| Web: | mayocliniclabs.com |
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| Email: | mcl@mayo.edu |
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| Values are valid only on day of printing | |
| Web: | mayocliniclabs.com |
|---|---|
| Email: | mcl@mayo.edu |
| Telephone: | 800-533-1710 |
| International: | +1 855-379-3115 |
| Values are valid only on day of printing | |
In this "Chat with the Chair" podcast, William Morice, II, M.D., Ph.D., Chair of the Department of Laboratory Medicine and Pathology (DLMP) at Mayo Clinic in Rochester, Minnesota, and President of Mayo Medical Laboratories, sits down with Benjamin Kipp, Ph.D., Director of the Advanced Diagnostic Laboratory at Mayo Clinic in Rochester, Minnesota, to learn more about the laboratory's research and purpose. Connect with Dr. Morice on Twitter @moricemdphd to let him know what you would like to hear next.
William Morice, II, M.D., Ph.D.: Good morning, Everybody. This is Bill Morice, Department Chair of Laboratory Medicine and Pathology at Mayo Clinic and President of Mayo Medical Laboratories, talking today with one of my longtime colleagues, and I like to consider him a friend, Dr. Ben Kipp. Ben, welcome.
Benjamin Kipp, Ph.D.: Good morning, Dr. Morice.
WM: We’re going to be talking today about something unique, to Mayo at least, that we’re trying to spearhead and that you’re an integral part of as a leader of the effort, and that’s the Advanced Diagnostic Lab (ADL). I think a lot of people have questions about the ADL. What is it, what is it about, why is it so important to our department and to Mayo Clinic and some of the things that we’re trying to accomplish in terms of working with companies outside of Mayo Clinic. So, we’ll touch on a lot of those things, but I think a lot of people have seen you around the department, and you’re taking more and more visible leadership roles. And let’s talk just a little bit about your own background because you have an interesting path to becoming a consultant here at Mayo. So, just tell us how long you’ve been here and how you got to where you are.
BK: It has been an interesting path. So, I actually started in Mayo Clinic in Rochester in 1999 as a cytotechnology student. I was a student for one year and then was hired as a cytotechnologist in mid-2000, and from there, I became a clinical cytotechnologist and then a cytotechnology development coordinator. I did a lot of development work and at the same time, I worked on my fellowship in clinical molecular genetics. I then moved on to be a consultant about five to six years ago. So, I really touched on the technical perspective, I worked in the development, and now I’m a consultant, so it’s been an interesting ride.
WM: I think it also probably gives you a very interesting, valuable, and unique perspective on what we’re trying to accomplish departmentally in terms of being more strategic with how we do our test development and putting more resources into it in a way that actually increases the throughput. I know everyone in the department has experienced frustration that it seems to take longer and longer to get stuff done and to get things accomplished. I’ve appreciated your participation in those efforts. Speaking now just a little bit about one of the things that I think I’ve experienced is that in our time—I came on staff in 2000, so we started right around the same time, I started in the department in 1994—the process of test development has become more complicated both in terms of the instrumentation that we use and the methodology that we use, including things like bioinformatics that would not even have been envisioned when I was a resident and also what our clinicians are asking of us. It seems like it used to be that they wanted one analyte. Now, with things like Foundation Medicine out there, they want things that would almost be considered more research; they want clinical tests. Do you think that’s an accurate depiction of what we’re confronting?
BK: I do. I think we’re faced with the fact that there are more complex technologies as well as more diversity among our clinicians as to what is needed for their patients. You know, it used to be we tested one marker at a time, which gave the clinicians the information they needed, and they integrated it into their practice. Now, they’re asking for two, three, four hundred markers, and again, that makes sense for them. They want all of the information they can get for their patients, but it puts a lot of pressure on the laboratory because when you’re going from 301 markers to 304, that’s another whole new test. So it has been very challenging, and there’s just obviously more projects than time.
WM: The other thing I think that’s really challenging is as that has happened on the one side, I think what we’ve seen on the other side is there’s more and more scrutiny or oversight of laboratory-developed tests by the outside world, and we’ve gone from a laboratory information system (LIS) Lab 3 that didn’t do a lot of things for us that we needed to do, but it was pretty flexible, to an LIS like SCC Soft, which is very much a "workflow LIS," and so it has a lot less flexibility in it. So on the one side, it seems like people are asking more and more for adaptability of our testing, and on the other side, it’s becoming more and more difficult to be adaptable and to be iterative in how we bring up tests.
