This year the Scientific Open Meeting will  take its cue from the advancement in paediatric clinical research to address patients needs and will entail the following two thematic sessions:

 –          Challenges And Opportunities Of Conducting Clinical Trials In Paediatrics

–          Management Of Thalassaemia And Haemoglobinopathies: An Ongoing Challenge

The Open Meeting will be the occasion to raise the attention on the progresses achieved by the clinical research and the challenges to be faced in conducting clinical trials in paediatrics, also highlighting the importance of the international cooperation through European Networks and the global initiatives to create synergies and foster clinical research. The second session will be more focused on the new pathways and therapeutic strategies for the management of thalassaemia and haemoglobinopathies and will also be the occasion to talk about the goals of the DEEP project.

In particular, the Open Meeting will be the occasion to discuss these topics and challenges by different stakeholders points of views.

More details on the event and the final agenda are available here and through our social network channels (Facebook and Google+).

After the sad decision to cancel the General Assembly Meeting in Tunis, due to the disorders which have occurred across the country, the 7th DEEP General Assembly (GA) will take place in Padua (Italy) on April 13th -15th, 2016 with the participation of the whole DEEP Consortium as well as of external experts.

Here you can find the final agenda of the Meeting, which can be browsed even through mobile devices.

The meeting will be focused on a general update of the project’s activities, the progresses and achievements of the DEEP project as well as the finalization of the DEEP-2 and DEEP-3 studies, that are of utmost priority. Among others, the financial resources reallocation according to the recruitment performance at any involved centre will be discussed during the meeting.

In the same context of the GA meeting, the DEEP-2 Investigator Meeting and the 4th Open Meeting will take place.

In particular, the Scientific Open Meeting on April 15th, 2016 will entail two sessions:

   –  Challenges And Opportunities Of Conducting Clinical Trials In Paediatrics

   –  Management Of Thalassaemia And Haemoglobinopathies: An Ongoing Challenge

The Scientific Open Meeting will be the occasion to raise the attention on the progresses achieved by the clinical research and the challenges to be faced in conducting clinical trials in paediatrics, also highlighting the importance of the international cooperation through European Networks and the global initiatives to create synergies and foster clinical research. The second session will be more focused on the new pathways and therapeutic strategies for the management of thalassaemia and haemoglobinopathies and will also be the occasion to talk about the goals of the DEEP project.

More details on the event and the final agenda are available here and through our social network channels (Facebook and Google+).

Moreover, Dr. Giannuzzi highlighted how this lack of harmonisation makes more difficult the approach in case of studies involving non-EU Countries, as DEEP, and especially ‘small populations’, such as children and patients affected by rare diseases, which typically are multi-centre and multi-national.

More details on the event and the list of all submitted abstracts are available here.

The workshop, organised with the support of ApoPharma Inc., was mainly focused on the Iron chelation therapy and has foreseen two different physician breakouts, interactive sessions where participants were divided into two groups and rotated for a 45 minute case forum, with participants encouraged to bring their “own clinical cases” to discuss and share with the experts. The physician breakouts, respectively on “Strategies to improve iron chelation” and “Challenges in managing hepatic iron overload” were aimed to enhance the understanding of optimal patient management.

On that occasion, Prof. Antonis Kattamis, Assoc Prof of Pediatric Hematology-Oncology and Head of the Division of Pediatric Hematology-Oncology at ‘Aghia Sofia’ Children’s Hospital presented the three DEEP studies which include the whole paediatric population affected by Thalassemia Major and other chronic transfusion-dependent anaemia.

More details on the event and the related agenda are available here.

Donato Bonifazi, DEEP Project Manager presented the project in the context of the international paediatric trials that have to face a default level of complexity, due to regulatory, methodological, ethical and administrative issues, especially when they are registrative and international as DEEP is.

In particular, the specific challenges that DEEP has addressed and is still facing with reference to the recruitment and patient’s retention have been described, since DEEP is a ‘Registrative’ CTs with economic burden, ethical stringent provisions and GCP-ICHE11 obligations that involves not only a paediatric multi-ethnic population with different cultures, laws and children of different ages but also a rare and disperse population involving different Rare Congenital Anaemia.

