International Partnership for Critical Markers of Disease (CMOD)

The Mission of CMOD
Goals and Objectives
Founders
Team Members
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 improve patient healthcare through the use of biological markers to identify, prevent & treat disease.

Goals and Objectives

The broad goal of the International Partnership for Critical Markers of Diseaseis 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 markers of disease among clinical and basic scientists, governmental regulatory agencies, pharmaceutical, biotech and diagnostic companies, healthcare providers, and patient groups;
• Offer educational programs which provide access to the most current information on biomarker and related sciences to meet educational needs;

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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 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 19 total years of research, with 17 years dedicated to clinical research.  Dr. Heinonen has authored over 50 publications and managed over 30 clinical trials, many of which have focused on critical markers of disease 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 and the Executive Director of the Canadian Atheroscleroses Imaging Network.

 

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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Team Members

Donald M. Black, MD, MBA, FACC Executive Officer, Global Development Program

Dr. Black is co-founder and President of Trialynx, and consulting and services company based in Ann Arbor MI and Princeton NJ. He received his Medical degree from the University of Michigan and completed his residency and fellowship at the University of Cincinnati, where he also studied business and law. Prior to founding Trialynx in 2010, Dr. Black was a GE Healthcare in November of 2004 as Global head of Research and Development at GE Medical Diagnostics and head of Molecular Imaging for PET, Spin Signal and Optical product. Before joining GE in November 2004, Dr. Black was Vice President of Global Strategic Development at Merck and Co. He was Vice President of Clinical Research at Parke-Davis/Warner-Lambert Co. (now part of Pfizer) from 1990 to 2000, where he was responsible for the clinical development of Lipitor as well as cardiovascular, renal, pulmonary and thrombotic research. From 2000 to 2002, he was Executive Vice President and Chief Operating Officer of Medical Research Laboratories International (now part of PPDI) in Cincinnati and Bruxelles. Dr. Black is also a Director of CMOD (Critical Markers of Disease) a non-profit organization working with regulators, academia and industry to develop a common understanding of the utility of biomarkers. His academic appointments include Associate Professor of Pediatric Cardiology at the University of Michigan (1990-2000) ,Professor of Medicine at the University of Cincinnati (2000-2003), and Adjunct Professor of Medicine, National University of Ireland at Galway (2010 to present). Dr. Black has over 150 abstracts, presentations, chapters and publications in journals such as the Journal of Lipid Research, Journal of Clinical Investigation, New England Journal of Medicine, and Journal of the American Medical Association, and has served on the editorial board of Atherosclerosis. Dr. Black received the Biolink Irish-American Bioscience Award in 2005.

 

Wally Rapattoni B. Pharm, M.Sc. Director, Canadian Alliance Development

Wally Rapattoni is a licensed pharmacist with over 20 years of experience in community and hospital pharmacy. She holds a M.Sc. in Physiology & Immunology from McGill University. She has worked in the pharmaceutical sector in various roles. She was a Medical Information Specialist at Pfizer, AstraZeneca Canada covering therapeutic areas such as Cardiovascular, CNS, Oncology, and Ophthalmology. Acted as Medical Advisor for AZ non-promoted products used in ORL and in the treatment of migraines. As Medical Science Liaison, she acquired scientific expertise with emerging molecules in Diabetes and Cardiovascular specifically Atherosclerosis and Acute Coronary Syndromes. Consistently received peer recognitions and company excellence awards for commitment, diligence to her work and passion for patients.

 

Ellen LaChance CMOD Project Manager

Ellen has been supporting CMOD since 2006 as the event coordinator for the annual US meeting, and has recently expanded her role to coordinate programs worldwide. Ellen has extensive experience working with investigators and study teams conducting research, providing education on federal and institutional rules and regulations governing human-subject research at the University of Michigan, and managing complex, multi-center, cardiovascular clinical trials at Trialynx Inc.

