ABSTRACT Public health systems face the contradiction of skyrocketing cancer incidence and cancer drug prices, thus limiting patient access to more effective treatments. The situation is particularly dire in low- and middle-income countries. We urgently need consensus on the main determinants of this problem, as well as specific, effective and feasible solutions. Analysis of available data reveals that the problem has reached its current magnitude only recently and is not related to the growing complexity of drug production technology, but rather to corporate profits and the failure of market mechanisms to allocate resources based on health needs. Despite the obstacles, there is ample room for effective intervention: joint price negotiations, cost transparency, greater support for creation of manufacturing capacity, and regulatory measures that facilitate introduction of generic and biosimilar drugs and reduce intellectual property barriers to better use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights. Such actions will not be effective if there is no consensus around them, or if low- and middle-income countries act in isolation. This is precisely where international organizations must intervene.

ABSTRACT Biotechnology has changed the pharmacopeia. It is expected that in the next five years, 50% of biological products will originate from biotechnology. Yet, treatments based on effective, costly biopharmaceuticals for prolonged use hamper the goals of ensuring universal therapeutic coverage and access to the best treatments. This conflict surfaced 30 years ago with synthetic drugs, and the solution was to create generics once the developers’ patents expired. Biosimilars are not generics, strictly speaking, as it is impossible to guarantee that they are molecularly identical to the original product; nor are they completely new products, as they rely on a great deal of prior work done by other scientists. National strategies are needed to ensure the broadest possible coverage in the best interests of the population. The key to a strategy to ensure access to the best treatment available lies in the concept of “totality of evidence,” which includes all information about a given molecular structure and its mechanism of action; safety and efficacy information from the first clinical trials; and monitoring data from products’ use in medical practice. A strategy of broad biological and molecular categorization plus intense pharmacovigilance would reduce development costs, the main barrier to widespread access.

The growth of companies in a highly competitive world depends on the superior performance of the development process of their products. Previous studies showed that today the main difficulty of the Molecular Immunology Center growth resides in the ability to enter international markets, and in the development of new products. The implementation of a product development management system based on the diagnosis of the current limitations will eliminate the restrictions and will be a tool for successfully implementing competitive products at the center. The product development management in the Center of Molecular Immunology is characterized in this paper starting from surveys and brainstorming results; and a product development management system is proposed to the institution as a tool to create a sustainable competitive advantage for the new products

El crecimiento de las empresas en un mundo altamente competitivo depende del rendimiento superior del proceso de desarrollo de sus productos. Estudios anteriores mostraron que hoy la dificultad principal del crecimiento del Centro de Inmunología Molecular está en la capacidad de penetrar los mercados de exportación, y el desarrollo de nuevos productos. La implementación de un sistema de gestión de desarrollo de productos a partir del diagnóstico de las limitaciones actuales permitirá eliminar las restricciones en el desarrollo de nuevos productos y constituirá una herramienta para el éxito de la realización de los mismos de manera competitiva. En este artículo se caracteriza la gestión de desarrollo de productos en el Centro de Inmunología Molecular, a partir de la realización de encuestas y tormentas de ideas y se propone un sistema de gestión para el desarrollo de productos en la institución que permita su uso como herramienta para su competitiva realización

The antipsoriatic, antiinflammatory, and analgesic effects of a red propolis extract, were assessed. This extract induces the formation of a granular layer in the mouse tail test, used as a model for psoriasis. Propolis at a 50 mg/kg dose (oral) showed antiinflammatory activity in the cotton granuloma model in rats, as well as in the capillary permeability test in rats peritoneum at a 10 mg/kg dose. Propolis extract (25 mg/kg, oral) presented analgesic properties in the acetic acid stretching model, while the 40 mg/kg dose was effective in the hot plate test in mice. These results demonstrate evidence about the potential usefulness of red propolis in inflammatory disorders, and particularly, in the management of psoriasis.

Se evaluaron los efectos antipsoriásico, antiinflamatorio y analgésico de un extracto de propóleo rojo. Este extracto induce la formación de la capa granular en la prueba de la cola de ratón usada como modelo de psoriasis. El propóleo a la dosis de 50 mg/kg (vía oral) mostró actividad antiinflamatoria en el modelo de granuloma por algodón en ratas, así como en la prueba de permeabilidad capilar en el peritoneo de ratas en la dosis de 10 mg/kg. El extracto de propóleo (25 mg/kg, vía oral) presentó propiedades analgésicas en el modelo de estiramiento por ácido acético, mientras que la dosis de 40 mg/kg fue efectiva en la prueba del plato caliente en ratones. Estos resultados demuestran evidencias acerca de la utilidad potencial del propóleo rojo en trastornos inflamatorios y particularmente en el tratamiento de la psoriasis.

Se demostró el efecto tóxico de la ciclosporina A (10 mg/kg) sobre las células ß- pancreáticas, al ser suministrada diariamente durante una semana a ratas Wistar, así como la reducción de su toxicidad por tratamiento conjunto de verapamil (1 mg/kg). El tratamiento con ciclosporina A produjo hiperglicemia, disminuyó la tolerancia a la glucosa y los niveles de insulina, lo que ocasionó una reducción del incremento de peso en las ratas. Desde el punto de vista ultraestructural, se observó desorden y destrucción celular. Se concluyó que el tratamiento con ciclosporina A y verapamil simultáneamente evitó los efectos tóxicos de la ciclosporina A.