Participant 4: ISS
Istituto Superiore di Sanità – Environment and Primary Prevention Department – Mechanisms of Toxicity Unit- Rome Italy
Participant leader: Dr. Emanuela Testai
Relevant experience and laboratory resources:
The Istituto Superiore di Sanità (www.iss.it) is the leading technical and scientific public body of the Italian National Health Service. Its activities include research, control, training and consultation in the interest of public health protection. The Department of Environment and Primary Prevention is a multidisciplinary body that combines chemical, toxicological, biological and epidemiological expertise in the qualitative and quantitative assessment of risks for human health and for the environment. The mission of the Therapeutic Research and Medicines Evaluation Department is to contribute to public health by controlling the quality, efficacy and safety of drugs and through research into new drugs and treatments for human diseases. Both Departments carry out scientific research, inspections and controls, provides documentation, reports and opinions, organizes training courses, prepares assessment documents and provides scientific consultancy services at national and international level and contributes to national and EU regulatory provisions.
The scientific activities of the people involved in the present project include studies on the effects of chemicals and pharmaceuticals on human health. Research on toxicity mechanisms, using advanced techniques, alternative methods including modelling and QSAR, chemobiokinetic studies and the identification of biomarkers, aims at characterizing health risks in the general population and in susceptible groups on account of genetic and/or acquired factors. The unit is involved in National and International Research Projects as well as in regulatory activity concerning risk assessment of drugs and chemicals for human health.
Principal staff involved:
Dr. E. Testai (F) is a senior scientist at ISS, where she has been working since 1985. During this period she has been the scientific leader of National research projects on metabolism and toxicity of xenobiotics. She is at present member of: the Scientific Committee for Health and Environmental Risks (SCHER) within DG-SANCO; the AFC Working Group (European Food Safety Authority- EFSA), the Italian Committees for Plant Protection Products and for Biocides; she serves as an expert within the Italian Working Group for the Risk Assessment of Existing Chemicals (EU Reg. 73/93/CE) and for the OECD Test Guidelines Program. She has carried out GLP (Good Laboratory Practise) inspections since 1997. She is a member of the Editorial Board of Drug Metabolism Reviews and Toxicology in vitro and she regularly peer reviews papers submitted for publications to several highly respected journals in toxicology and other scientific works.
Support to this project will also be given by: Dr. E. Di Consiglio (F), Dr. F.M. Buratti (F), Dr. S. Gemma (F) who have been working for several years with the group leader on research projects dealing with toxicokinetics, interindividual variability in xenobiotic metabolism, and risk assessment procedure; Dr. A. Meneguz (F) is a senior researcher at ISS with a long time experience in drug research and evaluation, and is serving as a national expert for EMEA; Dr. M.R. Varì is an expert in QSAR and modelling. Dr. A Stammati (F) will also co-operate, due to her wide experience in the field of in vitro toxicology and cellular models, with particular reference to intestinal absorption model.
Role of the participant in the project and main tasks:
The participant is responsible for co-ordinating WP3 and for producing/estimating data on in vitro biokinetics.