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.

Impact of (long) COVID on athletes' performance: a prospective study in elite football players.

OBJECTIVES: To investigate possible persistent performance deficits after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in elite athletes. METHODS: A prospective cohort study in three Belgian professional male football teams was performed during the 2020 - 2021 season. Participants were submitted to strength, jump, and sprint tests and an aerobic performance test (the Yo-Yo Intermittent Recovery test (YYIR)). These tests were repeated at fixed time intervals throughout the season. Assessment of SARS-CoV-2 infection was performed by a polymerase chain reaction (PCR) test before each official game. RESULTS: Of the 84 included participants, 22 were infected with SARS-CoV-2 during follow-up. At the first testing after infection (52.0 ± 11.2 days after positive PCR testing) significantly higher percentages of maximal heart rate (%HRmax) were seen - within the isolated group of infected players- during (p = .006) and after the YYIR (2 min after, p = .013), compared to pre-infection data. This increase in %HRmax was resolved at the second YYIR testing after infection (127.6 ± 33.1 days after positive PCR testing). Additionally, when comparing the first test after infection in formerly infected to non-infected athletes, significantly higher %HRmax were found during (p < .001) and after the YYIR test (p < .001),No significant deficits were found for the jump, muscular strength or sprint tests.Aerobic performance seems compromised even weeks after infection. Simultaneously, anaerobic performance seemed to be spared. Because of the potential detrimental effects on the immune system, caution might be advised with high-intensity exposure until aerobic performance is restored.KEY MESSAGESElite football players' aerobic performance seems to be affected for weeks after they return to sports after a SARS-CoV-2 infection.Similarly, anaerobic performance tests showed no discernible changes between both before and after SARS-CoV-2 infections.Regular YYIR testing is recommended to monitor aerobic performance after SARS-CoV-2 infection.

Embedding rapid reviews in health policy and systems decision-making: Impacts and lessons learned from four low- and middle-income countries.

BACKGROUND: Demand for rapid evidence-based syntheses to inform health policy and systems decision-making has increased worldwide, including in low- and middle-income countries (LMICs). To promote use of rapid syntheses in LMICs, the WHO's Alliance for Health Policy and Systems Research (AHPSR) created the Embedding Rapid Reviews in Health Systems Decision-Making (ERA) Initiative. Following a call for proposals, four LMICs were selected (Georgia, India, Malaysia and Zimbabwe) and supported for 1 year to embed rapid response platforms within a public institution with a health policy or systems decision-making mandate. METHODS: While the selected platforms had experience in health policy and systems research and evidence syntheses, platforms were less confident conducting rapid evidence syntheses. A technical assistance centre (TAC) was created from the outset to develop and lead a capacity-strengthening program for rapid syntheses, tailored to the platforms based on their original proposals and needs as assessed in a baseline questionnaire. The program included training in rapid synthesis methods, as well as generating synthesis demand, engaging knowledge users and ensuring knowledge uptake. Modalities included live training webinars, in-country workshops and support through phone, email and an online platform. LMICs provided regular updates on policy-makers' requests and the rapid products provided, as well as barriers, facilitators and impacts. Post-initiative, platforms were surveyed. RESULTS: Platforms provided rapid syntheses across a range of AHPSR themes, and successfully engaged national- and state-level policy-makers. Examples of substantial policy impact were observed, including for COVID-19. Although the post-initiative survey response rate was low, three quarters of those responding felt confident in their ability to conduct a rapid evidence synthesis. Lessons learned coalesced around three themes - the importance of context-specific expertise in conducting reviews, facilitating cross-platform learning, and planning for platform sustainability. CONCLUSIONS: The ERA initiative successfully established rapid response platforms in four LMICs. The short timeframe limited the number of rapid products produced, but there were examples of substantial impact and growing demand. We emphasize that LMICs can and should be involved not only in identifying and articulating needs but as co-designers in their own capacity-strengthening programs. More time is required to assess whether these platforms will be sustained for the long-term.

Mitigating the Risk of Digital Financial Exploitation.

