Alisa L. Niksch, MD - Chief Medical Officer of Genetesis
What is Genetesis, what is the technology and how does it work?
I’ve been involved with Genetesis since 2014. It’s a company that’s built a full stack cardiac diagnostics platform in those 4 years, incorporating hardware, software, data analytics, and machine learning. The platform aims to passively sense cardiac magnetic field activity, create a 3D map of that electrical activity, and use data analytics and machine learning as a platform to detect aberrations in the pattern of current flow and propagation in order to diagnose various cardiac disorders. The main focus of our research right now is acute coronary syndrome. We’re using it currently in the ER or observation units so we can compare our technology to current stress testing procedures, such as stress echo and nuclear stress tests, which allows us to compare sensitivity, specificity, and predictive value parameters of these technologies. We really want to undercut the price of those diagnostic modalities without compromising accuracy, and so, far we’re doing pretty well with our research.
How far along is the product in terms of regulatory considerations?
We’re about to complete a prospective trial in low to intermediate risk patients, and then we will launch a multicenter trial with higher risk patients so that every patient admitted, who would ordinarily be going to the cardiac cath lab for possible revascularization, will undergo our screening. Our screening is a 60-90 second scan that does not incorporate radiation, special IVs, dye, or contrast. It’s pretty efficient in terms of diagnostic speed, and it can be used for patients being triaged, discharged, or sent to the cath lab. We’re going to put it up against the gold standard, which is angiography.
Our negative predictive value right now with low to intermediate risk patients is close to 100% - about 98% at this point, so we're really proud of that. We think we can reduce hospital costs in terms of putting patients in an observation unit and having them undergo various types of stress testing, which is never a money maker for hospitals. Hospitals pretty much always lose money when we do that type of testing. There’s the additional safety risk of nuclear stress testing, so eventually we hope that we can use our technology as more of an outpatient modality that avoids some of the stress testing we do on a more routine basis. That's the next phase, but right now we’re happy with where we are in terms of broadening our appeal to both ER physicians and cardiologists.
It’s going to be a busy year for us because we want to start multicenter trials. Our engineers are eager to get that data to build the machine learning library and the neural network. We also have our FDA submission coming up this year. We’ve decided to apply for a Category 3 approval, to get a reimbursement code for providers who will be using the device for research purposes.
Mission and Vision:
I’m passionate about patient experience and what they go through when they have concerning symptoms or risk factors for heart disease. Oftentimes, however, patients are afraid to go to the ER because they know what they're going to have to go through: lots of blood draws, many EKG’s, overnight admissions for an average of 18 hours, etc. They could miss their grandchild’s little league baseball or softball game because they went in to the ER on that Saturday morning. What we really want to do is streamline and improve that experience by making it possible to arrive at a diagnosis more quickly. I think patients and physicians really want answers, but for patients, we want a solution that enables them to be able to show up for care and not be impeded by these many layers of testing, bureaucracy, all the things we do now that aren't the most pleasant for them. Ultimately, these levels of procedures may prevent them from seeking care.
Of course, on top of that, we want physicians to have better tools. ER physicians in particular have expressed to us that they are frustrated with the lack of sensitivity that ECG and the confusion that high sensitivity troponins offer. Furthermore, what physicians do to handle the low to intermediate risk patients who come to the ER with chest pain is really costly. The number of patients who actually end up going to angiography in the cath lab is 5-10 percent in a particular population, which is really low. You have lots of people who are just sitting there, and they're getting these expensive, semi-invasive tests, and it all ends up being negative so they go home anyways. Why do we do that? It seems crazy and expensive. In the end, every new technology that's out there, whether it's a digital health platform or a new device, is analyzed for its cost of care and how it can impact lowering the global cost of healthcare.
Could you talk about how the idea for this came about and how the company started?
My CEO is a pretty interesting person, he's a young guy in his early 20’s, believe it or not. He's always been fascinated by cellular electrophysiology and how we can capture that in a different way besides in a college laboratory doing patch clamp experiments. He wanted to aggregate that info and see how we could measure that in an organ system. The company started with more of a software platform to measure these aspects, but we didn't have any raw materials to implement that approach except for old fashioned ways of doing these experiments.
At some point, he knew something about my background in magnetocardiography and reached out on LinkedIn. My background as a pediatric cardiologist and electrophysiologist allowed me to use magnetocardiography to define arrhythmias in unborn infants, so we were doing a lot of fetal arrhythmia work. This work was a way of quantifying electrical activity noninvasively, and it was a little more direct in that it was a measurement of magnetic field activity which could be converted into electrical current data. Then we needed to find a way to build the hardware. We were able to build a sensor grid using newer technologies, and we ended up building the entire shielding apparatus A to Z, in addition to making the software more sophisticated. That’s how it has developed into this full platform of software and hardware. In the end, I think we wanted complete control of the data. We wanted to make sure it was our purview so that we could ensure the quality of our input data. We definitely didn't want to be victims of garbage in, garbage out, because that would have been a disaster. Relying on other people's quality assurance metrics and practices is hard to do while we are in the infancy of machine learning and AI. We can't trust anyone except ourselves in this situation; it’s a tough thing to do.
