Integrating frontiers: a holistic, quantum and evolutionary approach to conquering cancer through systems biology and multidisciplinary synergy.

Cancer therapy is facing increasingly significant challenges, marked by a wide range of techniques and research efforts centered around somatic mutations, precision oncology, and the vast amount of big data. Despite this abundance of information, the quest to cure cancer often seems more elusive, with the "war on cancer" yet to deliver a definitive victory. A particularly pressing issue is the development of tumor treatment resistance, highlighting the urgent need for innovative approaches. Evolutionary, Quantum Biology and System Biology offer a promising framework for advancing experimental cancer research. By integrating theoretical studies, translational methods, and flexible multidisciplinary clinical research, there's potential to enhance current treatment strategies and improve outcomes for cancer patients. Establishing stronger links between evolutionary, quantum, entropy and chaos principles and oncology could lead to more effective treatments that leverage an understanding of the tumor's evolutionary dynamics, paving the way for novel methods to control and mitigate cancer. Achieving these objectives necessitates a commitment to multidisciplinary and interprofessional collaboration at the heart of both research and clinical endeavors in oncology. This entails dismantling silos between disciplines, encouraging open communication and data sharing, and integrating diverse viewpoints and expertise from the outset of research projects. Being receptive to new scientific discoveries and responsive to how patients react to treatments is also crucial. Such strategies are key to keeping the field of oncology at the forefront of effective cancer management, ensuring patients receive the most personalized and effective care. Ultimately, this approach aims to push the boundaries of cancer understanding, treating it as a manageable chronic condition, aiming to extend life expectancy and enhance patient quality of life.

Evaluation of Different Decellularization Protocols for Obtaining and Characterizing Canine Cardiac Extracellular Matrix.

Cardiovascular diseases are considered the leading cause of mortality globally; even with low mortality in dogs, such diseases are described in the same way in companion animals and humans. This study aimed to devise an effective decellularization protocol for the canine myocardium through the association of physical, chemical, and enzymatic methods, assessing resultant alterations in the myocardial extracellular matrix to obtain a suitable scaffold. Two canine hearts were collected; the samples were sectioned into ±1 cm2 fragments, washed in distilled water and 1× PBS solution, and followed by treatment under four distinct decellularization protocols. Sodium Dodecyl Sulfate (SDS) 1% 7 days + Triton X-100 1% for 48 h (Protocol I); Sodium Dodecyl Sulfate (SDS) 1% 5 days + Triton X-100 1% for 48 h (Protocol II); Trypsin 0.05% for 1 h at 36 °C + freezing -80 °C overnight + Sodium Dodecyl Sulfate (SDS) 1% for 3 days, Triton-X-100 for 48 h hours (Protocol III); 0.05% trypsin for 1 h at 36 °C + freezing at -80 °C overnight + 1% Sodium Dodecyl Sulfate (SDS) for 2 days + 1% Triton-X-100 for 24 h (Protocol IV). After analysis, Protocols I and II showed the removal of cellular content and preservation of extracellular matrix (ECM) contents, unlike Protocols III and IV, which retracted the ECM and removed essential elements of the matrix. In theory, although Protocols I and II have similar results, Protocol II stands out for the preservation of the architecture and components of the extracellular matrix, along with reduced exposure time to reagents, making it the recommended protocol for the development of a canine myocardial scaffold.

Promoting knowledge translation: An ecosystem approach to evidence in health.

The dissemination and implementation of evidence in health contexts have been a concern of several international organizations responsible for recommending actions to health policymakers. World Health Organization has been advocating for an ecosystem of evidence to improve clinical practice and health professional education. Thus, in this article, we address the challenges to developing the evidence ecosystem from the point of view of health professional education, considering the contexts of practice and teaching, focused on knowledge translation. There are three pivotal challenges: producing qualified knowledge; adequate communication of the synthesized evidence; and institutional policy to sustain the implemented evidence in continuous and updated flow. The evidence ecosystem helps to understand these flows between the production and implementation of knowledge, based on the capacity and resources of different health systems. It needs to be developed in the field of health professional education, feedback in the contexts of practice and teaching, to contribute to third-generation knowledge being used by different users of health services.

Hurdles in translating science from lab to market in delivery systems for Cosmetics: An industrial perspective.

