Biopharmaceutical Sector Research Articles

Intellectual Property Business Models Using Patent Acquisition: A Case Study of Royalty Pharma Inc.

In the pharmaceutical industry, companies are currently facing great challenges in developing new products due to patent expiration and decreasing profitability. In particular, the decrease in R&D productivity caused by the constant increase in the development period and cost of innovative new drugs means that the expectations of investors cannot be met. This study examined the successful case of Royalty Pharma’s business model, which adopted securitization, a new investment method that makes advance payments of future profits in order to overcome the decline in R&D productivity and enables the pharmaceutical manufacturers (as patent owners) to resolve the issue of attracting investment funds, while also making these funds available for other development projects. It examined the role in the biopharmaceutical sector of patent aggregating companies in providing the competency to analyze patent technologies and to create investment megafunds, as well as the success factors that can lead to a virtuous cycle of product development. From this analysis, the application of a patent-based business model is proposed for small and mid-sized pharmaceutical industries

Scientific output of the emerging Cuban biopharmaceutical industry: a scientometric approach

Cuba has developed a biopharmaceutical sector that involves some of the country's most relevant scientific institutions. Despite the severe constraints on resources resulting from the U.S. embargo, the results achieved by this sector have contributed to put the country's health indicators at the same level of high-income nations. Recently, the creation of BioCubaFarma as a cluster of high-technology enterprises organized around a closed cycle model becomes one of the most relevant efforts of the Island in order to make biopharmaceuticals one of the country's leading export earners. The main aim of the current paper was to characterize BioCubaFarma through a battery of Scopus-based bibliometric indicators. A comparison with the most productive multinational pharmaceutical companies was made. Regression analysis of annual productivity, number of citations, scientific talent pool, innovative knowledge and other citation-based indicators was performed. Differences and similarities between BioCubaFarma and multinational companies in four Scopus subject categories related to this sector were identified. The most productive and visible institutions from BioCubaFarma were also characterized. Qualified human resources, innovative knowledge, leadership, high specialization in the field of vaccines development and non-dependence of international collaboration are strengths of the organization. However, it is still necessary to increase the number of articles published in highly visible journals with the aim to achieve a better citation-based performance. Moreover, to increase the contributions from less-productive institutions, more clinical research published in medical journals and more collaboration with universities and health institutions could also have positive benefits for BioCubaFarma's pipelines and portfolios.

Innovation through M&A in the biopharmaceutical sector

Purpose This paper aims to review the latest management developments across the globe and pinpoint practical implications from cutting-edge research and case studies. Design/methodology/approach This briefing is prepared by an independent writer who adds their own impartial comments and places the articles in context. Findings Acquiring innovation will continue to be a necessity for pharmaceutical companies and to enjoy a sustainable advantage, they have the obligation to look for competitive advantage through coordination between both upstream and downstream capacities. A strict focus on the core competency of the enterprise is fast becoming obsolete. Practical implications The paper provides strategic insights and practical thinking that have influenced some of the world’s leading organizations. Originality/value The briefing saves busy executives and researchers hours of reading time by selecting only the very best, most pertinent information and presenting it in a condensed and easy-to-digest format.

Unpacking Open Innovation: Absorptive Capacity, Exploratory and Exploitative Openness, and the Growth of Entrepreneurial Biopharmaceutical Firms

In this article, we explore the relationship between two key aspects of open innovation in small firms—absorptive capacity (ACAP) and external relationships—and their effects on growth in the U.S. and European biopharmaceutical sectors. Results from an international sample of 349 biopharmaceutical firms surveyed in the United States, United Kingdom, France, and Germany suggest that realized ACAP plays an important role in determining firms’ growth. In terms of the interaction between firms’ ACAP and external relationships, we find that engagement with exploratory relationships depends strongly on the continuity of R&D, while participation in exploitative relationships is more conditional on firms’ realized ACAP.

Designing Clinical Trials for New Drugs

Much has been written about the ethics of healthcare innovation and the role of pharmaceutical companies in innovation. Rightly or wrongly, the scholarship and media coverage has been disparaging. Many commentators fear that the biopharmaceutical sector no longer serves patients’ interests; they

Technology Complexity and Open Organization: Foreign Innovation Projects in the Biopharmaceutical Sector in China

High-technology enterprises are increasingly developing their technological advantages in foreign countries. In doing so, they need to make the decision whether to organize the R and D activity inside the organization or outside through alliance. The perceived assumption suggests that technological complexity dictates the internal organization of the R and D activity. However, emerging evidence suggests that technological complexity induces external alliance for the transformation of the organizational knowledge to new product. We test this proposition that there is a positive correlation between technological complexity and the external alliance of the firm. The hypotheses find support that complexities of (i) Scale, (ii) Scope, (iii) Intra-clusters and (iv)Inter-cluster of the patent claims predict external alliance. However, the odds of the external alliance are not in a linear manner. Rather, the odds of these predictors are high, low and high again. The article discusses theoretical and practical implications.