Maira Aamer CMOD Project Manager

Dr. Maira Aamer is a project manager for CMOD and clinical research associate at Trialynx. She received her medical degree at Kind Edward Medical University, and completed her residency at Mayo Hospital, Lahore. Dr. Aamer has several years of experience managing diabetic patients and conducting clinical research trials. She was actively involved in the treatment and management of patients at the Diabetic and Lipid Center. Additionally, she served as a medical director at a family practice. Her interests include use of biomarkers in early detection of cardiovascular diseases and endocrinology.

Cameron Marshall CMOD Project Manager

Cameron has a diverse background that includes research experience in oncology and cardiology, clinical trial management, pharmaceutical sciences, and patient counseling. With a degree in Human Biology from Michigan State University, and through his work as a Clinical Associate at Trialynx, Inc., Cameron has a special interest in the use of biomarkers for risk identification, disease modification, as well as product development.

 

Michael K. Schmidt CMOD Project Manager

Mike is a graduate of the University of Michigan, where he received training in kinesiology and optimum athletic conditioning. As a performance specialist trainer in the professional sports industry, Mike has worked with Olympic Athletes, as well as college, professional, and weekend athletes, obtaining a direct appreciation for the use of biomarkers in health maintenance. Through his work as a Clinical Associate for Trialynx Inc., Mike has gained direct experience working with multi-center clinical trials, and the implementation of soluble and imaging biomarkers in study design.

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CMOD History

2003 Cardiovascular Biomarkers and Surrogate Endpoints Symposium, Bethesda, MD

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, Bethesda, MD

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, Bethesda, MD

Each year since 2003, 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 (2005 Agenda) among the prominent faculty members and participants (2005 Faculty).

Circulation 2006 - Vascular Biomarkers and Surrogates in Cardiovascular Disease, Bethesda, MD

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.

2006 Cardiovascular Biomarkers and Surrogate Endpoints Symposium, Bethesda, MD

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 Commissioner 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, Bethesda, MD

The 2007 Cardiovascular Biomarkers and Surrogate Endpoints Symposium was held at the Bethesda North Marriott Hotel and Conference Center on October 17-19th and focused on a “Collaborative Approach to Biomarkers”. The topics for presentation and discussion fell into several main categories:1) Biomarkers Insights, 2) Cardiovascular imaging, 3) Lipids & Inflammation, 4) Biomarkers Models & Applications – Best Practices for Validation & Decision-making , 5) Genomics, 6) Trial Design Strategies, and 7) Regulatory Issues.

The meeting was attended by over 250 participants representing 100+ organizations located in the US, Canada, The Netherlands, UK, Switzerland, France, Japan & China.

2008 CMOD Biomarkers & Surrogate Endpoints Symposium, Bethesda, MD

The 2008 CMOD Biomarkers & Surrogate Endpoints Symposium was centered around the theme of “Building a Framework for Biomarker Application”. The meeting was organized in collaboration with representatives from: National Institutes of Health, US HHS Agency for Healthcare Research & Quality, US FDA, CDC, Health Canada, European Medicines Agency & public & private research institutes. Detailed sessions included 1) HDL controversies, 2) Product Development & Evidentiary Standards, 3) Special Imaging Workshop (Central Image Analysis – Optimizing Practices & Procedures), 4) Safety Biomarkers, 5) Surrogates for Regulatory Approval “A 360 Degree Perspective”, and 6) Biomarkers in Clinical Practice & Public Health. 

2009 CMOD Canadian Biomarkers & Surrogate Endpoints Meeting, Ottawa, Ontario, Canada

In collaboration with Health Canada and the Canadian Atherosclerosis Imaging Network (CAIN), the first CMOD Canadian meeting was held on January 5, 2009. The meeting focused on 2 main topics: 1) Atherosclerosis Imaging technologies & 2) New Frontiers in Imaging Biomarkers. The faculty was composed of Canadian & US experts as well as representatives from Health Canada, CIHR, NIH and industry. The program’s highlight was a panel discussion entitled “Academia, Industry & Regulatory Agencies: Working together for the future” which included some lively debates about the role of biomarkers & imaging technologies in the development of novel products.

