Pursuing an ID career in industry-sponsored research

Paul Sax: [00:00:11] Hello, everyone. This is Paul Sax. I'm editor in chief of Clinical Infectious Diseases. And welcome to the Let's Talk ID podcast. Today, we're talking with Dr. Steven LaRosa, who is a board-certified ID physician and is now chief medical officer at Athlon Medical in San Diego. Steve, welcome.

Steven LaRosa: [00:00:32] Hi, Paul. Thanks for having me on.

Paul Sax: [00:00:34] So Steve reached out to me because he thought it would be interesting to hear about a clinical pathway for ID fellows in particular or junior faculty in clinical trials. But before we get there, as you know, I like to start these interviews out by asking a guest to tell us a little bit about themselves. So, Steve, tell us about your background. How did you end up in medicine in general and ID in particular?

Steven LaRosa: [00:00:59] I'm originally came from Boston, from a family of non-physicians, and I'm one of those people that, from my earliest recollection, wanted to be a doctor. I still to this day don't know what it was. I wasn't exposed other than going to the pediatrician. That interest was sustained as I went through the undergraduate curriculum at Boston College, and I was fortunate enough to get into Boston University School of Medicine. There, what was striking, was the quality of the ID clinicians there. You know, BU has a storied past in infectious disease. And what struck me was at the time that they were the best, seemingly the best clinicians, best diagnosticians, best physical exam, and that was my role model. That's what I wanted to be. I was fortunate then to do a fourth year visiting rotation at the Cleveland Clinic and had the same experience, just a group of outstanding infectious disease clinicians, and that further solidified that that's what I wanted to do.

Paul Sax: [00:02:02] Got it. So it was the clinical excellence of doctors, which, of course, you don't have to convince me. [laughs] We see it all the time in our colleagues. But it's interesting. Just curious whether you have any speculation why that might be? Why do you think doctors have this clinical strength? Now, granted, we're being immodest here, but we're doing this primarily for an ID audience.

Steven LaRosa: [00:02:24] I think it attracts a group of people that want to answer questions so they're willing to do the investigative work. So I think for some of us, that was the fun. We really get into the details that nobody else uncovers and often do exams and find little clues on the exam that nobody uncovers. And that's it's a very satisfying puzzle to solve. And I think it just selects for a group of people where that is what gets them going.

Paul Sax: [00:02:50] Yeah, I totally agree. I mean, I actually have a very good friend who's an emergency room physician and he describes the sort of thrill of stabilization and triage, by contrast. Well, I totally get that. By contrast, I'm sure that you would agree that we ID doctors have a thrill of uncovering that little piece of history that cracks a case open. So getting back to your interest in ID, when you did your ID fellowship, what were your primary clinical and research interests and what did you think you ultimately would end up going into?

Steven LaRosa: [00:03:22] To take a step back, so when I was doing my residency in Cleveland, my focus was on trying to become as good a clinician as I possibly could. And just by coincidence or happenstance, I happened to do my rotation in the intensive care unit and at the time, the attending was, interestingly enough, the person who to this day is my is my boss. But I encountered this clinician who at the time was one of the leading clinical triallists in the area of sepsis, and I took care of patients that were being enrolled. He was enrolling lots of people in different trials of different inflammatory mediators. And it really got to me of cutting-edge technology, trying to mediate disease pathogenesis and actually seeing, even though there were placebo controlled trials, seeing these telling clinical effects. And I knew I wanted to go into ID already, but I said, that's the area that I want to go into. So as it relates to fellowship, the way things were structured in the past is when you interviewed for ID fellowships, particularly at large academic institutions, you had to have a good sense of what your area of interest is and actually identify a mentor. When I did that in my interview trials, I interviewed at Mass General and with a noted science sepsis researcher and wound up there. So the pathway I had originally envisioned was that I would eventually be a junior attending and junior investigator doing sepsis-based research. That's kind of how I got to the ID fellowship.

Paul Sax: [00:04:55] When you said sepsis research, would it have been basic research, translational research, human subject research?

