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AbstractEdible polymers are safe for consumption by humans and use in society. Shellac is a derivative of Lac, which has been used for a long time in many different industries due to its remarkable properties, which include film-forming, water resistance, thermoplastic, adhering, bonding, and simple solubility in spirit and aqueous alkali solvents. A paradigm shift has been observed in the variety of applications and uses of shellac due to the growing desire for natural products, particularly in the food, pharmaceutical, 3D printing, stealth technology, green electronics, and intelligent sensor industries. It is commonly used as an enteric coating in the pharmaceutical sector and as a preservative coating or confectioners glaze in the food industry. Being a natural and eco-friendly substance, shellac has a great deal of potential for more sustainable technologies. Due to the film’s strength and polymerization, shellac, however, has limitations. The low stability and mechanical brittleness of shellac, which result from self-polymerization reactions, limit its application even though it has great potential as an environmentally benign protective covering. This review offers a comprehensive understanding of lac, encompassing its characteristics, its uses, and its prospects for the future. This study aims to investigate a new method that may mitigate some of the disadvantages of shellac coating whilst improving the material’s stability and mechanical properties. [ABSTRACT FROM AUTHOR]

This article describes the processes that take place in the pharmaceutical regulatory environment and documentation on medicinal products. Granting of marketing authorization and other regulatory processes use dossiers on medicinal products as their primary resources. The pharmaceutical industry moved from paper to digital marketing authorization dossiers. The article discusses the tasks of those responsible for managing documentation in the pharmaceutical industry and regulatory agencies. There are people with various job roles who work on the dossiers on medicinal products in the companies and agencies, but they are primarily focused on the content. In most pharmaceutical and regulatory organizations, medicinal products dossiers must be kept for the long term or permanently. Hence, records managers and archivists are most welcome to work in this milieu. In this respect, the article outlines the competencies necessary for managing digital records and dossiers on medicinal products. Finally, the article explores future trends in archiving pharmaceutical documentation and proposes necessary standards and mechanisms for the task, as well as the information model of submission and archival information packages for this domain. [ABSTRACT FROM AUTHOR]

In 2019, Zolgensma, a gene therapy for patients suffering from Spinal Muscular Atrophy (SMA), became famous for being 'the most expensive drug ever'. Its high price was justified by 'the value' that the drug will bring to patients and society, illustrating a rationale that has come to be known as value-based pricing. This paper builds on the literature in valuation studies and economic sociology, and on the debates that the case of Zolgensma triggered in France, to provide a conceptual and empirical analysis of a value-based formulation of prices. We argue that formulating prices out of value produces an orientation towards the future which has epistemic and political consequences. We analyse Zolgensma's value-based price as a composite of narratives and calculations that operates as a regulatory tool, a contractual arrangement, and an object of expertise. In these different settings, its distinctive temporality questions the commensurability of estimated benefits and desirable futures, the treatment of uncertainty, and the relevance of past costs and future value. [ABSTRACT FROM AUTHOR]

The authors reflect on a report "Transparency and trust in the European pharmaceutical sector" published within issue of the periodical. Topics discussed include relation between transparency and trust in pharmaceutical regulators; need of integrating transparency in effective, evidenced- and science based benefit/risk communication; and need of different regulatory domains to obtain a understanding of the role of the institutional and situational context.

The Chinese pharmaceutical industry has seen rapid development, with industrial mergers and acquisitions (M&As) increasing over the recent years. However, the studies focused on the characteristics and identified limited impacts of these M&As. This paper then intends to fill the gap by analyzing 393 completed M&As deals in China's pharmaceutical industry from 2004 to 2016 concerning 54 firms. This paper found that: (1) firms' innovation performance is higher when the industrial M&As activities are intensive. (2) M&As activity improves firms' innovation output while overly frequent M&As exert negative effects on innovation output. Stock payment is negatively associated with firms' innovation output. (3) Firms' innovation performance is statistically different between state-owned enterprises (SOEs) and non-SOEs. Firms' innovation performance does not vary whether the acquisition was conducted by SOEs or non-SOEs. Apart from providing empirical evidence, this paper, in turn, proposes policy implications for further innovation development in the Chinese pharmaceutical industry. [ABSTRACT FROM AUTHOR]

This paper explores three novel research questions. First, is an increase in the number of countries involved in ownership of a co-patent an effective way to enhance patent quality? Second, if the objective is to raise patent quality, which are the right countries to collaborate with? And third, does cooperation with partners located in a tax haven affect patent quality? The empirical methodology relies on forward citations as an indicator of quality, and patent co-ownership as a measure of international collaboration. Our econometric findings show that, first, the average effect of international collaboration is a 4.9% increase in patent quality compared with those patents for which the assignees come from a single country (once we controlled for patent characteristics). When the number of countries in which the assignees are based increases, the effect of this wider collaboration on patent quality is also greater, though only for up to a maximum of five countries. Second, to produce patents of better quality, the most suitable countries with which to collaborate were found to be the United States, Switzerland, Japan, Germany and the United Kingdom. Finally, collaboration with firms located in a country categorized as a tax haven does not have any significant impact on patent quality. [ABSTRACT FROM AUTHOR]

