Medical Affairs and How To Deliver Long Term Results
Dr. Agim Beshiri is the Chief Medical Officer at Nutromics, where they have developed technology for continuous diagnostic monitoring through a ‘lab-on-a-patch’ approach. Dr. Beshiri is a leading industry expert in developing medical affairs organizations and driving medical research and education. Prior to joining Nutromics, he contributed at Abbott Laboratories for over 16 years, serving as Senior Medical Director. In this episode he shares about earning a medical degree and applying it inside industry, what doctors and companies need to recognize about each other, what Medical Affairs is and how it is structured, the long-term objectives of a company and how medical affairs can drive massive growth, and how Nutromics is positioned to help change how monitoring of critical parameters is performed.
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Episode Transcript
This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.
Patrick Kothe 00:31
Welcome! In our industry, we expect the product development phase to take time, technology development, clinical studies, and regulatory clearances or approvals take time. And we recognize that and that really aligns with what our expectations are. But once we hit the market, we want results and we want them fast. And often to achieve long term growth. We need long term thinking and execution. But that typically doesn't come from the sales and marketing organizations who are more focused on shorter term results. On the other hand, Medical Affairs has a different function and can provide that long term focus that can drive huge market shifts. Our guest today is Dr. Agim Beshiri, the Chief Medical Officer at Nutromics, where they've developed technology for continuous diagnostic monitoring through a lab on a patch approach. Agim is a leading industry expert in developing medical affairs organizations and driving medical research and education. Prior to joining neutronics, he contributed at Abbott Laboratories for over 16 years serving as Senior Medical Director. In our conversation we discussed earning a medical degree and applying it inside industry. What doctors and companies need to recognize about each other what medical affairs is and how its structured. The long term objectives of a company and how medical affairs can drive massive growth, and how new tronics is positioned to help change how monitoring of critical parameters is performed. Here's our conversation. So Agim, people who earn medical degrees often go off and practice clinical medicine. But there's a lot of other interesting things that people with medical degrees do. So can you explain a little bit about what your career journey has been?
Agim Beshiri, MD 02:50
So that's actually a very interesting question and an interesting topic, because most MDS don't expect to finish medical school and then end up in industry. Their expectation is that they will have a direct patient interaction, improve health care and improve outcomes one patient at a time, either in practice or in a clinical setting in a hospital in various specialities. It's also very humbling to know that the function and the value of a physician in the industry is highly valued and and much needed. And you don't really learn or figure that out until you are have entered the industry. For me, I spent quite a bit of time in Latin medicine and internal medicine until I was exposed to the industry, I believe it was more of a haphazard than a career direction that I was looking for. When industry, partners sales or commercial folks or r&d folks would come in and discuss their platforms or diagnostic platforms, I'd always have something to say about how would you translate it to clinicians? And why aren't you translating your data, the raw data or the scatter grams or the graph to the clinicians, because the results alone, the numbers aren't really the full story and they don't provide enough insight into what's going on with the patient. The data is there, all you have to do is translate it and you'll have better impacts to patient management's and better outcomes. And that's really what earned me the invite to industry and a few industry, large industry competitors wanted me to come on board and an interview and consider different positions. And that's what I ended up at Abbott diagnostics way back when.
Patrick Kothe 04:48
So it was a translating the language and the important topics into physician speak. Is that kind of what we're talking about here.
Agim Beshiri, MD 04:57
Well, so if I was doing go into a little bit more historical detail here about medicine and how medicine is taught physicians in medical school and even after medical school in, in the clinical setting aren't really taught about diagnostics, laboratory diagnostics, unless you're in a specific speciality in a lab or pathology. And General, physicians learn about which tests to order for a specific type of disease, or if they're suspecting a certain type of pathology and a patient, and then they would order that test or those lists of tests. And when the results come back, they would compare him to a reference range or a normal, it's abnormal, it's low, it's high, and so on. But there's much more to that a trajectory of a certain test a pattern of a certain test, some of the raw data of that certain test is probably more valuable than just the result and the reference range, because the results in the reference range are more population based, and they are not patient centric. But the raw data and the graphs and the amount of analysis of that sample that takes place in these instruments is really patient centric. It's analyzing everything in the blood about that specific patient. And if we could make clinicians understand the value of that, we would have more art of medicine and patient centric approach to the patient, then rather than, you know, hey, here's the result I got on on test a for Patrick. And I'm going to compare it to a reference range of a bunch of normal subjects out there where this reference when he was developed off of, and I'm gonna make a decision off of that. And I think that's the sort of paradigm that I really wanted to drive for. And I was passionate about even before joining industry.
Patrick Kothe 06:57
So I came let's, let's go back to that first month when you joined industry. Now, that's a few years back. But let's go back to that that month. What did you think when you joined and went inside the company? What was the difference between the people that you worked with in clinical medicine and people within industry,
Agim Beshiri, MD 07:16
we should understand that and medicine, we, some of us, involuntarily, and some of us may be like that type of personality and persona, but we develop this deity complex, it has to happen this way, or the patient dots. And everybody aligns to that. And you expect that everybody's on that same page. And, and then when it's critical, everyone's acting critically, and so on. And you feel like you're the only stakeholder in that setting. Yes, the whole team is supporting you, and you're driving for the best outcomes, but you feel like you're really the only main stakeholder. And when you join industry, especially large companies like where I was at, and these large mammoth organizations with hundreds of 1000s of employees, you're no longer the only stakeholder. So it's quite a bit of a shift in mindset. And for the folks that come from medicine, from medical specialties, and in clinical practice, if they can make that shift in mindset that, yes, I am a stakeholder, but I'm not the only one. And I have to understand what the other stakeholders need. And I have to be able also to educate the other stakeholders to the level of understanding from a medical perspective that I'm trying to bring to the organization, to the insights about patients about patient care about the health care system where your experience or my experience where would have come from, and try to have that understanding laid out to them in a way where they could translate it themselves to their own department, whether it be commercial or a, a regulatory department and so on. So I think that's really the biggest challenge and the shift in mindset for for folks coming in from a medical training and medical practice into the healthcare industry.
