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The World Health Organization has pointed out that the majority of developing countries currently rely on imported drugs, in spite of the fact that there is potential for them to produce their own drugs. The purpose of this paper is to present a framework as an innovation policy model that can strategically predict the outcome of drug development investment in developing countries.

In order to explore a model relevant to the policy-making process, the literature was systematically reviewed with a focus on the impact of policy changes on drug development in developing countries.

An innovation policy model consists of the relational influences of contextual variables of pharma capabilities, innovation incentives and political factors affecting drug development in developing countries, derived from a dissenting policy-making perspective. This was built to test two hypotheses of a positive relationship between the above variables; and a perspectives gap between the pharmaceutical companies and the policymakers. These hypotheses address issues related to the lack of drug development in developing countries.

This paper presents a conceptual framework for the evaluation and provides examples of its use, but it is currently at a relatively early stage of research. Further work is currently underway and will later be presented to the same journal.

Domestic drug development in developing countries needs to be feasible in order to ensure drug security. This predictive policy model provides a comprehensive approach to health policy reforms to examine innovation strategies.

This model includes measures to explore whether pharma capabilities, innovation incentives and/or political factors have an effect on domestic drug development in developing countries. It bridges the policy implementation’s operational process between pharmaceutical companies and policymakers.

Research sponsored by entities in developed countries, but conducted in developing countries, has recently been the focus of academic debate, international declarations and media controversy. Much of this attention has focused on whether the trials are exploitative and if so what should be done to avoid exploitation. This chapter takes Alan Wertheimer's principles of mutually advantageous transactions and applies them to the question of exploitation in international research. In this chapter, I develop an analysis of exploitation and apply this to the hypothesis that some pharmaceutical companies who run drug trials in developing countries wrongfully exploit the trial participants.

This paper aims to analyze the firm level determinants of profitability of Indian drug and pharmaceutical industry which is known for historically weak R&D initiatives.

The change in the economic environment brought out by the Trade-Related Intellectual Property Rights (TRIPS) compliance, this industry was found to have fast adjusted to a new working environment by substantially modifying its strategies. This study aims at using inflation-adjusted panel data for a period 2000-2013 and applies the fixed effects regression model with cluster standard errors.

The study has found that export intensity, A&M intensity, firm’s market power and stronger patent regime dummy have exercised positive influence on profitability. The negative and statistically significant influence of R&D intensity and raw material import intensity points to the need for firms to adopt suitable investment strategies.

The study suggests that firms are required to pay far more attention to optimize their operating expenditures, advertisement and marketing expenditures and improve their export orientation, as part of the long-term strategy.

This study uses a recent data-set to analyze the firm level profitability determinants in the Indian pharmaceutical industry and captures the effect of change in profitability pre and post-TRIPS.

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.

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.

This paper aims to analyze the present trends in pharmaceutical innovation and the impact of generic competition.

A secondary research was conducted to collect data related to new drug approvals of various classes over previous years; trends of investment in research and development; and the pipeline of new drug products of pharmaceutical companies.

While the new molecular entity (NME) approval rate has not improved over previous years, innovators have been aggressively pursuing the radical innovation process. Further, there has been a significant increase in incremental innovation. Pharmaceutical companies' investment in research has gone up resulting in higher number of application for new drug approvals. In India, pharmaceutical companies have significantly increased their research investment. However, the NME pipeline is still slim though there has been a significant surge in generic filings.

It provides a concise understanding of trends in pharmaceutical innovation and analyzes how various factors are shaping up the innovation process. It also throws light on the evolution story of Indian pharmaceutical companies to become drug innovators.

This paper aims to reflect on different issues and perspectives on returns on investments made by MNEs towards social development. Need for an inclusive society drives accountable and effective cooperation between different actors in a market. Although multinational enterprises (MNEs) that operate in developing markets invest in social development, their managers find it very challenging to incorporate social development agenda into their business practices. Therefore, academics should develop business models which can guide thoughts and actions of managers of MNEs towards social development while allowing them to hold on to the business objectives and targets.

A review of current literature with available anecdotes about business practices helped the author to form a viewpoint and make recommendations.

