As MD, expertise in the general, trauma and
vascular surgery, focused in the cardiovascular field, with PhD in thrombosis,
anticoagulant drug development and clinical research. Extensive expertise
acting as a bridge between the pharmaceutical company and clinical
applications. Significant networking and interaction with global cardiovascular
KOLs. Effectively manage teams in
a broad aspect of Medical Affairs: basic to late phase research (from
bench to bed-side), publications,
continuous medical education and health outcomes.
Expertise
in clinical development of new compounds, from early assessment, management
and registration strategy
(Brazilian regulatory affairs) regarding human clinical trials. Currently
developing comparative studies evaluating the immunogenicity of branded and
generic enoxaparin, in line with FDA requirements.
Large interaction with Pharmaceutical companies in
continuous medical education linked to marketing strategies for anticoagulant
drugs, including marketing MKT, medical letters, publications and conferences
in main medical strategic areas updating and interacting with KOLs.
Developed
over 5 of Phase IIIb and several phase III and IV programs. Leaded the Brazilian pioneer approval process
of a biosimilar version of enoxaparin, following stringent and innovative
regulatory rules regarding biological compounds. Since 2009 is
currently available for clinical use.
Medical
interaction and consulting activities with Sanofi-Aventis, Astrazeneca,
Boehringer-Ingelheim since 1998, Cristália Pharmaceuticals, Medapi Pharma and
Eurofarma Laboratories since 2000. Xi-melagatran clinical trial participation,
supporting its launch to the market
in 2006. Close partnership for the development of Dabigatran,
with Boehringer Ingelheim. Worked in the RECOVER and REMEDY trials, with active
relationship with PPD, CRO in charge and KOLs.
Experience
interfacing with CROs, recruiting centers and sponsors, leveling the
development of IRB approvals for clinical trials, increasing enrollment in
different thrombosis trials and monitoring issues.
Solid clinical background as MD, MHS, PhD and researcher in
the UMICHMS/ USA.
Considerable publication background, 31 major papers
published, 3 book chapters, posters and major oral presentations in
international medical meetings.
Visiting
professor at The Loyola University Medical Center, participating in the
development of new compounds, and new target for antithrombotic/anti-platelet
therapy. Experience in more than 10 international multi-center clinical trials,
as well as design, investigators meetings organization, regulatory affairs,
conduction of work teams, data analysis cooperation, publishing and conferences.
DETAILED
PROFESSIONAL ACTIVITIES
Medical Researcher of Vascular Surgery Section from
University of Michigan, AA, MI, USA (2008-2009)
- Researcher of Jobst Vascular Research Laboratory (JVRL) at
University of Michigan. Researcher,
Surgeon and Team Coordinator of the Abdominal Aorta Aneurysm (AAA) Program on
the JVRL
- Animal Basic Researcher, performing approximately two
hundred abdominal aortic microscopy guided surgeries in mice.
- Outcomes evaluation included genetic and PCR analysis
evaluating possible new targets for
AAA pharmacological therapy.
- Coach the students, residents and fellows in the program of
JVRL. Orientation, coordination of publications and education strategy for
the research conduction.
- Management of budget co-responsibility in basic research
Visiting Professor and Consulting, Loyola University
Medical Center, Maywood, IL (2008-present)
-
Reporting to the head of Thrombosis and Haemostasis
department, Prof Jawed Fareed, focused on Thrombosis research and new
anticoagulants development
- Management of prospective phase I, II, IIIb and IV human
anticoagulant trials, publications, education strategy for new anticoagulants,
including evaluation of new oral anti-coagulants
- Mentoring medical students, residents and faculty with
clinical trials and new anticoagulant compounds
Chief Executive Office - Fifty Medical Research S/S
(2003-2010)
- Coordination, conduction and Development of phase III and IV
clinical trials in partnership with
pharmaceutical companies
-
Personal management of budget responsibilities in clinical
trials
- Working in close partnership with Sanofi-Aventis,
AstraZeneca, Boehringher Ingelheim,
EurofarmaLaboratories, Cristália
Pharmaceutical and Medapi Pharma, developing original clinical
trials programs
and participating in international multi-center clinical trials
- Leading Clinical Research Teams: physicians, study nurses,
monitor, pharmacologists and trainees
-
Trials results publications
-
Conferences and lectures regarding the researches process,
methods and results
- Design and developing the biosimilar enoxaparin clinical
trial to Eurofarma Laboratory. Leading the final approval protocols for venous
thromboembolism compounds, from science to regulatory and patent protection
affairs, working as the chair of steering committee of the generic enoxaparin program. This compound was approved in 2009 in Brazil and is currently
available for medical use.
