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This study addresses FinTech implementation challenges in the banking industry in Palestine. This was accomplished by adopting qualitative research methods. Semi-structured interviews were conducted with interviewees from the Palestinian Monetary Authority, banks, and FinTech companies. Thematic analysis was conducted using NVivo 12 software to identify themes in the interview scripts. Research outcomes suggest that FinTech development in Palestine encounters a range of multifaceted challenges, which can be categorised using the TOE (technological, organisational, environmental) framework. On the technological front, issues such as underdeveloped IT and telecommunications infrastructure, restricted mobile frequencies due to Israeli occupation, limited IT expertise, cyber risks, low digital literacy, and minimal FinTech awareness hinder progress. Organizationally, resistance to change, inadequate agility, limited digital skills, and slow Sharia compliance updates in Islamic banking impede innovation. Environmentally, the absence of a dedicated FinTech framework, unclear regulatory guidance, limited market size, and strict AML/CFT regulations create uncertainties for non-bank entities and restrict investment opportunities. Addressing these interconnected barriers requires coordinated efforts across legal, financial, and technological sectors to foster FinTech integration and growth in Palestine. [ABSTRACT FROM AUTHOR]

The European Artificial Intelligence Act (AI Act) has profound implications for technological innovation in the medical and health care sector, transcending the boundaries of existing legal frameworks such as the Medical Device Regulation (MDR) and the General Data Protection Regulation (GDPR). This paper examines basic regulatory choices of the AI Act relevant for the field of digital health innovations by contextualizing its main goals, key obligations, and addressed actors. In light of these considerations, we present a scoping literature review that identifies potential regulatory challenges for stakeholders engaged in research, innovation and healthcare. Building on this, we point to concepts and methodologies to overcome such challenges in a way fostering innovation while realizing key constitutional and societal interests at the same time. [ABSTRACT FROM AUTHOR]

Purpose: This real estate insight provides a comprehensive analysis of the current state and future potential of tokenization in the real estate industry mentioning several challenges to overcome to take advantage of this technology. We highlight potential benefits, including enhanced liquidity, increased security and improved accessibility. Additionally, the real estate insight critically discusses potential drawbacks, such as regulatory challenges and technological risks, and explores the impact of tokenization on real estate prices. Design/methodology/approach: This real estate insight employs a comprehensive literature review alongside a qualitative analysis of various case studies to explore current implementations of tokenization within the real estate industry. Multiple applications of tokenization in the real estate industry are examined, including fractional ownership, property management and transaction processes. The study investigates the optimization potential of tokenization for asset liquidity in the real estate area, transaction transparency and security. It also critically discusses potential challenges, such as regulatory compliance, security vulnerabilities and market adoption. Findings: The future of real estate tokenization, driven by blockchain technology and smart contracts, offers significant potential for growth, enhancing liquidity and accessibility through fractional ownership. Smart contracts automate and secure transactions, while evolving standards and regulatory frameworks in regions like North America, Europe and Asia support market expansion. Since its initial implementation with the St. Regis Aspen Resort STO, a stream of successful projects has highlighted the viability of tokenization. However, challenges remain, including the need for regulatory clarity, industry and customer education, displacements of market participants and jobs and environmental impacts. Integrating advanced technologies like AI and IoT can further streamline property management and investment decisions. Practical implications: The real estate insight's practical implications extend to industry professionals, policymakers and technology developers. Professionals gain insights into how tokenization can enhance liquidity and security in the real estate sector, guiding strategic decision-making. For policymakers, understanding potential challenges like regulatory compliance and technological risks informs the development of supportive regulations. Technology developers can also benefit from understanding the sector-specific applications and concerns raised. Highlighting the need for robust security measures and regulatory compliance in tokenization systems may foster better design practices. Therefore, the real estate insight's findings could significantly shape the future development of tokenization integration in the real estate industry. Originality/value: This real estate insight offers original value through a comprehensive analysis of the current and future impacts of tokenization in the real estate industry. It examines various applications of tokenization and critically discusses the potential challenges. The focus on informing strategic decisions for professionals and policymakers enhances its utility as a resource. Additionally, by addressing both the benefits and drawbacks, this study contributes to the broader discourse on the societal implications of tokenization. In the context of rapid technological advancement, such thorough studies are rare, further underscoring the real estate insight's originality. [ABSTRACT FROM AUTHOR]

Small Modular Reactors (SMRs) offer transformative potential for maritime propulsion by providing significant benefits such as reduced emissions, enhanced fuel efficiency, and greater operational autonomy. However, their integration into the maritime sector presents complex regulatory challenges due to the convergence of nuclear and maritime laws. A unified, harmonized regulatory framework is essential to ensure safety, radioactive waste management, and accident prevention. While initiatives led by the International Atomic Energy Agency (IAEA) and International Maritime Organization (IMO) are progressing, key gaps remain, particularly regarding maritime-specific risk assessments, emergency response protocols, and cross-border regulatory harmonization. Enhanced collaboration between regulatory bodies, pilot projects, and transparent engagement with stakeholders will be critical to refining safety protocols and accelerating regulatory alignment. Public acceptance remains a vital factor, requiring rigorous environmental impact assessments (EIAs) and transparent communication to build trust and align SMR-powered vessels with global sustainability objectives. While challenges persist, they also present opportunities for innovation and international cooperation. By addressing these regulatory and public acceptance challenges through coordinated efforts and policies, SMR propulsion can become a cornerstone of a more sustainable, efficient, and technologically advanced maritime sector. Successful deployment will position SMRs as a key component of the global energy transition, driving progress toward low-carbon shipping and a greener maritime industry. [ABSTRACT FROM AUTHOR]

