Garth Sundem  00:01

Welcome to this episode of the Medical Affairs Professional Society podcast series, Elevate. I’m your host, Garth Sundem, communications director at MAPS. And today we’re talking with an old friend, Tim Mikhelashvili, CEO of Amedea Pharma, about a competition Tim runs called the innovation of Olympics and also more broadly about areas of innovation in Medical Affairs. So, Tim, welcome. And I know that from your perspective across many companies, and also, having run these Olympics for a couple of years, you’re in a position to see innovation firsthand. What are you seeing as areas of innovation in Medical Affairs?

Tim Mikhelashvili  00:48

Sure, Garth. Well, thank you very much. It’s truly a pleasure to be back here on your podcast, which I follow with a lot of enthusiasm. And yes, you know, I’ve now spent about 20 years in Medical Affairs across seven different companies with various different types of perspectives from big pharma to specialty and startups. And most recently, of course, more of a consulting role and a boutique agency and their former innovation in Medical Affairs is now evolving rapidly, you know, and I’ll focus on two areas. Number one, I think that we need more innovation in approaches to leadership, reflected through change management, I think. And then the second area to me is how do we demonstrate our impact to all of our stakeholders on patient outcomes, which I will would rephrase to not just the question of demonstrating our impact on healthcare outcomes, but how do we continuously improve our impact on healthcare outcomes, and on our business as well, which which I call a quality improvement system in Medical Affairs,

Garth Sundem  02:11

I’m just going to point out those are really interesting avenues to choose. Sometimes when we talk about innovation, we focus on the next neat, cool tool. Sure. And I kind of figured you were gonna say Let’s spend 20 minutes talking about artificial intelligence, but you’re talking about innovation in the core areas of Medical Affairs, you know, innovation and leadership and change management, innovation in showing our impact, which, which, which is not the way I thought this conversation was gonna go. But tell me about innovation in leadership, and I guess specifically change management. Or let me ask, is this innovation that you think is needed or innovation that you see happening? Or both?

Tim Mikhelashvili  02:57

It’s happening, it’s happening in some extent. But we can we certainly need it, I think, and you bring up a good point in terms of why I haven’t brought up, let’s say, AI, which is also of course, an area I’ve been following, as you know. And one of the reasons is that all of this new innovation and technology now at our disposal is forcing us to change our workflows change how we manage talent, how we manage our people and their lives as well. And so it’s and to raise your new standards and health care quality, I believe we have to design new, new ways of working well, you know, Medical Affairs teams, they raise the information, really, that ultimately guides critical decisions in health care, such as preventing hospitalizations, serious adverse events, improving treatment, efficacy, adherence, educating patients on their treatments, all of which are valuable. However, Medical Affairs teams also are a part of a business. And therefore, our leaders have to assume more responsibility for the business outcomes, not only the patient outcomes and clearly articulate their role in that endeavor, in my mind. And so they have to now learn how to add a little bit more urgency to more with less due to investments that have plateaued over time, you know, over the last few years, rather in relation to the sales growth of an industry that has grown, you know, and I think that begins with really creating more transparency in this era of unprecedented exposure to data. We are rich wired to have unprecedented or radical transparency in terms of how we improve our quality of the work that we do the impact how we are able to incentivize our teams to report both positive and negative outcomes from which we can learn and continue to improve our performance. And, you know, your your question also made me think about a recent expert panel was at the Financial Times us biopharma Summit, where Carmen villa was the head of ESG. Corporate Citizenship and equity and, and Gilead spoke about this generational gap and the need for both sides, both the company and the new talent to be more transparent about their expectations within the role, given that a lot of people do not really stay at jobs anymore in pharma in Medical Affairs longer than two or three years, right. So, really expecting them to give you a vision, their five year vision is really out of the question. And the alternative there is to provide them with opportunities to to be a little bit mobile. Right. And that’s what another panelist at that session. Andrew Kammen was an MBA at NYU Stern business school, and who represented the generation alpha or the new generation at the panel, what he talked about is this concept of de risking lateral moves and creating playgrounds, creating new playgrounds, where people can ideate and, and be recognized for their contributions. Right.

Garth Sundem  06:45

You know, you say, I think of them as sandboxes. Right? I mean, places to, to learn how to build new things. You know, even if your career growth, you know, maybe your goal is within Medical Affairs. Would you recommend that people step out people step laterally for a while?

