A PUTMAN LIFE SCIENCES WHITE PAPER

SPONSORED BY
IMPROVING TIME TO MARKET:
DRUG MANUFACTURINGS LEAN IMPERATIVE
e
Lean business practices, better IT integration and servant leadership are
already transforming the pharmaceutical industry.
2
I
f the 1980s were the best of times for the drug industry, the current decade is clearly the
worst. Once trusted by the public, buoyed by a steady stream of new blockbuster drugs,
and insulated by fat prot margins, drug makers must now contend with slower new drug
pipelines, plummeting public opinion, regulatory uncertainty and increasing competition from
generics, now a $60-billion global market [1]. The threat of drug counterfeiting has also increased,
forcing manufacturers to move aggressively to secure their distribution chains.
For drug makers today, operational excellence (Box, p. 3) is no longer the end goal, but a
prerequisite for survival. A growing number of pharmaceutical manufacturers are moving from
top-down management to team-based problem-solving, incorporating concepts such as Lean,
Pull manufacturing, Six Sigma, and quality by design, to improve efciency and quality, and
lower costs.
Industry leaders also realize that they need to leverage information technology (IT) more
effectively throughout their enterprises. Theres no question that drug companies have invested
heavily in IT, but most have failed to connect IT platforms effectively.
As a result, information sits, underutilized, in separate silos. Its nearly impossible to develop
trending data or to trace the root causes of problems when unrelated data are scattered in separate
mounds of paper, says Doug Souza, vice president of process manufacturing at Oracle Corp.
Theres a need for a single source of truth, Souza says.
Most drug makers, for example, have failed to integrate ERP with the plant oor or evenif
they have it, and only a minority dowith MES. CAPA software systems remain woefully
underutilized [2].
Drug development is another area where the power of IT has not been tapped to its full potential
(Box, p. 4). In its Outlook 2005, Tufts Center for the Study of Drug Development says that IT
will be essential to better understand the data generated during discovery and development, and to
improve R&D productivity [3].
NOT FOR THE FAINT OF HEART
The challenges start at the very beginning of the value chain, in discovery and R&D. The odds of
launching a successful drug have never been worse: Where it took $403 million to launch a new
drug successfully in 2001, it now takes $1.2 billion [4]. Many new discoveries ultimately prove to
be too insoluble, unstable or toxic to be used in any com-
mercial drug.
These difculties only intensify farther along the
chain, in manufacturing. Once a stepchild within the
industry, invisible to the outside world, manufacturing
is now viewed as a key to reducing costs and improving
quality. Its also receiving far more media attention, which
reached its height in the fall of 2004, when manufacturing
problems forced Chiron to stop producing Fluvirin vaccine
at its U.K. plant, crippling the U.S. vaccine supply.
Manufacturing deserves this attention because it costs
the industry over $90 billion each year, twice as much
as R&D. Drug
manufacturing
operations lag
behind those of
potato chip and
soap makers in
sophistication,
as former FDA
Commissioner Mark
McClellan has said in
a Wall Street Journal
TOP- AND BOTTOM-RATED
INDUSTRIES, 2005
1. Restaurant
2. Computer
3. Farming and agriculture
4. Grocery
5. Retail
21. The federal government
22. Pharmaceutical
23. Healthcare
24. The legal eld
25. Oil and gas
Source: Gallup poll of 1001 adults
Recent poll results show the publics
slipping support for pharma. With
the release of several motion pictures
critical of the industry, pharma has
joined Hollywoods rogues gallery,
along with tobacco, petrochemicals
and the nuclear power industry.
LEAN 101: THE ROOTS OF OPERATIONAL EXCELLENCE
Lean Manufacturing has become such an industrial mantra that its easy to forget that the concept