The field of organ transplantation is experiencing a transformative shift with the rise of Advanced Therapy Medicinal Products (ATMPs), which include gene therapies, somatic cell therapies, and tissue-engineered products. These therapies offer new, potentially curative treatments for longstanding medical challenges, impacting numerous patients. However, their adoption is hindered by complex regulatory frameworks, high production costs, and inconsistent access across Europe. The ESOT ATMP Task Force's position paper analyzes these challenges from research to clinical application, advocating for a coordinated strategy to position Europe as a leader in ATMP development. It proposes specific actions such as streamlining regulatory pathways to accelerate approvals, boosting funding for ATMP research, and creating specialized facilities for development and implementation. The paper also highlights the critical roles of patient engagement and real-world evidence in optimizing clinical and regulatory practices. [ABSTRACT FROM AUTHOR]

Cancer remains a leading cause of death globally. Cancer patients often seek alternative therapies in addition to, or instead of, conventional treatments like chemotherapy, radiation, and surgery. The progress in medical advancements and early detection provides more treatment options; however, the development of cancer drugs requires a significant amount of time, demands substantial investments, and results in an overall low percent of regulatory approval. The complex relationship between patent protection and pharmaceutical innovation complicates cancer drug development and contributes to high mortality rates. Adjusting patent criteria for alternative cancer therapeutics could stimulate innovation, enhance treatment options, and ultimately improve outcomes for cancer patients. This article explores the potential of alternative cancer therapeutics, chemopreventive agents, natural products, off-patent drugs, generic unpatentable chemicals, and repurposed drugs in cancer treatment, emphasizing the mechanisms and therapeutic potential of these unconventional compounds as combinatorial cancer therapies. The biological pathways, therapeutic effects, and potential to enhance existing therapies are reviewed, demonstrating their cost-effective and accessible options as adjuvant cancer therapies. [ABSTRACT FROM AUTHOR]

Combination products, amalgamating drugs, biologics, and medical devices, have revolutionized the healthcare landscape with their potential for innovative therapies. However, the intersection of diverse components within these products presents a complex regulatory environment, demanding rigorous attention to safety and efficacy. This article delves into the intricate landscape of regulatory considerations, safety, and efficacy assessments pertaining to combination products--a category at the intersection of drugs, devices, and biologics. The regulatory framework, primarily governed by the U.S. Food and Drug Administration (FDA), necessitates a nuanced classification determining the regulatory pathway. Collaboration between diverse regulatory centers, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), underscores the integrated approach required for these innovative healthcare solutions. Safety considerations unravel the potential risks and adverse events associated with combining diverse components, emphasizing the need for robust risk assessment and mitigation strategies. The evaluation of efficacy involves sophisticated methodologies, clinical trials, and post-market surveillance, with recent advancements incorporating digital technologies. This comprehensive exploration aims to contribute to the evolving understanding and best practices in the regulatory and scientific realms, fostering collaboration and innovation in the development and assessment of combination products. [ABSTRACT FROM AUTHOR]

This paper examines the pivotal role of social entrepreneurs in combating urban poverty across diverse global contexts. Urban poverty presents a multifaceted challenge, exacerbated by rapid urbanization, economic inequality, and inadequate access to essential services. Social entrepreneurs emerge as key players, leveraging innovative solutions to address these systemic issues. By integrating social objectives with entrepreneurial strategies, they create sustainable business models that empower marginalized communities and foster economic resilience. The study explores various case studies that highlight successful social enterprises worldwide, illustrating how these initiatives tackle specific urban poverty challenges such as unemployment, lack of education, and inadequate healthcare. Furthermore, the paper discusses the critical factors that contribute to the effectiveness of social entrepreneurship, including community engagement, collaboration with local governments, and the ability to scale solutions. Additionally, the paper highlights the importance of supportive ecosystems that facilitate social entrepreneurship, including access to funding, mentorship, and policy frameworks. It also addresses the challenges faced by social entrepreneurs, such as navigating regulatory environments and sustaining their impact in the long term. This paper emphasizes the transformative potential of social entrepreneurs in fostering inclusive urban development. By aligning economic growth with social progress, they contribute significantly to alleviating urban poverty and promoting sustainable communities. This review underscores the need for greater recognition and support for social entrepreneurship as a viable approach to addressing the pressing issue of urban poverty on a global scale. [ABSTRACT FROM AUTHOR]

Blockchain technology has emerged as a transformative innovation in the financial sector, offering enhanced security, transparency, and operational efficiency. This research paper reviews the various use cases of blockchain technology in finance, including cryptocurrencies, cross-border payments, smart contracts, supply chain finance, central bank digital currencies, and regulatory compliance. Utilizing a qualitative research design, data was gathered from industry reports and peer-reviewed academic papers, and analyzed using content analysis facilitated by NVivo software. The key findings reveal that blockchain significantly improves transaction efficiency and reduces costs. However, major challenges such as regulatory uncertainty, scalability issues, data privacy concerns, and integration with legacy systems hinder widespread adoption. The study underscores the need for clear regulatory frameworks, technological advancements, and strategic collaboration among stakeholders. The broader implications suggest that addressing these challenges is crucial for harnessing the full potential of blockchain technology to revolutionize financial services. [ABSTRACT FROM AUTHOR]

With an eye on the Indian economic scene, this research article investigates the legal obstacles of implementing block chain technology in companies. The paper uses quantitative analysis to evaluate how block chain innovation and startup expansion are affected by legal environments. Through an analysis of the Indian startup scene, the study seeks to shed light on the legal obstacles preventing block chain acceptance and present suggestions for a friendly legislative climate. Complementing the Sustainable Development Goals (SDGs) of the United Nations, the study also emphasises block chain's potential in advancing openness, security, and efficiency. This thorough study aims to guide stakeholders, businesses, and legislators on using block chain for inclusive and environmentally friendly development. By understanding the legal barriers in the Indian startup ecosystem, stakeholders can work towards creating a conducive environment for block chain technology to thrive. With its ability to enhance transparency and streamline processes, block chain has the potential to drive progress towards achieving the SDGs. By leveraging the insights from this study, businesses and policymakers can harness the power of block chain to promote sustainable and inclusive development. This collaboration can lead to innovative solutions that address social and environmental challenges while promoting economic growth. Through strategic partnerships and policy reforms, block chain technology can be harnessed to create a more sustainable future for all. [ABSTRACT FROM AUTHOR]

