Brussels, April 18 th, 2012 Policy developments and funding towards Personalised Medicine. Spain Is Europe ready for Personalised Medicine? Perspectives from funders and regions Fund for Health Research Dr. Rafael De Andrés Medina [email protected]2012 Spain
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Research Policy developments and instruments towards Personalised Medicine in Spain
EuroBioForum 2012 | 18 April 2012 Presentation by Rafael De Andrés Medina, Chief of the Technical Studies Department, Fund for Health Research (FIS), National Institute of Health Carlos III (ISCIII)
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Research (AES) within the National Plan for R+D+I.
ISCIII. MISSION [i]
is a Public Body of Spain with legal personnality whose main mission on Reearch is: • the generation of scientific knowledge in Biomedical and Health Sciences and
to promote innovation in health care and disease prevention reports to the Ministry of Economy and Competitiveness
and the Ministry of Health, Social Services and Equality.
Budget = 333 M € (2010))
• has is own legal personality (General Act 14/1986 of Health).
• reports to the Ministry of Economy and Competitiveness and the Ministry of
Health, Social Services and Equality.
• is entitled to plan, promote and coordinate Biomedical and Health Research
and Innovation in Spain (Act 14/2007 for Biomedical Research, that provides
the framework for regenerative and Personalised Medicine research too)
• funds Biomedical and Health Scientific and Technical research (Act14/2011 of
Science, Technology and Innovation).
• acts as intramural Research Performing Organisation (RPO), extramural
funding agency and regulatory in some areas too. e.g. in biobanking.
• redefines R+D+I capacities and capabilities of the Spanish National Health
System (SNS) R+D+I within S&T System of Spain for a robust structural
engagement within the European ones.
• promotes the Sectorial Initiative for Health Research -ISIS- (Act 16/2003, of
cohesion and quality of SNS) and manages the Strategic Action for Health
Research (AES) upon scientific plus strategic and opportunity assessments
Spain. Legal background
The National Institute of Health Carlos III (ISCIII)
SPAIN.
PLANING AND FUNDING FOR R+D+I
PLANING
FUNDING
• NATIONAL PLAN (NP) R+D+I
Ministry of Economy
& Competitiveness
(MINECO) • STRATEGIC ACTION FOR
HEALTH RESEARCH (AES) National Institute of
Health “Carlos III”
• NATIONAL STRATEGY
FOR INNOVATION (NSI)
Ministry of Economy
& Competitiveness
(MINECO)
• GENERAL DIRECTORATE
OF SCIENTIFIC &
TECHNICAL RESEARCH,
MINECO
NP R+D+I
(no prioritised
Research)
• NATIONAL INSTITUTE OF
HEALTH “CARLOS III” (ISCIII)
AES
RESEARCH
Intramural Extramural
•250 M € (2010)
ISCIII’s Reference Centers (7)
Competitive Structural
-Participated Centers
-Foundations (3)
-Consortia (10)
-Omics Platforms (4)
-Health Research Institutes (16)
-Alliances
- Joint Centers
- National-Regions-EU/international.
Strategic Action for Health
Research (AES) •Projects & infrastructure grants
Research &Technical Manpower
•Fellowships
•Contracts
•Mobility & Sabattical
• Loans
ISCIII. MISSION [ii]
EU:
-ERANets
-Art. 185/ex 169 TCE, JPIs, ESFRI-ERICs, …
BBa
BBb
BBc
BBd
BBf
BBe
Spanish Network of
BioBanks BBMRI
IMI
Academia Candidate biomarker
identification Candidate biomarker(s)
Laboratory driven Bioinformatics driven
Basic research
POC validation POC validated biomarker(s)
Preliminary assay
Clinical samples Clinical research
H2
H3
H4
H5
H6 BBH6 BBH2
BBH5
BBH4
BBH3
Spanish Technology Platform
Innovative Medicines
Validation of Drug Targets
H1
BBH1
Spanish approach:
National Infrastructure for Personalised Medicine
Clinical trials platform
CAIBER ECRIN
National or
International
Patent Offices Industry?
