Profits First, Health Second: The Pharmaceutical Industry and the Global South Comment on "More Pain, More Gain! The Delivery of COVID-19 Vaccines and the Pharmaceutical Industry's Role in Widening the Access Gap".

The pharmaceutical industry has a long history of prioritizing the research and sale of medicines that will yield the largest amount of revenue and placing the health of people second. This gap is especially prevalent in countries of the Global South. This article first explores the dichotomy in research between the Global North and the Global South and then looks at examples of how access to key medicines used in diseases such as HIV, oncology and hepatitis C is limited in the latter group of countries. The role of pharmaceutical companies during the COVID-19 pandemic prompted negotiations for a pandemic accord that would ensure more equity in both research and access when the next pandemic comes. However, efforts by a combination of the pharmaceutical industry and some high-income countries (HICs) are creating serious obstacles to achieving the goal of an accord that would place health over profits.

Collaborative Innovations in Childhood Cancer Therapies.

The outcome for children with cancer has improved significantly over the past 60 years, with more than 80% of patients today becoming 5-year survivors. Despite this progress, cancer remains the leading cause of death from disease in children in the United States and Europe, with significant short- and long-term toxicity of treatment continuing to impact most children. While the past 15 years have witnessed dramatic scientific innovation for certain cancers in adult patients, pediatric cancer treatment innovation lags increasingly behind. To help bridge the adult-pediatric therapeutic development gap, collaborative efforts are essential among stakeholders within and outside the pediatric oncology community. Prioritizing collaboration in areas such as cancer characterization, target identification and validation, drug discovery, and approaches to currently "undruggable" targets is imperative to improving the outcomes for children with cancer.

ChatGPT and Medical Research: A Meta-Synthesis of Opportunities and Challenges.

Introduction: The utility of ChatGPT in research is ambiguous, serving as both a boon and bane and presenting challenges and opportunities. Accordingly, this study aimed to delineate the merits and demerits of ChatGPT within the realm of research. Methods: A meta-synthesis methodology involving a seven-step process was adopted to pursue the research objectives. Data were collected from comprehensive studies across specialized research databases, such as Science Direct, Springer, Eric, Emerald, Sage Journals, Wiley Online Library, PubMed, and Google Scholar, within the time frame spanning from 2022 to 2023. A total of 57 articles were meticulously chosen for analysis through judgmental sampling. Subsequently, key concepts were distilled from these articles and categorized using the thematic analysis approach while considering Karl Llewellyn's octagonal model from 1963. Results: The outcomes underwent scrutiny employing the thematic analysis strategy devised by Wolcott. The results about the capabilities and constraints of ChatGPT encompass eight dimensions, including formulating the research problem, reviewing relevant literature, selecting an appropriate research design, defining the population and choosing the sample, collecting data, analyzing data, interpreting data, and discussing and drawing conclusions. The credibility of these dimensions was substantiated through adherence to the criteria established by Lincoln and Guba. Conclusion: ChatGPT manifests myriad potentialities and constraints within the research purview based on the results. In light of the expeditious progression of artificial intelligence across multifarious domains, integrating this technological paradigm in research becomes an inexorable imperative, and excluding its use in research is untenable. Thus, policymakers and higher education strategists should devise policies that harness ChatGPT's potential in research endeavors, engendering many opportunities.

Project-Based Public-Private Collaborations.

Project-based collaborations between a single academic group and a single pharmaceutical company arguably are the most frequent form of public-private partnership in preclinical research and development of new drugs. This chapter discusses the benefits of such collaborations for both sides and potential challenges that can arise before and during the conduct of a project. This is largely based on a survey of expectations and experience by 134 academic investigators with a history of engagement in a project-based collaboration with a pharmaceutical company as well as unstructured experience directly, and learned through discussions with colleagues, from the authors. Obviously, a key benefit for both sides is achieving goals that neither could easily achieve by itself. Scientific discovery, and publications, may be a shared benefit, while for academics, funding and access to compounds, and for industry, access to assay technology and reputational factors may be important. Major hurdles can be freedom to publish and assignment of intellectual property rights. On pragmatic grounds, reaching a contract can be cumbersome, which is largely attributable to the legal expectations and needs of both parties. However, overall satisfaction with project-based collaborations appears very high for academic investigators.