The article by Zhang and colleagues in this issue of The Journal calls attention to an important but underrecognized problem facing today's seniors and their loved ones. The risk of digital financial exploitation, particularly in the wake of the COVID-19 pandemic, has risen considerably in recent years and continues to rise today. Zhang et al. provide a helpful analysis of assessment tools currently available to forensic psychiatrists for the evaluation of financial capacity. Although many of these tools were not originally intended to encompass technologically based transactions, the risks of fraud and scams associated with payment apps, social media, and electronic fund transfers are considerable and growing. Fraudsters frequently target vulnerable older adults, and victims have lost large sums through some of the more prevalent schemes. Several strategies can help to mitigate the risk of severe losses and to increase the likelihood that lost assets can be recovered. Proactive education through increased awareness will prove helpful, but given the growing sophistication of modern digital cons, such as romance scams, increased technological safeguards are warranted in the setting of reduced financial capacity. When losses do occur, there are some resources for recovery and for filing complaints against perpetrators.

Cardiorespiratory Response to Six-Minute Step Test in Post COVID-19 Patients-A Cross Sectional Study.

BACKGROUND AND PURPOSE: New coronavirus disease 2019 (COVID-19) can cause persistent symptoms and physical weakness that can lead to a limitation in activities of daily living (ADL). There is a lack of evidence about the performance in the six-minute step test (6MST) of post-COVID-19 patients and healthy subjects. The aim of this study is to investigate the cardiorespiratory response induced by the 6MST in post-COVID-19 patients and compare it with the response of the six-minute walk test (6MWT). METHODS: This cross-sectional study was conducted on 34 post-COVID-19 patients and 33 healthy subjects. The assessment was performed at one month from a non-severe SARS-CoV-2 infection. Both groups were assessed by using the 6MST, 6MWT, and the pulmonary function test (PFT). Post COVID functional status (PCFS) scale was used for the post-COVID-19 group to assess functional status. Physiological responses; heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), blood pressure (BP), and Borg scale for fatigue and dyspnea were recorded before and after the 6MST and 6MWT. RESULTS: the performance of the post-COVID-19 group was worse than the healthy group in both tests. In 6MWT, the distance walked by the post-COVID-19 group (423 ± 7) was 94 m less than the healthy group, and the number of climbed steps in the 6MST (121 ± 4) was 34 steps less than the healthy group. Both results were statistically significant (p < 0.001). There was a moderate positive correlation between the 6MST and 6MWT in walked distance versus steps number (r = 0.5, p < 0.001). In addition, there was a moderate correlation between the two tests in the post (HR, RR, SpO2, systolic blood pressure SBP, diastolic blood pressure DBP, dyspnea, and fatigue) with p < 0.001. CONCLUSIONS: Six-minute step tests produced similar cardiorespiratory responses when compared to a 6MWT. The 6MST can be used as an assessment tool for COVID-19 patients to evaluate their functional capacity and ADL.

Epidemiological intelligence community network intervention: a community response for COVID-19 community transmission.

BACKGROUND: Expanding and providing access to early detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) through testing community-based strategies among socially vulnerable communities (SVC) are critical to reducing health disparities. The Epidemiological Intelligence Community Network (EpI-Net) community-based intervention sought to increase coronavirus 2019 (COVID-19) testing uptake and prevention practices among SVC in Puerto Rico (PR). We evaluated EpI-Net's community leaders' capacity-building component by assessing pre-post COVID-19 public health workshops' tests' score changes and satisfaction among trained community leaders. METHODS: A total of 24 community leaders from SVC in PR have completed four community workshops. Pre- and post-assessments were completed as part of the health promotors training program to evaluate participants' tests score changes and satisfaction outcomes. RESULTS: Preliminary results showed: (1) high intervention retention levels of community leaders (85.7% acceptance rate); (2) change in post-test scores for community engagement strategies (p = 0.012); (3) change in post-test educational scores in COVID-19 prevention practices (p = 0.014); and (4) a change in scores in public health emergency management strategies (p < 0.001). CONCLUSIONS: The overall workshop satisfaction was 99.6%. Community leaders have shown the importance of community capacity building as a key component for intervention feasibility and impact. TRIAL REGISTRATION: Our study was retrospectively registered under the ClinicalTrial.gov ID NCT04910542.

