Faculty

Faculty

ATAR Dan
Division of Cardiology
AKER UNIVERSITYHOSPITAL
Trondheimsvn. 235
N- 0514 OSLO
NORWAY
BERNAUD Corine
EU Medical Affairs Director, CV
AstraZeneca - ISMO Europe
Da Vincilaan 2 Box 2
B-1935 Zaventem
Belgium
BORER Jeffrey S.
Director
The Howard Gilman Institute For Valvular Heart
Diseases
Weill Medical College of Cornell University
47 East 88 th
Street
NEW YORK, NY10128-1152..
USA
BUCH Jan
Global Team Leader/Sr Medical Director
PFIZER Inc - NYHQ
235 East 42 nd
Street
NEW YORK - NY10017
USA
BURTON Paul
Senior Medical Director, Medical Leader
Johnson and Johnson Pharmaceutical Research
Division
920 Route 202
Raritan, NJ 08869
USA
FACULTY
COTTER Gadi
Director, Momentum Research
3100 Tower Blvd. Ste 507
Durham, NC 27707
USA
DEMETS David
Dept of Biostatistics & Medical informatics
University of Wisconsin Medical School
K6/446 Clinical Science Center
600 Highland Avenue K6/446CSC Box 4675
MADISON, WI 53792-4675
USA
DOMANSKI Michael
Chief, Atherothrombosis and Coronary Artery
Disease Branch
NHLBI,
6701 Rockledge Drive,
BETHESDAMD 20892
USA
GELLER Nancy
Director, Office of Biostatistics Research,
National Heart, Lung and Blood Institute
Rockledge II Suite 9093
6701 Rockledge Drive MSC 7913
Bethesda, MD 20892-7913
USA
GORDON David
Special Assistant for Clinical Studies
National Institutes of Health - Blood Institute
6701 Rockledge Drive, Room 8134
Bethesda, Maryland 20892-7940
USA

GUSTAFSSON Finn
Department of Cardiology
Copenhagen University Hospital
Rigshospitalet
Blegdamsvej 9
DK-2100 Copenhagen
DENMARK
HAMELIN Bernard
Directeur Médical Europe AZ
ASTRAZENECASA
Corporate Village
Da Vincilaan 2, Box 2
B- 1935 ZAVENTEM
BELGIUM
JULIAN Desmond
Dept of Cardiology University of Newcastle upon
Tyne,
Flat 1
7 Netherhall Gardens
LONDONNW3 5RN
UK
KARKOWSKYAbraham
Acting Deputy Division Director
FDA
White Oak CDER Office Building 22 - Room 4164
10903 New Hampshire Avenue
Silver Spring MD 20993
USA
KOLSKYHélène
Consultant
3, Clos de la Bergerie
78240 Chambourcy
FRANCE
FACULTY
LAFONT Antoine
Hôpital Européen Georges Pompidou
20, rue Leblanc
75908 PARIS cedex 15
FRANCE
LECHAT Philippe
Directeur de l'évaluation des médicaments
et des produits biologiques
AFSSAPS
143-147, boulevard Anatole France
93285 SAINT-DENIS CEDEX
FRANCE
LIPICKYRaymond
Director
LIPICKY, LLC
15201 Apricot Lane
North Potomac
GAITHERSBURG, MD 20878
USA
LUBSEN Jacobus
SOCAR RESEARCH SA
Chemin de Chantemerle 18
CH - 1260 NYON 2
SWITZERLAND
MITCHELYale
Executive Director, Clinical Research
MERCK & Co, Inc
Whitehouse Station
RAHWAYRY34-A228
NJ
USA

PFEFFER Marc
Brigham and Women's Hospital
Cardiovascular Division
75 Francis Street
BOSTON, MA02115
USA
PITT Bertram
Professor of Medicine Emeritus
24 Ridgeway
ANN ARBOR, MI 48104
USA
POCOCK Stuart
Medical Statistics Unit
London School of Hygiene and Tropical Medicine
Keppel Street
LONDON, WC1E 7HT
UK
FACULTY
POULEUR Hubert
Executive Director - CV/Metabolic -Global Outcomes
Research
PFIZER INC
235 East 42nd Street - 205/8/13
NEW YORK, NY10017
USA
REVKIN James
Senior Director, Pfizer, Inc. And Associate Clinical
Professor of Medicine
Yale University School of Medicine
NEW HAVEN, CT
USA
ROLAND Edmond
Hôpital Européen Georges Pompidou
20, rue Leblanc
75908 PARIS cedex 15
FRANCE
ROSSIGNOLPatrick
Médecin délégué
HOPITALJEANNE D'ARC
CIC
BP90303
54201 DOMMARTIN LES TOUL
FRANCE
SEREBRUANYVictor
Associate Professor of Medicine
Johns Hopkins University, Président, HeartDrug
Research LLC
7600
Osler Drive, Suite 307
TOWSON 21204 Maryland
USA
SHEAR Charles L. (Chuck)
Vice-President
CUMED Development
Pfizer Global Research Development
50 Pequot Ave, MS 6025-A4113
NEW LONDON CT06320
USA
SHURIN Susan
Deputy Director
NHLBI
Room 5A48
31 Center Drive MSC 2486
BETHESDA, MD 20892-2490
USA

