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

rdam@isciii.es

2012

Spain

• It manages the Strategic Action for Health

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

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

.

ISCIII extramural Research co-funding (2011)

The Andalusian Centre of Molecular

Biology & Regenerative Medicine(Seville)

The Centre of Regenerative Medicine

(Barcelona)

The Research Centre Principe Felipe

(Valencia)

The Andalusian Bank of Stem Cells

(Granada)

Organization, coordination and fostering of

basic, pre- clinical and clinical research in

regenerative medicine Total = 4.9 M € (2011)

Valentian Community

***

Andalusia:

2.0 M €

Catalonia:

2.0 M €

Aragon

0.45 M €

Castille & Leon

0.45 M €

Organization, coordination and fostering of

basic, pre- clinical and clinical research in

regenerative medicine

1.- What is the state of affairs in

Personalised Medicine in Spain [2B]

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.

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)

• to the clinical / public health

practices

• and the enterprises

(economic growth)

2) What are the challenges for Spain ]

Translation

“from the bench to the bedside

The Virtual Patient System

•

3) What is your expectation of the

Horizon 2020 and where do you see

opportunities for collaboration.

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

• Molecular modelling in health and medicine

FET Flagships

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.

Pay attention to undesired redundancies

www.isciii.es

Many thanks for your attention!!

Dr. Rafael De Andres-Medina

rdam@isciii.es