State educational standards (undergraduate level) on the professional activities of study of religious scholar and theologian: Characteristics and changes

Russian higher school strives to become competitive in the global educational market. This caused the modernization of Russian education, which was reflected in the change in educational standards in the areas of "Religious Studies" and "Theology". Which in turn leads to changes in perceptions about the professional activities of graduates of these areas. In this regard, it seems to be an interesting scientific task to trace changes in the characteristics of areas and types of professional activity, fixed in the standards of different generations of the undergraduate level to indicate the boundaries of the professional activity of a study of religion scholar and theologian. The qualitative methodological strategy of the study was used to identify changes in the characteristics of the fields and types of professional activity of the directions "Religious Studies" and "Theology". Within the framework of this strategy, a comparative analysis of materials (state educational standards in the areas of “Study of religion” (2000, 2011, 2015) and “Theology” (2002, 2011, 2014) was carried out. As a result it was revealed that the types of professional activities and practices of study of religion scholar and theologians intersect. The coincidence can be explained by the lack of experience and the relevant traditions of both study of religion and theological education in the Russian higher education institution, and differences by different developers and customers of this education. The analysis of standards in the field of “Religious Studies” allows us to state the absence of significant changes in the characteristics and types of professional activity of a study of religion scholar since 2000. At the same time, the list of theologians' activities was constantly expanding in the applied dimension. However, the lack of a detailed list of applied activities in the standard in the field of Religious Studies does not prevent them from being included in the educational program, but gives freedom to educational organizations to independently choose the types of activities and practices that are most in demand by educational program developers. © 2019 LLC Ecological Help. All rights reserved

ПОДАТКОВИЙ ПОТЕНЦІАЛ РЕГІОНУ, ЙОГО ОСОБЛИВОСТІ РОЗВИТКУ І РЕАЛІЗАЦІЇ

The slowdown in economic growth highlights the problem of developing tax capacity at various levels, therefore the article is devoted to the consideration of practical aspects of the assessment of the tax potential. On the example of the Belgorod region, trends in the development and increase of the tax potential were identified, measures of activation of the elements of the structure of the potential, which are essential for the budget, were proposed.The paper uses methods of comparative analysis, analysis of key indicators of tax and non–tax revenues. Conclusions are made on the need to prioritize areas for the development of tax capacity, to increase the region's independence and to create tax conditions for conducting entrepreneurial activity in the territory.Замедление темпов экономического роста выводит на первый план проблемы развития налогового потенциала на различных уровнях, поэтому статья посвящена рассмотрению практических аспектов оценки налогового потенциала. На примере Белгородской области идентифицированы тенденции развития и наращивания налогового потенциала, предложены меры активизации элементов структуры потенциала, которые имеют существенное значение для бюджета.В работе использованы методы сравнительного анализа, анализа ключевых показателей налоговых и неналоговых доходов. Сделаны выводы о необходимости выделения приоритетных направлений для развития налогового потенциала, повышения самостоятельности региона и создания налоговых условий для ведения предпринимательской деятельности на территории. Уповільнення темпів економічного зростання виводить на перший план проблеми розвитку податкового потенціалу на різних рівнях, тому стаття присвячена розгляду практичних аспектів оцінки податкового потенціалу. На прикладі Бєлгородської області ідентифіковані тенденції розвитку та нарощування податкового потенціалу, запропоновано заходи активізації елементів структури потенціалу, які мають істотне значення для бюджету.В роботі використані методи порівняльного аналізу, аналізу ключових показників податкових і неподаткових доходів. Зроблені висновки про необхідність виділення пріоритетних напрямків для розвитку податкового потенціалу, підвищення самостійності регіону та створення податкових умов для ведення підприємницької діяльності на території

World practice of providing scientific advice on the development and authorisation of innovative medicines