Tim Mikhelashvili  07:06

Absolutely, because it provides you a more global and a more accurate vision of the industry and and your potential contribution in various different areas, right. I mean, I think back to so my early days, I didn’t move out of Medical Affairs during my 20 years. But I was inspired by a lot of sales leaders, I can tell you marketing leaders, and you know it when that two year mark comes, for example, right, and some of this new next generation of Medical Affairs employee who demands demonstrates some great skills and data science kind of approaches you about different roles and that you don’t have any, maybe you can provide them a way to work in clinical development, for example, to work in clinical trials, to make that process a little bit more streamlined, or pursue others as well. For example,

Garth Sundem  07:56

I feel like, I’m right at this weird transition point now where I always had my finger on the pulse of exactly how to do all the slick technological things that needed doing. And I’m realizing now that everyone we’re hiring is better at these things than I am. And so I’m ready to the point where I’m starting to appreciate reverse mentorship, because all of it, man, I will tell you, I need it. But let’s let’s go to impact. So where is innovation needed or happening or lacking? What do you mean by innovation and impact?

Tim Mikhelashvili  08:37

Yeah, innovation in impact. So, first of all, I’m glad to see how much emphasis now the industry and Medical Affairs function in particular is making on demonstrating our impact. I never in my 20 years of my career have I seen almost every single session at large regional or national conferences dedicated to this topic. But I think the question again, is not how to better measure the impact, but how to produce a continuous quality improvement system in order to continuously improve our impact. And because Medical Affairs is a customer service function, our customers being our physicians, our patients ultimately reap the benefits of the innovation. We, you know, we have to get a little bit more innovative about getting that feedback from them directly as well. And, and also, you know, raising new standards of health care quality depends on not only our technical performance, our expertise and how we educate our physicians and patients more directly nowadays, but also on our internal operations. And our behaviors are how we communicate with each other on Medical Affairs teams, well, as well as cross functionally. That’s what I’ve learned. That’s what my 20 years in Medical Affairs has taught me. Right? It’s not just attributes of the product, or the qualities that predict your overall organizational success or your product launch success. Right? If if I don’t respond to you, my teammate Garth, on time, in an email, or deadline, chances are you may not meet that metric. Right, that goal. Right. And so it’s, so the point that I think is, I think, is one tool to kind of to consider is that if you want to improve your outcomes, you can’t just tell your team members to go out and practice and measure how they practice from time to time. You we have to actually be there when they practice set standards of their practice so that they don’t just go to work, expecting to have better outcomes, but they go to work, trying to be inspired to practice a little more, so that you incentivize them. Right, in a way that once they hit a particular standard, which we don’t have in Medical Affairs, as they practice, they have interactions with their physicians, they receive that those particular recognitions, and only then are you able to improve the quality of the outcomes as well, once you have you get your teams to practice a little more that it becomes part of their nature, somewhat like how you’re seeing a child who demonstrates a lot of potential in a sport, right, but they don’t want to practice. They just want to get their outcomes, the outcomes on patients in the case of Medical Affairs, but they just want to play the game, right? In order for them to get better have better speed, you have to tell them like, Look, if you go under 12 seconds in this five cone drill, you’ll have an hour playing time. And then you see that they do that. And over time you dig, you raise that standard again, and you say, because you’ve been giving out too much of your free time. Right? And you decrease it. So that’s that’s what we have to do a little bit more. And there’s no such a thing as, as a perfect or scientific kind of standard. That’s, that’s exact. But you have to start with some standards in order to see how you can improve your outcomes. Yeah,

Garth Sundem  12:53

you know, so a couple of things in there. One, I think it’s really interesting that you point out that it’s not just about how medical, it’s not just about how Medical Affairs measures impact, right? There’s all these tools, and they’re always evolving, and we’re going to measure in different ways, but why we’re measuring impact. And I think that Medical Affairs get stuck a lot of times measuring impact only to justify our budget. And you’re saying why to measure impact is so that we can do what we do better. You know, we’re going to measure impact so that we can improve our impact. And I also hear you saying that it’s not just about outcomes, measurements, you know, like how many goals you scored in the game, it’s about process as well along the way, so that you can improve, you know, measuring that five cone drill so that you can improve your process on the way to better outcomes is are both of those. Is that fair?

