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 speaking with Tim Mikhelashvili, Co-Founder and CEO of Amedea Pharma, and the winners of Tim’s Medical Affairs Innovation Olympics. So, Tim, before we meet our guests, and we talk about platforms to save time for physicians and researchers, can you tell us a little bit about your Olympics?

Tim Mikhelashvili   00:37

Sure, I’ll be glad to Garth. Some of the most memorable experiences and memories I have from working in the industry for about 18 years was ideation events in which employees came together. And we brainstormed over a certain period of time, and we competed as well, or other times when we got outside of our work routine. And we actually competed, you know, and we recovered from a lot of that work that brought us closer. So we shared that experience. And we created a celebration of sorts of both competition and innovation over one month, about a couple of months ago. And our slogan was there to share to build momentum for Medical Affairs. And so I truly was glad to see some of the global companies such as Takeda, Roche, Astellas submit their ideas, as well as other startups across the entire life science spectrum, as well as 19 expert judges from 12 Different companies. And I’m grateful to Medical Affairs Professor sigh for supporting the event. And I really took my hat off to all our competitors, who we’re going to hear off from today for their courage because I think innovation takes courage to share ideas and to accelerate drug development and access for patients and physicians as well.

Garth Sundem   01:55

All right, so joining us today are two of the winners, Johan Lauritsen, CEO and founder of PROBE, and Yair Saperstein, CEO and Co-Founder of AvoMD. We also had Silvia Carter, Community Director at Caring Community at Roche, who is mentioned in the article that will be linked from this podcast, but couldn’t join our call today. So we’ll also hear her idea. But you’ll have to go to the article to to really learn more about it. So let’s get started. Johan, could you tell us a little bit about PROBE?

Johan Lauritsen   02:32

Of course. Um, so yeah, PROBE is in short, and application slash platform that basically gives trial potential trial participants a overview of trials that they can apply to. So it’s like based on a three sheltered algorithm. So it’s like an algorithm that basically matches the users and their health data with relevant clinical trials that they’re liable for.

Garth Sundem   03:05

Oh, interesting. I’ll follow up on that in a sec. There’s a lot there. Okay, so, but Yair, here, can you tell us a little bit about AVOMD,

Yair Saperstein   03:14

AvoMD is bridging the gap between evidence and practice. Rather than tasking clinicians with understanding the 100 page PDFs that supposedly give them guidance on what to do but are really not actionable and accessible at the point of care, we help translate that into something which is actually actionable decision support, which can be inside or outside of the electronic health record, and allows for the societies producing the guidelines to have a form to turn it actionable, allows for the life sciences who really need that last mile to go from their products in the guidelines to now being actually at the point of care to have this last mile solution and allows for clinicians to benefit from having the actionable software, which guides their decisions and allows for them to practice at the best level in a way that standardized and can improve outcomes.

Garth Sundem   04:11

Okay, neat and Silvia couldn’t join us. So, Tim, we’re gonna have you pinch hit and please tell us a little bit about Sylvia’s work with care ring community at Roche.

Tim Mikhelashvili   04:22

Sure absolutely. is caring communities. A social media online community of Roche employees who are patients who are connected to caregivers are providers within this large organization. And I think Silvia Carter and Ursula Becker, who presented the idea, illustrated the the importance of the continuity of health care now where we realize that a lot of employees who help advance health care our patients themselves as well as caregivers, and the Community was started in 2020. And now numbers over 1000 employees. And it also draws on a lot of the insights from patients who become experts as well as healthcare providers to drive business development and clinical trial decision. So as a result of this internal collaboration, they developed a guidebook a clinical trial guidebook, in order to design clinical trials that are very relevant to the patient population, which I know Johann will talk about. And so I found the idea. Quite interesting. And it kind of brought me back to my first year in the industry at Sanofi Ventus, where we formed a multidisciplinary team to analyze the 1000s of medication errors among employees in this organization. And there’s Aquarela. And so we and we published it as well. So…

Garth Sundem   06:01

Interesting. You know, we always look externally for patient centers. And it also for insights, it’s so interesting that we could also look internally to our own community of employees for for these same patient Centricity insights. But okay, so let’s go to applications and software that save time for physicians and researchers. I will also say it sounds like we’re talking about improving clinical decisions, and eventually, you know, improving patient outcomes with with clinical trial enrollment. So Johan, pre filtered, you know, health data, the algorithm looks at your data and recommends clinical trials. I remember in a previous life, I was a communications manager at a university academic Cancer Center. And I was surprised that it wasn’t just phase one trials that people were looking for, for hope, everyone could be on some sort of clinical trial, and we wanted those people on clinical trials. So how do we get those people on clinical trials?

