Faculty

FACULTY

ATAR DanDivision of CardiologyAKER UNIVERSITYHOSPITALTrondheimsvn. 235N- 0514 OSLONORWAY

BERNAUD CorineEU Medical Affairs Director, CVAstraZeneca - ISMO EuropeDa Vincilaan 2 Box 2B-1935 ZaventemBelgium

BORER Jeffrey S.DirectorThe Howard Gilman Institute For Valvular HeartDiseasesWeill Medical College of Cornell University47 East 88 th StreetNEW YORK, NY10128-1152..USA

BUCH JanGlobal Team Leader/Sr Medical DirectorPFIZER Inc - NYHQ235 East 42 nd StreetNEW YORK - NY10017USA

BURTON PaulSenior Medical Director, Medical LeaderJohnson and Johnson Pharmaceutical ResearchDivision920 Route 202Raritan, NJ 08869USA

COTTER GadiDirector, Momentum Research3100 Tower Blvd. Ste 507Durham, NC 27707USA

DEMETS DavidDept of Biostatistics & Medical informaticsUniversity of Wisconsin Medical SchoolK6/446 Clinical Science Center600 Highland Avenue K6/446CSC Box 4675MADISON, WI 53792-4675USA

DOMANSKI MichaelChief, Atherothrombosis and Coronary ArteryDisease BranchNHLBI,6701 Rockledge Drive,BETHESDAMD 20892USA

GELLER NancyDirector, Office of Biostatistics Research,National Heart, Lung and Blood InstituteRockledge II Suite 90936701 Rockledge Drive MSC 7913Bethesda, MD 20892-7913USA

GORDON DavidSpecial Assistant for Clinical StudiesNational Institutes of Health - Blood Institute6701 Rockledge Drive, Room 8134Bethesda, Maryland 20892-7940USA

FACULTY

GUSTAFSSON FinnDepartment of CardiologyCopenhagen University HospitalRigshospitaletBlegdamsvej 9DK-2100 CopenhagenDENMARK

HAMELIN BernardDirecteur Médical Europe AZASTRAZENECASACorporate VillageDa Vincilaan 2, Box 2B- 1935 ZAVENTEMBELGIUM

JULIAN DesmondDept of Cardiology University of Newcastle uponTyne,Flat 17 Netherhall GardensLONDONNW3 5RNUK

KARKOWSKYAbrahamActing Deputy Division DirectorFDAWhite Oak CDER Office Building 22 - Room 416410903 New Hampshire AvenueSilver Spring MD 20993USA

KOLSKYHélèneConsultant3, Clos de la Bergerie78240 ChambourcyFRANCE

LAFONT AntoineHôpital Européen Georges Pompidou20, rue Leblanc75908 PARIS cedex 15FRANCE

LECHAT PhilippeDirecteur de l'évaluation des médicamentset des produits biologiquesAFSSAPS143-147, boulevard Anatole France93285 SAINT-DENIS CEDEXFRANCE

LIPICKYRaymondDirectorLIPICKY, LLC15201 Apricot LaneNorth PotomacGAITHERSBURG, MD 20878USA

LUBSEN JacobusSOCAR RESEARCH SAChemin de Chantemerle 18CH - 1260 NYON 2SWITZERLAND

MITCHELYaleExecutive Director, Clinical ResearchMERCK & Co, IncWhitehouse StationRAHWAYRY34-A228NJUSA

FACULTY

PFEFFER MarcBrigham and Women's HospitalCardiovascular Division75 Francis StreetBOSTON, MA02115USA

PITT BertramProfessor of Medicine Emeritus24 RidgewayANN ARBOR, MI 48104USA

POCOCK StuartMedical Statistics UnitLondon School of Hygiene and Tropical MedicineKeppel StreetLONDON, WC1E 7HTUK

POULEUR HubertExecutive Director - CV/Metabolic -Global OutcomesResearchPFIZER INC235 East 42nd Street - 205/8/13NEW YORK, NY10017USA

REVKIN JamesSenior Director, Pfizer, Inc. And Associate ClinicalProfessor of MedicineYale University School of MedicineNEW HAVEN, CTUSA

ROLAND EdmondHôpital Européen Georges Pompidou20, rue Leblanc75908 PARIS cedex 15FRANCE

ROSSIGNOLPatrickMédecin déléguéHOPITALJEANNE D'ARCCICBP9030354201 DOMMARTIN LES TOULFRANCE

SEREBRUANYVictorAssociate Professor of MedicineJohns Hopkins University, Président, HeartDrugResearch LLC7600Osler Drive, Suite 307TOWSON 21204 MarylandUSA

SHEAR Charles L. (Chuck)Vice-PresidentCUMED DevelopmentPfizer Global Research Development50 Pequot Ave, MS 6025-A4113NEW LONDON CT06320USA

SHURIN SusanDeputy DirectorNHLBIRoom 5A4831 Center Drive MSC 2486BETHESDA, MD 20892-2490USA

FACULTY

STAGNITTO MariaDirector Office of Clinical ResearchNHLBI6701 ROCKLEDGE DRroom 9093Bethesda MD 20892-7913USA

STEG Philippe GabrielService de CardiologieHOPITALBICHATCLAUDE BERNARD46, rue Henri Huchard75 877 PARIS CEDEX 18FRANCE

WEATHERLEYBethMomentum Research, IncVice President, Biometrics3100 Tower Blvd. Ste 802Durham, NC 27707USA

WEDELHansNordic School of Public HealthSahlgrenska University HospitalBox 12133S-40242 GOTHENBURGSWEDEN

WITTES JanetStatistics Collaborative1710 Rhode Island Ave, NWWASHINGTON, DC 20008USA

ZANNAD FaiezCIC INSERM - CHU and Department ofCardiologyHôpital Jeanne D'Arc54200 DOMMARTIN LES TOULFRANCE

ZARIFFANevineVice-President, Biomedical Data SciencesCardiovascular and Metabolism MDC,GlaxoSmithKline Pharmaceuticals2301 Renaissance Blvd,Building #510, BOX 61540KING OF PRUSSIA, PA19406USA

ZOLYNAS RobertSenior Medical Director, Medical LeaderJohnson and Johnson Pharmaceutical ResearchDivision920 Route 202Raritan, NJ 08869USA

Dan ATAR, MD

Dan Atar, MD, (48) is Head of Cardiology at Aker University Hospital, Oslo, Norway, and holds a fullProfessorship in Cardiology at the University of Oslo, Norway, along with a Visiting AssociateProfessorship at the Johns Hopkins Unversity, Baltimore, Maryland, USA. Dan Atar trained in Denmark, Switzerland, and the United States before receiving his boardcertification in Internal Medicine and Cardiology in 1995. His research focuses on myocardialbiomarkers, myocardial function, heart failure and cardiovascular pharmacology. He has written>100 articles and book chapters and holds the fellowship-titles FESC, FACC, and inaugural FAHA. Dan Atar is the Chairman of the ESC Working Group-3 (Cardiovascular Pharmacology and DrugTherapy), and Associate Editor of the international peer-reviewed journal "Cardiology" (Karger). He is on the writing committee for the upcoming ESC "Cardiovascular Disease Prevention" guideline,as well as the "ESC Guideline on acute and chronic Heart Failure" and the ESC position paper on"Bleeding complications".

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Corine BERNAUD,MD

She is presently European Medical Affairs Director Cardiovascular in AstraZeneca ISMO Europe.

Corine Bernaud joined the pharmaceutical industry 17 years ago after four years of medical practiceas a general practitioner and sports medicine specialist. She joined Pfizer France in 1990, then SankyoPharma France in 2004 and AstraZeneca in 2006. She has contributed to the design, monitoring andsteering of several clinical trials in cardiology and a number of publications in peer reviewed journals.

Jeffrey S. BORER,M.D

Biographical SketchHe is the Gladys and Roland Harriman Professor of Cardiovascular Medicine at Weill Cornell MedicalCollege, where he also is Professor of Radiology and of Cardiothoracic Surgery, both in CardiovascularMedicine, and, administratively, chairs the Section of Cardiovascular Pathophysiology and The HowardGilman Institute for Valvular Heart Diseases.

He received his undergraduate education at Harvard, his medical degree from Cornell, and his post-graduate training at the Massachusetts General Hospital and in the Cardiology Branch of the NationalHeart, Lung and Blood Institute of the NIH, where he subsequently established the Nuclear Cardiologyservice and served as its first Chief. He was a Senior Fulbright Hays Scholar and Glorney-Raisbeck Fellowin 1974-75 at Guy's Hospital, University of London, in London, England. In 1979, he returned to Cornell.

