1. EU RTD + FP6 - 1 - Discussion slides

2. EU RTD + FP6 - 2 - Life sciences, genomics and biotechnology for health (one of 7 thematic priorities) (2514 Mill. €) Confronting poverty- related communicable diseases Bio- technology for Health Cancer Research in the EU 6 th Framework Programme (FP6) Fundamental Genomics Application- oriented genomic approaches to other major diseases Com- bating Cancer (ca. 310 Mill. €) Advanced Genomics and its Application for Health Combating Major Diseases Cancer-related topics (ca. 140 Mill. EUR)

3. EU RTD + FP6 - 3 - Cancer Research in FP6 EU Support l Different Support Schemes: Networks of Excellence (NoE), Integrated Projects (IP), Specific Targeted Research Projects (STREP), Specific Support Actions (SSA) etc. l Specific calls for proposals (Topics determined through Expressions of Interest, Advisory Group, Programme Committee etc.) l Evaluation and „ranking“ through independent high-level international expert panel l EU contribution up to > 10 Mill. EUR/project for 3-5 years

4. EU RTD + FP6 - 4 - Cancer Research in FP6 Calls l 1 st call (deadline March 2003): 25 projects funded (for 37 Mill €) –Examples of topics: “molecular targets for treatments”, “phase I/II clinical trials”, “molecular imaging”, “networking of cancer registries and repositories”, “organ-specific metastatic growth processes in breast cancer”, “mechanisms of cancer-related pain” l 2 nd call (currently open, deadline 16 November) –Examples of topics: “networks for uncommon cancers”, “prevention of cancer in high-risk populations”, “immune control of tumours” l 3 rd call (2005) l Further information: http://www.cordis.lu/lifescihealth/cancer/home.htm

5. EU RTD + FP6 - 5 - A New European Research Strategy Joint effort by EU and member states to address structural deficits of European Research Establish critical mass! ↑ R+D to 3% of GDP! Strengthen “public-private partnerships! Promote innovation! Fragmentation Under-resourcing Unfavourable environment for research and innovation

6. EU RTD + FP6 - 6 - FP6 (2002-2006) EUR 17.5 billion

7. EU RTD + FP6 - 7 - Budgets of the EU Framework Programmes FP1 FP2 FP3 FP4 FP5 FP6 (Comparison: Annual Budget U.S. National Institutes of Health (only Health Sciences): 27 Bill. $)

8. EU RTD + FP6 - 8 - The EU’s budget 2002 Total value of commitments: EUR 98.6 billion

9. EU RTD + FP6 - 9 - Topics for the 1 st call Combating Cancer 2.2.0-1Translating basic knowledge of functional oncogenomics into cancer diagnosis and treatment IP NoE 1733 2.2.0-2Multidisciplinary research to explore and validate molecular targets for innovative treatmentIP3577 2.2.0-3Networking for treatment and/or prevention clinical trials aimed at impoving clinical practice in the light of new molecular knowledge NoE1372 2.2.0-4Innovative research in radiation therapyIP NoE 1022 2.2.0-5Molecular Imaging for early detection of tumours and monitoring of treatmentIP NoE 1653 2.2.0-6Networking of quality controlled cancer registries and repositories for molecular epidemiology and quality assessment NoE411 2.2.0-7Molecular mechanisms involved in organ-specific metastatic growth processes in breast cancer STREP CA 322 2.2.0-8Translational research on promising predictive and prognostic markersSTREP CA 1855 2.2.0-9Cancer-related painSTREP CA 000 Total1163225

10. EU RTD + FP6 - 10 - l Balanced coverage of basic-clinical research activities l 32 out of 116 proposals (27,5%) above threshold l Combating Cancer: 25 out of 32 proposals (78%) (14 IP, 4 NoE, 7 STREPs) l Satisfactory participation of SMEs (21 out of 25 projects) l Fundamental/Applied Genomics: 11 proposals (5 IP, 2 NoE, 4 STREP) l total EU-funding 171 million euro Evaluation 1 st Call Cancer Research in Priority 1

