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

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

Rebadging Gains Momentum Amidst COVID

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

Pfizer's Idea Orchard

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

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.

Moving Clinical Operations Forward During Pandemic

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

Looking Ahead to Factors Shaping Market Activity

According to EY's 23rd edition of its Global Capital Confidence Barometer, 89% of life sciences executives saw a drop in profits in 2020, with two-thirds saying they cancelled or failed to complete a planned acquisition (1). According to PwC, biotech acquisition activity in the US $2-$10 billion (€1.7-€8.5 billion) range is accelerating, and funding will continue to trend as well, with companies looking for strategic deal making and partnership opportunities (6). According to the government's impact assessment, up to 1800 transactions could be notified each year (11). [...]any transactions since 12 November 2020 could be eligible to be called for review retrospectively, so there is the possibility that a deal that has already been completed may be subject to intervention (11).

Addressing the Key Pitfalls Hindering Technology Transfer Success

The key challenges that are commonly faced by companies undertaking a tech transfer include: * Client expectations and initial project scope definition: the initial assumptions of the drug developer or marketing authorization holder (MHA) based on their initial information relating to the product can be a significant challenge. Typical examples include product stability issues (typically on legacy products) being evidenced due to a change to more compliant analytical methods;change to product brought about by compliance-related requirements on legacy products, such as nitrosamines, and elemental impurities guidelines, etc.;and regulatory requirements being misjudged at the onset of the project, among other factors. * Product knowledge management: particularly when undertaking tech transfers of legacy products or products in the initial discovery phase, there may be a lack of technical knowledge on the product itself to make a comprehensive and robust tech transfer process. All this may contribute to slowing down the transfer of knowledge, with implications for tech transfer timelines. * Standardization at receiving site: another challenge typically faced by receiving sites of CDMOs is a lack of standardization of their internal processes and or documentation brought about by multiple tech transfers with varying types of clients with multiple requirements. The originating site-particularly if it belongs to a small start-up-may not have team members with specialist experience in handling a transfer, so may need additional support in collating the required information to hand over to the receiving site.

Equipment Suppliers and CDMOs Advance Process Development

Rapid growth in biopharma is driving faster process development, more efficient manufacturing, and increased manufacturing capacity Process development is moving at unprecedented speed as manufacturers race to produce COVID-19 vaccines and treatments and the products needed to make them, such as viral vectors, as well as keep up with the burgeoning cell and gene therapy sector. Since 2020, EMD Millipore has been hard at work supporting developers of treatments for COVID-19. Because rapid scale up to high volumes of commercial product were needed, AstraZeneca called on multiple CMOs for production. Glover notes that, through the consortium, the CMOs worked to each use as similar a process as possible, which simplified the supply chain for equipment and raw materials.

Building Relationships Key for Smaller Sponsors

Strong collaboration critical as trial development advances Prior to the COVID-19 pandemic, biotech and emerging biopharma companies were increasingly turning to contract research organizations (CROs) to contain costs and secure therapeutic and clinical trial expertise to help meet their individual objectives. Therapeutic and clinical trial expertiseWith exploratory drug development often focused on multiple indications, a CRO with depth of tic expertise optimize clinical delivery enhancing quality and reducing timelines. Furthermore, years of therapeutic expertise and interaction with investigational sites ensure site engagement with heightened interest and attention to the target patient population.

APPLYING PRE-PANDEMIC BENCHMARKS TO ASSESS FUTURE SPEED STRATEGIES

To name but a few: they have rapidly mobilized scientific and operating teams;entered into an unprecedented number and variety of co-development arrangements;scaled-up manufacturing capabilities;and leveraged technology solutions and advanced analytics to access and analyze data from animal and early human studies and from commercially available therapies treating other diseases. Clinical trial durations and scope metrics were obtained from summaries of drug approvals available on the FDA website, from medical reviews, and from the ClinicalTrials.Gov website. [...]Phase III clinical trial durations have increased by more than 6% between the two time periods, from an average of 26.8 months in the 2008-2013 period to an average of 28.5 months per individual trial in the 2014-2018 timeframe. Very high variation was observed around the mean number of participants per clinical trial and this variation has increased over time. Mean clinical duration for non-orphan drug approvals increased substantially (16.2 months) in the 2014-2018 period, whereas mean regulatory review duration for non-orphan drugs decreased by one month.