Patrick Kothe 09:08
So as you got in and you're with your teammates, now, at at Abbott, did you think that they understood that the clinicians were lone wolf, so to speak, that it was it was their responsibility, they felt that it was just it was it was their decision, their responsibility, and they were less of a I want to be careful here. They were team players, but they're less of a team player, and more of an individual contributor.
Agim Beshiri, MD 09:36
There's variations to that. And I think that the best teams operating in a medical capacity and a medical affairs capacity and industry, are the ones that understand quickly and adapt quickly to the fact that we have to be able to support the organization at the medical level that they understand. And of course, At the beginning, you know, it takes a little bit of time for us to be able to capture the nuances of the different departments and individuals and personalities and leadership styles. To understand how you translate and deliver that medical message, or that medical vision or that medical strategy to the rest of the teams, I think that you're always going to have folks and there are plenty of examples historically, that can't adapt to that and do seem more like the lone wolf approach. And it happens this way or no, no other way at all. And those are not really the successful folks in medical affairs, and they don't end up driving a medical team, that becomes an integral part of the organization, providing that seamless support both ways, right, both internally to the organization, and then externally, to the collaborator, stakeholders and utilizers of that technology. And I speak really more focused on on a diagnostic lab diagnostics perspective, because an Abbott, the diagnostics organization did not have a medical affairs, entity or department at that time, but rather some some clinicians supporting more of a safety perspective and a and a on market vigilance perspective, for quality and regulatory purposes throughout the organization. If we want to be successful in that space, you really have to be able to integrate and become an integral part of the lifecycle of the product, from early development, all the way to on market and safety monitoring.
Patrick Kothe 11:46
It's really interesting because clinicians are trained to be the person that makes the decision, get all the information, take it all in, make a decision, make it quickly and be firm, and be the leader. And they're less collaborative than people inside a company. What's what's interesting to me about that is do we in industry really understand that about a clinician is because when we're selling into an enterprise, but that clinician is seeing themselves as being the decision maker, even though there are other things that are going on, the way you present, your technology may be different. It may be different because of the mindset and the training that that clinician has.
Agim Beshiri, MD 12:34
Absolutely. Look when especially from a diagnostics perspective, early on, we we put a strategy together to focus on determining who our stakeholders externally were. And the stakeholders and decision makers combined comprehensively in a healthcare system. So if we spoke about this 30 years ago, everyone would tell you, hey, a game is crazy, we just go to talk to the lab director. And if they like it, our diagnostic platform is sold. It's a piece of cake. But that has changed over the years, Patrick. So over the years, what what has happened is the lab, of course, is the bread and butter of a diagnostics company. However, the lab only has one stakeholder in there in the lab director or leader of laboratory, medicine, and then institution, and then you've got a whole plethora of other stakeholders outside of the lab, that is very important to take under consideration that being the clinicians, that being the C suite and the quality and financial individuals in that institution. And they've clinicians tend to make up the largest body of the stakeholders, because if enough clinicians see that there's value, there's scientific proof sources, there's publications, there's guidelines that talk about your methodology, your diagnostic platform, your test, having value and improving outcomes, then they will call up the labs they will call up the C suite. And they will call up their operations leadership and say, Why don't I have this at my disposal to improve patient outcomes. That's where you have to consider what is what your team is comprised of. Because if your team is comprised of only one set of skills, one background, common background and experience, then we won't have the ability for the first two minutes to have that discussion with the clinicians of the different specialities. Clinicians tend to be a little bit closed in that sense, they would like to have a peer to peer discussion, somebody that understands the pains and and the gains of patient management and how to manage patients. And therefore you do want to have a clinician sitting down and saying, Hey, I understand where you're coming from. And I'm trying to resolve this by providing us solution that makes sense. And if I could implement it in your place, I would, because I know what the value is in patient outcomes. This is a big driver for us and driving and developing a team that can drive for education externally.
Patrick Kothe 15:19
Well, you said it, I mean, a sales rep or a business person talking to clinician will get so far, a clinician talking to a clinician, it's a different level, even you know, it's it's a different level. If it's, you know, peer to true peer to peer, they're in the same network and physician, a physician versus physician insight accompany, and a clinician, it's a little bit different, different dynamic there. But the closer you get to that clinician to clinician exchange, the more impactful it is, is that your experience,
Agim Beshiri, MD 15:53
it opens the doors easier, and certainly the credibility is established a lot quicker, that does not go to say that physicians are the only experts at everything. That is not true at all. In fact, if you're in the diagnostic space, your medical scientific team needs to be very broad and experience and background and specialties. And I can say that very confidently that we had physicians, we had PhD scientists, we had true laboratorians, that managed laboratories for many, many years. And it varied on which test or which diagnostic platform we were talking about the open up the doors with with the different stakeholders. Now a clinician may sit down with another clinician and open up the discussion in the first 30 seconds where they give them the time of day to have that discussion. But that doesn't mean that we leave out the true expert on that topic, we would bring in that true expert, which in this case may have been a laboratory, not necessarily a physician at all, but a laboratory and with a deep understanding of the science and and the value of that test coming from a lab perspective. And this is something that I think he missed and quite a few organizations where they tend to focus on either only on the science, or only on the clinical side, or only on the commercial side. There's no limitation to who can be in, in these discussions. Of course, being at on label and off label is kind of what decides who's there. But there's no limitation on who at these discussions as long as they have the expertise to represent themselves and somebody is facilitating opening up the door and the discussion with the clinicians.
