Trials with Maya Z

Maya TrialHub (00:00)
Hello, everyone. This is Maya with Trials with MayaZ and I'm today with Esther Howard. I guess that I'm interviewing not for the first time. Actually, it's my second time, but there is a very good reason for that because Esther, first of all, she's the CEO of Bezyl a mental health company. And I hope Esther will tell us more about Bezyl, but also...

because Esther comes with incredible background in clinical research, running clinical trials. So before me giving any details, Esther, first of all, welcome. And second, can you give me a little bit more about yourself?

Esther Howard (00:37)
Sure, hey, Maya, so good to see you again. I'm excited to be here and you know me, I love to talk about what we're doing. But yeah, a little bit of background about me is I was in the clinical research industry for a little over, almost 20 years actually. I always stay a little over because my launch was actually over 20 years ago in research in health economics of developing countries.

Healthcare and how we can improve patients lives and healthcare in general has always been really important to me. When I shifted into clinical research, actually started in the finance route and then went into operations and running trials and then oversight of those trials and strategy and helping clients with them.

Maya TrialHub (01:19)
Wow.

Esther Howard (01:29)
the pathway from molecule to market. So helping small biotechs put their strategy in place and then also helping big pharma commercialize their assets and their molecules. So, and then of course with my finance background, running the entire trial was something I was really good at.

I mostly did operations, logistics, then of course regulatory, making sure that we were inspection ready. And I've been in front of probably every agency you can think of, FDA multiple times, and then all of the global agencies as well, even right down to the Taiwan FDA. The agencies were a big part of my career too.

Maya TrialHub (02:03)
Cool.

wow.

Esther Howard (02:16)
So yeah, that's that's my background and then I shifted a little bit when I started my own company a little over three years ago now So now here I am

Maya TrialHub (02:25)
And you have an amazing story behind this company, a story that we actually, that you shared last time we spoke. So I'll make sure that I put this in the link to make sure that everyone can hear this story because still every now and then I tell other people this story because it's really touching and it's very inspiring. But Esther, today I asked you to really come to my interview, like to this interview with your clinical research background because, and also,

I've heard there is something new that you're working on. So we will touch upon that as well, which is very relevant, very relevant to the mini series that I'm doing on understanding those country specific standard of care and the importance of understanding the local standard of care before starting any clinical trial. So you said it very well. You've done all sorts of clinical trials, global ones, from molecule to market. So you've seen a lot, you've worked with small biotech companies, with big pharma companies.

From your experience, what is the role of understanding patient journey, the patient journey country by country before you start your clinical trial?

Esther Howard (03:32)
I think that first of all, the patient journey itself needs to be more clearly defined. I learned over the last few years that when I would talk to, let's say a project manager and a CRO, what is the patient journey? They would have one way of kind of mapping out what that journey is. And then when I talk to the sponsor or the client who is responsible for the drug or the therapy,

Maya TrialHub (03:39)
and

Esther Howard (04:00)
They would also have their own and and it was about six years ago Maybe maybe seven years ago time is time just flies I was working with with someone in PRA Health Sciences They're now called ICON and She was the first person that said hey like let's sit down and align with each other on on what the patient journey actually is So that we're all talking about the same thing Because really it's three pronged

it's, you know, we've got the standard of care patient journey where, you know, a person is born and, and then they have health events that go along the way. Number two is the journey in the current disease, not excluding everything around them. So if we write a protocol for them to be part of a clinical trial, then that current disease in that protocol is really important. And third thing is everything that's going on in their life. And that's where

I have really started to put some emphasis in what we're doing at Bezyl so that educating people, like their journey isn't just illnesses. It's also how they're taking care of themselves and the stressors that may be coming around them. You know, do they have children or what is their age group or their ethnicity and the demographics that they live in? In the United States, we say what is their zip code, but in the rest of the world, like what country are they in and what

what region of that country. So their journey is three -pronged with their actual standard of care health journey, the disease that they're going through and perhaps the clinical trial protocol. And to me, the most important, but they're all equally important is like, what is their life demographics look like and the journey that is contributing to these other two things.

Maya TrialHub (05:53)
And I would add to that. So first of all, I fully agree. I think it's really about time to start writing about the difference between standard of care, patient pathway, patient journey. The reality is a standard of care is really what is like the, let's say the experience of the patient that is being defined by either the local reimbursement authorities, basically what the access to treatment.

let's like, whether it's private insurance or a governmental reimbursement authority, it doesn't matter. But actually, what is the allowed access to treatment? And not only the treatment, but all the procedures around that. like that's, that's more or less that kind of defines the basic of your patient journey. And then after that, you have the disease journey, which comes with all other things like from the symptomatic, but also the perception because

Esther Howard (06:39)
Exactly.

Maya TrialHub (06:49)
Very often I see when I read on the topic of quantifying the patient burden, I see people just trying to compare, let's say, one clinical trial to another clinical trial. And the number is a visit, for example. That's a very good example. But some diseases wouldn't care how many visits they're going to have because for multiple reasons. And others, one more visit than what they're used to, and that's it.

Esther Howard (07:12)
Right.

Maya TrialHub (07:18)
It's the of the world. It's the perception actually that makes people more receptive or not to some changes. And yes, like you said, their life is absolutely important and that altogether makes the whole patient journey. But why is it important for someone that's running a clinical trial to understand this patient journey? And are there any components of this patient journey?

that you absolutely must know so that you can optimize your strategy.

Esther Howard (07:51)
Yeah, so again, in this case, I think that there's two lines that I think are equally important. One is yes, of course the patient burden is very important. Like you just described, it could be that depending on the disease, if it's a cancer patient and they're just trying, they're a mother and they're trying to extend their life as long as possible. They want every single possible day.

they're going to go to their visits. They're good. The burden is going to be, welcome to them because it gives them what they need. so there's the journey in terms of like number of visits and there's the, like, like you described. but the, the other part of, of the journey is, is, is less clinical than that. It's also looking at, what are the things that are, are.

part of their daily life. So the reason why this is so important is because I see a lot of people measuring patient burden based on number of visits and they think, okay, this is like too much for them. But you haven't measured that against what it is that they're actually trying to achieve. My friend who actually inspired the Bezyl the reason why I launched Bezyl, Lori, before she died,

Maya TrialHub (09:05)
Mm.

Esther Howard (09:14)
She said it the best. She's like, I'm looking for time and I'm looking for quality with my daughter. So I will literally do anything. And I wish people understood that. So it's really important when we're looking at a clinical trial and we're trying to design it and we're saying patient burden, patient journey, we're thinking about what it is that the patient actually wants to achieve in their life. And the type of demographic of that patient is a pretty good indicator. can guess a lot. We're gonna be...

more educated than we think we are about like what they're probably going to need based on their demographics. And so from a pharma perspective, it's also really important to understand patient journey because when you're looking at the types of visits that are like the types of procedures that a patient wants or needs or that you're going to need in your protocol,

There are certain elements of the protocol that you're going to want to put in there for exploratory endpoints are my favorite conversation with Pharma and Biotech. I was literally, I'll tell you this story a little bit later, but I was literally two days ago meeting with someone who's developing a really cool device and we were walking through what they're going to do. both she and I were like getting really excited about all the exploratory endpoints that we could add to it.

Maya TrialHub (10:19)
Yeah.

Esther Howard (10:40)
But then we realized we're going to completely overwhelm the patient with the participants on this particular trial with these exploratory endpoints and all these other things we want to get while they're in the office doing the procedure. And then we're going to lose all our patients. like looking at what you actually need in the protocol versus what you want and it could be kind of cool and help you with something else. And then all of the surrounding aspects of their life. And then you can find that formula of like, okay,

it's really important to look at the patient journey so we can keep people, attract people to the trial, like give them that option to join the trial and participate in a clinical trial that could be potentially life -saving or improve the quality of their life. And then next, them there. Because obviously that's the reason we want to consider patient journey. The final thing I want to say about this is that the...

For me, the foundation of why a patient journey is so important is because it's the right thing to look at as humans. Of course, we have data that we need to collect, a protocol that we need to execute, and drug or a therapy we want to get to market. But the more that we look at the patient journey and just be human, the more it is the right thing to do.

and we're helping other people have better lives and in even the participation of a clinical trial protocol. And this is for me, I'm really passionate about this because I see people slashing their budgets and trying to like strip out anything that they don't need in their budget. And then they're not giving the patients the best experience possible.

Maya TrialHub (12:24)
Yeah. Well, Esther, thank you so much for saying that. And I do agree with you. I know that at the end of the day, you go to work, you have to do like, have to fill like different KPIs and milestones and stuff. And sometimes we kind of get away from at the end of the day, what do we do it for? But you're absolutely right. The main reason for understanding the patient journey is because that's the right thing. You want to make sure that the patient

has the right experience because let's not forget, all actually, we all depend on these patients, all of us. Like you don't know what you're gonna have tomorrow or what your close ones are gonna have tomorrow. like these patients joining clinical trials, they're helping advance medicine. So we all owe them, we owe them the focus on making it easier on them. But I have another question, which is a little bit more, let's say technical from the clinical trial perspective.

my background in feasibility and patient recruitment taught me that the number one question is where are the patients, where are the eligible patients? And I wonder, like you mentioned about the perception of the patients and like their experience. And that's why patient journey is so important. But like, if we are very practical, isn't like access to treatments, is that actually the thing that will answer you whether and where to find eligible patients?

Esther Howard (13:33)
Yeah

Maya TrialHub (13:51)
And how much actually companies are thinking about that?

Esther Howard (13:55)
I think they're thinking about it a lot. But I think that, this is such a great question because I'm so passionate about this one. Let me tell you why. I'm so, this one like really grips my heart. So my mom, I've talked about my mom a few times on LinkedIn and in different forums, but not a lot. So I'm going to take this opportunity to talk about her. She lives in the Arctic.

Maya TrialHub (14:04)
You

They get opportunities.

Esther Howard (14:25)
in the Arctic Circle, literally in Canada, the Arctic Circle, access to treatment for her means like very, it's very limited, very, very limited access to treatment. And so where she lives, there's a health center and you can get kind of your triaged care there. You can, the dentist comes twice a month.

Maya TrialHub (14:26)
Yeah.

Esther Howard (14:49)
So you have to get into the window of that dentist. There's certain specialists that will come up once a month maybe, if you're lucky, if a plane can get up there. And then there's also the next step is to fly down to the closest city. And then the next step from there is to fly down even further into Canada, down to Edmonton, where there's really good health care.

She's actually, even though I'm describing her situation as something that sounds like very unusual, it's not. We have people in the United States, in Montana, for example, that are spread out all over the state. So people's physical access to treatment is one thing, where my mom, like she lives in the Arctic Circle, incredibly remote and she can't get access to treatment.

Maya TrialHub (15:28)
Hmm.

Esther Howard (15:40)
And then there's other people around the world in general that like access to treatment physically is one thing. But the second part of access to treatment of course is the type of care, whether it's the type of, what kind of insurance you may have or what kind of plan you're on with your government or whatever it is. Every country has its nuances and I'm not even going to my opinions on what's better or not because that actually is irrelevant.

to me, it is what it is, we need to work with what that is, and do our best to evaluate their access to treatment. So when I talk to companies that are looking to start their clinical trials, and this actually just happened a few months ago, someone reached out and said, hey, can you help us navigate the indigenous population in Canada and help us bring clinical trials to them? And I was like, yes, I can.

