CSL (Japan)

Summary: Peace Winds (PW) is an international NGO that provides humanitarian aid to people facing crises worldwide. ARROWS (Airborne Rescue and Relief Operations With Search), a part of PW’s project, supports victims of man made and natural disasters. On January 1, 2024, the Noto Peninsula in Japan suffered a magnitude 7.6 earthquake. During that time, the PW staff and rosters (registered members) were dispatched to the affected area to provide disaster relief. This study aims to discuss the importance of a standardized handover process during humanitarian aid and identify the potential improvements to enhance effective disaster relief activities from the rosters’ perspective for future catastrophes. During the initial relief efforts, the PW staff and the rosters started gathering accurate information, evaluating the victims’ needs, and planning the next steps. However, due to the ever-changing nature of the situation, they needed to adapt to different tasks, which changed day by day. The rosters working on the next phase recognized the need to establish a standardized handover procedure to delegate responsibilities to later-joining rosters effectively. This structured handover process provided a clear overview of the relief efforts to the rosters involved at different times and for different durations. While the handover procedure was successfully created during this response, it could have been further optimized if it had been introduced from the onset of the activities. Thus, the handover process should be discussed in advance between the PW staff and the rosters during preparatory training. This approach may also apply to other organizations with similar personnel structures. An efficient handover process is crucial for disaster management. By discussing responsibility delegation and simulating the handover procedure during preparatory training, cooperation in the actual humanitarian activities could be optimized.

Garadacimab, an activated factor XII (FXIIa) inhibitor monoclonal antibody, is being evaluated for the long‐term prophylaxis of hereditary angioedema. Here, we report the results from a two‐part, phase 1, open‐label, single ascending dose study assessing the pharmacokinetics (PK), pharmacodynamics, safety, and tolerability after subcutaneous (SC) and intravenous (IV) administration of garadacimab in healthy Japanese and White participants. Part 1 assessed garadacimab PK after SC administration of a 200 mg dose in weight‐matched White and Japanese participants, and 600 mg dose in Japanese participants. Part 2 assessed 3 and 10 mg/kg IV doses in Japanese participants. Follow‐up for safety was over 84 days post‐dose. Overall, 37 participants received garadacimab dosing and 36 completed the study, with one participant lost to follow‐up. Following SC administration, time to maximum plasma concentration (tmax) occurred at 7 days post‐dose, and garadacimab exposure, based on maximum plasma concentration (Cmax) and area under the plasma concentration–time curve (AUC), increased less than 3‐fold when tripling the dose. PK was comparable between Japanese and White participants, with geometric mean ratios for Cmax and AUC close to 100%. Following IV administration, tmax occurred at the end of infusion, and garadacimab exposure increased in a dose‐proportional manner. Inhibition of FXIIa‐mediated kallikrein activity versus baseline was observed in all participants receiving the SC and IV doses. No anti‐drug antibodies against garadacimab were reported. Consistent with pivotal phase 3 (VANGUARD) outcomes, no safety concerns and no difference in the safety profile of garadacimab were observed between healthy Japanese and White participants.

The importance of data-centric decision-making has amplified the role of enterprise data warehousing solutions, leading to an increased demand for the ingestion of data from diverse sources in recent times. SAP BW/4HANA, an on-premises packaged data warehousing solutionfrom SAP offers advanced and flexible data ingestion capabilities to integrate heterogeneous data sources into a unified repository. This paper explores the various data ingestion mechanisms available in SAP BW/4HANA. It reviews the native SAP HANA-based Operational Data Provisioning framework that enhances extraction efficiency. The paper also examines the different source system types supported, including Operational Data Provisioning, SAP HANA, Big Data, and flat files. Additionally, it analyses the batch, real-time and hybrid ingestion patterns facilitated by SAP BW/4HANA. Data provisioning directly with SAP HANA database using tools like SAP Data Services is also discussed. Recommendations are provided for efficient data ingestion based on real-world implementation experience. The insights presented will equip technical teams with comprehensive knowledge regarding ingestion architectures in SAP BW/4HANA aligned to their integration and analytics requirements. By leveraging appropriate ingestion strategies, organizations can optimize the performance of their SAP BW/4HANA implementation and accelerate data-driven business innovation.

