Clinical researchnetwork for Parkinson’s diseaseand ...Clinical researchnetwork for Parkinson’s...

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NS-Park network Clinical research network for Parkinson’s disease and Movement Disorders Jean-Christophe Corvol

Transcript of Clinical researchnetwork for Parkinson’s diseaseand ...Clinical researchnetwork for Parkinson’s...

NS-Park network

Clinical research network for Parkinson’sdisease and Movement Disorders

Jean-Christophe Corvol

Maladie de ParkinsonPrévalence : 2% de la population > 65 ans

150 000 patients en France

Corps de Lewy

Dégénérescence des neurones

dopaminergiques

�Akinésie

�Rigidité

�Tremblement

Syndromes apparentés :

Atrophie multisystématisée, paralysie supranucléaire progressive,

Dégénérescence cortico-basale, démence à corps de Lewy…

•Gait failure•Dementia

Parkinson’s disease

Evolution and treatment

De Novo PD

•Fluctuations•Dyskinesia

Honeymoon

Dopaminergic

drugs

Extra-dopaminergic

lesions

Deep brain

stimulation

Dopaminergic lesions

Neuroprotection

Prevention of motor complications

Treatment of motor complications

Non motor symptoms

PD’s major challenges

NEJM 2009

Disease modifiers

SNCAMAPT

LRRK2

Physiopathology Early diagnosis

Rating scales

Study design

Lancet 2011

Brain imaging

Lancet Neurol 2012 Brain 2013

Personnalized medicine

Medical strategiesDevicesAnn Neurol 2011

Rare diseases

Brain 2009, Lancet Neurol, in press

Motor symptoms

Non motor symptoms

Lancet Neurol, 2012

New targets

Medical strategies

DevicesBiomarker of progression

Task1

Task2

Task3

Task4

Task5

Early diagnosis and genetics of PD

Motor symptoms and complications of PD

Non-motor symptoms of PD

Late PD

Rare movement disorders

Early

diagnosis

Prevention

Treatment

Rescue

New targets

NS-Park - Project

WG1

WG2

WG3

WG4

WG5

WorkingGroups

Historical NS-Park centers

CIC & movement disorder Clinic

Bordeaux Pr F Tison

Clermont Pr F Durif

Créteil Pr P Remy

Dijon Pr M Giroud

Grenoble Pr P Krack

Lille Pr A Destee

Lyon Pr E Broussolle

Marseille Pr JP Azulay

Montpellier Pr C Geny

Nantes Pr P Derckinderen

Paris Pr JC Corvol

Poitier Pr JL Houetto

Rouen Pr D Maltête

Strasbourg Pr C Tranchant

Toulouse Pr O Rascol

Associated centers

Amiens Pr P Krystkowiak

Aix Dr F Viallet

Besançon Pr P Remy

Caen Pr G Defer

Limoges Dr F Torny

Nancy Dr RN Gospodaru

Nice Dr C Giordana

Reims Dr A Doé de Maindreville

24 PD expert centers

16 CIC

> 12,000 patients

Guichet unique:

2 chefs de projet

Working groups Transversal tasks

Steering committee

CoordinationChair: Pr Corvol, Pr Rascol, Pr Durif

24 NS-Park centers + Partners

Early diagnosis

Genetics

Chair: Pr Brice, Pr

Destée,

Motors

complications

Chair: Pr Rascol,

Pr Corvol,

Non motor

symptoms

Chair: Pr Krack,

Pr Durif, Dr

Brefel-Courbon,

Pr Houeto, Pr

Vérin

Late PD

Chair: Pr Azulay,

Pr Dujardin, Dr

Welter

Rares diseases

and other

movement

disorders

Chair: Pr Anheim,

Pr Meissner, Pr

Vidailhet

Databases

Chair: Pr Corvol,

Pr Meissner, Pr

Lehericy, Pr

Thobois, Pr

Remy, Dr

Eusebio, Pr

Burbaud

Relationships

with

preclinical

teams and

industry

Chair: Pr Tison,

Pr Remy

Education

Chair: Pr

Tranchant, Pr

Defebvre

Clinical trials

methods

Rating scales

Chair: Pr Rascol,

Dr Devos

NS-Park - Expertise

• Basic research (Paris, Marseille, Lyon)

• Preclinical research (Neuratris, Bordeaux)

• DBS (Grenoble)

• Study design (Toulouse)

• Rating scales (MDS-UPDRS, ECMP, LARS…)

• Brain imaging (CATI)

• Dedicated biobank (BioCollection)

• Project managers– Grant preparation

– Feasibility

– Hospital costs, agreements

– Study coordination and follow-up

• European network

NS-Park – Major publications

EU RCT (France-Germany)

Device

PI: Y Agid (Paris)

NEJM 20138

French multicenter RCT

Drug – non motor

PI: Devos (Lille)

Lancet Neurol 201211

International (UK-Germany-

France-Netherlands-USA)

