solution Roadmap
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Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Standardized R&D project WBS templateLabor activity processing – time entry through CATSExperimental manufacturing activity processing –integrated with existing planning processesConsumption & procurement activity processing
MaterialsContract services
Document processing (with e-signature approval)Cost Allocation
Automatic postingsManually apportioned
Financial analysisBudget controlCapacity evaluation & leveling
Project System Solution for R&DIntegrated Business Processes
Please refer to the “supplementary reference materials” section towards the back of this presentation for additional details
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Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Pre-defined R&D project WBS templateIntegrated process design with materials management, procurement, manufacturing, and financePre-defined work centers rolesBaseline PS Module ConfigurationBaseline SAP DMS Configuration (with e-signature activation)Baseline SAP CATS ConfigurationBaseline SAP PP Configuration (work center capacity management)Pre-defined SAP security profilesPre-Configured Solution Project Documentation
Business process flowsUser / functional requirements specificationsBusiness process proceduresUnit / integration test scriptsEnd-user training materialsOur pre-configured R&D project system solution can save a
typical project up to 3 months in design and implementation
Pre-Configured R&D Project System Solution
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Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Solution Review: Rapid Compliant
Commercialization
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
• Shorten the time and reduce the cost to move from clinical supply manufacturing to scaled-up commercial manufacturing
• Eliminate the “toss it over the wall” syndrome after approval
R&DEarly
ClinicalSupply
LateClinicalSupply
ImprovedCommercialSupply
EarlyCommercialSupply
Over The Wall
?
Rapid Compliant Commercialization Overall Business Objective
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Rapid Compliant Commercialization
Accelerate
Real Experience. Real Advantage. •
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According to a cross-industry analysis performed by the Aberdeen Group*, the characteristics of a winning formula-
based product development strategy include:
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.
Key Business Capabilities
* = “Formula-Based Product Development: Recipes for Compliance and Success”, Aberdeen Group, Nov. 2004
Rapid Compliant Commercialization Capability Requirements
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Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
IMPROVEMENT AREA BEST-IN-CLASS
Reduction 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 Productivity
15% - 20%
New 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 2004
Areas of Average Business Improvement Across Maturities
Rapid Compliant Commercialization The Business Benefits are Quantifiable
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Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Program Maturity & Coverage
Time
STANDARDIZE
REALIZE ANDSTABILIZE
DEPLOYPROGRAM
Implement PLM & ERP Solution Pilot
ISA-88 RecipeManagement
Integrated Planning and
Analytics Electronic
Product Data
Establish FoundationalCapabilities
Enforced ManufacturingCompliance
ISA-88-based Recipe
Modeling
Leverage Infrastructureand Accelerate Process
StandardSolution
Architecture
Integrated Supply Chain Execution & Visibility
ElectronicBatch Record
ISA-95-based Interoperability
Internal Mfg.ArchitectureAssessment
External Mfg. Architecture Assessment
AutomatedComplianceProcesses
CAPA / NCRManagement
Modular & ConfigurableSolution Offering
Late Stage Clinical Mfg. Site
DeploymentContract Mfg.
