Paumard Laetitia, Hildebrand Heidrun, Engel Marianne, Lepola Pirkko, Montero Esther, Tennigkeit Frank, Rosenmöller Magda
IESE Business School, Barcelona, Spain.
Bayer AG, Research and Development Pharmaceuticals, Pediatric Medicine, Berlin, Germany.
Front Med (Lausanne). 2025 Jul 24;12:1599997. doi: 10.3389/fmed.2025.1599997. eCollection 2025.
The financial sustainability of publicly funded initiatives, particularly Public Private Partnerships (PPPs), is crucial for ensuring the intended long-term impact beyond the project's funding phase. Despite many initiatives aspiring to lasting impact, very few practical examples and little evidence are available on successful financial sustainability strategies, and even fewer are available on the path to achieve the financial autonomy of any successor organisation. This paper intends to shed light on this aspect by exploring the strategy and challenges towards the financial sustainability of conect4children (c4c), an Innovative Medicines Initiative (IMI)-funded PPP establishing a pan-European paediatric clinical trial network to facilitate and support the planning and conduct of paediatric clinical trials.
The c4c project was planned for a lasting impact from the start. An entire work package dedicated to financial sustainability was already sketched in the proposal and started from the onset of the project, including benchmarking against clinical trial networks globally, needs assessment leading to a value proposition, service portfolio definition, analysis of legal requirements, and the development of a sound business concept.
c4c adopted a combined approach, translating research findings into market-tested services through the parallel set-up of a standalone entity, c4c-Stichting (c4c-s). This strategy offers valuable insights into planning financial sustainability for similar large-scale initiatives and, more broadly, provides a significant contribution to the discourse on financial sustainability. These insights are highly relevant to Regulatory Science, as the sustainability of such infrastructures is critical to the success of regulatory science strategy and long-term public health outcomes.
公共资助项目的财务可持续性，尤其是公私合作伙伴关系（PPP），对于确保项目资金阶段之后的预期长期影响至关重要。尽管许多项目都渴望产生持久影响，但关于成功的财务可持续性战略的实际例子和证据却很少，关于任何后续组织实现财务自主之路的例子更是少之又少。本文旨在通过探讨connect4children（c4c）财务可持续性的战略和挑战来阐明这一方面，c4c是一项由创新药物倡议（IMI）资助的公私合作伙伴关系，旨在建立一个泛欧洲儿科临床试验网络，以促进和支持儿科临床试验的规划与开展。
c4c项目从一开始就计划产生持久影响。提案中已经勾勒出了一个专门致力于财务可持续性的完整工作包，并从项目启动时就开始实施，包括与全球临床试验网络进行基准对比、进行需求评估以形成价值主张、定义服务组合、分析法律要求以及制定合理的商业概念。
c4c采用了一种综合方法，通过并行设立一个独立实体c4c-Stichting（c4c-s），将研究成果转化为经过市场检验的服务。这一战略为类似大规模项目的财务可持续性规划提供了宝贵见解，更广泛地说，为关于财务可持续性的讨论做出了重大贡献。这些见解与监管科学高度相关，因为此类基础设施的可持续性对于监管科学战略的成功和长期公共卫生成果至关重要。
