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.

International civil society actors in Genetically Modificied Organisms as a field of struggle: a neo-gramscian study in Brazil and the United Kingdom

Since the international financial and food crisis that started in 2008, strong emphasis has been made on the importance of Genetically Modified Organisms (GMOs) (or “transgenics”) under the claim that they could contribute to increase food productivity at a global level, as the world population is predicted to reach 9.1 billion in the year 2050 and food demand is predicted to increase by as much as 50% by 2030. GMOs are now at the forefront of the debates and struggles of different actors. Within civil society actors, it is possible to observe multiple, and sometime, conflicting roles. The role of international social movements and international NGOs in the GMO field of struggle is increasingly relevant. However, while many of these international civil society actors oppose this type of technological developments (alleging, for instance, environmental, health and even social harms), others have been reportedly cooperating with multinational corporations, retailers, and the biotechnology industry to promote GMOs. In this thesis research, I focus on analysing the role of “international civil society” in the GMO field of struggle by asking: “what are the organizing strategies of international civil society actors, such as NGOs and social movements, in GMO governance as a field of struggle?” To do so, I adopt a neo-Gramscian discourse approach based on the studies of Laclau and Mouffe. This theoretical approach affirms that in a particular hegemonic regime there are contingent alliances and forces that overpass the spheres of the state and the economy, while civil society actors can be seen as a “glue” to the way hegemony functions. Civil society is then the site where hegemony is consented, reproduced, sustained, channelled, but also where counter-hegemonic and emancipatory forces can emerge. Considering the importance of civil society actors in the construction of hegemony, I also discuss some important theories around them. The research combines, on the one hand, 36 in-depth interviews with a range of key civil society actors and scientists representing the GMO field of struggle in Brazil (19) and the UK (17), and, on the other hand, direct observations of two events: Rio+20 in Rio de Janeiro in 2012, and the first March Against Monsanto in London in 2013. A brief overview of the GMO field of struggle, from its beginning and especially focusing in the 1990s when the process of hegemonic formation became clearer, serves as the basis to map who are the main actors in this field, how resource mobilization works, how political opportunities (“historical contingencies”) are discovered and exploited, which are the main discourses (“science” and “sustainability” - articulated by “biodiversity preservation”, “food security” and “ecological agriculture”) articulated among the actors to construct a collective identity in order to attract new potential allies around “GMOs” (“nodal point”), and which are the institutions and international regulations within these processes that enable hegemony to emerge in meaningful and durable hegemonic links. This mapping indicates that that the main strategies applied by the international civil society actors are influenced by two central historical contingencies in the GMO field of struggle: 1) First Multi-stakeholder Historical Contingency; and 2) “Supposed” Hegemony Stability. These two types of historical contingency in the GMO field of struggle encompass deeper hegemonic articulations and, because of that, they induce international civil society actors to rethink the way they articulate and position themselves within the field. Therefore, depending on one of those moments, they will apply one specific strategy of discourse articulation, such as: introducing a new discourse in hegemony articulation to capture the attention of the public and of institutions; endorsing new plural demands; increasing collective visibility; facilitating material articulations; sharing a common enemy identity; or spreading new ideological elements among the actors in the field of struggle.

Theoretical Approximations Between Brazilian and Spanish Authors' Production in the Field of Knowledge Organization in the Production of Journals on Information Science in Brazil

