Director: Dr. Patrizia Popoli
phone: (+39) 06 4990 2482-2737
mail: patrizia.popoli@iss.it; CNRVF.segreteria@iss.it
Activity
Promote drug discovery, development and testing in order to protect and improve public health; these objectives will be achieved through preclinical and clinical research activities, technical-scientific and regulatory evaluation of preclinical and clinical trials of new drugs, research and evaluation on the benefit-risk profile and place in therapy of drugs in the post-authorization phase.
Organization
The structure is organized in 3 units:
Pharmacological Research and Experimental Therapy
This unit makes use of the contribution of research groups united by the objective of identifying and validating new therapeutic approaches for diseases. This objective is pursued through the generation of new knowledge thanks to research in experimental pharmacology, the study of the pathogenetic mechanisms responsible for diseases, the development and / or refinement of experimental models, the verification of the efficacy and safety of new drugs (or repositioned drugs) in appropriate cellular and animal models of pathology. The development and biological evaluation of nanotechnology platforms for the delivery of therapeutic products represents a further approach to the development of effective and safe medicines. The unit is organized into 6 thematic areas: Central Nervous System, Chronic Inflammatory Diseases, Oncohematology, Pain Therapy, Molecular Pharmacology, Nanomedicine for Integrated Therapies.
Preclinical and Clinical Evaluation of Drugs
The unit carries out evaluation activities of the non-clinical and clinical aspects of drugs both in relation to Clinical Trials (SC) from Phase I (managed according to Ministerial Decree 27.04.2015), to Phases II and III (on specific AIFA request), and to national and international registration requests (centralized / decentralized / mutual recognition procedures). Other activities related to the evaluation aspects are related to the issue of technical opinions (e.g. scientific advice, procedures for inclusion in the lists L. 648/96) or to the evaluation within the VHP procedures (Voluntary Harmonization Procedure). The unit also assesses the admissibility of animal testing in the pharmacological field and participates in inspection activities related to Good Laboratory Practice (GLP).
Phase I clinical trials (Sperimentazione clinica di fase I)
Pharmacoepidemiology and Pharmacosurveillance
The research activities of the Unit can be synthetically collected in three main strands: conducting epidemiological studies to produce new knowledge on the benefit-risk profile of drugs after placing on the market; surveillance and conducting of epidemiological studies on potential adverse reactions to drugs, vaccines and products of natural origin, and support for national and regional pharmacovigilance activities; Diagnostic Therapeutic care Pathways (Percorsi Diagnostico Terapeutici Assistenziali, PDTA) and innovative models for improving the quality of care for people with chronic diseases. The unit also carries out institutional research activities (participation in technical tables and working groups) and training, information and communication (teaching in company and university courses, annual organization of conferences and workshops on the themes of research activity, dissemination of information, documents and data on research activities on web pages).
