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  1. Biomarker Qualification Program

Transcript: About FDA’s Biomarker Qualification Program

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One of the problems with biomarkers is there’s really no one in charge of developing them.

The community is divided into the biomedical research community that does discovery, the pharmaceutical industry and related industries that do development of specific medical products, and then us, the regulators, who oversee this process and set standards.

But there’s no group out there that says, “We develop new biomarkers,” and so thousands are discovered, and then papers are published about them, but the rest of the process, which has to do with—

Are they worth anything?

Are they actionable?

Can you use them to make decisions about people’s health?

For example, in drug development—there hasn’t been an orderly process whereby that would take place.

Because of this problem, a number of years ago FDA stepped into this space and said, “We can see the need for a new generation of biomarkers, and we can also see the fact that they aren’t being developed.”

And so we can’t use them as regulators. If there’s not enough information to make decisions on, we’re not going to bet peoples’ health on these, so they have to be developed.

So we said we will set up what we call qualification process.

We’ll set up a way that different groups can work on biomarkers, gather more information on them, and then we would state publically, “this is qualified to make this regulatory decision or to support this type of development program.”

The qualification process is a public process.

What we are seeking at FDA is public adoption of new biomarkers by the scientific community, and that would mean that anyone who was doing a trial, say, and wanted to monitor kidney safety or do enrichment, they don’t have to go through evaluating the biomarker, seeing if it’s fit for purpose in their development program, doing preliminary work on it, and all that.

It’s all laid out there in the data.

The evidence underlying the biomarker will also be available.

So if a company, a sponsor, patient group—whenever they want to use that biomarker for something, all the evidence will be gathered, and they’ll see whether it’s fit for purpose.

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