Pharma

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
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.
Copyright 2008 Grom Associates, Inc. and EnteGreat, Inc. All rights reserved.
Agenda
Introduction
Business Context and Success
Strategies for R&D / Commercialization
Rapid Commercialization Solution
Overview
Integrated Portfolio and Project
Management (IPPM)
Rapid Compliant Commercialization
Questions
Real Experience.
Real Advantage.
Copyright 2008 Grom Associates, Inc. and EnteGreat Inc. All rights reserved.
Company Overviews
GROM
EnteGreat
z Founded in 1982
z Privately held
z Leading provider of strategy,
integration, operation, and support
services for complex business
software solutions
Full off-shore capabilities
z Fortune 2000 customers in life
sciences & healthcare, consumer
products, aerospace & defense,
discrete manufacturing, and
technology services
z SAP National Partner since 1994
z Other competencies include Oracle,
Peoplesoft, JD Edwards, and Siebel.
z ~350+ consultants
z Independent and Unbiased
z Founded in 2000 - Mgmt team has

been working together since 1982
z Privately held
z Leading provider of supply chain &
manufacturing systems consulting and
solution integration services
Extensive experience integrating
SAP with plant environments since
1994
z Fortune 500 customers in life
sciences, consumer products, pulp &
paper, and specialty chemicals
z Active roles in industry groups such
as: ISA, MESA, Supply Chain Council,
World Batch Forum, and APICS
z SAP NetWeaver certification
z Independent and Unbiased
Real Experience.
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Copyright 2008 Grom Associates, Inc. and EnteGreat

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Rapid Commercialization
Business Context
Real Experience.
Real Advantage.
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
z Ageing population will drive up

utilization. The number of citizens over
age 65 is expected to double over the
next 40 years.
z Chronic diseases, such as diabetes, are
projected to become more prevalent.
z Increasing payer Influence and role of
government.
z Diminishing willingness to pay premium
prices for branded pharmaceuticals.
The share of generic drugs have tripled
over the past two decades.
z Rising commercialization costs. The

average cost of developing a new drug
is over $800MM.
z Declining R&D productivity. Number of
FDA approvals have remained flat over
past decade.
z Shorter product exclusivity due to
increased competition from other
branded and generic drugs.
z Increased regulatory stringency
Real Experience.
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For Pharmaceutical R&D, These are Bittersweet

Times
Creating Safe and Effective New Medicines
The Potential Has Never Been Greater
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 targets
Treatments based on an individuals
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)
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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 Leavitt
Secretary of Health and
Human Services

Times (Continued)
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Times (Continued)
Source: innovation.org
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Big Pharmaceutical Companies Are Undergoing

Significant Changes to Adapt
Sample Big Pharma Corporate Strategy Map
Maximize shareholder value
Financial
Grow
revenue
Optimize cost
Develop R&D
pipeline value
Grow earnings
Become the Leader in delivering value to customers

Customer
Patients
Payers
Business
Partners
Physicians
Policy
Stakeholders
Build effective and efficient business model

Internal
Process
Capabilities
People &
Culture
Focus on key
therapeutic
areas
Rethink 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

Create high performance
culture
Develop transformational
leaders
= Direct contribution by R&D

= Indirect contribution by R&D
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Develop the
capabilities to win
= Focus of todays
presentation
Rapid Development & Commercialization

Bottom Line Contributions
Drugs developed by the
fastest companies enjoyed as
much as a 17-month speed
advantage over average
performers and a 28.5 month
median 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 soonerFastest
companies terminated 56% of
discontinued projects in Phase I
versus 36% for slowest
Tufts Center for the Study of Drug Development (CSDD),
companies
Impact Report, Volume 8, Number 5, September/October 2006
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Rapid Development & Commercialization

Bottom Line Contributions (Continued)
A one-day advantage
typically saves $37,000 in out-ofpocket 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
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Tufts Center for the Study of Drug Development (CSDD),

