Ongoing Safety Research Articles

Eighteen-Month Interim Analysis of Efficacy and Safety of Givosiran, an RNAi Therapeutic for Acute Hepatic Porphyria, in the Envision Open Label Extension

Eighteen-Month Interim Analysis of Efficacy and Safety of Givosiran, an RNAi Therapeutic for Acute Hepatic Porphyria, in the Envision Open Label Extension

A Phase Ib, Open-Label, Randomized Study to Assess Safety and Preliminary Efficacy of Tafasitamab (MOR208) or Tafasitamab + Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma: Analysis of the Safety Run-in Phase

A Phase Ib, Open-Label, Randomized Study to Assess Safety and Preliminary Efficacy of Tafasitamab (MOR208) or Tafasitamab + Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma: Analysis of the Safety Run-in Phase

Real-World Safety of Emicizumab: The First Interim Analysis of the European Haemophilia Safety Surveillance (EUHASS) Database

Introduction: Long-term data from the HAVEN 1-4 clinical trials reaffirmed the safety and efficacy of emicizumab (HEMLIBRA®) prophylaxis in persons with hemophilia A (PwHA; Callaghan M et al. ISTH 2019 presentation). However, early data from the first Phase III trial, HAVEN 1, identified a risk for thrombotic microangiopathy (TMA) or thrombotic events (TEs) when emicizumab was used alongside activated prothrombin complex concentrate (aPCC [FEIBA]; dosed on average a cumulative amount of >100 U/kg/24 hours for ≥24 hours) leading to a warning in the label and ongoing safety monitoring. European Haemophilia Safety Surveillance (EUHASS) is a large pharmacovigilance program that monitors the safety of treatments for inherited bleeding disorders. The EUHASS registry includes real-world data on the use of emicizumab in a broad, representative population of PwHA. The objective of this analysis was to summarize thrombotic, TMA, and anaphylaxis events reported to EUHASS in association with emicizumab prophylaxis. Methods: EUHASS is an investigator-led program with 86 participating centers in 27 countries, with centers reporting information on all the individuals they treat, thus minimizing selection bias. Adverse event data were collected from all PwHA in EUHASS who received emicizumab prophylaxis during 2018. EUHASS adverse event data are not collected according to Medical Dictionary for Regulatory Affairs (MedDRA) classification; however, for this exploratory analysis, events were coded at MedDRA preferred term level as far as possible; endpoints are provided as descriptive statistics. Results: Data from 148 PwHA treated with emicizumab in 2018 were included in this analysis. Concurrent treatments included recombinant activated factor VII (rFVIIa; NovoSeven®; n=23 PwHA), factor VIII, (FVIII products other than Obizur®; n=9 PwHA) and aPCC (n=1 PwHA). Two adverse events were reported in 2018 (Table 1). One event was an acute reaction (rash), reported 48 hours after dosing of a PwHA treated with emicizumab only. He recovered from the rash; the frequency was 0.7% (1/148; 95% confidence interval [CI] 0.02-3.71%). The second event was a TE-a myocardial infarction that occurred 10 hours after emicizumab dosing in a PwHA age >65 years receiving emicizumab and aPCC. The frequency of TE events was calculated as 0.7% (1/148; 95% CI 0.02-3.71%). No TMA or anaphylaxis events were reported. Conclusions: Among PwHA treated with emicizumab at centers participating in EUHASS during 2018, only two adverse events were reported and there were no cases of TMA or anaphylaxis. While a full assessment is reserved for the final analysis, these interim real-world data are not inconsistent with the adverse event profile of emicizumab observed in clinical trials. No new or emerging safety signals for emicizumab were identified. However, this analysis was limited by the low number of emicizumab treated PwHA-especially in those without FVIII inhibitors, and relatively short exposure time to emicizumab. Disclosures Shang: F. Hoffmann-La Roche Ltd: Current Employment, Current equity holder in publicly-traded company, Other: All authors received support for third party writing assistance, furnished by Scott Battle, PhD, provided by F. Hoffmann-La Roche, Basel, Switzerland.. Selak Bienz:F. Hoffmann-La Roche Ltd: Current Employment. Gadiraju:I am 50% shareholder in my own private limited company (Ravi Gadiraju Pharma Ltd): Current equity holder in private company; F. Hoffmann-La Roche Ltd, Safety Scientist (Mar 19 to current): Current Employment; Britannia Pharmaceuticals, Senior PV officer (Feb 17 to Mar 19): Ended employment in the past 24 months. Chang:Genentech, Inc.: Current Employment, Current equity holder in publicly-traded company. Kuebler:Genentech, Inc.: Current Employment, Current equity holder in publicly-traded company.