Fit for purpose? The patents regime, the Fourth Industrial Revolution, and sustainable development

This article uses data from several publicly available databases to show that the distribution of intellectual property for frontier technologies, including those useful for sustainable development, is very highly skewed in favor of a handful of developed countries. The intellectual property rights (IPR) regime as it exists does not optimize the global flow of technology and know-how for the attainment of the sustainable development goals and is in need of updating. Some features of the Fourth Industrial Revolution imply that the current system of patents is even more in need of reform than before. COVID-19 vaccines and therapies and the vast inequality in access to these has highlighted the costs of inaction. We recommend several policy changes for the international IPR regime. Broadly, these fall into three categories: allowing greater flexibility for developing countries, reassessing the appropriateness of patents for technologies that may be considered public goods, and closing loopholes that allow for unreasonable intellectual property protections.

The launch of the EU Health Emergency Preparedness and Response Authority (HERA): Improving global pandemic preparedness?

The crowded global health landscape has been joined by the European Union Health Emergency Preparedness and Response Authority (HERA). HERA will assume four broad areas of responsibility: horizon scanning for major health threats; research and development; support for capacity to manufacture drugs, vaccines, and equipment; and procuring and stockpiling key medical countermeasures. In this Health Reform Monitor article, we outline the reform process and describe HERA's structure and responsibilities, explore issues that arise from the creation of this new organisation, and suggest options for collaboration with existing bodies in Europe and beyond. The COVID-19 pandemic and other infectious disease outbreaks have shown the need to treat health as a cross-border issue, and there is now a broad consensus that greater direction and coordination at the European level is needed. This ambition has been matched with a considerable increase in EU funding to tackle cross-border health threats, and HERA can be used to deploy this funding in an effective manner. Yet this is contingent upon clearly defining its role and responsibilities vis-à-vis existing agencies to reduce redundancies.

Innovation and internationalisation during times of economic growth, crisis, and recovery prior to Covid-19: A configurational approach comparing Spanish manufacturing family and non-family firms

Based primarily on the Resource-Based View and prior evidence, this study gauges the potential differences in innovative behaviour between international family firms and non-family firms when conditions change drastically in the business environment (i.e. from a situation of economic growth to one of downturn, and then to recovery). The research setting is a large sample of Spanish manufacturing firms between 2007 and 2016 (i.e. pre-Covid-19). During this period (2009-2013), the global economic and financial crisis affected Spain. Thus, three sub-periods are distinguished in the empirical analysis: growth, crisis, and recovery. Using Qualitative Comparative Analysis, our findings show that the paths of innovation activities that promote internationalisation via exporting in family and non-family firms are somewhat dissimilar in each sub-period, supporting the argument that the causal effect of innovation on internationalisation is heavily dependent on environmental conditions. Compared to non-family firms, our results show that when family firms internationalise, they follow a wide variety and more stable number of paths in innovation activities. Our findings also provide additional evidence to support the argument of heterogeneity among family firms.

What Members Need in Work Situations: Two Samples of Essential Managerial Leadership Behaviors: JMI

Violent incidents, terrorist attacks, senseless shootings, health issues such as the Coronavirus, and natural disasters call attention to managerial leadership in crisis situations. Yukl and Van Fleet (1982) did the seminal work on this topic extended by Peterson and Van Fleet (2008) and Peterson et al. (2012). More recently, Geier (2016) reported findings based on firefighters while Htway and Casteel (2015) and Kapucu and Ustun (2018) studied public sector organizations. Since these studies all involved nonprofit organizations, an extension to for-profit organizations is warranted. There are differences between profit organizations and not-for-profit organizations (Collins, 2001;Collins, 2005). Because of the goals involved, there may be differences in the managerial leadership behaviors required by these types of organizations. Hannah and Parry (2013) specifically recommend expanding leadership research to many different extreme situations in an effort to understand different managerial leadership behaviors that adapt to varying crisis situations. Two samples reported here identify the critical managerial leadership behaviors desired by for-profit organizational participants in both stable and crisis situations. Finally, implications, limitations, and future research are discussed.

