CLINICAL RESEARCH ASSOCIATE - CRA - MD.

Serhiy Lukovenkov, M.D.
Ft. Lauderdale, FL U.S.A.
Tel.: 281-235-4849 Fax: 866-808-8121
SS@Lukovenkov.Net
Licenses: MD, Russia; ACLS/BLS USA
US Citizen
Summary of Qualifications: Degreed Medical Doctor with more than twenty years of medical practice covering a wide range of medical disciplines, principally naval medicine, general surgery, clinical research in different medical areas.

Doctoral dissertation on the physiology associated with undersea activities (military submarine duty). Several scientific publications at major medical journals.


Research Experience: 2002-Present:
Hoffman LaRoche
- A multi center, open-label study evaluating the antiviral activity and safety of
Enfuvirtide (Fuzeon) QD or BID in triple-class experienced HIV-1 infected patients
changing their therapy to a standard of care regimen that includes initiating an integrase
inhibitor in EAP plus optimized background antiviral regimen.?
Protocol ML 20837 (AMICI)
Pfizer
- Early Access of Maraviroc in Combination with Other Antiretroviral Medications
for Treatment of HIV-1 Infected Patients with Virus Susceptible to it, i.e. HIV-1
that Exclusively uses the Chemokine co-receptor CCR5 for Cell Entry.?
Protocol A4001050
Merck Research Laboratories
- Early Access of MK-0518 in Combination with an Optimized Background Antiretroviral Therapy (OBT)
in Highly Treatment Experienced HIV-1 Infected Patients with Limited to NO Treatment Options.?
Protocol 023-00
Tibotec Pharmaceuticals, Ltd
- Early Access of TMC125 in Combination with Other Antiretrovirals in
Treatment-Experienced HIV-1 Infected Subjects with Limited Treatment Options.?
Protocol TMC125-C214
Napo Pharmaceuticals, Inc.
- Randomized, Double-Blind, Parallel-Group, Placebo-Controlled,
Two-Stage Study to Assess the Efficacy and Safety of Crofelemer 125mg, 250mg, and 500mg Orally
Twice Daily for the Treatment of HIV-Associated Diarrhea?
Protocol NP303-101 (ADVENT)
Gilead Sciences
- A Phase 2, Randomized Study of the Treatment of Antiretroviral Treatement-Experienced,
HIV-1 Infected Subjects Comparing Ritonavir-Boosted GS-9137 (GS-9137/r) Versus a
Comparator Ritonavir-Boosted Protease Inhibitor (CPI/r) in Combination with a Backround Antiretroviral Therapy?
Protocol GS-US-183-0105
Pfizer
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of a
Novel CCR5 Antagonist, UK-427,857, in Combination with Optimized Background Therapy
Versus Optimized Background Therapy Along for the Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects.?
Protocol A4001027
Boehringer Ingelheim
- Evaluation of the safety and efficacy of Ritonavir-boosted Aptivus (Tipranavir)
to that of Prezista (Darunavir) in three-class treatment-experienced patients with resistance to more than one PI.?
Protocol 1182.116 (POTENT)


Objectives: Clinical Research, Project Management, Medical Consultant.


Experience:
2007 University of Miami, Eye Research Institute, Miami, FL, USA
Senior Research Associate:
Assisted in managing large scale clinical trial projects or function as project manager for small scale projects, ensuring on-time, on-budget performance.
Monitored (pre-study, initiation, routine, and close-out visits) investigator sites for GCP compliance.
Negotiated study budgets with investigators.
Obtained, reviewed, and processed regulatory and administrative documents from investigator sites. Reviewed and developed protocols, CRFs.
Coordinated and presented at Investigators' Meetings.
Participated in proposal meetings with potential clients.
Prepared and reviewed Serious Adverse Event (SAE) reports.
Reviewed and verified completed CRFs. Reviewed clinical data in-house.
Resolved queries of CRF data with study site personnel

2007 Northpoint Medical Center Ft. Lauderdale, FL, USA
Director of clinical research:
Coordination of clinical research: overseeing outcomes and clinical research projects/drug trails on different phases of national and multi-site design on topics HIV related heath care disciplines.
Screening of potential study candidates for enrollment viability; documentation of clinical data; maintaining regulatory documentation; ensuring protocol adherence; arranging for a research study site; recruiting and enrolling clinical study participants; arranging follow-up visits; maintaining and dispensing drug and other study supplies; completing and ensuring the accuracy of case report forms and regulatory documents; ensuring the adherence to Good Clinical Practice guidelines.

