The DEEP Project, coordinated by the Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF), was presented on the 2nd of October, 2014, during the seventh edition of the Foresight Training Course, organised by the Gianni Benzi Pharmacological Research Foundation (FGB). The initiative was part of the European Projects Forum “Nex-t-work” (October 2-4, 2014), a forum aimed at networking and developing international relations with the various players of the EU grant-funded projects in order to share best practices.
The ‘Foresight Training Courses’ (FTCs) are short intensive courses devoted to create a critical mass of expertise in the different areas of Regulatory Sciences (medical devices, foods, medicinal products), with particular reference to the innovative advancement of the European Pharmaceutical and Biological products sectors. The meeting was the occasion to present DEEP with its achievements and results, and to focus the attention of the audience on congenital haemoglobinopathies, the most common congenital rare diseases in the world.
The importance of an international network and the innovative nature of the project have been highlighted by Dr. Donato Bonifazi, Project Manager of DEEP and CEO of CVBF: “DEEP belongs to the small number of ‘investigator-driven’ paediatric clinical trials; a study based on a recognised ‘therapeutic need’ and sponsored by a research group that will lead to the collection of information intended for regulatory purposes; a multi-ethnic Network in which the complexity of conducting paediatric clinical trials has to take into account the existing rules at European and non-European level. The biggest challenge of the project is to perform its clinical trials in accordance with the European ethical requirements for studies involving the paediatric population”.
The experience of Policlinico of Bari, as Coordinating Centre of the DEEP-1 Clinical Trial and host of the Drug Management Service for all Italian recruiting centres, was presented by Dr. Bonifazi, with particular reference to its key-role in performing management and clinical activities. The innovative role and tasks of the Hospital Pharmacy of the General Hospital of Bari were described by Director Dr. Lattarulo.
“The pharmacokinetic study allowed us to identify the optimal dose of deferiprone for children under 6 years and ongoing studies will provide us with important additional information on the efficacy and safety of this drug in pediatric patients,” stated Dr. Giovanni Carlo Del Vecchio, Unit of Paediatrics, while Mr. Sebastian Botzenhardt University Hospital Erlangen (Germany) provided updates on DEEP-3.
The meeting provided an opportunity to present DEEP, a European project specifically designed for children and aimed to better define the safety, the tolerability and the efficacy of this drug in order to make its anticipated therapeutic benefits available to the entire paediatric population.
In this occasion, the project poster was distributed among participants and exposed during the whole course. The full programme of the DEEP meeting and the list of speakers are available here. Here you can also download all the presentations of the speakers.
For further information on all the scientific events, please refer to the brochure of the VII Foresight Training Course, that can be browsed even through mobile devices.