was born out of necessity during hard times. After WWII and Japans crushing defeat, the nations
manufacturers needed to come up to speed with the rest of the world, at breakneck pace.
The Toyoda Automatic Loom Co., a textile rm that had diversied into bicycles, made the bold
decision to start manufacturing automobiles. Engineers Taiichi Ohno (Photo) and
Shigeo Shingo were recruited to get the new company, which later became Toyota, off
the ground. Their challenge was daunting: to boost productivity by a factor of ten.
Together, they and their successors mixed and distilled home-grown philosophies and
industrial engineering concepts that were developed, but never fully exploited, in the
U.S.
Toyoda had already designed a loom that stopped weaving whenever there was a
production problem. But Ohno and Shingo were also inspired by W. Edwards Demings
work in statistical process control, and by the U.S. automotive pioneers Henry Ford and Charles
Sorenson. They even visited a Ford plant in the 1950s. They also learned from Frederick Taylors
concept of Scientic Management, and Frank and Lillian Gilbreths idea of charting processes to
minimize waste.
The result? The Toyota Production System (TPS), designed to empower workers to improve
efciency and product quality and
minimize waste at their plants.
The U.S. rst began to hear about
Toyotas work in the 1970s, when
a consulting rm was established in
Japan to spread the best practices
it had learned to other countries.
Gradually, terms like Total Quality
and Just in Time entered the U.S.
business vocabulary.
But only in 1990 did many
industrial leaders outside of Japan
realize the full depth and breadth of
Ohnos legacy, when MIT scholar
James P. Womack analyzed the TPS in
his book, The Machine that Changed the World, which
coined the term Lean Manufacturing.
Ohno and his disciples had spent from the decades
between WWII and 1980 translating the works of some
of the U.S.s greatest industrial thinkers into Japanese
and getting them to t the auto industrys needs. Since
then, every industry the world over has been feverishly
translating back from the Japanese, and adapting Lean to
t its own unique needs.
The pharmaceutical industry, heavily regulated and
insulated for years by fat prot margins, is now starting to
embrace Lean Manufacturing concepts, which include:
quality-by-design
continuous improvement
the elimination of waste, whether inventory, defective
products, motion on the plant oor, or workers talents
and ambitions.
Important in achieving these goals are work teams and
3
C
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Y = f(x)
People support all results
Line
Fill Rate
X,x
X,x
X,x
X,x
X,x
Order
Fill Rate
X,x
X,x
X,x
X,x
X,x
Delivered
On Time
X,x
X,x
X,x
X,x
X,x
Day Sales
Outstanding
X,x
X,x
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Manufacturing
Cost
X,x
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Inventory
X,x
X,x
X,x
X,x
X,x
Compliance
X,x
X,x
X,x
X,x
X,x
Market
Supply Chain
Process
Demand
Manufacturing Strategy
Push/Pull Rhythm
Visual
Kanban
Planning/
Scheduling
Inventory Levels
Supplier Base
Suboptimal design
Poor process
capability
Operator, equipment,
material variability
Reformulation or
process redesign
Incremental
Improvement
Lean
Six Sigma
Design excellence Value Stream
map, FMEA
Toolbox: Standard Work, Mistake Proofing, 5S
Selecting Tools for Process Excellence
Lean Manufacturing
Market
Supply Chain Process
Demand
Manufacturing Strategy
Push/Pull
Rhythm
Visual
Kanban
Planning/Scheduling
Inventory Levels
Supplier Base
Continuous Improvement
Y = f(x)
People support all results
Line
Fill Rate
X,x
X,x
X,x
X,x
X,x
Order
Fill Rate
X,x
X,x
X,x
X,x
X,x
Delivered
On Time
X,x
X,x
X,x
X,x
X,x
Day Sales
Outstanding
X,x
X,x
X,x
X,x
X,x
Manufacturing
Cost
X,x
X,x
X,x
X,x
X,x
Inventory
X,x
X,x
X,x
X,x
X,x
Compliance
X,x
X,x
X,x
X,x
X,x
Market
Supply Chain
Process
Demand
Manufacturing Strategy
Push/Pull Rhythm
Visual
Kanban
Planning/
Scheduling