STAGNITTO Maria
Director Office of Clinical Research
NHLBI
6701 ROCKLEDGE DR
room 9093
Bethesda MD 20892-7913
USA
STEG Philippe Gabriel
Service de Cardiologie
HOPITALBICHATCLAUDE BERNARD
46, rue Henri Huchard
75 877 PARIS CEDEX 18
FRANCE
WEATHERLEYBeth
Momentum Research, Inc
Vice President, Biometrics
3100 Tower Blvd. Ste 802
Durham, NC 27707
USA
WEDELHans
Nordic School of Public Health
Sahlgrenska University Hospital
Box 12133
S-40242 GOTHENBURG
SWEDEN
FACULTY
WITTES Janet
Statistics Collaborative
1710 Rhode Island Ave, NW
WASHINGTON, DC 20008
USA
ZANNAD Faiez
CIC INSERM - CHU and Department of
Cardiology
Hôpital Jeanne D'Arc
54200 DOMMARTIN LES TOUL
FRANCE
ZARIFFANevine
Vice-President, Biomedical Data Sciences
Cardiovascular and Metabolism MDC,
GlaxoSmithKline Pharmaceuticals
2301 Renaissance Blvd,
Building #510, BOX 61540
KING OF PRUSSIA, PA19406
USA
ZOLYNAS Robert
Senior Medical Director, Medical Leader
Johnson and Johnson Pharmaceutical Research
Division
920 Route 202
Raritan, NJ 08869
USA

Dan ATAR, MD
Dan Atar, MD, (48) is Head of Cardiology at Aker University Hospital, Oslo, Norway, and holds a full
Professorship in Cardiology at the University of Oslo, Norway, along with a Visiting Associate
Professorship at the Johns Hopkins Unversity, Baltimore, Maryland, USA.
Dan Atar trained in Denmark, Switzerland, and the United States before receiving his board
certification in Internal Medicine and Cardiology in 1995. His research focuses on myocardial
biomarkers, 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 Drug
Therapy), 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".
____________________________________________________________________________
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 practice
as a general practitioner and sports medicine specialist. She joined Pfizer France in 1990, then Sankyo
Pharma France in 2004 and AstraZeneca in 2006. She has contributed to the design, monitoring and
steering of several clinical trials in cardiology and a number of publications in peer reviewed journals.

