The quality of molecular methods in the age of personalized medicine

Transcription

1 20 th IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine 45 th Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) PRE-CONGRESS SATELLITE MEETINGS May 18 th, 2013 The quality of molecular methods in the age of personalized medicine Florence, Italy in cooperation with Department of Clinical Physiopathology University of Florence Programme

2 20 th IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine 45 th Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) PRE-CONGRESS SATELLITE MEETINGS May 18 th, 2013 The quality of molecular methods in the age of personalized medicine Florence, Italy in cooperation with Department of Clinical Physiopathology University of Florence 1

3 David Barton Dublin, Ireland (EMQN) Stephane Berghmans Liège, France (ESF) Angela Brand Maastricht, Holland (PHGEN) Els Dequeker Leuven, Belgium (Eurogenetest/ESP) Adriano Henney Heidelberg, Germany (ESF) Roberta Madej Sunnyvale, CA, US (CLSI ) Michael Neumaier Mannheim, Germany (DGKL) Uwe Oelmueller Germany (QIAGEN) CHAIRS & SPEAKERS Mario Pazzagli Florence, Italy (EFLM) Francois Rousseau Quebec City, Canada (CanGèneTest) Jesus Rueda Bruxelles, Belgium (EDMA) Heinz Schimmel Geel, Belgium (European Commission-JRC-IRMM) Gerard Siest Nancy, France (ESPT) Giorgio Stanta Italy (IMPACTS-OECI-ESP) Paola Turano Florence, Italy (CERM) Kurt Zatloukal Graz, Austria (ITFOM) SCIENTIFIC COMMITTEE Mario Pazzagli, Italy Chair Sverre Sandberg, Norway Chair of the Science Committee EFLM Heniz Schimmel, Belgium Member of the European Commission-JRC-IRMM Francesca Torricelli, Italy Head of the Genetics Clinical Laboratory, AOU Careggi, Florence Gerard Siest, France President ESPT Adriano Henney, Germany European Science Foundation 2 Florence, Italy - May 18 th, 2013

4 PRELIMINARY PROGRAMME May 18 th, 2013 Aims Ensuring quality in laboratory practice requires a quality management system that includes both internal and external processes as indicated in national and international guidelines. For molecular methods the current quality assurance framework is mainly focused on monitoring the performance of well-established nucleic acids technologies and the detection of limited sequence variations for one or a small panel of genes. The rapid development of new technologies has now opened the door to address the full complexity of the factors that will contribute to an individual s disease susceptibility and disease characteristics. These technologies allow massive parallel testing using next generation sequencing, array technologies, NMR, mass spectrometry and others in combination with highly sophisticated software algorithms. They will allow the detection of a multitude of sequence variations, gene expression levels, proteomic and metabolomic patterns as the analytical basis for personalized medicine, first applications of which can be already seen in Oncology, Pharmacogenetics and Theranostics. Because of this higher level of complexity of potential actionable health information, it is necessary to implement new approaches of quality assessment to adequately monitor the performance of these new technologies. Scientific Societies acting in the area of Laboratory Medicine (IFCC, EFLM, ESPT, DGKL), International organizations (CDC, CLSI, ESF, IRMM, CERM), and representatives of International Projects and Networks (SPIDIA, PHGEN, ITFOM, EUROGENTEST, EMQN, CanGeneTest, IMPACTS, RfB) will present at the Meeting their view on the role of Molecular Methods in Personalized Medicine and how to monitor the quality to allow the clinical use of these new diagnostics. 08:00-09:00 Registration 09:00-10:45 Session I INTRODUCING PERSONALIZED MEDICINE IN HEALTH CARE AND LABORATORY MEDICINE Chairman: M. Neumaier (Mannheim, Germany) 09:00 Welcome M. Pazzagli (Florence, Italy) 09:15 A Forward Look on Personalized Medicine S. Berghmans (Liège, France) 09:45 Impact of Personalized Medicine on Health Care System A. Brand (Maastrich, Holland) 10:15 Internationally Harmonized Quality Criteria for Biological Samples and Data: the Cornerstone for the Advancement of Personalized Medicine K. Zatloukal (Graz, Austria) 10:45 Coffee break Florence, Italy - May 18 th,

5 PRELIMINARY PROGRAMME May 18 th, :15-13:00 Session II REFERENCE MATERIALS, REFERENCE METHODS AND PT/EQA PROGRAMMES Chairman: A. Henney (Heidelberg, Germany) 11:15 Reference Materials: Conceptual Considerations for a Rapidly Changing Field H. Schimmel (Geel, Belgium) 11:45 Reference Methods for Sequencing Analysis F. Rousseau (Laval, France) 12:15 Planning EQA programmes for Personalized Medicine M. Neumaier (Mannheim, Germany) 12:45 Implementation of a PT/EQA Programme for Next Generation Sequencing D. Barton (Dublin, Ireland) 13:15 Lunch 14:15-15:15 Session II (continuation) REFERENCE MATERIALS, REFERENCE METHODS AND PT/EQA PROGRAMMES Chairman: S. Berghmans (Liège, France) 14:15 PT/EQA Schemes for Oncology Biomarkers: a Necessity for Quality of Care E. Dequeker (Leuven, Belgium) 14:45 New Validation Approaches to improve Quality in Metabolomic Analyses P. Turano (Florence, Italy) 15:15 Coffee Break 4 Florence, Italy - May 18 th, 2013