Background: The goal of the public procurement of pharmaceuticals is to purchase sufficient quantities of high-quality pharmaceuticals at cost-effective prices for a given population. This goal can be undercut if corruption infiltrates the procurement process. Good procurement practices can help mitigate the risks of corruption and support equitable access to affordable and high-quality medicines. Objectives: This paper aims to 1) examine manifestations of corruption in the pharmaceutical procurement process and key factors behind them, and 2) identify how to design and implement effective anti-corruption, transparency and accountability mechanisms within this process. Methods: This paper was informed by a narrative literature review from 1996 to the present. The search focused on publications that addressed the issue of pharmaceutical procurement and governance and corruption issues. Our search included peer-reviewed literature, books, grey literature such as working papers, reports published by international organizations and donor agencies, and some media articles. Some documents used in this paper were already known to the authors. Results: Procurement is highly vulnerable to corruption particularly in the health sector. What is more, corruption in the procurement process does not appear to be limited to any one level of government or type of health system. The better integration of accountability, transparency and anti-corruption mechanisms in the procurement process is needed to reduce the risk of corruption. Conclusions: Lessons learned suggest that anti-corruption, transparency and accountability mechanisms in the pharmaceutical procurement process, such as open contracting and integrity pacts are helpful towards reducing the risk of corruption. [ABSTRACT FROM AUTHOR]

So far, PhUSE has been an exciting initiative. European Pharmaceutical Software Users now have a place where they can present and share their experience. In the first three PhUSE conferences (2005, 2006 and 2007), 273 papers were presented (89 in 2005, 85 in 2006 and 99 in 2007) in the following areas: 51 posters, 36 applications and development, 31 technical solutions, 22 coder corners, 18 coding solutions (2006 and 2007 stream), 17 statistics and pharmacokinetics, 17 tutorials, 13 CDISC and XML (2005 stream), 13 data management, 11 CDISC and regulatory (2007 stream), 10 professional development and management (2005 and 2006 stream), 10 regulatory compliance, electronic submission and validation (2005 and 2007 stream), 7 SAS starters (2005 and 2006 stream), 5 management (2007 stream), 4 industry starters (2007 stream), 4 professional development and training (2007 stream), 2 Microsoft tool (2007 stream), 2 Oracle clinical (2007 stream). The ultimate objective of this sort of ‘systematic review’ is to make a summary of the current contribution of PhUSE to the Pharmaceutical Software User Community. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this paper is to provide a validation framework to guide future validation practitioners towards completing utility validation projects in small and medium enterprise successfully and in shorter duration compared to current practice. Design/methodology/approach: Literature review was carried out on various existing validation frameworks to analyse the positive and negative elements of the frameworks. The identified positive key elements from this analysis were incorporated to develop a comprehensive validation framework that can be used by future validation practitioners to validate utility system in manufacturing companies. Findings: The case study results proved the capability and effectiveness of the new framework as the validation of the reverse osmosis water system was completed successfully with proper documentation and within shorter period compared to previous validation projects in the case study company. Research limitations/implications: The proposed validation framework is well suited for use in small and medium enterprise companies. Further studies should be carried out to ascertain the effect of the framework. Originality/value: This paper provides a comprehensive validation framework that can guide future validation practitioners towards completing validation projects in small and medium enterprise companies successfully and in shorter period. [ABSTRACT FROM AUTHOR]

Standardised Work (STW) is one of the most effective but least utilized Lean tools for business process improvement initiatives in the transactional office environment known as the 'Lean office'. The STW not only establishes a baseline for continuous improvement initiatives but also facilitates them by giving indications of key improvement opportunities in the present best practice. The STW is a thorough document in which the process workflow is broken into a number of consecutive work elements whose processing times are labelled according to their nature and required resources. Developing the STW for business processes in the manufacturing environment is quite common; however, it is quite rare and limited in the transactional office environment. This is primarily caused by the business-office processes' complexity or underestimating their influence on overall business success. In this study, we position and highlight the importance of the STW in the Lean office programme and propose a pragmatic and tractable framework for developing the STW for business-office processes through the use of a pilot process. The proposed STW framework was implemented successfully in the pharma industry. Finally, the paper is concluded by discussing the possible obstacles and providing future research directions. [ABSTRACT FROM AUTHOR]

The article focuses on the difficulty faced by low- and middle-income country (LMIC) researchers in accessing research literature. It mentions that the open-access (OA) movement emerged with the hope of making research papers freely accessible. It mentions about the discrimination that developing-country researchers face in different areas of scholarly communication.

Welcome to the April Edition of the Journal of Marketing Management which contains a wide range of the contemporary themes, methodologies and industries which characterise the intellectual scope of marketing's domain around the world. This edition presents purely conceptual articles, quantitative analysis of marketing literature, survey data and panel data as well as several studies using qualitative data collection and analytical techniques. The contexts for the collection vary from product markets to service markets, B2C and B2B perspectives as well as, unusually, two articles relating to the pharmaceutical innovation. [ABSTRACT FROM AUTHOR]

The pharmaceutical sector is one of the pillars of the world's economy. A significant proportion of its value lies in intellectual assets generated through continuous innovation and lengthy development cycles within a strictly regulated environment. The purpose of this paper is to address the gap between knowledge management (KM) as an expanding academic discipline in the pharmaceutical industry and at the same time a growing regulatory expectation. A systematic review of 137 refereed KM articles revealed six empirical research themes in the pharmaceutical industry. In a subsequent step, the discovered themes and subthemes were compared with the extant regulatory expectations as explained in 128 regulatory guidelines. Findings shed the light on the gap between academic KM research and the current thinking of regulatory bodies. Some regulated knowledge processes were underrepresented in academic literature. The paper offers also novel insights and recommendations for future developments in academic research, regulations, and/or industry. [ABSTRACT FROM AUTHOR]