In recent decades, a sweeping technological wave has reshaped the global economic landscape. Fueled by the unceasing forces of digital innovation and venture capital investment, this transformative machine has left a significant mark across numerous economic sectors. More recently, the emergence of 'deep tech' start-ups, focusing on areas such as artificial intelligence, nanotechnology, and biotechnology, has infused a fresh wave of innovation into various sectors, including the pharmaceutical and cosmetic industry. This review explores the significance of innovation within the cosmetics sector, with a particular emphasis on delivery systems. It assesses the crucial process of bridging the gap between research and the market, particularly in the translation of nanotechnology into tangible real-world applications. With the rise of nanotechnology-based beauty ingredients, we can anticipate groundbreaking advancements that promise to surpass consumer expectations, ushering in a new era of unparalleled innovation in beauty products.

Website for families of non-breastfed children: development and validation of content and interface / Sitio de Internet para familias de niños no amamantados: desarrollo y validación de contenido y de interfaz / Website para família de crianças não amamentadas: desenvolvimento e validação de conteúdo e de interface

ABSTRACT Objectives: to develop and validate the content and interface of a guidance website to support families in promoting Food and Nutrition Security for children under six months who are not breastfed. Methods: methodological study, Knowledge Translation, in two stages of creation: 1) content and validation on the criterion of accuracy in a panel of experts; 2) interface and validation on the criteria of content, language, illustrations, layout, motivation, culture and applicability. Results: the "Milky Way" website is freely available: https://www.ufsm.br/pet/ciencia-da-computacao/alimentacao-lactea. The content was structured in a decision tree made up of types of milk: milk formula, whole cow's milk and powdered milk; and utensils: bottle, cup and measuring spoon. There were 46 illustrations to elucidate the content, facilitate understanding and engage the target population. The Content Validity Index was 0.91. Conclusions: the website is a validated technology with evidence-based written and pictorial content translated for use with families.

RESUMEN Objetivos: desarrollar y validar el contenido y la interfaz de sitio web orientador para apoyar a familias en la promoción de Seguridad Alimentaria y Nutricional de niños menores de seis meses no amamantadas. Métodos: estudio metodológico, de Traducción del Conocimiento, en dos etapas de creación: 1) contenido y validación según el criterio de precisión por panel de expertos; 2) interfaz y validación según los criterios contenido, lenguaje, ilustraciones, maquetación, motivación, cultura y aplicabilidad. Resultados: el sitio "Vía Láctea" es de libre acceso: https://www.ufsm.br/pet/ciencia-da-computacao/alimentacao-lactea. El contenido se estructuró en un árbol de decisión compuesto por tipos de leche: fórmula láctea, leche entera de vaca y leche en polvo; y utensilios: biberón, taza y cuchara dosificadora. Hay 46 ilustraciones para elucidar el contenido, facilitar la comprensión y atraer a la población objeto. El índice de validez del contenido fue de 0,91. Conclusiones: el sitio web es una tecnología validada con contenidos escritos y visuales basados en pruebas y traducidos para su uso con las familias.

RESUMO Objetivos: desenvolver e validar o conteúdo e a interface de website orientativo para apoiar a família na promoção de Segurança Alimentar e Nutricional de crianças menores de seis meses não amamentadas. Métodos: estudo metodológico, de Tradução do Conhecimento, em duas etapas de criação: 1) conteúdo e validação no critério precisão em painel de especialistas; 2) interface e validação nos critérios conteúdo, linguagem, ilustrações, layout, motivação, cultura e aplicabilidade. Resultados: o website "Via láctea" está disponível em livre acesso: https://www.ufsm.br/pet/ciencia-da-computacao/alimentacao-lactea. O conteúdo foi estruturado em árvore de decisão composta por tipo de leite: fórmula láctea, leite de vaca integral e em pó; e utensílios: mamadeira, copinho e colher dosadora. Constam 46 ilustrações para elucidar conteúdo, facilitar compreensão e engajar população-alvo. O Índice de Validade do Conteúdo foi de 0,91. Conclusões: o website é uma tecnologia validada com conteúdo escrito e imagético baseado em evidências e traduzido para uso com famílias.

Functioning and Gene Expression of Adenosine A1 Receptor During Zebrafish (Danio rerio) Development.

