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The company's Lyoguard trays are being used in the production of mAbs;diagnostics tests for COVID-19 virus or antibodies;and some of the key raw materials used in messenger RNA (mRNA) vaccines, including synthetic oligonucleotides, adjuvants, and lipid nanoparticles, he says. [...]it's a question of capacity. Another problem is the fact that lyophilization involves very slow cooling, at a rate of one degree Kelvin per second, says Bill Williams, a professor at the University of Texas and inventor of the thin-film freezing process, which he developed years ago at the Dow Chemical Co. TFF Pharma licensed his technology and commercialized it in 2019. Williams and his team, with corporate and US government funding, are now focusing on research designed to optimize use of thin-film freezing to improve the processing and delivery of biologics, including vaccines, along with the cold chain.
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The regulation also sets out obligations on marketing authorization holders (MAHs) and medical devices manufacturers, authorized representatives, importers, distributors, and notified bodies duties to: * Provide information that will assist with the monitoring by the MSSG/MDSSG of shortages of medicinal products and devices contained in the critical medicines list and updating this when necessary * Provide a justification for any failure to provide the requested information by the established deadlines * Immediately provide any evidence of an actual or potential shortage of medicinal products or devices * Provide information to EMA by 2 Sep. 2022 that will enable the establishment of a Single Point of Contact (SPOC) network, and the industry Single Point of Contact (iSPOC) network, with mandates to updating this when necessary (7). Enhanced advisory role In addition to the measures designed to address medicinal and medical device shortages, an Emergency Task Force (ETF) will also be established within EMA to provide scientific advice and review evidence on medicines that have the potential to address public health emergencies, offer scientific support to facilitate clinical trials, and support existing EMA committees with their authorization and safety monitoring of medicines (8). According to the document published by EMA on Crisis Preparedness and Management, the key benefits for EMA of having these responsibilities include: * Accelerated evaluation and access to safe and effective medicines which could treat or prevent a disease causing, or likely to cause, a public health emergency * Improved quality of data and the effective use of resources through increased support at EU level towards the conducting of clinical trials in preparation for, and during a public health emergency * Improved coordination and harmonization at EU level in preparation for and during a public health emergency (7).
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In research and policies, the identification of trends as well as emerging topics and topics in decline is an important source of information for both academic and innovation management. Since at present policy analysis mostly employs qualitative research methods, the following article presents and assesses different approaches – trend analysis based on questionnaires, quantitative bibliometric surveys, the use of computer-linguistic approaches and machine learning and qualitative investigations. Against this backdrop, this article examines digital applications in cultural heritage and, in particular, built heritage via various investigative frameworks to identify topics of relevance and trendlines, mainly for European Union (EU)-based research and policies. Furthermore, this article exemplifies and assesses the specific opportunities and limitations of the different methodical approaches against the backdrop of data-driven vs. data-guided analytical frameworks. As its major findings, our study shows that both research and policies related to digital applications for cultural heritage are mainly driven by the availability of new technologies. Since policies focus on meta-topics such as digitisation, openness or automation, the research descriptors are more granular. In general, data-driven approaches are promising for identifying topics and trendlines and even predicting the development of near future trends. Conversely, qualitative approaches are able to answer "why” questions with regard to whether topics are emerging due to disruptive innovations or due to new terminologies or whether topics are becoming obsolete because they are common knowledge, as is the case for the term "internet”.
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This study investigates how article downloads from ScienceDirect changed after Temple University Libraries downsized its all-inclusive Elsevier big deal bundle to a selective custom package. After the libraries lost current-year access to nearly half of Elsevier's active journals, the total downloads from Elsevier journals declined by 16.2 percent over three years. Combined use of still-subscribed and open access journals fell 10.6 percent in the same three years, suggesting that the drop in total use is due not only to the loss of journals but also to factors that would affect the remaining journals, such as the COVID-19 pandemic and a slight decrease in enrollment. Patrons may have substituted articles from still-subscribed and open access journals for those that were canceled, though the data are not conclusive. Reliance on open access appears to have increased.