SiteDeployment
Inline Mfg. Site
Deployment
Rapid Compliant Commercialization Solution Roadmap
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Real Experience. Real Advantage. •
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mySAP PLM
SAP ERP
SAP ERP
NetWeaverPortal
SAP xMII
SAP ERP
NetWeaverPortal
3rd PartyApplications
Shop FloorSystems
Definition (in Late Stage Clinical & Commercialization)
MaterialRequirements
WorkProcedures
Sequence ofOperations
EquipmentRequirements
PersonnelRequirements
Execution (in Late Stage Clinical & Commercialization)
MaterialQualification
PersonnelQualification
EquipmentQualification
SequenceEnforcement
ElectronicWork
Instructions
DocumentationElectronic
Batch Record
Optimization
KPIsProcess Analytics
Rapid Compliant Commercialization Solution Architecture Overview
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Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
mySAP PLM
SAP ERP
SAP ERP
NetWeaverPortal
SAP xMII
SAP ERP
NetWeaverPortal
3rd PartyApplications
Shop FloorSystems
Definition (in Late Stage Clinical & Commercialization)
MaterialRequirements
WorkProcedures
Sequence ofOperations
EquipmentRequirements
PersonnelRequirements
Execution (in Late Stage Clinical & Commercialization)
MaterialQualification
PersonnelQualification
EquipmentQualification
SequenceEnforcement
ElectronicWork
InstructionsSegmentation Of Manufacturing Resource and Activity Models Into Standard Formats Enables Application of
Uniform Policies and Procedures
Manufacturing Assets& Procedures Models
Using ISA-88
Rapid Compliant Commercialization Conceptual Architecture
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DocumentationElectronic
Batch Record
Optimization
KPIsProcess Analytics
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
mySAP PLM
SAP ERP
Definition (in Late Stage Clinical & Commercialization)
MaterialRequirements
WorkProcedures
Sequence ofOperations
EquipmentRequirements
PersonnelRequirements
Execution (in Late Stage Clinical & Commercialization)
MaterialQualification
PersonnelQualification
EquipmentQualification
SequenceEnforcement
ElectronicWork
Instructions
21 CFR 58(Labs)
21 CFR 211(Pharmaceutical)
21 CFR 600/610(Biological)
SAP ERP
NetWeaverPortal
SAP xMII
SAP ERP
NetWeaverPortal
3rd PartyApplications
Shop FloorSystems
DocumentationElectronic
Batch Record
Optimization
KPIsProcess Analytics
The Regulator’s Motivation and Intent As Expressed inLaw, Additional Guidance, and
Actual Assessments and Judgments
Rapid Compliant Commercialization Conceptual Architecture
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Real Experience. Real Advantage. •
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SAP NetWeaverPLM APO
ERP
HR QM PM MM PP-PIEBR
BI
XI xMII
3rd PartyHR
3rd PartyEAM
3rd PartyLIMS
3rd PartyMES
Historian / SCADA
DCS / Batch
ISA-95 Documents (B2MML + Evolving Part 4) OPC
ODA
Rapid Compliant Commercialization Solution Architecture
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Real Experience. Real Advantage. •
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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 documentation
CMF® provides materials that accelerate the development of an SAP-based cGMP shop floor manufacturing execution environment
What is EnteGreat’s ?
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Real Experience. Real Advantage. •
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Seamless transition for manufacturing systemsInstant integration into the supply chainEliminates re-engineering or revalidationReady to begin compliance work in commercial productionCSVs and most documentation already in placeFacilitates efficient processing of post-approval changesIncreases clinical supply manufacturing efficiencyRapid access to data for bi-directional exchange, analysis, and continuous improvement
By using the same Compliant Manufacturing Framework for late stage clinical supply manufacturing that supports commercial
manufacturing, companies can achieve these added benefits:
Accelerated Solution for Rapid Compliant Commercialization – Benefits of using CMF®
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Real Experience. Real Advantage. •
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Typical Project Timeline Without CMF-based Prototyping
Proof Of Concept
Pilot
InitialImplementation
Deployment / Roll-Out
Schedule Acceleration: The Advantage
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Real Experience. Real Advantage. •
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Proof Of Concept
InitialImplementation
Deployment / Roll-Out
Pilot
Typical Project Timeline Without CMF-based Prototyping
Schedule Compression Opportunities
Schedule Acceleration: The Advantage
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Real Experience. Real Advantage. •
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Proof Of Concept
InitialImplementation
Deployment / Roll-Out
Pilot
Overall Schedule Reduction and Quicker Payback
Schedule Acceleration: The Advantage
Project Timeline With CMF-based Prototyping
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Real Experience. Real Advantage. •
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Improved New Product Development & Introduction• Faster product-to-market• Standardized mechanism for product definition / data architecture
from Development to CommercializationImproved 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
CommercializationImproved Batch Review / Dispositioning & Product Release
• Elimination of “clerical” batch record errors via Electronic Batch Record
• Exception-based electronic batch record reviewImproved 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 data
Rapid Compliant Commercialization Business Benefits
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Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
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.