Tim Mikhelashvili  14:00

Yeah, yeah, absolutely. Because you have to be able to get a better picture a more holistic and an accurate picture of how likely it is that that type of practice, that that formal presentation to a large group of physicians is, is in ultimately delivering that outcome. Right, that favorable recognition recommendation of your product in the treatment guidelines. So because not every outcome is the same auto worker was created equal, right? Just like not every activity, right? And so you have to rank and also adjust those outcomes but you just having very different types of databases and many different ones. To be able to tell us what we do is not enough anymore. Today, we have a plethora of these resources that helps us speed up our extraction of insights, medical insights, right response automatical information requests a little bit faster sentiment. But we have to be able to analyze that data and provide it in the right format to our customers. Well, we’ve

Garth Sundem  15:11

been talking about innovation from within Medical Affairs, but I know that especially through your innovation Olympics, which by the way, everyone should look up, we’ll link to it from the posted Medical Affairs.org. But if you’re listening, I’m sure you can google it as well. You get to see innovation from outside of Medical Affairs as well. So what are some of the things you’ve seen, or, you know, either specific, neat projects or even areas of innovation that you’ve seen people bringing in to your Olympics from from outside of Medical Affairs?

Tim Mikhelashvili  15:48

Yes, in this, you know, competitive environment, we, you know, experimented with the idea that you can have a unique ideation competition in the format of this Medical Affairs innovation, Olympics, and increased collaboration, partnerships, and also quality of performance in order to advance access to care, continuity to care quality. So this is a global event that, you know, I started in 2022. Now, it’s in third year, glad to be partnering with maps from its inception, and this year again, and we invite invited a lot of our scientists, innovators within Medical Affairs, across healthcare, in order to provide us with new solutions, different types of approaches, that they’re able to iterate and receive real time feedback on and compete with others, with amongst industry experts, healthcare quality leaders, and also being inspired to innovate more with patient advocates, Olympic gold medalist, CEOs from longevity medicine, apart from companies. So some of the innovative ideas that we’ve had have included a clinical decision support system that allows physicians are bombarded by a lot of different data to improve their diagnosis quickly by through an app through an app that concisely takes a lot of information from treatment guidelines and enables you to your healthcare quality. Evo MD. In fact, they went on to win other competitions, other major innovation competitions afterwards raised $5 million in seed funding in companies growing, and others have included various different Medical Affairs technology to summarize conference data very quickly. In furnaces, yeah, yeah, we’ve had a recent one, also a probe from Denmark from last year, which connects patients and potential study participants with clinical trials and thought leaders that they would otherwise not have access to. They don’t have have the education to understand what those inclusion criteria are, and which the app provides them with a lot of assistance. And actually, the CEO of that company happens to be a rare disease patients self. And I’ll finish up with two others, which was a sports medicine, medical grade device startup called Aura muscles, who won the bronze medal last year? Yes. And they apparently this year for the upcoming 2024 Paris Olympics. Their app was used to improve their performance or improve the performance of the Dutch national track and field team. So I’m very proud to have someone with a lot of these kind of graduates are all champions in amongst in healthcare and then finally Synchron x and this is just doesn’t doesn’t encompass all the you know, ideas. I’m just highlighting some some of the winners but Synchron mix. Kumar Sapir has a product a tapped app. It’s called Tap tip T which actually won last year, which allows clinic healthcare systems to mark remotely monitor patient adherence with the basically simply with a tap of a smartphone.

Garth Sundem  19:30

So you see it from inside of Medical Affairs and you see innovation from outside of Medical Affairs and books. I hope you will all join us in taking part in terms of Olympics starting here is why we’ll give you a registration link.

Tim Mikhelashvili  19:48

So Tim, and we registration opens up to July 1, July 1 and the event will take place Yes. And the event takes place October 1 to 16th. Okay, so well join us I can’t wait to see what we Get this year it’ll be it will be innovative. I think we can guarantee that.

Garth Sundem  19:57

All right, well thanks for joining us, Tim. To learn if you’re Garth it’s always a pleasure always to learn more about how your organization can partner with Amadea Pharma, visit AmadeaPharma.com. MAPS members don’t forget to subscribe. And we hope you enjoyed this episode of the Medical Affairs Professional Society podcast series, Elevate.