Download qualifications/professional experience/gcp training

INVESTIGATOR CV TEMPLATE
FULL NAME
:
First Name Surname
VLADIMIR KOVČIN
TITLE (Prof, Dr, Mr, Mrs, Miss or Ms)
:
Prof., Senior Res. Fellow, MD PhD
DATE OF BIRTH
:
Day Month Year
25.12.1957.
PRESENT POSITION
:
Medical oncologist at the Department for medical oncology
START DATE
:
Day Month Year
13.July.2009.
WORK ADDRESS
:
Clinical Hospital Center “Bežanijska Kosa”, Bežanijska Kosa bb,
11080 Belgrade, Serbia
WORK TELEPHONE NUMBER
:
Tel: +381 11 3010-700 Fax: +381 11 2606-520 or +381 11 3010787
Mobilphone +381 63 252-114
BUSINESS E-MAIL ADDRESS
:
[email protected]
[email protected]
LANGUAGES
:
Serbian – native
English – spoken and written
Franch – spoken
Russian – spoken and written
101136 (01.02.2013)
LICENCE No.
QUALIFICATIONS/PROFESSIONAL EXPERIENCE/GCP TRAINING:
Title
Medical Doctor
Date Obtained
(Chronological
Order)
10. Mar.1982
Name of Educational
Establishment
Faculty of Medicine,
University of Belgrade,
City
Country
Belgrade
Yugoslavia
(Serbia)
POSTGRADUATE MEDICAL / OTHER PROFESSIONAL OR SPECIALIST TRAINING:
Institution
University of Belgrade, Medical
Faculty
Date
Day / Month / Year
(Chronological Order)
10. May. 1989
Nature of Training/Qualification
Master of Sciences ("Determination of the
carcinoembryonal antigen in immune serum complexes of
the patients with malignantdiseases and CEA action in
serum fractionating")
1
QUALIFICATIONS/PROFESSIONAL EXPERIENCE/GCP TRAINING:
University of Belgrade, Medical
Faculty
University of Belgrade, Medical
Faculty
University of Belgrade, Medical
Faculty
24. Sep. 1990
Specialization in internal medicine
1993
Research Assistant for Oncology
28. Apr. 1995
Ministry of Science
US Medical School Belgrade
University of Belgrade, Medical
Faculty
Ministry of Science
European University, Belgrade,
US Medical School Belgrade
1997
22. Aug. 2005
14. Jul. 2008
Ph.D., Medical Sciences, (Cardiac rhythm alterations as a
manifestation of cardiotoxicity of single-dose
anthracyclines)
Research Fellow for Oncology
Associate Professor for internal medicine
Subspeciality in clinical oncology
26. Feb. 2007
23. Feb. 2009
Senior Research Fellow for Oncology
Associate Professor for clinical oncology
“Roche“ Belgrade
ACRP Association of Clinical
Research Professionals
NIDA Clinical Trials Network
06. July 2007.
18. – 20. Oct. 2007.
23. – 25. Sep. 2010.
06.11.2014
GCP Workshop for Investigators
GCP for Investigators, Research Physicians, Site Nurses
and other Research Professionals
GCP Course
Continuing GCP training thtought participation in
clinical trials and attendence on Investigator Meetings
INVESTIGATOR CV TEMPLATE (CONTINUED)
PREVIOUS POSITION(s) HELD & START / END DATES:
POSITION
Part time job
Investigator in training
G.P.
G.P. in training of Internal
Medicine
Specialist in internal medicine
Head of the department
Head of the Oncology
department
HOSPITAL
START DATE
Day / Month / Year
END DATE
Day / Month / Year
(Chronological
Order)
(Chronological
Order)
Immunological laboratory of the
Institute of Physiology of the
Medical Faculty in Belgrade
Immunological Research Center
“Torlak”, Belgrade
1980
1982
Since May1982
to September 1983
Institute of Oncology Radiology in
Belgrade - department for
chemotherapy
Institute of Oncology and
Radiology in Belgrade (department
for malignant haemopaties)
Institute of Oncology and
Radiology in Belgrade (department
for aggressive chemotherapy)
Institute of Oncology and
Radiology in Belgrade, department
for aggressive chemotherapy and
malignant haemopaties
Clinical Medical Center (KBC)
“Bezanijska Kosa”, Belgrade
September 1984
to 1986
September 1986
to 1990
October 1990
to 1995
August 1995
May 1997
May 1997
April 2001
2
PREVIOUS POSITION(s) HELD & START / END DATES:
Director
Head of the Oncology
department
General Manager
Head of the Department for
medical oncology
private Oncology Center
“Oncomed” in Belgrade
Clinical Hospital Center (KBC)
“Bezanijska Kosa”, Belgrade
CHC (KBC) “Bezanijska Kosa”,
Belgrade
Clinical Hospital Center (KBC)
“Bezanijska Kosa”, Belgrade
September 2001
September 2005
September 2005
July 2009
July 2009
Jun 2013
Jun 2013
Jan 2014
CLINICAL TRIAL EXPERIENCE:
THERAPEUTIC AREA
(Alphabetical Order)
INDICATION
STUDY PHASE
I
Adjuvant trials comparing
interferon alpha-2 to
gamma to control in
malignant melanoma No.
