Experimental Medicine Network
ECNP is supporting an initiative to build a European wide consortium of academic centres to develop, validate and maintain state of the art human experimental medicine models to support the discovery and development of new drug treatments in psychiatry. It is increasingly recognised that the introduction of experimental and translational medicine models at the interface between Phase 1 and Phase 2 clinical trials will be crucial for future success in psychiatric drug development. Experimental medicine studies are essential to bridge the gap between animal and human studies and to mitigate and manage the risk in this particularly difficult area of drug development. While this strategy commands a broad consensus, the tactics to enable its development are in their infancy. Expertise in experimental medicine resides largely in clinical academic centres that have access to volunteers, patients and the technology to develop such models. Our proposal is to initiate a coordinated effort across academia and industry by establishing an ECNP led consortium to develop, validate and maintain new human experimental medicine models in psychiatry and by building a network of European Centres with complimentary expertise.
Initially the experimental medicine network will be focus on establishing networks to support the development of experimental medicine methods in schizophrenia, depression, anxiety and cognition proposed by the academic members of the network and synopses and final protocols will be developed in collaboration with the pharma colleagues. The studies will then executed by the academic groups led by their Chief Investigators. Project management, quality control and the communication of results will be will be supported by professional CROs to ensure the studies meet or exceed high academic and industry standards and timelines. It is anticipated that once the experimental medicine models are established they will be made available to industry to evaluate the efficacy of NCEs.
Finally SMEs are currently being encouraged to lead FP7 initiatives in human experimental medicine. The aim of these initiatives is to bring together university groups with new methods and tools with SMEs who have the expertise to develop these into services and products that will ultimately be revenue generating for the EU. Combining strong academic groups working together with SMEs and Pharma is likely to have appeal for European funding organisations. Our aim is to request EU funding to support the initial networks in 2014 and to secure further funding from Horizon 2020 to support the studies undertaken.