the innovativemedicinesinitiative: building new modelsof ......a. f. cohen, nature reviews drug...
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The Innovative Medicines Initiative:
Building new models of collaborative research across
EuropeElisabetta Vaudano
IMI, Belgium
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
www.imi.europa.eu
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What is IMI ?
An European Public-Private Partnership
Focused on
Needs Common to
Pharmaceutical Industry and Patients
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 3: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/3.jpg)
The Innovative Medicines Initiative:
the Largest PPP in Life Sciences R&D
IMI Research funding
for
Academia, SMEs, patients
organisations, Regulatory
Authorities, etc.
* Research performed by
EFPIA member companies
= in kind contribution
IMI Research Projects
€1 billion€1 billion*
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 4: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/4.jpg)
EFPIA Member Companies
Participating companies (September 2010):
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 5: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/5.jpg)
IMI Objectives
• Making the pharmaceutical R&D process faster
and more effective, rather than directly delivering
new drugs
• Accelerating the development of safer and more
effective medicines for patients in Europe
• Improving the environment for pharmaceutical
R&D in Europe
• Boosting the biopharmaceutical sector in Europe
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 6: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/6.jpg)
…Burden of Mental Disorders is huge..
15% Cardiovascular
disease
7% Respiratory disease
4% Sense organ disease
3% Infectious/parasitic
disease3% Diabetes
3% Digestive disease
15% Others
25% Mental
Illness
12% Cancer
Serious mental illness costs ~ 320Billion/year
~100B Direct Costs
~ 200B Indirect Costs
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 7: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/7.jpg)
…and Unmet Need is Still Very High..
Efforts to discover and develop new drugs for brain disorders,
particularly those that might revolutionize disease treatment, have
been relatively unsuccessful, some of the reasons being…
….Most brain disorders are heterogeneous and multi-factorial
…..Target validation is challenging
….Complexity of symptoms is not simply the sum of its parts
……Diagnosis is based on subjective criteria
……Animal models are inadequate
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 8: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/8.jpg)
…Current R&D Models Show no
Significant Impact on R&D Innovation
Munos B., Nature Reviews Drug Discovery 8, 959-968 (December 2009)
1+1=1
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 9: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/9.jpg)
The Health-care Ecosystem is
changing….
• Health care reform and health IT, are driving the
system to include many companies not
traditionally involved in the health care business.
• Patients from been traditionally relatively passive
participants in health delivery are been
empowered by technological progress to become
educated super-consumers with a much more
active role in management of their health care.
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 10: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/10.jpg)
Pharma
Patients
Academia Physicians
BiotechsInsurers
Digital
healthcare
Governments
CROs
MedTech
Social media
The New Environment of “Big Pharma”
Regulators
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 11: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/11.jpg)
Key Concepts
• Pre-competitive research
• Open Innovation
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 12: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/12.jpg)
Open Industry-Academia Networks are
Key to Achieve Innovative Medicines
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 13: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/13.jpg)
Clinical pharmacology & Therapeutics | VOLUME 87 NUMBER 5 | MAY 2010
Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Precompetitive Research to Boost
Innovation in Biomedicine
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 14: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/14.jpg)
IMI Supports Precompetitive Research
IMI
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 15: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/15.jpg)
IMI is an Industry driven initiative
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 16: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/16.jpg)
