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BIOCANCER
Clinical Research S.A.
Junho - 2006
COMPANY
We are a Site Management Organization (SMO)
focused in running Clinical Trials. We are able to
assist pharmaceutical, biotechnology, medical device
and drug development services companies to have
access to Brazil’s large population of patients through
its already consolidated network of hospitals (either
private or public), laboratories, specialized personnel
and others.
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COMPANY
From the discovery-stage to late-phase clinical trials,
BioCancer's wide range of integrated services is
designed to help companies reduce costs, minimize
risks and accelerate time to market while optimizing
the overall quality and experience of the new drug
development process.
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DIFFERENTIATION
Our aim is to provide the highest quality, most
rapid and cost effective process for the
completion of clinical studies, allowing the
sponsor to reduce time taken from the start of
Phase I studies until the completion of all
Phase III studies, with the state-of-the-art
quality.
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SERVICES
The company's service offerings include: site
definition, patient and investigator
recruitment;
clinical trial planning; medical writing, protocol design
and review; database design; data entry and
verification; biostatistician analysis and the
generation
of
clinical
trial
reports.
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INFRA STRUCTURE
We manage: 7 hospitals, 3 private practice clinics, 1
fully equipped lab entirely devoted to research, a
tissue bank already approved and collecting samples,
and other facilities.
We have access to more than 10.000 patients/month
and we are able to support virtually any technological
requirement that might be necessary in the R & D
process from phase I to IV clinical trials.
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OUR TEAM
We are scientists, physicians
and technical
professionals
with
international
clinical
trial
experience providing expert consulting services to
government, Pharmaceutical and Biotechnology
Companies.
We are highly qualified in regulatory affairs, clinical
and preclinical studies management, medical
writing, quality assurance, data management, data
analysis, scientific report generation, information
research, technology assessment, and strategic
planning.
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BIOCANCER´S: LEADERSHIP TEAM
DR. ALBERTO WAINSTEIN, MD, PhD.
Chief Medical Officer
Dr. Wainstein has 10 years of clinical research experience. He has
served as the principal investigator or sub-investigator for many
studies involving pharmacokinetics, pharmacodynamics, drug-drug
interaction and mechanism of action. He is a general Surgeon in
charge at the Minas Gerais State Hospital Foundation, a general
Surgeon at the Civil Police Hospital; General Surgeon on duty at
Hospital Mater Dei; Preceptor of the residence program in Surgery at
Federal University Of Minas Gerais, Hospital das Clínicas;
Post Doctor fellow at Karmanos Cancer Institute;
Post-Doctor Fellowship in Tumor Immunotherapy - Albert
Einstein Cancer Center – New York – USA;
Post-Doctor Fellowship in Cancer Biological
Karmanos Cancer Institute – Michigan –USA;
Therapy
–
Phd at Ludwig Institute of Cancer Research - Hospital do
Cancer,
Master in Medicine
BIOCANCER´S LEADERSHIP TEAM
DR. CARLOS GUIMARÃES, MBA
Chief Executive Officer
Mr. Guimaraes is graduated in Business Administration at Federal
University of Minas Gerais –Brazil (UFMG), pos graduated in Finance
at Federal University of Minas Gerais –Brazil (UFMG), and got his MBA
Executive International
degree at FDC/Sauder Business School
(Vancouver, Canada).
Former director of successful Brazilian biotech company, he was
responsible for an extraordinary national and international expansion,
followed by a merge process that he also coordinated. He has a
broad international experience, a strong ability to lead teams, and an
exceptional performance in the commercial area. Over the last 10
years he has been running different business and since May 2006,
was in charge of lead Biocancer to a distinguish position in clinical
trials in the world.
BIOCANCER´S: LEADERSHIP TEAM
DRA. ANA PAULA DRUMMOND, MD, PharmD
Chief Scientific Officer
Bachelor’s degree in Pharmacy from the Federal
University of Minas Gerais (UFMG) (Belo Horizonte,
Brazil),
Specialization in Industrial Phamacology at Federal
University of Minas Gerais (UFMG);
MSc in Physiology and Pharmacology from the
Federal University of Minas Gerais (UFMG);
Ph.D. inumor Immunology from the Federal University
of Minas Gerais (UFMG);
Fellowship in Cell Biology at Karmanos Cancer Center
(MI, USA);
Fellowship in Cellular Immunobiology (Clinical Trials)
at Memorial Sloan-Ketering Cancer Cener (NY, USA);
Post-doctorate in Cancer Vaccines from the Federal
University of Minas Gerais (UFMG) ;
PROTOCOL’S PORTFOLIO
Some of our studies, among others (not listed):
•
A Phase I study, to evaluate the efficacy and safety of a
vaccine based on dendritic cells pulsed with specific peptides
in patients with prostate carcinoma who are hormone resistant.
(Biocancer own study)
•
A Phase I study, to evaluate the efficacy and safety of a
vaccine based on dendritic cells pulsed with apoptotic bodies
and lysates of autologous tumor in patients with metastatic
melanoma. (Biocancer own study)
•
A Phase I study, to evaluate the efficacy and safety of an
intralinphonodal vaccine based on multi-peptides associated
to GM-CSF in patients with melanoma and high risk of 11
recurrence. (Biocancer own study)
PROTOCOL’S PORTFOLIO
•
A Phase III, randomized, double-blind, placebo-controlled,
multi-center study to evaluate the efficacy and safety of XXXX
in patients with locally advanced or metastatic renal cell
carcinoma who have progressed following cytokine-based first
line treatment.
•
A phase III, randomized, double-blind, placebo-controlled to
evaluate the efficacy of XXXX in patients with clear cell renal
cancer with high risk of recurrence.
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PROTOCOL’S PORTFOLIO
•
•
•
A Phase III, randomized, double-blind, placebo-controlled,
multi-center, multi-national study to evaluate the efficacy and
safety of XXXX in patients with solid tumors treated with
platinum derivates.
A Phase III, randomized, double-blind, placebo control, multicenter, multi-national to evaluate the efficacy and safety of
XXXX in patients with solid tumors or hematological tumors
non-mileoides treated without platinum derivates.
A Phase III, randomized, double-blind, placebo-controlled,
multi-center, multi-national to evaluate the efficacy and safety
of XXXX in anemic patients with non-Hodgkin lymphoma, CLL
or multiple mieloma treated with anticancer therapy.
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PROTOCOL’S PORTFOLIO
• A Randomized, Placebo Controlled, Multi-Center
Phase 3 Trial of XXX on prolonging bone metastasesfree survival in men Hormone-Refractory Prostate
Cancer.
• A Phase 1 single centre, cross-over, single-blind study
to evaluate the safety, tolerability and pharmacokinetics
of different formulations of XXX in post menopausal
women.
• A Phase 1 single centre, cross-over, single-blind study
to evaluate the safety, tolerability and pharmacokinetics
of different formulations of YYY in post menopausal
women.
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PROTOCOL’S PORTFOLIO
•
•
•
A Phase 1 single centre study to evaluate the safety and
tolerability of XXX in sinusitis patients.
A Phase III study of XXX plus XXX versus XXX plus XXX in
patients with unresectable, locally recurrent or metastatic
breast cancer after prior anthracycline-based adjuvant
chemotherapy
Others.
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