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Innovation is not always enough. In the beginning of the 2000s established pharmaceutical firms had developed several drugs, yet these new products were far too few. Patents of many blockbuster drugs were to soon expire and substantial profit would then be lost. A potential solution emerged: implementing new biomarker technologies in drug development. Biomarkers are required for knowledge creation about the drug effect on underlying causes of a disease. The problem is this: although academia, industry, and policy makers have deemed biomarkers as necessary for successful drug development, pharmaceutical firms have not used them in actual drug development projects.  Since the 1990s, established pharmaceutical firms have invested financially and restructured organizationally in order to implement biomarkers. Still, cases show that more than 50% of project termination in Clinical Phase 2 (the bottle neck of drug development) can be attributed to the lack of implementing biomarkers.   Challenges of established firms transforming in the face of technology change is a commonly studied phenomenon within innovation management literature. Several explanations have attempted to determine why established firms fail in following technology change. However, most of this literature has been based upon an empirical context where technology change is conceptualized as an innovation of the dominant product design in the industry. Consequently, the challenge is to develop or adapt a discontinuous product innovation. Conversely, implementing biomarkers is a case of technology change that impacts R&amp;D. Since drugs lose their value when the patent protection expires, the established pharmaceutical firms need to continuously develop new block buster drugs – not just one product. More research is needed to fill this gap in the literature in order to develop an understanding of the established firm challenge in implementing biomarkers. This thesis builds upon a longitudinal case study of AstraZeneca. Using multiple data sources, the findings show that the dominant architecture of the drug development process during the 2000s impeded the implementation of biomarkers. AstraZeneca required an “architectural process innovation” in order to complete this implementation. The company’s process-based management structures distorted it from recognizing the need for process change. This thesis has three contributions: First, it describes the process change and the firm’s managerial challenges associated with biomarker implementation; Second, it contributes to the literature on the established firm challenge by developing an understanding of the phenomenon of architectural process innovation; Third, it develops a process-based framework for studying technology change that affects R&amp;D. / <p>QC 20151106</p>

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Background: The unethical treatment of factory workers is widespread, especially in developing countries. There is no international legal body with the jurisdiction to uphold universal labor rights. Hence, the responsibility to ensure worker well-being falls upon the multinational organizations that operate the supply chain. These focal firms often use social auditing; however, recent research reveals that this approach does not incorporate workers' experiences on a consistent basis. To address these shortcomings, a new technology has enabled organizations to connect directly with factory workers, we term the technology digital reporting tools (DRT).  Problem: Even though DRT potential is supported, their adoption rate amongst multinational organizations remains minimal. The benefits of these tools cannot be leveraged without firm implementation. In fact, the estimated market size for socially sustainable tools in global supply chains significantly outweighs their investment rates. This discrepancy must be explained to advance the industry.  Purpose: This thesis intends to deepen the understanding of individual and group level resistance within the change management field by researching a phenomenon that combines technology and social sustainability: DRTs. By recognizing the internal subjective experiences of potential users of DRT technology, we ultimately hope to inform DRT-providers and focal firms of internal and unrealized bottlenecks that hinder the adoption of these tools.  Method: The thesis employs an inductive research approach with a qualitative research design based on 8 semi-structured interviews. All respondents are potential users of the technology within focal firms.  Result: Upon researching the experience of potential users, we find that their willingness to suggest DRT to upper management is the primary mechanism that impacts adoption. We partitioned willingness to suggest into two aggregate dimensions: perceived acceptance of upper management and organizational culture. We find potential users hold an internal need to pitch DRT to upper management in monetary terms. Furthermore, half of DRT utility was unknown by respondents. Lastly, we correlate the sub-theories of change management to the different factors we identified.