Published on Jan 20, 2021

Video Transcript

[MUSIC PLAYING] JOHN WHYTE: Hi, everyone. I'm Dr. John Whyte, Chief Medical Officer at WebMD, and I'm continuing my discussion today with Dr. Rick Pazdur, who is the director of the Oncology Center of Excellence at FDA. You've also been a big proponent of same inclusion criteria or sometimes needlessly restricted. Are you pushing more about, perhaps liberalizing inclusion criteria or showing more regulatory flexibility as you're doing with COVID? Let's talk about COVID, and how that might play into it all, because we're saying it's even harder to get people in clinical trials. Do we need to be doing clinical trials at home? Some people are talking about that, something that we never thought about or making them less intrusive?

RICHARD PAZDUR: Yes, yes, and yes, OK? So let me talk about COVID, because how could you have a conversation-- a medical conversation today--


JOHN WHYTE: I can haven't talked about it at least 10 times today.

RICHARD PAZDUR: So this is a tremendous social disruption as well as disruption in the entire medical system, especially with the close down of the hospitals to routine medical care that occurred in the earlier part of 2020. So we took some very proactive steps. While the agency was doing COVID, COVID, COVID, COVID, we had to be ensuring that we were taking care of the cancer patients and the cancer community. And we felt that there was a tremendous need to really emphasize the really need to still approve drugs and write guidances dealing with oncology, and also have listening sessions with the community.

So we had probably between 12 and 15 listening sessions with patient groups, individual patient groups, established patient groups, the disease orientated special patient groups, ASCO, AACR, all stakeholders. And what we heard universally was something very disturbing. And that was the cancer patient or the patients with cancer telling us, we are the forgotten patients, OK? We're dealing with this disease. If you could imagine somebody dealing with cancer, the unknown that exists with cancer.

What's going to happen to me? What are the side effects? What's going to happen? How am I going to get my CT scan? Why can't my wife come with me to my doctor's appointment? All of these--


JOHN WHYTE: What did you do?

RICHARD PAZDUR: Yeah, well we did several things. First of all, hearing them is one important thing. And I'm not diminishing that because I think that's important in recognizing it. Secondly, with clinical trials, which we have some supervision over obviously, we would allow some decentralization of procedures, ways of obtaining informed consent. Moving forward, we want to emphasize that we want COVID patients or patients that have had a COVID and have obviously recovered and that will go on to cancer to be included in clinical trials. And we actually want to take a look at those patients to see an analysis if they have a different safety profiles when they are exposed to drugs.

In addition to that, we are very interested in looking at the approved cancer drugs and seeing what side effects-- what adverse effects that patients with cancer experience after they have recovered from COVID. As you are aware, many of the sequelae of cancer, for example, DVTs, pulmonary toxicity, cardiac toxicity, neurological toxicities, those, I should say, toxicities adverse events associated with COVID, because that affects those organs-- those have counterparts of toxicities of cancer drugs.

So for example, if you gave a patient with cancer that is receiving, for example, a imod that's being used for treatment of multiple myeloma, would they have an increased incidence of DVTs or thrombotic activity? Likewise, drugs that caused pulmonary toxicity, if patients have recovered from COVID and they receive these drugs, will they have a greater incidence of pulmonary toxicity? And the way we're doing this is we're talking, and this is very preliminary work at the present time, but with the major pharmaceutical firms to take a look at obtaining this through real world data.

JOHN WHYTE: Do you think that decentralization and regulatory flexibility will continue post-COVID?

RICHARD PAZDUR: Yes, I really do. I think COVID has taught us many things, how we work, for example. I have been always a proponent to minimize flexi place and now I could be the biggest supporter of it because I've realized how important it is. But there has to be certain frameworks. Everybody on the same platform have people in the room and people on the phone, so to speak but everybody has to be in the same platform. Likewise, if everyone uses the same flexibility in terms of decentralization of trials, I think that's going to be very important.

I think we have the flexibility. Will the pharmaceutical firms, in turn, have that flexibility internally as they construct their trials with their CROs? Here again, we see many times them collecting much more information and making many more visits to investigator sites than we would deem necessary. They could control the quality of their data. They can't control the outcome, so to speak, so they invest a lot of time and energy in controlling that data quality. Here again, I'm not against good data quality but we're not demanding perfection here. We realize that there's always going to be some degree of missing data.

JOHN WHYTE: We think it's been the role of artificial intelligence and machine learning, has it helped as much as people are saying in terms of finding new indications, the role of predictability? What's your take on the role of Ai machine learning.

