From Insight To Praxis: Achieving The Goal In Translational Research With Dorene Markel And Dr. Robert Levine
In the medical field, putting your medical research findings into practice can be quite challenging. In this interview with Dr. Robert Levine and Dorene Markel, we delve into the challenges in achieving the translation of medical research findings into clinical practice. In particular, they look into the barriers people face when trying to move forward with translational research. Dr. Robert Levine explains that in developing cures, it requires a massive collaboration in the field to accomplish the goal. Dorene Markel adds that one should not let problems dominate their life but instead focus on achieving what you’ve set. Tune in to learn more from this insightful conversation.
---
Listen to the podcast here
From Insight To Praxis: Achieving The Goal In Translational Research With Dorene Markel And Dr. Robert Levine
In this episode, we have a slightly different format. We have two guests. Let me go through their biographies and I think you'll understand why we have them and why they're quite interesting guests to have on the show. First is Dr. S. Robert Levine with his wife Mary Tyler Moore. He has been a longstanding diabetes research advocate. He has helped the JDRF, the Juvenile Diabetes Research Foundation organize and lead initiatives that built a health research advocacy program with a research budget that went from $10 million to $12 million to $100 million per year, which is substantial.
He has also served on the JDRF Executive Committee, Research Committee, Scientific Advisory Board, Research Executive Committee, and Lay Review Committee. He was the Founding Chairman of the JDRF's first clinical affairs working group which he organized to help oversee its first human trials. He is the past Chairman of JDRF's Government Relations Committee, and Founding Chairman of JDRF's Communications Committee, and past Chairman of the Board of Chancellors.
Very clearly, he understands all of the different aspects of working, growing, and building these foundations. More recently, Dr. Levine has led the development of the concept of the Mary Tyler Moore Vision Initiative as a way to honor his wife Mary, who suffered from vision-stealing diabetic retinal disease.
Along with him is Dorene Markel, who serves as the Managing Director of the Mary Tyler Moore Vision Initiative. Prior to that, she served in several leadership positions in Medicine at the University of Michigan for over 40 years. Her last position was as the Founding Managing Director of the Caswell Diabetes Institute at the University of Michigan, and director of the Brehm Center at Michigan Medicine.
She served as an Associate Director for Alliances and Collaborations for the Michigan Institute for Clinical and Health Research, home of the University of Michigan's NIH CTSA grant, and as a Director of the Clinical and Translational Research at the University of Michigan Medical School. She also played a key role in the development of the University of Michigan's NIH-funded Human Genome Center where Francis Collins was the Center Director, and she served as a Director of Human and Family Studies.
Ms. Markel is also one of the very first Genetic Counselors to be employed by Michigan Medicine, and among the first nationally to specialize in neurogenetic conditions. In this conversation, we go into a lot of different aspects of the challenges and the barriers people face when trying to move forward with translational research. There are a lot of insights to gain here. Sit back and tune in.
---
I'm Dr. Robert Levine. I am a Cardiologist by professional training, but I spent a good part of my young professional life working with my wife, Mary Tyler Moore in helping the Juvenile Diabetes Research Foundation in their efforts to find a cure for diabetes and its complications. After Mary passed, I made a commitment, along with the JDRF, to launch an initiative that would honor her legacy and her efforts in support of diabetes research, most specifically around the complication of diabetic retinopathy. It’s a diabetic retinal disease, which caused her a lot of challenges in her life, ultimately being nearly blinded by it.
With the help of others, including Dorene Markel, who's on this episode with us, I've launched something that we call the Restoring Vision Moonshot. It seeks to create a world without visual loss from diabetic retinopathy, more specifically to help develop the methods to preserve, restore, and protect the vision in people with diabetes or with diabetic retinal disease, including those with significant visual loss. To put it simply, to find cures for blindness and low vision due to diabetes.
I'm Dorene Markel. I'm in the process of transitioning from a 40-year career at the University of Michigan Medical School and Health System. I have always been a scientist at heart. I started out as a genetic researcher and genetic counselor and then moved into clinical research administration. I am now transitioning from being the Managing Director of the Caswell Diabetes Institute at the University of Michigan to being the Managing Director of the Restoring Vision Moonshot. It has been a joy to work with Robert in this retirement phase of mine. I wasn't looking for a next gig but this came along. It uses everything I know in a way that's wonderful.
Thank you both for coming on. I can't think of two greater examples of people fitting the role of innovation leaders. When I proposed this, you said, “We need to do this together.” It's a bit of an unusual format because we're doing two people instead of one, but I spend my days talking to groups of 10 or 15 and trying to get discussions out of them. I think two should be okay. To start off, if you could describe something that's sitting around you, on your desk, on the wall, or whatever. Robert, do you want to start?
I have next to me and always in direct view a picture of my wife, Mary. People don't necessarily know but in her heart, Mary was a dancer. Even though she suffered quite a number of different complications from diabetes, including neuropathy and peripheral vascular disease, she was largely able to overcome those problems. What she was never able to overcome was her progressive visual loss from diabetic retinopathy and its treatment.
