Multinational Pharmaceutical Companies Research Articles

A Modern Curriculum for Training Scientists in Model-Informed Drug Development: Progress Report on FDA Grant to Train Regulatory Scientists.

Under US Food and Drug Administration (FDA) grant (2U18FD005320-06), the Critical Path Institute (C-Path) and experienced private sector partners collaborated with global health organizations to create didactic video materials in an e-learning format on model-informed drug development (MIDD) topics relevant to a non-modeling audience. Several multinational pharmaceutical companies contributed case studies illustrating the application of the MIDD approach in practice. Training videos were created and divided into several modules: introducing the MIDD landscape for drug development and regulatory science, a review of various model types used for MIDD, discussions of how models inform drug development and regulatory decisions, future goals of MIDD, and discussions on the interconnectedness of models used for MIDD. Examples and vignettes from stakeholders and thought leaders were included. These educational materials fill a gap between academic and "on the job training" for regulators, academic, and industry scientists, delivering insights and value for those performing modeling and non-modelers reviewing the output of modeling and simulation work. A total of 13 hours of video content is currently available. A small panel of FDA reviewers is currently beta-testing the learning management system (LMS). Future efforts for this MIDD training initiative will include expansion of the content via an expanded and diverse faculty, 1:1 online mentorship sessions, and eventually broader access to this resource consistent with an open science approach and curriculum. The MIDD training LMS can accommodate a diverse learning ecosystem; further development may also accommodate different audiences in the future.

How Can General Managers Best Leverage Medical Affairs Now and in the Future?

General managers (GMs) play a crucial role as enterprise leaders of the country affiliate of multi-national pharmaceutical companies, balancing needs, objectives and governance across all local functions. One such function, Medical Affairs, has undergone a significant evolution from a support function into a strategic partner and in some organizations a strategic leader supported by the increasing complexity of medications and a shift to more specialized medicines. Although the function has progressed significantly, there is opportunity to elevate Medical Affairs to another level, with GMs and business unit directors (BUDs) recommending increased business acumen, strategic approach, innovation and project management as competencies that could be further cultivated. Examining the current trends in the industry, including the increasing complexity of innovative medicines and patient journeys, a higher burden of evidence for the reimbursement of medicines, innovative data generation opportunities, the changing stakeholder engagement expectations and the focus on corporate reputation, Medical Affairs is positioned as a key to assist in navigating the organization through these complexities. The GM can help to foster the evolving role of Medical Affairs, encouraging lateral moves for broader enterprise mindset, imparting a culture of shared governance responsibilities across functions to encourage innovative thinking and nurture upcoming leaders by investing in training to take advantage of the above trends and deliver best patient and organizational outcomes now and in the future.

The politics and governance of drug production in public-private partnerships: Brazil’s response to hepatitis C

ABSTRACT The local manufacture of advanced pharmaceutical products has been a long-standing objective of health and industry policy in many developing countries, including in Latin America. This strategy has been applied to fight epidemics such as HIV/AIDS, malaria, and the COVID-19 pandemic. However, we still know little about the politics and governance that enable such arrangements, especially when there is no consent from the originator company. This study focuses on the case of Brazil, a country that is well-known for its health-industry policy, which includes the local production of direct-acting antivirals (DAAs), a new treatment for hepatitis C. We seek to explain the factors that have contributed to Brazil’s successful production of generic versions of DAAs, and, later, to the decision by the Ministry of Health (MoH) to procure drugs from multinational pharmaceutical companies rather than from local laboratories. A lack of support for domestic production by important stakeholders, the patent holder’s attempt to block domestic production and the MoH’s adoption of more modern treatment guidelines under a different procurement logic all created an unfavourable environment for local production and procurement of DAAs. Our study draws implications for middle-income countries that wish to produce drugs domestically without voluntary license agreements.