Current challenges to healthcare, i.e. the emergence of new diseases, lack of therapies for known diseases and life-threatening conditions, identification of patients who do not respond to standard treatment, on the one hand, and the evolution of scientific understanding of disease processes, medicines, therapies, causes of treatment failures, and implementation in clinical practice of innovations related to molecular biology and genetic engineering, on the other hand, create conditions and opportunities for the development of innovative medicinal products. A relatively new class of medicines is based on human cells and tissues (the term used in Russian legislation is biomedical cell products, BCP). However, the inability to accurately predict the efficacy and financial rewards of such medicines for pharmaceutical companies, as well as significant labour and financial costs associated with their development and clinical use, hinder their entry into the market. The aim of the study was to analyse the foreign regulatory setting for the development and launch of human cell- and tissue-based products, as well as approaches of foreign regulatory authorities to scientific advice, which can be drawn upon by the Russian expert authority when providing advice to BCP developers. The paper summarises the results of analysis of regulations establishing the procedure for providing scientific advice by EU, USA, and Russian regulatory authorities, and analyses the advice provided for the human cell- and tissue-based products which are now authorised in the EU and USA. The analysis of advice provided by foreign regulatory authorities shows that the largest number of consultations were given for medicinal products based on genetically modified cells for the treatment of cancer and genetic diseases. The questions were mainly related to the contents of specifications for finished pharmaceutical products, safety evaluation, curtailing of preclinical studies due to the lack of relevant animal/disease models, the number of subjects and efficacy endpoints in clinical studies, assessment of the appearance of replication-competent retroviruses

Gene therapy of neurodegenerative diseases: achievements, developments, and clinical implementation challenges

Neurodegenerative diseases (NDDs) are promising objects for the development of gene therapy products, primarily, due to the possible cause of these diseases (disruption of a gene or several genes), lack of effective therapy, and negative impact on the quality of life of both patients and their families and friends.The aim of the study was to identify trends and challenges in the development and preclinical and clinical studies of gene therapy products for NDDs and to analyse the international experience of expert assessment of the dossier for Zolgensma®, which received a conditional marketing authorisation.According to the analysis of the ongoing studies of gene therapy products for NDDs, the following major challenges arise at preclinical and clinical stages. For animal studies, a particular challenge is to select a disease model, a route of administration, and a target for effective gene therapy for polygenic disorders. For clinical trials, problematic aspects are the selection of a control group, the development of inclusion criteria for patients with a genetic variant that is an indication for a gene therapy product and exclusion criteria for patients with antibodies to this gene therapy product, the selection and justifi cation of a safe therapeutic dose since a gene therapy product can be administered to a patient only once, and the complexity of assessing clinical benefi ts of transgene expression in the human body due to the inaccessibility of brain tissue for analysis. Recent years have witnessed a breakthrough in gene therapy with the introduction of Zolgensma® (Novartis) to the world pharmaceutical market to treat children with spinal muscular atrophy type 1. The article analyses the experience of expert assessment of the marketing authorisation dossier for Zolgensma®, which can be used by drug developers bringing new medicines to the market of the Eurasian Economic Union under conditional marketing authorisation, which implies that the benefi ts of immediate patient access to these medicines will exceed the risks associated with incomplete data on their characteristics

Advanced Therapy Medicines Based on Oncolytic Viruses (Part II: Development and Authorisation of IMLYGIC®)

The only oncolytic virus-based product authorised in the US and EU—IMLYGIC®, a genetically modified herpes simplex virus type 1 (by BioVex Inc., a subsidiary of Amgen, Inc.)—was developed and approved for clinical use as monotherapy for recurrent unresectable melanoma. The aim of the study was to analyse materials on IMLYGIC® development and authorisation in order to be able to use the data on specific aspects of preclinical and clinical trials of oncolytic virus-based products in the development of regulatory framework for Russia and the EAEU. The publicly available preclinical and clinical trial results demonstrate a decrease in the size of both tumours being injected and remote tumours/skin lesions, which supports the local and systemic effects of IMLYGIC® due to the lysis effect of the virus on the tumour cells. The clinical trials of IMLYGIC® were the first to use the durable response rate, and not the overall survival, as the primary endpoint of the efficacy of the anticancer drug. Benefits of IMLYGIC® therapy were observed across all the secondary endpoints, except overall survival. Significant efficacy of the drug therapy was demonstrated only in patients without visceral lesions, which resulted in limitations of indications for use. There have been no serious or severe adverse effects associated with IMLYGIC®. If symptoms of viral infection develop, they can be neutralized thanks to the product’s sensitivity to acyclovir. At present, advanced therapy medicinal products derived from an oncolytic virus may be authorised in Russia for clinical use as monotherapy or combination therapy, according to the EAEU regulations

