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Extended Interview: Janet Woodcock Discusses Cancer Biomarkers

Dr. Janet Woodcock, chief medical officer of the Food and Drug Administration, discusses how cancer biomarkers may change cancer screening and treatment.

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  • SUSAN DENTZER:

    What do biomarkers mean to FDA in terms of the future of drug discovery, diagnostics, therapeutics for patients, particularly patients suffering from cancer?

  • DR. WOODCOCK:

    Well, cancer is probably the most promising field right now for biomarkers, and from FDA's point of view, I think biomarkers are the future of medical therapy, both for diagnostic purposes as well as for cancer therapeutics. And it's going to be a very challenging road ahead in getting this new science of biomarkers into medical products the doctors and patients can actually use, but that is the future we need to move toward.

  • SUSAN DENTZER:

    And why is it the future?

  • DR. WOODCOCK:

    Because these new markers get to the mechanism of cancer. They get to the actual causes in the cancer cells of what's gone wrong, why they've turned into cancer cells. They provide a lens, a new way of looking at people so we could determine they have cancer earlier, diagnose earlier, as well as pick the right treatment.

  • SUSAN DENTZER:

    Let's talk about FDA's Critical Path Initiative, what it is, and how biomarkers fit into it.

  • DR. WOODCOCK:

    The Critical Path Initiative is the track that a new innovation, an idea, scientific idea has to follow from the laboratory, to actually get in the hands of doctors and patients. It has to go through a whole series of steps that we call the critical path. And the Critical Path Initiative is attempt to bring more science and pull those innovations along in a rigorous, safe, and useful way and move them faster into the hands of doctors and patients.

  • SUSAN DENTZER:

    And the role that biomarkers will play in that is what?

  • DR. WOODCOCK:

    Biomarkers are extremely important in the critical path because at every step of the way we need new biomarkers to predict whether or not a product is going to be safe enough, whether or not it's going to be effective, who it should be used in, and how to manufacture it properly. And biomarkers play a role in all of these critical steps that have to be taken.

  • SUSAN DENTZER:

    And they play a role in two senses, both in the diagnostic sense and in the therapeutic sense. Would you elaborate a bit on that?

  • DR. WOODCOCK:

    Yes. Well, biomarkers can be turned into diagnostic tests, of course, and those tests can be used to either detect, for example in cancer, detect a tumor much earlier than the kind of tests we use now, or they can be used to direct therapy. Or they can be used to say you are a patient who is at high risk for a side effect, and we shouldn't give you this therapy. So biomarkers can really help us make treatments safer.

  • SUSAN DENTZER:

    So they really are, as you say, just opening up a whole new world of understanding the disease and how to treat it.

  • DR. WOODCOCK:

    That's right. And it becomes – because all the science that we've invested in over the last 30 years, all of the medical advances people read about in the paper, they are now at the point where we can actually use them, turn them into real diagnostic tests that doctors can use on patients, looking at the proteins in their body, looking at the genes in their cancer cells and how they've mutated, looking at images of their cancer in ways we've never been able to do before, to tell us all kinds of new information.