Can you talk about your role of CMO within the company, why you decided to take it on, your day to day and how you balance those responsibilities with your practice?
It’s an interesting balance because it’s very separate from my clinical duties. This company was never affiliated with Tufts, and we don't use its resources here. My role as CMO is to translate the clinical purpose of the technology that we use, which entails things like giving our machine learning engineers the clinical guideposts for each branch point in the algorithm that they are developing. I remember at one point they were trying to be too fancy, and I had to let them know that we don't need to do that right now. We just needed to define X and Y. The logic and methodology of medical workflows--how we think as physicians--that has to be translated into an algorithmic formula, and this translation was one of the biggest roles I had initially. One of the big roles I have now is to help our research centers develop and design protocols that make sense clinically. I also assist the company with regulatory process requirements and meeting those criteria. We have a lot that we need to accomplish, so we have to balance all of those goals. There's a lot of communication involved. More people have come into the company in roles such as commercialization and R&D since I’ve started, so I have to be a part of the conversation with those individuals and teams as well. There are a lot of cross-functional purposes in my role, sort of putting a perspective on all these different aspects within the company. Depending on the type of technology developed by a company, a company may or may not need a CMO. In my company’s case we probably needed this role filled pretty early on in our life cycle just because the technology is complex. We had a lot of different questions and were obviously aggressively pursuing human research and regulatory processes, so there have been a lot of different roles I’ve had to play. It’s been a lot of fun but also lots of nights and weekends. It's definitely a challenge, and I would say, not for everyone.
I knew being a CMO would be challenging, and similar to what it has been for me. I think if you're still dedicated to practicing full-time, you know it'll be like that. Some people can transition more easily into a part time clinical role, but it’s very difficult to do that in my specialty. I know very few part time pediatric cardiologists out there. There are a few, but for a lot of subspecialty care within hospitals, they find that negotiating a part-time role is more challenging for a number of reasons. It’s not economically advantageous for medical centers to have part-timers because they still have to pay benefits for fewer hours that an individual is giving back. There are quite a number of physicians in the Boston area who have an entrepreneurial role, who have a very different profile of duties than I do, and as a result, their balance is very different than mine.
Were there any additional skills you needed to learn or develop on the job?
I don't have an MBA (and I don't know if I’ll ever get one), but I will say that there’s a lot of business acumen that you develop as you go through this process, and you're not going to learn it overnight. You also learn how to present the company in a clinical, economic, and global value sense. You learn how to sell. Don’t forget that every job is a sales job. A lot of the skills are pitching, selling, speaking to venture capitalists and investors, and learning what a term sheet is all about. The regulatory pathway isn't easy either. It's not like every physician comes out of medical school and knows how the FDA works, or what a 510(k) is. So that’s been a learning experience, too, in terms of defining the short term and long-term goals of those roadmaps. So, yes, I’ve learned and developed a lot of new skills.
If I had to give advice to somebody who would ever do something similar to what I’m doing, it would be this: if you don't have the perspective of being a lifetime learner, if you can honestly say to yourself that you just want a relatively safe, secure job, and have a fixed skill set for an extended period of time, then going into healthcare entrepreneurship is likely going to be a very unpleasant experience for that person. There are a lot of serial entrepreneurs who don't stick to one category of things. If you look at some entrepreneurs out there, you’ll notice that, for example, they’ll do a cardiology product, then pain management, then opioid addiction, then jump to big data and healthcare analytics, and move on from there. People who do that don't like to be bored.
What would you say you enjoy most about what you're doing?
What I really enjoy the most is that my position is really fulfilling for me. It’s my own personal experience, and I was never a one-trick pony in terms of my interest in science. I was a non-science major in college, and I never grew up being taught or surrounded by one consistent skill set. I constantly had some sort of art in my life. Every day I heard music from my mother playing on the piano. There were all kinds of different things that I sort of left behind a bit when I went to medical school. As a result, there was a part of me creatively that remained unfulfilled in many ways for many years. There's something about going into entrepreneurship and participating in analytic thinking, design, strategy and all of these different ways of presenting data and talking to people from different backgrounds and then translating what you're doing into things they want to hear about that taps into my creativity. That really gets me up in the morning. It's a lot of fun, and that's just me. I think everyone in this space has different reasons and entrepreneurial initiatives for being here, but the other thing that applies to me is the feeling of mastery over something. I think you get to a point in your career where you’ve seen most or all of it, and you want to acquire something new and be the master of that skill and continue to build on that. It harkens back to the lifetime learning philosophy I mentioned. That's a big part of what entrepreneurs and people involved in new projects and technology enjoy, especially in healthcare field. They want to help people but also master something, create something new, and know all about it.
