Updated: Feb 21
A very active area of current investigation and commercialization is molecular and functional biomarker development. These biomarkers can serve as surrogate endpoints for therapeutic efficacy and are increasingly viewed by the FDA as highly desirable. Attractive features are reduced trial size, shortened completion time, and reduced cost. Biomarkers can also be extended to use as diagnostic agents, either as stand-alone probes or in combination with therapeutic drugs in order to stratify patients for treatment and outcome monitoring.
Biomarkers are frequently being included in early-phase clinical trials as a very active area of current investigation and commercialization. Both molecular and functional biomarker development can serve as surrogate endpoints for therapeutic efficacy and are increasingly viewed by the Food and Drug Administration as highly desirable.
In late-phase trials, there are two types of biomarkers used to evaluate or predict outcomes - prognostic and predictive.
Overall, molecular and functional biomarker development remains a very active area of current investigation and commercialization. These biomarkers can serve as surrogate endpoints for therapeutic efficacy and are increasingly viewed by the Food and Drug Administration as highly desirable.
Please read these articles by the Founder of BioMolecular Imaging, Dr. J. James Frost:
Brain Amyloid and Inflammation Imaging: A Convergence of Concepts
Bridging the Preclinical - Clinical Divide in Translational Imaging: The Push, Pull and Pitfalls
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