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| October 19, 2009 |
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Symposium Introduction – Therese Heinonen
Session 1: Biomarker Innovations enabling drug and diagnostic development (chairs: Peter Libby, Peter Liu) |
| 12:30 PM ‐ 1:00 PM |
Introduction
Peter Libby |
| 1:00 PM ‐ 1:30 PM |
Biomarkers in cardiometabolic disease
Wolfgang Koenig |
| 1:30 PM ‐ 2:00 PM |
Biomarkers in drug development
Samuel Wright |
| 2:00 PM ‐ 2:30 PM |
Validation and use of biomarkers: from pre-clinical to clinical studies
Jean-Claude Tardif |
| 2:30 PM ‐ 2:45 PM |
Biomarker development - case study #1 (atherosclerosis)
Peter Gardiner |
| 2:45 PM ‐ 3:00 PM |
Biomarker development - case study #2 (lipidomics)
Reijo Laaksonen |
| 3:00 PM ‐ 3:30 PM |
The impact of biomarkers innovations on public health
George Mensah |
| 3:30 PM ‐ 4:00 PM |
Panel Discussion
Peter Libby, Peter Liu, Wolfgang Koenig, Samuel Wright, Jean-Claude Tardif, Peter Gardiner, Reijo Laaksonen, George Mensah, Irene Nunes, Oye Olukotun, Seigo Izumo, Gurvaneet Randhawa |
| 4:00 PM ‐ 4:30 PM |
--BREAK-- |
Special Evening Session: Biomarkers in heart Failure: Challenges & Opportunities
(co-sponosored by NIH / NHLBI) |
4:30 PM - 4:45 PM
12 min. present -
3 min. Q&A
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How do we rigorously evaluate biomarkers?
Michael Lauer |
| 4:45 PM - 5:00 PM |
The current state of biomarkers in heart failure?
Peter Liu |
| 5:00 PM - 5:15 PM |
Imaging biomarkers
Andrew Arai |
| 5:15 PM - 5:30 PM |
Clinical trial perspective
James E. Udelson |
| 5:30 PM ‐ 5:45 PM |
FDA perspective
Abraham Karkowsky |
| 5:45 PM ‐ 6:00 PM |
--BREAK-- |
| 6:00 PM - 7:30 PM |
Panel Discussion / Brainstorming Session |
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| October 20, 2009 |
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Session 2: Regulatory Roundtable: How can biomarkers streamline the regulatory process?
(chairs: Mary Parks, David Waters) |
| 8:00 AM ‐ 8:10 AM |
Introduction
Mary Parks |
| 8:10 AM ‐ 8:40 AM |
Diabetes guidelines
Hylton Joffe |
| 8:40 AM - 9:10 AM |
Industry perspective
Anders Svennson |
| 9:10 AM ‐ 9:40 AM |
Academic perspective
Helen Colhoun |
| 9:40 AM ‐ 10:00 AM |
--BREAK-- |
| 10:00 AM ‐ 10:30 AM |
Panel Discussion: Diabetes guidelines
Mary Parks, David Waters, Hylton Joffe, Anders Svennson, Helen Colhoun, Karen Hicks, Robert Temple, Agnes Klein, Douglas Throckmorton, Christoph Koenen, Peter Libby and Jean-Claude Tardif |
| 10:30 AM ‐ 11:00 AM |
Cox-2 inhibitors
Sharon Hertz |
| 11:00 AM ‐ 11:30 AM |
Selective Estrogen Receptor Modulators
Gerald Willet |
| 11:30 AM ‐ 12:00 PM |
Standardized Data Collection for Cardiovascular Trials: A Collaborative Effort
Karen Hicks |
| 12:00 PM ‐ 1:00 PM |
--LUNCH-- |
| 1:00 PM ‐ 1:30 PM |
Renal biomarker development: past, present and future
Melanie Blank |
| 1:30 PM ‐ 2:00 PM |
FDA perspective on the use of biomarkers
Robert Temple |
| 2:00 PM ‐ 2:40 PM |
Panel Discussion: CV complications of non-CV drugs
Mary Parks, David Waters, Sharon Hertz, Gerald Willet, Helen Colhoun, Karen Hicks, Melanie Blank, Robert Temple, Agnes Klein, Norman Stockbridge, and
Douglas Throckmorton |
| 2:40 PM ‐ 3:00 PM |
--BREAK-- |
Session 3: Streamlining clinical trials and communications
(chairs: Jean-Claude Tardif, Rob Califf) |
| 3:00 PM - 3:05 PM |
Introduction
Jean-Claude Tardif |
| 3:05 PM ‐ 3:30 PM |
The Biomarker Factory: Moving from Mom and Pop to an Industrial Model for Clinically Important Biomarkers
Robert Califf |
| 3:30 PM ‐ 3:55 PM |
From biomarkers to clinical trials
Jean-Claude Tardif |
| 3:55 PM ‐ 4:20 PM |
Biomarkers in the TIMI trials
Eugene Braunwald |
| 4:20 PM - 4:45 PM |
Communicating medical news to the lay public
Gina Kolata |
| 4:45 PM ‐ 5:30 PM |
Panel Discussion: Streamlining clinical trials
Jean-Claude Tardif, Robert Califf, Eugene Braunwald, Gina Kolata, Peter Libby, Eric Brass, Norman Stockbridge, Douglas Throckmorton, Michele Mercuri and
Laure Cloarec-Blanchard |
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| October 21, 2009 |
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Session 4: Medical Imaging Update
(chairs: Zahi Fayad, Marcelo DiCarli) |
| 8:00 AM - 8:10 AM |
Introduction
Zahi Fayad |
| 8:10 AM ‐ 8:40 AM |
Advances in SPECT & PET imaging: Novel approaches to diagnosis &
risk prediction
Marcelo DiCarli |
| 8:40 AM - 9:10 AM |
PET Imaging of Atherosclerosis
Ahmed Tawakol |
| 9:10 AM ‐ 9:40 AM |
Magnetic Resonance Imaging and Computed Tomography of Atherosclerosis
Zahi Fayad |
| 9:40 AM ‐ 10:00 AM |
--BREAK-- |
| 10:00 AM ‐ 10:30 AM |
QCA, IVUS, and Beyond
Jean-Claude Tardif |
| 10:30 AM ‐ 11:00 AM |
Informing policy decisions on the use of imaging technologies
Mark Grant |
| 11:00 AM ‐11:30 AM |
Panel Discussion:
Zahi Fayad, Marcelo DiCarli, Ahmed Tawakol, Joel Raichlen, George Mills, Jean-Claude Tardif, Mark Grant, Peter Libby, and Dwaine Rieves |
| 11:30AM ‐ 12:30 PM |
--LUNCH-- |
Session 5: Molecular Imaging Workshop (co-sponsored by SNM and CMOD)
(chairs: Peter Libby, Alexander McEwan) |
| 12:30 PM ‐ 1:45 PM |
Panel 1: Challenges of standardization and harmonization in multicenter molecular imaging clinical trials
Donald Black and Alexander McEwan
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| 1:45 PM ‐ 3:00 PM |
Panel 2: The potential role of molecular imaging biomarkers in the development or neurological and oncologic therapeutics
Daniel Skovronsky and Patricia Cole
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| 3:00 PM ‐ 3:45 PM |
Panel 3: Challenges and opportunities for using molecular imaging biomarkers in clinical research
Michael Graham and George Mills
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| 3:45 PM - 4:15 PM |
Summary and wrap-up -Alexander McEwan and Peter Libby
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