Cost-effectiveness comparison between blood biomarkers and conventional tests in Alzheimer's disease diagnosis.

Dementia management has evolved with drugs such as lecanemab, shifting management from palliative care to early diagnosis and intervention. However, the administration of these drugs presents challenges owing to the invasiveness, high cost and limited availability of amyloid-PET and cerebrospinal fluid tests for guiding drug administration. Our manuscript explores the potential of less invasive blood biomarkers as a diagnostic method, with a cost-effectiveness analysis and a comparison with traditional tests. Our findings suggest that blood biomarkers are a cost-effective alternative, but with lower accuracy, indicating the need for multiple specific biomarkers for precision. This underscores the importance of future research on new blood biomarkers and their clinical efficacy.

Strategic trends of pharmaceutical companies: A growth model through regional focus and inter-regional alliances.

Pharmaceutical companies face challenges in business continuity resulting from declining research and development productivity. This study examines the relationship between two strategic pillars: region and therapeutic area, while considering company size. The results indicate that a therapeutic area focus is an effective strategy for small/medium-sized companies, whereas a regional focus is effective for larger companies. These findings highlight the limitations of the traditional global pharmaceutical model from 2004 to 2018 and aim to contribute to the future corporate strategic planning of these companies.

Recent trends in interorganizational deal networks in pharmaceutical and biotechnology industries.

While there have been trends in drug discovery from small molecules to new chemical modalities since the large mergers and acquisitions (M&A) of pharmaceutical companies in the late 2000s, trends in interorganizational deal networks have not been well addressed. We investigated the changing trends in interorganizational deals in the pharmaceutical and biotechnology industries. The results demonstrated that there have been changing trends, including a growing number of spinouts from academia and M&A in the United States and Europe. These findings indicates that the traditional network in which large pharmaceutical companies drove drug discovery output has changed, and interorganizational deals among diverse players have become more active.

The gap between development and manufacturing in gene therapy: Strategic options for overcoming traps.

Gene therapy has been one of the most promising therapeutic approaches in recent years. This study analyzed a research and development (R&D) system for adeno-associated virus (AAV)-based gene therapies, and confirmed that there was a gap between the development and manufacturing capabilities. Although a start-up company that has no academic or manufacturing facilities can begin the clinical development process, it cannot successfully continue development activities without forming alliances and capital investment or, at a certain stage, without appropriate manufacturing and marketing strategies. We reviewed a series of case studies to categorize the acquisition patterns of pharmaceutical companies that are engaged in AAV gene therapy. These results provide insights into the R&D structures for AAV gene therapies from a technological management perspective.

Superiority of Mild Interventions against COVID-19 on Public Health and Economic Measures.

(1) Background: During the global spread of COVID-19, Japan has been among the top countries to maintain a relatively low number of infections, despite implementing limited institutional interventions and its high population density. This study investigated how limited intervention policies have affected public health and economic conditions in the COVID-19 context and aimed to gain insight into the effective and sustainable measures against new infectious diseases in densely inhabited areas. (2) Methods: A system dynamics approach was employed. Qualitative causal loop analysis and stock and quantitative flow model analysis were performed, using a Tokyo Metropolitan area dataset. (3) Results: A causal loop analysis suggested that there were risks in prematurely terminating such interventions. Based on this result and the subsequent quantitative modeling, we found that the short-term effectiveness of a short-term pre-emptive stay-at-home request caused a resurgence in the number of positive cases, whereas an additional request provided a limited negative add-on effect for economic measures (e.g., number of electronic word-of-mouth communications and restaurant visits). (4) Conclusions: These findings suggest the superiority of a mild and continuous intervention as a long-term countermeasure under epidemic pressures when compared with strong intermittent interventions.

Corporate Characteristics and Adoption of Good Manufacturing Practice for Dietary Supplements in Japan.

Good manufacturing practice (GMP) is advocated and implemented as a standardized procedure for manufacturing dietary supplements. However, in Japan as a case, only half of the manufacturers in this field so far adopt it. To address this issue, the present study aims to explore the effect of key characteristics of a company on the adoption of and compliance with GMP for dietary supplements. The focus is on the effect of expertise in the pharmaceutical industry. The relationships between company characteristics and the adoption of GMP were analyzed for 90 manufacturers in the dietary supplement industry in Japan. A binomial logistic regression analysis showed that each of the following three factors had a positive and significant effect on the company's adoption of GMP: company size in terms of revenue (odds ratio = 1.04, p = 0.019), possession of a manufacturing license for pharmaceutical products (13.7, p = 0.003), and number of own product categories manufactured (3.93, p = 0.00009). These findings strongly suggest that the company's manufacturing capability of pharmaceutical products works as a key driver for the better adoption of a quality standard in the dietary supplement industry in Japan. Few considerations were made for conditions of the adoption and implementation of GMP. The present study empirically contributes by providing key clues for issues in the dietary supplement industry and by forming a theoretical base for policymakers and the regulatory authorities.

Holistic cost-effectiveness analysis of anticancer drug regimens in Japan.

Japan officially introduced cost-effectiveness analysis (CEA) in 2019, whereas some countries, such as England, Sweden, Canada, and Australia, have experience with health technology assessment (HTA). Therefore, there are few reports that comprehensively examine the situation of health economic evaluation in Japan. In this paper, we review the health economic evaluation systems among those countries. We also conducted a case study that investigated the time-trend of cost, effectiveness, and incremental cost-effectiveness ratio (ICER) for anticancer drug regimens in Japan. We found a time-trend ICER for breast cancer (BC). Additionally, molecular targeting drugs for BC had a positive effect on the ICER, and both small molecular-targeting drugs and monoclonal antibodies (mAb) had a higher ICER for BC compared with conventional drugs. Finally, we discuss a possible way to implement a health economic evaluation system in Japan.

Trends in interorganizational transactions in personalized medicine development.

Personalized medicine is an innovative concept that allows patients with a validated companion diagnosis (CoDx) to receive treatment using the most suitable drug. Currently, a major movement in the pharmaceutical industry involves the integrated use of multiple resources from external sources. To ascertain preferable interorganizational collaborations and their suitable exits, we compared the related transactions in personalized and nonpersonalized cancer drugs. We found that there were significantly more of some alliance deals in personalized medicine, and that market licenses, one of the exits, were well correlated with other alliances only in personalized medicine. Furthermore, four types of collaboration mode were identified, and more active collaborations with external partners were found to lead to more successful outcomes in personalized medicine development.

Strategic R&D transactions in personalized drug development.

Although external collaboration capability influences the development of personalized medicine, key transactions in the pharmaceutical industry have not been addressed. To explore specific trends in interorganizational transactions and key players, we longitudinally surveyed strategic transactions, comparing them with other advanced medical developments, such as antibody therapy, as controls. We found that the financing deals of start-ups have surged over the past decade, accelerating intellectual property (IP) creation. Our correlation and regression analyses identified determinants of financing deals among alliance deals, acquisition deals, patents, research and development (R&D) licenses, market licenses, and scientific papers. They showed that patents positively correlated with transactions, and that the number of R&D licenses significantly predicted financing deals. This indicates, for the first time, that start-ups and investors lead progress in personalized medicine.