- Design, management and conduct the Antema Research to Medapi
Pharma. The haemostatic product based in type I collagen was tested personally
in animal model surgery and clinical human patients in the chronic wound and
ulcers treatment. The results were submitted to the national regulatory agency
that approved the human clinical use.
- Working in close partnership with Medapi Pharma, Evidence
MKT, the studies were published and
meetings conferences regarding the Antema
were done
-
Consultant - Marketing; Clinical Trials for Sanofi-Aventis
Brazil.
Medical Investigator at Hospital e Maternidade
Dr Christovão da Gama, São Paulo, Brazil (2001-2007)
Thrombosis and Haemostasis Division
-
Medical practice in all fields of Thrombosis and Haemostasis
-
Medical practice in Vascular and Trauma Surgery
-
Principal and/or co-investigator, dealing directly with
patients in clinical trials
-
IRB affairs
-
Extensive experience as manager of
clinical researches teams
-
Extensive experience managing and reporting severe adverse
events
- Development of research educational program to
pharmaceutical doctors, nurses, physicians and
technicians to hospital general
employees
- Leading Vascular and Trauma
Surgery MD Teams for research education, regulatory affairs,
ethical
discussions in clinical trials, comprehension of the advantages for the
patients,
professionals and institutions in being evolved with the Clinical
Trials
-
Enhances relationship with General Surgery and Cardiovascular
MD Teams for Publications and
Clinical Trials collaborative
- Communication of new therapeutic
strategies for patients directly evolved with disease
awareness campaigns as
well as patients advocacy.
Assistant Professor – ABC School of Medicine, São
Paulo, Brazil (1997-2007)
Surgical Technique and Experimental Surgery
General and Trauma Surgery
- Medical practice in all fields of
General and Trauma Surgery
- Extensive experience as medical
professor of general surgery fundaments for medical students.
Weekly class
lectures and animal model laboratory training for 10 years
- Experience mentoring residents in
general and trauma surgery in clinical care, emergency and
operation room for
10 years
- Mentoring and Supervising medical students and residents in
researches, publications and
meetings supporting their medical congress
participation
- Creator, Coordinator, Conductor
and Main Professor, of the First
Formal Academic Research
Program - Medical Research Fundaments -
for medical students, from 2004 to 2007.
BASIC
EDUCATION
-
PhD, Cardiovascular Surgery
& Clinical Trial: 2004 - 2008, EPM-UNIFESP, SP/ Brazil
- Fellowship, Vascular
Surgery: 2001 - 2005, Christóvão da Gama Maternity and Hospital, SP/
Brazil
-
MHS, Surgical Technique &
Experimental Models: 1999 - 2001, EPM-UNIFESP, SP/ Brazil
-
Medical Residence, Digestive Surgery: 1997 -
1999, ABC Medical School, SP/ Brazil
- Medical Residence, General
& Trauma Surgery: 1995 - 1997, ABC Medical School, SP/
Brazil
-
Medical Degree, MD: 1989 -
1994, ABC Medical School, SP/ Brazil
PROFESSIONAL
EDUCATIONAL ACTIVITIES
-
Clinical Researcher &
Visiting Professor: 2007 - 2011, Loyola University of Chicago, IL/
USA
-
Clinical Researcher: 2007, Jobst
Vascular Center - Toledo Hospital, OH/ USA
-
Cardiovascular Surgery Researcher
& Invited Professor: 2007 - 2010, UMICH-MS, MI/ USA
|
HUMAN
CLINICAL TRIALS EXPERIENCE
|
-
CLEPTS (Vascular)
Sanofi/Aventis: Prospective Cohort Registry Study/ Investigator/ Completed
-
PREVAIL (Neurology)
Sanofi/Aventis: Phase IV/ Investigator/ Completed
-
EXCLAIM
(Vascular) Sanofi/Aventis: Phase IV/ Investigator/ Completed;
- E-FLOW (Surgery)
Eurofarma: Fase IIIb/ Designer and Principal Investigator/
Completed. This project
included the development and final approval of a generic enoxaparin in
Brazil. The drug is commercially available since September 2009.