Reducing glycosylated hemoglobin (HbA1c) to near or less than 7% in patients with diabetes is associated with diminished microvascular complications, but this level is not consistently achieved. The purpose of this study was to examine the relationship between fluctuations in HbA1c and changes in estimated glomerular filtration rate (eGFR) and estimated stage of chronic kidney disease (CKD) in an academic primary care practice. We analyzed data from 791 diabetic primary care patients (25% white; 75% African American) enrolled between 1998 to 2002 and followed through 2008 (mean follow-up, 7.6 ± 1.9 years). We calculated baseline and final follow-up eGFR using the Modification of Diet in Renal Disease equation. We examined the relationship between fluctuations in HbA1c and changes in eGFR and stage of CKD using multivariable linear and logistic regression models that controlled for demographic and clinical variables associated with CKD progression. From baseline to follow-up, mean eGFR in African Americans declined to a greater extent and more rapidly than in whites. Age, mean systolic blood pressure, initial HbA1c, initial eGFR, and number of HbA1c values (all P<.01) were significant predictors of change in eGFR. Among HbA1c fluctuation measures, the strongest predictor of change in eGFR was the proportion of HbA1c values >7% (P=.02); however, this contributed little to explaining model variance. These data suggest that traditional demographic and clinical risk factors remain significantly associated with changes in eGFR and that the pattern of variability in HbA1c is only modestly important in contributing to changes in eGFR among African-American and white diabetic patients in primary care.

The nuclear signaling evoked by phosphoinositide‐ specific‐phospholipase C (PI‐PLC)beta1 targets specific regions of Cyclin D3 as well CD24 promoter, hinting at a role in haematopoiesis, given that both Cyclin D3 and CD24 are involved in the very early steps of this process. PI‐PLCbeta1 could also play a role in the progression of Myelodysplastic Syndromes (MDS) into Acute Myeloid Leukemia (AML) since the mono‐allelic deletion of PI‐PLC beta1 is responsible in MDS patients for a higher risk of evolution to AML. Given that a single patient treated with azacitidine, a DNA methyltransferase inhibitor, displayed a direct correlation between PI‐PLCbeta1 gene expression and drug responsiveness, we hypothesized that PI‐PLCbeta1 could be a target for demethylating therapy. By quantifying the degree of PI‐PLCbeta1 methylation and gene expression in MDS patients at baseline and during azacitidine administration we found an increase of PI‐PLCbeta1 mRNA in responder patients and a reduction of promoter methylation. The molecular response correlated to and anticipated the clinical one, suggesting that PI‐PLCbeta1 gene reactivation predicts azacitidine responsiveness. Our results demonstrate for the first time that PI‐PLCbeta1 promoter is hypermethylated in high‐risk MDS patients and that the amount of PI‐PLCbeta1 mRNA predicts the clinical response to azacitidine.

月太陽発電「ルナリング」構想は,工ネルギを化石燃料に依存するパラダイムから,月からの無限に近いクリーンエネルギを自由に使うという発想へ転換するものである.本構想では月の赤道を周回する太陽電池を設置し,発電した電力をマイクロ波などで地上へ伝送する-人類が使う工ネルギの全部の量を月から送り電力供給と水素製造を行う.食糧・水の確保や水素社会が促進されると同時に化石燃料の燃焼を停止させ炭酸ガスの排出を低下させる.実現には宇宙太陽発電システムや月資源探査,月面での製造技術が必要.月面口ポットや有人施設だけでなく,国際的な協定・合意など法制面の確立も必要.清水建設の20余年にわたる宇宙建設研究をべ-スに夢のある将来像を描いた.