Upload
others
View
6
Download
0
Embed Size (px)
Citation preview
Michel GoldmanDirecteur Exécutif
GTN IMI, Paris, 25 Juin 2010
Défis et opportunités
IMI in a Nutshell
A European Public-Private Partnership
Focused on Unmet Needs Common to
Pharmaceutical Industry and Patients
GTN IMI, Paris, 25 Juin 2010
Innovative Medicines Initiative:the Largest PPP in Life Sciences R&D
2 Billion Euro
1 Billion €1 Billion €
Public Private
Partnership
GTN IMI, Paris, 25 Juin 2010
Governance Structure
GTN IMI, Paris, 25 Juin 2010
Building the Future of Medicine
• More personalized
• More predictive
• More preventive
• More participative
GTN IMI, Paris, 25 Juin 2010
Key Concepts
• Pre-competitive research
• Open Innovation
GTN IMI, Paris, 25 Juin 2010
Page 502
The Path to Innovative Medicines
nature medicine volume 16 | number 4 | April 2010: 347
Rare Diseases as Surrogates in Drug Development
Disease Surrogate Molecular Drugsfor targets
Familial Common forms of HMG Co A Statinshypercholesterolemia hypercholesterolemia PCSK9 ?
Cryopyrin-associated Rheumatoid arthritis IL-1β β β β Rilonaceptperiodic syndromes Canakinumab
Idiopathic Allergic asthma IL-5 MepolizumabHypereosinophilia
Castleman Rheumatoid arthritis IL-6 T ocilizumabDisease
Tuberous sclerosis Various cancers mTor Temsirolimus
GTN IMI, Paris, 25 Juin 2010
• Unpredicted failures at late stage of drug
development
• Fragmented knowledge
Major Hurdles for the Developmentof Innovative Therapies
GTN IMI, Paris, 25 Juin 2010
Drug Safety: The Need for Novel Approaches
• Individual susceptibility
• Unwanted reactions to targeted therapies
• Late effects
CLINICAL PHARMACOLOGY & THERAPEUTICS/VOLUME 87 NUMB ER 5/ MAY 2010
Overall Structure of Research Projects
EFPIA comp
EFPIA comp
EFPIA comp
EFPIA compAcademic
Academic
Regulators SME
SME Pat.Org.
IMI beneficiaries EFPIA in kindcontribution
EFPIA comp
EFPIA comp
“Applicants consortium” “EFPIA consortium”
(no public funding)
GTN IMI, Paris, 25 Juin 2010
IMI Executive Office as a Neutral Third-Party
• To implement programmes and activities in the common interest of all stakeholders
• To monitor the combined use of public funds and industry investment
• To guarantee fair and reasonable conditions for optimal knowledge exploitation and dissemination
GTN IMI, Paris, 25 Juin 2010
The Call Process
GTN IMI, Paris, 25 Juin 2010
Ongoing Projects (1st Call)
15 Projects
395 Teams
Total budget:281 M€
Acronym EFPIA Coordinator Budget (M€)
SAFE-T Novartis Pharma 35.9
PROTECT European Medicines Agency 29.8
SUMMIT Boehringer Ingelheim 28.4
PHARMA-COG GSK 27.7
IMIDIA Sanofi-Aventis 25.4
NEWMEDS Lundbeck 24.0
U-BIOPRED Novartis Pharma 20.6
EUROPAIN AstraZeneca 18.2
PROactive Chiesi Farmaceutici 16.7
MARCAR Novartis Pharma 13.3
E-TOX Novartis Pharma 12.9
EMTRAIN AstraZeneca 7.7
EU2P F. Hoffman-La Roche 7.2
Pharma Train Eur. Federation of Courses 6.6
SafeSciMET F. Hoffman- La Roche 6.3
SMEs in Ongoing Projects
24 Companies13.9 M €
GABO:MI Newmeds
INNOVATIVE CONCEPTS PharmaCOG
INNOVATIVE HEALTH DIAGNOSTICS PharmaCOG
INTE:LIGAND SOFTWARE E-Tox
INTERFACE EUROPE Safe_T
ISLENSK ERFDAGREINING Newmeds
LEAD MOLECULAR DESIGN E-Tox
MOLECULAR NETWORKS GMBH E-Tox
NEUROSCIENCE TECHNOLOGIES Europain
OUTCOME EUROPE Protect
QUALISSIMA PharmaCOG
SYNAIRGEN RESEARCH U-BioPred
AEROCRINE U-BioPred