-
REMEDY Dabigatran (DVT
Vascular) Boehringer Ingelheim: Phase III/ PI/ Concluded
-
RECOVER Dabigatran (DVT
Vascular) Boehringer Ingelheim: Phase III/ Co-PI/ Concluded
-
PROVIDENCE Rifalazil
(Vascular) Activebiotics: Fase III - FDA Approval/ PI/ Concluded
-
CRIS-FLOW (LMWH Generic)
Eurofarma: Fase III - Sudy Designer/ PI/ Concluded
-
TAL 0057 - Human
Plasmin in PAD (Vascular) Talecris: Phase II/ Investigator/ Concluded
PHARMACEUTICAL
INDUSTRY EXPERIENCE
- Sanofi-Aventis: Lovenox -
Consultant from 1996 to 2005. Marketing strategies
nationwide,
lectures, meetings and symposium organization and team
trainee.
-
Sanofi-Aventis: Lovenox -
Advisory board from 2000 to 2002
- Sanofi-Aventis: Lovenox
- Nationwide Medical Continuous Education Program, more than
hundred conferences to physicians and residents from 1996 to 2002
- AstraZeneca: Ximelagatran
Assistance-Consultant from 2004 to 2006. Brazil Melagatran
- Marketing launch in 2006.
- Boehringer Ingelheim: Dabigatran (oral
anti IIa) Consultant in 2007.
- Independent Researcher from 1994 to
2007;
-
Multinational Pharmaceutical
Industry:
Medical Consultant since 1995;
-
National Pharmaceutical Industry: Medical
Consultant since 2001;
-
Eurofarma Laboratories: National
Generic Low Molecular Weight Heparin - Enoxaparin:
- Phase IIIb. Trial Design for
the Brazilian Regulatory Agencies. The Generic Compound (Versa)
was
approved to the clinical use by ANVISA (Brazilian Health Regulatory
Agency) 2009.
-
Cristália Pharmaceutical: Designed
a phase IIIb trial for another generic LMWH – enoxaparin.
-
Worked with different CROs as PI and/or Investigator: PPD, Eurotrials, Intrials
NATIONAL
INSTITUTES OF HEALTH
-
Researcher and Co-investigator of Dr. Gilbert Riversu
Upchurch, Vascular Surgery Professor of UMICHMS from 2008 to 2010
MEMBERSHIP
-
APM: Medical Paulista Association:
member since 1995
-
CBC: Brazilian College of
Surgeons: Member in 1997. Titular Member in 2005
-
ATLS: Assessment
from 1997 to 1998: Member
-
CBCD: Brazilian
College of Digestive Surgeons: Titular Member since 2002
-
ISTF: International
Surgical Thrombosis Forum: Senior Member since 2005
-
IUA/ International Union of
Angiology: Member since 2008
-
NATF/ North
American Thrombosis Forum International: Member since 2007
CORRELATED
PROFESSIONAL ACTIVITIES
|
- Brazilian Society of Angiology and Vascular Surgery: Continuous
Medical
- Education1999-2003
- more than 200 conferences nationwide - BR)