Inventory Levels
Supplier Base
Con
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o
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s
Im
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Lean Manufacturing
The tools for operational excellence
work best when they work together,
and are driven by integrated IT. see LEAN 101 on next page
4
interview often referred to as the Two-Story Blender article [5].
Half of their manufacturing outlays are wasted outright, reected in failed or recalled batches.
The reject percentage in the drug industry ranges from 5 to 10%, compared with 0.0001% in
the semiconductor industry, says John Danese, product strategy director of life sciences at Oracle
Corp., quoting gures from the WSJ. These reject rates cost the industry between $4.5 and $9
billion per year. But they are only part of the 80% of manufacturing activities that fail to add any
value to product [6].
CRUNCHING THE NUMBERS
To understand the scope of the drug manufacturing problem, MIT painstakingly documented how
manufacturing time is spent at a typical pharmaceutical facility. One presentation to the FDA four
years ago [7] traced the path that any product sample takes through a facility. For the manufac-
USING INFORMATION TECHNOLOGY
TO IMPROVE DRUG DEVELOPMENT
Cubist Pharmaceuticals, a research-focused biopharmaceu-
ticals company in Massachusetts, wanted to improve its
management of product safety monitoring and pharmaco-
viligance compliance. It also wanted to adopt leaner, more
efcient business practices to improve its ability to analyze
and act on nancial, sales and other data.
The company implemented Oracles Adverse Events
Reporting System to reduce the time required to respond
to FDA inquiries. The company also implemented an
automated process manufacturing solution to improve
inventory control and lot tracking capabilities. Since the
system was implemented, Cubist has enjoyed a single data
model that has since improved the accuracy and integrity of
its data.
tools such as:
Error-proong or Poka Yoke
5S, for Sort, Set in Order, Shine, Schedule and Score, a system for organizing the
workplace and minimizing unnecessary motion
Failure Mode and Effects Analysis (FMEA), a method for determining the impact of
product failure
Value Stream Mapping (VSM), a method for determining the gap between current and
ideal performance and developing a plan for reaching the ideal state.
These concepts are sometimes paired with Six Sigma, which has its roots in Walter
Shewharts studies of variability, but took shape when articulated by Motorola engineer
Bill Smith in the 1980s. The principle is based on the familiar acronym DMAIC, for design,
measure, implement, and control, the functions required to lower product defect levels to six
sigma, or parts per million levels. Where electronics is operating at six sigma today, the drug
industry is currently operating at between two and three sigma levels.
References
http://www.strategosinc.com/just_in_time.htm
http://www.pqa.net/ProdServices/leanmfg/lean.html
LEAN 101
5
THE DI GI TAL RESOURCE OF PHARMACEUTI CAL MANUFACTURI NG MAGAZI NE
Beating Patent Death
$0
$2,000
$4,000
$6,000
$8,000
$10,000
$12,000
$14,000
$16,000
2004
Diflucan,
Epogen/Procrit
2005
Clariold/Biaxin,
Zithromax,
Zocor, Zoloft, Novolin,
Recormon, Activase
2006
Imitrex, Paxil,
Pravachol, Premarin,
Neupogen
Pharmaceuticals
Biopharmaceuticals
% growth
$
U
.
S
.

