On strategic choices faced by large pharmaceutical laboratories and their effect on innovation risk under fuzzy conditions

ObjectivesWe develop a fuzzy evaluation model that provides managers at different responsibility levels in pharmaceutical laboratories with a rich picture of their innovation risk as well as that of competitors. This would help them take better strategic decisions around the management of their present and future portfolio of clinical trials in an uncertain environment. Through three structured fuzzy inference systems (FISs), the model evaluates the overall innovation risk of the laboratories by capturing the financial and pipeline sides of the risk.Methods and materialsThree FISs, based on the Mamdani model, determine the level of innovation risk of large pharmaceutical laboratories according to their strategic choices. Two subsystems measure different aspects of innovation risk while the third one builds on the results of the previous two. In all of them, both the partitions of the variables and the rules of the knowledge base are agreed through an innovative 2-tuple-based method. With the aid of experts, we have embedded knowledge into the FIS and later validated the model.ResultsIn an empirical application of the proposed methodology, we evaluate a sample of 31 large pharmaceutical laboratories in the period 2008–2013. Depending on the relative weight of the two subsystems in the first layer (capturing the financial and the pipeline sides of innovation risk), we estimate the overall risk. Comparisons across laboratories are made and graphical surfaces are analyzed in order to interpret our results. We have also run regressions to better understand the implications of our results.ConclusionsThe main contribution of this work is the development of an innovative fuzzy evaluation model that is useful for analyzing the innovation risk characteristics of large pharmaceutical laboratories given their strategic choices. The methodology is valid for carrying out a systematic analysis of the potential for developing new drugs over time and in a stable manner while managing the risks involved. We provide all the necessary tools and datasets to facilitate the replication of our system, which also may be easily applied to other settings

Measuring the efficiency of large pharmaceutical companies: an industry analysis

This paper evaluates the relative efficiency of a sample of 37 large pharmaceutical laboratories in the period 2008-2013 using a Data Envelopment Analysis (DEA) approach. We describe in detail the procedure followed to select and construct relevant inputs and outputs that characterize the production and innovation activity of these pharmaceutical firms. Models are estimated with financial information from Datastream, including R&D investment, and the number of new drugs authorized by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) considering the time effect. The relative performances of these firms –taking into consideration the strategic importance of R&D– suggest that the pharmaceutical industry is a highly competitive sector given that there are many laboratories at the efficient frontier and many inefficient laboratories close to this border. Additionally, we use data from S&P Capital IQ to analyze 2,071 financial transactions announced by our sample of laboratories as an alternative way to gain access to new drugs, and we link these transactions with R&D investment and DEA efficiency. We find that efficient laboratories make on average more financial transactions, and the relative size of each transaction is larger. However, pharmaceutical companies that simultaneously are more efficient and invest more internally in R&D announce smaller transactions relative to total assets

Absorptive capacity and internationalization of New Zealand high-tech SMEs in the agro-technology sector

This study investigates the relationships between firm's technology, absorptive capacity and the internationalization process in the high-tech SMEs. The research identifies the most influential factors that affect the international activities and expansion decisions of New Zealand high-tech SMEs with core capabilities in agro-technology. Mixed methods, qualitative and quantitative elements in the data collection and analysis, were employed in this research for a reason that a deeper understanding of the research subject and the analysis of complex issues such as the internationalization process and absorptive capacity required methodological variety. The use of qualitative and quantitative methods took place in parallel. Both methods were used to study the same subject but they had specific objective related purposes and they offered the possibility of developing rich empirical data as well as a more comprehensive understanding of the subject under the study. The findings show that it is absorptive capacity that explains internationalization process, not internationalization process that explains absorptive capacity. The practice of internationalizing is as much a reflection of a firm's absorptive capacity as it is its determinant. The research identifies that high-tech SMEs possess technological and non-core absorptive capacity which in a different way influence firms' strategies. The research suggests that firm's technological capabilities and the advantage of specialized knowledge along with their limited non-core absorptive capacity act as constraints to the development of the future international strategy in high-tech SMEs. The study expands the existing literature on internationalization by developing variables for evaluating absorptive capacity in firms. This helped develop an absorptive capacity model which can be used as a valuable tool for self-assessment by firms to facilitate gaining insight towards further growth and development. The research suggested that if firms were able to measure its absorptive capacity this may result in improved business activities and enhanced presence in the world market. The results of this study should encourage firms to identify, capture and articulate knowledge achieved by their ventures. Managers must develop and nurture skills that ensure effective integration of learning as their firms expand, particularly internationally. These findings and absorptive capacity model offered as a tool should encourage managers to explore when, where, and how to best use firm's resources in the business operations. This is particularly important in regards to the research context (high-tech SMEs) where scientists are managers as well

