Enabling Access to Clinical Trial Data: When is Unfair Use Fair?

This inquiry is prompted by the unprecedented policy of the European Medicines Agency that enables the disclosure of clinical trial reports submitted for drug marketing authorization, effective as of January 1, 2015. It addresses the question whether such practice is in compliance with the international standard of clinical data protection under Article 39.3 of the TRIPS Agreement. Most scholarly and policy debate regarding this provision analyzes whether it precludes the referential use of data to facilitate the approval of a generic drug. Rather than focusing on a particular use, this Article seeks to identify the principle underlying the protection obligation by which the legitimacy of “use X” can be evaluated. In doing so, it interprets the provision from literal, historical and teleological perspectives, and it analyzes a peculiar overlap between three legal regimes: unfair competition, trade secret, and sui generis data protection. The proposed principle allows avoidance of situations where, due to the ambiguous notion of unfair commercial use, the protection of data under the TRIPS Agreement can be stretched indefinitely. With regard to data disclosure for experimental use, it is argued that the protection obligation under 39.3 TRIPS does not justify monopoly type protection of clinical trial data, neither does it require the reservation of experimental use exclusively for the data originator, even if such use can have commercial benefits for competitors

Protecting Trade Secrets Under International Investment Law: What Secrets Investors Should Not Tell States, 15 J. Marshall Rev. Intell. Prop. L. 228 (2016)

The article addresses specifics of trade secret protection under international investment law. As a particular example, it analyzes protection of pharmaceutical regulatory data against the background of the growing public policy campaign for broader access to clinical trial data and the recent unprecedented practice of the European Medicines Agency of disclosing clinical dossiers submitted for drug marketing approval. Given the significant role of foreign direct investment in the global pharmaceutical industry and substantial, exponentially increasing costs incurred by drug originator companies in conducting clinical trials, the prospect of investor-state dispute over data disclosure does not appear purely hypothetical. The question is whether investor-state arbitration is an apt instrument to protect originators’ data against disclosure by drug regulatory authorities. The analysis suggests that the application of standards of international investment protection depends on the specifics of information at issue, its value, and functions in investors’ commercial operations. With regard to pharmaceutical test data, it is argued that the prospects of investor-state arbitration are rather unfavorable for the investor, when data is disclosed to support policy objectives in public healthcare and medical innovation

Understanding Perceptions of Problematic Facebook Use: When People Experience Negative Life Impact and a Lack of Control

While many people use social network sites to connect with friends and family, some feel that their use is problematic, seriously affecting their sleep, work, or life. Pairing a survey of 20,000 Facebook users measuring perceptions of problematic use with behavioral and demographic data, we examined Facebook activities associated with problematic use as well as the kinds of people most likely to experience it. People who feel their use is problematic are more likely to be younger, male, and going through a major life event such as a breakup. They spend more time on the platform, particularly at night, and spend proportionally more time looking at profiles and less time browsing their News Feeds. They also message their friends more frequently. While they are more likely to respond to notifications, they are also more likely to deactivate their accounts, perhaps in an effort to better manage their time. Further, they are more likely to have seen content about social media or phone addiction. Notably, people reporting problematic use rate the site as more valuable to them, highlighting the complex relationship between technology use and well-being. A better understanding of problematic Facebook use can inform the design of context-appropriate and supportive tools to help people become more in control.Comment: CHI 201

Recasting China’s Foreign Policy: Focusing on Post-Jiang Leaders’ Authority Building

This article is structured as follows. Part II provides a succinct summary of recent China’s assertive external conduct. Based on the created Assertive Foreign Policy Index, we choose several cases from the sample for the deeper analysis to understand the reasons behind foreign policy decisions. Part III illuminates the authority-building theoretical framework, redefined from Breslauer (1982) analysis of post-Stalin leaders. Through the authority-building framework lens, we can penetrate into China’s domestic politics, having a better understanding of the decision-making process. Part IV explains the specific characteristics of leaders’ authority-building in post-Jiang’s China and its implications to foreign policy. Part V provides an in-depth case study analysis, comparing Hu and Xi authorities and its influence on a range of foreign policy choices they have. Part VI concludes the analysis and provides some insight for further research