Establishing effective pharmaceutical governance is a challenge for government agencies, private enterprises, and professionals working on the ground, demanding complex ethical decisions from the actors involved, especially in a lower-middle-income country like Ghana. This letter aims to share the author's perspectives and additional considerations on the analyses of the reports in the paper "It is very difficult in this business if you want to have a good conscience": pharmaceutical governance and on-the-ground ethical labor in Ghana by Hampshire et al. The letter's authors discuss the need to advance universal health coverage in Ghana, the everyday ethics, and the disparities between the collective and individual moral consciousness of the participants, as well as other aspects of governance in the pharmaceutical sector. [ABSTRACT FROM AUTHOR]

This paper proposes a framework for firm use of HRM when engaging in open innovation. Whereas open innovation has gained wide recognition in the innovation management field, as firms open their boundaries to knowledge inflow and outflow to advance innovation, very few empirical papers link the HRM literature to this phenomenon. We base our analysis on an exploratory qualitative study of the pharmaceutical corporation AstraZeneca and its implementation of an open innovation initiative called BioVentureHub. We identify three main areas of HRM work: inbound, outbound, and coupled HRM work. Furthermore, we illustrate how these HRM activities relate to the development of the open innovation initiative and to current HRM and open innovation literature. The framework identifies HRM activities that target not only internal employees, but also external human resources engaged in the open innovation initiative. This HRM work is mainly conducted through informal means, separate from the host corporation's business as usual. Our empirical study contributes to the limited and mainly conceptual research connecting open innovation with HRM, increasing our knowledge of how corporations use HRM work to manage open innovation initiatives in practice. [ABSTRACT FROM AUTHOR]

Some emerging countries have made significant progress in developing local pharmaceutical and biotechnology but had less success in building medical device industries (MDIs). This paper explores the weak development of local MDIs by analysing the contrasting evolutionary trajectories of Indian healthcare technology sectors. The Indian pharmaceutical and biotechnological industries have emerged as leading global suppliers of generic drugs and vaccines, in marked contrast to the medical devices industry. This paper reveals that existence of a weak collaborative linkage between medical device manufacturers and the Indian health system, which largely lacks a systemic and cross-sectoral linkages, and weak communication between industry and government policy-makers have become a huge barrier to the development of the Indian MDI in the contemporary neo-liberal environment. The weak connection between technology and industrial policy and healthcare policy objectives has severely hampered both development of national technological capabilities and the creation of affordable health care. [ABSTRACT FROM AUTHOR]

The pharmaceutical supply chain has become highly consolidated. Currently, over 70% of all prescriptions are handled by three pharmacy benefit managers which each own a mail-order pharmacy. To compete in this environment, small and midsized pharmacies must seek efficiencies in their operations. The paper considers the value of cooperative partnerships between mail-order and chain pharmacies to leverage strengths of both players. To examine the viability of the strategy we develop a mathematical model that assesses the value of partnerships between independent organizations operating in different channels. The model is used to determine whether and to what extent pharmacies should consider partnerships that leverage a competing channel to allow mail-order customers to pick up prescriptions at chain stores in particular regions. Computational results provide insight into the impact of drug prices, reimbursement contracts, and revenue/cost-sharing policies on the optimal supply chain design and highlight conditions under which it is beneficial for chain and/or mail-order pharmacies to enter partnerships. [ABSTRACT FROM AUTHOR]

This paper seeks to contribute to the burgeoning research on corporate governance and research and development (R&D) by exploring the contingent role of firm size and its crucial role in defining conditions for competitive advantage. Using a generalised method of moments (GMM) estimator and a sample of U.S. publicly traded pharmaceutical firms from 2009 to 2018, we test several hypotheses related to the role of firm size in the relationship between corporate governance and R&D investment. Our findings show the importance of institutional context and point out the configurations of governance practices that lead to high and low levels of R&D investment. We find that the effect of corporate governance on R&D investment is contingent upon firm size. Larger and smaller firms differ in building and employing their strategic decisions. Our results indicate that larger firms facilitate R&D investment than smaller firms, showing that these firms are more prone to seek variation and visibility for accessing better resources. Our findings are relevant for firms aiming to implement strong governance mechanisms to track their R&D activities and for policymakers interested in promoting R&D investment. [ABSTRACT FROM AUTHOR]

Presents several abstracts related to research. 'Productivity Growth in the 1990s: Technology, Utilization, or Adjustment (Working Paper No. 8539),' by Susanto Basu, John Fernald and Matthew Shapiro, published in the October 2001 issue of the periodical 'National Bureau of Economic Research; 'Lean Mean R&D Machines⁄The TR Corporate R&D Scoreboard,' by Wade Roush, published in the December 2001 issue of the periodical 'Technology Review'.

The aim of this paper is to study the impact of generic substitution on pharmaceutical prices and expenditures in OECD countries. We first developed a theoretical model to obtain predictions on the impact of the policy and then used data on pharmaceutical prices and expenditures in 16 OECD countries to examine empirically the impact of the policy of generic substitution. Empirical results indicate that the average reduction of prices after the implementation of the policy is 3.1 percent. The estimate is obtained after controlling for the growth rates in prices, time trend, country-specific differences in prices, population age structure, and income levels. However, we are not able to show that the policy would have a statistically significant impact on pharmaceutical expenditures. The point estimate refers to a 1.6 reduction in expenditures. These results suggest that the consumption of pharmaceuticals increases as response to lower prices. [ABSTRACT FROM AUTHOR]

