Trials with Maya Z

Maya: Welcome again to Trials with Maya Z. I am double excited today because I have here a lady that I met recently, Esther Howard. Esther has more than 20 years in the clinical research industry before she started her own company, Bezyl.

And there are lots of stories behind this company, lots of stories [00:01:00] inspired by her know-how, by her experience, and by her passion, and just by her as a human being. So, Esther, please, introduce yourself and tell us a little bit more about Bezyl as well.

Esther: Sure. Sounds good. Thanks for having me, Maya. I'm excited to be here as well. So as Maya introduced me, I'm Esther Howard and I'm the founder and CEO of Bezyl. I started it just a little over two and a half years ago after a long career in the clinical research industry because I wanted to bring mental health support into healthcare and help people at a very personal level so that they can get through whatever journey they're going through, especially in clinical trials.

And I live in Phoenix, Arizona, but I'm originally from Canada and I've traveled and lived all over the world. So, I have lots of great stories and experiences and met lots of amazing people through all of that.

Maya: Unfortunately, we don't [00:02:00] have all the time in the world to listen to all these stories because they are absolutely incredible. And we'll speak about one of the stories that actually made me invite you to this episode today.

And it's very much related to how we should be thinking about clinical research and what can inspire us to make a change. But yes, tell us first about Bezyl.

Esther: Yes. So Bezyl is actually, I like to consider it a toolbox of support for people so that they have the tools that they need to get through what trials or tribulations they're going through in their life. So if a patient is on a clinical trial, there is a patient in their family, they can download the app and they can select the spheres of support that would be the most helpful in their life, starting with their family, their friends, neighbors, whoever that may be. But then add in also extra support. For example, if it's a home nurse [00:03:00] or if it's a drug shipment that they need or diaries or anything like that. We don't collect clinical trial data.

It's just to make the life of the patient easier, while they're going through the trial. And it is an application that you can download on your phone. It's super secure and simple to use. and it makes it easier to communicate between their spheres of support and access resources and training and whatever it is that they need.

So we have a base model that is just nice and simple for everyone in the world to use, but then we curate them for the patients in each trial.

Maya: Yeah. When I was introduced to you, Esther, our common friend said: " You need to get to know Esther because she's like you. She thinks so much about the patients." But I didn't know why actually you started thinking so much about the patients, and when we first chatted with you, Esther, you told me about your friend and how basically you came up with [00:04:00] the idea of Bezyl.

So share with us, actually, how did you come up with the idea of Bezyl and what really made you refocus not so much on your clinical research experience and background vs on how you can support patients?

Esther: Yeah, sure. So, to really tell the story of Bezel, I think that I need to be transparent and tell my own story first, and then how that led to Bezyl. Because mental health isn't something that we think about in clinical trials, even though every single person in the world has to deal with it in some way or another.

For myself, in particular, I grew up in a cult in Canada and I was in my late twenties, or early thirties when I escaped from this cult, it was like I made a decision to leave because suicide was feeling like the only hope that I had. [00:05:00] And I made the plan and I literally packed up my things and in the middle of the night escaped from the house with a backpack on my back.

And, you know, obviously, I had some support on the other side. I had a friend I had met and she allowed me to live in her home for a while, while I got myself back on my feet. But it really took the power of people helping me to get back on my feet and to be able to move forward again in life and rebuild.

And so fast forward, I ended up in a very successful career in clinical trials, working for a CRO and I ended up flourishing in life and really loving my career. And so 20 years later, one of my really good friends died of colon cancer and she was in her early forties. [00:06:00] She had a two-year-old daughter.

And we were very close. She and I had traveled the world together. We had gone on a trip to Israel. We were both skydivers. We had, you know, smashed the Virginia skydiving record together. We had a lot of history and one day, I was at her house about two weeks before she died, and I was just helping with, you know, things around the house.

