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  1. Biomarker Qualification Program

Making Biomarker Development Successful Transcript

Biomarker development and qualification is important for all the sectors in the biomedical research community, not just the FDA. It’s important to the companies, because it will help streamline drug development, make it more efficient and more informative. It’s important to the biomedical research community, because after all, just publishing these biomarkers isn’t that helpful; we need to understand their utility.

So developing a pathway of how you understand their performance and actually use them in decision-making is critical.

And then finally, of course, this is for the patients to help not only speed therapies but make us understand what therapies they’re getting better and how it’s going to work in them. So what we’re asking really is that the community—biomedical research community—participate, and they work with us, they work on the evidentiary criteria, step up to the plate as far as giving their data so that it can be combined and used in qualification efforts.

This effort really is going to take a village: We need the biomedical research community to participate, pharmaceutical industry, diagnostics industry. The nonprofits really to a great extent are leading this. We need the worldwide regulators to be on board, which they are so far, and other public/private partnerships overseas. And we need patient communities; they’ve actually stepped up to the plate and have driven a number of these qualification programs.

So to make this successful, everyone is going to have to engage. We need every group out there to step up to the plate and commit. If you’re doing a clinical trial, can you add on a biomarker so we can learn more about it? If you have clinical data, will you contribute it to this effort so that we can collectively learn more and it won’t simply be cabined away somewhere? If you are a nonprofit patient group, and you really have a passion for advancing treatments in that disease, can you spearhead an effort? Is there some gap or unmet need? And if you’re a researcher and you know you have a biomarker, then can you help get it down the path of really understanding how it works? That’s what we need from the community.

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