Enterprise Optimization

in the Pharmaceutical Industry

New Solutions and the Internet Spell Greater Value

There are tremendous new breakthroughs in the pharmaceutical industry–

but not necessarily where you might expect. The fact is, $28 billion of value
is waiting to be uncovered–not in products, but through more exacting
processes. It’s the value that’s trapped in pharmaceutical companies
by inefficiencies, bottlenecks, poor manufacturing cycle efficiency and
Headquarters
discontinuous workflows.
[world wide web] www.aspentech.com

Through enterprise optimization solutions that are now available—custom

worldwide headquarters
tailored for the pharmaceutical industry, organizations like yours are creating
Aspen Technology, Inc.
Ten Canal Park value in ways never before possible. New solutions and the Internet are
Cambridge, MA 02141 USA
[phone] +1 617 949 1000 making it possible to further sharpen a company’s competitive edge by
[fax] +1 617 949 1030
[e-mail] info@aspentech.com increasing efficiency, speeding time-to-market, improving asset agility,
uncovering additional value, and harnessing business opportunities offered
europe headquarters
by the New Economy. Here’s how it is being done.
AspenTech Europe S.A./N.V.
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2 New Opportunity to Uncover Additional Value

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AspenTech Asia Ltd.

2 Understanding What’s Required for Success
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Shell Tower, Times Square
3 Unique Characteristics of the Pharmaceutical
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[phone] +852 2/838 6077 4 Creating Value in the Pharmaceutical
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Enterprise
6 How AspenTech Delivers Enterprise
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Copyright © 2000. Enterprise Optimization, True Potential, Aspen Business Process Templates, Aspen Framework,
Aspen Engineering Suite, Aspen MIMI, Electronic Batch Record System, Aspen Manufacturing Suite, Aspen Marketplace
Solution, Aspen eSupply Chain Suite, Aspen B2B Foundation, Aspen Value Process, ApenTech and the aspen leaf logo
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Enterprise Optimization in the Pharmaceutical Industry

new opportunity to uncover additional value

Billions of dollars of value exist in the pharmaceutical market waiting to be claimed. Consider how much
could be gained by connecting your pharmaceutical organization to your customers, suppliers, and partners–
increasing informed decision-making speed, boosting time-to-market, and increasing efficiencies and profits.

Understandably, in the pharmaceutical industry, market forces continue to drive the adoption of the latest
advancements in enterprise optimization solutions. The latest generation of solutions is capable of generating
more value in each value-creation process chain, and offers the advantage of presenting new opportunities in
the Internet era.

Taking a More Pragmatic Approach

Over the past decade, pharmaceutical companies have enjoyed double-digit growth rates. Yet, maintaining
these growth rates has become extremely difficult because of declining windows of product exclusivity,
increased competition from generics, and new market entrants from third world countries. To maintain an
industry growth rate of just eight percent, industry analysts conclude that pharmaceutical companies will have
to triple the number of New Chemical Entities (NCEs) launched annually. Unfortunately, launching three times
the number of promising NCEs remains an enormous task and expensive at $600 million (US) each.

A more pragmatic approach is to employ new process improvement solutions that will lead to sustainable
increases in NCE discovery rates as well as other internal efficiencies that will increase effective patent protec-
tion time. Increased earnings unlocked by these internal improvements can fund additional NCE launches.

While there are billions of dollars of opportunity inside pharmaceutical organizations, the value remains
trapped in time-to-market opportunity costs, research and development inefficiencies, under-developed
processes for matching supply with demand, poor manufacturing cycle efficiency and discontinuous
workflows. Unlocking the value isn’t simple. It requires knowledge and implementation of the latest
technologies coupled with deep process knowledge across the pharmaceutical organization. This is the
essence of AspenTech’s Enterprise Optimization™ solution for the pharmaceutical industry.

Our specialized expertise provides an extraordinary understanding of the unique requirements of the pharma-
ceutical industry. AspenTech’s Enterprise Optimization solution employs best-in-class technologies such as
neural networks, chemical process simulation, statistical process control, expert systems, stochastic simula-
tion, linear programming and other advanced planning methods. We are the only supplier to provide such a
rich portfolio of advanced solutions designed to maximize and harvest the pharmaceutical industry’s True
Potential™.

understanding what’s required for success

A successful Enterprise Optimization solution must recognize and address the specific industry’s characteris-
tics. Likewise, it must define and improve the critical value-creation processes and enhance these processes
to leverage the opportunities offered by the Internet.