This work identifies and analyzes literature about knowledge organization (KO), expressed in scientific journals communication of information science (IS). It performs an exploratory study on the Base de Dados Referencial de Artigos de Periodicos em Ciência da Informacio (BRAPCI, Reference Database of Journal Articles on Information Science) between the years 2000 and 2010. The descriptors relating to "knowledge organization" are used in order to recover and analyze the corresponding articles and to identify descriptors and concepts which integrate the semantic universe related to KO. Through the analysis of content, based on metrical studies, this article gathers and interprets data relating to documents and authors. Through this, it demonstrates the development of this field and its research fronts according to the observed characteristics, as well as noting the transformation indicative in the production of knowledge. The work describes the influences of the Spanish researchers on Brazilian literature in the fields of knowledge and information organization. As a result, it presents the most cited and productive authors, the theoretical currents which support them, and the most significant relationships of the Spanish-Brazilian authors network. Based on the constant key-words analysis in the cited articles, the co-existence of the French conception current and the incipient Spanish influence in Brazil is observed. Through this, it contributes to the comprehension of the thematic range relating to KO, stimulating both criticism and self-criticism, debate and knowledge creation, based on studies that have been developed and institutionalized in academic contexts in Spain and Brazil.

Effect of Strength Training on Rate of Force Development in Older Women

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

ACUTE EFFECT of STATIC STRETCHING on RATE of FORCE DEVELOPMENT and MAXIMAL VOLUNTARY CONTRACTION IN OLDER WOMEN

Gurjao, ALD, Goncalves, R, de Moura, RF, and Gobbi, S. Acute effect of static stretching on rate of force development and maximal voluntary contraction in older women. J Strength Cond Res 23(7): 2149-2154, 2009-The purpose of this study was to investigate, in older women, the acute effect of static stretching (SS) on both muscle activation and force output. Twenty-three older women (64.6 +/- 7.1 yr) participated in the study. The maximal voluntary contraction (MVC), rate of force development (RFD) (50, 100, 150, and 200 ms relative to onset of muscular contraction), and peak RFD (PRFD) (the steepest slope of the curve during the first 200 ms) were tested under 2 randomly separate conditions: SS and control (C). Electromyographic (EMG) activity of the vastus medialis (VM), vastus lateralis (VL), and biceps femoris (BF) muscles also was assessed. The MVC was significantly lower (p < 0.05) in the 3 trials of SS when compared with the C condition (control: 925.0 +/- 50.9 N; trial 1 : 854.3 +/- 55.3 N; trial 2 : 863.1 +/- 52.2 N; and trial 3 : 877.5 +/- 49.9 N). PRFD showed a significant decrease only for the first 2 trials of SS when compared with the C condition (control: 2672.3 +/- 259.1 N/s; trial 1 : 2296.6 +/- 300.7 N/s; and trial 2 : 2197.9 +/- 246.3 N/s). However, no difference was found for RFD (50, 100, 150, and 200 ms relative to onset of muscular contraction). The EMG activity for VM, VL, and BF was not significantly different between the C and SS conditions. In conclusion, the older women's capacity to produce muscular force decreased after their performance of SS exercises. The mechanisms responsible for this effect do not appear to be related to muscle activation. Thus, if flexibility is to be trained, it is recommended that SS does not occur just before the performance of activities that require high levels of muscular force.

THE RATE of FORCE DEVELOPMENT OBTAINED AT EARLY CONTRACTION PHASE IS NOT INFLUENCED BY ACTIVE STATIC STRETCHING

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Dynamical properties for the problem of a particle in an electric field of wave packet: Low velocity and relativistic approach

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

The rate of force generation by the myocardium is not influenced by afterload

The influence of afterload on the rate of force generation by the myocardium was investigated using two types of preparations: the in situ dog heart (dP/dt) and isolated papillary muscle of rats (dT/dt). Thirteen anesthetized, mechanically ventilated and thoracotomized dogs were submitted to pharmacological autonomic blockade (3.0 mg/kg oxprenolol plus 0.5 mg/kg atropine). A reservoir connected to the left atrium permitted the control of left ventricular end-diastolic pressure (LVEDP). A mechanical constriction of the descending thoracic aorta allowed to increase the systolic pressure in two steps of 20 mmHg (conditions H1 and H2) above control values (condition C). After arterial pressure elevations (systolic pressure C: 119 ± 8.1; H1: 142 ± 7.9; H2 166 ± 7.7 mmHg; P<0.01), there were no significant differences in heart rate (C: 125 ± 13.9; H1: 125 ± 13.5; H2: 123 ± 14.1 bpm; P>0.05) or LVEDP (C: 6.2 ± 2.48; H1: 6.3 ± 2.43; H2: 6.1 ± 2.51 mmHg; P>0.05). The values of dP/dt did not change after each elevation of arterial pressure (C: 3,068 ± 1,057; H1: 3,112 ± 996; H2: 3,086 ± 980 mmHg/s; P>0.05). In isolated rat papillary muscle, an afterload corresponding to 50% and 75% of the maximal developed tension did not alter the values of the maximum rate of tension development (100%: 78 ± 13; 75%: 80 ± 13; 50%: 79 ± 11 g mm-2 s-1, P>0.05). The results show that the rise in afterload per se does not cause changes in dP/dt or dT/dt

