Spanish Technology Platform “Medicamentos Innovadores”

Spanish Technology Platform “Medicamentos Innovadores”

Spanish Technology Platform“Medicamentos Innovadores”

Ferran Sanz

Research Unit on Biomedical Informatics (GRIB)IMIM-Hospital del Mar

Barcelona Biomedical Research Park (PRBB)Universitat Pompeu Fabra

[email protected]


Spanish “Mirror” of IMI

Mission:To promote innovative pharmaceutical R&D, overcoming current bottlenecks (global and local).

Objectives:- To create a forum for all the Spanish actors interested in the progress of the pharmaceutical R&D.- To foster the collaboration among such actors.- To facilitate the bidirectional dialogue between Spanish and European initiatives on this matter.


Activities:

- Identification of priority research topics, taking into account the European SRA, as well as the needs and capabilities of the Spanish stakeholders (in particular, the Spanish pharmaceutical industry).- Promotion of collaborative research projects and other joint initiatives.- Communication to the Spanish society (including the authorities) on the importance of the pharmaceutical R&D:

- Meetings- Workshops- Web site- Newsletter (monthly frequency)


1st Annual Meeting (Barcelona, July 2005) More than 150 participants

2nd Annual Meeting (Madrid, July 2006) More than 250 participants

* participants from all kind of institutions including relevant authorities

http://www.medicamentos-innovadores.org



May-June 2005: Constitution of a coordination team covering the three pillars:

Industry: Farmaindustria (Javier Urzay) Academy: PRBB, Barcelona (Ferran Sanz) Clinical Research: Hospital Txagorritxu (Jaime Algorta)

Establishment of 3 working groups:

Clinical Research Knowledge Management Education & Training

with two coordinators per group covering different sectors (industry –pharma & biotech & CROs-, clinical sector and academia).


Ongoing efforts in Clinical Research addressing the following challenges:

Organizational (protocols, standards, legal issues, training, IT tools). BEST Project: Benchmarking on clinical trials.

Scientific (translational research, biomarkers, genotyping, knowledge management)

Political (clinical research as a political priority in the National Health System)

Social (active involvement of the patients)

BEST project

Wide participation of stakeholders:

MSC- DGF CC CEICs- DGF AEMPS- ISCIII

CEICsCCAAs

C. SANIDAD

GERENCIASHOSPITALES

y sus FUNDACIONES

PROMOTORES- INDUSTRIA- OTROS

INV. CLÍNICOSy SOC. CIENT.

ACADEMIAINV. BÁSICA

y TRASLACIONAL

PACIENTES

BEST HEALTH MIN.- DGF CC CEICs- DGF AEMPS- ISCIII

ETHICSCOM.

REGIONAL AUTHORITIES

HOSPITAL MANAGER

S

PROMOTERS- INDUSTRIAL- OTHERS

CLINICAL RESEARCHERS

y SOC. CIENT.

ACADEMIA

PATIENTS

BEST

SCIENTIFIC SOCIETIES

Current database: 24 pharmaceutical companies, 306 clinical trials, 295 hospitals, 2142 centers involved in the clinical trials, 129 ethic committees.

Confidentiality agreement Exploitation done: Times analysis:

Protocolo Final C13

Documentación Preparada C14

Envío CEIC C15

Envío AEMPS C18

Inicio Gestión Contrato C22

Fax Validación C19

Dictamen CEIC C16

Autorización C20Sello Entrada Conformidad C28

Firma Laboratorio C25

Recepción Firma Todas C26

Conformidad en Laboratorio C27

Visita Inicio C32Primer Paciente Local C33

Primer Paciente Internacional C34

T0

T1

T2

T3

T4 T5

T6 T7 T8

T14

T10

T11

T12

T9

T15 T16

T18

T17

Firma Hospital C24T13

Resp. LaboratorioResp. CEICResp. AEMPS

Resp. HospitalResp. Compartida

Protocolo Final C13

Documentación Preparada C14

Envío CEIC C15

Envío AEMPS C18

Inicio Gestión Contrato C22

Fax Validación C19

Dictamen CEIC C16

Autorización C20Sello Entrada Conformidad C28

Firma Laboratorio C25

Recepción Firma Todas C26

Conformidad en Laboratorio C27

Visita Inicio C32Primer Paciente Local C33

Primer Paciente Internacional C34

T0

T1

T2

T3

T4 T5

T6 T7 T8

T14

T10

T11

T12

T9

T15 T16

T18

T17

Firma Hospital C24T13

Resp. LaboratorioResp. CEICResp. AEMPS

Resp. HospitalResp. Compartida

BEST project

Next issues to be afforded:

International benchmarking Documentation Excellence network (researchers, chief scientific

officers of pharmaceutical companies….) Forums with Spanish regional authorities

BEST project

Integration and advanced exploitation of biomedical Integration and advanced exploitation of biomedical information in order to gain a more complete view of diseases, information in order to gain a more complete view of diseases, pharmacological treatments and drug adverse eventspharmacological treatments and drug adverse events

Knowledge management working group

Disease Pathway Target Ligand

Clinical information

“omics” information

Chemical information

Up to know, three meetings have been held with the active involvement of +20 organisations, including:

National Institute of Bioinformatics (INB) National Network on Biomedical Informatics (INBIOMED)

(taking advantage of the participation in the corresponding European NoE, INFOBIOMED)

Experts from pharmaceutical companies SME companies specialised in IT solutions supporting

pharmaceutical R&D Experts from academia


IT tools along the Drug Life Cycle

Information integration and subsequent exploitation

Targetidentification

Preclinical

assessment

Post-marketing monitoring

Identification & obtention of compounds

Clinical

trials

Targetvalidation

Computational genomics

Virtual screening

Structure-based drug design

ADMET prediction

Computational systems biology

Biosimulation

Medical Informatics

Current activities:

Production and dissemination of an inventory of the state-of-the-art technologies in the field, as well as their Spanish providers.

Detect the needs and priorities of the Spanish pharmaceutical industry.

Commission working in the strategies and tools for information integration.

Promotion of collaborative R&D initiatives, in areas like: Pre-clinical toxicology data sharing and joint modelling. Clinical trial data sharing.

Organisation of a series of workshops with the sponsorship of the National Institute of Bioinformatics


Schedulled workshops:

“omics” informatics in pharmaceutical R&D. Valencia. January 2007

Clinical informatics in pharmaceutical R&D. Madrid. March 2007 Molecular approaches in pharmaceutical R&D. Barcelona. May

2007 International Biomedical Informatics event (INFOBIOMED &

SEMANTIC MINING NoEs). Barcelona. June 2007

The format of the first three workshops will be:

One full day per workshop Keynote lectures of international experts Round table of technology providers (industrial and academic) Round table of technology users from pharmaceutical

companies


Objectives:• Involvement of all relevant parties in the E&T

Committee.• Training tailored in line with industrial needs• Focus on trans-disciplinary post-graduate education

(MSc degrees) related with the drug discovery and development pipeline

Activities:• Compilation of current relevant initiatives in Spain.• Definition of general guidelines for E&T supporting

innovative medicinal R&D in Spain.• Creation of a prompt response system able to identify

specific needs in drug discovery and set up adaptable, applied training courses.

Education & Training working group

Held on Santiago de Compostela (June 2006)

More than 70 professionals of all the pharmaceutical R&D sectors:

Public institutions: Universities, Hospitals, Research Foundations, Regulatory Authorities, etc.

Private companies: Pharmaceutical, biotech, CROs, etc.

1st Spanish Workshop on E&T in Pharmaceutical R&D

Education & Training working group


Funding scheme:

- Most of the expenses directly covered by the organisations participating in the platform activities.- Grants from Spanish Ministries of Industry, and Education and Science.- The Spanish Government launched a collaborative project finding scheme similar to the one planned in IMI (CENIT projects). Three big projects have already been funded in the pharma sector.* Constitution of a legal entity under study (keeping bureaucracy to a minimum)


For more information:

www.medicamentos-innovadores.org

Thank You

Documents

Spanish Technology Platform “Medicamentos Innovadores”