Participant 6: COMC.IHC
JRC - Joint Research Centre, Ispra, Italy
Including: European Centre for the Validation of Alternative Methods (ECVAM)
Participant leader: Dr. Pilar Prieto
ECVAM Relevant experience and laboratory resources:
ECVAM a Unit of the Institute for Health and Consumer Protection (IHCP), located in the European Commission’s Joint Research Centre, Ispra, Italy. Sister Units include the ECB and the Physical and Chemical Exposure (PCE) Unit. ECVAM is an international reference centre for the development and validation of alternative testing methods to replace, reduce or refine the use of laboratory animals in biomedical sciences with an emphasis on toxicology assessment. ECVAM is active in areas such as topical toxicity, target organ toxicity, target system toxicity, special aspects such as carcinogenicity, chronic testing in vitro, integrated testing, kinetic modelling, biologicals and biomaterials quality control and safety testing.
ECVAM Principal staff involved:
Dr (PhD) Pilar Prieto (F) received her Ph.D. degree in 1991 at the Faculty of Pharmacy of the Salamanca University (Spain). She continued her research at Novartis Pharma AG, (Basel, Switzerland) where she investigated the mechanism of pathogenesis of Cyclosporine A in liver and kidney in vitro. Since 1996 she has worked at ECVAM where she co-ordinates the research, development and validation activities in the area of systemic toxicity. She is WP leader and a member of the Steering Committee in ACuteTox, member of the Executive Board of Predictomics and a WP leader in Pulmo-net. She has over 10 years of expertise in the field of alternatives, contributing to the development of in vitro models for drug development, safety and toxicology assessment.
Dr (MD, PhD) Laura Gribaldo (F) Action Leader in the area of Validation of Drugs, responsible for the laboratories of Haemato-toxicology and Immuno-toxicology. Over 15 years of expertise in the field of alternatives, contributing to the development of in vitro models for drug development, safety and toxicology assessment. The laboratory team of Hemato-toxicology and Immuno-toxicology have developed new models in-house and coordinated multipartnership studies in Europe and the USA. Human and murine hematopoietic stem cells are routinely cultured and the laboratories are well equipped with cell culture and molecular biology facilities for these purposes. In the last few years the activity has focused on plasticity of cord blood and bone marrow cells, as well as on early markers of chemicals exposure applying gene expression analysis.
Dr (PhD) Anna Price (F) received her PhD in Life Sciences (Polish Academy of Sciences, Institute of Pharmacology, Krakow, Poland). She continued her research at the London University,Medical College followed by the position of Research Fellow at the Department of Biochemistry, University of Cambridge. Mainly responsible for the supervision of PhD studies, writing the grant proposal and regularly peer reviews publications and other scientific work. Acts as a expert in the area of Neurotoxicity testing of Acute-Tox (FP6 IP) and as a consultant for Pharmaceutical company. Over 25 years of experience in the field of neuroscience using in vitro approach as a tool to study mechanisms of neurotoxicity.
Dr (PhD) Siegfried Morath (M) received his PhD in biochemical pharmacology, biomedical sciences and biophysics in 2002 at the University of Konstanz (Germany). Since 2001 he has contributed to 32 scientific publications. Among other things as scientific officer at ECVAM (JRC Ispra) he is responsible for the supervision of metabonomics/metabolomics projects for the in vitro toxicity classification of chemicals and drugs.
Dr (MD) Agnieszka Kinsner (F) received her M.D degree in 2000 at the Medical University of Warsaw (Poland) and a Ph.D. degree in 2005 at the Faculty of Biology at the University of Konstanz (Germany). In her research she has been mainly studying the mechanisms of neuronal cell death induced by chemical and bacterial toxins using in vitro cell culture models. She is involved in the management of ACuteTox (FP6 IP) and is a member of the Steering Committee of Liintop (FP6 STREP). Agnieszka has over seven years of expertise in the field of alternatives, contributing to the development of in vitro models for drug development, safety and toxicology assessment. Since 2007 she is responsible for the research, development and validation activities in the area of predictive toxicology.
Donatella Carpi (F)
Dr. Claude Guillou
Role of ECVAM in the project and main tasks:
ECVAM has helped to develop the key concepts of alternative testing by holding workshops on strategies to replace in vivo systemic toxicity testing and on PBPK modelling. ECVAM’s input will be to ensure, together with the project coordinator, that data generated by the various WPs are consistent with the objective of building models for toxicity prediction, potentially applicable in other fields than drug development, such as the prediction of toxicity of chemicals. Based on previous experience and applying the key concepts of validation and regulatory acceptance, ECVAM will also help to maintain a pragmatic approach, aiming at the future use of the concepts and tools developed within the project for regulatory purposes. ECVAM will provide strategic input via its taskforces and external experts. ECVAM is also the leader of for the sub-WP regarding CNS toxicity testing within WP 2, and will also contribute to WPs 1, 4, 5 and 6.