Johan Lauritsen   07:08

Yeah, so the brief description of like, what the software is just from a technical point of view, what we actually say is that we’re trying to make clinical trials accessible for everyone. And the smart thing is that the way clinical trials are structured it is, as you mentioned, the phases they do talked about the phase one, trials, which is where it’s the first, usually the very early stage of human testing. And as you as you move on, to later phases, such as the most common one, like phase two, in phase three, the amount of participants needed for the trial usually grow and they will increase. So there is a huge need for a fast way to recruit a large amount of participants to clinical trials. But you know, the problem and you know, the thing with this is that the more participants there is, the higher the quality of the data will be. But how do we actually engage people to do because the reason we hypothesize, and is a chronic patient, myself experienced this, when I tried to gain access to a clinical trial, it was that it’s very, very hard to read, for example, in an exclusion criteria is, it’s very hard to know whether you suit the trial, which is also like, which trial should I actually apply to, and when you actually make the application and the whole application process is a mess as well. There’s just a lot of, you know, problems. And when you actually made the application for a trial, you have to go through a time consuming screening process with the investigators to trial once again. And we just thought that this was ridiculous, because then we thought that, okay, the physicians are just asking into basically health data when they’re doing the screening for the trials. So what if we just said, the patients and the participants have their own data? It’s their data, they own it. But if they could use their data, and like, unlock the potential of their health data, so actually get relevant trial suggestions that fits actually 100%? Or at least very close to their profile? Yeah. So there, there is like the most, that’s like the first thing, right? How do you get people to actually engage in trial, first of all, like make the application slash enrollment procedure issue, but what’s also is that there’s these documents, which is usually like the information for the participants, what they read what they should go through. And it’s like, it’s very, very badly structured, and it’s not very, as you mentioned before a patient centered. So what we do is that like, right now, we’re like extracting important information. How many? How many visits do you have to go away since While located for how long is the trial running? And what biopsies or samples are you going through, um, first, like the compensation for that. And on the long run, we hope to like make this videos where researchers simply just explain what their participants should expect from the trial.

Garth Sundem   10:19

And people who are looking at trials, they don’t, I mean, they’re already doing enough paperwork and sorting through their own care journey. Without having to sort through the paperwork of additional clinical trial participation. We just did this my, my daughter that a science project, and she has some asthma and thought, oh, for the science project, wouldn’t it be nice to do a clinical trial, and, you know, for school and write about the process of what a clinical trial is. So we sorted through clinical trials.gov Finally found, like it was, would work that all the paperwork, you know, what drove down word near Denver, drove all the way down there and did an intro visit, it turned out that we didn’t fit the criteria anyway. And the crushing burden. It’s so frustrating. So to have an algorithm that would say, Okay, here’s your condition, here’s your health data, here are the clinical trials that you know, would work for you, logistically is is very attractive. So then Yair, here, we get through these clinical trials, we have new treatments, new drugs, devices, new medicines, that that could help patients. How do HCPs learn about these best treatments? At the point of care? How do we make the best clinical decisions?

