O contexto atual da pesquisa clínica nas indústrias e faculdades de Medicina Veterinária do Estado de São Paulo, Brasil / The current context of clinical research in industries and schools of Veterinary Medicine in São Paulo State, Brazil

O mercado farmacêutico veterinário do Brasil é considerado um dos maiores do mundo e está em expansão. A pesquisa clínica é uma etapa importante para o desenvolvimento de produtos veterinários, no entanto, informações sobre essas atividades nas indústrias, fazendas experimentais terceirizadas e faculdades de Medicina Veterinária são escassas. Neste contexto, são descritas as atividades de pesquisa clínica nessas instituições do Estado de São Paulo. Para tanto, foram enviados questionários a representantes das indústrias farmacêuticas veterinárias e das faculdades de Medicina Veterinária do Estado. Os resultados mostraram que a maioria das indústrias tem seus escritórios na cidade de São Paulo, que em 2016 a maioria delas patrocinou entre 11 e 20 estudos, muitos deles em parceria com as faculdades. Todas as indústrias participantes já contrataram serviços de Contract Research Organization (CRO), embora relatem insatisfações com os mesmos. Por outro lado, representantes das faculdades de Medicina Veterinária declararam, em sua maioria, que conduziram dez desses estudos no ano de 2016, muitos deles com patrocínio das indústrias. Já estas se ressentem da falta de agilidade e compromisso das faculdades. A aproximação entre as indústrias de produtos veterinários e as faculdades de Medicina Veterinária foi vista pelos representantes tanto das faculdades quanto das indústrias como benéfica.(AU)

The Brazilian veterinary pharmaceutical market is considered one of the largest in the world and is in expansion. Clinical research is a crucial step in the development of veterinary products, however, information on these activities in industries, experimental farms and veterinary undergraduate courses are scarce. Given this context, this study intended to describe clinical research activities in these institutions in the state of São Paulo. For such, we sent a questionnaire to the representatives of pharmaceutical industries and institutions of veterinary medicine of the state. The results showed that the offices of most industries are located in the city of São Paulo. In 2016, most of these companies sponsored between 11 and 20 studies, many of them in partnership with departments of veterinary medicine. All industry participants contracted Contract Research Organization (CRO) services, despite reporting dissatisfaction with these services. On the other hand, most representatives from veterinary medicine courses reported that they performed 10 studies in 2016, many of them sponsored by industries. The industries resent the lack of agility and commitment of the institutions. The approximation between the veterinary industry and veterinary medicine courses was seen by representatives of both as beneficial.(AU)

O contexto atual da pesquisa clínica nas indústrias e faculdades de Medicina Veterinária do Estado de São Paulo, Brasil / The current context of clinical research in industries and schools of Veterinary Medicine in São Paulo State, Brazil

O mercado farmacêutico veterinário do Brasil é considerado um dos maiores do mundo e está em expansão. A pesquisa clínica é uma etapa importante para o desenvolvimento de produtos veterinários, no entanto, informações sobre essas atividades nas indústrias, fazendas experimentais terceirizadas e faculdades de Medicina Veterinária são escassas. Neste contexto, são descritas as atividades de pesquisa clínica nessas instituições do Estado de São Paulo. Para tanto, foram enviados questionários a representantes das indústrias farmacêuticas veterinárias e das faculdades de Medicina Veterinária do Estado. Os resultados mostraram que a maioria das indústrias tem seus escritórios na cidade de São Paulo, que em 2016 a maioria delas patrocinou entre 11 e 20 estudos, muitos deles em parceria com as faculdades. Todas as indústrias participantes já contrataram serviços de Contract Research Organization (CRO), embora relatem insatisfações com os mesmos. Por outro lado, representantes das faculdades de Medicina Veterinária declararam, em sua maioria, que conduziram dez desses estudos no ano de 2016, muitos deles com patrocínio das indústrias. Já estas se ressentem da falta de agilidade e compromisso das faculdades. A aproximação entre as indústrias de produtos veterinários e as faculdades de Medicina Veterinária foi vista pelos representantes tanto das faculdades quanto das indústrias como benéfica.