Learning to Contract under Uncertainty in Strategic Alliances: The Co-evolution of a Firm's Absorptive Capacity: JMI

Firms have often used strategic alliances as a strategy to cope with increased uncertainty. This paper argues that a firm needs to learn to leverage its absorptive capacity to exploit and explore the contracting knowledge in strategic alliances so as to enhance efficiency, scope, and flexibility. It conceptually examines how a firm's contractual absorptive capacity co-evolves with its knowledge environment under uncertainty as part of learning. By integrating transaction cost economics and absorptive capacity literatures, this paper offers a rich picture of the co-evolutionary processes underlying contractual absorptive capacity in strategic alliances under uncertainty. It also incorporates a more refined (and underexplored) conceptualization of asset specificity and uncertainty, two key constructs in transaction cost economics, into the coevolutionary framework of absorptive capacity in strategic alliances. It illustrates some of the concepts with examples from the hospitality industry, where the impact of uncertainty is clearly evident - particularly in view of the COVID-19 pandemic.

Workplace Bullying and Intention to Leave: The Mediating Role of Emotional Exhaustion

Bullying at work and its impact on employees' intention to leave are the focus of this study. Specifically, this research aims to determine the link between workplace bullying and emotional exhaustion and the intention to leave. Data were gathered from 234 employees working in the Saif group of Pakistan through questionnaires. The study sample was drawn using the convenience sampling technique. The non-probability sampling technique was used because of the Covid 19 situation;as per government notification, only 50% of the staff was present in the offices. This study used SPSS V. 25 for direct relationships, Hayes model 4 for mediation analysis, and for model fitness, we used CFA (Amos 22). The results show that workplace bullying has a statistically significant and positive impact on the intention to quit and emotional exhaustion plays a significant role in mediating this connection (β=0.38***, SE=0.074, LLCI=0.3077 and ULCI=0.6176). Based on these results, we conclude that workplace bullying is a mayor cause of employees' exhaustion and compels them to depart from an organisation at some point. In light of these results, supervisors or line managers play a vital role in organisational sustainability by retaining skilful employees by making the workplace environment friendly and cooperative in the long run.

EDUCATIONAL AND INNOVATIVE ELEMENTS OF HUMAN CAPITAL AND THEIR IMPACT ON ECONOMIC GROWTH

Human capital is an important factor for economic growth and the development of socio-economic systems. However, the appropriate expression of the value of human capital, the mechanism and its impact on economic development are still under discussion. It is hypothesised that there is a relationship between human capital and economic growth. To test this hypothesis, data on the group of Visegrad (V4) countries for the period 2000–2019 was analysed. The study examines the presence of a causal link between some attributes of human capital and economic growth and the conditions, under which its positive effects can be expected based on statistical methods. It also deals with the role and the applicability of some of its characteristics to express the impact of human capital on economic growth. The model revealed a positive, statistically significant relationship between gross domestic product per capita and the innovative capacity of human capital and the qualifications of employees. The impact of tools for human capital creation and development extends over a longer period and is reduced by the simultaneous action of other labour market factors. Currently, economies are affected by the Covid-19 pandemic. Corresponding changes are also noticeable in the way work is done, with more weight on the home office. It will be interesting to examine how this transformation will affect economic growth. The changes in the position of employees and the care of companies for human capital are also a good topic for further research that can be conducted every few years. © Daňová M., Širá E. Text. 2023.

COP27 perspective of resources management: From conflict to COVID-19 of emerging countries.

Resources management in the modern era is a crucial perspective of a sustainable environment linked with sustainable development. Therefore, it is crucial to re-estimate the resources-environment management nexus in a new setting. Concerning environmental management from the COP27 perspective, economies are taking various economic, financial, and environmental steps to reduce hazardous emissions in the region. Recently, BRICS economies have invested in renewables and enhanced capital formation to accelerate environmental recovery. In this respect, this study tends to examine the influence of electricity from renewable resources (ELREC), resources management (resources rents), research and development (RDEV) and gross fixed capital formation (GFCF) on carbon emissions of the BRICS economies throughout 1989-2021. Using various diagnostic tests, this study confirms the long-run equilibrium association between the variables. This study uses non-parametric estimation approaches and concludes that ELREC and RDEV significantly enhance environmental sustainability. Except for forest and oil resources, the rest of the forms of the resources increase emissions. On the other hand, economic growth and GFCF significantly lead to higher emissions, which degrades the environment. Resources rents also contribute to increasing carbon emissions.