Jeffrey S. BORER,M.D
Biographical Sketch
He is the Gladys and Roland Harriman Professor of Cardiovascular Medicine at Weill Cornell Medical
College, where he also is Professor of Radiology and of Cardiothoracic Surgery, both in Cardiovascular
Medicine, and, administratively, chairs the Section of Cardiovascular Pathophysiology and The Howard
Gilman Institute for Valvular Heart Diseases.
He received his undergraduate education at Harvard, his medical degree from Cornell, and his postgraduate
training at the Massachusetts General Hospital and in the Cardiology Branch of the National
Heart, Lung and Blood Institute of the NIH, where he subsequently established the Nuclear Cardiology
service and served as its first Chief. He was a Senior Fulbright Hays Scholar and Glorney-Raisbeck Fellow
in 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-reviewed
journals. Since 1977 he has served continually as an Advisor/Consultant to the Cardio-Renal Division of
the U.S.F.D.A., chairing the Cardio-Renal Advisory Committee for 3 separate terms, the last ending in
2004. He has authored a book on regulatory aspects of cardiovascular drug development and consults
regularly for the pharmaceutical and devices industries. From 1984 through 2005 he served continually as
an Advisor to NASA. He was President of the New York Cardiological Society in 1990-91, President of the
New York State Chapter of the American College of Cardiology from 1997 to 1999, member of the Board
of Governors of the American College of Cardiology from 1997-2000, member of Board of Governors of
the Society of Cardiac Angiography and Interventions from 1995 to 2000, and member of the Board of
Trustees of the Certification Board of Nuclear Cardiology from 1996 to 2002. Currently, he is President of
the Heart Valve Society of America. He has authored 4 books and authored or co-authored almost 400
journal articles, reviews and chapters. His research achievements have included (1) establishment of the
benefits of the drug, nitroglycerin, during acute myocardial infarction (1971-75); (2) development of realtime
radionuclide cineangiography and its application during exercise (1976-1979); (3) development of
non-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 other
volume overload states (1984-present). He has received several peer recognitions including the
Hans-Peter Krayenbeuhl Memorial Award of the International Society of Cardiology in 2002 and the Public
Service Medal of the National Aeronautics and Space Administration in 1999.
____________________________________________________________________________
Jan BUCH
1969 MD Copenhagen University. Denmark
1969 ECFMG Exam (Educational Council for Foreign Medical Graduates).
USA
Specialist 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, Denmark
1992-1999 Senior Associate Medical Director. Norvasc Team, Pfizer International, HQ, New York
1999-2001 Medical Director. Norvasc Team, Pfizer Pharmaceuticals Group
2001-2003 Senior Medical Director. Norvasc Team, Pfizer Pharmaceuticals Group
2003-2006 Senior Medical Director, Caduet/Norvasc Team, Pfizer Global Pharmaceuticals
2006 Senior Medical Director/World Wide Team Leader - Cardiovascular, Metabolic and
Endocrine. Pfizer Global Pharmaceuticals
2007 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 and
Johnson Pharmaceutical Research and Development in New Jersey, USA. Prior to that Dr. Burton was
the medical director for INTEGRILIN® (eptifibatide) at Millennium Pharmaceuticals Inc. in
Massachusetts, USAand Global Development Leader for Aranesp ® (darbepoetin alfa) New Indications
at 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 completion
of his medical education, Paul was awarded a Medical Research Council Clinical Training
Fellowship in cardiothoracic surgery. The focus of Paul's Ph.D was cardiac myocyte cell cycle regulation,
and its application to heart failure.
As global development leader for the new indications of Aranesp at Amgen, Paul was responsible for
overseeing 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 with
ischemic heart disease. At Millennium Pharmaceuticals Paul was responsible for the design and execution
of phase II-IV clinical trials in the area of acute coronary syndromes, including clinical leadership
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 College
of Surgeons and a Fellow of the American College of Cardiology.
Appointments
JOHNSON AND JOHNSON PHARMACEUTICALRESEARCH AND DEVELOPMENT. SEPTEMBER
2006 TO PRESENT
Senior Medical Director and Medical Leader for Rivaroxaban in ACS
JOHNSON AND JOHNSON PHARMACEUTICALRESEARCH AND DEVELOPMENT. NOVEMBER
2005 TO SEPTEMBER 2006
Medical Director and Project Physician for PROCRIT
MILLENNIUM PHARMACEUTICALS INC. JANUARY2005 TO NOVEMBER 2005
Medical Director and INTEGRILIN Project Physician responsible for all aspects of INTEGRILIN clinical
development and medical monitor for the EARLYACS study, an international phase III clinical trial of
10500 patients with acute coronary syndromes.
Additional responsibility for INTEGRILIN medical affairs, including KOLrelationship development and
investigator initiated study approval, speaker training, medical review and release and phase IV clinical
trial design.
AMGEN INC. JULY2002 TO JANUARY2005
Global Development Leader, Clinical Development.
Responsible for phase I-III clinical trial design and execution exploring Aranesp treatment in patients
with 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 the
treatment of heart failure, coronary artery disease and peripheral vascular disease.
IMMUNEX CORPORATION. 2001 TO JULY2002
Staff Scientist, Vascular Biology.
Focus on the application of translational medicine to heart failure and atherosclerosis.
NATIONALHEARTAND LUNG INSTITUTE, IMPERIALCOLLEGE SCHOOLOF MEDICINE. 1996-
2001
Lecturer 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 nursing,
and include postdoctoral training.)
INSTITUTION AND LOCATION DEGREE YEAR(s) FIELD OF STUDY
(if applicable)
Jerusalem University,
School of Medicine, Hadasah B.Msc 1986 Medicine
Jerusalem University,
School of Medicine, Hadasah M.D. 1989 Medicine
Professional experience
1989-1990: 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 of
Medicine "A"
1998-2001: Assaf Harofeh Medical Center Zerifin, Israel. Fellowship in Cardiology, Cardiology Department
1997-2004Medical coordinator of EMS services (Emergency Medicine); Rishon Letzion, Ramle and LOD
1997-2004 Director, Clinical Pharmacological Research Unit, Assaf-Harofeh Medical Center
2004-2007, Assistant Professor, Duke University Medical Center
2007 -present, CEO Momentum-Research Inc.
Editorial boards
1. Europena Journal of Heart Fialure, Elsevier.
2. Journal of Cardiac Failure
____________________________________________________________________________
David L. DEMETS
David L. DeMets, PhD is currently Professor and Chair of the Department of Biostatistics and Medical
Informatics at the University of Wisconsin - Madison.
Since receiving his PhD in 1970, he has been active in the design, conduct, and analysis of clinical trials
in 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 National
Institutes of Health where he became chief of a Biostatistics Research Branch. He has co-authored four
texts, Fundamentals of Clinical Trials, Data Monitoring in Clinical Trials: ACase Studies Approach and
Data Monitoring Committees in Clinical Trials: APractical Perspective, Statistical Methods for Clinical
Trials.
Dr. DeMets is a recognized international leader in statistical research and methods for the analysis of
clinical trials. He has collaborated in the development of statistical methods for the sequential analysis of
outcome data and the design of clinical trials. He has extensive national and international clinical trial
experience and has served on and chaired numerous NIH and industry-sponsored Data Safety and
Monitoring Committees for clinical trials in diverse disciplines. He served on the Board of Scientific
Counselors 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 North
American Region (ENAR) of the Biometric Society. In addition he was Elected Fellow of the Society for
Clinical Trials in 2006.

Michael John DOMANSKI, M.D.
Current position
Chief, 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 training
Bachelor of Aerospace Engineering (Highest Honor) - Georgia Institute of Technology, Atlanta, GA
Doctor of Medicine - University of Maryland School of Medicine, Baltimore, MD
Resident in Internal Medicine - Hershey Medical Center, Pennsylvania State University, Hershey, PA
Fellow in Cardiology - Vanderbilt University Hospital, Nashville, TN
Advisory and editorial boards
Food and Drug Administration (FDA) - Circulatory Devices Panel and other Panels over many years
Department of Veterans Affairs - Cooperative Studies Scientific Merit Review Board
Georgia 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 Trials
Co-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 Artery
Bypass Graft Trial - Post-CABG; Multicenter Unsustained Tachycardia Trial - MUSTT; Magnesium in
Coronaries - MAGIC; Prevention of Events with Angiotensin Converting Enzyme Inhibitors - PEACE;
Action to Control Cardiovascular Risk in Diabetes - ACCORD; Treatment of Preserved Cardiac Function
Heart Failure with an Aldosterone Antagonist - TOPCAT; Future Revascularization Evaluation in Patients
with Diabetes Mellitus: Optimal Management of Multivessel Disease -FREEDOM
Clinical Site Principal Investigator /Co-Principal Investigator - Atrial Fibrillation Follow-up Investigation In
Rhythm Management - AFFIRM (Prince Georges Hospital, Cheverly, MD and National Naval Medical
Center, Bethesda, MD); Prevention of Events with Angiotensin Converting Enzyme Inhibition - PEACE
(Prince Georges Hospital, Cheverly, MD) Beta-Blocker Evaluation Survival - BEST(National Naval
Medical Center, Bethesda, MD)
NHLBI Project Officer - Beta-Blocker Evaluation of Survival Trial (BEST); Post Coronary Artery Bypass
Graft Trial -Post-CABG; Atrial Fibrillation Follow-up Investigation in Rhythm Management - AFFIRM;
Magnesium in Coronaries Trial - MAGIC; Multicenter Unsustained Tachycardia Trial - MUSTT; Sudden
Cardiac Death in Heart Failure Trial - SCD-HeFT; Coronary Artery Bypass Graft - CABG Patch; Treatment
of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist - TOPCAT; Future
Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel
Disease - FREEDOM

