Now showing 1 - 10 of 14
  • Publication
    The Future of Pharmaceutical Manufacturing
    (Springer, 2014)
    Basu, Prabir K.
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    Basu, Prabir K.
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    Werani, Jürgen
    The pharmaceutical industry is definitely a high-tech industry, for its role in discovery of new medicines for the treatment of unmet medical needs. Pharmaceutical manufacturing is complex and sophisticated due to various reasons, but in its current state probably cannot be categorized as really high-tech, too. In fact, pharmaceutical manufacturing was considered as relatively low-tech even by the pharmaceutical companies themselves as recently as in 2002. When ex-FDA commissioner Mark McClellan sought a benchmark for future pharmaceutical manufacturing performance, he looked outside the industry, and challenged Pharma, "You need to improve…Other high-tech industries have achieved enormous productivity gains in manufacturing in the last 25 years. We should expect nothing less from the Pharmaceutical industry."
    Scopus© Citations 2
  • Publication
    Introduction to Leading Operational Excellence: Making OPEX a Competitive Weapon
    (Springer Berlin Heidelberg, 2013) ;
    Basu, Prabir K.
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    Basu, Prabir K.
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    Werani, Jürgen
    In our second book on Operational Excellence in the Pharmaceutical Industry titled "The Pathway to Operational Excellence", published in 2010, we had undertaken an imaginary journey to develop the framework and structure of the book. It gave us the opportunity to describe our experiences from working with dozens of different pharmaceutical manufacturers in the US and Europe. We suggested a sequence starting with preparing for the journey and finishing with the re-definition of the destination leading to the selection of the next destination so that the journey will be an on-going one. Two years later, we have decided to write another book. The main reason for doing this is the positive feedback we have received on the first two books. The other reason is our conviction that despite the renewed enthusiasm for outsourcing in the industry, manufacturing will remain a critical activity for every major pharmaceutical company, and the continuous improvement of manufacturing will not just be an option, but a necessity.
    Scopus© Citations 2
  • Publication
    A Look to the Environment and the Impact on OPEX
    (Springer Berlin Heidelberg, 2013) ; ; ;
    Basu, Prabir
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    Werani, Jürgen
    With a glimpse to global stock markets, the pharmaceutical industry has performed poorly compared to other industries over the last 10 years. Positive influencing factors like the strong growth in emerging markets (see Fig. 6.1), the aging population and influenza pandemics seem to be counterbalanced by other factors like increasing competition, the global financial and debt crisis, the patent cliff, an increasing complexity and a declining R&D productivity.
  • Publication
    Barriers and Success Factors in Managing Operational Excellence
    (Springer Berlin Heidelberg, 2013) ; ; ;
    Basu, Prabir K.
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    Werani, Jürgen
    In our previous book, "The pathway to Operational Excellence in the Pharmaceutical Industry", we developed a model that aimed at the sustainable implementation of Operational Excellence (OPEX) initiatives. Over the last 10 years, we have witnessed and examined several more OPEX programs, and this chapter will tie in these insights with our previous work. Knowing success factors and barriers in managing OPEX can provide guidelines as to how to design, review and adapt an excellence program. Thus, the first part of this chapter will discuss aspects that should be taken into consideration when launching an OPEX initiative. The subsequent part provides insights into challenges OPEX managers of more mature initiatives are likely to face. At the same time, this section serves as a bridge to parts II and III of the book by giving insights into practical applications in the industry, mostly written by industry leaders themselves.
    Scopus© Citations 2
  • Publication
    OPEX: A Definition
    (Springer Berlin Heidelberg, 2013) ; ; ;
    Basu, Prabir
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    Werani, Jürgen
    There is no clear-cut definition of Operational Excellence (OPEX) in theory or practice. Especially the inflationary use of the term for almost every launched improvement activity rather obscured than clarified its meaning. In some companies it has been used synonymously for cost-cutting, in others similar to Six Sigma or lean production. This chapter explains our understanding of, and our philosophy behind, OPEX. Based on this understanding we discuss the benefits of striving for OPEX in the Pharmaceutical Industry. We start with a short story from a completely different field, the management of a major airline's baggage handling department. This will foster the understanding of hindrances to excellence in today's companies. We proceed with examining existing excellence models, and derive common elements. This sets the stage for the introduction and the explanation of the St. Gallen OPEX Model. We then conclude this chapter with our definition of Operational Excellence.