COVID-19 in older adult residents in nursing homes: factors associated with mortality and impact on functional capacity.

Objective: To verify if the functional capacity prior to COVID-19 infection was different between Survivor and Non-survivor older adults. Also, to verify the effect of the isolation period after COVID-19 infection on the functional capacity of the Survivors residing in nursing homes. Materials and methods: Older adults residing in nursing homes were evaluated 30 days before the COVID-19 outbreak at the site for (i) general health characteristics (obtained from medical records); (ii) gait speed, handgrip strength and 30-s sit-to-stand; (iii) sarcopenia and (iv) estimated muscle mass. Comparisons were made between Survivors and Non-survivors of COVID-19. After the isolation, the Survivors performed the assessments again. Results: Twenty-one (81 ± 9.3 years) participants tested positive for COVID-19 and participated in the study, 12 survivors. No difference was observed between Survivors and Non-survivors in any of the outcomes evaluated. However, a moderate effect size was observed for handgrip strength, with lower values for the Non-survivors group (- 16%; d = 0.53). The isolation period reduced the number of sit-to-stand repetitions with moderate effect size in the Survivors (p = 0.046, gav = 0.66). Conclusion: Although the null hypothesis analysis did not find significant differences between the groups, the effect size suggests that older adults residing in nursing homes who died from COVID-19 had lower handgrip strength. In the survivors, the isolation period after COVID-19 infection only negatively impacted the sit-to-stand performance.

Pre-assessment and management of long COVID patients requiring elective surgery: challenges and guidance.

Whilst most patients infected with COVID-19 make a full recovery, around 1 in 33 patients in the UK report ongoing symptoms post-infection, termed 'long COVID'. Studies have demonstrated that infection with early COVID-19 variants increases postoperative mortality and pulmonary complications for around 7 weeks after acute infection. Furthermore, this increased risk persists for those with ongoing symptoms beyond 7 weeks. Patients with long COVID may therefore also be at increased postoperative risk, and despite the significant prevalence of long COVID, there are minimal guidelines on how best to assess and manage these patients perioperatively. Long COVID shares several clinical and pathophysiological similarities with conditions such as myalgic encephalitis/chronic fatigue syndrome and postural tachycardia syndrome; however, there are no current guidelines for the preoperative management of these patients to help develop something similar for long COVID patients. Developing guidelines for long COVID patients is further complicated by its heterogenous presentation and pathology. These patients can have persistent abnormalities on pulmonary function tests and echocardiography 3 months after acute infection, correlating with a reduced functional capacity. Conversely, some long COVID patients can continue to experience symptoms of dyspnoea and fatigue despite normal pulmonary function tests and echocardiography, yet demonstrating significantly reduced aerobic capacity on cardiopulmonary exercise testing even a year after initial infection. How to comprehensively risk assess these patients is therefore challenging. Existing preoperative guidelines for elective patients with recent COVID-19 generally focus on the timing of surgery and recommendations for pre-assessment if surgery is required before this time interval has elapsed. How long to delay surgery in those with ongoing symptoms and how to manage them perioperatively are less clear. We suggest that multidisciplinary decision-making is required for these patients, using a systems-based approach to guide discussion with specialists and the need for further preoperative investigations. However, without a better understanding of the postoperative risks for long COVID patients, it is difficult to obtain a multidisciplinary consensus and obtain informed patient consent. Prospective studies of long COVID patients undergoing elective surgery are urgently required to help quantify their postoperative risk and develop comprehensive perioperative guidelines for this complex patient group.

Exposure to conflicting COVID-19 information in undergraduates: Implications for pandemic-related information-seeking and concern, attention, and cognitive workload.

