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Delivering Regulatory Impact from Consortium-Based Projects.

Sharing lessons and key strategies to enhance the regulatory impact of consortium-based projects, Critical Path Institute® (C-Path) and Innovative Health Initiative (IHI) discuss how consortium-based projects can significantly enhance their regulatory impact and accelerate the development of new therapies.

Consortium-Driven Success Stories

The Nature commentary showcases three high-impact examples:

1. Islet Auto antibodies (T1D Biomarkers)
   In 2022, C Path’s Type 1 Diabetes Consortium secured EMA qualification for islet auto-antibodies as enrichment biomarkers in prevention trials. They aggregated and analysed sufficient patient-level data, applied rigorous analyses, and secured early regulatory advice; culminating in a formal qualification opinion.
2. Centiloid Scaling (Alzheimer’s Amyloid PET)
   In 2024, the IMI AMYPAD consortium gained EMA qualification for the Centiloid unit, standardizing amyloid PET quantification for use in early Alzheimer’s clinical trials. The group followed a structured plan: early regulatory engagement, evidence generation, and submission.
3. Other IMI and C Path Projects
   Additional consortia (Kidney progression biomarkers, Duchenne muscular dystrophy outcome measures, etc.) have seen downstream regulatory or clinical impact, demonstrating the generalisability of this collaborative, data-driven model. Visit RDCA-DAP to learn more and browse available data and tools.

Putting Strategy into Practice

C-Path’s approach and regulatory results demonstrates that consortium-led DDT development (anchored by regulatory strategy, data fairness, and stakeholder alignment) can achieve significant regulatory milestones. Powered by the Aridhia DRE, C Path’s data and analytics platform RDCA-DAP operationalises this approach by offering:

‘FAIR’ data centralisation, a one-stop-shop for data discovery, richly described data, and streamlined data access.

Advanced analytics workspaces for real-time tool development and validation in private and secure collaborative spaces.

Consortium collaboration, fostering data and knowledge sharing across different domains and therapy development challenges.

Direct regulatory engagement, bridging the gap between data, tools, and submission-ready outputs in a secure environment.

Following this framework, RDCA DAP is the engine that transforms collaborative ambition into regulatory reality, empowering consortia to deliver qualified biomarkers, standardised measures, and ultimately therapies for patients.

You can find the full text for the publication here.