Significance of digital and numeric (prolegomena to D. V. Pivovarov's symphonica)

Foundations of a new methodology for tolerant dispute proposed by Professor D. V. Pivovarov (1943-2016) are studied in the article. The purpose of the study is to clarify the essence of the concept of "symphonica"proposed by D. V. Pivovarov as a medium in the dialogue of secular and religion scholars. A distinction between "digital"and "numerical"mathematics is made based on Pythagoras, A. Comte, I. Kant and E. Husserl's teachings. It is proved that the positivist understanding of mathematics does not imply the meaning of numbers, whereas "numerical"mathematics only provides access to the "supratemporal realm of meanings"studied by phenomenology. In the present paper D. V. Pivovarov's "symphonica"is understood as a form of "inter-phenomenology"that ensures equal access to the ultimate phenomenological grounds of religions, philosophical systems and scientific theories. © Siberian Federal University. All rights reserved

Advanced Therapy Medicines Based on Oncolytic Viruses (Part I: Development and Authorisation of Products in China)

One of the promising areas in the development of innovative products for the treatment of cancer is the use of oncolytic (native or genetically modified) viruses (OLVs) for selective targeting of tumour cells and their destruction, especially as part of combination therapy. At present, there are three OLV-based products approved for medical use (two in China and one in the USА and EU). The aim of the study was to analyse data on specific aspects of OLV-based products’ development, preclinical and clinical research, and authorisation process in China. The authors analysed data freely available on the manufacturers’ websites, in public reports and documents of the Chinese regulatory authorities, in international clinical trial registries, and scientific publications. The products Gendicine® (SiBiono GeneTech Co., Ltd.) and Oncorine® (Shanghai Sunway Biotech Co., Ltd.) were originally developed and approved in China for clinical use as part of combination therapy. The analysis demonstrated long product development periods (Gendicine had been studied for 14 years before the start of the authorisation procedures), complex preclinical trial designs, and potential use of the products for several medical conditions with different tumour localisation. The identified specific aspects of OVL-based products’ development and authorisation in China could be taken into account in the regulatory practice of the Russian Federation

Current trends and risks associated with the use of therapies based on genome editing

Scientific relevance. To date, multiple approaches to genome editing have been developed based on different genome-editing systems (GESs) and genome modifications that result in single- or double-strand DNA breaks, either in vivo or ex vivo, followed by homologous recombination or non-homologous end joining to restore the sequence. However, the use of GESs is associated with a number of potential risks arising from the complex biology of such medicinal products and the fundamental role of their target, i.e. the DNA molecule.Aim. This study analysed the most relevant trends and risks associated with medicinal products based on genome editing, the ways taken to overcome these risks, and the research methods used to identify and control the development of undesirable effects.According to the literature, the adverse effects of GESs may arise both from the methods used to deliver GES components into the cell and from the functional activity of the GES itself, which includes insufficient on-target or undesirable off-target effects. This review indicates the main risks associated with the use of GESs. Preferable strategies to mitigate the risks of using GESs include repairing DNA breaks by homologous recombination, selecting GESs and related endonucleases that have greater specificity and restriction accuracy, increasing guide RNA specificity (for CRISPR/Cas), correcting the activity of the system regulating the cell cycle and apoptosis in a controlled manner, regulating the duration of expression and persistence of GES components in cells, etc.Conclusions. The requirement to include quality, efficacy, and safety data when submitting registration dossiers for advanced therapy medicinal products prompts the discussion of the main risks associated with such products

Spin-orbital Conversion of Bessel Light Beams By Liquid Crystal Elements

For the first time, the spin-orbital conversion of the linearly polarized Bessel beams in the process of their propagation in the electrically-controlled liquid crystal cell has been realized experimentally. Variations in the polarization, phase, and spatial structure of the beam have been analyzed. It has been shown that, when a Bessel beam is propagating along the liquid crystal director, the generated beam is orthogonally polarized, whereas the topological charge is varied by two unities. Keywords: Bessel light beams, spin-orbital conversion; liquid crystal