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 symposium was held in Bethesda, MD on August 1-2, 2003. Meeting faculty included: Peter Libby, Brigham and Women’s Hospital (co-chair); Jean-Claude Tardif, Montreal Heart Institute (co-chair); David Orloff, Director, Metabolism and Endocrine Division, FDA; Mary Parks, Metabolism and Endocrine Division, FDA; Elizabeth Nabel, Scientific Director, NHLBI, NIH; Guy Beaulieu, Chief, Cardio-Renal Division, TPD, Health Canada; Paul Ridker, Brigham and Women’s Hospital; Sam Tsimikas, UCSD; David Waters, UCSF; Pamela Ouyang, John Hopkins University; James Otvos, LipoScience; Daniel O’Leary, Tufts; Therese Heinonen, Clinical Lynx; John Deanfield, Great Ormond Street Hospital for Children; Petar Alaupovic, Oklahoma Medical Research Foundation; Don Black, Merck; Marcelo Di Carli, Harvard Medical School; Jamie Engert, McGill University; Zahi Fayad, Mt Sinai Medical Center; Daniel Gaudet, University of Montreal; and Steve Nissen, The Cleveland Clinic Foundation. 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. 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 symposium was funded through unrestricted educational grants from Merck & Co., Bristol-Myers Squibb Co, AstraZeneca L.P., Pfizer Canada, Merck Frosst Canada, Novartis, Novartis Canada, AtheroGenics Inc., Wyeth and Chronogen Inc. The meeting was attended by over 100 representatives from various industry, and academic institutions as well as the United States Food and Drug Administration and the United States Department of Health and Human Services, National Institutes of Health. Plans for future meetings were initiated following a rallying cry from meeting attendees to continue this worthwhile effort.
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, entitled, Assessing Cardiovascular Risk and Progression was expanded to include biomarkers in the setting of diabetes, acute coronary syndrome, and the development of devices. Additionally, the symposium expanded its international collaboration with the inclusion of the European perspective on biomarkers in drug development and contributions from the European Agency for the Evaluation of Medicinal Products (EMEA). In keeping with the expanded scope of the program, the meeting included presentations from the US Centers for Disease Control and Prevention, the US Food and Drug Administration, and acclaimed research from the Montreal Heart Institute, Brigham and Women’s Hospital, University of Washington, the Cleveland Clinic, Tulane University, the University of Amsterdam, University Hospital of Rotterdam and Foothills Hospital. The symposium was funded through unrestricted educational grants from Briston-Myers Squibb Co, AtheroGenics, Merck, Pfizer Canada, Wyeth, Merck-Frosst Canada, Eli Lilly, Aventis, Novartis, Servier, and AstraZeneca. The meeting attracted approximately 200 attendees and included representatives from the US, Canada, the Netherlands, Japan, Slovenia, Australia, Germany, France, Belgium, Italy, and Sweden.
The third annual Cardiovascular Biomarkers and Surrogate Endpoints Symposium was held September 23-24, 2005 in Bethesda, MD and entitled, Assessing Cardiovascular Risk and Progression. The meeting included presentations on Pathogenesis of Atherothrombotic Disease and Biomarker Identification, CRP, The Role of Imaging in Disease Detection and Treatment, The Critical Path Initiative, The Balance Between Safety and Efficacy, Special Regulatory Considerations from FDA and EMA, Genomics, Proteomics and Metabolomics. Provocative and informative discussions ensued following the scheduled presentations and during the breakout sessions that addressed the following questions: How should pharmacogenomics be used prospectively in clinical studies of drug safety and efficacy? The future of diagnostics – who are the drivers? How can we maximize the application and utility of safety biomarkers? What is a rational approach to biomarker validation? How do you develop a drug that does not target an accepted surrogate endpoint? Vascular imaging technologies – technical and clinical considerations? The meeting was financially supported through unrestricted educational grants. Industry attendees included representatives from Abbott Laboratories, Agilent Labs, Astra Zeneca, AtheroGenics, Bristol-Myers Squibb, Centocor, Chronogen, Columbia University, Cordis Corp, CSL, deCODE Genetics, diaDexus, Epix Pharmaceuticals, F. Hoffmann-LaRoche, GE Healthcare, Glaxo Smith Kline, Guidant Corporation, ISIS Pharmaceuticals, Johnson and Johnson, Kos Pharmaceuticals, Kowa Research, LipoScience, McNeil Consumer Health, Merck and Co., Merck Frosst, Merck-Schering, Novardis Pharma, Novo Nordisk, Organon Labs, Pfizer Inc., Portola Pharmaceuticals, Prisma Corp. Sanky Pharma, Takeda Global Research and Development, Viron Therapeutics and Wyeth. US FDA member attendance included CDER, CDRH, OVID, and the Division of Biology. Academic attendees included representatives from Harvard, Baylor College of Medicine, University of Montreal, University of Washington, Cleveland Clinic, University of Florida, Walter Reed Army Medical Center, McGill University, Boston University, Columbia University, Indiana University, University of Pittsburgh, University Hospital Wurzburg, and the Heart Research Institute, Sydney, Australia.