Yair Saperstein   11:38

Yeah, I mean, that’s, that’s the difficulty. It’s kind of hard to do it. Right. What happens is that there are these guidelines that put together the evidence for All right, here’s the evidence. And here’s your next steps of what you should be doing in these different scenarios. And they’re meant as guidance, right clinicians are the ultimate deciders in this case, it’s not like it’s taking away clinical decisions from them. But if you’re supposed to see 20 patients in a day 3040, or write however many are supposed to, you can’t go through 100 Page guidelines to help you decide on each decision where there might be many for them for the patients. So as a clinician, you want something that’s going to guide you more easily. And especially if it can help you with everything else that you’re supposed to do documentation, the whole process of ordering and medication management, the the other processes, like prior authorizations that’s needed for insurance on certain medications or not, when they are indicated, right, and how to go through all these external processes that just take up time. It’ll be great in the hypothetical sense, if I have the ability to get, here’s exactly what I need to know, to help make my decision and inform it. And then also, here’s something that in that process can also help me with all of these externals that I need to do so that I have more time for the things that are human, to interact with a patient to actually understand what they need to think it through, right, all of these different aspects. So the one side of it is these long guidelines. The other side of it is, this is not a problem that’s come up. Now, this is a problem that we’ve been trying to deal with as a medical and technology society for a while. And some of the solutions that have come up include electronic health record alerts, which say, Hey, you’re in this workflow, but you might not be doing it exactly right. How about come off it in this way. And by having these alerts, it really is more of an interruption to the workflow, whether it’s interruptive alerts or non interruptive alerts, it still is distracting you. And by doing it in this way, it causes alert fatigue. So 98%, I think, is the statistic now of these alerts are dismissed with no further action. So they’re not effective over a long period of time, right? And alerts are getting smarter. There are these smart alerts that only come up in the right context. And but then they’re still in the context of all these other alerts. So that doesn’t work too well, either. And then the third part of it is, there are other startups that are trying to solve this problem by saying, well, we can create a solution that solves this disease or that disease and how to make decisions on specific diseases. And while that’s wonderful, they’re very disparate, and they’re very siloed. You know, you need something as a clinician that’s able to incorporate for a complex patient, here’s all the things that you need to consider. And also, for my individual decision that I’m making, how do I make that decision? It’s not always by disease state within a very siloed decision that you need to access it takes longer to access than it is to even go through so these apps don’t really solve it in the way that care is actually given. With all that being put together and me being an internal medicine physician and feeling good You know, I said, There’s got to be a better way to do it. And my story was that I tried to create this in my own way. It involves index cards, writing out algorithms, storing some of my prefilled prior offs, and safe drives so that I can access it easily. Storing my pre written notes that I can just edit easily. And another drive that I can always pull in. And this dream and kind of low tech solution took me to PJ, my co founder, who was actually dealing with the same issue makes sense most clinicians do, and coming up with his own solution, which was basically the same thing, just that he had started building it about five years before I met him. And so when I met him, I was like, Wow, we got to work together, we got to figure this out and see how we can actually make this change. And so the way that we’re reimagining decision support is much more of a Netflix model, it’s like, as you are there in the context with your patient, you want to understand how, within the context of everything that’s known about my patient, what are the right pathways that I might want to use, you know, like Netflix shows here, the movies suggested to you, it’s like, here, the pathway suggested to you, and then you can go down the pathways that are relevant, because you have them there from the patient phenotypes from the patient context. So it’s not something that’s interrupting you and interrupting your current workflow. It’s a totally different reimagined workflow that makes it much faster to go down, generate notes, generate orders have prefilled, prior offs, everything that’s needed, but also allowing for physician inputs for different things that are relevant. Like if the patient doesn’t want to proceed with surgery takes you down a different path. It’s not a forced order set that takes you there. So I computer making the decision. This is the computer helping you with everything that’s needed within the context of everything known inside or outside of the electronic health record, so that you can be faster, more standardized and better.

Garth Sundem   17:03

Well, so first of all, I love that a tech company started on index cards and then transitioned to a safe drive. That’s a and it sounds like it’s good that you have a co founder who said, you know, maybe let’s move beyond index cards. The other thing that I thought was really interesting that you said, I think people are wary of kind of algorithmic care, they feel like, you know, the machines are going to dictate their care journey. But what you’re saying is, let’s, let’s use, let’s use care, care decision support, to take all of the busy work off the doctors plates, so the doctors can do the human work of doctoring. You got it. Okay, so, back to Johan. So, I’m interested to hear who who is using, you know, I’m thinking how do we bridge this into Medical Affairs specifically? So what are some of the types of patients? What are some of the types of conditions or researchers that may be among the first to sign up? For PROBE? You know, who are you seeing using your platform?

Johan Lauritsen   18:15

I hopefully in the long run, of course, he everyone using the platform, because when we’ve, you know, built issues database, then it will be very easy for the researcher to simply upload their trial and just make like, I don’t know if you know, GitHub, but there’s like, like a pull request, which basically means that I’m notifying everyone to come and help, and then can just basically notify all of the patients that fit their trials. And that’s, you know, that that’s like, there’s the healthy participants. And then of course, there’s more healthy participants than there’s not, of course, there’s the thing was like, how do we define a healthy participant? That’s, that’s a whole nother story, because no one’s really healthy, to be honest. But you know, the thing is that there’s like, if you look at it from from the perspective of like, the current manual, time consuming process, then there’s like, the lowest hanging fruit for us, which will be, for example, the Muscular Dystrophy is right, that’s I have spinal muscular atrophy. And the Muscular Dystrophy is have like, usually in the clinical trials, some insane amount of inclusion and exclusion criteria is and some of it is even something like you have to have this exact point mutation at the genome to actually participate in the trial. And people don’t even know what a point mutation is. So like, where do I start? Right? The data may be available, but but the most important thing is that if like, if the data is not available, then the algorithm actually says hi needs to get taken this test at the hospital and then we will know whether you fit the trial that but you’re very close to getting the trial. So that’s basically like the way we address that issue.