Patrick Kothe 17:39
Medical Affairs can mean a lot of different things. And it means different things in different size companies. So in general, when I say Medical Affairs, what how do you define that? What is medical affairs mean to you, inside a medical device company,
Agim Beshiri, MD 17:56
man, historically, Medical Affairs has been more of a pharma driven department and team and organization and the diagnostics industry, it's been more a more recent type of development, recent I mean, probably in the last 15 plus years, where Medical Affairs has sort of transitioned over to diagnostics as well. So we do have a bit of a different definition and function across these two different types of healthcare industries. On the pharma side, they they tend to be quite well defined within a, a franchise, or a indication, heavily tied into the organization's commercial structure and driving a commercial goal. And then diagnostics, we actually sort of pulled it back from just being the commercial support tool, and broadened it to say that we're involved in the like, lifecycle of that product or that platform, from its inception all the way to on market monitoring. That's a different paradigm for medical affairs. On the diagnostic side, it's much broader, much deeper, and really is, like I said, a structure that's required for the lifecycle of the product. And for me, the true definition of medical affairs is being able to translate those patient needs throughout every single one of those points in the lifecycle of a product from inception, to launch, and then two revisions and improvements and relaunch throughout. Of course, the the way that we do that is with a lot of data and direct interactions, not only with patients, not only with clinicians, but also with a lot of science and publications and the research that's ensued in those collaborations.
Patrick Kothe 19:51
So there's a lot of different things that you mentioned there from the front end of the development to product Product Support. And depending on the size of the company, it could be staffed completely differently. So let's let's, let's take a large company, one of the large, larger companies in the diagnostics space. Tell me about the the Medical Affairs Department how big it is, how many people are there what how it's divided out functionally,
Agim Beshiri, MD 20:23
I'll talk a little bit about Abbott diagnostics, which is where we're most of my career was spent. Prior to moving on to a smaller company in a startup and diagnostics, we had a fairly large global organization, the way we structured it is we structured the medical and scientific side to be really focused on the research and the lifecycle support from a r&d interaction, to a commercial interaction, to an on market and post market pre market and post market research a function. And then of course, we had the clinical piece that was really associated with running the clinical studies, the Clinical Affairs and writing the clinical studies for regulatory purposes, and submissions to the regulatory bodies. And then the on market surveillance was more of a a safety organization that looked at on market complaints and safety, and managers bathroo, our our quality system, and then an AGR model, which are an ACR team, that really covered the health economics and Outcomes Research modeling, and was an integral part of interacting with the rest of medical affairs that was involved in a lot of the research and the publications. So that whenever the opportunity existed, we could leverage that study that data for an ATR model. And this is basically the breakdown the size of may vary across the organizations. You know, Roche may be a bit larger as it is one of the largest diagnostic companies in the world, avid being right there next to Roche and Siemens and Beckman, but, you know, in our organization being a global organization, it was it was quite a few folks. And we're talking about 30, folks, and just on on the Medical Affairs side covering this on market and pre market study and research and commercial support. Rep. The organization obviously much larger, but I don't want to get into numbers, as I'm not sure that that's really a a driver of how an organization is structured is based on need. And specifically based on needing these specific areas, right, geographically, the market may have a larger need in Asia Pacific versus Europe versus the US. And you need to be dynamic and be able to scope where the resources are needed and address it accordingly.
Patrick Kothe 23:06
I know every company is a little bit different. But Clinical Affairs may sit outside of medical affairs, driving clinical studies is going to be outside of that or the management of clinical studies, regulatory affairs is outside of medical affairs, we're just talking about strictly medical affairs. And, and helping to, to frame some of these decisions that are made in the budget may sit with another department
Agim Beshiri, MD 23:33
and our case clinical was within the medical affairs organization, but not regulatory, to your point of framing, the need and budgetary needs to drive. The support that's required is really a long term piece. We can't equate a medical scientific strategy to a commercial strategy that is always looking for, you know, a quarterly report and a quarterly return and expression of of success. And medical, everything is long term. The short term is not the successful piece, the long term is what successful. If I were to give you an example, one of the responsibilities for an organization like ours would be how do we get a product from inception to guidelines? Right? Because the Holy Grail is once this has been guidelines, then clinicians, reimbursement, practice protocols, everything falls in line. And on average, you're looking at about a 10 year timeframe. A successful average is 10 year timeframe and you've done all the research. You've done all the education and I call these sort of the four pillars of a medical clinical strategy, research, education, consensus, and then finally guidelines. But you've done all the research both pre and post launch and is Continuous, you've developed the right k wells with the right investigators. And you've done the right education at symposia and congresses and, and the key opinion leaders are actually driving it on their own, because some of this is their own data. They've done the research with it, they believe in it. And they're driving it themselves. And then finally, we're establishing enough consensus committees and expert meetings, to where they are putting out white papers and publications making the recommendations. And these are the influencers, or they are the guideline writers in these committees. And that has to happen at local levels of national levels and international levels, for those specific specialities where that diagnostic platform or that test resides, and finally, all of that combined, drive a guideline, it is never a direct driver of a guideline to include what you what you have, and protocol, it's always an indirect. And if you do the right work, you do enough of it, and you do it at the right time to the right people, the guidelines do get impacted. And that's the Holy Grail, as I would call it. And that's one of our main responsibilities. That being an average of 10 year now very successfully, we have shown that can be done in two and a half years. But again, that's that's your extreme example of success. And it should be sort of a vision and an aim that we were shooting for that's that's sort of optimal. But you know, it's never short term, a Patrick, it's never three months, you know, the ROI on this study is two months later, we're gonna make so much and that's not how a medical works. And that's not how research and science and clinical works.