The traditional labour structures and economic models have been drastically altered as a direct result of the rise of the gig economy. On the other hand, it frequently encounters significant legal barriers, which necessitates the application of advanced crisis communication strategies. This study uses qualitative discourse analysis to investigate a select group of gig economy services such as Uber, Lyft, and DoorDash, in order to analyse public comments, news releases, and social media postings made by these companies. It highlights three key themes by applying grounded theory coding approaches. These themes are compliance and legal adherence, public welfare and safety, along with transparency and openness. The aforementioned facets are effectively included within a central category that is referred to as "Strategic Discourse Management," which displays a purposeful approach for managing public opinion as well as regulatory engagements. From this study, the three major themes which emerged from crisis communication used by the companies are deflection, normalisation and public engagement. This research makes an important contribution to the current body of literature on crisis communication within the contexts of the platform economy and gig economy while providing deep insight for players operating in India. [ABSTRACT FROM AUTHOR]

This manuscript explores the use of nanostructured chitosan for intranasal drug delivery, targeting improved therapeutic outcomes in neurodegenerative diseases, psychiatric care, pain management, vaccination, and diabetes treatment. Chitosan nanoparticles are shown to enhance brain delivery, improve bioavailability, and minimize systemic side effects by facilitating drug transport across the blood–brain barrier. Despite substantial advancements in targeted delivery and vaccine efficacy, challenges remain in scalability, regulatory approval, and transitioning from preclinical studies to clinical applications. The future of chitosan-based nanomedicines hinges on advancing clinical trials, fostering interdisciplinary collaboration, and innovating in nanoparticle design to overcome these hurdles and realize their therapeutic potential. [ABSTRACT FROM AUTHOR]

This study explores the technical, economic, and regulatory aspects of harnessing hydroelectric spilled energy for Green Hydrogen (GH2) production. Addressing challenges such as efficiency, infrastructure, and cost, it underscores the potential of GH2 in Brazil's electrical matrix. The research identifies substantial potential for this type of GH2 production in Brazil, estimating a range between 140,669.92 and 1,406,699.17 tons during the analyzed period, with emphasis on the Southeast/Midwest and North subsystems. This represents 7.43% of Brazil's annual potential for low-carbon hydrogen production. GH2-based electricity production could reach 2,814 to 28,134 GWh, supplying significant portions of Brazil's energy consumption. Notably, GH2's surplus electricity, entirely carbon-free, could mitigate up to 22.28 million tons of C O 2 emissions, highlighting its pivotal role in maximizing renewable energy utilization and supporting global decarbonization efforts, positioning Brazil as a prominent player in this GH2 production domain. • Brazil's untapped GH2 potential via hydro spills. • Identify key GH2 hubs in Brazil regions. • GH2 offsets 22.28Mt CO2 emissions. • Hydro spills generate valuable GH2. • GH2 transforms remote Northern areas. [ABSTRACT FROM AUTHOR]

The field of organ transplantation is experiencing a transformative shift with the rise of Advanced Therapy Medicinal Products (ATMPs), which include gene therapies, somatic cell therapies, and tissue-engineered products. These therapies offer new, potentially curative treatments for longstanding medical challenges, impacting numerous patients. However, their adoption is hindered by complex regulatory frameworks, high production costs, and inconsistent access across Europe. The ESOT ATMP Task Force’s position paper analyzes these challenges from research to clinical application, advocating for a coordinated strategy to position Europe as a leader in ATMP development. It proposes specific actions such as streamlining regulatory pathways to accelerate approvals, boosting funding for ATMP research, and creating specialized facilities for development and implementation. The paper also highlights the critical roles of patient engagement and real-world evidence in optimizing clinical and regulatory practices.

This study addresses FinTech implementation challenges in the banking industry in Palestine. This was accomplished by adopting qualitative research methods. Semi-structured interviews were conducted with interviewees from the Palestinian Monetary Authority, banks, and FinTech companies. Thematic analysis was conducted using NVivo 12 software to identify themes in the interview scripts. Research outcomes suggest that FinTech development in Palestine encounters a range of multifaceted challenges, which can be categorised using the TOE (technological, organisational, environmental) framework. On the technological front, issues such as underdeveloped IT and telecommunications infrastructure, restricted mobile frequencies due to Israeli occupation, limited IT expertise, cyber risks, low digital literacy, and minimal FinTech awareness hinder progress. Organizationally, resistance to change, inadequate agility, limited digital skills, and slow Sharia compliance updates in Islamic banking impede innovation. Environmentally, the absence of a dedicated FinTech framework, unclear regulatory guidance, limited market size, and strict AML/CFT regulations create uncertainties for non-bank entities and restrict investment opportunities. Addressing these interconnected barriers requires coordinated efforts across legal, financial, and technological sectors to foster FinTech integration and growth in Palestine.

Small Modular Reactors (SMRs) offer transformative potential for maritime propulsion by providing significant benefits such as reduced emissions, enhanced fuel efficiency, and greater operational autonomy. However, their integration into the maritime sector presents complex regulatory challenges due to the convergence of nuclear and maritime laws. A unified, harmonized regulatory framework is essential to ensure safety, radioactive waste management, and accident prevention. While initiatives led by the International Atomic Energy Agency (IAEA) and International Maritime Organization (IMO) are progressing, key gaps remain, particularly regarding maritime-specific risk assessments, emergency response protocols, and cross-border regulatory harmonization. Enhanced collaboration between regulatory bodies, pilot projects, and transparent engagement with stakeholders will be critical to refining safety protocols and accelerating regulatory alignment. Public acceptance remains a vital factor, requiring rigorous environmental impact assessments (EIAs) and transparent communication to build trust and align SMR-powered vessels with global sustainability objectives. While challenges persist, they also present opportunities for innovation and international cooperation. By addressing these regulatory and public acceptance challenges through coordinated efforts and policies, SMR propulsion can become a cornerstone of a more sustainable, efficient, and technologically advanced maritime sector. Successful deployment will position SMRs as a key component of the global energy transition, driving progress toward low-carbon shipping and a greener maritime industry.