The A1 adenosine receptor is the most widely expressed P1 receptor in vertebrates, performing inhibitory tone of the nervous system. Increased levels of adenosine are crucial to promote tissue protection in threatening situations, such as convulsion and hypoxia. Zebrafish is an established model organism for studies on health and disease. In this study, we evaluated the functionality of A1 adenosine receptor through development of zebrafish (6-7-day-, 3-, 8-, and 24-month-old), assessing: (I) the effects of the agonist N6-cyclopenthyladenosine (CPA) over locomotor parameters, (II) the anticonvulsant properties of CPA and adenosine per se in the pentylenetetrazol-induced seizure, and (III) the gene expression of adora1b through development. CPA promoted decreased distance traveled in the highest concentrations/doses tested (larvae: 75 to 500 µM; adults: 20 mg.kg-1), altered mean velocity (larvae: 50-500 µM; adults: 20 mg.kg-1) and time in the bottom zone of apparatus (adults: decrease in 20 mg.kg-1). Adenosine increased the latency of the larvae to reach stage II at 5 and 10 µM. CPA anticonvulsant effect against convulsive stage II was reached at 75 µM, although it decreased basal locomotor activity in larvae. For adults, CPA 10 mg.kg-1 was effective as anticonvulsant without locomotory effects. Adenosine had minor anticonvulsant effects in the concentration tested (larvae: 5 and 10 µM). The level of gene expression of adora1b was stable in brain from adult animals (8- and 24-month-old animals). These results suggest that zebrafish has similar responses to CPA as mammals. To avoid confounding factors, such as locomotor effects, during any brain function investigation using A1 adenosine receptor as a target, the concentration below 75 µM or below the dose of 20 mg.kg-1 of CPA is ideal for zebrafish at larval and adult stages, respectively.

Endo-Lysosomal and Autophagy Pathway and Ubiquitin-Proteasome System in Mood Disorders: A Review Article.

Mood disorders are disabling conditions that cause significant functional impairment. Due to the clinical heterogeneity and complex nature of these disorders, diagnostic and treatment strategies face challenges. The etiology of mood disorders is multifactorial, involving genetic and environmental aspects that are associated with specific biological pathways including inflammation, oxidative stress, and neuroprotection. Alterations in these pathways may reduce the cell's ability to recover from stress conditions occurring during mood episodes. The endo-lysosomal and autophagy pathway (ELAP) and the ubiquitin-proteasome system (UPS) play critical roles in protein homeostasis, impacting neuroplasticity and neurodevelopment. Thus, emerging evidence has suggested a role for these pathways in mental disorders. In the case of neurodegenerative diseases (NDDs), a deeper understanding in the role of ELAP and UPS has been critical to discover new treatment targets. Since it is suggested that NDDs and mood disorders share clinical symptomatology and risk factors, it has been hypothesized that there might be common underlying molecular pathways. Here, we review the importance of the ELAP and UPS for the central nervous system and for mood disorders. Finally, we discuss potential translational strategies for the diagnosis and treatment of major depressive disorder and bipolar disorder associated with these pathways.

Video clip for learning the physiology of lactation: evaluation by the family support network for breastfeeding women / Videoclip para aprender la fisiología de la lactancia: evaluación realizada por la red de apoyo familiar para mujeres en lactancia / Videoclipe para aprendizagem da fisiologia da lactação: avaliação pela rede de apoio familiar às lactantes

ABSTRACT Objective: to evaluate the adequacy of using a care-educational technology with video clips for learning the physiology of lactation by the family support network for breastfeeding women. Method: a methodological study guided by the Knowledge Translation in Action Model. The collection procedure was carried out from July to September 2022 in the city of Santa Cruz do Sul, state of Rio Grande do Sul, Brazil. After the childcare consultation, each puerperal woman indicated one or more members of her support network to participate in the research. In face-to-face interviews, 52 participants answered the following instruments: Assistive Technology Assessment and Face Validation of Educational Technologies in Health. Normality of the variables was verified using the Kolmogorov-Smirnov test. The quantitative variables with normal distribution were described by mean and standard deviation. Face Validity Index and Cronbach's Alpha were calculated. Results: the video clip was evaluated as adequate (1.75) in all attributes: Interactivity (1.75), Objectivity (2.00), Relevance and efficacy (2.00) and Clarity (2.00). Face validity was excellent (0.969). Both instruments obtained Cronbach's Alpha values of 0.883 and 0.852, respectively, indicating reliability in this population. Conclusion: the video clip for learning the physiology of lactation is suitable for use by the family support network for breastfeeding mothers.

