PROFESSIONAL AFFILIATION: Baptist Hospital of Miami
CURRENT LICENSE:
EDUCATION:
Medical College of Virginia State University of New York at Binghamton POST GRADUATE TRAINING: Fellowship in Cardiovascular Medicine College of Medicine and Dentistry of New Jersey Residency in Internal Medicine
Page Two Paul H. Seigel, M.D., F.A.C.C. POST GRADUATE TRAINING CONTINUED. Internship in Internal Medicine
CERTIFICATIONS AND EXAMS:
Diplomate of the American Board of Internal Medicine -
Diplomate of the American Board of Cardiovascular Medicine -
Diplomate of National Board of Medical Examiners -
ACEDEMIC APPOINTMENTS:
Florida International University, 2011-present
PRIVATE PRACTICE EXPERIENCE: James Bierfeld, M.D. Solo Practice Associates in Cardiology Miami Cardiology Group Managing Partner
Page Three Paul H. Seigel, M.D., F.A.C.C.
INVESTIGATIONS - RESEARCH:
Cardiovascular Research Center of South Florida
TIMI-50 (Schering Plough) , A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH530348 in Addition to Standard of Care in Subject with a History of Atherosclerotic Heart Disease. INVEST (Knoll Pharmaceuticals). Principal Investigator. This is an international clinical trial comparing a calcium antagonist (Verapamil Sinus rhythm) with a non-calcium antagonist treatment strategy (Atenolol) for the control of hypertension in patients with coronary artery disease. T.N.T. (Treating to New Targets) Parke-Davis/Pfizer. Principal Investigator. This study is to assess the CHD event reduction efficacy and safety of low-density lipoprotein cholesterol lowering to achieve LDL-C targets beyond currently recommended minimums when compared to only achieving the minimum.
Drug Used: Atorvistatin 10 mg up to 80 mg in the double-blind
CAMELOT (Pfizer, Inc). Principal Investigator. Comparison of Amlodipine versus Enalapril to Limit Occurrences of Thrombosis. GUSTO IV (Eli Lily and Co). Principal Investigator. This is a post-MI study through the Cleveland Clinic. BRAVO: Blockade of the GP IIB/IIA Receptor to Avoid Vascular Occlusion. Principal Investigator. PRESTO: Prevention of REStenosis by Tranilast and its Outcomes. Principal Investigator. A phase III Double blind Placebo Controlled Trial of three doses of Tranilast (Protocol 004). MOXON TRIAL (Covance). Principal Investigator.
Page Four Paul H. Seigel, M.D., F.A.C.C. INVESTIGATIONS – RESEARCH (continued):
STARSHIP (AstraZeneca) A 6 week, Randomized, open-Label, Comparative Sturdy to Evaluate the Efficacy and Safety of Rosuvastatin
Hypercholesterolemia in Hispanic Subjects.
ACTIVATE (SankyoPharma Development) A Randomized, Double-Blind placebo Controlled Study of the Efficacy and Safety of the ACAT inhibitorCS-505 versus Placebo for Reducing the Progression of Atherosclerosis in Subjects with Known Coronary Artery Disease Using Ultrasound (IVUS). EVEREST (Otsuka Pharmaceuticals) A Randomized, Double- blind Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized with Worsening Congestive Heart Failure. CHARISMA (Sanofinsynthelabo and Bristal Myers Squibb Co.) Clopidogrel For High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance. CP-529, 414 (Pfizer) A Randomized, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Combination
Angiographically Documented Coronary Artery Disease.
LUNAR (AstraZeneca) A 12-Week, Randomized, Open-Label, 3- Arm, Parallel Group, Multicenter, Phase IIIb Study Comparing the Efficacy and Safety of Rosuvastatin 20 mg and 40 mg with that of Atorvastatin 80 mg in Subjects with Acute Coronary Syndromes. NEB 302 (Bertek Pharmaceuticals) A Double-blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Dosing Study Evaluating the Effects of Nebivolol on Blood Pressure in Patients with Mild to Moderate Hypertension. NEB 306 (Bertek Pharmaceuticals) A Multi-Center, Parallel Group Extension Study to Determine the Safety and Efficacy of Long-Term Nebivolol Exposure in Patients with Mild to Moderate Hypertension.
Page Five Paul H. Seigel, M.D., F.A.C.C. INVESTIGATIONS – RESEARCH (continued):
NEB 323 (Bertek Pharmaceuticals) A Multi-Center, Open Extension Study to Assess the Safety and Efficacy of Long-Term Nebivolol Exposure in Patients with Mild to Moderate Hypertension. COMPELL (Kos Pharmaceuticals) An Open-Label, Comparative Efficacy Evaluation of Lipid Levels when Treated with Niaspan and Statin or Other Lipid-Modifying Therapies. MDT3-003 (Labopharm) A Four-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once a day 100, 200 and 300 mg Versus Placebo for the Treatment of Pain due to Osteoarthritis of the Knee. LECTURES/SYMPOSIUMS:
06/07 PRIMARY CARE SYMPOSIUM, Hawks Cay Resort
Topic Pre and Post Operative Evaluation of a Cardiac Patient
06/09 PRIMARY CARE SYMPOSIUM, Hawks Cay Resort 2007-Present PEER Group, Various locations.
For: Astra-Zeneca (Atacand) and Forest Labs (Bystolic)
PROFESSIONAL ORGANIZATIONS:
CURRICU LUM VITAE GREGORY M. KOCHAK , Ph.D. Affiliation: R&D Services, LLC, 663 N. 132nd Street, Suite 126, Omaha, NE 68154 SUMMARY OF SELECTED ACCOMPLISHMENTS • 18 Years experience in the pharmaceutical industry including senior management; 8 years in academia. Assembled and managed a multi-disciplinary department at an international pharmaceutical company. Assembled the