The In Silico Regulatory Airlock Initiative for Advancing Model-Informed Evidence Adoption

The Regulatory Airlock initiative aims to enhance the adoption of model-informed evidence in regulatory decision-making by fostering cross-sector collaboration, shared learning, and futureproofing strategies within a secure, pre-competitive environment. This Airlock prepares the way for the creation of a UK Centre of Excellence on in silico Regulatory Science and Innovation (UK CEiRSI) by delivering early wins, raising regulatory awareness, and nurturing a community of practice.

This initiative is structured around three primary objectives:

1. Cross-Sector Exploration: It seeks to identify and address hurdles and challenges across various sectors in adopting model-informed evidence for regulatory purposes.
2. Shared Learning Opportunities: The initiative aims to develop learning opportunities through hypothetical regulatory submissions, focusing on regulatory principles, capability needs, legal and ethical implications, and patient risk reduction.
3. Futureproofing and Sustainability: It ensures the long-term sustainability of the UK CEiRSI initiative by refining its design and fostering a learning ecosystem in regulatory science and innovation.

The Regulatory Pilots will prioritize model-informed evidence in both clinical and pre-clinical studies, initially focusing on medical devices and drugs. The pilots will involve 5-8 case studies of regulatory significance, aiming to deliver cross-industry collaboration and test existing frameworks like the FDA Model Credibility Assessment Framework and the UK CEiRSI MIE for Regulatory Decision Making Whitepaper.

Each pilot team, consisting of members from industry, academia, and regulatory affairs, will undergo a structured process over six months. This includes a discovery phase to define aims and select pilot teams, followed by an implementation phase where teams will prepare and present their case studies in panel sessions. These sessions will explore the use of model-informed evidence in regulatory contexts, assess model credibility, and discuss practical feasibility.

The initiative emphasizes shared learning and collaboration, with all pilot teams supporting each other’s work and disseminating findings through workshops, webinars, and a repository of best practices. Feedback from participants and stakeholders will be used to refine processes and plan future iterations.

Participants are expected to contribute significantly to the pilots and broader regulatory airlock process, supported by a central budget of up to £50-60k over six months. This collaborative effort aims to advance regulatory science, ensuring patient safety and public trust in the regulatory system.