This study investigates how businesses in emerging economies strategically use informal networks to navigate regulatory and market challenges. Through a comprehensive literature review and case studies from Uganda, Nigeria, and India, the research highlights the dual role of informal networks in both economic and social dimensions. These networks are essential for overcoming bureaucratic hurdles, accessing resources, and managing risks where formal institutions are often inadequate. The study introduces a dual-framework theory emphasizing the cost-saving and relational benefits of these networks. It also explores the behavioural factors--such as trust, relational capital, and social norms--that sustain these networks' effectiveness. Sectoral differences in the reliance on informal networks are analyzed, with a focus on agriculture, manufacturing, construction, retail, and services. The paper concludes by discussing policy implications and suggests ways to integrate informal practices into the formal economy while retaining their adaptive benefits. Future research directions are also proposed to better align informal networks with formal structures for sustainable growth in emerging markets. [ABSTRACT FROM AUTHOR]

The purpose of this study is to elucidate the importance of probiotics, regulatory challenges that are faced in developing probiotics as foods and drugs and as well as the Chemistry, Manufacturing and control (CMC)considerations for probiotics. Probiotics are friendly live microorganisms (in most cases, bacteria) that are similar to the beneficial microorganisms found in the human gut and, when consumed, have the potential to improve or maintain the intestinal microbial flora of consumers, thereby benefiting their health. The utilization of probiotics has been in existence for a very long time. Lactobacilli, bifidobacterial, and lactococciare are the examples of probiotics have long been assumed to be safe whereas the most important determinant for probiotics selection is human health safety. Probiotics can be consumed by consumers largely in the form of food and dietary supplements. They are also even available in the form of tablets, capsules and powders and in some other forms as well, yet, their claims of health advantages could put the conventional distinction between food and medicine in jeopardy. The position of the regulatory environment for probiotics within the existing categories has become hazy and quite unclear as a result of the introduction of numerous probiotic products into the global market. [ABSTRACT FROM AUTHOR]

The paper provides a comprehensive examination of heavy metal stress on medicinal plants, focusing on its impact on antioxidant capacity and biosynthetic pathways critical to their therapeutic potential. It explores the complex relationship between heavy metals and the physiological and biochemical responses of medicinal plants, highlighting how metal stress disrupts biosynthetic pathways, altering concentrations of secondary metabolites. This disruption may compromise the overall quality and efficacy of medicinal plants, requiring a holistic understanding of its cumulative impacts. Furthermore, the study discusses the potential of targeted genetic editing to enhance plant resilience against heavy metal stress by manipulating genes associated with antioxidant defenses. This approach represents a promising frontier in safeguarding medicinal plants in metal-contaminated environments. Additionally, the research investigates the role of phytohormone signaling in plant adaptive mechanisms to heavy metal stress, revealing its influence on biochemical and physiological responses, thereby adding complexity to plant adaptation. The study underscores the importance of innovative technologies and global cooperation in protecting medicinal plants' therapeutic potential and highlights the need for mitigation strategies to address heavy metal contamination effectively. [ABSTRACT FROM AUTHOR]

Combination products, amalgamating drugs, biologics, and medical devices, have revolutionized the healthcare landscape with their potential for innovative therapies. However, the intersection of diverse components within these products presents a complex regulatory environment, demanding rigorous attention to safety and efficacy. This article delves into the intricate landscape of regulatory considerations, safety, and efficacy assessments pertaining to combination products—a category at the intersection of drugs, devices, and biologics. The regulatory framework, primarily governed by the U.S. Food and Drug Administration (FDA), necessitates a nuanced classification determining the regulatory pathway. Collaboration between diverse regulatory centers, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), underscores the integrated approach required for these innovative healthcare solutions. Safety considerations unravel the potential risks and adverse events associated with combining diverse components, emphasizing the need for robust risk assessment and mitigation strategies. The evaluation of efficacy involves sophisticated methodologies, clinical trials, and post-market surveillance, with recent advancements incorporating digital technologies. This comprehensive exploration aims to contribute to the evolving understanding and best practices in the regulatory and scientific realms, fostering collaboration and innovation in the development and assessment of combination products.

Cancer remains a leading cause of death globally. Cancer patients often seek alternative therapies in addition to, or instead of, conventional treatments like chemotherapy, radiation, and surgery. The progress in medical advancements and early detection provides more treatment options; however, the development of cancer drugs requires a significant amount of time, demands substantial investments, and results in an overall low percent of regulatory approval. The complex relationship between patent protection and pharmaceutical innovation complicates cancer drug development and contributes to high mortality rates. Adjusting patent criteria for alternative cancer therapeutics could stimulate innovation, enhance treatment options, and ultimately improve outcomes for cancer patients. This article explores the potential of alternative cancer therapeutics, chemopreventive agents, natural products, off-patent drugs, generic unpatentable chemicals, and repurposed drugs in cancer treatment, emphasizing the mechanisms and therapeutic potential of these unconventional compounds as combinatorial cancer therapies. The biological pathways, therapeutic effects, and potential to enhance existing therapies are reviewed, demonstrating their cost-effective and accessible options as adjuvant cancer therapies.

