Regulatory Barriers Research Articles

Alternative therapeutics to control antimicrobial resistance: a general perspective

Antimicrobial Resistance (AMR) is a critical global health challenge, and in this review article, we examine the limitations of traditional therapeutic methods and the emerging role of alternative therapies. By examining the reasons behind the failure of conventional treatments, including the inadequacy of one-drug-one-enzyme approaches, the complex evolution of AMR, and the impact of drug biotransformation, we better understand why conventional treatments failed. Moreover, the review discusses several alternative therapies, including RNA-based treatments, aptamers, peptide-based therapies, phage therapy, and probiotics, discussing their applications, advantages, and limitations. Additionally, we discuss the obstacles to develop these therapies, including funding shortages, regulatory barriers, and public perception. This comprehensive analysis aims to provide insight into the future of AMR, emphasizing the need for innovative strategies and practical approaches.

The Hurdle of Access to Emerging Therapies and Potential Solutions in the Management of Dyslipidemias.

This review explores the many barriers to accessing lipid-lowering therapies (LLTs) for the prevention and management of atherosclerotic cardiovascular disease (ASCVD). Geographical, knowledge, and regulatory barriers significantly impede access to LLTs, exacerbating disparities in healthcare infrastructure and affordability. We highlight the importance of policy reforms, including pricing regulations and reimbursement policies, for enhancing affordability and streamlining regulatory processes. Innovative funding models, such as value-based pricing and outcome-based payment arrangements, have been recommended to make novel LLTs more accessible. Public health interventions, including community-based programs and telemedicine, can be utilized to reach underserved populations and improve medication adherence. Education and advocacy initiatives led by patient advocacy groups and healthcare providers play a crucial role in raising awareness and empowering patients. Despite the barriers to access, novel LLTs present a big opportunity to reduce the burden of ASCVD, emphasizing the need for collaborative efforts among policymakers, healthcare providers, industry stakeholders, and patient advocacy groups to address these barriers to improve access to LLTs globally.

An Exploration of Technological Innovations in the Audit Industry: Disruption Theory Applied to a Regulated Industry*

ABSTRACTTechnological innovation is increasing throughout the audit industry. Although prior research has explored how specific technological innovations have influenced the audit product and the profitability of the audit, the strategic implications of technological innovation for the audit industry have yet to be examined. To address this issue, we adopt Christensen's seminal theory of technological innovation (introduced in his 1997 book The Innovator's Dilemma) to gain insight into the results of 27 semistructured interviews with auditors and audit technical specialists. Consistent with Christensen's sustaining and efficiency strategic responses, our findings suggest that, at this time, technology is primarily being used by the audit industry to strengthen the audit industry's ability to serve mainstream clients by providing a “higher‐quality” and lower‐cost audit to replace menial tasks that historically have been done by junior auditors. We find that industry‐disruptive new market entry is currently prevented by regulatory and professional barriers; however, strategic disruption to the audit industry appears inevitable as technology is already being used in audits of nonregulated markets by new entrants. Strategically, the audit industry will survive in its current recognizable form only if self‐disruption occurs before the regulatory barriers are dropped, which requires significant upskilling in the industry to ensure that firms have the skills to be first movers whenever technological innovations are introduced.

Open Innovation as Fuel for the Circular Economy: an Analysis of the Italian Context

In recent years the circular economy (CE) has gained considerable interest in the academic debate as a tool for achieving sustainable development. The implementation of the circular economy model requires innovation to overcome technological, economic, environmental, social, and regulatory barriers. However, companies do not always have the means to innovate due to lack of information, limited technical skills and financial constraints; as a result, innovation remains a fragmented phenomenon. Open Innovation (OI) is a tool identified in the literature as useful for overcoming this problem and thus for the development of the CE, as it accelerates the exchange of knowledge and the realisation of the necessary innovations. Despite this, the relationship between CE and OI, and particularly the influence of OI on CE, has been little investigated. In line with this, the paper aims to explore this relationship by analysing the process through which OI supports the development of the CE, focusing on the knowledge exchange aimed at circular innovation, and categorising the actors contributing to this process and their roles. The study adopts a qualitative approach and uses methods of descriptive analysis and case studies. The sample consists of 240 Italian circular organisations that support circularity in different ways. The results made it possible to classify the main actors involved and their contributions to the CE through OI practices, revealing unseen circular activities that support classical circular activities (slowing, closing, and narrowing of material and energy circuits) and are identified in services, technology or research. As a theoretical contribution, the research provides a framework describing the actions and relationships among the actors involved in the CE initiatives, with a focus on the Living Lab practices.