Dr. Borer is Editor-in-Chief of Cardiology, one of the world's oldest peer-reviewed cardiovascular journals,and of Advances in Cardiology, and serves on the Editorial Boards of several major peer-reviewedjournals. Since 1977 he has served continually as an Advisor/Consultant to the Cardio-Renal Division ofthe U.S.F.D.A., chairing the Cardio-Renal Advisory Committee for 3 separate terms, the last ending in2004. He has authored a book on regulatory aspects of cardiovascular drug development and consultsregularly for the pharmaceutical and devices industries. From 1984 through 2005 he served continually asan Advisor to NASA. He was President of the New York Cardiological Society in 1990-91, President of theNew York State Chapter of the American College of Cardiology from 1997 to 1999, member of the Boardof Governors of the American College of Cardiology from 1997-2000, member of Board of Governors ofthe Society of Cardiac Angiography and Interventions from 1995 to 2000, and member of the Board ofTrustees of the Certification Board of Nuclear Cardiology from 1996 to 2002. Currently, he is President ofthe Heart Valve Society of America. He has authored 4 books and authored or co-authored almost 400journal articles, reviews and chapters. His research achievements have included (1) establishment of thebenefits of the drug, nitroglycerin, during acute myocardial infarction (1971-75); (2) development of real-time radionuclide cineangiography and its application during exercise (1976-1979); (3) development ofnon-invasive prognostic indices in patients with coronary artery and valvular diseases (1979-present); (4)exploration of the cellular and molecular bases of heart failure in regurgitant valvular diseases and othervolume overload states (1984-present). He has received several peer recognitions including theHans-Peter Krayenbeuhl Memorial Award of the International Society of Cardiology in 2002 and the PublicService Medal of the National Aeronautics and Space Administration in 1999.

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Jan BUCH

1969 MD Copenhagen University. Denmark1969 ECFMG Exam (Educational Council for Foreign Medical Graduates).

USASpecialist in internal medicine and cardiology from Copenhagen University

1969-1987 Employed at various university hospitals in Copenhagen. Denmark- 10-11 years at the main cardiological service at the university, Rigshospitalet (including 6 years in invasive cardiology

1987-1991 Medical Director. Pfizer, Denmark1992-1999 Senior Associate Medical Director. Norvasc Team, Pfizer International, HQ, New York1999-2001 Medical Director. Norvasc Team, Pfizer Pharmaceuticals Group2001-2003 Senior Medical Director. Norvasc Team, Pfizer Pharmaceuticals Group2003-2006 Senior Medical Director, Caduet/Norvasc Team, Pfizer Global Pharmaceuticals2006 Senior Medical Director/World Wide Team Leader - Cardiovascular, Metabolic and

Endocrine. Pfizer Global Pharmaceuticals2007 Global Team Leader/Senior Medical Director - Global CVM Medical

Group. Medical Division, Pfizer Inc

Paul BURTON, M.B.B.S., PH.D., M.R.C.S., F.A.C.C.

Dr. Paul Burton, M.B.B.S., Ph.D., M.R.C.S. F.A.C.C. is Senior Medical Director at Johnson andJohnson Pharmaceutical Research and Development in New Jersey, USA. Prior to that Dr. Burton wasthe medical director for INTEGRILIN® (eptifibatide) at Millennium Pharmaceuticals Inc. inMassachusetts, USAand Global Development Leader for Aranesp ® (darbepoetin alfa) New Indicationsat Amgen Inc., in California, USA.

Paul obtained his undergraduate degree (with honours including the University medal in Physiology)from King's College (London, UK) and his medical degree from Guy's Hospital (London). Upon com-pletion of his medical education, Paul was awarded a Medical Research Council Clinical TrainingFellowship in cardiothoracic surgery. The focus of Paul's Ph.D was cardiac myocyte cell cycle regula-tion, and its application to heart failure.

As global development leader for the new indications of Aranesp at Amgen, Paul was responsible foroverseeing phase I-III trial design and execution for the congestive heart failure and hepatitis programs,as well as exploration and clinical development planning around stem cell utilization in patients withischemic heart disease. At Millennium Pharmaceuticals Paul was responsible for the design and exe-cution of phase II-IV clinical trials in the area of acute coronary syndromes, including clinical leaders-hip of the 10,500 patient global mega-trial (EARLYACS) in high-risk acute coronary syndrome patients,as well as phase I studies for a novel anti-inflammatory molecule. He is a member of the Royal Collegeof Surgeons and a Fellow of the American College of Cardiology.

Appointments

JOHNSON AND JOHNSON PHARMACEUTICALRESEARCH AND DEVELOPMENT. SEPTEMBER2006 TO PRESENTSenior Medical Director and Medical Leader for Rivaroxaban in ACSJOHNSON AND JOHNSON PHARMACEUTICALRESEARCH AND DEVELOPMENT. NOVEMBER2005 TO SEPTEMBER 2006Medical Director and Project Physician for PROCRIT

MILLENNIUM PHARMACEUTICALS INC. JANUARY2005 TO NOVEMBER 2005Medical Director and INTEGRILIN Project Physician responsible for all aspects of INTEGRILIN clinicaldevelopment and medical monitor for the EARLYACS study, an international phase III clinical trial of10500 patients with acute coronary syndromes.Additional responsibility for INTEGRILIN medical affairs, including KOLrelationship development andinvestigator initiated study approval, speaker training, medical review and release and phase IV clini-cal trial design.

AMGEN INC. JULY2002 TO JANUARY2005Global Development Leader, Clinical Development.Responsible for phase I-III clinical trial design and execution exploring Aranesp treatment in patientswith heart failure.Responsible for overseeing clinical development activities in multiple other indications.Jointly headed Project Strategy Team for Aranesp New Indications with Global Commercial Leader.Clinical representative to G-CSF team exploring application of G-CSF to stem cell mobilization for thetreatment of heart failure, coronary artery disease and peripheral vascular disease.

IMMUNEX CORPORATION. 2001 TO JULY2002Staff Scientist, Vascular Biology.Focus on the application of translational medicine to heart failure and atherosclerosis.

NATIONALHEARTAND LUNG INSTITUTE, IMPERIALCOLLEGE SCHOOLOF MEDICINE. 1996-2001Lecturer and Clinical Research Fellow in Cardiothoracic Surgery. 1999-2001.Medical Research Council Clinical Training Fellow in Cardiothoracic Surgery. 1996-1999

GUY'S HOSPITAL. London, UK. 1995.House Surgeon.

GREENWICH HOSPITAL. London, UK. 1995. . House Physician.

Gad COTTER, MD, FACC

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nur-sing, and include postdoctoral training.)

INSTITUTION AND LOCATION DEGREE YEAR(s) FIELD OF STUDY(if applicable)

Jerusalem University, School of Medicine, Hadasah B.Msc 1986 MedicineJerusalem University, School of Medicine, Hadasah M.D. 1989 Medicine

Professional experience1989-1990: Internship, Sheba Medical Center, Tel-Hashomer, Israel.1991-1995: Israeli Defense Army. Medical officer and community doctor.1995-1997: Assaf Harofeh Medical Center Zerifin, Israel. Resident in Internal Medicine, Department ofMedicine "A"1998-2001: Assaf Harofeh Medical Center Zerifin, Israel. Fellowship in Cardiology, Cardiology Department1997-2004Medical coordinator of EMS services (Emergency Medicine); Rishon Letzion, Ramle and LOD1997-2004 Director, Clinical Pharmacological Research Unit, Assaf-Harofeh Medical Center2004-2007, Assistant Professor, Duke University Medical Center2007 -present, CEO Momentum-Research Inc.

Editorial boards1. Europena Journal of Heart Fialure, Elsevier. 2. Journal of Cardiac Failure

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David L. DEMETS

David L. DeMets, PhD is currently Professor and Chair of the Department of Biostatistics and MedicalInformatics at the University of Wisconsin - Madison.Since receiving his PhD in 1970, he has been active in the design, conduct, and analysis of clinical trialsin several disease areas. Following a postdoctoral appointment at the National Institutes of Health(1970-72), he spent ten years (1972-1982) at the National Heart, Lung and Blood Institute at the NationalInstitutes of Health where he became chief of a Biostatistics Research Branch. He has co-authored fourtexts, Fundamentals of Clinical Trials, Data Monitoring in Clinical Trials: ACase Studies Approach andData Monitoring Committees in Clinical Trials: APractical Perspective, Statistical Methods for ClinicalTrials.

Dr. DeMets is a recognized international leader in statistical research and methods for the analysis ofclinical trials. He has collaborated in the development of statistical methods for the sequential analysis ofoutcome data and the design of clinical trials. He has extensive national and international clinical trialexperience and has served on and chaired numerous NIH and industry-sponsored Data Safety andMonitoring Committees for clinical trials in diverse disciplines. He served on the Board of ScientificCounselors of the National Cancer Institute and Board of Directors of the American Statistical Association,as well as having been President of the Society for Clinical Trials and President the Eastern NorthAmerican Region (ENAR) of the Biometric Society. In addition he was Elected Fellow of the Society forClinical Trials in 2006.

