U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process (Drugs)
  4. Drug Development Tool Qualification Programs
  5. CDER Biomarker Qualification Program
  6. What Are Biomarkers and Why Are They Important? Transcript
  1. Drug Development Tool Qualification Programs

What Are Biomarkers and Why Are They Important? Transcript

What Are Biomarkers and Why Are They Important? Transcript

Biomarkers are characteristics of the body that you can measure. So your blood pressure is actually a biomarker.

Biomarkers are very important to medicine in general. We’re all used to going to the doctor and getting all our test results, right, and even imaging — x-ray results or CAT scans — those are biomarkers that tell how the body’s doing, and they’re measurable.

Biomarkers are integral to drug development; they’re really critical, because we need to measure the effects of investigational drugs on people during the clinical trials. And the way we do that is to look at their effect on biomarkers. And so it’s really important that we have a wide range of biomarkers that can measure everything we want to know about the effect of the investigational drug in people.

Drug development today has many problems, and the major problem is the failure rate. So even drugs that have gone through the whole preclinical process and gone through all sorts of animal testing and all sorts of other types of assays, once they get into people, they have maybe a less than 1 in 10 chance of actually getting on the market. Nine out of 10 may fail during that development. And we have to do better than that if we’re going to accelerate the treatment availability, if we’re going to lower the cost of drug development and not have it continue to escalate, and if we’re actually going to let a lot of innovators into this space of participating in drug development.

To really improve the success rate and improve the efficiency of drug development, we need a whole new generation of biomarkers that are more informative and that can tell developers earlier whether or not their drug may have toxicity or it really may not work at all, and to get that early read on what’s going to be successful. And so those biomarkers are ones that have yet to be developed.

View more Videos and Podcasts on FDA’s Biomarker Qualification Program