- Independent Researcher: 1999 - 2003
- Pharmaceutical Medical Researcher Consultant: 1999 - 2007
- Chief Executive Office (CEO): Fifty
Medical Research S/S: 2003 - 2011
|
TITLES
-
Visiting professor, Loyola University
Medical Center, Thrombosis and Haemostasis Unit
- Active Member International
Surgical Thrombosis Forum, in partnership with Ola Dahl, Bengk Eriksson
and Michael Lassen
-
Associated Member, Colégio
Brasileiro de Cirurgiões (Brazilian College of Surgeons) since1997
-
Associated Member, SBACV
(Brazilian Society of Angiology and Vascular Surgery) since 2003
-
Assistant Professor, Surgical
Departament of ABC Medical School since 1998
-
Senior Member: CBCD (Brazilian
College of Digestive Surgeons) since 2002
-
Specialty Certified (Brazilian Board): Digestive Surgery since 2002
-
Senior Member: Colégio
Brasileiro dos Cirurgiões (Brazilian College of Surgeons) since 2002
-
Specialty Certified (Brazilian Board): General Surgery since 2002
PUBLICATIONS
1. Gomes M, Ramacciotti E, Henriques AC, et al.
Generic versus branded enoxaparin in the prevention of venous thromboembolism
following major abdominal surgery: report of an exploratory clinical trial.
Clinical and applied thrombosis/hemostasis: official journal of the
International Academy of Clinical and Applied Thrombosis/Hemostasis 2011;
17:633-9.
2. Gomes M, Ramacciotti E, Hoppensteadt D, et
al. An open label, non-randomized, prospective clinical trial evaluating the
immunogenicity of branded enoxaparin versus biosimilars in healthy volunteers.
Clinical and applied thrombosis/hemostasis: official journal of the
International Academy of Clinical and Applied Thrombosis/Hemostasis 2011;
17:66-9.
3. Ramacciotti E, Clark M, Sadeghi N, Hoppensteadt D, Thethi
I, Gomes M, Fareed
J.
"Contaminants in Heparin: Review of the Literature, Molecular
Profiling and clinical implications. Clinical and Applied Thrombosis/Hemostasis
2011; 17(2): 123-35
4. Cerri J, Ramacciotti E, Gomes M, Tedeschi
Filho W, Piccinato CE. Latero-lateral femoro-femoral arteriovenous fistula: a
new surgical approach for hemodialysis patients with no vascular access. Acta
cirurgica brasileira / Sociedade Brasileira para Desenvolvimento Pesquisa em
Cirurgia 2011; 26: 72-6.
5. Gomes M, Ramacciotti E, Litinas E, Fareed J.
[Concerns on generic enoxaparin use in acute coronary syndrome]. Arquivos
brasileiros de cardiologia 2010; 95: 551-2.
6.
M. Gomes, A. Ghosh, K. Roelofs,
E. Ramacciotti, J. Futchko, O. Sadiq, P.K. Henke, J.L. Eliason, G.R.
Upchurch Jr. Increased
Serine Protease Activation Is Associated with AAA Formation in Males, But Not
in Females, in The Elastase Induced Rodent Aneurysm Model. Journal of Surgical Research 2010; 158 Volume 158(2): 305.
7. A. Ghosh, M. Gomes, L.
Ehrlichman, E. Ramacciotti, O. Sadiq, J. Futchko,
P.K. Henke, J. Eliason, G.R. Upchurch Jr.Increased Phosphorylated Extracellular
Signal-Regulated Kinase (ERK) in Abdominal Aortic Aneurysms in a Rodent Model
and in Humans. Journal of
Surgical Research 2010; 158(2):
217.
8. Gomes M, Ramacciotti E,
Miranda Jr F, Henriques AC, Fagundes DJ. Vascular Flow of the Gastric
Fundus after Arterial De-vascularization: An Experimental Study. Journal
of Surgical Research 2009; 152(1): 128-34.
9.
Dahl OE, Borris LC, Bergqvist D, Schnack Rasmussen M,
Eriksson BI, Kakkar AK, Colwell CW, Caprini JA, Fletcher J, Friedman RJ, Lassen
MR, Frostick SP, Sakon M, Kwong LM, Wakefield T, Ramacciotti E, Gomes M, Kakkar VV et al; International Surgical Thrombosis
Forum. Major joint replacement. A model for antithrombotic drug
development: from proof-of-concept to clinical use. Int Angiol 2008; 27:60-7.