That essentially stole Mary's joy with dance. I have a picture of Mary dancing with Ben Vereen on a television special called Mary's Incredible Dream, which was done in the ‘70s. That's always in a frame because that represents her joy, but also represents what we are trying to do with the Moonshot, which is restoring the joy that was stolen from her, in hopes that others would not suffer the same burden.
For the younger audience, can you describe who Ben Vereen was?
Ben Vereen is a magnificent performer, multi-talented in both song and acting, and a brilliant dancer.
I remember him from my youth. If you don't typically know many dancers but you knew he was a dancer, Ben Vereen would come to your mind. I think that puts it in perspective. Dorene, anything around you?
Not to copy Robert in talking about a portrait on the wall, in my dining room is a portrait of my mother's family. Why it's significant is they were immigrants from Italy whose town was bombed out during World War II. My grandfather came to work in the automotive plants here in the Detroit area. He was separated from my grandmother and the three children. This portrait was taken without my grandfather in it. He then had himself airbrushed in later. It shows resilience and taking risks in going where no one has gone before. If it hadn't been for his bravery, I wouldn't be sitting here talking to you now.
That's a great aspect. It's the same thing, pictures, but they're both very impactful and very powerful. You touched upon this already but maybe you can expand upon it. For Robert, your current role, and Dorene, your future role, what impact do you intend to make in that role? You alluded to it a bit already, Robert, but maybe you can expand upon that.
If you look at it from a personal standpoint, it is the motivation. Inspiration always starts with personal passion and the observation that I made of the impact of a disease process on my wife. The broader impact is if you look at the nature of diabetes and diabetic retinal disease, there are probably 100-plus million people today with diabetic retinal disease. Of that group, nearly half of them have what would be called vision-threatening diabetic retinal disease. Diabetic retinal disease is the leading cause of low vision and blindness globally in working-age adults.
Inspiration always starts with passion.
There has been a lot of progress at the bench in better understanding diseases using animal models and other methodologies. What there needs to be is someone putting a big goal out there and challenging the community to say, “We can restore the vision of individuals who have low vision and blindness due to diabetes.” It requires a massive global collaboration across fields and sectors, and is driven by this Moonshot goal.
The impact that we hope to have is what we call a principal accelerator. Researchers who are committed to finding cures will often start their conversation by saying, "If only I had this, then I could do that. Without that, I can't make progress.” There is what people call the valley of death, the translational challenges that are associated with any big bioscience or health science initiative.
What we're trying to do with the Moonshot is provide the community with critical path resources, which we call accelerators. It’s like a biorepository of human tissue so scientists can study the human condition and human disease as opposed to solely relying on animal models. They provide guidance on regulatory issues. They also provide resources that will enable the collection of millions of digital images of the retina that can then be used for artificial intelligence to provide signals about the disease, the disease progression, and potential response to therapy.
The impact that we hope to have is delivering to the community critical path resources, helping support the activities of the scientific community in delivering cures for blindness and low vision, and preserving the vision in people with diabetes, which is a massive global challenge.
Maybe you could expand upon why you think that requires collaboration. Isn't that already happening?
In any big science endeavor as it relates to health and developing cures, you have to recognize that not any individual, individual lab, individual institution, or even individual sector like academia can solve the problem. If you look at the average cost of the development of a new therapeutic, it's probably north of $2 billion now. Even simply from a resource perspective, no individual can accomplish that goal.
Translational Research: If you look at the average cost of the development of a new therapeutic, it's probably north of $2 billion now. Even simply from a resource perspective, no individual can accomplish that goal.
In the context of solving a problem that's as complex as diabetic retinal disease, there are so many different components. There are neural components, nerve components, and vascular components. There are broader metabolic issues that need to be addressed. There are technical issues that have to be addressed. If you want to treat eye disease, how are you going to do it? The eye is relatively protected. Systemic treatments like medications or oral medications won't necessarily have an impact on the eye. Do you do it by intravitreal injection? If you're going to do an injection, what's the transport mechanism that you're utilizing to deliver new gene therapy to the retina, and so forth?
There are so many different issues from the standpoint of understanding the disease to understanding complexity of the disease. How you approach a resolution of the problem, early or late, how you diagnose the disease and assess its progression, how you deliver a potential new therapeutic, what area you choose in your development, and then translate a discovery at the bench to a product that can be deployed. Also, doing the clinical research, and getting the resources together that allow you to complete the process, and then have regulatory approval and deliver it into the clinic, and make sure that everyone who can benefit from that new discovery has access to it and can benefit.
There's enormous complexity there, and there are so many different people that are involved. You want to rally the community or a disparate interest around a common goal. The whole point of the Moonshot is to state the goal and help rally the community around achieving that goal, then put together the core resources that are required to achieve it.