Comprehensive applications of the artificial intelligence technology in new drug research and development.

Purpose: Target-based strategy is a prevalent means of drug research and development (R&D), since targets provide effector molecules of drug action and offer the foundation of pharmacological investigation. Recently, the artificial intelligence (AI) technology has been utilized in various stages of drug R&D, where AI-assisted experimental methods show higher efficiency than sole experimental ones. It is a critical need to give a comprehensive review of AI applications in drug R &D for biopharmaceutical field. Methods: Relevant literatures about AI-assisted drug R&D were collected from the public databases (Including Google Scholar, Web of Science, PubMed, IEEE Xplore Digital Library, Springer, and ScienceDirect) through a keyword searching strategy with the following terms [("Artificial Intelligence" OR "Knowledge Graph" OR "Machine Learning") AND ("Drug Target Identification" OR "New Drug Development")]. Results: In this review, we first introduced common strategies and novel trends of drug R&D, followed by characteristic description of AI algorithms widely used in drug R&D. Subsequently, we depicted detailed applications of AI algorithms in target identification, lead compound identification and optimization, drug repurposing, and drug analytical platform construction. Finally, we discussed the challenges and prospects of AI-assisted methods for drug discovery. Conclusion: Collectively, this review provides comprehensive overview of AI applications in drug R&D and presents future perspectives for biopharmaceutical field, which may promote the development of drug industry.

The Artificial Intelligence-Powered New Era in Pharmaceutical Research and Development: A Review.

Currently, artificial intelligence (AI), machine learning (ML), and deep learning (DL) are gaining increased interest in many fields, particularly in pharmaceutical research and development, where they assist in decision-making in complex situations. Numerous research studies and advancements have demonstrated how these computational technologies are used in various pharmaceutical research and development aspects, including drug discovery, personalized medicine, drug formulation, optimization, predictions, drug interactions, pharmacokinetics/ pharmacodynamics, quality control/quality assurance, and manufacturing processes. Using advanced modeling techniques, these computational technologies can enhance efficiency and accuracy, handle complex data, and facilitate novel discoveries within minutes. Furthermore, these technologies offer several advantages over conventional statistics. They allow for pattern recognition from complex datasets, and the models, typically developed from data-driven algorithms, can predict a given outcome (model output) from a set of features (model inputs). Additionally, this review discusses emerging trends and provides perspectives on the application of AI with quality by design (QbD) and the future role of AI in this field. Ethical and regulatory considerations associated with integrating AI into pharmaceutical technology were also examined. This review aims to offer insights to researchers, professionals, and others on the current state of AI applications in pharmaceutical research and development and their potential role in the future of research and the era of pharmaceutical Industry 4.0 and 5.0.

Community-Working Occupational Therapists' Involvement in Research and Development Projects in Norway.

The aim of this study was to explore community-working occupational therapists' involvement in research and development projects. A cross-sectional survey of occupational therapists working in community-based services in Norway (n = 617) was conducted. In all, 117 of the 617 participants responded that they were involved in research and development projects. Greater likelihood of participation in research and development work were found for occupational therapists who had completed further education. Current and prioritized research topics were professional development and the development of interprofessional and professional service designs for occupational therapy. Service and quality development, rehabilitation and technology were areas where more knowledge was considered needed. To increase the growth and success of occupational therapy research and development, it is important that more occupational therapists in the municipality continue to complete further education. High-quality occupational therapy practice should be based on research and development projects in the municipalities.

Impact of COVID-19 on the neglected tropical diseases: a scoping review.

