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

描述（由申请人提供）：我们请求资金在约翰霍普金斯湾景（JHB）医学园区建立一个转化分子成像中心（TMIC）。目前，在约翰霍普金斯医学研究所（JHMI）没有这样的中心，全国范围内也很少有专门致力于将所有形式的新分子成像剂带到临床的中心。约翰霍普金斯医疗机构（JHMI）和其他地方的研究人员不断发现癌症、中枢神经系统疾病、心血管疾病和其他疾病的新治疗靶点、试剂和生物标志物。在人类受试者中验证新标志物和药物并加速其临床接受的有效方法是成像，这是一种固有的非侵入性和定量方法，越来越多地被制药行业采用。在JHMI和其他地方的临床前开发中不乏有前途的分子成像探针。然而，即使是最有前途的分子成像剂的临床翻译也是一项艰巨的任务，需要跨学科的团队和通常的商业投入。不幸的是，感兴趣的商业团体并不容易找到，这些团体的目标可能偏离最初发现的精神。除了在JHMI发现的许多新探针和技术之外，还有一个新兴的基础设施来促进临床翻译的机制-包括提供有关方案开发和寻求FDA批准的专家建议-例如临床和转化研究所和脑科学研究所。然而，将新的分子成像剂推向临床仍然很困难-进行关键的0期（首次人体）研究。这项申请旨在弥补这一差距，对JHB G号楼低层一个4 156平方英尺的设施进行翻修，该设施以前由NIDA成像小组占用。要求提供资金，以提供一个开发实验室，cGMP设施，包括配制材料的能力，以立即人类管理，和一个成像套件，其基石将是一个双模态PET扫描仪。通过由放射科和精神科，一个现实的财务计划，各种各样的项目成熟的翻译和具有关键互补技能的专业人员团队提供的慷慨匹配启动包，我们预计TMIC将成为一个宝贵的大学，区域和国家资源。

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.