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This Review initiates a wide-ranging discussion over 2023 by selecting and exploring core themes to be investigated more deeply in papers submitted to the Vaccines Special Issue on the "Future of Epidemic and Pandemic Vaccines to Serve Global Public Health Needs". To tackle the SARS-CoV-2 pandemic, an acceleration of vaccine development across different technology platforms resulted in the emergency use authorization of multiple vaccines in less than a year. Despite this record speed, many limitations surfaced including unequal access to products and technologies, regulatory hurdles, restrictions on the flow of intellectual property needed to develop and manufacture vaccines, clinical trials challenges, development of vaccines that did not curtail or prevent transmission, unsustainable strategies for dealing with variants, and the distorted allocation of funding to favour dominant companies in affluent countries. Key to future epidemic and pandemic responses will be sustainable, global-public-health-driven vaccine development and manufacturing based on equitable access to platform technologies, decentralised and localised innovation, and multiple developers and manufacturers, especially in low- and middle-income countries (LMICs). There is talk of flexible, modular pandemic preparedness, of technology access pools based on non-exclusive global licensing agreements in exchange for fair compensation, of WHO-supported vaccine technology transfer hubs and spokes, and of the creation of vaccine prototypes ready for phase I/II trials, etc. However, all these concepts face extraordinary challenges shaped by current commercial incentives, the unwillingness of pharmaceutical companies and governments to share intellectual property and know-how, the precariousness of building capacity based solely on COVID-19 vaccines, the focus on large-scale manufacturing capacity rather than small-scale rapid-response innovation to stop outbreaks when and where they occur, and the inability of many resource-limited countries to afford next-generation vaccines for their national vaccine programmes. Once the current high subsidies are gone and interest has waned, sustaining vaccine innovation and manufacturing capability in interpandemic periods will require equitable access to vaccine innovation and manufacturing capabilities in all regions of the world based on many vaccines, not just "pandemic vaccines". Public and philanthropic investments will need to leverage enforceable commitments to share vaccines and critical technology so that countries everywhere can establish and scale up vaccine development and manufacturing capability. This will only happen if we question all prior assumptions and learn the lessons offered by the current pandemic. We invite submissions to the special issue, which we hope will help guide the world towards a global vaccine research, development, and manufacturing ecosystem that better balances and integrates scientific, clinical trial, regulatory, and commercial interests and puts global public health needs first.
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Abstract Over the last years, pharmaceutical industries have adopted continuous improvement and operational excellence programs to optimize processes, improve quality and reduce operational costs. Worldwide, Lean Manufacturing (LM) and Six Sigma (SS), as well as the integration of the two methods: Lean Six Sigma (LSS) are the most used approaches in the continuous improvement of industries and services. This work aims to investigate the employment of the Lean Six Sigma methodology in the productive areas of pharmaceutical companies located in Brazil. Interviews were conducted with managers of pharmaceutical industries that apply the approach. The results indicated the greater use of Lean Manufacturing tools compared to Six Sigma and the influence of specific peculiarities of the pharmaceutical industry on the benefits that are achieved with the use of Lean Six Sigma. The approach is considered of great value as it provides substantial benefits to the pharmaceutical industry. It is concluded that the work corroborates to the theoretical and empirical knowledge about the methodology use in the context of Brazilian pharmaceutical industries, as well as contributes to the implementation, reformulation, and improvement of Lean Six Sigma programs in this industrial segment.
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Gestão da Qualidade Total/tendências , Indústria Farmacêutica/organização & administração , Custos e Análise de Custo/tendênciasRESUMO
The paper aims to contribute as a reflection on the public production of medicines in Brazil. Public producers present themselves as strategic in Brazil, either as price regulators, in meeting the demands of the Ministry of Health (MoH) on neglected products and those at risk of shortage to SUS. The study used the official bases of the MoH, National Health Surveillance Agency (ANVISA) and Website of Official Pharmaceutical Laboratories (OPL). Thirty-three OPL were identified, 16 with active production of drug registration at ANVISA. For the remaining 17 LFOs, no one identified active portfolio in the bases surveyed. There are 80% of the OPL portfolio concentrated in the first level of the Anatomical Therapeutic Chemical Classification, such as alimentary tract and metabolism, blood and blood forming organs, cardiovascular system, anti-infective for systemic use and nervous system. The OPL participation in the health complex is 48.6% of its portfolio dedicated to the strategic component, 30.6% for primary care and 20.7% for the specialized. It concludes the relevance of the OPL for the Brazilian health policy, with the better realignment of their potential in the face of technological advancement, health legislation, drug dependence and new treatment protocols.
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Política de Saúde , Brasil , HumanosRESUMO
INTRODUCTION: The triazoles represent a class of five-membered heterocyclic compounds of great importance for the preparation of new drugs with diverse biological activities because they may present several structural variations with the same numbers of carbon and nitrogen atoms. Due to the success of various triazoles that entered the pharmaceutical market and are still being used in medicines, many companies and research groups have shown interest in developing new methods of synthesis and biological evaluation of potential uses for these compounds. In this review, the authors explored aspects of patents for the 1H-1,2,3-, 2H-1,2,3-, 1H-1,2,4- and 4H-1,2,4-triazole families, including prototypes being considered in clinical studies between 2008 and 2011. AREAS COVERED: The triazoles have been studied for over a century as an important class of heterocyclic compounds and still attract considerable attention due to their broad range of biological activities. More recently, there has been considerable interest in the development of novel triazoles with anti-inflammatory, antiplatelet, antimicrobial, antimycobacterial, antitumoral and antiviral properties and activity against several neglected diseases. This review emphasizes recent perspective and advances in the therapeutically active 1H-1,2,3-, 2H-1,2,3-, 1H-1,2,4- and 4H-1,2,4-triazole derivative patents between 2008 and 2011, covering the development of new chemical entities and new pharmaceuticals. Many studies have focused on these compounds as target structures and evaluated them in several biological targets. EXPERT OPINION: The preparation of 1H-1,2,3-, 2H-1,2,3-, 1H-1,2,4- and 4H-1,2,4-triazole derivatives brings to light several issues. There is a need to find new, more efficient preparations for these triazoles that take into consideration current issues in green chemistry, energy saving and sustainability. New diseases are discovered and new viruses and bacteria continue to challenge mankind, so it is imperative to find new prototypes for these new diseases. Of great urgency is finding prototypes against bacteria that continue to increase resistance and for neglected diseases that affect a large part of humanity, especially the poor and vulnerable.