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# Diseases ‘Splintering into Molecular Subtypes’: Woodcock
- URL: https://www.fdaweb.com/diseases-splintering-into-molecular-subtypes-woodcock/
- Published: 2016-07-14T12:00:00.000Z
- Updated: 2026-09-14T21:14:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136181

CDER director **Janet Woodcock**, celebrating 30 years with FDA, says that in the next 30 years the pace of change will accelerate and there will be a splintering of diseases into molecular subtypes. Interviewed for an agency *Director’s Corner* [podcast](http://www.fda.gov/Drugs/NewsEvents/ucm511097.htm?ref=fdaweb.com), Woodcock predicts that placing diseases in molecular subtypes will enable the rise of precision medicine. “But it’s going to cause and is causing tremendous regulatory conundrums right now,” she adds, “because a disease is not a disease any more, and our approaches are going to have to change.”

Medicine, Woodcock says, will need much better diagnostics because something really should be diagnosed before it is treated. “As Americans, we kind of say, ‘Okay, let’s treat,’” she says. “But understanding what the disease is at the molecular level is really tremendous, and I think we’ll have diagnostics that’ll really be better probes into why people are sick, what’s wrong with them, and that would mean we can intervene better with targeted preventives. And I think prevention will become more salient over the next 30 years, and also targeted treatments that will look quite different than what we are dealing with today.”

The interview also covers breakthroughs in drug research and development that Woodcock has seen in her 30 years and breakthroughs in drug regulation and review. Asked where the next innovations will come from, she suggested they would likely be within CBER, dealing with gene therapy and tissue and cell engineering.

The key to sustaining drug innovation and development, she says, is the science. “We need the basic science, which is the engine to drive a new understanding of pathogenesis and understanding basic biology,” she says, “but then we need a lot of translational science that we’ve been pushing under the critical path initiative to understand biomarkers better and qualify them to have better trial design and so forth. And all of that is different kinds of science. And then matched with that, we have to have responsive regulation. We cannot maintain the same approaches we did in a prior era. Even though they were highly successful then and are a triumph, we have to recognize that we’re going to have to move on, too, as the science moves on. And I think that’s very hard for people, both inside the agency and externally.”