09.08.14
Last month, Gower Publishing released “Applying Lean Six Sigma in the Pharmaceutical Industry,” written by Bikash Chatterjee, President and Chief Technology Officer of Pharmatech Associates, and a member of Contract Pharma’s Editorial Advisory Board. Mr. Chatterjee has worked in pharma applying the principles involved for more than two decades in over 30 countries. He shared some of his thoughts on the topic with Contract Pharma recently.
Contract Pharma: When and why did you decide to write this book?
Bikash Chatterjee: Gower had approached me about writing a book on Lean, and, at the time, I thought the last thing the industry needed was another treatise on the topic. But I didn’t feel that a book had yet been written to weave together regulatory, compliance and LSS principles, so I decided to write it.
CP: Why do you think the industry needs to hear this message?
BC: LSS offers tremendous advantages for any organization, not only in terms of efficiency improvements but in reducing the level of variation. Predictability is the hallmark of any control strategy. Any firm whose managers are thinking about adopting a pharmaceutical quality by design (QbD) philosophy must embrace these concepts in order to be successful.
CP: We don’t seem to hear as much about pharma Lean Six Sigma programs as we did in years past. Why is that?
BC: Many industries look at LSS and get so enamored with the tools that they forget about the concepts behind them, and pharma companies are no exception. So many companies I have worked with had pilot programs or OpEx groups that were little more than toolkit specialists.
The wholesale adoption of these principles, as part of a core business strategy, has been limited so far. I have seen LSS bring some tremendously positive benefits to medical device manufacturers, but pharma is fickle. They love the concepts of 5S and value stream mapping, for instance, but most pharma companies do not embrace the underlying organizational component that is required to realize the full benefits. So today, in a market place where we are seeing unprecedented consolidations and organizational reengineering, we are just not in the right mindset to do LSS broadly.
CP: What impact do you think that merger and acquisition (M&A) activity have had on the operational excellence culture?
BC: The irony is that LSS can be a key component to establishing business performance in an M&A environment. Understanding the value streams that exist within both organizations being merged will allow the merging groups to leverage strengths and shorten stabilization times.
In an M&A environment, companies are measured by beating their loss targets on a quarterly basis. Minimizing disruption anywhere in the development pipeline will, by definition, aid in avoiding costs. Secondly, by streamlining and optimizing the onboarding process, employees can begin contributing more quickly. The other key component in this environment is in-licensing. To bolster pipelines, many firms are looking to buy products and technologies. Chartering and standardized work practices can dramatically improve the risk profile of these new programs.
CP: What will be needed to get China and India to embrace the principles of Deming?
BC: Five years ago, LSS was a foreign concept within pharma and biotech. Today, there is a growing appreciation of the benefits of these principles. There is a keen cost sensitivity in the emerging markets.
Those companies that have been successful in entering the U.S. market have adopted a corporate culture of pure execution. Many of us that do projects in these markets have to struggle with the ”that’s not how we do it here” mentality, but this commitment to standardized work practices have kept these companies out of trouble.
One area where there has been some traction is the adoption of lean facility design principles, which ultimately opens the door to implementing lean practices on the shop floor and in the infrastructure.
CP: What do you do when you’re not working?
BC: I love to cook and collect wine, so I’m lucky to be in the Bay Area. I have a keen interest in history and art, and enjoy travelling.
CP: Of the people you have worked with, who has inspired you the most?
BC: Of the many people I admire, one of my heroes within this industry is Alejandro Zaffaroni, the architect of Alza, Affymetric and several other highly successful drug companies. He was a visionary, able to see the future of the marketplace 10 years before it happened. His commitment to the young people of Uruguay, up until the day he died revealed an individual that never lost touch with his roots. He was truly inspirational.
Contract Pharma: When and why did you decide to write this book?
Bikash Chatterjee: Gower had approached me about writing a book on Lean, and, at the time, I thought the last thing the industry needed was another treatise on the topic. But I didn’t feel that a book had yet been written to weave together regulatory, compliance and LSS principles, so I decided to write it.
CP: Why do you think the industry needs to hear this message?
BC: LSS offers tremendous advantages for any organization, not only in terms of efficiency improvements but in reducing the level of variation. Predictability is the hallmark of any control strategy. Any firm whose managers are thinking about adopting a pharmaceutical quality by design (QbD) philosophy must embrace these concepts in order to be successful.
CP: We don’t seem to hear as much about pharma Lean Six Sigma programs as we did in years past. Why is that?
BC: Many industries look at LSS and get so enamored with the tools that they forget about the concepts behind them, and pharma companies are no exception. So many companies I have worked with had pilot programs or OpEx groups that were little more than toolkit specialists.
The wholesale adoption of these principles, as part of a core business strategy, has been limited so far. I have seen LSS bring some tremendously positive benefits to medical device manufacturers, but pharma is fickle. They love the concepts of 5S and value stream mapping, for instance, but most pharma companies do not embrace the underlying organizational component that is required to realize the full benefits. So today, in a market place where we are seeing unprecedented consolidations and organizational reengineering, we are just not in the right mindset to do LSS broadly.
CP: What impact do you think that merger and acquisition (M&A) activity have had on the operational excellence culture?
BC: The irony is that LSS can be a key component to establishing business performance in an M&A environment. Understanding the value streams that exist within both organizations being merged will allow the merging groups to leverage strengths and shorten stabilization times.
In an M&A environment, companies are measured by beating their loss targets on a quarterly basis. Minimizing disruption anywhere in the development pipeline will, by definition, aid in avoiding costs. Secondly, by streamlining and optimizing the onboarding process, employees can begin contributing more quickly. The other key component in this environment is in-licensing. To bolster pipelines, many firms are looking to buy products and technologies. Chartering and standardized work practices can dramatically improve the risk profile of these new programs.
CP: What will be needed to get China and India to embrace the principles of Deming?
BC: Five years ago, LSS was a foreign concept within pharma and biotech. Today, there is a growing appreciation of the benefits of these principles. There is a keen cost sensitivity in the emerging markets.
Those companies that have been successful in entering the U.S. market have adopted a corporate culture of pure execution. Many of us that do projects in these markets have to struggle with the ”that’s not how we do it here” mentality, but this commitment to standardized work practices have kept these companies out of trouble.
One area where there has been some traction is the adoption of lean facility design principles, which ultimately opens the door to implementing lean practices on the shop floor and in the infrastructure.
CP: What do you do when you’re not working?
BC: I love to cook and collect wine, so I’m lucky to be in the Bay Area. I have a keen interest in history and art, and enjoy travelling.
CP: Of the people you have worked with, who has inspired you the most?
BC: Of the many people I admire, one of my heroes within this industry is Alejandro Zaffaroni, the architect of Alza, Affymetric and several other highly successful drug companies. He was a visionary, able to see the future of the marketplace 10 years before it happened. His commitment to the young people of Uruguay, up until the day he died revealed an individual that never lost touch with his roots. He was truly inspirational.