Overcoming Engineering Challenges to Enable Commercial-Scale mRNA Vaccine Manufacturing

Increasing production capacity may necessitate the facility to cater for higher hazardous area category (e.g., H-Occupancy) design features, such as specialized building construction and potential blast zones. [...]an assessment should cover: * Quantification of flammable material use for production steps, including buffer preparation and LNP storage * Equipment and facility cleaning strategies that contribute to the facility flammable materials inventory * Impact of HVAC design to avoid hazardous atmospheres (e.g., full fresh air), use of local exhaust ventilation (LEV) or fume hoods * Solvent distribution methods (e.g., closed solvent delivery and waste removal systems) * Location of solvent bulk storage outside of the processing area/ facility, and piping in what is necessary plus removing spent solvent in a timely manner (e.g., piped transfer to a waste tank for removal by a specialist contractor). At present, the process cannot be fully single-use, so thought needs to be put into the cleaning and sterilization processes, plus the analytical support infrastructure needed for reusable product-contact surfaces. [...]it is recommended that for each mRNA project, consideration is given to the following aspects to determine the link between the equipment available and the facility design: * Need for custom/proprietary equipment * Independent production rooms with "through-wall" buffer transfer through iris ports in from logistics corridor (Buffer Prep/Hold) * Room electrical classification needs versus process step. * Equipment selection versus electrical and fire code requirements * Benefits and limitations of implementing single-use technologies, given that the process will be hybrid (with stainless steel). [...]the limited capacity for outsourcing of supporting functions, such as facility environmental monitoring or product sterility testing, should be considered during concept design.

Interdisciplinary Teaching Reform of Financial Engineering Majors Based on the Analytic Hierarchy Process in the Post-Pandemic Era

In the post-epidemic era, the labor market has become increasingly complex, making it even more crucial to incorporate sustainability into employment demand. As we enter the post-pandemic era, a globalization trend has become more apparent. It is crucial to modernize employability through educational reform in order to assist employees in enhancing their professional skills. This study began by analyzing the importance of financial engineering practice instruction and graduate employability in the post-epidemic era. Second, the study proposed the content and a plan for inter-disciplinary teaching reform to address talent cultivation needs based on labor market requirements. Third, a face-to-face survey and interview were conducted with students affected by changes in teaching, and the results were analyzed and summarized. On this basis, the impact of education reform was evaluated using both the expert scoring method and the analytic hierarchy approach. The results indicated that the suggested financial engineering teaching reform program improved the school's discipline strength, enrollment rate, employment rate, and competition awards, especially discipline strength. This research can be used to inform the teaching of financial engineering majors in various countries, assist job candidates in enhancing their professional skills, and build a formidable talent pool for the labor market.

Telecommuting and Teleworking (Teleportability): A Sustainable Socio-Economic Transformation Mechanism in the Post COVID-19 Era

Organizations, societies, and economies are the scope of sustainability in every community. The growing realization of electronically-enabled business as critical drivers of sustainable economic growth and development especially during crisis is no doubt propelling nations into harnessing the benefits of enterpreneural transformation in the 21st century and post covid-19 era. Teleworking and Telecommuting are technologies that have the ability to enable ubiquitous digital service transmissions needed to combat and curtail the prevalence of pandemics such as Covid-19. Capabilities of telecommuting can be effectively utilized to address the challenges associated with Covid-19 presently and in the post covid-19 era including threats in war-turned geographical spaces. However, there is the paucity of such knowledge, orientation and awareness amongst entrepreneurs, industries and companies in developing countries like Nigeria. This lacuna, if properly bridged will help unpack the link between production, consumption and service delivery in an emerging economy. This paper examines the notional impact of the concept of telecommuting and teleworking as a mechanism for a sustainable economic transformation and global repositioning of the work force beyond the covid crisis. Furthermore, it analyzes and juxtaposes the readibility of business environments to ensure their employee's safety in the work place and remote working, thus providing continuity to economic, productive and business activity. This conceptual study uses the interpretive paradigm, through deductive analysis to draw the conclusion that there is a very poor level of deployment of telecommuting and teleworking models in countries like Nigeria during crisis and pandemics and therefore recommends that organizations adopt this mechanism to propel safety of the workforce and reduce cost. With the approval for the operation of the 5G network in the Nigerian telecommunications space, entrepreneurs can explore the gains to sustain remote working or working from home in the post-covid-19 era.

