Representatives from all the DEEP Consortia gathered together in the Project General Assembly and Scientific Meeting that took place in Athens on July 3rd-5th2014. This event confirmed the positive outcomes of the DEEP project, that will grant soon paediatric patients with chronic iron overload an oral liquid formulation of the chelating agent deferiprone.
DEEP General Assembly was opened with the presentation of the successful results of the pharmacokinetic study of deferiprone (DEEP-1) and the implications for DEEP-2 study. The discussion moved on the issues related to the safety-efficacy trial DEEP-2, that is starting the recruitment phase. A very productive debate brought to an update on clinical, managerial, technical and regulatory implications of the trial.
The second day of the meeting was firstly dedicated to the long-term observational study of deferiprone (DEEP-3) with the presentation of preliminary results and the proposal of new strategies to overcome criticisms in the recruitment phase. Secondly, pharmacoeconomic and regulatory issues of the DEEP project were presented, with an analysis on deferiprone market and budget impact and a clear overview of the contents and timelines of the amendments to the Paediatric Investigation Plan.
Subsequently, an update on dissemination and communication activities was provided. The day concluded with some general issues concerning the budget and the general management of the project that were agreed with all participants.
The Scientific Meeting was opened with an overview of the new regulatory framework for European clinical trials and its implication for paediatric studies. Afterwards, main funding initiatives dedicated to drugs for children were outlined, together with possible points of strengths and weakness.
Important clinical issues were also discussed, with the presentation of the main aspects of Deferiprone therapy, either alone or in combined regimen, the management of iron overload in Sickle Cell Disease, the importance of Magnetic Resonance Imaging analysis and the new drugs for HepatitisC virus Infection treatment.
For further information on the DEEP project, visit the website and consult the periodic newsletters.