Objectives: To examine college students' conflicting COVID-19 information exposure, information-seeking, concern, and cognitive functioning. Participants: 179 undergraduates were recruited in March-April 2020, and 220 in September 2020 (Samples 1 and 2, respectively). Methods: Students completed the Attention Network Test, NASA Task Load Index, and COVID-related questions. Results: In Sample 1, exposure to conflicting information predicted poorer attentional performance and greater COVID-related information-seeking and concern; concern was correlated with workload. In Sample 2, conflicting information was associated with information-seeking. In Sample 1, but not Sample 2, cognitive effects of conflicting information were mediated by information-seeking and virus-related concern. Conclusions: Conflicting COVID-19 information may undermine students' cognitive functions, bearing implications for health, academic performance, and stress. Strategies for countering these effects include enhancing the clarity of institutional messaging, and tailoring course curricula and offering workshops to students, faculty, administrators, and counseling staff to augment students' capacity to comprehend and utilize COVID-related communications.

Subsidy strategy for reserving flexible capacity of emergency supply production

This paper investigates a government's subsidy strategy for motivating a manufacturer to set up a flexible production line for emergency supplies. Four subsidy strategies are proposed to ensure a desired service level in case of an emergency: zero subsidy, a fixed subsidy, a marginal subsidy, and a hybrid subsidy. We develop a game theoretical model to examine how the government can induce a manufacturer to set up a flexible production line that can respond promptly to an emergency, based on the manufacturer's cost structure (fixed and marginal costs). We find that when the marginal profit of an emergency product is higher than that of the manufacturer's regular product, a fixed (marginal) subsidy is the dominant strategy if the manufacturer's fixed (marginal) cost is high, while a hybrid subsidy strategy is dominant if both costs are high. When the marginal profit of an emergency product is lower than that of the manufacturer's regular product, neither a fixed subsidy nor a zero subsidy will be the dominant strategy. We also find that a marginal subsidy can ensure the effectiveness of the strategy, while a fixed subsidy helps improve strategy efficiency. We use government subsidy strategies implemented for Chinese COVID-19 emergency supplies as examples to demonstrate the effectiveness and efficiency of the subsidy strategies under the proposed framework. We also extend the discussion by considering the manufacturer's social consciousness.

Demonstrating the Value of Collaboration

[...]of the search for effective vaccines and treatments for COVID-19 being a priority, the development and manufacture of other treatments have been delayed, he adds. Through these industry collaborations, many developers have gained benefits, such as reduced time-to-market for new products, he specifies. [...]Quick believes that there will be more companies leaning towards outsourced services in the future, for development work and commercialization phases too. Given the disruption to the global pharmaceutical supply chain that has been experienced during the pandemic, O'Sullivan predicts that there will be opportunities for API suppliers in Europe, and elsewhere, to prosper from increased local demand, so long as the capacity and flexibility to deliver the required quantities are on available. [...]we will see significant investment by European API suppliers in expanded production capacity and capabilities in 2021 in order to attract Europe-based customers on the look-out for new local partners," he says. [...]Cruz emphasizes the rise of electronic health and customer records across Europe as an exciting prospect, particularly as it can lead to companies gaining a greater insight into treatments and customer needs.

The Limits of Power Concentration and Expert Knowledge in Emergency Management: Spain's Government Response during the First Phase of the Covid-19 Pandemic

Focusing on the central government's response to the Covid-19 crisis during the first wave in Spain, the article analyses the executive's strategy of power concentration, and the factors that shape its implementation. We sketch how the crisis erupted, the main measures and strategies adopted by the national executive, the role of the experts, and the interaction with other political actors and institutions. We also explore the second phase and how the political reaction evolved towards a more consensual approach. Paradoxically, the consequences for the political actors were apparently less harmful than expected, since the governments did not lose political support, and the electorate continued to support the policy measures adopted to mitigate the pandemic.