Patrick Kothe 26:44
So the old, saying, you know, start with the end in mind, the end in mind is, is the guidelines and the guidelines that come out from American Heart Association, or Lung Association, or whatever Association it is, this is this is the treatment algorithm, this is the guidelines, the preferred guidelines to do it. And so you're working with national groups with local groups, statewide groups, to start that conversation. And then you're building all of this data over time to support these things. So but you're but you're starting off with the end in mind, this is the goal. And now we've got to have all of these activities to support that goal.
Agim Beshiri, MD 27:26
Absolutely. And one thing I didn't mention earlier, when we spoke about diagnostics and clinicians is, if you go to the CDC website, and you look at the clinical laboratory page that they have up, you'll see that the CDC quotes that 70% of medical decision making is based off of diagnostics. Now, the art of medicine teaches us differently, that, you know, 70% or 80%, of medical decision making should be done based on history and physical, more of the clinical interaction with a patient. But over time, that has flipped and were more dependent on these objective tests and results and, and outputs from diagnostic platforms. So that being said, Remember, when we do get to guidelines, it does have a lot of value, because clinicians are dependent, and it is a form of information that is going to drive a lot of clinical decision making. And that's already well well expressed and depicted and referenced, even the CDC references that. So we have to be cognizant that our end goal in mind of guidelines is the ultimate impact that we could have to patient management and outcomes.
Patrick Kothe 28:40
So you mentioned one of the other things that drives this is reimbursement as well. And changing those guidelines will affect the reimbursement as well. But is that a separate strategy in medical affairs or is that go into a different group?
Agim Beshiri, MD 28:56
Typically, medical would be supporting that that is some some other team team member organization outside of medical affairs, either under a marketing or commercial type of setting that is looking at market access and reimbursement either together or individually in silos. But medical ends up being quite a large supporter of that organization, because the data to drive that is coming from these studies in this research that, you know, we would have spent the last 510 years developing and generating and of course the the support and the direct interaction sometimes with those investigators and those clinicians in those institutions than academic centers, is also going to be very helpful and the reimbursement strategy from a support organization that generates the data and and provides it for guidelines, we end up providing that for a lot of other things throughout the lifecycle of the product, commercial education more marketing activities, you know, external education, a lot of other activities that are not necessarily driven directly by the medical organization. Not to mention the regulatory process, that's usually a pretty big activity that ends up being quite dependent on all the medical work that has been done in the background.
Patrick Kothe 30:22
So changing guidelines, as you said, it's a long term game. But companies are are driven a lot by year to year things. What's the what's the political situation with medical affairs? And the business folks in the business? When when one is trying to do you have a good year, and you're trying to look at 10 years down the road?
Agim Beshiri, MD 30:45
You know, one of the largest challenges and we kind of you rightfully so started us off on that topic, you know, what is the challenge and industry when you join in, and I think this is one of the biggest challenges is being able to relay the value of something that takes 10 years to come to fruition, versus, you know, the quarter to quarter type of of revenue and ROI and reporting that needs to be done from a commercial perspective. And that's perfectly fine. It's how you marry those two, and have them interact, complimentary of each other that that really works. Is it a challenge? Absolutely. It's how will you address that challenge, and overcome that challenge that really matters. In my experience, and, and historical experience in my team, it was all always data driven. And you know, us showing a study, that was an investment of x, that may have taken three or four years to complete and publish and come to fruition, certainly showed a longevity of impact to the organization to outcomes, of course, to the commercial value, much more so than an you know, a short term commercial initiative that was more of a branding type of approach. So that to me is how well do you marry these two activities together, and how you can integrate them into your overall strategy, where both have value and they work off of each other very well.
Patrick Kothe 32:22
So I want to think about two scenarios. One is you've got to technology, it's the only technology that's available. And you're driving clinical trials, in support of that, to change a guideline where you are directly going to be benefiting on that change. That's one scenario. The other scenario is it's you have a product that's in a category of products. And that category of products, you've got competitors who also have similar products. And when guidelines gets get changed, everybody's boat gets floated a little bit higher, the first scenarios would be pretty easy to get resources to continue to drive that the second one, it's, it may be a little bit more difficult. Tell me tell me about about the differences between those two types of scenarios.
