International Partnership for Critical Markers of Disease (CMOD)

The Mission of CMOD
Goals and Objectives
Founders
The History of CMOD
Faculty

 

The Mission of CMOD

CMOD is a non-profit I.R.S. 501(c)3 tax exempt organization.

The mission of the International Partnership for Critical Markers of Disease (CMOD) is to accelerate the identification, validation and appropriate application of biomarkers in cardiovascular and related diseases.

Goals and Objectives

The broad goal of the International Partnership for Critical Markers of Disease is to create efficiencies toward improved patient healthcare. Toward this goal, the Partnership works to:

• Provide scientifically rigorous and balanced information on established and novel biomarkers and imaging technologies;
• Facilitate the cooperative exchange of ideas and information about critical biomarkers among clinical and basic scientists, governmental regulatory agencies, pharmaceutical, biotech and diagnostic companies, healthcare providers, and patient groups;
• Identify issues in biomarker identification and offer educational programs which provide access to the most current information on biomarker and related sciences to meet educational needs;
• Promote and support collaborative initiatives to advance the identification, validation and application of biomarkers most efficiently.


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Founders

 

Therese Heinonen, DVM

A graduate of Michigan State University College of Veterinary Medicine, Dr. Heinonen has an active interest in the evaluation of potential cardiovascular biomarkers and their appropriate application in clinical trials.  She received training in molecular biology at Merck Research Laboratories, and was a member of the Pfizer Global Research and Development cardiovascular senior management team where she made significant contributions to the clinical development of Lipitor. Including her current responsibilities as the Associate Director of Medical and Scientific Affairs at the Montreal Heart Institute Coordinating Center, Dr. Heinonen has accumulated over 17 total years of research, with 15 years dedicated to clinical research.  Current clinical research projects are focused in the areas of cardioprotection, neuroprotection, atrial fibrillation, heart failure, atherosclerosis, cardiovascular imaging and lipid modification. Addition areas of interest include strategies to improve upon clinical trial design and methodology.  Dr. Heinonen has authored over 40 publications and managed over 30 clinical trials, many of which have focused on cardiovascular biomarkers and imaging technologies.  Dr. Heinonen has worked as a consultant to government institutions, pharmaceutical companies, and diagnostic companies.   In 2003, Dr. Heinonen began organizing the annual Cardiovascular Biomarkers and Surrogate Endpoints Symposium and in 2006 co-founded the International Partnership for Critical Markers of Disease. Dr. Heinonen is also the owner of Clinical Lynx, Inc., a research support company.

 

Peter Libby, MD

Peter Libby, MD, is the Chief of Cardiovascular Medicine at the Brigham and Women’s Hospital in Boston, Massachusetts. He serves as the Mallinckrodt Professor of Medicine at Harvard Medical School. Dr. Libby directs the D.W. Reynolds Cardiovascular Clinical Research Center at Harvard. His current major research focus is the role of inflammation in vascular diseases such as atherosclerosis. Dr. Libby has received numerous awards and recognitions for his research accomplishments, including the 2006 Distinguished Scientist Award of the American College of Cardiology. His areas of clinical expertise include general preventative cardiology. An author and lecturer on cardiovascular medicine and atherosclerosis, Dr. Libby has published extensively in medical journals including Circulation, Journal of Clinical Investigation, Proceedings of the National Academy of Sciences, New England Journal of Medicine and Nature. He is the Editor-in-Chief of the coming edition of Braunwald’s Heart Disease. Dr. Libby has also contributed to the chapters on pathogenesis, treatment, and prevention of atherosclerosis to Harrison’s Principles of Internal Medicine. He has held numerous visiting professorships and has been selected to deliver over 50 named or keynote lectures throughout the world. Dr. Libby’s professional memberships include the Association of American Physicians, the American Society for Clinical Investigation, and honorary membership in the British Atherosclerosis Society. He currently serves as the President of the Association of University Cardiologists. He has served in many roles as a volunteer for the American Heart Association, including chairman of several research committees and member of the executive committees of the Councils on Arteriosclerosis, Circulation, and Basic Science. He has frequently served as a consultant to the National Heart, Lung and Blood Institute (NHLBI), including a 5-year term on the Board of Scientific Councilors. He was the recipient of a MERIT Award from the NHLBI. Dr. Libby earned his medical degree at the University of California, San Diego, and completed his training in internal medicine and cardiology at the Peter Bent Brigham Hospital (now Brigham and Women’s Hospital). He also holds an honorary MA degree from Harvard University.

