1 GTN IMI 25 juin 2010 MICHEL GOLDMAN€¦ · IMI in a Nutshell A European Public-Private...

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