Preparing Pandemic Vaccine Capacity

Among the challenges of a pandemic is the need to scale up to billions of doses, at a larger scale than typically needed for vaccines, from raw materials all the way through to the materials for the containers for fill/finish. Having adequate raw materials, building and staffing the facilities, and tech transfer are all keys to success. [...]we can plug into existing infrastructure, including services (gas, water, waste, etc.) as well as analytics and quality labs." Emergent BioSolutions says that its flexible CDMO capacity deployment model can respond quickly to demand fluctuations. The company's facilities in France, Switzerland, and the US are working on the project;at CordenPharma Colorado, unique high-pressure chromatography systems usually used for manufacturing peptides have been reallocated for purifying lipids.

Breaking the Ice with Group Flow: A Collaborative VR Serious Game for Relationship Enhancement

It is usually hard for unfamiliar partners to rapidly 'break the ice' in the early stage of relationship establishment, which hinders the development of relationship and even affects the team productivity. To solve this problem, we proposed a collaborative serious game for icebreaking by combining immersive virtual reality (VR) with brain-computer interface based on the team flow framework. We designed a multiplayer collaboration task with the theme of fighting COVID-19 and proposed an approach to improve empathy between team members by sharing their real-time mental state in VR;in addition, we propose an EEG-based method for dynamic evaluation and enhancement of group flow experience to achieve better team collaboration. Then, we developed a prototype system and performed a user study. Results show that our method has good ease of use and can significantly reduce the psychological distance among team members. Especially for unfamiliar partners, both functions of mental state sharing and group flow regulation enhancement can significantly reduce the psychological distance. © 2023 IEEE.

MR.Brick: Designing A Remote Mixed-reality Educational Game System for Promoting Children's Social & Collaborative Skills

Children are one of the groups most influenced by COVID-19-related social distancing, and a lack of contact with peers can limit their opportunities to develop social and collaborative skills. However, remote socialization and collaboration as an alternative approach is still a great challenge for children. This paper presents MR.Brick, a Mixed Reality (MR) educational game system that helps children adapt to remote collaboration. A controlled experimental study involving 24 children aged six to ten was conducted to compare MR.Brick with the traditional video game by measuring their social and collaborative skills and analyzing their multi-modal playing behaviours. The results showed that MR.Brick was more conducive to children's remote collaboration experience than the traditional video game. Given the lack of training systems designed for children to collaborate remotely, this study may inspire interaction design and educational research in related fields. © 2023 ACM.

WASHINGTON REPORT

FNIH will manage an ACTIV steering committee to develop an inventory of potential candidates, launch master protocols with a single control arm, and set criteria for ranking potential candidates for first-wave and subsequent evaluation. [...]a third group will tap NIH's extensive clinical trial network infrastructure to build capacity for expediting trials and to study different populations and disease stages. ?o advance vaccine development, another ACTIV group will form a collaborative framework to map epitopes and develop assays, establish protocols for sampling and immunological analyses, collect clinical data on immunological responses and endpoints, and engage with regulators on surrogate endpoints for clinical evaluation. Jill Wechsler MULTIPLE WEBSITES IDENTIFY AND TRACK RESEARCH ON COVID Widespread research activity is available from these and other organizations: * The University of Oxford Center for Evidence-Based Medicines lists more than 1000 clinical trials at http:// covid19.trialstracker.net/index.html * Bill & Melinda Gates Foundation with Cytel identifies more than 600 trials in the US and other regions at https://covid19-trialscom * TranspariMed offers a guide to multiple trials at https://www.transparimed.org/ * Bi°Century tracks vaccines and therapeutics in its COVID-19 Resource Center, https://www.biocentury.com/ clinical-vaccines-and-therapies * World Health Organization: https://www. who.int/emergencies/diseases/novelcoronavirus-2019/global-researchon-novel-coronavirus-2019-ncov/ * Regulatory Affairs Professionals Society: https://www.raps.org/newsand-articles/news-articles/2020/3/ covid-19-therapeutics-tracker

Connecting and relating in Brazil: Implications of remote work

COVID-19 triggered a monumental shift to remote work. The challenge of connecting and relating among knowledge employees emerged globally, and research about remote work in this unique circumstance surged. However, we know more about the impact of remote work on knowledge employees in low-context cultures than in high-context. Given that Brazil is high context, we explored how remote work impacted relating and connecting among knowledge employees in Brazil. First, employees lost the informality of work-life;instead of informal, fluid communication and collaboration, participants had to book appointments and schedule time to discuss simple issues. Second, good-humoured behaviours diminished, implicating connectedness. Third, non-verbal communication ceased, and employees lost facial expressions, eye contact, and other prevalent signs necessary for context. Fourth, the loss of unstructured exchange of experiences and ideas lessened tacit knowledge sharing. Fifth, workspace inequalities emerged as the employees' homes were unequipped for remote work. Lastly, the most significant win was work-life balance. Therefore, remote work in high-context cultures is not without peril;culture and socioeconomics underline remote work's self-generating, self-organizing mechanisms. Thus, corporate leaders and human resource professionals should address remote work as a layered phenomenon and, carefully, with employees, co-construct the notion of connecting and relating. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Flexible curriculum design for quantitative skills development: Building on the insights gained during COVID-19

Before the COVID-19 pandemic, technology-enhanced learning and its relation to student engagement, and the necessity of good student-staff relationships for creating a successful education environment were evident. The COVID-19 pandemic forced higher education to adapt to a challenging technology-led learning environment that demanded, inter alia, high levels of flexibility and human-centredness. Valuable lessons were learned that highlighted new perspectives on curriculum design and delivery in a normalised, technology-driven environment. Against the background of COVID-19-related literature on teaching and learning, the authors reflect on their insights regarding curriculum design and delivery of two quantitative skills modules during the COVID-19 pandemic, and its impact on further curriculum planning. The focus of the article is on the intentional flexibility built into curriculum offerings during 2020-2022. The study reviewed flexibility on three levels, namely student, facilitator (staff) and delivery levels, through a multi-method research methodology. Quantitative data related to the academic performance of 2 949 students enrolled for the two quantitative skills modules from 2020 to 2022. Qualitative data related to themes through thematic analysis of student and facilitator surveys, focusgroup discussions and semi-structured interviews. The improved student academic performance reported by the study could be attributed to, amongst other factors, 1) flexibility of the selected delivery option, 2) positive staff and student experiences and engagement, and 3) intentional inclusion of activities promoting student-staff relationships. The good academic results obtained during the pandemic led to important curriculum decisions for a normalised future for these modules, which will be built on flexibility and human-centredness. Among these decisions is to continue presenting the modules in an online environment, even though traditional face-to-face teaching options are available.

Opening Up Opportunities in 2023

"The ongoing journey to standardization on more aspects of submission and data exchange will continue to have an impact," he notes. lan Crone, business unit director Europe-fme Life Sciences, which provides business and technology services, points out that the web-based human variations electronic application form (eAF) for centrally authorized products (CAPs) has been available for use since 4 Nov. 2022 on the European Medicines Agency's (EMA's) new product lifecycle management (PLM) portal. Renato Rjavec, Amplexor Life Sciences "Many biopharmaceutical functions have spent the last decade modernizing their base technologies, most often in a cloud/software as a service environment platform that brings foundational benefit to individual functions," states Steve Gens managing partner. Internal productivity and external regulatory requirements are both driving this data connectivity within industry, he adds, which "requires a clear cross functional digitization strategy and focus on cross-functional data governance, master data management, and ensuring all data from these various authoritative systems [are] at the same high level. " "Many biopharmaceutical functions have spent the last decade modernizing their base technologies, most often in a cloud/ software as a service environment platform that brings foundational benefit to individual functions." -

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.

University–Industry Linkages in Agriculture: The Case of Palestine

The usual crisis mode of economic operations in Palestine intersects with the adverse consequences of COVID-19 and necessitates an innovative response to survive. This research builds on potential synergies between industry and university to expand the Palestinian agriculture sector resilience. We report on an explorative study that sought to understand the reality of the university–industry linkages (UILs) by considering information and experience gathered from 29 interviews in January 2020 and April 2021. Interviewees represent five key actor groups: farmers and agribusinesses, private institutions, universities, the Ministry of Agriculture, and NGOs. Content analysis revealed a nascent collaboration scope and uncovered the lack of a confident attitude among farmers towards agriculture research efforts, the poor communication performance, and misalignment of purpose. University actors need to encompass the UILs in their mission and touch farmers' needs by providing novelty evidence research. Yet, farmers and agribusinesses may take the initiative to communicate their problems and search for renovation. We developed a framework of underpinnings to enhance collaboration and a healthier agriculture sector. We suggest activating the cooperatives and diversifying farmers' income as deemed more resilient to face the pandemic.

Transformative service research approaches for visitor experiences in major sporting events

PurposeThis research conceptualises the hallmark event, Melbourne Cup in Australia, as a major sporting brand experience. While numerous studies have explored consumer engagement and experiences in major sporting events, few research studies highlight the negative issues, such as alcoholism, gambling and violence, that may affect consumer engagement and experience. This article addresses the challenges and opportunities of providing immersive and transformative experiences through transformative service research (TSR) approaches when such negative issues are swirling around.Design/methodology/approachThe paper is conceptual. It uses the example of Melbourne Cup to illuminate aspects of the conceptual framework.FindingsThe article unpacks a myriad of positive and negative immersive brand experiences and contributes a conceptual framework to understand the sporting brand experience phenomenon and shows how authentically responsible marketing approaches can improve the sport spectator experience.Research limitations/implicationsInsights from the extended TSR framework presents implications for various organisations that are involved with strategic destination marketing approaches. It guides key stakeholders to engage in dialogue and collaborate in order to improve the attendee transformative experience. Inviting collaborators will facilitate the exchange of ideas that will improve event organisation. Consistent approaches among hospitality service providers would improve alcohol service and create a safe environment for attendees. The TSR framework guides players of the experience to engage in meaningful dialogue with a common goal to improve consumer wellbeing. Education and training therefore are key elements in the consumer sporting brand experience.Practical implicationsThe adapted TSR framework offers insights to destination marketers such as sporting agencies, tour operators and sporting organisations/clubs. Marketers may promote bigger sporting events and organise tours via travel agencies and ignore key elements that may influence attendee decision. Destination marketing organisations (DMOs) can use the framework to promote effective planning and the key initiatives that the iconic event is involved with. The framework can be used as a guide to manage similar international events. Events of major or mega size and international reputation need specific frameworks that address crowd behaviours of similar sizes.Originality/valueAn extended transformative service approach is being conceptualised for major sporting brand experiences. Practical implications are also highlighted for DMOs when raising the profile of city brands.

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.

Taking a Collaborative Approach to Our Students' Research in Education Settings

In the United Kingdom (U.K.), all students who are studying for a Bachelor of Arts degree need to complete a piece of independent research in order to gain their "honours" (U.S. "honors") status. As a university faculty we have very specific ideas about the purpose of this research and the positive impact that we hope that it will have upon the U.K. settings (mainly schools and kindergartens) in which it is carried out, which we discuss in this article. Although our approach would appear successful, this judgement has so far been based upon the evidence of the final, summative project alone. Obtaining a small amount of funding from the university for students to act as co-researchers provided the ideal opportunity to explore the topic further by collecting empirical data from students and settings. Because our original plans for data collection were disrupted by COVID-19, we gained responses through an anonymous survey which enabled frank responses from both students and staff in settings. Although the data collected was, overall, encouraging, it did raise some issues for us, as faculty tutors, to consider. These include the way that we convey the portance of students carrying out their projects independently (that is, without university supervisor intervention) to settings themselves, and how we ensure that the students collaborate with settings at all stages of the project.

An Online Collaborative Biology Simulation Used by Ukrainian Students During the 2022 Russian Invasion

Although the Covid-19 pandemic disrupted learning for students worldwide, the 2022 Russian invasion of Ukraine has more severely impacted education for Ukrainian students. This study was conducted in the context of an educational technology master's thesis (Halchevska, 2022) at the University of Tartu, Estonia. A master's student with Ukrainian background contacted a biology teacher in Ukraine and offered to help teach an online collaborative lesson about genetics and the laws of inheritance. The lesson involved using an innovative computer simulation called the Collaborative Rabbit Genetics Lab. The learning materials were translated into Ukrainian. A quasi-experimental research design compared whether prior experience working with a collaborative seesaw simulation would influence outcomes later with the biology-related collaborative simulation. Data from two classes of 9th-grade students were collected using questionnaire items related to the perception of interdependence, an open-ended question about collaboration, and a focus group interview. The results indicate that prior practice with a collaborative simulation somewhat enhanced perceived collaboration the next time students worked with a similar type of interdependent task but did not affect task performance. The findings suggest that more guidance is needed to support learners in online collaboration when they solve interdependent tasks. Copyright © 2023 by SCITEPRESS – Science and Technology Publications, Lda. Under CC license (CC BY-NC-ND 4.0)

Track-and-Trace Progress Benefits Supply-Chain Security Efforts

COVID-19 vaccines, approved under emergency use authorization, were not required to meet serialization requirements, but they have been properly labelled to meet US Food and Drug Administration (FDA) requirements, he says, complete with 2D barcodes with GTIN, lot, and expiry date. The company decided to serialize its Diprovan anesthetic, a workhorse generic product, using radio frequency identification tags containing the four identifiers (2). "If an agent is handling your product on your behalf, they need to leverage GS1 Standards including GTINs for products [and] global location numbers (GLNs) for physical locations, and share data electronically using electronic product code information services (EPCIS) to capture events from manufacturing to serialization [and] capping to shipping.

Clinical Flexibility Breaks Through Drug Development Barriers

With J&J's vaccine, cell-line optimization was also crucial, not only for speeding the vaccine's development but for optimizing its manufacturability and stability, as Paul Stoffels, executive vice president and chief scientific officer told attendees at the 2020 Galien Forum (3). [...]more bio/pharma companies have been using data analytics, including artificial intelligence/machine learning (AIML), which can be applied to real-world data from such diverse data sources as electronic health records, lab test results, and insurance claims, to ensure that trial design and patient recruitment reflect actual conditions. Closer collaboration For bio/pharma companies, one fundamental change that is speeding drug development has been increased collaboration and cross-learning through partnerships, says Lance Minor, national co-leader of life sciences practice for the management consultant, BDO USA LLP. The new pilot would cover new, nontraditional methods of data collection or analysis methods;technologies such as tissue chips that serve as micromodels of specific organ systems for safety tests;and use of artificial intelligence and wearable sensors, which could be used during clinical trials.