BACKGROUND: This study investigates the impact of the COVID-19 pandemic on the prevalence, management, and control of the neglected tropical diseases (NTDs) highlighting the current or prospective impact of COVID-19 on research and development funding for, and execution of, NTD programmes. This review was conducted to determine if, and how, NTDs were affected by COVID-19, and whether those effects will delay the elimination goals of the Sustainable Development goals. METHODS: Using open-source available data from policy and documentation from official websites of the relevant stakeholders including but not limited to World Health Organization (WHO) documents and policies, government foreign aid documents, and the Policy Cures G-Finder reports, this scoping review explored ongoing challenges to supporting research and development (R&D) for the NTDs and in maintaining NTD control programs; examined the constraints posed for NTD management by the pandemic from disruptions to healthcare services, reduction of finance and explored the potential long-term implications and consequences for those poorer, neglected populations in low and middle income-countries (LMICs). This was done by a scoping review literature search, publications were subject to an initial practical screening step to ensure the most relevant publications were selected for full screening, with the focus on scoping the designated topic of the impact of COVID-19 on NTDs. We further undertook an evaluation of the socio-economic factors exacerbating the impact of COVID-19 on NTD burden. RESULTS: Multiple disruptions and setbacks, likely to affect NTD programmes and progress towards their elimination targets were identified in this study. R&D funding for the NTDs and AIDs and TB has declined since the funding high point of 2019, and for malaria since the high point of 2018. Significant changes in allocation of R&D funding within the NTDs are observed post pandemic, likely because of prioritization among donors. Diseases for which the least R&D investment was reported in place, prior to the pandemic (mycetoma, taeniasis/cysticercosis, trachoma and Buruli ulcer) have been particularly impacted post pandemic. We identified specific NTDs including schistosomiasis, leprosy, and rabies that have been affected by the COVID-19 pandemic and disruptions caused to on ongoing NTD control and elimination programs. Pandemic restrictions disrupted essential medical supply manufacturing and distribution impacting immunization programs and hindered efforts to control the spread of infectious diseases. NTD programmes have experienced numerous setbacks including delays in mass drug administration programs (e.g. for schistosomiasis), cancelled or delayed vaccination programs (e.g. for rabies) and closure of testing facilities has resulted in reduced diagnosis, treatment, and disease elimination for all NTDs. Lockdowns and clinic closures causing disruption to essential healthcare services restricted NTD surveillance and treatment programs. Community fears around contracting COVID-19 exacerbated the constraints to service delivery. Disparities in global vaccine distribution have widened with LMICs facing limited access to vaccines and disruption to immunization programs. Finally, the pandemic has led to increased poverty with poor and marginalized communities, impacting nutrition, healthcare access and education all of which have long term implications for NTD management and control. CONCLUSIONS: The COVID-19 pandemic profoundly impacted global health research and global health equity. Attention and funding were diverted from all sectors, significantly affecting research and development efforts set out in the World Health Organization's NTD elimination Roadmaps. Ongoing changes to funding, economic crises, logistics and supply chain disruptions as well as deepening poverty has put a strain on already weak healthcare systems and exacerbated LMIC healthcare challenges. In particular, the delays and constraints to NTD management and elimination programs will have long-reaching consequences highlighting the need for global cooperation and renewed investment to put the NTD roadmap back on track. Targets and milestones are unlikely to be met without significant investment for recovery, in place.

Modeling impact of inflation reduction act price negotiations on new drug pipeline considering differential contributions of large and small biopharmaceutical companies.

BACKGROUND/AIMS: Provisions of the Inflation Reduction Act mandating drug price negotiation by the Centers for Medicare & Medicaid Services have been criticized as a threat to pharmaceutical innovation. This study models potential impacts of the Inflation Reduction Act on drug approvals based on the differential contributions of large pharmaceutical companies and smaller biotechnology firms to clinical trials and the availability of capital. METHODS: This study examined research and development expense, revenue, and new investment (sale of common and preferred stock) by public biopharmaceutical companies and sponsorship of phased clinical trials in ClinicalTrials.gov. Financial data were incorporated in a model that estimates the number of drugs in each phase and approvals from reported phase-specific costs and transition rates, proportional sponsorship of trials by companies of different size, projected reductions in research and development spending based on company size, and three scenarios by which large companies may allocate reductions in research and development spending among clinical phases: (1) research and development proportionally reduced across phases; (2) research and development disproportionally reduced in phases 2-3; and (3) research and development disproportionately reduced in phases 1-2. RESULTS: Financial data were examined for 1378 public biopharmaceutical companies (2000-2018). Research and development expense was associated with revenue for 79 large companies with market capitalization ≥$7 billion with a 10% reduction in revenue reducing research and development expense by 8.4%. For 1299 smaller companies with market capitalization <$7 billion, research and development was associated with new investment, but not revenue. Smaller companies sponsored 55.2% of phase 1, 55.6% of phase 2, and 49.8% of phase 3 trials in ClinicalTrials.gov 2013-2018. In a model of clinical development that apportions clinical trials between large and smaller companies and determines the number of trials based on research and development resources, 400 drugs entering development produced 47.3 approvals (11.83% rate). A 10% reduction in revenue, reflecting the upper boundary of observed changes 2000-2018, with (1) proportional reduction across phases 1-3 produced 45.1 approvals (4.61% reduction); (2) disproportional reduction of phases 2-3 produced 42.8 approvals (9.55% reduction); and (3) disproportional reduction of phases 1-2 produced 46.9 approvals (0.95% reduction). CONCLUSION: This work suggests that the drug price negotiation provisions of the Inflation Reduction Act could have little or no impact on the number of drug approvals. While large pharmaceutical companies may reduce research and development spending, continued research and development by smaller companies and strategic allocation of research and development resources by large companies may mitigate any negative effects of the Inflation Reduction Act.

