Entry and competition in generic biologics

Patents for several blockbuster biological products are expected to expire soon. The Food and Drug Administration is examining whether biologies can and should be treated like pharmaceuticals with regard to generics. In contrast with pharmaceuticals, which are manufactured through chemical synthesis, biologies are manufactured through fermentation, a process that is more variable and costly. Regulators might require extensive clinical testing of generic biologies to demonstrate equivalence to the branded product. The focus of the debate on generic biologies has been on legal and health concerns, but there are important economic implications. We combine a theoretical model of generic biologies with regression estimates from generic pharmaceuticals to estimate market entry and prices in the generic biologic market. We find that generic biologies will have high fixed costs from clinical testing and from manufacturing, so there will be less entry than would be expected for generic pharmaceuticals. With fewer generic competitors, generic biologies will be relatively close in price to branded biologies. Policy makers should be prudent in estimating financial benefits of generic biologies for consumers and payers. We also examine possible government strategies to promote generic competition. Copyright © 2007 John Wiley & Sons, Ltd.

Developing drugs for developing countries.

Infectious and parasitic diseases create enormous health burdens, but because most of the people suffering from these diseases are poor, little is invested in developing treatments. We propose that developers of treatments for neglected diseases receive a "priority review voucher." The voucher could save an average of one year of U.S. Food and Drug Administration (FDA) review and be sold by the developer to the manufacturer of a blockbuster drug. In a well-functioning market, the voucher would speed access to highly valued treatments. Thus, the voucher could benefit consumers in both developing and developed countries at relatively low cost to the taxpayer.

The New Face of Global Hollywood: Black Hawk Down and the Politics of Meta-Sovereignty

This paper uses Ridley Scott’s 2001 film blockbuster Black Hawk Down to examine the claim that popular film is the ‘newest component of sovereignty’. While the topic of the film – the 1993 UN/US intervention in Somalia – lends itself to straightforward politicisation, this paper is equally interested in the film’s production history and its reception by global audiences. While initial reactions to the film focused on its ideological commitments (e.g. racism, collusion between Hollywood and the Pentagon, post-11 September patriotism), these readings continually posed an imagined ‘America’ against ‘the world’. This paper argues that Black Hawk Down is not about sovereignty as traditionally conceived, that is, about national interest shaping global affairs. Rather, Black Hawk Down articulates, and is articulated by, a new and emerging global order that operates through inclusion, management and flexibility. Drawing on recent theoretical debates over this new logic of rule, this paper illustrates how Black Hawk Down invoked much more diffuse, complex and deterritorialized categories than national sovereignty. In effect, Scott’s film goes beyond traditional notions of sovereignty altogether: its production, signification and reception deconstruct simple notions of ‘America’ and ‘the world’ in favour of what Hardt and Negri call ‘Empire’, what Zizek calls ‘post-politics’, and what we refer to as ‘meta-sovereignty’.

Estrategias para la internacionalización de la industria cinematográfica en Colombia

El cine es una de las actividades de entretenimiento o hobbies preferidos a nivel mundial, por lo que grandes empresas se han formando alrededor de este con el objetivo primordial de proveer todo los aspectos necesarios para crear y producir cine de calidad, que llame cada vez más la atención del público. Un ejemplo de esto es Hollywood, el clúster cinematográfico de Estados Unidos que se considera uno de los más importantes del mundo, en donde cada una de las películas producidas cuenta con los recursos necesarios tanto financieros, tecnológicos y laborales, para generar cine de buena calidad, garantizando así la mayoría de las veces éxito de taquilla, el cual les permite recuperar muy fácil la inversión. Sin embargo, con la globalización el mundo se ha convertido en un libro abierto, lo que implica poder conocer y ver las culturas de otros países, encontrando que las películas son un medio que facilita esta interacción, en las cuales se expone la cultura del país, sus costumbres, su arquitectura, su personalidad y su idioma, aspectos que hoy en día constituyen las industrias creativas o culturales, las cuales poseen un gran porcentajes de de crecimiento sobretodo en los países en vías de desarrollo. Para el caso de Colombia, vemos como a partir del año 2003 con la implementación de la ley de cine 814, nuestra producción empezó a florecer con películas como el Rey, Rosario Tijeras, la historia del Baúl Rosa, Te busco, Mi abuelo, mi papa y yo, entre otras. Películas que en un inicio presentaron una demanda alta, debido al furor y al apoyo nacional brindado. No obstante, demanda que cayó rápidamente debido a las historia repetitivas basadas en guerra sumándole la mala calidad de estas producciones, que fueron castigadas por los cinéfilos. Lo anterior, muestra como la falta de capacitación en todos los eslabones de la cadena productiva del cine, el difícil acceso a recursos financieros y el retraso en materia tecnología, son los mayores obstáculos para nuestro cine, obstáculos que no nos han detenido pero si atrasado, ya que vemos ejemplos como la Película María llena eres de gracia, dirigida por Joshua Marston, estrenada en el 2005, la cual se llevo varios premios internacionales y una nominación al óscar a mejor actriz. Trabajar en estos tres pilares y buscar cooperación internacional permitirá que el cine colombiano conquiste los mercado internacional y a la vez ir constituyendo las bases para crear un clúster latinoamericano de cine.