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For ongoing education on this area of focus, visit the Year-Round Community page at www.asug.com/yrc
James ChiGrom Associates
908-483-2000 x253jchi@grom.com
Jeff Clark908-483-2000 x256jclark@grom.com
Edward SullivanEnteGreat, Inc.412-523-2723
ed_sullivan@entegreat.com
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Real Experience. Real Advantage. •
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Supplementary ReferenceMaterials:
Pre-Configured PS SolutionIn Details
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Standardized R&D project WBS templateLabor activity processing – time entry through CATSExperimental manufacturing activity processing –integrated with existing planning processesConsumption & procurement activity processing
MaterialsContract services
Document processing (with e-signature approval)Cost Allocation
Automatic postingsManually apportioned
Financial analysisBudget control
Project System Solution for R&DIntegrated Business Processes
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Standardized R&D project WBS templateLabor activity processing – time entry through CATSExperimental manufacturing activity processing –integrated with existing planning processesConsumption & procurement activity processing
MaterialsContract services
Document processing (with e-signature approval)Cost Allocation
Automatic postingsManually apportioned
Financial analysisBudget control
Project System Solution for R&DIntegrated Business Processes
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Pre-Configured PS Solution for R&D Standardized R&D Project WBS Template
Real Experience. Real Advantage. •
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Pre-Configured PS Solution for R&D Standardized R&D Project WBS Template
Project Structure Area
Details Area
Work list and Template Area
Real Experience. Real Advantage. •
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Pre-Configured PS Solution for R&D Standardized R&D Project WBS Template
Gantt Chart
Tabular View
Real Experience. Real Advantage. •
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Planned Work DelayRemaining
WorkActual Work
Pre-Configured PS Solution for R&D Progress Analysis Report
Real Experience. Real Advantage. •
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Pre-Configured PS Solution for R&D Progress Analysis Report – Export to Excel
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Standardized R&D project WBS templateLabor activity processing – time entry through CATSExperimental manufacturing activity processing –integrated with existing planning processesConsumption & procurement activity processing
MaterialsContract services
Document processing (with e-signature approval)Cost Allocation
Automatic postingsManually apportioned
Financial analysisBudget control
Project System Solution for R&DIntegrated Business Processes
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Pre-Configured PS Solution for R&D Labor Activity ProcessingLabor Assignment & Planning
Personnel assignment
Real Experience. Real Advantage. •
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Actual Work (Time)
Pre-Configured PS Solution for R&D Labor Activity ProcessingTime Entry Through CATS
Real Experience. Real Advantage. •
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Pre-Configured PS Solution for R&D Labor Activity ProcessingTime Entry Approval
Approved Work Hours
Real Experience. Real Advantage. •
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Approved Work Hours Transferred to Project
Pre-Configured PS Solution for R&D Labor Activity ProcessingBooking of Actual Labor Hours to Project
Real Experience. Real Advantage. •
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R&D Personnel assigned to
Internal Activity
Costs
PlanActual
Pre-Configured PS Solution for R&D Labor Activity ProcessingPlan vs Actual Labor Hour & Cost Reporting
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Standardized R&D project WBS templateLabor activity processing – time entry through CATSExperimental manufacturing activity processing –integrated with existing planning processesConsumption & procurement activity processing
MaterialsContract services
Document processing (with e-signature approval)Cost Allocation
Automatic postingsManually apportioned
Financial analysisBudget control
Project System Solution for R&DIntegrated Business Processes
Real Experience. Real Advantage. •
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BOM assigned to Project Activity
Experimental Manufacturing Activity Processing BOM Assigned To Project Activity
Real Experience. Real Advantage. •
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MRP result
Convert Planned Order to Process Order
Experimental Manufacturing Activity Processing Planned Order to Process Order Conversion
Real Experience. Real Advantage. •
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Process Order
Costs
Plan Actual Variance
Experimental Manufacturing Activity Processing Assignment of WBS Number to Process Order
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Standardized R&D project WBS templateLabor activity processing – time entry through CATSExperimental manufacturing activity processing –integrated with existing planning processesConsumption & procurement activity processing
MaterialsContract services
Document processing (with e-signature approval)Cost Allocation
Automatic postingsManually apportioned
Financial analysisBudget control
Project System Solution for R&DIntegrated Business Processes
