Health-related Research Infrastructures and their Contribution to the EU s Grand Challenges. European Parliament 26 th October 2010 ERINHA

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1 Health-related Research Infrastructures and their Contribution to the EU s Grand Challenges European Parliament 26 th October 2010 ERINHA European Research Infrastructure on highly Pathogenic Agents Coordinator H. Raoul Website:

2 Global objective To strengthen the EU capacities in the fields of diagnosis and study of highly pathogenic infectious micro-organisms through the creation of a European BSL4 infrastructure (distributed infrastructure)

3 Context for the initiation of ERINHA Emergence et re-emergence of highly pathogenic micro organisms (Nipah, H5N1, CCHF, BT ) Fighting bioterrorism (all BSL4 pathogens listed) Restricted BSL4 capacities in EU Restricted number of experts in this field and all focused on virology Restricted/No access for some EU scientists and industrials No coordination of the related activities Evolution of the regulation and creation of new standards

4 5 main actions To create a coordination and governance body at the EU scale (avoid redundancy; optimize use of capacity) To upgrade some existing BSL4 laboratories and to built new areas (comply with regulation & standard; increase capacity) To harmonize procedures and protocols (comply with regulation & standard; ensure interoperability) To built program access for all (public & private, at European and international level) To built support infrastructure

5 Activities covered and Services provided Activities Diagnosis Research (to develop diagnosis tools, therapeutic and prophylactic means and ranking from academic to finalized) Services Biosafety and biosecurity Maintenance Training Experimentation Scientific support Management of collection Access to biological resources

6 Main impacts foreseen Provide a better protection of the population in front of infectious diseases related to highly pathogenic microorganisms Increase and strengthen the European scientific community Avoid anarchic proliferation of sensitive infrastructures Lead to creation of new private companies Increase EU competitiveness in the field of infectious diseases in the public and private sectors

7 Specific challenges Building of BSL4 area is very costly and needs very specific expertise Maintenance is also costly and can not be neglected to ensure proper protection of workers and environment To European issues European responds are needed

8 Interaction with other Health-related RI The 10 BMS RIs comprise complementary facilities, technologies and knowledge. The synergies of the BMS RIs will deliver important added value.

9 Interaction with other Health-related RI BBMRI Clinical development phase Approval phase Early-stage research and discovery Preclinical studies in animal models Phase I: safety; healthy individuals Phase II: efficacy, safety; patients Phase III: efficacy, safety; patients FDA review and approval Phase IV: long-term effects; post-market surveillance ERINHA ECRIN ~ 1-2 years ~ 1-2 years ~ 2-3 years ~ 1-2 years

10 Health-related Research Infrastructures and their Contribution to the EU s Grand Challenges European Parliament 26th October 2010 Thank you for your attention ERINHA European Research Infrastructure on highly Pathogenic Agents Coordinator H. Raoul Website: