Transcript Slide 1

Update on a recently launched European
R&D endeavour:
The Innovative Medicines Initiative
(IMI)
FERS meeting
Brussels, 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
http://www.imi-europe.org/
 First IMI calls to be published
on 30th April 2008 including
two respiratory calls
http://www.imi.europa.eu/
 ERS: Facilitator role to inform
and publicise the “respiratory”
calls of IMI.
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
Predictive
pharmacology
Predictive
toxicology
Identification and
validation of biomarkers
Cancer
Brain
Disorders
Inflammatory
Diseases
Metabolic
Diseases
Infectious
Diseases
Includes asthma, COPD,
rhinitis
Patient recruitment
Benefit / Risk
assessment
Pre-competitive bottlenecks
in the R&D process
Discovery
research
Preclinical
develop.
Translational
Translational
medicine
Clinical
Clinical
develop.
Develop.
Pharmaco
Pharmaco-vigilance
vigilance
Knowledge Management
Education & Training
Predictive
pharmacology
Predictive
toxicology
Identification
of biomarkers
Efficacy
Patient
recruitment
Validation of
biomarkers
Safety
Benefit/Risk
assessment
with regulatory
authorities
Financing of Research Projects
EU FP7 Budget
Cash €1 billion
IMI
€ Funding RESEARCH
Regulators
PROJECTS /
€ Funding CONSORTIA
Patients
In kind €1 billion
e.g. Imaging
Pharmaceutica
l
Companies
€ Funding
€ Funding
Small
Medium
Enterprises
Academi
a
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