Now showing 1 - 10 of 18
  • Publication
    Pharmaceutical Operational Excellence - A suitable concept for Kenya?
    (Space Sellers Ltd., 2014-04-30) ; ;
    The pharmaceutical environment The global pharmaceutical industry currently faces a great upheaval that poses severe challenges to organizations of all sizes. Companies which were blessed with success until yesterday are now confronted with patent expirations, R&D pipelines running dry and considerable overcapacities. A constantly increasing competition and complexity within pharmaceutical manufacturing make pharma a tough business [1]. The current situation which pharma endures came, however, not out of the blue. Moreover, especially large research driven and generic manufacturers, working on margins´ edge, searched for and developed their own defence mechanisms to sustain in global business. One of the most promising approaches to improve a company´s situation that hit pharma agenda at the turn of the century is the relentless effort to achieve operational excellence (OPEX).
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  • Publication
    Pharmaceutical OPEX - The Next Generation
    (Jameson Publishing, 2013-10-04) ;
    The history of operational excellence (OPEX) in the pharma industry is short. Since the first serious initiatives were launched at the beginning of the 21st century, OPEX gained momentum and became a priority at all hierarchies in pharma manufacturers all over the world. Simultaneously, the science of pharmaceutical manufacturing appeared on the agenda of the FDA. As a reaction to a continuously rising number of post-approval changes, the FDA started to push the industry toward developing a scientific understanding of pharmaceutical manufacturing processes and encouraged manufacturers to use innovative technologies like PAT (process analytical technology) for better process control. As a result, quality and productivity appeared on the agency's agenda, providing the industry with new opportunities and opening the way for OPEX. The incremental introduction of OPEX in the pharmaceutical industry happened in three major stages. To date, there is no clear-cut definition of the term operational excellence. In fact, the term itself is often used for newly launched improvement activities or as a proxy for cost-cutting programs, Six Sigma, and Lean initiatives, all of which contribute to its dilution over time. OPEX should be understood as the balanced management of cost, quality, and time while at the same time focusing on the customers' needs. To achieve these ends, OPEX comprises structural and behavioral changes thought to optimally support necessary activities. In order to maintain sustainability in changing or volatile environments, OPEX has to be pushed by top management and has to be designed to engage every employee. Obviously, OPEX is not only concerned with performance. It also encompasses the way leading to superior performance and to practices that allow an organization to continuously improve itself.
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  • 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 1
  • 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 3
  • 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