The Brazilian veterinary pharmaceutical market is considered one of the largest in the world and is in expansion. Clinical research is a crucial step in the development of veterinary products, however, information on these activities in industries, experimental farms and veterinary undergraduate courses are scarce. Given this context, this study intended to describe clinical research activities in these institutions in the state of São Paulo. For such, we sent a questionnaire to the representatives of pharmaceutical industries and institutions of veterinary medicine of the state. The results showed that the offices of most industries are located in the city of São Paulo. In 2016, most of these companies sponsored between 11 and 20 studies, many of them in partnership with departments of veterinary medicine. All industry participants contracted Contract Research Organization (CRO) services, despite reporting dissatisfaction with these services. On the other hand, most representatives from veterinary medicine courses reported that they performed 10 studies in 2016, many of them sponsored by industries. The industries resent the lack of agility and commitment of the institutions. The approximation between the veterinary industry and veterinary medicine courses was seen by representatives of both as beneficial.

Healthcare systems, the State, and innovation in the pharmaceutical industry.

This article discusses the relations between healthcare systems and the pharmaceutical industry, focusing on state support for pharmaceutical innovation. The study highlights the experiences of the United States, United Kingdom, and Germany, developed countries and paradigms of modern health systems (liberal, universal, and corporatist), in addition to Japan, a case of successful catching up. The study also emphasizes the experiences of China, India, and Brazil, large developing countries that have tried different catching up strategies, with diverse histories and profiles in their healthcare systems and pharmaceutical industries. Finally, with a focus on state forms of support for health research, the article addresses the mechanisms for linkage between health systems and the pharmaceutical industry, evaluating the possibilities of Brazil strengthening a virtuous interaction, favoring the expansion and consolidation of the Brazilian health system - universal but segmented ‒ and the affirmation of the innovative national pharmaceutical industry. Resumo: O artigo discute as relações entre os sistemas de saúde e a indústria farmacêutica, concentrando-se no apoio do Estado à inovação farmacêutica. Salienta as trajetórias dos Estados Unidos, Reino Unido e Alemanha, países desenvolvidos, paradigmáticos dos modernos sistemas de saúde (liberais, universais e corporativos), além do Japão, um caso de emparelhamento bem-sucedido. Também enfatiza as trajetórias de China, Índia e Brasil, países em desenvolvimento, extensos, que experimentaram diferentes estratégias de emparelhamento, dispondo de sistemas de saúde e indústrias farmacêuticas com trajetórias e perfis diversos. Finalmente, com foco nas formas estatais de apoio à pesquisa em saúde, considera os mecanismos de conexão entre os sistemas de saúde e a indústria farmacêutica, avaliando as possibilidades, no Brasil, de fortalecer uma interação virtuosa que favoreça a expansão e consolidação do sistema de saúde brasileiro - universal, conquanto segmentado ‒ e a afirmação da indústria farmacêutica nacional inovadora.

Healthcare systems, the State, and innovation in the pharmaceutical industry / Sistemas de salud, Estado e innovación en la industria farmacéutica / Sistemas de atenção à saúde, Estado e inovação na indústria farmacêutica

Abstract: This article discusses the relations between healthcare systems and the pharmaceutical industry, focusing on state support for pharmaceutical innovation. The study highlights the experiences of the United States, United Kingdom, and Germany, developed countries and paradigms of modern health systems (liberal, universal, and corporatist), in addition to Japan, a case of successful catching up. The study also emphasizes the experiences of China, India, and Brazil, large developing countries that have tried different catching up strategies, with diverse histories and profiles in their healthcare systems and pharmaceutical industries. Finally, with a focus on state forms of support for health research, the article addresses the mechanisms for linkage between health systems and the pharmaceutical industry, evaluating the possibilities of Brazil strengthening a virtuous interaction, favoring the expansion and consolidation of the Brazilian health system - universal but segmented ‒ and the affirmation of the innovative national pharmaceutical industry.

Resumen: El artículo discute las relaciones entre los sistemas de salud y la industria farmacéutica, concentrándose en el apoyo del Estado a la innovación farmacéutica. Resalta las trayectorias de los Estados Unidos, Reino Unido y Alemania, países desarrollados, paradigmáticos de los modernos sistemas de salud (liberales, universales y corporativos), además de Japón, un caso de emparejamiento exitoso. También enfatiza las trayectorias de China, India y Brasil, países en desarrollo, extensos, que experimentaron diferentes estrategias de emparejamiento en este ámbito, disponiendo de sistemas de salud e industrias farmacéuticas con trayectorias y perfiles diversos. Finalmente, centrándose en las formas estatales de apoyo a la investigación en salud, se consideran los mecanismos de conexión entre los sistemas de salud y la industria farmacéutica, evaluando las posibilidades, en Brasil, de fortalecer una interacción virtuosa que favorezca la expansión y consolidación del sistema de salud brasileño -universal, pese a estar segmentado-, y la consolidación de la industria farmacéutica nacional innovadora.

