Production, validation, and commercialization of MagniLium (hyperpolarized helium

描述（由申请人提供）：超极化气体MRI提供了前所未有的肺功能诊断能力。制药公司需要敏感的诊断终点来确定他们正在开发的COPD治疗的疗效，并通过FDA批准加速其进展并进入市场。COPD患者个体可以从改善的诊断和治疗中受益。如果花费在3000万患有COPD的美国人身上的350亿美元可以通过准确的评估用于有效的治疗，那么美国的医疗保健预算可能会受益。由于技术和法律的原因，发展的主要障碍是高质量超极化技术和服务的可用性。我们看到了克服这些障碍的明确道路。我们建议使用低成本的自旋交换光泵浦技术组装一个世界领先的3He偏振器。新的光泵浦技术，许多是我们最近才开发的，其他的将在本提案中开发，将允许在每天100巴升的情况下产生55%的偏振，并在三分之一的速度下产生高达70%的偏振。该项目的这一阶段包括将产品气体作为研究性新药（IND）提交给美国FDA。随后的阶段将包括原型的改进和复制，利用原型与临床和药物研究中心合作进行人体试验，并向FDA提交新药申请（NDA）。FDA安全港法将药物开发作为非侵权活动加以保护。

DESCRIPTION (provided by applicant): Hyperpolarized gas MRI offers unprecedented pulmonary functional diagnostic capability. Pharmaceutical companies require sensitive diagnostic end points to determine the efficacy of COPD therapies they have under development and accelerate their progress through FDA approval and into the marketplace. Individual sufferers of COPD could benefit from improved diagnosis and treatment. The US healthcare budget could benefit if the $35B spent on the 30 million Americans suffering from COPD could be directed towards effective treatments through accurate assessments. The primary obstacle to progress has been the availability of high quality hyperpolarization technology and services for both technical and legal reasons. We see a clear path to overcoming those obstacles. We propose to assemble a world-leading 3He polarizer using the low-cost spin-exchange optical pumping technique. New optical pumping technologies, many developed by us only recently and others to be developed in this proposal, will allow production of 55% polarization at 100 bar-liters per day and as high as 70% polarization at one-third that rate. This phase of the project includes submission of the product gas as an Investigational New Drug (IND) to the US FDA. A subsequent phase will include refinement and duplication of the prototype, utilization of the prototype to partner with clinical and pharmaceutical research centers for human trials, and submission of a New Drug Application (NDA) to the FDA. FDA safe harbor laws protect drug development as a non-infringing activity.