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CURRICULUM VITAE

NAME:
MELODY I. SANGER, BSN, RN, MD, CCRC, CCRP

TITLE:
Member, AALNC (American Association of Legal Nurse Consultants)
Director of Clinical Research, DSI (Drug Study Institute)
CCRC (Certified Clinical Research Coordinator) by the ACRP
CCRP (Certified Clinical Research Professional) by SoCRA (Society of Clinical Research Associates)
IRB Member, Jupiter Medical Center

ADDRESS:
1004 South Old Dixie Highway, Suite 201, Jupiter, FL 33458-7200

CONTACT US:
(24/7 phone) 561-575-1212 (fax) 561-745-6664

MEDICAL SCHOOL:
Noreste, Tampico, Mexico

DEGREE:
MD, June 1985 (not licensed to practice medicine)

UNDERGRAD:
BS, Nursing, New York University, January 1978

EXTERNSHIPS:
August 1983 through May 1985

INSTITUTIONS:
Prince Georges Hospital and Medical Center, Cheverly, MD (8/83-6/84)
Englewood Hospital, Englewood, NJ (9/84-5/85)

REFERENCES:
Available upon request

CERTIFIED IN:
Certified Clinical Research Coordinator (CCRC) by the Association of Clinical Research Professionals (ACRP)
Basic Cardiac Life Support
Advanced Cardiac Life Support
Venipuncture and Intraveneous Therapy
Certified Clinical Research Professional (CCRP) by the Society of Clinical Research Associates (SoCRA)

MEMBERSHIP IN PROFESSIONAL SOCIETIES:
Member, AALNC (American Association of Legal Nurse Consultants)
Emergency Room Nursing Association
Nurses Orthopaedic Association
Women's Sports Foundation
Lake Placid Sports Medicine Society
American Running and Fitness Association
American College of Sports Medicine
New York Road Runners Club
National Strength and Conditioning Association
American Association of Bariatric Physicians
Academy for International Medical Studies
American Association of Pharmaceutical Scientists (AAPS)
Association of Clinical Research Professionals (ACRP)
Drug Information Association (DIA)
American Pharmaceutical Association (APhA)
American Association of Clinical Chemistry (AACC)
Society of Clinical Research Associates (SoCRA)
American College of Clinical Pharmacy (ACCP)

PROFESSIONAL EXPERIENCE:
Brookdale Hospital, NY, Medical/Surgical Nursing (2/78-6/79)
Brookdale Hospital, NY, ER Nursing (6/79-6/81)
Per Diem Critical Care, Nursing (9/85-3/88)
Cardiac Stress Testing (3/86-3/88)
Executive Health Examiner's Per Diem Nursing (7/88-12/88)
Optifast Program at Stamford Hospital, CT, Clinical Coordinator (1/89-6/90)
The Jupiter Preventive Internal Medicine Center, FL (1/92-present)

ACCOLADES:
Book Review: Foundations of Clinical Research for the AAPP
Career Success: ClinicalTrialJobs.com

RESEARCH EXPERIENCE:
Since 1997, Lead Coordinator, Director of Clinical Research and Quality Assurance at the Drug Study Institute of the Jupiter Preventive Medicine Center
Research IRB, Inc., Board Member (11/00-5/02)
Palm Beach Gardens Medical Center IRB Board Member (1/03-7/04)
Jupiter Medical Center IRB Board Member (4/03-pres)

1997
Smart Study Asthma Research (Serevent, GSK)
Hypertension — Searle

1998
P.O.W.E.R. Trial (HTN) — Hoechst Marion Roussel
INVEST (HTN) — Knoll (honorable mention in publication)
C.O.H.E.R.E. Study (Coreg) — Smith Kline Beecham
Tamiflu — Roche

1999
Community Acquired Pneumonia — Abbott
Geriatric Nutrition Study — Mead Johnson
Cancer Nutrition Study — Mead Johnson
Flu Surveillance — Roche

2000
Blood Draw — Genomics
Hypertension (2/00) — Novartis
Diabetes — Novartis (Starlix)
IBS Registry — Glaxo Wellcome
MICAT — Micardis (HTN) — Boehringer Ingelheim
Genetics Registry — Novartis
Hypertension (5/00) — Novartis
Hypertension (OCTAVE) — Bristol-Myers Squibb
Flu Surveillance — Roche

2001
STRENGTH 1 & 2 (Cholesterol) — Genaissance
Diabetes Type 2 — Amylin
Diabetes Type 2 — Bristol-Myers Squibb
SAPPHIRE (HTN) — Alteon
AMAZE (HTN) — AstraZeneca (honorable mention in publication)
STELLAR (Cholesterol) — AstraZeneca (honorable mention in publication)
Vaccine — Aventis Pasteur
Community Acquired Pneumonia — Ortho McNeil
AT GOAL (Cholesterol) — Pfizer (EAS poster presentation)
LIFT (Osteoporosis) — Organon

2002
STELLAR (Cholesterol) — AstraZeneca (honorable mention in publication)
IRIS (Cholesterol) — AstraZeneca
Cholesterol — BMS
Cholesterol — Genaissance
AT GOAL (Cholesterol) — Pfizer (EAS poster presentation)
AMAZE (HTN) — AstraZeneca (honorable mention in publication)
SAPPHIRE (HTN) — Alteon
NEB-321 (HTN) — Bertek Pharmaceuticals
LIFT (Osteoporosis) — Organon
112 NIDDM — Amylin
113 NIDDM — Amylin
115 NIDDM — Amylin
025-00 NIDDM — Merck
018-00 NIDDM — Merck
CAP (Community Acquired Pneumonia) Levaquin — Advanced Biologics

