I-CORPS: VASCULARIZED ORGAN-ON-A-CHIP PLATFORM FOR BIOPHARMACEUTICAL TESTING

生物制药已经彻底改变了癌症、免疫、炎症和神经系统疾病的治疗。由于这些药物是静脉给药，然后通过血管分布到目标组织，它们的体外测试还不够预测。其次，由于这些药物是人性化的，预测动物研究的安全危害一直具有挑战性，志愿者遭受了严重的反应。由于这些原因，与药物开发相关的经济和时间，生物制药行业寻求人体器官芯片平台，以进行更具预测性的药物测试。不幸的是，目前还没有一种系统足够简单，供研究人员使用，具有足够的吞吐量，并且足够标准化以适应药物筛选工作流程。该项目的目标是通过为开发人体器官芯片平台奠定基础，帮助研究人员解决这一问题，该平台易于使用，高通量，并且以标准格式易于集成到他们的测试程序中。提出的创新是一个中等吞吐量的简单工具，一个任何研究人员都可以使用的工具，并且能够回答复杂的商业灌注系统所做的所有问题（如果服务于它们的所有硬件都可以放在一个实验室中，并且研究人员可以接受如何使用它们的培训）。拟议的血管化器官芯片平台（PerfusionPal）将采用标准格式，高通量，易于使用并适合常规制药工作流程。它将是诊断和预测；诊断以评估靶特异性、与非靶组织的交叉反应性和识别生物标志物；并且能够预测临床试验中的严重反应，如细胞因子风暴，输液反应，免疫抑制和脱靶器官负荷。PerfusionPal的商业化将对危险药物进行分类，并使安全药物从实验室到床边的更快、更便宜的开发，以造福患者、医疗保健行业和社会。

Biopharmaceuticals have revolutionized treatment of cancer, immune, inflammatory and neurological diseases. As these drugs are administered to patients intravenously and then distributed by vasculature to target tissues, their testing in vitro has not been predictive enough. Next, because these drugs are humanized, predicting safety hazards from animal studies has been challenging and volunteers suffered from severe reactions. For these reasons, economics and timeline associated with drug development, biopharmaceutical industry seeks human organ-on-a-chip platforms for more predictive drug testing. Unfortunately, there has not yet been a system that is simple enough for researchers to use, in adequate throughput, and standardized enough to fit into drug screening workflows. The goal of this project is to help solve this problem for researchers by setting a foothold for development of a human organ-on-a-chip platform that is easy for them to use, high-throughput, and in a standard format to readily integrate into their testing routine.The proposed innovation is a simple tool in a medium throughput, a tool that any researcher can use and be able to answer all the questions that complex commercial perfusion systems do (if all the hardware that services them could be put in one lab and researchers trained on how to use it all). The proposed vascularized organ-on-a-chip platform (PerfusionPal) will be in standard format, high throughput, easy to use and fit into routine pharmaceutical workflows. It will be diagnostic and prognostic; diagnostic to assess target specificity, cross-reactivity with off-target tissues and to identify biomarkers; and prognostic or capable of predicting severe reactions in clinical trials such as cytokine storms, infusion reactions, immune suppression and off-target organ liabilities. PerfusionPal commercialization will triage dangerous drug leads and enable faster and cheaper development of safe drugs from bench to bedside for the benefit of patients, healthcare industry and society.