Adopting lean product development in new production system introduction process for sustainable operational performance

This research explores adopting the lean product development (LPD) concept in the new production system introduction process (NPSIP) to achieve both pre-launching and post-launching operational performance considering sustainability aspects. An empirical study was conducted in a multi-national pharmaceutical company, having lean practice for over a decade. Two case projects for launching the new production system were followed in retrospect, and data was collected by interviewing experts. In the case company, evidence were found regarding adoption of soft lean practices in the NPSIP, however, lack of adoption of hard lean practices. Several challenges were identified that hinder achieving both pre-launching and post-launching operational performance, which could be mitigated by adopting LPD practices. This paper contributes to the broad lean literature by expanding its implication within the NPSIP context. Additionally, a set of LPD principles and practices is proposed that could be adopted in the NPSIP context. Adopting the LPD principles and practices in the NPSIP, manufacturing companies can launch a new production system faster, and achieve target sustainable operational performance faster, resulting in additional competitive advantage.

Knowledge sharing between subsidiary and headquarters: A framework proposal

The pharmaceutical industry (PI) is recognized as a knowledge-intensive industry. Based on the perspective of managers in the subsidiary, this research proposes actions to facilitate knowledge sharing in the relationship between subsidiary and headquarters in a multinational pharmaceutical company. An exploratory case study was conducted. Data were collected from documental content analysis and fourteen interviews with managers from various areas and departments. The benefits include the possibility of participating in global projects and the resultant positive exposure accrued by the subsidiary. While the predominant knowledge flow is from the headquarters to the subsidiary, there is an opportunity to expand the flow in the opposite direction. Based on this study, actions designed to mitigate this point of disruption can be undertaken. This research offers a framework that encompasses the flow of knowledge, the main facilitators and barriers to knowledge sharing between geographically dispersed multinational units, as well as the knowledge sharing mechanisms.

Suitability of paediatric legislation beyond the USA and Europe: a qualitative study on access to paediatric medicines

BackgroundPaediatric legislation has contributed to better access to appropriate treatments in the European Union and the USA by requiring paediatric research in return for financial incentives. This study explored whether...

Targeted Therapies and Drug Resistance in Advanced Breast Cancer, Alternative Strategies and the Way beyond.

"Targeted therapy" or "precision medicine" is a therapeutic strategy launched over two decades ago. It relies on drugs that inhibit key molecular mechanisms/pathways or genetic/epigenetic alterations that promote different cancer hallmarks. Many clinical trials, sponsored by multinational drug companies, have been carried out. During this time, research has increasingly uncovered the complexity of advanced breast cancer disease. Despite high expectations, patients have seen limited benefits from these clinical trials. Commonly, only a minority of trials are successful, and the few approved drugs are costly. The spread of this expensive therapeutic strategy has constrained the resources available for alternative research. Meanwhile, due to the high cost/benefit ratio, other therapeutic strategies have been proposed by researchers over time, though they are often not pursued due to a focus on precision medicine. Notable among these are drug repurposing and counteracting micrometastatic disease. The former provides an obvious answer to expensive targeted therapies, while the latter represents a new field to which efforts have recently been devoted, offering a "way beyond" the current research.

Technological mediation, mediating morality and moral imaginaries of design: Performance measurement systems in the pharmaceutical industry

In this paper, we seek to understand the ethics of accounting technology design. We commence by working with the concept of technological mediation, which is theorizing how technologies steer actions by evoking given behaviours and by contributing to perceptions and interpretations of reality that form the basis for choices and decisions to act. As such, this relation between people and technologies has important ethical consequences since it implies that technologies contribute actively to how humans do ethics. In this paper, we draw upon a postphenomenological approach (Ihde; Verbeek) to study and to theorise the moral mediations brought about by accounting technology, by examining how, in its design, technology can actively mediate the moral choices and guide the moral actions human beings make. Our central research question is ‘how is morality mediated in the design of accounting technologies?‘. This question is explored through an ethnographic study of the design of a new Performance Measurement and Compensation System in the Italian division of a multi-national pharmaceutical company. We offer two main contributions towards answering this question. First, by working within the theory of technological mediation, we develop the concept of a ‘moral imaginary’ as an approach to understanding designing the morality of things. Second, we elaborate a process model to theorise how moral mediations unfold in the design of accounting technology. From our conceptual motivation and the theoretical elaboration it inspired, we illuminate how the design of accounting technologies, in this case a PMS system, is a form of ‘engineering ethics’ through techno-moral mediation.

