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  • Dr. J. James Frost

Biomarker Consultants | Early Phase

Updated: May 10

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.

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.

New strategies of drug development highlight the importance of making very early decisions on the success likelihood for a therapeutic candidate, ideally in phase I or early phase II.

Biomarker imaging can often meet that goal by demonstrating organ and target bioavailability and knowledge of the dose-target occupancy relationship.

Accordingly, key go/no-go decisions can be made early on in the development chain and if the candidate features are poor, large expenditures for future phase III trials can be avoided.

“Those recovered financial resources can then be channeled back into research in order to bring new drug candidates forward.” - Dr. J. James Frost, Owner of BioMolecular Imaging

BioMolecular Imaging can guide your company through this process and enhance understanding of your candidate drug molecule’s physiology and pharmacokinetics at the target site.

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.

To learn more about BioMolecular Imaging, please visit or connect with:

Copyright © 2022 BioMolecular Imaging

BioMolecular Imaging is a registered trademark of BioMolecular Imaging D.B.A. BMI Consultants

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