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.
