Eric Abadie, M.D., Director, Therapeutics Evaluation, AFSSAPS, European Medicines Agency (EMEA) Paris, France
2004 Sept. 10-11 Bethesda - Abadie - EU view on surrogate endpoints
Abadie - Role of biomarkers in the development of medicines: An EU vewipoint
Abadie - Opportunities for the use of biomarkers and surrogate endpoints in the EU
Petar Alaupovic, Ph.D., Head, Lipid and Lipoprotein Laboratory, Oklahoma Medical Research Foundation
2003 Aug. 1-2 Bethesda - Alaupovic - Classifications of Lipoproteins
Jonathan Allis, Ph.D. Global Head, Imaging Technology General Electric Healthcare
2007 Oct. 17-19 Bethesda - Allis - Diagnostic Challenges and New Directions (for in-vivo imaging agents)
2008 Sept. 10-12 Bethesda - Allis - Central Imaging Issues in the Development of Diagnostic Agents
Pierre Amarenco, M.D. Department of Neurology and Stroke Centre Bichat - Claude Bernard University Hospital and Medical School Paris, France
2006 Sept. 18-20 Bethesda - Amarenco - Biomarkers in Cerebrovascular Disease
Todd Anderson, M.D. Foothills Hospital
2004 Sept. 10-11 Bethesda - Anderson - Characteristics of a Biomarker
2004 Sept. 10-11 Bethesda - Anderson - The working hypotheses for the study of endothelial function in humans:
Lawrence J. Appel, M.D, M.P.H. Professor of Medicine, Epidemiology and International Health (Human Nutrition) Johns Hopkins Medical Institutions Baltimore, MD
Naomi Aronson, Ph.D., Executive Director Technology Evaluation Center, Blue Cross and Blue Shield Association Chicago, IL
2007 Oct. 17-19 Bethesda - Aronson - View from the Technology Evaluation Center (TEC)
Robert Balaban, PhD, Director, Laboratory of Cardiac Energetics, NHLBI, NIH
2008 Sept. 11-12 Bethesda - Balaban - A Systems Biology Approach to Characterizing Targets and Markers
2011 Sept. 12-13 White Oak - Balaban - Advanced and Future Imaging Modalities
Ruth Barrington, PhD, Chief Executive Officer, Molecular Medicine Ireland, Dublin, Ireland
Thomas Barry, PhD, Molecular Diagnostics Research Group, National University of Ireland, Galway
Philip Barter, The Heart Research Institute Sydney, Australia
2008 Sept. 11-12 Bethesda - Barter - HDL Overview and Recent Trials
Barter - The Role of Lipoproteins in Inflammation
Steven R. Bauer, PhD, FDA, Center for Biologics Evaluation & Research, OCTG
2011 Sept. 12-13 White Oak - Bauer - Biomarker Utility in Cellular and Gene Therapy Product Development
Rob Beanlands, MD, Chief, Cardiac Imaging Director, National Cardiac PET Centre, U. Ottawa Heart Institute
Beanlands - PET as a tool for Molecular Imaging: Forging a Translational Path
Guy Beaulieu, M.D. Health Canada
Philippe Bedard, MD, FRCP(C), Division of Medical Oncology Drug Development Program, Princess Margaret Hospital University of Toronto
2011 May 23 Ottawa - Bedard - Biomarkers in Oncology Clinical Trials
Colin Berry, BSc., Ph.D. Cardiovascular MRI / CV Intervention Program NHLBI, National Institutes of Health Bethesda, MD
Berry - Endothelial progenitor cells and cardiovascular disease
Donald M. Black, MD, MBA, Chief Medical Officer, DalCor UK Pharma, Ltd.
2003 Aug. 1-2 Bethesda - Black - The Need for Biomarkers in Drug Development
Black - Lipids and Lipoproteins: New Targets and Populations at Risk
Black - Companion Diagnostics
2009 Oct. 19-21 Bethesda - Black - Solving issues with studies of Molecular Imaging agents
2010 May 17 Ottawa - Black - Providing Personalized Medicine with Molecular Imaging
Sandra E. Black, MD, FRCP(C), Brill Chair in Neurology, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Canada
2011 May 23 Ottawa - Black, S. - Prime time vs Pipeline: Neuroimaging biomarkers Neurodegeneration
Melanie Blank, MD, Medical Reviewer, Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA)
2008 Sept. 10-12 Bethesda - Blank - Clinical Evidentiary Standards for Biomarker Qualification
2009 Oct. 19-21 Bethesda - Blank - Renal Biomarkers of Acute Toxicity: Past, Present, Future
2010 Sept. 27 NIH Bethesda - Blank - The Predictive Safety Testing Consortium Qualification, a first example of a novel FDA process
2011 Sept. 12-13 White Oak - Blank - Novel Renal Biomarkers of Acute Kidney Injury and FDA Qualifications
Stefan Blankenberg, M.D. Department of Medicine University of Mainz Mainz, Germany
Suzanne Bracken, PhD, Program Officer in Translational Research, Molecular Medicine Ireland
2011 Sept. 12-13 White Oak - Bracken - Irish Biomarker Network
Eric P. Brass, MD, PhD, Prof of Med, Harbor-UCLA Medical Center
2006 Sept. 18-20 Bethesda - Brass - Defining the Balance Between Safety and Efficacy: Biomarkers as Safety Surrogates
2008 Sept. 10-12 Bethesda - Brass - Biomarkers of skeletal muscle injury
Brass - The Balance Between Safety and Efficacy: Biomarkers and Drug Safety
Eugene Braunwald, MD, Professor of Medicine, Harvard Medical School
2009 Oct. 19-21 Bethesda - Braunwald - WHEN THE TAIL WAGS THE DOG
H Bryan Brewer, MD, Medstar Research Institute
2008 Sept. 11-12 Bethesda - Brewer - Acute HDL Therapy
2010 Sept. 27 NIH Bethesda - Brewer - Treatment of the Residual Risk in the Statin Treated High Risk Cardiovascular Disease Patient
2011 Sept. 12-13 White Oak - Brewer - Current Insights into the Mechanisms of How HDL Protects Against Cardiovascular Disease
B. Greg Brown, M.D., Ph.D. University of Washington Medical Center
David G. Brown, Ph.D., Center for Devices and Radiological Health, FDA
2008 Sept. 10-12 Bethesda - Brown, D.G. - Evidentiary Standards for Biomarker Qualification: Imaging and Analysis Methods
W. Virgil Brown, M.D. Charles Howard Candler Professor of Medicine Emory University School of Medicine Atlanta, GA
Brown - Change in Inflammatory Biomarkers in the Postprandial State
Michael A. Brownlee, MD, Albert Einstein College of Medicine
2010 Sept. 27 NIH Bethesda - Brownlee - Biomarkers for Diabetes: Critical Issues
Diarmuid Cahalane, Founder of Open Innovation Partners Ltd, Cork, Ireland
Dolores Cahill, PhD, Professor of Translational Science, University College Dublin, Dublin, Ireland
Robert M. Califf, MD, Director, Duke Translational Medicine Institute
2009 Oct. 19-21 Bethesda - Califf - The North Carolina Biomarker Factory, Biomarkers in CV Disease
Califf - Biomarkers and Advanced Clinical Trial Designs
Gregory Campbell, Ph.D., Director, Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration
2008 Sept. 10-12 Bethesda - Campbell - Biomarker Product Development and Evidentiary Standards: Statistical Considerations
Chris Cannon, M.D. Brigham and Women’s Hospital
Laure Cloarec-Blanchard, MD, Servier International
Patricia Cole, MD, PhD, Director, Global Head, Imaging Biometrics, Esai Medial Research, Inc.
