Kemanusiaan Vs Kapitalisme di Era Pandemi Corona Virus Disease-19 (COVID19): Ekslusifitas Paten Vs Lisensi Wajib

Corona Virus Disease-19 (COVID-19) began to spread to various parts of the world since December 2019, which was first discovered in Wuhan, China. Of course this has brought great disaster to 216 countries in the world, because no country is immune to this virus and the epidemic has spread to various continents and attacked many aspects of the world community. Distressing conditions like this require the state to play a stronger role by providing better service protection. In addition, conditions like this raise big questions about how countries in the world deal with this. In the midst of the COcVID-19 pandemic, many scientists are racing to quickly find an effective vaccine to fight this virus. An example of one that succeeded is the discovery of Sinovac or called CoronaVac, where this vaccine is the result of research from Sinovac Biotech Co. which is a biopharmaceutical company focused on research, development, manufacture and commercialization of vaccines, and the company is based in Beijing, China. Seeing the COVID-19 pandemic that is increasingly paying attention, especially in developing countries, many countries are pressing for the temporary waiver of COVID-19 vaccine patents during this crisis. The reason is none other than so that production can be accelerated so that it is expected to be able to handle the COVID-19 pandemic. Of course this raises a polemic between developed countries and developing countries where there are two different interests, one country protects its investors and the other one protects its people. From this we can see that COVID-19 leaves a lot of room for its own problems.

Mini-review: The market growth of diagnostic and therapeutic monoclonal antibodies; SARS CoV-2 an example

BACKGROUND: The emergence of novel viruses poses severe challenges to global public health highlighting the crucial necessity for new antivirals. MAIN BODY: Monoclonal antibodies (mAbs) are immunoglobulins that bind with a single epitope. Mouse mAbs are generated by classic hybridoma technology and are mainly used for immunodiagnostics. For immunotherapy, it is critical to use monoclonal antibodies in the human form to minimize adverse reactions. They have been successfully used to treat numerous illnesses, accordingly, an increasing number of mAbs, with high potency against emerging viruses is the target of every biopharmaceutical company. The diagnostic and therapeutic mAbs market grows rapidly into a multi-billion-dollar business. Biopharmaceuticals are innovative resolutions which revolutionized the treatment of significant chronic diseases and malignancies. Currently, a variety of therapeutic options that include antiviral medications, monoclonal antibodies, and immunomodulatory agents are available in the management of COVID-19. SHORT CONCLUSION: The invasion of mAbs in new medical sectors will increase the market magnitude as it is expected to generate revenue of about 300 billion $ by 2025. In the current mini-review, the applications of monoclonal antibodies in immune-diagnosis and immunotherapy will be demonstrated, particularly for COVID-19 infection and will focus mainly on monoclonal antibodies in the market.

Seroprevalence of Brucella antibodies among vaccine manufacturing workers in contact with the Brucella melitensis Rev.1 vaccine strain

ABSTRACTBackgroundCattle vaccination remains an essential measure for the control of brucellosis. Strict preventive measures are applied to protect vaccine manufacturing workers (VMW) employed in processing these live attenuated vaccines. We analyzed the serological responses of VMW in contact with the Brucella melitensis Rev.1 strain.MethodsWe conducted an observational study of a cohort of VMW in a Spanish biopharmaceutical company, a leader in manufacturing veterinary products. The results of the Brucella serological tests carried out on these workers between 2012 and 2019 were reviewed, as well as demographic data, length of time in the company (seniority), and level of exposure. Multivariate analysis was performed with the logistic regression test.ResultsOf the 115 VMW studied, 47 (41%) showed positive Rose Bengal tests during company check-ups. Exposure levels were correlated with seropositivity, with an adjusted OR of 6.6 (95% CI: 2.1-20.3) for the high exposure and 2.0 (95% CI: 0.6-6.7) for the medium exposure groups. Sixteen (34%) seropositive VMW demonstrated an acute serologic pattern of IgG and IgM antibodies seropositivization, while 31 (66%) manifested a chronic serologic pattern of constant or intermittent positive IgG antibodies with persistently negative IgM antibodies. Seniority was inversely associated with the acute pattern: adjusted OR of 0.88 (95% CI: 0.79-0.97) for each year added. No seropositive VMW showed evidence of active brucellosis during follow up.ConclusionDespite strict safety measures, a percentage of VMW were exposed to the Rev.1 strain. Exposure levels were correlated with seropositivity. None of them developed symptomatic infection during follow-up. Two different serological patterns were observed: an acute IgM-positive pattern or a chronic IgM-negative pattern. Seniority was associated with the chronic pattern.

Analysis of R&D efficiency of new biopharmaceuticals based on large-scale quantitative analysis and careful case analysis

Research on the R&D efficiency of new biopharmaceuticals is geared towards enhancing efficiencies, such as improving drug development technologies and therefore speeding up the discovery and development of new treatments. Organisation theory is one way of exploring R&D efficiency and involves studying the behaviour of organisations with a view to enhancing organisational efficiency. Professor Tetsuya Miyashige and his team at the National Institute of Technology, Toyama College, Japan, are using large-scale quantitative analysis and careful case analysis to analyse the R&D efficiency of new pharmaceuticals. The goal is to contribute to the R&D management of pharmaceutical companies and to industrial economic policy for the pharmaceutical industry. A particular focus for the researcher is using biotechnology to analyse the R&D efficiency of 'antibody drug = biomedicine' in pharmaceutical companies. In collaboration with econometrician Professor Atsushi Fujii, University of Kitakyushu, Miyashige worked on the separation of R&D processes in biopharmaceutical R&D. This work involved analysing the R&D productivity of a biopharmaceutical company, with a focus on separation of the R&D processes and looking at blockbusters and biotech drugs. Another line of work involved empirically analysing the differences between blockbuster production in Japanese firms and in US/EU firms.

