Nikolaus Lembke

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).

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.

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.

Although highly standardised programmes of Operational Excellence (OPEX) have been implemented in almost every globally operating pharmaceutical company, the success of OPEX initiatives differs considerably. This article presents, based on the St.Gallen OPEX understanding, an overview of the factors that enable a sustainable OPEX culture and OPEX implementation. http://www.pharmafocusasia.com/strategy/creating-sustaining-cultural-change.html