Political Economy of the 'Virtual' Internationalisation of Higher Education to Foster Glocal Sustainable Development

Background: The COVID-19 pandemic challenged the higher education institution's face-to-face education. Higher education institutions have overcome this challenge through enhanced virtual education which has provided further opportunities to the higher education institutions. One of these opportunities is the 'virtual' internationalisation of higher education which enables higher education institutions to reach more students globally. Purposes: This paper aims to investigate the 'virtual' internationalisation of higher education's role in glocal sustainable development and how to enhance its use to support glocal sustainability and sustainable development. This paper emphasises importance of political economy of the 'virtual' internationalisation of higher education to support glocal sustainable development and environmental policies. Methodology/Approach: The aim of this paper is achieved based on an in-depth literature review. Findings: This paper highlights effective, strategic and successful 'virtual' internationalisation of higher education's role in competitiveness of higher education institutions. This paper highlights political economy of the 'virtual' internationalisation of higher education and provides recommendations and key success factors for the 'virtual' internationalisation of higher education to enhance glocal sustainable development and sustainability as well as environmental policies. This paper emphasises importance of considering the 'virtual' internationalisation of higher education in countries' sustainable development plans, strategies and policies. Discussion: Effective and strategic 'virtual' internationalisation of higher education can support higher education institutions' competitive advantage globally. They can support higher education institutions' success in getting intelligent students from all over the world. This can further contribute to their competitiveness. Furthermore, this can enable them to employ, in these 'virtual' internationalisation of higher education programmes, globally competitive and competent academic staff from all over the world. This paper can be useful to academics, policy-makers and researchers in the relevant field.

Cutting through the noise during crisis by enhancing the relevance of research to policymakers

Background:It is widely recognised that policymakers use research deemed relevant, yet little is understood about ways to enhance perceived relevance of research evidence. Observing policymakers' access of research online provides a pragmatic way to investigate predictors of relevance.Aims and objectives:This study investigates a range of relevance indicators including committee assignments, public statements, issue prevalence, or the policymaker's name or district.Methods:In a series of four rapid-cycle randomised control trials (RCTs), the present work systematically explores science communication strategies by studying indicators of perceived relevance. State legislators, state staffers, and federal staffers were emailed fact sheets on issues of COVID (Trial 1, N = 3403), exploitation (Trial 2, N = 6846), police violence (Trial 3, N = 3488), and domestic violence (Trial 4, N = 3888).Findings:Across these trials, personalising the subject line to the legislator's name or district and targeting recipients based on committee assignment consistently improved engagement. Mentions of subject matter in public statements was inconsistently associated, and state-level prevalence of the issue was largely not associated with email engagement behaviour.Discussion and conclusions:Together, these results indicate a benefit of targeting legislators based on committee assignments and of personalising the subject line with legislator information. This work further operationalises practical indicators of personal relevance and demonstrates a novel method of how to test science communication strategies among policymakers. Building enduring capacity for testing science communication will improve tactics to cut through the noise during times of political crisis.

Respiratory Muscle Strength in Patients after Covid-19

Respiratory muscles (RM) are a very important part of the respiratory system that enables pulmonary ventilation. This study aimed to assess the post-COVID-19 strength of RM by estimating maximum static inspiratory (MIP or PImax) and expiratory (MEP or PEmax) pressures and to identify the relationship between MIP and MEP and the parameters of lung function. We analyzed the data of 36 patients (72% male;median age 47 years) who underwent spirometry, and body plethysmography, diffusion test for carbon monoxide (DLCO) and measurement of MIP and MEF. The median time between the examinations and onset of COVID-19 was 142 days. The patients were divided into two subgroups. In subgroup 1, as registered with computed tomography, the median of the maximum lung tissue damage volume in the acute period was 27%, in subgroup 2 it reached 76%. The most common functional impairment was decreased DLCO, detected in 20 (55%) patients. Decreased MIP and MEP were observed in 5 and 11 patients, respectively. The subgroups did not differ significantly in MIP and MEP values, but decreased MIP was registered in the second subgroup more often (18%). There were identified no significant dependencies between MIP/MEP and the parameters of ventilation and pulmonary gas exchange. Thus, in patients after COVID-19, MIP and MEP were reduced in 14 and 31% of cases, respectively. It is reasonable to add RM tests to the COVID-19 patient examination plan in order to check them for dysfunction and carry out medical rehabilitation.Copyright © 2022 Obstetrics, Gynecology and Reproduction. All rights reserved.

The inspiratory activity of respiratory center and respiratory muscles strength after COVID-19.

