Building a roadmap to biomarker qualification: challenges and opportunities

Area of Science:

• Biomarker Development
• Regulatory Science
• Drug Discovery

Background:

• Traditional biomarker acceptance in drug development requires submission within a single program.
• The US FDA's Critical Path Initiative highlighted the need for a streamlined biomarker qualification process.
• The Center for Drug Evaluation and Research (CDER) established the Biomarker Qualification Program (BQP).

Purpose of the Study:

• To describe the features of the FDA's Biomarker Qualification Program (BQP).
• To introduce new initiatives promoting early FDA interactions for biomarker development.
• To discuss submitter feedback and BQP's program enhancements.

Main Methods:

• Description of the BQP framework and its operational aspects.
• Overview of new FDA initiatives supporting biomarker development.
• Analysis of feedback provided by program submitters.

Main Results:

• The BQP allows biomarkers to be qualified for a specific context of use (COU).
• Qualified biomarkers can be reused across multiple drug development programs for the same COU.
• New initiatives aim to facilitate early FDA engagement in biomarker development.

Conclusions:

• The BQP streamlines biomarker acceptance by enabling reuse across drug development programs.
• Early FDA interactions and program enhancements are crucial for advancing biomarker utility.
• The BQP is evolving to better support drug development through qualified biomarkers.