Transcript France, world leader in development of new anti

Early Clinical Study
in Cancer Patients
Paris Region
Paris 22, 23 February 2007
France, world leader in development
of new anti-cancer agents
Evidence for the efficacy of many anti cancer
drugs was first provided in France.
CPT-11
 CPT-11 was synthesized by Yakulto Honsha (Japan)
 Marketing approval in January 1994 in Japan, for the treatments
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of non-small cell and small cell lung cancers, cervical cancers,
and ovarian cancers.
Marketing approval in France in May, 1995, for the treatment of
advanced colon cancers. (Rhone-Poulenc Rorer )
Licensed in Japan in September 1995 for the treatment of
patients with colorectal cancer
Marketing approval in the USA in June 1996 for the treatment of
patients with colorectal cancer
Oxaliplatin
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Invented in 1976 by Dr. Kidani (Japan)
Marketing approval with the indication of colorectal
cancer in France in 1996
Marketing approval in the USA in 2002 with same
indication
Marketing approval with the same indication in Japan
in March, 2005
Taxotere
 Discovered by Pierre Potier (CNRS, France)
 1994 received the first marketing authorizations from Mexico
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and South Africa for the treatment of advanced breast cancer in
patients
1995: the first oncology drug to complete the European Union's
new centralized review procedure and receive regulatory
clearance in all 15 member countries in the treatments of
patients with advanced stage breast cancer
1996 Market approval for the US
Navelbine (Vinorelbine)
 Discovered by Pierre Potier (CNRS, France ) in 1978
 First Marketing approval in France in 1989 in NSCLC by Pierre
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Fabre
the American FDA in 1994 in NSCLC
France, world leader in development
of new anti-cancer agents
Eight anti-cancer drugs are manufactured in France for the rest
of the world.
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The Eli Lilly laboratories’ site for the worldwide supply of Alimta is
in Alsace
Ipsen produces Decapeptyl and Somatuline in France for the rest
of the world
Exolatine is packaged in France for about fifty countries.
Aventis Pharma has a production factory Taxotere for the rest of
the world
The same is true for Fasturtec, Gemzar and Vinorelbine.
France, world leader in development
of new anti-cancer agents
 12,000 people work in the field of cancer in the
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pharmaceutical industry in France
More than 230 clinical trials/year over the period 1998-2000
France, the second biggest market
in Europe for oncology product
1.420 billion dollars in 2002
and a study by Datamonitor
predicts an increase of 22%
by 2005
France, one of the countries with the
highest speed to market for drugs
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France is the only country in Europe having a procedure for premarket approval (ATU)
ATU procedure is an exceptional measure for marketing drugs
available that do not have marketing approval.
The aim is to enable early access to new treatments when they are
to be used for treating patients with serious disease and when
there is no therapeutically alternative.
ATU is issued by the AFSSAPS( the French National Drug Agency)
France, the most active region in
cancer clinical research
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For exemple
In 2002, 6241 patients participated into clinical studies organized
by EORTC (European Organization for Research and Treatment of
Cancer, the biggest European cancer research network.