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.
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. 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. In 2006, the symposium attracted approximately 250 attendees from over 60 institutions. Academic attendees included representatives from Harvard, University of Montreal, University of Washington, Claude Bernard University Hospital and Medical School Paris, France, Johns Hopkins Medical Institutions, Harbor-UCLA Medical Center, Washington Hospital Center Washington, D.C., University of Texas-Southwestern, Mount Sinai School of Medicine, Feinberg School of Medicine-Northwestern University, Duke University Medical Center, Mayo Clinic College of Medicine, Children’s Hospital Oakland Research Institute University of California, Oregon Health & Science University, and Walter Reed Army Medical Center. Participating industries included Amgen, AstraZeneca, Atherochem, AtheroGenics, Inc., Biophysical Corporation, Boehringer Ingelheim Pharmaceuticals, Bristol-Myers Squibb, Daiichi Sankyo Inc., Dairy Management Inc., diaDexus, Eli Lilly and Co., EPIX Pharmaceuticals, Esperion Therapeutics, A Pfizer Inc. Company, GE Healthcare, I.R.I.S. (Laboratories Servier), GlaxoSmithKline, Abbott Laboratories, Johnson & Johnson, LipoScience, Inc., Merck Research Laboratories, Merck/Rosetta, Mitsubishi Pharma America Inc, Novartis Pharmaceuticals, Novo Nordisk Inc., Ortho-Clinical Diagnostics, Pfizer Inc, Prognostix, Inc., Roche Diagnostics, Schering-Plough, Surface Logix, Inc., Takeda, Pfizer Canada, and CSL Limited. Academic attendees included representatives from Harvard, University of Montreal, University of Washington, Claude Bernard University Hospital and Medical School Paris, France, Johns Hopkins Medical Institutions, Harbor-UCLA Medical Center, Washington Hospital Center Washington, D.C., University of Texas-Southwestern, Mount Sinai School of Medicine, Feinberg School of Medicine-Northwestern University, Duke University Medical Center, Mayo Clinic College of Medicine, Children’s Hospital Oakland Research Institute University of California, Oregon Health & Science University, Tufts University, and Walter Reed Army Medical Center.
The 2007 Cardiovascular Biomarkers and Surrogate Endpoints Symposium was held October 17-19th at the Bethesda North Marriott Hotel and Conference Center, and was entitled, "A Collaborative Approach to Biomarkers." Day One was focused on New Insights, Advances and Practical Considerations and included presentations from Jean-Claude Tardif, Peter Libby, Robert Balaban, Alan Garber, Paul Ridker, Elizabeth Mansfield, and Douglas Throckmorton, representing academic institutions, and various divisions of the US FDA. Breakout sessions included Session 1 - Cardiovascular Imaging (co-chairs: Jean-Claude Tardif and Zahi Fayad), and session 2 - Lipids, Lipoproteins, and Inflammation (co-chairs: Peter Libby and Ernst Schaefer). Day Two was focused on Biomarkers Models and Applications - Best Practices for Validation and Decision-Making" and included presentations from George Mensah, Robert Powell, Eric Brass, Norman Stockbridge, Chris O'Donnell and Daniel Levy representing academic institutions, CDC, FDA, and NIH. Breakout sessions included Session 1 - Genomics, Proteomics and Metabolomics (co-chairs Chris O'Donnell and Felix Frueh) and Session 2 - Advanced Trial Design, Drug/Diagnostic Development Strategies, and Case Studies (co-chairs Robert Califf, Donald Black and Marc Pfeffer). Day Three was focused on Priorities, Perspectives, and Overcoming Challenges and included Agnes Klein, Health Canada; Eric Abadie, EMA; Mary Parks, Felix Frueh, Paula Trumbo, Bram Zuckerman and Federico Goodsaid, all representing different division of the FDA; as well as Naomi Aronson representing Blue Cross and Blue Shield Association.
