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Driving the Industry Forward.
1
 
FUTURE PHARMACEUTICALS
To lst to t tr trvw,lo o to
www.. 
 
2
www.uturepharmaus.com
manufacturing & supply chain
M
&
SC
Lean Six Sigma is a business management strategy that,while getting its start in the manufacturing industry, ismaking its way to pharmaceuticals and biotechnology.
Read on for insight from the pros of Six Sigma.
It’s allGreek toPharma
Mk P
 
Research and development (R&D) is alarge cost component or pharmaceutical companies.
 Have Lean Six Sigma (Lean) or Six Sigma methodolo-gies been useul in driving efciencies in that area?
Mk Pk
Absolutely. Perhaps the biggest opportunity in the R&D areais in the Design for Six Sigma (DFSS) space or Six Sigma for product devel-opment. Here is where the Six Sigma methodologies can help pull in thevoice of the customer — understanding their needs and requirements, con-vert those into technical requirements for engineers, and design a robustproduct that has built-in quality and capabilities. This helps us veer awayfrom the build-test-fix process and quality is designed in from the start. AtMotorola, this is where we’ve seen Six Sigma be a major help for us in R&D,and it is beginning to gain interest in our public Six Sigma University as well.
Mk Km
We’ve worked with six different pharmaceutical companiesover the last decade, and Lean and Six Sigma methodologies have beenextremely useful. We’ve seen them being used in drug discovery, using high-throughput technology, optimizing reagents, and designing assays; theopportunity is great. In essence, yes, these tools and methods of Lean andSix Sigma have been used, but I don’t think we’ve scratched the surface in theavailable opportunities in the R&D areas in the pharmaceutical companies.Consider the following fact: the concept-to-commercialization valuestream takes 15 years or more on average and it costs $880 million to takea product to market. Couple this with the fact that 90 percent of these failsomewhere along the cycle and it becomes apparent that the opportu-nity is great. Even though we’ve seen some successes, my feeling is thatthere’s still a long way to go.
MP
Let me add on to that idea. A decent sized pharmaceutical prod-uct brings in $250 to $300 million per year. If you think that you have approxi-mately 250 to 300 selling days in a year, that’s about $1 million for every daythat the product is on the market. So if you can reduce that research anddevelopment by even five days, you could be looking at an additional $5 mil-lion that goes straight to sales.
MP
Outside o drug manuacturing, do yousee any other areas in the pharmaceutical industrythat are ripe or applications o Lean or Six Sigmamethodologies?
MK
First, there’s no limit to potential applications, although limitation of our own resources will demand that we prioritize. Areas that we’ve seen,besides the R&D area, are packaging and shipping. For instance, one LeanSix Sigma project brought back more than $1 million in savings just bychanging the labeling technique used. There are other less apparent trans-actional processes, such as the regulatory process — preparing, compilingand reviewing drug submissions and new drug applications.We’ve seen it used in inventory control and management. Another ripe areathat isn’t always discussed is IT. That’s a major area that needs to be worked asthe dissemination of data and knowledge is really critical to this sector.
MPk
We agree, Six Sigma does lend itself very well to the sup-ply chain and this is usually the first area where these applications areapplied. Today, we are seeing Six Sigma take off in most of our transac-tional-based areas — IT, Finance, and Service for example. In transac-tional processes there are cycle time opportunities, defect-reductionopportunities, and customer satisfaction opportunities — all areas whereSix Sigma can help. It’s unlimited.
MP
Whether it’s the pharmaceutical or any other industry, the corecompetencies — marketing, finance, human resources — could benefit fromLean and Six Sigma methodologies.
C W
At Shertrack, our direct experience is with the supply chain.
 