The implementation of pharmacogenetic analysis within clinical trials faces methodological, ethical, and regulatory challenges, as well as tackling the difficulty in obtaining actionable information with a sufficient level of evidence to enable its integration into routine clinical practice. We discuss the current status of pharmacogenetics integration in clinical trials, underscore the associated challenges, and make some suggestions on the aspects to address in any clinical trial including a pharmacogenetic evaluation. We conducted a literature review, thoroughly reviewed the applicable regulations and available guidelines, and assessed the application dossiers submitted for evaluation to the Ethics committee of Hospital La Paz (Madrid, Spain) to extract information related to inclusion of pharmacogenetics evaluations. The integration of pharmacogenetics into clinical trials is becoming increasingly common. However, several regulatory, methodological and ethical aspects involved are insufficiently addressed. There is a need for specific and transparent guidelines that establish unified and compliant criteria for methodology, proper handling of samples in compliance with regulations, and the protection of data privacy and confidentiality. Participants should receive complete and appropriate information regarding the purpose, handling, storage, and transfer of their samples and data, and should have the right to decide about their processing. [ABSTRACT FROM AUTHOR]

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The growing world population, public awareness of animal welfare, environmental impacts and changes in meat consumption leads to the search for novel approaches to food production. Novel foods include products with a new or specifically modified molecular structure, foods made from microorganisms, fungi, algae or insects, as well as from animal cell or tissue cultures. The latter approach is known by various names: "clean meat", "in vitro meat" and "cell‐cultured" or "(cell‐)cultivated meat". Here, cells isolated from agronomically important species are expanded ex vivo to produce cell biomass used in unstructured meat or to grow and differentiate cells on scaffolds to produce structured meat analogues. Despite the fast‐growing field and high financial interest from investors and governments, cultivated meat production still faces challenges ranging from cell source choice, affordable expansion, use of cruelty‐free and food‐grade media, regulatory issues and consumer acceptance. This overview discusses the above challenges and possible solutions and strategies in the production of cultivated meat. The review integrates multifaceted historical, social, and technological insights of the field, and provides both an engaging comprehensive introduction for general interested and a robust perspective for experts. [ABSTRACT FROM AUTHOR]

This manuscript explores the use of nanostructured chitosan for intranasal drug delivery, targeting improved therapeutic outcomes in neurodegenerative diseases, psychiatric care, pain management, vaccination, and diabetes treatment. Chitosan nanoparticles are shown to enhance brain delivery, improve bioavailability, and minimize systemic side effects by facilitating drug transport across the blood–brain barrier. Despite substantial advancements in targeted delivery and vaccine efficacy, challenges remain in scalability, regulatory approval, and transitioning from preclinical studies to clinical applications. The future of chitosan-based nanomedicines hinges on advancing clinical trials, fostering interdisciplinary collaboration, and innovating in nanoparticle design to overcome these hurdles and realize their therapeutic potential.

Abstract The growing world population, public awareness of animal welfare, environmental impacts and changes in meat consumption leads to the search for novel approaches to food production. Novel foods include products with a new or specifically modified molecular structure, foods made from microorganisms, fungi, algae or insects, as well as from animal cell or tissue cultures. The latter approach is known by various names: “clean meat”, “in vitro meat” and “cell‐cultured” or “(cell‐)cultivated meat”. Here, cells isolated from agronomically important species are expanded ex vivo to produce cell biomass used in unstructured meat or to grow and differentiate cells on scaffolds to produce structured meat analogues. Despite the fast‐growing field and high financial interest from investors and governments, cultivated meat production still faces challenges ranging from cell source choice, affordable expansion, use of cruelty‐free and food‐grade media, regulatory issues and consumer acceptance. This overview discusses the above challenges and possible solutions and strategies in the production of cultivated meat. The review integrates multifaceted historical, social, and technological insights of the field, and provides both an engaging comprehensive introduction for general interested and a robust perspective for experts.

Recent coronavirus pandemic and its global socio-economic impact has re-emphasized the need for safe, fast, and efficient delivery of vaccines for humankind. With advent of technological advances, and to improve patient acquiescence, several techniques for fast, effective, and safe delivery of vaccines have been researched and published in the literature in last three decades. These delivery enhancement techniques include but are not limited to electroporation, microneedles (MN), ultrasound, iontophoresis, etc. This review aims at discussing the current research undergoing in vaccine delivery, specifically focusing on microneedles assisted, the historical background of microneedles and their introduction to drug delivery area, and a special focus on formulation challenges and stability in these systems. The review also sheds light on regulatory challenges one must keep in mind for bringing a successful microneedles-based vaccine delivery into market as well as a snapshot of current commercially available microneedles-based products in cosmetic and pharmaceutical industry.

Telemedicine is a component of the greater field of eHealth which entails the use of information communication technology for health and may be broadly understood as the provision of healthcare over distances making use of these information and communication technologies. Despite early resistance to telemedical practices, mHealth and eHealth have become omnipresent and as such the value of this form of healthcare service delivery can no longer be denied. However, medical service delivery cannot be unfettered and it is important that the implementation and practice of telemedicine be properly regulated. In order to do so, cognisance of the local environment and the specific challenges that the environment brings needs to be taken. Once the challenges are known, the appropriate remedies may be provided for in regulatory instruments. As such, this article attempts to identify the legal challenges posed to telemedicine in South Africa and to examine if, and if so, how these challenges are addressed by various regulatory instruments including legislation and ethical guidelines. [ABSTRACT FROM AUTHOR]