Privacy-Preserving Prediction of Postoperative Mortality in Multi-Institutional Data: Development and Usability Study.

To circumvent regulatory barriers that limit medical data exchange due to personal information security concerns, we use homomorphic encryption (HE) technology, enabling computation on encrypted data and enhancing privacy. This study explores whether using HE to integrate encrypted multi-institutional data enhances predictive power in research, focusing on the integration feasibility across institutions and determining the optimal size of hospital data sets for improved prediction models. We used data from 341,007 individuals aged 18 years and older who underwent noncardiac surgeries across 3 medical institutions. The study focused on predicting in-hospital mortality within 30 days postoperatively, using secure logistic regression based on HE as the prediction model. We compared the predictive performance of this model using plaintext data from a single institution against a model using encrypted data from multiple institutions. The predictive model using encrypted data from all 3 institutions exhibited the best performance based on area under the receiver operating characteristic curve (0.941); the model combining Asan Medical Center (AMC) and Seoul National University Hospital (SNUH) data exhibited the best predictive performance based on area under the precision-recall curve (0.132). Both Ewha Womans University Medical Center and SNUH demonstrated improvement in predictive power for their own institutions upon their respective data's addition to the AMC data. Prediction models using multi-institutional data sets processed with HE outperformed those using single-institution data sets, especially when our model adaptation approach was applied, which was further validated on a smaller host hospital with a limited data set.

5G and urban amenity: regulatory trends and local government responses around small cell deployment

PurposeAs part of the 5G rollout, small cell base stations will be deployed across cities. This paper aims to identify an international effort to remove regulatory barriers around deployment and outline emerging strategies Australian local governments are developing to ensure urban amenity in a deregulatory context.Design/methodology/approachThis paper analyses existing legislation, policy frameworks and grey literature and has conducted eight interviews with participants from the local government sector.FindingsThis paper identifies a global deregulatory trend around small cell deployment and that councils are trying to renegotiate their relationship with telecommunications carriers as 5G is rolled out. Three strategies are identified: the design and installation of smart poles, network sharing and partnerships.Originality/valueThis research contributes to scholarship focused on the 5G rollout and offers one of the first accounts of the emerging tensions between regulatory frameworks, commercial imperatives and municipal authorities, identifying urban amenity as a key area of concern.

Toward an innovation radar for cultivated meat: exploring process technologies for cultivated meat and claims about their social impacts

IntroductionCultivated meat has received growing attention since claims were made that cultivated meat can be produced more ethically and sustainably than the current meat production. However, there are still major challenges in the development of cell lines, scaffolding, growth media, and bioprocess, which need to be overcome to reach industrial production levels. Numerous technological innovations have been proposed to overcome these challenges but they have rarely been evaluated with regard to their social sustainability. Consequently, it remains unclear if and how cultivated meat would contribute towards creating inclusive food systems.MethodsTo bring more clarity, the study identifies different technological solutions that are used or developed for production of cultivated meat and identifies the positive and negative claims about the expected contributions of these technological solutions to social inclusion in food systems, using evidence from the literature review and 11 expert interviews. An innovation radar for cultivated meat is proposed to visualise the variety of technological innovations and the claims about their expected contributions to social sustainability.ResultsThe technologies in the areas cell line development, scaffolding, growth media, and bioprocess are expected to have an impact on inclusion in consumption of cultivated meat. Some cell innovations are expected to raise cognitive barriers due to complex technologies that might be difficult for the consumer to understand. Cultural barriers are expected to be raised by cell innovation entailing genetic engineering and medium innovation using FBS or animal components, which is considered to harm animals. Further, regulatory barriers are expected in the EU if genetic modification is used in the production process, which concerns the areas cells, media, and scaffolding. The innovations for scaffolds are expected to mainly lower cost and cultural barriers since most technologies are already used in the food industry. Bioprocess innovations promise to lower cost barriers, however it must be considered, that most of the collected data for innovations in the bioprocess domain are based on assumptions.DiscussionThe study concludes that at this point in time, the most socially sustainable approach to cultivated meat production is not obvious. Under the current technological state of the art, it is not thinkable that production and consumption of cultivated meat could be socially inclusive. As it remains poorly understood if technologies for cultivated meat production could raise or lower barriers to inclusive consumption and production, further research is needed.