Here are some ways Enterprise Optimization enables pharmaceutical industry leaders to improve business
performance:
• Innovation improving workflows to increase the NCE pipeline, and increase the number of NPIs while
reducing time-to-market.
• Collaboration actively involving customers, suppliers and partners to help improve value creation
across the extended supply chain, in process engineering/innovation and manufacturing.
• Integration creating more agile and responsive business processes both internally and among
external partners eliminating delays, costs, and dramatically improving organizational efficiency.
• Automation decreasing human errors, assisting in decision-making, speeding the scale of production
to meet clinical requirements and commercial production levels, extending beyond the effective
automation of the manufacturing assets and deriving more utility out of existing Enterprise Resource
Planning systems.
• Optimization enabling the enterprise to operate at globally optimal performance levels as opposed to
a series of local optima, which may not represent the best performance for the business as a whole.

© Copyright 2000 Aspen Technology, Inc. DECEMBER 2000 2

Enterprise Optimization in the Pharmaceutical Industry

unique characteristics of the pharmaceutical

industry
Critical Windows of Product Exclusivity
Extending the effective window of exclusivity of a drug is of paramount concern for sustaining sales and
earnings. Just consider that the projected revenue losses due to expiring patents over the period 2000–
2005 will exceed $20 billion (US).

Between 2000 and 2005, 130 pharmaceutical drugs are expected to lose their patent protection, opening the
floodgates for generic manufacturers to begin sales of their versions. Generic manufacturers begin planning
their production of these drugs years prior to the patent's expiration. As an example of the potential lost
market share, Glaxo Wellcome’s patent for Zantac expired at the end of July 1997. After only three months,
generic versions grabbed 60% of the prescriptions, dramatically impacting sales and earnings.

Extensive Regulatory Requirements

Regulatory compliance issues frequently cause significant time-to-market delays—time that reduces
competitiveness and revenues. Yet, pharmaceutical companies must adhere to multiple regulations imposed
by various organizations. These include the US Food and Drug Administration (FDA), the European Agency
for the Evaluation of Medicinal Products (EMEA), the Environmental Protection Agency (EPA), and the
Occupational Safety and Health Administration (OSHA). In addition to adhering to the regulations of these
governing bodies, pharmaceutical companies must follow established practices such as Current Good
Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).

Many of the guidelines and regulations are complex and subject to multiple interpretations. In addition,
while these regulations are necessary to ensure product safety and traceability, they tremendously increase
the requirements placed on pharmaceutical manufacturers. Two of the most notable examples are:
• In May 1987 the Food and Drug Administration published guidelines on general principles of validation,
requiring companies "[to establish] documented evidence which provides a high degree of assurance
that a specified process will consistently produce a product [that meets] pre-determined specifications
and quality attributes."
• August 20, 1997 the FDA put into effect 21 CFR part 11. This regulation has two parts, one pertaining
to electronic records, and the second pertaining to electronic signatures.

Complex Manufacturing Challenges

Because of the precise nature of pharmaceutical manufacturing, regulatory requirements dictate that strict
controls be integrated to assure precise batch and lot traceability as well as stringent quality control and
testing procedures. So to achieve higher asset agility and cycle time reductions, an Enterprise Optimization
solution must address the many complex manufacturing challenges faced by pharmaceutical companies.

Frequently, production is placed on hold until quality (QC) experts approve subsequent processing steps.
Significant delays can occur due to the variety of tests required. Many companies are looking for better
scheduling tools that will increase visibility of QC testing requirements.

Pharmaceutical manufacturing operations are often dynamic while, in most other industries, processes remain
constant for a particular product. In pharmaceutical manufacturing however, the processing steps can depend
on the subsequent product to be manufactured in the particular vessel or train, or the vessel’s preceding
contents. The primary reasons for these variations center on potential interactions which could reduce the
predictability, potency, or longevity of a compound. Typically, multiple levels of cleaning must be defined and
integrated into the production process.