Effect of Neurofeedback and Simulation-based Training Interventions on Radiation Therapy Therapists’ (RTTs) Mental Workload, Situation Awareness, and Performance

To help with ongoing quality assurance (QA) and patient safety improvement efforts in radiation therapy (RT) the objective of this research was to assess the impact of validated Alpha-Theta neurofeedback and simulation-based training interventions on radiation therapy therapist (RTT) mental workload, situation awareness and performance during routine treatment delivery tasks. 32 RTTs completed routine QA and treatment delivery tasks on clinical scenarios in a simulation laboratory. Participants, equally randomized to 4 groups (+/- neurofeedback, +/- simulation-based training; 8 per group) had pre- and post-intervention assessments of mental workload, situation awareness, and performance. We used analysis of variance (ANOVA) to compare the four study groups. Mental workload was quantified subjectively using the NASA Task Load Index (NASA-TLX). Situation awareness was quantified subjectively using the Situation Awareness Rating Technique (SART) and objectively using Situation Awareness Global Assessment Technique (SAGAT). Performance was quantified based on procedural compliance (adherence to pre-set/standard QA time-out tasks) and error detection (detection and correction of embedded treatment planning errors). Both neurofeedback and simulation-based training interventions were associated with significant improvements in performance (p<0.01), but had no significant impact on mental workload or subjective or objective quantification of situation awareness. Innovative interventions like simulation-based training and neurofeedback might be effective tools to improve RTTs performance; which in turn can lead to improvements in patient safety.

Energy access and pandemic-resilient livelihoods: The role of solar energy safety nets

Lack of energy access undermines the socio-economic conditions of households, reducing their resilience, particularly in the face of disruptive effects of the COVID-19 pandemic. Hundreds of millions of poor rural households, who live in remote and difficult-to-reach areas, are still without access to energy. Solar energy safety nets, in the form of targeted social assistance programs and off-grid technological solutions, do not only advance energy access but also develop capacities of households to prepare for, respond to, and recover from specific threats like pandemics. We discuss ongoing solar energy safety net programs in the largest off-grid solar markets of Bangladesh, India, Kenya, and Nigeria, and how such programs are affected by the COVID-19 pandemic. We find that solar energy safety net programs should be maintained and updated to emphasize their potential for building pandemic-resilient livelihoods. These programs can be supported with efforts to build local value chains and economies based on clean electricity. Well-designed solar energy safety net policies generate multiple co-benefits, including the resilience of households to pandemics.

UPFRONT VS BAILOUT STRATEGIES OF GPIIB-IIIA ANTAGONISTS IN THE TREATMENT OF ST-ELEVATION MYOCARDIAL INFARCTION DURING PRIMARY PERCUTANEOUS CORONARY INTERVENTION IN CONTEMPORARY PRACTICE: A DUAL-CENTER ANALYSIS

While the efficacy of GpIIb-IIIa antagonists with primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI) has previously been demonstrated, its ongoing role and safety in combination with more potent P2Y12-inhibitors are unclear, such that many centers no longer use GpIIb-IIIa antatogists routinely. We therefore sought to compare outcomes between two centers with divergent approaches to their use during PPCI.

