conect4children (c4c) lift-off!
The members of the “conect4children” (c4c) initiative have announced the start of a large collaborative initiative to create a paediatric network that will generate a sustainable infrastructure to optimize the delivery of clinical trials in children. The c4c consortium aims to enhance the competitiveness of Europe as a critical region for developing medicines for children 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.
The consortium heralds a novel collaboration between academic and private sectors that includes 33 academic and 10 industry partners from 20 European countries, more than 50 third parties and around 500 affiliated partners.
The six-year project is a pioneering opportunity to build capacity for the management of multinational paediatric clinical trials across Europe whilst ensuring the voices of children, young people and their families are heard. Strong links with regulators will be established.
Key goals and potential challenges
One of the key goals of the project is to support the use of innovative trial designs and new quantitative methods to foster development of new medicines and to support development in rare paediatric diseases and high medical need areas.
Having said that, there are many scientific and operational challenges faced by both pharmaceutical companies and academia when it comes to running paediatric clinical trials. In the words of Prof. Carlo Giaquinto of Fondazione PENTA Onlus and University of Padova, who coordinates the project: “c4c will address critical problems with the design, implementation and operational conduct of paediatric clinical trials, such as fragmented and redundant efforts between sponsors, sites and countries; the paucity of patients available for study in many paediatric indications and the need for multiple capable sites and expertise to make trials successful.”
The key element for ensuring the c4c project’s success is the synergy between public and private institutions, united in order to meet the specific needs of paediatric patients and their right to better medicines.
“Children must have access to innovative medical therapies that have been developed with the same degree of urgency and rigor as those for adults,” said Joanne Waldstreicher, MD, Chief Medical Officer, Johnson & Johnson. “With conect4children in Europe joining in this effort, complementing work under way with I-ACT for Children in the United States, we will be able to accelerate the availability of high quality scientific data that can improve the safe and effective use of therapies in children."
Dr. Mark Turner, Co-coordinator of the project, University of Liverpool, stated: “This network will have a significant impact on how we develop much-needed innovative and improved medicines for babies, children and young people. A number of collaborations built up over the past decade will contribute to this pan-European research network. The University of Liverpool is proud to be collaborating with institutions and research networks across Europe”.
The Bayer headquarters in Berlin recently played host to the hugely successful c4c Kick-off Meeting (23rd – 25th May). Among the 160+ attendees were the representatives from EMA, IMI and i-ACT, as well as the 43 partners. The energy and collaborative spirit of everyone involved made for a memorable and, above all, fruitful event. This meeting certainly bodes well for the c4c team moving forward over the coming months and years.
With a budget of about €140m (IMI2 support of €67m and industry partners’ in-kind contribution of €73m), c4c is one of the biggest initiatives funded by the Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU) under grant agreement n º 777389. The Innovative Medicines Initiative 2 Joint Undertaking is Europe’s biggest Public Private Partnership and is funded jointly by the European Union´s Horizon 2020 research and innovation programme and the European pharmaceutical industry (represented by EFPIA, the European Federation of Pharmaceutical Industries and Associations).