Moreover, the DEEP multisteps strategy to address these issues has been presented, resulting from the following key aspects:

• the organisation of a ‘trials management plan and infrastructure’ including SOPs preparation, data management, drug management, pharmacovigilance, monitoring, etc;

• the implementation of a unique procedure and a unique CTA ‘package of documents’;

• the developments of a ‘patients tailored approach’ including children, families and association.

To conclude Donato Bonifazi updated on the patients’ recruitment that is currently proceeding successfully thanks to a continuous and coordinated activity of the TMT and the PIs and the continuous discussion of the Protocol-related issues among Principal Investigators, Trial Management Team and all the study key contacts that has led the inclusion of many new centres.

The event was also the occasion to discuss, in the framework of an international multi-stakeholders debate, the present and the future of the paediatric research including the efforts made by the scientific community and the ongoing projects such as the proposed Paediatric Research Infrastructures (EPCTRI) and the global networks.

The choice to select Tunis as venue for the next General Assembly comes from the willingness to raise awareness on the recruiting centres that are the backbone of the recruitment activities and to focus the attention on the Mediterranean region, in line with the Horizon 2020 strategy aimed at strengthening the cooperation with the Mediterranean area through the promotion of joint research projects in the health field in order to promote the development and the Mediterranean integrity itself.

The meeting will be the occasion to talk about the goals and the progress of the project and its contribution to improving of the clinical management of children with transfusion-dependent thalaessemia and other hemoglobinopathies who need chelation therapy.

Tunis will also be the venue to encouraging the project Partners to strengthen the efforts towards recruiting increasing number of patients in the DEEP-2 and DEEP-3 studies in order to ensure finalization of these clinical studies which are very important for the overall success of the DEEP project.

More details on the event and the related agenda will be soon available through our social network channels (Facebook and Google+).

The Scientific Conference was officially opened by the Chief Executive Officer of CVBF Albania, Donato Bonifazi, the Mayor, Fatos Tushe and the General Secretary of the “Associazione TALASSEMICI”, Mura Zenelaj.

The event was promoted by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF), Branch of Albania in collaboration with Università Cattolica “Nostra Signora del Buon Consiglio” of Tirana, a private university whose academic activities are implemented in collaboration with important Italian Universities (University of Bari “Aldo Moro”, University of Rome “Tor Vergata”, University of Milan, University of Bologna, University of Palermo, Catholic University of Milan).

On that occasion, the poster of the DEEP project was presented.

More details on the event and the related agenda are available here.

To download the presentations of the scientific conference:

– D. Bonifazi, Consorzio per Valutazioni Biologiche e Farmacologiche

– A. Zaka, Dita nderkombetare e luftes kunder Talasemise (in Albanian)

– A. Ceci, M. Kreka, Nuove terapie farmacologiche nella talassemia

– G. Adorno, La terapia trasfusionale nella talassemia

– F. Brancati, La genetica della talassemia

– N. Capodicasa, La donazione volontaria del sangue

DEEP-2 is, at today, the first paediatric clinical trial conducted in Albania; for this reason Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) in collaboration with University Hospital Center “Mother Teresa” (UHCT) has selected the city of Tirana as venue for the 3^rd edition of the DEEP Open Meeting.

The event represented the occasion to raise the attention on the progresses achieved by the clinical research in Albania and the importance of the European Networks to create synergies to spread excellence and attract European funding. The meeting was accredited by the Albanian National Centre of Continuing Education, QKEV (providing with 5 CME credits of Continuing Education for healthcare professionals) and was structured into 2 thematic sessions focused on the Clinical Research in Albania and Networks and Projects in a Global Context, respectively. All sessions were carried out in English, with simultaneous translation English/Albanian available.

The meeting was opened by Anila Godo, Professor of Paediatrics at University Hospital Center “Mother Teresa” and Head of Onco-Haematology Service (Tirana), Donato Bonifazi, CEO of Consorzio per Biologiche Valutazioni e Farmacologiche and Ogerta Manastirliu, General Director of University Hospital Center “Mother Teresa” of Tirana.

