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)

1. Is Europe ready for Personalised Medicine?
Perspectives from funders and regions
2012
Policy developments and funding towards
Personalised Medicine. Spain
Dr. Rafael De Andrés Medina
rdam@isciii.es
Fund for Health Research
Spain
Brussels, April 18 th, 2012

2. 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.
• It manages the Strategic Action for Health
Research (AES) within the National Plan for R+D+I.
Budget = 333 M € (2010))

3. Spain. Legal background
The National Institute of Health Carlos III (ISCIII)
• 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

4. SPAIN.
PLANING AND FUNDING FOR R+D+I
Ministry of Economy
• NATIONAL PLAN (NP) R+D+I & Competitiveness
(MINECO)
• STRATEGIC ACTION FOR National Institute of
PLANING HEALTH RESEARCH (AES) Health “Carlos III”
• NATIONAL STRATEGY Ministry of Economy
FOR INNOVATION (NSI) & Competitiveness
(MINECO)
• GENERAL DIRECTORATE NP R+D+I
OF SCIENTIFIC & (no prioritised
TECHNICAL RESEARCH, Research)
FUNDING MINECO
• NATIONAL INSTITUTE OF AES
HEALTH “CARLOS III” (ISCIII)

5. ISCIII. MISSION [ii]
EU:
RESEARCH -ERANets
-Art. 185/ex 169 TCE, JPIs, ESFRI-ERICs, …
Intramural Extramural
•250 M € (2010)
ISCIII’s Reference Centers (7)
Competitive Structural
Strategic Action for Health -Participated Centers
Research (AES) -Foundations (3)
•Projects & infrastructure grants -Consortia (10)
Research &Technical Manpower -Omics Platforms (4)
•Fellowships -Health Research Institutes (16)
•Contracts -Alliances
•Mobility & Sabattical - Joint Centers
• Loans - National-Regions-EU/international.

6. Spanish approach:
National Infrastructure for Personalised Medicine
Academia
Laboratory driven Candidate biomarker
Basic research Candidate
Bioinformatics driven identification
biomarker(s)
Preliminary assay POC validated
Clinical research Clinical samples biomarker(s) POC validation
Validation of Drug Targets
OMICs platform BBH6 BBH2
ISSs EATRIS
• INB ELIXIR H6 H2
• Proteored BBa BBd
• CeGen BBH5
BBH1
BBf
BBb
H1
H5 H3
BBc BBe
BBH3
Spanish Network of H4
BBH4
BioBanks BBMRI
Clinical trials platform
Spanish Technology Platform IMI CAIBER ECRIN
Innovative Medicines
National or
International
Patent Offices
Industry? modified from Comella J. EATRIS[ES], 2010

7. Structuring Spanish Capacities for
Pan-European Biomedical
Research Infrastructures. .
Spain. ISCIII as funder and NIB as Scientific partner
ELIXIR
PM PM PM PM
Spain. ISCIII as funder with up to 10 M € per year and CAIBER as
ECRIN Scientific partner (40 CRO)
Spain. ISCIII as funder and Health Research Institutes´ network as
pan-European
EATRIS Scientific partner
infrastructures MRI
Spain. ISCIII as funder with up to 6 M € per year and 63 biobanks´
providing generic BBMRI network as Scientific partner
tools and services
modified from Demotes J, ECRIN 2009
pan-European investigation networks developping specific tools and scientific content
7

8. 1.- What is the state of affairs in
Personalised Medicine in Spain [1]
I
ISCIII EXTRAMURAL • National Institute of Bioinformatics
RESEARCH FUNDING (2011) (INB, 9 nodes) 1.5 M €
• National Institute of Proteomics
(PROTEORED, 19 nodes) 1.3 M €
OMICs • National Center for Genotyping
Technological Platforms: (CeGen, 3 nodes) 1 M €
• Spanish Biobanking Network (RETBIOH
63 biobanks + 11 affiliated) 6 M €
Other Platforms: • 16 certified Health Research Institutes
(ISS) for translational research ***.
• CLINICAL TRIALS PLATFORM
Total = 20.4 M € (2011) (CAIBER, 40 CRO) 8 M €
• Cell Therapy Research Network
(TERCEL, 28 groups) 2.6 €

9. 1.- What is the state of affairs in
Personalised Medicine in Spain [1A]
ISCIII strutured and funds
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.

