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Outsourcing is recognized as one of the critical factors for efficient execution of pharmaceutical supply chain management (PSCM), and many pharmaceutical companies engage in international outsourcing of services (IOS) to survive in global highly competitive business. Since the key success factors for both domestic & international alliances are partnership characteristics and strategic fit management, but there is no empirical research on this issue in Thai pharmaceutical partnership offshore outsourcing. Therefore, this survey of Thai and foreign companies, both contract providers (CPs) and contract manufacturers (CMs), seeks to indicate significant relationships among both outsourcing strategic fit and partnership types, including outsourcing performance outcome. This research is two-fold. First, the partnership types (Type I, II, & III), the strategic fit types (low fit, moderate fit, and good fit), and their correlations are analyzed. And second, their outsourcing performance (company revenues and growth rates) are presented. The results showed that the most of the Thai pharmaceutical outsourcing manufacturing are classified as the partnership Type II, as well as the moderate strategic fit, and strongly support the relationship between the two models. Both of the companies’ revenue and growth rate could predict the companies’ performances outcome for each of partnership and strategic fit types. However, it is not necessary that the most integrative type of partnership, Type III, will be always the best, because it depends also on the strategic fit between each pair of partners as well.

Knowledge-intensive business services (KIBS) firms focus on applying their expert knowledge to help solve the business problems of their clients: these clients confronted major new problems due to the COVID-19 pandemic and policy measures such as social distancing and travel restrictions, designed to reduce the rapid spread of the illness. Many KIBS were reliant upon extensive contact with clients, and within teams working on projects; they found their practices disrupted. This study aims to examine how KIBS are evolving to cope with both the sets of changes: those in their own operations, and those involving the emerging business problems of clients.

The main data sources are material contained in websites of a sample of leading firms in a range of KIBS sectors, and in media reports and other documentation of efforts to confront the pandemic.

The results indicate considerable efforts in KIBS to address emerging client problems, as well as to adapt their own practices. Their substantial role in confronting the pandemic and associated business difficulties has implications for future crises. KIBS are likely to be important players in shaping responses not only to future pandemics but also to the looming climate crisis.

The study demonstrates the growing role of KIBS and their “second knowledge infrastructure” in modern economies, exemplified by their role in the context of an emerging crisis.

This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants.

Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials.

The paper concludes that the ISO 9000 series of quality standards can act as a company‐wide framework for quality management within such organisations by helping to direct quality efforts on a long‐term basis without any loss of compliance.

This study is valuable because comparative analysis in this domain is uncommon.

This paper aims to investigate the nature and dynamics of the interaction between university spin-offs (USOs) and academia.

The theoretical framework is grounded in an interactive view based on the industrial marketing and purchasing literature on USOs and their development. The concepts of activity links, resource ties and actor bonds are used as a starting point for capturing the content and dynamics of the interaction. The empirical part of the paper consists of four case studies captured through interviews as the main data source and analysed to conclude how the interaction between the USO and academia developed over time.

The study identifies a multi-faceted and dynamic content of the interaction. The paper discerns and discusses research and development links, knowledge and equipment ties and social, legal, financial and organizational bonds with inventors, other academic partners and innovation support organizations. The dynamics are manifested both through changes within individual relationships and by adding/ending relationships. One main conclusion regards the existence of wave-like patterns of interaction with academic partners driven by the USOs’ needs and the establishment of customer relationships.

Most of the previous research has described a linear process in which the USO leaves academia once the idea has been transferred to a company. This paper contrasts this view by developing and using an analytical framework to capture the dynamic and continuous interaction between USO and academia.

The objective of this paper is to critique emerging legislation in the pharmaceutical industry, focusing on the clinical trials sector. Possible changes are identified and discussed in relation to their impact on phase I clinical trials conducted in the UK. It is concluded that smaller contract research organisations, which have benefited in the past from European Union legislative variation, may have resource problems in trying to cope with the changing business environment created through legislative harmonization. These SMEs must use this opportunity to seek clinical trials research partnerships in a new harmonized EU market.

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 purpose of this paper is to analyze the different assessments of a particular industry and its ability to innovative, renew and prosper, but also to look into the underlying assumptions that are hiding behind the systemic approaches utilized in these assessments. The point of departure is an empirical puzzle: one group of studies presents a rather optimistic view of the Swedish life science industry and its ability to economize on research, policy and industrial investments. Another group of studies presents much a darker view, questioning the capacity of new companies to reach economic endurance, as well as the possibility of keeping the actually successful companies within the country. At a first sight it appears as if the two groups of studies are resting on a common theoretical ground: all seem to depart from a systemic innovation perspective that challenges the idea of an independent business landscape.

