At a time when biopharma R&D productivity is declining and the cost of bringing a single drug to market exceeds $2.6bn, two companies are converging capabilities to address how clinical trials are designed, sized, and executed.
Harvest Integrated Research Organization (HiRO), a full-service global clinical research organisation, and Differentia Biotech Ltd., which provides knowledge-empowered modelling and simulation for drug development, have announced a Memorandum of Understanding (MOU) establishing a strategic collaboration between the two companies.
Under the MOU, HiRO and Differentia will pursue collaboration across two major areas, which address the pain points of biotech companies: joint exploration and development of clinical trial simulation models that combine HiRO’s global clinical operations, data science, and real-world data expertise with Differentia’s AI-powered digital twin and modelling and simulation platforms; and the development of new product offerings and commercial solutions built on those combined simulation capabilities.
The clinical trial simulation collaboration sits at the centre of the partnership. By pairing HiRO’s operational experience running trials across oncology, rare disease, cell and gene therapy, radiopharmaceuticals, and other complex indications with Differentia’s modelling and simulation platforms, the collaboration leverages simulation-informed approaches to support smarter trial design, more efficient patient selection, potential reduction in the number of subjects needed, and better-informed sponsor decision-making earlier in development.
CEO and founder of HiRO, Karen Chu, said: “Drug developers don’t just need faster trials, they need smarter ones. Differentia’s modeling and simulation expertise complements the operational discipline HiRO brings to every study, and this collaboration lets us explore how those strengths work together for the clients we both serve. We are aiming to support our biotech clients in better decision-making.”
Founder of Differentia, Shirley Wen, said: “As biopharma R&D productivity continues to decline, clinical development has become an increasingly significant source of cost, time, and risk. As FDA and global regulators increasingly embrace model-informed drug development, the industry must move from ‘test in humans first’ toward ‘simulate first, then test in humans.’ Together with HiRO’s clinical development expertise, we aim to improve clinical success, reduce trial size, and accelerate time to market—ultimately creating greater value and ROI for every asset.”
CEO and co-founder of Differentia, Kas Subramanian, said: “By fusing advanced AI and biosimulations with HiRO’s industry-leading clinical research expertise, we are creating high-fidelity digital twins that will fundamentally alter the drug development paradigm, allowing biotech pioneers to de-risk assets in a virtual environment and run the most efficient trials.”
HiRO and Differentia expect to share additional details on specific collaborative initiatives as the partnership progresses.