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Transcripts - Conversations on Cancer: Seasons of Change: Oncology Careers

Elaine Chang:

Welcome to the FDA Oncology Center of Excellence Conversations on Cancer Public Discussion series. Today we are thrilled to bring you a conversation titled Seasons of Change Oncology Careers. We have a fantastic group joining us today. Oncologists who have traverse career changes to and from academia, government, industry, community practice, education, administration, and retirement. I personally have had a longstanding interest in understanding how to build meaningful professional life and having an open mind about how that might look in different seasons or stages of life. We all go through chapters of life that could be defined by family situation, a shift in priorities or maybe even the whole profession changes. So in one of our division directors, Harpreet Singh proposed the idea of this conversation coming from an interest in the social aspects of how oncologists make career decisions later in life, I said, I want to make this happen. So now I want to thank our audience for joining and turn it over to OCS director Rick Pazdur to welcome you to the program.

Richard Pazdur:

Thank you, Elaine. It's really a pleasure to be here. Conversations on Cancer is a ongoing series that we have in the Oncology Center of Excellence and basically it is designed to bring social issues and the convergence of social issues in oncology together. And this is one of many topics that we have throughout the year and really welcome our panelists here. This is something that I have been looking forward to for many years. Many of the people that are on this panel I have known throughout my career and our careers have intersected throughout a period of 30 to 40 years basically here in various roles. And it's going to be interesting to see how people view changes in oncology over their careers. Why they went into the field. Oncology was a much different subspecialty when many of us entered the field. It was really in its embryonic form and it's blossomed into a field that I never imagined it would in, when I started in medical oncology in 1979.

So it's going to be really a fascinating discussion to hear many of these leaders that we have organized or have come to this symposium to give us a glimpse in their career of why they went into oncology. What they thought oncology would look like when they started their careers. What were anticipated changes that they saw coming. What regrets possibly they had. What positive things that they viewed. And obviously at the end we want to hear of their perspectives of what they see the future of oncology being. So I'll turn it over to back to Elaine and we can begin this discussion and perhaps we should start with everybody introducing themselves.

Elaine Chang:

Thank you, Rick. Yes, let's introduce our panel. I'm going to call on each of you and ask you to introduce yourself, give a high level summary of your career journey, just the institutions, the types of work you've done. We'll get to the interesting details later. And as always, these conversations are meant to be fun and informal like we're chatting in a living room, so we'll go by first names. Let's start with Carole.

Carole Miller:

Hi, I'm Carole Miller. I started as a laboratory tech in the laboratory of immunology at the NIH. Was blessed to work with an oncologist and an immunologist who I eventually went to work for the FDA and then changed my decision from what I wanted to do and decided to go to medical school to become an oncologist. After medical school I did a residency and fellowship at, I went to Maryland, then went to Hopkins for residency and fellowship in medical oncology. I joined the transplant program and stayed at Hopkins for a total of about 18 years where I did mainly new drug development and supportive care for patients with hematologic malignancies.

After about 18 years at Hopkins, I had a sort of a major career change. I left Hopkins but stayed in Baltimore and moved across town to run a mid-sized community cancer center, which is part of a large network of hospitals called Ascension Health. And I have been there since. I am thrilled to be part of this panel and hear about all, everybody's experience.

Elaine Chang:

Thanks Carole. How about Karen Next?

Karen Antman:

I went to Columbia Medical School and one of my classmates got Hodgkin's Disease. Actually it was a classmate from college and went down to the NIH for a study. This is back in the mid-seventies. And he showed up again in September the following year and I very untactfully said, what are you doing here? Because he had had stage four Hodgkin's disease. And he said he had gone down and gone on experimental treatment for his Hodgkin's disease and his cohort was doing very well, thank you very much. And I thought this was spectacular. This was, and somebody with an invariably fatal disease that then got a relatively new drug development combination chemotherapy and he actually subsequently did great. So I went into medical oncology, trained at the Dana-Farber Cancer Institute and stayed there for 16 years on the faculty doing sarcomas, mesotheliomas and breast cancers, bone marrow transplants, supportive care.

We had program project grants. They taught me how to be an investigator. Our teams got larger. I was recruited to Columbia as a cancer center director, Columbia University back where I started medical school. Stayed there for 13 years as the cancer center director. Really enjoyed that. And from there to the NIH in the National Cancer Institute where I was deputy director for Clinical and Translational Science for a couple of years before being recruited as a dean at Boston University School of Medicine. And certainly the training as, in cancer lab clinical public health, it's exactly what cancer centers do. It's the perfect training to be a dean. So multiple different parts of a career changed over time and you get to reinvent yourself every decade.

Elaine Chang:

Love that, reinvent yourself every decade. So let's go to Mace next.

Mace Rothenberg:

Hi, Mace Rothenberg. My first month of internship at Vanderbilt was spent on the hematology oncology unit. And at the end of that month it was interesting because there were three of us who were just fascinated by what we were doing that wasn't able, wasn't possible just a few years before. And all three of us ended up going into hematology oncology. There were another three who basically said, you're kidding yourselves. You're just making sick people sicker before they die. And they went into other specialties in this. And so it's interesting how one's first rotation in the residency can have a big impact. So after residency I went to the NIH for my fellowship. I stayed on for three more years, getting experience in clinical and translational research. I worked as special assistant to the director of Bishop Cancer treatment, Bruce Chabner, and became really fascinated with new drug development.

I was then recruited to the University of Texas, San Antonio, so right down the highway from MD Anderson where Rick was. And we were both working in the area of new drug development in GI oncology and was there for seven years and really enjoyed bringing two drugs from phase one early development all the way through FDA approval, gemcitabine and [inaudible 00:08:12] . And both of those happened to be involved in GI cancer. So that kind of now made me somewhat of an expert by default of new therapies for those diseases.

In 1998, I was recruited back to Vanderbilt to lead the phase one program and also got involved in translational research in GI cancer through the SPORE brand from the NIH. So really enjoyed doing that and envisioned myself having a long happy career in academia. But then in 2008, the phone rang and it was a unexpected opportunity to actually lead oncology clinical drug development at Pfizer.

And after thinking long and hard about a transition from academia to industry, decided that I could make a even bigger impact than what I was doing working within industry. So I was there working, leading oncology clinical drug development for 10 years during which time we brought 11 new cancer drugs to the market. And then in 2019, I was asked to become chief medical officer for Pfizer, a time that coincided with the development of the COVID vaccine. So I had a front row seat for that. I retired from Pfizer and full-time employment in March of 2021. And since that time I've kept myself busy in science medicine and drug development through various boards, consulting and other activities. So really pleased to be here today. Thank you.

Elaine Chang:

Thank you. And Melanie, next

Melanie Royce:

Thank you. It's really a pleasure to be with these esteemed colleagues. I started really in the late 1980s to early 1990s with a PhD at the University of Cincinnati. And my work was really on carcinogenesis and neurogenesis. So what do you know? I'd end up in oncology sort of, I didn't know that then, but after my PhD actually overlapping some years I was also taking a degree in medicine. And at that point after my residency, I said, I'm going to oncology. There were five of us in the group that were going to oncology and they thought we were nuts. Why would you go into oncology? And I actually remember telling some of my colleagues, you wait in the future, oncology will be it. And what do you know? It was very prophetic because many changes, we were understanding cellular processes faster than you can keep up.

And that was really my inkling that something big is going to happen in oncology. And my husband told me enough of this cold weather, find somewhere to train where it's warm and what do you know? MD Anderson? That's where I went and that's where I met Dr. Pazdur. I stayed at MD Anderson after my fellowship at the breast department. And I thought I would have a career in academia for the rest of my life. And perhaps the majority of that would be at MD Anderson. Several of my mentors were in MD Anderson for a very long time. But Dr. Cheryl Willman from the University of New Mexico called me and said, listen, you are needed here. Here you can have an impact on the lives of people who need an NCI designated cancer center. Those words resonated very well to me.