Improving Agility Through Scalability

Miniaturized, modular, and continuous manufacturing processes will help speed scale-up, address supply chain complexity, and prevent shortages of important medications, Janet Woodcock, director of the United States Food and Drug Administration's (FDA's) Centre for Drug Evaluation and Research (CDER), noted during a meeting of the US National Academy of Sciences (NAS) in late February 2020. Describing the research at the NAS meeting (2), Rao said his team has conducted a demonstration project involving Neupogen (filgrastim) and is working with GE on development of remote bioreactor sensors to monitor analytes, oxygen, and carbon dioxide in smallscale systems in real time (2). [...]since research results were first published, he notes, robotics have been improved, and now include integrated online measurement systems using infrared (IR), FourierTransform IR, and high-pressure liquid chromatography and mass spectrometry so that key parameters can be measured in real-time, permitting online process monitoring as well as process optimization. Use of Raman and nuclear magnetic resonance (NMR) spectroscopy, refractive index, excipient identification, metabolite monitoring, and cell counts has now become routine, in both process development and manufacturing, says Christy.

Can Pharma Quality Go High Tech?

"There were questions of how to handle tech transfer, factory and site acceptance tests, and regulatory inspections when the world was no longer travelling," he says. Since July, Stracquantanio says, usage of the platform has expanded by a factor of 17, and new site deployments by a factor of ten. The company is now using the remote approach with all major global regulatory agencies. Since Catalent hosts or performs more than 500 audits each year, new technology has allowed Catalent to keep pace, while observing social distancing requirements, Montano adds. Live facility tours are filmed with a 360-degree camera, and 3-D tours with a 3-D mapping camera, says Sandy Immerman, vice president of Information Technology (IT), Pharma Services. [...]this year, Immerman says, Thermo Fisher has hosted multiple regulatory inspections and more than 125 client audits, focusing efforts on current good manufacturing practice (CGMP) activities in work that has involved FDA, the European Medicines Agency, which issued formal guidance on the use of this technology last May (3), the Russian Ministry of Health (MoH), and the Swedish Medical Products Agency.

COVID-19, uncertainty and acceleration of innovation

The aim of this Special Issue is to review and discuss, through practical examples from different countries, the rapid and effective responses of industries, societies and governments to the high level of uncertainty and risks created by the COVID-19 pandemic. This unprecedented health crisis has pushed managers, scientists, policy makers and many other social, economic and health actors to think ‘out of the box' and provide quick solutions by reducing the process of innovation, introducing new business models and new ways of ‘doing things' in many areas such as medicine, finance, retailing, communication, teaching, supply chains and sustainable development. This Special Issue also highlights the importance of holistic approach and collaboration between different disciplines and stakeholders.

Reviewing in a pandemic? A commentary on COVID-19 and domestic homicide review

PurposeThis paper is a commentary on COVID-19's impact on Domestic Homicide Reviews (DHRs), the system in England and Wales that enables learning from domestic abuse-related deaths.Design/methodology/approachDrawing on a practitioner–researcher perspective, this paper reflects on how COVID-19 affected the delivery and experience of DHRs, the place of victims at the heart of this process and what the pandemic's impact might mean moving forward.FindingsThis paper explicates some of the challenges of undertaking DHRs in a pandemic. Critically, however, it argues that these challenges illuminate broader questions about the practice of DHR.Originality/valueThis paper's originality comes from the author's practitioner–researcher perspective and its use of COVID-19 as a lens to consider DHRs.

Supply Chain Vulnerabilities in a Post-Pandemic World

[...]what could that look like? "In an ideal world, I'd like to see life sciences supply chains break down the linear and functional siloed approach that exists today to become a dynamically connected ecosystem that integrates the full supply chain network in a collaborative and optimized way," says Stephanie David, vice president, Pariveda. In addition to inherent flaws in the foundational setup of the supply chain and the need for fewer manual processes, there are functional shortcomings as well-particularly with regards to cold chain storage and distribution. [...]more importantly, I believe that the supply chain's robustness will depend on the appetite for innovation and the ability of life sciences supply chain leaders and the skills of their organization (people) to drive the acceleration and adoption of digital capabilities required to effect change across the end-to-end supply chain," says David. "Because the supply chain is the operational backbone of life sciences companies, it is important that supply chain leaders can connect and clearly articulate the value and business outcomes of these initiatives to the wider enterprise-sales, marketing, operations, finance, etc."