Nancy L. GELLER
She has been the Director of the Office of Biostatistics Research at the National Heart, Lung and Blood
Institute 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 cardiovascular
trials, 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 as
President of the International Society for Clinical Biostatistics from 1999-2000. She is an Associate Editor
of Biometrics and a member of the Editorial Board of the journal Clinical Trials. She is a Fellow of the
American 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 angiotensin
converting enzyme inhibition in patients with stable coronary artery disease: the Prevention of
Events with Angiotensin Converting Enzyme Inhibition (PEACE) Trial. New England Journal of Medicine
351:2058-2068.
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 the
AFFIRM Investigators. (2005). Clinical factors that influence response to treatment strategies in atrial
fibrillation: the AFFIRM study. American Heart Journal 149:645-649.
Geller, N.L. and Friedman, L. (2005). Cooperative heart disease trials. Encyclopedia of Biostatistics, Peter
Armitage 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. Clinical
Trials. (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 Membranes
and Other Particulate Systems -- Information and Artifact.)
1973 M.D., University of Chicago Pritzker Medical School
1981 M.P.H., Department of Epidemiology, University of North Carolina, Chapel Hill
(Thesis: Dietary Determinants of Plasma Cholesterol Change in the Recruitment Phase
of 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 cardiovascular
epidemiology and clinical trials. Topics include:
- The LRC-CPPT, ALLHAT-LLT, and other cholesterol lowering trials. Lead author of LRC collaborative
study 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 optical
activity as a structural probe of particulate systems. As an NHLBI post-doctoral fellow, Dr. Gordon was the
primary author of four peer-reviewed publications on the isolation and characterization of cytoplasmic
actins.

Finn GUSTAFSSON, M.D., Ph.D.
Education
M.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
Employment
1.8.1994-31.1.1995 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 associate
Dept. of Medical Physiology
University 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 work
Has 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 Physiologica
Scandinavica, 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, MD
ISMO 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 and
received his Master in Science degree in Pharmacology and Cellular Biology at the University of Paris in
1987.
Later in 1993, he obtained his eMBAfrom the "Institut Administration des Entreprises" at the University of
Paris.
Bernard practiced at the Hospital of Marseille in Oncology and Radiotherapy and in the Hospital of Paris
in 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 to
Astra 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 and
was the Medical responsible for Nexium (phase II/III) and supported the pre-launch marketing activities for
phase IIIb/IV. In 1999 he was promoted Global Director GI Therapeutical Area and he returned to
AstraZeneca France in 2001 where he was appointed Medical Director.
In 2005, Bernard joined AstraZeneca ISMO, as EU Medical Director and is responsible for the Medical
Affairs, Clinical Research and Medical Information.
____________________________________________________________________________
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. In
1962, he went to Sydney, Australia to set up one of the first coronary units. He was Cardiologist in the
Royal 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 Heart
Foundation from 1986 to 1993.
He was President of the British Cardiac Society from 1985-87. He was awarded the Gold Medal of the
European Society of Cardiology in 1998. He received the Mackenzle Medal of the British Cardiac Society
in 2003 and the International Service Award of the American College of Cardiology in 2005. He was
awarded 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 or
editor of some 20 books on cardiological topics. He has been involved in the design, monitoring and
analysis 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 history
FDA- 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)
____________________________________________________________________________
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. Montpellier
post-doctoral fellowship at the Cleveland Clinic Foundation 1989-1991
Professor of medicine, University PARIS V, Head of the dept of interventional cardiology, HEGP
Adjunct staff, biomedical engineering Dept, Cleveland Clinic Foundation 1991-2006
Research fields
arterial 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 smooth
muscle cells.
- In 2007, creation of U 849 : arterial repair(therapeutic options in interventional cardiology).
Principal scientific and administrative responsibilities
Head of EMI-U 0016 until 2006
Head of U 849 from 2007
CSS 4 (INSERM) until 2003
Supervision of DEA(6) & thesis (6)
Member of the commission du 3 e cycle, Université Paris V
Member of the research committee of HEGP
Review in the peer review process of journals: ATVB, Heart, Journal of the American College of
Cardiology, American Journal of Cardiology, Cardiovascular Research, Biomaterials, Circulation.
Industrial ccoperations and valorisation
Nine patents involving bioresorbable stent, decorin and prevention of intrastent restenosis identification
and therapeutic use of side population cells, use of gingival fibroblasts in the treatment of pathologic
remodeling
Creation of 2 start-up :Arterial Remodeling Technologies (2003);ScarCell (2007)
Scientific information
70 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 the
European Society of Cardiology
-Director, International Affairs, Medical School PARIS-DESCARTES
Teaching activities
Faculté de médecine Paris: cardiology, physiology

