related education - Oncomip

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10 Δεκ 2012 (πριν από 4 χρόνια και 9 μήνες)

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CAPTOR
PHUC 2012
2
CAPTOR
PHUC 2012
3
nomthèmecréditporteur
ICANCoeur /métabolisme45 M€APHP/Pitié/P&M
Curie
POLMITMaladieInfectieuse72 M€APHM/Universitéde
Marseille
Mix
-
SURG
microchirurgie
67 M

Université de
InstitutHospitalo-Universitaire
Lauréats
07-2010
CAPTOR
PHUC 2012
4
Mix
-
SURG
microchirurgie
67 M

Université de
Strasbourg
LYRICRythmologie45 M€Université de
Bordeaux
A-ICMNeurosciences55 M€APHP/Pitié/R.
Descartes
IMAGINEGénétique64 M€APHP/Necker/R.
Descartes
•Xavier Bertrand, ministre du Travail, de l’Emploi et de la Santé, Laurent Wauquiez,
ministre de l’Enseignement supérieur et de la Recherche, Nora Berra, secrétaire d’Etat
chargée de la Santé, et René Ricol, Commissaire général à l’investissement
annoncent le lancement du nouvel appel à projets «Pôle Hospitalo-Universitaireen
Cancérologie» (PHUCancer) dans le cadre du Programme d’Investissements
d’Avenir.
«Le 27 juin dernier le Président de la République a souhaité qu’une initiative innovante
sur la thématique du cancer puisse voir le jour dans le cadre des investissements d’avenir
et vienne consolider les actions en matière de santé et de biotechnologies menées
jusqu’ici.
PHUC –appeld’offre
11-2011
jusqu’ici.
L’appel à projets publié par l’Agence nationale de la recherche vise à faire émerger un
pôle hospitalouniversitaire en cancérologie faisant une large place au renouvellement des
idées. Il offre la possibilité aux meilleures équipes scientifiques et médicales françaises de
proposer des projets de recherche ambitieux qui pourront regrouper dans un
périmètre régional des compétences et une qualité de recherche de niveau
international.
Des innovations de rupturedans le domaine du soin ou du diagnostic sont attendues et la
valorisation des découvertes émanant du secteur public ainsi que les programmes
de recherche partenariale devront faire partie des projets déposés.
Le projet lauréat se verra proposer un soutien financier pouvant aller jusqu’à 20 millions
d’euros sur 5 ans. Il s’adresse à l’ensemble des établissements d’enseignement supérieur
et de recherche et à leurs partenaires organismes de recherche et établissements
hospitaliers».
CAPTOR
PHUC 2012
5
The «real world»
-Duringtreatment:

Acute adverse effects

Reducedobservance

Reducedclinicalbenefit
Drug discovery
Experimentalpharmacology
Drug evaluation
Clinicalresearch
Drug and practices
Social pharmacology
Cancer pharmacology : a major stake
7
-Aftertreatment/maintenance
therapy:

Impact on QoL

interactwithco-morbidity

Unexpecteddelayedside-effect
￿Pharmacovigilance
￿Pharmacoepidemiology
Educational value
Scientists/MD-PhD
Educational value
MDs/R&D
Educational value
New jobs
WP1 : Drug Discovery 1 -Targets in DNA replication→ P Fabre
2 -Tyrosine kinase inhibitors (TKI)→ Novartis
3 -Oncometabolic pathways→ Affichem
4 -Novel immunotherapeutics→ Innate Pharma
5 -Vasculogenesis-based drug discovery→ Sanofi
1
1
WP2 : Clinical research (1)
Myeloma : Toulouse Contribution (1990-2000)
•Standard TT
VAD followed by High Dose Therapy
Attal
M et al, N
Engl
J Med 1996
Introduction of high dose therapy as front line treatment
60
70
80
90
100
Patients without progression (%)
•Induction :
VRD (Velcade, Revlimid, Dexa)(Rousselet al, ASH 2011)
Myeloma : Toulouse Contribution (2000-2010)
Introduction of targettedtherapy as front line treatment
≥VGPR
≥PR
DT
ST
Attal
M et al, N
Engl
J Med 1996
•Objective
To reach the best response
AttalM et al, N EnglJ Med 1996 •Area of research
Double transplantation
AttalM et al, N EnglJ Med 2004
P-value<10
-7
Placebo
Lenalidomide
0
10
20
30
40
50
60
Patients without progression (%)
307255211169102572261Placebo
30726723621617210349101Lenalidomide
N at risk
0
6
12
18
24
30
36
42
48
Months of follow-up
•High dose regimen :
V + High Dose Melphalan(Rousselet al, Blood 2009)
•Maintenance :
Thalidomide (Attalet al, Blood 2009);
Lenalidomide(Attalet al, NEJ M (in
revision)
Attal et al, New Engl J Med, in revision
1
2
WP2 : Clinical research (2)
Electronicregistration (via eCRF)
Initial treatment(Cycle RVD 1 / 21 days) , Lenalidomide
25mg/d (days1 to 14), Bortezomib1.3mg/m
2
(days1, 4, 8, 11),
Dexamethasone20mg/d (days1,2,4,5,8,9,11,12)
Electronicrandomization(via eCRF)
Arm A
Arm B
IFM/DFCI 2009 Study Design
• Activated in October 2010
• 1/2012 : 500 patients enrolled
•Total: 1000 patients
Myeloma : Toulouse Contribution (2010-2020)
Arm A
Arm B
Cycles RVD 2 and 3
PeripheralStem CellCollection 5x10
6
/k
(cyclophosphamide 3g/m
2
and lenograstim10mcg/kg/d)
Autograft
Cycles RVD 4 to 8
Cycles RVD 4 and 5
Maintenance 12 months(Lenalidomide10mg/d for 3 months
then15mg/d if welltoleratedfor total treatmentduration of 12
months)
1
3
WP3 : Social pharmacology
Background :lymphoma patients treated with RCHOP in the «real world»
Events
GELA
RCHOP21
ECOG
RCHOP21
RICOVER
RCHOP14
Numberof
patients
202318306
Febrile
neutropenia
12%17%53%
Thrombopenia*NR%14%NR
Mucositis*G3 G43%NR7%
Nausea*
4%
NR
3%
US practice 2004
US practice 2004
AMA currently
AMA currently
1-Ambulatory Medical Assistance
(AMA1AMA1)
Randomized studies (Fortis)
Extension to other tumours
Extension to other national centres
The AMA projects
The AMA projects
AMA1
Acute adverse effects, observance, QoL
Pharmacovigilance
CAPTOR
PHUC 2012
14
Nausea*
4%
NR
3%
Renaltoxicity1%NR5%
Toxicdeath8%5%8%
♥The AMA projects :
Ambulatory Medical Assistance 1 (AMA 1AMA 1)
nurse-based telephone survey
Active phase
AMA-After Cancer (AMAAMA--ACAC)
Nurse-based telephone survey
Off-therapy or maintenance
♥The AMA projects :
Ambulatory Medical Assistance 1 (AMA 1AMA 1)
nurse-based telephone survey
Active phase
AMA-After Cancer (AMAAMA--ACAC)
Nurse-based telephone survey
Off-therapy or maintenance
Relative dose intensity CHOP lymphoma
Midi-Pyrénées regional network 201220% patients treated with RDI <85% !
Relative dose intensity CHOP lymphoma
Midi-Pyrénées regional network 201220% patients treated with RDI <85% !
Fonction de la distribution de survie
0.000.250.500.751.00
delaiefs
0200400600800100012001400
STRATES :
RDIcomplet=0RDIcomplet=1
p<0.00011
n% RDI >85ORp
AMA9695.21-
Non AMA9371.20.060.0004
Relative dose intensityin lymphomapatients treatedwithRCHOP (2012)
Relative dose intensityin lymphomapatients treatedwithRCHOP (2012)
Extension to other national centres
Extension to emerging countries
2-AMA-After Cancer (AMAAMA--ACAC)
Creation of database for pharmaco-vigilance
-Feasibility (current)