Barriers and enablers to implementation of pressure injury prevention in hospitalized adults: a mixed methods systematic review protocol.

The objective of the proposed systematic review is to determine the barriers and enablers (or facilitators) to the implementation of pressure injury prevention among adults receiving care in the hospital setting. Hospital-acquired pressure injuries are preventable; however, they remain an ongoing safety and quality health care concern in many countries. There are various evidence-based preventative interventions for pressure injuries, but their implementation in clinical practice is limited. An understanding of the different factors that support (enablers or facilitators) and inhibit (barriers) the implementation of these interventions from different perspectives is important, so that targeted strategies can be incorporated into implementation plans. This review will include quantitative, qualitative, and mixed methods studies that investigate barriers and/or enablers in relation to hospital-acquired pressure injury prevention in hospitalized adults. Only English publications will be considered, with no publication date restrictions. The systematic review will be conducted in accordance with the JBI methodology for mixed methods systematic review. Published studies will be searched in PubMed, CINAHL, Embase, PsycINFO and Scopus. Gray literature will also be considered. Critical appraisal and data extraction will be performed using standardized tools, followed by data transformation. Data synthesis will follow the convergent integrated approach.

Exposures in adult outpatients with COVID‐19 infection during early community transmission, Tennessee

Exposures in adult outpatients with COVID‐19 infection during early community transmission, Tennessee

Emerging From the COVID-19 Crisis With a Stronger Health Care Workforce

The COVID-19 pandemic has highlighted the limitations of the current health care workforce. As health care workers across the globe have been overwhelmed by the crisis, oversight entities and training programs have sought to loosen regulations to support ongoing care. Notably, however, workforce challenges preceded the current crisis. Now may be the time to address these underlying workforce challenges and emerge from the COVID-19 pandemic with a stronger health care workforce.Building upon historical exemplars in the context of the current crisis, the authors of this Perspective provide a roadmap to rapidly and safely increase the workforce for COVID-19 and beyond. The authors recommend the following: (1) a comprehensive approach to guide health care workforce development, (2) streamlining transitions to the next level of practice, (3) reciprocity among state licensing boards or national licensure, (4) payment reform to support a strengthened health care workforce, and (5) efforts by employers to ensure the ongoing safety and competence of the bolstered workforce. These steps require urgent collaboration among stakeholders commensurate with the acuity of the pandemic. Implemented together, these actions could address not only the novel challenges presented by COVID but also the underlying inadequacies of the health care workforce that must be remedied to create a healthier society.

Health Care After the COVID-19 Pandemic and the Influence of Telemedicine

Health Care After the COVID-19 Pandemic and the Influence of Telemedicine

Meta-analysis of blinded and unblinded studies for ongoing aggregate safety monitoring and evaluation

During the course of clinical development, ongoing aggregate safety monitoring and evaluation are needed to understand the evolving safety profile and to ensure effective risk-management strategies for medicinal products. CIOMS reports and global regulatory guidance (including from ICH, US FDA, and EMA) compel sponsors for assessment of safety based on aggregate data. To identify and characterize the risks of medicinal products at a program level in a more timely and informed manner, aggregate safety evaluations should combine all available information, including from ongoing blinded trials, completed unblinded trials, and other data sources. In this article, we propose two Bayesian meta-analytic approaches for synthesizing blinded and unblinded studies in order to characterize the evolving safety profile of medicinal products at the program level. With the proposed approaches, sponsors can dynamically update knowledge of their product safety profiles as data accrue. Application of the procedures to a real and a hypothetical clinical trial program are provided to illustrate how the proposed approaches can be used to analyze a pre-specified event of interest and to screen for risk-elevated events.

Seasonal Influenza Vaccination During Pregnancy and the Risk of Major Congenital Malformations in Live-born Infants: A 2010-2016 Historical Cohort Study.