Philippe LECHAT
Professor Philippe LECHAThas joined the French Health Products Safety Agency as Head of the
Medicinal Products and Biologics Evaluation Department in July 2007 and has been appointed as CHMP
member since October 2007.
Philippe Lechat is a 55 years old physician cardiologist. He obtained his Ph D in Pharmacology from the
Pitié-Salpêtrière Faculty of Medicine, Paris and is Pharmacology Professor. His professional involvement
led him to become Head of the Pharmacology Department at the Pitié Salpêtrière Hospital. He was also
very much concerned with experimental and clinical research.
Philippe Lechat was thus Responsible for the Clinical Research Unit and Chairman of the Committee for
the Protection of Patients. He participated in the carrying out and follow up of several multicentric and
international (especially in the cardio-vascular area) clinical studies.
Besides, he brought his contribution to the French Health Products Safety Agency and became member
of 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 much
involved in the creation and development of the French Society of Pharmacology.
His principal areas of expertise are cardiology, cardio-vascular pharmacology, pharmaco genetics and
clinical pharmacology.
His is also the author of more than 150 international scientific publications and has participated in several
scientific reviewing and editorial committees.
____________________________________________________________________________
Raymond John LIPICKY, MD
He is the Director of LIPICKY, LLC (a consulting company) having retired (March 2002) after 21 years of
service) from the U.S Food and Drug Administration (FDA) where he held the position of Director, Division
of 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 he
held the positions of Professor of Pharmacology and Professor of Medicine and Director, Division of
Clinical Pharmacology at the time he joined FDA. He is a graduate of the University of Cincinnati College
of Medicine, trained in Internal Medicine and Cardiology. He currently also has an appointment as Visiting
Scientist at the Marine Biological Laboratory (Woods Hole, MA) where, for about 30 years, he had a
summer laboratory pursuing an interest in drug effects on electrically-excitable membranes.
____________________________________________________________________________
Jacobus LUBSEN
Jacobus Lubsen's (1942) main interests are the translation of clinical problems into appropriate clinical trial
design and/or their decision analytic modelling. He studied engineering in Delft, medicine in Rotterdam
and epidemiology at the Harvard School of Public Health in Boston. After completing a cum laude thesis
on acute chest pain syndromes in general practice, he started in 1978 the Clinical Epidemiology group at
the Department of Cardiology (Thoraxcentre) of the Erasmus University Rotterdam. In 1985 he was
appointed professor of medicine at Erasmus and in 1987 Chairman of the Centre for Clinical Decision
Analysis. From 1990 - 2006 he was scientific director of SOCAR Research SA, a Swiss-based
cardiovascular clinical research organisation. At SOCAR, he was 'responsible biostatistician' of the
ACTION 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 clinical
trials and decision analysis, and lectures frequently at international meetings. He is a past member of the
Dutch Health Council.

YaleB. MITCHEL, MD
Yale B. Mitchel, MD joined Merck Research Labs in 1991 and has contributed to the clinical development
of 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 Atherosclerosis
section of the department.
Dr. Mitchel received his Bachelor of Science in biology from Carnegie Mellon University and earned his
MD 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 fellowship
under 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 a
hepatic 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 the
International Atherosclerosis Society.
____________________________________________________________________________
Marc A. PFEFFER, MD, PHD
Dr. Marc A. Pfeffer, a graduate of Rockford College in Rockford, Illinois, received both his doctorate in
physiology and biophysics and his medical degree from the University of Oklahoma in Oklahoma City. He
completed his internship, residency and clinical fellowship at the Peter Bent Brigham Hospital, Harvard
Medical School in Boston. Dr. Pfeffer is currently the Dzau Professor of Medicine at Harvard Medical
School and physician in the Cardiology Division at Brigham and Women's Hospital. Dr. Pfeffer also serves
as medical director of Partners Research and Education Program (PREP).
Dr. Pfeffer has distinguished himself as a translational investigator. Along with his late wife, Dr. Janice
Pfeffer, and Eugene Braunwald, M.D., their studies in an experimental model of myocardial infarction first
introduced the concept of an insidious deleterious structural remodeling of the impaired ventricle. They
demonstrated in both animals and man that angiotensin converting enzyme (ACE) inhibitors could
attenuate these adverse structural and functional changes providing the rationale for the use of these
agents in patients experiencing a myocardial infarction. Pfeffer led the first definitive clinical trial
demonstrating that this use could prolong survival and prevent the development of heart failure, which has
improved 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 key
practice-changing, randomized controlled clinical trials. Indeed, a common theme for his substantial
contributions has been in the utilization of the randomized controlled trial to enhance the academic
mission. 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, TOPCAT
and TREAT. He is generally considered as a team builder and takes pride in academic advancement of
trainees and junior faculty collaborating on the trials, and embedding important mechanistic substudies
within the major randomized trials to enhance our understanding of the pathophysiology of the disease
processes. Pfeffer's trials have set high standards for relationships with the sponsors whether industry or
NHLBI. He is known for his fairness in data sharing and assisting others in developing meaningful
scholarly 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 cited
by other scientists. In 2006, Pfeffer was listed by Science Watch as having the most "Hot Papers" (highly
cited) in all of clinical medicine.
On a local level, his leadership abilities are well recognized and appreciated at the Brigham and Women's
Hospital 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 physician
satisfaction and education for those less academically oriented. As the leader of Partners Research and
Education Program (PREP), he has developed networks of community-based physicians who enjoy
making meaningful contributions to clinical investigation.