Lengthy Research and Development Cycles

While thousands of compounds are discovered annually, only a small percentage of these NCEs actually enter
the pre-clinical stage, and less than ten percent become approved products. Identifying and developing the
NCE into a successful product takes from five to nine years at an average cost of $600 million (US). Seventy-
three percent of this cost is associated with NCE failure during the process. As a result, expediting the
research and development cycle speeds products to market and reduces costs.

© Copyright 2000 Aspen Technology, Inc. DECEMBER 2000 3

Enterprise Optimization in the Pharmaceutical Industry

Long Lead Times in Demand Planning

Long lead times can mean lost market share. Unavailable pharmaceutical products force consumers to seek
substitutes. People can’t afford to be patient with their health.

That’s why it is imperative for suppliers to understand demand and how they will meet it. However, demand
planning, production planning, scheduling, inventory and deployment planning can be extremely difficult
because some key active ingredients have lead times in excess of six months. Some production processes
may require up to 16 months due to process cycle time. And less-than-perfect coordination around packaging
and labeling of new product introductions or campaigns can also delay the time-to-market.

Many pharmaceutical companies try to hedge against these complexities by over-producing by two to four
times the potential expected demand. But by clogging their supply chains, they are often creating more
problems than they are solving, making it harder to respond to actual market dynamics and increasing
manufacturing costs through excessively large inventories.

Demanding Clinical Trials Workflows

Only in the pharmaceutical industry does the research and development process include clinical trials,
comprised of three complex phases. During these phases, process and product development work continues
and manufacturing must ramp up as the required quantities of the NCE increase with each step. Enterprise
Optimization must support and ease this ramp-up process.

For NCEs that are ‘on-track’ for approval, the volume requirements often grow exponentially due to study
design requirements. For example, a single compound with a target demand of ten units, can grow into 1000
when the clinical study designer considers multiple dosage forms, un-blinded, single and double-blinded
studies and the inclusion of placebos in the patient kits.

NCEs’ attrition rates per clinical phase are 30%, 50%, and 33% for Phase’s I, II, and III respectively. The cost
of each NCE failure increases dramatically as it nears the latter phases of clinical trials. This is compounded
by the problem of potentially promising NCEs becoming waylaid due to a shortage of protocol patients since
participation in a study is voluntary and dropout rates tend to be high. Solutions must provide timely and
complete information to quickly identify failed NCEs as early in the clinical trial process as possible.

In addition, substantiating a case for regulatory authorities requires accurate and comprehensive data. Data
must be saved and easily communicated to regulatory agencies with minimal effort.

creating value in the pharmaceutical enterprise

AspenTech creates value for pharmaceutical manufacturers by focusing first on where it’s needed most.
Here’s how our solutions help pharmaceutical companies leverage the Internet, achieve streamlined regulatory
compliance, capture industry knowledge and best practices, and improve new product development. We help
companies reduce the cost of goods sold, deliver greater ERP returns, and provide support for clinical trials.
And AspenTech improves production management and control, supports Internet-enhanced collaboration and
improves time-to-market.

Internet-Enhanced Collaboration
AspenTech delivers value through the Internet by improving coordination with peer researchers, customers,
suppliers, and trading partners. Our capabilities over the Internet include:
• Collaborative Planning Forecasting and Replenishment (eCPFR)
• Collaborative Capable-to-Promise (eCTP)
• Collaborative Able-to-Promise (eATP)
• Collaborative Vendor Managed Inventory (eVMI)
• Collaborative Logistics
• Digital Marketplace

Using B2B Process Paks™, pharmaceutical manufacturers can implement collaborative efforts easily, scale
them to meet their requirements, and take advantage of AspenTech’s extensive experience in leveraging the
Internet to add value.

© Copyright 2000 Aspen Technology, Inc. DECEMBER 2000 4

Enterprise Optimization in the Pharmaceutical Industry

Streamlined Regulatory Compliance

AspenTech Enterprise Optimization automatically stores information required for internal analysis and
regulatory compliance. During production execution, compliance is automatic because the rules are
embedded in the AspenTech solution. Data automatically populates an electronic database that can be
used across the enterprise. As a result:
• Batch, lot, and genealogy data are available for regulatory requirements as well as internal analyses.
• Data to support Pre-Approval Inspections (PAI) and Clinical Trials Material (CTM) are automatically
archived.
• Environmental data is available to perform impact analyses and support regulatory requirements.
• Data to support health and safety impact analyses are available to the organization.