Agim Beshiri, MD 33:06
Those two types of scenarios are very common ones, Patrick, they're not uncommon at all. And I, I realized you weren't there, because from experience, you know, those would be common in the industry. And the way we would address those is that scenario number one may be a specific disease state that we are leaders at. And we differentiate ourselves at a very high level, with lots of data with outcomes with, you know, supporters externally and our collaborators worldwide. And that's the easy one, the easier one to to get support for. The other case is we tend to have commoditized tests or platforms or assays, because everybody else has them. And there's no real differentiation there. So any additional activity that you perform, is going to also elevate your competitors. And it's going to end up being a one for one in the end. I think we have to know what what we're in the game for here. And if we joined and if we're showing up to work every day, just to drive for the differentiated products and the differentiated strategies. And I think we need to be leaders in healthcare in total comprehensively and not in a single disease state. And diagnostics. We were looking at pretty much every every disease state there is with 300 Plus tests being made available to to hospital labs and reference labs and smaller, large or large labs alike. And that being said, we have to be leaders in health care. So we may have an initiative and an opportunity where we do take a leadership role and a product or a test that is not time differentiated from our competitors. But we know it'll bring more insight, it'll bring more attention. And it'll impact that disease state for better outcomes. And that's the type of investment to me which, as has a higher value, because everybody understands that we're doing it for the good of healthcare, and patients and outcomes. And that's the type of leadership that I would value more. The other one is quite easy to understand. And you can base it off in numbers, and we run off of it. But we have to be able to be in health care, or health care industry for both all the time.
Patrick Kothe 35:35
From a classic marketing standpoint, you have responsibility, just depending on where you sit. So for example, if you're if you're the number four player in a market, your responsibility is to go get market share, that's what your responsibility is, if you're the number one or number two player, your responsibility is to expand the market, it's not to take additional shares to expand market. So in those two examples, it depends on who you are. And and what that what that responsibility is and what your vision is, as well as a company. Are you just in it for the dollars? Are you in it to help as well. But from a general marketing standpoint, there's also you know, that laid on top of there, what's your responsibility as a market leader?
Agim Beshiri, MD 36:19
And look, I think we have to have that discussion with ourselves first, and then with our leadership and our colleagues in the organization. If we are there just for the dollars, regardless of which position we are in the market, I think that's the wrong reason to be there. And that's not why I joined industry. And that's not why I joined my current organization either. So we have to look at healthcare comprehensively. Yes, we may be in different market positions. But that comes to a marketing strategy and how we address the market, and should not change how we address disease, and disease burden, and unmet clinical need. I know that we see this more often on the pharma side when we talk about orphan drugs and things like that, where you have whole organizations or entire companies really focused on an orphan drug where no one's going to invest in it, because it's a small number of people in patients that would be treated and costs and so on. But it's needed. And I think we need to look at it same way in diagnostics, we have to be able to look at, you know, orphan diagnostics, we have to be able to look at where, you know, we will be elevating the standard of care, regardless if it also includes our competitors, because there's a value there, there's a leadership value there that should be tied into our vision. And if it's not, then we're not there for the right reasons.
Patrick Kothe 37:42
Again, you mentioned that it's different than a large company versus a startup. And you mentioned that you've joined us startup neutronics, which we're going to get to in a few minutes. But just from a medical affairs standpoint, if you're in a startup, you don't have that 30 person department yet, you have needs going on. So from a startup or developing stage company, what should companies do to address the function of medical affairs,
Agim Beshiri, MD 38:13
there's quite a bit of a nuance, although the same needs are there, whether you're a startup or a multinational 100,000 employee organization, and going from from 30, just just direct reports to all the other indirects. And and the other team members and colleagues within the department and outside of the department, I think is is quite a bit of a paradigm shift as well. However, you have to understand that, in my experience, when we joined diagnostics, there, there really wasn't it almost felt like a startup, although the rest of the organization was there. It felt like a startup from a medical affairs perspective. And joining a true startup, it's about the multiple hats, right? And you have to be ready, willing and able, because you're so tied into that vision of what you share with with that organization that you've joined about patient care and prevention, you're ready and able to throw on the CMO, the Medical Affairs, scientific, clinical regulatory and ATR hats all the time. And that's perfectly fine. If you have that level of versatility and experience. Not all individuals joining a startup organization may have that or maybe the startup organization doesn't even have any medical personnel at all, and they haven't hired anybody yet. And that's where the external collaborations are extremely important. I leverage that right now, within our organization, that network, that global network of collaborators is, I would say priceless. So spending that time and experience establishing that global collaboration is probably one of the most Most Important things someone could bring over to a startup from from medical perspective, because you can invent things fairly quickly, instead of running a marketing research or a medical research or a, a consulting company that would cost a few million to come up with a qualitative analysis of what you're thinking, as far as an indication or a strategy or a research pipeline, you could run that by our colleagues and within the first couple of days, and you guys get pretty cost effective responses, meaning at no cost. But, of course, that's the the the value that someone would add, coming from a big company establishing this, this collaboration and network over the years, the academic sites, the research sites, and the investigators, and then being able to apply that to the to a small startup, I think, is invaluable, where the differences have direct support internally live, if you can put on the multiple hats and be ready to develop the team when you think it's the right time to start expanding and developing the team. That's very important. And probably one of the things that most folks get wrong. You know, you can develop too early, you can expand too early, and you know, blow away what you have in the bank and not not apply it in the right prioritized areas to the pipeline, or you can expand too late and you're not growing fast enough to address the needs both internally in the organization and externally, with the stakeholders, that would be decision makers. So it's a very fine line and a balance that needs to be maintained. And I think so far we're doing it right at nootropics.