The main contents presented and discussed during the Open Meeting are summarized below.

SESSION I – Clinical Research in Albania

The first session of the Open Meeting represented an opportunity for both European and Albanian key opinion leaders and experts to share their experiences in the field of paediatric clinical research. This session was, indeed, an occasion to discuss about many topics related to the conduction of paediatric clinical trials such as the barriers that researchers encounter to the timely development of safe and efficacious medicines especially for children, the related need to set up infrastructures for each study in each site, the collaborative efforts in medicine and research.
In particular, it was stressed the importance of the international cooperation in the activities performed in clinical research as a way to encourage interdisciplinary participation in developing solutions through high-impact, mission-driven collaborations with leading health providers, governments and educational institutions. In this way, the identification of the essential profiles involved in the concrete conduction of clinical research will be supported by the sharing of an high-quality and effective know-how, starting from the basis up to high specialisations proficiency.

The theme of clinical research was also addressed in light of the recent release of the Albanian Law on Drugs and Pharmaceutical services (31st July, 2014), and with a particular focus on the role of Albanian Universities in supporting clinical research as well as the achievements and challenges of the Continuing Medical Education.

Among the various Albanian personalities who attended the meeting, Prof. G. Kuli-Lito on behalf of the University Hospital Center “Mother Teresa”; the General Director of Health Policy and Planning, G. Bejtja, on behalf of the Albanian Ministry of Health and E. Shehu, Director of National Center of Continuing Education of Tirana.

SESSION II – Networks and Projects in a Global Context

The second session of the DEEP Open Meeting was focused on the importance of the Networks and Projects in a global context and on their impact on clinical research in paediatrics.

Among the several initiatives described at European and global level to promote paediatric research and reduce the extent of the off-label use, a special focus was dedicated to the experience of the University Hospital Center “Mother Teresa” (UHCT) in two EU-funded projects, in which it is involved as partner: the DEEP (DEferiprone Evaluation in Paediatrics) project and in particular the DEEP-2 Study and the GAPP (GAbapentin in Paediatric Pain) project. The international activities promoted in the clinical research field and in collaboration with an international research consortium will, indeed, provide support for aligning Albanian standards and practices with those present in the European Union for establishing working procedures to make innovation feasible.

An important example of European collaboration was also provided by the proposal of a new European Research Infrastructure for Paediatric Clinical Trials (EPCT-RI), as a new instrument identified in the European Research Agenda with reference to facilities, resources and related services used by the scientific community to conduct top-level research in their respective field.

Here you can download all the presentations of the Open Meeting.

More details on the event and the related agenda are available here.

The main contents presented and discussed during the General Assembly meeting are summarized below.

Session I – Pharmacokinetic evaluations

The meeting opened with the presentation of the pharmacokinetic (PK) study results (DEEP-1 trial) in terms of study design, trial conduction, objectives and endpoints, the key features of a model-based approach, the comparison among existing PK data related to the administration of deferiprone and the role of the pharmacokinetic evaluation in the DEEP-2 study. Moreover, it was highlighted the step-by-step procedure and recommendations for the collection, handling and storage of the samples for the PK evaluation.

Session II – Statistics and economics

This session represented an overview of the statistical approach and handling of data applied within the DEEP-2 study as well as of the results obtained from the non inferiority assessment of deferiprone (DFP) in comparison with deferasirox (DFX). The pharmaco-economic study aimed to provide an Health Technology Assessment (HTA) evaluation on the use of deferiprone formulation in paediatrics, was also presented, with a focus on the preliminary results collected thanks to the on-going survey in 6 centres (1 Cyprus, 1 Greece, 2 Italy, 1 UK and 1 Germany). The ultimate goal is to predict how a change in the mix of drugs used to treat iron overload in the paediatric population will affect the expenditure on healthcare in different settings.

Sessions III / IV – Open Meeting

On the occasion of the 6th DEEP General Assembly, the 3rd Open Meeting was held in order to foster and highlight the potential of the clinical research in Albania and underline the importance of the involvement in Networks and projects in a global context, to create synergies to spread excellence and attract European funding.

Contents of the Open Meeting are summarised in the “Special focus Open Meeting“.

