PhaSER Biomedical Partners with MHRA to Accelerate Safer, Human-Relevant Drug Development Using 8HUM Humanised Models
Dundee, UK – 21st October 2025 – PhaSER Biomedical has announced a landmark collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA) and University of Dundee (UoD), through funding from the Regulatory Innovation Office (RIO), to transform the future of preclinical drug development through the integration of humanised models and artificial intelligence.
The project aims to drive innovation in the regulatory space: using data obtained using PhaSER’s novel humanised metabolism mouse model to generate and validate an AI-assisted computation models to predict clinical drug-drug interactions (DDIs). This DDI prediction model will assist both regulators and industry in streamlining the regulatory approvals process, allowing for safer medicines to reach patients faster.
Transforming the Drug Development Paradigm
Traditional drug development is costly and time-consuming, with around 90% of candidates failing once they reach human trials. By pairing AI-enhanced computational models; generated and validated using PhaSER’s 8HUM humanised metabolism mouse model, this partnership seeks to streamline early decision-making, predict clinical drug–drug interactions (DDIs) more accurately, and reduce late-stage attrition.
The collaboration builds on the MHRA’s wider mission to modernise regulatory science, supporting the use of human-relevant data and advanced technologies to improve translational accuracy and reduce reliance on animal studies.
Julian Beach, Executive Director, Healthcare Quality and Access, MHRA:
“This partnership exemplifies how artificial intelligence and humanised models can be combined to generate stronger, more predictive evidence earlier in the development process. By incorporating these tools into regulatory science, we can make drug development faster, more ethical, and more relevant to real-world patient outcomes.”
Humanised Innovation Backed by Regulatory Confidence
This project puts the MHRA and PhaSER at the forefront of efforts to reimagine how preclinical data informs clinical and regulatory decision-making, and highlights confidence in the 8HUM model playing a key role in in this paradigm shift. As such, sponsor companies are already welcomed to include in vivo 8HUM data as part of their regulatory submissions - a key step in building confidence around humanised evidence models.
Chris Wardhaugh, CEO, PhaSER Biomedical:
“This collaboration demonstrates a shared commitment between regulators and innovators to redefine how medicines are developed. The 8HUM model gives us a uniquely human-relevant lens on drug metabolism and safety, while our work with the MHRA ensures that these insights can translate directly into regulatory practice.”
Professor Roland Wolf, Founder and CSO, PhaSER Biomedical:
“Predicting complex drug interactions remains one of the great challenges in modern therapeutics. By combining AI, computational modelling, and our validated humanised systems, we can accelerate the arrival of safer, more personalised medicines - while reducing dependence on animal testing.”
Supporting the 3Rs and the Future of Human-Relevant Research
PhaSER is aligned with the principles of the 3Rs (reduction, refinement, replacement) and believes the humanised 8HUM model plays a central role in bridging the gap between traditional animal testing and New Approach Methods (NAMs). Use of the humanised model can already help reduce the number of animals used in drug development through increased translatability and therefore lower attrition rates, whilst we work towards developing and validating in silico replacement NAMs.
About PhaSER Biomedical
PhaSER Biomedical is a UK-based biotechnology company developing advanced humanised models that transform preclinical decision-making and accelerate safe, effective drug development. Its flagship 8HUM humanised mouse model provides a highly predictive system for evaluating metabolism, toxicity, and drug-drug interactions - reducing clinical risk, attrition, and time to market.
Through partnerships with regulatory agencies, academic institutions, and industry leaders, PhaSER is helping to shape a new era of human-relevant science.