And so I moved from Houston, Texas to the University of New Mexico. I was there for 17 years. I was asked, really, I was one of the first recruits for them to convert from their P20, which is their cancer center planning grant to their P30 grant, which is for NCI designation, and then eventually a comprehensive cancer center designation. And that was an experience that I find very invaluable. So from being director of the breast program and then eventually running their research office or the being chair of their PRMC.

And then eventually things happened in my personal life that we can talk about that, that made me think, wait a minute, I'm not getting any younger. I barely see my husband. Actually, he also worked at the cancer center and that's the only place where I saw him awake. At night I saw him asleep. So I said, there's got to be a change in my life. And then where else could I be in public service? And come to mind FDA, I knew Dr. Pazdur. I knew he had a career that was very fulfilling. And so I think that this was the right move for me and I'm very happy with that move.

Elaine Chang:

Thank you, Melanie. And last, but certainly not least, Phil?

Phil Bonomi:

Thanks Elaine. I was a second year resident at Geisinger Medical Center in Danville, Pennsylvania when the United States Navy invited me to join them at the Philadelphia Naval Hospital as a general medical officer. And when I first got that news I, oh my goodness, I want to finish my residency, so on and so forth, turned out to be probably one of the most important points in my life. I had two years of being a general practitioner and there I realized I wanted to subspecialize. What did I want to subspecialize in?

Well, finally I thought, cancer. If you do something for a cancer patient, that really has a big impact. Plus one of my mentors in my residency was an oncologist who was kind of a role model for me. So I decided to pursue a fellowship. I went back to my hometown of Chicago and I was a fellow at Rush University Medical Center, two years in medical oncology.

I'm definitely an old dinosaur in today's day and age because I stayed at that institution for a total of 47 years. And when I finished my fellowship, I was asked to stay on the staff. And I did that and I was a general oncologist and I eventually evolved more and more into a thoracic oncologist. During the first 15 years, I was participant in ECOG studies and GOG studies, cervical cancer. And then in 2002, I was asked to be the director of the section of medical oncology. I wasn't really looking for a leadership position, but I thought, well, I could help the people, I could help them mentor the people in the section and then I could help the section grow. So I took that and I stepped out of doing cooperative group work. I still did clinical trials and throughout my career I saw a lot of patients every, pretty much, I had periods where I saw patients five days a week, inpatient, outpatients and inpatients too.

So one of my recommendations to people is a little more balance. I was a little too heavy on the clinical and not as heavy on some of the other things. And then during, as a director of the division, I still saw a lot of patients, still participated in clinical trials and investigator initiated trials at Rush. And then in 2016, I stepped down as the director of the division, continued to work for another five years as an oncologist, and I became more interested in database studies and in cancer cachexia.

And I retired in June of 2022. And since then I've continued to work on some of our translational, translational research projects related to cancer cachexia. And so I like doing this and I don't regret for one second having made that decision to go into oncology.

I've learned last, one last thing, teaching. I love teaching. We did it kind of as a preceptorship at Rush. You signed a fellow and they'd worked with you for that whole year. And one of my greatest satisfactions is seeing the people who have gone on at, with Rick being an example of that, so highly successful, has done so much good for the field of oncology and many others have too. So that was very gratifying.

Elaine Chang:

Wonderful. I'm hearing a theme I think of...

Richard Pazdur:

What about me? I'm always forgotten. I'll come back to that forgotten story. Okay. Because there's a story there.

Elaine Chang:

Rick. Yes. Let's let's hear your story. That one is great.

Richard Pazdur:

Well, I never was going to go into oncology. Okay? I was all set and signed up for a cardiology fellowship. And I was at an institution where cardiology reigned supreme. They ran the entire hospital in the 1970s, okay? It was a cath mecca, so to speak. And I was one of the cogs in that cath mecca and, cardiac catheterization I'm talking about. And during my residency, my last year of my residency, after I was all signed up for my cardiology fellowship, they said, Rick, since you're going into cardiology, why don't you take three months in the cath lab because we have an opening there and we could really use you there and you could get a feeling of what cardiology is like. Well, I did the cath lab for three months and I said, I can't do this for the rest of my life. This is the most boring thing in the world to be stuck in this basement with a lead apron sticking catheters in people, and describing their coronary arteries basically.

And it was like, I can't, just can't do this. So I was scrambling because I had already signed up for my cardiology fellowship for another area, and I was taking a oncology rotation in a community hospital. And I said, this is kind of interesting, and it's kind of a new field here, and I've got to find out if there's any openings. So I went down to the gift shop and got $10 worth of quarters, went to the phone booth, that was the phone booth in 1970s, closed the door and just started calling up all of the programs. And I called up Rush Presbyterian St. Luke's, and lo and behold, they had an opening, like somebody dropped out. So I said, I'll take it. It's from Chicago. I don't have to leave. And that's how I got into oncology basically. And I've never had any regrets after that.

I did two years with Phil in the program there. And to give you some idea that Rush was the largest program in the city at that time. And it had, I believed only 12 medical oncologists. And I always say, I couldn't believe they actually had one person that specialized in only one tumor. And that was Janet, the late Janet Walter. And I couldn't believe that somebody could be so subspecialized just to do one tumor. It was like anathema to me. But anyway, I did oncology for two years at Rush, and then another year at University of Chicago doing hematological malignancies and other solid tumors also. And I happened to pick up a New England Journal of Medicine Want Ads, and I saw a want ad for a faculty position at Wayne State in Detroit. I had no idea. I had never heard of Wayne State before other than sending some patients for phase one studies there and discovered they had a fantastic program that was probably larger than anything in the city of Chicago.

It had about 40 or 50 medical oncologists at that time with departments specializing in various diseases, breast cancer, lung cancer, GI malignancies, et cetera. And was on the faculty there for eight years. I ran the fellowship program there and I echo Phil's comments that it's very rewarding to see your trainees blossom. And then opened up the want ads again and saw one ad for MD Anderson. Telephoned an old mentor and he said, come on down, Rick.

And I spent 13 years there and was very happy again running the phase one drug program there, as well as some colon cancer research programs there. And was intent on spending my entire life at MD Anderson. I had come with some of the pharmaceutical companies to the FDA to sell the FDA on some of the drugs that we were working on, okay? So I know what it's like to be on the other side of the table. And then again, guess what happened? I was looking at the New England Journal of Medicine want ads, and I saw an advertisement wanted a director of oncology, and I said, huh, this has potential. So I applied in 1999, and the rest is history, so to speak. So I'll leave it at that.

Hey, could I tell a story about being forgotten?

Elaine Chang:

Oh yes.

Richard Pazdur:

You forgot me. Okay. And this Phil will understand. Okay. This was after I was, I graduated, I was completing my fellowship at Rush Presbyterian and they had this big, the guy that run the program used to have these big parties in the physician dining room where they serve these jumbo shrimp cocktails and all of this fancy food. And the guy got out, stepped up on the chair and was reading everybody's accolades of all of the fellows. So he went over this fellow that was graduating, that fellow was graduating, that fellow was graduating, and he said, let's give everybody a hand here. Applause and welcome our, congratulate our graduating class. Guess what he forgot? He forgot me. I didn't say anything and I just left the party, pissed off obviously. And you know who that was, Phil? I want...

Phil Bonomi:

Oh, I do.

Richard Pazdur:

And he was so embarrassed he called me into his office and had a party, especially for me. So that's my forgot...

