Entry strategies into biosimilars: assessment of entry modes into the field of biosimilars from the perspective of pharmaceuticals, generics and biologics companies

Indústria farmacêutica de hoje está em transição. Como grandes blockbuster drogas estão perdendo ou estão prestes a perder a proteção de patente, e as grandes empresas farmacêuticas não estão substituindo os produtos com novas drogas químicas inovadoras, a indústria busca novas áreas de crescimento. Uma dessas áreas é o mercado de biossimilares, que está sendo inseridos por produtos farmacêuticos, genéricos e empresas de produtos biológicos. Mesmo que o grande potencial de mercado será acordado por volta de 2020, quando importantes blockbusters biológicos perder a proteção de patente, as empresas precisam decidir logo se querem participar ou não devido a elevadas barreiras à entrada técnicos, bem como de desenvolvimento de longo prazos. Como todas as empresas vêm de diferentes origens, compreendem capacidades diferentes e têm diferentes incentivos de entrada, a questão que surge é se esses fatos estão relacionados com as suas estratégias de entrada correspondentes. A tese utiliza estudos de caso de cada segmento da indústria farmacêutica - produtos farmacêuticos, biológicos e genéricos - e examina através de entrevistas semi-estruturadas, por isso que os participantes do estudo de caso entrevistados explicitamente escolhido sua estratégia de entrada. Os dados de entrevistas será então ligada a quadros estratégicos da revisão da literatura e irá ser utilizado para uma comparação global e análise. O estudo revelou que o fundo do participante do mercado que influenciam a sua estratégia de entrada. Os principais pontos de influência derivam tanto as barreiras à entrada, bem como os incentivos de entrada. A tese não é possível determinar o sucesso futuro do modo de entrada analisados no novo mercado.

Extreme poverty and development: the role of state in the assurance of minimal existence conditions

This paper follows the idea of Amartya Sen, Nobel Prize of economic, about the role of State in the assurance of minimal existence condition, and aim to answer how countries of Latin America (specifically Brazil) and countries of Europe (specifically United Kingdom) deal with the assurance of this minimal existence conditions. According to Amartya Sen’s view, development must be seen as a process of expanding substantive freedoms, such expansion being the primary purpose of each society and the main mean of development. Substantive freedoms can be considered as basic capabilities allocated to individuals whereby they are entitled to be architects of their own lives, providing them conditions to “live as they wish”. These basic capabilities are divided by Amartya Sen in 5 (five) kinds of substantive freedoms, but for this article’s purpose, we will consider just one of this 5 (five) kinds, specifically the Protective Safety capability. Protective Safety capability may be defined as the assurance of basic means of survival for individuals who are in extreme poverty, at risk of starvation or hypothermia, or even impending famine. Among the means available that could be used to avoid such situations are the possibility of supplemental income to the needy, distributing food and clothing to the needy, supply of energy and water, among others. But how countries deal whit this protective safety? Aiming to answer this question, we selected the problem of “fuel poverty” and how Brazil and United Kingdom solve it (if they solve), in order to assess how the solution found impacts development. The analysis and the comparison between these countries will allow an answer to the question proposed.

Pompidou & Pompeia: a parallel between the management strategies of two cultural institutions in the French and Brazilian contexts

A presente pesquisa foi conduzida na forma de um estudo de caso de duas instituições culturais no contexto francês e brasileiro. O Centro Pompidou é um projeto presidencial de museu financiado pelo Estado, com a missão de tornar a arte moderna em todas as suas expressões acessíveis ao público em geral. O Sesc Pompeia é um centro multidisciplinar de cultura e esporte - financiado pelo dinheiro dos impostos e administrado pela Federação do Comércio . O Sesc Pompéia é dedicado à oferta de educação informal através do cultivo da mente e do corpo. O estudo examina se as teorias de dependência de recursos e de poder podem ser utilizadas para conceituar a relação que o Centro Pompidou e do Sesc Pompéia tem com seus stakeholders financeiros. Mais especificamente, será discutido em que medida o grau de dependência influencia a estratégia de gestão das instituições. O objetivo é de responder a pergunta seguinte: quais são as estratégias que as instituições adotam para reduzir sua dependência com relação a seus principais stakeholders financeiros? Finalmente algumas implicações práticas de gestão serão elaboradas a partir do paralelo entre as estratégias das duas instituições.

WTO-plus commitments on the elimination of export duties: evidence of a two-tier membership?