Using a comparative case study on the closure of the research and development facilities of a pharmaceutical company in two regions in Sweden, this paper investigates the emergence of regional economic resilience from an agency perspective. Findings include a networked region engendering agency from non-state actors whilst substantial state intervention is needed to facilitate agency from a less networked region. The paper finds broad confirmation that interactions of actors are due to how a region is organized and the contingencies of its institutional context. Collective agency depends on the ability of actors to align interests and coalesce agendas which, as shown by the two cases, can be based on shared regional affinity as in the case of Södertälje or innovation strategies as in the case of Lund. Regional economic crises bring forth conditions and impetus for temporary modes of cooperation that mobilize resources to launch adaptive resilience strategies. Conflicts in resource distributions or operational complexity make developing agency-based resilience challenging. Emergent regional outcomes from agency-based resilience from these two cases exhibit adaptation with the potential for adaptability in Lund, and adaptability with degrees of adaptation in Södertälje. [ABSTRACT FROM AUTHOR]

A recent literature review highlighted the knowledge-based view as an important current theory in the strategic management area. The current paper utilizes that theory as the context for employing bibliometrics to uncover the publishing and patenting citation patterns in a group of twelve US pharmaceutical companies over a 13-year period. Our initial findings suggest that firms self-cite a great deal, and that they rely heavily on public science. In addition, we found that Merck and Co. is the most frequently cited company in both the science and technology areas, though somewhat less so in technology. The managerial implications, particularly from a knowledge perspective, are discussed as well as some suggestions for future research. [ABSTRACT FROM AUTHOR]

In the pharmaceutical industry, a reverse payment (pay-for-delay) is a payment from an originator to a generic producer to delay her entry. In some recent cases, the US and EU antitrust authorities have banned these agreements per se, while in others they have used a rule of reason. This paper analyzes their dynamic effects and shows that a ban per se may reduce consumer surplus when the generic producer may go bankrupt and her financial situation is private information. Reverse payments are more beneficial when competition among few players is soft, the economy is in a downturn, and the period of drug usage after patent expiry is long. Results suggest that a rule of reason is more suited than a ban per se. [ABSTRACT FROM AUTHOR]

Big data analytics has attracted significant scholarly attention over the past few years due to its critical role in directing organizational decision making. Big data analytics capabilities (BDAC) are increasingly being suggested to be of great help in providing competitive advantages to the firms across industrial settings. Although, prior research has examined the influence of BDAC from a technological perspective; there is a lack of a research from a broader strategic perspective. Correspondingly, this study builds on dynamic capabilities view to propose a conceptual model that investigates the direct and indirect effects between three dimensions of BDAC on environmental scanning and organization's strategic intent. This study adopted the questionnaire-based survey method to collect the data from 179 senior managers of pharmaceutical companies in Egypt. The results revealed that only the technological dimension of BDAC significantly affected the strategic intent only through supporting data-driven culture and organizational learning. The results also reveal that BDAC is positively associated with environmental scanning, which consequently affects strategic intent. Our results further reveal that environmental scanning mediates the relationship between BDAC and organization's strategic intent. The paper concludes by offering some valuable theoretical and practical implications. [ABSTRACT FROM AUTHOR]

Scientific evidence on the safety and efficacy of pharmaceutical drugs, substances and herbal medicines is important in medical advertising and promotion. Following guidelines for conducting a scoping review, we systematically searched PubMed, SCOPUS and Web of Science to identify in peer reviewed articles medications that were promoted and used widely in Africa during the COVID-19 pandemic. We also searched for information about how safety concerns about untested/or not properly tested drugs were communicated to the public during the pandemic. Of the 2043 articles identified, 41 papers were eligible for inclusion. Most studies were clinical trials (n = 11), systematic reviews (n = 9), quantitative studies (n = 9) the rest were qualitative studies, reviews and reports. We found that following global trends, several drugs, traditional and herbal treatments were used and repurposed for the treatment of respiratory symptoms of COVID-19 in Africa. The results highlighted the value of some herbal medicines for treatment during the COVID-19 pandemic, as well as the risks posed by the unregulated sharing of advice and recommendations on treatments in Africa, and globally. [ABSTRACT FROM AUTHOR]

This paper focuses on the recent interest in patient engagement (PE) in drug development, expressed in the growing number of calls for engagement, novel organizations dedicated to changing the culture of drug development, and guidelines for directing and evaluating PE. By reviewing materials produced by actors in the field and analyzing publications reporting on PE initiatives, I map sites of action where PE is being conceived and practiced, delineate how PE is being shaped, and analyze relationships emerging within and around the collectives involved. Pharmaceutical industry players actively mold the landscape of PE in drug development through creating tools and frameworks for PE. These instruments for guiding the implementation of PE are disseminated via training and dedicated events, concurrently disseminating a particular configuration of PE. PE emerges as an attempt to open new avenues for increasing productivity amidst concerns about the future of drug innovation, while PE practices fit smoothly into the arrangements for producing and distributing pharmaceutical knowledge largely shaped by the industry. The ongoing participatory turn in drug development is taking place without shifting the established concentration of epistemic power among commercial entities. [ABSTRACT FROM AUTHOR]

With an estimated population of 8.3 million, Sierra Leone has no existing pharmaceutical manufacturing company at present. The recent COVID-19 pandemic brought to the limelight the fragility and weakness of the Sierra Leonean pharmaceutical industry as it resulted in severe drug shortages and medicine insecurity in the country due to the restrictions imposed on importations, which validates the uncertainties if the country can sufficiently meet its local pharmaceutical needs and health demands. In this paper, we highlight the current situation of the Sierra Leonean pharmaceutical sector and provide recommendations for the country towards building a functional pharmaceutical industry based on lessons learnt from the COVID-19 pandemic. [ABSTRACT FROM AUTHOR]