M
i
l
l
i
o
n
s
$
U
.
S
.

M
i
l
l
i
o
n
s
%

g
r
o
w
t
h
$U.S. Billions
Pharmaceuticals Approaching Patent Expiration
Numbers represent 2002 combined sales
Global Generics Growth
Patent Expiration Outlook through 2005
$0
$5,000
$10,000
$15,000
$20,000
$25,000
$30,000
$35,000
10.5%
11.0%
11.5%
12.0%
12.5%
13.0%
13.5%
14.0%
1998 1999 2000 2001 2002
$0 $5 $10 $15 $20 $25 $30 $35 $40
Drugs Losing Patent
Protection by 2005
Off-Patent Drugs
without Generic
Competition
$37 billion
$7 billion
GLOBAL GENERICS GROWTH
Source: Datamonitor
THE DI GI TAL RESOURCE OF PHARMACEUTI CAL MANUFACTURI NG MAGAZI NE
Beating Patent Death
$0
$2,000
$4,000
$6,000
$8,000
$10,000
$12,000
$14,000
$16,000
2004
Diflucan,
Epogen/Procrit
2005
Clariold/Biaxin,
Zithromax,
Zocor, Zoloft, Novolin,
Recormon, Activase
2006
Imitrex, Paxil,
Pravachol, Premarin,
Neupogen
Pharmaceuticals
Biopharmaceuticals
% growth
$
U
.
S
.

