Your surrogate endpoint biomarker could take nearly 4 years to qualify under the FDA's Biomarker Qualification Program—if it even makes it through.

New data from Friends of Cancer Research reveals a sobering reality about the FDA's Biomarker Qualification Program:

→ Median qualification plan development: 32 months
→ For surrogate endpoints: 47 months
→ Surrogate endpoints qualified through the program since 2016: 0

Here's what this means for drug development:

If you're banking on qualifying a novel response biomarker through the BQP, you're likely facing years of delays—with no guarantee of success.

Meanwhile, your program is burning capital. Your investors are asking questions. And patients are waiting.

The better approach?
Build your biomarker strategy around what's already validated—or prepare for a marathon, not a sprint.

Are you evaluating biomarkers in a way that can actually deliver within your program's timeline?

Read more - article linked 👇

https://link.springer.com/article/10.1007/s43441-025-00889-6