Background: Deaths due to opioid overdose continue to rise in the United States. Despite availability of effective treatment for opioid use disorder, uptake is low among those who misuse opioids. Methods: This paper explores the role of misconception, stigma, and misinformation in influencing decisions to initiate medications for opioid use disorder among patients and providers. Conclusion: Misinformation about opioids has been prevalent among future healthcare providers and first responders as well as pharmaceutical companies, which may have implications for treatment. Among individuals with opioid use disorder, treatment uptake and adherence have been negatively affected by misconceptions about treatment efficacy and side effects, as well as stigma. We discuss the role of social media, education, and the community, in mitigating misinformation and addressing misconceptions about opioids and treatment options. [ABSTRACT FROM AUTHOR]

Targeting a series of advanced manufacturing technology (AMT) ‘interventions’ provides the potential for significant step changes across the pharmaceutical value chain, from early stage ‘system discovery’ and clinical trials, through to novel service supply models. This research explores future value network configurations which, when aligned with disruptive shifts in technology (process and digital), may enable alternative routes to medicines production and the delivery of additional value to ‘end-users’, i.e. patients and health care providers. We draw on a categorisation of AMTs that may enable a shift from the traditional ‘batch’ and centralised manufacturing paradigm of ‘make-to-stock’, towards more re-distributed ‘continuous’ manufacturing and ‘make-to-order’ models. Despite reported benefits in the academic literature (e.g. reduced footprints, improved quality, enhanced flexibility and inventory savings), current adoption rates of continuous technologies in this sector remain low (c. 5%). This paper presents new data sources, in our study of AMT adoption in a global pharmaceutical context – assessing the barriers to implementation, and the pathways to delivering future continuous manufacturing scenarios. Our findings capture the high level of disparity in viewpoints, highlighting the uncertainties and transformational challenges ahead – in terms of opportunity areas, technological readiness and a future vision for the sector, as a whole. [ABSTRACT FROM PUBLISHER]

On the basis of the original data on thecurricula vitaeof a group of Italian inventors patenting in the pharmaceutical field, this paper distinguishes between inventors' employers and applicants, and provides new information on their professional careers and their patent ownership regimes, that is whether or not intellectual property rights on inventions are retained by their employers. In addition, the paper confirms that inventors' mobility is an important determinant of knowledge impact and, interestingly, shows that ownership, too, is associated with a greater potential for knowledge diffusion. [ABSTRACT FROM PUBLISHER]

Many organisations consider business analytics to be a key organisational capability. To date, there is little evidence on how organisations have included analytics at the heart of their strategy processes. This paper addresses this issue by exploring the activities within a strategy process and considering the potential role that business analytics might play in providing support to such processes. We perform a search in multidisciplinary databases for evidence of the use of business analytics within strategy processes and we reflect on its use in two case studies performing strategic analysis within the pharmaceutical industry. The findings indicate business analytics is still an emerging field without a structured approach. Business analytics can provide important data-driven insights into strategy processes; we therefore recommend its further integration with other traditional OR and strategy tools in order to support strategic decision-makers. [ABSTRACT FROM AUTHOR]

Repeated measurements are widely encountered in medical or pharmaceutical studies, which can be analyzed by both longitudinal data and functional data analysis methods, particularly when the underlying process is continuous and the number of measurement points is not too small. Motivated by real problems of clustering patient profiles in clinical trials, this paper gives an overview of the clustering methods for repeated measurement data and compares three longitudinal data methods and two functional data methods with extensive simulation studies. Methods with appropriate properties are applied to the real data to produce interpretable results. [ABSTRACT FROM AUTHOR]

There are a number of papers discussing the need for version control in the development of programs in the pharmaceutical industry. From simple CVS or RCS command line interfaces to the more complex and graphical tools like Rational Rose, programmers are told: there is a system out there to version your software, so do it! This is an important step in software development, but it is not the ‘be all end all’ for programmers. Since the industry insists on a review (Quality Control or ‘QC’) step to ensure that the specifications of the statisticians are met by the code of the programmers, it makes sense to have that same system allow for the ‘flow’ of validated code from the programmer to the statistician to the production version of the code. This paper discusses the process that was originally used until the company purchased a version control system in 2001– a paper-based system – and the evolution of our workflow from this paper-based system, through a commercial application and into an internally built system. This will include a discussion on some of our decisions and our design conclusions, as well as maintenance and future directions. The second paper in this series will cover the initial research and development of our own in-house system that started in 2004. This will include the development of user requirements, designing and building the system. The final paper in this series will discuss the current use and enhancements to the system over time, as well as future changes to the architecture to meet the ever changing corporate and industry needs. [ABSTRACT FROM AUTHOR]

This paper reports on the pattern of differences in the wholesale price of identical drugs across Central American countries. The countries differ in such economic factors as percapita income, income distribution, and nature and extent of the public health system. A panel-data regression technique is used to test whether the same drugs are sold at different prices across the countries. The analysis is made for drugs in eleven therapeutic groups. Results show that there are significant differences in the price of drugs across the countries and that a regional price-discrimination strategy could be in place. [ABSTRACT FROM PUBLISHER]

This paper draws upon published literature, focus groups, workshops, and individual patient views to identify general use of Internet for health information and, specifically, use of cross-border Internet pharmacy Web sites to locate and purchase prescription drugs. The paper applies the theoretical frameworks of risk perception theory and social cognition theory to attempt to explain why American patients continue to shop for prescription medications through cross-border Internet pharmacies (CBIP) despite its questionable legal status and potential for serious harm. [ABSTRACT FROM PUBLISHER]