6 PRELIMINARY PROGRAMME May 18 th, :45-16:45 Session III GUIDELINES Chairman: F. Rousseau (Laval, France) 15:45 CLSI Guidelines for Molecular Methods: are They Suitable for Personalized Laboratory Medicine? R. Madej (Sunnyvale, CA US) 16:15 Standardization of the Preanalytical Phase for Molecular Methods U. Oelmueller (Germany) 16:45-18:15 Session IV NEEDS/REQUIREMENTS FROM SOCIETIES/INDUSTRY Chairman: J. Rueda (Bruxelles, Belgium), M. Pazzagli (Florence, Italy) Participants: Gerard Siest (Nancy, France) European Society of Pharmacogenomics and Theranostics (ESPT) Jesus Rueda (Bruxelles, Belgium) European Diagnostic Manufacturers Association (EDMA) Giorgio Stanta (Italy) European Network on Archive Tissues (IMPACTS-OECI-ESP) Mario Pazzagli (Florence, Italy) European Federation of Laboratory Medicine (EFLM) 18:15-18:30 Concluding remarks Mario Pazzagli (Florence, Italy) Florence, Italy - May 18 th,

7 GENERAL INFORMATION ORGANISING SECRETARIAT Biomedia srl Via L. Temolo 4, Milan (Italy) Ph.: ext. no. 221 Fax DESTINATION AND MANAGEMENT AGENCY Biomedia Travel OFFICIAL LANGUAGE The official language of the Congress is English. MEETING VENUE Palazzo Nonfinito Via del Proconsolo Florence, Italy Palazzo Nonfinito is located in Via del Proconsolo 12. As its name implies, it is unfinished. Bernardo Buontalenti designed it in 1593 for the Strozzi family. Buontalenti built only the courtyard and the first floor but was not able to complete this large building. At present Palazzo Nonfinito houses the Museo Nazionale di Antropologia ed Etnologia (National Museum of Mankind). Although it is not one of the most important tourist attractions in Florence, the National Museum of Mankind has a relevant collection of ancient archeological findings from all over the world, grouped according to their geographical origin. 6 Florence, Italy - May 18 th, 2013

8 GENERAL INFORMATION REGISTRATION DESK AND INFO POINT The Registration Desk and the Info Point will be available on May 18th from AM till the end of the working session. REGISTRATION FEE Full Registration: Full Registration*: Reduced Registration age 35 years: Reduced Registration age 35 years*: 150,00 (VAT included) 130,00 (VAT included) 80,00 (VAT included) 64,00 (VAT included) *Reduced fee for registered delegates to the EuroMedLab Milano 2013 Congress Registration fee includes: Entrance to plenary session and the exhibition area Satellite Symposium Information Package Certificate of attendance Coffee break and working lunch vouchers Transfer from SM venue to the EML2013 Congress venue and Milan Piazza San Babila (down town) No other stops are foreseen. The Bus will leave on May 18 th at the end of the working session. Transfer must be booked online during registration and by May 1 st. No transfer service will be provided without pre-registration. REMITTANCE Modalities of payment are indicated in the online registration platforms. CURRENCY Registration fees and charges for all events related to the EuroMedLab Milano 2013 Satellite Symposium must be paid in euros. CANCELLATION AND REFUND Cancellations must be sent in writing to milan2013.satellitemeetings@biomedia.net The amount equal to 80% of the fee paid will be refunded for cancellations received by 31 March Until 30 April, 2013 a refund of 50% of the fee will be granted. After 30 April 2013 no refunds will be issued. All refunds will be paid in euros after the congress. Florence, Italy - May 18 th,

9 GENERAL INFORMATION CANCELLATION OF THE SATELLITE MEETING The Satellite Meeting secretariat reserves the right to cancel the event and shift venue in case of force majeure. Neither Biomedia nor the Congress Organizing Committee shall be liable for any damage claims. NAME BADGE All participants will receive a name badge when they check in at the Registration Desk. This badge must be worn at all times because only registered participants will be admitted to the lecture hall. CERTIFICATE OF ATTENDANCE A certificate of attendance will be issued at the Registration Desk at the end of the working session. HOW TO REACH FLORENCE By train Santa Maria Novella railway station is located in Florence down town. The Meeting Venue is located at about 800 meters. By Airplane Florence is served by two airports with daily flights to the major European, Middle East and African countries, both of them conveniently linked to the city center: Amerigo Vespucci (Peretola) Airport: It is placed around 4 km / 3 miles in the north-west of Florence. Buses from Florence Peretola Airport Fly by Bus are operated by SITA and ATAF and take 20 minutes to connect the airport to Santa Maria Novella railway station. By taxi is about 15 minutes drive. Galileo Galilei Airport / Pisa International Airport: Located in Pisa, this is the main airport in Tuscany. It can be reached in less than one hour (80km) from Florence through a punctual train and bus system and has an easy access to the motorway. For more information about Florence visit the site: 8 Florence, Italy - May 18 th, 2013

10 EUROMEDLAB SATELLITE MEETINGS SECRETARIAT Biomedia srl - Via Libero Temolo, Milan Italy