Cell and gene therapy regulatory, pricing, and reimbursement framework: With a focus on South Korea and the EU

Ever since relevant bioengineering technologies have sufficiently matured to the platformizable commercialization stage, a slew of money has flocked to the cell and gene therapy market over the last few years, resulting in an abundance of clinical studies in the field. Newer modalities have brought up a string of regulatory and legislative tasks, such as developing guidelines and legislative rules to systematically regulate newer pharmaceutical products. Accordingly, another layer of legislation and guidelines tailored for cell and gene therapies has been introduced and is expected to evolve on par with technological progress. Furthermore, authorities have shifted to pricing and reimbursement policies that can share risks for cost and outcome among stakeholders altogether, such as developers and the government, while expanding the accessibility of patients to innovative cell and gene therapies. This review attempts to capture the salient regulatory features of the cell and gene therapy market in the context of South Korea and the European Union and points out where two sovereign entities currently stand on each policy element and how each tackles regulatory challenges. We can observe the converging trend where regulatory, pricing and reimbursement rules of adjoining countries in the supranational union or member countries of a consortium are getting more aligned. Evidently, concerted efforts to share regulatory science knowledge and embrace reference pricing have played their parts. The authors argue that policy priorities should be placed on initiatives to harmonize with other medical authorities to better the rights of patients and clear out the uncertainties of developers, ultimately to share and advance regulatory science and layout forward-looking policies at opportune times

The yeast lipin orthologue Pah1p is important for biogenesis of lipid droplets

Article on yeast lipin orthologue Pah1p and its importance for biogenesis of lipid droplets

La Montología Global 4D: Hacia las Ciencias Convergentes y Transdisciplinarias de Montaña a través del Tiempo y el Espacio

With mountain studies we use integrative approaches for geoliteracy about productive socioecological landscapes, and motivate further transdisciplinary research in montology. We conceived this white paper as a confluence of individual expertise and collective reasoning towards forming synergistic research clusters dealing with convergent mountain science, to advance montology to a new level, whereby innovative thinking about sustainability science and regenerative development incorporates alternative propositions for maintenance, improvement, or regeneration of living conditions of mountainscapes. We seek to use this contemporary framing of sustainability and ecological restoration as the impetus to better understand nature-culture relations, framed on lived-in mountains that operate in four dimensions (length, width, depth, and time) oriented at maximizing the cross-cutting of themes around mountains as productive socioecological systems, in a new academic institutionalized convergent unit. We conclude with a call for consilient, sustainable, regenerative development in the world’s mountains.La utilización de los estudios de montaña requiere de narrativas integradoras para la geoalfabetización sobre paisajes socioecológicos productivos y motiva más investigaciones transdisciplinares en el campo de la montología. Concebimos este artículo como la confluencia de la experiencia individual y el razonamiento colectivo hacia la formación de grupos de investigación sinérgicos que se ocupan de la ciencia de montaña convergente, para hacer avanzar la montología a un nuevo nivel, mediante el cual el pensamiento innovador sobre la ciencia de la sustentabilidad y el desarrollo regenerativo incorpora propuestas alternativas para el mantenimiento, la mejora, o regeneración de las condiciones de vida de los paisajes de montaña. Buscamos utilizar este marco contemporáneo de sustentabilidad y restauración ecológica como el ímpetu para comprender mejor las relaciones de la naturaleza y la cultura, desde una perspectiva transdisciplinar, en montañas habitadas que operan en cuatro dimensiones (largo, ancho, alto y tiempo). El artículo está orientado a potenciar la transversalidad de temáticas en torno a las montañas como sistemas socioecológicos productivos, en una nueva disciplina académica institucionalizada y convergente. Concluimos con un llamado a un desarrollo regenerativo, sustentable y consiliente en las montañas del mundo

Narrated Landscape as Counterweight to Perception of Placelessness in Contemporary Urban Landscape: Re-Visioning Place in Gwangbok -Dong and Nampo -Dong, Busan, South Korea

175 p.Thesis (Ph.D.)--University of Illinois at Urbana-Champaign, 2009.Although the contemporary commercial urban landscape is often assessed as placeless, this research proposes that even these seemingly anonymous places are repositories of thriving community values and meanings. Seeking a more complex reading, this research extends the scope of analysis from physical space to human use in order to reveal the longitudinal, emotional, and experiential perspectives of a living landscape. The site---the commercial districts of Gwangbok-dong and Nampo-dong in Busan, South Korea---is significant because the landscape is a place currently dominated by anonymous commercialization but has strong social history that has only minor traces in the existing landscape. Methods employed include interpretive-historical analysis, narrative inquiry, and ethnography and utilizes tactics of mapping, participant observation, and interviews. An analysis of the spatial history reveals that the current landscape of Gwangbok-dong and Nampo-dong is a result of South Korea's long relationship to Japan for commerce and governance, as well as the later Korean modernization process. Interviews with older residents reveal memories of the area as a melting pot of war refugees during the Korea War (1950-1953), as an essential commercial and black-market site during the difficult post-war period, as a place for leisure opportunities during the period of the industrial development (1960-80s), as a protest spa, during the fight for democracy, and as space of illusionary future under anonymous urban development. Observations reveal the site in constant friction as people struggle to claim the space for the public use, compete against high-end branded stores, seek alternative opportunities to socialize and relax, and strive to make a living between tradition and modernization. By studying the site from these three perspectives, this research was able to reveal unique place meanings of Gwangbok-dong and Nampo-dong as opposed to the perception of placelessness. An important result to this complex reading of place is its revelation of a rich historical evolution leading to current conditions, insight into personal meanings from long-term participants in the landscape who may not be the current decision-makers in current urban development, and patterns of use that reveal the landscape as multi-functioning resources that people modify and adapt to meet their daily needs.U of I OnlyRestricted to the U of I community idenfinitely during batch ingest of legacy ETD

Study of the Assembly Trigger for Spider Silk Proteins

Dragline silk has many remarkable properties, allowing it to be utilized in bulletproof vests, clothing, and nanotechnology. Elucidation of the molecular mechanisms that govern the process of spider silk assembly has substantial scientific merit. Currently, the prevailing theory of spider silk assembly involves a pH trigger that converts a liquid-crystalline state of spider silk proteins into a solid fiber during extrusion. Here we explore an alternative hypothesis that oxidation-reduction (redox) states may trigger dragline silk assembly. To investigate this assertion, a series of recombinant DNA techniques were utilized to express one of the constituents of dragline silk, cysteine-rich protein 4 (CRP4). The CRP4 cDNA was cloned and inserted into bacterial plasmids for expression studies. The CRP4 expression constructs were then subject to DNA sequencing, followed by transformation into different strains of bacteria to investigate a redox trigger. Western blot analysis and mass spectrometry were performed to examine CRP4 polymerization under different redox conditions and confirm its expression, respectively. Once a deeper understanding of the assembly trigger is attained, it could advance mass production of spider silk as an eco-friendly alternative, allowing fine control over the spider silk assembly process