Direction of Pre-clinical Research and Development is aimed at the discovery and development of ground-breaking agents and new formulations with high technologic content, such as modified-release systems and solubilization/suspension platforms. The facility employees 40 researchers and uses external laboratories computational design and synthesis of New Chemical Entities (NCE), analysis and quality control, biological and pharmacological evaluation, pharmacokinetics and toxicology. The Research Unit is also able to follow the formulation process of the finished product autonomously in their facilities.
Numerous and appreciated are the collaborations with external research institutions, both national and international, universities and Research Consortia.
This Direction operates mainly in the antitumoral, hemato-oncologic, immunologic, antithrombotic and cardiovascular areas, and the active ingredients produced are small synthetic molecules, peptides and biological medications. The development of some of the projects is performed in collaboration with research groups of other companies of Italfarmaco Group, where the plants for industrial manufacturing of peptides and biological drugs operate.
One of the operating technological platforms concerns the synthesis of drugs with epigenetic activity, that is capable of interacting and modulating the cell processes of genic expression in oncology, the therapeutic area for which the activity of these compounds was originally identified. The laboratories of Italfarmaco have been among the first worldwide to discover a role for epigenetic drugs also in degenerative and autoimmune processes and metabolic dysfunctions.
Recently, another project aimed at the generation of library of antibodies and related molecules has been started, which will be developed in the above-mentioned treatment areas.
Besides the discovery of new chemical entities, the Direction, by means of sophisticated and innovative analytical and biological tests, is also engaged in the assessment of the biological and immunogenicity potential of the drugs manufactured by Group’s companies. These studies have recently contributed to the approval of a first biological drug by Chemi S.p.A., a company of Italfarmaco Group, for the American market. Biological/immunogenic evaluations of different biological drugs and synthetic drugs manufactured by Chemi, and destined to the European, American and Japanese markets, are currently underway.
Besides the development of new chemical and biological entities, the laboratories of Direction are involved in the ideation and implementation of new and established formulation approaches of sustained-release drugs (from a week up to one month), especially of peptide nature, and in the formulation of drugs already available on the market but with evident administration problems.
In the last 10 years the laboratories of the Pre-clinical Direction of Research and Development, thanks to the commitment of their investigators, has been granted the approval of numerous patents and contributed to the approval of many drugs manufactured by Italfarmaco both in Italy and worldwide.