Magnetic field of an in-plane vortex inside and outside a layered superconducting film

In the present work we study an anisotropic layered superconducting film of finite thickness. The film surfaces are considered parallel to the be face of the crystal. The vortex lines are oriented perpendicular to the film surfaces and parallel to the superconducting planes. We calculate the local field and the London free energy for this geometry. Our calculation is a generalization of previous works where the sample is taken as a semi-infinite superconductor. As an application of this theory we investigate the flux spreading at the super conducting surface.

Dissociated time course recovery between rate of force development and peak torque after eccentric exercise

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Application of methylotrophic yeast Pichia pastoris in the field of food industry - A review

Since ancient times, the utilization of yeasts by the man has a great impact on the socio-economic development. After the advent of the technology of recombinant DNA, great advances have occurred due to the acquisition of strains of mutant yeasts in the field of applied research, and Saccharomyces cerevisiae has soon been outstanding as an interesting candidate for the expression of heterologous proteins of biotechnological interest. As the time goes by other alternative systems of expression have been shown because they have advantages over Saccharomyces cerevisiae. Among those new systems, Pichia pastoris is outstanding as methylotrophic yeast capable of growing in a culture medium containing methanol as the only source of carbon and energy. The induction of production of glycerol-3-phosphate dehydrogenase (GPD, NAD(+): oxido-redutase EC 1.1. 1.8) by Pichia pastoris was accomplished in the medium containing methanol. One of the most important key parameters in Pichia pastoris expression system is the methanol concentration. Bibliographic reviews on the Pichia pastoris production system have shown that the best culture conditions vary according to the strain used and/or kind of heterologous protein desired to be expressed. Therefore, we have sought to develop a system, involving expression of glycerol-3-phosphate dehydrogenase in the yeast Pichia pastoris, for generating sufficient quantities of the enzyme in order to asses its potential value for use in various food bioanalytical determination. Dehydrogenases have been widely used in the enzymatic assays of diverse composites of industrial interest, being enclosed among them glycerol and a number of important bioanalytical applications.

The magnetic field of a current carrying cosmic string

The magnetostatic field of an infinite rectilinear current placed in the stationary gravitational field of a rotating cosmic string is found. An interesting aspect of this problem is that although the metric is mathematically very simple, its physical meaning is not trivial. It depends only on topological parameters. So, the cosmic string vacuum space-time is locally equivalent to the Minkowski space-time, but not globally. The calculations are so simple that they can easily be shown in the classroom. © 1997 American Association of Physics Teachers.

The saturated magnetic field of the neutron stars

Considering the ferromagnetic screening for the decay of the X-ray neutron star magnetic field in the binary accretion phase, the phase transition of ferromagnetic materials in the crust of neutron star induces the ferromagnetic screening saturation of the accreted crust, which results in the minimum surface magnetic field of the accreting neutron star, about 108 G, if the accreted matter has completely replaced the crust mass of the neutron star. The magnetic field evolution versus accreted mass is given as Bs ∝ ΔM-0.9, and the obtained magnetic field versus spin period relation is consistent with the distribution of the binary X-ray sources and recycled pulsars. The further thermal effect on the magnetic evolution is also studied.