2009 Oct. 19-21 Bethesda - Cole - The Potential Role of Imaging Biomarkers in Oncologic Therapeutics Development
Helen Colhoun, Professor of Public Health, University of Dundee, Scotland
2009 Oct. 19-21 Bethesda - Colhoun - FDA Diabetes Guidelines Academic Perspective
Eric Colman, MD, Deputy Director, Division of Metabolism and Endocrine, Center for Drug Evaluation and Research, FDA
2008 Sept. 10-12 Bethesda - Colman - HDL as a Surrogate for New Drug Approval
Carolyn C. Compton, M.D., Ph.D., Director, Office of Biorepositories and Biospecimen Research, National Cancer Institute
2008 Sept. 10-12 Bethesda - Compton - Biospecimen Best Practices: What They Are and Why We Need Them
Gloria Crispino, PhD, Clinicial Trial Statistician, Institute of Technology Tallaght, Dublin, Ireland
Janet Dancey, MD., FRCPC
2011 May 23 Ottawa - Dancey - The Burden of Cancer
Simhan Danthi, PhD, , NHLBI, NIH
2011 Sept. 12-13 White Oak - Danthi - Cardiovascular Molecular Imaging
Jean Davignon, M.D. Director Hyperlipidemia and Athero Research Clinical Research Institute of Montreal Professor of Medicine, University of Montreal Montreal, Quebec
2007 Oct. 17 Bethesda - Davignon - An Overview of Traditional Lipid Biomarkers : Recent Observations, Neglected Issues and Controversies
Jill Davies, MeDCAN Clinic
2011 May 23 Ottawa - Davies - keeping busy people healthy
Pim De Feyter, M.D. University Hospital Rotterdam
James de Lemos, M.D. Associate Professor and CCU Director University of Texas-Southwestern Medical School Dallas, TX
2006 Sept. 18-20 Bethesda - de Lemos - Biomarkers in Heart Failure
2008 Sept. 10-12 Bethesda - de Lemos - Biomarkers in Population Screening and Surveillance
2008 Sept. 10-12 Bethesda - de Lemos - Biomarkers and Thrombosis
de Lemos - Novel Biomarkers in Heart Failure
Clarissa Desjardins, PhD, CEO, Center of Excellence in Personalized Medicine
2010 May 17 Ottawa - Desjardins - Personalized Medicine Landscape
2011 May 23 Ottawa - Desjardins - Promoting the science and practice of personalized medicine
Marcelo Di Carli, MD, Chief, Nuclear Medicine, Brigham and Women's Hospital
2003 Aug. 1-2 Bethesda - Di Carli - Positron Emission Tomography
2009 Oct. 19-21 Bethesda - Di Carli - Advances in SPECT and PET Imaging: Novel Approaches to Diagnosis and Risk Prediction
Jay M. Edelberg, M.D., Ph.D. Director, Cardiovascular Biomarkers Clinical Pharmacology & Discovery Medicine GlaxoSmithKline
Elizabeth Eisenhauer, Canadian Partnership Against Cancer, The Canadian Cancer Research Alliance
2011 May 23 Ottawa - Eisenhauer - Pan-Canadian Efforts in Accelerating Research and Anticipatory Science
Benjamin Eloff, PhD, Office of the Commissioner, US FDA
Jamie Engert, M.D., Genomic Medicine Center, Chicoutimi Hospital
2003 Aug. 1-2 Bethesda - Engert - Understanding CAD using Genomics
Zahi A. Fayad, PhD, Professor of Medicine, Mount Sinai School of Medicine
2003 Aug. 1-2 Bethesda - Fayad - Vascular MR and Spiral CT
2009 Jan. 5 Ottaa - Fayad - Computed Tomography and Positron Emission Computed Tomography
2009 Oct. 19-21 Bethesda - Fayad - Imaging – MRI & CT
Mark Ferguson, PhD, Director General, Science Foundation Ireland
Giora Feuerstein, M.D. Assistant Vice President Head, Discovery Translational Medicine Wyeth Research
Robert Fiorentino, MD, Medical Reviewer, Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, United States FDA
2011 Sept. 12-13 White Oak - Fiorentino - Drug-Induced Increases in Blood Pressure and Cardiovascular Risk
Brian C. Foster, Therapeutic Products Directorate, Health Products and Food Branch, Health Canada
2010 May 17 Ottawa - Foster - Hepatic Safety
Felix W. Frueh, Ph.D. Office of Clinical Pharmacology Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Springs, MD
2007 Oct. 19 Bethesda - Frueh - Challenges for Co-Development of New Medical Products: A Regulatory Perspective
2008 Sept. 10-12 Bethesda - Frueh - Individualized and Personalized Healthcare
Bruce Furie, M.D. Professor of Medicine Harvard Medical School Boston, MA
2006 Sept. 18-20 Bethesda - Furie - Thrombosis: New Strategies for Anti-thrombotic Therapies
Brandon D. Gallas, NIBIB/CDRH Laboratory for the Assessment of Medical Images, FDA, Center for Devices and Radiological Health, Office of Science and Engineering Labs, Division of Imaging and Applied Math
2008 Sept. 10-12 Bethesda - Gallas - Regulatory Considerations in Central Image Analysis
Jean-Jacques Garaud, MD, Head of Global Drug Development, F. Hoffmann-La Roche Ltd.
