4 IMI projects Benefits and perspectives O.BLIN

IMI projects: Benefits and Perspectives
Prof Olivier BLIN
Marseille
France
PharmaCog: Jill Richardson & R Bordet, Coordinators
Challenges of Neuroscience Diseases
1. Disease
Understanding
There is an urgent requirement for tools
that provide
objective
measures to enable:
2. Target Identification
 Stratification of patient populations (diagnosis)
 Classification3.
ofDiagnostic
disease severity
(surrogate endpoint)
Criteria
 Subjective
 Prediction of treatment outcome (risk factor)
 Few Biomarkers
4. Clinical Evaluation
 Placebo Effects
 Drug response (pharmacodynamics)
5. Brain Penetration
6. Treatment Duration
 Tolerance \ Sensitization
Drug development in AD has delivered
only Symptomatic Treatments
Ab production
Ab aggregation
Ab clearance (immunotherapy)
Tau aggregation/phosphorylation
Cholinergic drugs
Others
Donepezil
Rivastigmine
Galantamine
Memantine
Mangialasche et al., 2010
The Challenges that are Impeding the Progress
of Drug Discovery in AD
Lack of validated
models for target
selection
Lack of validated
models to
support ranking
and dose
selection
Discovery
Research
More extensive target
validation required due
to lack of precedented
mechanisms
Preclinical
Develop.
Lack of validated
models to
predict clinical
efficacy
Translational
Medicine
Phase I & II
Lack of markers to
demonstrate
effective dosing
Currently long trials
with large numbers of
patients are required
to detect clinical
benefit
Phase
III
Phase IV
Lack of markers to
determine clinical
efficacy
Need to detect the assets most likely to succeed earlier
Public Private Partnerships are essential to
addressing the high hurdles of AD Drug Discovery
Eli Lilly
EMA
GSK
Eisai
AstraZeneca
Lundbeck
Univ Essen
Janssen
Merck
VUMC
Univ Leipzig
Boehringer
UCB
IHD
Novartis
Hoffman-La Roche
Univ Bristol
Univ Verona
Univ Lille
AlzProtect
Start date: 1/1/2010
FBF Brescia
Mario Negri
Alzheimer Europe
Duration:
5 years
Partners:
38
Univ Perugia
CNRS
Servier
Exonhit
Univ
Genoa
INSERM
Univ
Barcelona
Partnership between:
Academia
Industry
SMEs
Patient Groups
EMA
Univ
Murcia
AMU
Qualissima
ICDD
Alzheimer
Hellas
Univ Foggia
Fondazione SDN
Univ Sacre Cuore
Total cost: €27.7M
IMI - PharmaCog
Objectives
Develop pre-clinical and clinical models with greater
predictive value to support early hint of
efficacy studies
Develop and validate translatable
pharmacodynamic markers to support
dose selection
Identify and validate markers of disease
progression and patient stratification
Gain industry and regulatory acceptance of
models and markers
Develop pan European network of experts
Selected challenges
rTMS
Sleep Deprivation
Hypoxia
Perspectives
• Improve dissemination &
communication
• Think different (impact)
• Breakthough approaches
• Repeat the experience (H2020, IMI2)
• Increase the level of exigence
• Diversify the partner’s expertise
• Cross-fertilization
Benefits
• Embark on a unprecedented travel
• Interaction with international groups
• Engagement with regulators, agencies and
stakeholders
• Interaction with SMEs
• Better understanding of large industry groups
rules & behaviors
• Scientific publications
• Personnal benefit: 贝励辉
Personal Interests Disclosure
Available on Afssaps.fr (since 2004) and sante.gouv.fr (since 2010)
Public
Private
- Prof & Head Pharmacology Dpt, Marseille
- VP Section X of CS for CSFRS
- Member Follow up Committee,
French National Plan against
NeuroDegenerative Diseases 2014-2019
- Expert EC
- Non profit Association 1901
- Scientific expertise
- Biosqual shareholder
- Industry (past)
2011-2013: GSK global SNC
discovery medicine
24 nov 2014
Innate optimism…and Strategy
We all that are engaged to this loss
Knew that we ventured on such dangerous
seas
That if we wrought out life 'twas ten to one;
And yet we ventur'd, for the gain propos'd
Chok'd the respect of likely peril fear'd;
And since we are o'erset, venture again.
Come, we will put forth, body and goods
Lord Bardolph.
Henri IV, Shakespeare.
Acknowledgements:
The Pharmacog Team
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David Bartres-Faz, University of Barcelona
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Laura Lanteaume, Isabelle Evrard-Amabile, •
University of Marseille
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Fabien Pifferi, CNRS
Regis Bordet, University of Lille
•
Xavier Langlois, Janssen
Giovanni Frisoni, Cristina Bagnoli, IRCCS
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Fatebenefratelli
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Sophie Dix, Eli Lilly & Co. Ltd
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Gianluigi Forloni, Mario Negri Istituto di
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Ricerche Farmacologiche
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Claudio Bablioni, University of the Studies of •
Foggia
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Alex Teligadas, Alzheimer Europe
Peter Schoenknecht, Universitätklinikum
Leipzig
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Maria-Trinidad Herrero Ezquerro, Universidad
de Murcia
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Philipp Spitzer, Universität Duisburg-Essen
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Severine Pitel, Qualissima
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Maria Isaac, EMA
Pascal Beurdeley, Exonhit
Jean de Barry, Innovative Health Diagnostics
Nathalie Compagnone, Innovative Concept in
Drug Development
Bernd Sommer, Boehringer Ingelheim Pharma
GmbH & Co KG
Cristina Lopez Lopez, Novartis Pharma AG,
Esther Schenker, Institut de Recherche Servier
Heike Hering, Merck Serono S.A.
Emilio Merlo-Pich, F. Hoffmann-La Roche
Jan Egebjerg, H. Lundbeck A/S
Yves Lamberty, UCB
Jill Richardson, Oscar della-Pasqua, Lesley
Stubbins, David Wille, Graham Somers
GlaxoSmithKline R&D Ltd
Pierre Payoux, Institut National de la Santé et de
la Recherche Médicale
Marina Bentivoglio, University of Verona
Philippe Verwaerde, Alzprotect
Lee Dawson, Eisai