The 2008 Cardiovascular Biomarkers and Surrogate Endpoints Symposium was held September 10-12th in Bethesda, Maryland, and entitled "Building a Framework for Biomarker Application." This 3 day symposium entailed 7 Separate sessions including HDL Controversies (chairs: Philip Barter, H. Bryan Brewer, and Jay Heinecke), Product Development and Evidentiary Standards (chairs: Wolfgang Koenig, Jean-Jacques Garaud, and Robert Balaban), Special Imaging Workshop (chairs: Jean-Claude Tardif and Douglas Throckmorton), Safety Biomarkers (chairs: Norman Stockbridge and Eric Brass), Surrogates for Regulatory Approval (chairs: Mary Parks, David Water Waters and Allen Taylor), Product Development and Evidentiary Standards (chairs: Federico Goodsaid, Christopher Cannon and Christopher O'Donnell), and Biomarkers in Clinical Practice and Public Health (chairs: George Mensah, James De Lemos and Gurvaneet Randhawa). Participating industries included Merck Research Laboratories, GE Healthcare, AstraZeneca, F. Hoffmann-La Roche, ClinXus, Centers of Excellence in Personalized Medicine, Pfizer Canada, CSL Limited, Pfizer, Cortria Corporation, Via Pharmaceuticals, AtCor Medical, deCode Genetics, ZORA Biosciences, Novartis, LipoScience, Servier Canada Inc., Wyeth, and Boehringer Ingelheim. Organized in collaboration with representatives from: CMOD, Bringham and Women's Hospital, Montreal Heart Institute
The 1st Annual Canadian Symposium was held January 5th in Ottawa, Ontario, Canada. Sessions included Cardiovascular Focus - Atherosclerosis Imaging Technologies; New Frontiers in Imaging Biomarkers - Molecular Imaging Technologies. Industry participation included a presentation on An Approach to the commercial Development of Molecular Imaging Agents from GE Healthcare. Organized in collaboration with representatives from: CMOD, Bringham and Women's Hospital, Montreal Heart Institute, Canadian Institutes of Health Research, Health Canada, Mount Sinai School of Medicine, University of California, San Francisco, McMaster University, Robarts Research Institute, Sunnybrook Health Sciences Centre, and University of Ottawa Heart.
Manufacturing PET Radiopharmaceutical. Organized in collaboration with representatives from: CMOD, Society Nuclear Medicine (SNM), Bringham and Women's Hospital, Montreal Heart Institute
The Ninth Annual 2009 Cardiovascular Biomarkers and Surrogate Endpoints Symposium - Streamlining to Promote Innovation and Efficiency, was held October 19-21st in Bethesda Maryland. Organized in collaboration with representatives from: CMOD, Bringham, Women's Hospital, Montreal Heart Institute, US Food and Drug Administration (FDA), National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), US Agency for Healthcare Research and Quality (AHRQ), Health Canada (HC), Canadian Institutes for Health Research (CIHR), Society Nuclear Medicine (SNM) and other public and private research organizations. Industry participation including GE Healthcare ,CSL Ltd., F. Hoffmann-La Roche, Avid Radiopharmaceuticals, Merck Research Laboratories, Perceptive Informatics, Global Medical Affairs, Servier International, Esai Medial Research, Inc., and BG Medicine. Academic attendees included representatives from Harvard Medical School, Montreal Heart Institute, Harbor-UCLA Medical Center, Duke Translational Medicine Institute, University of Dundee, Scotland, Brigham and Women's Hospital, Mount Sinai School of Medicine, U of Ulm Medical Center, Tampere University Hospital, Massachusetts General Hospital, and University of California, San Francisco.
