Improving Profitability of Life Sciences Industries Using...

By Valentijn de Leeuw

ARC WHITE PAPER

AUGUST 2013

Improving Profitability of Life Sciences Industries Using Good Asset Information and

Compliance Management Practices

Executive Summary .................................................................... 2

Halving the Time from Product to Operational Readiness .................. 3

Integration of Process Design, Engineering and Plant Operation ........ 5

Integrating Asset Information and Compliance Management ............. 8

Expected Benefits and Impacts on Risk and Profitability .................. 11

Recommendations ..................................................................... 15

References ............................................................................... 16

VISION, EXPERIENCE, ANSWERS FOR INDUSTRY

ARC White Paper • August 2013

2 • Copyright © ARC Advisory Group • ARCweb.com

Executive Summary

Squeezed between pressure from consumers and regulators alike to in-

crease drug quality and safety, and from governments to reduce healthcare

costs, the life sciences industry must transform the way it develops, manu-

factures, and commercializes new drugs. This challenge also represents a

tremendous opportunity for the industry. Companies such as Sanofi and

Novartis have pioneered new ways to improve process development, plant

engineering, asset management, and compliance management, yielding

impressive results. Both companies have used one of the Siemens software

solutions, COMOS, to help streamline their process for maintaining asset

information used throughout development, engineering, operations

maintenance, and compliance management processes.

Combined with other process streamlining activities, this helped reduce

engineering effort by between 10 and 20 percent. ARC Advisory Group

also estimates that these process streamlining efforts can help reduce the

time it takes a drug company to move from drug development to opera-

tional readiness for full scale production by around three to seven months

to help reduce investment risk and improve profitability.

As we’ll also explore in this paper, in the coming years, leading life sciences

companies will also implement modular production technologies and

modular engineering processes to further reduce the development and en-

gineering phases. These will help them to anticipate and adapt rapidly to

changes throughout a drug’s lifecycle.

COMOS software provides an “asset data hub” for process design,

engineering, maintenance, operations and compliance management. This

provides life sciences manufacturers with close to real-time visibility into

engineering information, asset state, and asset health. This is paramount to

help accelerate development and engineering processes. The solution links

operational risk assessment to asset requirements and test plans,

accelerating certain regulatory approval tasks. It also enables accurate and

timely decision making during operations and maintenance and helps

ensure up-to-date plant documentation. In addition to cost and time

benefits in R&D; business benefits include reduced operational and safety

risk; increased productivity of engineering, maintenance and operations; in

certain cases faster operational readiness of assets and operations

personnel; and more accurate and less costly regulatory compliance.


Copyright © ARC Advisory Group • ARCweb.com • 3

Tutzing Principles

Be fast: the market does not wait

Think and engineer using standard solutions and modules

Create reusable models for processes, information and work flows

Know your impact on profitability and risk of your project

Avoid perfectionism: precision is expensive and takes more time

Create relationships of trust with providers and clients

Maintain continuity from development until commissioning

Halving the Time from Product to Operational Readiness

In this section we present the “Tutzing Principles,“ which represent a para-

digm shift in thinking in pharmaceutical and biotechnological process

development. We’ll also present associated research results that promise

dramatic reductions in process development, engineering and plant con-

struction time in the near future. In further sections, we will build upon

these principles to explain methodologies and systems that can be applied

today and discuss the potential benefits.

The “50 Percent” Concept Under pressure to improve R&D productivity, time-to-operational-

readiness and reduce investment risk in the specialty chemicals and life

sciences industries, the participants of the German Tutzing Symposium in

June 2009 defined the principles that could ultimately lead to reducing

development, engineering, construction,

and commissioning time by 50 percent.

While this long-term goal remains distinc-

tively German, international research that

enable “Tutzing” goals have made great

strides toward this objective. For example

modular production and process intensi-

fication both offer high potential for

reducing time to operation and much

more.

