Anatomy Of An Imaging Biomarker

Like the drug development process itself, developing, implementing, and using imaging biomarkers is a highly collaborative multidisciplinary effort. As depicted in Figure 1, an imaging biomarker may be defined conceptually by two aspects: image acquisition and image analysis. Image acquisition refers to all activities and technologies related and leading to the acquisition of image data, such as imaging hardware operation, maintenance and quality control, subject positioning, contrast agent or radiotracer preparation, injection protocols, and physiological monitoring. Image analysis includes all postacquisition activities, such as image reconstruction, processing, quantification, and interpretation. These two aspects of an imaging biomarker require significant

Figure 1 An imaging biomarker may be defined by its methods for image acquisition and analysis. Both aspects require input from numerous scientific and engineering disciplines.

input from a diverse array of scientific and engineering disciplines, including biology, chemistry, physics, biomedical and nuclear engineering, computer science, and mathematics as well as medicine. Each of these specialties has several critical roles in the implementation and use of imaging biomarkers:

• Biologist/physiologist/molecular biologist/pathologist: help establish the biological relationship between the image- based measurement and the physiological function or disease process; help establish the rationale for studying particular image-based measures; and help interpret the quantitative results.

• Pharmacologist/physician/pathologist: help establish the clinical relationship between the imaged-based measurement and the relevant therapeutic outcomes during treatment; and help understand all possible actions of the treatment (beneficial and deleterious) [37] to aid in the interpretation of imaging results.

• Biochemist/radiochemist: provide understanding of physiological processes and molecular targets at the biochemical level; and design, synthesize, characterize, and test optical, magnetic, and molecular probes and radiotracers.

• Mathematician/statistician/computer scientist: provide the fundamental mathematical, statistical, and quantitative basis for image acquisition, reconstruction, and analysis; and provide software tools for performing many tasks associated with image acquisition, reconstruction, quantification, analysis, visualization, and interpretation.

• Imaging physicist/biomedical and nuclear engineer/technologist: provide the physical basis for imaging technologies, signal generation and detection, hardware design, and optimization; provide the technological expertise for isotope production to be used for generating radiotracers; and operate the imaging equipment, performing image acquisition, processing, and analysis tasks.

Project Management Made Easy

Project Management Made Easy

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