The highest number of patients included into studies were:
 France 1262
 The Netherlands: 1261
 The United Kingdom: 716
 Germany: 426
Paris Region (Île de France)
a structured and dynamic region for
drug’s development
 High population and patient concentration: 11 million
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inhabitants
High concentration of medical resources: 42,000
physicians/ 50,000 beds
High concentration of public/private establishments:
42% of biomedical research
20% of the healthcare market supply in Oncology
Paris Region (Île de France)
a structured and dynamic region for
drug’s development
 The biggest French and international laboratories are
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present
50% of biotechnology companies are located
90% of CROs
The large consultancies specialized in regulatory affairs
The headquarters of the AFSSAPS, the French National
Drug Agency
France has launched its national
plan to fight cancer on 23th March 2003
A national cancer institute and 7 Cancéropôle
cancer centers have been set up to bring together
the major research bodies
The Paris Region Cancéropôle Cancer Centre
(Cancéropôle île de France)
presided by Prof. Claude Huriet
 Being the head of the French Cancéropôle network
 Its mission is o federate skills and research capabilities in
cancer research in the Paris Region through 7 Areas
Seven areas inside of Cancéropôle île
de France
 Tumor identify cards
 From tumor biology to innovative cancer treatments
 Host-tumor relationship: immune responses, angiogenesis
 Targeted screening and specific prevention of cancer
 Functional imaging of cancer
 New clinical research with novel tolls for the definition and
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evaluation of clinical trials
Human and social science
Area 6: Clinical Research
Its principal goal is to ensure the new and effective
treatments will be available more readily to patients
The bureau of Phase I/II oncology
study inside of Area 6
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Represented by
Jiali LI, Chief Manager, MD, PhD
Karine Buffard, Assistant Manager, Pharm.D
Hôpital Saint-Louis
1 Ave. Claude Vellefaux
75010 Paris, FRANCE
Tel. 33-1-4803-7244
[email protected]
karine. [email protected]
Executive committee constituted by
Top French Authorities
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Pierre BEY (Institut Curie)
Véronique DIERAS (Institut Curie)
Fabien CALVO (AP-HP)
Michel MARTY (AP-HP)
Olivier RIXE (AP-HP)
Jean Nicolas MUNCK (Centre René Huguenin)
Eric Angevin (Institut Gustave Roussy)
Gilles VASSAL (Institut Gustave Roussy)
Members of Executive committee
Pierre BEY, Professor of Oncology Radiotherapy
 Responsible person for Area 6
 Director of Curie Institute’s Hospital
 Former Director of Regional anti cancer center (Lorraine-Centre
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Alexis Vautrin),1991/2001
Former General Secretary of French Federation against cancer
(FNCLCC)
Members of Executive committee
Michel MARTY, Professor of Medical Oncology
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Top authority of French National Drug Agency (AFSSAPS) since 1993:
Member, drug approval commission
Expert, transparency commission
Chairman, anti-neoplastic agents working group/approval commission
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President of Scientific Committee, French League against Cancer
Expert of Commission for Proprietary, Medicinal Products, EMEA
President of EuroCancer
Author of more than 450 publications
Members of Executive committee
Gilles Vassal, Professor of Pediatric Oncology
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Chairman of the European Consortium for Innovative Therapies for Children
with Cancer
Expert of pediatric oncology, at EMEA and AFSSAPS
Director of clinical and translational research at the IGR
Author of more than 300 publications
Facilities for clinical cancer research
in Cancéropôle île de France
 2 main French and European reference cancer centers :
Gustave Roussy Institute, Curie Institute
 A third French cancer center, the René Huguenin center
 The biggest hospital network in Europe: the AP-HP (Assistance
Publique-Hôpitaux de Paris) including 14 establishments in
Oncology
The Gustave Roussy Institute
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Established in 1921, the leading European anticancer centre
2,500 employees
Fifteen departments with 400 beds
30,000 patients attend its clinics and 42,000 patients treated and
11,000 new patients per year
More than 400 researchers working in 11 research units
Technology platform: tumor biology, host-tumor interaction,
functional/metabolic imaging, epidemiology, healthcare economics
Almost 20 years experience in conducting Phase I/II studies
12 Phase I trials, 14 Phase I/II trials and 47 phase II have been
conducted in the Institute during the year of 2004
Curie Institute
 Established in 1921 by Marie Curie and Claudius
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Regaud
>1,700 people employees
>650 researchers working in 12 research units
227-bed with 27 departments
8,000 new patients are treated each year
Technology platform: Genomics, bioinformatics,
pharmacology, immunology; functional imaging
More than 100 clinical trials including studies
sponsored by the Institute are conducted each
year during the last 4 years
The René Huguenin Center
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Founded in 1959
2500 new cases of cancer each year including
>1000 breast cancer
Established in 1959
650 employees
150 beds
Technology Platform: tumor bank/serum bank;
genomics, pharmacokinetics; host-tumor
relationships; Oncogenetics, metabolic/functional
imaging
Long experience for conducting phase I/II studies
of new anti cancer agents
Assistance Publique-Hôpitaux de Paris
(AP-HP)
 Biggest hospital network in Europe
 39 establishments with >25,000 beds
 With 32% of hospital admissions in oncology in the
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Paris Region (40 800 new patients a year)
16 of them have particularly well-developed
oncology
6 sites are highly specialized in oncology practice
and clinical study
Settling in the Paris Region
Guarantees successful entry
into the European market