Modular Production

The F3 Factory project, financed by some

25 companies and the EU, started the

same month the Tutzing Symposium was

held, provides a highly visible example of this research. The goal of F3 Fac-

tory was to overcome the disadvantages of large-scale continuous

processing (high capital investment and rigidity) and small scale-batch pro-

cessing (inefficiency) and combine the respective advantages by

introducing efficiency to multi-purpose, multi-product facilities; and flexi-

bility to world-size continuous facilities. Research objectives included:



The Potential of Modular Production

Considerably lower capital investment

Lower working capital requirements

Significantly lower engineering cost for upscaling

Far lower energy consumption

Flexible production quantities

Exploitation of PAT and science-based production technologies

Geographically mobile production

Capability to serve highly dynamic supply chains

Provide more compact and less costly process designs that lower

environmental impact to support “process intensification”

Develop standardized, modular, plug-and-play chemical produc-

tion equipment capable of handling many chemical processes

Develop engineering methodologies for intensified processes

The project has delivered many promising results and several modular

processes have been developed. These include one for specialty polymers,

a specialty chemicals surfactant for a CPG

application, and an active pharmaceutical

ingredient (API) process. All have

demonstrated significant gains in both

cost and sustainability.

Intensified processes – using small

equipment with a very high sur-

face/volume ratio – are highly efficient in

heat transfer and mixing of fluids; requir-

ing much less steel for the same

production capacity. They also have low-

er residence times. These translate into

reduced capital investment cost, reduced,

energy consumption, and lower working capital. The idea is that, to scale

up production capacity, a manufacturer needs only to add standardized,

small-sized units; rather than engineering a larger plant. This reduces en-

gineering cost and time, and reduces equipment cost even further because

larger series of equipment can be built. The concept requires a new engi-

neering approach that optimizes the process within the constraints of a

choice of standard modules, rather than tailoring equipment to the process.

The trend is to produce smaller quantities, introducing gradual improve-

ments in product and process and responding flexibly to market demands.

This provides the potential to exploit the flexibility of a plant designed for a

range of operating conditions, and thus for designing equipment to fit an

expected range, rather than a single optimum. The use of adaptive produc-

tion optimization and quality management systems in line with the latest

FDA cGMP guidelines will be favorable in these conditions since they will

absorb process modifications and variability in processing conditions when

some or all of the end-product remains identical.



The use of the modular production concept would eliminate a range of en-

gineering and validation tasks, since varying production rates can be

handled by adapting the number of production lines required to produce

the required quantities.

We expect these concepts to have a major impact on reducing process de-

velopment effort and duration in both pharmaceutical and biotechnological

processes in the next few years.

Integration of Process Design, Engineering, and Plant Operation

Important improvements in the duration of process development are acces-

sible today. In particular, the Tutzing principles of modular engineering

and reuse, which are not restricted to modular production units, can con-

tribute to these benefits. Integrated engineering, asset information

management, and compliance management will also help reduce the time it

takes to develop new manufacturing processes.

Tauchnitz’ Vision

In 2005, Thomas Tauchnitz of Sanofi (then Sanofi-Aventis) published a vi-

sion for “integrated engineering” (Tauchnitz, 2005). Dr. Tauchnitz explains

that “three basic requirements shall be respected: every information is generated

and maintained at only one location, existing knowledge is reused where possible,

and the software tools stay interfaced while the production plant is in operation.”

He sketched the workflow starting with process design using process simu-

Bayer’s Process Equipment Container



Benefits of Integrated Engineering and Operations

The usage of a single, consistent and up-to-date database for design,

engineering, construction, handover, operations and maintenance can help

increasing productivity, shortening project time, accelerate operational readiness, and improve regulatory

compliance.

Tauchnitz’ Principles for Computer Integrated Production and Engineering

Every information is generated and maintained at a single location

Existing knowledge is reused where possible

The system remains in use while the plant is in operation

lation software, followed by the transfer of the resulting process infor-

mation to an engineering software tool, common to all engineering

disciplines involved in front-end and detail engineering. He explained how

modular engineering should be implemented –

with standardized, generic engineering mod-

ules comprising all functions built and

maintained within the common tool.