Sustainable Supply Chain Management: A Comparative Analysis of Green Practices in Various Industries

In recent years, sustainable supply chain management (SSCM) has emerged as a critical component for organizations aiming to enhance their environmental performance while maintaining economic viability. This study presents a comparative analysis of green practices across various industries, including manufacturing, retail, and agriculture. By examining the implementation of sustainable practices such as waste reduction, energy efficiency, and sustainable sourcing, this research highlights the diverse approaches adopted by different sectors in their quest for sustainability. The analysis employs a mixed-methods approach, incorporating both qualitative and quantitative data collected from industry reports, case studies, and surveys of supply chain professionals. Key findings reveal that while some industries, like retail, have made significant strides in adopting circular economy principles, others, such as manufacturing, still face challenges in integrating sustainable practices due to regulatory and cost-related barriers. Furthermore, the study identifies best practices and innovative strategies that have led to successful implementation of SSCM, including collaboration with stakeholders and investment in green technologies. This analysis not only underscores the importance of contextual factors in shaping green practices but also offers valuable insights for organizations seeking to enhance their sustainability efforts. By fostering a deeper understanding of industry-specific challenges and opportunities, this research contributes to the growing body of knowledge on sustainable supply chain management and provides a roadmap for future initiatives to promote environmental stewardship across sectors. Keywords: Sustainable supply chain management, SSCM, green practices, comparative analysis, sustainability, drivers, stakeholders

Investigating Financial Resource Sufficiency for Entrepreneurial Growth: A Case of SMEs in Pakistan

This research paper delves into the critical nexus between entrepreneurship and finance, focusing on entrepreneurs' challenges and strategies in accessing and utilizing financial resources to increase growth. The study highlights the fundamental role of finance in enabling small entrepreneurial ventures to thrive and contribute to economic development. It then proceeds to identify key challenges, including access to capital, financial literacy gaps, and regulatory barriers that hinder entrepreneurial finance. Through a comprehensive review of existing literature and case studies, the paper explores the various strategies entrepreneurs employ to overcome these challenges, including traditional financing methods, alternative funding sources such as crowdfunding, venture capital, and financial management techniques. Additionally, the research discusses the evolving landscape of fintech solutions and their impact on facilitating access to finance for entrepreneurs. Moreover, it examines the role of government policies and institutional support in fostering an enabling environment for entrepreneurial finance. The results of this study present valuable recommendations for policymakers, financial institutions, and entrepreneurs seeking to understand the complex landscape of entrepreneurial finance and focus on strategies to exploit the full potential of innovative ventures.

The State of Technology Innovation in Nigeria: Trends, Challenges and Opportunities

This writeup examines the state of technology innovation in Nigeria, focusing on emerging trends, prevalent challenges, and untapped opportunities. As Africa’s largest economy and most populous country, Nigeria has shown significant potential for technological advancement and innovation. However, various factors, including infrastructure limitations, funding constraints, and regulatory barriers, have posed challenges to the growth of the technology sector. By analyzing current trends, identifying key challenges, and exploring potential opportunities, this study aims to provide insights into the landscape of technology innovation in Nigeria and offer recommendations for fostering its development.

