30.10.2014 Brussels, Belgium Japan Health Sciences Foundation delegation: Welcome!
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30.10.2014 Brussels, Belgium
Japan Health Sciences Foundation delegation:
Welcome!
Elisabetta Vaudano IMI 30.10.2014 Presentation to Japan Health Sciences Foundation
Brussels, Belgium
The Innovative Medicines Initiative: The European engine for pharmaceutical innovation
What is the Innovative Medicines Initiative? What has IMI delivered so far? Some IMI achievements Moving from the first to the second phase of IMI Challenges
Outline
‘We must acknowledge that no single institution, company, university, country, or government has a monopoly on innovation.’
Rethinking drug discovery – Turning the Titanic? Elias A. Zerhouni, President Global R&D, Sanofi Editorial in Science Translational Medicine, January 2014
The pillars of innovation
Scientific excellence
Market access
Patient access
Rewarding systems
IMI – Europe’s partnership for health
> €5 bn
Partnership 2008 - 2024
€2.5 bn
€2.5 bn
IMI – key concepts
Focus on unmet needs Non-competitive collaborative research Competitive Calls for proposals Open collaboration in public-private consortia Data sharing & dissemination of results Industry contribution is in kind Collaboration by design in, and outside IMI
Topic definition phase
How an IMI Project is born (historical 2 stages option)
Grant Preparation phase
Stage 1
Identification of topics and willingness to collaborate by EFPIA companies and associated partners
Signature of Consortium Agreement and Grant Agreement
Submission of short proposals by applicant consortia & evaluation by independent experts
Patients’ organisations
Academic research
teams
Regulators
Hospitals
SMEs
Mid-size enterprises
Industry consortium
Stage 2
Preparation of full proposal & evaluation by independent experts/ethical panel
Industry consortium
Applicant consortium
Call launch
Invitation to selected team to merge with industry team
Start of the grant
preparation phase
Project launch!
IMI’s flexible intellectual property policy
Support to industry
Freedom of access
Compensation for IP
Dissemination of information
Incentive to participate flexibility
+ trusted party
What has IMI delivered so far
IMI 1 – € 2 bn budget breakdown
Infectious diseases
Drug discovery
Brain disorders
Metabolic disorders
Drug safety Stem cells
Cancer Data management
Inflamatory disorders
Biologicals Geriatrics
Lung diseases Education &
training Sustainable chemistry
Drug delivery Drug kinetics
Relative effectiveness
An international, cross-sector community 650
acad-emic
teams
120 SMEs
409 EFPIA teams
25 patient orgs
17 regul-ators
Over 6 000 researchers working for: collective intelligence
networks improved R&D
productivity innovative approaches
to unmet medical needs
IMI’s IP policy allows unprecedented levels of sharing
Companies pooling legacy
toxicity data
European platform for
antibiotic development
Companies pooling &
sharing old trial data European
Lead Factory compound collection
Project partners
validate each other’s findings
Key collaborative activity areas:
Diabetes, CNS disorders, Tuberculosis, Patient Reported Outcomes, Cancer, Preclinical Safety and Education &
Training.
IMI signed horizontal agreements with: Critical Path, Juvenile Diabetes Research Foundation as
well as with Clinical Data Interchange Standards Consortium.
Collaboration
IMI projects have signed 14
MEMORANDA OF UNDERSTANDING With other international consortia
IMI projects deliver excellent science
0 0.5 1 1.5 2 2.5 3
IMI
FNIH
Wellcome Trust
TI Pharma
World average
Citation index
The measures of success
SUCCESS
New models developed &
published
Setting new standards
Implement-ation by industry
Impact on regulatory guidelines
Better Science = Better Decisions
Some IMI achievements
Later in the Agenda:
25 000 killed
€1.5 billion
How IMI is tackling Infectious Diseases IMI Stem Cell activities Cancer in IMI Patients focussed activities and projects
Action on Alzheimer’s disease
Matrix of biomarkers Test efficacy
of new treatments
Linking & analysing data Identify those
at risk
New classification of AD/PD Personalised
treatments
‘Adaptive’ clinical trials Faster drug
development & patient access
IMI invests €167 million in 4 projects and is a partner of the G7 Global Action against Dementia
January 2014
Autism – a common disorder
Affects 1 in 80 Lifelong condition Difficulties in social
interaction & communication, unusual repetitive behaviours
Major impact on families & carers
Partnering with Patients and collaborating globally
New insights into underlying causes and their potential reversibility
Insights on gender & autism 2 major clinical studies for early
detection and stratification of ASD Working with regulators on
treatment guidelines
EU-AIMS – delivering results on autism