2006 Lakeview Health Systems Ft. Lauderdale, FL, USA
Utilization Reviewer:
Review chart notes and operative reports to render objective written opinions
Provide independent medical opinions that quickly resolve complex problems
Pre-certification, concurrent reviews and retrospective reviews

2006- Assent Consulting Houston, TX
Chart Reviewer: Responsible for database searches and chart reviews. Identifying patients for a clinical study by looking at IC9-codes and patient charts to determine who is eligible for the study.

2002-2005 Texas Heart Institute Houston, TX
Research Assistant/Project Coordinator: Experience in a cardiovascular research environment, managing numeral projects, extensive skills in medical and technical literature review, collection of research data and preparing reports, studies conduct and management. The primary duties include working closely with a collaborative group of technicians, physicians, and researchers in the development of technologies for monitoring congestive heart failure and myocardial ischemia. Assisting PI with all aspects of study conduct and management. Worked with Study Director on specifically assigned experimental protocols in accordance with GLP standards.

2004-2005 MD Anderson Cancer Center Houston, TX
Postdoctoral Fellow: Postdoctoral Fellow position at Diagnostic Radiology.
Evaluation of CT Angiographic data, research activity in improving imaging process, developing new prognostic criteria for CAD.


2002-2005 Hermann Memorial Hospital Houston, TX
Fellow in Cardiology: Clinical duties as a fellow physician: initial medical exams - physical exams, medical history, patient records, assessment, treatment plan, and clinical notes dictations, patient?s follow up.


1990-2002 West Europe
Physician Naval Medical Practice: Responsible for providing medical services on vessels.
Performed medical admission, diagnostics, treatment, ER services, and minor surgery.


1987-1990 NAVY Fleet Vladivostok, Russia
NAVY Surgeon: Chief of Medical Service of nuclear submarines and warships. Responsible for provision of emergency medical aid, minor surgery and other medical treatment as required. Provided professional medical services as required by diving activities.


1986-1987 Medical Academy St. Petersburg, Russia
Doctoral Student: Performed medical research in the Physiology of Undersea Activities.


Education:

1995 University Medical Center, St. Mary Hospital, Chapter Plain Hospital,
Emergency Transport System, Toxicology and Drug Screening Laboratory, Department of Psychiatry at Texas Tech University Health Science Center
Lubbock, Texas
Invited by the hospitals to participate in a seven week rotation, observing the detailed medical care being provided by the above hospitals.

1995 Lubbock South Plains Chapter Hospital Lubbock, Texas
Training course ?Substance Abuse in the Prison?

1994 NGO Forum on Drug Demand Reduction Bangkok, Thailand
Participant of the Forum

1988 Sevastopol NAVY Hospital Sevastopol, Ukraine
Five month General and Urgent Surgery Internship. Management of
Medical Service at hospitals, submarines and
warships.

1981-1987 Military Medical Academy, NAVY Department St. Petersburg, Russia
Grade: Physician, Chief of NAVY Medical Service, responsible for
management of medical service at shore hospitals, floating hospitals, nuclear submarines and warships


1977-1981 Kherson Medical School Kherson, Ukraine
Grade: Physician Assistant ? Pre-Physician (Pre-Med equivalent)



Interests: Diving, photography, video advanced editing, computers - hardware, software networking.


References:
Gregory Gladish, MD, University of Texas M. D. Anderson Cancer Center, Houston.
Assistant Professor, Diagnostic Radiology. Phone: 713-792-3140 fax: 713-745-1399

Mohammad Madjid, MD, Asst. Prof. of Medicine, UTHSC. Phone: 832-355-9330



Publications:

Am J Cardiol. 2006 Jan 15;97 (2):287-293 16442381
Usefulness of Multidetector Computed Tomography for Noninvasive Evaluation of Coronary Arteries in Asymptomatic Patients.


Acad Radiol. 2007 Dec ;14 (12):1509-1519 18035280
Three-Dimensional Isotropic Wavelets for Post-Acquisitional Extraction of Latent Images of Atherosclerotic Plaque Components
from Micro-Computed Tomography of Human Coronary Arteries.


Invest Radiol. 2007 Nov ;42 (11):771-776 18030200
Quantification of Roughness of Calcific Deposits in Computed Tomography Scans of Human Coronary Arteries.