Through AspenTech Enterprise Optimization, regulatory compliance is achieved and time-to-market decreases
because many previously unsynchronized processes are now automated and connected. Resultant electronic
data can be used for electronic submissions, further streamlining the New Drug Application (NDA) process.

Built-in Industry Knowledge and Best Practices

AspenTech delivers business process solutions designed to meet the specific needs of customers in the
pharmaceutical industry. Aspen Business Process Templates™ (BPTs) combine best-in-class software
products with best practices, business processes and deep process and supply chain knowledge. The BPTs
act as a configurable starting point for companies implementing Enterprise Optimization solutions, and are
based on the Web-enabled Aspen Framework™ integration software. Customers can automate and optimize
business processes across the extended enterprise, including manufacturing, the innovation and engineering
lifecycle, supply chain logistics, and B2B workflow integration.

The breakthrough here is the move toward ‘configurable’ process industry solutions rather than ‘custom’
solutions. The Business Process Templates result in faster time-to-benefit, and dramatically reduce implemen-
tation cost while increasing solution deployment—by as much as 30% to 50% for a typical implementation.
Configuration creates substantial cost savings over build-it-from-scratch solutions while maintaining a high
degree of flexibility aimed at leveraging the unique competitive advantages of the customer.

Improved New Product Development (NPD)

Much of the product development process actually occurs within the window of patent protection. Any
process improvement in NPD increases the effective window of exclusivity, increasing sales and profitability.
Critical activities in NPD include formulation refinement, data archiving, and technology transfer (to scale
up production). The Aspen Engineering Suite™ has the ability to perform "What if" scenario modelling and
evaluation for formulation, dosage form, and process determinations. "What if" outcomes are known before
committing any physical capability or resources through the use of complex modelling methods. As a result,
the time required to select candidate drugs and move them to the next stage is drastically reduced.

NPD production data are accumulated into a large repository to allow for quick responses to Pre-Approval
Inspections (PAI) and Clinical Trials Material (CTM) requirements.

The Aspen Engineering Suite also includes an enabling tool that facilitates the transfer of products to other
production equipment and production locations. AspenTech facilitates the scaling of formulas that occurs at
this stage to optimize and ease production for various pilot and commercial manufacturing facilities.

Reduced Costs of Goods Sold

AspenTech allows pharmaceutical manufacturers to reduce costs of goods sold through production improve-
ments and decreased inventories. Aspen advanced modelling, simulation, and analysis tools provide greater
levels of understanding about the process, including equipment utilization. Through this increased knowledge,
processes are optimized, increasing batch yields and manufacturing cycle efficiency from the chemist to bulk
manufacturing. And inventory levels are reduced to optimal levels through Aspen MIMI™, an advanced
supply chain solution platform that makes inventory hedging an obsolete practice.

Greater Returns from ERP

During the 1990s, Enterprise Resource Planning (ERP) was thought to be the panacea of global enterprises.
Unfortunately, pharmaceutical companies realized that ERP packages provide partial solutions at best.
According to Gartner Group, even the most ambitious projects barely cover 30 - 40% of an enterprise’s
business processes. Even reaching that point can still consume tens, sometimes hundreds, of millions of
dollars and hundreds of staff years of effort. And once all those resources are invested, the need remains
to find or build solutions covering the remaining 60 - 70% of the business processes.

© Copyright 2000 Aspen Technology, Inc. DECEMBER 2000 5

Enterprise Optimization in the Pharmaceutical Industry

AspenTech Enterprise Optimization solutions add dramatic business value to existing ERP implementations by
providing enterprise-wide integration among manufacturing facilities and the global supply chain. ERP systems
provide the integration backbone for business transactions, and AspenTech provides the integration backbone
for information, knowledge, and insight, which represents the majority of the value from integration. Together,
the two systems can improve supply chain visibility, enhance decision support and provide better quality data.

The most significant opportunities for business performance improvement through ERP-to-plant system
integration accrue in:

• Production Planning – by planning and optimizing specific production orders, based on a clear picture
of enterprise capacities, constraints, and throughput.