Analysis of R&D efficiency of new biopharmaceuticals based on large-scale quantitative analysis and careful case analysis

Research on the R&D efficiency of new biopharmaceuticals is geared towards enhancing efficiencies, such as improving drug development technologies and therefore speeding up the discovery and development of new treatments. Organisation theory is one way of exploring R&D efficiency and involves studying the behaviour of organisations with a view to enhancing organisational efficiency. Professor Tetsuya Miyashige and his team at the National Institute of Technology, Toyama College, Japan, are using large-scale quantitative analysis and careful case analysis to analyse the R&D efficiency of new pharmaceuticals. The goal is to contribute to the R&D management of pharmaceutical companies and to industrial economic policy for the pharmaceutical industry. A particular focus for the researcher is using biotechnology to analyse the R&D efficiency of 'antibody drug = biomedicine' in pharmaceutical companies. In collaboration with econometrician Professor Atsushi Fujii, University of Kitakyushu, Miyashige worked on the separation of R&D processes in biopharmaceutical R&D. This work involved analysing the R&D productivity of a biopharmaceutical company, with a focus on separation of the R&D processes and looking at blockbusters and biotech drugs. Another line of work involved empirically analysing the differences between blockbuster production in Japanese firms and in US/EU firms.

Unravelling processes of alliance capability development: longitudinal processual insights from an emerging country multinational enterprise

PurposeThe purpose of this paper is to explore and unbundle the complex processes underpinning development of alliance capabilities, particularly in the context of emerging country multinational enterprises. More specifically, this paper focuses on how firms internalize and translate knowledge generated from experiences gained by participating in international collaborations.Design/methodology/approachThe authors adopt an exploratory case study approach to undertake in-depth processual analysis of alliance capability development in an Indian biopharmaceutical company. The authors focused their analysis on the initial four international alliances the company formed and identified key elements pertaining to alliance capabilities that the company internalized and those that it could not, as this was key in understanding alliance capability.FindingsThe research shows that based on experiences from previous alliances, the Indian organization was able to overhaul its negotiation and governance designing processes and practices as well as made robust changes to its internal communication and coordination practices. Interestingly, the company organization, however, did not make any significant changes to its processes and practices regarding partner selection.Practical implicationsThe results from our study can be used by managers to develop processes and practices when it comes to developing alliance capabilities.Originality/valueThe paper is novel, as it addresses two specific gaps in the nascent alliance capability literature. First, it provides insights on how different constituent elements/aspects of alliance capability actually develop and integrate within the organizational system over time, and in the process, the paper identifies that some aspects are better internalized as compared to other aspects. Second, by focusing the attention on an Indian biopharmaceutical company, the authors attempt to address a gap in alliance capability development research, which has been neglected in emerging country multinational entities.

Pure Biologics – From a Bootstrapped Boutique CRO to an Integrated Drug Discovery Public Company

The present article is a case study of a Polish biopharmaceutical company, “Pure Biologics”. The company was founded in 2010 by a group of scientists and, over the last nine years, grew substantially from just a few individuals to nearly one hundred professionals. Initially, a privately-funded civil partnership, Pure Biologics, has been transformed into a publicly-traded company. Such a transformation has been possible not only because of the expertise and growing experience of corporate management, but also the specific economic environment and substantial public funding dedicated to innovative Small and Medium Enterprises (SMEs).

A day in the life of a Senior Scientist

Dr Cristina Gutierrez-Caballero is a molecular and cellular biologist. She graduated with a BSc in Biology from the University of Salamanca (Spain), where she subsequently completed her PhD studying proteins involved in cell division and their role in cancer, aging and longevity. After her PhD, Dr Gutierrez-Caballero continued her research in cell division at the University of Warwick as a postdoctoral researcher, funded by Cancer Research UK. More recently, her interests have transitioned towards translational work and drug discovery, and in 2017, she started a position as a Senior Scientist in Exonate Ltd, an early-stage biopharmaceutical company that develops novel drugs to treat age-related macular degeneration (AMD). Lorenza Giannella (Training Manager, Biochemical Society) spoke with her about her work.

Performance Management at AbbVie

This case study describes design and implementation of the performance management process (PMP) at AbbVie, a global, research-based biopharmaceutical company with approximately 30,000 employees worldwide; it is dedicated to developing and delivering a consistent stream of innovative new medicines. Following its separation from Abbott in 2013, over the course of 5 years AbbVie built a tailor-made PMP, guided by scientific knowledge of human behavior and the unique cultural imperatives of the new company. This case study demonstrates how traditional human resources tools can be used to create a culture of high performance and innovation. The company posits that business strategy, culture, and leadership precede any system design considerations and need to be primary drivers of these. The success of implementation is in the vertical and horizontal integration of all the elements of the performance management (PM) system. The chapter discusses the challenges and key principles of PMP design in a global matrixed organization and shares the company’s perspectives on the successes, opportunities, and future directions of the AbbVie PMP evolution.

On the development of miransertib for rare diseases: an interview with ArQule's Brian Schwartz

Brian Schwartz is CMO of ArQule, a clinical-stage biopharmaceutical company developing small-molecule kinase inhibitors for precision medicine oncology and rare diseases. In this interview he tells us more about the company's current projects, which include drug development for the rare diseases Proteus syndrome and PROS.