Patrick Kothe 41:45
It's, it's similar to a quality system. If you're a startup company, you're not going to have this you're not you're not going to implement Medtronic quality system into your startup, because you don't need it. It's not necessary, it's too much. So you build according to where you are, and then you add on. And you may get to that at some point in time. But you don't do it today. Because it's too unwieldy. It's not necessary. So you build what you need. And same thing with, with medical affairs, as you described as build what you need today. But I think what you're also describing is keeping the end in mind, if you want to get to that 10 years, I'm going to change guidelines. If you don't start today. Well, the next best day to start is tomorrow. But if you wait a year from now, and the things that you're doing today aren't going to help to get you there in 10 years, you've wasted a year. So it's it's understanding, maybe you're not building a team, but it's understanding the strategy to that you're trying to get to and some of the key elements that you can afford to do today that are going to get you there 10 years from now,
Agim Beshiri, MD 43:01
you're spot on Patrick, and what I'd say there, there are some clear advantages of being in a startup, when we talk about some of these topics that you also raise right now, large companies are great, the resources are great, you know, you've got the infrastructure and the teams. But the decision making tends to be one of the slowest processes there could possibly be. It's like turning the Titanic, right? It's not very easy to turn. And it's not very quickly turned either. But in a startup, you do have that agility, you do have that dynamicism that that can take place, you can change direction and course on a dime, if need be. But making the right decisions on what to do that and how to do that how much of that needs to happen at a certain point in time is extremely important. But it's there and it's available. And you can practice that and you can turn it into a tool that's very useful in certain settings. The higher I got into the corporate environment than larger organizations, it seemed like decisions were taking longer to make. And that's that's one of the detriments of large organizations, not to say that they're not successful. Of course, they are obviously they are. And not to say that they're not could come to great companies. But you know, that agility and that dynamicism, I think is one of the things that you end up losing.
Patrick Kothe 44:22
Those of us that have been in the big companies and been in startups, the grass is always greener, depending on where you are. And you just you made that jump from the big company to the small company. Is that is that the first startup that that you've done?
Agim Beshiri, MD 44:38
It's the first one after about 17 years and Abbott diagnostics, but it addresses some of my passions and the vision that I had it aligns very well with because what, what I was working on and diagnostics over, you know, the larger part of my career at Abbott was trying to address that gap between the lab In the clinicians, and one of the ways that you can address it is by education by more research. But it's still the same technology. I mean, we've improved technology, and our laboratory diagnostic methods over the years incrementally, and it's great, lots of impact to patients and outcomes and management. But we've never gotten to the point yet. And we couldn't go to the point where I needed to be is to revolutionize the technology completely. And go into a setting where now we have that capability with the DNA sensing methodology to have continuous monitoring. What I did at Abbott was come up with machine learning algorithms to address these limitations and gaps between data points of diagnostic results. And here we can generate, you know, direct diagnostic results continuously so that we don't have that gap to address. And it's, again, I'll go back to the Titanic example, with the iceberg. And you've probably seen slides and presentations of the iceberg, you know, smaller on top and, and underneath the water, you don't know what there is, because it's usually much larger. Well, I like to use that example and say, well, when when you look at an iceberg and out the ocean, on top, you see a single data point, think about a patient's test result, you're looking at a single data point. But if you were able to continuously monitor before you got to that single data point, you would see the full extent of the disease, or the condition or the syndrome, and maybe an earlier warning and an alert, so you could address it and start turning the Titanic, you know, 100 miles before you got near that iceberg. And that's really what I couldn't possibly do with the existing methodologies, and diagnostics where we needed a, a an innovation that would give us that capability to be able to practice that and bring that to fruition.
Patrick Kothe 46:57
So let's talk about neutronics. What are you guys trying to trying to tackle there? And how are you trying to do it?
Agim Beshiri, MD 47:04
As I said, you know, we're trying to take a very revolutionary approach from this single point, diagnostic approach to a continuous monitoring of diagnostic tests, biomarkers, drugs, and nitro mix, we're utilizing a DNA or synthetic DNA after method, which is basically taking the same biological phenomenon that happens in our bodies every day. What happens in these peptide or protein sensors inside our bodies is once they are exposed to a target that they're looking for, that they're specific for, all they do is they conform over that target, confirm that it is that target, and then they relax and let go of the target wait for the next target to come next to them to confirm. And that same phenomenon we utilize in DNA after birth dancers. The technology has been around for many, many years, since the 90s, and has been utilized in different ways. Qualitatively not quantitatively for academia. Professor Kevin plaques go out of USC UCSB a few years back, further develop that methodology to be able to be used in vivo, so on the body and in the body and be able to detect continuously and quantitatively meaning to generate concentrations and results continuously. And that's really the revolutionary stuff that I believe is going to make quite a bit of a big change in diagnostic health care. And not for every test Patrick, we don't need it for we don't You don't need it for cholesterol cholesterol is a very slow moving, not a dynamic test or analyte. But you will need it for critical settings, ICU setting, pediatric ICU and neonatal ICU. And the methodology is minimally invasive. It's very short, one millimeter microneedle arrays and even shorter than that for the neonatal ICU. Meaning we don't need to draw any blood sample we don't have to take sample out and send it to the lab and wait for turnaround times and so on. It's a patch method. It's it's like the continuous glucose monitors that are very well known in the world today from Mabbott and Medtronic and Andechs calm, but we use a completely different method is not prone to the limitations that the enzymatic methods and these continuous glucose monitors have.
Patrick Kothe 49:41
So how are you applying the technology? What's What's the entry point? What what are you going after first?
