2009 Maryland CMOD Syposium - October 19-21

7th Annual CMOD Biomarkers and Surrogate Endpoints Symposium

"Streamlining to Promote Innovation and Efficiency"


Welcome - Intro

Session 1: Biomarker Innovations enabling drug and diagnostic development
(chairs: Peter Libby, Peter Liu)

Description: Individual experts will provide an overview of promising research across disease states, including the use of proteomics, genomics, and metabolomics. Industry representatives will provide examples of commercial applications of novel technologies.

Introduction Peter Libby
Biomarkers in cardiometabolic diseaseWolfgang Koenig
Biomarkers in drug development - Samuel Wright
Validation and use of biomarkers: from pre-clinical to clinical studiesJean-Claude Tardif
Biomarker development - case study #1 (heart failure)  - Peter Gardiner
Biomarker development – case study #2 (lipidomics)Reijo Laaksonen
The impact of biomarkers innovations on public health - George Mensah
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

Special Evening Session: Biomarker in Heart Failure (co-sponsored by NIH / NHLBI)

Session 2: Regulatory Roundtable: How can biomarkers streamline the regulatory process?
(chairs: Mary Parks, David Waters)

Description: Representatives from FDA and Health Canada will provide their insights regarding the utility of biomarkers for use in drug develop-ment. This session will highlight recent controversies and provide examples of challenges, progress and ongoing efforts in this area.

Introduction - Mary Parks
Diabetes guidelinesHylton Joffe
Industry perspective - Anders Svennson
Academic perspectiveHelen Colhoun
Panel Discussion: Diabetes guidelines
Mary Parks, David Waters, Hylton Joffe, Anders Svennson, Helen Colhoun, Karen Hicks,
Robert Temple, Agnes Klein, Douglas Throckmorton, Yan Gong, Peter Libby and Jean-Claude Tardif

Cox-2 inhibitorsSharon Hertz
Selective Estrogen Receptor ModulatorsGerald Willet
Consistency of CV endpointsKaren Hicks
Biomarker development: past, present and futureMelanie Blank
FDA perspective on the use of biomarkersRobert Temple
Panel Discussion: CV complications of non-CV drugs
Mary Parks, David Waters, Sharon Hertz, Gerald Willet, Helen Colhoun, Karen Hicks,
Robert Temple, Agnes Klein, Norman Stockbridge, and Douglas Throckmorton

Session 3: Streamlining clinical trials and communications
(chairs: Jean-Claude Tardif, Rob Califf)

Description: Focusing on recently completed, and ongoing, large-scale cardiovascular clinical trials, the use of biomarkers will be reviewed and debated by experts in drug development, clinical trial design, translational medicine, economics, epidemiology and public health. Additionally, the need to accurately and effectively communicate clinical trial results to the medical community and the general public will be examined.

Introduction - Jean-Claude Tardif
The Biomarker Factory: Moving from Mom and Pop to an Industrial Model for Clinically Important BiomarkersRobert Califf
From biomarkers to clinical trialsJean-Claude Tardif
Biomarkers in the TIMI trials: when the trial wags the dogEugene Braunwald
Communicating medical news to the lay public - Gina Kolata
Panel Discussion: Streamlining clinical trials
Jean-Claude Tardif, Robert Califf, Eugene Braunwald, Gina Kolata, Peter Libby, Eric Brass,
Norman Stockbridge, and Douglas Throckmorton

Session 4: Medical Imaging Update
(chairs: Zahi Fayad, Marcelo DiCarli)

Description: Imaging technologies have been pivotal in elucidating the mechanism behind cardiovascular and related diseases, as well as assessing the effectiveness of therapeutic intervention. This session will highlight the state-of-the-art imaging technologies and their application in research and clinical practice settings. Industry representatives will provide examples of commercial applications of novel technologies.

Introduction - Zahi Fayad
Integrating radiology and cardiologyMarcelo DiCarli
Magnetic Resonance Imaging - Ahmed Tawakol
Positron Emission Tomography and Computed TomographyZahi Fayad
QCA, IVUS, and Beyond Jean-Claude Tardif
Informing policy decisions on the use of imaging technologiesMark Grant
Panel Discussion:
Zahi Fayad, Marcelo DiCarli, Ahmed Tawakol, Joel Raichlen, George Mills, Jean-Claude Tardif, Mark Grant, Peter Libby, and Dwaine Rieves

Session 5: Molecular Imaging Workshop (co-sponsored by SNM and CMOD)
(chairs: Peter Libby, Alexander McEwan)

Description: Technological advances have empowered molecular imaging methods to elucidate pathophysiology, treat diseases and monitor therapeutic response. Advances in molecular imaging and the associated regulatory challenges will be examined by representatives from FDA, industry, academia, and professional societies.

Panel 1: A Regulatory perspective on challenges of standardization and
harmonization in multicenter imaging clinical trials

Challenges for the development and commercialization of molecular imaging agents
Donald Black
Trial design and statistical considerations for molecular imaging biomarkers
Alexander McEwan

Panel 2: The potential role of imaging biomarkers in the development of therapeutics
The potential role of imaging biomarkers in the development of neurological therapeutics
Daniel Skovronsky
The potential role of imaging biomarkers in the development of oncologic therapeutics
Patricia Cole

Panel 3: Removing the barriers to use imaging biomarkers in clinical research:
Progress of the SNM clinical trials network

Overview and progress of the clinical trials network
Michael Graham
Nuts and Bolts of participating in the clinical trials network
George Mills

Summary and wrap up - Alexander McEwan and Peter Libby