Michael John DOMANSKI, M.D.

Current positionChief, Atherothrombosis and Coronary Artery Disease Branch; Division of Cardiovascular Disease;National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD Professor of Internal Medicine - Uniformed Services Medical School, Bethesda, MD

Education & specialized trainingBachelor of Aerospace Engineering (Highest Honor) - Georgia Institute of Technology, Atlanta, GADoctor of Medicine - University of Maryland School of Medicine, Baltimore, MDResident in Internal Medicine - Hershey Medical Center, Pennsylvania State University, Hershey, PAFellow in Cardiology - Vanderbilt University Hospital, Nashville, TN

Advisory and editorial boardsFood and Drug Administration (FDA) - Circulatory Devices Panel and other Panels over many yearsDepartment of Veterans Affairs - Cooperative Studies Scientific Merit Review BoardGeorgia Institute of Technology - Member, College of Engineering Advisory Board Editorial Boards - American Journal of Cardiology; Journal of Invasive Electrophysiology

Publications (past 5 years)54 peer-reviewed publications, Editorial/Position Statements, and Reviews (sole or lead author on 19)1 edited book manuscript on Clinical Trials under contract 9 published abstracts

Leadership Positions in Clinical TrialsCo-Chairman - Beta-blocker Evaluation Survival Trial - BEST

Steering Committee Member - Atrial Fibrillation Follow-up Investigation in Rhythm Management -AFFIRM; Anti-arrhythmics versus Implantable Cardioverter Defibrillator Trial - AVID; Post Coronary ArteryBypass Graft Trial - Post-CABG; Multicenter Unsustained Tachycardia Trial - MUSTT; Magnesium inCoronaries - MAGIC; Prevention of Events with Angiotensin Converting Enzyme Inhibitors - PEACE;Action to Control Cardiovascular Risk in Diabetes - ACCORD; Treatment of Preserved Cardiac FunctionHeart Failure with an Aldosterone Antagonist - TOPCAT; Future Revascularization Evaluation in Patientswith Diabetes Mellitus: Optimal Management of Multivessel Disease -FREEDOM

Clinical Site Principal Investigator /Co-Principal Investigator - Atrial Fibrillation Follow-up Investigation InRhythm Management - AFFIRM (Prince Georges Hospital, Cheverly, MD and National Naval MedicalCenter, Bethesda, MD); Prevention of Events with Angiotensin Converting Enzyme Inhibition - PEACE(Prince Georges Hospital, Cheverly, MD) Beta-Blocker Evaluation Survival - BEST(National NavalMedical Center, Bethesda, MD)

NHLBI Project Officer - Beta-Blocker Evaluation of Survival Trial (BEST); Post Coronary Artery BypassGraft Trial -Post-CABG; Atrial Fibrillation Follow-up Investigation in Rhythm Management - AFFIRM;Magnesium in Coronaries Trial - MAGIC; Multicenter Unsustained Tachycardia Trial - MUSTT; SuddenCardiac Death in Heart Failure Trial - SCD-HeFT; Coronary Artery Bypass Graft - CABG Patch; Treatmentof Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist - TOPCAT; FutureRevascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of MultivesselDisease - FREEDOM

Nancy L. GELLER

She has been the Director of the Office of Biostatistics Research at the National Heart, Lung and BloodInstitute of the National Institutes of Health since 1990. She directs a group of 11 statisticians who collaborate in the design, implementation, monitoring and analysis of multicenter clinical trials in heart,lung and blood diseases and sleep disorders. She has been or is involved in a number of cardiovasculartrials, including Post-CABG, PEACE, AFFIRM, the Women’s Health Initiative, FREEDOM and ACCORD.During the summer of 2007, she served on the FDAadvisory panel assessing the safety of Rosiglitizone.She has research interests in clinical trial methodology, especially in issues of clinical trial design, monitoring and multiplicity, i.e, multiple endpoints and multiple treatment comparisons. She served asPresident of the International Society for Clinical Biostatistics from 1999-2000. She is an Associate Editorof Biometrics and a member of the Editorial Board of the journal Clinical Trials. She is a Fellow of theAmerican Statistical Association.

Some recent Cardiovascular Clinical Trial Articles by Dr. Geller

The PEACE Investigators (includes N. Geller as member of Writing Committee). (2004). Effects of angio-tensin converting enzyme inhibition in patients with stable coronary artery disease: the Prevention ofEvents with Angiotensin Converting Enzyme Inhibition (PEACE) Trial. New England Journal of Medicine351:2058-2068.Curtis, A.B., Gersh, B.J., Corley, S.D., DiMarco, J.P., Domanski, M.J., Geller, N., Greene, H.L., Kellen,J.C., Mickel, M., Nelson, J.D., Rosenberg, Y., Schron, E., Shemanski, L., Waldo, A.L., Wyse, D.G.for theAFFIRM Investigators. (2005). Clinical factors that influence response to treatment strategies in atrialfibrillation: the AFFIRM study. American Heart Journal 149:645-649.Geller, N.L. and Friedman, L. (2005). Cooperative heart disease trials. Encyclopedia of Biostatistics, PeterArmitage and Theodore Colton, Eds. John Wiley & sons, New York and Chichester, Vol II, 1169-1180.Anderson, G.L., Kooperberg, C., Geller, N., Rossouw, J.E., Pettinger, M., and Prentice, R.L. (2007).Monitoring and reporting of the Women’s Health Initiative randomized hormone therapy trials. ClinicalTrials. (In press.)

David Jeremy GORDON

Special Assistant for Clinical Studies, DCVD, NHLBI, NIH

Education:1971 Ph.D., Department of Chemistry, University of Chicago

(Thesis: Optical Activity as a Structural Probe in Biological Membranesand Other Particulate Systems -- Information and Artifact.)

1973 M.D., University of Chicago Pritzker Medical School1981 M.P.H., Department of Epidemiology, University of North Carolina, Chapel Hill

(Thesis: Dietary Determinants of Plasma Cholesterol Change in the Recruitment Phaseof the Lipid Research Clinics Coronary Primary Prevention Trial)

Major Projects:- Lipid Research Clinics (LRC) Coronary Primary Prevention Trial (CPPT) - Cholesterol Reduction in Seniors Program (CRISP) Pilot Study - NHLBI Conference on Cost and Health Implications of Cholesterol Lowering- Workshop on Analysis of Cholesterol-Lowering Trials- Antihypertensive and Lipid Lowering to prevent Heart Attack Trial (ALLHAT)- Women's Angiographic Vitamin and Estrogen (WAVE) Trial- Bypass Angioplasty Revascularization Investigations II Diabetes (BARI 2D) Trial- Cell Therapy Network

Advisory Panels:- National Cholesterol Education Program Adult Treatment Panel I-II (ex officio)- National Cholesterol Education Program Adult Treatment Panel III

Research Interests/Publications:Dr. Gordon has authored or co-authored more than 70 publications in the field of cardiovascularepidemiology and clinical trials. Topics include: - The LRC-CPPT, ALLHAT-LLT, and other cholesterol lowering trials. Lead author of LRC collaborativestudy design and 2nd results paper.- Role of circulating HDLand triglycerides in coronary artery disease.- Seasonal variation in cholesterol.- Exercise ECG testing as a correlate of cardiovascular risk factors and predictor of cardiovascular events.- Meta-analysis of cholesterol trials.- Impact of diet, exercise, and weight on circulating lipids.- Cholesterol in the elderly.As a graduate student, Dr. Gordon was the primary author of four peer-reviewed publications on opticalactivity as a structural probe of particulate systems. As an NHLBI post-doctoral fellow, Dr. Gordon was theprimary author of four peer-reviewed publications on the isolation and characterization of cytoplasmicactins.

Finn GUSTAFSSON, M.D., Ph.D.

