After two years of virtual meetings, as the c4c Project Leadership Team, we were pleased to see so many c4c Beneficiaries in person at the General Assembly in June in Ghent. It was a beautiful setting and the Belgium National Hub team made us all welcome.

As 2022 draws to a close, we would like to reflect on the continued progress that c4c has made. With the help of a Dutch legal firm, we are now focussing our attention on establishing the New Legal Entity (NLE) in mid-2023 to be followed by the transition of initial c4c services to the NLE by the end of 2023. This will allow a period where the c4c project will run in parallel to the NLE allowing a seamless transition.

To make our dream happen we will need the input and the support of c4c Beneficiaries to decide how the management structure of the NLE will finally look and how we can transfer the activities created under Innovative Medicines Initiative (IMI) to the NLE in the most successful and efficient way.

As well as the work on the NLE all c4c work packages have made good progress this year.

The first Business Plan for the NLE has been developed using very valuable feedback from all of our different customers and stakeholder groups.

The Strategic Feasibility Advice Service has received 40 advice requests to date, 26 of which have been completed. The expert database was expanded in 2022 and now includes more than 400 experts.

A 2nd c4c Multistakeholder Meeting (MSM) was held virtually in February, on Atopic Dermatitis. This was well-attended, and a particular highlight was a young adolescent patient giving her account of living with the persistent itch of atopic dermatitis. A 3rd MSM (hybrid meeting) is planned for February 2023 on Type 1 diabetes and medical devices, the day before the Advanced Technologies and Treatments for Diabetes conference in Berlin.

Two of the original four industry proof of viability (PoV) studies started in 2022 and the additional two will start in 2023. The two non-industry PoV studies, KD-CAAP and TREOCAPA, continue to progress.

The work on data harmonisation and implementing the FAIR (Findable, Accessible, Interoperable, and Reusable) data principles has continued to progress. Working with our third party CDISC, the Paediatric User Guide which provides advice and examples on how to implement CDISC data standards for use in paediatric studies, will be launched soon. There is also active collaboration with another IMI project FAIRPlus, to establish a methodology to increase the Findability Accessibility Interoperability and Reusability of the metadata used to describe paediatric studies. This work will result in a new ‘recipe’ for the FAIR cookbook.

The c4c Training Academy has continued to thrive, offering multiple training courses to c4c Beneficiaries. The 2nd Advanced course on paediatric trials and paediatric drug development started in September 2022.

We look forward to working with all Beneficiaries and stakeholders next year in transitioning c4c into the future NLE and network. In the meantime, we wish you a Merry Christmas and a Happy New Year.