Knowledge Management in the Pharmaceutical Industry: Between Academic Research and Industry Regulations

The pharmaceutical sector is one of the pillars of the world’s economy. A significant proportion of its value lies in intellectual assets generated through continuous innovation and lengthy development cycles within a strictly regulated environment. The purpose of this paper is to address the gap between knowledge management (KM) as an expanding academic discipline in the pharmaceutical industry and at the same time a growing regulatory expectation. A systematic review of 137 refereed KM articles revealed six empirical research themes in the pharmaceutical industry. In a subsequent step, the discovered themes and subthemes were compared with the extant regulatory expectations as explained in 128 regulatory guidelines. Findings shed the light on the gap between academic KM research and the current thinking of regulatory bodies. Some regulated knowledge processes were underrepresented in academic literature. The paper offers also novel insights and recommendations for future developments in academic research, regulations and/or industry

Towards technological rules for designing innovation networks: a dynamic capabilities view.

Inter-organizational innovation networks provide opportunities to exploit complementary resources that reside beyond the boundary of the firm. The shifting locus of innovation and value creation away from the “sole firm as innovator” poses important questions about the nature of these resources and the capabilities needed to leverage them for competitive advantage. The purpose of this paper is to describe research into producing design-oriented knowledge, for configuring inter-organizational networks as a means of accessing such resources for innovation

Regulatory Readiness Level: a Tool to Enhance Early Regulatory Adoption in Academic Discovery

The development of pharmaceuticals products is a complex and arduous process. It requires significant investment (both financial and time). The costs of developing products range from $314 million to$2.8 billion, with the time of bringing a new drug to market up to 15 years. The overall probability of success from phase 1 to approval is estimated at between 9% to 12%. Concerns have been raised in the fall off of new approvals and the decreasing number of innovative therapies coming through pharmaceutical R&D divisions. Academia is recognised as a source of such new therapies, but their strengths do not lie in successfully getting product to market. Difficulties arise in the academic setting, due to their lack of understanding and knowledge of the rigorous regulatory requirements that are needed to gain clearance to market pharmaceutical products. Additional tools are needed to aid academic researchers navigate the necessary regulatory pathways. Whilst Technology Readiness Level (TRL) tools exist, they are simplistic in nature and do not provide the necessary detail to facilitate this process. An expansion of the TRL is proposed as one such solution, in the form of a Regulatory Readiness (RRL) tool. This tool will serve as a suitable method to ensure academics have the knowledge and skills to incorporate regulatory science into their product development processes

Patent collateral, investor commitment, and the market for venture lending

This paper investigates the market for lending to technology startups (i.e., venture lending) and examines two mechanisms that may facilitate trade within it: (1) the ‘salability’ of patent collateral; and (2) the credible commitment of existing equity investors. We find that intensified trading in the secondary patent market is strongly related to the annual rate of startup lending, particularly for startups with more redeployable patent assets. Moreover, we show that the credibility of venture capitalist commitments to reinvest in their startups’ next round of financing can be critical for startup debt provision. Utilizing the crash of 2000 as a severe and unexpected capital supply shock for VCs, we show that lenders continue to finance startups with recently funded investors better able to credibly commit to refinance their portfolio companies, but withdraw from otherwise-promising projects that may have needed their funds the most. The findings are consistent with predictions of incomplete contracting and financial intermediation theory.Accepted manuscrip

Using the Balanced Scorecard to Achieve Sustained IT-Business Alignment: A Case Study

High levels of investments in IT and related products and services by firms over the last several decades produced only mixed results. Research shows that one of the most significant determinants of successful IT investments is the alignment between IT and the competitive strategies of a firm. Yet it is largely unclear to both researchers and practitioners how to achieve such alignment in the complex business environment. In this paper, we present and analyze the findings from a case study on how one company uses a well-established strategic management tool, the balanced scorecard, as the framework for aligning its IT initiatives with business strategies. The result is a forward-looking, strategy-oriented corporate culture and financial success for the company. Based on our findings, we expand the Reich and Benbasat alignment model by adding relationship management as an antecedent of alignment and balanced scorecard as a tool for achieving, managing, and sustaining such alignment. Managerial and research implications are discussed, as are directions for future research