Reaching Outer Space and Enabling the mRNA Revolution: A Critical Role of Partnerships for Successful Drug and Vaccine Development.

mRNA and targeted delivery of mRNA carry the promise to enable targeted treatment of undruggable diseases with high unmet medical needs. The transient nature of mRNA opens options for safe influencing of protein biology, immune responses, and complex ailments without impacting DNA heritage. Technical challenges such as mRNA stability and targeted delivery require next generation solutions, which attracted substantial funding and research interests. To build an integrated mRNA value chain and enable the development of novel therapeutics, Merck KGaA Darmstadt, Germany has initiated an internally incubated program, "Targeted mRNA Delivery" (TMD). This collaborative approach brings together scientists, researchers, engineers, and commercial experts from diverse backgrounds to overcome the multidimensional challenges associated with mRNA technology. In this chapter, the multiple opportunities and challenges for the development of mRNA formulations and therapeutics are described comprehensively. Specifically, the TMD program is presented as a use case to show how intrapreneurs were gathered to establish internal mRNA capabilities and foster collaborations for technology development. In the realm of targeted mRNA delivery, partnerships, encompassing internal partnership and external private, public, and hybrid collaborations, play a crucial role in driving innovation and addressing these hurdles. Within multinational pharmaceutical companies, the establishment of "internal startups" is an effective solution to drive innovation to the next level with support from different business sectors, where existing capabilities and positioning are seamlessly blended with the agility and speed of a startup.

Employee Turnover Due to Job Stress: National versus Multinational Pharmaceutical Companies in Pakistan

Consistent performance and good quality of work are very much necessary for businesses. Here are many more factors to losing an employer’s performance in the market. Worker departure is more excessive in the business sector nowadays, which is a very poor and challenging issue in organizations, especially in Pakistan’s pharmaceutical sector. Upper-level supervisors and researchers concentrate on the effect of employee departure. The actual reason for this work is to locate the various reasons and address these problems in both national and MNC pharmaceutical companies in Pakistan. The study will focus on the reputation of these sectors on behalf of employees and how to control employees quitting services from the company, find out the reasons, work on them, control employee attrition, and retain the salesforce. There are a lot of differences between national and multinational pharmaceutical companies in terms of hiring, training, and retaining; employee motivation plays an important role in employees staying long-term in the company. The human resources department measures everything, conducts interviews, and so on. For good hiring people nowadays, employees leaving the organization is a critical issue for the employer. They can hire them when only one employee leaves the company, especially in the pharmaceutical sector. The company loses their sales in a specific territory in terms of volume and units, but this is the only industry in Pakistan where there can be huge and high turnover in the sales and marketing profession as compared to all other industries, even more and more yearly new pharmaceutical companies are coming up in the market where a for employee have extra another opportunities are available, but still in this medical profession of sales and marketing the turnover rate is seeing high. Employees leave for various reasons. The First thing is undue Sales Pressure by the company. Secondary things happen, including extra difficult tasks given by the supervisor/manager, ambiguous unchallenging tasks, the poor concentration of the manager, inadequate support, lack of appreciation, and no career growth in the company, perceived that employee received pay equity as compared to other employees and also the advantage of achieving more favorable jobs in different companies Exit policies are important for the employees of multinational companies but not for the employee of national companies Sales targets should also be realistic and flexible following the market conditions including the competitors In order to manage the trust, Firstly the management has to improve its HR style for the leaving employee, from no worries to consultative and caring or laissez-fair where individual grievances are considered noteworthy.