This Review initiates a wide-ranging discussion over 2023 by selecting and exploring core themes to be investigated more deeply in papers submitted to the Vaccines Special Issue on the "Future of Epidemic and Pandemic Vaccines to Serve Global Public Health Needs". To tackle the SARS-CoV-2 pandemic, an acceleration of vaccine development across different technology platforms resulted in the emergency use authorization of multiple vaccines in less than a year. Despite this record speed, many limitations surfaced including unequal access to products and technologies, regulatory hurdles, restrictions on the flow of intellectual property needed to develop and manufacture vaccines, clinical trials challenges, development of vaccines that did not curtail or prevent transmission, unsustainable strategies for dealing with variants, and the distorted allocation of funding to favour dominant companies in affluent countries. Key to future epidemic and pandemic responses will be sustainable, global-public-health-driven vaccine development and manufacturing based on equitable access to platform technologies, decentralised and localised innovation, and multiple developers and manufacturers, especially in low- and middle-income countries (LMICs). There is talk of flexible, modular pandemic preparedness, of technology access pools based on non-exclusive global licensing agreements in exchange for fair compensation, of WHO-supported vaccine technology transfer hubs and spokes, and of the creation of vaccine prototypes ready for phase I/II trials, etc. However, all these concepts face extraordinary challenges shaped by current commercial incentives, the unwillingness of pharmaceutical companies and governments to share intellectual property and know-how, the precariousness of building capacity based solely on COVID-19 vaccines, the focus on large-scale manufacturing capacity rather than small-scale rapid-response innovation to stop outbreaks when and where they occur, and the inability of many resource-limited countries to afford next-generation vaccines for their national vaccine programmes. Once the current high subsidies are gone and interest has waned, sustaining vaccine innovation and manufacturing capability in interpandemic periods will require equitable access to vaccine innovation and manufacturing capabilities in all regions of the world based on many vaccines, not just "pandemic vaccines". Public and philanthropic investments will need to leverage enforceable commitments to share vaccines and critical technology so that countries everywhere can establish and scale up vaccine development and manufacturing capability. This will only happen if we question all prior assumptions and learn the lessons offered by the current pandemic. We invite submissions to the special issue, which we hope will help guide the world towards a global vaccine research, development, and manufacturing ecosystem that better balances and integrates scientific, clinical trial, regulatory, and commercial interests and puts global public health needs first. [ABSTRACT FROM AUTHOR]

The development of new antibiotics is paramount in combating the escalating threat of antibiotic resistance, which poses significant challenges to global public health. However, this endeavor is hampered by regulatory and economic obstacles that impede the translation of scientific innovations into clinically effective therapies. Regulatory requirements, market dynamics, and reimbursement policies create barriers to antibiotic research and development, leading to a limited pipeline of novel antimicrobial agents. Addressing these challenges requires collaborative efforts from policymakers, regulators, pharmaceutical companies, and the healthcare community. Regulatory reforms, market-based incentives, and sustainable antibiotic use strategies are essential for expediting antibiotic development, stimulating investment, and preserving the effectiveness of existing antibiotics. This review examines the regulatory and economic challenges in antibiotic development and proposes strategies to overcome them, emphasizing the importance of innovation, stewardship, and global cooperation in safeguarding the efficacy of antibiotic therapies. [ABSTRACT FROM AUTHOR]

Biopharmaceuticals have emerged as a cornerstone of modern medicine, offering targeted and effective treatments for a diverse array of medical conditions. This review provides an overview of the key applications, challenges, and opportunities in biopharmaceutical development. Key applications include cancer immunotherapy, rare genetic disorders, autoimmune diseases, infectious diseases, and neurological disorders. Challenges such as complex manufacturing processes, regulatory requirements, and high costs are discussed, alongside opportunities arising from advances in biotechnology, personalized medicine, and collaborative partnerships. The importance of prioritizing patient safety, accessibility, and affordability is emphasized. By embracing innovation and collaboration, the biopharmaceutical industry can continue to revolutionize healthcare and improve patient outcomes. [ABSTRACT FROM AUTHOR]

• Overview of tumor-specific neoantigens as targets for personalized cancer therapies and their role in immune system recognition. • Discussion of clinical trials using neoantigens in cancer immunotherapy and the challenges posed by tumor heterogeneity and immune tolerance. • To explore advanced technologies for neoantigen identification and future strategies to improve their clinical application. Neoantigen, unique peptides resulting from tumor-specific mutations, represent a promising frontier in oncology for personalized cancer immunotherapy. Their unique features allow for the development of highly specific and effective cancer treatments, which can potentially overcome the limitations of conventional therapies. This paper explores the current prospects and challenges associated with the application of neoantigens in oncology. We examine the latest advances in neoantigen identification, vaccine development, and adoptive T cell therapy. Additionally, we discuss the obstacles related to neoantigen heterogeneity, immunogenicity prediction, and the tumor microenvironment. Through a comprehensive analysis of current research and clinical trials, this paper aims to provide a detailed overview of how neoantigens could revolutionize cancer treatment and the hurdles that must be overcome to realize their full potential. [ABSTRACT FROM AUTHOR]

Recent coronavirus pandemic and its global socio-economic impact has re-emphasized the need for safe, fast, and efficient delivery of vaccines for humankind. With advent of technological advances, and to improve patient acquiescence, several techniques for fast, effective, and safe delivery of vaccines have been researched and published in the literature in last three decades. These delivery enhancement techniques include but are not limited to electroporation, microneedles (MN), ultrasound, iontophoresis, etc. This review aims at discussing the current research undergoing in vaccine delivery, specifically focusing on MNs assisted, the historical background of MNs and their introduction to drug delivery area, and a special focus on formulation challenges and stability in these systems. The review also sheds light on regulatory challenges one must keep in mind for bringing a successful MNs-based vaccine delivery into market as well as a snapshot of current commercially available MNs-based products in cosmetic and pharmaceutical industry. [ABSTRACT FROM AUTHOR]

The recent implementation of the General Data Protection Regulation (GDPR) establishes a set of formal requirements that reinforce personal data protection, namely, those concerning the collection, treatment, and dissemination of data on research participants. With the application of this new legal provision at the European level, new types of restrictions are emerging, whose nature and reach intensify the tension between demands for privacy and scientific freedom in research. In this article, we take as a reference an ongoing research taking place in Portugal, in the field of Sociology of Health, concerning the consumption of medicines by professionals exposed to high-performance pressure. Our main objective is to identify and analyse the implications of regulatory challenges faced in the research process and how the researchers managed and overcame them. We present a critical narrative that sheds light on the nature of the choices taken while also assessing the practical implications for the operationalisation of the research. We conclude by noting that, despite the benefits that may flow from the application of GDPR, the new requirements regarding the protection of personal data may override the ethical principles of scientific research and strengthen regulatory restrictions on conducting research. In the research concerned, the significant practical implications were indirect access to participants, a more time-consuming process in terms of participant adherence and a temporal discrepancy between the different stages of recruitment. [ABSTRACT FROM AUTHOR]