For example, a reactor module would contain

temperature and pressure measurement and

control, valves for material transfer, level con-

trol, safety equipment and automation, stirring

etc. The corresponding equipment lists, design

documentation, safety procedures, testing and qualification procedures

would be part of the template as well. Instead of engineering every new

equipment, replacement, modernization or repair action from scratch; the

engineer would instantiate a module from the library, adapt it as needed,

and then integrate it within a larger system.

This would leave the engineer more time to optimize the design and im-

prove and maintain the generic modules. Since all disciplines have access

to the same up-to-date information, collaboration is improved and errors

and iterations are minimized. It appears that Dr. Tauchnitz’s vision

inspired the Tutzing principles of using standard

engineering solutions and modules and creating

reusable models for processes, information, and

work flows.

Dr. Tauchnitz recognized that compliance manage-

ment could be performed efficiently in the same

software environment. He explained that the analy-

sis of risks related to the process and the equipment

on the product quality can be systematically derived

from engineering information and partially auto-

mated by the engineering tool. The results of the

analysis must be reflected in appropriate requirement specifications and

designs. Once the design is finalized, testing and qualification plans can be

derived automatically from the engineering information. Test and qualifi-

cation results, can be linked back to equipment requirements and the risk

analysis, providing compliant validation. Tauchnitz also observed that

concern for testing and qualification extends beyond life sciences.



COMOS

COMOS is Siemens’ software solution for plant engineering and operations in the process

industries. It supports process design, basic and detail engineering activities, e.g. like piping and instrumentation engineering as well as electrical,

instrumentation and control engineering. In addition, COMOS supports plant operations and

maintenance management up to decommissioning. It offers document management solutions including workflow enforcement and change control as well as risk evaluation, testing and qualification options for regulatory compliance. According to Siemens,

with its object-oriented approach and single database for all lifecycle phases and disciplines, COMOS provides instantaneous and complete transparency of information related to a plant

object for all stakeholders. Configurable workflows enable different disciplines and roles in engineering

and operations processes to collaborate in a structured manner.

Based on these capabilities:

Engineers have direct access to information changed by colleagues in other disciplines. This can increase the degree of parallel engineering.

Object-orientation enables modular engineering. Applied throughout the enterprise, it improves standardization that generates time and cost benefits, facilitates cooperation and increases flexibility in personnel assignment

The time to find information is reduced substantially, which leads to productivity improvements.

Operational readiness can be predicted more reliably and reached sooner.

Configurable workflows enable compliant, quality controlled processes, projects, and document generation

Plant documentatioin is kept up-to-date to meet regulartory obligations

Dr. Tauchnitz also extended his concepts to configuring industrial automa-

tion and production systems, such as

distributed control systems (DCS) and

manufacturing execution systems (MES)

and other Manufacturing Operations

Management (MOM) systems.

The next step for Dr. Tauchnitz is the

transfer of the engineering information

to operations and maintenance and

keeping it up to date with the goal to

transform “as-built” information into

“as-maintained” information to ensure

accuracy and save time.

Finally, Thomas Tauchnitz develops the

vision for implementing standardized

processes across the extended enter-

prise, reducing the number of systems

and interfaces, and organizing central-

ized maintenance and support and

promoting company-wide knowledge

management.

Status Today

To implement his vision in greenfield

projects at Sanofi in Germany, Dr.

Tauchnitz utilized the COMOS software

solution, which maps well to his ap-

proach. Tauchnitz told ARC that

engineering and implementing standard

modules requires substantial effort, but

once the modules are defined, the engi-

neering effort is lowered considerably

compared to former practices. In col-

laboration with Siemens, Tauchnitz’s

team developed a bi-directional inter-

face between COMOS and the PCS7

process automation system. According

to Dr. Tauchnitz, this automation con-



The First Commercial Scale Modular Production Units Are Coming on Stream

Novartis’ biologicals manufacturing facility in Singapore planned to go in operation in

2016, is according to Chris Snook, head of Novartis Group Country Management „[...]

designed to lean principles and a mix of new disposable technology and stainless steel

vessels; equipment modules allowing high degree of repetition on design and

automation.“ Would there be a better way to exploit modular engineering and integrated

information and asset management? (Source: Gil Y. Roth, 2013)

figuration and programming interface produced a 20 percent savings in

engineering effort, but this only represents a fraction of the benefits. How-

ever, since modular engineering techniques and integrated, cross-discipline

engineering practices affect people’s work processes and practices, a suc-

cessful implementation also requires careful planning of change

management, including user participation and continued management

coaching and support.