EducationM.D., University of Copenhagen, June 1994. Ph.D., University of Copenhagen, October 2000. Thesis: "Conducted vasoconstriction and intercellular communication in rat mesenteric arterioles".Certified as a specialist in Cardiovascular Medicine (Danish National Board of Health), March 2007

Employment1.8.1994-31.1.1995 Registrar, Dept. of Cardiology

Bispebjerg University Hospital

1.2.1995-31.7.1996 Registrar(Internal medicine, Surgery, General practice)Kalundborg Hospital

1.8.1996-28.2.1997 Research associate, Dept. of Cardiology Frederiksberg University Hospital

1.3.1997-31.3.2000 Research associateDept. of Medical PhysiologyUniversity of Copenhagen

1.4.2000-28.2.2002 Registrar / senior registrar Dept. of Cardiology E, Frederiksberg Hospital

1.3.2002-21.2.2004 Registrar / senior registrar depts. of cardiology, rheumatology and hematology (Rotation Internal Medicine)Bispebjerg University Hospital and Rigshospitalet

1.3.2004 -31.7.2006 Senior registrar, Dept. of Cardiology Rigshospitalet (Copenhagen University Hospital)

1.8.06-31.7.2007 Clinical fellow, Toronto General Hospital, Heart Failure and Transplant

1.8.07 Staff Cardiologist, Heart Failure and Transplant, Department of Cardiology, Rigshospitalet, Copenhagen

Scientific workHas published articles on heart failure epidemiology, intervention in heart failure and microvascular physiology.

Number of articles published (or in press) in scientific biomedical journals: 68 (first author on 27)

Manuscript reviewer for JAMA, European Journal of Heart Failure, Cardiovascular Research, Cardiology,International Journal of Cardiology, Journal of Human Hypertension, Blood Pressure, Acta PhysiologicaScandinavica, Clinical Drug Investigation, Heart Drug, Chest, Expert Review of Cardiovascular Therapy.

Member of the Board for the Danish Heart Failure Clinics Network.

Member of the nucleus in the Working Group for Heart Failure of the Danish Society of Cardiology since 2004.

Has served as a investigator on several multicentre, randomized clinical trials.

Member of the steering comittee of the NT-proBNPstratified follow-up in outpatient heart failure clinics(NorthStar).

Member of the Working Group of Cardiovascular Pharmacology and Drug Therapy (ESC).

Web editor for the Working Group of Cardiovascular Pharmacology and Drug Therapy (ESC).

Bernard HAMELIN, MDISMO EU Medical Director

Bernard is European Medical Director of AstraZeneca, Regional office in Brussels, Belgium.

Bernard obtained his Medical degree at the University of Paris, School of Medicine in 1983 andreceived his Master in Science degree in Pharmacology and Cellular Biology at the University of Paris in1987.Later in 1993, he obtained his eMBAfrom the "Institut Administration des Entreprises" at the University ofParis.

Bernard practiced at the Hospital of Marseille in Oncology and Radiotherapy and in the Hospital of Parisin the departments of Hepatogastroenterology, ICU, Kidney Transplantation, Virology and Haematology.His residency and fellowship was performed in the department of hepatogastro-enterology.

He joined Astra France in 1991 as Clinical Research Physician, Medical Responsible for GI and moved toAstra Hässle in Mölndal, Sweden in 1994 as Project Team Leader of the mosapride project team.

In 1997, Bernard moved to Astra Merck Pharmaceuticals, PA, USAas Clinical Research Physician andwas the Medical responsible for Nexium (phase II/III) and supported the pre-launch marketing activities forphase IIIb/IV. In 1999 he was promoted Global Director GI Therapeutical Area and he returned toAstraZeneca France in 2001 where he was appointed Medical Director.

In 2005, Bernard joined AstraZeneca ISMO, as EU Medical Director and is responsible for the MedicalAffairs, Clinical Research and Medical Information.

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Desmond JULIAN

Professor Desmond Julian undertook his undergraduate medical education in Cambridge and London,and trained in cardiology at the National Heart Hospital, London, Harvard Medical School, and Edinburgh.In 1961 he was the first to put forward the concept of the coronary care unit in an article in the Lancet. In1962, he went to Sydney, Australia to set up one of the first coronary units. He was Cardiologist in theRoyal Infirmary Edinburgh from 1964 to 1975 and Professor of Cardiology in the University of Newcastle-upon-Tyne from 1975 to 1986, and subsequently Medical Director of the British HeartFoundation from 1986 to 1993.

He was President of the British Cardiac Society from 1985-87. He was awarded the Gold Medal of theEuropean Society of Cardiology in 1998. He received the Mackenzle Medal of the British Cardiac Societyin 2003 and the International Service Award of the American College of Cardiology in 2005. He wasawarded Honorary MDs from the Universities of Gothenburg and Edinburgh.

He was Editor of the European Heart Journal from its inception in 1979 to 1988. He is the author oreditor of some 20 books on cardiological topics. He has been involved in the design, monitoring andanalysis of many of the major clinical trials in cardiology , including ISIS trials, CONSENSUS and 4S.

Abraham M. KARKOWSKY, M.D., Ph.D.

Education - B.S. Brooklyn College, Brooklyn, N.Y. (1969)- S.M. Massachusetts Institute of Technology, Organic Chemistry (1972)- Ph.D. Mount Sinai School of Medicine, Biomedical Sciences-Pharmacology (1977)- M.D. University of Miami School of Medicine (Ph.D. to M.D. program) (1980)

Additional Training- Post-doctoral fellowship in Medicinal Chemistry, Sidney Farber Cancer Center. 1977-1978- Post-doctoral Fellowship in Genetics, NIH 1983-86

Medical Training - Internship-residency in pediatrics Albert Einstein College of Medicine, Bronx Municipal Hospital Center,1980-83

Work historyFDA- 1986-current- Medical reviewer 1986-89- Team Leader 1989-Current- Acting deputy director- 2006-7 (intermittent).

Practice Moonlighter:- Prince George hospital 1984-91- Southern Maryland Hospital 1985-87- Office practice 1994-99 (part time)

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Hélène KOLSKY

Since January 2007 dismissed after an acquisition by MEDA

From 2000 to January 2007: 3M healthcare

From February 2004 to January 2007: scientific & institutional affairs Manager

From 2002 to 2004 : European position as medical manager MENA& North Africa

January 2000-february 2004 : Medical manager, Therapeutic areas: Cardiology, Dermatology /Immunology, Respiratory.

1992 - 1999: BAYER PHARMA: Manager of the all therapeutic areas (cardiology, metabolism, CNS)

1979 - 1992: HOECHST: clinical project leader and then manger of the cardiovascular area (5 physicians)

Antoine LAFONT

Student at Necker medical school, Paris, PhD thesis (bioresorbable stents in vivo) Univ. Montpellierpost-doctoral fellowship at the Cleveland Clinic Foundation 1989-1991Professor of medicine, University PARIS V, Head of the dept of interventional cardiology, HEGPAdjunct staff, biomedical engineering Dept, Cleveland Clinic Foundation 1991-2006

Research fieldsarterial remodeling after injury

Summary of research activity-role of constrictive remodelling on the occurrence of restenosis (Circ Res 1995). -Back in Paris, creation of a university research unit (2505) ( arterial remodelling) in 1998-In 2000, creation of the EMI.U0016 on arterial development.-In 2003, startup (Arterial Remodeling Technology)-In 2004, potential beneficial properties of gingival fibroblasts on arterial repair in expansive remodeling,

by inhibiting the activity of MMP9, and overexpressing TIMP2 and TGF beta in contact with smoothmuscle cells.

- In 2007, creation of U 849 : arterial repair(therapeutic options in interventional cardiology).

Principal scientific and administrative responsibilitiesHead of EMI-U 0016 until 2006Head of U 849 from 2007CSS 4 (INSERM) until 2003Supervision of DEA(6) & thesis (6)Member of the commission du 3 e cycle, Université Paris VMember of the research committee of HEGPReview in the peer review process of journals: ATVB, Heart, Journal of the American College ofCardiology, American Journal of Cardiology, Cardiovascular Research, Biomaterials, Circulation.

Industrial ccoperations and valorisationNine patents involving bioresorbable stent, decorin and prevention of intrastent restenosis identificationand therapeutic use of side population cells, use of gingival fibroblasts in the treatment of pathologicremodelingCreation of 2 start-up :Arterial Remodeling Technologies (2003);ScarCell (2007)

Scientific information70 invited lectures (2000-2007)

International activities-Coordinator of 2 international, multicentric, randomised, double blind study (FROST, PRACTICE) -Chairman, working group on interventional cardiology, European Society of Cardiology 2003-2006-Past Chairman of the European Association of Percutaneous Cardiovascular Interventions of theEuropean Society of Cardiology-Director, International Affairs, Medical School PARIS-DESCARTES

Teaching activitiesFaculté de médecine Paris: cardiology, physiology

Philippe LECHAT

Professor Philippe LECHAThas joined the French Health Products Safety Agency as Head of theMedicinal Products and Biologics Evaluation Department in July 2007 and has been appointed as CHMPmember since October 2007.Philippe Lechat is a 55 years old physician cardiologist. He obtained his Ph D in Pharmacology from thePitié-Salpêtrière Faculty of Medicine, Paris and is Pharmacology Professor. His professional involvementled him to become Head of the Pharmacology Department at the Pitié Salpêtrière Hospital. He was alsovery much concerned with experimental and clinical research.Philippe Lechat was thus Responsible for the Clinical Research Unit and Chairman of the Committee forthe Protection of Patients. He participated in the carrying out and follow up of several multicentric andinternational (especially in the cardio-vascular area) clinical studies.Besides, he brought his contribution to the French Health Products Safety Agency and became memberof the Marketing Authorization Committee and Chairman of the Thrombosis Working Party.In addition, Philippe Lechat participated in the activities of various learned societies. He was thus muchinvolved in the creation and development of the French Society of Pharmacology.His principal areas of expertise are cardiology, cardio-vascular pharmacology, pharmaco genetics andclinical pharmacology.His is also the author of more than 150 international scientific publications and has participated in severalscientific reviewing and editorial committees.