Behavior of Science and Engineering Students to Digital Reading: Educational Disruption and Beyond

This paper investigates the impact of digital reading during educational disruption on science and engineering students' learning experience. Before the pandemic, some studies explored whether university students preferred using printed or digital resources for their academic readings. Amidst the pandemic, online learning became essential. Several studies showed students' preference for printed text. This paper extends a pilot study that was conducted during the first COVID-19 wave in China. A survey consisting of Likert questions and open questions was designed using MS-Forms. The survey was shared with the science and engineering students in Years 2–4 (Levels 1–3) of their study at SWJTU-Leeds Joint School, Southwest Jiaotong University in Chengdu, China. This covered students from four undergraduate programs: Civil Engineering with Transport, Electronic and Electrical Engineering, Mechanical Engineering, and Computer Science. In total, 223 students participated in this study. The survey was anonymous and was made available to students for a month. The participation rate is nearly 27%. Findings indicate that the behavior of science and engineering students toward digital reading was different than other majors, and it is generally favorable. The necessity for online learning during educational disruption has encouraged some students to develop their digital reading skills. © 2023 by the authors.

FDA'S 'GOLD STANDARD' CRITICAL FOR BIOPHARMA R&D

Last week, eight prominent biotech industry executives publicly emphasized the importance of rigorous clinical research and complete study data to support any authorization or approval of a new covid vaccine or treatment. Hahn raises concerns These statements aim to offset fears that fda might soften its approval standards due to pressure from the White House to make available a covid vaccine in October. Continuing predictions from the White House about a vaccine being available in two months, and instructions from the Centers for Disease Control and Prevention (CDC) that state public health departments should be prepared to distribute a vaccine by the end of October, heightened concerns that political pressure will lead to some kind of authorization of a new vaccine before the Nov. 3 election.

Impact of Modality on Workload among Engineering Undergraduates during the COVID-19 Pandemic

The COVID-19 pandemic created unprecedented disruptions in models for engineering student training. At The Citadel, an undergraduate-focused college in the Southeastern United States, a variety of modalities were implemented following the onset of the pandemic, including emergency online and Hyflex learning. We conducted a longitudinal study to analyze the cognitive load among our undergraduate engineering students throughout changing modalities. Using data from the NASA Task Load Index (TLX) and open-ended reflections on student challenges, we found that total workload (a surrogate for cognitive load) was generally highest during emergency online learning in the second half of Spring 2020 semester, with experiences possibly varying across different demographic and academic groups. Emergency online challenges were often related to time management, personal organization, and responsibility for learning. In contrast, HyFlex challenges were often related to technology and communication challenges. While emergency online learning was a cognitive load disruption, that disruption was often associated with personal and/or academic development. HyFlex learning mediated cognitive load disruption;although, student challenges may have been simple nuisances rather than mediators of developmental change. © 2023 American Society of Civil Engineers.

Applying blockchain technology to ensure compliance with sustainability standards in the PPE multi-tier supply chain

Because of the Covid-19 pandemic, urgent surging demand for healthcare products such as personal protective equipment (PPE) has caused significant challenges for multi-tier supply chain management. Although a given firm may predominantly focus on an arms-length solution by targeting the first-tier supplier, the firm can still struggle with extended multi-tier suppliers it cannot choose which use unsustainable practices. One key goal is compliance across various dimensions with production, environmental and labour standards across the multi-tier supply chain, a goal that blockchain technology can be applied to manage. Based on a comprehensive literature review, this research develops a system architecture of blockchain-based multi-tier sustainable supply chain management in the PPE industry designed to identify and coordinate standards in production and social and environmental sustainability in multi-tier PPE supply chains. The architecture was validated by theoretical basis, expert opinions and technical solutions. We conclude with managerial implications for implementing blockchain technology to advance sustainable multi-tier supply chain practices.

