1. IMI Comments on SRA (version July 2005) MSCG meeting 20 March 2006 Bernd Rainer

2. Concerted Feedback/Input on SRA received from: Austria, Denmark, France, Germany, Hungary, Ireland, The Netherlands, Poland, Sweden, UK, Romania, Turkey, Norway.

3. Additional input on SRA from: EMEA - CHMP - COMP In-vitro-Technology Industrial Platform (IVTIP) European Federation of Pharmaceutical Sciences (EUFEPS) ClinPharm Int. GmbH (CRO) Univ. Bologna

4. Overall feedback: very positive France: “INSERM and its academic partners.. are strongly supportive of this initiative.” Ireland: “The initiative is worthwhile and sound.” The Netherlands: “….in general we welcome this initiative.” Norway: “An ambitious research agenda which addresses important topics with well coordinated plans” “Sweden has a strong potential to contribute to the realisation of PPPs, as the initiative suggests.” “UK enthusiastically supports IMI's priorities and is delighted that they have been agreed across a wide group of stakeholders.“ EMEA-CHMP: “The document is ambitious and most of the points well taken.”

5. Safety Reinforce Clinical safety and include Pharmacovigilance as tasks for ECDS - More specific name for ECDS as it is to deal with research - Clarify role and activities of the European Centre for Drug Safety (ECDS) - Interaction of ECDS with the European Centre for Validation of Alternative Methods (ECVAM) - Close link between ECDS and EMEA necessary - Include recommendations of the European Risk Management Strategy (ERMS) - Standardised Bio-banks - Mention CHMP guideline on Microdosing - Clinical databases and pharmaco-epidemiological studies SMEs active in safety research need to be involved Create links/involve running European Research projects Liaise with Nanomedicines TP Research on Biomarkers should be a core activity.

6. Efficacy Add. Therapeutic area/model diseases: Infectious Diseases - resistance to antibiotics - pandemic influenza; include prevention/vaccines - rare diseases Extend scope of diseases: Inflammatory: Auto-immune metabolic diseases with high prevalence, Sepsis/septic shock, liver fibrosis. Diabetes: Cardiovascular diseases, obesity Brain diseases: rename CNS disorders Link/interaction with ICTRP (Clinical Trials Registry Platform) Further specification of proposed research approaches Emphasise research on Biomarkers for identification of responders and non-responders; validation of biomarkers is key element Create links/involve running European Research projects

7. Knowledge Management Make whole chapter more comprehensible More focus on project support (too much emphasis on IT) - Predictive Modelling of disease - Systems Biology should receive more attention - Health Technology Assessment (HTA) should be considered - Role of regulators in data sharing Consultation process to address the most promising themes - only by industry itself (without public ressources)?

8. Education & Training Facilitate mobility between academia, industry and regulators EMRA should also address accreditation of curricula and courses Need for Safety scientists (link to Safety) Communication should be added to E&T Avoid duplication of existing programmes (like Marie-Curie) Questioning the need for pharmaceutical medicine as a separate discipline Integrative training is key to ensure overall understanding of in vivo physiology.

9. Other comments Incorporation of relevant EC funded projects and networks; IPR issues need to be addressed and clarified; define legal, ethical and other conditions for pre-competitive data-sharing. Communication and PR should be a strategic tool in implementation Pharmaceutical Engineering/manufacturing process of drugs; Stronger Involvement of SMEs; Personalised medicines/pharmacogenomics/genetic markers More emphasis should be put on prevention Integration of national networks and learned societies; Infrastructures for different activities (clinical databases, monitoring facilities, etc.) of transversal nature allowing for extension to other disease areas Timeframe seems too short to achieve goal of improving competitiveness of industry. Clarify relation with EMEA roadmap. Reinforce involvement of financial world