ANDR GABRIEL, MD CCRP

16 Woodside Terrace, West Orange, NJ 07052 Tel: 917-216-4565 (Mobile) 212-305-9282 (Office), Email: apg2120@columbia.edu

EDUCATION
Sept 2010 Present Student, Master of Science in Epidemiology Mailman School of Public Health Department of Epidemiology Columbia University Medical Center, New York, NY Research Scholar, Division of Cardiology Columbia University Medical Center, New York, NY Research Scholar, Cardiovascular Institute Mount Sinai Medical Center, New York, NY Doctor of Medicine MD
Integrated Arts and Medicine Program (INTARMED) Program, a 7-year accelerated program

Oct 2008 Present Jun 2007 - Sep 2008 Jun 2000 Apr 2005

University of the Philippines - Manila, Philippines Jun 1998 Apr 2004 Bachelors of Science in Medical Sciences University of the Philippines Manila, Philippines

PROFESSIONAL WORK EXPERIENCE

Jul 2009 present Oct 2008 Jun 2009 Jun 2007 Sep 2008 Feb 2007 May 2007 Feb 2006 Jan 2007 Oct 2005 Dec 2006 Sep 2005 Dec 2006 May 2004 Apr 2005 April 2004 May 2004 Jun 2003 Mar 2004 Associate Research Scientist, Faculty of Research: Columbia University, Division of Cardiology Staff Associate, Faculty of Research: Columbia University, Division of Cardiology Clinical Research Coordinator: Mount Sinai Medical Center, Cardiovascular Institute Clinical Research Volunteer: Mount Sinai Medical Center, Cardiovascular Institute Asst. Manager, Utilization Department: StayWell Insurance Guam, Manila Satellite Ofc. Medical Lecturer, Medical Transcription Academy, Manila, Philippines House Officer, Unciano General Hospital, Antipolo City, Philippines House Officer, Metro Rizal Doctors, Cainta, Rizal Philippines Medical Intern, Philippine General Hospital, Manila, Philippines Clinical Research Clerk, Philippine General Hospital, Section of Plastic Surgery and Maxillofacial Reconstructive Surgery Clinical Clerk, Philippine General Hospital, Manila, Philippines

SCHOLASTIC HONORS / AWARDS RECEIVED

2005 2001 2001
st

Outstanding Intern, Philippine General Hospital, Manila, Philippines 1 Place, Gruppo Medical Awards for Outstanding Research in Herbal Medicine
st

1 Place, 10th Student Research Forum, Committee on Research Implementation and Development

2000 1999 1998

3rd Place, Year Level III Annual Physiology Research Forum University Scholar (GPA equivalent of 3.7) Qualifier, INTARMED program
INTARMED program, an Integrated Arts and Medicine Course (a 7-year accelerated program). Applicants are selected from the first 100 out of the normally 5,000 qualifiers of the University of the Philippines College Admission Test (UPCAT). More than 50,000 are taking this test annually. From the 100 are selected the 60 who will undergo further interviews and psychological tests. Finally 40 are admitted annually to the program as certified by the Committee on Admissions of the College of Medicine of UP Manila.

LICENSURE / CERTIFICATION EXAMS

Feb 2009 Jun 2008 Aug 2005 CCRP, Certified Clinical Research Professional: SoCRA, Philadelphia, USA NIH Stroke Scale Certification, New York, USA Physician Licensure Examinations, Manila, Philippines Philippine Board of Medicine Certified

RESEARCH EXPERIENCE
Dates: Role: Principal Investigator: Institution: July 2009 Present (Associate Research Scientist) Oct 2008 June 2009 (Staff Associate) Associate Research Scientist, Faculty of Research Shunichi Homma, MD Columbia University, Division of Cardiology

Project: WARCEF: A two-arm (1:1) double blind randomized multicenter trial whose primary aim is to compare the efficacy of Warfarin vs. Aspirin for preventing stroke, death and heart attacks in patients with heart failure. Sponsor: National Institutes of Health NINDS Responsibilities: Participates in all aspects of clinical quality issues in the European sites Submitting NDA/sNDA Writing Clinical study reports, safety narratives Experienced in Clinical trial management and protocol development with medical and scientific knowledge in assigned Cardiovascular Medicine therapeutic area. Strong written and verbal communication skills as well as proven ability to interact with different functional groups. Expertise and certification in GCP/ICH guidelines and FDA regulations, clinical trial design and basic knowledge of statistics, Certification in Neuro-related scales specific to variety of diseases mostly neurologic vascular events, Alzheimers disease, etc. Prepares study report shells. Contribute to or review drafts of study reports. Operationally manages one or more clinical studies. Field clinical site operational questions during conduct of the clinical trial. Work with Project Management to establish and revise timelines for studies/projects. Closely monitors and tracks clinical trial progress as appropriate. Reviews laboratory diagnostic results and Echocardiogram reports of patients who may be eligible in the study Interacts with Statistical Analysis Center to ensure that there are adequate clinical supplies for a given clinical trial Assists in planning Investigator Meetings. Leads Quality Assurance calls with the European CROs Attends internal and external meetings. Contributes to the development of documents such as Endpoints / SAEs Conduct review and assessment of serious spontaneous reports of adverse events and perform causality assessment of clinical trials and solicited reports Determine regulatory report ability of cases obtained from clinical trials, spontaneous and solicited in a timely fashion (SAE MedWATCH Reports in the US and SUSAR Reporting in the EU) Perform triage on cases and determine seriousness and relatedness to study drug Escalate complex case issues to the Principal Investigator or clinical adjudicator as appropriate Review and provide assurance of medical content and clinical relevance of regulatory safety documents

Follow-up of cases to obtain additional information as assigned Identify and resolve case issues for study endpoints, coordinate with adjudication team and clinical sites as appropriate Manage and coordinate with CROs for clinical sites in Germany, Netherlands, Poland, Czech Republic, Slovakia, Hungary, Ukraine and the United Kingdom Jun 2007 - Sep 2008 Clinical Research Coordinator Jeffrey Olin, DO Mount Sinai Medical Center, Cardiovascular Institute

Dates: Role: Principal Investigator: Institution:

Project 1: GenePAD : Genetic Determinants of Peripheral Arterial Disease Sponsor: National Institutes of Health NHLBI Responsibilities: Facilitated this NIH funded study which to determine genetic factors that predisposes certain individuals to develop peripheral arterial disease. Wrote and edited CSRs and uploading it in the eCRF Facilitates interaction with investigators, study subjects (patients and families) and study sponsors Identify and recruit potential candidates for participation in clinical studies Performed quality control on regulatory documents Responsible for initiation and maintenance of documentation of all study requirements (i.e. IRB submission and annual renewal, consent forms, and regulatory documentation). Co-produced CSR Standard Operation Procedures (SOPs) and the template. Responsible for completing case report forms, and works with study monitors. Participate in executive committee calls Participates in designing surveys used in study protocols. Evaluates and analyzes clinical research data Prepares abstracts and scientific papers and presents research data at meetings Served as a representative on project study team Responsible of preparing blood tissue specimens obtained during study visits for genetic analysis

Project 2:

Sponsor: Responsibilities: Completed project activities associated with the Phase II clinical research study while developing an understanding of the drug-development process, Good Clinical Practices, and relevant regulations Identifying and recruiting potential research patients Maintained basic on-site activities to ensure the compliance of FDA regulations and proper adherence to trial protocols and IRB at Mount Sinai Medical Center Prepared necessary study materials and regulatory documents Updated in-house site files during the course of the study and Sponsor audit where the site obtained favorable reviews from the auditors Assisted PI and clinical monitors in accomplishing various tasks within the genetic therapeutic area in Vascular Medicine Worked independently to create initial drafts of CSRs. Reviewed CSRs to ensure adherence to academic standards. Helped develop departmental SOPs. Maintained access database. Researched and obtained articles using medical literature resources. Ensured documents adhered to internal document standards. Assisting with patient data collection and analysis The data collection involves administering Treadmill Stress Test, Ankle Brachial Index and phlebotomy for laboratory blood work Prepare blood tissue specimen obtained at study visit and ship to central laboratory using IATA guidelines Project 3: Sponsor: CORAL : Cardiovascular Outcomes in Renal Atherosclerotic Lesions National Institutes of Health

WALK : A Phase 2, Randomized, Double blind, Placebo-controlled, Parallel-group, Multicenter, Dose-Selection Study of Ad2/Hypoxia Inducible Factor (HIF)-1a/VP 16 in patients with intermittent claudication Genzyme Corporation