PART 1 OF 4 ENDS [00:23:04]

Richard Pazdur:

So that's my forgotten story. Which you forgot about, Elaine.

Elaine Chang:

Yes. You're a co-moderator, but you have as much experience to share as any of the panelists. So I'm hearing from a lot of you that things did not necessarily turn out the way you expected to, or how you imagined your career at the beginning may not be how it actually ended up. And so I want to hear more about how your career goals changed over time. Maybe Mace, you can start us off?

Mace Rothenberg:

Sure thing. When I was thinking about this question, I realized there's a thread that runs through my entire career. And that is, how could I contribute to the greatest of my ability?

So that goes all the way back to when I was a medical student and there would be a cardiac arrest going on. People would be doing things that I had just watched before and had no ability to do, like running the code, intubating the patient. But there were things that I could do, like drawing bloods. So I saw what I could do and I did it.

And I think that recognizing that at every step along the way, what I could do that would really help move the field forward, what would help patients, what would help the program, what would help my colleagues?

So early on when I was a fellow, just learning about what opportunities there were in the laboratory, in the clinic, recognizing where my skills were. Because I had a year in the laboratory and I realized I could do this, but I didn't have the same feeling and passion for actually seeing patients. And I was very fascinated with new drug development. So that informed my decision to accept a physician working with a director of division of cancer treatment, where new drugs that are being developed at that time kind of coordinated.

And one of the drugs was Taxol, Taxus brevifolia. And it was derived from the bark of the Pacific yew tree. And that office was trying to help coordinate the harvesting of that bark with the derivation of that new experimental drug at the time.

And so doing things that could really help was, in one of my responsibilities in that role, helping to coordinate scientific meetings, that I had a chance to meet Dan Von Hoff, who was one of the speakers at that meeting. And then a few months after that, he called me up and he said, "I think we have an opportunity that might be well suited for you, your interests and your background."

And so I realized that I could actually go from an office where I was helping other programs to work and develop and get access to investigational drugs, to actually rolling up my sleeves and being a participant in one of the largest programs of its type at the time. So I moved to San Antonio. I never planned on that, it was an opportunity for me actually contribute more. I had the background, I was ready to take that next step.

Got great experience in those seven years working with a variety of drugs, designing phase one trials. Recognizing that the design of each trial should be tailored to the particular qualities of that drug, there wasn't a cookie cutter approach. How we could work with the laboratory, not only to perform the kinetic, but the biomarkers. So all the things that I learned during that time.

And then got a call about going back to Vanderbilt and actually leading the phase one program. So I was ready, I think, to take that next step up. And with each step along my career path, it was a bit of an unexpected opportunity, but it made me reflect on where I was at that point in my career. And then I felt I had reached a plateau. And that this was now an opportunity for me to take the skills and knowledge that I had developed and to now apply that, that even bigger impact.

So that's really the thread that took me from San Antonio to Nashville and Vanderbilt, and then from Vanderbilt to Pfizer, and now Pfizer onto the boards. And so it really has been tremendously rewarding, because I think just the way my constitution is, I like to challenge myself in new ways. And I continue to do that even after I've left full-time employment.

Richard Pazdur:

Others going to jump in on this?

Mace Rothenberg:

Sure.

Richard Pazdur:

Of the panel?

Carole Miller:

Well, I think-

Phil Bonomi:

I'll jump in, Rick, I think that... Go ahead, Carole, please.

Carole Miller:

Oh, I'm just saying, it's interesting what Elaine said about how our career paths change over time. But I think if you listen to all of us, our commitment to oncology as our passion and our guiding light hasn't changed.

And I just was reading an article recently that 96% of oncologists at the end of their career, if asked if they would do it again, 96% said yes, which is the highest of any specialty. And it is because it is a always changing field, you can never get bored with it.

When I started, I thought I was going to be in laboratory research. That was where I was going to be. I was going to do basic oncology in my fellowship. And then, just like Rick said about going into the cath lab and saying, "This isn't for me," I decided I was a clinician first and a clinical researcher second.

And then switched over to be able to do clinical research and patient care at Hopkins. And I loved it. I got to do some really interesting research and clinical practice brought some great drugs, worked with a lot of great drugs and great patients.

But somewhere I decided I wanted to be more in a smaller hospital where I was part of the community, not just the community of the physicians but the outreach into the community as well. Which is where I decided to take what I learned at Hopkins and what I learned from caring for patients in a academic center to build a bigger program that reached in a community.

And the community I serve is a very inner city population and it's been a great experience for me. So oncology always, but I've gotten back more into continuing research in the community, which is needed in where they can get to research. And good clinical practice in a community-based hospital is where I've sort of found where I fit the best. And I'm going to stay here, and at some point retire from this and join Mace on some boards in the community that I've served as an oncologist.

Richard Pazdur:

Phil, you want to jump in?

Phil Bonomi:

Well, I think both Carole and Mace, first of all, they found their passion. And I think for people looking for a roadmap on how he or she should go about their career, you need to find your passion.

And I think the other key thing, and both Carole and Mace kept this in mind, keep an open mind. See and say [inaudible 00:30:22], don't just... I remember back when I did immunology, because we had a lot of that at RUSH, as you remember. And we saw the resounding failures, one after another. But I give credit to the people that didn't give up on it. They figured out the immune checkpoints, and obviously there's an explosion of progress.

And the other, in terms of what you're doing. When I went into the oncology, I thought progress was the opposite of what you thought. I thought it was going to be really fast, but it wasn't fast at all. It was 30 years in lung cancer before there was some real major breakthrough, and that was the targeted therapies.

But I think passion, find your passion. Keep an open mind, your passion might change. So follow it.

Richard Pazdur:

Karen, do you want to jump in?

Karen Antman:

Yeah. I thought I was going to be an oncologist taking care of patients, but Columbia and then Harvard kept telling me that you had to quote, "Move the field." So they helped you learn how to write a grant, a training grant. I did what they told me. It said the goal for the grant, I said I was going to cure cancer. They said, "No, no, no, no, no. Your goal is one little tiny part of that." So they taught me how to write a grant.

And then I was sitting in the lab for a couple of years, because that was supposed to be your way to a career in oncology at a respected research dense medical school. And I kind of didn't feel... I'm like Mace a little bit. I didn't go to medical school to cure tumors in hamsters, I wanted something a little bit more clinical.

And just then Tom Fry got to be the president of CALGB. He needed an assistant who could help write protocols. And that was a terrific learning experience because we would go visit cancer centers. All of the people who were in the group, we were doing a lot of phase one and, well, mostly phase two drugs and all of those protocols. We did protocols so that you didn't actually have to read them as carefully, because the only thing that got swapped out was the drug part so that you wouldn't make mistakes.

And so I met some, like Dan Van Hoff, a lot of the names that I met all of them at the meetings and they were all chairs... These were all the heroes that were the chairs of the various drug companies or drug studies. And then one day Tom Fry calls me into his office and says that the PI of one of the program project grants has just been recruited to Duke and the grant was due in three weeks.

He knew I could write by that time. And so we wrote this grant for the bone marrow transplant program in three weeks. I hadn't transplanted anybody, but between the time that we wrote the grant and the time the site visit occurred, I had transplanted 52 people. So we got the grant, just months and months between the application and whatever.

Meanwhile, the Europeans were telling me that sarcomas were responding to Ifosfamide. So I actually filed the IND... People told me how at the FDA, they were very helpful, how to do an IND for Ifosfamide. I think that when they commercialized Ifosfamide, they actually cross filed on my original IND.

So you learn these things and they help you in the next step. And the next step is obviously working to make the next generation of oncologists, so that's becoming a division chief for oncology, you had the fellows, the cancer center. And then going to the NIH.

