c4c (conect4children) is a large collaborative European network that aims to facilitate the development of new drugs and other therapies for the entire paediatric population. In this sense, the voices of children, young people and their families are a pivotal part of the innovative approach of c4c project. It places patients at the centre and will assign them an active role in the development of the different clinical trials that are going to be conducted during this project. For this reason, and in order to guarantee patients’ involvement in all the activities of the project, c4c has setup a database to gather information on patients, caregivers, patients organizations and/or YPAGs (Young Person’s advisory boards) of rare/paediatric diseases (specially Kawasaki disease, Cystic Fibrosis, Osteogenesis Imperfecta and Patient Ductus arteriosus in neonates). If you wish (or know someone who could wish) to be part of the c4c pool of expert patients, you can find out more by following the instructions here!
In the framework of the “conect4children” (collaborative network for European clinical trials for children – c4c) project, the first National Hub F2F meeting will take place in Amsterdam on 25 and 26 September. In particular, a Training Day is foreseen on 25 September, focused on network procedure s and how to work together in a consistent way. For this Training Day only, NHs will be invited to include up a maximum of 5 team members for wider dissemination of the training. c4c is a large collaborative European network that aims to enhance the competitiveness of Europe as a critical region for developing medicines for child ren by using existing expertise, patient access and developing common processes to be applied to disease natural history studies, registries, studies of new therapies and comparisons of existing therapies. c4c has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777389. The Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. More information are available here.
39th National Congress of SIF – 20-23 November 2019. The achievements of DIVA project will be presented
In the framework of the DIVA (Innovative devices for the prevention of recurrent vaginites) project, the abstract "Innovative approach to recurrent vaginitis" has been accepted for poster presentation at the 39th National Congress of SIF (Società Italiana di Farmacologia) that will take place in Florence on 20-23 November 2019. CVBF is partner in DIVA, a project aimed to develop a specific treatment for vaginitis relapsing with the aim of reducing the antibiotic-therapy. DIVA project intends to develop an innovative treatment specific for recurrent vaginitis with the aim to reduce the use of the antibiotic therapy. In particular, this objective is acquired through the development of: A food enriched with probiotic lactobacilli with antimicrobial activity and dietary fibres; Device / cosmetic with bacteriostatic and fungicidal action derived from plant products; Sanitary towels functionalized with bacteria and fungicidal extracts derived from plant products; Further details on DIVA project are available at this link.
SAVE THE DATE: EUCROF Training Day on “Essentials of Paediatric Clinical Research”, 24 October 2019 in Madrid, Spain
On 24 October 2019, EUCROF Paediatric Working Group will organise a F2F training on “Essentials of paediatric clinical research” that will take place at the Centro Nacional de Invesigaciones Oncológicas in Madrid. Donato Bonifazi, CEO of CVBF, and member of the EUCROF Paediatric Working Group, will take part in the workshop as speaker, along with several experts who will illustrate what it is needed to know when preparing, conducting and monitoring paediatric clinical trials. The training intends to provide an overview of the regulatory landscape for paediatric clinical research, ethical and regulatory issues, specific protocol considerations, informed consent and assent processes as well as site interactions, relationships with paediatric research networks and infrastructures. You are still on time for registering to this event! For registration and more information about the agenda and speakers, visit the EUCROF website here.
The 4th EPTRI General Assembly Meeting will be held on 21 and 22 October 2019 in Warsaw hosted by the Ministry of Health and organised in collaboration with the Polish partner, the Children Memorial Institutel. EPTRI is aimed to design a new paediatric Research Infrastructure, intended to accelerate paediatric drug development including most relevant technological innovations in research for children’s health. The meeting will represent the occasion to discuss the challenges of the future EPTRI’s work and the sustainability of the new infrastructure as well as the assessment of feasibility studies foreseen within the project and aimed to test the process, the scientific interest, the availability of requested services and facilities needed to conduct highly innovative paediatric research. More information about the project and the agenda are available at this link.
