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Once a decision has turned out poorly—such as Merck's decision to launch and support the painkiller Vioxx—it is easy to criticize. However, are these bad outcomes the result of a good decision which turned out unlucky, or are they decisions where the bad outcome could have been predicted? This case follows Merck's pharmaceutical product Vioxx from initial development to launch and subsequent withdrawal, and considers the decisions made at each stage by the Merck executives involved. The case concludes by examining the financial impact of the Vioxx withdrawal on the company and on the Merck stock value.

This case allows the students to examine the various steps of Vioxx's development and launch. By doing so, they can consider whether the decision-making process broke down and why. By connecting the Vioxx launch and withdrawal to changes in Merck's cash flow and stock market value, the students can document the impact of such decisions on the value of the firm.

China was the only developing country that participated in the human genome project and contributed 1 per cent of human genome sequencing in 2000. And it finished rice genome sequencing independently in 2002. China’s biomedical industry, however, remains largely an academic affair. The industry is characterized by its inability to support and commercialize innovative research, which in turn has resulted in the prevalence of generic drugs. Managers of Chinese firms have been focusing on the shortterm profits that can be generated by generics rather than the longer‐term potential profits arising from innovative research. But the viability of such short‐cut strategy is now called into question as the IPR infringements will mean hefty fines to the violators in the wake of China’s WTO accession. There is hence an urgent need to make the timely transformation from academic affair to commercialization. This paper examines the reasons why biomedical industry remains largely an academic affair in China by stacking China against the key success factors of biomedical industry in the world. It then suggests the ways to make the transformation by filling the gap between basic research and commercial products and cultivating the necessary business environment for biomedical drugs in China.

Drug repurposing involves the identification of new applications for existing drugs. Owing to the enormous rise in the costs of pharmaceutical R&D, several pharmaceutical companies are leveraging repurposing strategies. Parkinson's disease is the second most common neurodegenerative disorder worldwide, affecting approximately 1–2 percent of the human population older than 65 years. This study proposes a literature-based drug repurposing strategy in Parkinson's disease.

The literature-based drug repurposing strategy proposed herein combined natural language processing, network science and machine learning methods for analyzing unstructured text data and producing actional knowledge for drug repurposing. The approach comprised multiple computational components, including the extraction of biomedical entities and their relationships, knowledge graph construction, knowledge representation learning and machine learning-based prediction.

The proposed strategy was used to mine information pertaining to the mechanisms of disease treatment from known treatment relationships and predict drugs for repurposing against Parkinson's disease. The F1 score of the best-performing method was 0.97, indicating the effectiveness of the proposed approach. The study also presents experimental results obtained by combining the different components of the strategy.

The drug repurposing strategy proposed herein for Parkinson's disease is distinct from those existing in the literature in that the drug repurposing pipeline includes components of natural language processing, knowledge representation and machine learning for analyzing the scientific literature. The results of the study provide important and valuable information to researchers studying different aspects of Parkinson's disease.

Between 1985 and 2000, the six largest US pharmaceutical firms entered a very active period of partnerships with other pharmaceutical firms to expand their knowledge of biotechnology-based research and development (R&D) frameworks and to bolster the growth of their drug portfolios. The purpose of this study is to examine the annual reports published by these companies for evidence of strategic framing of these partnerships.

A content analysis method was most appropriate for this study, as it allows for analysis of a large amount of information and accurate analysis over time. Ninety-six annual reports from the six major US pharmaceutical firms (Abbott, Bristol Myers Squibb, Eli Lilly, Johnson and Johnson, Merck, and Pfizer) were coded. The final codebook included 18 categories derived from framing theory. After collection, the data were uploaded to SPSS for statistical analysis.

Results indicate that mention of partnerships grew considerably in depth and length over time, but companies did not consistently employ frames to describe why or how they engaged in external partnerships.

This is the first study to assess mentions of pharmaceutical firms' external efforts to build their R&D programs and drug portfolios, from the intersecting perspectives of framing theory and the resource-based view (RBV) of the firm, to illustrate how changes were communicated to shareholders during a dynamic period of change within the industry.

The aim of this paper is to describe an innovative practice that has implication for new product developers within and outside the pharmaceutical industry.

The case describes an approach to managing the risk inherent in marketing drugs. The organization's original name has been retained, although individual managers' names have been changed at its request. Interviews with former company employees and publicly available data were used to write the case study.

The paper provides information and action approaches to new product developers that may reduce the risk of losing products to regulatory action. The subject company devised a risk management response to its product development. Their results offer direct implications for new product development teams in the drug industry. By extension, the implications may aid traditional companies outside of the pharmaceutical industry.

As in all case studies, the specific conditions found in one organization may not be found more generally in others. Readers are cautioned that the conclusions drawn in the case may have limited applicability.

The case depicts an innovative application of the risk minimization to the new product development process. Other organizations may find the technique of value in their own efforts.

The case is the first to describe a successful application of risk management to the product development/product management process. It offers the potential of improving the lifetime of pharmaceutical products in the marketplace, allowing the company a longer time to reap profits.