18871 (EORTC)
Cardioprotection with
Cardioxane in patients with
breast cancer treated by
FAC regimen
(EUROCETUS)
GM-CSF in treatment of
leucopenia induced by
aggressive chemotherapy of
solid tumors (SANDOZ)
G-CSF with the ACVBP
regimen for high grade
Non-Hodgkin lymphoma
(ROCHE)
Epirubicin-CDDP vs.
VP16-CDDP for small cell
lung cancer (CEEOG)
CDDP-5FU regimen for
advanced head and neck
cancer (Central and East
European Oncology Group
- CEEOG)
UICC Epidemiology &
Prevention Program:
Familial Cancer Prevention
Project
QUASAR1 – UKCCCR
study of adjuvant
chemotherapy for colorectal
cancer
II
III
YOUR ROLE IN
STUDY
(e.g. Principal
Investigator,
study nurse,
etc)
(Patient Numbers
& Year etc).
1984.
IV
Metastatic
malignant
melanoma
X
Coinvestigator
Breast Cancer
X
Coinvestigator
Leucopenia
induced by
aggressive
chemotherapy of
solid tumors
X
Coinvestigator
High grade NonHodgkin
lymphoma
X
Coinvestigator
Small cell lung
cancer
Advanced head
and neck cancer
X
X
Coinvestigator
Coinvestigato
Hereditary cancer
of breast, lung
and colorectal
Adjuvant
chemotherapy for
colorectal cancer
ADDITIONAL
STUDY
INFORMATION
X
Investigator
1999.
Investigator
2000.
3
02-CoFacor study of firstline chemotherapy for
metastatic colorectal cancer
Phase II Docetaxel plus
Tesmilifene (YMB 1002) in
patients with MBC (YM
BioSciences)
Phase III Weekly Tacosol
vs. weekly Paclitaxel in the
treatment of MBC (SONUS
Pharm)
FIND-2 Fentanyl Inhalation
in Neoplastic Disease (LAB
Pharma Ltd)
PBI-1402 and anemia in
cancer patients (ProMetic
Bio Sciances)
MVA-BN HER-2 with 1st
or 2nd line treatment for
MBC (BN
ImmmunoTherapeutics)
Phase III of NOV002C301in combination with
Paclitaxel and Carboplatin
(Novelos Therapeutics)
A multyicenter,
randomized, duble-blind
study of Sunitinib in
MCRC receivning
FOLFIRI as first line
treatment (Pfizer)
A Phase III, Multicenter,
Randomized, PlaceboControlled Bevacizumab +
Chemotherapy in
previously treated MBC
(Genetech)
A randomized, withdrawal,
active and placebocontrolled, duble-blinde
oral CG5503 (Grunenthal
GmbH)
Randomized, duble-blinde,
biosimilar G-CSF
(Filgrastim v.s. Neupogen)
in subject receiving
doxorubicin and docetaxel
(Mayne Pharma)
RIBBON2 randomized,
placebo-controlled,
bevacizumab and
chemotherapy in previously
treated MBC (Quintiles)
Randomized Two-ParallelArm of E7389 vs
Capecitabine in Patients
with MBC previously
treated with Antrayclines
and Taxanes
Chemotherapy
for metastatic
colorectal cancer
First line
chemotherapy for
metastatic breast
cancer
Second line
chemotherapy for
metastatic breast
cancer
Breakthrought
pain in
maintenance
opioid th.
Anemia in cancer
patients
Coinvestigator
2005.
Principal
investigator
2006.
Principal
investigator
2006.
X
Principal
investigator
2007.
X
Principal
investigator
2007.
Principal
investigator
2007.