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Needlestick injuries (3.1%) were associated with mental health problems presumably related to the transmission of infectious diseases and liquid nitrogen related injuries were reported in 3.1% of respondents. Overall the survey concluded that embryologists experienced a number of occupational health problems of which musculoskeletal and mental health and work stress issues were the dominate issues emerging from the survey which appeared to be linked to lack of control of workflow and irregular breaks as well as workplace stress. [...]these have been difficult to describe but with the ability to sequence multiple genes in a single assay decisions will have to be made on which genes should be identified as being responsible for susceptibility to breast cancer. Recently two high quality major studies (4,5) have identified a number of genes that are statistically associated with breast cancer risk.
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PurposeThe purpose of the paper was to survey transformational leadership traits in three academic libraries in the Gauteng province in South Africa. The three academic libraries were chosen based on the fact that two of the universities were residential research-intensive universities and the third was an academic library of a distance learning university.Design/methodology/approachThe study adopted a quantitative approach with a survey design in three academic libraries in the Gauteng province in South Africa in which a close-ended questionnaire yielded quantitative data. The study included 29 academic staff from the rank of assistant librarian to the director from the three academic libraries, as these are the personnel in leadership positions. To code and analyse, quantitative data from a Likert scale, SPSS version 25 was used. Cronbach's alpha was used to evaluate the instrument's reliability on the five constructs used in this study to determine readiness to adopt a transformational leadership style. The overall level of internal consistency exceeded the theoretical minimum of 70 percent. The Shapiro-Wilk test was used to determine the normality of the data and the p values were greater than 0.05 (p > 0.05). Tables have been used to present descriptive and inferential statistics based on data.FindingsParticipants expressed favourable opinions about academic libraries' ability to learn from the best practices of others in the profession, with mean scores greater than 3.5 on a 5.0 scale. Participants' perceptions of transformative versus traditional management styles yielded a moderate mean score of 3.0, with moderate mean scores ranging from 2.8 to 3.3. The average score for talent identification and succession planning in academic libraries was 3.5. Perceptions of leadership responsibilities had a mean score of 4.1, with attributes on leadership responsibilities scoring at least 3.5. Perceptions of problems for the next generation of leaders in academic libraries were moderate, with a mean score of 3.2 on a scale of 5.0.Research limitations/implicationsOnly three of the seven public university libraries in the Gauteng province in South Africa were surveyed in this study. The sample size was reasonably small for generalizations beyond the South African Gauteng province academic libraries. However, it was felt useful for this particular case. A survey of all 26 South African public universities is required to assess transformational leadership traits in academic libraries.Practical implicationsNext-generation leaders in South African academic libraries are perceived as not being aggressive in terms of team building, coaching and motivating others.Social implicationsIn the wake of COVID-19, new leadership traits such as scenario planning are needed for academic libraries.Originality/valueLeadership studies abound in the library and information studies (LIS) profession and they are not new. However, research on transformational leadership in South African libraries is still in its early stages. As a result, this study fills a gap in the literature on transformative leadership in academic libraries in South Africa.
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Objectives: To ascertain whether and how working as a partnership of two World Health Organization collaborating centres (WHOCCs), based respectively in the Global North and Global South, can add insights on "what works to protect healthcare workers (HCWs) during a pandemic, in what contexts, using what mechanism, to achieve what outcome". Methods: A realist synthesis of seven projects in this research program was carried out to characterize context (C) (including researcher positionality), mechanism (M) (including service relationships) and outcome (O) in each project. An assessment was then conducted of the role of the WHOCC partnership in each study and overall. Results: The research found that lower-resourced countries with higher economic disparity, including South Africa, incurred greater occupational health risk and had less acceptable measures to protect HCWs at the onset of the COVID-19 pandemic than higher-income more-equal counterpart countries. It showed that rigorously adopting occupational health measures can indeed protect the healthcare workforce; training and preventive initiatives can reduce workplace stress; information systems are valued; and HCWs most at-risk (including care aides in the Canadian setting) can be readily identified to trigger adoption of protective actions. The C-M-O analysis showed that various ways of working through a WHOCC partnership not only enabled knowledge sharing, but allowed for triangulating results and, ultimately, initiatives for worker protection. Conclusions: The value of an international partnership on a North-South axis especially lies in providing contextualized global evidence regarding protecting HCWs as a pandemic emerges, particularly with bi-directional cross-jurisdiction participation by researchers working with practitioners.