 

Jean-Claude Tardif, MD

Jean-Claude Tardif is professor of medicine at the Montreal Heart Institute, where he also serves as a cardiologist and Director of the Research Center. Dr. Tardif graduated from the University of Montreal with his medical degree in 1987 and completed his fellowship in cardiology in 1992. Returning to Montreal, he took up a position as cardiologist at the Heart Institute that same year. Dr. Tardif is the Director of the Cardiovascular Health Network of Fonds de Recherche en Sante’ du Que’bec and also holds the Canadian Institutes of Health research and Pfizer chair in atherosclerosis. Dr. Tardif has authored and co-authored more than 400 articles and abstracts in peer-reviewed publications including The New England Journal of Medicine, The Journal of the American Medical Association, Circulation, and the Journal of the American College of Cardiology. In addition, he has written 25 book chapters and has edited several books. He is the principal investigator of several large international clinical trials in the field of atherosclerosis.

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CMOD History

2003 Cardiovascular Biomarkers and Surrogate Endpoints Symposium

Beginning in 2003, Dr. Peter Libby, Mallinckrodt Professor of Medicine, Harvard Medical School and Chief of Cardiovascular at Brigham and Women's Hospital; Dr. Jean-Claude Tardif, Director of the Montreal Heart Institute Research Center, and Dr. Therese Heinonen, Associate Director, Medical and Scientific Affairs, Montreal Heart Institute organized the first Cardiovascular Biomarkers and Surrogate Endpoints Symposium. The objectives were to 1) educate participants in state-of-the-art technologies for assessing atherosclerotic risk and progression; 2) to provide participants with an understanding of the issues related to applying these technologies in a setting of drug development; and 3) to provide a forum for improved understanding between academia, industry, and regulatory agencies. During the symposium, the participants explored the use of various diagnostic and research tools applied to clinical trials to assess risk for, and determine the progression of, atherosclerotic vascular disease (2003 Agenda). The principles behind these technologies and measures were addressed, including recent technical advancements, and the advantages and limitations of these technologies. New and cumulative data generated using these biomarkers were discussed, as were regulatory issues regarding the use of biomarkers and surrogate endpoints as the basis of drug approval. The faculty included experts from academia, industry, and government agencies (2003 Faculty). From the very first symposium in 2003, an environment of collaboration and cooperation has been fostered to the extent that faculty members have included representatives from government, academia, and industry. Additionally, symposium participants have included experts from all segments of the healthcare profession and have included colleagues from public and private institutions worldwide.

2004 Cardiovascular Biomarkers and Surrogate Endpoints Symposium

In September of 2004, 6 months after the publication of the FDA's Critical Path Initiative, the Cardiovascular Biomarkers and Surrogate Endpoints Symposium, continued its efforts to educate, inform, and foster collaboration between academia, industry, and regulatory agencies with the establishment of the symposium as an annual event. The scope of this second annual symposium (2004) was expanded to include biomarkers in the setting of diabetes, acute coronary syndrome, and the development of devices (2004 Agenda). Additionally, the symposium became a truly international collaboration with the inclusion of the European perspective on biomarkers in drug development with contributions from the European Agency for the Evaluation of Medicinal Products (EMEA). The faculty was reflective of the scope of the program (2004 Faculty).

2005 Cardiovascular Biomarkers and Surrogate Endpoints Symposium

Each year since, the symposium has grown in attendance and timeliness. The symposium has also generated new calls for critical follow-up, coordination, and collaboration in the spirit of the FDA's 2004 Critical Path Initiative. The third annual Cardiovascular Biomarkers and Surrogate Endpoints Symposium was held in September 2005. Provocative and informative discussions ensued following the scheduled presentations and during the breakout sessions (2005 Agenda) among the prominent faculty members and participants (2005 Faculty).

Circulation 2006 - Vascular Biomarkers and Surrogates in Cardiovascular Disease

In June 2006 the American Heart Association Journal, Circulation, published a Special Report Article authored by Jean-Claude Tardif, MD; Therese Heinonen, DVM; David Orloff, MD; and Peter Libby, MD entitled Vascular Biomarkers and Surrogates in Cardiovascular Disease. The article summarized the authors' perspective distilled from the proceedings of the 2003, 2004 and 2005 Cardiovascular Biomarker and Surrogate Endpoints Symposia (Attachment).

