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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

www.imi.europa.eu @IMI_JU

Thank you

Elisabetta Vaudano Elisabetta.vaudano@imi.europa.eu