INFO2009 2012-13 Resource Group 12 Security and Privacy

This is an educational resource that covers a number of realistic attacks on privacy from a technical perspective along with the legal issues you might face if you don't take adequate precautions with data. The format is engaging and entertaining, framing real-world issues in a familiar medium - namely that of a trailer for a blockbuster film.

Transformers

Review and critical reflection on 'Transformers' as an example of the contemporary blockbuster, exploring questions of genre, aesthetics, representation, and cultural and industrial contexts.

Texture, realism, performance: exploring the intersection of transtexts and the contemporary sitcom

Contemporary US sitcom is at an interesting crossroads: it has received an increasing amount of scholarly attention (e.g. Mills 2009; Butler 2010; Newman and Levine 2012; Vermeulen and Whitfield 2013), which largely understands it as shifting towards the aesthetically and narratively complex. At the same time, in the post-broadcasting era, US networks are particularly struggling for their audience share. With the days of blockbuster successes like Must See TV’s Friends (NBC 1994-2004) a distant dream, recent US sitcoms are instead turning towards smaller, engaged audiences. Here, a cult sensibility of intertextual in-jokes, temporal and narrational experimentation (e.g. flashbacks and alternate realities) and self-reflexive performance styles have marked shows including Community (NBC 2009-2015), How I Met Your Mother (CBS 2005-2014), New Girl (Fox 2011-present) and 30 Rock (NBC 2006-2013). However, not much critical attention has so far been paid to how these developments in textual sensibility in contemporary US sitcom may be influenced by, and influencing, the use of transmedia storytelling practices, an increasingly significant industrial concern and rising scholarly field of enquiry (e.g. Jenkins 2006; Mittell 2015; Richards 2010; Scott 2010; Jenkins, Ford and Green 2013). This chapter investigates this mutual influence between sitcom and transmedia by taking as its case studies two network shows that encourage invested viewership through their use of transtexts, namely How I Met Your Mother (hereafter HIMHM) and New Girl (hereafter NG). As such, it will pay particular attention to the most transtextually visible character/actor from each show: HIMYM’s Barney Stinson, played by Neil Patrick Harris, and NG’s Schmidt, played by Max Greenfield. This chapter argues that these sitcoms do not simply have their particular textual sensibility and also (happen to) engage with transmedia practices, but that the two are mutually informing and defining. This chapter explores the relationships and interplay between sitcom aesthetics, narratives and transmedia storytelling (or industrial transtexts), focusing on the use of multiple delivery channels in order to disperse “integral elements of a fiction” (Jenkins, 2006 95-6), by official entities such as the broadcasting channels. The chapter pays due attention to the specific production contexts of both shows and how these inform their approaches to transtexts. This chapter’s conceptual framework will be particularly concerned with how issues of texture, the reality envelope and accepted imaginative realism, as well as performance and the actor’s input inform and illuminate contemporary sitcoms and transtexts, and will be the first scholarly research to do so. It will seek out points of connections between two (thus far) separate strands of scholarship and will move discussions on transtexts beyond the usual genre studied (i.e. science-fiction and fantasy), as well as make a contribution to the growing scholarship on contemporary sitcom by approaching it from a new critical angle. On the basis that transmedia scholarship stands to benefit from widening its customary genre choice (i.e. telefantasy) for its case studies and from making more use of in-depth close analysis in its engagement with transtexts, the chapter argues that notions of texture, accepted imaginative realism and the reality envelope, as well as performance and the actor’s input deserve to be paid more attention to within transtext-related scholarship.