The fact that you're asking just means the world to me. And so then I said, but for what disease? And they told me, and I'm not going to tell you what it is because I don't want to, I'm blind who it was. They told me, and I was like, well, that's not really a prevalent disease in the indigenous population. So we could set up all of the infrastructure there in the world.

Maya TrialHub (16:46)
Yeah.

Yeah.

Esther Howard (16:59)
we're not really gonna help anybody. You're gonna waste a lot of money and you're gonna lose the opportunity to provide access to treatment or clinical trials to the population that you actually do wanna target target. So for the indigenous people, was like, do you have any breast cancer trials? That would be a great one or something, lung cancer or diabetes. Diabetes is a great one.

Those are the types of things. So if you look at access to treatment, it's like, okay, they don't have like in the indigenous population in the Arctic and Canada and the remote population, they don't have access to good treatment for things like breast cancer and lung cancer and diabetes and heart disease, things that are prevalent to them.

They have to travel great distances to get that care. And even then they don't have like the best insurance or the, you know, the best, like what they need in order to get what even exists. So to bring a clinical trial to that population is incredibly exciting for them. So, so we ended up talking about a trial that was very relevant to the population. And now I'm supporting bringing them to, to the North to see if it works.

and the, I will tell you when I mentioned it to my mom and the, at those at the health center, they're so excited. The perception that that's, that's the other part of this is like, there was this perception. We, we talk on our stages and in, our podcasts and stuff about how people don't, well, we gotta like try to convince them somehow to have this trial. Like where did that, where did that idea come from? Of course that's possible in some.

populations of people, some demographics and ethnicities and that type of thing. But in general, it's not the case. You don't know what they want until you offer it to them. Just, yeah.

Maya TrialHub (18:53)
Yeah, no, absolutely. A great story, Esther. I have many stories like that, but the recent one that I also want to share, like in that regards. So first of all, about the motivation of people. When they don't have access to the same level of health care like somewhere else, for example, they are definitely more motivated. I'm originally from Bulgaria. And in Bulgaria, for example, we have very good health care. For example, access to doctors is super like

much more easier than, say, if you compare it to Germany and the UK, have to wait a lot more there. At least for the time being, it's a lot better here. But for example, some of the like, we don't have the same drugs and treatments that are reimbursed like in Germany, in the UK, for example. And let's say if someone comes with clinical trial that and usually these drugs are very, very expensive. Like imagine, immunological drugs, for example.

or some like gene therapy, don't even want to mention. But like there are lots of treatments that let's say for one reason or another, they decided to not reimburse here. And then you have to pay out of your pocket, but they are very expensive drugs. And actually for the standard of the country, that's not very feasible. So then people are way more open to join these clinical trials because for them, even the control group is an exciting opportunity. Even if it's not, let's say the new

component. So yes, this definitely impacts the motivation. And another example I wanted to give you is to share was a few weeks ago, we worked with a company with very interesting, like new, like treatment idea. And they wanted to compare to a very new treatment on the market. But in their eligibility criteria,

the patients that are eligible should have been at least two years on this treatment before they're eligible for being on a part of the clinical trial. And in the states, that was absolutely fine because this new treatment that is in the control group has been approved and it's on the market for at least three years. So you had a year to actually like for these patients to be on this treatment. But all of the...

They opened a bunch of sites everywhere because it was a global study by that time. And they opened also like Romania is one of the best recruiting countries. That's actually a mistake that I see all the time going to Poland, Romania, and even Bulgaria thinking, these countries recruit so well, I'm gonna go there and they will definitely speed up my timelines, my everything, only to find out that Romania does have this treatment, but only for one year.

So there were no patients that were on this treatment for two years, no eligible patients.

So it's, yeah, so that's an example that that reminds me of of that Actually Esther, that is a great transition to the topic of real world data. Your new domain, let's put it that way. I can't wait to hear more because I also don't know much. I just, you just mentioned that last time we were discussing this episode. Actually, can real world data help us understand better this access to treatment, the patient journey? Yes.

Esther Howard (21:48)
Such a good example.