Even this year the Europe Biobank Week (EBW) will take place to provide a platform to discuss current issues and future perspectives in the biobanking field. The EBW 2019 edition will take place in Lübeck, Germany, from October 8 until 11. CVBF will participate to the Conference, by presenting two posters. The first one is entitled "How a new European Paediatric Translational Research Infrastructure (EPTRI) could support personalised medicine in children" and will be presented on behalf of the EPTRI (European Paediatric Translational Research Infrastructure) Consortium. A second poster, entitled “#wecare_ye project: a new EU initiative to promote the paediatric patients engagement" will show the work carried out in the framework of #wecare_ye, a project coordinated by CVBF and aimed to create four new Young Persons Advisory Groups (YPAGs) in Romania, Czech Republic, Greece and Belgium. For more details about the EBW, please click here.
On 2-4 October 2019 Bambino Gesù Children’s Hospital in partnership with the International Society of Pediatric Innovation (iSPI) will organise the Conference “Shaping the Future of Paediatrics” at Centro Congressi Piazza di Spagna in Rome. The Conference will feature demo sessions on innovation in paediatrics and speeches about 5 main topics: Advances in clinical paediatrics and precision medicine Artificial Intelligence in the clinic Building the hospital of the future Digital therapies and digital communication for paediatrics Start-up pitch for paediatrics One of the most engaging items will be the Manifesto Fostering Innovation in Pediatrics, aimed to favour the establishment of an ecosystem for innovation in paediatrics, that we be presented at the beginning of the conference. Also CVBF, represented by the CEO Donato Bonifazi, and the Coordinator of the Training and Advocacy Area, Mariangela Lupo, will participate in the Conference, providing their contribution on the session “Innovation Created by Young Patients and Families”, that will take place on 3th October. The session will represent a panel to connect with young patients and their families and to give voice to paediatric patients and caregivers in health care innovation. At this link it is possible to register. The agenda of the meeting is available here.
On 24-26 September 2019, the European research and innovation days will take place in Brussels and will welcome researchers, scientists, innovators and policy makers. The event will be web streamed and will cover fundamental areas of science, engineering, medicine and wider social and environmental concerns. It will feature three main elements: a high-level Policy Conference, the Innovative Europe Hub and the ‘Science is Wonderful’ exhibition of EU-funded projects. European Research and Innovation Days is the first annual policy event of the European Commission, bringing together stakeholders to debate and shape the future research and innovation landscape. For more information, please click here.
On September 17-18, 2019, the first General Assembly of EJP RD will take place in Gdansk, Poland. The General Assembly will be twinned to the workshop “Rare disease perspectives in Central – Eastern Europe”. The European Joint Programme on Rare Diseases (EJPRD) is a Co-fund action aimed to create a comprehensive, sustainable system allowing virtuous circle between research, care and medical innovation. The Assembly will represent an occasion to share the concrete strategies and the future activities to be carried out to strengthen and join the efforts in the field of Rare Diseases research. The project sees the participation of CVBF in particular in the work package 19 that supports the Rare Diseases (RD) community to more effectively translate high quality research into high impact interventions for the RD patient community, by creating a bridge between basic research and medical innovation, known as the “bench to bed-side” approach. Moreover, CVBF is involved in the evaluation of the quality of the EJP RD activities and the achievement of the expected project goals within the Coordination and Management Work Package. Further details are available on the official EJP RD official web page.
We are pleased to inform you that the n.46 of “Quaderni della SIF”, the journal edited by the Italian Pharmacology Society, has been published and includes the article “The off-label use in paediatrics”. The authors of the article, Viviana Giannuzzi (Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus) and Kejla Musaraj (Consorzio per Valutazioni Biologiche e Farmacologiche) have highlighted the importance of this theme, underlining that in the hospital environment, approximately 13-69% of paediatric prescriptions are off-label, while for not hospitalized patients the off-label use reaches at 100%, as indicated in the Report of the European Commission of 2017. Nevertheless, paediatric drugs need studies that confirm effectiveness, safety and quality on children specifically, as reported in the European Pediatric Regulation and it is necessary a wide discussion to overcome the difficulties in terms of methods, ethical and economic matters. The full article is available at this link.