M
i
l
l
i
o
n
s
$
U
.
S
.

M
i
l
l
i
o
n
s
%

g
r
o
w
t
h
$U.S. Billions
Pharmaceuticals Approaching Patent Expiration
Numbers represent 2002 combined sales
Global Generics Growth
Patent Expiration Outlook through 2005
$0
$5,000
$10,000
$15,000
$20,000
$25,000
$30,000
$35,000
10.5%
11.0%
11.5%
12.0%
12.5%
13.0%
13.5%
14.0%
1998 1999 2000 2001 2002
$0 $5 $10 $15 $20 $25 $30 $35 $40
Drugs Losing Patent
Protection by 2005
Off-Patent Drugs
without Generic
Competition
$37 billion
$7 billion
PATENT EXPIRATION OUTLOOK THROUGH 2005
Source: Barr Laboratories
turing processes tracked, QC testing times dwarfed process times, in some cases exceeding them by
factors of 5 or 6.
Testing itself accounted for only 2% of the time spent on quality control. Documentation and
paperwork, coordinating, batch sampling and waiting made up the balance. As a result, equipment
utilization for the industry averages 30%.
Where manufacturers may have accepted this level of performance when margins were higher, its
untenable today. And it wont help drug makers meet the post-blockbuster age of hybrid drug-devices
and targeted, personalized medicine, which demands an extremely exible development and
manufacturing infrastructure.
SEIZING THE DAY
More than ever before, drug makers need to increase R&D and manufacturing effectiveness, reduce
product costs, speed time to market and seize every day that a branded drugs patent protection
remains in force. Industry leaders realize that Lean Manufacturing concepts and a better use of IT are
the keys to resolving many of these problems. Theyre taking charge and transforming their busi-
nesses, and the industry.
But they face an uphill struggle. The industry is now in a Catch-22, says Oracles Danese.
Manufacturing inefciencies make regulatory compliance more difcult, but these inefciencies
themselves are the resultat least, in partof a regulatory approach that has fostered the status
quo.
6
VALIDATION: FEAR AND LOATHING
Years of command and control-style regulation from FDA have led to inertia, and worries that
improving an established process or investing in a better technology will trigger costly and time-
consuming revalidation. And these worries are justied. Ten years ago, validation costs accounted
PAT AND QUALITY BY DESIGN
Analytical instrumentation is being used to drive down pharmaceutical cycle time. More
manufacturers are using process analytics to test product quality during production. The
chemical industries moved in this direction over 10 years ago as did early adopters such as Eli
Lilly, which rst used in-process analytics for quality control in the 1980s to improve cycle
times for synthetic insulin. The company adapted analytics to its chromatography operations
and reduced cycle times signicantly.
Pzer has also embraced process analytics, as have most major manufacturers. Driving
increased interest today is FDA, which formally endorsed Process Analytical Technologies
(PAT) in 2002, when it issued its sweeping 21st century cGMPs to modernize pharmaceutical
industry regulation. That same year, it published a draft framework for a PAT program.
The nal draft guidance, published last year, broadened the range of sensors that could
be considered as well as the statistical underpinnings. FDA now sees PAT not just as a
manufacturing tool but as a quality optimization tool that can be used throughout a drugs life
cycle.
As dened by FDA, PAT means much more than analytics but also mathematical modeling
such as multivariate techniques, which allow drug manufacturing data to be analyzed in real
time. The most important thing about PAT is that it opens up possibilities for more advanced
process control in pharmaceutical manufacturing, taking pharma plants one step closer to a
future where theyre controlled continuously.
Through ASTMs E-55 Committee, the industry is now working to develop standards for
PAT, and Pzer is now driving an industry effort to establish open standards for the IT used in
PAT.
REACTIVE AND PROACTIVE ELEMENTS OF A QUALITY DECISION SYSTEM
Reactive Proactive
Testing to document quality
Quality by Design (QbD) and real-
time process controls to achieve
real-time release
Repeating deviations and out of specication investigations
Right First Time
Multiple CMC Regulatory Review Cycles
Single CMC Regulatory Review
Cycle
Need for Prior Approval Supplement for process optimization and
continuous improvement efforts on approved products
Process optimization and continu-
ous improvement efforts reliably
managed within a facilitys quality
system
Procrustean approach for demonstrating therapeutic equivalence of
generic products
QbD approaches for demonstrat-
ing therapeutic equivalence of
generic products
Work environmentfear and apprehension
Work environmentpride of work-
manship and Continuous Learning
PAT is a key tool for helping drug manufacturers reach a Desired State, driven by scientic
and engineering principles. It is outlined here by Ajaz Hussain, former deputy director of FDAs
CDER. Reprinted with permission, Pharmaceutical Manufacturing, June, 2005, p. 21
7
for 20 to 30% of all ERP implementation project costs, says Doug Souza. Now, theyre down to 15
to 20%, but validation still remains a major cost factor, and its all too tempting to skimp, to save the
additional costs.
As a result, the average pharmaceutical plant is 20 years behind the times. While a small number of
pioneers are using electronic batch recordkeeping software, MES and e-compliance tools, most drug
manufacturing facilities still handle all batch documentation on paper, an expensive, time consuming