Green Technology Opportunities and Challenges in Sustainable Marine Logistics

The maritime logistics sector plays an important role in supporting global trade, but also contributes to significant greenhouse gas emissions and environmental impacts. To overcome these challenges, the adoption of green technologies is becoming increasingly important in achieving sustainable maritime logistics. This research aims to explore the opportunities and challenges of implementing green technology in the maritime logistics industry. Through literature studies, interviews with stakeholders, and case studies, this research identifies three main opportunities, namely reducing emissions and environmental impacts, operational efficiency and cost savings, as well as regulatory compliance, and improving company reputation. However, significant challenges were also identified, including high initial investment costs, lack of supporting infrastructure, regulatory barriers, and limited incentives. To overcome this challenge, collaboration between government, industry, financial institutions, and civil society is needed to develop a comprehensive regulatory framework, provide incentives, and facilitate investment in supporting infrastructure. Further research is also needed to analyze the environmental impacts and life cycle costs of different green technologies, as well as explore innovative business models and funding strategies. The transition towards green and sustainable maritime logistics is not only important to preserve the environment, but also to ensure long-term economic and social sustainability.

Importance of early consideration of scaling and sustainability for aging-related care models: Case study of Hospital at Home.

For aging-related research, there is a pressing need to attend to the dissemination and implementation of evidence-based interventions. Some aging-related interventions with established effectiveness may be poorly disseminated and implemented due to behavioral, organizational, payment, or other constraints. To provide insight into the beginning to end process of translation and implementation, we present a case history of the three-decade progression of Hospital at Home (HaH) now nearing national dissemination. We summarize research at various phases with particular attention to implementation considerations. Reviewing over three decades of HaH-related research dating from initial discovery to translation and implementation, we found that the content and importance of different constructs (e.g., inner practice vs. outer environmental setting) and the choice of implementation strategies differed depending on implementation context (testing of effectiveness, scaling, or sustainability). Early effectiveness studies mostly examined implementation issues related to the intervention, the practice setting, and the individuals involved. However, explicit and early consideration of scale and sustainment was not the primary focus. For example, HaH program intake is primarily through hospital emergency departments (ED). Initial efforts would have benefited from incorporating strategies (e.g., incorporating ED leadership into program leadership) to address night and weekend admissions. Many regulatory barriers did not surface during initial considerations. Considering implementation issues late may contribute to delay in bringing discoveries to population impact. The experience with HaH suggests that scale and sustainability bear earlier consideration because barriers and facilitators to implementation are likely to be different in content and importance at different phases of implementation.

FOSTERING COMPETITIVE ENVIRONMENTS FOR ENTREPRENEURS: INSIGHTS AND BEST PRACTICES

Today, it is critical fostering competitive environments in nurturing entrepreneurial success. In an era characterized by dynamic market landscapes, this study delves into key insights and best practices that contribute to creating an ecosystem conducive to the growth and sustainability of entrepreneurial ventures. This research investigates the challenges and perspectives in fostering a competitive environment for entrepreneurship, focusing on individual and institutional barriers faced by entrepreneurs. Drawing on a combination of qualitative data from semi-structured interviews and insights from existing literature, the study identifies key constraints such as regulatory barriers, legal uncertainties, financial challenges, human resource management issues, and inner fears and insecurities among entrepreneurs. Through a systematic analysis, the research proposes recommendations for policymakers and stakeholders to address these constraints and create a conducive environment for entrepreneurial activity. These recommendations include simplifying regulatory procedures, enhancing financial support mechanisms, improving talent development programs, fostering a supportive organizational culture, and combating corruption effectively. The study emphasizes the importance of a holistic approach that addresses both individual and institutional barriers to entrepreneurship, highlighting the need for collaboration between the public and private sectors. By implementing these recommendations, countries can unlock entrepreneurial potential, drive innovation, and achieve sustainable economic development. Keywords: entrepreneurial activity, competitive environment, challenges, solution, Kazakhstan.

Enhancing biotin production in Bacillus subtilis: Overcoming native pathway limitations

Biotin is essential for metabolizing the three major nutrients and is vital for animal growth and development. Industrially, biotin production has relied on chemical synthesis, a method fraught with disadvantages including complex processes, environmental risks, and high costs. Consequently, researchers have increasingly recognized the benefits of biosynthesizing biotin. Native transcriptional regulation and metabolic bottlenecks restrict biotin production. Replacing the native promoter and bioO with the constitutive P43 promoter, along with swapping the native birA for a non-regulatory variant from Mycobacterium tuberculosis, significantly upregulated biotin biosynthetic gene expression, effectively bypassing native transcriptional regulation. Subsequent strategies to bypass the inefficient native BioW included knocking out ydbM in the β-oxidation pathway—a potential pimeloyl-CoA degrader, expressing heterologous bioW genes, and introducing alternative pimeloyl-ACP biosynthetic pathways, collectively increasing biotin titers to 6.91 mg/L. This study demonstrates a multi-faceted approach to overcoming metabolic and regulatory barriers, providing a template for enhancing biotin production in B. subtilis, with implications for the broader field of microbial biotechnology.

