A new paper titled “Delivering regulatory impact from consortium-based projects” has recently been published in the journal Nature Reviews Drug Discovery.
Multiple consortia have been established in the past two decades with the aim of tackling roadblocks in the development of medical products, often by developing new tools to support decision making by regulatory agencies. In this paper, authors share lessons learned from these efforts that could help maximise the regulatory impact of consortium-based projects.
The paper also highlights examples of consortium-based projects that have achieved regulatory successes, such as those that have been part of the Innovative Medicines Initiative (IMI) and Critical Path Institute (C-Path). We’re pleased that our AMYPAD project is featured among these successes, as our collaborative efforts led to the European Medicines Agency endorsing the Centiloid method as a measure of amyloid positron emission tomography (PET) to quantify brain amyloid deposition.
Authors Martha A. Brumfield, Graham C. Higson, Cécile Ollivier and Nathalie Seigneuret concluded the paper by sharing thee key learnings that are applicable to any multi-stakeholders’ consortium effort with the view to maximise the regulatory impact of the project outputs:
- A clear and robust regulatory strategy needs to be defined and outlined as part of the project definition if data are likely to be used for regulatory purposes.
- A data management plan needs to be developed and tailored to the specific regulatory objectives as early as possible in the project. A sustainability plan should be developed so that the data generated during the project are readily available following completion of the project.
- Early engagement with regulatory agencies is essential, led by a collaborator with regulatory science expertise and relevant experience.
You can read the paper here: https://doi.org/10.1038/d41573-025-00098-8