Changes in Internet use during the COVID-19 confinement in Ecuador, Peru, Colombia and Argentina

the CoVid-19 pandemic drastically changed different aspects of the daily lives of millions of people, generating an increase in the use of the internet for maintaining social contact, teleworking or online studies. this study explores the extent to which the internet connection pattern changed during the CoVid-19 confinement in a sample of adults from four latin american countries, considering gender and age. a descriptive study was carried out, including a non-probabilistic convenience sample design. the final sample was comprised of 1488 participants. this analysis shows that internet habits changed in terms of frequency, duration, and time of use. We observe differences when it comes to gender and age. in women, the increases in use are greater for the different variables analyzed, especially for the frequency of connection at night. in terms of age, the younger the age, the greater the increase in internet connection time throughout the day and connection time at night. (PsycInfo Database Record (c) 2023 APA, all rights reserved) (Spanish) la pandemia de CoVid-19 cambio drasticamente diferentes aspectos de la vida cotidiana de millones de personas, generando un incremento del uso de internet para el mantenimiento del contacto social, el teletrabajo o los estudios online. en este articulo se evalua en que medida presento cambios el patron de conexion a internet durante el confinamiento por CoVid-19 en una muestra de adultos de cuatro paises de america latina, considerando el sexo y la edad. se propuso un estudio descriptivo, con diseno no probabilistico de muestreo por conveniencia. la muestra final quedo compuesta por 1488 participantes. el analisis muestra que los habitos de conexion a internet se modificaron en terminos de frecuencia, duracion y horarios, observandose diferencias en funcion del sexo y la edad. en mujeres son mayores los incrementos de uso para las distintas variables analizadas, especialmente para la frecuencia de conexion nocturna. en cuanto a la edad, a menor edad se observa un mayor aumento del tiempo de conexion a internet a lo largo del dia y de conexion en horario nocturno. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

How Frauds in Times of Crisis Target People

While there are no new frauds, internet technology provides new opportunities for fraudsters by facilitating volumes of attacks that law enforcement then struggles to address. Moreover, since context can affect how potential victims respond to frauds, crisis context influences how fraudsters design frauds. This article assesses fraudsters' fraud design strategies during two external crisis events that impacted Australia: The Black Summer Bushfires that occurred from September 2019 to March 2020 and the onset and first year of the COVID-19 pandemic that occurred from January 2020 through January 2021. Targets, during these crises, were more likely to be vulnerable according to Steinmetz's model victim for social engineering framework. This study shows that, in both crises, fraudsters deployed the social engineering techniques of "authority” and "scarcity,” techniques that are more likely to be successful based solely on initial contact. Fraudsters designed their requests to be easily actioned and crafted their scams to reference very recent events as the external crisis events evolved. Thus, they targeted broad audiences with minimal personal involvement. Furthermore, this study shows that fraudsters, when disseminating their scams via social media outlets, attempted to build "social proof” to expand their potential victim pool to include the marks' social circles.

Rebadging Gains Momentum Amidst COVID

Rebadging also reduces fixed or direct costs for clients, as well as the legal risks associated with using contractors in full-time, long-term engagements. * Employees are assured secure employment, re-assigned back to their original employer (as a vendor contractor) or via new positions within the FSP vendor. * Vendors find rebadging not only an important source of revenue, but also gain broader access to top-level talent, critical for any successful service provider. While FSP models with or without rebadging are ultimately about capacity management, the best vendors deliver wide-ranging value to help the client: * retain access to a dedicated team of full-time equivalent (FTE) staff for a broad range of services (data management, medical writing, program leadership, clinical supplies, regulatory, clinical monitoring, statistics, medical, etc.). * increase flexibility, including on-demand access to time and materials (T&M) or unit-based models that can deliver services with work volume that does not require dedicated FTEs. * access additional vendor expert staff from across the globe and shift or centralize services to increase efficiency, reduce timelines and save costs. * accelerate and optimize key HR processes, including hiring, onboarding and training. [...]in the EU and elsewhere, ARD-type regulations are in place to help ensure employers don't take advantage of their employees by offshoring their work or forcing them to rebadge with lower salaries and benefits. [...]joining a successful FSP vendor gives the employees a range of value beyond job security. Vendors The global market for outsourced clinical development services to CROs, including FSP providers, is estimated at approximately US $44.3 billion, and projected to grow to US $57.2 billion by 2024 (CAGR: 6.5%).'