X
Principal
investigator
2007.
X
Principal
investigator
2007.
Second line
MBC
X
Principal
investigator
2007.
Chronic tumor
related pain
X
Principal
investigator
2007.
X
Principal
investigator
2007.
Metastatic breast
cancer
X
Principal
investigator
2007.
Metastatic breast
cancer
X
Principal
investigator
2008.
HER-2 positive
metastatic breast
cancer
NSCLC
First line
chemotherapy for
metastatic
colorectal cancer
Breast cancer
X
X
X
Xb
X
4
Registration Phase III
Study of Lucanix in
Advanced NSCLC.
Randomized, Doubleblined, Placebo controlled
A Multicenter Phase III
Randomized Trial of
Adjuvant Therapy For
Patient with HER2-positive
BC Comparing Chemoth +
Trastuzumab vs Chth. +
Trastuzumab+Bevacizumab
Phase III, Randomised,
Placebo-controlled,
Double-blind of Once-daily
Orally ZD4054 in Nonmetastatic Hormoneresistant Prostate Cancer
QUASAR2 – UKCCCR
study of adjuvant
chemotherapy for colorectal
cancer
A randomized phase III of
paclitaxel + bevacizumab
vs.
capecitabine
+
bevacizumab for the firstline treatment of HER2negative MBC
Phase III trial of oral BIBF
1120 + pemetrexed v.s.
placebo + pemetrexed in
patients with stage IIIB/IV
NSCLC after failure of first
line chemotherapy
A Phase 3, Randomized,
Neratinib Versus Lapatinib
+ Capecitabine for the
Treatment of ErbB2+
Locally Advanced or
Metastatic BC
A Double-blind
Randomised, Phase I/IIb
Study Safety and Efficacy,
Pharmacokinetics and
Immunogenicity for CT-P6
and Herceptin in MBC
A randomized, phase II
study of pertuzumab and
trastuzumab in combination
with standard neoadjuvant
CHT treatment of HER2 +
early breast cancer
A Randomised, Phase III
Study of CT-P6 and
Herceptin both in
combination with Paclitaxel
in MBC
NSCLC
X
Principal
investigator
2008.
X
Principal
investigator
2009.
X
Principal
investigator
2009.
X
Principal
investigator
2009.
X
Principal
investigator
2009.
X
Principal
investigator
2009.
Metastatic breast
cancer
X
Principal
investigator
2009.
Metastatic breast
cancer
X
Principal
investigator
2010.
Principal
investigator
2010.
Principal
investigator
2010.
Breast Cancer
Prostate Cancer
Adjuvant
chemotherapy for
colorectal cancer
Metastatic breast
cancer
NSCLC
Breast Cancer
HER2 +
Metastatic breast
cancer
X
X
5
Randomized, placebo
controlled Phase III ,
efficacy of recMAGE-A3 +
AS15 ASCI as adjuvant
therapy in patients with
MAGE-A3 positive
resected stage III MM
Double-Blind, Single-Dose,
Two-Period Crossover
Study to Evaluate the
Bioequivalence of a Test
(T) Formulation of
Capecitabine (R)
Formulation (Xeloda®) in
Patient with MBC and CRC
Randomized double-blind
Phase III trial of
FOLF(HA)iri vs FOLFIRI
for second or third line
therapy in irinotecan-naïve
patients with MCRC
Non-Inferiority Stady of
Neugranin or Pegfilgrastim
in patients with BC
receiving Myelosuppressive
Chemotherapy
Phase I/II Safety and
Tolerability of Multiple
Doses of Oral Tasidotin
HCL in Advanced Solid
Tumors and Combination
of Oral Tasidotin
HCl with DTIC in MM
A randomized, double
blind, phase II trial of
ombrabulin with platinum
and taxane in first line
treatment of patients with
locally advanced or
metastatic NSCLC
A Randomized, Phase
IIB/III Study of Ganetespib
with Docetaxel vs
Docetaxel in Subjects with
Stage IIIb or IV NSCLC
A phase III, study to assess
the safety and efficacy of
netupitant and palonosetron
for the prevention of
chemotherapy-induced
nausea and vomiting
A phase III, study of
efficacy and safety of
MetMab and Tarceva
(erlotinib) in patients with
incurable NSCLC
An open-label, multicenter
expanded access study of
RO5185426 in patients
with metastatic melanoma.
Melanoma
X
Principal
investigator
2010.
X
Principal
investigator
2010.