Movies, Mind and Meaning : Studying Audience and Favourite Films

Construction of identity and meaning is becoming increasingly important in both media studies and religion scholarship. (Lövheim, 2004) Meaning construction outside traditional religion has become more interesting for religious studies and what individuals in the audience do with all messages circulated through media in everyday life has attended increasing interest within media studies (Stout and Buddenbaum, 2001). Motion pictures, soap operas and advertising are all examples of media contents which generate ideas among its audience which to a various degree are used as resources within the construction of identity (Jansson, 2001). The investigation of what modern humankind’s world views look like and what components they are composed of, in this context seems to be an important topic of investigation (Holm and Björkqvist, 1996). The ways in which the development of media has effected the daily lives of individuals is interest as is the nature of the self and the ways in which the process of self-formation is affected by the profusion of mediated materials (Thompson, 1995). Film and religion are my interest within this larger frame. The topic is not exactly new but the combination of film and religion has during the last ten years resulted in a rapidly growing number of books by scholars interested in this field (Lyden, 2003). One growing focus is on the role that films can and do play within the emerging and developing valuesystem of people in the West today (Marsh, 2004). The British theologian Clive Marsh’s point of departure is very similar to my own. Viewers bring to a film life-experience, immediate concerns and worldviews and the exploration of this interplay between movies and the interpreting process of meaning making is the very focus in this paper. Theoretically, the semeiological model of Alf Linderman is combined with cultural cognitive approaches used by a number of Scandinavian media scholars developing perspectives in audience theory (Linderman, 1996, Höijer and Werner, 1998). 13 individuals, their favourite movie and what it means to them in their life My aim is to examine how individuals comprehend film and what the meaning process look like. In this paper I present the outcome of 13 interviews with young people about their favourite film. I suggest how it is possible to interpret how they interrelate film comprehension with their personal beliefs and their culturally constructed worldview from a sociocognitive point of view. Examples of films chosen range from Disneys Lion King (1994), sciencefiction and fantasy successes like The Matrix (1999) and Lord of the Rings (2001) or the next best movie ever according to www.IMdb.com The Shawshank Redemption (1994) as well as the Swedish blockbuster Så som i himmelen (2004), aka “As in Heaven”.

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.

O Guarani: produto cultural midiático

Pós-graduação em Letras - IBILCE

Cancer and aging: a multidisciplinary medicinal chemistry approach on relevant biological targets such as proteasome, sirtuins and interleukin 6

It is well known that ageing and cancer have common origins due to internal and environmental stress and share some common hallmarks such as genomic instability, epigenetic alteration, aberrant telomeres, inflammation and immune injury. Moreover, ageing is involved in a number of events responsible for carcinogenesis and cancer development at the molecular, cellular, and tissue levels. Ageing could represent a “blockbuster” market because the target patient group includes potentially every person; at the same time, oncology has become the largest therapeutic area in the pharmaceutical industry in terms of the number of projects, clinical trials and research and development (R&D) spending, but cancer remains one of the leading causes of mortality worldwide. The overall aim of the work presented in this thesis was the rational design of new compounds able to modulate activity of relevant targets involved in cancer and aging-related pathologies, namely proteasome and immunoproteasome, sirtuins and interleukin 6. These three targets play different roles in human cells, but the modulation of its activity using small molecules could have beneficial effects on one or more aging-related diseases and cancer. We identified new moderately active and selective non-peptidic compounds able to inhibit the activity of both standard and immunoproteasome, as well as novel and selective scaffolds that would bind and inhibit SIRT6 selectively and can be used to sensitize tumor cells to commonly used anticancer agents such gemcitabine and olaparib. Moreover, our virtual screening approach led us also to the discovery of new putative modulators of SIRT3 with interesting in-vitro and cellular activity. Although the selectivity and potency of the identified chemical scaffolds are susceptible to be further improved, these compounds can be considered as highly promising leads for the development of future therapeutics.