Industry Cognitive Distance in Alliance Portfolios and Firm Innovation Performance

Drawing from the literature on attention-based view of the firm, knowledge base diversity and cognitive distance in alliances, this paper distinguishes between intra- and inter- industry alliances and investigates the effect of increasing numbers of such alliances on firm innovation performance. Intra-industry alliances offer lower opportunities for innovation compared to inter-industry alliances and are less demanding on firm management due to higher cognitive similarity between partners from the same industry. We propose that trade-offs between innovation opportunities and management efforts will result in an inverted U and a U shaped relationship between the number of intra- and inter-industry alliances and innovation returns respectively. We explore our hypotheses in the context of the UK bio-pharmaceutical sector, and obtain support for both hypotheses.

Empowering openness: the case of CROs-related innovation networks in the Italian bio-pharmaceutical sector

The present work focuses on the study of healthcare networks as key tool for innovation creation and spreading, by deploying the emergent paradigm of Open Innovation. The study analyses the organisational methods through which bio-pharmaceutical companies open their innovation processes and enter into a relationship with external subjects called Contract Research Organizations (CROs) for the exchange of technology and knowledge. The paper describes the results of a survey conducted in the Italian bio-pharmaceutical sector, which showed how the high potential of Italian CROs has yet to be fully expressed, and outlining the ways through which the logic of openness is being exploited in the Italian context. The paper also tries to give some insights to the existing research on Open Innovation, studying the adoption of this approach in an industry where the adoption and implementation of openness-driven practices has been so far rather under-researched.

Biopharmaceutical Innovation System in China: System Evolution and Policy Transitions (Pre-1990s-2010s).

This article sets up the initial discussion of the evolution of biopharmaceutical innovation in China through the perspective of sectoral innovation system (SIS). Two data sources including archival documentary data and field interviews were used in this study. Archival documentary data was collected from China Food and Drug Administration (CFDA) and Chinese National Knowledge Infrastructure (CNKI). In addition, industrial practitioners and leading researchers in academia were interviewed. Biopharmaceutical in China was established through international knowledge transfer. The firms played more active role in commercializing biopharmaceutical in China though universities and research institutes were starting to interact with local firms and make contribution to biopharmaceutical industrialization. The transition of the Chinese government's policies continuously shapes the evolution of biopharmaceutical sector. Policies have been dramatic changes before and after 1980s to encourage developing biopharmaceutical as a competitive industry for China. A SIS for biopharmaceutical has been shaped in China. However, currently biopharmaceutical is still a small sector in China, and for the further growth of the industry more synthetic policies should be implemented. Not only the policy supports towards the research and innovation of biopharmaceuticals in the early stage of development should be attended, but also commercialization of biopharmaceutical products in the later stage of sales.

Opinion] Is There a Prescription for Finding Top Talent in the Life Sciences Market?

Strategic resourcing models employed within the biopharmaceutical sector have been a hot topic lately—and for good reason. In the last decade, markets for life sciences products and services have increased exponentially, which means having the right talent in place is essential for any company

Reality of Some Indicators about the Technological Cooperation in the Biopharmaceutical Sector in Mexico

Reality of Some Indicators about the Technological Cooperation in the Biopharmaceutical Sector in Mexico

Brokering knowledge in networks: institutional intermediaries in the Taiwanese biopharmaceutical innovation system

The literature maintains that in the development models of the Asian tigers in the 1980s, policy-induced intermediaries played the key mediating roles in acquiring technology from abroad to enhance local capabilities. In this paper, we examined how the intermediaries fare in terms of their expected brokerage roles in the context of the Taiwanese biopharmaceutical sector. By applying social network methods to data on this specific sub-sector, we demonstrate that the intermediary organisations under-performed in terms of brokering the transfer and diffusion of foreign technologies. Two factors underlie this result: intermediaries need to possess sufficient capabilities to be able to drive the strategy of stimulating a science-intensive sector through foreign technology, and intermediaries alone are not sufficient for the success of this strategy. We conclude that, instead of heavily relying on intermediaries to act as brokers, enabling research organisations and firms to play more effective brokerage roles may be a more successful strategy to develop a science-intensive sector such as biopharmaceuticals.