Resumo: O artigo discute as relações entre os sistemas de saúde e a indústria farmacêutica, concentrando-se no apoio do Estado à inovação farmacêutica. Salienta as trajetórias dos Estados Unidos, Reino Unido e Alemanha, países desenvolvidos, paradigmáticos dos modernos sistemas de saúde (liberais, universais e corporativos), além do Japão, um caso de emparelhamento bem-sucedido. Também enfatiza as trajetórias de China, Índia e Brasil, países em desenvolvimento, extensos, que experimentaram diferentes estratégias de emparelhamento, dispondo de sistemas de saúde e indústrias farmacêuticas com trajetórias e perfis diversos. Finalmente, com foco nas formas estatais de apoio à pesquisa em saúde, considera os mecanismos de conexão entre os sistemas de saúde e a indústria farmacêutica, avaliando as possibilidades, no Brasil, de fortalecer uma interação virtuosa que favoreça a expansão e consolidação do sistema de saúde brasileiro - universal, conquanto segmentado ‒ e a afirmação da indústria farmacêutica nacional inovadora.

[Penicillin production in Chile between 1944 and 1954]. / Producción de Penicilina en Chile entre 1944 y 1954.

Penicillin production in Chile was a pioneering development; however there is not much information to learn about it. The Chilean Institute for Bacteriology (Instituto Bacteriológico de Chile) produced penicillin between 1944 and 1973. The stage starting in 1953 is better known since there was an agreement with United Nations. Our research focused on building a story about production between 1944 and 1954 based on archival information and the national and international historic context. Our results place Chile amongst the pioneer countries in the successful industrialization of the drug. Our conclusions are that this was a proper industrial production as opposite to a pilot plant - a name commonly used to call the early factory. We explain the production plant trajectory by making relations between technological change and governance. Finally, we believe the later expansion of the plant, in the context of the agreement with the United Nations, took place under unpromising governance conditions, which called for passive innovation and technology management.

Emergence of biopharmaceutical innovators in China, India, Brazil, and South Africa as global competitors and collaborators.

Biopharmaceutical innovation has had a profound health and economic impact globally. Developed countries have traditionally been the source of most innovations as well as the destination for the resulting economic and health benefits. As a result, most prior research on this sector has focused on developed countries. This paper seeks to fill the gap in research on emerging markets by analyzing factors that influence innovative activity in the indigenous biopharmaceutical sectors of China, India, Brazil, and South Africa. Using qualitative research methodologies, this paper a) shows how biopharmaceutical innovation is taking place within the entrepreneurial sectors of these emerging markets, b) identifies common challenges that indigenous entrepreneurs face, c) highlights the key role played by the state, and d) reveals that the transition to innovation by companies in the emerging markets is characterized by increased global integration. It suggests that biopharmaceutical innovators in emerging markets are capitalizing on opportunities to participate in the drug development value chain and thus developing capabilities and relationships for competing globally both with and against established companies headquartered in developed countries.

Influenza vaccine production for Brazil: a classic example of successful North-South bilateral technology transfer.

Technology transfer is a promising approach to increase vaccine production at an affordable price in developing countries. In the case of influenza, it is imperative that developing countries acquire the technology to produce pandemic vaccines through the transfer of know-how, as this will be the only way for the majority of these countries to face the huge demand for vaccine created by influenza pandemics. Access to domestically produced influenza vaccine in such health crises is thus an important national defence strategy. However, technology transfer is not a simple undertaking. It requires a committed provider who is willing to transfer a complete production process, and not just the formulation and fill-finish parts of the process. It requires a recipient with established experience in vaccine production for human use and the ability to conduct research into new developments. In addition, the country of the recipient should preferably have sufficient financial resources to support the undertaking, and an internal market for the new vaccine. Technology transfer should create a solid partnership that results in the joint development of new competency, improvements to the product, and to further innovation. The Instituto Butantan-sanofi pasteur partnership can be seen as a model for successful technology transfer and has led to the technological independence of the Instituto Butantan in the use a strategic public health tool.