Green innovation: exploring the impact of environmental patents on the adoption and advancement of renewable energy

PurposeThe MENA region faces energy security and environmental challenges, necessitating the adoption of sustainable energy for sustainable development. Green innovation has emerged as a crucial factor in promoting renewable energy adoption and building an enduring and eco-friendly energy system. This research examines the influence of green innovation on clean energy adoption from 1985 to 2019.Design/methodology/approachTo ensure the robustness of the analysis, this study employs three indicators as proxies for renewable energy and develops three models that incorporate urbanization, CO2 emissions, and economic growth as control variables. Various statistical tests, including panel unit root tests, diagnostic tests, the Least Squares Dummy Variables (LSDV) method, and a Granger causality test, are utilized. In addition, the study incorporates the Augmented Mean Group (AMG) method as a robustness check.FindingsThe findings reveal a positive relationship between green innovation and the advancement of renewable energy across all models. This highlights the significance of investing in green innovation as a fundamental driver for promoting sustainable energy generation in the MENA region. The research also emphasizes the positive impact of economic growth on renewable energy development. Furthermore, urbanization contributes to the progress of renewable energy. Additionally, the study demonstrates that increased CO2 emissions are associated with higher levels of sustainable energy generation.Originality/valueThis study addresses a research gap by investigating the impact of green innovation on clean energy progress in the MENA region, an aspect overlooked in existing literature that primarily focuses on regulatory barriers. Specifically, it examines the influence of green innovation, measured through environmental-related technology patents, on sustainable energy systems in MENA. Utilizing patents as a metric offers advantages by directly assessing innovation deployment and providing broader geographical coverage.

Exploring Flexibility Potential of Energy-Intensive Industries in Energy Markets

The European Union, in pursuit of the goal of reducing emissions by at least 55% by 2030 and achieving climate neutrality by 2050, is deploying different actions, with industry decarbonization as a key strategy. However, increasing electricity demand requires an intensification of energy generation from clean technologies, and the energy system’s expansion is hindered by renewable generation’s climatic dependencies and the imperative for substantial electrical infrastructure investments. Although the transmission grid is expected to grow, flexibility mechanisms and innovative technologies need to be applied to avoid an overwhelming growth. In this context, this paper presents a thorough assessment, conducted within the FLEXINDUSTRIES project, of the flexibility potential across seven energy-intensive industries (automotive industry, biofuel production, polymer manufacturing, steel manufacturing, paper mills, pharmaceutical industry, and cement production). The methodology followed during the analysis entails reviewing the state-of-the-art existing flexibility mechanisms, industries’ energy markets engagement, and technical/operational readiness. The results highlight the feasibility of the proposed actions for enabling energy market flexibility through demand-response programs, quantifying energy opportunities, and pinpointing regulatory and technical barriers.

THE IMPACT OF DIGITAL TRANSFORMATION ON NIGERIAN SMALL AND MEDIUM-SIZED ENTERPRISES (SMES) IN THE GLOBAL BUSINESS LANDSCAPE