X
Principal
investigator
2011.
X
Principal
investigator
2011.
X
Principal
investigator
2011.
X
Principal
investigator
2011.
X
Principal
investigator
2011.
X
Principal
investigator
2011.
X
Principal
investigator
2012.
X
Principal
investigator
2012.
Colorectal and
breast cancer
Colorectal cancer
BC,
myelosuppression
Melanoma
NSCLC
NSCLC
Prevention of
chemotherapyinduced nausea
and vomiting
NSCLC
Melanoma
metastatic
X
X
6
Open-label, Ph. IIIb study
of Erlotinib (Tarceva) for
locally advanced or
metastatic NSCLC
A Ph. II, Randomised, of
Lapatinib with Vinorelbine
or Capecitabine in
Women with ErbB2Overexpressing MBC
A ph. III study to assess the
safety of assisted- and selfadministed s.c. trastuzumab
as adjuvant therapy in
patients with operable
HER2- positive early BC
A ph. III, randomized,
study of safety and efficacy
of peg-filgrastim vs
Neulasta in subject with BC
receiving TAC
chemotherapy in adjuvant
setting
A Ph. III, controlled,
randomized, efficacy and
safety study of Mylan’s
Hercules v.s. Herceptin®
in combination with
docetaxel in patients
with HER2+ MBC
Phase II randomized trial of
MEK inhibitor
MSC1936369B or placebo
with gemcitabine in
metastatic pancreas cancer
A Randomized, Phase 3
Study of Ganetespib with
Docetaxel versus Docetaxel
Alone in Patients with
Advanced Non-Small-Cell
Lung Adenocarcinoma
A phase III, randomized,
vemurafenib (RO5185426)
adjuvant therapy in patients
with surgically resected,
cutaneous braf-mutant
melanoma at high risk
for recurrence
A Single Dose,
Bioequivalence Study of
Capecitabine 500 mg
Tablets under Fed
Condition
Randomized double-blind
Ph. III trial of FOLF(HA)iri
vs FOLFIRI for second or
third line in irinotecannaïve patients with MCRC
NSCLC
Breast
X
Breast
Prevention of
chemotherapyinduced
neutropenia
Breast
NSCLC
Melanoma
adjuvant
Bioequivalence
Chemotherapy
for metastatic
colorectal cancer
2012.
Principal
investigator
2012.
X
Principal
investigator
2012.
X
Principal
investigator
2012.
X
Principal
investigator
2012.
Principal
investigator
2013.
X
Principal
investigator
2013.
X
Principal
investigator
2013.
X
Coinvestigator
2013.
X
Principal
investigator
2013.
X
Breast
Pancreatic cancer
Principal
investigator
X
7
Ph. 3 Study Evaluating the
Efficacy and Safety of ABP
980 vs Trastuzumab in
Subjects with HER2
Positive Early Breast
Cancer
Comparative Efficacy and
Safety Study of RGB-02
and Neulasta® in patients
undergoing treatment
known to induce
neutropenia
Early Breast
Cancer,
Biosimilarity
Biosimilarity,
Prevention of
chemotherapyinduced
neutropenia
X
Principal
investigator
2014.
X
Principal
investigator
2014.
MEMBERSHIPS:
Member of the Serbian Medical Association (SMA) since 1984.
Member of the Haematological section of SMA and member of its board
Member of the Carcinologic section of SMA
Secretary of the Republic Committee for Oncology since 1986.
Member of the European Society for Medical Oncology (ESMO), since 1994.
Member of the Hellenic Society Against Lung Cancer since 1994.
Secretary of the Scientific Committee of the Institute for Oncology and Radiology, Belgrade, since 1994.
Member of the Aristoteles University, Naussa, Greece, since 1994.
Member of the Multinational Association of Supportive Care in Cancer (MASCC), 1995.
Member of the European Haematological Association (EHA) since 1995
Member of the Subcommittee for Hematopoietic Support of the Multinational Association of Supportive Care in Cancer
(MASCC), since 1995.
Member of the Balkan Union of Oncology (BUON), since 1995.
Member of the New York Academy of Sciences (NYAC). since 1998.
Member of the American Society of Clinical Oncology (ASCO). since 2001.
Member of the Association of Clinical Research Professionals No 1008013 (ACRP). since 2007.
