ABSTRACT

Imaging biomarkers are measurable characteristics obtained

through imaging technologies that indicate a specific biological

process is occurring in the body. Compared with biochemical,

molecular, and histological biomarkers, imaging biomarkers have

the advantage of being non-invasive as well as spatially and

temporally resolved. They provide a unique form of information

to compliment traditional techniques and measurements, including

a drug’s pharmacokinetics and distribution profile and interaction

with its target. Imaging biomarkers have the capability to provide

a direct pathophysiological correlation between disease mechanism

and therapy. The read-outs obtained using imaging biomarkers

are therefore potentially the closest analogs to clinical outcomes.

They help speed the process of drug development as the functional

imaging shows effectiveness earlier than any anatomic changes.

Additionally, the role of imaging in patient diagnostics and manage-

ment is well established. It is quite fitting that imaging biomarkers

play an increasing role in both drug development and patient care in

multiple disease areas.