• Material Requirements Planning – by using accurate inventory levels for Active Pharmaceutical
Ingredients (APIs), excipients, intermediates and finished products. Our optimization tools also perform
much more accurate and precise MRP calculations.

• Quality Management – by capturing quality and certification requirements for both raw materials and
finished products, and by generating certificates for finished products.

• Plant Maintenance – by utilizing asset management solutions that (1) identify equipment needing repair
or re-calibration, and (2) automatically generate the necessary maintenance work orders.

Working together with ERP, Enterprise Optimization delivers an accurate picture of the complete manufactur-
ing environment, the supply chain, and business/financial data, making investments in ERP more valuable.

Support for Clinical Trials Materials (CTM)

AspenTech collects and stores process and development data for internal analyses, and to support
submissions to regulatory agencies. A robust, accessible information repository decreases the time required
to collect and collate the information, adding incremental improvement to the product development process.

Improved Production Management and Control

In pharmaceutical manufacturing, the variability of production runs including lot sizes, number of products,
equipment, dynamic equipment conditions, and complex operating instructions spawns the potential for
human error and decreased productivity. Aspen Electronic Batch Record System (eBRS), a manufacturing
execution system (MES), is an integral component of the Aspen Manufacturing Suite™. Aspen eBRS enforces
production procedures while assuring regulatory compliance. All production information is acquired and
archived abiding by the rules and regulations for electronic records and signatures (21 CR Part 11). As a
result, human errors are reduced, manufacturing cycle efficiency increases, and the administrative cost of
documenting compliance is reduced.

Reduced Time-to-Market
Reducing the time to market results from various improvements realized throughout the implementation of
AspenTech’s Enterprise Optimization solution.
Some sources of time-to-market reductions are:
• Reducing time to scale-up production
• Increasing the efficiency of the formulation team by sharing information
• Assuring regulatory compliance during CT production
• More efficiently screening candidate NCEs
• Reducing the time to gather data required for regulatory submissions
• Improving the scheduling performance due to long lead-time ingredients
• Using "What If" scenarios to know before doing, and prevent time consuming errors

how AspenTech delivers enterprise optimization

AspenTech’s commitment is to identify and unlock the tremendous value available to pharmaceutical
companies by dramatically improving critical business processes across the enterprise. Our Enterprise
Optimization solution impacts the entire enterprise from the product lifecycle through the plant, and over the
Internet to collaborative partners and customers. With optimized processes in place, the Aspen Marketplace
Solution’s best-in-class technology also enables the creation of new private and public marketplaces. The
three major areas of value-creation include:

© Copyright 2000 Aspen Technology, Inc. DECEMBER 2000 6

 Enterprise Optimization in the Pharmaceutical Industry

• eSupply Chain Management by optimizing internal planning and coordination functions and laying the
groundwork for our Aspen Marketplace Solution, which tightens collaboration between the enterprise
and external business and trading partners.

• Product and Process Innovation by developing new products and processes, providing information for
clinical trials and efficiently transferring the technology to full-scale production.

• Manufacturing by increasing manufacturing agility, and efficiently making on-spec products while
adhering to regulatory requirements.

Across the Enterprise

"No other supplier offers a solution as
comprehensive for process manufacturers
to integrate the supply chain, engineering
innovation and manufacturing value
chain—all of which are required to fully
optimize their operations, enable
e-business and gain maximum value."
Dick Hill, Vice President, ARC Advisory
Group, October 10, 2000.
The Aspen eSupply Chain Suite™ enables pharmaceuti-
cal companies to integrate, automate and optimize global
supply chains and enable e-business through business
process integration with trading partners. With this
Internet-based technology, pharmaceutical companies
make better quality decisions which, in turn, increase
profitability. The Aspen eSupply Chain Suite provides
pharmaceutical manufacturers with the applications to
determine the most profitable mix of products; source raw
materials at the right time, quality, cost and location; and
deliver products to the right place at the right time at the
lowest cost.