Impact Report, Volume 8, Number 5, September/October 2006
Solution Overview
Real Experience.
Real Advantage.
Marketing &
Field Sales
Rapid
Commercialization
Compliant
Manufacturing
Channel
Management
Supply Chain
Optimization
Lean Manufacturing
Validation and Quality Assurance

Regulatory Compliance
Data Migration and Data Governance
Base GEM
Methodology
Industry
Specific
Threads
Industry
Solutions
GROM Solution Portfolio for Life Sciences
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Value Levers
Components
Solution
Solution Overview Rapid Commercialization
Portfolio
Management
R&D Project
Management
Specification
Management
Recipe
Management
Electronic
Filing
Product
Development
Integrated
Production
Planning
Manufacturing
Execution
Inventory And
Warehouse
Management
Internal
Production
Ramp-up
Manufacturing
Performance
Analysis
Clinical Trial
Supply Chain
Electronic
Batch Record
Quality
Management
Contract Mfg.
Production
Ramp-up
Faster
Time-to-Market
Increased Personnel
Productivity
Lower NPDI
Costs
Increased Revenue
Lower IT Costs
Improved Plant
Utilization
Improved Capital
Planning and
Investment
Established
Process & Change
Control
Increased Market
Share
Architecture
Simplification
= Areas with accelerated solutions
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Solutions Featured in Todays Presentation
n Integrated Portfolio and Project Management

o Rapid Compliant
Commercialization
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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 & Outsourcing
The industry is stepping up its
use of global outsourcing practices
to 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 FDAregulated clinical trials will be
conducted abroad
Demand for CRO services is
expected to grow by 16% annually
over the next five years
Managing R&D activities across diverse and widely dispersed
teams is becoming an exceptionally difficult proposition
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Portfolio And Project Management

Competitive Advantages To be Gained
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 3.3But when well executed, it can provide
times as likely asa Laggards
to
significant competitive
advantage
hit these targets
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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
z Standardized processes across global
R&D chain for both internal and external
resources
z Centralized and secure access to
development data
z Formal project and program
management methodologies
z Formal review process that includes
external parties throughout development
process
z Design performance / metrics formally
measured across global R&D chain
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Key Technology Enablers

z Integrated project, program, and
resource management tools
z Real-time, web-enabled, interactive
collaboration tools
z Product Lifecycle Management (PLM)
z Product Data Management (PDM)
Integrated Portfolio & Project Mgt.

Solution Roadmap
IPPM
Maturity
Level
xRPM
OPTIMIZE
Portfolio
Management
Portfolio
Evaluations
Resource
Management
PLM
MANAGE AND
COLLABORATE
cProjects
cFolders
Recipe
Management
Project System
CONTROL
Activity &
Milestone Mgt
Material
Planning
Financial
Planning
Document
Management
Procurement
Activities
Time
Recording
Capacity
Evaluation
Production
Activities
Budget
Control
Pre-Configured
Solution
Offering
Time
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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
Real Experience.
Real Advantage.
Please refer to the supplementary reference materials section

towards the back of this presentation for additional details
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Pre-Configured R&D Project System Solution

9 Pre-defined R&D project WBS template
9 Integrated process design with materials management,
procurement, manufacturing, and finance
9 Pre-defined work centers roles
9 Baseline PS Module Configuration
9 Baseline SAP DMS Configuration (with e-signature activation)
9 Baseline SAP CATS Configuration
9 Baseline SAP PP Configuration (work center capacity
management)
9 Pre-defined SAP security profiles
9 Pre-Configured Solution Project Documentation
Business process flows
User / functional requirements specifications
Business process procedures
Unit / integration test scripts
End-user
trainingR&D
materials
Our pre-configured
project system solution can save a
Real Experience.
Real Advantage.
typical project up to 3 months in design and implementation

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Solution Review:
Rapid Compliant
Commercialization
Real Experience.
Real Advantage.