Industry perspective on Chinese hamster ovary cell ‘omics’

The biopharmaceutical sector has become a significant segment of pharmaceutical industry. More than 200 biopharmaceutical products have reached market approval and more than 350 additional products are currently in clinical trials [1]. Chinese hamster ovary (CHO) cells are the main host for production of recombinant therapeutic proteins. The 2011 CHO-produced biopharmaceutical sales were nearly US$60 billion [2]. Approximately 45% of new products approved in the period from 2006 to 2010 produced in CHO cells and seven out of ten of the world’s top-selling biopharmaceutical drugs are expressed in CHO cells [1]. Despite some progress in improving therapeutic protein productivity, the cellular machinery of CHO cells is still not well understood and consequently good knowledge of recombinant protein production is missing. Therefore, functional genomics to better understand and improve productivity of CHO cell lines in pharmaceutical and biotech industry is getting more and more relevant. This includes applied genomic screening as well as cell line engineering tools. Thanks to recent advances in decoding the CHO cell genome and transcriptome [3–6] novel cell line engineering technologies as gene knockout (e.g., zinc finger nucleases [ZFNs], transcription activator-like effector nucleases [TALENs], clustered regularly interspaced short palindromic repeats [CRISPRs]), RNA interference (e.g., si/shRNA) as well as overexpression or introduction of new genes can now be applied to modify CHO cell lines. The expectation is that the now available Chinese hamster genomic information will lead to better understanding of the expression of recombinant proteins in CHO cells. This includes the utilization of genomics/ transcriptomic tools (e.g., next-generation sequencing [NGS], expression/comparative genomics microarray techniques), proteomic tools (e.g., mass spectrometry [MS]), as well as metabolomic techniques (e.g., nuclear magnetic resonance spectroscopy).

Cancer immunotherapeutics: evolution of monoclonal antibodies to peptide immunogens.

The Wistar Institute under Hilary Koprowski's direction played a preeminent role in bringing the fruits of basic science to clinic through biotechnology and life science enterprises. Koprowski's early view on the utility of monoclonal antibodies has been validated to some extent, because monoclonal therapeutics form one of the fastest growing and most successful and lucrative segments within the biopharmaceutical sector. Over 30 monoclonal antibody drugs have now been approved in the United States and Europe. However, monoclonal antibodies might be viewed in the context of a bridge to the future for vaccines. The Wistar Institute's reputation, while built on vaccines for infectious diseases, can be translated in years to come into vaccines for cancer.

Strategic Decision Making under Uncertainty: R&D and Pricing Strategies in Biopharmaceuticals

This symposium explores the antecedents, drivers, and impacts of product decision making in the biopharmaceutical industry. While research in strategy and economics has explored how policies impact new product development and how firms compete, many gaps remain in terms of our understanding of decision making and performance. The papers featured are aimed at addressing these gaps. This session will feature the presentation of three papers focusing on: (1) the effect of intellectual property policy change on neglected disease research, (2) the relationship between research portfolio depth and breadth and firm performance, and (3) the drivers of price increases of patented pharmaceuticals. A discussant will unify the themes presented across the papers, provide developmental commentary, and suggest related avenues from future research on product development and portfolio management in the biopharmaceutical sector. Firm-Level Pricing Strategy: When Irrelevant Products Are Relevant Presenter: David Ridley; Duke U. Presenter: Colleen M Cunningham; Duke U. Search Processes and Product Development Success: Evidence from the Global Pharmaceutical Industry Presenter: Nilanjana Dutt; Bocconi U. Presenter: Elena Vidal; Baruch College-The City U. of New York Intellectual Property Rights and Research on Neglected Diseases Presenter: Keyvan Vakili; London Business School

Tracing National and Global Forces in a Taiwanese SME's Product Innovation

Taiwan's competitiveness in the global arena has often been attributed to the country's dynamic small and medium-sized enterprises (SMEs). In the most recent decade, the Taiwanese government has increased support to innovative SMEs, and with the emergence of new fields such as biotechnology, companies with highly innovation-driven agendas are surfacing. The innovation focus provides not only new opportunities but also challenges for Taiwanese SMEs. In this article I aim to increase the understanding of how national and global forces affect SME innovation in Taiwan. To this end, I use an industrial network approach to trace the national and global interdependencies that follow the network of a Taiwanese SME in the biopharmaceutical sector.

