Initial Review Report On Imi Projects – WP1 Final Report
D1.02 aimed to analyse and monitor IMI and non IMI project outputs, and to perform a gap analysis of the wealth of evidence generation in the context of MAPPs. In other words, tools and methods developed by IMI and other EU projects, which could benefit MAPPs have to be identified. To this effect, a two-phase process was identified.
We first focused on mature IMI projects and according to pre-specified criteria, we selected those worth an in-depth analysis. Of the 60 IMI projects available when Phase 1 review was started, 32 were judged eligible for an in-depth review. The remaining were either put on hold pending further research, or rejected as judged not mature enough or not relevant to MAPPs. An in-depth analysis of projects’ outputs was then performed according to a predefined methodology by experts in CMC, preclinical, clinical and drug access linked to real-world data, regrouped in four different workstreams. Final review and consolidated analysis was subsequently performed by the experts who performed the initial project selection.
This report summarises the findings of the initial review of IMI projects completed so far, together with a preliminary gap analysis. Several IMI outputs have been identified that could contribute the MAPPs agenda, although most of them would require some further work in order to be fully implemented in drug development, e.g. a specific/cluster of biomarkers to identify a safety issue or a target patient population.
The plan is to update this report including the gap analysis, as soon as the review of EU non IMI projects is completed, and to revisit the review of IMI projects to include projects that were initially put on hold. Final gap analysis should be completed together with proposed recommendations before end of 2017, when the project will be terminated.