and often inaccurate approach, says Dennis Constantinou, senior industry director for Oracles Life
Sciences Strategy and Marketing. Its difcult to circulate and update standard operating procedures
(SOPs) via paper-based systems, he says. In addition, there are often multiple data sources for any
given procedure, resulting in confusion, inconsistency, redundancy and increased risk.
Sarbanes-Oxley requirements make paper-based processes all the riskier.
Recently, a former employee sued Wyeth for alleged irregularities with SOPs
related to Prevnar vaccine manufacturing. He invoked, not cGMP code,
but Sarbanes-Oxleys whistleblower clause [8].
A NEW DAY AT FDA
FDA is vigilant about enforcement, exacting stiff penalties for com-
pliance failures, resulting in hundred-million-dollar consent decrees.
Within the past few years, however, the Agency has begun to take a
total quality systems approach to regulation, adopting risk-man-
agement principles to focus on critical parts of any inspection.
FDA is also encouraging manufacturers to develop a philosophy of
quality by design, and greater process understanding and control, by using
statistical process control, multivariate analysis and process analytical technologies (PAT; Box,
above). As a result, the term control is starting to move away from its association with command
and control, and wasteful documentation and validation practices, to suggest systems in which
USING RFID FOR SUPPLY CHAIN MANAGEMENT
Radio frequency identication (RFID) has become the track and trace technology of choice
for manufacturers looking to optimize supply chains and ensure drug security from factory to
consumer. Drug manufacturers are outtting cases and pallets, and even individual pill bottles
and blister packs, with RFID chips that register data each time they pass by scanning devices
throughout the supply chain.
While manufacturers have come to grips with how to handle all of that data, they are just
beginning to integrate it with computer systems in order to optimize manufacturing processes,
shipping and distribution. The holy grail for RFID success is to integrate RFID data seamlessly
and in real-time with a rms enterprise resource planning (ERP) system.
Manufacturers like SkinCeuticals and Colorcon are nding their Oracle 11i ERPs to be
extremely adept at processing and leveraging RFID with help from software vendors providing
composite, rather than custom, applications.
One such application is the Gemini Simplied Interface Suite by ClearOrbit, Inc. (Austin,
Texas). Manufacturers want to use their Oracle ERP to drive supply chain functions and dont
want the burden, and cost, of maintaining an independent database to handle RFID and bar
coding information, says John Reece, president of ClearOrbit.
SkinCeuticals (Garland, Texas), a developer of innovative dermatology products,
accessorized its Oracle 11i with ClearOrbit, integrating information from diverse devices such
as Symbol RF scanners, Hewlett-Packard laser jet printers and Zebra bar code printers with the
ERP. The solution enabled SkinCeuticals to maintain real-time validation and control over its
supply chain, while also doubling shipping efciency and reducing warehouse space by 50%.
Software extensions such as these will allow more manufacturing professionals to gather and
interact with data where it residesin the ERP.
8
manufacturers understand and are in control of their processes.
Nevertheless, lingering fear, and what some have called a GMP bureaucracy have
kept some manufacturers from taking the simple steps required to improve processes.
SUPPLY CHAIN MANAGEMENT: TOWERS OF BABEL
Even after the drugs are made and packaged, problems abound. Pharmaceutical supply
chain management (SCM) is light years away from that of Detroits automakers: cycle
times average 40 days; most facilities carry too much inventory, yet are occasionally caught
short when demand for a drug spikes unexpectedly.
Few drug rms have taken the painful steps required to optimize the data used to manage
their supply chains. At some pharmaceutical companies, different facilities are using different IT
platforms to handle SCM, and a simple purchase order will mean different things to purchasing
agents at different facilities within the same company.
A growing number of companies are tackling SCM, standardizing their data and adopting a
single IT platform to use information more effectively. California-based Genencor International, for
example, moved to Oracles 9i database and E-Business Suite modules, and found that the software
helpd it reduce distribution and air freight costs signicantly, said Dave DeYoung, Genencors
director of application development.
Pennsylvania-based Colorcon, a global manufacturer and specialist in pharmaceutical tablet
coating, moved all its global operations to Oracles E-Business Suite, and has since improved
inventory accuracy to over 99%. With our Oracle implementation, we have cut our production
lead time in half, achieved near perfect inventory accuracy and improved our ability to provide
sales follow-up, says Colorcon CIO Perry Cozzone.
The next step in smart SCM will involve using track and trace technology. Smart companies are
using new technologies such as radio frequency identication (RFID) to better leverage their ERP
platforms (Box, p. 7).
SEIZING COMPETITIVE ADVANTAGE
Despite these challenges, more drug companies are moving to embrace Lean and operational excel-
lence, whether in manufacturing, development or the research lab (Tables, below). Their rst chal-



