HiRO 与 Differentia Biotech 签署合作 MOU ，联合开发临床试验仿真模拟技术能力
此次合作将 HiRO 全球临床运营专业能力与先进数字孪生技术相结合，为面临研发周期压缩和试验成本持续上升挑战的生物科技公司提供“以仿真模拟优先”的药物开发新路径
美国新泽西州萨默塞特，2026年8月20日——在生物医药研发效率持续下降、单款药物上市成本已超过 26 亿美元的背景下，HiRO 与 Differentia 整合双方能力，对临床试验的设计、样本规划与执行模式进行升级革新。
贺维斯特医药科技有限公司（HiRO）是一家面向全球的创新型临床研究机构（CRO）。与药物研发领域知识驱动型建模与模拟的先驱企业 Differentia Biotech Ltd.（以下简称“Differentia”）今日宣布签署合作 MOU，正式建立战略合作关系。双方在 HiRO 办公室正式签署协议，这标志着两家公司在为全球生物医药申办方提供更一体化、数据驱动的解决方案方面，迈出重要一步。
根据此次 MOU 协议，HiRO 与 Differentia 将围绕生物科技公司面临的实际痛点，在两个重点方向展开合作：一 、共同探索并开发临床试验模拟模型，将HiRO 在全球临床运营、数据科学和真实世界数据方面的经验，与 Differentia 的 AI 驱动数字孪生及建模模拟平台结合；二、基于双方整合后的模拟能力，共同开发新的产品与商业化解决方案。
临床试验仿真模拟是此次合作的核心。HiRO 在肿瘤、罕见病、细胞与基因治疗、放射性药物等复杂领域拥有临床试验运营经验，结合 Differentia 的建模与仿真模拟平台，双方将通过仿真模拟驱动的方法，助力实现更科学的试验设计、更高效的患者筛选，并有望减少所需受试者数量，帮助申办方在药物开发早期获得更充分的决策依据。
双方一致认为，随着临床开发复杂度不断提高，申办方亟需将严谨的临床试验执行与先进的建模和仿真模拟能力结合，以此优化试验设计、管控研发风险，高效推进复杂治疗领域项目开发。
从左至右：HiRO 创始人兼首席执行官 Karen Chu；Differentia Biotech 创始人 Shirley Wen
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药物研发企业需要的不只是更快推进试验，更要实现更智慧的临床试验开发。Differentia 在建模与仿真模拟方面的专业能力，与 HiRO 在每项研究中坚持的严谨临床运营高度互补。此次合作让我们能够探索如何将双方优势真正结合起来，更好地服务共同的客户。我们的目标，是帮助生物科技企业做出更好的开发决策。”
— Karen Chu，HiRO 创始人兼首席执行官
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随着生物医药研发效率持续下降，临床开发环节所承担的成本、时间与风险压力也愈发突出。FDA 及全球监管机构越来越重视模型引导的药物研发，行业也需要从‘先开展人体试验’逐步转向‘先仿真模拟，再开展人体试验’。结合 HiRO 在临床开发方面的专业能力，我们希望提升临床成功率、减少试验规模并缩短上市时间，最终为每一项研发资产创造更高价值和投资回报。”
— Shirley Wen，Differentia Biotech 创始人
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将先进 AI 生物模拟能力与 HiRO 领先的临床研究专业能力深度融合，构建高保真的数字孪生体系。这将从根本上重塑药物研发模式，让生物科技创新企业能够先在虚拟环境中降低研发项目风险，再以更高效率开展临床试验。”
— Kas Subramanian，Differentia Biotech 首席执行官兼联合创始人
随着合作推进，HiRO 与 Differentia 预计将进一步公布具体合作项目的相关信息。
关于 HiRO
贺维斯特医药科技有限公司（HiRO）是一家面向全球的创新型临床研究机构（CRO）。为肿瘤、罕见病、皮肤病、代谢性疾病以及细胞与基因治疗、放射性药物等专业领域提供端到端临床试验服务。团队累计拥有30余年服务中小型及大型生物科技和制药企业的经验，现有 500 余名专业人员，已在 85 个国家交付 1,600 项临床试验。HiRO 兼具全球覆盖能力与本地化执行经验，业务覆盖北美、欧洲、亚太地区及澳大利亚和新西兰。更多信息请访问 www.harvestiro.com。
关于 Differentia Biotech
Differentia Bio 是一家总部位于旧金山的科技公司，致力于为药物研发和生命科学打造AI驱动的数字孪生模拟与决策智能平台。通过结合 AI 与定量生物科学，Differentia 帮助生命科学领域的决策者在真正投入时间、资金和患者资源之前，先对关键决策进行模拟。其经验证、具备监管应用条件的模拟能力，可帮助生物医药企业优化开发方案、加快监管申报，并提升研发资产及产品组合的价值。更多信息请访问 www.differentiabio.com。
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HiRO Marketing - info@harvestiro.com
Memorandum of Understanding establishes a framework for joint development of clinical trial simulation capabilities
The partnership unites global clinical operations excellence with advanced digital twin technology, delivering simulation-first drug development to biotech sponsors navigating an era of compressed timelines and escalating trial costs.
SOMERSET, NEW JERSEY, US - August 20, 2026 - At a time when biopharma R&D productivity is declining and the cost of bringing a single drug to market exceeds $2.6 billion, two companies are converging capabilities to change how clinical trials are designed, sized, and executed.
Harvest Integrated Research Organization (HiRO), a full-service global clinical research organization (CRO), and Differentia Biotech Ltd. (“Differentia”), a pioneer in knowledge-empowered modeling and simulation for drug development, today announced a Memorandum of Understanding (MOU) establishing a strategic collaboration between the two companies. The agreement was formalized at HiRO’s office, marking a new step in both organizations’ efforts to bring more integrated, data-driven solutions to biopharmaceutical sponsors worldwide.
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 modeling 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 center 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 modeling 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.
The collaboration reflects a shared view that sponsors increasingly benefit from pairing disciplined clinical trial execution with advanced modeling and simulation, helping to inform smarter trial design, manage risk, and support timelines across complex therapeutic areas.
L-R: Karen Chu, CEO & Founder, HiRO; Shirley Wen, Founder, Differentia Biotech
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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 & Founder, HiRO
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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
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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 & Co-Founder, Differentia Biotech
HiRO and Differentia expect to share additional details on specific collaborative initiatives as the partnership progresses.
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 serving small, mid-size, and large biotech and pharma clients, 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. Learn more at www.harvestiro.com.
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. For more information, visit www.differentiabio.com.
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HiRO Marketing - info@harvestiro.com
