BIOCHIP DEVELOPMENT FOR CANCER DIAGNOSIS Paradigmatic model of integration between knowledge and methodology



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Ministero dell'istruzione dell Università e della Ricerca International Congress PROGETTO FIRB 2003 RBLA03S4SP NANOSIZED CANCER POLYMARKER BIOCHIP BIOCHIP DEVELOPMENT FOR CANCER DIAGNOSIS Paradigmatic model of integration between knowledge and methodology 25 th September 2009 Auditorium Ospedale dell Angelo, Mestre - Venezia AZIENDA ULSS 12 VENEZIANA DIPARTIMENTO DI PATOLOGIA CLINICA CENTRO REGIONALE INDICATORI BIOCHIMICI DI TUMORE

ABSTRACT This final event has been organised to present the project results and it will be a stimulating forum for a comprehensive review of the topical issues of the project within a multi-professional setting, where attendees can expect to find excellence, expertise and multidisciplinary perspectives. We intended to design the meeting into two parts; the first is focused on the presentation of the scientific results of the project, whereas in the second the scientific, cultural and organizational issues dealing with the project (relationships between cancer and the immune system, cancer biomarkers, biochips for clinical laboratory investigation, evidence based medicine and research project management) are presented from an educational point of view. SCIENTIFIC STEERING COMMITTEE Massimo GION Department of Clinical Pathology AULSS 12 - ABO Association, Venezia Giorgio FASSINA Xeptagen S.p.A., Vegapark Marghera, Venezia Bruno SAMORÌ Department of Biochemistry G. Moruzzi Bologna University UNDER THE PATRONAGE OF SPECIAL THANKS INCHGOWER ASSOCIATES LIMITED (UK)

PRESENTATION We are pleased and honoured to chair the meeting Biochip Development For Cancer Diagnosis, Paradigmatic Model of Integration between Knowledge and Methodology since it represents the ideal conclusive act of a multi-institutional research project focused on the discovery of new biomarkers, the development of a nanosized biochip for their determination and its validation for the clinical use. Why is the meeting the ideal conclusion of this project? First of all, the project has been scientifically successful in the discovery of new biomarkers and in the development of nanosized biochips to reliably measure them in clinical samples. Therefore, this meeting offers the opportunity of presenting for the first time the innovative device set up and validated on genuine clinical scenarios. Secondly, the project was designed with the scope of putting together skills, knowledge and proficiencies that the state of the art suggests to be mandatory for the management of a research project. It is well recognized that the mere scientific and technological competence, although necessary, is no more per se sufficient to arrive at the expected results. As a matter of fact, additional expertises are necessary to guide scientific activities to a successful outcome. First, the available knowledge must be continuously updated through a systematic revision of the literature with the goal of discriminating reliable evidence from preliminary findings. The former evidence should be periodically delivered to the research teams of the project to update in real time their research strategy with reference to available data. Secondly, all the activities of the project must be carefully planned, harmonized, and, when necessary, properly adjusted according to planned contingency plans. Project management is regularly applicated in Randomized Clinical Trials, whereas there is a deficit in the use of it in research projects focused on biological aspects or diagnostic testing. Thirdly, a research project in which biological samples are used requires strategic care on preanalytical aspects. Needless to say, stringent guidelines are necessary to establish how clinical samples and clinical data are to be collected, prepared, stored and ultimately used. Standard operating procedures, banking protocols and bioinformatic systems are therefore core activities of the project. All these transversal activities have been planned, carefully performed, monitored and optimized during the project so that we can assert that they are themselves results of the project and the settled procedures may be viewed as deliverables of the project. We are also pleased to tell that all the members of the consortium constituted during the project, are willing to continue the cooperation for the discovery of new devices for the early diagnosis of cancer. We are delighted to believe that this is due at least in part to the role of well managed transversal activities in strengthening the sense of belonging to the consortium of the diverse Research Units. Massimo Gion Giorgio Fassina Bruno Samorì