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Raymond John LIPICKY, MD

He is the Director of LIPICKY, LLC (a consulting company) having retired (March 2002) after 21 years ofservice) from the U.S Food and Drug Administration (FDA) where he held the position of Director, Divisionof Cardio-Renal Drug Products, Office of Drug Evaluation I, Center for Drug Evaluation and Research.Previously, he was on the faculty of University of Cincinnati, College of Medicine (for 14 years) where heheld the positions of Professor of Pharmacology and Professor of Medicine and Director, Division ofClinical Pharmacology at the time he joined FDA. He is a graduate of the University of Cincinnati Collegeof Medicine, trained in Internal Medicine and Cardiology. He currently also has an appointment as VisitingScientist at the Marine Biological Laboratory (Woods Hole, MA) where, for about 30 years, he had asummer laboratory pursuing an interest in drug effects on electrically-excitable membranes.

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Jacobus LUBSEN

Jacobus Lubsen's (1942) main interests are the translation of clinical problems into appropriate clinical trialdesign and/or their decision analytic modelling. He studied engineering in Delft, medicine in Rotterdamand epidemiology at the Harvard School of Public Health in Boston. After completing a cum laude thesison acute chest pain syndromes in general practice, he started in 1978 the Clinical Epidemiology group atthe Department of Cardiology (Thoraxcentre) of the Erasmus University Rotterdam. In 1985 he wasappointed professor of medicine at Erasmus and in 1987 Chairman of the Centre for Clinical DecisionAnalysis. From 1990 - 2006 he was scientific director of SOCAR Research SA, a Swiss-basedcardiovascular clinical research organisation. At SOCAR, he was 'responsible biostatistician' of theACTION study, the first-ever clinical outcome trial in patients with stable symptomatic coronary disease.As a part-time faculty member at the Erasmus University, he contributes regularly to teaching in clinicaltrials and decision analysis, and lectures frequently at international meetings. He is a past member of theDutch Health Council.

YaleB. MITCHEL, MD

Yale B. Mitchel, MD joined Merck Research Labs in 1991 and has contributed to the clinical developmentof lovastatin, simvastatin and the novel cholesterol-absorption inhibitor ezetimibe. He currently is an executive director of Clinical Research, Cardiovascular Disease at Merck and leads the Atherosclerosissection of the department.

Dr. Mitchel received his Bachelor of Science in biology from Carnegie Mellon University and earned hisMD at New York Medical College. He did his internal medicine residency at the Bronx Municipal Hospital,a teaching hospital of the Albert Einstein College of Medicine, and completed his endocrine fellowshipunder the supervision of Dr. Howard Eder at the Albert Einstein College of Medicine. As a faculty member at Albert Einstein College of Medicine, Dr. Mitchel's research focused on the identification of ahepatic receptor for high-density lipoproteins and apoprotein A-I, and human lipoprotein metabolism.

Dr. Mitchel is board certified in internal medicine and endocrinology, and is a fellow of the Arteriosclerosis,Thrombosis and Vascular Biology Council of the American Heart Association and a member of theInternational Atherosclerosis Society.

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Marc A. PFEFFER, MD, PHD

Dr. Marc A. Pfeffer, a graduate of Rockford College in Rockford, Illinois, received both his doctorate inphysiology and biophysics and his medical degree from the University of Oklahoma in Oklahoma City. Hecompleted his internship, residency and clinical fellowship at the Peter Bent Brigham Hospital, HarvardMedical School in Boston. Dr. Pfeffer is currently the Dzau Professor of Medicine at Harvard MedicalSchool and physician in the Cardiology Division at Brigham and Women's Hospital. Dr. Pfeffer also servesas medical director of Partners Research and Education Program (PREP).

Dr. Pfeffer has distinguished himself as a translational investigator. Along with his late wife, Dr. JanicePfeffer, and Eugene Braunwald, M.D., their studies in an experimental model of myocardial infarction firstintroduced the concept of an insidious deleterious structural remodeling of the impaired ventricle. Theydemonstrated in both animals and man that angiotensin converting enzyme (ACE) inhibitors couldattenuate these adverse structural and functional changes providing the rationale for the use of theseagents in patients experiencing a myocardial infarction. Pfeffer led the first definitive clinical trialdemonstrating that this use could prolong survival and prevent the development of heart failure, which hasimproved the prognosis of untold numbers of survivors of myocardial infarction.

From his major initial discovery, Dr. Pfeffer's career trajectory has been to lead a number of other keypractice-changing, randomized controlled clinical trials. Indeed, a common theme for his substantialcontributions has been in the utilization of the randomized controlled trial to enhance the academicmission. Dr. Pfeffer has had a principal role in several practice-changing clinical trials such as SAVE,CARE, HEART, VALIANT, CHARM and PEACE. He is currently a leading investigator in ARISE, TOPCATand TREAT. He is generally considered as a team builder and takes pride in academic advancement oftrainees and junior faculty collaborating on the trials, and embedding important mechanistic substudieswithin the major randomized trials to enhance our understanding of the pathophysiology of the diseaseprocesses. Pfeffer's trials have set high standards for relationships with the sponsors whether industry orNHLBI. He is known for his fairness in data sharing and assisting others in developing meaningfulscholarly works from study databases. His studies have improved medical practice and patient prognosis.

The influence of a scientist's work in their field can be assessed by how often their publications are citedby other scientists. In 2006, Pfeffer was listed by Science Watch as having the most "Hot Papers" (highlycited) in all of clinical medicine.

On a local level, his leadership abilities are well recognized and appreciated at the Brigham and Women'sHospital as Dr. Pfeffer was recently asked to serve as the Interim Chair of the Department of Medicine.Pfeffer also effectively uses the vehicle of randomized controlled clinical trials to promote physiciansatisfaction and education for those less academically oriented. As the leader of Partners Research andEducation Program (PREP), he has developed networks of community-based physicians who enjoymaking meaningful contributions to clinical investigation.

Bertram PITTM.D.

Education1945-49 Forrest Hills High School, Forest Hills, NY1949-53 Cornell University, New York, New York, B.A1953-59 University of Basel, Switzerland, M.D.

Postdoctoral training1959-60 Intern, Beth Israel Hospital, New York, NY1960-62 Assistant Resident, Beth Israel Hospital, Boston, MA1961-62 Teaching Fellow in Medicine, Harvard University, Boston, MA1962-63 Chief Resident, Medicine, Beth Israel Hospital, Boston, MA1962-63 Assistant in Medicine, Harvard University Teaching Fellow in Medicine,

Tufts University, Boston, MA1966-67 National Heart Institute Special Fellow, Department of Medicine, Division ofCardiology,

Johns Hopkins University, Baltimore, MD

Academic appointments1967-68 Instructor in Medicine, Johns Hopkins University1968-72 Assistant Professor Medicine, Johns Hopkins University1972-77 Associate Professor of Medicine, Johns Hopkins University1977-91 Professor of Internal Medicine, Director, Division of Cardiology, University of Michigan School

of Medicine1991-99 Professor of Internal Medicine, Associate Chairman for Academic and Industrial

Programs, Department of Internal Medicine, University of Michigan School of Medicine

1999- Professor if Internal Medicine, University of Michigan School of Medicine

Certification and licensureMedical Licensure 1960 Connecticut

1960 New York1963 Massachusetts1967 Maryland1978 Michigan

Board Certification 1973 American Board of Internal Medicine1973 American Board of Cardiology

Honors and awards1976-66 Bronze Award, American Heart Association - Maryland Affiliate1977 Haille Selassie Lecturer, British Heart Foundation1978 Outstanding Cardiology Staff - University of Michigan2000 Johns Hopkins University Society of Scholars2001 Forest Dewey Dodrill Award for Excellence-American Heart Association2002 Paul Dekruif Lifetime Achievement Award - University of Michigan

Membership and offices in professional societiesAmerican Physiological Society - Circulation Group ; American Federation for Clinical Research ;American Heart AssociationCouncil on Circulation: 1982-83 Chairman

