Online Program

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Thursday, September 13
Thu, Sep 13, 11:45 AM - 1:00 PM
Various Rooms
Roundtable Discussions

TL34: Regulatory Pathways and Design Considerations in Development of Biomarker-Guided Therapies (300612)

*Alexei Constantine Ionan, FDA/CDER 

This roundtable discussion explores regulatory pathways and design challenges in biomarker-based clinical trials to facilitate development of biomarker-guided therapies.

The 21st Century Cures Act includes provisions for drug development tools, codifying FDA’s role in qualifying biomarkers. We will discuss regulatory pathways and study design considerations for biomarker incorporation in drug development.

What are the most pressing current challenges in development of biomarker-guided therapies?

How can FDA and Industry facilitate development of biomarker-guided therapies?