The Direction of Clinical Research and Development, in close collaboration with other functions, is charged of the research and development of new molecules from the first administration in humans to their license and marketing. More specifically, the Clinical R&S is performing trials in healthy volunteers and patients in order to assess the potential of new molecules in myeloproliferative neoplasms, neuroendocrine tumors, prevention of seroma, in Duchenne’s muscular dystrophia. The results of these studies, expected to be available between the end of 2016 and 2017, will enable to establish the passage to the license step. The R&D Clinical Direction has recently concluded a study in children with Duchenne muscular dystrophy demonstrating that Givinostat , an inhibitor of histone Deacetylases developed by Italfarmaco , prevents the replacement of muscle fibers with scar tissue. Based on these results, and after encountering Regulatory Authorities European and Americans, the R & D Clinical Direction conduct the necessary studies for the Givinostat registration request for Duchenne Muscular Dystrophy. The Clinical Direction also performed clinical trials aimed at the license of a new liquid formulation of riluzole ( Teglutik ) in the United States and a of a biosimilar product in Europe.
The Direction currently includes a group of graduated senior scientists belonging to the bio-medical area and in charge of the ideation and implementation of clinical development plans of the molecules of R&S portfolio. The enforcement of clinical trials is also delegated to external CROs with which the Direction cooperates in project teams.
Corporate projects are developed by the Direction of Clinical R&S according to modern criteria of development of new drugs, thus using, as possible, translational medicine approaches, aimed at early investigation in the patient and enabling to collect data on the same, and subsequently develop a better formulation of the drug to be used more targetedly for the disease.