PROGRAM 9.00 Registration 9.30 Welcome address and introduction Session I: Project results Chairmen: A. Gatta, A. Bellone/L. Cognolato 10.00 Multimarker biochip for the diagnosis of hepatocellular carcinoma G. Fassina 10.30 Development of the electrochemical biochip B. Samorì, D. Gazzola 11.00 Novel polymeric materials for the fabrication of biochip R. Solaro 11.30 IgM-linked biomarkers and cancer P. Pontisso 12.00 Additional project accomplishments: The systematic review of the literature: methods and results The bio-bank: a common resource and an opportunity for new studies Project management: from working tool to educational project M. Gion 13.00 PRESS CONFERENCE LUNCH Session II: Seminars Chairmen: S. Pecorelli, P. Pierimarchi, G. Rasi 14.30 The relationship between immune system and cancer: Immunosurveillance and Immunosuppression P. Zanovello 15.00 The role of HTA in the IVD development M. Cerbo, T. Jefferson 15.30 Biosensors: biomolecules spotting technologies and commercially available devices C. Panciatichi 16.00 Bio-banks evolution. Reevaluation of the role of the patient as a partner D. Mascalzoni 16.30 Research management F. Panozzo 17.00 Discussion and conclusions 17.30 Poster Session

FACULTY Alessandro BELLONE R&D Technologies Department & Life Science Business Development Olivetti I-Jet S.p.A., Arnad (AO) Marina CERBO AGE.NA.S., Roma Livio COGNOLATO R&D Technologies Department & Life Science Business Development Olivetti I-Jet S.p.A., Arnad (AO) Giorgio FASSINA XEPTAGEN S.p.A. VEGAPARK MARGHERA, Venezia Angelo GATTA Department of Clinical and Experimental Medicine Molecular Hepatology, Padova University Daniele GAZZOLA Department of Biochemistry G. Moruzzi, Bologna University Massimo GION Department of Clinical Pathology AULSS 12 ABO Association, Venezia Tom JEFFERSON AGE.NA.S., Roma Deborah MASCALZONI Institute of Genetic Medicine - EURAC Research, Bolzano Cristina PANCIATICHI R&D Technologies Department & Life Science Business Development Olivetti I-Jet S.p.A., Arnad (AO) Fabrizio PANOZZO Faculty of Economics - Ca Foscari University, Venezia Sergio PECORELLI Gynecologic Oncology Division, Brescia University Pasquale PIERIMARCHI Institute of Neurobiology and Molecular Medicine CNR, Roma Patrizia PONTISSO Department of Clinical and Experimental Medicine Molecular Hepatology, Padova University Guido RASI AIFA Italian Medicines Agency, Roma Bruno SAMORÌ Department of Biochemistry G. Moruzzi, Bologna University Roberto SOLARO Department of Chemistry and Industrial Chemistry, Pisa University Paola ZANOVELLO Department of Oncology and Surgical Sciences, Padova University

ADDRESSEE The event is designed primarily for researchers involved in the project FIRB and will be open to other professional figures. The abstracts will be published in The International Journal of Biological Markers, Vol. 24 - No. 3, July-September 2009. REGISTRATION Registration Fee: FIRB 2003 RBLA03S4SP participant: free Professions ECM (medical doctors, chemists, biologists, laboratory technicians): Euro 60,00 (+ VAT 20%) TOTAL Euro 72,00 Others (students, etc): Euro 30,00 (+ VAT 20%) TOTAL Euro 36,00 The registration form must be filled in and sent to the Organizing Secretariat within the 10 th September 2009: by e-mail (iscrizioni@eidonweb.it) by fax (+39 041 9656573) Registration to the Congress will be retained valid when payment has actually been made. Please send the Organizing Secretariat a copy of the payment receipt. The registration fee includes: sessions attendance, congress kit, attendance certificate, open coffee and lunch, ECM certificate. ECM CREDITS n. 3 ECM credits for the following professions: medical doctors, chemists, biologists and laboratory technicians. ORGANIZING SECRETARIAT Eidon Centro di Formazione e Studi Padiglione G. Rama Via Paccagnella, 11 30174 Zelarino - Venezia Tel. 041/9656559 - Fax 041/9656573 www.eidonweb.it - iscrizioni@eidonweb.it EVENT COORDINATING UNIT Sabrina Meo - Ornella Scattolin, ABO Association Mauro Rizzato, Inchgower Associates Ltd Tel. 041/5295782 Fax 041/5294910 cnabo@ulss12.ve.it