I was always interested in global health. I was an exchange student in Czechoslovakia when I was in college and I saw my first operation in Budapest, not the United States. And they convinced me that going into medicine was okay for a woman, because basically everybody in the United States kept telling me that that wasn't the case. But they had 50% of their doctors are women.

So at the NIH, they deployed me to Jordan for a while because we had a cancer center there. You remember there was the Gulf War. And because of depleted uranium, there were plenty of children who developed ALL. And they would airlift them over to the King Hussein Cancer Center in Jordan, and we would get them into remission and send them back.

So you find you have different stages of your career. Meanwhile, we had two kids, my husband and I. He's a cardiologist. And they-

Richard Pazdur:

So did he get stuck in a cath lab?

Karen Antman:

No, he did not. He was doing the same new drug development and the intensive care [inaudible 00:35:31]. I did not want to do that. But we took the kids all over. And the wonderful thing about academia is that you get to see the health of other countries from your colleagues in other countries. We took the kids too. They're both doctors by the way, and they married classmates, so we have six docs in the family.

So things change over time. I really meant the, "Reinvent yourself every decade if you can," because basically that keeps you on a learning curve. It sounds like everybody else was doing that too, because you were switching after a while.

Richard Pazdur:

One of the things I wanted to talk about is I had a perception in late 1970s when I started, I had a perception. I was thinking about, "What would oncology look like?" And I got to say I was completely wrong, but it reflected what was going on on oncology.

First of all, I thought all drugs would come from the NCI. Secondly, no pharmaceutical companies would be interested in oncology. The reason why, oncology had a lot of stigma associated with it. Remember this was even before Betty Ford, et cetera. The drugs were toxic, there wasn't really a commercial market, the short term use, you couldn't make a profit off of them, they were toxic. Companies didn't want to get associated with this kind of morbid situation of death and dying in oncology, so to speak.

And I thought most of the practice would occur in academic centers. I said, "These therapies are so marginal, everybody should be going on protocols. And this is the thing, everybody should be going on protocols." And here again, I couldn't be more wrong in my thoughts. A, 40% of all pharmaceutical activity is now in the field of oncology. So I was completely wrong on that. Believe me, they've made an economic model. Number two, basically still only 5% of patients, if that, go on clinical trials. So it wasn't a area of burgeoning clinical trial in enrollment, so to speak. In the United States at least.

And basically private practice oncology is where the bulk of patients in the United States are treated. So I'm wondering, did other people have concepts of how the field might have changed during their career? From a retrospective type of thing looking forward, what did you think the field would look like? Did anybody have the same kind of experience that I did? Or maybe I'm unique in that, I don't know. Anyone like to [inaudible 00:38:19]?

Carole Miller:

I think one of the amazing things is the change in the longevity of your relationship with your patients. When I was a fellow in early faculty, you either cured them and saw them for five years and then they went back to their primary carers, or you didn't cure them and they died from their disease.

I did clinical trials with the Imatinib in '99. And 20 some years later, I have a bunch of patients who still come and see me every three to six months, depending on whether they're on or off drug, because we even actually have been able to stop some of the drugs. And so the concept of my oncology patients worrying about when I'm going to retire, I never thought I would get to that.

And that's sort of the wonders of what we learned through clinical research, that if you know what turns a cancer cell on and off and how to control it, you can alter the lives for the long term. Even if you have to keep giving them therapy, it's still a pretty amazing treatment option for patients.

So that's what I've noticed as changing. I never thought that we would be where we are now with long, long term patients still acquiring therapy.

Mace Rothenberg:

I remember when I was a resident and decided to go into oncology, I would tell people. And rather than saying, "Oh, isn't that wonderful?" They'd say, "Isn't that depressing?" And I would have to tell them, "No. I see it as very hopeful, that the field is changing faster than any other field in medicine. And all the challenges we face today are things that we may be able to overcome tomorrow."

So I guess that's my nature, is being an optimist. And you have to be an optimist to be an oncologist, to be in drug development. But I think that we've been very fortunate to have our careers over these past 30 and 40 years, because I don't think any field has changed nearly as much as oncology has during the time.

Richard Pazdur:

But much of that change has occurred within the past 20 years, basically. A lot of it. The first 10 years of my career, especially being in GI oncology, was, "How do you give 5-FU you in 10 different ways?" And that was it, which was like mind numbing, so to speak.

And then obviously other drugs came out, Irinotecan, Oxaliplatin, et cetera. But here again, it wasn't the same explosion as we're seeing now. Which really, I think, represents a lot of the groundwork that had been done from the basic sciences throughout this period of time. And we're seeing the fruition of a lot of that work, so to speak.

Other comments? Melanie, do you have anything you want to [inaudible 00:40:57]?

Melanie Royce:

Yeah. I mean, perspective-wise, as my career is probably half the number of decades that most of the panel have. But even in the beginning there, 2000, you have already beginning an explosion of some chemotherapies, but then eventually the targeted therapies later in the latter decade of that. So I don't have that sort of further on perspective.

But even prior to that, with the background in cell biology and our beginning understanding of cellular processes, I was very hopeful that oncology would really change in terms of landscape. And I echo Carole's sentiment. I still have patients who call me on my personal cell phone today and say, "Happy New Year, Merry Christmas."

They're very thankful because they thought they would not be around to celebrate another milestone. But in fact, they have. And that's to thanks of many oncologists, people in government who look at all these application in pharma. So we all are a community, whether we like it or not, we really are in the same soup.

Elaine Chang:

Melanie, I love hearing about these personal relationships that you have with patients. And I'm sure it was a hard decision to leave that and come to FDA, and back to having an open mind that many of the panelists have mentioned. How did you make that decision to come to FDA and make a pretty drastic change?

Melanie Royce:

Yeah. So before answering that question, I want to share a little bit of how I make my choices in life. So first, you have to have what you call a guiding star. Because values, many different values are presented to you at any one point, so how do you judge which value you would follow versus not? Many things that happen in life can be accidental, but your next step should be a chosen one rather than an accidental one.

Although Dr. Karen, what she said, "You have to learn to reinvent yourself." I first heard that with Madonna, the singer, who always reinvents herself. Well, guess what? As a medical doctor, and if you have another degree, you are one of the most highly educated people in the world. So why should you box yourself to any one choice when you are at a crossroad?

When you're at a crossroad, look at all your choices and see where lies your passion? Where lies your, when you get up in the morning, you will jump up with joy because you are happy with what you're doing? If you lose that, life is simply just day, after day, after day.

So that certainly governed my transition from M.D. Anderson, where I could have had a very good academic life. But the service, essentially doing something for people, meant a lot to me when I moved to New Mexico because they're an underserved population. And so that was one of my guard in life, that your life should be also of service and not just a life for yourself.

Family is important to me. That helped me decide to go to M.D. Anderson because my husband said, "Look, I don't want to be stuck somewhere cold anymore. I've been wanting to go somewhere warm." I can train as equally well at the NCI or Memorial Sloan as well as I can at M.D. Anderson. So guess what? That was the choice.

But the other issue, of course, is what Rick said, that the treatment is now in the community. Well, when I was at the University of New Mexico, when the [inaudible 00:45:24] program got reorganized and became the NCORP program, I was the PI for their NCORP program.

And we really showcased the fact that our catchment is statewide, and that we had satellite sites almost everywhere in the state. And we were going to take care and provide research, clinical participation, clinical research, to those that lived in far communities from the cancer center through our satellite systems. And the NCI really loved that, that we could offer those.