Small and Medium-sized Enterprises (SMEs) are pivotal economic entities, and their adaptability in an evolving global business landscape is integral to sustainable growth. This study delves into the profound influence of digital transformation on Nigerian SMEs, offering a comprehensive analysis of the extent to which digitalization shapes their competitiveness, operations, and associated challenges. Employing a quantitative research approach, data from a diverse sample of Nigerian SMEs is collected to assess the relationship between digital transformation and SME outcomes. Demographically, the surveyed SMEs portray a multifaceted distribution across various industries, business sizes, geographic locations, annual revenues, and years in operation. A substantial proportion actively integrates digital tools and technologies into their operations, underscoring their recognition of the strategic value of digitalization. Perceived benefits of digital transformation encompass amplified operational efficiency, extended market access, innovation, elevated customer satisfaction, cost savings, and streamlined internal processes. However, challenges, notably financial constraints, a dearth of digital skills among employees, and regulatory barriers, reflect the multifaceted nature of obstacles faced by SMEs in their digital transformation journey. The study establishes a significant relationship between digital transformation and SME competitiveness. SMEs acknowledge its role in amplifying their global market reach, augmenting their competitiveness on a global scale, strengthening their competitive position within industries, nurturing international partnerships, expanding market share, and enhancing brand visibility in global markets. In essence, this research posits that digital transformation plays an indispensable role in the growth and competitiveness of Nigerian SMEs within the global business landscape. The findings serve as a cornerstone for informed decisions, strategies, and interventions to augment the digital capabilities of Nigerian SMEs, fostering their resilience and competitiveness in an increasingly digital world.

Development of steel circularity passport: Literature review, research gaps, and program rules in New Zealand

This article conducted a systematicliterature review to find the most recent progress, barriers and opportunities in developing building material passports for structural steel reuse. To reuse steel a Circular Economy shall be implemented. A steel circular economy adoption requires the development of steel circularity passports, structural steel reusability assessment and reversible structural design. A programme rule was presented that can serves as a guideline for the development of a steel circularity passport in New Zealand. The programme rule outlined essential data and details, data resources and reliability, and steel identification process. Finally, a case study was used to demonstrate the significant benefits of applying the proposed programme rule in mitigating challenges presented by unidentified structural steel components. The 18-storey former council building has total 4,600 square meters located in Auckland downtown, New Zealand. It was found regulatory, technical, and economic barriers shall be addressed to enable steel reuse in New Zealand and presence of steel passports can facilitate steel reuse in practice by addressing the barriers in New Zealand.

Emerging Research Topics in Drone Healthcare Delivery

The application of drones to assist with healthcare delivery has grown rapidly over the last decade. This industry is supported by a growing research field, and we have undertaken a systematic review of the published literature. Web-based searches returned 290 relevant manuscripts published between 2010 and 2024. We applied Topic Modelling to this corpus of literature, which examines word association and connectedness within the research papers. The modelling identified two emerging research themes with little connection between them: those who used drones to deliver time-critical medical items and those who used drones to deliver non-time-critical medical items. The former was in response to medical emergencies, while the latter was for enhancing resilience in the healthcare supply chain. The topics within these research themes exhibited notable differences. The delivery of time-critical medical items theme comprised the topics of ‘Emergency Response’, ‘Defibrillator and Organ Delivery’, and ‘Search and Rescue’, whilst non-time-critical delivery researched the topics of ‘Supply Chain Optimisation’ and ‘Cost-Effectiveness’, ‘Overcoming Remoteness’, and ‘Pandemic Response’. Research on ‘Engineering and Design Considerations’ and ‘Ethical and Social Considerations’ cut across both research themes. We undertook further analysis to assess research topic alignment and identify knowledge gaps. We found that efforts are needed to establish a more standardised terminology for better alignment across the two emerging research themes. Future studies should focus on evaluating the impact of drone delivery on patient health using systematic methods. Additionally, exploring the economic viability of drone-based health services and addressing regulatory barriers are crucial for efficient and effective drone deployment in healthcare delivery systems.

The Main Barriers Limiting the Development of Smart Buildings

Smart buildings play a key role in the complex ecosystem of cities and are often subject to barriers that limit their development. Although identifying these barriers is fundamental to creating an enabling environment for this segment’s expansion, few works aim to identify these challenges. This work has two main objectives: (1) to research the main barriers limiting the development of new smart building projects and (2) to prioritize these barriers from the perspective of professionals with experience in the field. We adopted an exploratory approach common in research that focuses on identifying and prioritizing variables related to a phenomenon, which is based on two main actions: obtaining information through a careful literature review and consulting professionals who work in the concerned field. The results showed that professionals assessed the 23 barriers identified through bibliographic research as important, with the most important being related to lack of qualified professionals, shortage of government policies, higher initial and construction costs, macroeconomic barriers and access to financing, high cost of intelligent systems and technologies, regulatory barriers, lack of knowledge about the current and potential benefits of smart buildings, and more complex design and construction.