Time to reopen discussion on a more collaborative ethics committee assessment – perhaps cross-border?

IMI (Innovative Medicines Initiative) logo

Interested in joining a consortium to work on this exciting topic? A couple of tips on why and how to engage…

Patients are demanding faster access to new medicines and the regulatory environment is lagging behind evolving science. Conventional R&D models are no longer financially viable and have become a major hurdle to efficient drug development, while general response rates to modern medicines are not satisfactory. A more flexible pathway would not only accelerate patient access to crucial therapies but would also increase their probability of success as the therapies would be given to those patients most likely to respond. The cost for both industry and healthcare providers could also significantly decrease. However, a pre-requisite for the success of the implementation of adaptive pathways lies in the full and common understanding of its value, not just for industry, but across the entire innovation life cycle: for regulators, HTAs, payers, governments, clinicians and, most importantly, patients. (see more at:

IMI decided to address this challenge under IMI 2 and launched a call for coordination and support action (CSA) to bring together relevant stakeholders from the public and private sectors under a neutral collaborative framework. IMI’s aim is to foster discussion and coordinate scientific activities to progress innovative, pragmatic and viable solutions required to implement MAPPs within the current pharmaceutical legislation. (see more at:

The deadline for joining a consortium to submit a proposal is just around the corner – 11 February 2015. Still achievable:

Magda Chlebus

Magda Chlebus, Executive Director of Science Policy & Regulatory Affairs at the European Federation of Pharmaceutical...
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