Absorptive capacity and openness of small biopharmaceutical firms – a European Union–United States comparison

The complementarities between internal capabilities and external linkages have been widely acknowledged in the open innovation literature, yet little is known about the extent to which internal capabilities affect firms' openness within different institutional contexts. This paper therefore empirically explores the relationship between absorptive capacity (ACAP) and openness in the United States and European biopharmaceutical sectors. Based on analysis of data from a large‐scale international survey of 349 biopharmaceutical firms in the United States, the United Kingdom, France and Germany, the results suggest that exploratory openness depends more strongly on the research and development (R&D) aspect of firms' potential absorptive capacity, whereas exploitative openness is more conditional on firms' realized absorptive capacity (RACAP). The results also highlight the major differences between firms' openness and ACAP in the United States and Europe – in the United States, firms' skill levels prove more significant in contributing to firms' engagement with exploratory relationships, whereas in Europe, continuity of R&D proves more important. Engagement with exploitative relationships, however, is more conditional on firms' RACAP in Europe only.

Effect of Freeze-Thawing Study on Curcumin Liposome for Obtaining Better Freeze-Dried Product

Liposomes are widely used in the pharmaceutical, biopharmaceutical, cosmetic, and nutraceutical sectors as an efficacious drug-delivery system for improving the bioavailability and protection of the entrapped drug molecule. The present study evaluates freeze-thaw as a simple approach for screening the most appropriate lyoprotectant. The freeze-thaw study is based on the principle that an excipient, which protects liposomes during the first step of freezing, is likely to be an effective lyoprotectant. Curcumin liposomes with high entrapment efficiency were prepared using a lipid film hydration technique. The freeze-thawing study was carried out using various lyoprotectants such as sucrose, mannitol, lactose, dextrose, and maltose. Sucrose showed minimal particle size change with better cryoprotection after the freeze-thaw study. The internal and external addition of sucrose during formulation has shown significant effects on the retention of particle size and curcumin content during the freeze-thawing and drying studies, respectively. Scanning electron microscopy revealed round vesicles with a size ∼131 nm, which correlated well with zeta sizer particle size measurements. Infrared spectra and X-ray diffraction suggested interaction between the sugar and the liposomes and amorphization of the final freeze-dried product. The good correlation between freeze thawing and freeze drying suggests the freeze-thaw study as a simple and quick approach for screening optimal cryoprotectant for freeze drying.

Rational Engineering of a Human Anti-Dengue Antibody through Experimentally Validated Computational Docking

Antibodies play an increasing pivotal role in both basic research and the biopharmaceutical sector, therefore technology for characterizing and improving their properties through rational engineering is desirable. This is a difficult task thought to require high-resolution x-ray structures, which are not always available. We, instead, use a combination of solution NMR epitope mapping and computational docking to investigate the structure of a human antibody in complex with the four Dengue virus serotypes. Analysis of the resulting models allows us to design several antibody mutants altering its properties in a predictable manner, changing its binding selectivity and ultimately improving its ability to neutralize the virus by up to 40 fold. The successful rational design of antibody mutants is a testament to the accuracy achievable by combining experimental NMR epitope mapping with computational docking and to the possibility of applying it to study antibody/pathogen interactions.

Self-Fulfilling Prophecies of the European Knowledge-Based Bio-Economy: The Discursive Shaping of Institutional and Policy Frameworks in the Bio-Pharmaceuticals Sector

Discourses matter. They help to shape institutions and policies. A new discourse has emerged in recent EU innovation policy centred on the idea of a knowledge-based bio-economy (KBBE). It is officially defined as ‘the sustainable, eco-efficient transformation of renewable biological resources into health, food, energy and other industrial products.’ The KBBE agenda links current problem diagnoses, research priorities, technological innovation, and societal benefits. In analysing the KBBE discourse, this paper draws on the sociology of technological expectations, which emphasises the performative, mobilising and self-fulfilling roles of such future-oriented visions. For example, the KBBE agenda shapes European research and innovation priorities in the bio-pharmaceutical sector. It frames socially relevant bio-knowledge in terms of pre-competitive research which can eventually facilitate new commercial products and patentable knowledge. Moreover, the agenda defines new institutional and policy frameworks necessary to realise societal benefits from these products and knowledge.