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
R&D
Early
Clinical
Supply
Late
Clinical
Supply
Over
The
Wall
?
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Early
Commercial
Supply
Improved
Commercial
Supply

Capability Requirements
According to a cross-industry analysis performed by the
Aberdeen Group*, the characteristics of a winning formulabased product development strategy include:
Key Business Capabilities

z Integrated Product Data Architecture - To support both production scaling and
regulatory requirements
z Detailed Audit Trail Throughout the entire material flow
z Integration with Value Chain Participants To enable quick and complete
reporting on all product and ingredient sourcing and distribution data
z 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.
z 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.
Real Advantage.
* = Formula-Based Product Development: Recipes for Compliance and Success, Aberdeen Group, Nov. 2004
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The Business Benefits are Quantifiable
Areas of Average Business Improvement Across Maturities
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
New Product Revenue as a % of Total Revenue
15% - 20%
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
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Solution Roadmap
Program Maturity
& Coverage
Leverage Infrastructure
and Accelerate Process
DEPLOY
PROGRAM
Late Stage
Clinical Mfg. Site
Deployment
Inline Mfg.
Site
Deployment
Contract Mfg.
Site
Deployment
Integrated Supply
Chain Execution & Visibility
Implement PLM &

ERP Solution Pilot
REALIZE AND
STABILIZE
STANDARDIZE
ISA-88 Recipe
Management
Electronic
Batch Record
Enforced
Manufacturing
Compliance
Electronic
Product Data
Integrated
Planning and
Analytics
CAPA / NCR
Management
Establish Foundational
Capabilities
ISA-88-based
Recipe
Modeling
ISA-95-based
Interoperability
Automated
Compliance
Processes
Standard
Solution
Architecture
Internal Mfg.
Architecture
Assessment
External Mfg.
Architecture
Assessment
Modular & Configurable

Solution Offering
Time
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Solution Architecture Overview
mySAP PLM
SAP ERP
SAP ERP
3rd Party
Applications
NetWeaver
Portal
Shop Floor
Systems
Definition (in Late Stage Clinical & Commercialization)

Material
Requirements
Personnel
Requirements
Equipment
Requirements
Sequence of
Operations
Work
Procedures
Execution (in Late Stage Clinical & Commercialization)

Material
Qualification
Personnel
Qualification
Equipment
Qualification
Sequence
Enforcement
Electronic
Work
Instructions
SAP ERP
Documentation
NetWeaver
Portal
SAP xMII
Electronic
Batch Record
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Optimization
Process Analytics
KPIs

Conceptual Architecture
mySAP PLM
SAP ERP

Material
Requirements
Personnel
Requirements
Equipment
Requirements
Sequence of
Operations
Work
Procedures
Manufacturing Assets
& Procedures Models
Using ISA-88
SAP ERP
3rd Party
Applications
NetWeaver
Portal
Shop Floor
Systems

Material
Qualification
Personnel
Qualification
Equipment
Qualification
Sequence
Enforcement
Electronic
Work
Instructions
Segmentation Of Manufacturing Resource and Activity

Models Into Standard Formats Enables Application of
Uniform Policies and Procedures
SAP ERP
Documentation
NetWeaver
Portal
SAP xMII
Electronic
Batch Record
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Optimization
Process Analytics
KPIs

Conceptual Architecture
mySAP PLM
SAP ERP

Material
Requirements
Personnel
Requirements
Equipment
Requirements
21 CFR 211
(Pharmaceutical)
SAP ERP
NetWeaver
Portal
3rd Party
Applications
Sequence of
Operations
Work
Procedures
21 CFR 58
(Labs)
21 CFR 600/610
(Biological)
The Regulators Motivation and Intent As Expressed in

Electronic
Material Additional
PersonnelGuidance,
Equipment andSequence
Law,
Shop Floor
Work
Qualification
Qualification
Qualification
Enforcement
Systems
Instructions
Actual Assessments and Judgments
SAP ERP
Documentation
NetWeaver
Portal
SAP xMII
Electronic
Batch Record
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Optimization
Process Analytics
KPIs

