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The purpose of this paper is to provide an overview of knowledge capture in the biopharmaceutical industry, focusing primarily on the transition from paper‐based to electronic data capture (EDC) systems.

The paper draws on biopharmaceutical industry literature and data from example clinical studies to describe the issues involved in transitioning to EDC in the clinical trials environment.

While electronic data capture systems provide greater efficiencies along the clinical trial supply chain, the industry is still far from achieving wide scale utilization of such technologies. The barriers to successful implementation are multifaceted, involving not only the information technology itself, but also user acceptance issues, lack of interoperability standards, and regulatory compliance. Major shifts in organizational culture and a unified effort within the industry will be necessary in order to derive full benefits from electronic capture systems in the future.

This study was limited in that case data from only one company was used to supplement the literature review. Further research is warranted to better understand the factors that facilitate adoption of electronic knowledge capture systems in the biopharmaceutical industry.

While the need for knowledge management in the healthcare industry is indisputable, there has been remarkably slow progress in this area, and a dearth of research exploring implementation issues. The value of this type of inquiry is profound as it will help us better understand the issues in implementation and adoption, and ultimately to deliver more effective and safe drugs to the public in a more efficient manner.

While the phenomenon of R&D offshoring has become increasingly popular, scholars have mostly focused on R&D offshore outsourcing from the point of view of the client firms, who are often from an advanced country. By examining vendor firms, in this paper the authors shift the focus to the second party in the dyadic relationship of R&D offshore outsourcing. Specifically, the authors compare vendor firms with nonvendor firms from the same emerging economy and industry to look at whether vendor firms from emerging economies can improve their innovation performance by learning from their clients. The authors also look at the role of depth and breadth of existing technological capabilities of the vendor firm in its ability to improve its innovation performance.

This study is based on firm-level data from the Indian biopharmaceutical industry between 2005 and 2016. The authors use the Heckman two-stage model to control for self-selection by firms. The authors compare the innovation performance of vendor firms with nonvendor biopharmaceutical firms (group vs nongroup analysis) as well as innovation performance across vendor firms (within group comparison).

The authors find that, compared to nonvendor firms, R&D offshore outsourcing vendor firms from emerging economies have higher innovation performance. The authors argue that this higher innovation performance among vendor firms is due to learning from their clients. Among vendor firms, the authors find that the innovation gains are contingent upon the two factors of depth and breadth of the vendor firms' technological capabilities.

This paper makes three contributions: First, the authors augment the nascent stream of research on innovation from emerging economy firms. The authors introduce a new mechanism for emerging economy firms to learn and upgrade their capabilities. Second, the authors contribute to the literature on global value chains, by showing that vendor firms are able to learn from their clients and upgrade their capabilities. Third, by examining the innovation by vendor firms, the authors contribute to the R&D offshore outsourcing, which has largely focused on the client.

The study findings have important implications for both clients and vendors. For client firms, the authors provide evidence that knowledge spillovers do happen, and R&D offshore outsourcing can turn vendors into potential competitors. This research helps firms from emerging economies by showing that becoming vendors for R&D offshore outsourcing is a viable option to learn from foreign firms and improve innovation performance. Going outside geographic boundaries may be a large hurdle for these resource-strapped, emerging economy firms. Providing offshore outsourcing services for narrow slices of R&D activities may be a starting point for these firms to upgrade their capabilities.

This paper is among the first to quantitatively study the innovation performance of vendor firms from emerging economies. The authors also contribute to the nascent literature on innovation in emerging economy firms by showing that providing R&D offshore outsourcing services to client firms from advanced countries can improve firms' innovation performance.

This research explored the literature regarding successful leadership practices and how these practices form the organizational context that leads to success in the biotechnology industry. Dominate themes emerged in general leadership strategies, leading research and development scientists, moving ideas from research to the consumer and the culture of research versus practice. Themes include leaders must be adaptable and able to lead effectively in a dynamic environment. Leaders need to consistently articulate the vision throughout the organization. Leaders need to be strategic decision-makers and flexible enough to allow the vision to adjust to the culture and the environment. Leaders need to communicate effectively and create an organization where communication flows efficiently at all levels. Leaders need to recognize clear cultural differences between functional groups, and they need to empower employees at all levels to make strategic decisions. Leaders need to know which decisions must be retained as his or her sole responsibility.

To gain the highest performance in technological efforts, firms have to balance their technology sourcing portfolio, i.e. they have to decide how to source the required technology and whom to source from. This paper aims to tackle the issue by investigating the factors affecting the technology sourcing portfolio composition and the effect of the portfolio diversity on the performance outcome.

An inductive multiple case study was performed. Data of four biopharmaceutical producer firms in the period of 1998-2017 were collected. To expand the under study time span, the under study firms were all chosen from the first-comer ones. They entered the NBP arena in the 1998-2008 period, i.e. the period in which Iranian NBP industry was in its formation stage.

This paper detects the affecting technology-, firm-, industry- and national level factors in Iran biopharmaceutical industry and analyses their influencing mechanism. It is demonstrated that there are factors in a developing country, specifically Iran, which do not matter in developed countries. In addition, the synergistic effect of using various technology sources vehicles is confirmed.