ALZPROTECT PharmaCOG
ARGUTUS MEDICAL Safe-T
BIOCOMPUTING PLATFORMS Summit
BIOSCIENCE CONSULTING U-BioPred
CHEMOTARGETS E-Tox
CHOICE PHARMA Proactive
CXR BIOSCIENCES Marcar
EDI GMBH Safe_T
ENDOCELLS SARL Imidia
EXONHIT THERAPEUTICS SA PharmaCOG
FIRALIS S.A.S. Safe-T
OPPORTUNITIES • Networking - deal opportunities
• Access to multicentric studies on large cohorts
• International visibility
• Private fund opportunities
THREATS
• Transfer or sharing of the IP and know-how
• Diffusion of sensitive information
• Administrative burden
SME Viewpoint
GTN IMI, Paris, 25 Juin 2010
Regulators in Ongoing Projects
- European Medicines Agency (EMA)
- MHRA (UK)
- DKMA (DK)
- AEMPS (SP)
- SwissMedic (CH)
- AFSSAPS (FR)
GTN IMI, Paris, 25 Juin 2010
Patients’ Organizations in Ongoing Projects
- Int . Alliances of Patients’Organizations
- Alzheimer’s Europe
- Eur. Genetic Alliances’ Netw.- Genetic Interest Group
- European AIDS TreatmentGroup
- European Lung Foundation
- Int. Primary Care Resp. Group
- British Lung Foundation
- Asthma UK
- Lega Italiano Anti-Fumo
- Dutch Asthma Foundation
GTN IMI, Paris, 25 Juin 2010
Lessons from Ongoing Projects
• IMI is more than an industry-academia PPP :
successful involvement of regulatory agencies, patients’ organizations
and SMEs
• First successes and enthusiasm provide « proof-of-concept »
evidence for IMI-type PPPs
• Boundaries of pre-competitive research and IP rules sometimes
difficult to define
• Need for dedicated tools for data and knowledge management
GTN IMI, Paris, 25 Juin 2010
Topics
• Knowledge Management
• Cancer Biomarkers
• Rapid diagnosis for infections
• Inflammatory disorders
2nd Call for Proposals (1)
124 Expression of Interests
1118 Applicants
GTN IMI, Paris, 25 Juin 2010
2nd Call for Proposals (2)
• Participation of 25 Member States (All 27 MS except Malta and Latvia) ;
• Participation from 7 FP7 Associated Countries : Albania, Bosnia, Israel, Norway, Serbia, Switzerland, Turkey;
• Participation from 7 FP7 Third Countries : Canada, China, Korea, Russian Federation, Senegal, Ukraine, United States
38 patients’ organizations204 SMEs
GTN IMI, Paris, 25 Juin 2010
3rd Call: Indicative Topics• Improved early prediction of drug induced liver injury (DILI) in man
• Cardiovascular safety
• Immunogenicity: Assessing the clinical relevance and risk minimization of antibodies to biopharmaceuticals
• Immunosafety of vaccines – New biomarkers associated with adverse events (early inflammation and autoimmune disease)
• Improve the scientific and preclinical models and tools for tuberculosis medicines research
• Functional MRI application in CNS drug development
• Translational endpoints in autism
• Personalized medicine in diabetes treatment
• Training programs for the informed patient
GTN IMI, Paris, 25 Juin 2010
Open Innovation in the Health Sector: Major Challenges Ahead
• Involvement of patients and laypersons
• Frontiers of pre-competitive research
• Indicators of performance
• Management of intellectual property
GTN IMI, Paris, 25 Juin 2010
GTN IMI, Paris, 25 Juin 2010
• Added value of IMI- from an industrial perspective- from a public health perspective
• Europe at the forefront of innovative partnerships for drug development
• Sustainability of IMI
A Top Priority: Communication
MERCI !
GTN IMI, Paris, 25 Juin 2010