Council on Radiology1987 Fellow, Council on Clinical Cardiology, American Society for Clinical Investigation - Emeritus2003 Membership, International Society for Heart Research1994 Fellow, American College of Cardiology, Trustee1993 American Society of Nuclear Cardiology, Founding Member1990-93 President, Michigan Chapter of American College of Cardiology1988-92 Cardiovascular Norms Committee, Member, American College of Cardiology Michigan HeartAssociation of University Cardiologists American College of Physicians1988-91Cardiovascular Norms Committee, American College of Cardiology1985-90 American Journal of Noninvasive Cardiology Consultant, Society for Cardiac Angiography1985-87 Chairman, Young Investigator's Award Committee, American College of Cardiology1985 Vice Chairman of the Cardiovascular Council, Central Society for Clinical Research1982 Association of American Physicians ; Society of Nuclear Medicine ; Fellow, American College ofChest Physicians

Stuart John POCOCK

DegreesBA(Upper, 2nd Honours, Mathematics) 1967 - Cambridge UniversityMSc with Distinction (Statistics) 1968 - Imperial College, London UniversityPhD (Medical Statistics) 1972 - London School of Hygiene & Tropical Medicine

Posts held1989 - Professor of Medical Statistics, London School of Hygiene & Tropical Medicine.1987-89 Professor of Medical Statistics, Royal Free Hospital School of Medicine1984-87 Reader in Medical Statistics, Royal Free Hospital School of Medicine1978-84 Senior Lecturer in Medical Statistics, Royal Free Hospital School of Medicine1974-78 Statistician (lecturer scale) University of Edinburgh Medical School1972-74 Visiting Assistant Professor, State University of New York at Buffalo1969-72 Statistician (lecturer scale), London School of Hygiene & Tropical Medicine

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Hubert POULEUR, M.D., Ph.D.

He is Executive Director in Pfizer Global Research and Development.

Dr. Pouleur received his M.D. degree from the University of Louvain, Belgium, in 1973 and joined aFellowship Program in Internal Medicine and Cardiology. From 1977 to 1978, he was a NIH FogartyInternational Fellow at the University of California at San Diego. He became specialist in Internal Medicineand in Cardiology in 1978 and obtained a PhD in Cardiovascular Physiology from the University of Louvainin 1980. From 1979 to 1993, Dr. Pouleur was a faculty member of the University of Louvain MedicalSchool, becoming Associate Professor in 1983 and Professor in 1991. In addition to his teachingactivities, he was involved in basic pharmacologic research and in clinical research, and was a recipientof multiple grants including a grant from the National Heart, Lung and Blood Institute from 1986 to 1992,as one of the P.I.'s of the SOLVD project. In 1993, Dr. Pouleur joined Pfizer Central Research in Grotonand moved to the NYHeadquarters in 2001. From 1993 to 2000, his drug development experienceencompassed more than a dozen of new clinical entities, leading to the approval of 6 new drugs.

Dr. Pouleur is a past member of the Council of the European Society for Clinical Investigation, a Fellow ofthe American College of Cardiology, a Fellow of the American Heart Association, a Fellow of the Councilof Circulation of the AHAand a Fellow of the European Society of Cardiology. He is author or co-author ofmore than 180 articles published in peer reviewed journals.

James H. REVKIN, MD, FACC, FACP

Senior Director, Pfizer Inc.

Research and professional experience1977-81 Brown University School of Medicine and Department of Physiological Biochemistry,

Brown University, Providence, RI, USA

1981-84 Resident in the Department of Medicine and Visiting Clinical Fellow at the Collegeof Physicians and Surgeons of Columbia University,Columbia-Presbyterian Medical Center, New York, NY, USA

1984-87 Postdoctoral Fellow, Section of Cardiovascular MedicineDepartment of MedicineYale University School of Medicine, New Haven, CT, USA

1987-88 Postdoctoral Fellow, Cardiovascular Research Trainee, Center forBioengineering, University of Washington, Seattle, WA, USA

1988-90 Assistant Professor of Medicine,Director, Heart Failure/Transplant Cardiology Program, Division of Cardiology, Department of Medicine, University of Washington, Seattle, WA, USA

1990-93 Assistant Professor of Medicine, Director, Yale University Heart Failure/Transplant Cardiology Program, Section of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, CT, USA

1993-99 Director of Section of Cardiovascular MedicineWaterbury Hospital Health Center, Waterbury, CT, USA

1995-present Associate Clinical Professor of Medicine, Yale Heart Failure CenterTransplant Cardiology Program, Section of Cardiovascular Medicine,Department of Medicine, Yale University School of Medicine, New Haven, CT, USA

1999-present Pfizer Global Research and Development, Cardiovascular and Metabolic Diseases,New London, CT, USA

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Edmond ROLAND MD, FAHA

Dr Roland is graduated from the University of Paris, France and board certified in cardiology. Afterseveral years of clinical appointment in academic institutions, he joined the pharmaceutical industry andspent several years in the US. As Head of worldwide cardiovascular clinical research, he gainedextensiveexperience in global drug development and international regulatory processes. Since 2001, he has resumed clinical activities. Currently, Dr Roland is an attending cardiologist at the teachinghospital "Hopital Européen Georges Pompidou" in Paris. He is also a Clinical Expert for the French Agencyfor Safety of Health Products (afssaps). In addition, he is a member of the EMEAEfficacy Working Partysub-group on cardiovascular issues. The mission of this subgroup is to develop EMEAguidancedocuments for clinical trials on cardiovascular products.

Patrick ROSSIGNOL

Education (degrees, dates, universities)- Master degree (DEA) in Biology and Pathology of the epithelia, 1998, University of Paris VI "Pierre etMarie Curie"- Medical Doctorate, specialty nephrology, 2000, University of Paris V " Necker-Enfants Malades "- Complementary fellowship in Vascular medicine : 2004, University of Paris V "Necker-Enfants Malades “- Ph. D. "Biology and pharmacology of hemostasis" : 2005, University of Paris VII "Denis Diderot"

Professional/research experience- 11/2000-31/10/2002: Ph. D. student, INSERM Unit 460, Dr Michel, Paris.- 11/2002-31/10/2003: Fellowship in vascular biology, Center for Molecular and Vascular Biology,

Katholieke Universiteit Leuven (Belgium) : Pr Lijnen, Pr Collen- 11/2003-04/2006: Chief-Assistant, then Assistant Professor (05/2006-04-2007) :

Vascular Medicine and Hypertension department, Pr Fiessinger, Hôpital Européen Georges Pompidou (Assistance Publique-Hôpitaux de Paris), Paris, and Faculté de Médecine René Descartes-Paris V ; associate researcher,INSERM 765 (formerly U 428), Pr Emmerich.

- 05/2007- Assistant-Professor (Therapeutics), delegate physician of the Nancy UniversityHospital & INSERM Clinical Investigation Centre (Coordinating physician : Pr Zannad) ; associate researcher, INSERM 684, Dr Lacolley.

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Victor L. SEREBRUANY, M.D., Ph.D.

Education1984-1989 Ph.D. Pharmacology. Thesis : "Hemostatic disorders and their pharmaceutical

correction in children with nephrotic syndrome". Institute of Pediatrics & Children's Surgery (Moscow, USSR)

1982-1984 Postdoctoral Fellowship in Perinatology. Institute for Postgraduate Medical Education (Moscow)

1976-1982 M.D. - Second State Medical Institute (Moscow)

Additional training1991 Accounting, economics, industrial psychology

Johns Hopkins University (Baltimore, MD)1988 Business, politics, international trade

Political State University (Moscow, Russia)

Professional experience2006 - present Associate Professor of Medicine, Johns Hopkins University

2000 - present Owner, HeartDrug Research, LLC

1999 - 2005 Editor for Americas, "HeartDrug™" International Journal for Cardiovascular Clinical Trials (Karger Publishers, Basel, Switzerland)

1999 - 2003 Assistant Professor, Department of Medicine, Johns Hopkins University

1997 - 2003 Research Director, Sinai Center for Thrombosis Research.

1997 - 2000 Managing Partner, "HeartDrug™ Research, LLC"

1995 -1997 Director, Cardiovascular Research. Union Memorial Hospital.

1994 - 1995 Research Associate , Division of Cardiology, University of Maryland

1992 - 1994 Postdoctoral Fellow, Division of Cardiology, University of Maryland

1991 - 1992 Sr. Research Assistant , Division of Pediatric Nephrology Johns Hopkins University1989 - 1991 Sr. Research Scientist., Head, Division of Clinical Pharmacology.

Institute of Pediatrics & Children's Surgery, Moscow, USSR

1984 - 1989 Research Scientist., Division of Pediatric Nephrology Institute of Pediatrics & Children's Surgery, Moscow, USSR

Charles L. SHEAR, Dr.P.H., F.A.H.A., F.A.C.E.