This descriptive paper examines the prevalence of ‘WTO-plus’ commitments in accession protocols of newly acceded Members, with a focus on commitments on the elimination of export duties. It presents preliminary results of a mapping exercise carried out with respect to these commitments and seeks to answer two questions. First, can any general conclusions be drawn as to the prevalence of these commitments or are they, per definition, country-specific. Second, has the political nature of the WTO accession process allowed for the creation of a two-tier membership. The first question is answered by relying on data gathered as part of the ongoing PhD-research project conducted by the author. The project aims to construct a typology of WTO-plus commitments to allow for a more detailed analysis of the relationship between these commitments and the baseline obligations in the covered agreements. The accession of China to the WTO is commonly considered as the prime example of the inclusion of WTO-plus obligations in accession protocols. The paper tries to answer the question whether this particular accession was truly unique in nature, or whether the inclusion of “Plus” obligations is less exceptional than often assumed. Additionally, the accession protocols of other recently acceded-Members are examined to establish whether the hypothesis holds. In the PhD-research project this comparative methodology will also be applied to map WTO-plus commitments in other areas, such as anti-dumping and transparency. The second question will be answered in two stages. In a preliminary stage, international institutional law will be used to by analyzing the way in which the WTO’s Dispute Settlement Body has dealt with this type of WTO-plus commitment in its jurisprudence. The second stage deals with the question of hierarchy: Accession Protocols are negotiated with the WTO Membership, by each country willing to accede to the WTO. This poses questions as to their exact position in the system of WTO law. To establish whether evidence of a two-tier membership is present, one first has to turn back to the question whether Accession Protocols are a separate (or independent) legal instrument or an “integral part” of the WTO system of covered agreements. If newly acceded Members do not benefit from the general exceptions in order to balance their more stringent, WTO-plus, obligations, this may support the conclusion that the membership of the World Trade Organization is becoming, in fact, two-tiered.

Is child labor harmful? the impact of working as a child on adult earnings

This paper explores the question: is working as young laborer harmful to an individual in terms of adult outcomes in income? This question is explored through the utilization of a unique set of instruments that control for the decision to work as a child and the decision of how much schooling to acquire. These instruments are combined with two large household survey data sets from Brazil that include retrospective information on the child labor and schooling of working-age adults: the 1988 and 1996 PNAD. Estimations of the reduced form earnings model are performed first by using OLS without controlling for the potential endogeneity of child labor and schooling, and then by using a GMM estimation of instrumental variables models that include the set of instruments for child labor and schooling. The findings of the empirical investigations show that child labor has large negative impact on adult earnings for both male and female children even when controlling for schooling. In addition, the negative impact of starting to work as a child reverses at around age 14. Finally, different child labor activities are examined to determine if some are beneficial while others harmful with the finding that working in agriculture as a child appears to have no negative impact over and above the loss of education.

Assessment of value creation in private equity: the acquisition of Burger King by 3G Capital

This thesis elaborates the creation of value in private equity and in particular analyzes value creation in 3G Capital’s acquisition of Burger King. In this sense, a specific model is applied that composes value creation into several drivers, in order to answer the question of how value creation can be addressed in private equity investments. Although previous research by Achleitner et al. (2010) introduced a specific model that addresses value creation in private equity, the respective model was neither applied to an individual company, nor linked to indirect drivers that explain the dynamics and rationales for the creation of value. In turn this paper applies the quantitative model to an ongoing private equity investment and thereby provides different extensions to turn the model into a better forecasting model for ongoing investments, instead of only analyzing a deal that has already been divested from an ex post perspective. The chosen research approach is a case study about the Burger King buyout that first includes an extensive review about the current status of academic literature, second a quantitative calculation and qualitative interpretation of different direct value drivers, third a qualitative breakdown of indirect drivers, and lastly a recapitulating discussion about value creation and value drivers. Presenting a very successful private equity investment and elaborately demonstrating the dynamics and mechanisms that drive value creation in this case, provides important implications for other private equity firms as well as public firms in order to develop their proprietary approach towards value creation.

Notes on cyclical tendency to the overvaluation of the real

This note addresses the question “To what extent financial regulation in Brazil was effective in neutralizing the tendency to the overvaluation of the exchange rate in Brazil since the 1994 Real Plan?” Aiming at answering this question, this note is organized as follows: after this short introduction, we briefly describe the Brazilian exchange rate behavior after the Real Plan, emphasizing its key role in keeping prices stable. In section 3, the recent measures adopted by the Brazilian Central Bank (BCB) aiming at avoiding the overvaluation of real will be summarized. In section 4, we argue in favor of a new policy mix that could avoid overvaluation of the currency. Finally, some issues will be raised in order to effectively neutralize the overvaluation of real.