JOHN WHYTE: I think [INAUDIBLE] where we go with two things. Number one, new drug development and new targets of therapies, how to drug very rare diseases that share common targets with common diseases, for example. And also, on analysis of safety and subgroups of patients, where we'll be able to get greater granularity with artificial intelligence in this area. But I see this as a work in progress.

JOHN WHYTE: Do you think we'll be doing cancer clinical trials in the home?

JOHN WHYTE: Yes. I could see that. I could see that.

JOHN WHYTE: We never thought that a few years ago. But that's even about all possible.

RICHARD PAZDUR: No, I think that that would be possible, where people will-- well you see that now with telemedicine. Who would have thought you would just call the doctor and just communicate as we're communicating. And I think if we are honest with-- in oncology and many diseases, the physical exam is important but most of the time, doctors have the laboratory evaluation done before the visit. There's Echocardiogram, if you're seeing cardiologist. So most of that information is already there. And they're going to rely on that information.

I think it just speeds up the entire process of instead of taking an entire day off of work, you could spend 15 minutes on a computer talking to the doctor and probably get the same result. Obviously for some situations, that is not going to be a situation where you need to do a detailed physical examination on a patient. But that is not always the case.

JOHN WHYTE: What is cancer drug development look like five years from now?

RICHARD PAZDUR: I think we're going to see more targeted therapies. My hope-- my sincere hope is that we will see a continuation of the advances that we have seen in tumor immunology. I think that this is a major area of growth. I have been very impressed with the checkpoint inhibitors PD1 drugs and other checkpoint inhibitors of the diversity of the diseases that they have affected and have had a positive effect in. And I think we've learned how to manage the toxicity.

Again, I think it's going to be very instrumental how we select patients. But I hope that we will be able to move beyond the PD1 story to the next class of drugs or the next understanding of immunological diseases. If you would ask that question, John, of where we would be in 20 or 30 years, I would like--


JOHN WHYTE: I was going to.

RICHARD PAZDUR: I would like to answer that question for you.

JOHN WHYTE: Yeah, sure. Let me hear it.

RICHARD PAZDUR: Because after, as I tell people my only regret of the medical oncology at oncologist at this time in practice for 40 years is that I will not be here for the rest 40 years.

JOHN WHYTE: Well, you never know.


RICHARD PAZDUR: --but just myself.

JOHN WHYTE: You cannot be the director of the Oncology Center [INAUDIBLE] So what does it look like in 20 years?

RICHARD PAZDUR: I think what we'll do-- I think you're going for a physical examination and collect some blood on you and there'll be some circulating DNA in your system. You won't be able to find where the tumor is, OK? It just won't be visible, OK? And probably do a routine test on you. You can't see anything, but there's circulating DNA. They'll give you some type of immunological therapy to turn on your immune system, measure it, measure the circulating DNA in your system, and then cure you of the disease. Because we know that all therapies are better in the earliest stages of disease rather than an advanced disease when you could see it on an X-ray. And that's where I think we will be in the next millennium.

And that's why I think we I have much, how should I say it, higher feeling potential for the immunological therapies rather than the targeted therapy, looking at specific molecular targets. Once these targets exist, and the tumor is established. Yes, I think we will have advances there. But the true advances in medicine have generally occurred through immunological advances such as smallpox vaccines and polio vaccines, the scourges, even the coronavirus.

JOHN WHYTE: We were talking monoclonal antibodies. mRNA.

RICHARD PAZDUR: Now, the climb out of this pandemic is going to not be through a therapeutic, it's going to be through the prevention of the disease.

JOHN WHYTE: I'm not sure it's going to take 20 years Dr. Pazdur, because we already have some laboratory research looking at blood tests to look at some proteins, et cetera the cancer cells--

RICHARD PAZDUR: None. You may be right. I only am a poor medical oncologist. I am not a fortune teller. If I was a fortune teller, I'd be playing the stock market.

JOHN WHYTE: There you go. Well, Dr. Pazdur, I want to thank you for taking the time to speak today. I was telling people earlier today I'm interviewing an icon of cancer of research in cancer development.

RICHARD PAZDUR: But that does that mean, I'm like Kerr or Madonna?

JOHN WHYTE: It does. You can take it that way. But you really have been a leader in advancing drug development, of getting drugs approved, and saving people's lives, improving the quality of people.

RICHARD PAZDUR: Well, John, I'd just like to say, it's not about me, it's really about the people that I work with. And I have just had a tremendous ability to have a first class team of people that are oncologist and are scientists that work with us and our support people our administrative people that have provided an environment to do this.

JOHN WHYTE: But you're demonstrated the leadership as well. And having worked there, I know how difficult it can be at times. So thank you for all that you do.

RICHARD PAZDUR: OK, thank you, John.