The respiratory pump that provides pulmonary ventilation includes the respiratory center, peripheral nervous system, chest and respiratory muscles. The aim of this study was to evaluate the activity of the respiratory center and the respiratory muscles strength after COVID-19 (COronaVIrus Disease 2019). Methods. The observational retrospective cross-sectional study included 74 post-COVID-19 patients (56 (76%) men, median age - 48 years). Spirometry, body plethysmography, measurement of lung diffusing capacity (DLCO), maximal inspiratory and expiratory pressures (MIP and MEP), and airway occlusion pressure after 0.1 sec (P0.1) were performed. In addition, dyspnea was assessed in 31 patients using the mMRC scale and muscle strength was assessed in 27 of those patients using MRC Weakness scale. Results. The median time from the COVID-19 onset to pulmonary function tests (PFTs) was 120 days. The total sample was divided into 2 subgroups: 1 - P0.1 <= 0.15 kPa (norm), 2 - > 0.15 kPa. The lung volumes, airway resistance, MIP, and MEP were within normal values in most patients, whereas DLCO was reduced in 59% of cases in both the total sample and the subgroups. Mild dyspnea and a slight decrease in muscle strength were also detected. Statistically significant differences between the subgroups were found in the lung volumes (lower) and airway resistance (higher) in subgroup 2. Correlation analysis revealed moderate negative correlations between P0.1 and ventilation parameters. Conclusion. Measurement of P0.1 is a simple and non-invasive method for assessing pulmonary function. In our study, an increase in P0.1 was detected in 45% of post-COVID-19 cases, possibly due to impaired pulmonary mechanics despite the preserved pulmonary ventilation as well as normal MIP and MEP values.Copyright © Savushkina O.I. et al., 2023.

Establishment of an infrastructure for rapid pandemic response at the Frederick National Laboratory

The sudden onset of the 2019 SARS-CoV-2 pandemic required agile development of standards and efficient validation of assays to assess prevalence of infection as well as immune responses to infection and vaccination. Leveraging their experience in HPV serology and standards, the Vaccine, Immunity and Cancer Directorate (VICD) at the Frederick National Laboratory for Cancer Research (FNCLR) pivoted to address this unmet need in SARS-Co-V2 serology clinical testing and research. This standardization effort required the collection and processing of large volumes of blood from SARS-Co-V2 infected and uninfected individuals into serum and peripheral blood mononuclear cells (PBMCs). Collaborations with specimen collection sites across the United States were established. Following qualification for anti-SARS-CoV-2 IgG and IgM levels in independent laboratories, VICD assembled reference evaluation panels, which were used to assist the FDA's performance evaluation of commercial assays submitted for EUA approval. To date, 185 different shipments of the standard or validation panel have been sent to both domestic and international labs. These materials are also available to the SARS-CoV-2 serology community for assay calibration and performance evaluation which greatly facilitates assay data harmonization. In addition, the NCI Serological Sciences Network (SeroNet) was born from this initiative and expertise, resulting in the establishment of Capacity Building Centers (CBCs) for sample collection from different healthy, cancer and immunocompromised cohorts at Mount Sinai, Arizona State University, the University of Minnesota, and Northwell Feinstein. The NCI and FNLCR simultaneously collaborated to develop a network of investigators focused on advancing research on the immune response to SARS-CoV-2 infection and vaccination among diverse and vulnerable populations, including cancer patients. Their research has resulted in over 326 peer-reviewed publications. The CBC's have enrolled patients in longitudinal studies, resulting in a centralized collection of annotated, well characterized serum, PBMCs and clinical data. Numerous cancer cohorts, but predominantly Multiple Myeloma, are included. Furthermore, technology development was supported at the CBC's. Based upon this success, the VICD in collaboration with NCI is pursuing an even more innovative effort in pandemic preparedness to establish a Center for Serology and Data Emergency Preparedness (CESDEP);a global network able to activate and pivot to address pandemic-level threats, while continuing to expand the development of immunological assays that can inform clinical decisions for cancer and other immunocompromised patients.