Agim Beshiri, MD 49:47
No, that's a great question. So you know, we were not going after glucose and diabetes. We know that market very well. Of course there's formidable competitors. And that market and are doing very well, we want to go into a space where the clinical unmet need is huge, where we are true to our vision of zero preventable deaths where we're diagnostics can be readily made available, and are typically not available or utilized appropriately or optimally. And we're gonna go into the therapeutic drug monitoring space in the critical setting. And what I mean by that is drugs that are highly toxic, but are still utilized because they're the only thing that can be utilized to save the patient's life. And their therapeutic range is very narrow. So if you're over that therapeutic range, they become toxic or deadly. And if you're below that therapeutic range, they tend to be ineffective, and you may end up causing resistance and, and so on. One of the drugs is a very commonly used antibiotic called vancomycin and the critical setting in the ICU. And vancomycin has very bad nephrotoxic effects. One it is overused and and highly dosed. But it is one of the most common used antibiotics for sepsis. And right now, all we do is we take sort of a population approach of how many milligrams per kilogram of weight do we give to this patient. And that's not very patient centric. And then we look at maybe one or two levels of that vancomycin, a peak or a trough to go off into the next dose of vancomycin. And that means without first dose, we could have already damaged the kidneys caused acute kidney injury. And then we go to the next dose and is still not very patient centric, and it lacks a lot of data points. And we make another decision for another dose, and may end up just accumulating damage and having poor outcomes as a result. Now, about 100,000 patients a year die from this, which is very unfortunate. And the cost to the healthcare system are is in the billions. So the unmet need is there. And right now it is these immuno assays coming from the core lab, based on an order from the clinician, run this test in the lab, give me a result, and maybe we'll make a better decision for the next dose. And what we're saying is we could have our methodology placed on the patient on their skin. Just before the infusion takes place. Once the infusion takes place, we're monitoring that continuously. And we're looking at it in a very personalized, patient, patient centric way to guide the clinician and the nurse and the clinical pharmacologist on adjusting dosing appropriately, and preventing toxic events and deadly events from taking place.
Patrick Kothe 52:48
It's just an excellent application Adams, I'm thinking I spent 10 years in the heart valve industry. And I'm thinking about Coumadin or Warfarin monitoring. And the way Warfarin has been monitored in the past is a monthly test. And Warfarin is something that prevents clouding, your levels get too high, you bleed, you don't take enough you clot. And you could die either way. But if you're if you're looking at it on a monthly basis, it's oscillating every day, depending on your diet, your sleep green vegetables, all kinds of different different things.
Agim Beshiri, MD 53:26
Don't eat your salad before you go in for testing.
Patrick Kothe 53:29
Yeah, and there have been weekly tests. Now there's some home test units that have done that, but it's a it's a similar situation. More monitoring, continuous monitoring will allow somebody to be in therapeutic range.
Agim Beshiri, MD 53:44
Yep, absolutely. That's an excellent example of Patrick. And you know, our technology can can do drugs, and Warfarin is a drug. And it can also do analytes, and hormones and all of the other endogenous markers that we need to marker that we need to monitor. And that's the beauty of it is not limited to one or two on top of it, it can also do multiple markers at once, so we could monitor the drug. And the effect, we could monitor both at the same time on the same patch. And that's called multiplexing, which is very hard to do even on the on the big laboratory analyzers on the bench. But you know, to your point, if we continue on beyond that there are also other drugs that are blood centers that we don't even have a test for some of the more novel anti platelet therapies. We don't even have a test for that. We just base it on population data and say if you start bleeding, stop taking it. Well, that may not be good enough. And now I know that we've deemed them safe in these in these studies. But are we really as effective and could we personalize the dosing even better if we could monitor them directly on the patient make them even more patient centric, but you know, there's immunosuppressants you know that every every patient that has had a transplant for the their lifespan, they're going to end up on immunosuppressants. They come in for levels every now and then, where we certainly could could do that a lot better and make sure that we keep them in a nominal range, so that they don't end up getting an infection that their body can't fight off, because their immunosuppressant treatment was a little too high. So all these examples are great, I mean, but in the acute setting, we still have a lot of opportunity to improve patient management, just because clinicians don't have that data at hand, and they're not looking at trends. Like I said that they're not looking at the big iceberg underneath the water surface, they're only looking at those little peaks that are above the surface, and those single data points and I could I could talk about myocardial infarction, people coming in with chest pain, we could talk certainly about sepsis, where, you know, there's plenty of algorithms looking at sepsis alerts to say, hey, please pay attention to this patient, because they, they are at high risk, or they're showing some signs of sepsis. And they're driven by AI algorithms. And if we added to that, you know, a direct biomarker coming off of that patient and directly monitoring them continuously to say, hey, we've got a trajectory. And a trend like this, for this marker that we know is associated with about Swiss, it would be a different response to that patient. And you know, many other disease states and conditions and syndromes that we can address. But we have to have a starting point, Patrick, we get set, it's a great starting point, we have to have a starting point where we're resolving a clinical unmet need, we have a solution that makes sense. And the methodology is is a great fit for that, for that implementation.
Patrick Kothe 56:42
And it sounds like vancomycin monitoring is going to be a real good candidate to do that, as you said, there's not an alternative out there. There's not a competitor out there. It's something that that's a large problem, a significant problem, something that you you can bring technology to and really help to solve an issue.
Agim Beshiri, MD 57:00
Absolutely, absolutely. And we're we're extremely excited to be able to have all the collaborators and the support so far, that has come to the organization to drive this forward. As as you know, everyone on the team is very passionate about this vision, I gotta tell you, No, I did join them, because of two factors. And one of them, obviously, was the technology. But the technology doesn't go anywhere without two people. And we do have a great team so far. And we're only going to be looking to add great people to that team.
