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
2. ๏ Open collaboration in public-private consortia
(data sharing, dissemination of results)
๏ โNon-competitiveโ collaborative
research for EFPIA pharma
companies
๏ Competitive calls to select partners of
EFPIA companies
Key Concepts of IMI
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. 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. โฌ 1 945 135 308
โฌ 759,185,796
Infectious diseases
โฌ 214,136,227
Drug discovery
โฌ 182,980,698
Brain disorders
โฌ 116,880,300
Metabolic disorders
โฌ 116,287,312
Drug safety
โฌ 78,225,417
Stem cells
โฌ 72,710786
Cancer
IMI funding
Corporate contribution
โฌ 70,310,746
Data management
โฌ 69,739,527
Inflammatory disorders
โฌ 55,930,958
Biologicals
โฌ 49,310,000
Geriatrics
โฌ 37,966,496
Lung diseases
โฌ 37,378,289
Education and
training
โฌ 30,601,855
Sustainable
chemistry
โฌ 20,426,255
Drug delivery
โฌ 18,118,249
Drug kinetics
โฌ 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 Europeโs IMI effort: budget breakdown
6. IMI invests โฌ167 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 Alzheimerโs disease
8. The Vision for IMI2 โ 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. 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
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