Key business processes that Aspen eSupply Chain Suite integrates, automates and optimizes include:
• Portfolio and Enterprise Planning
• Comprehensive Demand Management
• Capacity Planning
• Inventory Management
• Production Planning, Scheduling, and Execution
• Distribution and Logistics Management
• Reporting and Analysis
• Capable to Promise

Across the Process Lifecycle

The Aspen Engineering Suite optimizes the process of taking pharmaceuticals from initial concept to general
availability on the market. This suite includes features supporting collaborative work processes with external
partners through the Internet. The result is accelerated time-to-market for new pharmaceutical products and
expansion of the effective window of exclusivity.
Key business processes addressed by the Aspen Engineering Suite include:
• Process Development and Improvement
• Product Research and Design
• Process Engineering
• Technology and Knowledge Transfer
• De-bottlenecking and Troubleshooting

In the Plant
The Aspen Manufacturing Suite optimizes processes involved in the conversion of raw materials into finished
pharmaceutical products. It provides the manufacturing agility and responsiveness needed to meet the
demands of the Internet era by dramatically improving throughput, reducing costs and managing compliance
to regulatory requirements. The Aspen Manufacturing Suite gives pharmaceutical manufacturers the ability to
make products at the lowest cost, with the highest added value, and at the minimal time required to best
satisfy customer needs—all while meeting safety and environmental objectives.

Key business processes addressed by the Aspen Manufacturing Suite include:

• Production Planning and Scheduling
• Production Improvement
• Production Accounting
• Customer Management
• Performance Analysis
• Asset Management

© Copyright 2000 Aspen Technology, Inc. DECEMBER 2000 7

Enterprise Optimization in the Pharmaceutical Industry

To the World
Aspen B2B Foundation™ is a family of products that meets the specific B2B requirements for integrating
inter-company and business processes. It streamlines the extended supply chain by allowing pharmaceutical
companies to automate key business functions such as order management, inventory management, collabora-
tive forecasting and planning.

This means that not only can companies exchange data in a mutually acceptable format, but that they can
also tie or integrate their disparate processes to each other. Each company is able to participate using the
most appropriate technology based on their role and the significance of their data exchange. B2B Foundation
enables Web-enabled B2B collaboration—the underpinning of successful collaborative applications such as
collaborative Capable to Promise (eCTP) and collaborative Vendor Managed Inventory (eVMI).

what’s the potential for your company?

AspenTech has identified $28 billion (US) of value trapped in the inefficiencies of pharmaceutical organiza-
tions. So it’s quite likely there are tens, maybe hundreds of millions of dollars trapped in your company’s
operations. To help assess the potential for your company, we offer the Aspen Value Process™ (AVP).

The Aspen Value Process (AVP)

The Aspen Value Process is an assessment and delivery methodology designed to discover the millions of
dollars in value that may be trapped in your operations and determine how those benefits could be realized.
It is a highly collaborative process in which we first educate your business and operational leadership team
on what is possible, and then engage in systematic analyses focused on your metrics, key performance
indicators, and objectives. AspenTech's own industry expertise and benchmark data serve as a key source
of information.

Together, we assess what level of improvement can be made by the application of our technology and services
to your business. The result of the assessment is a thorough cost-benefit analysis, ROI, and an action plan
detailing projects that will deliver the value. Customers are active participants and owners of the process, and
in many cases, present results to management themselves.

about AspenTech
AspenTech (http://www.aspentech.com) is the leading supplier of intelligent e-business solutions that make
process manufacturers powerful competitors. With deep process knowledge and best-in-class technology,
our products automate, optimize and accelerate performance by helping companies create and access net
markets, use the Internet to increase partner collaboration, and make business processes and extended
supply chains more efficient. We offer the broadest family of scalable solutions in the industry.

AspenTech is the one company with proven solutions that enable process manufacturers and their partners
to acheive dramatic results.

Discover how AspenTech can take your process to the power of e by visiting us at www.aspentech.com.

AspenTech’s Pharmaceutical Clients

Abbott Laboratories, AstraZeneca, Aventis, Baxter, Bayer AG, Biolabs, Bristol-Myers Squibb, Eli Lilly, Genentech, Glaxo Wellcome,
Hoffman LaRoche, Johnson & Johnson, Merck & Co., Monsanto Company, Novartis, Novo Nordisk, Pfizer, Pharmacia & Upjohn, Purac,
Sanofi, Schering AG, Schering-Plough, Searle, Shionogi, SmithKline Beecham, Warner Lambert, Yoshitomi Pharmaceuticals.

WP 105 12/00

© Copyright 2000 Aspen Technology, Inc. DECEMBER 2000 8