Exploring residents' willingness to pay for the research and development of renewable energy: A survey from first-tier cities in China.

The research and development (R&D) of renewable energy (RE) is crucial for cost reduction in electricity generation and enhancing power system stability. Compared to traditional fossil fuels, it demands more financial support. To investigate Chinese residents' willingness to pay (WTP) for the R&D of RE and its influencing factors, we conducted a large-scale online survey in four first-tier cities in China in 2023. The research findings indicate that (1) Chinese residents are willing to pay approximately 31.20 yuan (4.34 USD) per month for the R&D of RE. (2) WTP is higher under a mandatory payment model than a voluntary one. (3) Electricity consumption, environmental concern, environmental behavior, willingness to participate, satisfaction with government RE policies, and trust in the government's environmental governance capability significantly influence WTP. (4) Younger, male, and larger household residents exhibit higher WTP. Based on these findings, targeted policy recommendations were proposed.

Biotech's role in advancing HIV vaccine development.

HIV vaccine development has been hindered by significant challenges over four decades. Despite persistent efforts, all efficacy trials to date have yielded disappointing results. This has pushed the field back to the discovery phase and created uncertainty about the future involvement of large pharmaceutical companies. Currently, the HIV vaccine landscape is dominated by startup biotech firms, which face a complex array of obstacles. These include evolving HIV prevention methods, waning interest in vaccine research, and difficulties securing sustainable funding. This viewpoint explores the challenges faced by these biotech companies and the support mechanisms necessary for their continued involvement in HIV vaccine development. By leveraging insights from both pharmaceutical and biotech sectors, we propose a multi-faceted approach that includes enhanced communication, fostering innovation, and implementing strategic funding models.

SAFEvR MentalVeRse.app: Development of a Free Immersive Virtual Reality Exposure Therapy for Acrophobia and Claustrophobia.

Background: Specific phobias impact over 400 million people worldwide. Digitalizing mental health could alleviate the burden. Still, although the corporate-driven Metaverse is expanding rapidly, there needs to be more momentum in harnessing virtual reality exposure therapy uptake. Objective: This study aims to conceptualize, develop, and deploy a free Virtual Reality Exposure Therapy (VRET) application specifically designed for treating acrophobia and claustrophobia. This pilot study, which holds the promise of a future where mental health is more accessible and effective, explores the feasibility of leveraging transdisciplinary collaboration among specialists to create a safe, accessible, and effective VRET solution. Methods: We conducted a Delphi heuristic approach involving bioethicists, neuroscientists, and tech developers. Second, we reviewed the existing psychological theories and therapeutic strategies for addressing phobias in VR. Third, we conceptualized a thematic analysis-derived framework for a safe, adaptive-gamified free exposure to virtual reality acrophobia and claustrophobia (SAFEvR ACT). Finally, we provide an overview of the iterative improvements made during 12 workshops and 76 weekly briefings on developmental implementations. Results: We developed the SAFEvR ACT into a proof-of-concept application freely deployed on the MentalVerse app platform. Our safety-focused approach can benefit from prevalidation perspectives within future randomized control trials. Conclusions: The resulting application derived from the SAFEvR ACT framework represents a blueprint to counter the current lack of iVR mental health uptake by offering a free VRET alternative. Future research should aim towards developing similar free platforms to lessen mental health burdens and gather quantitative data. We conclude with a call to action to researchers to fine-tune our current approach and take a stand for free digital mental health within MentalVeRse.app.

