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Researchers continue to seek understanding of industrialization as a state managed process. How to create and implement new industries based on advanced knowledge is on the policy agenda of many advanced nations. Measures that promote these developments include national capacity building in science and technology, the formation of technology transfer systems, and the establishment of industrial clusters. What these templates often overlook is an analysis of use. This chapter aims to increase the understanding of the processes that embed new solutions in structures from an industrial network perspective. The chapter describes an empirical study of high-technology industrialization in Taiwan that the researcher conducts to this end. The study shows that the Taiwanese industrial model is oversimplified and omits several important factors in the development of new industries. This study bases its findings on the notions that resource combination occurs in different time and space, the new always builds on existing resource structures, and the users are important as active participants in development processes.

Global health objectives have stimulated changes to the international vaccine market. The authors seek to suggest that modern vaccine categories will aid in the formation of standardized clinical trial processes through the implementation of suggested policy strategies.

A systematic review of literature for the period of 2000‐2010 was conducted by searching academic databases of peer‐reviewed articles (e.g. Medline, PsychInfo, and Social Science Citation Index) for multiple keywords, namely: clinical trial, regulatory standards, vaccine development, vaccine manufacturing, and vaccine distribution. The search yielded surprisingly few items that were able to provide an adequate baseline of clinical trial processes for fundamental analysis. Consequently, additional material was obtained through an exploratory literature review. The method included hand‐searching reference lists and tables of contents and search engines (Google Scholar) for national and international clinical trial regulatory processes, global health organizations, and trends in vaccine marketing.

Establishing modern vaccine designations is essential towards addressing the current trends of vaccine development. Identification of the market drivers will aid in the goal of establishing international protocols that can better position industry to streamline response in several areas including research, economic development, manufacturing, and distribution.

Categorization of modern vaccine development can guide the international formulation of manufacturing and distribution policy strategies to elicit a cross‐cultural global delivery system.

This paper contributes to academic literature threefold. It categorizes vaccines, depicts the fundamental clinical trial phases vital to global health, and provides policy options driven by modern vaccine production designations.

Major technological innovations are usually associated with central R&D facilities in large companies and leading edge technologies that are key to unlocking business opportunities in promising, embryonic markets. The purpose of this paper is to identify and analyze several factors that determine the success of a major process innovation in a mature but changing industry. The paper furthermore shows that the periphery of a company can be as innovative as headquarters and central R&D‐labs.

This paper is based upon an in depth case study of the “Business Group Influenza” (BGI) at Solvay, a multinational company in the chemical and pharmaceutical industry based in Brussels. BGI turned a mature business into a growth engine for the company through the development of a cell culture technology. Next, we identified 20 success factors of innovations based on extensive literature research. These factors can be placed in four main categories; strategic factors, market environment factors, development process factors, and organizational factors. In this paper, we apply these key drivers to the renewal of Solvay's influenza vaccine business.

It is found that a systematic analysis of the case using the 20 key drivers allows us to evaluate the management of this major innovation process. In this way, one can easily spot the drivers that need more attention or require another management approach. We also find that the management of attention of the top‐management is crucial in long‐term innovation projects.

The contribution of this study is twofold. On the one hand, the rejuvenation of Solvay's influenza vaccine business shows that changing markets conditions in combination with a breakthrough process technology can turn a cash cow into a growth business. On the other hand, the systematic analysis of key innovation drivers allows one to identify the strength and weaknesses in the management of a long‐term, breakthrough process innovation.

The purpose of this paper is to identify, analyze and describe the novel approaches that affect vaccine development in lower-middle income countries (LMICs).

The vaccine market in LMICs currently focuses on traditional Expanded Program for Immunization vaccines instead of new ones. Unlike the successful introduction of those traditional vaccines, the introduction of new vaccines appears to be very slow, mainly due to financial issues. This paper systematically reviews a set of published papers on vaccine development and analyzes them against a specific region-setting framework.

Public–private partnership alone could not ensure long-term vaccine sustainability. Several factors that encourage domestic vaccine development were identified. The findings demonstrate that the regulatory approach of hybrid collaboration and market opportunity strategies can be a major breakthrough for domestic vaccine development in LMICs.

Further research is required to include qualitative and quantitative methods for policy analysis, as all of the discussion in this research focused on literature reviews. The authors did not discuss how strategic decisions are affected from a political perspective and this needs to be specified in future research. Think tanks, considerably and fundamentally, affect policy ideas and decisions. However, important breakthroughs continue to be made at the same time.