Domestic influenza vaccine production in Mexico: a state-owned and a multinational company working together for public health.

The Mexican Government developed a plan in 2004 for pandemic influenza preparedness that included local production of influenza vaccine. To achieve this, an agreement was concluded between Birmex - a state-owned vaccine manufacturer - and sanofi pasteur, a leading developer of vaccine technology. Under this agreement, sanofi pasteur will establish a facility in Mexico to produce antigen for up to 30 million doses of egg-based seasonal vaccine per year, and Birmex will build a facility to formulate, fill and package the inactivated split-virion influenza vaccine. As at November 2010, the sanofi pasteur facility has been completed and the Birmex plant is under construction. Most of the critical equipment has been purchased and is in the process of validation. In addition to intensive support from sanofi pasteur for the transfer of the technology, the project is supported by the Mexican Ministry of Health, complemented by Birmex's own budget and grants from the WHO developing country influenza technology transfer project.

Nomenclature and guideline to express the amount of a membrane protein synthesized in animal cells in view of bioprocess optimization and production monitoring.

Studies of a bioprocess optimization and monitoring for protein synthesis in animal cells face a challenge on how to express in quantitative terms the system performance. It is possible to have a panel of calculated variables that fits more or less appropriately the intended goal. Each mathematical expression approach translates different quantitative aspects. We can basically separate them into two categories: those used for the evaluation of cell physiology in terms of product synthesis, which can be for bioprocess improvement or optimization, and those used for production unit sizing and for bioprocess operation. With these perspectives and based on our own data of kinetic S2 cells growth and metabolism, as well as on their synthesis of the transmembrane recombinant rabies virus glycoprotein, here indicated as P, we show and discuss the main characteristics of calculated variables and their recommended use. Mainly applied to a bioprocess improvement/optimization and that mainly used for operation definition and to design the production unit, we expect these definitions/recommendations would improve the quality of data produced in this field and lead to more standardized procedures. In turn, it would allow a better and easier comprehension of scientific and technological communications for specialized readers.

O papel dos institutos públicos de pesuisa na inovaçäo farmacêutica / The role of public research institutes in pharmaceutical innovation

Procura identificar o papel dos institutos de pesquisa na dinâmica da inovaçäo do setor farmacêutico. Tem por objetivo elevar sua contribuiçäo para o desenvolvimento näo só científico e tecnológico, mas também social e econômico, dos países em desenvolvimento. Baseia-se no conceito de sistema nacional de inovaçäo. Verifica como se dá a inovaçäo no setor farmacêutico. Faz uma abordagem institucional e histórica. Enfatiza as especificidades dos atores e suas interaçöes nos espaços econômicos em questäo. Analisa o caso do Brasil. Percebe que a especificidade do sistema brasileiro de inovaçäo na área farmacêutica exige dos institutos públicos de pesquisa o desempenho de um leque mais amplo de funçöes que as tradicionais contribuiçöes para o estoque de conhecimentos científicos explorado pela indústria e a prestaçäo de serviços técnicos.

Produçäo descentralizada de medicamentos essenciais no Instituto de Tecnologia em Fármacos do Estado do Rio de Janeiro: um diagnóstico estratégico de sua implementaçäo / Descentralized production on essential drugs in the Instituto de Tecnologia em Farmacos - Rio de Janeiro

Discute a política de descentralizaçäo da assistência farmacêutica no que diz respeito à produçäo e distribuiçäo de medicamentos. Efetuou-se um estudo de caso em Far-Manguinhos/FIOCRUZ analisando sua estrutura organizacional e administrativa, assim como as estratégias utilizadas para implementar o processo de descentralizaçäo preconizado pelo sistema único de saúde (SUS). Usou-se como referencial teórico artigos clássicos que contextualizam a realidade do setor farmacêutico nacional e mundial. O estudo se desdobra através da evoluçäo política do setor da saúde no Brasil, com ênfase na política de medicamentos adotada a partir da criaçäo da Central de Medicamentos - CEME, até a atualidade. Säo feitas sugestoes que poderäo nortear outras discussoes sobre assistência farmacêutica no Brasil.