The Coordination Unit of the Initiative fosters progress in the field of advanced therapies by supporting all phases related to the development of these medicinal products. The pre-clinical or non-clinical (regulatory term) research is one such phase which precedes the design of a clinical trial in humans.
Pre-clinical research is of extreme importance to minimize the risks associated with clinical trials testing new drugs in humans. By means of in vitro and in vivo studies in animal models, it seeks to predict the safety and efficacy of medicinal products which must be later demonstrated through clinical research in patients.
The Coordination Unit supports preclinical research by means of a three-strand approach: identifying lines with translational potential mainly but not exclusively in the Andalusian Public Healthcare System, assessing the suitability of the research from a preclinical regulatory point of view and offering advice and assistance to the research lines and groups identified.
Therefore, the work model presented in this area impacts upon the adherence of a therapeutic candidate to the most stringent regulatory requirements before entering the clinical research phase.
The banner "Preclinical projects by pathologies" lists some of the Andalusian research lines so far identified by the coordination unit as having different level of maturity in terms of translational potential from a regulatory point of view.
The development of this basic and preclinical research often requires specialized technology. Much of this is already available in the main monographic centres, as well as in other Andalusian centres (universities and research institutes).
The banner "Services offered by Andalusian Research Centres" summarizes those services offered in Andalusia with the view to help researchers to identify the publicly funded resources available in this Region more quickly. This information has been obtained from the “Investiga+” data base and directly verified by the research centres.