That's a very nice statement about the complexity. As long as we know something about diabetic retinopathy, you might think that it should be relatively straightforward to solve. You've nicely illustrated that there are lots of complexities to it. Dorene, since you're stepping into this new role, how do you plan to ensure that the collaboration happens? How do you plan to drive that? What are the factors from your 40 years of experience make that difference between an innovation leader and someone that's just doing research?
What I bring to the table and what I've been known for at Michigan, other than being an administrator and organizer, is being a connector. What I have been doing is connecting the dots, taking people to Robert that he needs to know, and having people who haven't met each other start working together and know of each other's work. I’m bringing scientists together around a common goal, and making it easy for them to achieve that goal together. That's what my role is all about.
I've done this with another coalition of scientists called the Brehm Coalition. They are very senior people. There had never been an interdisciplinary group of beta cell biologists and immunologists in type-1 diabetes research who were working collaboratively together before. We brought them to the table and they start sharing each other's view of the world through their scientific lens. All types of wonderful new things came from that, new research, collaborations, small and big ones, and new infrastructure. I'm hoping to take what I have learned in the past and bring it to this project. As you heard, Robert has the passion and the vision. I hope to help make him successful in doing this, and make our team successful.
It's very interesting because there's this whole idea that you have different levels of organizations. The level-five organization is one where there's somebody making connections. Typically, it's somebody that's making connections between two different people. It's like triads that connect together into a network. That's a nice description of what you've said there, and maybe some ideas of how you do that. Is it that you call somebody?
Robert already knows a ton of people. It's also making connections to the right people at the right time because you can over-connect as well, then you spread yourself too thin. We're a very small team now, so we're being very strategic about who we talk to about this project, and what we want them to do. Part of it is just communicating that this project exists.
There is power in communication and information being out there. People are finding us by hearing about it from other people as well. We're early in revving up the engine phase. Robert has had his foot about to push down on the pedal for a long time here. I'm not the brakes but we want to take the curves cautiously, and make sure we're not getting ahead of ourselves.
The reason why I took this role is I was not looking for a retirement gig as I've been telling people. It truly taps into everything I have ever done in my career and utilizes it. I'm trying to bring all of that into this role, both with my prior knowledge as a scientist and my work as a clinical research administrator. I’m facilitating a lot of new startup programs at Michigan, and figuring out how you do something big in little pieces to get it off the ground and going.
To reinforce, one of the ways in which we benefit from Dorene's concept of being a connector is that both she and I have been around for a while. Many people think of innovation, especially scientific innovation, as being the sole territory of the young. It's true. New energy, new perspective, and asking naive questions are all very important and critical to any success. You need the energy of youth, but having more senior leaders around to help with perspective and doing the connections or helping with connections, understanding the breadth of a field, and putting collaboration together are also important to the success of any innovative initiative.
Translational Research: You need the energy of youth, but having some more senior leaders around to help with perspective and doing or helping to build the connections, understanding the breadth of a field and putting the collaboration together is also important to the success of any innovative initiative.
That's very interesting because recently, in some of the consortiums we work with, we have been talking about connectors. There's a nice alignment there. To be honest, I didn't prime you with that word. You came up on your own. It's nice to see that we're aligned. Often, because that's who has time, we think of the younger people doing the connection, the post-docs of students. That's important. You raised a very important point. You have to be able to relate to past experiences and make that connection, and perhaps fuel that excitement about why that connection is important. That's a very great insight.
I also have a faculty appointment at Michigan but I truly see myself as an administrator. Administrators get to know a lot of people, both on the management side of your organization, as well on the academic research side of the organization. Being able to cross those divides between the two halves of the company and/or university, and inform people so you can move things along is critical.
I guess what you’re saying then is if you want to be an innovation leader, don't just think about the research side of things but think also of those committees you get to put on. There's some value to that. I want to shift and maybe move to another question here. What is the most fulfilling project or outcome you have recently or somewhat in the recent past experienced? The big Moonshot is not here yet.
I have been fortunate to be at the forefront of creating a number of significant programs, centers, and institutes at the University of Michigan. This last one, the Caswell Diabetes Institute, the creation of that was probably not only the most fulfilling but the hardest. There wasn't an NIH RFA to create a clinical research institute, a cancer institute, a genome center, or any of these other things that universities have built over time. There wasn't a donor that was ready to fund an institute. We did have a donor, Mr. Brehm, who was funding a diabetes center, but it was more space than the resources to build the type of institute that we needed.
I was looking around the University of Michigan and I started telling people that we have all the puzzle pieces to put together an institute that is broad in how it looks at diabetes, policy, public health, bench science, clinical research, and all of the complications. Everybody is working in these areas already at the University of Michigan. They're just not working together.
I started lobbying for a diabetes institute. We put together a working plan for one, a proposal, and a budget. I got a number of faculty on board, then we changed the leadership of our health system. The plan sat there for a while until the new leader came on board, then we started working all over again. Lo and behold, the university allowed us to start the framework for an institute. We called it M Diabetes because everything at the University of Michigan is a block M. People are aware of that already.