BackgroundAvailable evidence indicates that seasonal inactivated influenza vaccination during pregnancy protects both the mother and her newborn and is safe. Nevertheless, ongoing safety assessments are important in sustaining vaccine uptake. Few studies have explored safety in relation to major congenital malformations (MCMs), particularly in the first trimester when most organogenesis occurs.MethodsAnonymized UK primary care data (the Clinical Practice Research Datalink), including a recently developed Pregnancy Register, were used to identify live-born singletons delivered between 2010 and 2016. Maternal influenza vaccination was determined using primary care records and stratified by trimester. Ascertainment of MCMs from infant primary care records was maximized by linkage to hospitalization data and death certificates. The relationship between vaccination and MCMs recorded in the year after delivery and in early childhood was then assessed using multivariable Cox regression.ResultsA total of 78 150 live-birth pregnancies were identified: 6872 (8.8%) were vaccinated in the first trimester, 11 678 (14.9%) in the second, and 12 931 (16.5%) in the third. Overall, 5707 live births resulted in an infant with an MCM recorded in the year after delivery and the adjusted hazard ratio when comparing first-trimester vaccination to no vaccination was 1.06 (99% CI, .94–1.19; P = .2). Results were similar for second- and third-trimester vaccination and for analyses considering MCMs recorded beyond the first birthday.ConclusionsIn this large, population-based historical cohort study there was no evidence to suggest that seasonal influenza vaccine was associated with MCMs when given in the first trimester or subsequently in pregnancy.

Voretigene Neparvovec: A Review in RPE65 Mutation-Associated Inherited Retinal Dystrophy.

Voretigene neparvovec (Luxturna®), a recombinant adeno-associated virus vector-based gene therapy, delivers a functioning copy of the human retinal pigment epithelium-specific 65kDa (RPE65) gene into retinal cells of patients with reduced or absent levels of RPE65 protein, providing the potential to restore the visual cycle. A single-dose subretinal injection of voretigene neparvovec administered in each eye is approved in several countries worldwide for the treatment of vision loss in adult and paediatric patients with confirmed biallelic RPE65 mutation-associated inherited retinal dystrophy (IRD) and with sufficient viable retinal cells. In the pivotal phase III trial, significant improvements from baseline were seen in the mean bilateral multi-luminance mobility test scores in the voretigene neparvovec group compared with the control group at 1year. The beneficial effects of voretigene neparvovec treatment were maintained after up to 4years of follow-up (with follow-up continuing for 15years). Control recipients were eligible to receive voretigene neparvovec at 1year, and showed improvements at subsequent follow-ups (≤ 3years post injection) consistent with those in patients who received voretigene neparvovec at baseline. Most adverse reactions in voretigene neparvovec recipients were transient, asymptomatic and non-serious, and resolved without sequelae (may have been related to voretigene neparvovec, the subretinal injection procedure, concomitant corticosteroid use or a combination thereof). Retinal detachment occurred in one patient at year 4. Although ongoing additional long-term efficacy and safety data are required, voretigene neparvovec is an important novel gene therapy for patients with RPE65 mutation-associated IRD and sufficient viable retinal cells.

ACS Safety Resources: How a Community of ACS Volunteers Shapes Safety

Chemical safety is a discipline that cuts across all other chemical disciplines and also impacts other laboratory sciences. It is an essential part of chemistry and continues to evolve with the science it supports. This paper provides a short background about ACS’s growing involvement with chemical safety education that stems from support from ACS leadership of passionate efforts of volunteers collaborating across many ACS organizations to develop chemical safety resources. ACS provides many chemical safety resources and programs to assist with nearly every aspect of chemical education in support of integration of safety in chemistry curricula, research, and outreach activities. This paper includes a listing of many chemical safety resources available from the ACS at little or no cost. The table of resources identifies the documents (some are printed), their electronic location on the ACS website, their intended audience, the ACS organization that developed the resource, an annotated description of the resource, and the year the current version was published. A glimpse of ongoing chemical safety products under development by ACS and its volunteers is also provided.