What Makes Team Leaders Proud? What Keeps Them Awake at Night?

MOST SIGNIFICANT TEAM ACHIEVEMENTS THIS YEAR
Cost Reduction 58.3%
Product Quality Improvement 58.3%
Improved Morale and Team Spirit 58.3%
Cross-training of Staff 50.0%
Better Connection to Customer/Product 41.7%
Equipment Downtime Reduction 25.0%
Improved Customer Service 25.0%
Maintenance Improvements 16.7%
Cycle-time Reduction 16.7%
TOOLS FOR IMPROVEMENT
Just-in-time 50%
Lean Manufacturing 41.7%
Design Of Experiments 25%
Process Capability Analysis 16.7%
Pull Manufacturing 16.7%
Six Sigma 16.7%
5-S 8.3%
Measurement Systems Analysis 8.3%
Gauge R&R 8.3%
CRITICAL CHALLENGES FACING MANUFACTURING
SOPs and Training 77%
Quality Management and Testing 62%
Documentation 62%
Management Support 54%
Validation 54%
Dealing with Regulatory Agencies 31%
Finding and Retaining Skilled Staff 31%


Source: Pharmaceutical Manufacturing
Drug manufacturing team leaders are using a number of tools to
improve efciency and quality.
9
lenge is to determine the voice of the customer, and establish which characteristics are most critical
to ensuring product quality. They then apply SPC tools such as process capability analysis and Design
of Experiments to determine their level of process knowledge.
Pzer has made great strides in this regard with its Right First Time program [9], which uses
operational excellence, process analytical technologies and equipment and process trending to reduce
variability at its plants. The companys ultimate goal: eliminating root causes of all product and
process variation.
At J&Js PSGA facility in Puerto Rico, a team led by Noemi Santiago, director of technical
operations for solids, has integrated Lean and Six Sigma techniques to assess the root causes of
potential quality problems and identify solutions. Six Sigma and Lean can add signicant value, even
when applied in isolation, she wrote in Pharmaceutical Manufacturing [10]. However, they become
even more powerful when integrated. Cross-functional teams were a key to the initiative, and have
been a critical part of J&Js corporate Process Excellence Program, one of the rst of its kind in the
drug industry.
SERVANT LEADERSHIP
Such teams signify a change from the top-down to the bottom-up management paradigm, so
essential in establishing a visual workplace, as Gwendolyn Galsworth writes in her book, Visual
Workplace-Visual Thinking [11]. The leaders role in this new paradigm is to help value-add as-
sociates become more effective in their work and more engaged, she writes. He is servant-leader; as
such, he attunes and listens to the needs of those whom he serves.
Facilities that incorporate bottom-up management principles are already reaping rewards. Baxter
Healthcare Corp. launched a Lean Manufacturing effort at its North Cove facility, establishing cross-
functional teams involving representatives from lling, packaging, sterilization manufacturing, quality
and distribution and other functions.
The team, rst-place winner of ASQs 2005 Team Excellence awards and a
Bronze Winner in Pharmaceutical Manufacturings 2005 Team of the Year
competition, now sees the whole operations needs, rather than focusing on its
own narrow production goals. In the past, an operator explained, each unit at
the facility would maximize output, whether or not the next link in the chain was
ready for it or not. They now work in Lean Kanbans, synchronizing efforts closely,
both upstream and downstream [12].
Teams have also transformed Novartis Suffern, N.Y. facility, which only
a few years ago had been considered less competitive than the companys
other plants. A Lean program was established two years ago with the goal
of reducing operating costs by 40%. Its now exceeded those goals, taking an
approach unusual for the drug industry by organizing teams based on product line.
All people involved in making that product report to a single team leader. The front-line supervisor
position has been eliminated, replaced by facilitators and coordinators, roles designed to empower
operators [13], who close out batch records using an electronic system.
BMS has also used teams to transform its Indiana Technical Operations team from the destined
for closing list to a corporate benchmark. Employees are involved in decision-making and project
planning and trained in team development, plant and corporate management, nancial and process
analytics. Were indifferent to titles, says Mark Powell, head of the ITOs operational effectiveness
group [14].

References
1. De Palma, A., Beating Patent Death, Pharmaceutical Manufacturing, February 2005, p. 18. http://
www.pharmamanufacturing.com/articles/2005/148.html
2. Bartholomew, D., Expand your CAPA-bility, Pharmaceutical Manufacturing, October 2005, p. 53
3. Outlook 2005, Tufts Center for the Study of Drug Development, http://www.pharmamanufactur-

10
ing.com/whitepapers/2005/40.html
4. DiMasi, J.A., Hansen, R.W., Grabowski, H.G., The Price of Innovation: New Estimates of Drug
Development Costs, Journal of Health Economics, 2003.
5. Abboud, L., New Prescription for Drug Makers: Update the Plants, The Wall Street Journal,
September 3, 2003.
6. Ibid
7. Raju, G.K., New Opportunities for Pharmacutical Manufacturing, a 2001 presentation to FDAs
Science Board, www.pharmamanufacturing.com/whitepapers/2004/118.html
8. Shanley, A., Whistleblower or Disgruntled Employee? Lawsuit Alleges GMP Violations,
Pharmaceutical Manufacturing, April, 2004, p. 10; www.pharmamanufacturing.com/arti-
cles/2004/110.html
9. Shanley, A., Right the First Time, Pharmaceutical Manufacturing, June 2004, p. 38 http://www.
pharmamanufacturing.com/articles/2004/114.html
10. Santiago, N., Achieving Manufacturing Process Excellence, Pharmaceutical Manufacturing,
September 2004, p. 24, http://www.pharmamanufacturing.com/articles/2004/91.html
11. Galsworth, G., Visual Workplace Visual Thinking, Visual-Lean Enterprise Press, Portland,
Oregon, 2005, p. 58
12. Thomas, P., et al., 2005 Team of the Year: The Finalists Tell Their Stories, Pharmaceutical
Manufacturing, April 2005, p. 19; http://www.pharmamanufacturing.com/articles/2005/220.
html
13. Ibid, p. 25; http://www.pharmamanufacturing.com/articles/2005/192.html
14. Ibid, p. 22, http://www.pharmamanufacturing.com/articles/2005/231.html