Contribution to the chemoreception capacity of juvenile Loggerhead sea turtles (Caretta caretta, L.)

Loggerhead sea turtle juveniles (Caretta caretta), pelagic stage, are found in waters of Madeira archipelago. Pelagic turtles are in the main growth phase of their life cycle and consequently higher energy needs. However, knowledge about the ecology of pelagic loggerhead sea turtles is still quite rudimentary, mainly about the mechanisms that lead them to find food in the vast ocean. Studies with other pelagic species, such as procellariiform birds, revealed that the olfactory system play an important role for the detection of feeding areas, through the detection of concentration peaks of DMS (dimethylsulfide), a scent compound that naturally exists in the marine environment and it is related to areas of high productivity. Based on the assumption that loggerhead sea turtles use a similar mechanism, behavioural experiments were conducted in order to analyze the chemoreception capacity to DMS (airborne chemoreception - theoretically responsible for the long distance detection of areas with food patches; and aquatic chemoreception - theoretically responsible for the short distance detection of preys). The first step was to observe if pelagic loggerheads demonstrate sensitivity to DMS and the second was to verify if they really use the DMS, in natural conditions, as an airborne cue to find areas where food patches might be available. Four juveniles of loggerhead sea turtles were tested in captivity and three wild turtles in the open ocean. The results of airborne chemoreception experiments in captivity revealed that one turtle clearly demonstrated sensitivity to DMS and the sea experiments confirmed this result. However, the experiments were not conclusive on the question whether the pelagic turtles actually use the DMS as an airborne cue to detect long distance food patches. In aquatic chemoreception experiments was not observed sensitivity to DMS by the three sea turtles tested. In the classical conditioning experiment, where DMS and food were given nearly at the same time revealed that after a certain period of time, the sea turtle tested did not associated the DMS stimulus with a possible food reward. The main cause of mortality of loggerhead sea turtles in Madeira waters is due to the accidental capture (bycatch) by deep pelagic longlines fishery which the target species is the black-scabbard (Aphanopus carbo) fish. Chub mackerel (Scomber japonicus) is one of the baits used in this fishery. Aquatic chemoreception experiments were conducted in order to evaluate the attractiveness of the chub mackerel for sea turtles. For the three sea turtles tested, the results showed that in 90% of the cases the sea turtles were extremely attracted by the underwater smell of this fish.

Study of postures in sugarcane cutters in the Pontal of Paranapanema-SP, Brazil

The expansion of sugarcane monoculture in Brazil in the last decades has pointed out to the necessity of considering the question of sugarcane cutters occupational health. In this work we present a cross-sectional study aiming to examine the occupational posture of a group of sugarcane cutters, which work in a cane field located in the region of Pontal do Paranapanema-SP, Brazil. The study was made using the Ergonomic Analysis of Work - EAW methodology and the postural analysis method by Win-OWAS. Through the obtained records of postures, it was observed that during a workday the sugarcane cutters remain standing erect on two legs or in one leg 66% of the time and that their trunk remain tilted and in rotation, according to 63% of the positions categorized. It was also observed that the sugarcane cutter trunk performs repetitive and boundless movements during his routine of work, which can expose this individual to additional wear of their musculoskeletal functions. The activities in which the individual engages have favorable or adverse influence on his posture. The repetitive movements involved in specialized occupations are equivalent to repeated exercises, thus may be responsible for the excessive development of certain muscle groups. The study suggests that the postures adopted by sugarcane cutters can overload their musculoskeletal system and predispose the cutters to work-related musculoskeletal diseases.

Giving up reporting the aggressor: reports of female victims of domestic violence

The goal of this study is to describe the experience of female victims of domestic violence, who forfeited the lawsuits against their aggressors. The interviews were oriented by the question: What was your experience of forfeiting the denunciation of your aggressor? Three themes emerged from the convergence of the testimonies: time passed from the aggression to the denunciation and then to the forfeiting; the partner, the family, the women's precinct; reflecting about the experience, which described the studied phenomenon. The women expressed ambiguous feelings for their aggressor: affection, anger, humiliation and fear. They recognize that they are dominated and humiliated, but notions of justice and equality between spouses do not appear in the testimonies. Forfeiting can be understood in the context of the reproduction of the traditional family structure, conditioned to economic and social factors. Results highlight implications about the role of the Women's Precinct and the healthcare institutions in the care for women who were victims of domestic violence.