We already had the structure, idea, concept, and buy-in from the university, then a donor came forward. Elizabeth Caswell’s name is on the institute. At my little retirement party roast, one of my old bosses got up and spoke about persistence. It was not ever giving up and being persistent, and then finally seeing all those pieces come together. We have something wonderful and I'm very proud of it.
When you were doing that, you had no funding and no donor. There’s nothing basically, but you got people to put some input into that. Did anybody ever say, “There's no funding here. I don't want to help you."
If they did, I didn't listen to them.
Were you able to get a lot of people to help you with this in the early stages?
I got all of the chairs of the departments that care for patients with diabetes together in a room and said, “We need to do this.” Ophthalmology, internal medicine, pediatrics, and nursing, I got them at a table and everybody was excited about the idea. Once you get buy-in from people at that level, then you can go to the dean and go, “All your department chairs want to do this. Let's do this.”
Why do you think they pitched into it?
Everybody knew it was a good idea, and that we had the ability to bring things together and do more than we were doing already. That was a lost opportunity if we didn't do that.
It's an interesting series of events because you hear people say, "We need funding to do this." You built something or at least the framework for something, then the funding came. That's an important aspect of this, and also building it piece by piece like you did. That's the essence of being an innovation leader.
Something that both Robert and I are very passionate about is the patient and family's voice. We put a patient and family advisor on the working group committee that came up with the plan for this institute a decade before the institute ever became real. That family advisor was Elizabeth Caswell. She tapped me to be on different walk committees for JDRF, diabetes walks, and back and forth. Before you know it, this was happening.
Did she have input on the plans and building?
Absolutely. Elizabeth has family members with type-1 diabetes. She doesn't have type-1 herself, but she is a workhorse in the nonprofit community to drive forward research and innovation in type-1. She was the perfect person to have on our working committee. We are very dear friends now. She continues to have an impact on the institute as well.
As a result of Dorene's relationships at the University of Michigan, her leadership in helping develop the Caswell Diabetes Institute, and her relationship with Elizabeth, we're able to host the Restoring Vision Moonshot at the Caswell Diabetes Institute at the University of Michigan. They've been very supportive of this next thing to do, which was a natural emerging initiative from the base at the Caswell Diabetes Institute.
I would like to just add, in terms of experience in these things, Dorene and I are similar in that what we look to as the positive things we've been able to accomplish in our lives are substantially about bringing people together around a common cause. For me, it was helping the JDRF back in the ‘90s and early 2000s in building one of the most successful grassroots or grass tops research advocacy organizations in the country.
Folks don't know that story, but it resulted in statutorily required dollars for type-1 diabetes research that can be used for strategic purposes like clinical trial networks, consortia, and other such things with a total of billions of dollars being directed for specifically type-1 research. In the period from 1998 to 2003, when the rest of the Federal government was subject to austerity measures under the Balanced Budget Act, we were able to double the NIH budget.
That was based on JDRF leadership as a 50-state grassroots advocacy organization bringing the case to Congress and to the administration at the time, which was the Clinton administration, then followed in the first Bush years. Biomedical research was the crown jewel of Federal government funding and needed to be protected, and not just protected but substantially enhanced for the benefit of everyone.
That took an enormous amount of bringing people together from the standpoint of building the grassroots organization, but also bringing both sides of the aisle together in Congress, and building substantial support from both the Democrats and the Republicans, and two different administrations in the White House. It reminds us that there are things that we share that are of interest to us and are a priority to us so that we can work together. You just have to have the right framing of the issue, the right messages to bring people to get to yes, and to work very hard together to achieve those shared goals.
The summary message is persistence. One of the things that I see young people sometimes lack is the patience to know that things are not going to happen fast. Some of these things are going to take not months but years. You just have to keep at it. Our incentive system in academia and grants don't lend itself slowly. It's a bit of a challenge but it's worth it.
Young people sometimes lack the patience to know that things will not happen fast.
This may be a little bit of a distraction from the thread, but I do want to mention something that your audience might be interested in. I was at the premiere of a documentary called The Human Trial. The Human Trial is about a 10-year journey of a documentarian who herself has type-1 diabetes and was looking for a cure. She got linked to a company that's doing stem cell research, encapsulated stem cells that have been converted to insulin-producing beta cells.
This was the story of patients 1 and patient 2 in that trial. It shows the frustration, the elation, and the challenges of discovery, translating that discovery into new therapeutics, and how difficult it is to construct trial concepts and execute those trials to get results. Including the difficulty of early-stage biotech companies in having the funding that's necessary and so forth. It's something that anyone who's interested in bioscience and health innovation should go and see. It's TheHumanTrial.com. You can find out where it's being shown. You can join a virtual screening.