Bertram PITT
M.D.
Education
1945-49 Forrest Hills High School, Forest Hills, NY
1949-53 Cornell University, New York, New York, B.A
1953-59 University of Basel, Switzerland, M.D.
Postdoctoral training
1959-60 Intern, Beth Israel Hospital, New York, NY
1960-62 Assistant Resident, Beth Israel Hospital, Boston, MA
1961-62 Teaching Fellow in Medicine, Harvard University, Boston, MA
1962-63 Chief Resident, Medicine, Beth Israel Hospital, Boston, MA
1962-63 Assistant in Medicine, Harvard University Teaching Fellow in Medicine,
Tufts University, Boston, MA
1966-67 National Heart Institute Special Fellow, Department of Medicine, Division of
Cardiology,
Johns Hopkins University, Baltimore, MD
Academic appointments
1967-68 Instructor in Medicine, Johns Hopkins University
1968-72 Assistant Professor Medicine, Johns Hopkins University
1972-77 Associate Professor of Medicine, Johns Hopkins University
1977-91 Professor of Internal Medicine, Director, Division of Cardiology, University of Michigan School
of Medicine
1991-99 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 licensure
Medical Licensure 1960 Connecticut
1960 New York
1963 Massachusetts
1967 Maryland
1978 Michigan
Board Certification 1973 American Board of Internal Medicine
1973 American Board of Cardiology
Honors and awards
1976-66 Bronze Award, American Heart Association - Maryland Affiliate
1977 Haille Selassie Lecturer, British Heart Foundation
1978 Outstanding Cardiology Staff - University of Michigan
2000 Johns Hopkins University Society of Scholars
2001 Forest Dewey Dodrill Award for Excellence-American Heart Association
2002 Paul Dekruif Lifetime Achievement Award - University of Michigan
Membership and offices in professional societies
American Physiological Society - Circulation Group ; American Federation for Clinical Research ;
American Heart Association
Council on Circulation: 1982-83 Chairman
Council on Radiology
1987 Fellow, Council on Clinical Cardiology, American Society for Clinical Investigation - Emeritus
2003 Membership, International Society for Heart Research
1994 Fellow, American College of Cardiology, Trustee
1993 American Society of Nuclear Cardiology, Founding Member
1990-93 President, Michigan Chapter of American College of Cardiology
1988-92 Cardiovascular Norms Committee, Member, American College of Cardiology Michigan Heart
Association of University Cardiologists American College of Physicians
1988-91Cardiovascular Norms Committee, American College of Cardiology
1985-90 American Journal of Noninvasive Cardiology Consultant, Society for Cardiac Angiography
1985-87 Chairman, Young Investigator's Award Committee, American College of Cardiology
1985 Vice Chairman of the Cardiovascular Council, Central Society for Clinical Research
1982 Association of American Physicians ; Society of Nuclear Medicine ; Fellow, American College of
Chest Physicians

Stuart John POCOCK
Degrees
BA(Upper, 2nd Honours, Mathematics) 1967 - Cambridge University
MSc with Distinction (Statistics) 1968 - Imperial College, London University
PhD (Medical Statistics) 1972 - London School of Hygiene & Tropical Medicine
Posts held
1989 - Professor of Medical Statistics, London School of Hygiene & Tropical Medicine.
1987-89 Professor of Medical Statistics, Royal Free Hospital School of Medicine
1984-87 Reader in Medical Statistics, Royal Free Hospital School of Medicine
1978-84 Senior Lecturer in Medical Statistics, Royal Free Hospital School of Medicine
1974-78 Statistician (lecturer scale) University of Edinburgh Medical School
1972-74 Visiting Assistant Professor, State University of New York at Buffalo
1969-72 Statistician (lecturer scale), London School of Hygiene & Tropical Medicine
____________________________________________________________________________
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 a
Fellowship Program in Internal Medicine and Cardiology. From 1977 to 1978, he was a NIH Fogarty
International Fellow at the University of California at San Diego. He became specialist in Internal Medicine
and in Cardiology in 1978 and obtained a PhD in Cardiovascular Physiology from the University of Louvain
in 1980. From 1979 to 1993, Dr. Pouleur was a faculty member of the University of Louvain Medical
School, becoming Associate Professor in 1983 and Professor in 1991. In addition to his teaching
activities, he was involved in basic pharmacologic research and in clinical research, and was a recipient
of 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 Groton
and moved to the NYHeadquarters in 2001. From 1993 to 2000, his drug development experience
encompassed 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 of
the American College of Cardiology, a Fellow of the American Heart Association, a Fellow of the Council
of Circulation of the AHAand a Fellow of the European Society of Cardiology. He is author or co-author of
more than 180 articles published in peer reviewed journals.