2008 Sept. 10-12 Bethesda - Garaud - The Role of Soluble and Tissue Biomarkers in Early Development – Balancing Evidence and Risk in Decision
Garaud - Drug Development Challenge
Alan J. Garber, M.D., Ph. D. Professor, Medicine, Biochemistry, Molecular and Cellular Biology Baylor College of Medicine Houston, TX
2007 Oct. 17 Bethesda - Garber - UKPDS Design
Peter Gardiner, Vice President, Medical Affairs & Senior Medical Officer at BG Medicine
2009 Oct. 19-21 Bethesda - Gardiner - The HRP Initiative: Biomarker Development – Case Study: Atherosclerosis
Daniel Gaudet M.D., PhD., CRC in preventive genetics, Associate professor of medicine, Université de Montréal, Lipid Clinic, Chicoutimi Hospital
2003 Aug. 1-2 Bethesda - Gaudet - Genetics of CoronaryArtery Disease: A brief -and obviously incomplete- overview
Robert Gerszten, M.D. Professor of Medicine Massachusetts General Hospital Boston, MA
2006 Sept. 18-20 Bethesda - Gerszten - Biomarker Discovery and The Challenges of and The Challenges of Validation
Marcie Glicksman, PhD., Co-Director, Laboratory for Drug Discovery in Neurodegeneration (LDDN), Harvard NeuroDiscovery Center
2011 May 23 Ottawa - Glicksman - Laboratory for Drug Discovery in Neurodegeneration (LDDN)
Anne Goodbody, PhD., Centre for Probe Development and Commercialization
2011 May 23 Ottawa - Goodbody - Practical Challenges in Personalized Medicine: Molecular Imaging
Federico Goodsaid, Ph.D. Office of Clinical Pharmacology Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring, MD
2006 Sept. 18-20 Bethesda - Goodsaid - Genomic Biomarker Validation and Pharmacogenomic Initiatives at the FDA
2008 Sept. 10-12 Bethesda - Goodsaid - Biomarker Qualification Project
2008 Sept. 10-12 Bethesda - Goodsaid - Markers of Renal Toxicity
Goodsaid - Pilot Process for Biomarker Qualification at the FDA
Michael Graham, Ph.D., MD, President, Society of Nuclear Medicine
2009 Oct. 19-21 Bethesda - Graham - Molecular Imaging Workshop: Challenges and Opportunities for Using Molecular Imaging Biomarkers in Clinical Research
Mark Grant, MD, Tech Evaluation Center, Blue Cross Blue Shield Association
2008 Sept. 10-12 Bethesda - Grant - Biomarkers, Informative Evidence, and Policy Decisions
2009 Oct. 19-21 Bethesda - Grant - Informing Policy Decisions on the Use of Imaging Technologies
Philip Greenland, M.D. Harry W. Dingman Professor, Preventive Medicine Executive Associate Dean for Clinical and Translational Research Feinberg School of Medicine-Northwestern University
Steven Gutman, MD, Director, Office of In Vitro Diagnostics, FDA
Gutman - Biomarkers – Challenges and Opportunities
Rory Hachamovitch, M.D., M.Sc. Los Angeles, CA
Hachamovitch - Advances in Nuclear Medicine* and Potential Economic Impact
Steven M. Haffner, M.D. Professor of Medicine University of Texas Health Centers San Antonio, TX
2006 Sept. 18-20 Bethesda - Haffner - Biomarkers in Diabetes, Metabolic Syndrome and Renal Disease
Patricia Harlow, Ph.D., Division of Cardiovascular and Renal Products, CDER, FDA
2008 Sept. 10-12 Bethesda - Harlow - Non-Clinical Evidentiary Non-Clinical Evidentiary Qualification
Robert A. Harrington, M.D. Professor of Medicine Duke University Medical Center Durham, NC
2004 Sept. 10-11 Bethesda - Harrington - Acute Coronary Syndromes
2006 Sept. 18-20 Bethesda - Harrington - Cardiovascular Biomarkers: New Insights Based on Technological Advances and Landmark Trials
Thomas Hatsukami, M.D. University of Washington
2004 Sept. 10-11 Bethesda - Hatsukami - Magnetic Resonance Imaging of the High-Risk Atherosclerotic Plaque
Stanley Hazen, M.D., Ph.D. The Cleveland Clinic
2004 Sept. 10-11 Bethesda - Hazen - Linking Inflammation, Oxidation and Cardiovascular Disease: Myeloperoxidase and NO-derived Oxidants
Jay Heinecke, M.D. University of Washington School of Medicine
2004 Sept. 10-11 Bethesda - Heinecke - Oxidized HDL in Atherogenesis
2008 Sept. 11-12 Bethesda - Heinecke - HDL: Time for a new paradigm?
Heinecke - Lipoprotein Oxidation in the Pathogenesis of Atherosclerosis
Therese Heinonen, DVM, Director, MHI Coordinating Center and Co-Founder/Exec Dir., CMOD, USA
2003 Aug. 1-2 Bethesda - Heinonen - Historical Perspective
2004 Sept. 10-11 Bethesda - Heinonen - The Need for Biomarkers in Drug Development
2005 Sept. 23-24 Bethesda - Heinonen - Welcome to the 2005 Cardiovascular Biomarkers and Surrogate Endpoints Symposium
2006 Sept. 18-20 Bethesda - Heinonen - Welcome to the 2006 Cardiovascular Biomarkers and Surrogate Endpoints Symposium
2007 Oct. 17-19 Bethesda - Heinonen - Welcome to the 2007 Cardiovascular Biomarker and Surrogate Endpoint Symposium
Sharon Hertz, M.D., Deputy Director Anesthesia, Analgesia, and Rheumatology Products CDER
2009 Oct. 19-21 Bethesda - Hertz - CV Risk and NSAIDs FDA Perspective
Karen A. Hicks, MD, Medical Officer, CDER, US FDA
2009 Oct. 19-21 Bethesda - Hicks - Standardized Data Collection for Cardiovascular Trials: A Collaborative Effort
Chris Howard, Solution Architect, IBM Innovation Centre, Dublin, Ireland
Thomas Hudson, Ontario Institute for Cancer Research
2011 May 23 Ottawa - Hudson - Practical Challenges in Personalized Medicine
Patrice Hugo, PhD., Chief Scientific Officer Clearstone Central Laboratories
2010 May 17 Ottawa - Hugo - What is Required to Ensure a Smooth Transition From an R&D Test to a Test Used Within a Clinical Environment?
Ilan Irony, MD, Clinical Team Leader, DMEP, OND, CDER, US FDA
2010 Sept. 27 NIH Bethesda - Irony - Diabetes Guidelines and Clinical Trial Challenges
Narayanan Iyer, BSc, LLB, BCL, Health Canada
2010 May 17 Ottawa - Iyer - Personalized Medicine: Science Policy Perspectives from the Health Portfolio
Seigo Izumo, MD, Director OF Cardiovascular Research BIDMC
Allan S. Jaffe, M.D. Professor of Medicine Mayo Clinic College of Medicine Rochester, MN
Hylton V. Joffe, MD, Metabolism and Endocrine, CDER, US FDA
2008 Sept. 10-12 Bethesda - Joffe - DIABETES SURROGATES An FDA Perspective
2009 Oct. 19-21 Bethesda - Joffe - Diabetes Guidelines
Dominique Johnson, PhD, Director, MHICC
Koen Kas, PhD, Professor, University Ghent, CSO, Pronota, Ghent, Belgium
John J.P. Kastelein, M.D., Ph.D., Department of Vascular Medicine, Academic Medical Center, University of Amsterdam
2004 Sept. 10-11 Bethesda - Kastelein - Carotid IMT – A CAD surrogate?
Cormac Kilty, PhD, Chief Technical Officer, EKF Diagnostics, London, England
Agnes Klein, MD, Director, Center for Evaluation of Radiopharmaceuticals and Biotherapeutics, Health Canada, Ottawa, Canada
2007 Oct. 17-19 Bethesda - Klein - Canadian Regulatory Approach to Biomarkers: An evolving perspective
2008 Sept. 10-12 Bethesda - Klein - Rewards and Risks of using Surrogate Endpoints in the Approval of Drugs
2010 Sept. 27 NIH Bethesda - Klein - Rewards and Risks of using Biomarkers in Drug Development
2010 May 17 Ottawa - Klein - Rewards and Risks of using Biomarkers in Drug Development
2011 Sept. 12-13 White Oak - Klein - Current Regulatory Status of Biomarkers in Canada
Michael Klimas, Ph.D. Executive Director, Imaging Franchise Lead Merck & Co., Inc.
Christoph Koenen, Vice President, Global Medical Affairs, Bristol-Myers Squibb Co.
Wolfgang Koenig, MD, Professor of Medicine and Cardiology, University of Ulm Medical Centre, Ulm, Germany
2005 Sept. 23-24 Bethesda - Koenig - Combined Blood Biomarkers: Diminishing Returns or are More Better?
2008 Sept. 10-12 Bethesda - Koenig - Biomarkers in Cardiovascular Drug Development: The Critical Gap
2009 Oct. 19-21 Bethesda - Koenig - Biomarkers in Cardiometabolic Disease
Ronald M. Krauss, M.D. Senior Scientist and Director, Atherosclerosis Research Children’s Hospital Oakland Research Institute University of California Berkeley, CA
Lewis H. Kuller, MD, DrPH, Cardiovascular Health Study, University of Pittsburgh
Kuller - White Matter and Ventricular Grade on MRI of the Brain as a Marker of Aging in Demenita
Philippe L’Allier, M.D. Associate Director, QCA Core Labs Montreal Heart Institute Montreal, Quebec Canada
Reijo Laaksonen, MD, PhD, Chief Med Officer and Co-Founder, Zora Biosciences, Espoo, Finland
2009 Oct. 19-21 Bethesda - Laaksonen - Biomarker development case study #2 (Lipidomics)
Hanno Langen, PhD, Global Head of Protein and Metabolite Technologies, Hoffmann-LaRoche, Basel, Switzerland
Michael S. Lauer, MD, FACC, FAHA, Director, Division of Cardiovascular Sciences (DCVS) National Heart, Lung, and Blood Institute (NHLBI)
2009 Oct. 19-21 Bethesda - Lauer - How Do We Rigorously Evaluate Biomarkers?
Jeffrey M. Leiden, MD PhD, Managing Director, Clarus Ventures LLC
2008 Sept. 10-12 Bethesda - Leiden - Educating Patients and Physicians About Medical Risk/Benefit Decisions
Lawrence A. Leiter, MD, FRCPC, FACP, Head, Division of Endocrinology & Metabolism, St. Michael’s Hospital, Professor of Medicine & Nutritional Sciences, University of Toronto
2008 Sept. 10-12 Bethesda - Leiter - Glycemic control and CVD: A clinician’s perspective
Claude Lenfant, M.D. Former Director National Heart, Lung, and Blood Institute
2004 Sept. 10-11 Bethesda - Lenfant - A TALE OF TWO CLINICAL TRIALS
Andrew Levey, MD. Chief, Division of Nephrology, Tufts Medical Center
2011 Sept. 12-13 White Oak - Levey - Biomarkers of Kidney Disease: Cystatin C
Daniel Levy, MD Director, Framingham Heart Study Director, Center for Population Studies National Heart, Lung, & Blood Institute Bethesda, MD
Levy - NHLBI’s SABRe CVD Biomarker Initiative
Timao Li, Ph.D. Acting Manager, Cardiovascular-Renal Division Bureau of Cardiology, Allergy and Neurological Sciences Therapeutic Products Directorate Health Canada Ottawa, Ontario Canada
Peter Libby, MD, Mallinckrodt Professor of Medicine, Harvard Medical School, Chief of Cardiovascular Medicine, Brigham & Women’s Hospital
2006 Sept. 18-20 Bethesda - Libby - Pathogenesis of Atherosclerotic Disease and Biomarker Identification
2010 May 17 Ottawa - Libby - Biomarkers and Personalized Medicine Novel Approaches and Clinical Utility
2010 Sept. 27 NIH Bethesda - Libby - Biomarkers of Atherothrombosis
2011 Sept. 12-13 White Oak - Libby - Common Threads, Common Targets
Robyn R. Lim, Ph.D., Scientific Advisor, Office of Legislative and Regulatory Modernization, Health Canada
2011 May 23 Ottawa - Lim - Benefit-Harm-Uncertainty Management: Biomarker Challenges and Opportunities in a New Regulatory Oversight Framework
Joao Lima, M.D. Associate Professor of Medicine and Radiology Johns Hopkins Medical School Baltimore, MD
Jonathan R. Lindner, M.D. Associate Professor of Medicine and Associate Chief for Education Cardiovascular Division Oregon Health & Science University Portland, OR
Lindner - Targeted Molecular and Cellular Imaging
Lance Liotta, MD, PhD, The Center for Applied Proteomics and Molecular Medicine, George Mason University
2011 Sept. 12-13 White Oak - Liotta - Proteomic Technology
Ray Lipicky, M.D. Former Director U.S. Food and Drug Administration, Director, LIPICKY LLC
2004 Sept. 10-11 Bethesda - Lipicky - The Pharma/Regulatory Interface
Peter Liu, MD, PhD, Professor of Medicine, University of Toronto
2009 - Liu - Imaging Initiative RFAs
2009 Oct. 19-21 Bethesda - Liu - Biomarkers for Heart Failure
2010 Sept. 27 NIH Bethesda - Liu - Heart Failure & Role of Biomarkers
2011 Sept. 12-13 White Oak - Liu - Biomarker in Heart Failure: Towards Tailored Therapy
Eva Lonn, MD, MSc, FRCPC, FACC, Professor of Medicine, McMaster University
Lonn - Carotid Intima Media Thickness Use in Cardiovascular Risk Assessment and in Clinical Trials
Klas Malmberg, MD, PhD, FESC, Karolinska Institutet, Stockholm, Sweden, Clinical Science Leader, F. Hoffman-La Roche Ltd, Basel, Switzerland
2010 Sept. 27 NIH Bethesda - Malmberg - The New MI Phenotype OR Coronary disease and glucose abnormalities
G. B. John Mancini, M.D. Professor of Medicine, Division of Cardiology Director, CV Imaging Core Lab Vancouver Hospital Head, Department of Medicine, University of B.C.
Elizabeth Mansfield, Ph.D. Senior Policy Analyst Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health US FDA
2008 Sept. 10-12 Bethesda - Mansfield - Getting Biomarkers There from Here: Understanding Test Performance
Mansfield - Novel Diagnostics: FDA Perspectives
Catriona McMahon, MD, Vice-President, Medical Affairs, AstraZeneca Canada Inc.
McMahon - Working Together for the Future: Industry Perspective
Jessica L. Mega, MD, MPH, Cardiovascular Division, Brigham and Women’s Hospital
2010 May 17 Ottawa - Mega - Clopidogrel and Genetic Variance
David O. Meltzer, M.D., Ph.D. Director of the Center for Health and Social Sciences Department of Medicine and Dept. of Economics University of Chicago
George A. Mensah, MD, Centers for Disease Control and Prevention
2004 Sept. 10-11 Bethesda - Mensah - Application to Clinical Practice & Public Health
2008 Sept. 10-12 Bethesda - Mensah - BIOMARKERS IN CLINICAL PRACTICE AND PUBLIC HEALTH: Challenges in Translating the Science
Michele Mercuri, MD, PhD, Vice President, Daiichi-Sankyo Pharma Development
2010 Sept. 27 NIH Bethesda - Mercuri - Thrombosis: possible use of pharmacogenomics to improve optimization of subjects’ antiplatelet therapy
Pierre Meulien, PhD, President and Chief Executive Officer, Genome Canada
George Mills, MD, VP, Medical Imaging Consultant, Perceptive Informatics
2008 Sept. 10-12 Bethesda - Mills - Imaging Biomarker – Surrogate Lexicon Qualification of Imaging Surrogate Criteria
2009 Oct. 19-21 Bethesda - Mills - Molecular Imaging Workshop: Challenges and Opportunities for Using Molecular Imaging Biomarkers in Clinical Research
Gary F. Mitchell, M.D. Cardiovascular Engineering, Inc. Waltham, MA
Clemens Mittmann, M.D. Federal Institute for Drugs and Medical Devices (BfArM) Bonn, Germany
2006 Sept. 18-20 Bethesda - Mittmann - European Regulatory View on Cardiovascular Biomarkers and Surrogate Endpoints in Clinical Trials
Jacques Mizrahi, M.D., F. Hoffmann-La Roche Ltd.
2008 Sept. 10-12 Bethesda - Mizrahi - B Cells is pivotal to Type 2 Diabetes progression Emerging Molecular Biomarkers & Translational Models A system Biology Approach.
Alan Moody, Radiologist in Chief, Sunnybrook Health Sciences Centre
Moody - Magnetic Resonance Imaging of Atherosclerosis
Vincent Mooser, MD., Medical Genetics/Clinical Pharmacology And Discovery Medicine, GlaxoSmithKline
Mooser - Collaborative Models for Biomarkers Development
David A. Morrow, M.D., MPH TIMI Study Group Cardiovascular Division Brigham and Women’s Hospital Boston, MA
2006 Sept. 18 Bethesda - Morrow - Biomarkers in Acute Coronary Syndromes
Allison Mueller, Neurology Group Leader Global Regulatory Affairs GE Healthcare Medical Diagnostics R&D
Mueller - An Approach to the Commercial Development of Molecular Imaging Agents
C. Daniel Mullins, PhD, Professor, Pharmacoeconomics, University of Maryland
2010 Sept. 27 NIH Bethesda - Mullins - Pharmacoeconomics and Value Assessments of Drugs and Biomarkers
Elizabeth Nabel National Institutes of Health
Ilaria Nardello, National Coordinator, the Marine Institute, Ireland
Steve Nissen, M.D. The Cleveland Clinic Foundation
Irene Nunes, OD, PhD, Merck Research Laboratories
Christopher O'Donnell, M.D. Senior Advisor to the Director for Genome Research Associate Director of the Framingham Heart Study NHLBI, National Institutes of Health
2006 Sept. 18-20 Bethesda - O'Donnell - NIH Cardiovascular Biomarkers Initiatives
2008 Sept. 10-12 Bethesda - O’Donnell - Beyond Risk Factors: Protein, Imaging and Genomics Biomarkers for Prediction and Prevention of CVD—From Observational Studies to Clinical Trials
O’Donnell - NHLBI Cardiovascular Genomic Initiatives: Implications for CVD Biomarker Research
Terri O’Grady, RPh, PhD., Canadian Agency for Drugs & Technology in Health
2011 May 23 Ottawa - O’Grady - Reimbursement Challenges for Innovative Technologies
Daniel H. O’Leary, M.D., Chairman, Department of Radiology, New England Medical Center
2003 Aug. 1-2 Bethesda - O'Leary - Carotid Intima-Media Thickness (IMT)
Oye Olukotun, MD, CEO, CardioVax Inc.
Pat O’Mahony, DVM, MBA, Executive Director, Irish Medicines Board, Chairman, European Medicines Agency (EMA), Dublin, Ireland
2010 Sept. 27 NIH Bethesda - O’Mahony - International Harmonisation
2011 Sept. 12-13 White Oak - O'Mahony - European Medicines Agency Biomarkers Priorities
David G. Orloff, M.D. Medical Director Medpace, Inc.
2003 Aug. 1-2 Bethesda - Orloff - Anti-atherosclerosis Drug Development: Beyond Statins and LDL-C
2004 Sept. 10-11 Bethesda - Orloff - DMEDP view of surrogates
2008 Sept. 10-12 Bethesda - Orloff - Biomarkers in Drug Development
Orloff - Surrogates in Drug Development for ASCVD: Arterial wall disease measures
Orloff - Surrogates and Biomarkers in ASCVD Drug Development
James Otvos, PhD., Chief Scientific Officer, LipoScience, Inc., Adjunct Professor, Department of Biochemistry, North Carolina State University
2003 Aug. 1-2 Bethesda - Otvos - Lipoprotein Particle Subclasses Measured by NMR: The Case Against Cholesterol as the Basis of Lipoprotein Quantification
Pamela Ouyang, M.D., Johns Hopkins Bayview Medical Center
2003 Aug. 1-2 Bethesda - Ouyang - Electron Beam CT Coronary Calcium as a Surrogate for Coronary Atherosclerosis
Mary Parks, MD, Director, Metabolism and Endocrine, CDER, US FDA
2006 Sept. 18-20 Bethesda - Parks - Use of Biomarkers for FDA Regulatory Decision Making In Division of Metabolism and Endocrinology Products
2007 Parks - CV Biomarkers in FDA Regulatory Science - Metabolism and Endocrine: What's New in 2007 s New in 2007
2008 Sept. 10-12 Bethesda - Parks - LDL-C as Surrogate for Drug Approval
2009 Oct. 19-21 Bethesda - Parks - Regulatory Roundtable: How can biomarkers streamline the regulatory process?
2010 Sept. 27 NIH Bethesda - Parks - Use of Biomarkers in Product Development in the Division of Metabolism and Endocrinology
Gerard Pasterkamp, MD, PhD, Chief Scientific Officer, Cavadis; Experimental Cardiology Laboratory, University Medical Center Utrecht, the Netherlands
Michael Perelman, M.D. Vice President, Global Project Mgmt Schering-Plough Research Institute
Marc Pfeffer, M.D., Ph.D. Professor of Medicine Harvard Medical School Brigham and Women’s Hospital Boston, MA
2006 Sept. 18-20 Bethesda - Non- Novel Cardiovascular Biomarkers
Michael S. Phillips, Ph.D. Director of Pharmacogenomics Genome Quebec Montreal, Quebec
2004 Sept. 10-11 Bethesda - Phillips - Pharmacogenomics: Medicine and Genetics - Future or Present?
2010 May 17 Ottawa - Phillips - Pharmacogenomics: A Research Prospective
2011 May 23 Ottawa - Phillips - CASE STUDIES: How are Genomic Biomarkers being used Today and in the Future
Hubert Pouleur, MD, PhD, Vice President, Cardiovascular-Metabolic Disease Strategy, Pfizer Inc, New York, New York, USA
Robert Powell, PharmD Director, Pharmacometrics Office of Clinical Pharmacology Center for Drug Evaluation and Research US Food and Drug Administration
2007 Oct. 18 Bethesda - Powell - Biomarkers in Model Based Drug Development
Aidan Power, Pfizer PharmaTherapeutics Research
2010 May 17 Ottawa - Power - Case Study: Rx Crizotinib (PF-2341066), Dx ALK BAP FISH assay
Margaret Prescott, M.D. Metabolic and Cardiovascular Research Department Novartis Institute for Biomedical Research Summit, NJ
Joel Raichlen, MD, Senior Director, AstraZeneca
Daniel Rader, M.D. University of Pennsylvania School of Medicine
2004 Sept. 10-11 Bethesda - Radar - Lipoproteins and other related risk factors
Paolo Raggi, M.D. Tulane University School of Medicine
Gurvaneet Randhawa, MD, Agency for Healthcare Research and Quality
Patricia Reilly, Member of the Cabinet of Máire Geoghegan-Quinn, European Commissioner for Research, Innovation and Science, Dublin, Ireland
Alan Remaley, MD, PhD, Laboratory of Lipoprotein Metabolism, NHLBI, NIH
2011 Sept. 12-13 White Oak - Remaley - A Mechanistic Understanding of HDL Properties
Paul Ridker, MD, Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital
2010 Sept. 27 NIH Bethesda - Ridker - Biomarkers, Inflammation, and CRP: Lessons from the JUPITER Trial Experience
Dwaine Rieves, MD, Director, Medical Imaging and Hematology, CDER, US FDA
2008 Sept. 10-12 Bethesda - Rieves - Regulatory Considerations in Central Image Assessments
Eric Rimm, Sc.D. Associate Professor of Epidemiology and Nutrition Harvard School of Public Health Boston, MA
John Rioux, Ph.D. The Laboratory of Genetics and Genomic Medicine of Inflammation Université de Montréal and Montreal Heart Institute
2007 Oct. 17 Ottawa - Rioux - The Genomics of Inflammation: Can current and future genetics approaches identify useful markers?