It was produced by Marla and Robert Oringer, who have two children with type-1 diabetes. It's been supported by the Beyond Type 1 group, which is Nick Jonas's not-for-profit. It's worth seeing because it lays both sides of the challenge, the suffering of the patients and the challenges they face, and the risks that they're taking in participating in clinical trials. Also, the elation and frustration of researchers who are trying to find cures, and are hitting up against all kinds of different obstacles in that path.
I think that's a very important thing to think about and realize because the news tends to be overly optimistic in medical research. That perhaps colors our perception that this should be faster in reality. In that vein of persistence, the next question is, what was the lowest point of your career? How did you get through it?
Let me take this one, Dorene. I'll do a short one because Dorene has one that's compelling. In 1988, I was a faculty member in cardiovascular disease at Mount Sinai. I chose to go out into private practice. I built a cardiovascular health promotion center, including a learning center. I had a multidisciplinary group with me including nutritionists, exercise physiologists, nurses, educators, behavioral psychologists, and so forth.
It’s my idealized view of how you could attach and attack the problem of cardiovascular disease. On a lovely August evening in 1988, we had a break-in at the office, and someone literally put a gun to my head. That forced an assessment on my part, "Is this what I want to be doing? Is this how I want to be doing what I want to be doing? How can I better achieve my goals, have a greater impact, and so forth?”
Following that incident, I walked away from my practice and started to focus more on my work with my wife, Mary, and with the Juvenile Diabetes Research Foundation, looking toward finding a cure for diabetes and its complications. It was clear by that point that the path to having a much broader impact was opened to me because of the access that I had to extraordinary organizations with Mary and her persona, and her ability to bring attention to the topic. I chose a different direction, which is an important change in life at facing down with a gun to my head.
The Lion Tracker's Guide To Life
I think that's very powerful. There's a book called The Lion Tracker's Guide To Life by South African Boyd Varty. Early in his life, he had a similar experience and that affected him. It led him to now leading people on lion-tracking expeditions to redefine their life. There's a common thread there about that near-death or traumatic experience that then makes you go, “What am I doing?”
Mine is more related to the transitions that sometimes are forced upon you in your career. Back in 1990, just prior to that, I had been asked by Francis Collins to help him work on developing a grant to the NIH for one of the first human genome centers in the country. We were one of the first four that were funded, and we were successful.
We were so successful that Francis Collins was asked to leave the University of Michigan and go to the NIH to head the Human Genome Project, and then later became the director of NIH for a few decades. He took a lot of scientists with him. I had two young children and my husband works in the automotive industry in the Detroit area. We weren't that movable at the time so I stayed. At the end of our five years of being a successful genome center and launching Francis off to NIH, we didn't get refunded.
That was my ten years at the University of Michigan, and I got a pink slip because I was 100% grant funded. I was in a very unique role and there wasn't another role for me. I had to reinvent myself at that time. All of the clinical administrators thought I was a researcher, and all of the researchers thought I was an administrator.
I had to carve a new niche for myself. It was at that time that I had an opportunity to take a risk to move over to something called the General Clinical Research Center, which was a very large NIH grant to the medical school, and launch a clinical trials office. I knew nothing about clinical trials and clinical research. I told the director at that time, “I don't know why you're asking me to do this,” because I know a lot about genetic research. I don't know much about clinical research. He said, “I think you’d be good at this.”
I turned down another job with the VA which was a sure thing. I took a risk and went in a completely different direction. It was the best thing that ever happened to me. I mentor a lot of particularly younger women because a lot of people think you have to have your career path all painted down a solid line and know what you're going to do from A to B to C, and you just don't.
It’s keeping your head up and not feeling sorry for yourself. I did feel sorry for myself for a little while and I was angry at the university. I had put in ten years. They owed me something, but I got over that fast. I looked, "What are my possibilities? What can I do next?" I thank the NIH for not refunding our genome center. I don't think the University of Michigan was happy about that, but it put me in a direction that I've been very happy with.
What do you think he saw in you? You don't make the connection, especially at that time. Genes and the clinical trial center are completely different.
I had been the liaison between our human genome center and our clinical research center because I was responsible for engaging families and patients in genetic research. We were doing human disease gene hunting back then. I got to know the director of clinical research, but I wasn't doing clinical research. I think he saw creativity, strength, innovation, and good people skills.
I take pride in my ability to connect to people in a deep way. Most of the people I work with are also my friends. I know people tell you that you shouldn't be friends with people who work under you or whatever. That's just not the case. Not everyone is my dearest friend but they're my family. You spend a lot of time at work. You need to have trusting relationships with the people around you. I established that with the Clinical Research Center Director. He wanted that as part of his team.
Spend a lot of time at work and build trusting relationships with the people around you.
That's speaking to leadership skills. In the very first of the series from the show, I interviewed a researcher named Peter Barnes. If you knew the respiratory field, he was the leader for decades. At one point, he was in the top ten scientists in the world by publication metrics. At one point early in his career, he didn't want to go into research but somebody said, “You should do research.”