2003
STELLAR (Cholesterol) — AstraZeneca (honorable mention in publication)
IRIS (Cholesterol) — AstraZeneca
COMETS (Cholesterol) — AstraZeneca
POLARIS (Cholesterol) — AstraZeneca
112 NIDDM — Amylin
113 NIDDM — Amylin
115 NIDDM — Amylin
025-00 NIDDM — Merck
018-00 NIDDM — Merck
BUP 3012 Chronic Pain Hip & Knee — IRD Stamford (Purdue Pharma LP)
HTN ATTACH — AstraZeneca
Glucometer Study — Home Diagnostics

2004
STELLAR (Cholesterol) — AstraZeneca (honorable mention in publication)
STARSHIP (Cholesterol) — AstraZeneca
ATTACH (HTN) — AstraZeneca
BUP 3012 Chronic Pain Hip and Knee — IRD Stamford (Purdue Pharma LP)
BUP 3011 Chronic Pain Hip and Knee Pain in patients on narcotics
BUP 3015 Chronic LBP — IRD Stamford (Purdue Pharma LP)
113 NIDDM Amylin
POLARIS (Cholesterol) — AstraZeneca
Co-Diovan (HTN) Novartis
INCLUSIVE (HTN) BMS and Sanofi-Synthelabo
Pravachol Hepatitis (BMS)
DiZo (Novartis) Zocor + Diovan
Pfizer Lipitor Torcetrapib Protocol #A5091018

2005
STARSHIP (Cholesterol) — AstraZeneca
BUP 3012 Chronic Pain Hip and Knee — IRD Stamford (Purdue Pharma LP)
BUP 3011 Chronic Pain Hip and Knee Pain in patients on narcotics
BUP 3015 Chronic LBP — IRD Stamford (Purdue Pharma LP)
Co-Diovan/DiZo (HTN) Novartis
Pravachol Hepatitis (BMS)
APD356-003 (Obese) — Arena/PPD/Quintiles/RCRC
Altea Narcotic Patch
APD356-004 (Obese) — Arena/PPD/Quintiles/RCRC
Palladone, Narcotic Pill, Purdue Pharma
Rivoglitazone, CS-011-203, (NIDDM) — Sankyo Pharma Development (SPhD)/MedPace/MRLi/Quorum
Dabigatran vs. Coumadin, Protocol #1160.26, Boehringer Ingelheim
BUP 3015 Chronic LBP — IRD Stamford (Purdue Pharma LP)
BUP 3019 Chronic LBP — IRD Stamford (Purdue Pharma LP)
Vax014, Smallpox
LBP, DOV, Bicifadine
Progenics Opioid-Induced Bowel Dysfunction MNTX

2006
Abbott Cholesterol Fenofibric Acid M05-748
Abbott Cholesterol Fenofibric Acid M05-758
Abbott Vicodin CR OA Hip & Knee MO4-697
Altea Therapeutics Chronic Hip and Knee OA Pain Trial
Covalent HTN Darusentan
BMS TZD Diabetes Study Saxagliptin
Daiichi Sankyo Pharma Development/Integrium Benicar HTN
Daiichi Sankyo Pharma Development/Medpace Rivoglitazone NIDDM
Encysive, TBC3711, Resistant HTN
GSK 012 Alvimopan Opioid-Induced Bowel Dysfunction
GSK 014 Alvimopan Opioid-Induced Bowel Dysfunction Extension
GSK/CTMS Constipation Observational Trial
Inc Research/Alpharma Kadian Hip & Knee Pain
Inc Research/Alpharma Kadian Hip & Knee Pain Long-Term Extension
Kos Pharmaceuticals Inc. Niaspan ER + Zocor
LBP, DOV, Bicifadine
Merck/Integrium Lipitor + Zetia
Myogen, Resistant HTN, Darusentan
NIDDM-HDN Novo Nordisk
Pain Therapeutics, Inc., Hip, Knee & LBP, Tamper Resistant Oxycodone
Pain Therapeutics, Inc., Tamper Resistant Oxycodone
Pfizer, PPAR, NIDDM
Pozen/Scirex HI RISK PUD, 303
Pozen/Scirex, PN200, AT RISK PUD 302
Sanofi-Aventis, IDDM, Apidra
Takeda 003 NIDDM
Takeda 004 ICON NIDDM HTN
Takeda 475-009 Cholesterol Lipitor
Takeda 475-010 Cholesterol Lipitor Extension
Takeda 475-020 Cholesterol Zocor
Takeda 475-022 Cholesterol Crestor
Takeda-ICON HTN-NIDDM 536
Takeda SYR-320PI-002 NIDDM
Wyeth Opioid-induced Bowel Dysfunction 3200A3-200-WW

2007
Abbott Laboratories/ICON Crestor + Tricor
Alpharma/Inc Research OA Hip & Knee
Daiichi Sankyo Inc./ICON Benicar-HCT
Forest Research Institute/Integrium Nebivolol HTN
Merck/Integrium EZ Path Trial Lipitor + Zetia
Penwest/i 3 Research Nubain ER OA Hip or knee
Sciele Pharma Inc./Integrium Pravafen
Pfizer/Quintiles Precision Trial; Celebrex
Purdue Pharma LP/PRA International LBP Buprenorphine

AVAILABILITY:
For Investigational New Drug Trials