But one thing happened in my life, it was-

PART 2 OF 4 ENDS [00:46:04]

Melanie Royce:

... but one thing happened in my life, it was already there, but I just accidentally found out about it. I have a genetic mutation and all of a sudden, one of my values had to be, your health is important. It was never really in one of my... I exercised, I ate fairly well, but it wasn't number one and then I realized, if something happened to me, I can't just drop my patients. I don't know if all clinical oncologists have this guilt feeling that, I can't be just asking my colleagues to take care of my patients or just suddenly drop out and my patients have no one.

So I said, "I have to make a choice in my career what I should do, where it's still meaningful, it's still serving the public, and I can still do something." And guess what? Rick first came to my mind and I said, "I need to know whether moving to the FDA is the right choice."

Richard Pazdur:

And it was. Let's go to the others, okay? What do other people want to talk about? I got a question for you, which is kind of a loaded question, but I want to hear before I ask this question, about other people's point of views. This loaded question is, the biggest regret of my career is, blank.

Carole Miller:

[inaudible 00:47:32].

Mace Rothenberg:

I could start.

Richard Pazdur:

Okay.

Mace Rothenberg:

Early in my career, in my two years in the laboratory, we were working in multi-drug resistance and it was very compelling. We were working with patient samples. It was a protein that was expressed. It did act as efflux drug transporter, and we were identifying drugs that could potentially block some, which some drugs were available. And so there was an opportunity to actually write the clinical trial to test an hypothesis patients, but I felt that nobody else was talking about it. No one else was doing it, and therefore there must be some flaw to it. So I did it. It was only a year or two later that people began to write those protocols.

We had limited impact but the key is that I didn't have the self-confidence at that time to say, "You know what? There may be some things that you have a little bit deeper insight into. You have a unique perspective to relate that to other issues and to be able to do something that others haven't done yet." So I look back on that and that was a very important lesson learned and I now have, when I've encountered similar situations, I've been confident enough to be able to take that step forward and it's often been the right step.

Richard Pazdur:

Others want to jump into the regret question?

Phil Bonomi:

Yes. My biggest regret is early in my career I wasn't very good at work-life balance. It got better as I went along and of course it's much better now but yeah, it's [inaudible 00:49:15].

Richard Pazdur:

[inaudible 00:49:15]. You were a patient machine, as you said.

Phil Bonomi:

It was too much and you know, one of the Frank Henderton, who was the chairman of radiation therapy at Rush, he gave me the advice. He said, "Just keep learning, try to have work-life balance and your career kind of takes care of itself." And I think there's a lot of truth in that. But I think, and I think the younger generations now, I think they're really very cognizant of they want work-life balance and I, that's important and I can tell you from somebody who wasn't so good at that, that is my regret.

Richard Pazdur:

Yeah, I see that. I do the interviews, I interview all of our medical officers and there's... I'm very impressed about the number of highly qualified people that we have from really fantastic training programs that are coming to the FDA and that's not a conventional pathway of what physicians see themselves doing. People think of going into academic medicine, private practice, but the FDA, as I always say, nobody writes on their medical school application as a reason for going to medical school is to work at the FDA, that's for sure. So we see that and I think one of the major issues is a work-life balance, [inaudible 00:50:35] so to speak, especially when you have potentially two physician careers, so to speak, [inaudible 00:50:42] and children, it's very hard to be in, certainly private practice and certainly academic medicine has changed dramatically. And perhaps we could also talk about that but what other regrets? And anybody want to share other [inaudible 00:51:02]?

Elaine Chang:

I wanted to go back to what Phil said about my generation, I'm what's called a geriatric millennial and I do agree that our generation is focused on work-life balance and I talk about this with other people like fellows who are graduating and looking for jobs but it's... Do you think anybody can answer this? Is my generation too focused on work-life balance? Is there such thing as making up for, as Phil is doing now in retirement, at the end of your career, can you make up for work-life balance?

Richard Pazdur:

No.

Phil Bonomi:

You miss some opportunities Elaine with when your kids are young, yeah. You miss those if you don't do it, so don't miss those.

Richard Pazdur:

But I think also there are generational aspects that also reflect social changes in the society, et cetera, that has occurred during this 40 year period of time and we can even talk, and one of the questions that I wanted to ask since we have a array of female oncologists here, is the role of female physicians in general and how it has really changed throughout one's career with now I believe there are more female medical students than male medical schools in many-

Phil Bonomi:

Yes.

Richard Pazdur:

... across United States, which would be unheard of when I started medical school and inroads in traditionally male dominated specialty, so to speak, orthopedic surgery and urology, et cetera, so to speak.

Karen Antman:

Apparently the number of women at this point, the fraction is about 51% so it is a majority across the United States schools area.

Richard Pazdur:

Yeah.

Karen Antman:

But I think that, as it Richard said, I think that the culture has changed. The generation before us kind of had a kick butt strategy of teaching medical students and residents and things like that. It was what's the matter, can't you take it? And so everybody was trying to do this career that was... Where you had to prove how tough you were and one of my colleagues said that he was glad to see women around because they would say, why would anybody want to do that? And so I think that women did change medicine to a certain extent. I think that this generation changed medicine because we saw what happened and we don't run medicine that way anymore.

We realize that balance is really important because it wasn't so great for us and we also have a bigger, broader view. The European physicians do not work 80 hour and 120 hour work weeks, they work a work week that's much more like, and the academics too, much more like 40 to 50 hours maybe. So I think that all of us are getting a broader view and finding that we can be better doctors, better academics, better teachers if we basically take, also have a component of our life that wasn't allowed in the past.

Richard Pazdur:

And a happier person too.

Karen Antman:

Happy, you make a better, you make a much better doctor if you're a full, a multi-dimensional physician, especially in oncology.

Elaine Chang:

And Karen, as a leader in a medical school, have you been able to change policies to help facilitate more?

Richard Pazdur:

Well, the call schedules and stuff, Karen, they've changed [inaudible 00:54:46].

Karen Antman:

It's totally expected at this point. The residencies would lose their residency if they work people over the work hours they're supposed to have. I personally think that people should be allowed to take care of their patients until there's a break in the medical issue and then make it up later because I don't think that people should be ripped away from their very, very sick patients just because they're running out of the time. So I think that that's actually been an important change. But we've emphasized wellness as does every other medical school at this point and balance and it's important, to make better doctors, not just in oncology. People burn out. You don't do anybody good if you burn out.

Richard Pazdur:

Yeah. Mace, I wanted to turn to you and talk about one of our favorite subjects here at the FDA and that is regulated industry, so to speak, and how you see industry has changed throughout your career. Obviously you've had a unique opportunity of seeing industry from both sides of the table, so to speak, as an investigator, as a member of the pharma industry, so to speak. And could you talk about that? Because I've definitely seen changes and all of us have seen it obviously on how we interact with the pharmaceutical industry. Gone are the days of a lot of largess, so to speak, and want you to comment on that.

Mace Rothenberg:

Yeah, well there are several dimensions to that answer. First, because we have an all oncology group here, I'd just like to point out that oncology is different than other divisions within the FDA and that really is a reflection of what you've achieved over the 20 plus years that you've been there Rick in terms of taking the regulations, which change every so often, very slowly, very rarely and then interpreting them and putting an understanding of how we can incorporate new opportunities, new science, new endpoints, new ways of measuring the risk benefit relationship. So it really has led oncology to be the leading division within the FDA in terms of adapting those new changes into the way the regulations are applied.

When I became CMO, I was surprised when I began interacting with some of the other groups within Pfizer and they would have a question about what next step they should take. And I would often say, "Have you reached out to the review division at the agency?" And they looked at me like why would we do that? I said, "'Cause they may be able to provide you with some guidance." And they said "No, they basically are just citing the regulations." And that really surprised me and disappointed me so just to give others, I know you can't say anything [inaudible 00:57:54] like this so I'm saying this, that oncology has really benefited and really is at the forefront of this, incorporating new approaches based on the science.