Mainstreaming disaster risk management technical and vocational education and training (DRM-TVET) program in higher education institutions: flexible ladderized capacity building model amid COVID-19

Disasters are increasingly becoming more destructive in their impacts. Lives have been lost and properties damaged due to the lack of institutional and personnel coping and adaptive capacities. Several policies in the Philippines have noted the importance of capacity development in implementing Disaster Risk Management (DRM). To meet the above necessity, in 2017, Philippine School of Business Administration (PSBA), Manila, one of the higher education institutions pioneered a specialization of DRM in its existing Master in Business Administration program. However, meeting the demand for Disaster Risk Management Technical and Vocational Education and Training (DRM-TVET) through Formal Degree Program (FDP) and keeping FDP sustainable is still facing a number of challenges. The main drivers of these challenges include but are not limited to the following: time constraint on the part of participants to complete 2–4 years' FDP;lack of institutions offering DRM-TVET programs;and unavailability of a Learning Management System. The main objective of this research is to develop an Alpha-Flexible Ladderized Capacity Building Model (A-FLCBM) amid COVID-19. Further, the study should also provide logical flow and recommendations to operationalize the remaining activities of the Conceptual Framework in developing the Beta (B)-FLCBM amidst COVID-19. In this regard, the researchers collected pertinent data through a substantive, thorough, sophisticated literature review and examined the available mandates on existing Flexible ladderized models. Further, a Conceptual Framework (CF) is also developed and partially operationalized. The output allowed researchers to develop A- FLCBM amidst COVID-19 using the PSBA curriculum as a pilot case. However, the framework activities, i.e., dry run, Technical Education and Skills Development Authority (TESDA) registration for National Certification (NC), development of B-FLCBM, and the empirical assessment of DRM-TVET and FDP sustainability will be covered in future studies. The A-FLCBM comprises of interrelated activities including mode of learning and well-designed DRM NC short courses, workshops, and trainings for the trainers. The Model is aligned with the Executive Order 358, promulgated in 2004. Further, the Ladderized Education (LE) system introduced through Commission on Higher Education Memorandum Order No. 43, 2008 Series, was also considered for wider-scale and accelerated implementation of LE nationwide and globally. The implementation of B-FLCBM will provide a unique opportunity to develop the skills required to be a professional in the DRM and business continuity field, improving the quality of life and raising awareness on the importance of preventing and mitigating disasters and reducing the loss incurred by countries in terms of lives, property, and economy. © 2023 Elsevier Inc. All rights reserved.

Outsourcing's, Race Toward Novelty

According to Jeetendra Vaghjiani, senior director of clinical development and strategic marketing at Lonza, emerging biotech companies are reliant on contract development and manufacturing organizations (CDMOs) because of their development and manufacturing capacity, expertise, and flexibility. Because of the high attrition rate associated with drug development, the better your preclinical programme, the stronger the position you can establish in terms of programme design and patient identification (2). [...]because of the relative scarcity of approvals over the past decade, companies looking to capitalize on this new market are likely to require specialized knowledge to get through the approvals process.

Managing systemic risk in emergency management, organizational resilience and climate change adaptation

PurposeThis paper applies the theory of cascading, interconnected and compound risk to the practice of preparing for, managing, and responding to threats and hazards. Our goal is to propose a consistent approach for managing major risk in urban systems by bringing together emergency management, organisational resilience, and climate change adaptation.Design/methodology/approachWe develop a theory-building process using an example from the work of the Greater London Authority in the United Kingdom. First, we explore how emergency management approaches systemic risk, including examples from of exercises, contingency plans and responses to complex incidents. Secondly, we analyse how systemic risk is integrated into strategies and practices of climate change adaptation. Thirdly, we consider organisational resilience as a cross cutting element between the approaches.FindingsLondon has long been a champion of resilience strategies for dealing with systemic risk. However, this paper highlights a potential for integrating better the understanding of common points of failure in society and organisations, especially where they relate to interconnected domains and where they are driven by climate change.Originality/valueThe paper suggests shifting toward the concept of operational continuity to address systemic risk and gaps between Emergency Management, Organizational Resilience and Climate Change Adaptation.