The difference between the assessments becomes comprehensible once the authors allow for a variety of systemic approaches in innovation thinking. The authors propose an ideal-typical distinction between two types of system perspectives; those that view technology as entangled in its environment and those that view technology as disentangled from its environment. The authors use the national innovation system (NIS) and the industrial network (IMP) approaches to exemplify the two perspectives.

An implication of the study is that the term “systemic perspective” is very broad and encompassing, something that in turn points to the importance of being clear about what the authors mean with a system, but also with what the theoretical assumptions focus on and abstract away from.

The ideal-typical distinction between two types of system perspectives; those that view technology as entangled in its environment and those that view technology as disentangled from its environment. The authors use the NIS and the IMP approaches to exemplify the two perspectives.

Economics, business management

The case study is relevant for MBA, Master's and under graduate (economics, international and business economics) students.

Biocon is one of the top 20 companies from India in the Forbes list of “Best under a Billion” companies. It has emerged from being an enzyme-producing firm to a biotech powerhouse under the guidance of Ms Kiran M. Shaw. It is an innovative company with a varied scientific skill base and progressive manufacturing facilities for developing and commercializing biopharmaceuticals. This study attempts to explore the international foray of Biocon using the eclectic OLI framework. Entrepreneurship, need for integrated business model, innovation, quality control, etc. constituted the ownership (O) factors, important for Biocon to earn the more than compensating advantage in the overseas market. The locational factors were less important in case of Biocon as the global expansion was driven by a motive of either market seeking or cashing in on the cost advantage of its operations. The dominant mode of entry has been the joint ventures. The overseas patterns exhibited by Biocon can be captured fully by the O-L-I framework.

To understand the economic theory of OLI and the ownership, locational and internalisation advantages, link the OLI framework with the international foray of Biocon, Biocon's internationalization journey, major overseas deals signed and the economic rationale behind the deals.

Teaching notes are available for educators only. Please contact your library to gain login details or e-mail support@emeraldinsight.com to request teaching notes.

Quintiles Transnational Holdings Inc., the largest global provider of biopharmaceutical development and commercial outsourcing services, grew its revenue at a CAGR of 7.3% and EBITDA at 13.9% between 2008 and 2012.

The case is set in December 2012–April 2013, when the majority of the firm was owned by founder Dennis Gillings and four private equity firms (Bain Capital, TPG Capital, 3i Capital and Temasek Life Sciences) after it was taken private in a management-led buyout in 2003 and a subsequent buyout in 2008. Five years after the second buyout, the private equity firm owners were looking to monetize their positions and considered different strategic alternatives: M&A sale to strategic or financial buyers, IPO, or capital restructuring through special dividends.

Students will step into the role of an associate at the lead investment bank working with Quintiles. They must consider the case information and determine an IPO strategy, process, potential conflicts, and valuation.

After reading and analyzing the case, students will be able to:

• Apply valuation techniques (discounted cash flow (DCF) and publicly traded comparables) in pricing an IPO

• Analyze the roles of different parties involved in the transaction

• Discuss the process of a company filing for an IPO

• Evaluate different strategic alternatives available to a private equity—backed company

• Address conflict of interest in management—led buyouts

Apply valuation techniques (discounted cash flow (DCF) and publicly traded comparables) in pricing an IPO

Analyze the roles of different parties involved in the transaction

Discuss the process of a company filing for an IPO

Evaluate different strategic alternatives available to a private equity—backed company

Address conflict of interest in management—led buyouts

Risk management is becoming an increasingly important topic in healthcare. The dangers of conducting clinical trials were brought to the attention of the public by the media in 2006 with the TGN1412 phase 1 clinical trial. Clinical trials are however important for the development of new drugs. There are a number of gatekeepers for the safety of trials but risk assessment is now becoming an important aspect. This paper aims to focus on clinical trials.

A new risk assessment tool was developed to collect data relating to the contributory factors and control measures associated with clinical trials. The responses to a series of 29 questions are then scored to inform a risk rating for the clinical trial

The theoretical model was converted into a Microsoft Excel spreadsheet with drop down boxes for the responses to the questions. Research management staff have found the tool simple and quick to use. A printout of the assessment can be placed in the study folder as evidence. Highlighted risks are then flagged up to the organisation's corporate risk register and an action plan developed.

The tool has been utilised to assess risks of all research projects from educational studies such as MSc, PhD to medical device trials and drug trials. Furthermore it has assessed risks in the acute, primary care and mental health sectors.