Social capital, organizational learning and enterprise performance: an empirical study on pharmaceutical companies in China

With the transformation and upgrading of China's industrial structure, the market-driven restructuring of the global pharmaceutical value chain and the innovation-led structuring of the pharmaceutical industry have led to increasingly fierce competition among pharmaceutical enterprises and the challenge is choosing to survive or to die. In order to meet these challenges, it is necessary for pharmaceutical enterprises to deeply carry out organizational learning. Therefore, what is the effect that various types of social capital have in promoting intra-organizational and inter-organizational learning in Chinese pharmaceutical enterprises? Which types of organizational learning should be adopted to achieve collaborative innovation and improve innovation performance of Chinese pharmaceutical enterprises, thus promoting their overall performance and sustainable development? Combining empirical research with case study, including normative research, and from the perspective of exploratory learning and exploitative learning, this thesis makes a comprehensive and in-depth study of the impact of social capital on enterprise performance in Chinese pharmaceutical enterprises, theoretically explores the connections between the main research variables, constructs a theoretical model, and puts forward the hypotheses of this study. After validation, the main conclusions are drawn as follows: (1) External social capital is conducive to exploratory learning of pharmaceutical enterprises, while internal social capital is favorable for exploitative learning of pharmaceutical enterprises. (2) Exploratory learning of pharmaceutical enterprises plays a positive role in improving the ability of exploitative learning, but exploratory learning and exploitative learning have different impact on different aspects of enterprise performance. (3) Organizational learning plays an intermediary role between social capital and business performance of pharmaceutical enterprises.Com a transformação e melhoria da estrutura industrial da China, a que se junta a restruturação da cadeia de valor da indústria farmacêutica, mais orientada para o mercado e para a inovação, o desafio está entre sobreviver ou morrer e, para tal, as empresas desta indústria deverão introduzir na sua estrutura interna formas de aprendizagem organizacional contínua. Que efeito têm os diferentes tipos de capital social na aprendizagem intra e inter organizacional no caso das empresas farmacêuticas na China? Que tipos de aprendizagem organizacional devem ser adoptados para se conseguir melhorar a inovação nessas empresas e assim promover o seu desempenho e desenvolvimento sustentável? Esta tese procura responder a estas perguntas através de um estudo empírico e da análise de um caso para, a partir da perspetiva das aprendizagens incremental e exploratória, estudar o impacto do capital social no desempenho das empresas farmacêuticas chinesas escolhidas como objeto de estudo. Teoricamente exploraram-se as relações entre as variáveis da pesquisa e elaborou-se um modelo conceptual a partir do qual se propuseram as hipóteses. Os principais resultados revelam que: (1) o capital social externo afeta positivamente a aprendizagem exploratória das empresas estudadas enquanto que o mesmo sucede com a influência que o capital social interno tem na aprendizagem incremental; (2) A aprendizagem exploratória desempenha um papel positivo na capacidade de melhorar a aprendizagem incremental mas ambos os tipos de aprendizagem têm impactos diferentes no desempenho das empresas estudadas; (3) a aprendizagem organizacional, refletida na interação entre as aprendizagens exploratória e incremental desempenha um papel mediador no desempenho das empresas objeto da amostra

The patent management trichotomy: Patenting, publishing, and secrecy

Purpose Extant research and practice of patent management are often occupied with how to best utilize patenting as a source of competitive advantage. This paper instead suggests a patent management trichotomy where firms make strategic decisions between patenting, publishing, and secrecy. Approach The paper is conceptual in nature and draws on received IP-management literature to develop an analytical framework. Findings We suggest that the choice between patenting, publishing, and secrecy can be understood in terms of differences in the degree to which the firm can appropriate value from the invention and the degree to which it can operate freely. Originality/value Through an analysis along the dimensions of direct and indirect appropriation as well as static and dynamic freedom to operate, the article conceptualizes the choice between patenting, publishing, and secrecy in a way useful for management decisions as well as for academics