RESUMEN Objetivo: evaluar lo adecuado de utilizar una tecnología de atención-educativa del tipo videoclip para aprender la fisiología de la lactancia con la red de apoyo familiar para mujeres en lactancia. Método: estudio metodológico guiado por el Modelo de Traducción del Conocimiento en Acción. Los datos se recolectaron entre julio y septiembre de 2022 en la ciudad de Santa Cruz do Sul, estado do Río Grande do Sul, Brasil. Después de la consulta de puericultura, cada puérpera indicó al menos un integrante de su red de apoyo para que participara de la investigación. En sendas entrevistas presenciales, 52 participantes respondieron los siguientes instrumentos: Evaluación de Tecnología de Asistencia y Validación de la Apariencia de Tecnologías Educativas en Salud. La normalidad de las variables se verificó con la prueba de Kolmogorov-Smirnov. Las variables cuantitativas con distribución normal se describieron con valores medios y desviaciones estándar. Se calcularon el Índice de Validez de la Apariencia y el coeficiente Alpha de Cronbach. Resultados: el videoclip fue evaluado como adecuado (1,75) en todos los atributos: Interactividad (1,75), Objetividad (2,00), Relevancia y eficacia (2,00) y Claridad (2,00). La validez de la apariencia fue excelente (0,969). Ambos instrumentos obtuvieron coeficientes Alpha de Cronbach de 0,883 y 0,852 respectivamente, indicando confiabilidad en esta población. Conclusión: el videoclip para aprender la fisiología de la lactancia es adecuado para ser usado por la red de apoyo familiar para mujeres en lactancia.

RESUMO Objetivo: Avaliar a adequação do uso da tecnologia cuidativo-educacional, do tipo videoclipe, para aprendizagem da fisiologia da lactação pela rede de apoio familiar às lactantes. Método: Estudo metodológico, guiado pelo Modelo de Tradução do Conhecimento em Ação. A coleta foi desenvolvida na cidade de Santa Cruz do Sul, no Estado do Rio Grande do Sul, Brasil, no período de julho a setembro de 2022. Após a consulta de puericultura, a puérpera indicou um ou mais membros de sua rede de apoio para participar da pesquisa. Em entrevista presencial, 52 participantes responderam os instrumentos: Avaliação de Tecnologia Assistiva e Validação de Aparência de Tecnologias Educacionais em Saúde. A normalidade das variáveis foi verificada com o teste de Kolmogorov Smirnov. As variáveis quantitativas com distribuição normal foram descritas pela média e o desvio padrão. Foram calculados o Índice de Validade de Aparência e o Alpha de Cronbach. Resultados: O videoclipe foi avaliado como adequado (1,75) em todos os atributos interatividade (1,75), objetividade (2,00), relevância e eficácia (2,00) e clareza (2,00). A validade de aparência foi excelente (0,969). Ambos os instrumentos obtiveram Alpha de Cronbach, 0,883 e 0,852 respectivamente, apontando a confiabilidade nesta população. Conclusão: O videoclipe para aprendizagem da fisiologia da lactação está adequado ao uso pela rede de apoio familiar às lactantes.

Methodological quality of network meta-analysis in dentistry: a meta-research

Abstract This meta-research aimed to provide an overview of the methodological quality and risk of bias of network meta-analyses (NMA) in dentistry. Searches for NMA of randomized clinical trials with clinical outcomes in dentistry were performed in databases up to January 2022. Two reviewers independently screened titles/abstracts, selected full texts, and extracted the data. The adherence to PRISMA-NMA reporting guideline, the AMSTAR-2 methodological quality tool, and the ROBIS risk of bias tool were assessed in the studies. Correlation between the PRISMA-NMA adherence and the AMSTAR-2 and ROBIS results was also investigated. Sixty-two NMA studies were included and presented varied methodological quality. According to AMSTAR-2, half of the NMA presented moderate quality (n = 32; 51.6%). The adherence to PRISMA-NMA also varied. Only 36 studies (58.1%) prospectively registered the protocol. Other issues lacking of reporting were data related were data related to the NMA geometry and the assessment of results consistency, and the evaluation of risk of bias across the studies. ROBIS assessment showed a high risk of bias mainly for domains 1 (study eligibility criteria) and 2 (identification and selection of studies). Correlation coefficients between the PRISMA-NMA adherence and the AMSTAR-2 and ROBIS results showed moderate correlation (rho < 0.6). Overall, NMA studies in dentistry were of moderate quality and at high risk of bias in several domains, especially study selection. Future reviews should be better planned and conducted and have higher compliance with reporting and quality assessment tools.