Pfizer's Idea Orchard

Recognizing reality, Uwe Schoenbeck, PhD, senior vice president and chief scientific officer for Emerging Science & Innovation (ES&I) at Pfizer, has synthesized and made functional core lessons from two of the past decade's best business books: According to Schoenbeck, ESLs are highly experienced in the relevant disease area and embedded within the respective therapeutic areas, resulting in high strategic alignment of the opportunity being sourced and avoiding opportunities that are not a strategic fit (1). The ES&I team, in conjunction with colleagues working in Business Development, has stood out for bringing genuinely creative partnership ideas and innovations into an already creative and crowded environment. [...]a collaboration with Codex DNA will potentially streamline the mRNA production process by facilitating synthetic DNA assembly, another notable fruit of the team's labour to bring forth a competitive pipeline in gene therapy.

Flipped online approach with learning analytics for supporting higher education students' learning. Course feedback results

Using learning analytics and dispositional learning analytics in teaching is difficult. Examples of their use are required for higher educational institutions and teachers. In this paper, we present a flipped learning approach in online settings (due to COVID-19) with particular emphasis on learning analytics and dispositional learning analytics. For this, an understanding of flipped approaches (i.e., flipped classroom and flipped learning) as well as the role of technology in the teaching context is required and presented. The role of technology includes (1) a digital learning system, (2) a conferencing system, (3) the collection and use of learning analytics and dispositional learning analytics, and (4) content-specific technology. Additionally, our aim is to present students' course feedback results from quantitative research methods course practices (2020, 2021) for preservice teachers (i.e., students;N = 70). The content is highly challenging for these students, causing fear, frustration, anxiety, and boredom. Generally, the results for pedagogy were positive, but the results of students' learning perceptions were lower. Based on the approach and results, discussion with new insights is provided. © 2022 Copyright for this paper by its authors. Use permitted under Creative Commons License Attribution 4.0 International (CC BY 4.0). CEUR Workshop Proceedings (CEUR-WS.org)

Unraveling the Impact of COVID-19 Pandemic Dynamics on Commercial Water-Use Variation

Water use was impacted significantly by the COVID-19 pandemic. Although previous studies quantitatively investigated the effects of COVID-19 on water use, the relationship between water-use variation and COVID-19 dynamics (i.e., the spatial-temporal characteristics of COVID-19 cases) has received less attention. This study developed a two-step methodology to unravel the impact of COVID-19 pandemic dynamics on water-use variation. First, using a water-use prediction model, the water-use change percentage (WUCP) indicator, which was calculated as the relative difference between modeled and observed water use, i.e., water-use variation, was used to quantify the COVID-19 effects on water use. Second, two indicators, i.e., the number of existing confirmed cases (NECC) and the spatial risk index (SRI), were applied to characterize pandemic dynamics, and the quantitative relationship between WUCP and pandemic dynamics was examined by means of regression analysis. We collected and analyzed 6-year commercial water-use data from smart meters of Zhongshan District in Dalian City, Northeast China. The results indicate that commercial water use decreased significantly, with an average WUCP of 59.4%, 54.4%, and 45.7%during the three pandemic waves, respectively, in Dalian. Regression analysis showed that there was a positive linear relationship between water-use changes (i.e., WUCP) and pandemic dynamics (i.e., NECC and SRI). Both the number of COVID-19 cases and their spatial distribution impacted commercial water use, and the effects were weakened by restriction strategy improvement, and the accumulation of experience and knowledge about COVID-19. This study provides an in-depth understanding of the impact of COVID-19 dynamics on commercial water use. The results can be used to help predict water demand under during future pandemic periods or other types of natural and human-made disturbance.