    Scopus© Citations 4
  • Publication
    Structures of Operational Excellence Initiatives
    (Springer Berlin Heidelberg, 2013) ; ; ;
    Basu, Prabir
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    Werani, Jürgen
    One of the most differentiating factors comparing Operational Excellence (OPEX) initiatives from one company to the other is the way how they are organizationally embedded into the respective global and local organizations. There is a lack of evidence about the right structure and the optimal amount of trained people to successfully launch and maintain an excellence initiative. Some companies launched the initiative with the intention to suspend it as soon as the final objective, to make it part of the daily work, would have been reached, others believed in very decentralized structures or contrary invested in quite big central offices. We will try to clarify some aspects of this discussion, not only by relying on evidence from pharmaceutical OPEX programs, but also by reviewing evidence from other industries, especially the automotive industry. We will start with a basic consideration of what the general task of a structure is, than we will specify the objective an OPEX structure has to fulfill, followed by an overview of typical dimensions of an organizational structure. We will then discuss if the structure should change over the lifecycle of an OPEX Initiative and will conclude with a suggestion for an ideal OPEX structure.
  • Publication
    The Current State of Operational Excellence Implementation: 10 Years of Benchmarking
    (Springer Berlin Heidelberg, 2013) ; ; ; ; ;
    Basu, Prabir
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    Werani, Jürgen
    This chapter reviews the current state of Operational Excellence (OPEX) in the pharmaceutical industry. Based on the St.Gallen OPEX Benchmarking data, the level of implementation of OPEX practices and tools as well as the development of selected Key Performer Indicators (KPI) is discussed.
    Scopus© Citations 2
  • Publication
    Managing Global Pharmaceutical Manufacturing Networks
    (Springer Berlin Heidelberg, 2013) ; ; ; ;
    Basu, Prabir
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    Werani, Jürgen
    This chapter presents both the reasons and a possible approach for tackling the challenges of today's globally dispersed manufacturing networks of pharmaceutical companies. Despite of years of discussions about end-to-end value chains the main activities in production optimization in the pharmaceutical industry are still focused on single plant level. Nevertheless we are sure that the industry will have to follow the example of other more advanced manufacturing industries and systematically address production optimization from a true network perspective in the near future. The content of this chapter will in a first part cover the history of why global companies' manufacturing is scattered around the world, why this development was not managed from a holistic perspective and what problems and challenges arose with that. It will then give several real life examples for difficulties and challenges such companies face and it will describe some targets and the current gaps between the status-quo and these targets. In the second part of this chapter we present some frameworks that can help managers to align site and network level and to systematically close the gap between status quo and the targets. Those frameworks are illustrated with one real life example each. Further we will show some implications for the framework application in the pharmaceutical context. In part three we will sum up the content and close the chapter.
    Scopus© Citations 11
  • Publication
    Matching Problems with Tools
    (Springer Berlin Heidelberg, 2013) ; ; ; ;
    Basu, Prabir
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    Werani, Jürgen
    In order to provide a profound understanding of the use of tools, it is necessary to discuss them in the context of objectives that can be reached by their application. A tool and its mere application are not just self-contained. This becomes apparent when looking at the further development of Deming's famous PDCA cycle by Kaoru Ishikawa. He expanded the two steps "Plan" and "Do" by an extra step each, making six steps out of the four: Determine goals and targets, determine methods of reaching goals, engage in education and training, implement work, check the effects of implementation and take appropriate action. These kinds of cycles are typical for many approaches in quality management/improvement. It is a pragmatic step-by-step approach for collecting data, analyzing them and deriving solutions (Fig. 18.1).
  • Publication
    Leadership Principles & Operational Excellence
    (Springer Berlin Heidelberg, 2013) ;
    Werani, Jürgen
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    Basu, Prabir
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    Werani, Jürgen
    For a long time, pharmaceutical companies mostly laid stress on the training of specialists and technical aspects in their pursuit of Operational Excellence. This focus on methods and tools somewhat distracted from one of the most important success factors for a sustainable implementation: leadership. The importance of leadership has been notoriously underestimated. We will start this chapter with a short introduction to leadership, and then highlight the importance of leading the "right way" at all levels of an organization: from the OPEX specialists, over the OPEX leader in a plant and the plant leader himself to the responsible person for OPEX at a corporate level and the Top Management. We will build a leadership model helping us to put leading in an OPEX context, and will then discuss what kind of leadership is the most appropriate for a sustainable implementation of OPEX.