The objective of the eighth millennium development goal is to promote global partnership between MNEs and domestic firms with or without intervention of a subsidiary. Addressing the particular needs of developing countries, such as capability enhancement or poverty reduction by managers of MNEs in a global setting, becomes a very complex issue. Investments by MNEs in developing countries towards these objectives are driven by different factors such as operational transparency, technological efficiency, investment types, innovation capability, branding strategy, quality assurance, public–private partnership, market-based pricing, reciprocity, distribution for penetration, etc., apart from linkages they create for developing resource-based competencies required for survival in a competitive market.

Empirical investigation of the viewpoint presented here will be required to convert recommendations into models applicable by managers of MNEs.

This study will help to enable managers of MNEs to perform need-based socially responsible actions.

This study will facilitate participation of MNEs in social development through their contributions towards poverty reduction and capability enhancement.

This paper pushes managers and academic scholars to think about the strategies required to incorporate social agenda into business models of MNEs benefiting from developing markets.

Foreign firms have certain advantages which may spillover to domestic firms in the form of improvements in total factor productivity (TFP) growth. The purpose of this paper is to empirically observe the presence of TFP spillovers of foreign direct investment (FDI) to domestic firms through analyzing source of TFP growth in Indian drugs and pharmaceutical industry.

This paper examines the sources of TFP spillovers of FDI in Indian drugs and pharmaceutical industry over the period 1999 to 2014. The data of 304 firms has been used for estimation of the growth rates of TFP and its sources under stochastic frontier analyses based Malmquist productivity index framework. For frontier estimation, the Wang and Ho (2010) model has been executed using translog form of production function.

The results show that there exists significant TFP spillover effect from the presence of foreign equity in drugs and pharmaceutical industry of India. The results also show that the major source of TFP fluctuations in the said industry is managerial efficiency that has been significantly affected by FDI spillover variables. In sum, the phenomenon of significant Intra-industry (horizontal) efficiency led productivity spillovers of FDI found valid in case of Indian drugs and pharmaceutical industry.

The number of foreign firms is very less to imitate the significant impact of foreign investment on TFP growth of Indian pharmaceutical industry at aggregated level; and the Wang and Ho (2010) model is failing to capture direct impact of FDI on technological change under Malmquist framework.

Since, there exists dominance of domestic firms in Indian drugs and pharmaceutical industry, the planners should follow the policy which not only attract FDI but also benefit domestic firms; for example, developing modern infrastructure and institution which will further help domestic firms to absorb spillovers provided by the Multinational Corporations and also accelerate the growth and development of the economy.

In no case, the foreign firms should dominate the market share otherwise the efficiency spillover effect will be negative and the domestic firms will be destroyed under the self-centric approach of foreign firms protected by the recent patent laws.

The study is a unique attempt to discuss the production structure and sources of TFP spillovers of FDI in Indian drugs and pharmaceutical industry with such a wide coverage of 304 firms over a period of 16 years under Wang and Ho (2010) model’s framework. The existing studies on TFP spillovers are using either a small sample size of firms or based upon traditional techniques of measuring spillover effects.

Intentions of managers of pharmaceutical multinational enterprises (MNEs) to adopt business strategies, which will aid global health and wellbeing, are in some ways linked with their understanding of the returns that their company will receive from these investments. However, the MNE’s managers are unaware of business strategies that will allow them to link their business activities with the corporate objectives of contributing to Sustainable Development Goals (SDGs). Pharmaceutical companies are moving toward monopolistic practices by acquiring local companies for manufacturing purposes or by engaging local companies in contract manufacturing and directing the focus of these companies away from innovation and toward profit making. At the same time, pharmaceutical MNEs are promoting global health and wellbeing as their SDGs. This study uses knowledge from existing sources and expert insights to explain the returns that MNEs can get from their investments related to global health and wellbeing. One of the important recommendations from the ethical point of view is engaging local firms in the innovation process; from the marketing perspective, this study recommends the use of a corporate brand and not a product brand for offering generic medicines. The operations perspective explains how MNEs can incorporate the social agenda into their mainstream business strategies. Limitations of the study are discussed, and avenues for future research are explained.

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.