Solution Architecture
PLM
HR
APO
QM
PM
SAP NetWeaver
BI
MM
PP-PI
EBR
ERP
XI
ODA
xMII
ISA-95 Documents (B2MML + Evolving Part 4)
3rd Party
HR
3rd Party
LIMS
3rd Party
EAM
3rd Party
MES
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DCS /
Batch
OPC
Historian /
SCADA
What is EnteGreats
Simply stated
Compliant Manufacturing Framework is a library of
proven best practices accelerators for executing
regulated manufacturing using SAP
9 Proven templates for defining manufacturing objects and

activities in a cGMP environment using industry standards
such as ISA-88 and ISA-95
9 Proven templates and examples for configuring and

implementing cGMP manufacturing applications
9 Proven content for US FDA/GAMP CSV documentation

9 Proven content for training and system documentation
CMF provides materials that accelerate the development of an SAPbased cGMP shop floor manufacturing execution environment
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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:
9 Seamless transition for manufacturing systems

9 Instant integration into the supply chain
9 Eliminates re-engineering or revalidation
9 Ready to begin compliance work in commercial
production
9 CSVs and most documentation already in place
9 Facilitates efficient processing of post-approval
changes
9 Increases clinical supply manufacturing
efficiency
9 Rapid access to data for bi-directional exchange,
analysis, and continuous improvement
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Schedule Acceleration: The
Advantage
Typical Project Timeline Without CMF-based Prototyping
Proof Of
Concept
Pilot
Initial
Implementation
Deployment / Roll-Out
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Advantage
Typical Project Timeline Without CMF-based Prototyping
Proof Of
Concept
Schedule
Compression
Opportunities
Pilot
Initial
Implementation
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Advantage
Project Timeline With CMF-based Prototyping
Proof Of
Concept
Overall Schedule
Reduction and
Quicker Payback
Pilot
Initial
Implementation
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Business Benefits
9 Improved New Product Development & Introduction
Faster product-to-market
Standardized mechanism for product definition / data architecture
from Development to Commercialization
9 Improved Supply Chain Performance
Increased responsiveness and flexibility

Improved manufacturing reliability and performance against plan
9 Reduced Labor (Operations & Quality)
Reduced effort to transform Clinical product definition data for

Commercialization
9 Improved Batch Review / Dispositioning & Product Release

Elimination of clerical batch record errors via Electronic Batch
Record
Exception-based electronic batch record review
9 Improved Quality and Compliance
Compliant First-Time
Supports top-down quality management (QSIT)
9 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
Real Experience.
Real Advantage.

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Questions
Well gladly take additional questions

after todays session.
Just stop by booth 1787 !!
Real Experience.
Real Advantage.
Thank you for participating

Please remember to complete and return your
evaluation form following this session.
James Chi
For ongoing education on this area of focus, visit the

Year-Round Community page at www.asug.com/yrc
Grom Associates
908-483-2000 x253
jchi@grom.com
Jeff Clark
908-483-2000 x256
jclark@grom.com
Edward Sullivan
EnteGreat, Inc.
412-523-2723
ed_sullivan@entegreat.com
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SESSION CODE: 4400
Supplementary Reference
Materials:
Pre-Configured PS Solution
In Details
Real Experience.
Real Advantage.

Labor activity processing time entry through
CATS
Materials
Contract services
Document processing (with e-signature
approval)
Cost Allocation
Automatic postings
Financial analysis
Budget control
Real Experience.
Real Advantage.

CATS
Materials
Contract services
approval)
Cost Allocation
Automatic postings
Financial analysis
Budget control
Real Experience.
Real Advantage.
Pre-Configured PS Solution for R&D

Standardized R&D Project WBS Template
Real Experience.
Real Advantage.

Project Structure Area
Details Area
Work list and

Template Area
Real Experience.
Real Advantage.

Tabular View
Gantt Chart
Real Experience.
Real Advantage.