11. EU RTD + FP6 - 11 - EVALUATION 1 st CALL COMBATING CANCER l Validation of current innovative oncogenomics technologies ( INTACT, TRANSFOG ) l Comprehensive coverage of molecular pathways (p53, angiogenesis, proteases, hypoxia, telomerase) ( ACTIVEP53, MUTP53, EUROXY, STROMA, ANGIOTARGETING, CANCERDEGRADOME, MOL CANCER MED ) l A focused effort on breast, leukemia and prostate cancer ( PRIMA, P-MARK, DNA-METHYLATION, TRANS-BIG, LEUKEMIANET, BRECOSM, METABRE ) l Web-based brain tumour diagnosis/prognosis ( E-TUMOUR ) l Improvement of radiotherapy using adult stem cell lines ( FIRST ) l Promising molecular targets ( MCL NETWORK, PROTHETS, ENACT) l A good coverage of molecular imaging technologies, devices and radiotherapy ( EMIL, BIOCARE, MAESTRO ) l The establishment of harmonised procedures for quality controlled bio-banks for basic and clinical research ( CCPRB ) A good coverage of molecular imaging technologies, devices and radiotherapy (EMIL, BIOCARE, MAESTRO)

12. EU RTD + FP6 - 12 - EVALUATION 1 st CALL BASIC AND APPLIED ONCOGENOMICS/ BIOTECHNOLOGY FOR HEALTH l Optimised delivery systems and technologies for vaccination (THERAVAC, ALLOSTEM, DC-VACC, GENOMES TO VACCINES, DENDRITOPHAGES) l Disease models (ZF-MODELS, FUNGENES) l Basic and applied Genomics (LYMPHANGIOGENOMICS, MITOCHECK, THE EPIGENOME)

13. EU RTD + FP6 - 13 - Overview 3 rd call Cancer Budget: ± 95 Million Euro 3 IP / 2 NoE 3 STREPS 75 % 25 % 1 SSA/CA

14. EU RTD + FP6 - 14 - Topics 3 rd call Cancer Research into immune control of tumours for prevention and therapy IP Relevant models for pre-clinical tests and evaluation of new therapies IP Research on tumours associated with infectious agents IP Development of European networks to promote research into uncommon cancers in adults and children NoE Prevention of cancer in high risk populations NoE 2.2

15. EU RTD + FP6 - 15 - Prevention, detection and treatment of familial cancers, such as cancer of the prostate, ovary, breast, colon and skin STREP Molecular-oriented detection and treatment of minimal disease STREP Tumour-host interactions STREP SSA/ CA Feasibility study for the coordination of national cancer research activities* *Deadline 9 Sept ! Topics 3 rd call Cancer 2.2

16. EU RTD + FP6 - 16 - New Screening techniques and strategies in the early diagnosis of solid tumors IP Topics 3 rd call BASIC AND APPLIED ONCOGENOMICS/ BIOTECHNOLOGY FOR HEALTH Highly sensitive tests for the assessment of haematological malignancies STREP Overcoming the limitations of stem cell therapy for solid tumours IP Development of new non-viral gene delivery technologies for ex vivo gene-based therapies STREP Exploring the potential of human umbilical cord blood stem cells for application other than allogeneic haematopoietic transplantations STREP Oncolytic virus vectors for cancer virotherapy (especially oriented towards involvement of SMEs) STREP 1.21.1

17. EU RTD + FP6 - 17 - Japan: 3.0 USA: 2.7 EU-15: 1.9 Total R+D expenditure Total expenditure on R+D (in % of GDP)

18. EU RTD + FP6 - 18 - Source: HM Treasury

19. EU RTD + FP6 - 19 - Public funding for health research GBAORD = Government buget appropiation or outlays on R+D; GUF = general university funds Source: EUROSTAT Distribution of GBAORD by socio-economic objective in % 2002

20. EU RTD + FP6 - 20 - Health expenses EU Source: OECD Health Data 2003

21. EU RTD + FP6 - 21 - What research for health? The “health research value chain”: l Basic research l Translational research l Clinical research l Outcomes research l Health systems research