Medicine donations: a review of policies and practices

BackgroundTo help promote the effective delivery of drug donations, the World Health Organization (WHO) developed the Guidelines for Medicine Donations. The need for revisions is timely given the large-scale influx of medicine donations since the start of the COVID-19 pandemic. This study analyses current policies of donors and recipients that are commensurate with the recommendations in the Guidelines and examines current practices, challenges, and revision suggestions.ResultsA search for medicine donation policies of donors and recipients was conducted in May/June 2022 and repeated in January 2023. Potential donor countries were identified from the high-income countries on the United Nation’s (UN) List of G20 Countries. Potential pharmaceutical company donors were selected from those with 2021 revenue of $30 billion or greater. Potential non-government organization donors came from the WHO list of non-governmental organizations (NGOs) and two other sources. Potential recipient countries were those on the UN List of Least Developed Countries. These four lists were supplemented with actual donors and recipients identified from the literature. All policies retrieved were screened to identify which of the 12 recommendations from the WHO Guidelines were incorporated. We identified 38 policies from 1 donor country, 6 brand-name multinational pharmaceutical companies, 6 NGOs and 25 recipient countries. Most policies incorporated all 12 recommendations. Twenty-five of the 38 policies were developed in 2010 or later. The majority of actual donors and recipients did not have policies that were publicly available. A rapid literature review for publications from 2010 onwards identified challenges in implementing the WHO Guidelines and suggested for revisions. Challenges included: (1) information management; (2) medication presentation; (3) influence from the pharmaceutical industry; (4) donation sustainability; and (5) the belief that donations are inherently good.ConclusionsOur findings suggest that both donors and recipients could further align their policies with the existing Guidelines and both groups should be consulted on any revisions to ensure that their experiences are reflected and their needs are addressed. While the current WHO Guidelines for Medicine Donations are a solid base for medical humanitarian efforts, evidence points to the need for an update to meet current challenges.

Reduction in Packaging Wastes Through Identification of Lean Wastes to Deliver Efficient Waste Controlling Techniques for a Pharmaceutical Industry

The purpose of this paper is to propose a method of reducing material and time waste during packaging in the pharmaceutical industry. This is done by means of identifying the four major lean wastes i.e., motion, inadequate processing, waiting, and defects. These wastes are identified and reduced by means of using lean tools and proposing other cost-effective solutions that would increase process efficiency. Material waste is dealt with through selecting optimal requirements under the constraint limits of ergonomics, engineering, and machine space availability. Along with reduction in change over time, a strategy ensuring improvement in the primary packaging area was developed. The validity of this research has been brought about by means of a case study of a multinational pharmaceutical company. The proposed system proves to be highly beneficial in ensuring wastage and time reduction in changeovers. This strategy provides improved results without any new costs introduced and the production targets were met faster. There is also a special consideration given to the ergonomic aspect of the production processes.

Drug repurposing of FDA-approved anti-viral drugs via computational screening against novel 6M03 SARS-COVID-19.

The COVID-19 pandemic has been recognized as severe acute respiratory syndrome, one of the worst anddisastrous infectious diseases in human history. Until now, there is no cure to this contagious infection althoughsome multinational pharmaceutical companies have synthesized the vaccines and injecting them into humans, buta drug treatment regimen is yet to come. Among the multiple areas of SARS-CoV-2 that can be targeted, protease protein has significant values due to itsessential role in viral replication and life. The repurposing of FDA-approved drugs for the treatment of COVID-19has been a critical strategy during the pandemic due to the urgency of effective therapies. The novelty in this workrefers to the innovative use of existing drugs with greater safety, speed, cost-effectiveness, broad availability, anddiversity in the mechanism of action that have been approved and developed for other medical conditions. In this research work, we have engaged drug reprofiling or drug repurposing to recognize possible inhibitors ofprotease protein 6M03 in an instantaneous approach through computational docking studies. We screened 16 FDA-approved anti-viral drugs that were known for different viral infections to be tested againstthis contagious novel strain. Through these reprofiling studies, we come up with 5 drugs, namely, Delavirdine,Fosamprenavir, Imiquimod, Stavudine, and Zanamivir, showing excellent results with the negative binding energiesin Kcal/mol as - 8.5, - 7.0, - 6.8, - 6.8, and - 6.6, respectively, in the best binding posture. In silico studies allowedus to demonstrate the potential role of these drugs against COVID-19. In our study, we also observed the nucleotide sequence of protease protein consisting of 316 amino acid residuesand the influence of these pronouncing drugs over these sequences. The outcome of this research work providesresearchers with a track record for carrying out further investigational procedures by applying docking simulationsand in vitro and in vivo experimentation with these reprofile drugs so that a better drug can be formulated againstcoronavirus.

