MHRA Joins Forces with Network Scientists and PhaSER Biomedical to Modernise Drug Regulation via Humanised Models and AI
In a move that highlights its shift towards proactive, innovation-led regulation, the Medicines and Healthcare products Regulatory Agency (MHRA) has entered a major collaboration with PhaSER Biomedical and one of our Network members at the University of Dundee. Supported by funding from the UK Government’s Regulatory Innovation Office (RIO), the initiative aims to transform early drug development by uniting humanised biological systems with advanced artificial intelligence.
At the centre of the project is PhaSER’s 8HUM mouse model, an extensively humanised system engineered to carry human versions of key drug-metabolising genes, including cytochrome P450 enzymes and major transcription factors that control their expression. By providing highly human-relevant metabolic data, the model enables more accurate predictions of how new medicines are processed within the human body.
The collaboration will channel data generated using 8HUM into machine-learning platforms designed to forecast drug–drug interactions (DDIs) earlier and with greater precision. The project, known as DAIRR (Determination of AI and Computational Approaches to Reduce the Risk of Drug Interactions), aims to help developers identify potential safety issues bin advance of clinical trials, thereby reducing the likelihood of late-stage failures and accelerating access to safer medicines.
The scientific direction of the project is led by Professor Roland Wolf, PhaSER’s Founder and Chief Scientific Officer, who is also a member of the MRC National Mouse Genetics Network’s Degron Cluster. Roland’s involvement underscores the project’s alignment with the Network’s core ambition: to build and apply the best possible preclinical models to ensure the most robust, translatable results before medicines and therapies reach human patients. By combining validated humanised systems with AI-driven prediction tools, the project directly supports the Network’s goal of enhancing preclinical evidence and improving patient safety while reducing dependence on less human-relevant animal models.
The collaboration also reflects a broader evolution in UK regulation. Through DAIRR and similar initiatives, the MHRA is moving towards a more anticipatory model; one in which regulators help shape the scientific standards and tools that will define the next generation of drug development. As humanised models and computational technologies converge, the approach may set a new benchmark for evaluating and approving future therapies.
Prof Roland Wolf said, “We are really excited about this government-funded collaborative project between the MHRA and PhaSER to use humanised mice to create a computational model which accelerates the drug regulatory process. An ultimate goal is to develop an online computational prescribing database for doctors which reduces the risk of adverse drug/drug interactions, particularly for patients on multiple drugs. PhaSER’s involvement with the MRC National Mouse Genetics Network and the Mary Lyon Centre provides great added value to this programme, and we look forward to further direct involvement with the Network and the MLC going forward”
Prof Owen Sansom, Director of the MRC National Mouse Genetics Network, said,
“Human-relevant models are at the heart of the UK’s vision for modern biomedical research, and they must be matched by regulation that can move just as quickly. This project brings both sides into alignment, creating a genuine shift in how we get better, safer medicines to patients.”