PUBLICATIONS:
Name of Publication
Journal
Date Published
Month / Year
(Chronological Order)
EDTA clearance in monitoring cisplatin dose
escalation in patients with bulky metastatic germ
cell tumors of the testis
A clinical investigation of salmon calcitonin
(Miacalcic) in patients with bone metastases
from stage D prostatic carcinoma
A pilot study to assess the efficacy of salmon
calcitonin in the relief of neuropathic pain
caused by extraskeletal metastases
Primary gastric non-Hodgkin’s lymphoma
localized to the gastric wall: No adjuvant
treatment following radical surgery
Non -IPSID small intestinal lymphoma: Evidence
for disseminated disease at presentation
Modulation of cisplatin antitumor activity by
short infusional high-dose cytosine arabinoside
in advanced pretreated head and neck carcinoma:
a phase II study
Etude pilote de la zorubicine a hautes doses dans
les stades avances des sarcomes des tissus mous
de l adulte.
Richter syndrome with emphasis on large-cell
non-Hodgkin
lymphoma
in
previously
unrecognized subclinical chronic lymphocytic
leukemia
Acta Oncologica
27, 5, 541-543, 1988
Sandorama
4, 26-30, 1991
Support Care Cancer
2:71-73,1994.
Oncology
51: 270-272, 1994.
Neoplasma
41, (6), 359 -362, 1994.
Journal of Chemotherapy
8(4); 304-309, 1996.
Bull Cancer
83; 1002-1007, 1996.
Neoplasma
44, (1), 63 -68, 1997
8
PUBLICATIONS:
Gonadotropin serum levels in patients with
germ-cell tumors of the testis: inter-relations,
possible cross-reactions and interpretation of
beta-HCG level
Randomised Study of High-dose Epirubicin
Versus
High-dose
Epirubicin-Cisplatin
Chemotherapy for Advanced Soft Tissue
Sarcoma
Randomized study of zorubicin versus zorubicincisplatin in undifferentiated carcinoma of the
nasopharynx (UCNT)
Gastric metastases of melanoma; two cases
report
Does the simulltaneous application of
granulocyte colony stimulating factor and
erythropoietin contribute to bone marrow
exhaustion? A case report
Disturbed cardiac rhythm as a manifestation of
cardiotoxicity
of
individual
doses
of
anthracycline cytostatics
Subcutaneous mastectomy and immediate breast
reconstruction performed in 15 year old female
patient with phyllodes tumor
Survival advantage for carboplatin substituting
cisplatin in combination with vindesine and
mitomycin C for stage IIIB and IV squamous-cell
bronchogenic carcinoma: a randomized phase III
Comparison of the efficacy of two different
dosage dacarbasine-based regimens and two
regimens without dacarbasine in metastatic
melanoma: a single-centre randomized four-arm
study
Efficacy and safety of bevacizumab in
combination with oxaliplatin, irinotecan and
fluoropyrimidine-based therapy in advanced
colorectal cancer
Hormonotherapy for patients with early breast
cancer – is the consensus possible?
J.Biol.Markers
12,(2), 55-60, 1997
Eur J Cancer
33, (2), 220-225, 1997.
Ann Oncology
8: 739-744, 1997.
Melanoma Res
8, (1), 90-91,1998.
Jurnal of BUON
1: 81-84, 1998.
Med Sci Monit
5 (1): 32-39, 1999.
Med Sci Monit
5 (5): 950-952, 1999.
Lung Cancer
34: 1-13, 2001
Melanoma Res.
12 (1): 91-98, 2002.
Archive of Oncology
15 (1-2): 10-14, 2007.
Archive of Oncology
17, Supp 1: 19, 2009.
Disconection of chamber and catheter as a
complication of central venous catheter type
port-a-cath
Association between systemic non-criteria APS
manifestations and antibody type and level:
results from the Serbian nationalcohort study
Evaluation of the efficiency and tolerability of
monotherapy with oral etoposide in elderly
patients (70+ years of age) with advanced non
small cell lung cancer and poor performance
status.
Revisiting effect of the chemotheraphy with 5fluorouracil in patients with gastric cancer.
Multivariate Analysis of Prognostic Factors in
Male Breast Cancer in Serbia.,
Med Oncol
28: 1176-1179, 2011
Clinical and Experimental Rheumatology
31: 234-242, 2013
Eur. Med. Health and Pharm.
J. Vol. 6. 2013.
Wulfenia J.
21, (5), 267-285, 2014
Asian Pac J Cancer Prev
15 (7), 3233-3238; 2014
SIGNATURE: __
___
DATE:
19/Aug/2014
(Hand written)
9