2006 Cardiovascular Biomarkers and Surrogate Endpoints Symposium

Most recently, the Forth Annual Cardiovascular Biomarkers and Surrogate Endpoints Symposium was held in September 2006 and co-sponsored by the Montreal Heart Institute and the US FDA Center for Food Safety and Applied Nutrition, further expanding the global reach of this initiative. The 2006 program included focused presentations and discussions on cerebrovascular disease, thrombosis, functional imaging, NIH initiatives, pre-clinical issues, nutrition, and special considerations of gender, race and ethnicity (2006 Agenda). Significant new contributions were made by representatives from the US FDA pharmacology division, and the United States Department of Health and Human Services Agency for Healthcare Research and Quality (AHRQ). Additionally, important contributions were made by Health Canada with continued contributions on the European perspective from EMEA. The keynote address was given by Dr. Scott Gottlieb, Deputy Commission of the United States Food and Drug Administration followed by presentations and discussions led by over 35 invited faculty members (2006 Faculty). In 2006, the symposium attracted approximately 250 attendees from over 60 institutions (Participating Institutions).

2007 Cardiovascular Biomarkers and Surrogate Endpoints Symposium

The 2007 Cardiovascular Biomarkers and Surrogate Endpoints Symposium will be held at the Bethesda North Marriott Hotel and Conference Center on October 17-19th. The program and faculty for 2007 is currently in the early development stage (2007 Agenda). The proposed topics for presentation and discussion fall into 4 main categories: 1) overview of technologies and technical considerations, 2) creating efficiencies in biomarker application from drug discovery, diagnostic development, and early and late stage clinical trials; 3) knowledge sharing from biomarker initiatives - public, private, cardiovascular and non-cardiovascular (i.e., oncology); and 4) economic, policy and healthcare implications surrounding biomarkers. The program organizers currently have commitments from several government, academic, and industry representatives to participate in the symposium as faculty members and expert panelists (2007 Agenda). There is also early interest from several European and Asian government representatives to join the program this year, further expanding the global reach of this initiative. The goal is to expand the participation of FDA representatives in the program and collaborate with FDA to further develop the program agenda and support the Critical Path Initiative. Register for 2007 Symposia

Funding

Funding for this symposium has been provided by the Montreal Heart Institute as unrestricted educational grants from private corporations including: AstraZeneca, Bristol-Myers Squibb, CSL Limited, GE Healthcare, GlaxoSmithKline, LipoScience Inc., Medicure Inc., Merck Research Laboratories, Novartis, Pfizer, Pfizer Canada, Servier, Takeda, and Wyeth Research. In 2006, US FDA Center for Food Safety and Applied Nutrition directly paid for travel expenses and honorarium of some invited faculty members and for the printing costs associated with handout materials. Additional funding is obtained from registration fees paid by the attendees. The meeting co-chairs do not benefit financially from this symposium, except for payment of their travel expenses and a modest honorarium. All money generated in association with this symposium is used solely for the purpose of planning, organizing and conducting the symposium.

Continuing Medical Education

For all four years (2003-2006), the Continuing Medical Education (CME) office of the University of Montreal has designated this educational activity as qualifying for the issuance of CME credits to the participants and attendees. The CME office of the University of Montreal is fully accredited by the Canadian Association of Medical Schools, by the Quebec College of Physicians and by reciprocity by the American Council of Continuing Medical Education.

Establishment of the International Partnership for Critical Markers of Disease (CMOD)

The organizers, sponsors, faculty and participants of this symposium have over the past 4 years expressed an increasing desire to expand the educational component of this collaborative effort and to expand the mission and focus of what has been created. There is a clear need to advance the science of cardiovascular and other related biomarkers through collaboration, education, and the dissemination of information worldwide. The organizers of the symposium (Drs. Libby, Tardif and Heinonen) have established a non-profit organization, the International Partnership for Critical Markers of Disease (CMOD), to continue these efforts in a sustained and effective way, while in parallel supporting the FDA's Critical Path Initiative. The International Partnership for Critical Markers of Disease aims to advance the science of biomarkers used to identify, monitor and develop treatments for cardiovascular and related diseases. CMOD will expand upon the success of the Cardiovascular Biomarkers and Surrogate Endpoints Symposium to create a collaborative framework and facilitate the exchange of ideas and information among the international government, industry, academic, and healthcare constituencies.

Additionally, by including representatives from other Critical Path Initiative efforts related to cardiovascular biomarkers (i.e., The Biomarkers Consortium , the Cardiac Safety Research Consortium, the Predictive Safety Testing Consortium, Concept Paper on Biomarker Qualification, Drug-Diagnostic Development Guidance Document and Standardization of Imaging Technologies in Clinical Trials) the goal is to build awareness of these initiatives and to share knowledge and resources.

Through CMOD and the 2007 Cardiovascular Biomarkers and Surrogate Endpoints Symposium, the ultimate goal is to create efficiencies toward improved patient healthcare.

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