Steven LaRosa: [00:05:04] As the fellowship was developed, as you remember, is you did all your clinical, your 12 months of required clinical training, up front and then you shunted to the lab of interest. So I was doing basic science as well as animal research. It was therapeutics, which meshed, but what was clear to me as I came to the completion, was where my interest really lied is in clinical trials. So I needed some segway and it really wasn't, as part of the fellowship training, it really wasn't an option as to how do I get the training to do what I want to do in my career.

Paul Sax: [00:05:37] So you wanted a transition from the lab to doing patient care research?

Steven LaRosa: [00:05:43] Yeah.

Paul Sax: [00:05:43] Did anyone give you any career counseling about it or did you get any career counseling at all?

Steven LaRosa: [00:05:48] As my fellowship was winding down, I was board eligible, and I had a few grants. I brought up this discussion at least, you know, this is we're talking 25 years ago, going into industry-sponsored research was really not looked upon favorably as you know, the terms "going over to the dark side" were used. "Career suicide" was used. It wasn't something that anybody talked about. So you really were, especially someone completing training, you really were on your own.

Paul Sax: [00:06:17] And so what happened?

Steven LaRosa: [00:06:19] So what happened was I called my mentor from residency and he had just happened to have left Cleveland Clinic to start leading a large sepsis research program at Eli Lilly. And he said, Why don't you come work for me as a clinical research physician? And I had never considered this. I didn't even know it was an option. But he had a nice way of putting it, and I think this might be useful for the fellowship, he said. Listen, at worst, think of this as another fellowship. You come do it for a couple of years and say you don't like it. You can always go do something else. Which is also important because it was also viewed at that time at least as a one-way valve. If you want to do industry-sponsored research, you'd never be able to do anything again. You'd certainly never be allowed to come back to academics, which clearly actually wasn't the case, and that's what I was hoping to impart as well. So I went to go work for him at Eli Lilly running a clinical research trial in sepsis.

Paul Sax: [00:07:12] How did you enjoy that experience?

Steven LaRosa: [00:07:14] It was as advertised. Essentially, I thought of it as a very intense but enjoyable, another fellowship, I learned about clinical trial design, about statistics, about the regulations, about human subjects, research. It was just a fantastic experience. And what was even more fantastic is that the agent we worked on actually worked and the FDA approved it. So it was a lifesaving therapy and we got to have publications and so forth. So it really was a great experience and a great career starter.

Paul Sax: [00:07:47] Now, just for the sake of history, maybe you could share with us what that product was?

Steven LaRosa: [00:07:53] So this was back in 2001. It activated recombinant human activated protein C, which eventually was called Xigris and was on the market was used around the world, but the company was required to do some subsequent clinical trials and we'll talk about had moved on back to academia. And unfortunately, those trials, they weren't consistent with the trial that got the drug approved and Lilly voluntarily removed the drug from the market. It wasn't from a safety issue, but today it still is the only drug that's been approved for sepsis.

Paul Sax: [00:08:26] Yeah, I mean interesting to see its trajectory. You know, you got very close to the data that led to its approval, of course. And then when it was not confirmed in subsequent studies, that must have been a disappointment. How did you take that?

Steven LaRosa: [00:08:41] Well, it was a disappointment. I think what was clear from the initial trial was there clearly a like, most drugs, a clearly a population that it was meant to be used. It wasn't everybody with sepsis. And then, unfortunately, when you get into follow on trials, it's not studied exactly the way it was studied initially. I still think the drug likely has a role. It could be lifesaving. It's unfortunate that it got essentially abandoned.

Paul Sax: [00:09:07] Well, you say you went back to academics. Now, there are definitely examples of people like you who go back and forth between industry and academics, but not a lot. So tell me what that experience was like. You're now going back to academic medicine from industry.

Steven LaRosa: [00:09:23] You know I had viewed still at that point in my career, even though I was in industry, I viewed myself as a sepsis researcher and I wanted to continue. I wanted to basically study the next agent in a pipeline or in the pipeline. And one of the things that at least at Lilly, I was going to be doing lots of medical affairs in terms of post-approval marketing, and I wanted to I wanted to work on the next trial. And early on I had not satiated my clinical thirst either. I still view myself, even though I'm not doing any clinical work right now, as a clinician, first and foremost. And again, it was not a one-way valve. I called Dave Longworth at Cleveland Clinic and said, You know, I'm interested in going back to the clinic, but I have this other I have this skill set in clinical trials in substance. And I'd like to take care of patients and run a sepsis clinical trial program. And he was gracious enough to say, I'll take you back. I went back to Cleveland Clinic and did sepsis clinical trials and took care of patients.

