Critical Success Factors in Biomedical Research and Pharmaceutical Innovation

Section 1 Theory.- 1 Research methodology and study domain.- 1.1 The methodology of the study of management and organization.- 1.1.1 The trajectories of theory construction and theory application.- 1.1.2 The TC/TA matrix.- 1.2 Research questions and main hypothesis.- 1.3 Overview of previous studies.- 1.4 Classification of research and development.- 1.5 Industrial innovation.- 1.6 Research and development in the Netherlands.- 1.7 Biomedical research and pharmaceutical innovation.- 1.7.1 Universities.- 1.7.2 Institutes.- 1.7.3 Companies.- 1.8 Concluding remarks.- 2 Structure, behaviour and control.- 2.1 Description of systems.- 2.1.1 Systems and their environment.- 2.1.2 Tight versus loose coupling.- 2.2 Contingencies.- 2.3 Mintzberg’s typology of organizations.- 2.4 The systems theory of control.- 2.4.1 The requirements for effective control.- 2.4.2 Feedback and feedforward control.- 2.5 Universities and institutes.- 2.5.1 Mintzberg’s typology.- 2.5.2 Environmental and organizational constraints.- 2.5.3 Management control.- 2.6 Companies.- 2.6.1 Mintzberg’s typology.- 2.6.2 Environmental and organizational constraints.- 2.6.3 Management control.- 2.7 Concluding remarks.- 3 Structure, behaviour and control in research units.- 3.1 Organizational learning.- 3.2 Research as a value adding learning loop.- 3.2.1 The empirical cycle.- 3.2.2 Management control in the different phases of the empirical cycle.- 3.2.3 The learning loop as a model for organizational change.- 3.2.4 Industrial innovation as a system of value adding learning loops.- 3.3 The double unity cell.- 3.3.1 Universities and institutes.- 3.3.2 Companies.- 3.4 Concluding remarks.- Section 2 Design.- 4 Theory construction.- 4.1 The structure of theory.- 4.2 Theoretical constructs and hypotheses.- 4.3 The defined and empirical concepts.- 4.3.1 Management control.- 4.3.2 Contingencies.- 4.3.3 Performance and effectiveness.- 4.4 Check on completeness.- 4.5 Concluding remarks.- 5 Hypotheses.- 5.1 Management control.- 5.1.1 The objectives and goals.- 5.1.2 Profit versus not-for profit.- 5.1.3 Environmental and task uncertainty.- 5.2 The contingencies.- 5.2.1 Size, economies of scale and threshold level.- 5.2.2 Project size, programmatic homogeneity.- 5.2.3 Time-allocation, research versus clinical practice.- 5.2.4 Age, the life cycle concept.- 5.2.5 Power, internal versus external orientation.- 5.3 Different cross-sections in industry.- 5.3.1 Radical versus incremental orientation.- 5.3.2 Pure play pharmaceuticals versus conglomerates.- 5.3.3 Anglo-American versus continental European companies.- 5.4 Concluding remarks.- 6 Methods of data collection and study methodology.- 6.1 Instruments of data collection.- 6.1.1 Structured interviews and research questionnaires.- 6.1.2 Operational measures for performance and effectiveness.- 6.2 Reliability of instruments.- 6.3 Methods of data analysis.- 6.4 Study population.- 6.4.1 Representativeness of the study sample.- 6.4.2 Approach of study population.- 6.5 Concluding remarks.- Section 3 Results.- 7 Data collection.- 7.1 Response rate.- 7.2 Analysis of non-response.- 7.3 Representativeness.- 7.3.1 Performance and Effectiveness.- 7.3.2 Respondents.- 7.3.3 Unit head versus senior scientific staff.- 7.4 Reliability of instruments.- 7.4.1 The contingencies, and performance and effectiveness.- 7.4.2 Management control.- 7.5 Concluding remarks.- 8 Universities and institutes.- 8.1 Contingencies.- 8.1.1 Staffing structure and age distribution.- 8.1.2 Staffing structure and size.- 8.2 Management control.- 8.3 Performance and effectiveness.- 8.3.1 Size and research performance.- 8.3.2 Annual growth rate.- 8.4 Bivariate associations.- 8.5 Multivariate associations.- 8.6 Organizational level.- 8.7 Concluding remarks.- 9 Companies.- 9.1 Size, performance and effectiveness.- 9.2 Management control.- 9.2.1 Bivariate associations.- 9.2.2 Multivariate associations.- 9.3 Different cross-sections of the study sample.- 9.4 Concluding remarks.- Section 4 Discussion and Conclusions.- 10 Universities and institutes.- 10.1 High and low performers.- 10.2 Organizational level.- 10.3 Differences between universities and institutes.- 10.3.1 Citation score.- 10.4 Economies of scale, threshold level and programme homogeneity.- 10.5 Research and clinical practice.- 10.6 The life cycle concept and age distribution.- 10.7 Internal and external orientation.- 10.8 Customer orientation.- 10.9 Concluding remarks.- 11 Industrial pharmaceutical innovation.- 11.1 High and low performers.- 11.2 Economies of scale.- 11.3 Threshold level.- 11.4 Discovery versus development.- 11.5 Radical versus incremental orientation.- 11.6 Pure play pharmaceuticals and conglomerates.- 11.7 Anglo-American and continental European companies.- 11.8 Concluding remarks.- 12 General conclusions.- 12.1 The research questions.- 12.1.1 High and low performers.- 12.1.2 Comparison of the strata.- 12.2 Study evaluation.- 12.2.1 Strengths and weaknesses of the study design.- 12.2.2 Theory modification.- 12.2.3 Suggestions for further research.- 12.2.4 Theory application.- 12.3 Concluding remarks.- References.- Appendices (A to J).- A Research Questionnaires.- B General questions about R&D management.- C Operationalizations.- D Factor structures.- E Comparison of research units in universities and institutes.- F Spearman rank correlations in universities and institutes.- G Qualitative comparison of universities and institutes.- H Different cross-sections of the industrial study sample.- I Base-line description of the industrial study sample.