Progress Analysis Report
Actual
Work
Remaining
Work
Real Experience.
Real Advantage.
Planned
Work
Delay

Progress Analysis Report Export to Excel
Real Experience.
Real Advantage.

CATS
Materials
Contract services
approval)
Cost Allocation
Automatic postings
Financial analysis
Budget control
Real Experience.
Real Advantage.

Labor Activity Processing
Labor Assignment & Planning
Personnel assignment
Real Experience.
Real Advantage.

Time Entry Through CATS
Actual Work (Time)
Real Experience.
Real Advantage.

Time Entry Approval
Approved Work Hours
Real Experience.
Real Advantage.

Booking of Actual Labor Hours to Project
Approved Work Hours

Transferred to Project
Real Experience.
Real Advantage.

Plan vs Actual Labor Hour & Cost Reporting
Costs
R&D Personnel
assigned to
Internal Activity
Real Experience.
Real Advantage.
Actual
Plan

CATS
Materials
Contract services
approval)
Cost Allocation
Automatic postings
Financial analysis
Budget control
Real Experience.
Real Advantage.
Experimental Manufacturing Activity Processing

BOM Assigned To Project Activity
BOM assigned to
Project Activity
Real Experience.
Real Advantage.

Planned Order to Process Order Conversion
MRP result
Convert Planned Order

to Process Order
Real Experience.
Real Advantage.

Assignment of WBS Number to Process Order
Costs
Plan
Process Order
Real Experience.
Real Advantage.
Actual
Variance

CATS
Materials
Contract services
approval)
Cost Allocation
Automatic postings
Financial analysis
Budget control
Real Experience.
Real Advantage.
Consumption & Procurement Activity Processing

Material Planning
Material
Reservation
Quantity
Real Experience.
Real Advantage.

Material Consumption
Real Experience.
Real Advantage.

Booking of Material Costs to Project
Costs
Plan
Real Experience.
Real Advantage.
Actual
Variance

Planned vs Actual Material Cost Analysis
Across Projects
For All
Selected Project
Costs
Actual
P
R
O
J
E
C
T
Plan
Raw Material Consumption
Real Experience.
Real Advantage.
Variance

External Service Order Planning
Purchase
Requisition
Service Activity
Real Experience.
Real Advantage.

Service Acceptance Through Entry Sheets
Real Experience.
Real Advantage.

Booking of External Services to Project
Costs
Plan
Real Experience.
Real Advantage.
Actual
Variance

External Services Analysis
Status Indicator
Real Experience.
Real Advantage.

CATS
Materials
Contract services
approval)
Cost Allocation
Automatic postings
Financial analysis
Budget control
Real Experience.
Real Advantage.
Document Processing
With e-Signature Approval
Document Status
Digital Signature
Real Experience.
Real Advantage.
Document Processing
With e-Signature Approval
Document attached to
Project Activity
Real Experience.
Real Advantage.

CATS
Materials
Contract services
approval)
Cost Allocation
Automatic postings
Financial analysis
Budget control
Real Experience.
Real Advantage.
Cost Allocation
Manual Cost Apportionment to Project
Amount
R&D Generics
Cost Center
Travel & Enter

Cost Element 612000
Real Experience.
Real Advantage.
Project Root WBS

Element
Cost Allocation
Booking of Apportioned Costs to Project
Costs
Actual
612000 Travel & Entertainment
Real Experience.
Real Advantage.
Plan
Variance

CATS
Materials
Contract services
approval)
Cost Allocation
Automatic postings
Financial analysis
Budget control
Real Experience.
Real Advantage.
Financial Analysis
Planned vs Actual Costs Analysis
Hierarchical View
Costs
Plan
Actual
Real Experience.
Real Advantage.
Variance
Financial Analysis
Planned vs Actual Costs Analysis
Cost Element View
For Selected Project
Costs
Actual
Real Experience.
Real Advantage.
Plan
Variance