THU0416 PEGLOTICASE RESPONSE IMPROVEMENT BY CO-TREATMENT WITH METHOTREXATE: RESULTS FROM THE MIRROR OPEN-LABEL CLINICAL TRIAL IN PATIENTS WITH UNCONTROLLED GOUT

Background:Gout is a painful inflammatory arthritis caused by persistently elevated serum uric acid (sUA) levels. Pegloticase, an infused recombinant PEGylated uricase, rapidly lowers sUA levels by converting uric acid to allantoin, a water-soluble molecule that is readily excreted by the kidneys. In the phase 3 clinical trials, 42% of patients1dosed with pegloticase every two weeks maintained sUA levels below 6.0 mg/dL during months 3 and 6 of pegloticase treatment. The loss of pegloticase efficacy has been attributed to the development of anti-drug antibodies (ADAs)1-3and these ADAs have been associated with infusion reactions (IRs).1,2Case reports4and prospective case series5, 6indicate that methotrexate (MTX) may allow patients to attain more complete therapeutic benefits, presumably through attenuation of pegloticase immunogenicity. The current study prospectively examines the efficacy and safety of MTX-pegloticase co-therapy in patients with uncontrolled gout.Objectives:To assess efficacy and safety of concomitant pegloticase and MTX therapy in patients with uncontrolled gout.Methods:Adult patients with uncontrolled gout who were beginning pegloticase therapy were considered for enrollment in this ongoing multicenter, open-label, efficacy and safety study of pegloticase with MTX co-treatment (NCT03635957). Patients were administered oral MTX (15 mg/week) and folate (1 mg/day) 4 weeks prior to the first pegloticase infusion (Day 1) and throughout the pegloticase treatment period. Blood was drawn prior to each infusion to measure sUA level, monitor clinical parameters, and examine for ADA development. All patients followed typical IR prophylaxis protocols (fexofenadine one day before and the morning of each infusion and acetaminophen and IV corticosteroid the morning of each infusion). Patients also received gout flare prophylaxis with either NSAIDs, colchicine or prednisone initiated at least 1 week prior to Day 1. The primary study outcome was the proportion of responders, defined as sUA &lt;6 mg/dL for at least 80% of the time during month 6 (weeks 20, 22, and 24). All analyses were performed on a modified intent-to-treat population, defined as patients who received ≥1 pegloticase infusion.Results:A total of 17 patients were screened and 14 patients (all men, average age: 49.3 ± 8.7 years) were enrolled. On Day 1, mean sUA was 9.2 ± 2.5 mg/dL and 12 of the 14 patients had visible tophi. At the 6 months timepoint, 11/14 (78.6%, 95%CI 49.2-95.3%) met the responder definition, with 3 patients discontinuing after meeting stopping rules (pre-infusion sUA values greater than 6 mg/dL at 2 consecutive scheduled visits). All patients tolerated MTX. One serious AE of bacterial sepsis occurred (resolved). AEs that occurred in &gt;1 patient during the co-treatment period were: diarrhea and upper respiratory tract infection in 3 patients each, sinusitis, muscle strain, and hypertension in 2 patients each. Gout flares occurred in 12/14 (85.7%) patients. No new safety concerns were identified.Conclusion:An increased proportion of patients maintained therapeutic response at 6 months when treated concomitantly with MTX and pegloticase (78.6%) when compared to the previously reported 42% using pegloticase alone.1These results support and reflect the improved response rates demonstrated in two prior case series.5,6A definitive randomized double-blinded trial evaluating pegloticase with MTX vs. pegloticase with placebo is ongoing.

Ongoing, first-in-human, phase I dose escalation study of the investigational CD47-blocker TTI-622 in patients with advanced relapsed or refractory lymphoma.