22. EU RTD + FP6 - 22 - A New European Research Strategy Joint effort by EU and member states to address structural deficits of European Research Establish critical mass! ↑ R+D to 3% of GDP! Strengthen “public-private partnerships! Promote innovation! Fragmentation Under-resourcing Unfavourable environment for research and innovation

23. EU RTD + FP6 - 23 - Japan: 3.0 USA: 2.7 EU-15: 1.9 Total R+D expenditure Total expenditure on R+D (in % of GDP)

24. EU RTD + FP6 - 24 - Source: HM Treasury

25. EU RTD + FP6 - 25 - Public funding for health research GBAORD = Government buget appropiation or outlays on R+D; GUF = general university funds Source: EUROSTAT Distribution of GBAORD by socio-economic objective in % 2002

26. EU RTD + FP6 - 26 - Health expenses EU Source: OECD Health Data 2003

27. EU RTD + FP6 - 27 - What research for health? The “health research value chain”: l Basic research l Translational research l Clinical research l Outcomes research l Health systems research

28. EU RTD + FP6 - 28 - Need for Clinical Trials l Only mean to validate in the clinical context the effectiveness of new drugs or other treatments, procedures, preventive approaches, etc l Normally performed by industry, but influenced by market possibilities l Lack of investment on drugs for orphan diseases (small n° of patients), vaccines, poverty-related diseases, non-patent protected drugs, non-drug treatments (surgery, radiation, etc), non-profit academic clinical trials l Difficulties with EU Pharmaceutical legislation (EU Directive for clinical trials)

29. EU RTD + FP6 - 29 - Impact of research – potential for cost savings

30. EU RTD + FP6 - 30 - Impact of research – potential for cost savings N Engl J Med 2001;344:817-23 Introduction of HAART (highly active anti- retroviral treatment)

31. EU RTD + FP6 - 31 - Clinical research (costs) Lancet, 2002

32. EU RTD + FP6 - 32 - A New European Research Strategy Joint effort by EU and member states to address structural deficits of European Research Establish critical mass! ↑ R+D to 3% of GDP! Strengthen “public-private partnerships! Promote innovation! Fragmentation Under-resourcing Unfavourable environment for research and innovation

33. EU RTD + FP6 - 33 - Japan: 3.0 USA: 2.7 EU-15: 1.9 Total R+D expenditure Total expenditure on R+D (in % of GDP)

34. EU RTD + FP6 - 34 - Source: HM Treasury

35. EU RTD + FP6 - 35 - Public funding for health research GBAORD = Government buget appropiation or outlays on R+D; GUF = general university funds Source: EUROSTAT Distribution of GBAORD by socio-economic objective in % 2002

36. EU RTD + FP6 - 36 - Health expenses EU Source: OECD Health Data 2003

37. EU RTD + FP6 - 37 - What research for health? The “health research value chain”: l Basic research l Translational research l Clinical research l Outcomes research l Health systems research

38. EU RTD + FP6 - 38 - Impact of research – potential for cost savings

39. EU RTD + FP6 - 39 - Impact of research – potential for cost savings N Engl J Med 2001;344:817-23 Introduction of HAART (highly active anti- retroviral treatment)

40. EU RTD + FP6 - 40 - Clinical research (costs) Lancet, 2002

41. EU RTD + FP6 - 41 - Total public R+D funding GBAORD = Government buget appropiation or outlays on R+D PPS= Purchasing power standards

42. EU RTD + FP6 - 42 - Total public R+D funding

43. EU RTD + FP6 - 43 - Pharma research

44. EU RTD + FP6 - 44 - Pharma research

45. EU RTD + FP6 - 45 - Cancer Research in FP6 Example: TRANSBIG l Project Type: l Project Type:Network of Excellence l Project title: l Project title:TRANS-BIG - Translating molecular knowledge into early breast cancer management: building on the BIG network for improved treatment tailoring l Coordinator: l Coordinator: Dr. M. Piccart-Gebhart (Institut Jules Bordet, Brussels/BE) l Total budget: l Total budget: 24 m € l EU contribution: l EU contribution: 7 m € l N° of partners: l N° of partners:39 partners l N° of countries: l N° of countries: 21 countries