Paul Sax: [00:10:21] That's wonderful that you were able to combine what you learned from translational research into clinical trials and then expand on that. Let's now take you to the current day. What are you doing now? I mean, you've had a varied career in a variety, you know, a number of different places.

Steven LaRosa: [00:10:38] So what happened after Cleveland is there was a number of industry sponsored research activities that I was involved with over a number of years. Anything from clinical evaluation committees to data safety monitoring boards, consultant chief medical officer, during the same time, I was an active clinician through this entire time and it became a running joke at home is how many different activities is Dad involved with? I had my job and then I had a number of other research-related activities. About three years ago, in fact, I made the decision to just to segway back through the valve, back to full time biotech and research. So first I did it at Enthesis, which was working on life saving antibiotics, and I was doing clinical development there. And then about two years ago, I was recruited to come be the chief medical Officer at Athlon. We actually have a device that I was brought out here still in the throes of the Covid pandemic,

Paul Sax: [00:11:32] Wow.

Steven LaRosa: [00:11:32] And we have a clinical device that actually can remove, it's still investigational, but can remove Covid from the blood stream, at least in vitro and in a few patients. And we're still, we haven't abandoned it, but it can remove life threatening viruses, and also can remove cancer-related exosomes. So we're in oncology. And guess that's the other thing from an ID perspective is because we're all solidly trained in internal medicine, that our skill sets actually lend themselves to do things even beyond infectious disease.

Paul Sax: [00:12:04] And I think one thing you've alluded to and told us, even though you haven't explicitly said it, is that your skill set became quite broad.

Steven LaRosa: [00:12:12] Right.

Paul Sax: [00:12:13] Because of the fact you had this clinical training, you had this research training, and then you had this clinical trials training and all those different things, you mentioned, you know, writing a protocol, evaluating data, knowing how to present it, being on a safety committee, they're really critical for drug development. So let's now talk about what you think career advice should be during fellowship, especially related to the pathway that you chose.

Steven LaRosa: [00:12:41] The first thing is in terms of the way fellowships go about their selection and recruiting process, maybe the process would be focusing in, on not only people with very strong clinical skills as indicated by their residency training, but have that be the starting point and let them start off as pluripotential stem cells, not necessarily differentiated and then expose them to a variety of pathways. And there are so many pathways now, right? There's stewardship, there's infection control, there's administration, there's teaching, there's clinical trials. Have them exposed to all those potential pathways and not have to differentiate things from the beginning. And also think that a lot of attendings who do clinical trial work, particularly industry-sponsored clinical trials, they kind of keep that separate. And I think it's good to expose the fellows to those activities and see if that's something that interests them. And also maybe changing the philosophy of it's not the dark side, it's not a one way valve. It's an option. You actually could do very high-quality research. The regulations are actually much more stringent than if you're doing investigator-initiated trials at a hospital. It actually is a viable path and it's something also to be considered, especially in this day and age, where we're talking about physician compensation, lifestyle and burnout. The quality of life is quite good. The compensation is good, it's varied. So you could do safety, you can do pharmacokinetics, you can do clinical operations. So it could be, you won't get bored. There's something in it for everyone. And people do now more fluidly go back and forth to the clinic. I teach at the medical school in San Diego. I teach microbiology so you don't have to give up teaching. I do it as a volunteer. And I know a lot of people in industry who actually even do some small amount of clinical service to keep their chops up. And I try to do that with CME and otherwise, but it's not a one-way valve. You don't have to give up your love for clinical medicine.

Paul Sax: [00:14:46] Well, Steve, this has been a terrific discussion about a career path that I agree with you, should be considered for our fellows and our junior faculty. I have been discussing with Dr. Steven LaRosa, ID doctor and chief medical officer at Athlone Medical in San Diego, his very interesting career path, one in particular that focuses on clinical trials in industry. Thanks so much for joining us, Steve.

Steven LaRosa: [00:15:10] Thanks for the time, Paul.