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  IMI topics of the second call for proposals
  
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  IMI: EMTRAIN Project
  
  IMI: SAFESCIMET Project
  
  IMI: Press release eTOX
  
  IMI: Eu2P Project
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Bayer Schering Pharma committed to efficient and safe drug development

The European pharmaceutical manufacturers’ association EFPIA and the European Commission launched the Innovative Medicines Initiative (IMI) in February 2008 with the aim of making the drug-development process more efficient and safer. Bayer Schering Pharma is involved in the projects and in the task of establishing the IMI organization. In addition, Professor Andreas Busch, the member of the Bayer Schering Pharma Management Board responsible for research, is helping to shape the work done by the Initiative in his role as a member of the Governing Board.

June 26, 2009:

With a budget of €2 billion, the IMI is the biggest collaboration between the public sector and industry (public-private partnership) in the field of medicine. Half of the budget stems from subsidies awarded by the European Commission, the other half is provided by EFPIA-affiliated companies in the form of non-financial contributions.

Objective: More reliability in the prediction of safety and efficacy of new drugs

Background IMI
The Innovative Medicines Initiative (IMI) was set up jointly in 2008 by the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA) to accelerate the research and development of new and better drugs in Europe through cooperation between the pharmaceutical industry, academic research, hospitals, regulatory authorities and patient organizations.

“Promising new substances often stumble over safety problems or lack of efficacy after many years of development and many millions of euros have been invested in them,” explains Dr. Matthias Gottwald, R&D Liaison Officer at Global Drug Discovery, who coordinates IMI-related activities at Bayer Schering Pharma. The IMI will promote the development of new methods and technologies to enable the safety and efficacy of new drugs to be predicted more reliably in the future.

“The IMI enables pharmaceutical companies and academic partners, small and medium-sized enterprises involved in fields such as biotechnology or software, patient-advocacy organizations and regulatory authorities to work together to address problems that an individual institution would not be able to solve on its own,” Gottwald explains.

Bayer Schering Pharma experts contribute to the IMI projects

Aims of IMI
The IMI's aim is to dismantle barriers to innovation in order to make the development of new therapies faster and more efficient. This is to be achieved by: by developing methods and technologies that more precisely predict the safety and efficacy of new active ingredients, by means of knowledge management, and by promoting advanced and further training. The IMI has been equipped with a research budget of €2 billion over a six-year period, half of which comes from the EU Commission and half from the pharmaceutical industry.

Aims of IMI

The IMI's aim is to dismantle barriers to innovation in order to make the development of new therapies faster and more efficient.
This is to be achieved by:

by developing methods and technologies that more precisely predict the safety and efficacy of new active ingredients,
by means of knowledge management, and
by promoting advanced and further training.

The IMI has been equipped with a research budget of €2 billion over a six-year period, half of which comes from the EU Commission and half from the pharmaceutical industry.

In May 2009, independent adjudicators picked a first selection of 15 projects focusing on safety prediction, greater understanding of the disease processes involved in diabetes, Alzheimer’s disease and asthma, and initial and continuing training to receive support from the IMI. Bayer Schering Pharma is involved in eight of these projects, six of which are being handled by Global Drug Discovery. The company’s contribution represents a value of €5.5 million.

The company is also currently supporting preparations for the second call for projects that will be launched in autumn 2009 and will focus on projects from the fields of oncology, infectious diseases, chronic inflammatory disorders and knowledge management. The IMI will issue calls for projects each year until 2013.

Bayer Schering Pharma is also participating in the establishment of the IMI organization in Brussels. BSP employees, their counterparts at other companies and the European Commission are jointly managing the Initiative’s operative business until the IMI recruits its own staff.

Bayer Schering Pharma contributes to eight projects of the Innovative Medicines Initiative (IMI) first call:

Safety:

Development of expert systems for in silico toxicity prediction / eTOX Expected outcome: toxicity database for pharmaceutical substances and a computer based system for the prediction of drug-induced toxicity and drug secondary pharmacology

Non-genotoxic carcinogenesis / MARCAR Expected outcome: proven reliable role of early biomarkers in prediction of cancer development

Qualification of translational safety biomarkers / SAFE-T Expected outcome: new specific and sensitive safety biomarkers and their respective assays for human sample for improved predictivity between non-clinical and early clinical studies
Strengthening the monitoring of the benefit/risk of medicines / PROTECT new methodologies in pharmacovigilance and pharmacoepidemiology

Education & Training:

European Medicines Research Training Network / EMTRAIN Expected outcome: a European biopharmaceutical research training platform providing a sustainable academia-industry cross-disciplinary approach to efficient organisation of training courses on emerging science and technologies across Europe.
Safety Sciences for Medicines Training Program / SAFESCIMET Expected outcome: training programme integrating all safety-relevant disciplines linking animal and human/patient safety data thereby facilitating a more holistic evaluation of new medicines.
Pharmaceutical Medicine Training Program / PHARMTRAIN Expected outcome: establish a network of academic centres that delivers postgraduate training programmes in pharmaceutical medicine including quality management of the processes and outcomes.
Pharmacovigilance Training Program / EU2P Expected outcome: pan-European training and education network platform in Pharmacovigilance and pharmacoepidemiology to train professionals for the pharmaceutical industry and regulatory authorities, healthcare organisations members and experts for the further development of the academic centres to improve the understanding and effectiveness of risk communication.