Introduction: Welcome to the director's corner, an audio podcast series featuring the director of FDA Center for Drug Evaluation and Research.
Anne Rowzee: Hello. I'm Anne Rowzee from CDER’s Office of Communications. In this session of the director's corner, we're celebrating a milestone in Dr. Woodcock's career, 30 years of federal service at the FDA. We'll talk about the breakthroughs she's witnessed, some of which she perhaps pushed across the finish line. And we'll also ask her to share some of her predictions for the future of drug products. Hi, Dr. Woodcock. Congratulations on your anniversary.
Dr. Woodcock: Thank you.
Anne Rowzee: Okay, so let's dive in. What are some of the breakthroughs you've seen in drug research and development during your time here at FDA?
Dr. Woodcock: Well, it is interesting when you've been here a long time. I mean, when I started, they were talking about recombinant DNA, and it was very scary, right? So we had some of the first recombinant proteins, were coming to the market at the time that I started at the FDA. Also, monoclonal antibodies, and it's taken them a very long time but now they're really taking off. But during that time, it was, you know, a struggle with the monoclonal antibodies, but it was a completely new technology. And now, it switches to where we're in genetics and molecular medicine and it's a whole new world. But it's been evolution over that time.
Anne Rowzee: So on the flipside of that, let's talk about breakthroughs you've seen in drug regulation and review.
Dr. Woodcock: Well, at the early stages of my career here, the AIDS epidemic was raging. And that was the time when we put into place accelerated approvals. And, of course, that was very controversial at the time, um, but it was very good. We ended up helping control the epidemic by getting antiviral drugs out there and so forth. And then in the late '90s and early 2000s, although we had a lot of controversy about safety, we really revolutionized the safety review, and it really nowadays has, I think, almost no resemblance to what we did before. It's a really a very detailed safety review, and we learned so much about some of the common safety problems like drug-drug interactions. We're able to predict drugs that cause liver failure and so they don't get on the market anymore, and we have the screening for drugs that influence cardiac repolarization so those are screened out early or, or dealt with. So, there's been a real change in safety review. And what was happening in the '90s with recalls for things we didn't anticipate now happens rather rarely because the development programs and the analysis can predict that.
Now, linked to that is the rise of clinical pharmacology. That was started by my predecessor, Carl Peck. And but nowadays, we really understand much better drug exposure. We understand all the different factors for a drug that lead into different changes in exposure, like whether eating a meal or not or for an oral drug or whether you're male or female or all these different things, body size, kidney function, liver function.
So we're a much greater lens, and we really understand a lot of, about the response, too. And so recently, one of the innovations has been the breakthrough therapy program that we have which is really in response to some of the new science and some of the very effective drugs that are coming on, like drugs that can cure Hepatitis C.
Anne Rowzee: Yes. So, which field do you think is on the cusp of its next revolutionary innovation?
Dr. Woodcock: Well, I think there are a couple, and they're actually not in CDER. I think that the biologic center's probably bracing itself for gene therapy finally coming of age and tissue and cell engineering of different kinds. I don't think that's quite as close. I think there's a lot of work, but that will be a revolution when it happens, and that'll be very exciting. Not that drugs are gonna be left behind. There are gonna be a lot of innovations in drug therapy as well.
Anne Rowzee: So what do you think is the key to sustaining innovation in drug research and development?
Dr. Woodcock: Well, in my mind, it all comes down to the science. We need the basic science which is the engine to drive a new understanding of pathogenesis and understanding basic biology, 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.
Anne Rowzee: All right, so I'm going to ask you now to make sort of a long-range forecast. How do you think drug products and medical practice will be different 30 years from now?
Dr. Woodcock: Well, nothing like having had a 30-year run to try to look at the next 30 years. But, I'll tell you, a lot is gonna happen. A lot is going to change, and the pace of change is accelerating, which is difficult, of course, for all of us to deal with. I think first we're going to see the splintering of diseases into molecular subtypes, and this will enable the rise of precision medicine, but it's going to cause and is causing tremendous regulatory conundrums right now because a disease is not a disease is not a disease anymore, and our approaches are going to have to change.
For medicine, I think we're going to have much better diagnostics. We have to remember that for medicine, diagnosis is the key. You should really diagnose something before you weighed in and treat it, okay? But as Americans, we kind of let's treat, okay, let's treat. But understanding what the disease is at the molecular level is really tremendous, and I think we will have diagnostics that'll really be better probes into what's made, why are people sick, what is wrong with them and, and that would mean that we can intervene better with targeted preventatives. And I think prevention will become more salient over the next 30 years, as time goes on and also targeted treatments that'll look quite different than what we are dealing with today. So, I think it's very exciting and that the future of translating science by medical science into therapeutics is going to be very bright.
Anne Rowzee: Okay, well thank you so much for talking with me today. And I'll just check back with you in 30 years, and we'll check on these predictions.
Dr. Woodcock: That'll be great.
Thanks for listening. For more information about what you heard today, please visit our web site at www.fda.gov/drugs