Genetics. PI: A. Brice (Paris)Lancet 201112

French multicenter RCT

Drug - motor

PI: Rascol (Toulouse)

Neurology, 20137

EU RCT (France-Germany-UK)

Rare disease

PI: G. Bensimon (Paris)Brain 200911

French multicenter RCTs

Rare disease

PI: F Durif (Clermont Ferrand)Neurology, 20136

NS-Park - Activity

Phase II

40%

Phase III

27%

Phase IV

10%

Other*

23%

30 clinical studies

0

2

4

6

8

10

12

14

16

18

Academic Industry

Phase IV

Phase III

Phase II

OtherNu

mb

er

of

stu

die

s

*cohortes, rating scale validation

Motor

37%

Dyskinesia

27%

Non motor

20%

Rare MD

13%

Disase

modifying

3%

International

47%National

53%

NS-Park – Ongoing studies

Etudes en cours

• Académiques

– PREMANDYSK (Toulouse, Rascol) prévention dyskinésies

– BADGE-PD (Paris, Corvol), pharmacogénétique

– APATHIE (Clermont, Durif), rasagiline

– BEAD-PD (Paris, Corvol), pharmacogénétique

• Etudes industrielles

– Completed: Novartis, Addex, Allon, BIA

– Phase II, salivation, NeuroHealing

Etudes à venir, collaborations

• Académiques– MSA-DOPS (Toulouse, Rascol)

– PREDISTIM (Lille, Devos)

– STARTLATE (Paris, Welter), stimulation

• Collaborations industrielles– Biomarqueurs, IPSEN, SANOFI

– Comp. motrices, IPSEN

– Phase I, AFFIRIS

– Phase II, CHELSEA, APOPHARMA,

– Phase II-III, LILLY

– Phase III, STADA

– Autres: ONO, Ad Scientiam, Neurolixis, B&A therapeutics…

ONO pharma

Ipsen

Lundbeck

Sanofi RD

Chelsea

Lilly

STADA

Ipsen RD

Neurohealing

AFFIRIS

Neurolixis

Apopharma

B&A therapeutics

POC, phase II

Phase III

Repositionning

Phase IVPersonalized

medicine

Drug development

Biomarkers

Preclinical

models

Basic research

Physiology

NS-Park pipeline

NS-Park – Database and registry

Clinical database

Medical activity, registry, cohorts, CRF

Imaging database

SOPs for brain MRI and DATscan

Centre d’Analyse et de Traitement

des Images

Biobank

Parkinson’s disease biobank

Number of clinical

trials in EU in

Parkinson’s disease

Source: ClinicalTrial.gov

(2014)

NS-Park – European strategy

Austria:

Werner Poewe

Spain:

Eduardo Tolosa

Italy:

Paolo Barone

David Burn

T. Klockgether

O Rascol: Chair of the MDS European Section:

⇒ Identify EU networks in the field of PD and movement disorders

⇒Joint application to EU calls (Horizon 2020)

NS-Park – European strategy

PD Genetics

DenDRON

KKS

Other EU networks

Neuratris

CATI (Center

for Image

Acquisition

and

Processing)

BioCollection

Clinical research infrastructures

Patients associations

AMADYSFrance

Parkinson APTES

ARAMISEPSP France

Reference Centers rare

diseases

MSAGilles de la

Tourette PSP

GeneticDystonia

Industrial Partners

Shared with INIs

Legal counseling

EU lobbying

Education

Quality

Patents

Clinical

Novartis

Merck

Addex

Kyowa

Chelsea

UCB

Neuroderm

Preclinical

Ipsen

Sanofi

UCB

ONO

Medtronic

FCRIN platforms

Data managment

Statistics

Methodology

Drug manufacturing

FCRIN Office

Why use NS-Park?

• EU grant (Horizon 2020) in PD or aging

• Clinical trials in PD or movement disorders

– POC studies, design, feasibility, recruitment,

follow-up…

• Biomarker research (wet or imaging)

• Device development for PD

• Rare patients: genetic forms (LRRK2, GBA…),

rare movement disorders

How to use NS-Park?

• Coordination: � JC Corvol (Pitié-Salpêtrière)

� F Durif (Clermont-Ferrand)

� O Rascol (Toulouse)

• Project managers:– Véronique Chaigneau or Estelle Dellapina

– Tel: 05.61.77.24.07

– Email: [email protected]

• Web site: http://reseau-cic-parkinson.inserm.fr/

Thank you !

NS-Park - Funds and budget

Coordination

23%

Centers

24%Driving

initiatives

19%

Databases

19%

Shared with

other INI

15%

0

50

100

150

200

250

300

350

400

2014 2015 2016 2017 2018

FCRIN Other incomes

Inco

me

s(k

€)

Inco

me

s(k

€)

0

50

100

150

200

250

300

2014 2015 2016 2017 2018

CRA in centers

Project coordination

Valorization

Industrial fees

INSERM

2 project managers

+ operating costs

to sustain NS-Park