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Immunotherapy using chimeric antigen receptor-modified T cells has demonstrated high response rates in patients with B cell malignancies, and chimeric antigen receptor T cell therapy is now being investigated in several hematologic and solid tumor types. Chimeric antigen receptor T cells are generated by removing T cells from a patient's blood and engineering the cells to express the chimeric antigen receptor, which reprograms the T cells to target tumor cells. As chimeric antigen receptor T cell therapy moves into later-phase clinical trials and becomes an option for more patients, compliance of the chimeric antigen receptor T cell manufacturing process with global regulatory requirements becomes a topic for extensive discussion. Additionally, the challenges of taking a chimeric antigen receptor T cell manufacturing process from a single institution to a large-scale multi-site manufacturing center must be addressed. We have anticipated such concerns in our experience with the CD19 chimeric antigen receptor T cell therapy CTL019. In this review, we discuss steps involved in the cell processing of the technology, including the use of an optimal vector for consistent cell processing, along with addressing the challenges of expanding chimeric antigen receptor T cell therapy to a global patient population.

Bio-plastics are rapidly growing in popularity, and many new techniques and approaches are emerging as a result of intensive research and development (R&D) activities. Many industries worldwide are installing their new production capability. Bio-plastics have attracted political leaders’ interest, especially in light of the evolving bio-economic orientation, through their use of renewable resources and their effects on sustainable growth. Related market determinants are defined, classified, and used as a base for their own estimates. The evolution of global production capacity is modeled annually for the timeframe up to 2030 by applying a system dynamics strategy. For a long-term forecast to catch the inherent volatility, various scenarios are identified and added to the model to represent different trends in the price of gross domestic product (GDP), oil, and bioplastic feedstock. Thus, our findings show the sensitivity in the macro-economic climate of the bioplastics sector. The simulations are completed by a debate on the regulatory environment and its future effect on industry development at the European level. The findings show considerable potential for development but are vulnerable to political and economic impacts.

This work investigates whether host countries institutional factors and firm characteristics can help the understanding of Brazilian multinationals' choices of ownership mode for their foreign direct investments (FDI). Brazil is a privileged locus for research on emerging market multinationals (EMNEs), given its growing stock of outward FDI. The paper contributes to a better understanding of the international strategic choices of EMNEs. First, the phenomenon under study is examined using the theoretical lenses of institutionalism. Second, the study looks at the relationship between state support and choice of ownership mode, a new issue in the area of international business. Third, differences between the decisions taken by manufacturing and service EMNEs are also examined. Fourth, the study focuses on an emerging country, Brazil. The quality of the regulatory environment of the host country, and differences in beliefs, cultural identity and management practices between the host country and the country of origin are factors of the institutional environment significantly related to the choice of ownership mode by Brazilian EMNEs. As to firm characteristics, our results show that state support favors the choice of joint ventures, and that service EMNEs also significantly prefer joint ventures, when compared to manufacturing firms. The findings also support the view that EMNEs are less sensitive to institutional weaknesses in host countries.

This study delves into the potential direct impact of Fintech adoption, regulatory environment, technological infrastructure, and customer trust on the competitiveness of Fintech solutions. The study employs a questionnaire to gather data from 228 respondents in Jordan aged 18 or older, who were aware of Fintech and were selected through social media and other relevant channels. The outcomes from the Smart PLS path analysis reveal that Fintech adoption significantly impacts the competitiveness of Fintech solutions, supported by regulatory influence and technological infrastructure. Customer trust is crucial, fostering competitiveness through security, transparency, and reliability in Fintech services. Notably, the study contributes theoretical insights by underscoring the pivotal role of cultural acceptance in the dynamics of Fintech adoption and trust. From a practical standpoint, the findings suggest the formulation of tailored strategies for diverse markets, with an emphasis on trust, and an adaptation of product development to align with cultural nuances. However, the study acknowledges limitations and underscores the importance of longitudinal and comparative research to comprehensively grasp the cultural influences on Fintech.

Marine renewable energy promises to assist in the effort to reduce carbon emissions worldwide. As with any large-scale development in the marine environment, however, it comes with uncertainty about potential environmental impacts, most of which have not been adequately evaluated—in part because many of the devices have yet to be deployed and tested. We review the nature of environmental and, more specifically, ecological effects of the development of diverse types of marine renewable energy—covering marine wind, wave, tidal, ocean current, and thermal gradient—and discuss the current state of knowledge or uncertainty on how these effects may be manifested. Many of the projected effects are common with other types of development in the marine environment; for example, additional structures lead to concerns for entanglement, habitat change, and community change. Other effects are relatively unique to marine energy conversion, and specific to the type of energy being harnessed, the individual device type, or the reduction in energy in marine systems. While many potential impacts are unavoidable but measurable, we would argue it is possible (and necessary) to minimize others through careful device development and site selection; the scale of development, however, will lead to cumulative effects that we must understand to avoid environmental impacts. Renewable energy developers, regulators, scientists, engineers, and ocean stakeholders must work together to achieve the common dual objectives of clean renewable energy and a healthy marine environment.