Following completion of his doctoral work in epidemiology at Tulane University School of Public Health andTropical Medicine, Dr. Shear was on faculty at a number of medical schools where he continued his focushis research on cardiovascular disease. He joined the pharmaceutical industry in 1986 with MerckResearch Laboratories. In 1991, he joined Pfizer Global Research and Development where he nowserves as Vice President and interim head of Cardiovascular, Endocrine and Metabolic Diseases ClinicalDevelopment. He has numerous original contibutions to the medical literature and is a recognized leaderin the development of novel cholesterol regulating drug therapies.

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Susan Blakely SHURIN

INSTITUTION AND LOCATION DEGREE (if applicable) YEAR(s) FIELD OF STUDYHarvard College, Cambridge MA BA 1965 BiologyGeorgetown University, Washington DC None 1966-68 Physiology &

BiophysicsJohns Hopkins University, Baltimore MD MD 1971 Medicine

Positions and Employment- Intern, Johns Hopkins Hospital, Harriet Lane Home, Pediatrics, 1971-72- Resident, Boston University, Boston City Hospital, Pediatric Service, 1972-73- Chief Resident in Pediatrics, Boston University, Boston City Hospital, 1973-74- Fellow in Pediatric Hematology/Oncology, Children's Hospital Medical Center of Boston/Dana FarberCancer Center, 1974-76; Research Fellow in Oncology, Massachusetts General Hospital, 1976-77- Fellow, Executive Leadership in Academic Medicine (ELAM), Drexel University, 2000-2001- Professor of Pediatrics, CWRU 1993-2005 [Assistant Professor 1977-1986; Associate Professor 1986-1993] - Chief, Division of Hematology/Oncology, Rainbow Babies/Children's Hospital, 1986 2002- Vice President and Secretary of the Corporation, and Professor of Pediatrics, Case Western ReserveUniversity, 2002-2005 - Partner, Isaacson Miller Inc, Boston MA, 2005- Deputy Director, National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health,Bethesda MD, 2006 to the present

Professional ActivitiesCase Western Reserve University: Member and Chair of University Faculty Senate; Member and Chair ofSchool of Medicine Faculty Council; Committee on Medical Education; Committee on Students;Committee on Tenure and Promotions; multiple other standing and ad hoc committee memberships.Rainbow Babies and Childrens Hospital, University Hospitals of Cleveland, Case Comprehensive CancerCenter: Medical Director: ambulatory and inpatient patient care services; Hemophilia Treatment Center;Bone marrow transplant service; Neuro-oncology service; Executive committees of Departments ofPediatrics and Cancer Center Federal and state consultation: Chair of State of Ohio Bureau for Children with Medical Handicaps andBone marrow transplantation Board; service on multiple NIH study sections, working groups and data safe-ty monitoring boards.Officer/Director: American Cancer Society, National Hemophilia Society, CureSearch (COG), LeukemiaSociety

Leadership roles in National/International Professional associations: - American Society of Hematology: multiple committee memberships and chairmanships- American Society of Pediatric Hematology/Oncology; multiple committee memberships and chairmans-hips; Secretary-Treasurer, 1995-2003- American Academy of Pediatrics: Section on Pediatric Hematology-Oncology; faculty for courses - Society for Pediatric Research/American Pediatric Society: committee memberships and chairmanships;APS Council member- Children's Cancer Group and its successor cooperative pediatric oncology cooperative group, Children'sOncology Group: Executive Committee member; Bioethics Committee Chair 1993-1003; DSMB member;member and chair of multiple study committees; member of acute lymphoblastic leukemia and brain tumorStrategy Groups, designing and selecting studies.Laboratory interests: phagocytic cell function, sickle cell disease, mechanisms of hemolysisClinical research interests: Interventional trials in non-malignant hematology (hemoglobinopathies, throm-bocytopenia, neutrophil disorders, bleeding and thrombotic disorder), malignancies (leukemia, solidtumors), and hematopoietic stem cell transplant. Ethical conduct of research at individual and institutionallevels, including informed consent and return of results to participants. Active Medical licenses: Ohio, Maryland. Active Board Certification in Pediatrics and PediatricHematology-Oncology.

Maria R. STAGNITTO, RN, MSN

Education2007-(2008) Certificate in Public Leadership

Brookings Institution, Washington, DC2004- 2006 Career Development Program,

Senior Executives in Health and Human Services - Washington, DC1985-1987 Post Master's Certificate Program, Nursing Middle Management

George Mason University, Fairfax, Virginia1975-1977 Master's of Science in Nursing (MSN)

Seton Hall University, College of Nursing - South Orange, New Jersey1970-1974 Bachelor of Science in Nursing (BSN)

Seton Hall University, College of Nursing - South Orange, New Jersey

Professional experience 2005-Current: Director, Office of Clinical ResearchNational Heart, Lung, and Blood Institute, NIH, Bethesda, MD

Responsible for creating a central clinical research office for extramural affairs to 1) coordinate clinicalregulatory activities internally with NHLBI Divisions and other Government agencies and Institutes of theNational Institutes of Health; 2) serve in an advisory role to scientific and health care staff, principalinvestigators and research staff related to adverse experiences; 3) provide education/training forextramural staff managing clinical research; 4) serve as a central point for negotiations with FDA, CMS,drug and device companies and other third parties; 5) maintain central databases and policies; 6) evaluate existing programs for standardizing data collection in clinical trials; 7) implement research informatics solutions; 8) maintain surveillance over developments in designated areas of responsibility andadminister a program of research contracts, cooperative agreements and grants as assigned.

2000-2005: Associate Director, Office of Clinical Affairs, Division of Intramural ResearchNational Heart, Lung, and Blood Institute, NIH, Bethesda, MD

Responsible for creating a central clinical research office for intramural research. Responsible fordeveloping and implementing policies and practices related to the conduct of human subjects research byNHLBI. Independently analyze each clinical research protocol prior to implementation, determining policycompliance and impact on resources, and evaluating short term and long term needs of the clinicalbranches. Serve as the Executive Secretary for the Institute's Scientific Review Committee. Responsiblefor organizational oversight of the Investigational Review Board (IRB) for NHLBI and serve as theExecutive Secretary of the IRB. As the Associate Director, also serve as the Executive Secretary to thethree Intramural Data Safety Monitoring Boards. Serve in an advisory role to the Director, ClinicalResearch Program, as well as other senior management officials within the NHLBI, and with NIH officialsto evaluate current procedures and recommend and implement changes.

Professional membershipsPublic Responsibility in Medicine and Research (PRIM&R)Sigma Tau National Nursing Honor SocietyGamma Nu ChapterGreater Washington Area Chapter of the American Association of Critical Care NursesAmerican Nurses AssociationMaryland Nurses Association, District V

Community membership1995-Present Board Member, Friends of the Clinical Center1998-2001 President, Friends of the Clinical Center2001-2002 Past-President, Friends of the Clinical Center1997-2000 Co-chair Capital Campaign, Barrie School and Camp

Philippe Gabriel STEG, MD, FESC, FACC, FCCP

Dr Steg has been a Professor of Cardiology in Université Paris VII - Denis Diderot, since 1994. He worksas interventional cardiologist and is director of the Coronary Care Unit of Hôpital Bichat-Claude Bernardin Paris, France. He is also director of the research team "Clinical Research in Atherothrombosis", inINSERM U-698, Hôpital Bichat-Claude Bernard, Paris.

Dr Steg's research interests are in the field of coronary artery disease. He is involved in studies of mechanical and pharmacologic intervention in acute myocardial infarction, but has also recently turned hisattention to secondary prevention, long-term risk assessment and management of atherothrombosis. He is a former president of the Thrombosis Working Group of the French Society of Cardiology andbelongs to the nucleus of the Thrombosis Working Group of the European Society of Cardiology. He is aformer member of the Institut Universitaire de France, a fellow of the European Society of Cardiology,American College of Cardiology, and American College of Chest Physicians and former chairman of thePublic Relations committee of the European Society of Cardiology.

Dr Steg participated in the steering or executive committees of trials such as CAPTIM, GUSTO-V, CHARISMA, OASIS-5 and 6, and was the principal investigator of investigator-driven and industry-sponsored clinical trials and registries. He is co-chair of the GRACE and the REACH Registries publication committees. He was DSMB or CEC member or chair for several large trials.

Dr Steg has authored more than 300 articles in peer-reviewed international journals, and is a member ofthe editorial board for Circulation, JAMA, the European Heart Journal and for Theheart.org.

He is a member of the Task Force updating the ESC guidelines on the Management of acute myocardialinfarction in patients presenting with STsegment elevation, a member of the international ESC/ACC-AHA/WHF/WHO Task force for the definition of myocardial infarction and a member of the GuidelineCommittee for the VIII Guidelines on antithrombotic therapy of the ACCP.

