INTERACTIVE
ROUND TABLE DISCUSSION |
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1st
International Course
INTEGRATED
BIOMARKERS
BIOCHEMICAL AND BIOIMAGING ENDPOINTS
IN CARDIOCEREBROVASCULAR DIAGNOSIS, PREVENTION, THERAPY,
AND DRUG DEVELOPMENT
Lugano
(Switzerland) - October 27-29, 2005
Under
the Auspices of:
European Association of Nuclear Medicine
European Federation for Pharmaceutical Sciences
Fondazione Italiana per il Cuore
International Atherosclerosis Society
International Federation of Clinical Chemistry and
Laboratory Medicine
International Task Force of Prevention of Coronary
Heart Disease
Society of Atherosclerosis Imaging
World Heart Federation |
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SATURDAY, OCTOBER 29, 2005
AFTERNOON: from h.13.30 to h. 18.00
Interactive
Round Table Discussion
REMARKS BY STAKEHOLDERS
Regulatory Agencies, Health Organizations, Scientists, Scientific
Societies, and Industry
Goal:
To define the needs in the needs in Regulatory regulatory issues,
health economy, and Clinical clinical Trials trials in the area
of diagnosis, prevention and treatment of inCardiocerebrovascular
cardiocerebrovascular Diseasedisease.
Purpose of the session:
The speakers will present their viewpoints and their needs to
be satisfied by through the use of integrated biomarkers in cardiocerebrovascular
disease to comply with regulatory requirements and evidence- based
medicine in the development of clinical trials.
Focus of the interventions:
- Strategic value of the biomarkers
- Bottlenecks faced in developing (and/or sustaining) the use
of biomarkers
- Is the integration of biomarkers a solution?
- What can and should be done to increase the use of integrated
biomarkers?
Co-Chairs:
G.
Assmann (Münster, Germany)
W. Koenig (Ulm, Germany)
R. Paoletti (Milan, Italy)
| 13.30-13.45 |
Opening
remarks
Introductory remarks from Academia:
G. Assmann (Münster, Germany)
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| 13.45-14.00 |
Viewpoints
of the Regulatory Agencies:
Mehul Desai (Division
of Cardio-Renal Drug Products, Center for Drug Evaluation
and Research – US Food and Drug Administration)
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| 13.45-14.00 |
Viewpoints
of the Pharmaceutical industry:
Stephen A. Williams
(Head, Global Clinical Technology, Pfizer)
Filip Mussen (Senior
Director, Regulatory Affairs Europe, Merck Research
Laboratories, Merck Sharp and Dohme)
Viewpoints of the Pharmaceutical
+ diagnostic industry:
Thomas Metcalfe (Head
of the Roche Biomarker Program, F. Hoffmann-La Roche)
Ronald Grobe-Einsler
(Head, Global Clinical Pharmacology, Bayer HealthCare)
Viewpoints of the Bioimaging
industry:
David F. Rollo (Chief
Medical Officer, Philips Medical Systems)
Anke Siebert (Manager
Business Development, Siemens Medical Solutions)
Enzo Grossi (Director,
Medical Department, Bracco)
Leonard Fass (Director
Academic Relations, GE Healthcare)
Viewpoints of the Clinical Research Organizations:
Jean-Claude Provost
(Vice President Imaging Services & General Manager,
Cardiology & Neurovascular Business Unit, Synarc)
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| 15.15-15.35 |
General
discussion |
| 15.35-16.00 |
Coffee
break |
| 16.00-17.00 |
Viewpoints
of the Scientific Societies:
Mauro Panteghini (Vice
Chair Scientific Division, International Federation
of Clinical Chemistry and Laboratory Medicine)
Marcello Galvani (European
Society of Cardiology - Working Group on Acute Cardiac
Care/Study Group on Biomarkers in Cardiology)
Gérard Siest
(Human Proteome Organisation)
Piero R. Biondetti (Italian
Society of Radiology)
Viewpoints of the Industry
Associations:
Karima Boubekeur (Innovative
Medicines Project - European Federation of Pharmaceutical
Industries and Associations)
Viewpoints of the Health Organizations:
Georges Dagher (Project
Manager, Clinical Research and Therapeutics Department,
INSERM)
|
| 17.00-17.20 |
Remarks
by the Regulatory Agencies:
Mehul Desai (FDA)
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| 17.20-17.50 |
Final
Discussion |
| 17.50-18.00 |
Closing
Remarks by the Chairs |
| 18.00 |
End
of the Session |
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SCIENTIFIC-ORGANIZING
SECRETARIATS:
Main
Office
Biomarkers 2005
Fondazione Giovanni Lorenzini
Medical Science Foundation
Via Appiani 7 - 20121 MILAN - ITALY
Phone: + (39) 02 29006267
Fax + (39) 02 29007018
E-mail:
biomarkers@lorenzinifoundation.org |
Branch
Office
Biomarkers 2005
Giovanni Lorenzini
Medical Foundation
6535 Fannin, M.S. A-601
Houston, Texas 77030-2704 (USA)
Phone: (+1) 713 7970401
Fax: (+1) 713 7968853
E-mail:
biomarkers@bcm.tmc.edu |
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