Driving the Industry Forward.
3
 
FUTURE PHARMACEUTICALS
it’s all greek to pharma
Mr. Pestorius is a Master Black Belt and author o the book,
Apply-ing the Science of Six Sigma to the Art of Sales and Marketing,
aswell as multiple articles on the application o Lean and Six Sigma.He is a graduate o the U.S. Naval Academy and Xavier University.He has extensive sales and sales management experience in theelectrical, medical and aviation industries. He currently leads anational sales orce or a major pharmaceutical rm.
MiKe Pestorius
Vc Prsdt of Sx Sm
sanofi-aventis
Dr. Kiemele has more than 30 years o teaching, consulting, andcoaching experience. Having mentored more than 30,000 leaders,scientists, engineers, managers, trainers, practitioners, and col-lege students, he is world-renowned or his Knowledge Based KISS(Keep It Simple Statistically) approach to engaging practitioners inapplying statistical methods. Dr. Kiemele has been involved in theorigin and evolution o Six Sigma, as he trained the rst Six SigmaBlack Belts at the Six Sigma Research Institute at Motorola.
MarK KieMele
Prsdt d Co-foudr
air academy associates
SherTrack is a provider o Demand Driven Predictive Manuactur-ing solutions based on LEAN/Six Sigma. Mr. Wearring has had a20-year career delivering new sotware solutions and managingthe associated business process change issues or clients in chem-icals, plastics, automotive, computer and aerospace industries.As Executive Program Manager or Siemens Product LiecycleManagement, Mr. Wearring led the initial deployment o a newcollaboration platorm developed jointly with Microsot.
Colin Wearring
Vc-Prsdt d CTO
shertrack
Mr. Potosky is the Corporate Director or Motorola’s internal SixSigma Program, Corporate Director or Motorola University’sexternal Six Sigma Program, and Lead Master Black Belt or MobileDevices. Mr. Potosky’s responsibility or Motorola University’sexternal program is to provide tailored training to companies andindividuals in support o their own Lean Six Sigma journey. Train-ing occurs at Motorola’s corporate campus and around the world.
MiKe PotosKy
Corport Drctor of Sx Sm
motorola
Let me discuss the exceptional return on investment (ROI) that you can typi-cally find in that area. We’ve had the opportunity to work with Bayer’s BusinessExcellence team, and we were able, through the use of digital modeling, tocomplement their Six Sigma initiative and expand their ability to deal withcomplex supply chain issues. To do this, we helped implement an analytic toolthat allows them to use quantitative methods earlier in the design phase.After beginning in the early design phase, these same tools are usedin production, so that the implementation and control phases were alsomore robust and well-connected. As the focus in pharmaceuticals movesaway from building blockbuster drugs and becomes a more cost-pres-sured commodity market, our opinion is that production operations hasa lot of money on the table and a real opportunity to make a good ROI inthat area.
MP
How would one balance the structure thatcomes with Lean and Six Sigma with the need or crea-tivity and innovation?
CW
Those ideas are complementary. Lean allows you to focus efforts onidentifying and reducing low-value efforts and low-value activities, whichactually frees the time of individuals involved in the overall activity to focuson the more innovative aspects of their processes.In something such as a pharmaceutical discovery — with a large amountof data and the need to make intelligent selections based on that data — theapplication of quantitative methods that are inherent in Six Sigma bring sig-nificant value to the table, especially when combined with intelligent use of computer models and decision-support tools.
MK
I don’t think it’s as much about balancing this as it is about integrat-ing the two. Although the picture has been painted that Lean and Six Sigmaare diametrically opposed to creativity and innovation, I think most peo-ple would refute that. The way that we get that balance is through a tech-nique we call systematic innovation, where the innovation process becomesrepeatable, reliable and predictable. I don’t think any company today, phar-maceutical or otherwise, can afford to bet the future of their company onthese “eureka” moments of a select few discovery scientists. It isn’t that wedon’t need those scientists, but I think we’ve got to find a structure. Lean SixSigma is a structure that allows for the pulling of the emotional methods of creativity and the psychological methods as well as other structured inno-vations — techniques like TRIZ — the theory of inventive problem solving,robust design, tolerance design, and other optimization techniques. Theseare synergistic; people who say that say Lean Six Sigma and innovation areopposites on the spectrum don’t know the Lean Six Sigma I know, becauseinnovation is a critical part of the Lean Six Sigma initiative.
MP
It sounds like the consensus is that Lean andSix Sigma provide ramework and structure or creativ-ity and innovation to fourish.
What advice would yougive a pharmaceutical company that is consideringlaunching a Lean or Six Sigma initiative?
MPk
One of the key success factors is to have top-down support —from the CEO and Senior Leadership team on down. But, even with vary-ing levels of top-down support, many companies can be successful followingthree basic steps. One: focus on your process stability; reduce the variationfirst and then go after the mean. Two: focus on your customer; solve real prob-lems for them. Three: work on developing your people to be effective prob-lem-solvers; Six Sigma is a recipe and methodology to solve problems. If youcan keep that in mind and correctly identify which problems to work on (withsupport from your leadership), Six Sigma can help your company improve.
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sbonacorsi

Are you interested in connecting with a Lean Six Sigma Thought Leader or Consulting Professional, Please feel free to contact me directly. Warm Regards, Steven Bonacorsi Vice President, MBB, MBA, MS-CIS, PMP Toll Free 888-826-2484 Cell Phone 603-401-7047 Main Fax 480-730-7980 sbonacorsi@theaitgroup.com Tomorrow starts today... so let's work hand-in-hand to Create the Future... http://www.theaitgroup.com – Lean Six Sigma Training and Events http://www.sixsigmalive.net – Lean Six Sigma Online Courses & Certification http://www.linkedin.com/in/stevenbona... - Add me directly to LinkedIn http://www.linkedin.com/e/gis/37987/6... - Lean Six Sigma LinkedIn Group http://lean6sigma.ning.com – Join the Lean Six Sigma Business Network http://ezinearticles.com/?expert=Stev... - Lean Six Sigma Articles http://www.konnects.com/profile/sbona... - Please add me directly to Konnects

reply02 / 10 / 2009
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