10. Warwick D, Dahl OE,
Ramacciotti E, Gomes M, Fisher WD et al. Orthopaedic
thromboprophylaxis: limitations of current guidelines. J Bone Joint Surg Br
2008; 90:127-32.
11. Ramacciotti E, Gomes M. Financiamento, Autoria e Credibilidade em Pesquisa Básica
e Clínica. Vascular In 2008; Ano 3, 23: 9.
12. Ramacciotti
E, Gomes M, Tedeschi Filho W. Trombose Venosa
Profunda, Cascata de
Coagulação, Inflamação e Novas Drogas. Vascular In 2008;
Ano 3, 24: 12-3.
13. Ramacciotti E,
Galego SJ, Gomes M,
Goldenberg S, De Oliveira Gomes P, Pinto Ortiz J. Fistula size
and hemodynamics: an experimental model in canine femoral arteriovenous
fistulas. J Vasc Access 2007; 8(1): 33-43 (1-11).
14. Ramacciotti
E, Gomes M, de Aguiar ET,
Caiafa JS, de Moura LK, Araújo GR, Truzzi A, Dietrich-Neto F; CLE-PTS
Investigators. A cost analysis of the treatment of patients with post-thrombotic
syndrome in Brazil. Thromb Res 2006; 118(6): 699-704.
15. Gomes M. Antema Monography - Fascículo Especial Medapi, 2004; 2: 44p.
16. Gomes M, Ramacciotti E. Critérios para Análise Crítica de um Trabalho
Científico. Atualidades
Cirúrgicas - Col Bras Cir SP 2004; 25: 3.
17. Gomes M, Ramacciotti E. Tromboembolismo Venoso e Cirurgia Minimamente
Invasiva.
Programa de Auto-Avaliação em Cirurgia, Cirurgia Minimamente
Invasiva - Col Bras Cir 2004;
Ano 3 -
Fascículo III - contracapa.
18. Gomes M, Ramacciotti E. Câncer e Doença Tromboembólica. Programa de
Auto-Avaliação em Cirurgia, Câncer de Pulmão - Col Bras Cir 2004; Ano
3 - Fascículo II - contracapa.
19. Henriques AC,
Pezzolo S, Gomes M.
Out-patient VL cholecistectomy – report of 70 cases.
Arquivos Médicos do
ABC 2003; 27: 06-8.
20. Gomes M, Ramacciotti E. Profilaxia da Doença Tromboembólica no
Paciente Idoso. Programa
de Auto-Avaliação em Cirurgia. Paciente Idoso -
Col Bras Cir 2002; Ano 2 – Fascículo II, contracapa.
21. Gomes M., Ramacciotti E. Profilaxia do Tromboembolismo Venoso em
Cirurgia Geral. Programa de Auto-Avaliação em Cirurgia, Tromboembolismo Venoso
- Col Bras Cir 2002; Ano 2 - Fascículo I - 20p.
22. Gomes M, Ramacciotti E. Profilaxia da Doença Tromboembólica no
Paciente Obeso Mórbido.
Programa de Auto-Avaliação em Cirurgia.
Paciente Obeso Mórbido - Col Bras Cir 2002; Ano 1 –
Fascículo II,
contracapa.
23. Gomes M, Oliveira P, Ramacciotti E. Anatomical Evaluation of the Gastric Fundus
after Partial Arterial Section: Experimental Study in Dogs. Acta Cir Bras
2001; 17: 52
24. Henriques AC, Gomes M, Pezzolo S et al
Isoperistaltic gastric tube for the complicated
esophagus cancer. Rev
Col Bras Cir 2001; 28: 408-13
25. Henriques AC,
Pezzolo S, Gomes M, Godinho
CA, Bazália VAS, Speranzini MB. Intra-operative preparation
of the colon. Rev Col Bras Cir 2001; 28: 271-3.