James H. REVKIN, MD, FACC, FACP
Senior Director, Pfizer Inc.
Research and professional experience
1977-81 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 College
of Physicians and Surgeons of Columbia University,
Columbia-Presbyterian Medical Center, New York, NY, USA
1984-87 Postdoctoral Fellow, Section of Cardiovascular Medicine
Department of Medicine
Yale University School of Medicine, New Haven, CT, USA
1987-88 Postdoctoral Fellow, Cardiovascular Research Trainee, Center for
Bioengineering, 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 Medicine
Waterbury Hospital Health Center, Waterbury, CT, USA
1995-present Associate Clinical Professor of Medicine, Yale Heart Failure Center
Transplant 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
____________________________________________________________________________
Edmond ROLAND MD, FAHA
Dr Roland is graduated from the University of Paris, France and board certified in cardiology. After
several years of clinical appointment in academic institutions, he joined the pharmaceutical industry and
spent several years in the US. As Head of worldwide cardiovascular clinical research, he gained
extensiveexperience in global drug development and international regulatory processes. Since 2001,
he has resumed clinical activities. Currently, Dr Roland is an attending cardiologist at the teaching
hospital "Hopital Européen Georges Pompidou" in Paris. He is also a Clinical Expert for the French Agency
for Safety of Health Products (afssaps). In addition, he is a member of the EMEAEfficacy Working Party
sub-group on cardiovascular issues. The mission of this subgroup is to develop EMEAguidance
documents 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 et
Marie 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 University
Hospital & INSERM Clinical Investigation Centre (Coordinating physician :
Pr Zannad) ; associate researcher, INSERM 684, Dr Lacolley.
____________________________________________________________________________
Victor L. SEREBRUANY, M.D., Ph.D.
Education
1984-1989 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 training
1991 Accounting, economics, industrial psychology
Johns Hopkins University (Baltimore, MD)
1988 Business, politics, international trade
Political State University (Moscow, Russia)
Professional experience
2006 - 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 University
1989 - 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 and
Tropical Medicine, Dr. Shear was on faculty at a number of medical schools where he continued his focus
his research on cardiovascular disease. He joined the pharmaceutical industry in 1986 with Merck
Research Laboratories. In 1991, he joined Pfizer Global Research and Development where he now
serves as Vice President and interim head of Cardiovascular, Endocrine and Metabolic Diseases Clinical
Development. He has numerous original contibutions to the medical literature and is a recognized leader
in the development of novel cholesterol regulating drug therapies.
____________________________________________________________________________
Susan Blakely SHURIN
INSTITUTION AND LOCATION DEGREE (if applicable) YEAR(s) FIELD OF STUDY
Harvard College, Cambridge MA BA 1965 Biology
Georgetown University, Washington DC None 1966-68 Physiology &
Biophysics
Johns 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 Farber
Cancer 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 Reserve
University, 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 Activities
Case Western Reserve University: Member and Chair of University Faculty Senate; Member and Chair of
School 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 Cancer
Center: Medical Director: ambulatory and inpatient patient care services; Hemophilia Treatment Center;
Bone marrow transplant service; Neuro-oncology service; Executive committees of Departments of
Pediatrics and Cancer Center
Federal and state consultation: Chair of State of Ohio Bureau for Children with Medical Handicaps and
Bone marrow transplantation Board; service on multiple NIH study sections, working groups and data safety
monitoring boards.
Officer/Director: American Cancer Society, National Hemophilia Society, CureSearch (COG), Leukemia
Society
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 chairmanships;
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's
Oncology 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 tumor
Strategy Groups, designing and selecting studies.
Laboratory interests: phagocytic cell function, sickle cell disease, mechanisms of hemolysis
Clinical research interests: Interventional trials in non-malignant hematology (hemoglobinopathies, thrombocytopenia,
neutrophil disorders, bleeding and thrombotic disorder), malignancies (leukemia, solid
tumors), and hematopoietic stem cell transplant. Ethical conduct of research at individual and institutional
levels, including informed consent and return of results to participants.
Active Medical licenses: Ohio, Maryland. Active Board Certification in Pediatrics and Pediatric
Hematology-Oncology.

Maria R. STAGNITTO, RN, MSN
Education
2007-(2008) Certificate in Public Leadership
Brookings Institution, Washington, DC
2004- 2006 Career Development Program,
Senior Executives in Health and Human Services - Washington, DC
1985-1987 Post Master's Certificate Program, Nursing Middle Management
George Mason University, Fairfax, Virginia
1975-1977 Master's of Science in Nursing (MSN)
Seton Hall University, College of Nursing - South Orange, New Jersey
1970-1974 Bachelor of Science in Nursing (BSN)
Seton Hall University, College of Nursing - South Orange, New Jersey
Professional experience
2005-Current: Director, Office of Clinical Research
National Heart, Lung, and Blood Institute, NIH, Bethesda, MD
Responsible for creating a central clinical research office for extramural affairs to 1) coordinate clinical
regulatory activities internally with NHLBI Divisions and other Government agencies and Institutes of the
National Institutes of Health; 2) serve in an advisory role to scientific and health care staff, principal
investigators and research staff related to adverse experiences; 3) provide education/training for
extramural 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 and
administer a program of research contracts, cooperative agreements and grants as assigned.
2000-2005: Associate Director, Office of Clinical Affairs,
Division of Intramural Research
National Heart, Lung, and Blood Institute, NIH, Bethesda, MD
Responsible for creating a central clinical research office for intramural research. Responsible for
developing and implementing policies and practices related to the conduct of human subjects research by
NHLBI. Independently analyze each clinical research protocol prior to implementation, determining policy
compliance and impact on resources, and evaluating short term and long term needs of the clinical
branches. Serve as the Executive Secretary for the Institute's Scientific Review Committee. Responsible
for organizational oversight of the Investigational Review Board (IRB) for NHLBI and serve as the
Executive Secretary of the IRB. As the Associate Director, also serve as the Executive Secretary to the
three Intramural Data Safety Monitoring Boards. Serve in an advisory role to the Director, Clinical
Research Program, as well as other senior management officials within the NHLBI, and with NIH officials
to evaluate current procedures and recommend and implement changes.
Professional memberships
Public Responsibility in Medicine and Research (PRIM&R)
Sigma Tau National Nursing Honor Society
Gamma Nu Chapter
Greater Washington Area Chapter of the American Association of Critical Care Nurses
American Nurses Association
Maryland Nurses Association, District V
Community membership
1995-Present Board Member, Friends of the Clinical Center
1998-2001 President, Friends of the Clinical Center
2001-2002 Past-President, Friends of the Clinical Center
1997-2000 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 works
as interventional cardiologist and is director of the Coronary Care Unit of Hôpital Bichat-Claude Bernard
in Paris, France. He is also director of the research team "Clinical Research in Atherothrombosis", in
INSERM 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 his
attention 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 and
belongs to the nucleus of the Thrombosis Working Group of the European Society of Cardiology. He is a
former 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 the
Public 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 industrysponsored
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 of
the 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 myocardial
infarction 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 Guideline
Committee for the VIII Guidelines on antithrombotic therapy of the ACCP.