Fourth Generation Evaluation as a path for Knowledge Translation in mental health / La Evaluación de Cuarta Generación como camino para la Traslación del Conocimiento en salud mental / Avaliação de Quarta Geração enquanto percurso para a Translação do Conhecimento na saúde mental

ABSTRACT Objective: To discuss the use of the Fourth Generation Evaluation methodology as a powerful theoretical-methodological path for the implementation of Knowledge Translation in child and adolescent mental health. Method: It comprises the description of the stages and fieldwork of a research that evaluated mental health practices aimed at adolescents in a Child and Adolescent Psychosocial Care Center, between August and December 2018, with the health care team. Results: Using strategies to involve workers in all stages, a dialectical construction of knowledge, the adaptation of the path to the field - with the implementation of interventions suggested by the participants - and the research path itself, in its condition of product/result, enable the interface with Knowledge Translation. Final considerations: The characteristics discussed allow to suggest using the Evaluation as an alternative to the implementation of Translation, especially in the field of mental health.

RESUMEN Objetivo: Discutir el uso de la metodología de Evaluación de Cuarta Generación como un camino teórico-metodológico para la implementación de la Traducción del Conocimiento en salud mental del niño y del adolescente. Método: Comprende la descripción de las etapas y el trabajo de campo de una investigación que evaluó las prácticas de salud mental dirigidas a adolescentes en un Centro de Atención Psicosocial de Niños y Adolescentes, entre agosto y diciembre de 2018, con el equipo. Resultados: Utilizar estrategias para involucrar a los trabajadores en las etapas, construir conocimiento dialécticamente, la adecuación del camino al campo - implementar intervenciones sugeridas por los participantes- y el camino de la investigación, en su condición de producto/resultado, habilite la interfaz con Traducción del Conocimiento. Consideraciones finales: Las características discutidas permiten sugerir el uso de la Evaluación como una alternativa a la implementación de la Traducción, especialmente en el campo de la salud mental.

RESUMO Objetivo: Discutir o uso da metodologia da Avaliação de Quarta Geração como um percurso teórico-metodológico potente para implementação da Translação do Conhecimento na saúde mental infantojuvenil. Método: Compreende a descrição das etapas e do trabalho de campo de uma pesquisa que avaliou as práticas em saúde mental voltadas aos adolescentes em um Centro de Atenção Psicossocial infantojuvenil, entre agosto e dezembro de 2018, com a equipe assistencial do serviço. Resultados: A utilização de estratégias para envolver os trabalhadores em todas as etapas, a construção do conhecimento de maneira dialética, a adaptação do percurso ao campo - com a realização de intervenções sugeridas pelos participantes - e o próprio percurso da pesquisa,em sua condição de produto/resultado, viabilizam a interface com a Translação do Conhecimento. Considerações finais: As características discutidas possibilitam sugerir que se utilize a Avaliação como alternativa à implementação da Translação, sobretudo no campo da saúde mental.

Cost-related variables in the public purchase of dental materials for endodontic application: 10-year analysis

Aim: This study analyzed public procurements for different endodontic materials used in the Brazilian public health system and evaluated the variables related to their cost. Methods: A time-series study was performed by screening materials for endodontic application in the public Brazilian Databank of Healthcare Prices from 2010 to 2019. Data were categorized according to material composition and clinical application. The collated variables were used in a multiple linear regression model to predict the impact of unit price in procurement processes. Results: A total of 5,973 procurement processes (1,524,693 items) were evaluated. Calcium hydroxides were found in 79% of the observations (4,669 processes). Prices drop each year by US$1.87 while MTAs and epoxy resins are increasingly purchased at higher prices (US$50.87; US$67.69, respectively). The microregion, the procurement modality, and the type of institution had no influence on unit prices in the adjusted model (p > 0.05). Conclusions: Calcium hydroxide-based materials were the cheapest and most frequently purchased endodontic materials in the public health care system. Novel formulations are being implemented into clinical practice over time and their cost may be a barrier to the broad application of materials such as MTAs, despite their effectiveness

Where to Invest Project Efforts for Greater Benefit: A Framework for Management Performance Mapping with Examples for Potato Seed Health.

