Abstract The goal of this study is to assess the relationships between the country’s regulatory institutions and the relational capability and performance of clinical-trial strategic alliances. The country’s regulation is made up of a set of formal institutions, i. e. codified rules, which aim to determine social actors’ practices. Strategic alliances are long-term cooperative relationships voluntarily established between two or more autonomous companies with shared interests and goals to create competitive advantage. Clinical-trial strategic alliances are organized according to the contractual relationship and parties’ relational capabilities that aim to overcome difficulties in the partnership activities and ensure intercompany cooperation, reflecting on organizational efficiency and effectiveness, and impacting on alliance performance. This work developed a critical review of the literature and expanded it through the establishment of novel relational propositions regarding the relationship between formal regulatory institution of countries and strategic alliances for clinical trial of new medicines.

Abstract The objective of this study is to analyze the choice between internal and external supplier at the manufacturing stage in the Brazilian pharmaceutical industry. We developed a structural equation model with hypotheses on experience, diversification, asset specificity, and vertical integration. We collected data for 1566 drugs registry, including its pharmaceutical form, therapeutic class and operation time of the firm and group. We found that the higher the experience, the lower the vertical integration in the manufacturing stage and a clear mediating effect of experience on the relationship between diversification and vertical integration. As firms advance in experience and the spread of the capabilities throughout the industry, agents concentrate activities on the relevant stages in value creation and strategically outsource the manufacturing. As the firm increases the diversification in the product portfolio, the experience favours the building of capabilities to manage the production lines and strategies for outsourcing. This result suggests a low risk for strategic alliances at the manufacturing stage.

The purpose of this research is to establish a conceptual framework that contributes to explaining sustained competitive advantage, forming an analytical framework that brings the resource-based view and organizational analysis' neoinstitutional approaches closer together. A detailed epistemological articulation has been undertaken to advance the understanding of strategy and competitive advantage in organizations, aggregating contribution to the literature with the proposal of a theoretical model that steadily articulates elements from organizational institutionalism and the resource-based view. Hence, the major contribution is to associate the resource-based view and organizational analysis' neoinstitutional theory as a means to reformulate the notion of institutional isomorphism, and have a potential new explanation for organizational diversity and the existence of organizations that are more capable of generating (or maximize) value than others. In its formulation, the similarity among organizations in their fields provides the baseline for organizational performance. Thus, it is from this baseline level that organizations would then be able to differentiate themselves and generate sustainable competitive advantage through active and selective response to different institutional pressures.

A moderna biotecnologia caracteriza-se pela elevada dependência da pesquisa em ciências básicas, pela multidisciplinaridade e complexidade de sua base de conhecimento e pela elevada incerteza associada às suas descobertas. Como consequência, essa indústria fomentou uma rede de alianças reunindo organizações distintas, tais como universidades, institutos de pesquisa, fundos de investimento, agências governamentais e laboratórios farmacêuticos. Este trabalho analisou a influência da estrutura social formada por essa rede de alianças no crescimento econômico das empresas brasileiras da moderna biotecnologia, segmento de saúde humana, no período de 2004 a 2008. Os resultados sugerem que à medida que a empresa de biotecnologia acumula experiência em fazer e gerir alianças, ganhando capacidade relacional, desenvolve competências que influenciam positivamente o depósito de novas patentes e o seu crescimento em termos do número de funcionários.

Modern biotechnology is characterized by high dependence on basic science research, by its multidisciplinary approach and the complexity of its knowledge base, and by the high uncertainty associated with its findings. As a result, this industry has fostered a network of alliances, grouping together different organizations such as universities, research institutes, venture capital funds, government agencies and pharmaceutical laboratories. This work investigates the influence of the social structure of this network of alliances in the economic growth of Brazilian private modern biotechnology companies in the period from 2004 to 2008. The results suggest that while the biotechnology sector accumulates experience in making and managing alliances, gaining relational capability, it develops competencies that positively influence the filing of new patents and headcount growth.