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COVID-19 has recently affected global trade flows, and the primary reason is that shipping failed to adapt rapidly to meet the need for on-time delivery. Given blockchain's "revolutionary” potential, this paper aims to understand how blockchain can address longstanding inefficiencies and challenges in the shipping industry. This analysis proposes a model of how an industrywide blockchain-based consortium powered by smart contracts could resolve end-to-end contract issues with trustworthiness, thus improving efficiency in terms of time and cost. A mixed-method approach was conducted. That included 27 surveys and 20 interviews with representatives of shipping industry members. This study contributes to the blockchain and shipping supply chain literature by offering empirical data about the application of an industry-led consortium blockchain with cost, scalability, and volatility perspectives. As for the managerial implications, incentives and education are required to stimulate collaboration and commitment to blockchain for more efficient and effective global shipping trade flows.
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Administrative "success" or "failure" during the pandemic are hard to assess given uncertainties both of criteria and of data. But there can be no doubt about the mishandling of the pandemic at crucial junctures by the Indian government, or about the culpability of prime minister Narendra Modi himself. He has this in common with other "strongmen" of contemporary world politics, but Modi was unusually successful in turning the events of the pandemic to reinforce his dominance. The immediate political factors that influenced the Indian response had to do with political leadership and with the "decisionism" that characterised Modi's actions, but in the context of the pursuit of the goals of Hindu nationalism. This article explains the responses of the Indian government drawing on a framework based on the comparative analysis of Baum and her co-authors. It shows how the events of the pandemic reflect on India's politics and on the character of the Indian state, using a state-in-society approach suggested by the interlocking arguments of Migdal, Mann and Evans. This highlights and explains the very different responses of the major states of the country.
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IntroductionScottish Medicine Consortium (SMC) meetings were suspended in March 2020 in response to the coronavirus disease 2019 (COVID-19) pandemic. This led to a high number of submissions awaiting appraisal, prompting interim process changes to ensure minimal disadvantages to patient access. We expanded the eligibility criteria for the shorter (abbreviated) submissions process and expedited advice for submissions the New Drugs Committee (NDC) intended to accept. This study aimed to evaluate the impact of the COVID-19 pandemic and these interim process changes on the characteristics of submissions received, acceptance rates, and time to advice publication.MethodsData for all submissions received between January 2015 and November 2021 (n=720) were extracted from an organizational database. Characteristics of and acceptance rates for submissions received before and after the start of the pandemic were compared using chi-squared and one-proportion Z-tests, respectively. Additional analyses explored the number of submissions received per month and the time from receipt of submission to NDC and SMC decision.ResultsThe numbers of full and abbreviated submissions increased from March 2020 (6% in each case), with a corresponding decrease in the number of medicine-indication pairs (e.g., pembrolizumab for breast cancer) for which companies did not submit (8%;p=0.01). An increase in the SMC acceptance rate was also observed (62 to 72%;p=0.03). Fewer submissions were received in 2020 (n=65), compared with the pre-pandemic average (mean=79.6), whereas the total in 2021 to date was higher than average (n=92). Time series analysis suggested an increasing trend in monthly submissions (from approximately 6 to 9), which is the likely reason for the increase in average time to decision (146 versus 170 days).ConclusionsProcess changes in response to the pandemic have been effective in expediting advice for submissions with sufficiently robust evidence. This demonstrates agility and efficiencies for submitting companies and patient groups, with no perceived impact on process rigor. The average number of submissions has increased since March 2020, and further work is warranted to understand the influence of process improvements on reducing time to advice.