Policymakers and donors often need to identify the locations where technologies are most likely to have important effects, to increase the benefits from agricultural development or extension efforts. Higher-quality information may help to target the high-benefit locations, but often actions are needed with limited information. The value of information (VOI) in this context is formalized by evaluating the results of decision making guided by a set of specific information compared with the results of acting without considering that information. We present a framework for management performance mapping that includes evaluating the VOI for decision making about geographic priorities in regional intervention strategies, in case studies of Andean and Kenyan potato seed systems. We illustrate the use of recursive partitioning, XGBoost, and Bayesian network models to characterize the relationships among seed health and yield responses and environmental and management predictors used in studies of seed degeneration. These analyses address the expected performance of an intervention based on geographic predictor variables. In the Andean example, positive selection of seed from asymptomatic plants was more effective at high altitudes in Ecuador. In the Kenyan example, there was the potential to target locations with higher technology adoption rates and with higher potato cropland connectivity, i.e., a likely more important role in regional epidemics. Targeting training to high management performance areas would often provide more benefits than would random selection of target areas. We illustrate how assessing the VOI can contribute to targeted development programs and support a culture of continuous improvement for interventions.[Formula: see text] Copyright © 2022 The Author(s). This is an open access article distributed under the CC BY 4.0 International license.

Significance of a neglected tropical disease: lessons from a paradigmatic case of 'success in translation'

In a previous publication, I stressed the fundamental importance of research for improving health using as an example the control of Chagas disease in the Americas.(1) For that purpose, I analysed the major scientific breakthroughs and public health events from the 1909 discovery of Chagas disease and its causative pathogen, Trypanosoma cruzi, by Carlos Chagas,(2) through the successful control of its transmission by insect vectors in large regions of the Southern Cone countries in the 90s.(3) In the twenty years since that publication, Brazil and Latin American countries had to cope with a number of serious public health threats, old and new: (i) recrudescence of well-known diseases, such as dengue and yellow fever; (ii) emergence of viral diseases that had been restricted to other continents (Zika, Chikungunya); (iii) new epidemics (H1N1) or (iv) pandemics (COVID-19). Are there still some lessons from that success story against a neglected disease of the 90s that would be relevant today in the context of these recent challenges?

Hyperoxia and Lungs: What We Have Learned From Animal Models.

Although oxygen (O2) is essential for aerobic life, it can also be an important source of cellular damage. Supra-physiological levels of O2 determine toxicity due to exacerbated reactive oxygen species (ROS) production, impairing the homeostatic balance of several cellular processes. Furthermore, injured cells activate inflammation cascades, amplifying the tissue damage. The lung is the first (but not the only) organ affected by this condition. Critically ill patients are often exposed to several insults, such as mechanical ventilation, infections, hypo-perfusion, systemic inflammation, and drug toxicity. In this scenario, it is not easy to dissect the effect of oxygen toxicity. Translational investigations with animal models are essential to explore injuring stimuli in controlled experimental conditions, and are milestones in understanding pathological mechanisms and developing therapeutic strategies. Animal models can resemble what happens in critical care or anesthesia patients under mechanical ventilation and hyperoxia, but are also critical to explore the effect of O2 on lung development and the role of hyperoxic damage on bronchopulmonary dysplasia. Here, we set out to review the hyperoxia effects on lung pathology, contributing to the field by describing and analyzing animal experimentation's main aspects and its implications on human lung diseases.

On Innovation.

Innovation has become an increasingly common topic in healthcare. Private companies, developers, payers, and regulators are devoting attention toward innovative products and processes as a crucial component of their interests in and occupation with healthcare services. Even when there is no consensus as to its definition, "innovation" -as opposed to "invention"- is broadly understood to refer turning a good idea into a practical solution. Adoption and applicability are key components of implementation that are sustained not only on innovation's attributes themselves but also in the characteristics of providers, users, and implementing organizations, as well as the external environment. Regulatory agencies often face the need to make decisions about proposed innovations with obsolete or inadequate normative frameworks and with a high degree of uncertainty about its eventual performance or its risks. Early interaction between developers and dedicated multidisciplinary teams at regulatory agencies may prove instrumental for speeding up the time required for proper evaluation and product registration, as well as the establishment of quality validation mechanisms. Community involvement both in the adoption and vigilance on innovative products and processes is crucial for completing the process of defining their roles and uses.

