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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.
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