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Discontinuation of the United States Medical Licensing Examination (USMLE) Step 2 Clinical Skills (CS) exam and Comprehensive Osteopathic Medical Licensing Examination (COMLEX) Level 2 Performance Evaluation (2-PE) raised questions about the ability of medical schools to ensure the clinical skills competence of graduating students. In February 2021, representatives from all Florida, United States, allopathic and osteopathic schools initiated a collaboration to address this critically important issue in the evolving landscape of medical education. A 5-point Likert scale survey of all members (n=18/20 individuals representing 10/10 institutions) reveals that initial interest in joining the collaboration was high among both individuals (mean 4.78, SD 0.43) and institutions (mean 4.69, SD 0.48). Most individuals (mean 4.78, SD 0.55) and institutions (mean 4.53, SD 0.72) are highly satisfied with their decision to join. Members most commonly cited a "desire to establish a shared assessment in place of Step 2 CS/2-PE" as their most important reason for joining. Experienced benefits of membership were ranked as the following: 1) Networking, 2) Shared resources for curriculum implementation, 3) Scholarship, and 4) Work towards a shared assessment in place of Step 2 CS/2-PE. Challenges of membership were ranked as the following: 1) Logistics such as scheduling and technology, 2) Agreement on common goals, 3) Total time commitment, and 4) Large group size. Members cited the "administration of a joint assessment pilot" as the highest priority for the coming year. Florida has successfully launched a regional consortium for the assessment of clinical skills competency with high levels of member satisfaction which may serve as a model for future regional consortia.
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Brumby et al describe what was done to run a virtual Doctoral Consortium at Conference on Human Factors in Computing Systems (CHI) 2020. The event was originally planned as an in-person, two-day event to take place in Honolulu, Hawaii, on April 25, 2020. Because of the Covid-19 pandemic, the decision was taken in March 3 that the CHI conference would not go ahead as a physical event. Most events were canceled;however, the Doctoral Consortium continued as a self-contained track and was swiftly reorganized to successfully run as a virtual event on April 28. Here, they describe the key steps involved in organizing the Doctoral Consortium as a virtual event, from the technology involved to how to schedule activities. Given the expected long-term impact of the Covid-19 pandemic on conferences for the coming year, they hope to provide useful information for the organizers of similar events.
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The pharmaceutical industry has gone through dramatic changes since the birth of biotechnology. Pharmaceutical companies no longer have a monopoly on drug development, nor do they represent the primary source of biomedical innovation. Since biotech firms have emerged on the scene and academia has embraced translational research as a way to help advance their own discoveries, pharma companies have begun to foster relationships with those sectors in a strategy to externalize innovation. Public–private partnerships offer a low-risk way for pharmaceutical companies to tap into academic talent and stay abreast of cutting-edge research into new targets, technologies, and tools for advancing drug development. The COVID-19 pandemic broke many barriers, bringing fierce competitors together more closely than ever before via precompetitive collaborations to expedite the creation of countermeasures in response to the crisis. The question is whether this will trigger long-term change that can accelerate the translation of laboratory discoveries to new medicines and reduce their costs. © 2021 Elsevier B.V. All rights reserved.
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With the development of instructional design literature and the potential of online courses to support learning, there exists a gap between theoretical knowledge (theory) and practice (reality). The objective of this study is to determine the effectiveness of the design of online courses for teaching and learning, and what designers and instructors in online learning environments should collectively consider in terms of the quality of the design for online courses. A quantitative design methodology was used to measure the validity and reliability of a rubric used as an evaluation tool in three online short courses at a university level. Scores were measured and analysed using simple descriptive statistics, and qualitative aspects of the online course analysis were integrated to ascertain a summative conclusion of the three online courses and whether the rubric, as a design framework, needed further improvement or not. The rubric offered a framework to determine what components contribute towards quality design in online courses.
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Speed read Six African countries to get technology for manufacturing COVID-19 vaccines Only 12 per cent of the African population are fully vaccinated Countries should secure markets for the home-produced vaccines, experts say [KAMPALA] Six African countries are to receive technology that will enable them to manufacture COVID-19 vaccines, in an effort to reduce reliance on producers outside the continent, the World Health Organization (WHO) has announced. The rollout is part of a global initiative aimed at helping low- and middle-income countries to access the technology for producing mRNA vaccines at scale and to international standards in order to stem the COVID-19 pandemic. “Diversifying mRNA vaccine manufacturing capacity to low- and middle-income countries should be a global health priority,” said Doctors Without Borders (MSF), in response to the WHO announcement.