The second element that I realized was that as much of an effort was made over the years for regulatory harmonization, we're not there yet and that other regulatory agencies will have different concerns about a filing than the FDA would. And it puts sponsors in a difficult position to say, okay, if we design our pivotal trial in this way, we're going to be pissing off some regulatory agency, which one [inaudible 00:58:35]?

Richard Pazdur:

Well, I just have to laugh. This morning we had a cluster call with all of our international colleagues, including EMA, Canada, Australia, many of them and you could see these differences of opinions and many of them are held very strongly and we can't force our opinions on anyone, that's for sure and one of the division directors said, "We appreciate your viewpoints, but we want to show you, we think, in a very diplomatic fashion, you're wrong."

Mace Rothenberg:

Mm-hmm. [inaudible 00:59:14].

Richard Pazdur:

[inaudible 00:59:14] a polite way of saying that, but she probably did as best as she could to point that out but I had to chuckle when you brought that up because it is true. And what people don't realize is obviously there is a great deal of subjectivity, not in the data itself, but in the interpretation of the data because even within the FDA, within our review staff, there could be differences of opinion, that's for sure and we have to discuss that and hopefully come to a collective unity as a group but that just happens, that's just the, and I'm sure the same thing happens in the pharmaceutical industry. There's different viewpoints on what one should do with a given set of data and how one should interpret it.

Mace Rothenberg:

And I think understanding how the interaction between a sponsor and the FDA could be a very productive one. And I think what a lot of companies don't realize is the FDA, as I've... As you've said in these meetings, we're not going to solve your, you're not going to develop your medicine for you. We're not going to tell you, but instead to bring several options to be able to explain the rationale between each of those options and to establish a dialogue. And I think that especially when my experience, when you have a first in class molecule that really can address an unmet medical need, the agency has been very interactive and we saw that, especially with the COVID-19 vaccine, where things that normally would've taken weeks if not months, were dealt with over some phone calls over a few minutes or hours. It's recognizing that what is often viewed as this agency, this-

Richard Pazdur:

Monolithic.

Mace Rothenberg:

... faceless and monolithic agency can actually be very flexible and responsive when it arises.

Carole Miller:

But there's a dark side to that as well. I mean, I think that people are... We have to realize that you have to continue to have the public trust and show where the data goes and the science goes. I think it's been incredibly disappointing recently about the lack of interest, not from the FDA I think but from the community in respecting knowledge as compared to opinions and I think the FDA and the oncology community has been pretty strong about, despite in general, making sure we're following the data and I think that's really important to continue to do. I love rules, that's why it's nice being an oncologist. There's a lot of rules to follow.

Richard Pazdur:

Well, that brings us to the issue of medical distrust, so to speak and you see that rampant in today's society. I don't know if it's fostered somewhat by the political divide, but also by social media, et cetera, where anybody could say anything to an audience and people just accepted. I'm shocked at some of the things that I consider very intelligent people accepting as fact because somebody said it, okay, and it feeds into their kind of narrative of what they believe, so to speak. And I think that's always, and especially this came up with the vaccines and vaccine resistance and even the acceptance of some of the COVID therapeutics too.

Mace Rothenberg:

Yeah. I wasn't going to bring this up because it's not specifically related to oncology, but I just can't help myself 'cause actually our careers were trying to address unmet medical needs of our patients and that has actually now expanded in my life to actually addressing this very issue. How do you restore the trust that has been lost over these last few years? Not just because of COVID and the vaccines, but in general medicine and medical advances and through a series of conversations that actually started years ago, but over the last years really accelerated. I've actually been spending majority of my time not on a board and not consulting, but actually leading a new not-for-profit for to create a museum of medicine, biomedical discovery, and actually have had a series of meetings.

We have a board, this is at the early stages, but there needs to be a venue where people understand the connection between science and medical advances that restores their trust and faith in that system and has people have a place where they could understand and put this into perspective and context, not just about what's affecting our society today, but the diseases that have been addressed and overcome over decades and centuries. So stay tuned. It's at earliest stages, but we're moving forward with this effort.

Elaine Chang:

Mace, that's really exciting and I'm hearing that you're really proud of this and I think something that I want to hear from everybody is what are you most proud of and what do you want your legacy to be? What do you want to be known for? Because many of you have done some very interesting things and just broad range of things.

Karen Antman:

[inaudible 01:04:47]-

Carole Miller:

That's a tough one but I do think-

Richard Pazdur:

[inaudible 01:04:49].

Carole Miller:

... [inaudible 01:04:49] remember for is being a doctor who built a great team, that was able to give compassionate, data-driven care and support my community, not just medically, but also socially. I think that as oncologists, we have a special way of, and as doctors as a whole, we need to give back to our communities outside of the hospital as well as in the hospital so that's what I am proud that I think I am doing at this point in my career.

Richard Pazdur:

I can jump in here and I frequently refer to my reviewers and staff as all my children, so to speak and they could be, they're at that age, so to speak, that they could be my children. And I spent most of my life, and we talked about threads in your career and one of the reasons didn't necessarily have to do with oncology, but one of the things, very early on, really, even in high school, I realized I wanted to be involved in academic medicine and that's why I moved to various academic places and were head of fellowship programs, et cetera, both at Anderson, at Wayne State, and then even here really, we have a huge educational program and we spent a lot of time in teaching both community, but primarily our review staff. And one of my greatest things is I look back at my mentors and really they will forever live in my mind.

And I hope that the people that I have trained will look at me favorably in the sense of when I am long and gone, long and gone from this world that they will say, I remember that guy from Kelly at [inaudible 01:06:36] City, Illinois, okay? From the south side of Chicago. He helped me remember this or understand this and I view him from a really positive light. And that's what I strive for basically. A lot of that has to do, I don't have any children so that's why I use that phrase loosely as all my children because I really do have a concern for them and I hope that shows.

Many times when people come and tell me that they're leaving, they expect me to argue with them and I say, "No, you need to take chances. If this is a good career opportunity, I don't want you to stay here to make the FDA better. I want you to develop your career, okay?" And that's my greatest pleasure to see people move out. There's always this thing about the revolving door between pharmaceutical industry and the FDA and Mace knows about that, it's played up quite heavily in trade press and the press. I don't look at that as a bad thing, I just look at it as a normal thing that people will have different careers as we've all had here, so to speak. Others want to comment?

Karen Antman:

Rich, I think a stint in government actually helps to broaden people in almost no matter what they do after that so a student in the FDA would be great for [inaudible 01:07:58].

Richard Pazdur:

Well, Karen, at least they're used to bureaucracy, that's for sure. Can't get more bureaucratic than this.

Karen Antman:

They try to, they know how to avoid it but you talk about your academic children. I have biological children, but I also really value the people that I know that we had conversations about, would you stay in academic medicine? Would you go into private practice? And I kind of tried to talk to them into going into academic medicine. Even people who were originally in the clinical trials office at the Dana-Farber when I was a baby junior faculty person. We had technicians that then went to medical school, got MD PhDs, and now are full professors that respected medical schools so it's, I think that your academic children are absolutely your legacy in a way. Was it Phil talking about legacy before or was it Mace? It was one of you.

Mace Rothenberg:

Yeah.

Karen Antman:

It's the next generation.

Phil Bonomi:

Yes.

Richard Pazdur:

One of the-

PART 3 OF 4 ENDS [01:09:04]

Karen Antman:

It's the next generation.

Phil Bonomi:

Yes.

Richard Pazdur:

One of the things I wanted to ask also is, all of you have been in academic medicine. How has that changed over your career, and has the change been for the positive or negative? Phil, you're on the screen and you have-

Phil Bonomi:

Oh, definitely.

Richard Pazdur:

You retired so you could give us the truth.

Phil Bonomi:

Oh, definitely positive.

Richard Pazdur:

Really?

Phil Bonomi:

I think what we see, obviously a lot of progress. We see people have become sub-specialists for one disease or a few diseases and they can get much... Whatever you do more of, you get better at it, and you're better at teaching it, so that's good, too. And I think, and again, we have many women, females now, in medicine, as it should be. And-

Richard Pazdur:

I'm talking about also, Phil, the documentation, the procedures, the pressures that are on the physicians. Do you think they're [inaudible 01:10:01]?

Phil Bonomi:

Well, yeah. So, Rick, yeah. Electronic record is great because you can read it, and you can get better documentation, but it needs to be really severely pared down because I would say if I saw, towards end of my career, patients four days a week, four full days a week, I spent another full day, either in the morning, evening, weekend, finishing the notes. That part is not good, and we need to try to figure out a way to make that more efficient.

Richard Pazdur:

Others want to comment the changes in academic medicine?

Karen Antman:

I think there's a broader respect for different aspects of research. When I was junior, it was lab was the only thing that counted. And then, it was clinical research started to count. Then, people discovered that public health was important, and then there was the extra translation from the results of a trial to the population. So, there was population health and outcomes. So, there are multiple kinds of things that now have respect in academia that had no respect at the beginning.

Richard Pazdur:

Yeah. Because before it was, you were either, you know, had to have a lab and NIH grants and see patients and do this and be a teacher, blah, blah, blah, blah, blah, blah. And that's almost humanly impossible for anybody to do, especially as fields got more complicated and basic research became more complicated and you were competing against full-time PhD physicians that had their own full-time programs, postdocs, et cetera. That's why most people had a great disadvantage. Others want to comment on this? Carol? Or I see Mason [inaudible 01:11:48].

Mace Rothenberg:

Well, we all know what attracted us into these careers many years ago. We were drawn to the field and the fact we could be physician investigators in that model. And over the course of our careers, that model has changed in some ways that we don't even recognize anymore. So I think people look back and say, "Gee, if I had the decision to make all over again today, would I make the same decision?" We don't realize is you're viewing that from a 30 or 40 year lens, but you have to view it from today's lens. People who are coming up in the field today, they're just as excited to enter the field of academia today as we were when we entered it 30 and 40 years ago. They're seeing things through a different lens and appreciating things in ways that we don't.

So, I think it's constantly changing, and change is good. Some changes put more onus and pressure on one group or another, and we could argue whether that is a good or bad thing, but we often don't remember the things that we no longer have to do, we're no longer burdened by that replaced by new burdens. That's why it's difficult.

Richard Pazdur:

We don't have to return phone calls. We return texts.

Mace Rothenberg:

Right.

Richard Pazdur:

Melanie, any comments you want to make on this?

Melanie Royce:

Yes, and I think it refers mainly to medical school and postgraduate training. And that is, one of the things that I noticed when I was in academia is that there were fellows that were extremely great. We wanted to retain them within the academia. They're interested in clinical research or basic research. But two, for instance, come to mind very prominently. And they said to me, "I wish, Dr. Royce, I could stay in academia, but I have kids, and I have loans to pay." And when I asked them how much their loans were, I was flabbergasted. 250,000 to educate themselves as doctors? I mean, who would want to be burdened with that loan? The last thing you want to say to your child, "I can't send you to school because I'm a doctor." That's like, what the heck does that mean? Because they come out with so much debt. Something has to change for that because how would we retain these people who want to stay in academia, but the monetary rewards of academia is not sufficient for them to take care of themselves and their family and the loans that they have to bear.

Elaine Chang:

That's a very important topic. I think we've touched on a few things in academia that could be drawbacks, could be burdens. And I think in every job there are things that are not ideal, and there's no perfect job. There are things that you won't like. So, even though we all want to have passion, wake up every day and be excited to work, what advice would you have for young oncologists who see the less than desirable aspects of their job, and how do you work through those days when you're not excited?

Richard Pazdur:

Well, as my late wife used to say... And Phil knew her very well because she was his nurse, okay? "If the job was so great, they wouldn't have to pay you, Rick," every time I would come home and complain about a job. And that was her wisdom, and she was a very wise woman. And I think the issue is every job has a hassle. There isn't any perfect job, so to speak. Everybody has a headache, so to speak, and you have to balance them out and kind of step back and say, "I got to give myself a break here and think about what's going on and what are the big picture issues." I can't tell you how many times I get calls from people that are in industry or academic medicine or whatever and they call me and they want a job at the FDA.

And I realize they don't want a job at the FDA. They had a bad day. They want an escape. Okay? And I always tell people, you never want to move away from something. You want to move towards something in your career. And so, I'm talking to them, and they're complaining, complaining, complaining. And I say, "Do you even know what we do here at the FDA?" "Oh yeah. You do book reports on drugs," or something like that. They have no faintest idea what we're doing here. But you have to step back and realize the world's not perfect. You're going to have bad days and good days and figure out what's the composite, so to speak. And I think that's true of everybody because there's a hassle, a mean patient, an argumentative patient, if you're inpatient care. A crazy drug company that's screaming at you telling you, "You don't know what the hell you're doing, and you should be fired. You're killing people. You have no idea what you're doing. You should be canned from your job immediately."

We all have these crazy things that go on in our lives, so to speak, and deal with people. But I think that's one of the major things is really taking a big picture view of your job and not getting discouraged. Because we're all going to have bad days, that's for sure.

Carole Miller:

And we all have to acknowledge that being an oncologist is hard, and you have to tell that to the new people as they're coming in. It's incredibly rewarding. It's incredibly exciting and scientifically, but it is not an easy specialty because you make a lot of tough decisions. Sometimes you make them right. Sometimes you make them wrong. And you have patients who are having the worst time of their life. And then, you're adding on talking to them about bad drugs and then paying for these drugs. Where I work, I often say, because I'm involved in some community boards and things, "Why are you concerned about this and this?"

I said, "Well, for my patients in Southwest Baltimore, when they come in, sometimes cancer isn't the biggest problem in their life." And that's sort of amazing to me and sort of makes me think that I can take care of this part of their life, but they have so many other things building up and to deal with that I've got to be strong and support them in how I can. But what we do is tough. It's expensive. And it's stressful both for us and for the patients we serve. And so, what I tell people, "Do you want to be an oncologist? If you're going to do it, you got to really love it because it's not easy. And most people, when they do it, love it, which is great.

Richard Pazdur:

Since time is running out, one of the closing questions that I have for all of you is the following. My most memorable patient was... And let's not give names, but was... And why. Or is. Phil, you've gone through so, so many patients in your career with your name written on it. And I'd love to hear [inaudible 01:19:31].

Phil Bonomi:

I still remember the name of the patient you wrote one of your first papers on cases with neuroendocrine carcinoma, and I bet you do, too.

Richard Pazdur:

Yes.

Phil Bonomi:

But, actually, what I remember most is here at the end of my career, I've got a handful of non-small cell lung cancer patients with brain metastases. They got treated either with immunotherapy or chemo immunotherapy, metastases and other sites. And a number of them are five years out and free of disease off therapy. I mean, I never thought I'd see that in my career. I never thought I'd see that. But we're not just talking about one. I got about probably four or five. Just unbelievable. They didn't need brain radiation because they weren't symptomatic, but they [inaudible 01:20:18].

Karen Antman:

How did you treat [inaudible 01:20:19]?

Phil Bonomi:

What's that?

Karen Antman:

How did you treat them to succeed in that? Or they were incredibly lucky? How did you...