10. 1.- What is the state of affairs in
Personalised Medicine in Spain [1B]
ISCIII also 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.

11. 1.- What is the state of affairs in
Personalised Medicine in Spain [2]
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.
.• transplant of pancreatic isolates; cell therapy for diabetic
complications, diabetic foot, diabetic cardiopathy,
• cardiopathy,
• ELA, multiple sclerosis,
• skin regeneration,
• Khron disease,
• muscular dystrophies;
• bone and cartilagous regeneration;
• cell therapy in medular lesions;
• hepatic regeneration

12. 1.- What is the state of affairs in
Personalised Medicine in Spain [2B]
ISCIII extramural
Research co-funding (2011)
The Andalusian Centre of Molecular
Biology & Regenerative Medicine(Seville)
Andalusia:
The Andalusian Bank of Stem Cells
2.0 M €
(Granada)
Valentian Community The Research Centre Principe Felipe
*** (Valencia)
Catalonia:
2.0 M € The Centre of Regenerative Medicine
(Barcelona)
Aragon
0.45 M € Organization, coordination and fostering of
basic, pre- clinical and clinical research in
Castille & Leon regenerative medicine
0.45 M €
Organization, coordination and fostering of
basic, pre- clinical and clinical research in
Total = 4.9 M € (2011) regenerative medicine

13. 1.- What is the state of affairs in
Personalised Medicine in Spain [2C]
The Plan for Advanced Therapies within a Regenerative
Medicine scope(Council of Ministers of Spain,11 th October 2007)
ISCIII co-funds:
• The Andalusian Centre of Molecular Biology and Regenerative Medicine (Seville)
cell therapy applied to diabetes and neurodegeneration
• The Andalusian Bank of Stem Cells (Granada)
Biology of reprogramming and retrotransposition; embryonic, hematopoietic and
mesenchymal stem cells; cell and gene therapy.
• The Research Centre Principe Felipe (Valencia)
cell therapy; reprogramming and biohybrids; Molecular Neuroendocrinology,
Biomaterials; Biology of the stem cells.
• The Centre of Regenerative Medicine (Barcelona)
adult, embryonic and induced stem cells and its use for the treatment of
neurodegenerative diseases (ELA, spinal cord muscular atrophy, Alzheirmer, ...);
bone, cartilage, and hepatic regeneration; and right – left vertebrate heart patterning.
• The organization, coordination and fostering of basic, pre- clinical and clinical
research in regenerative medicine in Aragon and Castille & Leon Regions.
The Fundation Inbiomed (San Sebastian)
• works in Cell Therapy for cardiovascular and neurodegenerative diseases; tumor stem cell,
engineerized skin production for the treatment of epidermoydes bullosa.

14. 2) What are the challenges for Spain
]
Translation
“from the bench to the bedside
• to the clinical / public health
practices
• and the enterprises
(economic growth)

15. 3) What is your expectation of the
Horizon 2020 and where do you see
opportunities for collaboration.
Personalised Medicine can be a good candidate for
joint programing like schemes upon agreed common national,
European and international scientific priorities via joint calls and
programme funding alignments.
• It should include Horizon 2020 and global positioning, as well
as e.g. International scientific evaluation applied both to
national, multi-country and European funding schemes.
FET Flagships
The Virtual Patient System
• Molecular modelling in health and medicine
• offering a revolution in healthcare: aiming at the ultimate goal of developing
personalised preventive medicine based on individual data
processed against globally integrated medical knowledge
Pay attention to undesired redundancies

16. Dr. Rafael De Andres-Medina
rdam@isciii.es
www.isciii.es
Many thanks for your attention!!