Is there a field of medicine you feel exists where you haven't seen all of it?
In my own field of training, pediatric cardiology, you can never say you've seen everything, but there are plenty of specialties where I haven't seen it all. Just because you're a cardiologist doesn't mean you can't go to a specialty you didn't train in and learn about it, master it, talk to people, and really get a sense of what's going on in the field, including its challenges or pain points. You need to be a good listener when you're out there because someone's going to make a great point. But, if you’re arrogant about it and you think you have all the answers and you're going to solve this problem, you might miss an important detail. If you miss that detail, there's going to be a flaw in your plan, and it might be a very big flaw, so listening is how you pick those things up. Listening is also how you learn about those larger issues in other fields which may be important to you in the future in terms of your career and other projects you take on.
Can you talk a little bit about your career path in terms of medical school and how you ended up where you are right now?
I think that I had zero idea I was going to be doing this. When I came out of my training, I was bound to be a clinical doc and do some clinical research since I came out of academic medical centers and really wanted to continue that. I had some frustrations that came along with my first job. My first job was a very unpleasant time for me for a number of reasons. Part of it was also that I felt kind of stuck my role at the time, and like I said, I didn’t feel that I was able to be creative or independent or think outside the box. I moved to Boston and searched for something different, for something else that I could use my skill set for. I got some really good advice from somebody who told me that the first thing I needed to do was to build my network by reaching out to people who intrigued me and with whom I felt a connection. It was a very interesting process to cold-email and contact people on LinkedIn. In fact, I got some very cool and kind responses. They may not have had anything for me to do, but they were interested in connecting. A lot of them were not doctors but entrepreneurs or CEOs that I read about; I would flag those names, and I would find them and tell them that I was interested in what they were doing. I built some connections that way. I ended up advising several companies both informally and formally and was able to meet up with a lot of people here. I got involved in some hackathons and various project like that. It just built further into more complex, higher-level relationship that eventually led to my current position at Genetesis, which was very fortuitous but still along the same lines.
A lot of this stuff is beyond what medical school teaches you - from the reading of employment contracts to learning how to network. You do have to learn how to push past a certain boundary, and students are often not taught to think that way or stray outside the established lines. I think MD/MBA programs are some of the few programs that allow students to think along those parameters so you get that exposure. In more traditional MD programs, it’s a really isolating feeling when you leave the walls of training and have to go out into the world and all you know is your residency class and maybe your fellowship class. Then you have your first job, and you have to keep going. For me, one advantage I tried to give myself throughout my fellowship programs at Columbia and Stanford was that I would try to make sure that I had friends outside of medicine. My best friends in New York, for instance, worked at Citigroup and Revlon, so they’re not your typical medical school/science based medical friends. There are a lot of different perspectives I think you can gain from branching out and having relationships that don’t always fit in the puzzle that is medical school and residency.
What advice do you have for future healthcare professionals?
I would say don’t limit yourself to one way of thinking about your skill set or thinking that you’re only destined to do one thing. There are probably many things you can do with your training. You can be a clinical practitioner, a researcher, an entrepreneur, or a healthcare consultant for the government or an NGO. I would also say as a corollary (in some ways) that if you’re eager to do something like that, I understand your eagerness, but I wouldn’t go and do something like that right after medical school. I would even hesitate in doing that right after residency. One of the things that I feel has brought real value to what I bring to the table is my experience of knowing how medicine actually works. Residency isn’t actually how medicine works. You don’t feel the bureaucracy, the politics, the burden of antiquated technology, the pressure of reimbursement, or the healthcare economic structure that we’re living under. You don’t necessarily have that perspective right out of residency.
I’m not suggesting waiting until you’re 55 to do what you want to do because that’s not ideal either. I would really say that depending on how you want to have an impact, if you’ve practiced and seen the pain and how many practices and hospitals are under pressure, I think the comfort level you have to market a product and communicate its value into a system in which all of that stuff is very important would increase. The investors that you’re pitching to already know all that stuff; they know the economic impact, they see the money behind it. You’re not going to be able to know everything, but you need to be able to put a human face on it. I would again encourage people not to get out there too early. I think you may find yourself a little lost in that world.
As students in healthcare, we often have significantly longer training periods than our counterparts in MBA or other programs. How could we leverage our training over the employee experience gained more rapidly by students from other programs?
