Update on a recently launched European R&D endeavour:

The Innovative Medicines Initiative (IMI)

FERS meetingBrussels, 7th April 2008

Background to IMI IMI is a totally new and unique

pan-European R&D initiative officially adopted on 20th December 2007.

ERS supported IMI in a joint statement co-signed by 9 other medical specialities in October 2007

First IMI calls to be published on 30th April 2008 including two respiratory calls

ERS: Facilitator role to inform and publicise the “respiratory” calls of IMI.

 

http://www.imi-europe.org/

http://www.imi.europa.eu/

IMI in a nutshell

IMI is a public-private partnership between the European Commission and the European Pharmaceutical industry to

promote biomedical innovation in Europe and to address the bottlenecks

in the R&D process.

Facts about IMI• IMI represents a major new European R&D investment

under the EU Seventh R&D Framework Programme (FP7).

• The IMI Joint Undertaking has been set up by the Council Regulation (EC) No 73/2008 of December 20th 2007.

• The founding members of the IMI Joint Undertaking are the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Commission (EC)

• The IMI Joint Undertaking will be established in Brussels• The partnership is a €2 billion public-private partnership

for biomedical research in Europe

IMI focuses on five disease areas

Cancer

BrainDisorders

MetabolicDiseases

InflammatoryDiseases

Infectious Diseases

Predictive pharmacolo

gy

Predictive

toxicology

Identification and validation of biomarkers

Patient recruitmen

tBenefit / Riskassessment

Includes asthma, COPD, rhinitis

Pre-competitive bottlenecks in the R&D process

Discoveryresearch

Preclinicaldevelop.

Translationalmedicine

Clinicaldevelop.

Pharmaco-vigilance

Predictive pharmacology

Predictive toxicology

Efficacy Safety

Discoveryresearch

Preclinicaldevelop.

Translationalmedicine

Clinicaldevelop.

Pharmaco-vigilance

Discoveryresearch

Preclinicaldevelop.

Translational ClinicalDevelop.

Pharmacovigilance

-

Predictive pharmacology

Predictive pharmacology

Predictive toxicologyPredictive toxicology

Efficacy Safety

Identification of biomarkersIdentification of biomarkers

Validation of biomarkers

Validation of biomarkers

Benefit/Risk assessment

with regulatoryauthorities

Benefit/Risk assessment

with regulatoryauthorities

Patient recruitment

Patient recruitment

Knowledge ManagementEducation & Training

Financing of Research Projects

Cash €1 billion

e.g. Imaging e.g. Imaging Regulators

€ Funding € Funding

Patients

SmallMedium

Enterprises

Academia

Pharmaceutical

Companies

IMI RESEARCH PROJECTS / CONSORTIA

€ Funding

EU FP7 Budget

In kind €1 billion

€ Funding

IMI “Respiratory” 2008 calls

• One call to build an EU severe asthma consortium focused on disease understanding– To harness efforts of already established groups presently working

independently. – Ultimately the severe asthma cohorts will enable scientific research,

leading to validation of novel biomarkers and clinical measures/ outcomes and will serve as a vehicle to develop relevant translational models

• One call to on COPD patient-reported outcome (PRO) to be used in clinical trials to evaluate treatments– This call would require development of a framework to understand

the patients’ experience of COPD, to inform strategies to measure outcomes meaningful to patients and to develop/ select and validate PRO measurement tools, to use in clinical trials evaluating treatments for the disease.

Role of ERS and FERS members

• National respiratory societies can help disseminate and publicise information about IMI 2008 calls

• Publication date of first IMI calls to be published on: 30th April ’08

• Calls published on official European IMI websites of EU and EFPIA, but also on the ERS website:– www.imi.europa.eu (EU)– www.imi-europe.org (EFPIA-IMI)– www.ersnet.org

• More general info on IMI: – see ERS Newsletter, March 2008– see ERJ Editorial, May 2008

Next steps: IMI “respiratory” calls

• Monitor the ERS website for a general summary of the ERS and EFPIA hosted “IMI Summit” held in Leuven, 9-11th January ’08: – Informing about IMI initiative, and the R&D bottlenecks in

drug development. – Brainstorming in asthma & COPD, for 2009 IMI calls