Renovation for the JHBMC Translational Molecular Imaging Center Core Facility (TM

JHBMC 转化分子成像中心核心设施 (TM

• 批准号: 7937339
• 负责人: David Hellmann
• 金额: $ 700万
• 依托单位: JOHNS HOPKINS BAYVIEW MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-01 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7937339
• 关键词: Adopted; Biological Markers; Brain; Cardiovascular Diseases; Central Nervous System Diseases; Clinic; Clinical; Core Facility; Cyclic GMP; Development; Disease; Drug Industry; Funding; Goals; Human; Image; Individual; Institutes; Institution; Malignant Neoplasms; Mechanics; Medical; Methods; Modality; National Institute of Drug Abuse; Pharmaceutical Preparations; Phase; Positron-Emission Tomography; Psychiatry; Radiology Specialty; Reagent; Research Infrastructure; Research Personnel; Resources; Science; Techniques; Translational Research; Translations; Universities; human subject; imaging probe; interest; molecular imaging; new therapeutic target; novel marker; pre-clinical; protocol development; skills; square foot

DESCRIPTION (provided by applicant): We request funds to develop a Translational Molecular Imaging Center (TMIC) on the Johns Hopkins Bayview (JHB) medical campus. There is currently no such center at the Johns Hopkins Medical Institutions (JHMI) and few, if any, nationally that are dedicated specifically to bringing new molecular imaging agents - of all modalities - to the clinic. Researchers at the Johns Hopkins Medical Institutions (JHMI) and elsewhere are continually uncovering new therapeutic targets, reagents and biomarkers for cancer, central nervous system disease, cardiovascular disease and other disorders. An efficient way by which to validate new markers and drugs in human subjects and hasten their clinical acceptance is by imaging, an inherently noninvasive and quantitative method that is being increasingly adopted by the pharmaceutical industry. There is no lack of promising molecular imaging probes in preclinical development at JHMI and elsewhere. However, clinical translation of even the most promising molecular imaging agents is an imposing task, requiring a transdisciplinary team and usually commercial input. Unfortunately, interested commercial parties are not readily available and the goals of such parties may diverge from the spirit of the original discovery. In addition to the many new probes and techniques discovered at JHMI, there is an emerging infrastructure to facilitate the mechanics of clinical translation - including provision of expert advice regarding protocol development and seeking FDA approval - such as the Institute for Clinical and Translational Research and the Brain Science Institute. Nevertheless, it remains difficult to move new molecular imaging agents to the clinic - to undertake that critical Phase 0 (first-in-man) study. This application seeks to bridge that gap by providing renovations to a 4,156 square foot facility, formerly occupied by the NIDA imaging group, in the lower level of Building G at JHB. Requested are funds to provide a development lab, cGMP facilities, including the capability of formulating materials for immediate human administration, and an imaging suite, the cornerstone of which will be a dual modality PET scanner. Through a generous matching start-up package provided by the Departments of Radiology and Psychiatry, a realistic financial plan, a wide variety of projects ripe for translation and a team of dedicated individuals with key complementary skills, we anticipate that the TMIC will become a valuable university, regional and national resource.

描述（由申请人提供）：我们要求资金在Johns Hopkins Bayview（JHB）医疗校园开发转化分子成像中心（TMIC）。目前，约翰·霍普金斯医疗机构（JHMI）没有这样的中心，而且在全国范围内很少有专门用于将各种方式的新分子成像剂（以所有方式）带到诊所。约翰·霍普金斯医疗机构（JHMI）和其他地方的研究人员不断地发现新的治疗靶标，试剂和生物标志物，用于癌症，中枢神经系统疾病，心血管疾病和其他疾病。通过成像，一种有效的方法来验证人类受试者中的新标记和药物并加快其临床接受，这是一种固有的无创和定量方法，该方法越来越多地被制药行业采用。在JHMI和其他地方，在临床前发育中没有任何有希望的分子成像探针。但是，即使是最有前途的分子成像剂的临床翻译是一项艰巨的任务，需要跨学科的团队，通常是商业投入。不幸的是，感兴趣的商业政党不容易获得，此类政党的目标可能与原始发现精神不同。除了在JHMI发现的许多新探针和技术外，还有一个新兴的基础设施来促进临床翻译的机制 - 包括提供有关协议开发的专家建议和寻求FDA批准的专家建议，例如临床和翻译研究所以及脑科学研究所。然而，将新的分子成像剂转移到诊所仍然很难进行临界阶段0（人类第一阶段）研究。该应用程序试图通过为4,156平方英尺的设施提供装修，该设施以前由NIDA成像集团占用，该设施在JHB的较低级别G级。要求提供开发实验室，CGMP设施的资金，包括制定直接人类管理材料的能力，以及一个成像套件，其基石将是双重模式PET扫描仪。通过放射学和精神病学部门提供的慷慨匹配的启动套餐，现实的财务计划，各种各样的翻译项目，以及具有关键补充技能的专门敬业的个人团队，我们预计TMIC将成为有价值的大学，地区和国家资源。