You think about these pivotal moments because it has probably led to your ability to set up the diabetes center and what you're doing now. That's a very fascinating story to look out for the people who can give you some advice or believe in you. They probably know you somehow better than you know yourself at that time. What do you think the future of medicine is?
It has probably gotten to a point where this is not a unique comment. COVID has taught us a great deal but I've been talking about these things since the 1990s. It's about leveraging technology for broader access and reaching improved outcomes including developing methods for self-care support, home testing, and remote consultation. Broader than that is the application of learning sciences as a big longitudinal data set.
That's what I used to call the systemic assessment of everyday practice in order to generate new insights about disease and what works to prevent and treat and use applications development to help adoption. The big challenges in healthcare have always been at the professional level, adoption of data-driven, new understandings of disease, adoption of new therapies, understanding proper patient selection, and application of new discovery.
There are decision-support methods that are necessary at the clinician level, but there is also decision-support and self-care support that needs at the patient level. We're finally in a moment in time when we have the ubiquity of smartphones. We have an enormous amount of data capacity in terms of memory capacity. You have AI emerging and applications developed. All those things lend themselves to the deployment of technologies for the better evaluation of patients and their better care, both on the professional side, as well as on the self-care side.
I used to say that healthcare is an action taken at the intersection of two information streams or two data streams, the professional and the personal. Outcomes are based on the quality of that interaction and the periodicity of the sampling of those two data streams. We're at a moment in history when those data streams are now continuous. They can be collected and evaluated on an ongoing basis.
You can use one individual's experience as almost a clinical trial for themselves. You can match it against the experience of thousands of other patients, and come to a point where you can optimize care and outcomes. What technology allows us to do is start to close the gaps in access and outcomes that exist across communities and across the world.
Translational Research: Technology allows us to close the gaps in access and outcomes across communities and the world.
There are two aspects of what you said there that made me think. One is it's very important that the young clinician and the researcher now need to be data literate or data science literate. They don't necessarily need to be a data scientist. They need to understand things about data science because data is going to be very important, as you highlighted there.
The other that I've seen, I don’t know if you've seen this as well, is there's a gap that occurs because a new therapy comes to market. $2 billion was put to bring it into the market. Once it gets its market assets, there's a drop in research because people want to use the drug. That's where we need people like you to explain how to use these drugs because they're more complicated than before. This is where we need the innovation leaders to step up and make that implementation science because it takes sometimes decades to go to the next level.
Post-market research is critical. New technologies allow you to finish your clinical trial of 1,000, 2,000, or 5,000 patients which are highly selected participants. You launch a new drug out into the broader community. It's now being prescribed in the context of multiple comorbidities and other drugs with different interactions and so forth. The research hasn't stopped. It's just started at that point.
Two of the people I introduced Robert to were the chair and vice chair of a relatively new department in our medical school called the Department of Learning Health Sciences. That's where my faculty home is. That field is about taking all of the data that's created and generated through normal clinical care that's not utilized for research unless somebody sets up a separate research project.
We’re figuring out how we capture the data in a way that can be used for research, how we then utilize that data, and how we improve clinical care in a real-time loop rather than waiting for seven years for a publication to come out. Maybe somebody will change practice guidelines, then your health system or your practice will adopt that. We have all new types of graduate programs, and people who are coming back to get degrees. They've been in healthcare to learn more about using data science and using the data that's created in clinical care as well.
That's also a very important part of innovation. People think innovation is being innovative, but it's about making things come to practice. Sometimes that goes down to the very far end of innovation like how you use it, but even getting the word out about the new therapy. I think disease foundations are very important in this part of the innovation chain as well. I want to go back to maybe a bit about both of you. Maybe Dorene at least has less now. You have a lot of competing priorities and lots of things to do. How do you manage that?
I don't have less now. Robert is keeping me hot.
It's something universal. I see it in everybody that's in this game because it's complex. There are lots of new opportunities and lots to be done. How did you manage your competing priorities? How do you decide what you're going to do on a given day? How did you decide you wanted to come and spend an hour and a half with me on this show?
Robert and I talked a little bit about this question. He has two wonderful new dogs in his house, and I have two grand puppies that are in my house all the time, and the barking dog gets attention. That's the message now. Not only do you have to give the barking dog attention but you can't allow that to dominate your life either. You still have to say, “I have got to get this done now. I'm going to turn off my email for two hours. I'm going to stop answering texts.” We are so overwhelmed with information coming in that if we don't turn it off, we never have time to think, plan, be creative, or be innovative.
Giving yourself some time. Try to set out priorities in the morning for what you need to get done today, and not let every little emergency get in the way of your big goal for the day. Reflect at the end of the day and say, “Did I get my list done that was important?” I start off with a list at the top of my calendar every morning of the things that I'm hoping to get done that day. Some get eliminated and erased like done, which feels good. Some get moved to the next day. Every day, I try to have a few moved to the next day.