FIRB PROJECT PROJECT FIRB 2003 Nanosized cancer polymarker biochip RBLA03S4SP Design, production and validation facility for opto- and chemo-electronic biosensors for the simultaneous detection of biomarkers associated to neoplastic diseases It is a four-year project, approved and funded by a FIRB-MIUR grant, aimed to define innovative diagnostic devices through the interaction and dialogue between clinicians, academics and scientists from industrial settings. The project has been successful in setting up and validating an optoelectronic biochip for the simultaneous determination of several biomarkers to be used for the early detection of liver adenocarcinoma. In addition, in order to support the development of the biochip, several transversal research areas have been activated and improved, such as biological sample banking, evidence based literature search and new biomarker discovery. Regarding the Biobank, multiple aliquots from approximately 700 cases and 700 matched control, both with full clinical information, have been carefully collected, prepared and stored. Concerning Evidence Based literature search, over 7000 papers have been identified and approximately 1300 selected and distributed to research units. Finally, 31 new biomarkers have been discovered and immunometric assays for the determination of at least 20 of them have been set up and validated. For further information please see: https://serviziweb.ulss12.ve.it/firbabo FIRB PROJECT CONSORTIUM Associazione ABO per l'applicazione delle Biotecnologie in Oncologia c/o Centro Regionale Indicatori Biochimici di Tumore - Azienda ULSS 12 Veneziana Research Unit Head: Massimo GION Università degli Studi di Pisa Dept. of Chemistry and Industrial Chemistry Research Unit Head: Roberto SOLARO Università degli Studi di Bologna Department of Biochemistry "G. Moruzzi" Research Unit Head: Bruno SAMORI Olivetti Ink Jet Technology R&D, Arnad Aosta Research Unit Head: Alessandro BELLONE Università degli Studi di Padova Department of Clinical and Experimental Medicine Molecular Hepatology Research Unit Head: Angelo GATTA Consorzio per l'area di Ricerca Scientifica e Tecnologica di Trieste Laboratory of Molecular, Biostructural and Nanomaterial Modeling Research Unit Head: Vladimir FRECER XEPTAGEN S.p.A, Venezia-Marghera Research Unit Head: Giorgio FASSINA Consiglio Nazionale delle Ricerche - Roma Institute of Neurobiology and Molecular Medicine of the National Research Council Research Unit Head: Pasquale PIERIMARCHI Università degli Studi di Brescia Divisions of Gynecologic Oncology and Urology"A. Nocivelli Research Unit Head: Sergio PECORELLI

CONGRESS VENUE Auditorium Ospedale dell Angelo Padiglione G. Rama Via Paccagnella, 11 30174 Mestre- Venezia By Train From Mestre Railway Station to reach the Ospedale dell Angelo take the H1 or H2 ACTV buses (every 20 minutes): Bus H1 (at the minutes 07/27/47 of every hour, starting from 6.07 to 21.47) Bus H2 (at the minutes 15/35/55 of every hour, starting from 5.53 to 22.15) Padiglione G. Rama is the green building at the opposite side of the hospital. For further information regarding fares and train schedules, click on the web site www.trenitalia.it For further information regarding fares and bus schedules, click on the web site www.actv.it By Aeroplane From Marco Polo Airport to reach the Mestre Railway Station take the ACTV bus n. 15 (at the minutes 07/37 of every hour, starting from 8.07 to 20.37). Then follow the previous information. By Car From the A4/A27 highway take the Castellana Exit and follow the road signs for Ospedale dell Angelo. Padiglione G. Rama is the green building at the opposite side of the hospital.