BK: That’s true, and I think a lot of it is due to the fact that, as you mentioned, there are more bioinformatics pieces. There’s a lot more data, and I think that the data is crossing more divisions and more departments. So, it’s not just that we have a specimen going to Anatomic Pathology and being interpreted and then at the same time a single marker. Now, what we’re trying to do is get the histological diagnosis, also look at copy-number variance, look at mutation analysis, and when you start to put together four and five different groups worth of information and try to encompass it and put it in an integrated report, it puts a lot of stresses on all of the IT systems.
WM: I’m glad you agreed with me on those things because a lot of those are my ideas and thoughts behind the ADL, which is something I’ve been working at since I started the job in 2015. It was really just based on the idea that, for all of the things that we’ve just described, we needed to create an environment that was more of a “sandbox,” if you will—something that had more flexibility, that used to live within the clinical labs but really does not anymore and that also requires a lot more investment. When we did one analyte and had flexibility in the lab, it was pretty easy for me as a consultant and even for you in your development tech days to say, yes, we can work on that on the side. That just doesn’t exist anymore. So, the ADL is really an attempt to try and bring these technologies and some of these resources like bioinformatics into an environment that’s more flexible so we can adapt to what the clinicians are asking of us. It’s still in test mode, so we don’t know if it’s going to work, but we want to try to see if it’s going to work. I mean, is that still the spirit of the laboratory? Because you currently are serving as the director of the lab, correct?
BK: Correct, and I think that’s exactly right. I think that the clinical laboratories—when we look at the test development there—the tests that are being developed are generally disease focused, they’re generally low-risk, high-reward projects, things that have been FDA approved, and we know the clinical utility. But if you’re developing tests for now, which we need to do, it puts limits on how much you can do thinking forward. So the ADL is really designed to think about high-risk, high-reward projects, projects that maybe encompass more than one disease; for example, all of solid tumors or all of hemoglobinopathies. They are risky because they’re expensive, and there are a lot of different markers being assessed for. The technologies are new; we don’t know how they’re going to work. Again, the bioinformatics requires all new pipelines, so it does take resources, but at the end of the day, I think the information you learn from these types of studies is going to be very important for the clinic.
WM: I couldn’t agree more, and as you were talking, one of the things that crossed my mind was during my interview process for this role as chair, one of the most surprising things to me was a question that Dr. Noseworthy asked me early on. His question was, "Are all the tests that you bring up, are those just FDA kits?" I was quite dumbfounded, and I replied, "No, exactly the opposite." I said my whole career was bringing up a group of really odd esoteric assays to understand natural killer (NK) cells, and that’s been not only a wellspring of clinical tests, it’s also what my academic career was based on because I used that information. To his credit, because this really is an investment, the safe thing for the clinic when we bring up tests that are FDA-approved, is that they know what the return is going to be, and they look to the laboratory to be a major financial engine for the institution like every hospital does. But our argument back to Dr. Noseworthy and our board then was that we need a place where it’s purely an investment in understanding the diagnostic, and you’re not going to see the return right away because we need to have more risk, as you described. So, it’s been coming along. We have had a physical space created within the ADL, correct?
BK: Correct. It’s relatively small compared to where we’re moving, but yes, we are working on five different projects at the moment. One of them is a whole-genome project, looking on the hereditary side of things. So again, pushing the boundaries. Rather than looking at a focused disease panel or assessing an exome, we’re going to push the boundaries for the whole genome to see if by assessing more of the genome, we can identify markers that associate with specific diseases. But again, it’s taxing. It’s a lot of work, and the genome encompasses a lot of different areas, so it’s interesting work. We’re also working on a large cancer panel, again looking at things that are coming forward such as mutation-tumor burden and microsatellite instability, as well as the copy-number variance and mutation analysis. Interestingly, we are also looking at longer-read next-generation sequencing, which is like a PacBio system, so we’re looking at some hemoglobinopathy tests in which we could really use those large fragments due to the homology in the region. A lot of that work is moving forward, and we also haven’t forgotten about the diagnostic side of things. So a lot of what we talk about is the therapeutics, especially in the cancer world, but on the diagnostic side, if you can detect these cancers earlier, they may not require the invasive treatments that most people have to go through. So again, we’re looking at new technologies like digital droplet PCR to see if we can push the boundaries on how we detect these cancers earlier.