And we sat down on the couch together, cuz she was having a good moment. She was able to have a conversation. She was in less pain at that moment. We sat down on the couch together with her daughter laying in between us and she looked at me and she said, "Esther, everybody sees me as a cancer patient. They bring me gifts that remind me of cancer. Everyone talks about cancer. Cancer is the main focus, and it's true. I am a cancer patient, but they forget that it's actually my mental health that I'm truly struggling with. And she looked at her daughter and she said, "I'm about to die and leave my daughter [00:07:00] behind without a mother. I'm going to leave you and my friends and my family, and she said, it's not like she was scared of death, but, you know, death is definitely something that she had to embrace now. And the mental health toll on a young woman that's taking care of her still wants to be a mom and a wife, and a friend, a sister and a, you know, daughter.

Cancer is the least important thing in her life. And bringing her gifts that remind her of cancer, like hair products and creams for her skin isn't going to really help. So she told me the thing that would help her the most is if it was easier for her to ask for help from her family and her friends.

So she picked up her phone and she scrolled through it, and she said, "How do I even choose who to call? I don't want to use a group text message chain because that becomes really cumbersome and when I do call somebody, then, you [00:08:00] know, they might not respond and so then I don't want to bother them. They might be at work and it's just really difficult to ask for help."

And then she said, "On the flip side, people offer help, but they say the common phrase, "Let me know what you need." And that's what we have to say to people. We have to do that because we don't know what else to do. She said, "I just wish they knew more proactively the things that they could do to help me without me even asking or, you know, maybe offer more directly the things that they can do so that I'm not managing my own care."

And she said, "These are the things that would strengthen my mental health and help me get through each day." And so when we had this conversation, everything flooded. It was a very emotional moment for me. Not just because I was losing my friend, but because I had realized what she just described is exactly how I got through my own mental health journey and still do to this [00:09:00] day.

And so that's when I got to work and I called a friend of mine who was a software developer, and he and I literally on his dining room table, started sketching out how we could make spheres of support, make it easier for people to ask for help and empower others to offer help, and just focus on the patient and their families and the people around them, and not be so encumbered by the details of everything else that also needs to happen.

But really focus on this gap where we don't think about the patients' lives.

Maya: Esther, I wonder, now that you went through this whole experience, which is horrible, and I'm pretty sure that many people can recognize themselves in your shoes one way or another, I wonder - with having spent 20 years in clinical research, but then going through this story, did this experience really change the way you're looking at clinical trials?

And how would you now [00:10:00] change? Because obviously, you're no longer a part of the clinical research industry, at least not directly. How would you change clinical trials now? How would you change the way you've planned clinical trials before and the way you've managed clinical trials before? What would be the top three things that you're going to change?

Esther: Yeah, so, well, first of all, I'm very much still part of the clinical trial industry, just in a different way. Part of the patients' lives instead of the protocol writing and, you know, the protocol execution like I used to be. But I don't forget about those things, because that's still important.

First of all, the thing that I would change is focusing more on the patients' lives. We hear it all the time. We hear people talking about patient experience, the voice of the patient, you know, patients' lives. Those are great buzzwords, but being more tactical and truly listening to the patient is one step further than just [00:11:00] interviews of patients and what they say about a clinical trial experience.

I'm not knocking any of those things that we already do, but I'm just saying we should take the patient experience one step further. And make it more personal for them so that we recognize if we have a clinical trial and it's composed of, you know, let's say it's just a phase one small trial with 20 people in it, that's 20 different lives.

Every single person is coming up into that trial with a different perspective. So we have to acknowledge the complexity of that and be more supportive of their lives so that they can participate in the trial. They want to participate in the trial. People don't not show up for their visits because they just don't feel like being at that visit.

Something came up in their life. And so I think that there's a lot more we can do in the industry to really support the patient's experience, [00:12:00] not forgetting about the fact that they have family and friends and other people that are also participating in that trial with them. And I think we can do a lot better job supporting the patient experience and that strengthens mental health.

Maya: Yeah. Yeah. Absolutely. I'm listening to you. And at the same time I'm thinking, because, you know, I'm having similar conversations with people that are on the site, for example, working as investigators or coordinators or CRAs. And they will tell me, for example, "Hey, we need to consider the site's perspective and their experience.

