Bottlenecks

There are several pre-competitive barriers or bottlenecks in the discovery and development of new medicines for patients as identified in the Innovative Medicines Initiative (IMI) Strategic Research Agenda (SRA).

The greatest need in biopharmaceutical research and development is to predict lack of efficacy and to anticipate safety concerns of new medicines at the earliest possible stage. This requires the fine tuning of: discovery research; preclinical development; translational medicine; clinical development and pharmacovigilance. The radically novel initiative proposed by IMI is to co-ordinate these areas by linking the four pillars of research and development:

• Improved prediction of efficacy evaluation
• Improved prediction of safety evaluation
• Knowledge management
• Education and training

The interdependency of these four pillars not only requires cross-bridging of multiple contributing disciplines but also iterative exchange between pre-clinical and clinical developments. Failure of the latter has likely been one of the major reasons for the present hold-up in biopharmaceutical innovation and development. The novelty promoted by IMI is to link the following key steps in this process:

• Predictive pharmacology and toxicology
• Identification of predictive biomarkers
• Patient studies
• Validation of biomarkers
• Benefit/risk assessment

The U-BIOPRED project addresses these demands from the IMI SRA (see section 2.3) and follows this concept for the ‘Understanding Severe Asthma’ call.