China has constantly been adjusting drug pricing regulation, trying to balance between drug companies and the public, but the outcome is not as expected. Until recent years, the government has carried out comprehensive medical reform. It not only abandoned the 'medicine mark-up' mechanism that has been implemented for more than 60 years, which changed the drugs' price structure to reduce the prices, but also implemented the '4 + 7' volume-based purchasing system, which further improved the centralized bidding procurement system, tried to return the pricing power to the market mechanism, and exchanged the huge market share for the low prices. As of today, medical reform has been implemented for more than three years. Although many studies have discussed its results, most of them only focused on the impact of medical reform on drug prices, but ignoring the impact on R&D incentives of pharmaceutical companies and ignoring the influence on related industries. This paper is devoted to discussing the impact of medical reform on drug prices, the R&D of pharmaceutical companies, and retailed industries. [ABSTRACT FROM AUTHOR]

Corporate Social Responsibility (CSR) disclosures have gained great attention both in media and academic community through years in manufacturing companies. Fewer evidence was provided regarding CSR in pharmaceutical sector due to the characteristics of such firms. In this paper, we shed light on CSR disclosures' practices adopted by Hikma Pharmaceutical (Plc.). Based on previous literature in the field, we adopt a content analysis of Hikma Plc. CSR disclosures related to the three main fields defined by the Global Reporting Initiative (GRI) standards 2016: Economic standards (GRI 200), such as values of integrity, business ethics through anti-corruption practices, and competitiveness through tax optimisation. Environmental standards (GRI 300), especially ISO14001 certification that specifies the requirements for an environmental management system that an organisation should use to be considered as environmentally responsible. Social Standards (GRI 400), especially those that respect and uphold the principles of human rights of the UK Modern Slavery Act (MSA). Our results show that Hikma Plc. displays a higher level of compliance with GRI international standards, mainly in the social field more than economic and environmental disclosures. Our study can be used as a useful framework for CSR disclosures in the pharmaceutical industry in Jordan and abroad. Our findings help in guiding investors when allocating resources in the pharmaceutical industry and regulators when issuing new standards on CSR policy. [ABSTRACT FROM AUTHOR]

The Asian region has passed a long and rocky road during the past several decades to establish itself as the second leading regional biotech market globally. China has become the second largest pharmaceutical market while Japan holds a strong second position as the global hub for medical devices development and innovation. Pharmaceutical expenditure continues to outpace real GDP growth in most of these countries. The trend is likely to be continued for a decade ahead, driven by a myriad of factors ranging from aging populations, rapidly growing welfare and increased citizen expectations raising demand for novel medicines and technologies. Satisfaction of these unmet needs in terms of supply is coming from the large multinational companies in wealthier among these societies. Domestic born and largely state-owned manufacturing industries continue to play a crucial role in an array of middle-income countries. Global biotech hub of Singapore is hosting over 1.5 times more headquarters of large pharmaceutical companies than Beijing, Tokyo, Shanghai and Hong Kong combined together. Japanese Takeda, Astellas, Daiichi Sankyo and Otsuka and Chinese Sinopharm, Guangzhou Pharmaceuticals Corporation, SPH and Yunnan Baiyao are now enlisted in leading Top 25 pharmaceutical companies rankings as per their annual net revenues in 2020–2021. Global industry landscape is evolving with ever more Asian companies obtaining the sharp innovative competitiveness leading development of cutting-edge medical technologies. Asian societies demand for pharmaceuticals and medical services continue to be characterized with unmet needs and striving to increase supply capacities. Financial obstacles of affordability of life saving medicines to the ordinary citizens shall be gradually overcome with an array of reimbursement strategies and extended insurance coverage policies. Observing the broad landscape throughout Asian region, we may witness that optimism in terms of domestic real GDP growth and consecutive biotech industry forecasts remains firmly rooted in years to come. Biosimilars are not a focus of the paper. [ABSTRACT FROM AUTHOR]

Aim: The pharmaceutical or drug supply chain is the means through which prescription medicines are manufactured, stocked, and delivered to consumers. How the complexity and fragmentation of this supply chain shape or reshape the decisions and courses of action as well as risk aversions of its actors (stakeholders) is the question we address in reviewing recent literature presented at the 2021 AEAASSA economics convention. In doing so, we identify key aspects or dimensions of the supply chain that remain unexplored or under-explored in the empirical literature. Approach: All original research relevant to the pharmaceutical supply chain were selected from the AEA-ASSA convention panel sessions. Empirical evidence was thematically identified, and the theoretical and practical implications of findings on firm and stakeholder decision-making were analyzed. Findings: Stakeholder choices and risks in the action steps or stages of the supply chain are conditioned or framed by variables that are less prominent and seldom documented in the empirical literature. These include firm ownership and marketing, the provider's IT system, pricing and discounts negotiated by pharmacy benefit managers (PBMs), health insurance coverage, employer plan sponsorship, and hassle costs of drug prescribing and monitoring. On the other hand, prominent and well documented policy initiatives, like international reference pricing and renationalization or "decoupling" from global value chains, can have unintended effects on supply chain actors and end-users, including reverse redistribution. The continuing and changing multi-dimensional character of the supply chain adds to its complexity and fragmentation. Conclusions: Organizational, operational, and value-adding measures to overhaul the drug supply chain and make it perform better have been proposed in the surveyed literature and elsewhere. Yet, aspects of the supply chain that bear a direct impact on firm short-term financial success typically assume precedence in evaluations of performance and effectiveness. Whether and to what extent the drug supply chain will change to cope and adapt to the major challenges and upheavals it currently faces are lingering questions. [ABSTRACT FROM AUTHOR]

This paper evaluates the individual and combined effects of exporting and outward foreign direct investments (OFDI) on firms’ technology investments at home using firm-level data from the pharmaceutical industry in India. The analysis accounts for unobserved firm heterogeneity and the endogeneity of the choice of foreign market participation, and shows that exporting has been an important channel through which Indian multinational expansion has encouraged greater domestic technological activity. However, all else constant, higher levels of OFDI have rather acted as substitutes for such technological efforts. [ABSTRACT FROM PUBLISHER]

Readers’ trust on the medical literature has been eroded, and journal editors and some editorial boards are taking measures to ensure that authors fully and accurately report research findings and disclose conflicts of interest. This article describes a case study in which the papers editor of the World Health Organization (WHO)Bulletininfluenced the content of an article that had been approved by the external reviewers. The editor objected to the publication of the large price differentials of the new molecular entities (NMEs) across the Latin American countries where they had been tested and the limited added therapeutic value of the NMEs that had been assessed by independent drug bulletins. This article summarizes the exchanges with WHO staff and posits the hypothesis that the WHOBulletinmight be affected by the shifts in WHO financing. Several authors have raised concern about the impact of financial conflicts of interest in WHO activities in the field of nutrition, intellectual property, and in the emergency response to the flu pandemic. Moreover, it has been reported that powerful WHO contributors pressured WHO into revising its publication policy. This is the first time that authors question if these conflicts of interest are also affecting the editorial independence of the WHOBulletin. [ABSTRACT FROM PUBLISHER]

Public health advocates aim to maximise affordable access to good quality essential medicines. This goal often conflicts with the profitseeking ambitions of the pharmaceutical industry. Since the World Trade Organisation's Trade-Related Aspects of Intellectual Property Rights agreement, the extension and enforcement of intellectual property (IP) rights has become the dominant discourse in global medicines governance. Public health advocates operating within this framework face significant obstacles and challenges. This paper presents an historical perspective to the contemporary debate over medicines and patents by examining the evolution of international medicines governance between the 1940s and 1970s. This research indicates that debates around IP and medicines were more advanced in terms of equity and access in the 1960s and 1970s than they are today. While acknowledging the existence of obstacles and challenges for advocates, the paper argues that alternative frameworks can and should be reasserted in global debates about medicines governance. [ABSTRACT FROM AUTHOR]

This paper builds upon the literature which provides conflicting theoretical insights and empirical results concerning the importance of companies’ collaborative relations, their position within a network of collaborative relations and the effects on their innovative performance. Taking the importance of collaborations and networks in the pharmaceutical industry into account, the paper untangles the influence of the firm’s co-publication relations with different types of partners and its network position on the company’s product innovation in a specific disease area—cancer. We find rather robust evidence that in particular, companies’ indirect connections within the co-publication network, including connections to academic institutions and biotechnology companies, support product innovation. In contrast to evidence in the strategic alliance literature, direct co-publication links to biotechnology companies do not support product innovation in terms of new cancer medications. [ABSTRACT FROM AUTHOR]

This paper discusses re-emergence of Korean medicine(s) in the global context with a focus on a natural drug JOINS, a highly contentious drug regarding its legal status. By following through its life world, the paper contends that the drug is the embodiment of the postcolonial anxiety that crosses the intersections between the aspiring nation and globalizing strategies of the bio-pharmaceutical industry. JOINS is a natural drug prescribed to alleviate the symptoms of degenerative arthritis. SK Chemicals, Ltd., a giant domestic pharmaceutical company developed the drug by utilizing the knowledge of traditional pharmacopeia and put it on the market in 2001. In the domestic market, the drug is treated as a prescription drug, implying that Western medicine-trained doctors (as opposed to Korean medicine doctors) are entitled to prescribe drugs. It also indicates that the drug has undergone a series of lab tests such as toxicity, efficacy, and clinical trials in compliance with regulatory guidelines. However, the domestic standards are not rigorous enough to satisfy international standards, so that it is exported as a nutritional supplement abroad. The government, the pharmaceutical industry, and the Western medicine profession are happy with how the drug stands domestically and internationally. Rather, it is Korean doctors who try to disrupt the status quo and reclaim their rights to traditional knowledge, who have been alienated from the pharmaceuticalization of traditional knowledge. Thus, the JOINS tablet embodies the complex web of modern Korean society, professional interests, the pharmaceutical industry, and globalization. [ABSTRACT FROM AUTHOR]

This paper presents three embedded episodes in the life of a polyherbal drug indicated as a preventative measure for hangovers. Invented and marketed in 2005 by a leading ayurvedic pharmaceutical company in India, PartySmart is a reformulated compound based on ayurvedic, biomedical and phytochemical sources. This creative process has involved multiple translations, resulting in hybrid pharmacological models, including, for instance, ayurvedic post-digestive tastes and biomedical effects on enzymatic activities. These modes of therapeutic action are conceptualizations of an active drug – i.e. a digested and metabolized drug. A problem arises, however, in the fact that the ingestion of this drug is linked to alcohol consumption in a country where it is widely considered in negative terms. For this reason, PartySmart was seen as an ambivalent presence in the firm's catalogue and thus a series of interventions aiming to uphold the image of this drug transformed both its social inscription and its materiality. This transformation also took a different, global trajectory as the drug gradually developed as a transnational pharmaceutical commodity and became a new object in new latitudes. By focusing on the social and material dimensions of this drug in these contexts, this paper calls upon science studies to expand the scope of pharmaceutical anthropology. It brings together various layers of analysis to offer new perspectives on contemporary herbal formulations as they traverse material cultures, medical epistemologies, sociopolitical borders, legal environments and social practices. [ABSTRACT FROM AUTHOR]