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Material
Quantity
Reservation
Consumption & Procurement Activity ProcessingMaterial Planning
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Consumption & Procurement Activity ProcessingMaterial Consumption
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Costs
Plan Actual Variance
Consumption & Procurement Activity ProcessingBooking of Material Costs to Project
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
CostsActual Plan Variance
For All Selected Project
Raw Material Consumption
PROJECT
Consumption & Procurement Activity ProcessingPlanned vs Actual Material Cost AnalysisAcross Projects
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Service Activity
Purchase Requisition
Consumption & Procurement Activity ProcessingExternal Service Order Planning
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Consumption & Procurement Activity ProcessingService Acceptance Through Entry Sheets
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Costs
Plan Actual Variance
Consumption & Procurement Activity ProcessingBooking of External Services to Project
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Status Indicator
Consumption & Procurement Activity ProcessingExternal Services Analysis
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Standardized R&D project WBS templateLabor activity processing – time entry through CATSExperimental manufacturing activity processing –integrated with existing planning processesConsumption & procurement activity processing
MaterialsContract services
Document processing (with e-signature approval)Cost Allocation
Automatic postingsManually apportioned
Financial analysisBudget control
Project System Solution for R&DIntegrated Business Processes
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Document Status
Digital Signature
Document ProcessingWith e-Signature Approval
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Document attached to Project Activity
Document ProcessingWith e-Signature Approval
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Standardized R&D project WBS templateLabor activity processing – time entry through CATSExperimental manufacturing activity processing –integrated with existing planning processesConsumption & procurement activity processing
MaterialsContract services
Document processing (with e-signature approval)Cost Allocation
Automatic postingsManually apportioned
Financial analysisBudget control
Project System Solution for R&DIntegrated Business Processes
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
‘R&D Generics’Cost Center
‘Travel & Enter…’Cost Element -
612000
Project Root WBS Element
Amount
Cost AllocationManual Cost Apportionment to Project
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
CostsActual Plan Variance
612000 – Travel & Entertainment
Cost Allocation Booking of Apportioned Costs to Project
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Standardized R&D project WBS templateLabor activity processing – time entry through CATSExperimental manufacturing activity processing –integrated with existing planning processesConsumption & procurement activity processing
MaterialsContract services
Document processing (with e-signature approval)Cost Allocation
Automatic postingsManually apportioned
Financial analysisBudget control
Project System Solution for R&DIntegrated Business Processes
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
CostsPlan Actual Variance
Financial AnalysisPlanned vs Actual Costs AnalysisHierarchical View
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
CostsActual Plan Variance
For Selected Project
Financial AnalysisPlanned vs Actual Costs AnalysisCost Element View
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Standardized R&D project WBS templateLabor activity processing – time entry through CATSExperimental manufacturing activity processing –integrated with existing planning processesConsumption & procurement activity processing
MaterialsContract services
Document processing (with e-signature approval)Cost Allocation
Automatic postingsManually apportioned
Financial analysisBudget control
Project System Solution for R&DIntegrated Business Processes
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Planned Costs of Project
Budget allocatedWBS Element
Budget ControlAllocation of Budget to ProjectWBS Element View
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Planned Costs of Project
Budget allocated
Period
Budget ControlAllocation of Budget to ProjectFiscal Period View
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Control Message When Project Costs Exceeds Allocated Budget
Budget ControlMessage When Budget is Exceeded
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
For Selected Project
CostsBudget Actual Variance
Summary – Year wise
Budget ControlBudget vs Actual Cost Analysis
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Standardized R&D project WBS templateLabor activity processing – time entry through CATSExperimental manufacturing activity processing –integrated with existing planning processesConsumption & procurement activity processing
MaterialsContract services
Document processing (with e-signature approval)Cost Allocation
Automatic postingsManually apportioned
Financial analysisBudget control
Project System Solution for R&DIntegrated Business Processes
Real Experience. Real Advantage. •
Copyright © 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Capacity Evaluation
Capacity Planning
Overload
Capacity Evaluation & LevelingResource Capacity Analysis