Responsibilities: Coordinates the process of clinical research, including the IRB process and budget negotiations. Write and edit Clinical Study Reports (CSRs), Clinical Investigator Brochures (CIBs), and Regulatory Agency Response documents Recruits, screens, enrolls and evaluates patients that participate in study Educates patients in significant aspects of study. Ensures that clinical studies are conducted in accordance with guidelines of the FDA and other regulatory agencies. Serves as a liaison between physicians, patients, staff and sponsors. Clinical Research Volunteer for the Following Studies: Project: Sponsor: Principal Investigator: PACE-MI : A Multicenter trial that aims to evaluate whether pacemaker facilitated beta-blocker therapy after myocardial infarction reduces the combined endpoint of total mortality and non-fatal re-infarction vs.Standard Medical Therapy alone. National Institutes of Health Davendra Mehta, MD

Project: CONNECT : Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision, is a randomized, prospective study that will include 2,000 patients at 150 centers across the United States. The primary endpoint is to demonstrate that Medtronics wireless remote management system reduces the time to clinical decision for arrhythmias (abnormal heart rhythms), cardiovascular disease progression, and system issues compared to patients who receive only in-office care. Sponsor: Principal Investigator: Medtronic Avi Fischer, MD

CLINICAL EXPERIENCE
Feb 2006 Jan 2007 Asst. Manager, Utilization Department: StayWell Insurance Guam This is a full time position whose main responsibility is to make sure that medical claims are in accordance with Good Clinical Practice Guidelines. I worked under the supervision of the Manager of the Utilization Department where we both report to the medical director on clinical issues that need authorization. The position trained me in the Milliman Care Guidelines, ICD coding and an insight into the American healthcare system since this was Guam based insurance company with a satellite office in Manila, Philippines. Medical Lecturer, Medical Transcription Academy, Manila, Philippines This is a part time faculty position at the institution where I taught basic medical sciences to students for their Medical Transcription course. The institution boasts of a 93% certification rate from the Philippine Accreditation board House Officer, Unciano General Hospital, Antipolo City, Philippines Part-time position. The Unciano General Hospital is a 200-bed teaching hospital which provides health care facilities to a wide variety of Medical and Surgical patients. My duties as a House Officer included seeing outpatients, catering to in-patient care which includes ER and ICU admissions. Commonly encountered cases where Bronchial Asthma, Meningitis, Rheumatic Fever, Pulmonary Tuberculosis, Community Acquired Pneumonia, Myocardical Infarctions, Cerebrovascular Accidents, Urinary Tract Infection, and Gastroenteritis. I was involved in procedures like IV line placement, peritoneal and pleural paracentesis, lumbar puncture, endotracheal intubations and cardiopulmonary resuscitations. I also educated patients and their families about their medical conditions as well on their follow-ups. House Officer, Metro Rizal Doctors, Cainta, Rizal, Philippines This is a part-time position. This is a secondary hospital where I was responsible for manning the emergency room, hospital admissions and doing bedside rounds on admitted patients. Typical emergency cases include Status Asthmaticus, Congestive Heart Failure Exacerbation, Cardiopulmonary Resuscitations, Pneumonia, Myocardial Infarction, and Pulmonary Tuberculosis. Updates the attending physicians for continuity of care.

Oct 2005 Dec 2006

Sep 2005 Dec 2006

Sep 2005 Dec 2006

Professional Organizations
Associate Member, American College of Epidemiology Society of Clinical Research Associates (SoCRA): Entitled to use "CCRP" (Certified Clinical Research Professional) after the name by SOCRA (Society of Clinical Research Associates) since passing the certification exam. American Heart Association (AHA) American Association for the Advancement of Science (AAAS) University of the Philippines Medical Alumni Society of North America (UPMASA) Philippine Medical Association (PMA) Philippine General Hospital Palliative Care (PalCare) Organization Antipolo City Lights Jaycees Founding Member 1998 present UP College of Medicine Class 2005 President 1998 2000 Academic Committee, UP College of Medicine 1998 2000