Beth DAVISON WEATHERLEY

EducationInstitution Date Degree

High School George Washington H.S.Charleston, WV 1978 Diploma

College Duke University,Durham, NC 1982 AB, Chemistry, Specialization in

Biological Chemistry, second major Psychology

Graduate School University of Maryland,College Park, MD 1987 MS, Poultry Science,

Neuroscience ProgramGeorgetown University,Washington, DC 1989 MS, Biostatistics and Epidemiology

University of North Carolina,School of Public HealthChapel Hill, NC 2003 PhD,

Epidemiology, minor Biostatistics

Scholarly societiesPhi Lambda Upsilon National Honorary Chemical SocietySigma Xi

Professional training and academic careerInstitution Position/Title Dates

National Institute of Allergy and Infections Diseases Chemist 1982-1984

University of Maryland, College Park Graduate Research Assistant 1984-1986

Nova Pharmaceutical Corporation Senior Research Pharmacologist 1986-1987Clinical Data Specialist 1987-1988

Biometric Research Institute, Inc. Biostatistician 1988-1989Assistant Project Director 1989-1990Project Director 1990-1994Manager, Scientific/Technical Staff 1992-1994Associate Director of Biometrics 1994-1995

Department of Epidemiology, School of Public Health, University of North Carolina Predoctoral Fellow 1997-2000

Postdoctoral Fellow 2003-2004

Stat-Tech Services, LLC Senior Statistical Director 2004-2005

Duke Clinical Research Institute, Duke University Medical Center Senior Statistician 1996-19972001-2007

Momentum Research, Inc Vice President, Biometrics 2007-present

Hans WEDEL

I have been professor in Epidemiology and Biostatistics at the Nordic School of Public Health, Gothenburg,Sweden since 1982.During six years I was the chairman of the "Committee for Research and Education"at Nordic School of Public Health. For six years I was a member of the prioritising group for Epidemiologyand Social Medicine at the Swedish Medical Research Council. I have been president of the SwedishEpidemiological Society and the Swedish Society of Biostatistics. I was educated as a statistician atGothenburg University. My special research areas are cardiovascular epidemiology and clinical trials incardiovascular medicine.

I have kept my interest in both epidemiology and clinical trials during the years. Until 1982 I was the responsible statistician for several large cohort studies in Gothenburg and workedclose together with medical doctors and computer specialists.During 1979-80 I was a visiting-scientist at Biostatistics Branch, NHLBI, Bethesda, Maryland. In 1993 I hada sabbatical year partly at University of Wisconsin, Madison and partly at Stanford University. I have been on the Steering Committee or DSMB for several large clinical trials. I was the statistician onthe Steering Committee for HAPPY, MIAMI, HOT, 4S, MERIT, CONSENSUS-2, OPTIMAAL, LIFE,DIGAMI I+II, and at present ASCOTand CORONA. I was a member of the DSMB for STOPI+II, ATLAS,FRISCII, LOWASA, IDEAL, ALERT, EXPRESS, CARE-HF and ESSENTIALand now for HEAAL, DIRECT,AURORA, SCAST, NOCTETand DOT-HF.

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Janet WITTES

Janet Wittes, Ph D. is the President of Statistics Collaborative, Inc. which she founded in 1990. From 1974to 1983 she was on the faculty of the Department of Mathematical Sciences at Hunter College. In 1983she joined the Biostatistics Research Branch, National Heart, Lung, and Blood Institute as its Chief. Herresearch has focused on the design and analysis of randomized clinical trials. She is a Fellow of theAmerican Statistical Association, the American Association for the Advancement od Science, and theSociety for Clinical Trials. She is a past President of the International Biometric Society - Eastern NorthAmerican Region (1995) and the Society for Clinical Trials (2001). From 1990 through 1995 she servedas Editor-in-Chief of Controlled Clinical Trials. She is a member of many Data and Safety MonitoringBoards (DSMBs) for randomized clinical trials sponsorised by both industry and government. Coauthoredwith Drs. Michael Proschan and Gordon Lan, her recently (2006) published book “Monitoring ClinicalTrials: AUnified Approach” deals with methods for interim analysis of data. She received her A. B. inMathematics from Radcliffe College (1964) and her Ph. D. from the Department of Statistics of HarvardUniversity (1970).

Faiez ZANNAD, MD, PhD, FESC Cardiology and Centre d'Investigation Clinique, InsermNancy University

He is Professor of Therapeutics at the Medical Faculty of the Henri Poincaré University of Nancy. He obtained his MD as a Cardiology specialist in 1979 from the Faculté de Médecine de Nancy. In 1981he served as a Research Fellow at the Clinical Pharmacology Medical Research Unit of Oxford University,UK and in 1986 he obtained his PhD in cardiovascular clinical pharmacology at the University of Lyon. Heis currently Head of the Division of Heart Failure, Hypertension and Preventive Cardiology/ department ofCardiovascular Disease of the academic hospital of Nancy, and Director of the Clinical InvestigationCenter (CIC), mutually funded by the academic hospital and the INSERM and of a research group at anINSERM Unit (U684, Cardiac Fibrosis, Stiffness and cardiovascular risk) at the Faculté de Médecine. He is coordinator of a Joint Research Program on transition from Hypertension to Heart Failure, in the EUfunded Network Excellence "InGeniousHyperCare". He conducts his research, in the area of physiopathology and pharmacotherapeutics of hypertension and heart failure. Dr Zannad is Chairman ofthe Board of the French Society of Hypertension, Fellow of the European Society of Cardiology (ESC),Vice-chairman of the ESC Working group on pharmacology and drug therapy as well as a member of alarge number of international societies in cardiology, hypertension, pharmacology and therapeutics. He iscurrently Co- Editor in chief of Fundamental and Clinical Pharmacology, the official journal of the EuropeanFederation of Pharmacological Societies (EPHAR) and a member of the Editorial boards of a number ofjournals in the field of Cardiology, Hypertension and Cardiovascular Pharmacology. He has contributedmore than 300 scientific publications and published several books on cardiovascular pharmacotherapyand on Heart Failure. He is chairman and organizer of several international meetings: "CardioVascularClinical Trialists (CVCT) Forum and Workshop" (Cannes and Paris, with Bertram Pitt and DesmondJulian); "Acute Heart Failure Syndromes" (Cannes and Chicago, with Mihai Gheoghiade) and "Biomarkersin Heart Failure" (Cannes, with Kirkwood Adams). Dr. Zannad is involved in a number of major cardiovascular clinical trials, as a Principal Investigator and/or as a chair or member of several SteeringCommittees, Critical Event Committees and Data Safety and Monitoring Boards. Steering Committeemembership: APSI, FIRST, CIBIS I and II (Executive committee), RALES (Executive committee), CAPRI-CORN, FOSIDIAL(Chairman), VALIANT, RECOVER, MOXCON, EPHESUS (Executive committee),AURORA(Executive committee) , EVEREST(Executive committee), EMPHASIS-HF (Chairman), CriticalEvent Committee: CAPRICORN, RESPECT, SCOUT, Data and Safety Monitoring Board HEAAL, Protocolwriting groups RALES, CAPRICORN, CIBIS II and EPHESUS, EVEREST.

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Névine ZARIFFA

Névine is Vice-President of Biomedical Data Sciences in the Cardiovascular & Metabolism MedicineDevelopment Center at GlaxoSmithKline Pharmaceuticals. The Division encompasses most of thequantitative sciences at GSK including Biostatistics, Epidemiology and Mathematical Modelling. For thepast six years she has served as a member of the Leadership Team which manages this part of the GSKportfolio bringing a quantitative skill set to decision making. She works with clinical and regulatorycolleagues within and outside the company to optimise drug development. Along with the rest of hercolleagues, she is continuously evaluating novel statistical and mathematical approaches to improve thespeed and quality of molecules as they develop into new medicines for patients. Névine holds a BSc inpure mathematics from McGill University and a MMath in Statistics from the University of Waterloo.

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Robert ZOLYNAS, DVM, MBA

Associate Director, Cardiovascular Clinical ResearchJohnson & Johnson PRDRaritan, NJ

Dr. Zolynas is Associate Director of Cardiovascular Research at Johnson & Johnson PRD where plans,initiates, and manages global cardiovascular clinical trials. He received his Doctor of Veterinary degreefrom Lithuania Veterinary Academy and MBAfrom Indiana State University. Dr. Zolynas joined J&J PRDin August 2005. Prior to joining J&J PRD, Dr. Zolynas was with Schering-Plough Corp. for over 6 yearswhere he held various positions of increasing responsibility within clinical operations organization.