Contemporary Hollywood And The Attention Economy

This thesis had two goals: to explore the transformation of Hollywood from the 1930s to present, and to investigate how Contemporary Hollywood functions in a growing attention economy. Evident in the types of films that it produces as well as its evolving industrial structure, Contemporary Hollywood significantly differs from the Classical Hollywood of the 1930s. New digital technologies like surround sound and computer-generated imagery (CGI) have allowed studios to create a different type of film like the blockbuster and to have more extensive control over their films. Additionally, growing exhibition and distribution platforms have also fundamentally altered the industrial landscape of Hollywood. In order to combat this more egalitarian distribution system, Contemporary Hollywood has turned to conglomeratization. But, what has caused such a radical shift in the form and function of Contemporary Hollywood and its films? This thesis argues that Hollywood is failing to thrive in this new media landscape¿not because of changing technologies¿but because of a changing consumer. Richard Lanham theorizes that we are living in a growing attention economy, where human attention is the most valuable commodity in such an information-saturated society. For the current consumer, there is near-constant media over-stimulation: he or she is exposed to any number of screens (mobile phones, laptops, tablets, televisions, etc.) at any given time. Because we can access anything from anywhere at anytime, we¿ve become somewhat schizophrenic and impatient in terms of the media that we consume in our lives.

Reclaiming Indigenous Narratives through Critical Discourses and the Autonomy of the Trickster

How do prevailing narratives about Native Americans, particularly in the medium of film, conspire to promote the perspective of the dominant culture? What makes the appropriation of Indigenous images so metaphorically popular? In the past hundred years, little has changed in the forms of representation favored by Hollywood. The introductory chapter elucidates the problem and outlines the scope of this study. As each subsequent chapter makes clear, the problem is as relevant today as it has been throughout the entire course of filmic history. Chapter Two analyzes representational trends and defines each decade according to its favorite stereotype. The binary of the bloodthirsty savage is just as prevalent as it was during the 1920s and 30s. The same holds true for the drunken scapegoat and the exotic maiden, which made their cinematic debuts in the 1940s and 50s. But Hollywood has added new types as well. The visionary peacemaker and environmental activist have also made an appearance within the last forty years. What matters most is not the realism of these images, but rather the purposes to which they can be put toward validating whatever concerns the majority filmmakers wish to promote. Whether naïvely or not, such representations continue to evacuate Indigenous agency to the advantage of the majority. A brief historical overview confirms this legacy. Various disciplines have sought to interrogate this problem. Chapter three investigates the field of postcolonial studies, which makes inquiry into the various ways these narratives are produced, marketed, and consumed. It also raises the key questions of for whom, and by whom, these narratives are constructed. Additional consideration is given to their value as commodities in the mass marketplace. Typically the products of a boutique-multiculturalism, their storylines are apt to promote the prevailing point of view. Critical theory provides a foundational framework for chapter four. What is the blockbuster formula and how do the instruments of capital promote it? Concepts such as culture industry and repressive tolerance examine both the function and form of the master narrative, as well as its use to control the avenues of dissent. Moreover, the public sphere and its diminishment highlight the challenges inherent in the widespread promotion of an alternative set of narratives. Nonetheless, challenges to prevailing narratives do exist, particularly in the form of Trickster narratives. Often subject to persistent misrecognition, the Trickster demonstrates a potent form of agency that undeniably dismantles the hegemony of Western cinema. The final chapter examines some of the Trickster's more subtle and obscure productions. Usually subjugated to the realm of the mystical, rather than the mythical, these misinterpreted forms have the power to speak in circles around a majority audience. Intended for an Other audience, they are coded in a language that delivers a type of direction through indirection, promoting a poignant agency all their own.

A cidade cartão-postal no cinema de Woody Allen

Este trabalho examina a representação das cidades na obra de Woody Allen. No intuito de compreender a saída do cineasta patrimônio da cidade de Nova York para a Europa, retoma-se criticamente a questão da Era da Lista Negra, das runaway productions e dos blockbusters. Para analisar os filmes de Allen na Europa considera-se importante entender como a cidade de Nova York configura-se no início da carreira do diretor, notadamente, em filmes que estabelecem um contraponto entre o Brooklyn e Manhattan. Em seguida, examina-se a questão crítica fundamental do trabalho: o cartão-postal corporativo na Europa. Nesse sentido, propõe-se a análise dos cartões-postais de Barcelona, Paris e Roma. O filme Vicky Cristina Barcelona adquire centralidade nesta pesquisa por apresentar de maneira exemplar a paisagem postiça da cidade encarcerada sob intervenção corporativa.

Terraforming: Ecopolitical Transformations and Environmentalism in Science Fiction /

Terraforming is the process of making other worlds habitable for human life. This book asks how science fiction has imagined how we shape both our world and other planets and how stories of terraforming reflect on science, society and environmentalism.