Thank

Maya TrialHub (22:17)
how do you see real world data fit into clinical trials?

Esther Howard (22:22)
It's my favorite topic now. Right now it's, it's what we're, I'm completely entrenched in, real world data right now. I have something going on at Bezyl that I'm really, really excited about. So, so I remember back when real world data became the fad on the street. Like it's something that we were all talking about because we were all, we knew that we were going to learn things that we didn't even know what those things would get, were going to be. And we didn't even know.

data could be, like the people that were the experts in real world data, we looked up to them, but even they didn't know how powerful real world data could be. And the starting point for real world data came from looking at the patient journey, looking at their standard of care, looking at their reimbursement and the things that we knew were probable to have happened.

So just because, and the reason why I use the word probable is because just because you prescribe a drug to a patient, there's varying numbers depending on who you ask, but it doesn't mean that they filled that prescription. So it doesn't mean they actually took that prescription. I am a classic case of, the doctor is gonna prescribe something to me and I'll probably never fill the prescription for whatever reason.

That's not an uncommon behavior. So real world data in the healthcare systems, no matter what country you're looking at, what system you're evaluating, has its flaws. But it gives us general idea on patient journeys. So we have an idea, like if there was a prescription made, whether the patient took it or not, it was made for a reason. So there's something that's tied to it and perhaps there's a disease or a pain or adverse event of some kind that was happening.

that was being handled. But then there's this other part of real world data that I think is even more important and that is the patient's life and what it is that they need in their life to improve their life. And right now at Bezyl we have the very unique opportunity to actually get the data from the patients themselves about what

what it is that they need, what it is that they're doing, kind of what their life is like. And it goes back to our original conversation in this episode about what is the patient journey. And I said that there's three prongs and one of those prongs is everything going on in their life. We can't forget that prong. So if we tie real world data to the patient journey, all three of those prongs, it's much more accurate.

And so one of the things that we are able to get now with our patients at Bezyl is we see what people are asking for from each other. And we're able to, things like I'm lonely, or I just want to chat or I need a ride, or we get some really interesting ones, childcare and pet care, of course, those kinds of things come up. And this is part of real world data.

The other thing that we get is we're able to cross compare those things with what is going on in their lives, depending on the population, not everybody in Bezyl, we get to see this, but depending on our customer and some of our customers are in healthcare now. So we're able to compare against their data and our data and really bolster it and really get into the nitty gritty of what it is that

defines a patient's journey and helps us learn what it is that they need in their life to be more successful in their journey. And of course, a lot of this comes from the mental health model that we've created, but by supporting mental health, we're able to look at life stressors, the things that we can add. if I am, I love to use the example of my friend who who inspired

Maya TrialHub (26:31)
Yeah.

Esther Howard (26:40)
Bezyl Lori, when she died, before she died, like weeks before she died, and she was telling me, you know, I have a two year old daughter, and I just need people to come over and read to my daughter. And I get lonely a lot. And I just wish that I had somebody to chat with me during those lonely times. And it was easier for me to let my friends know I need that pain. She had no...

Maya TrialHub (27:04)
Hmm.

Esther Howard (27:07)
good way of documenting properly her pain in her journey. So she had colon cancer and of course it was late stage, very, very late stage and she went through a lot of pain. And so in the current model, we don't have a way of being able to document the type of pain she was experiencing, how often it was and how severe it was during those times, because what happens is she goes to her doctor's visit

And she has to remember the last three, four, six weeks or whatever it is, last sometime, unfortunately in the last 72 hours of like what that pain was like. And so they get a general idea on, her pain scales, but it's not that accurate. And she complained about this to me, but she also hated, like there's a lot of companies out there.

many of them are my friends, so I love the intention, but she also was like, there's no way that I'm going to use a very cumbersome journal to document my pain. Every single time I have pain, I need something easier to be able to document it. But she, things like pain, the loneliness that she experienced, the fear of death, the anxiety of how am I gonna continue to be a mom for this last few weeks of my life?