In that similar vein, what I learned from Bill Brehm who Dorene already mentioned. She helped establish the Brehm Coalition. Bill and I knew one another many years prior. He was one of the engineers in the Apollo project, among other things. He was on the Mercury project but in the Apollo mission. He taught me a great deal about Moonshots and how to organize them. People don't recognize that in the early 1960s when JFK challenged the US to land a man on the moon and return them safely to Earth within the decade, there was a lot of science but that was unknown how you would do that.
How they managed that initiative was they brought together the best and brightest, but they had to project manage against specific milestones. You manage your competing priorities by understanding what your goals are, recognizing what the milestones are, and doing an analysis of, “Is this cool and interesting thing that I'm doing today or have in front of me directly connects to the outcome that I'm seeking?”
Manage your competing priorities by understanding what your goals are.
If it doesn't, then you have to make a choice to either set it aside and do the things that directly impact the outcome that you're seeking, or decide that you're changing your milestones and goals, and going in a different direction. You can't do everything. It's about understanding what your goals are and what the milestones are, and doing a self-analysis. Is what I'm doing now directly connects to achieving that goal?
That's a good message there. Too many of us don't have goals or don't set goals. That makes a huge difference. What's something you do when nobody else is looking that enhances your performance as a leader?
What I do is more of a self-reflection, which is scenario projection. As a leader, you want to project confidence. You also have to deal with your own doubt or your self-doubt about direction. What I try and do is ask the tough question of myself. What if I'm wrong? I look at different scenarios, “What happens if?” Look at worst-case scenarios and project out.
When I was still in practice, it was that ability in the immediate moment to project out, “How can this go south?” That allowed me to take the actions necessary at that time to keep us going in the right direction in terms of patient care. I think it’s the same thing. It's not necessarily something you want to expose your team to all the time. It's important to have open conversations about competing approaches and opinions.
For a leader, it's also important to show confidence but you must reflect on the day, what you've heard from your colleagues, what you're seeing in the space, and how the landscape is evolving. Challenge yourself to ask the question, “What if I'm wrong? What do we do if this happens?” Make sure you're prepared.
Dorene, do you have something?
I completely agree with the reflection piece that Robert stated. This is one of the things that I do and it used to drive my kids nuts when they were growing up. I like to talk to strangers. I like to see what other people think and feel, and have conversations. I have broad interests. I love to keep on top of everything that's going on in the news. Keeping connected to the world and to people who have other ideas different from yours.
I've had some amazing things come from elevator conversations with strangers. Also, just being randomly kind. Helping that person in the hallway who seems lost, even though you're in a hurry for a late meeting, and helping them find their way. It's such a good feeling to connect with other people. Doing that allows you to be a much better leader than if you are aloof and feel that there are only certain people you have time for.
It's both in the same way. It's perspective-taking in a way because you're getting different perspectives or your own internal. This is a bit more of a concrete question, but what do you read? Do you read journals, articles, or books? Anything you recommend?
I only read the journal articles I have to read, but there are a lot of them I have to read. I also serve on an IRB, so I have to read a lot to stay current with the studies that we're reviewing. What I like to do is have two things I'm reading at the same time. One, something that helps me grow as a person or a leader or a human being, and then something fun. I was telling Robert that it's getting harder to find time to do that but audiobooks are amazing. I can put an audiobook on and go for a walk, get some exercise, walk the dog, or whatever, and be listening to a book and gain from that. I highly recommend audiobooks.
I thought a little bit about this. I leaned towards first-person writing, so I read speeches from historical figures. I appreciate Frederick Douglass's speeches. Teddy Roosevelt’s Citizenship in a Republic speech talks about the man in the arena, and that the credit is not due to the critics but to the person in the game.
Walter Isaacson has great biography of Steve Jobs and he had a follow-up on that called The Innovators. He looked at the others who are responsible for computation and the internet. The important message of The Innovators is that it's not always about the disruptor, the individual, and big ideas. It's also about building teams and collaboration that support innovation. The first-person stuff and biographies are where I lean towards.
The question was inspired when I was writing a book. Somebody said, “People don’t read books anymore.” I'm trying to dig into countering that point of view.
There is one book that I would recommend since you ask. The reason why I bring it up is because people wouldn't necessarily have it on their radar. A close colleague and friend of mine, Dan Ciampa, was a 25-year CEO of Rath & Strong, which is a manufacturing consultant company. He was one of the fathers of the so-called Total Quality Movement. He's now a CEO coach. He has a book called Taking Advice, which is worth any leader reading because it's so important that we learn how to listen and take advice from others.
We're getting down to the end, so we'll come to one question. What advice would you give the younger version of yourself?
I alluded to it a bit already, which is to be brave and take risks. It's interesting because I want to turn that around a little bit. A lot of times, you take more risks and you're braver when you're young than you do as you get later in your career because you have more to lose. I find myself saying, "What would I have done when I was in my twenties and didn't know any better? Would I have taken a risk on this? Should I take a risk on it now?" I reflect back on the bravery I had in my youth but also carry that forward into my more mature years.
