IMIComments on SRA (version July 2005)

MSCG meeting

20 March 2006

Bernd Rainer

Concerted Feedback/Input on SRA received from:

• Austria, Denmark, France, Germany, Hungary, Ireland, The Netherlands, Poland, Sweden, UK, Romania, Turkey, Norway.

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

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.”

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.

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, obesityBrain 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

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)?

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.

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