- Innovative Medicines Initiative -
Elisabetta Vaudano
 Open collaboration in public-private consortia
(data sharing, dissemination of results)
 “Non-competitive” collaborativ...
REGULATORS ON
BOARD OF
12
PROJECTS
50%of projects have
REGULATORY AUTHORITIES
representatives in Scientific
Advisory Board...
Key collaborative activity areas:
Diabetes, CNS disorders, Tuberculosis, Patient Reported Outcomes,
Cancer, Preclinical Sa...
€ 1 945 135 308
€ 759,185,796
Infectious diseases
€ 214,136,227
Drug discovery
€ 182,980,698
Brain disorders
€ 116,880,300...
IMI invests €167 million in 4 projects aiming at:
 Developing models to predict the efficacy of drug candidates in patien...
January 2014
The Vision for IMI2 – The right prevention and
treatment for the right patient at the right time
Biologically
heterogeneou...
IMI2 Key Facts and Strategic Research
Agenda
Bigger budget: 3,45 Billion
Euro, equally shared by EU
and industry
Partnersh...
Thank you
www.imi.europa.eu
@IMI_JU
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Global Dementia Legacy Event: Elisabetta Vaudano DVM PhD

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Session Two: Barriers to investment in research to find a disease modifying therapy or cure for dementia.

Elisabetta Vaudano DVM PhD, Coordinator Scientific Pillar, Principal Scientific Manager, Innovative Medicines Initiative

Published in: Health & Medicine, Business
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  • EMA established in 1995
    Networking agency - Coordinates the existing scientific resources of the Member States to evaluate and supervise medicinal products for both human and veterinary use throughout the European Union.
    The EMA is primarily involved in the centralised procedure for obtaining an EU marketing authorisation. (27 MS + No/IS = 47 Agencies)
    The Agency also gives scientific advice to research-based companies on the development of new medicinal products and develops guidelines on quality, safety and efficacy testing requirement.
    Responsibility for clinical trial authorisation remains at national level
  • Global Dementia Legacy Event: Elisabetta Vaudano DVM PhD

    1. 1. - Innovative Medicines Initiative - Elisabetta Vaudano
    2. 2.  Open collaboration in public-private consortia (data sharing, dissemination of results)  “Non-competitive” collaborative research for EFPIA pharma companies  Competitive calls to select partners of EFPIA companies Key Concepts of IMI
    3. 3. REGULATORS ON BOARD OF 12 PROJECTS 50%of projects have REGULATORY AUTHORITIES representatives in Scientific Advisory Boards 61%of projects reported some form of PATIENT INVOLVEMENT
    4. 4. 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
    5. 5. € 1 945 135 308 € 759,185,796 Infectious diseases € 214,136,227 Drug discovery € 182,980,698 Brain disorders € 116,880,300 Metabolic disorders € 116,287,312 Drug safety € 78,225,417 Stem cells € 72,710786 Cancer IMI funding Corporate contribution € 70,310,746 Data management € 69,739,527 Inflammatory disorders € 55,930,958 Biologicals € 49,310,000 Geriatrics € 37,966,496 Lung diseases € 37,378,289 Education and training € 30,601,855 Sustainable chemistry € 20,426,255 Drug delivery € 18,118,249 Drug kinetics € 14,910,397 Relative effectiveness NATURE MEDICINE | NEWS Partners AiCuris Johnson&Johnson Animal Health Medimmune Division of Sanofi Merck Astellas Merck Sharp AstraZeneca & Dohme Corp Basilea Merial Boehringer Ingelheim Novartis Cubist Pfizer GSK Rempex Janssen Sanofi AstraZeneca Novartis Bayer Pfizer Janssen Sanofi Lundbeck UCB Merck Abbott Janssen AbbVie Lundbeck AC IMMUNE Merck Amgen Novartis Astellas NOVO NORDISK AstraZeneca Orion Corporation BIOGEN IDEC Pfizer Boehringer Ingelheim Roche Eisai Sanofi Eli Lilly SERVIER ESTEVE UCB Grunenthal Vifor GSK First phase of Europe’s IMI effort: budget breakdown
    6. 6. IMI invests €167 million in 4 projects aiming at:  Developing models to predict the efficacy of drug candidates in patients  Connecting data on 40 millions of individuals to decipher links between genetic background, biological abnormalities, brain imaging changes, mental symptoms and disease progression  Identifying subgroups of the disease allowing to tailor therapies according to the different causal factors involved  Implementing innovative trial designs How IMI addresses Alzheimer’s disease
    7. 7. January 2014
    8. 8. The Vision for IMI2 – The right prevention and treatment for the right patient at the right time Biologically heterogeneous patient population Graphic adapted from C. Carini, C. Fratazzi, Eur. Pharm. Rev. 2008, 2, 39-45 effective not effective Adverse events Trial and Error effective not effective adverse events Dx Test A B Ce.g. biomarker Information based treatment decisions vs The Next Phase: IMI2
    9. 9. IMI2 Key Facts and Strategic Research Agenda Bigger budget: 3,45 Billion Euro, equally shared by EU and industry Partnership Not limited to EFPIA members Dementia and Neurodegeneration have been identified as key research priorities
    10. 10. Thank you www.imi.europa.eu @IMI_JU
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