Patrick Kothe 57:34
Well, as I was doing some research before our recording here, I came across on on the website, the vision statement of the company, as we were talking about it earlier about starting with the end in mind, the vision statement really jumped out to me and the vision statement is neutronics vision is to create a world with zero preventable deaths due to the lack of timely molecular patient data. Talk about a big mission, or a big a big vision. That's a big vision.
Agim Beshiri, MD 58:08
Absolutely. Look, I mentioned that very briefly in our discussion, zero deaths, where it is preventable. And the vision is, like I said, we're all passionate about that vision. And we really want to drive for that. It's aspirational. It's, it's it's as large as you could possibly imagine. But it doesn't mean that we can't have a crack at it. And we can't take all necessary steps to try to achieve it. You know, what if we have other folks that want to follow our lead and want to jump on board, where the loss, it's only a benefit to us to healthcare to patients and to the world so that that that would be great. And like I said before, it's not just about one disease state. It's not just about the big blockbuster indications. It's not just about that big ROIs of cardiovascular, academic and cardiovascular diseases are first indication and done that's, that's the biggest disease state burden. globally. It's a mammoth every other disease state combined, both in cost and mortality. But you know, that's not the only one out there that we can help resolve and we could be very effective, and we need to be much more comprehensive as healthcare leaders. And we'd love to see followers and competitors trying to do the same.
Patrick Kothe 59:31
Like game again, congratulations on joining the team. And the challenge that you guys are taking on sounds like a significant challenge, but something with with a lot of payoff. We started off our discussion talking about the role of medical affairs and I want to come back to that and ask you one final question. So we talked about the role that Medical Affairs has been playing, but let's look a little bit into the future. What do you think that role will be or should be in the future.
Agim Beshiri, MD 1:00:02
So again, I'll speak about diagnostics, because diagnostics tends to be a little bit further back and, and medical affairs and clinicians and medically trained folks in that industry specifically Pharma has, as you already know, a farm is usually riddled with, with physicians from the leadership roles of commercial to r&d to, to marketing, to regulatory, and so on. And in diagnostics, that's usually not the case, it's mostly with within medical affairs. So I really think the future is to expand medical trained medical experience into the different departments in the different areas. And hopefully, these physicians and clinicians would have that interest, apply what they know, and more the business driven or r&d driven roles. Because again, I think there would be a lot of value there. For diagnostics, just like it has served pharma, it would also serve diagnostics. The other piece I would say is in the future of medical affairs, at Metromix, just like we did at Abbott is, is who you bring on, and how you expand the team. And your team will not have a future if you can't resolve three of the basic things of your team members as you bring them in or before you bring them in. And this evaluation is very hard, there's no template for it, there is no pal from everybody. The same way there. It's not as easy as I will say it. But you have to establish that you're bringing on folks with with high integrity, you have to establish that you're bringing out folks that have loyalty to principles, not loyalty to Patrick or to a game or to traumas, but to principles wherever their principle may come from, like being very military principles may be sports, may be family may be, you know, ideological and theological, I don't know but loyal to principles, folks that are loyal to principles are going to be loyal to their their passions and their jobs and their team. And then finally, the last piece that I would say is you have to have ethical people, these, these three things you cannot develop at this age. And at this level of the career, you have to have those and they happen to be developed over a period of time, or in the early years, or in the background. And some of may even be innate, we don't know. But it's crucial that you bring people on board those characteristics. As far as the experience goes, the specialties, the background, the training, the medical education, the laboratory experience, the diagnostic experience, be very comprehensive, I know that we tend to be quite siloed. And well, I just want a bunch of other MDs, and we're done. But that's not how the stakeholders see the organization, the stakeholder, they're gonna see the organization, they see us and they see industry as experts. And if we're going to be the experts, we're going to have to have that expertise coming from many different backgrounds and experiences, we've got a very bright future, and the future of medical affairs is how you make it. And you have to make it comprehensively, but stick to some of these three key elements in order to maintain that team as strong as possible.
Patrick Kothe 1:03:17
I really enjoyed that conversation with a game is his experiences in the in vitro diagnostics field, and it's different than mine. But the concept of utilizing clinicians is a very familiar one. And the focus of that group on long term objectives is something we should all listen very closely to a few of my takeaways. First, how physicians think we all know that to be effective, we need to understand how the other person is thinking. And as medical device people understanding our customers is paramount when he described how physicians are trained, and how personal accountability and decision making is drilled into them and kind of got me thinking about how we interact with with clinicians as we're introducing technologies to them. Often what we're hearing is that even though they have personal accountability and want to make the decisions, a lot of those decisions are being taken away from them. And how is that making them feel? So as we get to know our customers even better, how should we be interacting with them, when we know that they like to have the decision in their hands, but sometimes it's being taken away. The second thing is changing guidelines is the big goal. And if we can get to a point where the clinical data is so predominant that you change the guidelines, it can mean huge market share shifts, or product adoption shifts to your products. So how do you get there is the road roadmap who's responsible for Word is one of the more important things who's going to drive that long term. And the last thing is we need to have patience and fund it, regardless of who's doing it patients and funding. And the final takeaway is, whether you're a startup or a large company, set the strategy and get started. It may involve using outside resources at first, but you can also bring them in when you're able to. Thank you for listening. Make sure you get episodes downloaded to your device automatically by liking or subscribing to the mastering medical device podcast wherever you get your podcasts. Also, please spread the word and tell a friend or two to listen to the mastering medical device podcast as interviews like today's can help you become a more effective medical device leader. Work hard. Be kind
