A Memorandum of Understanding has been signed between UK CEiRSI (UK Centre of Excellence on In-Silico Regulatory Science and Innovation) and Triangle CERSI (Triangle Center of Excellence in Regulatory Science and Innovation). The MoU formalises an already thriving collaboration between the two centres, united in their goal to revolutionise regulatory science.
Triangle CERSI is one of five Food and Drug Administration (FDA)-funded centres across the US, designed to promote innovation in regulatory science and accelerate access to complex emerging technologies. Located in Research Triangle Park, North Carolina, Triangle CERSI is a partnership between University of North Carolina at Chapel Hill and Duke University, in collaboration with North Carolina State University, North Carolina Central University, and the Burroughs Welcome Fund.
UK CEiRSI, jointly funded by InnovateUK and the Medical Research Council (MRC), operates under the leadership of the Christabel Pankhurst Institute in partnership with Unit M. This pioneering consortium has established a comprehensive national network that unites elite academic institutions-including University of Oxford, University of Cambridge, University College London (UCL), University of Edinburgh, University of Strathclyde, Queens University of Belfast and Swansea University-with key regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Health and Care Excellence (NICE) and Health Research Authority (HRA). With participation from 85 additional national and international stakeholders spanning academia, industry, and regulatory affairs, UK CEiRSI represents an unprecedented collaborative effort to integrate robust in-silico evidence into medical product development and regulatory decision-making pathways.
Professor Alejandro Frangi, Executive Director of UK CEiRSI, expressed his enthusiasm for the collaboration: "This partnership represents a strategic milestone in global regulatory harmonisation. Triangle CERSI's pioneering work in virtual imaging trials and pharmaceutical regulatory science perfectly complements our comprehensive in silico capabilities across drugs and medical devices. By synchronising our regulatory approaches across continents, we're not simply sharing knowledge-we're building a unified scientific foundation that will accelerate innovation, reduce redundancy, and ultimately deliver safer, more effective medical technologies to patients worldwide. Together, we're transforming regulatory barriers into bridges."
Christin Daniels, Executive Director of Triangle CERSI, highlighted the importance of the partnership: "Partnering with UK CEiRSI creates a synergistic alliance to modernize regulatory science. Ensuring faster, safer solutions for patients worldwide requires a unified regulatory language. By combining Triangle CERSI's expertise in pharmaceutical evaluation and safety, clinical trial optimization, in silico models and other New Approach Methodologies with UK CEiRSI's impressive national network focused on comprehensive in silico technologies, we aim to close the gap between the pace of innovation and speed of adoption along the regulatory pathway on both sides of the Atlantic."
Professor Richard Jones, Vice-President, Regional Innovation and Civic Engagement at the University of Manchester, said: "
The MOU sets the stage for a series of joint initiatives, including workshops, training programs, and collaborative research projects. These efforts will not only advance regulatory science but also contribute to the development of a skilled workforce capable of navigating the complexities of modern healthcare.
- "In-Silico" is a term used to describe experiments or studies that are performed using computer simulations or software.