Maya TrialHub (28:13)
Yeah, mom.

Esther Howard (28:28)
None of that gets documented. so now with the Bezyl app, we're really working hard on how can we make it as easy as possible for a patient to document their own journey from their own real lives. And it's not looking like what we saw before, where we take those data points along the way from the providers. It's not looking the same at all.

Maya TrialHub (28:50)
Good night.

Esther Howard (28:57)
Hopefully within this next year, we can actually show publish some of this research we're doing where we're showing like what a patient's documented journey is alongside what we would have documented before is actually quite different. Not only are we missing things, but we're also recording them incorrectly because they don't happen the way that the system is recording that they happen.

Maya TrialHub (29:19)
Yeah.

Esther Howard (29:23)
And so I think that it's really important for us to take a step back and recognize that we have this opportunity with looking at data and being able to find all of the different places that we can find data and measure it, evaluate it, leverage AI like we've never leveraged AI before and even machine learning so that we can.

be more suggestive to patients to help them along the way. But there's this massive opportunity in the world right now where we can really take real world data and help make the lives of patients so much easier. And I think that in the clinical trial world, we are positioned perfectly for this if we would just take the invest, invest the time and the money into like doing it right.

Maya TrialHub (29:52)
Hmm.

Esther Howard (30:19)
I understand the need of pharma to get a drug or a therapy to market as quickly as possible, and that still needs to happen. That priority can't be lost. In fact, it needs to be strengthened. But when we sit back and we look at the ways that we can collect data and the things that we can collect data from and what we can learn so that we can move along that pathway better.

I think we can be doing a much better job than we are today.

Maya TrialHub (30:50)
Actually, that was exactly my last question. What are the implications, Esther, now speaking to the pharma and biotech companies and the CROs, if they don't understand the patient journey, if they don't use standard of care, real -world data, insights, what will happen with their clinical trials at end of the day?

Esther Howard (31:16)
I think that we're losing a lot of opportunity by not understanding patient journey. And I'll always say understanding patient journey is first and foremost our responsibility as humans. That's going to be my platform that I'll always say. But just purely from a financial perspective and our ability to further science, if we don't understand the patient journey, then the drugs and the therapies that we're pushing out into the commercial world are not going to be as effective as they should be.

And we need to be able to be more representative of the populations that we're providing those drugs and therapies to. And we need to be able to be pushing not just from an ethnicity perspective and a global perspective, but also from individual needs and what they're actually going to use. I'm not even going to get into adherence to treatment in this episode, but that could be like a whole, we should get Bernard and we should have that conversation together.

But I think that we're losing the opportunity to provide the most personalized medicine to people by not understanding the patient journey. And if we want to personalize medicine and treatment and care, we have to invest in understanding patient journey for real. not like, you know, the people say it's the 80 -20 rule. We're not there. We're not at 80 -20. We're lucky to be at 60 -40.

Maya TrialHub (32:32)
Yeah.

and

Esther Howard (32:44)
that is even arguable. Yeah. Yeah.

Maya TrialHub (32:44)
If actually we are there, it's very arguable because maybe we're 60 -40 in countries like in the United States, but I would argue that everything outside of the United States, including Canada, we're not at 60 -40 because, yeah, because all these other countries have a completely different healthcare system and all the people that I speak with, let's say primarily based out of the States, not all, but the majority of them don't even recognize

Esther Howard (32:57)
Yeah, I would agree. Yeah.

Maya TrialHub (33:12)
what this difference means for the actual, like for the patients, for their eligibility, for their availability, for their motivation, and so on and so forth. thank you so much for once again making the time to speak with me, to sharing your insights, incredible stories. From the conversation, I can see that there will be one more episode sometime like in the future, but it's always a pleasure, always a pleasure to speak with you and keep us posted on your work with Bezyl

Esther Howard (33:36)
Of course.

Definitely. Thank you, Maya.