PROPOSAL FOR FP7 PROGRAM Federal Research and Clinical Centre of Pediatric Hematology, Oncology and Immunology (FRC-PHOI) Leninsky Prospect, 117, Moscow 117513, Russia mmaschan@yandex.ru Calls INFRA-2007-2.2.1.15, INFRA-2007-2.2.1.16, INFRA-2007-2.2.1.18 Keynote Personnel: Rumiantsev Alexander MD, PhD, Director of the center, professor of pediatrics, Russian State Medical University, author of more than 300 publications in the field of pediatrics, hematology/oncology, immunology. Maschan Alexei MD, PhD, deputy director of the center, professor of pediatrics, Russian State Medical University, author of more than 100 publications in the field of pediatric hematology/oncology. Maschan Michael, MD, head of hematology department, Russian Children’s Clinical Hospital, assistant professor of pediatric hematology, Russian State Medical University BACKGROUND Federal Research and Clinical Centre of Pediatric Hematology, Oncology and Immunology (FRC-PHOI) is the leading research and clinical facility in Russia. Established 1991 as Research Institute of Pediatric Hematology on the base of the largest national teaching hospital (Russian Children’s Clinical Hospital), it has grown up into most important organization in the field of pediatric cancer in Russia. The clinical branch of the centre incorporates 10 departments of pediatric and adolescent hematology, oncology and immunology of 5 major hospitals of Moscow region. In 2005 the preparatory phase for the construction of the new clinical and laboratory complex has been started. With over 200 specialized hematology / oncology beds and advanced laboratories equipped according to GMP standard it will become one of the largest state-of-the-art pediatric cancer facilities worldwide. At the present time the Centre provides comprehensive care for over 500 new patients from all over Russia per year thus collecting unique clinical and laboratory data on vast range of pediatric malignant and non-malignant diseases. FRC-PHOI currently coordinates research and clinical efforts of pediatric cancer departments in 80 regions of the country, which forms a unique base for conducting multi-center clinical trials. Due to large referral area encompassing the whole country our institution is able to gather information on rare cancers, inherited immune and metabolic disorders and bone marrow failure syndromes on large groups of patients, which is not always possible in this scale at single centers in Europe. The clinical care and research are focused on development and implementation of new protocols of hematopoetic stem cell transplantation, chemo- and radiation therapy. The pediatric bone marrow transplantation program of our institution is at present the largest in Russia, doing both related and unrelated transplants. After bringing into the operation of the new complex hosting modern BMT units, it will be able to make up to 300 transplants per year. IMPACT FORESEEN This center will build the basis for the national registry of unrelated bone marrow donors, which would improve the quality of the European donor pool by adding donors of different ethnic background. Already possessing an own steadily growing bio-bank for rare diseases, FRCPHOI is going to become the foundation for the national human blood and tumor tissue bank. FRC-PHOI is a major platform for clinical trials, including phase III trials obligatory for registration of new pharmaceutical compounds and diagnostic techniques for pediatric use. Founding on these advantages the Centre is a good platform and a promising partner for participation in such projects of the ESFRI Roadmap as EATRIS (INFRA-20072.2.1.15), European Bio-Banking and Biomolecular Resourses (INFRA-2007-2.2.1.16) and Infrastructures for Clinical Trials and Biotherapy (INFRA-2007-2.2.1.18).