Integrating Asset Information and Compliance Management

Dr. Tauchnitz’ vision is still not a reality for many companies. Engineering

procurement and construction (EPC) companies and their subcontractors

do all their engineering work with computer-aided design software. How-

ever when a plant is commissioned, documentation is still often handed

over on paper. As a result critical engineering

and configuration information is lost that

could otherwise provide the owner-operators

with significant operations and maintenance

value.

With hard-copy, paper documents for opera-

tions and maintenance, changes are

documented as hand-written corrections. In

the best case, electronic documents are updat-

ed afterwards. This process is both time

consuming and error prone, information is

regularly out of date, and interactions be-

tween disciplines lead to unnecessary

iterations. Many engineering databases and

systems do not have the functionality to support operations and mainte-

nance and, as a result, a maintenance management system must be primed

with “as-built” information, extracted from the handover documents. When

the company needs to modify, maintain or modernize a plant or a produc-

tion line; plant personnel often have to start by tediously searching for as-

built and as-maintained data to input into the engineering systems. One

can easily imagine the time this takes and the risk of inaccuracy and incom-

plete data this involves.



Halving the Time from Development to Market Is within Reach

Recently Novartis finalized a project commonly carried out with MIT, to

produce Diovan, using an „ultra lean“ continuous process, reducing production

time from one year by the tranditional batch route to six hours. Novartis’ CEO

Jimenez mentioned in his speach at MIT , that continuous processing of

pharmaceuticals could „cut the time from product development to market entry in

half“ (Source: Joseph Jimenez, 2012)

The following case study, involving the worldwide rollout of COMOS at

Novartis, demonstrates that the integrated engineering vision implemented

in this type of system can be applied succesfully to both brownfield and

greenfield projects, in engineering, operations and maintenance. We’ll also

see that since COMOS also supports this, Novartis developed a roadmap to

integrate both asset management and compliance management.

Novartis’ Journey Towards Paperless Asset Lifecycle Documentation

Novartis’ primary goal for engineering IT is to make asset lifecycle infor-

mation available to engineering, operations, and maintenance groups using

tablets, desktop computers, or shared large-screen monitors. Novartis

came independently to an implementation strategy consistent with the

Tauchnitz principles described above. Novartis used COMOS as the main

application for technical information, in conjunc-

tion with SAP PM and CMX, an application for

paperless calibration.

Christoph Jauslin, Head of Engineering IT at

Novartis reported about the implementation at

the COMOS software conference in April 2012.

The reduction to only a few applications re-

quires high availability and synchronization.

For replicated information, exceptions are made

based on the principle of “single location,” and

replaced by replication with “single ownership.”

Novartis wanted to implement the system for

both new and existing plants. The company

migrated all available electronic information and

shut down legacy applications after the transfer. The company started

scanning static, paper-based information and storing it electronically, a

process that will take several years. More dynamic paper-based infor-

mation likely to require updating is or will be re-created electronically in

the appropriate software application.

Mr. Jauslin mentioned that business processes changes related to the im-

plementation required tight collaboration between the respective

departments. Engineering workflows were simplified, and the reduced

number of interfaces reduced manual data entry requirements. The com-

pany has now rolled out system and the associated standardization in its



plants from California to China, enabling facilities around the world to col-

laborate without email attachments. In Basel, Switzerland, this resulted in a

reduction from seven applications to one and the company plans to roll out

the system to the few remaining plants in the world.

The implementation was done discipline by discipline. It took a few

months to get the users up and running and then another two to three years

to enter all data and enable full benefits to be realized. Today Mr. Jauslin

estimates the engineer-

ing effort is reduced by

10 to 15 percent on an

ongoing basis.