2010 May 17 Ottawa - Rioux - Biomarkers: GWAS, Sequencing and Integrative Biology
Robert Roberts, MD, FRCP(C), MACC, Director, Ruddy Canadian Cardiovascular Genetics Centre, President & CEO, University of Ottawa Heart Institute
2011 May 23 Ottawa - Roberts - Heart Disease and your Genes
Yves Rosenberg, MD, MPH, Acting Branch Chief, Atherothrombosis and Coronary Artery Disease Branch, NHLBI, NIH
2011 Sept. 12-13 White Oak - Rosenberg - HDL-Targeted Therapies: Fibrates and Niacin Trials
Robert Rosenson, MD, Professor of Medicine, Mt. Sinai School of Medicine
2011 Sept. 12-13 White Oak - Rosenson - HDL Quantity and Quality as Markers of Disease
Amy E. Rudolph, Ph.D. Clinical Director Global Medical CV Metabolic Endocrine Pfizer, Inc
Kerry-Anne Rye, The Heart Research Institute, Sydney, Australia
2008 Sept. 11-12 Bethesda - Rye - Anti-Inflammatory Properties of HDL
Frank Sacks, M.D. Professor of Cardiovascular Disease Prevention Department of Nutrition Harvard School of Public Health Boston, MA
Patrice Sarrazin, PhD. Senior Scientific Evaluator In Vitro Diagnostic Devices Medical Devices Bureau Therapeutic Product Directorate, Health Canada
2011 May 23 Ottawa - Sarrazin - Regulatory Oversight of Genetic Testing in Canada
William J. Sasiela, Ph.D. Chief Medical Officer Aegerion Pharmaceuticals, Inc.
2005 Sept. 23 Bethesda - Sasiela - The Need for Biomarkers as Valid Surrogates of Atherosclerosis: A Case of Catch-22’s?
Ernst Schaefer, M.D. Director, Lipid Metabolism Laboratory Tufts University Boston, MA
2007 Oct. 17 Bethesda - Schaefer - High Density Lipoproteins
Carina Schmidt, MSc, Chief Executive Officer, Athera Biotechnologies, Stockholm, Sweden
Daniel Schultz, M.D. Director, Center for Devices and Radiological Health US Food and Drug Administration Rockville, MD
2007 Oct. 17-19 Bethesda - Schultz - The Biomarkers Consortium
Sonia Skarlatos, MD, Deputy Dir., Division of CV Sciences, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA
2010 Sept. 27 NIH Bethesda - Skarlatos - NHLBI Initiatives
Daniel M. Skovronsky, MD, PhD, Founder and CEO Avid Radiopharmaceuticals
2009 Oct. 19-21 Bethesda - Skovronsky - The Potential Role of Imaging Biomarkers in the Development of Neurological Therapeutics
David M. Smalley, PhD, Biomedical Research Facility Cardiovascular Research Center University of Virginia
J. David Spence, M.D. Director, Stroke Prevention and Athero Research Centre Robarts Research Institute London, Ontario, CANADA
Spence - Carotid Ultrasound Phenotypes: Assessing Atherosclerosis Burden and Response to Therapy
George Steiner, M.D. Toronto General Hospital
Norman Stockbridge, MD, Director, Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, FDA
Stockbridge - The Use of Biomarkers for FDA Regulatory Decision-Making - Cardio-Renal
Stockbridge - Cardiac Safety Research Consortium
Anders Svensson, MD, Head, Clinical Development, Metabolism, F. Hoffman-La Roche
2010 Sept. 27 NIH Bethesda - Svensson - Aleglitazar – a case study
Alan Tall, Columbia University Medical Center
2008 Sept. 11-12 Bethesda - Tall - A Mechanistic Understanding of the Anti-Atherogenic Properties of HDL
Jean-Claude Tardif, MD, Director, Montreal Heart Institute (MHI) Research Center; Prof. of Medicine, U of Montreal, Canada Research Chair in translational and personalized medicine
2006 Sept. 18-20 Bethesda - Tardif - The role of imaging in cardiovascular disease detection and treatment
2008 Sept. 10-12 Bethesda - Tardif - Central image analysis at the Montreal Heart Institute
2009 Oct. 19-21 Bethesda - Tardif - Validation and use of biomarkers: From pre-clinical to clinical studies
2009 Oct. 19-21 Bethesda - Tardif - IVUS, QCA and other approaches to assess atherosclerosis
2009 Oct. 19-21 Bethesda - Tardif - From biomarkers to clinical trials
2010 Sept. 27 NIH Bethesda - Tardif - The role of imaging biomarkers of atherosclerosis
2010 May 17 Ottawa - Tardif - Streamlining drug development and clinical trials with biomarkers
2011 May 23 Ottawa - Tardif - Integrating biomarkers and emerging sciences in clinical trials
2011 Sept. 12-13 White Oak - Tardif - Integrating blood-based and imaging biomarkers in clinical trials
2011 Sept. 12-13 White Oak - Tardif - Completed and ongoing clinical trials with CETPi and HDL infusions
Ahmed Tawakol, MD, Professor of Medicine, Massachusetts General Hospital
Allen J. Taylor, MD, Professor of Medicine, Georgetown University, Department of Medicine, Washington Hospital Center
2008 Sept. 10-12 Bethesda - Taylor, A.J. - Surrogates in CV Drug Approval: Clinician’s Perspective
2010 Sept. 27 NIH Bethesda - Taylor, A.J. - Imaging in Clinical Trials: Guidelines and Challenges
2011 Sept. 12-13 White Oak - Taylor, A.J. - Quality and Imaging in CV Trials The Role of the Core Lab
