Critical Markers of Disease

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Resources (Exclusive Benefit for CMOD Members and 2007 Symposium Registrants)

Read what the leading experts have to say about cardiovascular biomarkers, emerging data and initiatives. Learn about the importance of cardiovascular biomarkers in disease prevention, diagnosis, treatment, and research and development programs.

For membership information contact info@cmod.org.

FDA CRITICAL PATH INITIATIVE

PHARMACOGENOMICS

CEPMed - Centre of Excellence in Personalized Medicine

Cepmed, Centre of Excellence in Personalized Medicine aims to become a world leader in the development of individualized therapeutics by capitalizing on the latest advancements in genomics and biomarker research, and their rapid integration into large scale clinical trials. Given the critical importance of a patient's genetic background in the success or failure of a given therapy, there is an urgent need to introduce approaches and tools that take advantage of these individual variations to streamline the drug development process. The integration of pharmacogenomics and biomarkers into preclinical and clinical development are essential steps to reduce the attrition rate of emerging therapeutics and improve their effectiveness and safety.

Cepmed is a member of the Centres of Excellence in Commercialization and Research (CECR), a unique initiative of the Government of Canada to stimulate the development of marketable technologies, products and services by drawing on the outstanding talent and infrastructure available in health and teaching institutions throughout Canada. In particular, Cepmed relies on a tightly knit network of expertise and technological platforms at the Montreal Heart Institute (MHI) and at Genome Quebec, including among others the MHI Research Institute focused on biomarkers, bioinformatics and biobanking of DNA samples (genetic cohort of 30,000 patients), the MHI Coordination Center (MHICC) for clinical trials, the McGill University-Genome Quebec Innovation Centre and the Genome Quebec-MHI Pharmacogenomics Centre, a GLP-compliant, state-of -the-art, multi-platform facility.

With major financial support from the CECR program and matching funds from the private sector, Cepmed has a working capital of more than $22M and functions in close partnership with the pharmaceutical and biotechnological industries. By co-investing in competitive and pre-competitive development programs, Cepmed leverages its partners' know-how and needs in product development to ensure a rapid and productive transition of novel technologies from discovery stage to clinical practice.

Finally, this large financial support is invested to promote the knowledge transfert and to accelerate the use of personalized medicine approaches (pharmacogenomics, biomarkers, molecular imaging etc.) in clinical trials and health care systems. For these reasons, Cepmed is very proud of its partnership with CMOD.

Cepmed would likte to contribute, with Montreal Heart Institute and its other partners (among them Pfizer, Astra Zeneca, Merck, Novartis, Genome Québec etc.) to the improvement of Canadian people health and at term, to the economic growth of Québec and Canada.

For further information, please contact Carole Jabet (Phone: 514.603.3320 or Email: carole.jabet@cepmed.com)

COLLABORATIVE PROJECTS

Canadian Atherosclerosis Imaging Network (CAIN)

Global Atherothrombosis Investigative Network (GAIN)

GAIN is a unique organization of experienced investigators committed to working together toward a common goal – excellence in atherothrombosis research. With expertise ranging from basic research to the execution of clinical imaging studies and large international cardiovascular outcomes trials, GAIN is uniquely able to provide partnering organizations with the leadership and skills needed for the efficient and effective execution of research projects, and communication of the results. Areas of internationally recognized strengths include:

Experimental Medicine
Translational Medicine
Pharmacogenomics
Metabolomics and Proteomics
Lipids and Lipoproteins
Biomarker Development
Multi-modality Imaging Technologies
Positron Emission Tomography (PET)
Computed Tomography (CT)
Magnetic Resonance Imaging (MRI)
Intravascular Ultrasound (IVUS)
Carotid Ultrasound (IMT and 3-D ultrasound of plaques)
International Randomized Clinical Outcomes Trials
Study Coordination – Project Management, Site Management and Monitoring
Clinical Endpoint Committee
Data Safety Monitoring Board
Publication and Communication

GAIN is pursuing collaborative research projects to evaluate the role of advanced technologies in the detection, assessment and monitoring of atherothrombotic disease, as well as the application of these technologies for the assessment of therapeutic interventions. GAIN has networks of sites on all continents and is supported by the Montreal Heart Institute Coordinating Centre (MHICC), a renowned academic research organization.

