SBIR Phase II: A Novel Device for Convenient Therapeutic Drug Monitoring of Tacrolimus

SBIR II 期：一种方便监测他克莫司治疗药物的新型装置

• 批准号: 1330934
• 负责人: Tian Lan
• 金额: $ 75万
• 依托单位: GlucoSentient, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-10-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1330934&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Novel; Device

This Small Business Innovation Research (SBIR) Phase II project is aiming to develop and validate a point-of-care monitoring for tacrolimus, an immunosuppressive medication widely used by organ transplant patients. The product being developed combines the existing, well-developed and low cost glucose meter technology with the gold standard immunoassay platform, leading to a product that can potentially improve the treatment outcome of transplant patients. Currently, monitoring of tacrolimus level is achieved by using laboratory assays, which has a long turn-around time and frequent monitoring is more difficult. However, tacrolimus is a drug whose toxic level is only couple times higher than its therapeutic level, and current infrequent monitoring approach is less effective to ensure the most effective drug levels in patients. The Phase II project will be achieved by first optimizing the glucose meter based tacrolimus assay developed in Phase I, following by the development and validation a disposable device which will house the assay and a glucose monitor which has an improved sensitivity. We anticipated the system composed of a disposable and a reader will be developed and validated at the end of the Phase II project, preparing the technology for clinical validation.The broader impact/commercial potential of this project lies in the future development of the technology that will expand the potential test targets beyond tacrolimus. Numerous drugs currently on the market have a narrow therapeutic range, as well as many effective drugs that cannot be marketed due to lack of close monitoring methods to reduce their toxic effects. The innovative therapeutic drug monitoring device we are developing will allow many of these drugs become more available. For our current target market, with hundreds of thousands of transplant patients using tacrolimus worldwide for the remainder of their lives, the commercial potential for our product is immense. The social impact is considerable, and for just kidney transplants, 29% of the allografts will fail in the next five years due to improperly managed immunosuppressant medications costing hundreds of millions of dollars for post failure treatment and dialysis. Providing patients with a convenient tool to manage their medication can significantly reduce the number of failed kidneys, leading to better life to the patient and huge savings for the society.

这个小企业创新研究（SBIR）第二阶段项目旨在开发和验证他克莫司的即时监测，他克莫司是一种广泛用于器官移植患者的免疫抑制药物。正在开发的产品将现有的、成熟的、低成本的血糖仪技术与金标准免疫分析平台相结合，从而产生一种可能改善移植患者治疗结果的产品。目前，他克莫司水平的监测是通过使用实验室测定来实现的，其具有较长的周转时间，并且频繁监测更困难。然而，他克莫司是一种毒性水平仅比其治疗水平高几倍的药物，并且目前不频繁的监测方法对于确保患者中最有效的药物水平不太有效。II期项目将通过首先优化I期开发的基于葡萄糖仪的他克莫司测定法，然后开发和验证将容纳测定法的一次性装置和具有改进灵敏度的葡萄糖监测仪来实现。我们预计由一次性和阅读器组成的系统将在第二阶段项目结束时开发和验证，为临床验证技术做准备。该项目更广泛的影响/商业潜力在于该技术的未来发展，这将扩大他克莫司以外的潜在测试目标。目前市场上的许多药物的治疗范围很窄，还有许多有效的药物由于缺乏密切的监测方法来减少其毒性作用而无法上市。我们正在开发的创新治疗药物监测设备将使许多这些药物变得更加可用。对于我们目前的目标市场，全球有数十万移植患者在其余生中使用他克莫司，我们产品的商业潜力是巨大的。社会影响是相当大的，仅仅是肾移植，29%的同种异体移植将在未来五年内失败，由于管理不当的免疫抑制剂药物，花费数亿美元用于失败后的治疗和透析。为患者提供一个方便的工具来管理他们的药物可以显着减少肾功能衰竭的数量，从而改善患者的生活，为社会节省大量资金。