In the company’s con-

tinued quest for

paperless documenta-

tion, Novartis also

wishes to transition to

paperless qualification

documentation. Busi-

ness goals are to

reduce errors by re-

ducing or eliminating

manual entry and cop-

ying of information,

global harmonization and acceleration of workflows, and improved data

management and information availability. COMOS is designed to meet the

requirements for compliance with US FDA 21 CFR 11 electronic signatures

for paperless risk analysis. To fulfill all Novartis requirements, Siemens

recently implemented additional functionality covering more extended

project support. This includes scope and compliance document templates

for engineering, construction, and operation; and document lifecycle man-

agement with approval workflow and project controlling capabilities.

The functional scope that Novartis plans to implement in COMOS to sup-

port the company’s business processes includes e-Document Management,

e-Workflows and Reports, e-Testplan Management, and e-Risk Manage-

ment. Additional plans include a web browser interface for people who

rarely using the system to easily review, approve, and sign a document.

!

`COMOS Provides Asset Information Quality and Usability for Engineering and Operations/Maintenance



Consistent with Dr. Tauchnitz’ vision, COMOS’ object orientation enables

users to execute test plans during commissioning by engineering module,

and link test and qualification results using existing engineering infor-

mation. In the medium term, system access in the plant will be provided on

tablets. In operations and maintenance phases, the documentation can be

updated following maintenance or repair and kept compliant. Mr. Jauslin

estimates that the implementation of integrated compliance management

will lead to a total saving of engineering effort of 20 to 25 percent, or an

additional 10 percent.

Expected Benefits and Impacts on Risk and Profitability

The experiences at Sanofi and Novartis indicate a reduction of engineering

effort in the process development activities in a range of 10 to 20 percent.

Monitoring & controlling

High-level risk

assessment Review & approval

Test & confirmation

Review & approval

Definition & setup

Review & approval

User requirements

Detail design

Performance qualification

Implementation

Validation master plan

Validation report

Quality, project & test planning

Quality report & handover

Installation qualification

Functional design Operational qualification

Creation & release

Review & approval

COMOS Provides Project and Workflow Support for Integrated Asset Information and Compliance management



Both companies’ willingness to publish these figures leads us to believe

these figures could be conservative.

Based on the benefits reported by both companies, ARC assessed the im-

pact of reducing the process development time and effort on the overall

duration and cost of pharmaceutial R&D. We discuss the impact of these

on discounted cash flows, financial risk and profitability.

Impact of Gains in Process Development and Upscaling Effort on R&D Costs

The vivid discussions on the topic in recent literature indicate that

accurately determining absolute costs

for drug development remains an elu-

sive goal. We found two similar

estimates of the average cost structure

of pharmaceutical companies in relative

terms (European Commission, 2009;

APV and University of Sankt-Gallen,

2007), and will consider these sufficient-

ly reliable to make a conservative

estimate of benefits for investment justi-

fication, for which accuracy is not

required.

Research-driven pharmaceutical manu-

facturers spend around 20 percent on

R&D (European Commission, 20091; see

1 Notethatpercentagesdonotaddupto100%astheyrepresenttheaverageofpercentageswithrespecttocompany’sturnovers

Allocation of R&D Investments by function in percent. Source: PhRMA cited by EFPIA 2012

Average cost factors as percent of turnover for prescription medicines. Source: European Commission (2009).

0% 10% 20% 30% 40% 50% 60% 70% 80% 90%

Research driven manufacturers

Generics manufacturers R&D costs

Manufacturing costs

Marke ng and promo on costs

General adminstra on and overhead

Distribu on costs

Other



figure above), of which more than half is devoted to the clinical trials

(EFPIA, 2012; see figure below). Process development for manufacturing

and quality control starts before the phase I clinical trials. Plant engineer-

ing starts in phase III and both activities end when full-scale production

starts. We roughly estimate process development to represent 20 percent of

expenditure for clinical trials, or around 10 percent of total R&D cost. The

PhRMA data cited by DiMasi et. al. (2003) mentioned 8.3 percent, confirm-

ing our estimate. The range of savings of between 10 and 20 percent using

an integrated engineering approach compared to using traditional land-

scape of islands of applications would then result in an average estimated

saving of 1 to 2 percent of turnover and a similar percentage per drug.