Blending Academic Writing: The Use of Technology to teach amid Covid-19 Pandemic

Due to the Covid-19 pandemic, teachers have to hesitantly switch to the virtual world of teaching, known as enriched virtual blended learning in which technology, surely plays a significant role in material delivery and discussion. Studies related to blended learning in English language classes, especially in academic writing classes, have been done in many countries, but they are still lacking in the Indonesian setting. This study aimed to investigate the effectiveness of technology utilization in enriched blended learning to teach academic writing and the students' perspectives towards the use of technology in blended learning. This study involving forty-five students in a university in Jakarta applied both quantitative and qualitative methods. A pre-test and a post-test were assigned before and after the blended learning period to study the effectiveness of blended learning. In addition, surveys and interviews were conducted to investigate the students' perspectives. The results indicated that the use of technology in blended learning effectively helped students develop their academic writing skills despite being a new experience. Furthermore, despite some limitations, this strategy of using technology in teaching-learning was accepted with optimism as they started to get accustomed to it. Hence, the use of technology is promising for the future of learning. © 2023 IEEE.

Modeling of Physical Activity Behavioral Interventions Relying on MPC Strategy

Physical inactivity is becoming an important threat to public health in today's society. The COVID-19 pandemic has also reduced physical activity (PA) levels given all the restrictions imposed worldwide. In this work, physical activity interventions supported by mobile devices and relying on control engineering principles were proposed. The model was constructed relying on previous studies that consider a fluid analogy of Social Cognitive Theory (SCT), which is a psychological theory that describes how people acquire and maintain certain behaviors, including health-promoting behaviors, through the interplay of personal, environmental, and behavioral factors. The obtained model was validated using secondary data (collected earlier) from a real intervention with a group of male subjects in Great Britain. The present model was extended with new technology for a better understanding of behavior change interventions. This involved the use of applications, such as phone-based ecological momentary assessments, to collect behavioral data and the inclusion of simulations with logical reward conditions for reaching the behavioral threshold. A goal of 10,000 steps per day is recommended due to the significant link observed between higher daily step counts and lower mortality risk. The intervention was designed using a Model Predictive Control (MPC) algorithm configured to obtain a desired performance. The system was tested and validated using simulation scenarios that resemble different situations that may occur in a real setting.

Smart-thing design by children at a distance: How to engage them and make them learn

In recent years, research in Child-Computer Interaction has shifted the focus from design with children, giving them a voice in the design process, to design by children to bring child participants different benefits, such as engagement and learning. However, design workshops, encompassing different stages, are challenging in terms of engagement and learning, e.g., they require prolonged commitment and concentration. They are potentially more challenging when held at a distance, as in recent years due to the COVID-19 pandemic. This paper explores at-a-distance smart-thing design by children, how it can engage different children and support their learning in programming. The paper reports a series of design workshops with 20 children, aged from 8 to 16 years old, all held at a distance. They were all organised with the DigiSNaP design framework and toolkit. The first workshop enabled children to explore what smart things are, to start ideating their own smart things and to scaffold their programming. The other workshops enabled children to evolve their own smart-thing ideas and programs. Data were gathered in relation to children's engagement and learning from different sources. Results are promising for future editions of smart-thing design at a distance or in a hybrid modality. They are discussed along with guidelines for smart-thing design by children at a distance. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Design for an Intelligent Waste Classifying System: A Case Study of Plastic Bottles