Sales Revenues for New Therapeutic Agents Approved by the United States Food and Drug Administration From 1995 to 2014.

OBJECTIVES: This study aimed to analyze worldwide sales of new therapeutic agents and to estimate the time it takes for product sales to exceed industry-wide average drug development costs. METHODS: Data obtained from company reports were analyzed to track worldwide sales of new medicines approved by the US Food and Drug Administration from 1995 to 2014. All sales figures were reported in 2019 US dollars. Kaplan-Meier curves were used to evaluate the time it took for discounted product sales to exceed the average costs associated with developing 1 new drug (accounting for the costs of failed trials), using published estimates of these costs. RESULTS: Based on data for 361 of 558 new therapeutic agents approved over the study period (median follow-up 13.2 years), mean sales revenue per product was $15.2 billion through the end of 2019; the median was $6.7 billion. These products jointly generated global sales of $5.5 trillion since approval. Revenues were highly skewed, with the 25 best selling products (7%, 25 of 361) accounting for 38% of this amount ($2.1 trillion of $5.5 trillion). Approximately 47% of products had discounted sales that exceeded the estimated industry-wide average costs of development within 5 years of approval, and 75% within 10 years. After attributing potential production, marketing, and other costs, these numbers dropped to 21% of products within 5 years of approval, and 46% within 10 years. CONCLUSIONS: Sales of new medicines approved from 1995 to 2014 were highly skewed, but many products had net discounted sales that exceeded the industry-wide average costs of development within 10 years of approval. An understanding of how sales revenues accrue in the years after initial approval, alongside data on business costs, can inform discussions about how to incentivize private investment in innovation while ensuring affordable prices for patients and the healthcare system.

Exploratory screening for micro-RNA biomarkers in canine multicentric lymphoma.

Lymphoma is one of the most frequent hematopoietic tumors in dogs and shares similar features with human counterparts. MicroRNAs (miRNA, small non-coding RNAs) are pivotal in gene regulation fine tuning and cancer hallmarks are influenced by their aberrant expression. Consequently, miRNA biomarkers may assist predicting therapeutic response and clinical outcome by providing less-invasive novel diagnostics tools. The aim of this study was to detect dysregulated miRNAs in lymphomatous lymph node tissues in comparison to lymph node material or PBMCs from healthy control dogs. Potential significant differences in miRNA expression profiles between four lymphoma entities were evaluated. A customized PCR array was utilized to profile 89 canine target miRNAs. Quantification was performed using qPCR, relative expression was determined by the delta-delta Ct method, and p-values were calculated with student's t-test. In the 14 diffuse large B-cell lymphoma (DLBCL) patients, 28 and 24 different miRNAs were significantly dysregulated compared to lymph node material or PBMCs. Sixteen miRNAs occurred in both control groups, with 12 miRNAs being down- and four miRNAs being upregulated. The six peripheral T-cell lymphoma (PTCL) samples showed 24 and 25 dysregulated miRNAs when compared to the healthy controls. A combined analysis of DLBCL and PTCL samples revealed seven shared and 19 differently expressed miRNAs. Potential biomarkers in T- and B-cell lymphoma could be the miRNA-17/92 cluster and miRNA-181-family together with miRNA-34a and miRNA-150. Diagnostic utility of potential biomarkers must be validated in larger, prospective cohorts of canine lymphoma cases and in higher numbers of physiological patient material.

Convalescent Plasma and the US Expanded Access Program: A Personal Narrative.