El desafío de la innovación desde la perspectiva regulatoria / The challenge of innovation from a regulatory perspective

Actualmente, la innovación está en la agenda de diferentes actores del sistema de salud. Tanto empresas privadas como pequeños desarrolladores, pagadores y reguladores interpretan de manera creciente a la innovación como un componente esencial de su desarrollo. Cada uno de los interesados debe identificar el aspecto innovador de un nuevo producto o desarrollo en relación a su área de competencia. Aun cuando no exista una definición consensuada sobre innovación, se entiende que ésta -a diferencia de la invención- se refiere a la transformación de una buena idea en una solución práctica. En este sentido, la implementación de una innovación requiere de la adopción (decisión) y de la aplicabilidad, sustentadas no solamente en los atributos del desarrollo en sí, sino también en las características de los proveedores, usuarios y organizaciones adoptantes, y en las del ambiente externo. Muchas veces, las agencias reguladoras se enfrentan a las innovaciones con normativas que resultan obsoletas o insuficientes, y con mayor grado de incerteza respecto de su desempeño. La interacción temprana entre los desarrolladores y equipos multidisciplinarios establecidos a tal fin en las agencias reguladoras puede resultar un instrumento fundamental a los fines de acortar los plazos de evaluación y registro, y de establecer mecanismos adecuados de evaluación de calidad. La participación de la comunidad tanto en la adopción como en la vigilancia de desarrollos innovadores completa el proceso de definición de sus potenciales usos y roles.

Innovation has become an increasingly common topic in healthcare at present. Private companies, developers, payers and regulators think of innovation as a crucial component of their development. Each one of the interested parties may identify the innovative aspect of a new product or development related to their disciplinary field. Even when there is no definition agreement on innovation, it is understood -as opposite to invention- that it refers to turning a good idea into a practical solution. Implementation recognizes adoption and applicability as key components in which not only the innovation attributes are considered but also the characteristics of the providers, users and implementing organizations, as well as the external environment. Regulatory agencies often face innovations with obsolete or inadequate normative framework, and also, high degrees of uncertainty regarding its performance. Early interaction between developers and multidisciplinary teams established to that effect at regulatory agencies may become a fundamental instrument to speed up the times of evaluation and registration, and establish suitable mechanisms for quality evaluation. Involvement of the community in both the adoption and vigilance of innovative developments complete the process of defining its potential roles and uses.

Pesquisa Translacional: uma interpretação / Translational research: an interpretation

A Pesquisa Translacional (TR) parece estar se tornando o principal mote da pesquisa em saúde neste início de século. Nascida nos Estados Unidos da América (EUA), vem se disseminando rapidamente pelo mundo desenvolvido bem como pela periferia. O artigo discute os principais tópicos relativos a ela. A sua definição e o seu escopo, as razões de ter nascido nos EUA e o porquê de ter nascido neste século. Debate as relações entre a TR e os fundamentos da política científica nos EUA, estabelecidos ao final da Segunda Grande Guerra. Interpreta a demanda de uma indústria farmacêutica poderosa e em crise, associada a dificuldades de outputs científicos em quantidade adequada para atendê-la como um móvel suficiente para explicar a intervenção do governo norte-americano na pesquisa biomédica através do NIH. Entende que é difícil prognosticar o futuro da TR, mas que não se trata de uma proposição sustentada em terreno teórico-conceitual sólido. Tematiza também a oportunidade e as possibilidades da TR em países com sistemas nacionais de inovação imaturos, como é o caso do Brasil. Finalmente, propõe que a existência de um sistema universal de saúde seja a principal ferramenta organizadora das respostas possíveis da pesquisa em saúde às demandas de inovação por parte da sociedade.

Translational Research (TR) appears to be developing into the key health research issue of the beginning of this century. Initially proposed in the United States, TR is spread rapidly throughout both the developed and the developing world. This article discusses the main topics it covers, such as its definition and scope and the reasons why it has emerged in the USA and in this century. It examines the relationship between TR and the basic principles of US scientific policy established at the end of World War II. It sees the demands of a mighty pharmaceutical industry, currently facing a major crisis, linked to scientific genomic and post-genomic output impairments in terms of real innovative products and processes as being the explanation for US government intervention in biomedical research via the NIH. It realizes that it is not easy to predict the future of TR and suggests that it is not sustained by a solid conceptual and theoretical framework. It also discusses the opportunities and possibilities of TR in countries with nascent national innovative systems, such as Brazil. Lastly, it suggests that the existence of a universal health system can be an important tool to provide potential research answers tin health for the demands of innovation on the part of society.