We would be pleased to discuss potential opportunities for collaboration. For more information, or to arrange a meeting, please contact Dr Therese Heinonen at 810-923-9108 or Dr Jean-Claude Tardif at 514-376-3330 ext.3612.

GAIN Collaborative Investigators:

Jean-Claude Tardif, M.D.
Director, MHI Research Centre, Montreal Heart Institute
Professor of Medicine, University of Montreal Montreal, Canada
on behalf of the Global Atherothrombosis Investigative Network

Christie Ballantyne, M.D.
Professor of Medicine, Chief, Section of Atherosclerosis and Vascular Medicine,
Methodist DeBakey Heart and Vascular Center and Baylor College of Medicine,
Houston, TX, USA

Philip Barter, M.D., Ph.D.
Director of the Heart Research Institute
Sydney, Australia

Zahi Fayad, Ph.D.
Professor of Radiology and Medicine
Mount Sinai School of Medicine
New York, NY, USA

John J. P. Kastelein, M.D., Ph.D. Chairman, Department of Vascular Medicine, Academic Medical Centre
University of Amsterdam
Amsterdam, the Netherlands

Wolfgang Koenig, M.D.
Professor of Medicine and Cardiology
University of Ulm Medical Center
Ulm, Germany

Ahmed Tawakol, M.D.
Program Leader, Cardiovascular Disease at the Center for Integration of Medicine and Innovative Technology, Massachusetts General Hospital, Harvard Medical School,
Boston, MA, USA

David Waters, M.D.
Professor of Medicine, University of California
San Francisco, CA

TRANSCRIPTS FROM PAST CARDIOVASCULAR BIOMARKER AND SURROGATE ENDPOINT SYMPOSIA

CURRENT GOOD MANUFACTURING PRACTICES FOR PET DRUG PRODUCTS IN THE UNITED STATES

"Building partnerships that lead to innovation and better patient outcomes."
International Partnership for Critical Markers of Disease
PO Box 132200 • Ann Arbor, MI 48113
Phone: 734.929.2095
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Expert Speaker	Topic
Eric P. Brass, M.D., Ph.D. Harbor-UCLA Medical Center	The Balance Between Safety and Efficacy: Biomarkers as Safety Surrogates (2006)
James De Lemos, M.D. University of Texas-Southwestern Medical School	Biomarkers in Heart Failure (2006)
Zahi A. Fayad, Ph.D., FAHA, FACC Mount Sinai School of Medicine	In Vivo Imaging of Atherosclerosis by Multimodality MR, CT, and PET (2006)
Timao Li, Ph.D. Health Products and Food Branch, Health Canada	Canadian Regulatory View on Cardiovascular Biomarkers and Surrogate Endpoints in Clinical Trials (2006)
Christopher O’Donnell, M.D. NHLBI, National Institutes of Health	NIH Cardiovascular Biomarker Initiatives (2006)
Gurvaneet Randhawa, MD, MPH Center for Outcomes and Evidence (COE) Agency for Healthcare Research and Quality	Integrating Biomarkers into Practice: The Need for Data on Clinical Outcomes (2006)
Norman Stockbridge, M.D. Center for Drug Evaluation and Research US Food and Drug Administration	The Use of Biomarkers for FDA Regulatory Decision Making – Cardio-Renal (2006)
Jean-Claude Tardif, M.D. Montreal Heart Institute	The Role of Imaging in Disease Detection and Treatment (2006)
Douglas C. Throckmorton, M.D. Center for Drug Evaluation and Research US Food and Drug Administration	The FDA Critical Path Initiative – Opportunities and Challenges (2006)
Paula Trumbo, Ph.D. Center for Food Safety and Applied Nutrition US Food and Drug Administration	The Use of Biomarkers for FDA Regulatory Decision Making – Health Claims (2006)