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
Spanish Technology Platform “Medicamentos Innovadores”
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.
Spanish Technology Platform “Medicamentos Innovadores”
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)
Spanish Technology Platform “Medicamentos Innovadores”
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
Spanish Technology Platform “Medicamentos Innovadores”
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).
Spanish Technology Platform “Medicamentos Innovadores”
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
Knowledge management working group
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
Knowledge management working group
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
Knowledge management working group
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
Spanish Technology Platform “Medicamentos Innovadores”
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)