WM: Great. A lot of really exciting stuff. I think that I should point out for the people listening—Dr. Kipp knows this already—when you look at where the institution is looking to invest in personalized medicine and some of these things, it’s really through the Center for Individualized Medicine (CIM), so one really important supporter of this effort both financially as well as medically is Dr. Keith Stewart and CIM. They are major co-investors. This is a logical place because Dr. Stewart, as the CIM Medical Director, is going out to all of these departments and asking, "What are some of the advanced modalities you need for analyzing your patients?" So that’s where a lot of these ideas are coming from. They are helping to fund, I think, some of the hemoglobinopathy stuff. They’re helping to fund a lot of these things, the whole genome, so they’re really important collaborators for us. I think the other thing that is really crucial for us is that at the same point in time, the institution has been challenging all of the departments to say, "Look at the outside world," and rather than just being purchasers of services and equipment from companies, can we actually work with them in a collaborative way to develop some of these technologies? Because in my time at Mayo Clinic, my observation has been that we’re more cautious, so we let people develop technologies on their own dime and then in-source them and refine them for clinical use, really adding value to those platforms but not seeing the return other than doing the testing. It’s been a really important part of that effort to actually work with Business Development colleagues to get access to some of these platforms earlier because I think people really want access to them. They want to be at the cutting edge, our consultants, don’t you agree?
BK: I agree. I also agree that we can’t do it alone in the Department of Laboratory Medicine and Pathology (DLMP), and so collaborating with CIM, collaborating with our clinical colleagues across the street, makes these projects a lot more interesting and helps us get to success.
WM: Collaborating with industry . . . you’ve been with me on some of the trips, which we can’t probably name here, but it’s a lot of work. I think there’s interest, but it’s easier said than done, don’t you think?
BK: Absolutely. A lot of it is what I call the "fishing-lure syndrome," where everything is flashy and looks really cool, but at the end of the day, most of those have a hook. So, it’s our job to find the hook and to improve the process. Again, I think there’s a lot of exciting stuff outside of Mayo Clinic, too. I think a lot of these companies have really cool projects, but we have to push the boundaries, we have to know where they work, and we have to know where they fail so that we can implement them for our patients.
WM: Just so people know, the building that’s going up at Discovery Square One, we’re going to have a full floor. That’s where the ADL will "live." Hopefully, we’ll have other companies that will locate on that floor. I guess the last thing then for our staff—because some of those who have been around a while might listen to this and say, "DLMP has done this before, and it ends up just being someone’s personal playground," that there’s not really open access. My dream is that we bring in these platforms, potentially with industry collaboration, and it’s open access in that we send the requests for proposal, and then we actually fund some of the work on those. I think that it’s important that it’s really seen as something that’s open to everyone in the department who has interests in any of these platforms.
BK: Absolutely, and just to clarify for everybody that’s listening, the projects that are selected or are not selected don't come from yours truly. This is not "Dr. Kipp’s playground." Essentially, I direct the laboratory, but the projects are selected by a group of individuals, including members from all of our divisions, and essentially by Dr. Stewart, Dr. Morice, our Associate Administrator Scott Beck, and their teams. This is open for everybody. It’s a very inviting place. We want the best projects there, and we want collaboration with our clinical partners as well as our DLMP partners to push these things forward.
WM: Yes, thank you, and I think that people will hear more. We’re just in the process now of standing some of those things up, and we’ve earmarked funds. We’ve gotten approval from our Board of Governors to earmark funds to actually pay for these projects, and we want to do something like we do for our research funds where we open it up for applications. Also, just to stress, this isn’t just about genomics. Even though you’re the director, we’re going to go beyond genomics, right?
BK: Absolutely correct. Genomics is just one piece of this very complex puzzle.
WM: Excellent. All right, well, thank you very much for your time. Hopefully, if people have more questions, they’ll reach out either to you or to their division chair, or to Scott or me, just to find out more. Thanks a lot for your time, Dr. Kipp.
BK: Thanks, Dr. Morice.