Between early April 2020 and late August 2020, nearly 100,000 patients hospitalized with SARS-CoV2 infections were treated with COVID-19 convalescent plasma (CCP) in the US under the auspices of an FDA-authorized Expanded Access Program (EAP) housed at the Mayo Clinic. Clinicians wishing to provide CCP to their patients during that 5-month period early in the COVID pandemic had to register their patients and provide clinical information to the EAP program. This program was utilized by some 2,200 US hospitals located in every state ranging from academic medical centers to small rural hospitals and facilitated the treatment of an ethnically and socio-economically diverse cross section of patients. Within 6 weeks of program initiation, the first signals of safety were found in 5,000 recipients of CCP, supported by a later analysis of 20,000 recipients (Joyner et al. in J Clin Invest 130:4791-4797, 2020a; Joyner et al. in Mayo Clin Proc 95:1888-1897, 2020b). By mid-summer of 2020, strong evidence was produced showing that high-titer CCP given early in the course of hospitalization could lower mortality by as much as a third (Joyner et al. in N Engl J Med 384:1015-1027, 2021; Senefeld et al. in PLoS Med 18, 2021a). These data were used by the FDA in its August decision to grant Emergency Use Authorization for CCP use in hospitals. This chapter provides a personal narrative by the principal investigator of the EAP that describes the events leading up to the program, some of its key outcomes, and some lessons learned that may be applicable to the next pandemic. This vast effort was a complete team response to a crisis and included an exceptional level of collaboration both inside and outside of the Mayo Clinic. Writing just 4 years after the initiation of the EAP, this intense professional effort, comprising many moving parts, remains hard to completely understand or fully explain in this brief narrative. As Nelson Mandela said of the perception of time during his decades in prison, "the days seemed like years, and the years seemed like days."

(3D) Bioprinting-Next Dimension of the Pharmaceutical Sector.

To create a review of the published scientific literature on the benefits and potential perspectives of the use of 3D bio-nitrification in the field of pharmaceutics. This work was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for reporting meta-analyses and systematic reviews. The scientific databases PubMed, Scopus, Google Scholar, and ScienceDirect were used to search and extract data using the following keywords: 3D bioprinting, drug research and development, personalized medicine, pharmaceutical companies, clinical trials, drug testing. The data points to several aspects of the application of bioprinting in pharmaceutics were reviewed. The main applications of bioprinting are in the development of new drug molecules as well as in the preparation of personalized drugs, but the greatest benefits are in terms of drug screening and testing. Growth in the field of 3D printing has facilitated pharmaceutical applications, enabling the development of personalized drug screening and drug delivery systems for individual patients. Bioprinting presents the opportunity to print drugs on demand according to the individual needs of the patient, making the shape, structure, and dosage suitable for each of the patient's physical conditions, i.e., print specific drugs for controlled release rates; print porous tablets to reduce swallowing difficulties; make transdermal microneedle patches to reduce patient pain; and so on. On the other hand, bioprinting can precisely control the distribution of cells and biomaterials to build organoids, or an Organ-on-a-Chip, for the testing of drugs on printed organs mimicking specified disease characteristics instead of animal testing and clinical trials. The development of bioprinting has the potential to offer customized drug screening platforms and drug delivery systems meeting a range of individualized needs, as well as prospects at different stages of drug development and patient therapy. The role of bioprinting in preclinical and clinical testing of drugs is also of significant importance in terms of shortening the time to launch a medicinal product on the market.

Orphan drug policy analysis in China.

Rare diseases have various types, low incidence rates, complex conditions, and are often difficult to diagnose. Due to China's large population, there is a significant number of rare disease patients, but there is a shortage of orphan drugs. Consequently, these patients often find themselves in a situation where necessary medications are either unavailable or unaffordable. To address this urgent clinical need, China has implemented a series of orphan drug policies aimed at improving drug accessibility and affordability. In terms of drug accessibility, companies are encouraged to expedite drug development through the implementation of tax incentives, guidance for clinical research on rare diseases, and the provision of data protection periods of 6 years, along with market exclusivity periods limited to a maximum of 7 years. Moreover, exemptions for clinical trials, acceptance of overseas clinical trial data, and the creation of a list prioritizing clinically urgent new drugs from overseas have been introduced to expedite the drug registration application, review, inspection, and approval processes. In terms of drug affordability, the import value-added tax on rare disease drugs has been reduced by 3%, and various provinces and cities have established a representative rare disease protection model, which includes special funds, medical assistance programs, and serious disease insurance. The national medical insurance catalog has been adjusted to reduce the financial burden on rare disease patients, resulting in an increase in the number of orphan drugs covered by the catalog to 95 as of March 2024. By comparing orphan drug policies in the United States, the European Union, Japan, Australia, and other countries (or regions), we will provide relevant suggestions to further improve orphan drug policies in China, thus bringing more treatment options and hope to patients with rare diseases.