Inaccessibility to infrastructures and global communication barrier problems are features of Iran innovation system. Such features discourage the foreign firms to make long-term investments in Iran which consequently deprives Iranian firms of their knowledge and technology. The modification of these problems is suggested.

Factors such as access to infrastructures and global communication barrier are not prevalent in developed countries; therefore, less attention has been paid to them in the literature.

Although previous research has reached an agreement that finding appropriate alliance partners and reducing selection uncertainty are important for achieving high alliance performance, it has not explored (1) how organizations reduce selection uncertainty, (2) what mechanism enables organizations to do so, and, more generally, (3) how organizations form alliances. This research examined these research questions by conducting fieldwork at 20 biopharmaceutical organizations in the Untied States. I identified three mechanisms for reducing selection uncertainty, including the (1) relational, (2) internal, and (3) contextual mechanisms. One of the findings implies that alliances do not always emerge out of embedded ties, and that there exist variations in organizational usage and reliance on ties and personal rapport in constructing interorganizational networks.

This study empirically examines the relationship between institutional ownership and innovation activity in the unique setting of the clinical trials for US biopharmaceutical companies. We used multiple statistical techniques in the period from 1990 through 2006 for firms in the biopharmaceutical industry to examine this relationship. Contrary to the widely believed relationship discussed in the literature, our findings suggest that institutional investors vary in their reactions to innovative progress. Specifically, we find that institutional investors with a long-term investment horizon (i.e., dedicated owners) increase their holdings of a firm’s equity as the number of the firm’s products increases in phases I and II of FDA clinical trials. These findings are robust for heteroskedasticity and autocorrelation as well as for different operationalizations of the change of institutional ownership.

In this chapter a typology is presented that typically describes strategic patent management practices in four development categories. The underlying framework integrates patent functions with strategic planning attitudes. Policy makers can apply it to survey the actual use of patents in order to identify the potential for improvement in SME-owned patent exploitation. Managers of these organisations can use it to evaluate the current patent management practice for taking the next step towards a more active use of patents. Operationalisation of the framework into a questionnaire is grounded in a pilot study of three biotechnology firms, differing in size and age. The result has consequently been applied in a case study consisting of 16 small-sized biopharmaceutical companies in the Netherlands. After presenting results from this sample of patent management practices, we present our findings and discuss the validity and use of the typology for the above-mentioned purposes.

In the network strategy view, relative competitive advantage stems not merely from opportunity structures embedded in networks but also from the distribution of ability and motivation among firms. Thus, there is a need to “bring the firm back in” to the network strategy narrative. We demonstrate that a mixed-methods design, blending large-sample data with micro-data on specific firms and their networks, can increase our understanding of the interplay of network structure and actor mechanisms, thus bridging the chasm between theory and practice in network strategy. We believe this is a critical step toward the “strategic design of networks.”

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.

This exploratory investigation conflates emerging constructs and themes analytically induced from a systematic survey of 142 scholarly and practitioner articles and 45 expert interviews with senior professionals operating in the biopharmaceuticals industry.

The findings identify seven theoretically and empirically grounded technological rules associated with effective inter‐organizational networking for innovation. They embody evidence ex post of networking theory and practice. Based on van Aken's seminal work, they comprise design‐oriented knowledge to provide a solution architecture of viable action options for managers, a priori, to purposefully design innovation networks. Collectively these rules represent a tentative taxonomy, a means of classifying design principles, to assist managers in navigating their decision‐making processes.

This study demonstrates the need for explicit design‐oriented knowledge for configuring inter‐organizational networks. Finally, the implications of the findings for strategic management theory are discussed from a dynamic capabilities view. The significance of a dynamic capability which addresses the renewal of network‐specific resources is highlighted.

Using a dynamic capabilities lens, this paper aims to study the impact of genomics generally and gene therapy specifically on the rare disease sector of the biopharmaceutical industry.

In this study, 24 genomics-based, rare disease-focused biopharma companies were studied and several variables were tested with respect to enterprise value growth. The companies were analyzed as a group of rare disease firms, as well as by size.

The authors found that number of employees, revenues, number of pipeline and marketed products and retained earnings are strongly correlated (in that order) with enterprise value in rare disease focused biopharma companies. These correlations seem to be weaker as a company’s market capitalization size decreases, indicating that there tends to be increasing returns to scale.

This study found that increasing rates of cumulative returns to enterprise value growth depends on accumulating knowledge-based employees and expanding product portfolios of disruptive genomics-based technologies for treating rare diseases. Aggregating skilled and innovative employees (especially in bigger companies) can be seen as a cumulative bolstering factor in leveraging dynamic capabilities which can be recognized, understood and transformed into commercial success (i.e. increasing returns in enterprise value). In other words, technology managers’ job is to manage not only the financial aspects of the technology but also human resources, asset configuration and strategic alliances efficiently toward faster and better innovation. Strong dynamic capabilities can be formed with the accumulation of experience, articulation and codification of knowledge and an adaptive ability to change the way they solve problems as their environment transforms.

This is the first study to demonstrate and measure a relationship between dynamic capabilities and enterprise value in genomics-based rare disease firms. Further, this study highlights the importance of building the capability and capacity to absorb expertise and accumulate knowledge for new product innovations and sustainable competitive advantage in industries characterized by disruptive innovation.