Taylor, A.J. - Carotid IMT as a Surrogate of Cardiovascular Disease Risk
Doris Taylor, PhD, Director of the Center for Cardiovascular Repair, Stem Cell Institute, University of Minnesota
2011 Sept. 12-13 White Oak - Taylor, D. - Stem Cells and Bio-Devices in Cardiac Repair
Robert J. Temple, MD, Deputy Director of Clinical Science, Center for Drug Evaluation and Research, United States FDA
2008 Sept. 10-12 Bethesda - Temple - FDA Policy on Surrogates for Regulatory Approval
2009 Oct. 19-21 Bethesda - Temple - FDA Perspective on the Use of Biomarkers
2011 Sept. 12-13 White Oak - Temple - Biomarkers
Douglas Throckmorton, MD, Deputy Center Director, Center for Drug Evaluation and Research, United States FDA
2004 Sept. 10-11 Bethesda - Throckmorton - A Regulator’s View
2005 Sept. 23-24 Bethesda - Throckmorton - The FDA Critical Path Initiative – Opportunities and Challenges
2006 Sept. Bethesda - Throckmorton - The FDA Critical Path Initiative – Opportunities and Challenges
2010 Sept. 27 NIH Bethesda - Throckmorton - Can Biomarkers Improve Clinical Trial Design?
2011 Sept. 12-13 White Oak - Throckmorton - Update on The Critical Path Initiative
Paula R. Trumbo, Ph.D. Team Leader, Nutrition Science Evaluation Center for Food Safety and Applied Nutrition US Food and Drug Administration College Park, MD
2006 - Trumbo - The Use of Biomarkers for FDA Regulatory Decision Making – health Claims
Trumbo - Regulatory Considerations and Nutrition Labeling
Sotirios Tsimikas, M.D., Director, Vascular Medicine, Associate Professor Of Medicine, University of California, San Diego
2003 Aug. 1-2 Bethesda -Tsimikas - Detecting Oxidized LDL to Assess Vulnerable Plaques: Markers and Imaging
James E. Udelson, MD, Tufts Medical Center, Boston, MA
2009 Oct. 19-21 Bethesda - Udelson - Challenges in Heart Failure: Challenges and Opportunities - Clinical Trial Perspective on Biomarkers as Surrogate Measures
Roger Ulrich, Ph.D., Fellow ATS, Chief Development Officer, Calistoga Pharmaceuticals Inc. Seattle, Washington
2008 Sept. 10-12 Bethesda - Ulrich - Differentiating Biomarkers for Drug-Induced Liver Injury
Professor Spiros Vamvakas, Head of Section for Scientific Advice, European Medicines Agency
John Wagner, MD, Ph.D. Director, Clinical Pharmacology Merck & Co., Inc.
Karin Wåhlander, PhD, Vice President for Translational Science, AstraZeneca, Sweden
Marc Walton, MD, PhD, Associate Director, Office of Translational Sciences, Center for Drug Evaluation and Research, United States FDA
2011 Sept. 12-13 White Oak - Walton - Biomarkers and Qualification: A focus on drug development
G. Russell Warnick, Chief Scientific Officer, Sr. VP for Laboratory Operations, Berkeley HeartLab, Inc.
Warnick - Lipoprotein Measurement Current Issues
Robert Wasserman, Roche
2010 May 17 Ottawa - Wasserman - Patient Selection Strategies for the Development of MDM2 Inhibitors
David D. Waters, MD, University of California, San Francisco
2003 Aug. 1-2 Bethesda - Waters - Angiography
2003 Aug. 1-2 Bethesda - Waters - Overview of Lipids and Lipoproteins
2008 Sept. 10-12 Bethesda - Waters - From Biomarker to Surrogate - the Evidence
2009 Jan. 5 Ottawa - Waters - Quantitative Coronary Arteriography to Assess the Effect of Pharmacologic Agents on the Progression/Regression of Coronary Atheroslcerosis
Ralph Weissleder, M.D., Ph.D. Director, Center for Molecular Imaging Research Professor of Radiology, Harvard Medical School Boston, MA
Gerald Willett, MD, Reproductive and Urologic Drug Products, CDER, US FDA
2009 Oct. 19-21 Bethesda - Willett - Selective Estrogen Receptor Modulators and Cardiovascular Risk
Samuel Wright, PhD, Director, Cardiovascular Therapeutics, CSL Ltd.
Helen Wu, PhD., Research Leader, Genomics & Oncology, Roche Molecular Systems, Inc.
2010 May 17 Ottawa - Wu - From Biomarkers to Companion Diagnostics: Opportunities and Challenges of Rx-Dx Co-Development
James J. Zhang, M.D., Ph..D., MBA Global Clinical Development Siemens Molecular Imaging, Inc Siemens Medical Solutions USA
Issam Zineh, PharmD, MPH, Associate Director for Genomics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, United States FDA
2011 Sept. 12-13 White Oak - Zineh - Regulatory Innovation: Evolution of the The Pharmacogenomics Use Case
Bram Zuckerman, M.D. Director, FDA Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health (CDRH)
2004 Sept. 10-11 Bethesda - Zuckerman - Vulnerable Plaque and Device Development - FDA CDRH Perspective
2008 Sept. 10-12 Bethesda - Zuckerman - Biomarkers in Device Development and Evaluation: An FDA Division of Cardiovascular Devices Perspective
Zuckerman - Role of Cardiovascular Biomarkers and Surrogates: An FDA Division of Cardiovascular Devices Perspective
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