3030 Background: CD47 is an immune checkpoint that binds signal regulatory protein alpha (SIRPα) and delivers a "do not eat" signal to suppress macrophage phagocytosis. Cancer cells frequently overexpress CD47 to escape immune surveillance. TTI-622 is a fusion protein consisting of the CD47-binding domain of human SIRPα linked to the Fc region of human IgG4. TTI-622 acts as a decoy receptor, preventing CD47 from delivering its inhibitory signal and enabling macrophage activation and anti-cancer activity via pro-phagocytic signals present on cancer cells. Unlike many CD47-blocking antibodies, TTI-622 does not bind to human erythrocytes and thus may not cause anemia in patients. Methods: In phase 1A, patients with advanced relapsed or refractory lymphoma received IV TTI-622 once per week with dose increased based on traditional 3+3 escalation. Dosing was on a mg/kg basis with the third and subsequent weekly doses approximately 2-fold higher than the first 2 doses (e.g., 0.05, 0.05, and 0.1 mg/kg for weeks 1, 2 and 3). Blood samples were obtained for PK analysis and assessment of CD47 receptor occupancy (RO) on peripheral T cells. Results: At data cut-off, 19 patients (11 M, 8 F) of median age 62 years (range, 24-86) with the following lymphomas: DLBCL 10; HL 6; and TCL, MCL and FL, 1 each, with a median of 3 prior therapies (range, 1-8) were enrolled. No DLTs have been observed in 5 dose levels (0.05 to 4.0 mg/kg). Grade ≥3 related neutropenia occurred in 2 patients; other related AEs occurring in 2 patients each included abdominal pain, fatigue, and nausea; no patients experienced a related SAE. Acute, post-dose platelet decreases occurred transiently and generally were Grade 1- 2; no related Grade ≥3 thrombocytopenia or anemia AEs have been observed. Preliminary PK data indicate a dose-proportional increase in exposure and a T1/2 of approximately 4-5 days following repeat infusions (Week 6). Preliminary biomarker data reveal approximately 60% RO at the end of the first infusion of 2 mg/kg and more sustained 24-hour RO at 1 and 2 mg/kg vs ≤ 0.8 mg/kg. To date, 1 patient with stage 4 non-GCB DLBCL (5 prior therapies) initially achieved PR by Wk 8 and CR by Wk 36, with response ongoing. Conclusions: TTI-622 is well tolerated at doses up to 4 mg/kg per week. Preliminary data indicate dose-dependent increases in PK exposure and target engagement with 1 DLBCL patient having achieved a durable, ongoing CR. Dose escalation is ongoing and additional safety, PK, biomarker and response data will be available at the time of meeting presentation. Clinical trial information: NCT03530683 .

SPEARHEAD-1: A phase II trial of ADP-A2M4 SPEAR T cells in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma.

TPS11569 Background: ADP-A2M4 specific peptide enhanced affinity receptor (SPEAR) T-cells are genetically engineered to target MAGE-A4+ tumors in the context of HLA-A*02. MAGE-A4 has been described as having high expression in synovial sarcoma (SS) and myxoid/round cell liposarcoma (MRCLS) [1, 2]. This Phase 2 trial was initiated based on the favorable benefit:risk profile of ADP-A2M4 observed in a Phase 1 trial (NCT03132922) of ADP-A2M4 which demonstrated compelling clinical responses in patients with SS. Methods: This Phase 2, open-label trial (SPEARHEAD-1; NCT04044768) is designed to evaluate the efficacy, safety and tolerability of ADP-A2M4 in patients with advanced/metastatic SS or MRCLS who are HLA-A*02 positive and whose tumors express the MAGE-A4 protein. Enrolled patients are to undergo apheresis, and their isolated T-cells are then transduced with the MAGE-A4c1032 TCR, and expanded. Prior to ADP-A2M4 infusion, patients are to receive lymphodepleting chemotherapy consisting of fludarabine (30 mg/m2/day x 4 days) and cyclophosphamide (600 mg/m2/day x 3 days). Patients are to receive 1 – 10 × 109 transduced T-cells. An independent Data Safety Monitoring Board will review ongoing safety and benefit:risk during the interventional phase of the study. Disease will be assessed by independent review per RECIST v1.1 by CT/MRI at weeks 4, 8, 12, 16, 24, and every 2 months thereafter until confirmed disease progression. As of 24 Jan 2020, there were 17 clinical sites open in the US, one in Canada, and two in Spain.

