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Biomarkers

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.

EARLY PHASE

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.

LATE PHASE

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:

About BioMolecular Imaging


BioMolecular Imaging (BMI Consultants) is a molecular imaging and clinical trial consultancy owned and operated by Dr. J. James Frost M.D./Ph.D out of Baltimore Maryland. BMI has been involved with clinical, therapeutic & diagnostic imaging focused on Oncology, Brain, Biomarkers, Cardiology and Central Image Interpretations for over 20 years.


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