Richard Pazdur:

Well, you know, in non-small cell, it's probably around 20% of the patients who get treated with immunotherapy alone or chemo immuno. They were looking like they're long-term survivors. You stop the therapy and they're still in remission. But to me, it's most incredible because brain metastases were such a horrendous prognosis. And to see that during my lifetime, part of the reason I did agonize some about retiring as I like doing this. I like seeing... We seeing people doing better. Nothing better than helping somebody who's sick to feel better. It's a wonderful feeling. And I'm grateful I had the opportunity and all of us had the opportunity to do that.

Carole Miller:

I have a patient who was on the phase 2 imatinib in accelerated phase CML in 1999, who I still follow, who's now six years off the drug in a PCR of negative state. And just being through his journey through that, he was on three different clinical trials, loved it, works for the Leukemia Lymphoma Society, and is on our IRB here at St. Agnes, giving back to us. But to think of that. I mean, that is one of the pivotal things I remember about my career, that this accelerated phase, never going to transplant, and is off drug that far down the road. So, that's my greatest patient memory.

Richard Pazdur:

Others?

Karen Antman:

We had a Jehovah's Witness minister who came in with the crit of 15 and a GI stromal tumor, they bleed like mad, and a fistula to the surface. And we had phase 1 imatinib for GI stromal tumors at that point. The surgeons wouldn't operate on him because with a crit of 15, you have no wiggle room whatsoever from a medical perspective. So, basically, you couldn't also give him the pill because basically the fistula was actually, the pill would just pop out. So, we put a Foley catheter in the fistula, blew it up, gave him the pill, and he had a very nice response to the imatinib with his GI stromal tumor. His crit came up to about 32, and the surgeons took it out. It was just kind of like we did everything we could, and Rich, you're going to have a fit because I told you that his crit was 15, so we got zinged on using the drug, but he did fine.

Richard Pazdur:

I can't say that this is a favorite, but it's something that I think about a lot. And it revolves around, and I'll just use this as a case example, but there are many that fit into this in my memory. A man that was in his late 30s that was in Detroit when I was working there at Wayne State that had CML. And at that time, obviously we just had hydroxyurea and busulfan, basically. And the man was not that dissimilar in age from myself. And you saw this person go from chronic, accelerated blasts, and death, basically. And I always think of him as a kind of emblematic patient because now this man probably would be living a normal life expectancy. And that has always given me that hope for the future. And I've seen so many major therapeutic advances. Phil, when I was first working with you in the 1970s, the only treatment for renal cell carcinoma was your favorite drug, Megace, basically. That was it.

Phil Bonomi:

Which wasn't really much of a treatment.

Richard Pazdur:

That was it. Interferon didn't even exist at that time. That was it, basically. And now, I'm not talking about it being a curative therapy, but obviously, we have so many therapeutic options that are available to us. And you see this in so many other diseases where there have been major advances including lung cancer, breast cancer. GI stromal tumor is a disease that did not even exist at that time, basically, in anybody's lexicon. So, it's an interesting phenomena to take a look back at where we've come as far as a specialty in one's career and what the impact is on those patients that didn't benefit because these drugs were not available. But we got to know those patients, and a sense of sadness that I have that we didn't have those drugs. There's no one to blame or anything. It's just being at the wrong time at the wrong place in the wrong place in history, basically, when one gets a disease, sometimes.

Mace Rothenberg:

I have a similar story to yours of a patient I treated at the NIH when I was a fellow, and he had an aggressive lymphoma. He would come in, and he was just really upbeat. He was a gentleman in his 50s, and he not only lifted the spirits of those around him, but also other patients and the staff. It was really wonderful. And then, unfortunately, his lymphoma progressed after treatment. And I remember seeing him come into the hospital, not the clinic, but the hospital because he was so sick, and he just looked at me and said, I just want you keep comfortable." And he did it with a courage that really has stayed with me all over these 40 years.

And I think we may not be aware on a day-to-day basis that every patient who see is put in this position, not by choice, not by desire, but by chance that they end up being a cancer patient and how courageous they are to go through what they go through every day, how their lives have been turned upside down by this disease. And it really is a privilege to be able to be a participant and help them get through this today much more successfully than we did 40 years ago. But it's still a sacred privilege.

Richard Pazdur:

Well, this hour and a half really wrapped up relatively quickly. Okay. We have four minutes left here. And if we could just go around and what you see the future being of oncology. Okay? Let's focus on the future. And here again, we have four minutes, so let's make a quick assessment of what the future of oncology. And Carol has a smile on, so I'm calling on her.

Carole Miller:

A drug for every mutation and a mutation for every drug. The personalized medicine in oncology to the fullest.

Richard Pazdur:

Melanie.

Melanie Royce:

Oh, exactly that. That there will be more therapies for patients, and they will be more selective.

Richard Pazdur:

Okay. Karen?

Karen Antman:

Identifying people at risk and preventing it in the first place.

Richard Pazdur:

Phil?

Phil Bonomi:

Continued improvement of immunotherapy with increasing numbers of long-term survivors.

Richard Pazdur:

And Mase?

Mace Rothenberg:

New platforms for therapies that don't fall into the existing categories of chemotherapy or radiotherapy or targeted therapy or immunotherapy, things like mRNA therapies, things like targeted protein degradation. If you look back over the last few decades, the biggest advances have been made every 10 years with the introduction of a new platform.

Karen Antman:

And Richard, what's yours?

Richard Pazdur:

Similar to yours. I feel an emphasis has to be placed on prevention and early detection. I think that's one of the major things, I see, obviously, earlier detection by circulating tumor cells or whatever. And then getting that on a yearly basis as kind of a normal physical examination. And then, detecting tumors before they're clinically apparent. And then, I'm a big believer in immunotherapy, as Phil is, and that will, since these are immunological diseases, basically be giving the drugs, not PD-1 drugs necessarily, but the next generation of these drugs, so to speak, to really very early patients. And I believe that what we're even seeing with the PD-1 drugs, the true benefit of these patients, of these drugs are going to be in the neoadjuvant setting in the very early disease settings rather than in metastatic disease. Okay. Elaine, any closing comments before I just thank everybody?

Elaine Chang:

Well, of course, I appreciate everyone's time. I especially appreciate how you all are visionaries, and all of these closing comments have really given me an inspiring vision of the future.

Richard Pazdur:

Well, I want to thank everybody. This was a great conversations on cancer. The hour and a half went by really fast, and let's do it again sometime in another 40 years. Okay?

Elaine Chang:

Thank you.

Richard Pazdur:

Bye.

Phil Bonomi:

Thank you for the opportunity.

Karen Antman:

By that time we'll have new drugs.

Phil Bonomi:

Yeah. Okay. Thanks again, everybody.

Mace Rothenberg:

Thank you.

Phil Bonomi:

And thank you for the support staff that worked with us on this, getting the AV setups and the numerous calls, et cetera, and getting everybody together. And we have a terrific staff here at the FDA that does this, and I want to acknowledge all those that have participated in putting this program together, including our great host, Elaine. Thank you, Elaine.

Mace Rothenberg:

Well done.

Richard Pazdur:

Nice job. Bye-bye.

Carole Miller:

And Laura, for her couple minutes of panic-

Richard Pazdur:

And Laura.

Carole Miller:

... when none of us could get on the phone call. So, thank you for...

Richard Pazdur:

[inaudible 01:30:48] again.

Phil Bonomi:

Great.

Richard Pazdur:

Okay. Thank you all.

Carole Miller:

Thanks everybody for including me.

Melanie Royce:

Thank you.

Richard Pazdur:

Bye. [inaudible 01:30:55]

PART 4 OF 4 ENDS [01:30:55]

 
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