PFI: AIR-TT: PharmaFlux: Drug Evaluation on a Biomimetic Microfluidic Device

这个PFI: AIR技术翻译项目的重点是翻译一个治疗分析平台，旨在减轻新疗法从高通量评估过渡到后期测试阶段相关的科学、财务和时间风险。治疗分析平台非常重要，因为它将有助于制药公司以更及时、更具成本效益和可持续的方式将可行的新疗法推向市场。将这项技术推向市场将反过来为开发新疗法的制药公司和最终接受治疗的患者带来好处。该项目将通过治疗分析平台验证目前的概念验证测试，该平台将使用制药和生物技术公司生产的当前治疗系统进行测试。该平台具有以下独特特点：流量可控、样本量要求小、可扩展、设计布局灵活、可模拟特定疾病条件、易于使用/数据收集。与目前市场上领先的基于静态生长细胞的分析平台相比，这些功能具有以下优势：降低运营成本，高通量测试能力，提供更高效率的新疗法开发，降低与大量时间和资金投资相关的风险，以及更好地将新疗法推向市场。该项目解决了以下技术差距，因为它从研究发现转化为商业应用。该平台的基线测试已经在一些治疗递送系统（如纳米颗粒）上完成。验证分析平台的下一步是将该技术应用于目前在制药工业中使用的成熟治疗系统。因此，基准测试的各个阶段将以表征候选治疗递送（细胞结合和相互作用）、疾病状态疗效标记物和不同剪切速率下基于细胞的毒性为目标进行。利用分析平台将提供数据，然后可以直接或间接地与当前的行业标准和发布的数据集进行比较，以验证平台。此外，参与该项目的研究生和本科生将通过文献综述、实验室研究、产品设计以及与制药和生物技术公司合作伙伴的战略规划，获得研究、商业化和创业经验。目前，该项目聘请了宾夕法尼亚州伯利恒当地一家名为Particle Sciences的公司，该公司是路博润生命科学公司的一部分，在后期体内测试之前协助表征新的治疗输送载体，以确保实现全面优化。在未来的测试过程中，作为从研究发现到商业现实的技术转化工作的一部分，将获得更多的行业合作伙伴。

This PFI: AIR Technology Translation project focuses on translating a therapeutic analysis platform designed to mitigate scientific, financial, and temporal risks associated with transitioning new therapeutics from high-throughput evaluations to later stages of testing. The therapeutic analysis platform is important because it will serve to assist pharmaceutical companies in the efforts of bringing viable new therapeutics to market in a more timely, cost effective, and sustainable manner. Bringing this technology to market will in turn provide benefits to pharmaceutical companies developing new therapeutics and the patients whom ultimately receive treatment. The project will validate current proof-of-concept testing with the therapeutic analysis platform, which will be carried out using current therapeutic systems produced by pharmaceutical and biotechnology companies. This platform has the following unique features: capability of controllable flow, small sample volume requirements, scalable, flexible design layout, ability to mimic specific disease conditions, and ease of use/data collection. These features enable advantages of reduced operating costs, high-throughput testing capabilities providing greater efficiency of new therapeutic development, reduced risk associated with large investments of time and funding, and greater follow-through to market for new therapeutics when compared to the leading competing statically-grown cell-based analysis platforms in this market space today.  This project addresses the following technology gaps as it translates from research discovery toward commercial application. Baseline testing of the platform has been completed on a few therapeutic delivery systems such as nanoparticles. The next steps in validation of the analysis platform is the application of the technology to well-established therapeutic systems currently utilized in the pharmaceutical industry. As such, various stages of benchmark testing will be performed with the goal of characterizing therapeutic candidate delivery (cell binding and interactions), disease state efficacy markers, and cell-based toxicity at various shear rates. Utilization of the analysis platform will provide data which can then be directly or indirectly compared to current industry standards and published data sets for validation of the platform. In addition, graduate and undergraduate students involved in this project will receive research, commercialization and entrepreneurship experiences through literature reviews, lab-based research, product design, and strategic planning with pharmaceutical and biotechnology company partners.The project currently engages a local Bethlehem, PA company, Particle Sciences, a part of Lubrizol Life Sciences, to assist in the characterization of novel therapeutic delivery vehicles prior to later stage in vivo testing to ensure that full optimization is achieved. Additional industry based collaborators will be acquired throughout future testing as a part of this technology translation effort from research discovery toward commercial reality.