ISSs EATRIS OMICs platform
• INB ELIXIR
• Proteored
• CeGen
modified from Comella J. EATRIS[ES], 2010
PM PM PM PM
ECRIN
EATRIS
MRI
BBMRI
pan-European
infrastructures
providing generic
tools and services
pan-European investigation networks developping specific tools and scientific content
Structuring Spanish Capacities for
Pan-European Biomedical
Research Infrastructures. .
Spain. ISCIII as funder with up to 10 M € per year and CAIBER as Scientific partner (40 CRO)
Spain. ISCIII as funder and Health Research Institutes´ network as Scientific partner
Spain. ISCIII as funder with up to 6 M € per year and 63 biobanks´ network as Scientific partner
ELIXIR Spain. ISCIII as funder and NIB as Scientific partner
7
modified from Demotes J, ECRIN 2009
I
ISCIII EXTRAMURAL RESEARCH FUNDING (2011)
OMICs
Technological Platforms:
• National Institute of Bioinformatics
(INB, 9 nodes) 1.5 M €
• Spanish Biobanking Network (RETBIOH
63 biobanks + 11 affiliated) 6 M €
• National Center for Genotyping
(CeGen, 3 nodes) 1 M €
• National Institute of Proteomics
(PROTEORED, 19 nodes) 1.3 M €
• CLINICAL TRIALS PLATFORM
(CAIBER, 40 CRO) 8 M €
Total = 20.4 M € (2011)
Other Platforms: • 16 certified Health Research Institutes
(ISS) for translational research ***.
1.- What is the state of affairs in
Personalised Medicine in Spain [1]
• Cell Therapy Research Network
(TERCEL, 28 groups) 2.6 €
1.- What is the state of affairs in
Personalised Medicine in Spain [1A]
Technological Platforms:
The National Institute of Bioinformatics (INB): 9 nodes
• works in computational biology and gives service support to RPO and enterprises
for genomic and proteomic projects
• INB is the Spanish scientific partner in ELIXIR.
The National Institute of Proteomics (Proteored): 19 nodes
• supports to the research community and develops new technological applications.
The National Center for Genotyping (CeGen): 3 nodes
• big scale SNPs (Single Nucleotide Polymorphisms) for RPO, hospitals and
enterprises.
• These services on the Spanish population genotyping are focused in the molecular
basis of prevalent diseases and the inter-individual genetic variation response to
pharma drugs.
The cell therapy research network (TERCEL):
• 27 groups based in Madrid, Andalusia, Catalonia, Valentian Community,
Castille and Leon, Navarre, Galicia, Extremadura and Murcia.
ISCIII strutured and funds
The Spanish 63 biobanks (+ 11 affiliated ones) Network (RETBIOH)
• Most are disease based biobanks. It also includes the population based
National Bank of DNA (BancoADN) managing representative DNAsample
collections of the Spanish population to serve for a rational, efficient, ethic
and legal use in research, providing warranty of meeting donor´s right.
• RETBIOH is the Spanish scientific partner of BBMRI.
The 16 certified Health Research Institutes (ISS) for translational research
• Each core is based on a hospital plus other PROs´ S&T capabilities.
• IISs is the Spanish scientific partner in EATRIS.
CAIBER (40 CRO in leading University hospitals)
• The Spanish platform for clinical trials and
• CAIBER is the Spanish scientific partner in ECRIN.
ISCIII also strutured and funds
1.- What is the state of affairs in
Personalised Medicine in Spain [1B]
The Council of Ministers of Spain approved (11 th October 2007)
the Plan for Advanced Therapies within a Regenerative Medicine
scope: Therapeutic alternatives (including clinical trials) for 12
pathologies with no therapeutic protocol.
.
1.- What is the state of affairs in
Personalised Medicine in Spain [2]
• transplant of pancreatic isolates; cell therapy for diabetic