HiRO and Differentia have signed a Memorandum of Understanding establishing a framework for joint development of clinical trial simulation capabilities
On average, bringing a new drug to market costs more than $2.6 billion, and R&D productivity across the biopharma industry continues to slide. Against that backdrop, Harvest Integrated Research Organization (HiRO) and Differentia Biotech have signed a Memorandum of Understanding (MOU) establishing a strategic collaboration to bring AI-powered clinical trial simulation to sponsors navigating tighter budgets and shrinking timelines.
The MOU lays the groundwork for a joint approach to trial design, combining HiRO’s operational depth as a full-service global CRO with Differentia’s digital twin and modeling and simulation technology.
L-R: Karen Chu, CEO & Founder, HiRO; Shirley Wen, Founder, Differentia Biotech
What the MOU Covers
- Joint development of clinical trial simulation models pairing HiRO’s clinical operations, data science, and real-world data expertise with Differentia’s AI-driven simulation platform.
- New commercial offerings built on top of those combined simulation capabilities, giving sponsors access to tools that didn’t exist as an integrated package before.
The goal is straightforward: help sponsors design smarter trials, choose the right patients, potentially reduce the number of subjects a study needs, and make better-informed decisions earlier in development, all before a single patient enrolls.
“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.”
– Karen Chu, CEO and Founder, HiRO
Why Clinical Trial Simulation Matters Right Now
HiRO already runs trials across some of the industry’s most complex spaces, including oncology, rare disease, cell and gene therapy, and radiopharmaceuticals. These are exactly the areas where poor trial design is costliest, since patient populations are small, timelines are tight, and a single misstep can set a program back years.
That’s where AI-powered clinical trial simulation earns its keep. Instead of designing a trial and finding out three years in that assumptions were off, Sponsors can model outcomes, risk, and patient selection strategies before committing real capital and real patients.
“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.”
– Shirley Wen, Founder, Differentia Biotech
Building Digital Twins for Drug Development
At the center of the collaboration is Differentia’s digital twin technology: AI-driven models that let sponsors simulate a trial’s outcomes before running it in the real world. Paired with HiRO’s experience across complex therapeutic areas. The goal is to give biotech companies a way to de-risk development decisions long before patients are enrolled.
“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.”
– Kas Subramanian, CEO and Co-Founder, Differentia Biotech
What’s Next
More details on specific collaborative initiatives will be shared as the MOU progresses. For sponsors weighing how to get more out of limited trial budgets and increasingly complex protocols, this alliance is worth watching.
About HiRO
Harvest Integrated Research Organization (HiRO) is a full-service global CRO delivering end-to-end clinical trial services across oncology, rare diseases, dermatology, metabolic disease, and specialized modalities including cell and gene therapy and radiopharmaceuticals. With more than 30 years of collective experience, over 500 professionals, and 1,600 trials delivered across 85 countries, HiRO combines global reach with regionally informed execution across North America, Europe, APAC, and ANZ.
About Differentia Biotech
Differentia Bio is a San Francisco-based technology company building the AI-powered digital twin simulation and decision intelligence platform for drug R&D and life sciences. Combining AI with quantitative biosciences, Differentia enables life science decision makers to simulate critical decisions before committing real-world time, capital, and patients. Its validated, regulatory-ready simulation capabilities help biopharma decision makers to optimize development, accelerate regulatory submissions, and improve the value of their assets and portfolios.