It’s not that that there aren’t some disadvantages to that. A few people I knew in Silicon Valley who heard me talking about the politics in medicine kind of laughed at me and told me that my job wasn’t special. I said, “What do you mean?” They said “Your job is no different and what you’re experiencing is no different from someone who works at Google, Ebay, Oracle, or any other company. You’re going to have the same work politics, contract issues, complaints about pay, etc. It’s the same thing.” As I’ve gone along, I’ve realized that that’s becoming more and more true, and I’m starting to appreciate it more than when I first started. By the time I started my first job, they had had 4 - 7 jobs, if you say that the average turnaround time for tech companies in Silicon Valley is 18 months. So yes, there is a kind of “employee intelligence,” that they developed earlier than I did. It’s not all about being a doctor and having a large knowledge base and expertise in your field. It’s also about learning how to be a good employee and a doctor. It’s an interesting way of thinking about that differential.
Doctors come out of medical school and fellowship, and they’re very sheltered and protected. They’re let out into the world and most of them don’t know how to be a good employee. I understand that there are abusive workplaces, but a lot of people end up having similar complaints. Whether you go into a clinical job, a startup, a corporate entity like Philips, or whatever, there may be a different culture, but the common issues are all there. That’s the experience you miss out on if you leave your training by the age of 28-30. Yes, your colleagues who graduated earlier may have had 3 jobs by then and have that employee experience, so your learning curve may be a little steeper. However, you have to balance that with the skill set you’re bringing to the table. Everyone will have to go through that, but if your value proposition is that you’ve had a few more years of training and experience and are able to see more than other people on your team, that will score big points for you in the long run.
I also think that (not trying to be ageist here) it’s effective to have people of different ages in the room. The younger people on my team tend to have the exuberance and enthusiasm and evangelistic kind of stance, and I’m more of the measured, practical, common-sense, value-based person. It all makes a nice package for people. You have to have some experience in the room in order to balance out your company. Not that if you get the golden opportunity, you shouldn’t take it. Think about what it means for you, and if you should stay in school for a little bit longer to broaden your scope. As a medical student, you don’t really know what’s going to happen years down the road in your career; all you can do is talk to people in your orbit, but they may not always have the answers, either. A lot of people who’ve gone through similar career trajectories as me would say that it’s been of value to have at least practiced for a while or still have their little toe in the clinical world so that they’re abreast of what’s going on. That’s not necessarily possible for everyone though.
What has been the biggest challenge you think you’ve faced in the process of joining the startup world? And maybe even in your career?
This is always a really hard question for me, to put my finger on one big challenge. One of the challenges that is inevitable when you’re interested in early stage startups and technology is that unless you’re a founder, you’re likely going to be coming in at a stage during which you’re going to be evaluating the current team and the quality of the product. A lot of the stuff is unknown in terms of the pathway ahead, which requires a certain amount instinct and intuition when deciding which projects to participate in. It’s not scientific. It’s something where you have to choose between opportunities, as tempting as some offers might be. Is it something that you think is worth your time? Is it something that will benefit you? It might not yield anything financially of value to you, but it might be a stepping stone onto the next project, especially if it’s something like an advisory role. Other questions to consider are: Does this get me anywhere? Does this give me more visibility, attention, or connections? It’s not easy. Some people are good at making these decisions, and some are not. For the people that aren’t that good at it, it becomes a numbers game. This isn’t how doctors normally think, so you have to train yourself to think that way. I’m more of an analytical person. It’s like picking a stock in the stock market, trying to figure out which one will go up. You study the pros and cons and try to make an educated decision; that’s more my tendency and more of what doctors like to do. But these are hard questions.
And then I think the other challenge is balancing time. It’s a constant struggle to figure out how to squeeze in a call if I have clinic until 6 o’clock, and then a networking event at night, and then putting together a slide deck for a conference next month. All of these things kind of converge and make your life crazy. You just have to be ready for that. It’s a little bit chaotic.
I’m asked a lot about being a woman in this space too. I think I would say that I haven’t been met with a lot of challenges from that perspective. I think there are other women who have, so it just depends. I am helping to build a women’s healthcare entrepreneurship initiative through the PULSE program at MassChallenge because I think there’s a lot of underutilized networking potential and expertise out there. I’m hoping to leverage that more effectively than what exists out there right now. It also puts me in a different leadership type role which is challenging and new, but stay tuned. I think we, especially as physicians, need mentorship all around. I’m part of an enterprising physician’s dinner group every month, and I’ve made great friends coming out of that, but we all have different lifestyles and profiles of how we spend our time. There’s no real right or wrong way of doing it. There are just different ways of doing things, and we learn from each other in terms of what we’ve gone through. The most important thing is not that we’re senior or junior to each other, but that we have each other’s back if we have a just a simple question, or if we’re trying to explore a new opportunity.