Granulocytic sarcoma of the small intestine with CBF beta/MYH11 fusion gene: report of an aleukaemic case and review of the literature

Granulocytic sarcomas (GS) are rare extramedullary tumours composed of immature myeloid cells. Inversion of chromosome 16 [inv(16)] is a cytogenetic marker for M4Eo subtype of acute myeloid leukaemia (AML). The possibility of an association between the development of granulocytic sarcoma of the small intestine (GSSI) and the M4Eo subtype of AML was suggested in nine previous case reports.Here we report an aleukaemic case of GSSI with inv(16) and its molecular equivalent, the CBFbeta/MYH11 fusion gene, detected by reverse transcriptase-polymerase chain reaction (RT-PCR), that after treatment with conventional AML chemotherapy followed by autologous bone marrow transplantation, achieved complete haematological and molecular remission on bone marrow examination. After chemotherapy, a thickened ileum wall positive for CBFbeta/MYH11 on tumour mass samples was still observed on computed tomography (CT) studies, raising the question of residual GS representing a reservoir of malignant cells. This case demonstrates the critical need of multidisciplinary diagnosis and follow-up of this entity combining immunopathologic, cytogenetic and molecular studies, reinforcing the potentiality of risk-adapted therapy strategies, as it is increasingly claimed for patients with overt AML. (C) 2003 Elsevier Ltd. All rights reserved.

MORPHOLOGICAL EVIDENCE FOR PROTANDRIC SIMULTANEOUS HERMAPHRODITISM IN THE CARIDEAN EXHIPPOLYSMATA OPLOPHOROIDES

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

On the behaviour of zeros of Jacobi polynomials

Denote by x(n,k)(alpha, beta) and x(n,k) (lambda) = x(n,k) (lambda - 1/2, lambda - 1/2) the zeros, in decreasing order, of the Jacobi polynomial P-n((alpha, beta))(x) and of the ultraspherical (Gegenbauer) polynomial C-n(lambda)(x), respectively. The monotonicity of x(n,k)(alpha, beta) as functions of a and beta, alpha, beta > - 1, is investigated. Necessary conditions such that the zeros of P-n((a, b)) (x) are smaller (greater) than the zeros of P-n((alpha, beta))(x) are provided. A. Markov proved that x(n,k) (a, b) < x(n,k)(α, β) (x(n,k)(a, b) > x(n,k)(alpha, beta)) for every n is an element of N and each k, 1 less than or equal to k less than or equal to n if a > alpha and b < β (a < alpha and b > beta). We prove the converse statement of Markov's theorem. The question of how large the function could be such that the products f(n)(lambda) x(n,k)(lambda), k = 1,..., [n/2] are increasing functions of lambda, for lambda > - 1/2, is also discussed. Elbert and Siafarikas proved that f(n)(lambda) = (lambda + (2n(2) + 1)/ (4n + 2))(1/2) obeys this property. We establish the sharpness of their result. (C) 2002 Elsevier B.V. (USA).

Limit on the fermion masses in technicolor models

Recently it has been pointed out that no limits can be put on the scale of fermion mass generation (M) in technicolor models, because the relation between the fermion masses (m(f)) and M depends on the dimensionality of the interaction responsible for generating the fermion mass. Depending on this dimensionality it may happen that m(f) does not depend on M at all. We show that exactly in this case m(f) may reach its largest value, which is almost saturated by the top quark mass. We make a few comments on the question of how large a dynamically generated fermion mass can be.

Early Miocene bivalves from the Cape Melville Formation, King George Island, West Antarctica

Seven species of marine bivalves, including six new taxa, are described from the Cape early Miocene Melville Formation which crops out on the Melville Peninsula, King George Island, West Antarctica. The bivalve assemblage includes representatives of the families Nuculidae, Ennucula frigida sp. nov., E. musculosa sp. nov.; Malletidae, Neilo (Neilo) rongelii sp. nov.; Sareptidae, Yoldia peninsularis sp. nov.; Limopsidae, Limopsis psimolis sp. nov.; Hiatellidae, Panopea (Panopea) sp. cf. P. regularis; and Pholadomyoida (Periploma acuta sp. nov.). Species studied come from four sedimentary sections measured in the upper part of the unit. Detailed morphologic features of nuculoid and areoid species are exceptionally well preserved and allow for the first time reconstruction of muscle insertions as well as dentition patterns of Cenozoic taxa. Known geological distribution of the species is in agreement with the early Miocene age assigned to the Cape Melville Formation. The bivalve fauna from Cape Melville Formation is the best known from Antarctic Miocene rocks, a time of complex geologic, paleogeographic and paleoclimatic changes in the continent. The new fauna introduces new taxonomic and palaeogeographic data that bear oil the question of opening of sea gateways and distribution of Cenozoic biota around Antarctica.