SEMINARS / TRAINING / SPECIAL COURSES ATTENDED 1. International Stroke Conference: Los Angeles, California. January 2010 2. International Stroke Conference: San Antonio, Texas. January 2010 3. Good Clinical Practice / HIPAA: Columbia University Medical Center, NY. Oct 2008 4. Infectious Control Seminar: Columbia University Medical Center, NY. June 2008 5. Stroke Scale Certification: National Institutes of Health. June 2008 6. Educational Program on Cultural Competency: Mount Sinai Medical Center. Sep 2007 7. Basic IRB Training Course: Mount Sinai Medical Center. Jun 2007 8. Infectious Control Seminar: Mount Sinai Medical Center. Jun 2007
9. Phlebotomy Class: Mount Sinai Medical Center. Jul 2007

10. Data Security in Human Subject Research Training:Mount Sinai Medical Center: Apr 2007 11. Human Participant Protections Education for Research Teams: National Institutes of Health: Apr 2007
12. HIPAA Training Session: Mount Sinai School of Medicine, Apr 2007

13. Phosphatidylcholine (PPC), a Modern Membrane Therapy for Fatty Liver and for Chronic Viral Hepatitis by Karl
Josef Gundman, MD PHD

14. 10th ed. Milliman Care Guidelines (Evidence Based Medicine). Feb 2006
15. Adverse Drug Reactions. Philippine General Hospital. Jan 2005 16. Basic Life Support Training: Philippine General Hospital. May 2004

17. Workshop on Directly-Observed Treatment Short Course (DOTS) For Tuberculosis Foundation for the Control of
Infectious Diseases, Inc and Philippine Tuberculosis Initiatives for the Private Sector. Aug 2004

18. Joy in Caring, a seminar by Dr. Patch Adams on doctor-patient relationship: Manila Midtown Hotal, Dec 2002 SELECTED SCIENTIFIC PRESENTATIONS AND PUBLICATIONS 1. Evaluation of the Task Shifting in Community-Based DOTS Program as an Effective Control Strategy for
Tuberculosis: Andre Gabriel MD, Charles Mercado MD. The Scientific World Journal, August 2011. PMID in Process.

2. A Review of Serologic Biomarkers for Acute Cerebrovascular Disease: Andre Gabriel MD and Charles Mercado
MD, Abstract Presentation at the 2011 Epidemiology Congress in Montreal, Canada. June 2011.

3. Data Retention once A Participant Withdraws Informed Consent: Andre Gabriel MD,.Open Access Journal of
Clinical Trials, April 2011. PMID in Process Low Lifetime Recreational Activity is a Risk Factor for Peripheral Arterial Disease: Andrew M Wilson, MBBS, PhD; Amir H. Sadrzadeh Rafie, MD; Jonathan Myers, PhD; Themistocles Assimes, MD, PhD; Mamie Higgins, Andre Gabriel MD, Jeffrey Olin, DO; John P Cooke MD, PhD. J Vasc Surg, June 2011. PMID 21664093.

4. Sex Differences in Peripheral Arterial Disease: Amir H. Sadrzadeh Rafie, MD; Marcia L. Stefanick, PhD; Stacy T.
Sims, PhD; Tiffany Phan, BS; Mamie Higgins, BS; Andre Gabriel, MD; Themistocles Assimes, MD, PhD; Naras Balasubramanian PhD;Kevin T. Nead; Jonathan Myers, PhD; Jeffrey Olin, DO; John P. Cooke MD, PhD. Vascular Medicine 2010 15:443. PMID 21183651.

5. An Evaluation of the Use of Carageenan as a Plasma Expander (Platform Presentation), Andre Gabriel. Annual
Research Forum, Committee on Research and Development. 2005.

6. Panelist, Ethical Issues in Stem Cell Research: Philippine General Hospital, 2005.

7. Advances in Oral and Maxillofacial Reconstructive Surgery, Department of Otolaryngology, Philippine General
Hospital, (Platform Presentation), Andre Gabriel, Apr 2004.

8. Review of Related Literature on Malignant Germ Cell Tumors : Clinical Characteristics, Treatment and Outcome,
The Experience in a Tertiary Government Institution. Andre Gabriel (Platform Presentation), 2004.

PEER REVIEWER FOR THE FOLLOWING PUBLICATIONS

Journal of General Medicine Drug Healthcare and Patient Safety Journal of Clinical Trials

Research Reports in Clinical Cardiology