Medicines development and regulation in Africa

Africa is one of the world’s fastest-growing economic regions, with a rise in its pharmaceutical industry value from $4.7 billion in 2003 to $20.8 billion in 2013. Multinational pharmaceutical companies are becoming more active in drug production and clinical trials across Africa, and there is an increase in the number of local companies engaged in medicines development and marketing. Such expansion of the local pharmaceutical industry requires trained pharmaceutical specialists to support it. The current situation and future requirements for local medicines development, regulation, education and training needs are discussed.

LifeTrain: Driving lifelong learning for biomedical professionals

This article describes LifeTrain — the European common framework for continuing professional development in the biomedical sciences. An important goal of LifeTrain is to support biomedical professionals to work collaboratively across disciplines, sectors and national boundaries. LifeTrain is an open community with a unifying goal; it brings together many excellent, but disparate, activities into a process towards establishing a focused and coherent framework for continuing professional development in the biomedical sciences. This collaborative approach provides the critical mass to make a major contribution to strengthen the skills and competencies of biomedical professionals in a rapidly changing environment. LifeTrain's signatories, which include multinational pharmaceutical companies, research infrastructures, professional and scientific bodies, higher-education institutes and research institutes, have agreed to the principles of the framework and to continue to collaborate to implement LifeTrain. We warmly invite others to join us.

The Efficacy of Human Resource Management Practices in Building Organizational Commitment of Employees: Evidence from Pharmaceutical Sector of Pakistan

This study aimed to investigate the adoption level of standardized HRM practices (compensation, performance evaluation, and promotion) by local and multinational pharmaceutical companies in Pakistan. Furthermore, the study also attempted to analyze the impact of these practices on organizational commitment of employees in the investigated firms. Using random sampling technique, data was collected from 503 sales representatives of various pharmaceutical companies operating in the country. Results of one-sample t test presented that multinational companies have a higher level of adoption of standardized HRM practices than local companies. Similarly, multiple regression analyses demonstrated that compensation, performance evaluation and promotion practices significantly influence employees' organizational commitment. These findings provide support for the contingency approach to HRM. The study's practical implications suggest that the manufacturing companies should adopt standardized HRM practices to increase organizational commitment among their employees.

As pharma is to people, so infrastructure is to cities

The pharmaceutical industry is a profit-making sector of the healthcare system and has grown into a self-regulating complex system over the years. Starting from the pre-clinical to clinical development of drugs to the authorisation and marketing thereof, a typical multi-national pharmaceutical company of today operates in complex ways which partly emerge from the multiple interactions within and without the company. The complexity is further given by the unpredictability of the outcomes: merely 1 out of 10 drugs that are in development are likely to be approved. The plethora of regulations by authorities such as the European Medicines Agency pose a negative feedback on this complex system which is further aggravated by the reimbursement landscape of each country, taking a toll on the innovative side of this privately funded sector.
 By analogy, infrastructure operations with distinct supply systems delivering specific critical products and services, pharmaceutical companies have become the exclusive suppliers of drugs within the healthcare system. Increasingly traditional public sector infrastructure provision has been privatised, as has national health services drug development, resulting in high levels of regulation in each, constraining innovation and profitability, hall-marks of the private sector. Just as infrastructure delivers the life-blood of cities, pharma delivers medicines for the health of individuals: both aim for public health and societal good. Failures in infrastructure delivery, such as unaffordability by the poor, match with pharma failures to provide equitably to all individuals: the poor cannot afford the best drugs. The urban sprawl in cities and the rise of informal settlements without sufficient infrastructure, can be observed in health care by the rise in use of alternative and unreliable medications by sections of the population who are excluded from pharma penetration.
 Our work studies such analogies between infrastructure and pharmaceutical companies in the hope of a better understanding of the operations of and connections with each other and inspirations about finding solutions from these two similar, yet distinct complex systems.