Impact of Gains in Duration of Plant Engineering on Time to Operational Readiness, Cash Flow, and Financial Risk

Can savings in engineering effort translate into shortened time to industrial

production? When interviewed by ARC, users and EPC’s report that for

companies that work sequentially, the proportion will be very high. Com-

panies whose major project constraint is time, use a high degree of

engineering parallelism. To compensate for the iterations and rework relat-

ed to the parallelism, those companies use additional resources.. These

companies will experience less shortening of engineering and scale-up

phases however, they will experience a higher-than-average impact on total

engineering efficiency. This is because they will recover part of the non-

productive iterations and effort by using an integrated engineering meth-

odology and a common engineering repository such as COMOS. Very high

degrees or parallelism are found in EPC companies, where fine chemical

and pharmaceutical manufacturers report parallelism from close to none,

up to around two-thirds.

ARC considers that the transformation of half the gains in engineering ef-

fort into gains in shortening engineering and upscaling would be a

conservative estimate. This is between 5 and 10 percent of the process de-

velopment and plant engineering tracks of five to six years for a typical

pharmaceutical project, or a range of three to seven months, corresponding

to a 2 to 6 percent of the time from patent to full-scale production. If these

gains can be exploited to shorten the time to operational readiness will de-

pend on the fact if engineering is on the critical path of the project. In some

cases the approval process is the limiting factor.



Contribution to the “50 Percent” Concept

With a conservative estimation of 5 to 10 percent reductions in the duration

of the process development and plant engineering tracks, accessible today

to pharmaceutical firms, we’ve identified a considerable portion of the goal

of 50 percent of the Tutzing goal. The use of modular plant equipment may

add another 20 to 30 percent of gains, and possibly more (See Side Box on

p.9). Other gains could be realized from business process integration and

acceleration. Further integration with business processes outside engineer-

ing could bring further gains in effort and acceleration, as Novartis

mentions at the COMOS

Software Conference.

Impact on Cash Flow,

Payback, and Financial

Risk

As shown by Bramsiepe

et. al. (2011), when short-

ening the product-to-

production period when

investment, production

cost and annual revenues

remain identical; dis-

counted cash flows are

more favorable than the

cost savings alone, since

interest contributions

accumulate during a

shorter period. As a con-

sequence payback times

reduce more than pro-

portional to the time

gains, net revenues build up faster and reduce financial risk compared to

the same product developed over a longer period In addition, shortening

time-to-market provides access to higher market shares, making the cash

flow development even more favorable.

Benefits for Operations and Maintenance

For research-driven pharmaceutical producers, the manufacturing cost rep-

resents around 20 percent of expenditures. For generics producers this

amount is over 50 percent (European Commission, 2009; see figure on page

Phases Of The Research And Development Process (source: EFPIA)



12). A 2007 benchmarking study by APV and the University of Sankt-

Gallen in Switzerland showed that world-class providers can reduce these

costs significantly while maintaining or improving performance aspects

such as quality. The study identifies maintenance practices as one of four

major business processes contributing to operational excellence and busi-

ness results.

In line with the Tauchnitz vision, use of a single, consistent and global data

hub such as COMOS, kept up-to-date at all times by all disciplines, creates

instantaneous and complete transparency of information for each plant

object and for all parties. When engineering and asset information is hand-

ed over to operations it can be kept up to date and exploited for trouble

shooting operations, routine maintenance, and more involved activities,

such as replacement or repair of equipment, capacity extensions or modern-

ization of automation and instrumentation.

Expected gains that directly impact manufacturing cost include reduced

effort, significantly shortened project times, reduced cost and effort for

compliance with the requirement of up-to-date plant documentation. Fur-

thermore, faster and more appropriate reactions to operations issues reduce

both unwanted downtime and operational risks. At this time, we have no

quantified information on maintenance productivity using COMOS. The

aforementioned benchmarking study identifies 16 percent of gains in man-

ufacturing costs, identified as the difference between average and top 10

percent performers. If we attribute only a quarter of that to maintenance

practices, and half of that to integrated engineering and a common tech-

nical repository, this corresponds to 2 percent of manufacturing costs, or a

little less than half a percent of turnover.

