1. 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 Barcelona fsanz@imim.es

2. 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.

3. 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)

4. 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

5. Spanish Technology Platform “Medicamentos Innovadores” • http://www.medicamentos-innovadores.org

6. 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).

7. 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)

8. BEST project Wide participation of stakeholders: BEST BEST HEALTH MIN. MSC PROMOTORES PROMOTERS - - DGF CC DGF CC CEICs CEICs - INDUSTRIA - INDUSTRIAL - - DGF AEMPS DGF AEMPS - OTROS - OTHERS - - ISCIII ISCIII REGIONAL AUTHORITIES CCAAs ETHICSCOM. ACADEMIA ACADEMIA CEICs CLINICAL RESEARCHERS INV. CL Í NICOS C. SANIDAD INV. B Á SICA y SOC. CIENT. y TRASLACIONAL GERENCIAS HOSPITAL MANAGERS SCIENTIFIC SOCIETIES HOSPITALES y SOC. CIENT. y sus FUNDACIONES PATIENTS PACIENTES

9. BEST project • 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:

10. BEST project • Next issues to be afforded: • International benchmarking • Documentation • Excellence network (researchers, chief scientific officers of pharmaceutical companies….) • Forums with Spanish regional authorities

11. Disease Pathway Target Ligand Clinical information “omics” information Chemical information Knowledge management working group Integration and advanced exploitation of biomedical information in order to gain a more complete view of diseases, pharmacological treatments and drug adverse events

12. Knowledge management working group • 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

13. IT tools along the Drug Life Cycle Post-marketing monitoring Clinical trials Identification & obtention of compounds Preclinical assessment Target identification Target validation Computational genomics Virtual screening Structure-based drug design ADMET prediction Medical Informatics Computational systems biology Biosimulation Information integration and subsequent exploitation

14. Knowledge management working group • 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

15. 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

16. Education & Training 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 generalguidelines 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.

17. Education & Training working group 1st Spanish Workshop on E&T in Pharmaceutical R&D • 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.

18. 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)

19. Spanish Technology Platform “Medicamentos Innovadores” • For more information: • www.medicamentos-innovadores.org • Thank You