A high proportion of depressed patients fail to respond to antidepressant drug treatment. Treatment‐resistant depression (TRD) is a major challenge for the psychopharmacology of mood disorders. Only in the past decade have novel treatments, including deep brain stimulation (DBS) and ketamine, been discovered that provide rapid and sometimes prolonged relief to a high proportion of TRD sufferers. In this review, we consider the current status of TRD from four perspectives: the challenge of developing an appropriate regulatory framework for novel rapidly acting antidepressants; the efficacy of non‐pharmacological somatic therapies; the development of an animal model of TRD and its use to understand the neural basis of antidepressant non‐response; and the potential for rapid antidepressant action from targets (such as 5‐HT1A receptors) beyond the glutamate receptor. LINKED ARTICLES: This article is part of a themed issue on New discoveries and perspectives in mental and pain disorders. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v179.17/issuetoc [ABSTRACT FROM AUTHOR]

The etiologies of several cardiovascular, inflammatory, neurological, hereditary disorders, cancer, and infectious diseases have implicated changes in the genetic set up or genetic mutations as the root cause. Nucleic acid based therapeutics (NBTs) is a new class of biologics that are known to regulate gene expression at the transcriptional and post-transcriptional level. The NBTs include oligonucleotides, nucleosides, antisense RNA, small interfering RNAs, micro RNA etc. In recent times, this new category of biologics has found enormous potential in the management of cardiovascular, inflammatory, neurological disorders, cancer, infectious diseases and organ transplantation. However, the delivery of NBTs is highly challenging in terms of target specificity (intracellular delivery), mononuclear phagocyte system uptake, stability and biodistribution. Additionally, management of the above mentioned disorders require regular and intrusive therapy making non-invasive routes preferable in comparison to invasive routes like parenteral. The nasal route is garnering focus in delivery of NBTs to the brain in the management of several CNS disorders due to the associated merits such as non-invasiveness, possibility of chronic delivery, improved patient compliance, avoidance of hepatic and gastrointestinal metabolism as well as ability to bypass the BBB. Hence in recent times, this route has been sought by the reserachers as an alternative to parenteral therapy for the delivery of several NBTs. This review shall focus on an array of NBTs delivered through nasal route, their challenges, applications and opportunities. The novel delivery systems for incorporating NBTs; their targeting strategies shall be critically reviewed. The challenges towards regulatory approvals and commercialization shall also be discussed at large. Comparison of learnings derived from the success and barriers in nasal delivery of NBTs will help in identification of futuristic opportunities for their translation from bench to bedside. [ABSTRACT FROM AUTHOR]

The etiologies of several cardiovascular, inflammatory, neurological, hereditary disorders, cancer, and infectious diseases have implicated changes in the genetic set up or genetic mutations as the root cause. Nucleic acid based therapeutics (NBTs) is a new class of biologics that are known to regulate gene expression at the transcriptional and post-transcriptional level. The NBTs include oligonucleotides, nucleosides, antisense RNA, small interfering RNAs, micro RNA etc. In recent times, this new category of biologics has found enormous potential in the management of cardiovascular, inflammatory, neurological disorders, cancer, infectious diseases and organ transplantation. However, the delivery of NBTs is highly challenging in terms of target specificity (intracellular delivery), mononuclear phagocyte system uptake, stability and biodistribution. Additionally, management of the above mentioned disorders require regular and intrusive therapy making non-invasive routes preferable in comparison to invasive routes like parenteral. The nasal route is garnering focus in delivery of NBTs to the brain in the management of several CNS disorders due to the associated merits such as non-invasiveness, possibility of chronic delivery, improved patient compliance, avoidance of hepatic and gastrointestinal metabolism as well as ability to bypass the BBB. Hence in recent times, this route has been sought by the reserachers as an alternative to parenteral therapy for the delivery of several NBTs. This review shall focus on an array of NBTs delivered through nasal route, their challenges, applications and opportunities. The novel delivery systems for incorporating NBTs; their targeting strategies shall be critically reviewed. The challenges towards regulatory approvals and commercialization shall also be discussed at large. Comparison of learnings derived from the success and barriers in nasal delivery of NBTs will help in identification of futuristic opportunities for their translation from bench to bedside.

[Display omitted] Chimeric Antigen Receptor-T cell (CAR-T) therapy has evolved as a revolutionary cancer treatment modality, offering remarkable clinical responses by harnessing the power of a patient's immune system to target and eliminate cancer cells. However, the development and commercialization of CAR-T cell therapies are accompanied by complex regulatory requirements and challenges. This therapy falls under the regulatory category of advanced therapy medicinal products. The regulatory framework and approval tools of regenerative medicine, especially CAR-T cell therapies, vary globally. The present work comprehensively analyses the regulatory landscape and challenges in CAR-T cell therapy development in four key regions: the United States, the European Union, Japan, and India. This work explores the unique requirements and considerations for preclinical studies, clinical trial design, manufacturing standards, safety evaluation, and post-marketing surveillance in each jurisdiction. Due to their complex nature, developers and manufacturers face several challenges. In India, despite advancements in treatment protocols and government-sponsorships, there are still several difficulties regarding access to treatment for the increasing number of cancer patients. However, India's first indigenously developed CAR-T cell therapy, NexCAR19, for B-cell lymphoma or leukemia, approved and available at a low cost compared to other available CAR-T therapies, raises great hope in the battle against cancer. Several strategies are proposed to address the identified hurdles from global and Indian perspectives. It discusses the benefits of aligning regulatory requirements across regions, eventually facilitating international development and enabling access to this transformative therapy. [ABSTRACT FROM AUTHOR]

