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[p. 1] ; columns 2–3 ; 34 col. in. ; There are three governments in Utah: the territorial government, the government of the so-called State of Deseret, and the government of the church. Appointed federal officers who are practicing polygamy. The immense tithing of the Mormon people. The people are now preparing for military resistance to the federal government if it interferes with their religion in any way.

Humans find themselves inhabiting an uncanny milieu of accelerated cultural transition, uncertainty, and geopolitical crisis. The transformation of human and nonhuman worlds in the wake of technological progress narratives have raised troubling ontological spectres. 'How', for instance, 'do we conceive of being when the distinction between organic and machinic dissolves, when reality is folded into virtuality, [when] the body is morphed by technology, and [when] computer networks digitise knowledge?' (Davis 1994: 1). As material relational agents, technological media leave phenomenological traces in the bodies they penetrate. 'How do they touch us … do they merely reflect off our skin [and] the surface of our internal organs?' ( Dunne 2005 :107). Electromagnetic frequencies that infiltrate somatic realms are accompanied by other affective vibrations too. This article explores the apocalyptic affects that jump between bodies entangled with technological media and in digital networks. It explores the ontological, epistemological, phenomenological, and ethical residues of such dark affective entanglements while positing how they might be harnessed in pedagogical practices that aim to work toward more affirmative somatechnical relations. It constitutes a theoretical/experimental exploration of the pedagogical value of affect theory in the context of progress-driven apocalyptic unease and seeks ways in which the sensibilities of fear and alienation constructed around the speeds and atmospheres of spectacular media culture might be productively wielded in Higher Education pedagogy as weapons of transformation.

This paper uses Deleuzoguattarian schizoanalysis to interrogate concepts of social justice in relation to the crisis of neo-liberal capitalism by referring to the work of the Situationist International movement, the posthuman philosophy of Giles Deleuze and Félix Guattari as well as Afrofuturism. Providing an array of new theoretical responses as well as pedagogical models that directly engage with social justice issues, Deleuze and Guattari offer an immanent model for a politics and pedagogy that is primarily concerned with becoming. I argue that finding new ways of dealing with the notion of change, or in terms of Deleuzoguattarian philosophy, becoming, is critical to making sense of contemporary concerns around issues of decolonisation as well as the move toward progressive transformation in education. This paper argues, furthermore, that addressing issues of social justice requires a type of shizoanalytical approach that is future-orientated and aligned with posthuman and not postmodern concerns. A schizoanalytical approach, as I will argue, intersects not only with critical posthumanism, but also with the new materialist and affective turns in current scholarship, drawing together varied environmental, political, and social concerns that pertain to the practice and scholarship of contemporary pedagogy in South Africa and elsewhere. ; ISI

Gene and cell-based therapies (GCTs) have the potential to revolutionize healthcare. Recently, genetically modified T cell products reached the market, which have remarkable clinical benefits for patients with certain blood cancers. However, there are concerns about how to incorporate GCTs into existing regulatory systems for medicinal products. GCTs are different from other medicinal products and there are many uncertainties about efficacy and safety, particularly on the long term. This thesis investigates the design and implementation of regulations for marketing authorization of GCTs in the European Union and other countries such as the United States and Japan. Results show that regulatory authorities are searching for justified flexibility to ensure protection of public health without discouraging product development. Authorities around the world are moving towards a regulatory approach that combines early patient access based on less clinical evidence with further data collection once products are authorized for the market. Yet, specific requirements and procedures for GCT marketing authorization differ among countries. Some countries also implemented regulatory pathways that exempt products from marketing authorization regulations in order to facilitate research and availability in clinical practice. The thesis concludes that different choices are made by countries in how to balance the protection of public health and the facilitation of product development. Sharing knowledge on product development, including knowledge on clinical outcomes, is important to strike an appropriate balance between the protection of public health and the facilitation of product development, which could ultimately benefit patients on a regional and global level.

The main goal of this paper is to introduce the higher derivatives multivalent harmonic function class, which is defined by the general linear operator. As a result, geometric properties such as coefficient estimation, convex combination, extreme point, distortion theorem and convolution property are obtained. Finally, we show that this class is invariant under the Bernandi-Libera-Livingston integral for harmonic functions.

This intra-view explores a number of productive junctions between contemporary Deleuzoguattarian and new materialist praxes via a series of questions and provocations. Productive tensions are explored via questions of epistemological, ontological, ethical, and political intra-sections as well as notions of difference, transversal contamination, ecosophical practices, diffraction, and, lastly, schizoanalysis. Various irruptions around biophilosophy, transduction, becomology, cartography, power relations, hyperobjects as events, individuation, as well as dyschronia and disorientation, take the discussion further into the wild pedagogical spaces that both praxes have in common.

A comparative analysis of assessment procedures for authorization of all European Union (EU) applications for advanced therapy medicinal products (ATMPs) shows that negative opinions were associated with a lack of clinical efficacy and identified severe safety risks. Unmet medical need was often considered in positive opinions and outweighed scientific uncertainties. Numerous quality issues illustrate the difficulties in this domain for ATMP development. Altogether, it suggests that setting appropriate standards for ATMP authorization in Europe, similar to elsewhere, is a learning experience. The experimental characteristics of authorized ATMPs urge regulators, industry, and clinical practice to pay accurate attention to post-marketing risk management to limit patient risk. Methodologies for ATMP development and regulatory evaluations need to be continuously evaluated for the field to flourish.

BACKGROUND AIMS: As part of the advanced therapy medicinal product (ATMP) regulation, the hospital exemption (HE) was enacted to accommodate manufacturing of custom-made ATMPs for treatment purposes in the European Union (EU). However, how the HE pathway has been used in practice is largely unknown. METHODS: Using a survey and interviews, we provide the product characteristics, scale and motivation for ATMP manufacturing under HE and other, non-ATMP-specific exemption pathways in seven European countries. RESULTS: Results show that ATMPs were manufactured under HE by public facilities located in Finland, Germany, Italy and the Netherlands, which enabled availability of a modest number of ATMPs (n = 12) between 2009 and 2017. These ATMPs were shown to have close proximity to clinical practice, and manufacturing was primarily motivated by clinical needs and clinical experience. Public facilities used HE when patients could not obtain treatment in ongoing or future trials. Regulatory aspects motivated (Finland, Italy, the Netherlands) or limited (Belgium, Germany) HE utilization, whereas financial resources generally limited HE utilization by public facilities. Public facilities manufactured other ATMPs (n = 11) under named patient use (NPU) between 2015 and 2017 and used NPU in a similar fashion as HE. The scale of manufacturing under HE over 9 years was shown to be rather limited in comparison to manufacturing under NPU over 3 years. In Germany, ATMPs were mainly manufactured by facilities of private companies under HE. CONCLUSIONS: The HE enables availability of ATMPs with close proximity to clinical practice. Yet in some countries, HE provisions limit utilization, whereas commercial developments could be undermined by private HE licenses in Germany. Transparency through a public EU-wide registry and guidance for distinguishing between ATMPs that are or are not commercially viable as well as public-private engagements are needed to optimize the use of the HE pathway and regulatory pathways for commercial ...