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Speed read Consortia in India and Sub-Saharan Africa seek to expand genomic surveillance Initial focus on informing response to COVID-19 variants of concern Longer-term goal of sustaining local capabilities to mitigate future pandemics Access to fast, accurate genomic sequencing information is key to ending the COVID-19 pandemic, says Manisha Bhinge, managing director of programmes for the Rockefeller Foundation’s Health Initiative. [...]in India we have a consortium of four partners across the country that provides sampling strategies that increase representation and depth within that country to allow us greater insight – more timely, granular and accurate insight – around variants of concern. Deciding which group of people needs the vaccine first, for example, requires an understanding of where there is inherent risk within a population and that’s when metadata is incredibly useful.
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Speed read Innovation must be ramped up to tackle malaria, scientists urge Gene drive technology could reduce mosquito populations Pace of malaria innovation has slowed, say experts Scientists are hoping that adoption of gene drive technology could reduce mosquito populations as they call for new innovations in the fight against malaria, a fatal disease widespread in Sub-Saharan Africa. The World Health Organization (WHO) says the Africa region accounted for around 94 per cent of all global malaria cases and deaths in 2019. Fredros Okumu, entomologist and director of science, Ifakara Health Institute, Tanzania “It is a cost-effective way to cut down malaria vectors, and is simple to implement because the mosquitoes themselves do the work,” said Birungi during a Roll Back Malaria Partnership virtual boot camp on malaria control innovation on 15 November.
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In a world where governments are looking at alternative ways of developing economies, infrastructure development remains a key aspect of these aspirations. For Middle East economies, which have relied on oil proceeds, the growth strategy is not as before as the oil prices have been fluctuating and resulting in low fiscal incomes. Saudi Arabia is one such economy. Thus, in the Kingdom's development strategy outlined in Vision 2030, there has been an emphasis on private players coming into partnering with the government in infrastructure and broader economic development projects. While the concept is easy on paper, running successful Public-Private Partnerships (PPP) projects is a complex endeavor given the conflicting interests of the partners themselves. This research investigated the critical success factors of PPP projects in Saudi Arabia based on the reflections of a quantitative study for infrastructure projects. For descriptive analysis, the entire population of participants (1200 respondents was used), and for the inferential statistics, a sample of 543 respondents was used in a Structured Equation Model tested on Smart PLS was used. The model tested critical success factors mediated by Openness and Communication and a multigroup analysis moderated by job level (representing the level of decision-making classified into strategic formulators - strategic level and above;and strategic implementersoperational managers). The models had an R2 of a stratified sample of 54.5% for the strategic level model and 45.9% for the strategic implementers model. Both models confirmed the importance of Procurement transparency, Risk sharing and allocation, Knowledge management. However, they had differences in the influence of governance, Openness and Communication and efficiency of the financial model. Governance had a significant influence on the success of PPPs only at the operational level while having a fully mediated relationship with Openness and Communication at the operational level. The study then produced two frameworks that are relevant for policymakers and potential private players to understand the relevant factors to be prioritised at each decision-making level to ensure the successful completion of PPPs in Saudi Arabia.
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The studies included in this report summarizes novel insights, current developments, and observations that were specific to the region and provides an excellent opportunity to the diverse research groups all across the world to interpret the research trend and emerging medical science challenges in the Australasian region. Kroon presented their observations on credentialing the radiotherapy centers in the Australasian region on stereotactic ablative body radiotherapy of early stage lung cancer. Credentialing of radiotherapy centres in Australasia for TROG 09.02 (Chisel), a Phase III clinical trial on stereotactic ablative body radiotherapy of early stage lung cancer.
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Most of the results are restricted to single center reports with regard to the T1D. [...]there is the need for the wide scale assessment of the current models of prevention and treatment whether they are delivering the desired results for the reduction of the societal and the individual burden of type 1 diabetes. [...]a research was designed for the extraction of the clinical data from the Australasian region diabetes data network prospective diabetes registries and the inclusion criteria were the individuals with the t1D in the age group of 16 to 25 years at their last recorded healthcare visit with t1D duration of the one year. The study concluded that there was widespread and persistent sub-optimal glycemic control in the young people with t1d in the Australasian region and highlighted the imminent need for the better comprehension of the situation and devise ways and strategies for the healthcare services to support the improvement in the glycemic control in this group of the population4.