The development of vaccines in LMICs is expected to be a mechanism to overcome the inadequate access to vaccines in those countries, as solving this problem requires tackling issues from both the supply and demand sides.

This is a literature review that creates recommendation and approaches for domestic vaccine development in LMICs. This review aims to encourage LMICs to produce their own vaccines for sustainability of the vaccine access through vaccine development lifecycle, instead of expecting donor that provides funding and vaccines (vaccine access) in certain period of time. Donor is not always the solution for the problem, since vaccine development requires finance to function infrastructure. There are many efforts in revoking this, including World Health Organization through several reports; however, this effort still has many doubts. Therefore, the article would like to try to see this as a viable solution from the policy perspectives, with several examples to make recommendations more practical.

The purpose of this paper is to define the role non-governmental organizations (NGOs) play across the vaccine development and delivery spectrum within the vaccine enterprise. As demonstrated in this paper, NGOs can play a critical role in prioritizing and accelerating the development and introduction of new vaccines against diseases that disproportionally burden children, women, and communities in the poorest countries around the world.

The author has used case studies from decades of work by PATH, an international NGO, to help develop and implement vaccines, to illustrate the roles of NGOs can play during each of the stages along the development and delivery spectrum.

There are four key considerations that can help determine the ability of a given vaccine to be introduced and scaled within a health system: accessibility, affordability, acceptability, and availability. As more vaccine candidates are identified and move along the development and delivery pathway, there will be increased demand for NGOs to continue playing a pivotal role to address these considerations.

This paper aims to highlight a few of the lessons learned from PATH's four decades of experience in the hope they will contribute and be applied to the evolving environment of vaccine enterprise.

The purpose of this paper is to explore how state actors mobilise resources in business networks to facilitate innovation.

A single case study method is used. The case from the Chinese biotechnology sector illustrates how state actors mobilise resources in a network context in order to develop, produce and use a vaccine.

The case findings demonstrate that state actors indirectly, as well as actively, are involved in the whole innovation process by mobilising resources necessary for the development, production and use of the vaccine. State actors influence other actors, both political and business, and provide resources in order to facilitate innovation.

The paper illustrates that state actors, in the specific case, play an important and active role throughout the whole innovation process. This opens up the issue of the possible extended role of state actors in innovation.

Over the past decades, Chinese state actors have played an active role in the business landscape. This paper explores state actors’ influence on the innovation process on the network level.

Despite significant progress in Iran's immunization programs, vaccine policymaking in the country still faces various challenges and shortcomings. To address these issues and ensure sustained progress toward achieving comprehensive vaccination policies, it is essential to identify the critical factors influencing vaccine policies in Iran. Our study aims to provide evidence-based insights that can inform the development of effective and equitable vaccine strategies, leading to a more sustainable and efficient approach to vaccination in the country.

This mixed-method study aimed to analyze the factors influencing the future of human vaccine policy using Cross Impact Analysis. Firstly, a scoping review was conducted to identify the factors affecting the future of human vaccine development. Secondly, a semi-structured interview was conducted with experts in this field to add more factors and confirm the identified factors within the Iranian context. Finally, a Cross-Impact Analysis (CIA) approach was applied to comprehend the complex relationships between the identified factors. Thematic analysis was used for the qualitative data, and MICMAC analysis was applied to characterize the relationships between the factors.

Seventeen key driving force factors were identified through comprehensive review and interviews. These factors were assigned weighted values ranging from zero to three and subsequently analyzed using MICMAC software. Employing the Cross-Impact Analysis (CIA) technique, the study characterized the impact of each factor on vaccine policy and elucidated the intricate interactions between them. The findings underscored that robust leadership and governance, an innovative ecosystem, and well-established immunization information systems emerged as pivotal driving forces shaping vaccine policy in Iran.

While this study contributes valuable insights into the driving factors influencing vaccine policy in Iran, it is important to acknowledge several limitations. The results rely on the subjective perceptions of a diverse group of specialists, and future research could delve into additional factors in other countries to identify common themes and differences.

This study provides evidence to assist policymakers in making informed decisions regarding vaccines in Iran. The findings suggest that enhancing access to vaccines, fostering trust in the healthcare system, and prioritizing equity in distribution can contribute to increased vaccination rates and a reduction in vaccine-preventable diseases.