Garth Sundem   19:59

So So you’re saying healthy patients to well, healthy patients? Is that an oxymoron? healthy, healthy, healthy participants. So you’re saying anyone in a clinical trial, and I see these things all the time, you know, I’m near CU Boulder, and sometimes I think it’d be fun to go run on a treadmill and have them measure my oxygen, whatever, you know, just just to see interesting things in clinical trials. You know, are you saying that, that people should sign up for PROBE? And go looking for fun and interesting clinical trials as well?

Johan Lauritsen   20:32

Yeah, that’s definitely what I’m saying. medical trials is for everyone. And I think the reason that, you know, when I talked to people about, you know, just the very second normal people that doesn’t have any background within, like medical care. When I say the word clinical trials, they just look very weirded me, because for many people is such a strange thing. And that’s because we have not been very good at actually explaining what the clinical trial is. So people run away whenever you mentioned the word clinical, right? So so what we should do is that we should focus on which is a part of like making pilot trials accessible by actually simplifying that concept of clinical trials and reducing it to reducing the language to someone that everyone understand, right? And the way that we do this is actually saying, well, the old saying, right, we’re standing at the shoulder of giants. There are so many diseases like even paracetamol, right? People would never have been able to use painkillers, if it wasn’t for someone actually doing clinical trials. And much of the much like, for example, if you have like lung inflammation, then if we didn’t have like penicillin, you would never have been able to treat that. And like 1010 years ago, now, maybe like 1020 30 years ago, there was a lot of people actually dying from this lung disease, because there wasn’t any available drugs. So and then the last thing is that when you have like healthy participants, right, because chronic participants are already motivated to be a part of the trial because of their disease, right? They want to help but for healthy participants, it can usually they maybe they have, for example, a relative, a close relative with a chronic disease. So what is the most direct way that a relative can help the drug problem and help the life quality of the relative? Well, that is by engaging in a clinical trials, so we know whether a drug will be something that can help them or not, it doesn’t matter, you know, money can buy time and money can buy happiness, and it surely can’t by self, by a drug and the therapy for the patients. Right? So there is an obvious like motivation for for everyone, I think, to actually be a part of the trials.

Garth Sundem   22:57

And by simplifying you also demystify and de stigmatize clinical trials, Yair, no, I see the same thing. When When, when a patient when a doctor recommends a clinical trial to a patient, the patient says, oh, no, you know, am I in really big trouble? You know, do or do I? Am I beyond the standard of care? And all of a sudden, I need a clinical trial? Well, yes, that sometimes is the case. But it’s also the case that anybody can participate in a clinical trial. All right, so not to speak for Silvia. But I want to hear more about patient communities and the insights that we can get from internal industry, patient communities. Do you know some of the things that Silvia is finding from caring at Roche, as part of the competition? What did you hear?

Tim Mikhelashvili   23:48

Yes, so I really want to ask Silvia to probably share a lot of that in those details. On the next episode, or perhaps in that innovate article. I know that they have a big employee population across 60 countries that scattered across, you know, worldwide, and they’ve they’re already improving their clinical trials. What you know what I’ll mention, though, to, you know, our participants here today or winners from the innovation Olympics, is that I think we in Medical Affairs really need to listen to their insights because they are physicians, their health care providers, as well as a patient right in your hands case, and they’re solving I think, for health care. Continuity, you know, by accelerating drug development and connecting the right patients to clinical trials as clinical trials represents a huge costs in drug development, two thirds of the total costs to develop a drug for a product which is about $6 billion. And, and and also in the US Yeah, use case with Abel, MD. I think they he’s, he’s helping our industry across life sciences, improve quality of health care. I know that they’re partnering with a lot of organizations associated professional medical associations. And so I think ultimately if we had listened to the insights, but given that they are winners in a Medical Affairs innovation Olympics event, I think that already tells us that we are listening to their insights and are continuing the conversations.

Garth Sundem   25:31

All right. Well, let’s leave it there for today. I do want to say that it’s interesting that, you know, you’re in your hand, you’re both designing from within the systems you’re designing for, you know, Yair, a year as a physician and Johan, as a patient, like you looked at a problem, there was a problem, and you’re solving something very organic, which I think is really interesting instead of sort of layering something in from the outside. But thank you, Tim, Yair, Johan for joining us today. To learn more about how you can partner with these platforms visit AmedeaPharma.com, AvoMD.io and PROBE.dk. MAPS members, don’t forget to subscribe, and we hope you enjoyed this episode of the Medical Affairs Professional Society podcast series: “Elevate”.