The use of plastic bottles has become a significant environmental concern, and recycling them has become a priority. Small and medium-sized recycling companies must collect and categorize large volumes of plastic bottles and sell them to larger recycling firms, a process that is time-consuming, costly, and labor-intensive. This manual sorting process can pose health risks, particularly during the COVID-19 pandemic, and can affect worker productivity. To address these issues, this study proposes the development of an automated conveyor belt system that can rapidly and accurately separate plastic bottles by type. The system utilizes an opaque and transparent plastic bottle separation platform, which saves time, cost, and manpower. This system design provides recycling SMEs with a competitive advantage by serving as a practical application model and a prototype with an easy-to-use concept. Key tools employed in this research include product design development (PDD), Kansei engineering, manufacturing process design, controlling system, and fault tree analysis (FTA). The light sensors are critical components in the separation process, detecting the opacity or transparency of the bottles' surfaces. The proposed prototype's reliability will be assessed by FTA, which considers all potential failures. This study contributes to the body of knowledge surrounding the integration of conveyor systems and provides valuable information for businesses seeking to optimize their sorting processes. The guidelines developed in this study can serve as a starting point for further research on the integration of conveyors in waste sorting plants. © 2013 IEEE.

Student-teacher out-of-class communication on engineering courses during the COVID-19 pandemic: from face-to-face to videocalls

Out-of-class communication between teachers and students is essential throughout university engineering courses for in-depth explanations of the concepts covered in class. This study evaluates this aspect throughout the COVID-19 pandemic. Thus, a survey that addressed this issue was administered to students at the beginning (March 2020) and at the end (May 2020) of the COVID-19 lockdown in Spain, and at the end of each semester of the 2020/21 and 2021/22 academic years. The results were analyzed with statistical, qualitative, and mixed methods. E-mail usage was widely observed at the beginning of the pandemic, while the use of online videoconferencing tools progressed during that time, thanks to their temporal and spatial flexibility, and the direct and personal nature of student-teacher contact through those channels. Its success was linked to the prior training of teachers in the use of videoconferencing, the establishment of fixed schedules for the meetings, and the use of digital whiteboards that instantaneously display writing when discussing problems. According to the opinions of students, videocalls could be used for questions on theoretical and easy practical aspects despite the resumption of out-of-class face-to-face meetings. Videoconferencing tools for educational communication between engineering students and teachers seem to be here to stay. © 2023 Informa UK Limited, trading as Taylor & Francis Group.

Moving Clinical Operations Forward During Pandemic

In the short and long term, sponsors should think through: * Protocol modifications to incorporate remote patient and site assessments or other virtual elements. * Patient visit requirements and anticipated data collection challenges. * Effective resumption of activities when the pandemic situation improves. * Improvements to risk management planning.8 * Overall impact on clinical trial and clinical program timelines (including time to approval). [...]each passing day brings new information about the spread of COVID-19 globally. [...]to plan for the short and long term, sponsors should go back to the drawing board and reevaluate overall clinical study design, including patient eligibility, feasibility, enrollment, timelines, and budgets against the evolving global landscape. [...]alarming projections indicate that socialdistancing countermeasures may need to be in place well into 20219, which means that biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.

Artificial Intelligence-Based Smart Tele-Assisting Technology for First-Year Engineering Students

Engineering programs emphasize students career advancement by ensuring that engineering students gain technical and professional capabilities during their four-year study. In a traditional engineering laboratory, students "learn by doing", and laboratory equipment facilitates their discipline-specific knowledge acquisition. Unfortunately, there were significant educational uncertainties, such as COVID-19, which halted laboratory activities for an extended period, causing challenges for students to perform and obtain practical experiments on campus. To overcome these challenges, this research proposes and develops an Artificial Intelligence-based smart tele-assisting technology application to digitalize first-year engineering students practical experience by incorporating Augmented Reality (AR) and Machine Learning (ML) algorithms using the HoloLens 2. This application improves virtual procedural demonstrations and assists first-year engineering students in conducting practical activities remotely. This research also applies various machine learning algorithms to identify and classify different images of electronic components and detect the positions of each component on the breadboard (using the HoloLens 2). Based on a comparative analysis of machine learning algorithms, a hybrid CNN-SVM (Convolutional Neural Network - Support Vector Machine) model is developed and is observed that a hybrid model provides the highest average prediction accuracy compared to other machine learning algorithms. With the help of AR (HoloLens 2) and the hybrid CNN-SVM model, this research allows students to reduce component placement errors on a breadboard and increases students competencies, decision-making abilities, and technical skills to conduct simple laboratory practices remotely. © 2023 IEEE.