Sharing data to improve clinical trials for schizophrenia
By redesigning clinical trials, you could: make them shorter (6 weeks 4 weeks)
require fewer people (79 46 patients per arm)
cut costs (savings of €2.8 million)
gain insights into effects of treatment on negative symptoms (e.g. lack of emotion)
23 000 patients
67 studies
25 countries 1 database
IMI contributes to drug safety
SAFE-T project
153 potential biomarker candidates for drug-induced injury of kidney, liver & vascular system evaluated
17 exploratory clinical studies
Dialogue with regulatory agencies
MoU with PSTC (C-Path)
eTOX: Novel toxicity predictive systems
5th release of the Vitic Nexus eTOX database 537 substances (165 confidential) linked to 1 703 study designs (Bayer, Boehringer, Esteve, GlaxoSmithKline, Lundbeck, Novartis, Pfizer, Roche, Sanofi, Servier and UCB) 3rd release of the ChOX database 411 toxicology-linked targets; 162 287 distinct compounds and 701 181 activities 90 predictive models developed
How IMI facilitates the development of new diabetes therapies IMI already invested €117 million in 3 projects aiming at: Solving scientific challenges Developing reliable measures of diabetes
activity and complications Developing treatments tailored to the different
needs of individual patients
The IMI IMIDIA Project
Creating a Collaborative Network for Diabetes
Target screening Hit-to-lead Lead-to-candidate Preclinical Phase I Phase II Phase III
IMI’s drug discovery platforms
European Lead Factory
ND4BB Drug Discovery Platform
‘Qualified’ hit
Lead Clinical candidate Phase 1 ready
ELF Budget: €92 m EFPIA
in-kind €80 m IMI JU europeanleadfactory.eu
ENABLE Budget: €26 m EFPIA in-kind €58 m IMI JU
European Lead Factory Focus: identification of new hits
ENABLE focus: to move promising hits into early clinical development nd4bb-enable.eu
IMI2
IMI 2 – building on successes of IMI1
32
European Commission From H2020
1638 mln
Other sectors
213 mln
EFPIA direct and indirect members
1425 mln
IMI2
3276 mln
Focused: stratified medicines and healthcare priorities Healthcare solutions: prevention and treatment End-to-end: R&D, regulatory and access – move
integration a step further Multi-sector: within and beyond life sciences
The Vision for IMI2
Molecular diagnosis based on biological
knowledge
We “treat” a population. Some respond and some don’t
We “treat” a targeted population They all respond
From population to individual
33
Goals of IMI 2 programme
Increase the success rate of clinical trials of new medicines & vaccines
Speed up the earlier stages of drug development
Develop new treatments for areas of unmet need Develop new biological markers to diagnose diseases and
assess treatments
Improve the drug development process by creating tools to assess the efficacy, safety and quality of medicines
Strategic Research Agenda Antimicrobial resistance Osteoarthritis Cardiovascular diseases Diabetes Neurodegenerative diseases Psychiatric diseases Respiratory diseases Immune-mediated diseases Ageing-associated diseases Cancer Rare/Orphan Diseases Vaccines
Major Axis of Research
36
Target & Biomarker
Identification (safety & efficacy)
Innovative clinical trial paradigms
Innovative Medicines
Patient tailored
adherence programmes
Reclassification of disease by molecular means
Target Identification and validation(human biology)
Determinants of drug /vaccine Safety and efficacy
Biomarker identification/validation (precision medicine) Innovative methodologies to
evaluate treatment effect
Adoption of innovative clinical trial designs Benefit/Risk Assessment
Innovative drug delivery methodologies
Manufacturing for personalised medicines
Healthcare delivery: focus on the treatment programmes not just the medicine
Innovative adherence programmes
Discovery and Development of novel preventative and therapeutic agents
European Health
Priorities
Drive change in delivery of medical practice
Learnings & Challenges
Scientific focus Stronger focus on needs of
patients and society Research Agenda aligned
with WHO priorities Increased emphasis on
improving patient access to innovative medicines
Focus on personalised medicine
Lessons learnt – from IMI 1 to IMI 2
Rules & procedures More entities eligible for
funding Simpler funding rules Open to projects with other
sectors (ICT, diagnostics, imaging, animal health, etc.)
Simpler reporting procedures
7 priority themes and enablers resulting in 6 SGGs + 1 CSA
39
Neuro-degeneration Immune-Mediated diseases Metabolic Disorders (incl
diabetes) Translational safety Data and Knowledge
Management Medicines Adaptive
Pathways to Patients (CSA) Infection control
Composition / Structure of a SGG
40
Other challenges
Measuring success Need to reward innovation Avoid duplication
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