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Dried Blood Spot Collection of Health Biomarkers to Maximize Participation in Population Studies

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What evidence do we need for biomarker qualification?

Chris Leptak¹, Joseph P Menetski², John A Wagner³

¹Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.

Science Translational Medicine

|November 24, 2017

Summary

A new framework clarifies biomarker qualification for drug development. This multistakeholder initiative, involving government, industry, and academia, aims to standardize evidence requirements for regulatory acceptance.

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Area of Science:

Biomarkers and Drug Development
Regulatory Science
Translational Medicine

Background:

Biomarkers are crucial for efficient drug development.
Biomarker qualification by the U.S. Food and Drug Administration (FDA) lacks a predictable process.
Standardizing evidence requirements is essential for regulatory acceptance.

Purpose of the Study:

To propose a framework for defining the evidence needed for biomarker qualification.
To facilitate a clear and predictable process for biomarker acceptance by regulatory bodies.
To support broad applications across diverse biomarker categories and uses.

Main Methods:

A multistakeholder effort involving government, industry, and academia.
Development of a proposed framework for biomarker qualification.
Focus on defining the necessary evidence for regulatory approval.

Main Results:

A proposed framework for biomarker qualification has been developed.
The framework aims to standardize the evidence required for FDA acceptance.
The initiative promotes collaboration across sectors.

Conclusions:

The proposed framework can streamline the drug development process.
A clear, predictable biomarker qualification pathway is achievable.
This initiative offers a scalable solution for various biomarker types.