The Second Annual CMOD Canadian Biomarkers and Surrogate Endpoints Meeting “Biomarkers and Personalized Medicine” was held May 17th at Banting Theatre, Health Canada Campus- Tunney’s Pasture, Ottawa, Ontario. Organized in collaboration with representatives from: CMOD, Bringham and Women's Hospital, Montreal Heart Institute, CEPMed, CAIN, and Canadian Institutes of Health Research.
The 2010 Cardiovascular Biomarkers and Surrogate Endpoints Symposium - Science, Economics and the Globalization of Healthcare was held September 27th at Lister Hill Center Auditorium on the Campus of NIH. Co-sponsored by CMOD and National Institutes of Health and organized in collaboration with representatives from: CMOD, NIH, Bringham and Women's Hospital, Montreal Heart Institute, and FDA. Industry participation included Trialynx, F. Hoffmann-La Roche Ltd, President, Daiichi-Sankyo Pharma Development, and Perceptive Informatics. Academic attendees included representatives from Harvard Medical School, Montreal Heart Institute, Washington Hospital Center, University of Maryland, Albert Einstein College of Medicine, Mount Sinai School of Medicine, Massachusetts General Hospital, and Washington Hospital Center.
The 2011 CMOD Canadian Biomarkers and Surrogate Endpoints Meeting “Biomarkers and Emerging Sciences” was held May 23rd at Banting Theatre, Health Canada Campus - Tunney’s Pasture, Ottawa, Ontario. The Symposium was sponsored by Health Canada, CMOD, and CEPMed and organized in collaboration with representatives from: CMOD, Health Canada, Bringham and Women's Hospital, and Montreal Heart Institute.
The Ninth Annual Cardiovascular Biomarkers and Surrogate Endpoints Symposium held September 12-13th at FDA campus in White Oak, Maryland. The program provided colleagues with the opportunity to learn of clinical challenges in cardiovascular and related diseases that may be addressed with the development of biomarkers and emerging sciences such as genomics, proteomics, and imaging. Particular emphasis was placed on biomarker development, qualification, incorporation into clinical trials, analysis, and interpretation. Included were a number of case studies from leaders in the field, including medical and regulatory science experts from the United States, Canada and Europe. Academic attendees included representatives from Harvard Medical School, Montreal Heart Institute, Molecular Medicine Ireland, Health Canada, Tufts Medical Center, George Mason University, University of Toronto, European Medicines Agency Management Board & Irish Medicines Board, Mt. Sinai School of Medicine, University of Montreal, Washington Hospital Center, University of Minnesota, and Georgetown Universit
The 10th Annual Cardiovascular Biomarkers Symposium was held May 1st and 2nd at Dublin Castle, Dublin Ireland. Sessions included Unraveling the Natural History of Disease, Commercial Developmement and Application, Biomarkers as Tools for Toxicity Testing, European Priorities, and The Business of Biomarkers. The Symposium was organized in collaboration with representatives from: European Medicines Agency, Montreal Heart Institute, Irish Medicines Board, University College Dublin, Molecular Medicine Ireland, and Brigham and Women’s Hospital. Industry participation included Trialynx Inc., IBM Innovation Centre, Hoffmann-LaRoche, AstraZeneca, EKF Diagnostics, Zora Biosciences, Pfizer Inc, Athera Biotechnologies, Open Innovation Partners Ltd, and Genome. Academic attendees included representatives from Harvard Medical School, Brigham and Women’s Hospital, Montreal Heart Institute, European Medicines Agency (EMA), European Commissioner for Research, Innovation and Science, Molecular Medicine Ireland, University College Dublin, University of Ulm Medical Centre, University Ghent, CSO, Pronota, National University of Ireland, Institute of Technology Tallaght, University Medical Center Utrecht, and the Marine Institute, Ireland.
Funding for the symposiums 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. The 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 CMOD meetings, 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 Cardiovascular Biomarkers and Surrogate Endpoints Symposium, the ultimate goal is to create efficiencies toward improved patient healthcare.