The Effectiveness of European Regulatory Governance : The Case of Pharmaceutical Regulation

While the regulation of healthcare in EU member states has remained largely unaffected by EU influence, the opposite is true for the regulation of pharmaceutical safety. Since the thalidomide crisis, supranational influence has constantly and continuously expanded in this regulatory field. The emergence of European pharmaceutical policy raises two main questions adressed in the present study. The first question relates to the delegation of regulatory competencies in the pharmaceutical sector. Pharmaceuticals are important for the maintenance of public health but at the same time represent a consumption risk. Therefore, the need for public intervention arises. Governments play an important role in the financing of pharmaceuticals and the protection of their citizens from potentially harmful products. The protection of its citizens is one of the key tasks of the state. The evident delegation of regulatory powers to the European level in the field of risk regulation thus seems to be at odds with the member states’ need to legitimize their activities. The present study thus tries to develop an explanation for the delegation of regulatory competencies in the area of pharmaceutical regulation and in the field of risk regulation in more general terms. The second part of the study analyses in how far the Europeanization of pharmaceutical regulation has impacted on the quality of regulation and its effectiveness, depicting the degree of regulatory goal attainment. The study covers the development of pharmaceutical regulation from the late 1950s until the end of 2008

Business and non-profit organizations facing increased competition and growing customers' demands

Klasyfikacja tematyczna: Dynamika gospodarki \u15bwiatowej i narodowej. Rozw\uf3j gospodarczy; Teoria i psychologia organizacji; Metody zarz\u105dzani

National system of innovation in biotechnology in a developing country – a Gerschenkronian approach to biopharmaceuticals and bioagriculture in Iran

This study is a qualitative analysis to investigate the extent and characteristics of the influence of the national system of innovation (NSI) on the performance of the biotechnology sector in a developing country. While developing country ̳leapfrogging‘ would, at first sight, seem to contradict mainstream theorising about latecomer innovation, it fits well with a Gerschenkronian focus on therole of substitutes to overcome major stumbling blocks to economic developmentand the role of institutions such as banks in directing investment. This makes it compatible with an older, more traditional literature. Yet, even though such success can readily be understood for scale-intensive heavy industries with well-established technological trajectories, it does not seem so simple for biotech, where success is still highly uncertain, even for firms in developed countries, and where directed governance structures of the sort authors such as Gerschenkron highlight are not normally deemed useful. To identify what influences the uneven performance of the bioagricultural and biopharmaceutical sectors in Iran, a parallel approach to Gerschenkron‘s is implemented in this thesis, to determine whether the characteristics of Iran‘s NSI in biopharmaceuticals differ from those of bioagricultural sector and whether these differences explain the differing performance. The study makes extensive use of interviews as well as documentation to assess the actual unfolding of events. The findings were unexpected at the outset of the project as the uneven development in the biotechnology sector of Iran turns out to have been caused less by technological failure than by regulatory failures on the part of government. This demonstrates that while the government can speed up economic development by overcoming barriers (through for example promoting successful access to technological knowledge, research and development), it can also hamperinnovation by failing to provide appropriate legislation and to adjust laws and regulations to the stage of technological development that the biotechnology sector of a developing country has achieved. Thus Gerschenkron‘s conclusion about the state as a substitute for ̳economic backwardness‘ is turned on its hea