2009 CMOD Workshop on manufacturing PET Radiopharmaceuticals, Bethesda, MD

CMOD partnered with SNM to co-sponsor the special workshop, entitled “Manufacturing PET Radiopharmaceuticals” on May 1, 2009.

A series of presentations outlined PET drug Regulations including USP Chapter 823 and CGMP guidelines were assessed & discussed. A report summarizing this workshop was subsequently published in the Journal of Nuclear Medicine.

2010 CMOD Canadian Biomarkers and Surrogate Endpoints Meeting, Ottawa, Ontario, Canada

The 2010 CMOD Canadian Biomarkers and Surrogate Endpoints Meeting was held on May 17, 2010 in the Banting Theatre, located on the Health Canada campus in Ottawa, Ontario, Canada. The theme for this meeting was “Biomarkers and Personalized Medicine” and the auditorium was filled to capacity. Highlights of the program included presentations from Clarissa Desjardins from the Center of Excellence in Personalized Medicine (CEPMED); Agnes Klein, Director, Center for Evaluation of Radiopharmaceuticals and Biotherapeutics, Health Canada; Peter Liu, CIHR Scientific Director, Institute of Circulatory and Respiratory Health Canadian Institutes of Health Research, Jean-Claude Tardif, Research Director, Montreal Heart Institute, and Peter Libby, Chief of  Cardiovascular Medicine at the Brigham and Women’s Hospital.

2010 CMOD Biomarkers & Surrogate Endpoints Symposium, Bethesda, MD

The 8th annual CMOD US Biomarker Symposium was held on September 27, 2010, Lister Hill Center Auditorium, located on the campus on the National Institutes of Health, Bethesda, Maryland. The symposium there was "Science, Economics and the Globalization of Healthcare" and included Dr. Sonia Skarlatos, Deputy Director, Division of Cardiovascular Sciences,
National Heart Lung and Blood Institute as co-chair. Discussions focused on the potential use of biomarkers to streamline product development, and decrease the economic burden of healthcare worldwide.

2011 CMOD Canada Biomarkers Meeting, Ottawa, Ontario, Canada

The 3rd annual CMOD Canada Biomarkers Meeting was held in Ottawa, Ontario, Canada on May 23-24, 2011 and was co-sponsored by Health Canada. This program, which included 150 attendees, provided colleagues with the opportunity to learn of clinical challenges in cardiovascular disease, diabetes, neurovascular/degenerative disease, and cancer that may be addressed with the development of biomarkers and emerging sciences such as genomics, proteomics, and imaging technologies. Particular emphasis was placed on the role of personalized medicine in the advancement of healthcare, including global challenges and solutions. This program included a number of case studies from industry and academic leaders in the field, and addressed advancing regulatory sciences and policy in the face of emerging technologies and challenges.

Funding

CMOD is a 501(c)3 non-profit organization. Funding as unrestricted educational grants has been received from private corporations including: AstraZeneca, Atcor Medical, BG Medicine, Boehringer-Ingelheim, Bristol-Myers Squibb, Cerenis Therapeutics, Cortria, CardinalHealth, CEPMed CSL, Limited, Daiichi-Sankyo, Decode Genetics, GE Healthcare, GlaxoSmithKline, Hoffman-La Roche, Infra Redx, LipoScience Inc., Medicure Inc., Merck Research Laboratories, Novartis, Novo Nordisk Pfizer, Pfizer Canada, Servier, Takeda, VIA and Wyeth Research. 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, conducting and reporting symposia.

Continuing Medical Education

For nine years (2003-2011), the Continuing Medical Education (CME) office of the University of Montreal has issued CME credits to the participants and attendees of CMOD meeting. 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)

There is a clear need to improve patient healthcare through the use of critical markers to identify, prevent & treat disease. Education and the dissemination of information worldwide is critical to meeting this urgent need.  Drs. Libby, Tardif and Heinonen have established a non-profit organization, the International Partnership for Critical Markers of Disease (CMOD), to meet these challenges in a sustainable and effective way. The International Partnership for Critical Markers of Diseaseaims 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.

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