In any pharmaceutical packaging process, error rates must be kept very low to prevent defective or incorrect medicine from reaching the consumer. Published articles include a focus on the inspection of ampoule content for the presence of contaminants. Methods of inspection include optical cameras that record sequential images to detect the movement of floating objects via feature extraction and classification. Other methods employ spectral imaging and dying of ampoules to detect cracks. Thermal imaging is also used to inspect structural integrity and mechanical stress; however, this approach is marked by relatively high cost. This paper describes the enhancement of an optical vision-based inspection system for a glass ampoule packaging process. The developed solution involves a reconfiguration of the illumination system of the ampoule trays as well as reprogramming of a real-time optical camera. The camera is linked to the process controller and triggers the ejection of trays containing faulty ampoules. Eight defect types are of interest, namely: missing ampoules; ampoules without a label; crushed ampoules; ampoules with a broken tip - present or missing; ampoules with a broken base; cracked ampoules; empty ampoules. The original inspection system performance was inadequate and only detected 2 of the 8 defect types reliably. The improved system which is described in this paper has adequately detected all aforementioned defect types. Experiments show that the overall detection rates have improved from 55% to 99.6% on average. Average camera detection accuracy has improved from 38% to 99.5%. In addition, the false positives, i.e. rejection rates, were reduced from 45% to 7%. [ABSTRACT FROM AUTHOR]

Dynamic scheduling of manufacturing systems is encountered in many real-world industries such as the food and pharmaceutical industries. The scheduling of these systems must not only be efficient but also reactive to cope with dynamic job arrivals and machine breakdowns. Over the last decade, products within Product-Driven Control Systems (PDCS) have become smart entities capable of actively handling the manufacturing process. In this paper, a PDCS based on the design of Smart Products is proposed. A generic model of the decisional strategy allows Smart Products to characterize different decisional contexts and thus switch efficiently from one scheduling rule to another using a novel Hyper-Heuristics (HH) based approach. The implementation and testing of the proposed PDCS on hybrid flexible flow-shops with multiple constraints inspired by the pharmaceutical industry are presented. The comparative study with 168 combinations of scheduling rules from the literature highlighted the superiority of the HH to minimize the Mean Completion Time. Furthermore, the proposed approach enhanced both the global performance and the reactivity of the manufacturing control system. [ABSTRACT FROM AUTHOR]

This paper examines how accumulated internal R&D investment and foreign technology in-licensing experience independently and interactively affect creative imitation by latecomer firms. Based on the data of 61 listed Korean pharmaceutical firms over 19 years (1999 ∼ 2017), we showed that either accumulated internal R&D investment or foreign technology in-licensing experience has a positive impact on the development of creative imitation by latecomer firms. However, we found that a simultaneous increase in accumulated internal R&D investment and foreign technology in-licensing experience leads to less creative imitation outcomes, implying the existence of an internal tension between these two learning modes. [ABSTRACT FROM AUTHOR]

Improving the productivity of a manufacturing firm is very imperative in order to obtain high profits in such a competitive market. Equipment is an important part of a manufacturing system and its efficiency directly affects the quality and cost of the product contributing to overall productivity of a manufacturing plant. This paper focuses on calculating the overall equipment effectiveness (OEE) at a local pharmaceutical industry and investigates the key factors which influence the overall equipment effectiveness. OEE is an important tool which identifies areas that may have bottleneck in the production line, covering three major aspects such as the availability, performance, and quality rate of the output of equipment. On the basis of OEE, six significant losses were identified. The preliminary results of the analysis showed that OEE for the dry suspension (D/S) section is only 23% which is substantially below the benchmark of OEE level i.e. 85%. The results also presented that prime cause involves a high difference between the performance level of world class and dry suspension (D/S) process which is due to unavailability of machines for a longer period of time and malfunctioned machines producing products in large quantities that need to be reworked or scraped. In order to achieve the world class level of OEE, the performance level of dry suspension (D/S) process needs to be enhanced to 95%. A preventive maintenance strategy could be implemented in the industry in order to avoid inefficient practices and enhance the performance of the whole plant. [ABSTRACT FROM AUTHOR]

Introduction: The UK Pharmaceutical Industry is arguably one of the most important industries to consider in the negotiations following the Brexit vote. Providing tens of thousands of jobs and billions in tax revenue and research investment, the importance of this industry cannot be understated. At stake is the global leadership in the sector, which produces some of the field's most influential basic science and translation work. However, interruptions and losses may occur at multiple levels, affecting patients, researchers, universities, companies and government. Goals: By understanding the current state of pharmaceutical sector, the potential effect of leaving the European Union (EU) on this successful industry can be better understood. This paper aims to address the priorities for negotiations by collating the analyses of professionals in the field, leading companies and non-EU member states. Research methods: A government healthcare policy advisor and Chief Science Officer (CSO) for a major pharmaceutical firm were consulted to scope the paper. In these discussions, five key areas were identified: contribution, legislative processes, regulatory processes, research and outcomes, commercial risk. Multiple search engines were utilised for selecting relevant material, predominantly PubMed and Google Scholar. To supplement this information, Government documents were located using the "GOV.UK" publications tool, and interviews and commentaries were found through the Google News search function. Conclusion: With thorough investigation of the literature, we propose four foundations in the advancement of negotiations. These prioritise: negotiation of 'associated country' status, bilaterally favourable trade agreements, minimal interruption to regulatory bodies and special protection for the movement of workforce in the life sciences industry. [ABSTRACT FROM AUTHOR]