26. Henriques AC,
Pezzolo S, Gomes M, Godinho
CA, Bagarollo CA. Out patient video-aparoscopic colecistectomy. Rev
Col Bras Cir 2001; 28: 27-9.
27. Henriques AC, Gomes M, Bagarollo CA. Appendex
adenocarcionoma: 2 cases report. Rev Col
Bras Cir 2001; 28:
393-5.
28. Henriques AC, Horta
SHC, Pezzolo S, Waisberg J, Boratto SF, Helal S, Gomes M, Speranzini
MB. Local Anestesia for Selected
Patients. Arq Gastroenterol 200; 158-61.
29. Henriques AC,
Pezzolo S, Godinho CA, Gomes M,
Speranzini MB. Gastric tricobezoar. Arq
Med ABC 2000; 23: 6-8.
30. Henriques AC, Gomes M, Miotto MJ, Abreu E, Pezzolo
S. Videolaparoscopic cholecistectomy – a report of 130 cases. Arq Med ABC
1997; 1 e 2: 11-4.
31. Henriques AC, Gomes M, Pezzolo S, Speranzini
MB. The wandering Spleen. An up-to Date of the question. Arq Bras Cir
Dig 1995; 10: 114-7.
32. Henriques AC, Gomes M, Abreu E, Bento JA, Cruz RRM,
Pezzolo S, Speranzini MB. Intercostal abdominal hernia. Rev Col Bras 1995; 22:
161-5
33. Gomes M, Henriques AC, Pezzolo S, Speranzini MB. Post-traumatic spleen
pseudo-cyst. Rev
Col Bras Cir 1995; 22: 107-10.
BOOK
CHAPTERS
1. Gomes M, Ramacciotti E. Profilaxia do Tromboembolismo Venoso
em Pacientes Cirúrgicos.
“Doenças Vasculares Periféricas”. Maffei,
Lastória, Yoshida, Rollo, Giannini, Moura. 4 Ed.
Editora, 2008.
2. Ramacciotti O, Gomes
M, Ramacciotti E, Faure R. Coagulopatias na Gestação. “Peixoto
Pré
Natal”. Editora Rocca Ltda. 2003.
3.
Ramacciotti O, Gomes
M, Ramacciotti E, Faure R. Vasculopatias na Gestação. “Peixoto
Pré
Natal”. Editora Rocca Ltda. 2003
RESEARCH,
CHAPTERS AND ARTICLES ON GOING
1. Cafer Adiguzel, Omer Iqbal, Debra Hoppensteadt, Josephine
Cunanan, Eduardo Ramacciotti, Marise Gomes, Jawed Fareed. Danaparoid effect on the
inhibition of microparticles generation, platelet aggregation and P-selectin
expression. Loyola University Medical Center, Maywood, IL, USA.
2. Cafer Adiguzel, Omer Iqbal, Debra Hoppensteadt, Josephine
Cunanan, Eduardo Ramacciotti, Marise
Gomes, Jawed Fareed. The inhibition of microparticles generation,
platelet aggregation and activation by enoxaparin. Loyola University Medical
Center, Maywood, IL, USA
3.
Marise Gomes, Eduardo
Ramacciotti, Alexandre Cruz Henriques, Cynthia K Shortell, MD, Fausto
Miranda Jr, Anti-Xa evaluation of two low-molecular heparin enoxaparins
(Lovenox and generic eurofarma enoxaparin) in the prevention of
venous thromboembolism following major abdominal surgery. Fifty Medical
Research/ BR, ABC School of Medicine/ BR, Duke University/ USA, UNIFESP School
of Medicine/ BR.
4. Cafer Adiguzel, Omer Iqbal, Hoppensteadt Debra, Josephine
Cunanan, Eduardo Ramacciotti, Marise
Gomes, Jawed Fareed. Generic versions of LMWH can be differenciated
in HIT sera mediated platelet aggregation. Loyola University Medical
Center, Maywood, IL, USA
5.