This study provides a unique contribution to the field of vaccine policy by utilizing the cross-impact analysis to examine the complex interactions among various factors. The results of this analysis demonstrate that these interactions can significantly impact the overall system, highlighting the need for policymakers to consider multiple factors when formulating effective strategies. By revealing the significance of these interactions, this research offers valuable insights into the development of successful policies that can shape a desirable future for vaccine policy in Iran. Future studies could ratify the findings from this research by applying other methodological approaches.

Africa has the most deaths from infections yet lacks adequate capacity to engage in vaccine development, production and distribution, the cornerstone of efficiently managing and eliminating several infectious diseases. Research has scarcely explored the role of institutional logics in vaccine development, production and distribution, collectively known as end-to-end vaccine manufacturing. This study aims to explore how institutional logics influence firms to engage in the vaccine manufacturing value chain in Africa.

We conducted multiple case study research using five vaccine manufacturing firms from four African countries in three regions. Qualitative interviews were conducted among 18 executives in 5 vaccine manufacturing firms.

We identified that the state, corporate and market institutional logics disparately influence the different parts of the vaccine manufacturing value chain. These institutional logics co-exist in a constellation that also shapes the organizational forms. Their constellation has dominant logics that guide behavior, while subdominant and subordinate logics influence behavior to a limited extent. The findings show that institutional logics are a function of contextual factors, such as historical events, technological changes and pandemics.

The study developed a typology that identifies vaccine manufacturing firm archetypes, institutional logics and their constellations underpinned by contextual factors. The findings have implications for firms and policymakers, as they may guide the end-to-end vaccine manufacturing interventions adapted for their regions.

This paper uses financial report information to analyze the accounting results of the COVID-19 vaccine development for Johnson & Johnson (J&J). This paper also uses stock price information to analyze the market reactions to the COVID-19 vaccine development and the state of clinical trials for J&J.

This instructional case investigates the interaction between J&J and the COVID-19 vaccine. This paper uses information from financial reports to analyze the accounting results of the COVID-19 vaccine development for J&J. This paper also uses stock price information to analyze the market’s reactions to the COVID-19 vaccine development and the state of clinical trials for J&J.

This case has been used in both undergraduate and graduate levels to highlight the application of accounting theories to practice and improve the understanding of financial statements, especially when Covid-19 has affected the global economy. Under this new context, students could explore new ideas from accounting aspect.

The case aims to investigate the interaction between J&J as a pharmaceutical company and COVID-19. It provides a context in which to discuss the consequences of COVID-19 vaccines from several financial perspectives, such as stock prices, accounting policies, earnings and cash flows:

LO1: Understand the responses of stakeholders to J&J’s COVID-19 vaccines.

LO2: Understand the accounting policies that J&J and its competitors follow regarding COVID-19 vaccines related to revenues, R&D expenditures and government funds.

LO3: Apply Ball and Brown’s theory to the impact of COVID-19 vaccine development on earnings quality of J&J and its competitors.

LO4: Assess the importance of COVID-19 vaccines in management decision-making through dividend policy and management compensation structure.

The purpose of this paper is to outline the organization and governance of the US vaccine and immunization enterprise. It describes the major components of the US system including the various relationships between major federal government entities, stakeholders, and advisory committees that inform government policymaking at various points in the system.

The authors describe the complex interdependent network of partners that engage in a wide range of activities such as disease surveillance, research, vaccine development, regulatory licensure, practice recommendations, financing, service delivery, communications, and post-licensure monitoring.

The US system of governance is highly participatory and focuses on a transparent and open engagement, with input from a wide range of partners to inform decision-making. This collaborative framework allows many inputs to be heard and helps support the US vaccine and immunization system as it evolves to meet the continued public health needs in the USA through the optimal use of safe and effective vaccines.

This is an invited article on the US vaccine and immunization enterprise. The development and availability of vaccines in the USA has had profound impact on mortality and morbidity and public health (Centers for Disease Control and Prevention, 2011). The success of this enterprise is a result of a blended public and private sector system with partnerships at the federal, state, and local levels of government to optimize the use of safe and effective vaccines. Governance structures have been established to support the interaction and decision-making among the federal and non-federal actors toward the common goal of controlling and preventing infectious diseases.