CATS
Materials
Contract services
approval)
Cost Allocation
Automatic postings
Financial analysis
Budget control
Real Experience.
Real Advantage.
Budget Control
Allocation of Budget to Project
WBS Element View
Planned Costs of Project

WBS Element
Budget allocated
Real Experience.
Real Advantage.
Budget Control
Allocation of Budget to Project
Fiscal Period View
Budget allocated
Planned Costs of
Project
Period
Real Experience.
Real Advantage.
Budget Control
Message When Budget is Exceeded
Control Message When Project
Costs Exceeds Allocated Budget
Real Experience.
Real Advantage.
Budget Control
Budget vs Actual Cost Analysis
Costs
For Selected
Project
Budget
Actual
Variance
Summary
Year wise
Real Experience.
Real Advantage.

CATS
Materials
Contract services
approval)
Cost Allocation
Automatic postings
Financial analysis
Budget control
Real Experience.
Real Advantage.
Capacity Evaluation & Leveling

Resource Capacity Analysis
Capacity Planning
Overload
Capacity Evaluation
Real Experience.
Real Advantage.

Pharma

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James Chi & Jeff Clark - Grom Associates, Inc.

Ed Sullivan - EnteGreat, Inc.

Rapid Commercialization Strategies

Key Learning Points

Understand the business drivers for

z Founded in 2000 - Mgmt team has

Copyright 2008 Grom Associates, Inc. and EnteGreat

The Pharmaceutical Industry is Under a Great

Internal Industry Pressures

z Ageing population will drive up

z Rising commercialization costs. The

Copyright 2008 Grom Associates, Inc. and EnteGreat

For Pharmaceutical R&D, These are Bittersweet

Exciting scientific advances offer greater

Copyright 2008 Grom Associates, Inc. and EnteGreat

The next ten years will be seen as

For Pharmaceutical R&D, These are Bittersweet

Copyright 2008 Grom Associates, Inc. and EnteGreat

For Pharmaceutical R&D, These are Bittersweet

Copyright 2008 Grom Associates, Inc. and EnteGreat

Big Pharmaceutical Companies Are Undergoing

Become the Leader in delivering value to customers

Build effective and efficient business model

Rethink the way

Rethink the way

Create a high performing organization

= Direct contribution by R&D

Copyright 2008 Grom Associates, Inc. and EnteGreat

Rapid Development & Commercialization

Copyright 2008 Grom Associates, Inc. and EnteGreat

Rapid Development & Commercialization

Copyright 2008 Grom Associates, Inc. and EnteGreat

Tufts Center for the Study of Drug Development (CSDD),

Validation and Quality Assurance

GROM Solution Portfolio for Life Sciences

Copyright 2008 Grom Associates, Inc. and EnteGreat

Solution Overview Rapid Commercialization

= Areas with accelerated solutions

Copyright 2008 Grom Associates, Inc. and EnteGreat

Solutions Featured in Todays Presentation

n Integrated Portfolio and Project Management

Copyright 2008 Grom Associates, Inc. and EnteGreat

Portfolio And Project Management:

Copyright 2008 Grom Associates, Inc. and EnteGreat

Portfolio And Project Management

Copyright 2008 Grom Associates, Inc. and EnteGreat

Portfolio And Project Management

Copyright 2008 Grom Associates, Inc. and EnteGreat

Key Technology Enablers

Integrated Portfolio & Project Mgt.

Copyright 2008 Grom Associates, Inc. and EnteGreat

Project System Solution for R&D

Please refer to the supplementary reference materials section

Pre-Configured R&D Project System Solution

typical project up to 3 months in design and implementation

Rapid Compliant Commercialization

Eliminate the toss it over the wall syndrome after approval

Copyright 2008 Grom Associates, Inc. and EnteGreat

Rapid Compliant Commercialization

Key Business Capabilities

Rapid Compliant Commercialization

Reduction in Product Costs

Reduction in Engineering Change Orders Cycle Time

Reduction in Design Cycles