Jawed Fareed, Marise
Gomes, Eduardo Ramacciotti, Cafer Adiguzel, Anthony Comerota,
Debra A. Hoppensteadt, Andrew Nicolaides. Contaminantes, recall
process and unfractionated heparin preparations: an internal major public
health problem. Loyola University Chicago IL/ USA, Jobst Vascular Center
OH/ USA.
6. Marise Gomes, Eduardo
Ramacciotti, Anthony Comerota, Cafer Adiguzel, Debra A. Hoppensteadt, Andrew Nicolaides, Jawed Fareed. An open, non-randomized, prospective
clinical trial comparing the pharmacodynamics of two enoxaparins
(branded sanofi-aventis and generic biochimico/ Lovenox and Cutenox), 40mg
OD, 6-14 days in healthy volunteers. Fifty Medical Research SP/ BR, Jobst Vascular Center OH/ USA, Loyola University IL/ USA.
7. Cafer Adiguzel, Omer Iqbal, Hoppensteadt Debra, Josephine
Cunanan, Eduardo Ramacciotti, Marise
Gomes, Jawed Fareed. Distint batches of branded parnaparins have
diferents HIT sera mediated plateled aggregation. Loyola University
Medical Center, Maywood, IL, USA.
8. Cafer Adiguzel, Omer Iqbal, Debra Hoppensteadt, Josephine
Cunanan, Eduardo Ramacciotti, Marise
Gomes, Jawed Fareed. Suledoxide mediated inhibition of tissue factor
activation of platelet a potential mechanism for observed therapeutic effects
in diabetes nephropathy. Loyola University Medical Center, Maywood, IL, USA.
9. Gomes M, Ramacciotti E,
Comerotta A, Hoppensteadt D, Fareed J. Immunogenic profile of enoxaparin
and it’s generic Cutenox in healthy volunteers and medical ill
patients.
10. Gomes M, Ramacciotti E, Hoppensteadt, Walenga J M, Lewis B, Thethi I, Fareed J.
Journal of Clinical and Applied Thrombosis and Haemostasis.
Department of Pathology and Pharmacology, Cardiovascular
Institute, Loyola University Medical Center, Maywood, IL 60153, USA.
11. Ramacciotti
E, Gomes M, Hoppensteadt,
Walenga JM, Lewis B, Fareed J. An Open Label, Non Randomized, Prospective
Phase IV Clinical Trial Evaluating the Imunogenicity of Branded Enoxaparin Versus Biosimilars in Healthy
Volunteers. American Heart Association 2010. Department of Pathology and Pharmacology, Cardiovascular
Institute, Loyola University Medical Center, Maywood, IL 60153, USA
12. Gomes M et al. Differential
Pharmaco-equivalence of Branded and Generic Low Molecular
Weight Heparins in Mediating Immunologic Responses." submitted to
Clinical and Applied
Thrombosis/Hemostasis, 2010.
RECENTLY
ATTENDANCE EVENTS
SCIENTIFIC
MEETINGS AND PRESENTATIONS
21st International Thrombosis Congress 2010 - Milan/
Italy
-
Pharmacodynamic Differences Between Biosimilar and Branded
Enoxaparins with Reference to Their Immunogenic Profile. Gomes M, Ramacciotti E, Rao G,
Hoppensteadt D, Jeske W, Walenga J M, Fareed J
-
Guidelines for Development of generic/ Bio-SimiLar LMWHs.
Where Do We Stand? Gomes M,
Ramacciotti E, Hoppensteadt D, Jeske W, Walenga J M, Litinas E, Fareed J
- Oversulfated Chondroitin Sulfate is not sole Contaminant in
recalled Heparins. Fareed J, Ramacciotti E, Hoppensteadt D, Sadeghi N, Van
Thiel D, Gomes M, George M.
North American Thrombosis Forum 2010 - Boston/
USA
-
VIP Thrombosis Working Group Session
-
North American Thrombosis Summit
-
Scientific and Clinical Discussion on Current Topics of
Anticoagulation
LANGUAGES
-
Portuguese
-
English