Beth DAVISON WEATHERLEY
Education
Institution 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 Program
Georgetown University,
Washington, DC 1989 MS, Biostatistics and Epidemiology
University of North Carolina,
School of Public Health
Chapel Hill, NC 2003 PhD,
Epidemiology, minor Biostatistics
Scholarly societies
Phi Lambda Upsilon National Honorary Chemical Society
Sigma Xi
Professional training and academic career
Institution 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 1986-1987
Clinical Data Specialist 1987-1988
Biometric Research Institute, Inc. Biostatistician 1988-1989
Assistant Project Director 1989-1990
Project Director 1990-1994
Manager, Scientific/Technical Staff 1992-1994
Associate 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 1996-1997
2001-2007
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 Epidemiology
and Social Medicine at the Swedish Medical Research Council. I have been president of the Swedish
Epidemiological Society and the Swedish Society of Biostatistics. I was educated as a statistician at
Gothenburg University. My special research areas are cardiovascular epidemiology and clinical trials in
cardiovascular 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 worked
close together with medical doctors and computer specialists.
During 1979-80 I was a visiting-scientist at Biostatistics Branch, NHLBI, Bethesda, Maryland. In 1993 I had
a 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 on
the 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.
____________________________________________________________________________
Janet WITTES
Janet Wittes, Ph D. is the President of Statistics Collaborative, Inc. which she founded in 1990. From 1974
to 1983 she was on the faculty of the Department of Mathematical Sciences at Hunter College. In 1983
she joined the Biostatistics Research Branch, National Heart, Lung, and Blood Institute as its Chief. Her
research has focused on the design and analysis of randomized clinical trials. She is a Fellow of the
American Statistical Association, the American Association for the Advancement od Science, and the
Society for Clinical Trials. She is a past President of the International Biometric Society - Eastern North
American Region (1995) and the Society for Clinical Trials (2001). From 1990 through 1995 she served
as Editor-in-Chief of Controlled Clinical Trials. She is a member of many Data and Safety Monitoring
Boards (DSMBs) for randomized clinical trials sponsorised by both industry and government. Coauthored
with Drs. Michael Proschan and Gordon Lan, her recently (2006) published book “Monitoring Clinical
Trials: AUnified Approach” deals with methods for interim analysis of data. She received her A. B. in
Mathematics from Radcliffe College (1964) and her Ph. D. from the Department of Statistics of Harvard
University (1970).

Faiez ZANNAD, MD, PhD, FESC
Cardiology and Centre d'Investigation Clinique, Inserm
Nancy 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 1981
he 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. He
is currently Head of the Division of Heart Failure, Hypertension and Preventive Cardiology/ department of
Cardiovascular Disease of the academic hospital of Nancy, and Director of the Clinical Investigation
Center (CIC), mutually funded by the academic hospital and the INSERM and of a research group at an
INSERM 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 EU
funded Network Excellence "InGeniousHyperCare". He conducts his research, in the area of
physiopathology and pharmacotherapeutics of hypertension and heart failure. Dr Zannad is Chairman of
the 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 a
large number of international societies in cardiology, hypertension, pharmacology and therapeutics. He is
currently Co- Editor in chief of Fundamental and Clinical Pharmacology, the official journal of the European
Federation of Pharmacological Societies (EPHAR) and a member of the Editorial boards of a number of
journals in the field of Cardiology, Hypertension and Cardiovascular Pharmacology. He has contributed
more than 300 scientific publications and published several books on cardiovascular pharmacotherapy
and on Heart Failure. He is chairman and organizer of several international meetings: "CardioVascular
Clinical Trialists (CVCT) Forum and Workshop" (Cannes and Paris, with Bertram Pitt and Desmond
Julian); "Acute Heart Failure Syndromes" (Cannes and Chicago, with Mihai Gheoghiade) and "Biomarkers
in 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 Steering
Committees, Critical Event Committees and Data Safety and Monitoring Boards. Steering Committee
membership: 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), Critical
Event Committee: CAPRICORN, RESPECT, SCOUT, Data and Safety Monitoring Board HEAAL, Protocol
writing groups RALES, CAPRICORN, CIBIS II and EPHESUS, EVEREST.
____________________________________________________________________________
Névine ZARIFFA
Névine is Vice-President of Biomedical Data Sciences in the Cardiovascular & Metabolism Medicine
Development Center at GlaxoSmithKline Pharmaceuticals. The Division encompasses most of the
quantitative sciences at GSK including Biostatistics, Epidemiology and Mathematical Modelling. For the
past six years she has served as a member of the Leadership Team which manages this part of the GSK
portfolio bringing a quantitative skill set to decision making. She works with clinical and regulatory
colleagues within and outside the company to optimise drug development. Along with the rest of her
colleagues, she is continuously evaluating novel statistical and mathematical approaches to improve the
speed and quality of molecules as they develop into new medicines for patients. Névine holds a BSc in
pure mathematics from McGill University and a MMath in Statistics from the University of Waterloo.
____________________________________________________________________________
Robert ZOLYNAS, DVM, MBA
Associate Director, Cardiovascular Clinical Research
Johnson & Johnson PRD
Raritan, 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 degree
from Lithuania Veterinary Academy and MBAfrom Indiana State University. Dr. Zolynas joined J&J PRD
in August 2005. Prior to joining J&J PRD, Dr. Zolynas was with Schering-Plough Corp. for over 6 years
where he held various positions of increasing responsibility within clinical operations organization.