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HiRO and Differentia Biotech Partner to Digitize Clinical Trials

With the cost of bringing a new drug to market now exceeding $2.6 billion, Somerset-based HiRO and Differentia Biotech are shifting the industry toward a simulation-first development model. The two firms have signed a memorandum of understanding to integrate AI-powered digital twins into global clinical trial operations.

HiRO and Differentia Biotech Partner to Digitize Clinical Trials
Photo: Bio & News

The strategic alliance seeks to address declining R&D productivity by merging HiRO’s operational expertise in oncology and rare diseases with Differentia’s modeling platforms. By utilizing high-fidelity digital twins, the partnership aims to de-risk assets in virtual environments before human subjects are involved. This approach is designed to optimize patient selection, reduce the total number of subjects required for trials, and accelerate regulatory timelines.

Karen Chu, CEO of HiRO, noted that the industry requires smarter study designs to navigate current fiscal pressures. According to Differentia founder Shirley Wen, the collaboration reflects a broader regulatory shift toward model-informed development, moving the sector away from the traditional "test in humans first" paradigm. The companies plan to develop a series of new commercial offerings that leverage these simulation capabilities, with further details on specific collaborative projects expected in the coming months.

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