It’s flipping the actual question. What would a younger person tell you to do as an older person?
You get stuck in your ways as you get older, particularly in science. You start exploring one cellular pathway and that becomes your life. There are other things out there.
There are two kinds of things that I want to answer on. The first is to take a job, be indispensable, and learn. Find a mentor who you value and who can help you along. That's important. As a young person, you're not going to find the perfect situation. What you want to find is the right context or the right mentor. Take a job and do anything and everything. Learn everything that you can. Don't think that one thing is less important than another because you're young. You got to learn everything and be indispensable because that's how you get elevated.
You need to learn everything and be indispensable because that's how you get elevated.
That's what Dorene demonstrated in her career. She became indispensable to very big projects and people recognized it in broader forward. I want to end with a quote from my wife, Mary. It's along the lines of what Dorene said. This is a direct quote from her, “Take chances and make mistakes. That's how you grow. Pain nourishes your courage. You have to fail in order to practice being brave and to succeed.”
That's great. That's a good way to end. Do you have anything else you want to close with? Otherwise, we could stop there. It has been a fantastic interview and it has gone well with the two of you. Thank you a lot for coming on.
Thank you for having us.
We'll put out all these great recommendations. I'm looking forward to seeing the reaction when we get this one out there.
Thank you. Goodbye, everyone.
Important Links
Dorene Markel - LinkedIn
About Robert Levine
Dr. Levine has been a long-standing diabetes research advocate. While Mary used her public recognition, personal experience with type 1 diabetes (T1D) and grace to offer hope to T1D families and build awareness and support for the research and advocacy programs of JDRF, Dr. Levine worked to help JDRF build an organization that could handle its rapid growth and expanding influence. Dr. Levine helped organize and lead initiatives that built a grass-roots/grass-tops health research advocacy program that is arguably one of the most effective in modern US history, as well as helped develop the strategy and processes to manage a JDRF research budget that grew from $10-12 million per year to over $100 million per year, moving from one focused on small-scale bench research, to one supporting large-scale Research Center and Mission-driven initiatives, clinical trials, and consortia targeting the translation of scientific advances into therapeutic benefits for people with diabetes and its complications. Dr. Levine has served on the JDRF Executive Committee, Research Committee, Scientific Advisory Board, Research Executive Committee, and Lay Review Committee. He was the founding Chairman of the JDRF’s first Clinical Affairs Working Group which he organized to help JDRF oversee its first human trials and later its growing clinical trials program. He is a past Chairman of JDRF’s Government Relations Committee, the founding Chairman of JDRF’s Communications Committee, and past Chairman of the Board of Chancellors.
Dr. Levine has led the development of the concept for the “Mary Tyler Moore Vision Initiative” as a way to honor his wife, Mary -- who suffered from vision stealing diabetic retinal disease -- and her commitment to finding a cure for T1D and its complications.
Dr. Levine graduated summa cum laude from Loyola-Stritch Medical School in 1979 and completed his specialty training in Internal Medicine and Cardiovascular Disease at Mount Sinai Medical Center in New York City. He was the founding Director of Mt. Sinai’s Cardiac Health & Rehab Program.
About Dorene Markel
Dorene Markel, M.S., M.H.S.A., serves as the Managing Director of the Mary Tyler Moore Vision Initiative. She was recruited to this consultant role upon retiring from the University of Michigan Medical School in June 2022. Dorene served in several leadership positions in Michigan Medicine over 40 years.
Her last position was as the founding Managing Director of the Caswell Diabetes Institute at the University of Michigan and Director of the Brehm Center at Michigan Medicine. Her faculty position has become active emeritus in the Medical School’s Department of Learning Health Sciences. Her interests are related to clinical and basic research administration, scientific consortium building, ethical issues in human genetic research, human-focused and community engaged clinical research, and learning health systems. Ms. Markel played leadership roles in growing the clinical and translational research enterprise at Michigan Medicine. She served as the Associate Director for Alliances and Collaborations for the Michigan Institute for Clinical and Health Research (MICHR) home of UM’s NIH-CTSA grant, as the Director of Clinical and Translational Research at the University of Michigan Medical School and as the founding Managing Director of MICHR.
She also played a key role in the development of the NIH Human Genome Center at the University of Michigan (Dr. Francis Collins, Center Director) where she served as the Director of Human and Family Studies. Ms. Markel was the first Genetic Counselor to be employed by Michigan Medicine, and among the first nationally to specialize in neurogenetic conditions. She also served for 8 years on the IRB for Michigan Medicine as a genetics research expert. Ms. Markel received a Master’s Degree in Human Genetics, specializing in genetic counseling, from the University of Michigan Medical School and a Master’s Degree is Health Services Administration from the University of Michigan School of Public Health. Ms. Markel also volunteers as a co-chairperson of the Our House Community Ambassador Committee, a community non-profit that supports and mentors youth as they age-out of the foster care system.