Recent advances in hepatitis E virus research and the Japanese clinical practice guidelines for hepatitis E virus infection.

Acute hepatitis E was considered rare until reports emerged affirming the existence of hepatitis E virus (HEV) genotypes 3 and 4 infections in Japan in the early 2000s. Extensive studies by Japanese researchers have highlighted the pivotal role of pigs and wild animals, such as wild boars and deer, as reservoirs for HEV, linking them to zoonotic infections in Japan. Currently, when hepatitis occurs subsequent to the consumption of undercooked or grilled pork, wild boar meat, or offal (including pig liver and intestines), HEV infection should be considered. Following the approval of anti-HEV immunoglobulin A antibody as a diagnostic tool for hepatitis E by Japan's Health Insurance System in 2011, the annual number of diagnosed cases of HEV infection has surged. Notably, the occurrence of post-transfusion hepatitis E promoted nationwide screening of blood products for HEV using nucleic acid amplification tests since 2020. Furthermore, chronic hepatitis E has been observed in immunosuppressed individuals. Considering the significance of hepatitis E, heightened preventive measures are essential. The Japan Agency for Medical Research and Development Hepatitis A and E viruses (HAV and HEV) Study Group, which includes special virologists and hepatologists, held a virtual meeting on February 17, 2024. Discussions encompassed pathogenesis, transmission routes, diagnosis, complications, severity factors, and ongoing and prospective vaccination or treatments for hepatitis E. Rigorous assessment of referenced studies culminated in the formulation of recommendations, which are detailed within this review. This comprehensive review presents recent advancements in HEV research and Japanese clinical practice guidelines for HEV infection.

Facilitating the ethical sourcing of donor hematopoietic stem cells for cell and gene therapy research and development.

Aim: Unrelated stem cell donor registries (DRs) are increasingly engaging in the field of cell and gene therapy (CGT). This study aims to explore the values, concerns, needs and expectations of donors and members of the public on donating hematopoietic stem cells (HSCs) for CGT.Methods: Seven focus groups were conducted in 2019 with members of the public, prospective donors and donors on the Anthony Nolan DR in the UK.Results: Participants expressed concerns over increased frequency of donation and incidental findings and required more information on the type of research including the purpose and possible outcomes.Conclusion: Addressing donors' concerns, needs and expectations on donating cellular materials for CGT research and development is essential to maintaining the highest standards for donor care and safety within this rapidly emerging field.

This study aims to explore the values, concerns, needs and expectations of people who donate, or consider donating, their stem cells (cells that can develop into many different types of cells) for research that could lead to new medical treatments. We focused on the thoughts of these donors about providing their cells for use in cell and gene therapy (CGT) research, a field that is rapidly advancing but still forming its rules and ethical guidelines. In 2019, we conducted seven focus groups (FGs) with a total of 73 people in the UK. This included individuals who are registered as potential stem cell donors on the Anthony Nolan unrelated stem cell donor register (DR), those who have already donated stem cells and members of the general public. We explored their thoughts about their donated cells being used for research to develop new therapies rather than for direct treatment of patients. Questions during the FGs touched on topics such as the roles of various organizations in managing donated cells, the commercial use of these cells and where responsibilities lie in ensuring ethical practices. Participants expressed a strong desire for openness and clear communication regarding how their donated cells are used in research. They wanted to ensure that any use of their cells aligns with their personal values and the ethical standards of the organizations handling the donations. Participants expected DRs like Anthony Nolan to safeguard their interests and the ethical use of their cells. This study highlights that while donors are generally willing to contribute to advancements in CGT research, they need clear, understandable information about how their donations are used. This is crucial for maintaining their trust and willingness to donate. Overall, this study underscores the importance of ethical practices and donor engagement in the growing field of CGT, ensuring that donor contributions are respected and used responsibly.