The Resource for Molecular Imaging Agents in Precision Medicine is a program spanning three campuses of The Johns Hopkins University (JHU). In our view precision medicine is using all data at hand regarding a particular patient to enable the best possible care for that patient. We believe that carefully designed molecular imaging agents can contribute to this. Through infrastructure built and personnel recruited and trained over the past two decades within the Department of Radiology we are now poised to offer this unique center with a heavy emphasis on the provision of chemistry - new reagents, methods and training in their development and practice - for molecular imaging. The biological theme of the PMRC is relationships between cancer, inflammation and immunity, deeper study of which is an unmet need. Although brilliant research continues worldwide in the development of new molecular imaging agents, few have had actual impact on addressing human infirmity and many do not justify the cost of their development.

In March 2014 the NIBIB conducted a study "to better understand the reasons why more molecular imaging agents and instrumentation developed with NIH grant support are not being translated to the clinic nor subsequently commercialized." To address those shortcomings, the JHU PMRC will be highly translational by leveraging the Center for Translational Molecular Imaging (CTMI) at the Johns Hopkins Bayview medical campus, the F. M. Kirby Center for Functional Brain Imaging at the Kennedy Krieger Institute, the Division of Cancer Imaging Research, the Division of Nuclear Medicine and Molecular Imaging (DNMMI), and the Institute for Cell Engineering at the JHU School of Medicine, all of which are highly integrated into numerous departments and schools at JHU. We have generated agents that have been licensed and are in the process of commercialization.

However, to date those activities have been performed on an ad hoc basis, and we intend to expand upon them in two new ways:

(1) provide targeted and unique Technical Research and Development (TR&D) projects that will

(2) enable widespread dissemination and training in their use, enhancing the capacity of the centers and divisions noted above to perform their intended functions - discovery with intent to educate, promote new collaborative, transdisciplinary research and to manage a variety of conditions, while addressing some unanticipated effects of emerging cancer immunotherapies.

The unique aspect of the JHU PMRC is its focus on provision of new, precision materials, to test these pre-clinically and progress them to human use, delivered on-site or to our collaborators in a format suitable for their implementation. We will assure proper off-site utilization through continual, reciprocal education and "push-pull" interactions. The program is agnostic to imaging modality and composition of the materials to provide, relying upon the specific expertise within each TR&D.

In addition to sharing the goal of leveraging chemistry for imaging, the four TR&Ds will be linked through the aforementioned biological theme. They can briefly be summarized as focusing on new theranostics (TR&D 1), molecular-genetic imaging systems (TR&D 2), agents for probing immunity (TR&D 3), and targeted agents for chemical exchange saturation transfer, or CEST (TR&D 4). TR&D 1 will also serve as the Pre-clinical Validation Core in support of the other TR&Ds, particularly with respect to small animal imaging. TR&D 1 will also develop and optimize our in-house image processing tools to analyze pre-clinical, multi-modality image data acquired in our studies and make these tools user-friendly and accessible to the broader community. We recognize that our collaborators (and service recipients) require guidance regarding human positron emission tomographic data analysis for some of the reagents that will be generated in the PMRC. Accordingly, within TR&D 3 will be housed the Clinical Validation Core for translational/human PET studies, complementing the pre-clinical core of TR&D 1. The techniques developed and optimized for user-friendly applications and in some cases the investigational new drug (IND) application for the agent required will be disseminated to collaborators and other interested parties through TR&D 3.

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