Bayesian statistics plays a pivotal role in advancing medical science by enabling healthcare companies, regulators, and stakeholders to assess the safety and efficacy of new treatments, interventions, and medical procedures. The Bayesian framework offers a unique advantage over the classical framework, especially when incorporating prior information into a new trial with quality external data, such as historical data or another source of co-data. In recent years, there has been a significant increase in regulatory submissions using Bayesian statistics due to its flexibility and ability to provide valuable insights for decision-making, addressing the modern complexity of clinical trials where frequentist trials are inadequate. For regulatory submissions, companies often need to consider the frequentist operating characteristics of the Bayesian analysis strategy, regardless of the design complexity. In particular, the focus is on the frequentist type I error rate and power for all realistic alternatives. This tutorial review aims to provide a comprehensive overview of the use of Bayesian statistics in sample size determination, control of type I error rate, multiplicity adjustments, external data borrowing, etc., in the regulatory environment of clinical trials. Fundamental concepts of Bayesian sample size determination and illustrative examples are provided to serve as a valuable resource for researchers, clinicians, and statisticians seeking to develop more complex and innovative designs.

This study investigated the effect of tax avoidance (TAV) on company value in Jordan, with a specific focus on the moderating role of leverage. The sample is 55 Jordanian industrial firms listed on the Amman Stock Exchange for the study period from 2005 to 2022. Given the evolving regulatory landscape and the importance of tax planning strategies for corporate performance, understanding these dynamics is critical. Employing panel data analysis spanning several years, the study examined the link between tax avoidance, leverage, and company value. The results indicated a significant negative association between TAV and firm value (the correlation between them is –29.3%), suggesting that firms engaging in higher levels of TAV experience lower market valuations. Additionally, the analysis reveals that leverage plays a crucial moderating role in this relationship, amplifying the negative impact of TAV on firm value. The study also found a strong correlation between firm value and size, and the relationship between firm value and ROA remains significant and positive. These findings provided valuable information for policymakers, corporate executives, and investors navigating the complexities of contemporary business environments in Jordan and beyond.

The COVID-19 pandemic has affected human life in every possible way and, alongside this, the need has been felt that office buildings and workplaces must have protective and preventive layers against COVID-19 transmission so that a smooth transition from ‘work from home’ to ‘work from office’ is possible. However, a comprehensive understanding of how the protective environment can be built around office buildings and workspaces, based on the year-long experience of living with COVID-19, is largely absent. The present study reviews international agency regulation, country regulation, updated journal articles, etc., to critically understand lessons learned from the COVID-19 pandemic and evaluate the expected changes in sustainability requirements of office buildings and workplaces. The built environment, control environment, and regulatory environment around office buildings and workplaces have been put under test on safety grounds during the pandemic. Workers switched over to safely work from home. Our findings bring out the changes required to be affected in the three broad environmental dimensions to limit their vulnerability status experienced during the pandemic. Office building designs should be fundamentally oriented to provide certain safety protective measures to the workers, such as touch-free technologies, open working layouts, and workplace flexibilities to diminish the probability of getting infected. Engineering and administrative control mechanisms should work in a complementary way to eliminate the risk of disease spread. Country regulation, agency regulations, and operational guidelines need to bring behavioral changes required to protect workers from the COVID-19 pandemic.

This paper investigates the mediating effect model and threshold effect model used to examine the relationship between the regulatory environment and advancements in green technology. Spatial factors are incorporated into the model constructed in this paper, and spatial autocorrelation tests are conducted on relevant data. The created model is labored to assess the effectiveness of green innovations in Zhejiang Province from 2010 to 2021, and on this basis, the changes in efficiency values are elaborated on different scales and spatial and temporal dynamics. Then, carbon finance and resource allocation are used as mediating variables. Thus, the two variables of carbon financing and resource allocation are utilized in the mediating model to assess the effect of the regulatory environment on green technological innovation. Finally, this paper investigates the threshold effect of the regulatory environment in the procedure of technology service industry agglomeration affecting green innovations efficiency, and according to this, to experimentally determine whether the regulatory environment has a threshold value, a panel threshold model is built. After the model test, when the intensity of the regulatory environment is greater than 0.0334, the coefficient of technology service industry agglomeration is meaningfully negative −0.0687, representing that the different intensity of the regulatory environment makes a significant difference in the effect of technology service industry agglomeration. Therefore, the regulatory environment is conducive to green technological innovation, and green technological innovation tends to form agglomeration in the region.