Recommendations

Based on the research conducted for this paper, ARC Advisory Group rec-

ommends that life sciences companies:

Define a long term strategy for innovation and drug development with

stimulating and ambitious goals for improvement (refer to the Tutzing

principles and Dr. Tauchnitz’ vision).

Analyze process development and plant engineering, operations and

maintenance processes, including information processes. Define global



medium-term goals and evaluate processes and their results. Optimize

the processes and IT landscape and re-evaluate. Make a business case

to quantify the incremental benefits.

When implementing change, make sure the culture change aspect is

given the time and attention it needs. This is a prerequisite for sustain-

able improvement.

Create oversight and monitor, evaluate, support, benchmark and con-

tinuously improve processes and applications globally through

governance and/or corporate excellence initiatives.

References

J. A. DiMasi et al., 2003, „The price of innovation: new estimates of drug

development costs“, Journal of Health Econonomics, Vol. 22, pp, 151-185.

C. Bramsiepe et al., 2011, “Schneller zur Produktion“, Chemietechnik, 3,

2011.

European Federation of Pharmaceutical Industries and Associations

(EFPIA), 2012, “The Pharmaceutical Industry in Figures,

http://www.efpia.eu

European Commission, DG Competition, 2009, “Pharmaceutical Sector In-

quiry Final Report”.

C. Jauslin, 2012, “Successful Global Implementation”, presentation at the

“International COMOS software conference”, Berlin, April 18th and 19th,

2012.

Joseph Jimenez, 2012, “A Defining Moment: The Future of Manufacturing

in the US“, MIT Technology Review, MIT Leaders for Global Operations,

May 10th, 2012, http://www.youtube.com/watch?v=vhpmSf1db4Q.

Siemens Process News, February 2010, “We are moving in the Right Direc-

tion“.

Gil Y. Roth, 2013, “Newsmakers: Novartis’ Chris Snook“, Contract Pharma

(www.contractpharma.com), April 2013.



Thomas Tauchnitz, 2005a,“CIPE oder: Die Zeit ist reif für eine Integration

des Prozessentwurfs-, Engineering- und Betreuungs-Prozesses. Teil 1.” (CI-

PE or: It’s time for an Integration of the Process Design, Engineering and

Plant operation process. Part 1.), atp (Automated technical practice ) Vol.

47, Issue 10, pp. 36-43.

Thomas Tauchnitz, 2005b, “CIPE oder: Die Zeit ist reif für eine Integration

des Prozessentwurfs-, Engineering- und Betreuungs-Prozesses. Teil 2.” (CI-

PE or: It’s time for an Integration of the Process Design, Engineering and

Plant operation process. Part 2.), atp (Automated technical practice ) Vol.

47, Issue 11, pp. 56-464.

University of St. Gallen and APV, 2007, “International Benchmarking

Study: Operational Excellence in the Pharmaceutical Industry, Industry

Report”



Analyst: Valentijn de Leeuw Editor: Paul Miller

Acronym Reference: For a complete list of industry acronyms, please refer to www.arcweb.com/research/pages/industry-terms-and-abbreviations.aspx

AIM Asset Information Management API Active Pharmaceutical Ingredient APV Arbeitsgemeinschaft fuer

Pharmazeutische Verfahrenstechnik

cGMP Current Good Manufacturing Practices

CPG Consumer Packaged Goods DCS Distributed Control System

EPC Engineering, Procurement, and Construction

EU European Union FDA Federal Drug Administration F3 Flexible Fast Future MES Manufacturing Execution System PhRMA Pharmaceutical Research and

Manufacturers of America R&D Research and Development

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All information in this report is proprietary to and copyrighted by ARC. No part of it may be reproduced without prior permission from ARC. This research has been sponsored in part by Siemens. However, the opinions expressed by ARC in this paper are based on ARC's independent analysis.

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Improving Profitability of Life Sciences Industries Using...

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