Theatre, Science, and the Popular: Two Contemporary Examples From Scandinavia

This article explores relations between theatre, science, and the popular, which have largely been overlooked by Nordic theatre studies. The aim here is to introduce and understand the variety of ways theatre may communicate science to the public, the point of departure informed by the historical development of the relations between the three concepts and Edmund Husserl’s phenomenological critique of modern science. The two analytical examples are Swedish Charlotte Engelkes’ and Peder Bjurman’s Svarta hål – en kvantfysisk vaudeville (2014) and Danish Hotel Pro Forma’s adult per­formance for children Kosmos+ En Big Bang forestilling om universets vidundre (2014).History of science reveals complex combinations of science and the popular in theatri­cal events that raises the question if the audience’s understanding of the scientific sub­ject matter itself always was – or has to be – the purpose of the popular science perfor­mance, or if it rather was – and is – about spurring interest by inspiring sentiments of wonder and reflection on science’s impact on life and outlooks. Newer conceptual devel­opments also suggest that it is not always the case that theatre is a tool for sci­ence popularisation, as a specific genre science theatre, but that scientific information and concepts are artistically interpreted by theatre, and not always in ways affirmative of the science. This later variant is called science-in-theatre. The two genres are demon­strated through the analyses of Svarta hål and Kosmos+, the claim being that the first was an ambiguous exposition of science, i.e. science-in-theatre, whereas the second established an artistically visionary affirmation, as regular science theatre

Para-Anthropo(s)cene Aesthetics Between Despair and Beauty: A Matter of Response-Ability

The Anthropocene is gaining recognition as an epoch in Earth’s history in which mankind is changing the environment and the biosphere (Steffen et.al. 2011). Hotel Pro Forma’s visual opera NeoArctic (2016) and Yggdrasil Dance’s dance meditation Siku Aapoq/ Melting Ice (2015) explore how to aesthetically shape the ecological impact on human existence. The article discusses the performances’ impact on potential responses to the climate crisis. In NeoArctic, human activities have caused “overflow feedback”: a constant flow of digital vistas of pollution, raging weather, temperature rises alternate with the planet’s eternal processes, while underscored by ambience and operatic electro-pop. The images are front-projected onto the stage backdrop to create a literal overflow of the steadfast choir-performers, in which they almost disappear or become ghostly shadows, implying their imminent demise or insignificance on a planetary scale. Siku Aapoq engages with Greenland’s melting icecap: two dancers, Norwegian and Inuit, interact with a fabric understood as the melting ice, while enveloped in evocative lights, the crackling of glaciers, Inuit chants, ambience, and jazz. The Norwegian and the Inuit take turns enacting the ice, suggesting the interconnectedness with nature of both cultures. Both performances seem to invite acceptance of inevitable disaster. Yet, human prevalence is implied in the stagings by convergence of past and future in the present, which suggests that the future is still undecided, and survival depends on an ability to respond to the materiality of the environment that we are already entangled in through a profound sense of beauty. Theoretically, the analyses mainly draw on agential realism (Karen Barad) in order to outline a “para-Anthropo(s)cene aesthetics” that may reach beyond the human and engage spectators in realizing their ethical entanglement and the call for climate action. Considering intentions and reception, and the dystopian nature of the performances, the responses to climate change that the aesthetics may instigate are discussed

Pluripotency factors functionally premark cell-type-restricted enhancers in ES cells.

Enhancers for embryonic stem (ES) cell-expressed genes and lineage-determining factors are characterized by conventional marks of enhancer activation in ES cells1-3, but it remains unclear whether enhancers destined to regulate cell-type-restricted transcription units might also have distinct signatures in ES cells. Here we show that cell-type-restricted enhancers are 'premarked' and activated as transcription units by the binding of one or two ES cell transcription factors, although they do not exhibit traditional enhancer epigenetic marks in ES cells, thus uncovering the initial temporal origins of cell-type-restricted enhancers. This premarking is required for future cell-type-restricted enhancer activity in the differentiated cells, with the strength of the ES cell signature being functionally important for the subsequent robustness of cell-type-restricted enhancer activation. We have experimentally validated this model in macrophage-restricted enhancers and neural precursor cell (NPC)-restricted enhancers using ES cell-derived macrophages or NPCs, edited to contain specific ES cell transcription factor motif deletions. DNA hydroxyl-methylation of enhancers in ES cells, determined by ES cell transcription factors, may serve as a potential molecular memory for subsequent enhancer activation in mature macrophages. These findings suggest that the massive repertoire of cell-type-restricted enhancers are essentially hierarchically and obligatorily premarked by binding of a defining ES cell transcription factor in ES cells, dictating the robustness of enhancer activation in mature cells

Cognitive Function in Older Breast Cancer Survivors after Chemotherapy​

https://openworks.mdanderson.org/sumexp23/1103/thumbnail.jp