PRIORITY AREAS OF INNOVATION IN CORPORATE STRATEGIES OF MULTINATIONAL PHARMACEUTICAL COMPANIES IN GLOBAL COORDINATES

The purpose of the article is to substantiate global trends in the research and innovation activities of multinational pharmaceutical companies and to identify key directions of transformation in corporate innovation strategies in the context of increased international competition in the global pharmaceutical market. Methodology. The methodological basis of the work is the following methods of scientific research: dialectical, historical-logical, system-structural analysis of economic processes and phenomena, analysis and synthesis, the method of quantitative and qualitative comparisons. Results. One of the key global sustainable development goals of the United Nations for the period up to 2030 is to ensure the health and well-being of nations, which in global terms can be achieved primarily on the basis of the large-scale research activities of multinational pharmaceutical companies and the systematic commercialisation of the results of corporate research and development. In recent decades, under the influence of technoglobalisation processes, the innovatisation of pharmaceutical companies' activities has accelerated. It finds its concentrated expression in the steady increase of R&D costs, diversification of their structure, mass commercialisation of innovative developments and strengthening of their transdisciplinarity, accelerated capitalisation of R&D costs, etc. According to the world experience, the most effective innovative strategies of pharmaceutical companies today are such as mergers and acquisitions, strategic alliances of pharmaceutical and biotechnology companies, innovative outsourcing and insourcing, cointegration and pseudo-concentration, corporatisation of patent portfolios and research technologies, venture financing of R&D of pharmaceutical companies. At the same time, mergers and acquisitions are increasing the capitalisation of the global pharmaceutical industry, strengthening its expansion into global markets, redistributing its regional segments and diversifying the sources of funding for pharmaceutical companies' research activities. Value/оriginality. Current trends and features of corporate strategy formation in multinational pharmaceutical companies are identified. Strategic orientations of research activities of pharmaceutical companies in specialised areas of clinical research in the context of therapeutic categories are determined. The process of capitalisation of pharmaceutical companies is analysed and the tendency to activate the use of corporate mergers and acquisitions (M&A) strategy in the pharmaceutical business is revealed. It is proposed to create strategic alliances of multifunctional pharmaceutical companies with biotech companies using the M&A strategy. It is recommended that pharmaceutical companies strengthen their innovation orientation in the design of their strategies by combining patent portfolios and research technologies, as well as jointly implementing large-scale innovation programmes and projects.

Screening as Governmental Technology: The Nationwide Collection of Mental Health Data on Students in South Korea.

In 2012, all the students in South Korea from elementary to high school went through the government's mental health screening. From a historical perspective, this paper examines why and how the Korean government launched the mass screening of students' mental health and what enabled this nationwide data collection. By analyzing its driving forces, this paper reveals the ecology of power being forged at the intersection of multinational pharmaceutical companies, mental health experts, and the Korean government in the 2000s. The paper argues that, against the backdrop of the growing market for multinational pharmaceutical companies in South Korea, the rise in school violence became the catalyst for bringing old and new governmental tools, plans, and resources, putting all students under mental health screening. It shows the continuity as well as the transformation of developmental governmentality in a broader social change of South Korea under the influence of globalization. By doing so, the paper illuminates the shaping of the governmental technology - which was developed rather than imported and deployed rather than recommended - that enabled the nationwide collection of students' data in the context of globalizing and politicizing ideas and practices in mental health.

Supply chain agility and firm performance: testing serial mediations in pharmaceutical industry

PurposeThe supply chain agility (SCA) is becoming a source of competitive differentiation but debate on its antecedents which can result in optimal firm performance is still non-pervasive in the literature. Taking this gap into consideration, the current research aimed at investigating various enablers of supply chain agility of Pakistani pharmaceutical industry.Design/methodology/approachThe data were collected from 204 top executives working in different supply chain functions including planning, supplying, operations and purchasing in national and multinational pharmaceutical companies in Pakistan.FindingsThrough serial-mediation model, results revealed the strength of various SCA enablers, along with the mediating roles of delivery dependability.Originality/valueThis study adds in the literature on how various supply chain enablers and competencies help the organizations to achieve supply chain agility and performance, especially in a developing country.