OPINION – Drug development in Brazil: is it possible?

Although it does not seem, Brazil has always had a prominent position in drug development. Several drug development stages pass or passed thought the country. However, it is also true that we still have a backlog regarding patents of new drugs and new technologies, and also regarding some of the steps of early biopharmaceutical or pharmaceutical development, especially preclinical stages. There are many reasons for this backlog, such as poor stimulus to science in general, or particularly the medical and pharmaceutical sciences, lack of policies for securing masters and doctors in their home country, erratic investments by industry and government and also a relative isolation of the national market from global practices.

Additionally, we believe there is another aggravating factor, which is an apparent lack of interaction between stakeholders of drug development. On the one hand, the unawareness of the pharmaceutical industry about the development of the local scientific potential in recent decades, and on the other hand, the inefficiency of the scientific community to disseminate the knowledge generated that are applicable to the industry. And yet, a late involvement of regulatory agencies in the decision-making processes of pharmaceutical developments. Thus, initiatives that promote interaction between such actors are of great importance to foster the innovation chain, so that promising molecules discovered in Brazilian universities and research centers can be developed together with the pharmaceutical industry, increasing the chances of potential new drugs entering the market.

The preclinical development steps of pharmaceutical products include numerous essentially scientific tasks, encompassing various regulated activities. Many of these are still dependent of the application of animal models, although it is important to highlight that some steps can already count on alternative tools rather than animal models. Brazil has evolved considerably in its techniques for application of animal models and regulated bioanalytical methods, as well as in the scientific application (proof of concept).

A well-structured preclinical development will optimize the clinical steps, increasing the chances of success by predicting certain properties of the pharmaceutical or biopharmaceutical in question. Examples of these predictive strategies are: the in vitro models with induced pluripotent cells, used to evaluate safety and efficacy; and in silico models for dynamic or kinetic simulation and for toxicological prediction; among others.

Currently, Brazil has professionals and companies with full capacity not only to identify promising technologies in Brazilian institutions, but also to elaborate and implement pre-clinical activities as part of a drug development strategy. It is up to the industry to dialogue more closely with the scientific and regulatory community and to bet on the local capabilities and thus filling in some gaps of the various medical needs still unmet.

GC-2 has several lines of non-clinical activities that help promoting more effective pharmaceutical developments, such as in silico models for kinetic and dynamic simulation with antimicrobials, in silico models for toxicological prediction of new products or degradation products, in vitro models with pluripotent induced cells (cardiotoxicity), and qualified partners to perform toxicological regulated in vivo steps.

Biominas Brasil has plenty experience in the identification and analysis of technologies originating from universities and research centers, has developed its own methodology already applied to several large companies in the sector, besides having extensive knowledge of technological trends in various areas of Life Sciences and a close relationship with researchers and Technology Transfer Offices (TTOs, in Portuguese NITs- Núcleos de Inovação Tecnológica).