Biotech share price is highly volatile, compared to most other industries. There is limited explanation for what causes such a high volatility. The purpose of this study is to explore how R&D strategies selected by biotech firms affect their share price volatilities. Specifically, the paper empirically investigates the impact of drug discovery and development diversification on share price volatility.

Regression analysis is applied to observe the effect of R&D strategy on share price volatility. Share price volatility is regressed on the measure of drug discovery and development diversification. Strategies are classified into two categories: diversified vs. concentrated. Meanwhile, other factors that have an influence on share price volatility such as firm maturity, firm size, and book‐to‐market ratio are controlled. For robustness, a return model is also used to further test the effect of R&D strategy, and sensitivity analyses using alternative drug discovery and development diversification measures are performed. Empirical data was collected for publicly‐traded biotech firms from COMPUSTAT, CRSP and Biospace.

The major finding of this study is the significant impact of R&D strategy in term of drug discovery and development diversification on share price volatility. Firms that have more diversified drug portfolios are associated with lower share price volatilities; and lower stock returns. In contrast, firms that have more concentrated drug portfolios are associated with higher share price volatilities; and higher stock returns.

Future research can explore effects of other aspects of the drug discovery and development as well as other firm attributes on biotech share price volatility. In addition, share price volatility may have impacts on managerial issues such as employee stock option issuance. Such impacts should also be studied.

This study targets a major aspect (i.e. R&D strategy) of the very fundamental value drive in the industry (i.e. drug discovery and development) to shed light on the limited understanding of what contribute to biotech share price volatility. The benefit of produce diversification has been examined in some other industries; however, its benefit is largely unknown in the biotech industry. This study has implications for investor risk assessment and corporate risk management.

The purpose of this paper is to identify best practices from high‐technology industries that face many of the same challenges around uncertainty, complexity, and risk that are faced by the pharmaceutical industry.

This research has conducted an extensive review of risk management literature and research conducted in high‐technology industries to collect some of the key best practices for high‐risk research projects.

A literature review of recent risk management publications from three high‐technology industries yielded 13 best practices in project risk management that could potentially be applied to pharmaceutical R&D projects to improve managing risks and uncertainties of managing projects. By reviewing these lessons learned from industries that share many of the challenges of the pharmaceutical R&D projects, it is suggested that the implementation of risk management in the context of drug development projects will require adaptation to the specific needs and challenges of those projects.

Implementing a risk management process is very challenging for pharmaceutical R&D projects, as there are high degrees of complexity, uncertainty, and large amounts of resources at stake. Many of the techniques could be applied to all stages of drug development, but some are clearly most applicable to particular stages. Some will work for small, medium and large pharmaceuticals, though the way they are implemented should be modified to meet the needs and resources of the particular company.

This study will serve as a basis for exploration and discussion that will result in controlled application and experimentation with these approaches, and this in turn could lead to real improvements in the use of risk management in pharmaceutical companies.

An exploration of the methods they have employed to address risk in R&D projects, as well as the outcomes of the application of those methods, should reveal tools, techniques, processes, training, and approaches that can be effectively applied to pharmaceutical development projects, and support the value of spending resources to employ risk management practices.

The paper aims to explore the nature of initiatives and strategies of inter-organizational cooperation to cross the valley of death in the biopharma industry.

The authors conducted an exploratory case study analysis in the Biopharma Innovation Ecosystem in Greater Boston Area (USA), which is one of the oldest, and most successful IE in the US, specialized in the Biopharma domain, by conducting a round of expert interviews with key informants in the area, chosen as representatives of the different types of actors engaged in the drug development processes at different stages.

Main findings suggest that cooperation can contribute to surviving the valley of death by reducing the barriers within the drug development pipeline through the promotion of strategic relationships among actors of different nature, including the establishment of government-led thematic associations or consortia, agreements between university and business support structures, proximity to venture capitalist and the promotion of a general culture of academic entrepreneurship within universities.

The authors believe that this paper contributes to the literature by shedding light on the nature of the specific cooperative initiative the barriers in drug development and help to survive the valley of the death.

The study focuses on drug safety regulation capture, reveals the inner mechanism and evolutionary characteristics of drug safety regulation capture and provides suggestions for effective regulation by pharmacovigilance.

The article introduces prospect theory into the game strategy analysis of drug safety events, constructs a benefit perception matrix based on psychological perception and analyzes the risk selection strategies and constraints on stable outcomes for both drug companies and drug regulatory authorities. Moreover, simulation was used to analyze the choice of results of different parameters on the game strategy.

The results found that the system does not have a stable equilibrium strategy under the role of cognitive psychology. The risk transfer coefficient, penalty cost, risk loss, regulatory benefit, regulatory success probability and risk discount coefficient directly acted in the direction of system evolution toward the system stable strategy. There is a critical effect on the behavioral strategies of drug manufacturers and drug supervisors, which exceeds a certain intensity before the behavioral strategies in repeated games tend to stabilize.

In this article, the authors constructed the perceived benefit matrix through the prospect value function to analyze the behavioral evolution game strategies of drug companies and FDA in the regulatory process, and to evaluate the evolution law of each factor.