Hand sanitisers amid CoViD-19: A critical review of alcohol-based products on the market and formulation approaches to respond to increasing demand.

The world is facing a medical crisis amid the CoViD-19 pandemic and the role of adequate hygiene and hand sanitisers is inevitable in controlling the spread of infection in public places and healthcare institutions. There has been a great surge in demand for hand sanitisation products leading to shortages in their supply. A consequent increase of substandard products in the market has raised safety concerns. This article, therefore, presents a critical review of hand sanitation approaches and products available on the market in light of the scientific evidence available to date. This review also provides a range of hand sanitisation product formulations, and manufacturing instructions to allow for extemporaneous preparations at the community and hospital pharmacies during this urgent crisis. In addition, this emergent situation is expected to continue, hence hand sanitisers will be in demand for an extended time, and the availability and purchase of substandard products on the market create an ongoing safety concern. Therefore, this article shall also provide various commercial organisations, interested in stepping forward the production and marketing of hand sanitisers, with a guide on the development of products of standardised ingredients and formulations.

Investigation and verification aiming at establishing a method for evaluating the structural stability of "agricultural reservoirs"

Japan is home to more than 170,000 agricultural irrigation reservoirs, many of which were constructed as many as 400 years ago. With many of these structures built in times with less knowledge of materials and modern engineering methods, there is a great variability in both quality and structural integrity of these reservoirs. These small earth dams are managed by a variety of autonomous bodies and many are also privately owned. This means that not only are many of these reservoirs ancient, but they also vary considerably in construction and condition. Due to Japan's location on top of four tectonic plates, as many as 1,500 earthquakes occur in the island nation each year. Earthquakes and other natural disasters have a profound impact on all types of structures, from buildings and homes to roads and agricultural structures and these must be assessed and built to cope with these phenomena. The death of a little girl in the July 2018 Flood in western Japan highlighted the importance of structural safety of reservoirs to Professor Hiroshi Mori, from the Department of Agricultural and Environmental Engineering at Hirosaki University in Japan. Mori's work is focused on the development of a sounding method of surveying the embankments of agricultural irrigation reservoirs as well as a method of estimating the safety of these structures. It is necessary to carry out these safety evaluations on both existing and abolished reservoirs to ensure their ongoing safety as well as assess them for any repairs that might be required.

Evaluation of gas and particle sensors for detecting spacecraft-relevant fire emissions

Fire detection faces challenges of increasing sensitivity, accuracy, and response speed while reducing false alarms. Air quality sensors measure fire emission signatures similar to smoke detectors but are often more sensitive. Recent advancement in air quality sensors provides an opportunity to improve fire detection. This study used low-cost and research-grade gas and particle sensors to detect and characterize emissions from laboratory smoldering and flaming tests of three spacecraft-relevant materials. The electrochemical carbon monoxide (CO) sensor sensitively detected fire emissions in all but a pyrolysis test, whereas the metal oxide volatile organic compound (VOC) sensor with cross sensitivity for CO detected fire emissions in all tested cases. Several low-cost particle sensors, although saturated at high concentrations, detected smoke at low concentrations. A combination of CO/VOC and particle sensors would provide sensitive fire detection distinct from non-combustion nuisance sources. In support of the ongoing Spacecraft Fire Safety Experiments (Saffire), the DustTrak DRX aerosol monitor was evaluated for smoke measurement. It measured particle concentrations over a wide range and its single particle counting provided additional size distribution data similar to that of an optical particle counter. However, the single particle counting accuracy degraded at high concentrations due to coincidence errors.