Session V – Ethics Board Meeting

This session gave the chance to discuss the difficulties encountered in the authorisation process of the DEEP project, due to the lack of harmonised procedures among European Countries and even more among European and non-EU Countries, highlighting the principle that European ethical and legal rules should prevail over regional or local issues.

Session VI – Investigator Meeting/DEEP-2 The Safety-Efficacy Trial

The session was focused on the study conduct and protocol implementation; practical aspects, such as planning initial and monthly visits according to the protocol and  monitoring safety and efficacy of study drugs, were addressed. Experience of many European and non-European recruiting centres for DEEP-2 (Italy, Greece, Cyprus, Egypt and Turkey) were presented with respect to the study conduct, number of patients currently screened and enrolled in the trial, the forthcoming recruitment and specific problems, such as the consent and the assent form to be signed in specific situations.

Session VII – DEEP-2 Emerging issues  

This session was focused on the open issues addressed and still to be dealt with, related to the study authorization and approval and the slowness of regulatory approval, the achievement of the study population size, Good Clinical Practice (GCP) and protocol compliance, as well as drug supply at the end of the trial. It was an important occasion to discuss about the state of the art of the DEEP-2 study and to present the new clinical sites included in the DEEP project in Morocco, Turkey and Lebanon to ensure the achievement of the study population size, and the consistency of the new patient recruitment plan with the expectation of patients to be enrolled (344) according to the Protocol.

Session VIII – DEEP-2 CRAs Training

Monitors involved in the DEEP-2 study was trained to perform a correct and standardized site visit report and to collect and transmit study documents, as part of monitoring activities to be performed at each clinical site. A specific session about critical issues raised during the monitoring activities and their correct handling was performed in order to guide monitors’ actions in specific critical situations. In particular, the session was the occasion to standardize the monitoring activities at each site involved in the study, in order to ensure high quality of clinical research and respect of patients’ rights and guarantee patients’ safety at the highest level.

Session IX – DEEP-3 Long-term safety study

The session opened with an overview of DEEP-3 study, including the patients distribution by centre and the detailed recruitment status. It was also highlighted the experience of the Paediatric Haematology of the Cairo University from the preliminary data screening to the approval pathway, the collection of data responding to the study inclusion criteria and the main challenges faced. In order to optimise the recruitment, it was proposed to include further two centres in Egypt which are already involved in DEEP-2 (Alexandria and Zagazig), to involve Turkish and Moroccan new sites  and to strengthen the recruitment efforts in Cyprus and Greece.

Session X – DEEP General Assembly

The status of the DEEP project in terms of deliverables, milestones, reports and budget as well as next steps and timelines was presented during the last session, in particular in light of the project review committed by the European Commission. The importance of the dissemination activities to raise awareness of the project, its activities and outcomes as well as to communicate results in peer-reviewed scientific journals and to lay media was also highlighted.

The meeting represented an excellent opportunity to foster fruitful scientific debates and networking, by providing a great opportunity for exchanging information, while discussing advancement in the work packages and partners’ involvement.

All the presentations of the 6^th General Assembly meeting can be downloaded from the dedicated page.

The “Nextwork” Forum represents a large-scale event where all project managers and dissemination leaders coming from EU Member States and the neighbouring States, can discuss about  European projects by sharing opinions and evaluations with stakeholders and other interested people, thus creating a benchmark of awareness, perception, opinion and action.

The theme of this edition event, was “Let’s cooperate for a new European Renaissance”, and was aimed at networking and developing international relations with the various players of the EU grant-funded projects in order to share best practices.

On that occasion,  the DEEP project has been presented by Donato Bonifazi, DEEP Project Manager,  in the “Project- Best practice presentations” session and a dedicated page on the project has been published on the Nextwork Forum official website and viewable at the following link.

Here you can download the presentation  of the DEEP project.

The initiative was an important occasion to showcase the DEEP project, share experiences at European level, create awareness among different audiences and develop international relations with the various protagonists of the EU grant-funded projects (academic and educational Institutions, universities, companies, Public Authorities, associations and research centres).

For further information on all the scientific events, please download the brochure of the event.