Cancer therapy has undergone a drastic revolution in the past few decades with the introduction of several novel therapies, like immunotherapy (active and passive), stem cell-based therapies, and nanocarrier-based therapies. These therapies have addressed the issues of conventional cancer therapy (chemotherapy or radiotherapy), like specificity and off-target effects. Further, the introduction of such treatments has improved survival and converted a terminal disease into a more manageable condition. However, many clinical, ethical, and regulatory issues are raised with such novel additions. Several effective therapies are under research but could not come to market or are delayed due to regulatory concerns for marketing approval. The scope of this review encompasses the examination of these regulatory issues and discuss their possible solutions. A practical and flexible regulatory approach, harmonized globally, could help the patients suffering from a terminal illness to lead a quality life. [ABSTRACT FROM AUTHOR]

Background: Solubility properties of drugs intensify a crucial role during the formulation development process. Aqueous solubility is one of the most significant factors concerning drug bioavailability analysis. Cyclodextrins [CDs] are supportive, competent excipients, required an ever-rising way to disguise unwanted pharmaceutical characteristics, exclusively poor aqueous solubility. Main Text: CDs are actively useful in medicinal industries for copious purposes, including improving drug solubility, safety, physicochemical stability, and bioavailability. Different solubility enhancement methods can resolve several approaches to trouble insolubility. Conclusions: Among all, the reported one complexation technique has been incorporated as one of the imperative and the exigent concept, to enhance the solubility of poorly water-soluble drugs. The standard CDs and their explicit derivatives are quite essential in enabling pharmaceutical excipients, which improve the aqueous solubility of poorly soluble drugs, raise the permeability of drugs through the biological membranes, and advances the drug dissolution rate and bioavailability. This review discusses some of the findings and broad applications of CDs and their derivatives in various drug delivery areas. This review also addresses the aspects regarding the new CD-based therapeutics, possible future uses and issues, and regulatory perspective in the modern scenario.

The integration of fog computing into healthcare promises significant advancements in real-time data analytics and patient care by decentralizing data processing closer to the source. This shift, however, introduces complex regulatory, privacy, and security challenges that are not adequately addressed by existing frameworks designed for centralized systems. The distributed nature of fog computing complicates the uniform application of security measures and compliance with diverse international regulations, raising concerns about data privacy, security vulnerabilities, and legal accountability. This review explores these challenges in depth, discussing the implications of fog computing's decentralized architecture for data privacy, the difficulties in achieving consistent security across dispersed nodes, and the complexities of ensuring compliance in multi-jurisdictional environments. It also examines specific regulatory frameworks, including Health Insurance Portability and Accountability (HIPAA) in the United States, General Data Protection Regulation (GDPR) in the European Union, and emerging laws in Asia and Brazil, highlighting the gaps and the need for regulatory evolution to better accommodate the nuances of fog computing. The review advocates for a proactive regulatory approach, emphasizing the development of specific guidelines, international collaboration, and public-private partnerships to enhance compliance and support innovation. By embedding privacy and security by design and leveraging advanced technologies, healthcare providers can navigate the regulatory landscape effectively, ensuring that fog computing realizes its full potential as a transformative healthcare technology without compromising patient trust or data integrity., Competing Interests: Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Jeyaraman et al.)

The article provides a description of the Autonomous ship, studies existing relevant projects, and examines the related Operational, Regulatory, and Quality assurance challenges raised due to the development and actual deployment of such vessels in the near future. After reviewing the main operational procedures, existing regulations, and quality assurance standards, a number of possible solutions and approaches to overcome the identified challenges are indicated. Some of the conclusions may be used not only in the Autonomous ships but also in traditionally manned vessels.

This paper addresses the regulatory challenges facing Islamic banking in Nigeria with a view to streamlining the system's legal framework. An empirical method is adopted, with research being carried out using 150 respondents in Ilorin, Nigeria. The paper found that the challenges facing Islamic banking in Nigeria have had an overall negative effect on that sector's operation. The study concludes that, if the challenges are not addressed, Islamic banking will suffer setbacks in Nigeria. The paper recommends a regulatory framework for Islamic banking in Nigeria. [ABSTRACT FROM AUTHOR]

Underpinning China's severe and continuing environmental degradation is a stubborn gap between environmental regulation and regulatory enforcement at the local level. In the past, scholars have sought explanations for the causes of this implementation gap by interviewing frontline environmental officials. Due to the fact that the self-perception data used in most of those existing studies were gathered prior to 2012, the possible factors contributing to the compromised effectiveness of local environmental enforcement from 2012 onward remain largely unknown. This empirical weakness should not be overlooked, as the prevailing institutions governing China's local environmental management practices have been experiencing many frame-breaking transformations since 2012. Drawing on semi-structured interviews with leaders of environmental law enforcement teams in all administrative districts of Guangzhou in 2017, this paper not only summarizes pervasive elements which negatively impact the current effectiveness of environmental regulatory efforts, but also provides qualitative evidence and theoretical accounts for three enforcement dilemmas stemming from reform measures taken by the central government. [ABSTRACT FROM AUTHOR]

RNA-based medicines have potential to treat a large variety of diseases, and research in the field is very dynamic. Proactively, The European Medicines Agency (EMA) organized a virtual conference on February 2, 2023 to promote the development of RNA-based medicines. The initiative addresses the goal of the EMA Regulatory Science Strategy to 2025 to "catalyse the integration of science and technology in medicines development." The conference focused on RNA technologies (excluding RNA vaccines) and involved different stakeholders, including representatives from academia, industry, regulatory authorities, and patient organizations. The conference comprised presentations and discussion sessions conducted by panels of subject matter experts. In this meeting report, we summarize the presentations and recap the main themes of the panel discussions.