Step 2:
Consortia eligible for EU funding
compete through expressions of interest
which are ranked by independent experts
Step 1:
A set of EFPIA companies
define a topic on which they
commit to collaborate
Acad 1 Acad 2 Acad 3
Acad 4Patients’
Organ 1Regul 1
Patients’
Organ 2
Other*
SME 1SME 2
Pharma 1
Pharma 5
Pharma 2
Pharma 3Pharma 4
Pharma 6
Pharma 1
Pharma 5
Pharma 2
Pharma 3Pharma 4
Pharma 6
Acad 1 Acad 2 Acad 3
Acad 4Patients’
Organ 1Regul 1
Patients’
Organ 2
Other*
SME 1SME 2
Step 3:
The top-ranked EU-fundable
consortium join the EFPIA
companies to form the
final consortium which develops
the full proposal, subject to
peer-review before final approval
Building
a IMI Consortium
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EMA supports IMI activities
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N ENGL J MED 362: 865-869, March 11, 2010
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 19: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/19.jpg)
Call 1 Call 2 Total
Projects 15 8 23
EFPIA Companies 21 21 23
Academic teams 195 103 298
SME teams 24 23 47
Patients’ organisat. 9 2 11
Total Budget (M€) 281 172 453
IMI Projects overview Call 1 &2
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 20: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/20.jpg)
IMI Four Strategic Pillars
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 21: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/21.jpg)
First call (2008) funded projects
15 Projects
Total budget:
281 M€
3 Neuroscience
Projects
Total budget
nearly
60 M€
6.3F. Hoffman-La Roche SafeSciMET
6.6Eur. Federation of CoursesPharma Train
7.2F. Hoffman-La Roche EU2P
7.7AstraZenecaEMTRAIN
12.9Novartis PharmaE-TOX
13.3Novartis PharmaMARCAR
16.7Chiesi FarmaceuticiPROactive
18.2AstraZenecaEUROPAIN
20.6Novartis PharmaU-BIOPRED
24.0LundbeckNEWMEDS
25.4Sanofi-AventisIMIDIA
27.7GSKPHARMA-COG
28.4Boehringer IngelheimSUMMIT
29.8European Medicines AgencyPROTECT
35.9Novartis PharmaSAFE-T
Budget (M€)EFPIA CoordinatorAcronym
6.3F. Hoffman-La Roche SafeSciMET
6.6Eur. Federation of CoursesPharma Train
7.2F. Hoffman-La Roche EU2P
7.7AstraZenecaEMTRAIN
12.9Novartis PharmaE-TOX
13.3Novartis PharmaMARCAR
16.7Chiesi FarmaceuticiPROactive
18.2AstraZenecaEUROPAIN
20.6Novartis PharmaU-BIOPRED
24.0LundbeckNEWMEDS
25.4Sanofi-AventisIMIDIA
27.7GSKPHARMA-COG
28.4Boehringer IngelheimSUMMIT
29.8European Medicines AgencyPROTECT
35.9Novartis PharmaSAFE-T
Budget (M€)EFPIA CoordinatorAcronym
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 22: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/22.jpg)
3rd Call Topics
• Early prediction of drug-induced liver injury
• Risk minimization of antibodies to biopharmaceuticals
• Immunosafety of vaccines
• Translational research on autism spectrum disorders
• Personalized medicine in type II diabetes
• New strategies to treat tuberculosis
• Patient awareness on pharmaceutical innovation
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 23: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/23.jpg)
The Path to Innovative Medicines
nature medicine volume 16 | number 4 | April 2010: 347
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The Translational Process of Drug
R&D
A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010)
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 25: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/25.jpg)
Biomarkers are Critical for the R&D of
Innovative Drugs
No drug candidate should enter the clinic without a
species-independent biomarker as the central
element of translational medicine
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 26: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/26.jpg)
The Translational Process of Drug
R&D
A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010)
Biomarker
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 27: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/27.jpg)
Pharma-Cog
Prediction of Cognitive
Properties of New Drug
Candidates for
Neurodegenerative Diseases
in Early Clinical Development
http://www.alzheimer-europe.org/FR/Research/PharmaCog
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain
![Page 28: The InnovativeMedicinesInitiative: Building new modelsof ......A. F. Cohen, Nature Reviews Drug Discovery 9, 856-865 (2010) Public Private Partnerships Boost Alzheimer's Disease Drug](https://reader034.vdocument.in/reader034/viewer/2022050111/5f48af0cd257b55daa63b466/html5/thumbnails/28.jpg)
Thank you for your attention!
Public Private Partnerships Boost Alzheimer's Disease Drug Discovery.
IMI Official Satellite Symposium of the AD/PD 2011 Conference,
9th March 2011, Barcelona Spain