-Setting up 2013
3-Pharmaco-Epidemiology (UMR 1027)
Data-linkage of AMA-AC database with French
National Health Insurance System (SNIIR-AM)
AMA-AC
Delayed adverse effects, co-morbidity
Pharmaco-epidemiology
1
4
WP4 : Education
WP1 -related education :
Master of Oncology -Biology Health Biotechnology (BSB) -
doctoral school (PhD) : Rank A+ (AERES
)for students of
Faculty of Science & Engineering
WP2 -related education :
Currently :
Master of pharmacology and clinical drug
development
for young MD or Pharmacists
development
for young MD or Pharmacists
Project
: Master of Clinical Research in Oncology
for clinical
oncologists and R&D pharmaceutical executives
WP3 -related education :
Currently
: Professional Master of Patient Pathway for
Chronic Disease
for health care professionals (social
workers, psychologists, or nurses) (2011)
Project
: other new jobs
for qualified employees
(OncoResonanceFoundation)
15
Governance & partnership
Director
G. Laurent
General Secretary
To be recruited
Operational Direction Board
Public Institutions
INSERM
CNRS
Toulouse University
IUC
Operational Direction Board
WP1: JJ. Fournié& P. Brousset
WP2: M Attal& JP Delord
WP3: G. Laurent & M Lapeyre
WP4: R. Bugat& D. Rougé
Local Partners
Toulouse Oncopole
Pole de CompetitivitéCBS
Pierre Fabre
Sanofi
Scientific Advisory Board
W Vainchenker (France)
D. Olive (France)
P. Fumoleau (France)
J Lazzo (USA)
J Hickman (France)
J Caron (France)
A Carvajal (Spain)
Foundations & Strategic
Partners
Foundation RITC
Foundation InNaBiosante
SATT Toulouse Tech Transfer
16
Expected impact
Impact for teaching & training
WP1 : PhD and MD/PhD training
WP2 : R&D training
WP3 and WP4 : new jobs for professionals
Financial plan
Partners
Contribution (€)
ANR Request (€)Total Cost (€)
Coordination
0 424 500 578 100
WP1: drug discovery
16 185 240 7 084 00023 269 240
WP2 : clinical trials
20 608 3206 595 00027 203 320
WP3 : social pharmacology
4 326 9004 063 0008 389 900
WP4 : education
3 354 1202 019 0005 373 120
Overhead costs (4%)
-807 420 -
Total43 820 760
20 992 920
64 813 680
4% overheads of tax base included
• Equipment :
• Staff :
• Functioning :
GANTT
Year 1Year 2Year 3Year 4
Year 5 : EndStart
CAPTOR Management
WP1 Research
DNA replication
TK Inhibitors
Metabolic targets
Immunotherapies
Vasculogenesis
Kick-off meeting
Yearly CAPTOR
progress meeting 1
Yearly CAPTOR
progress meeting 2
Final meeting
Yearly CAPTOR
progress meeting 3
Yearly CAPTOR
progress meeting 4
Durable
WP3 Socal Pharmacology
AMA-1
AMA-AC
Pharmacoepidemiology
WP2 Clinical
Molecular Clinical Pharmacology
Early trials
Hematology
Breast Cancer
WP4 Education
WP1-rtd education
WP2-rtd-education
WP3-rtd-education
Durable
Structures
19
SWOT
•Toulouse Oncopoledynamic
•Clinical trials and transitional research
•Links with on-site Pharmacompanies
•Social Pharmacology
•Educational programs
STRENGHTS
STRENGHTS
To conclude
CAPTOR
PHUC 2012
21
Back-up slides
Financial Providers
•Financial management of CAPTOR funding by Toulouse University
•Source of income:
––WP1:WP1:
INSERM , CNRS, University of Toulouse, Region, UE, Industrial Partners, INCa,
ARC, Ligue, Toulouse Idex, Labex Toucan, RTRS, Innabiosante (Foundations), CBS
--
WP2:WP2:
Industrial Partners, Toulouse Hospitals, Government (PHRC), NCI
24
--
WP2:WP2:
Industrial Partners, Toulouse Hospitals, Government (PHRC), NCI
--WP3:WP3:
Toulouse Hospitals, Industrial Partners & future partners (Region, ARS)
--WP4:WP4:
University of Toulouse, Toulouse Hospitals, Grand Toulouse (City),
Conseil Regional, Toulouse Idex, Labex Toucan, scholarship fees
Staff
––WP1: WP1:
~100 persons = 1140 man-months/CAPTOR, requested: 972 m-m
––WP2: WP2:
~180 persons = 1926 man-months/CAPTOR, requested: 1320 m-m
•a total of ~ 310 persons (3384 m-m) already involved, 3552 m-m requested
25
––WP3: WP3:
~10 persons = 102 man-months/CAPTOR, requested: 810 m-m
––WP4: WP4:
~ 20 persons = 216 man-months/CAPTOR, requested: 450 FTE