And it's about how you balance that and how you make it operationally because there is another conversation, another discussion around decentralized clinical trials, for example. And the discussion there is how do we create a protocol with decentralized trial components, or let's say, more remote capabilities, but [00:13:00] still address that some people would prefer to be more at the site and others prefer to be at home, and so on and so forth.

So, you've been in the operations before, like any practical hints, and practical advice, how can we really address the patient's needs, and the site's needs, and make that operationally possible? Is that even possible?

Esther: Yeah, yeah, it's definitely a hot topic and one that I actually love. So, first of all, if I think back on all the times that I helped take a protocol and operationalize it, and get it out there. I can think of a lot of mistakes that I made. One way we didn't bring the right stakeholders to the table was when we were designing the operational strategy.

Now, obviously, it would be impossible and impractical to bring every single site to the table to have a say in how we are going to operationalize the protocol. You can't do it that way. [00:14:00] But we still have ignored the sites completely when we do it. So, there can be site representatives that can be part of the team that helps us operationalize the protocol.

The other thing that I was thinking about just recently was that if you look at the evolution of technology and clinical research and how we are using technology better now to decentralize trials and to make trials easier and cheaper and faster and all that good stuff.

But one thing that I think we need to start changing our conversation on is less about how we decentralize a trial and more about how we use the technology and the things that we've learned in this last decade and solve a specific problem. So, when people ask me what I think about decentralized clinical trials, well, of course, I love the concept, but I don't really talk about decentralized trials.

I don't talk [00:15:00] about it like that anymore. I talk about an oncology trial, I think: "Okay, we've got this phase one breast cancer trial that is for, you know, a small group of women. And I just start solving the actual problems and then looking for the tools that can help us solve the problems better rather than take these tools and go look for problems.

And I think that because we have all of these DCT companies out there right now that have all these great tools and they're out there looking for problems and they're, you know, fantastic. I am friends with all of those founders, but they're looking for problems rather than it being the other way around where we have the sites and the sponsors collaborating and looking for the tools that they need to solve the problem.

So it just needs to be flipped in conversation. And then I think that we can get further faster that way.

[00:16:00]

Maya: You mentioned speaking with different stakeholders. You mentioned the site, but you didn't mention the patients. And I will go back to my question. How do we take them into consideration and how can we operationally, take their input because I know it's very difficult.

A lot of the clinical trials that I've seen may have an advisory board of patients and patient advocates. Sometimes that may be a group of advocates just from one country, though they may be covering 10-plus countries. And do you have any [00:17:00] advice on how can you make sure that you take the patient's input in the best way, in the best format possible, and make it operationally possible to really consider their needs and expectations?

Esther: Yeah, it's even harder to get all of the patients to contribute to a trial. Just like it's hard to get all of the sites to contribute to a trial, right? But here's the thing, we're all patients. So the voice of the patient, actually, should be coming from the people that are already designing the trial.

We are already all patients, and if we think about ourselves that way as a starting point, it's amazing how we can change what we do. My favorite story to tell people is about, I don't know, maybe 10 or 12 years ago. I took a protocol and I was designing the operational strategy for it, and within the protocol, they wanted to collect a stool sample from the patient at [00:18:00] 2:00 PM every day.

Maya: Okay.

Esther: So, think about the challenge of collecting that stool sample at that time every day. What person, what human being is going to be able to deliver this sample at 2:00 PM every day and in what time zone? And so I read it and I thought it was a joke. It was not April 1st, so I knew it wasn't a joke.

And I asked, I was like, how is this possible? And they were like, "Well, that's what we need." And I said, "Well, are you able to deliver the sample at 2:00 PM every day?" We just need to think about our own lives when we're designing these protocols. That's a really great starting point because yes, we want the patient voice for sure, but we are all patients.

We've all gone to medical appointments. We've all had medical challenges of some kind, but most importantly, we all have personal lives and we're all human [00:19:00] beings. And so there's a common thread of commonality there that we're not even thinking about our own lives as a patient when we're doing it because we're so caught up in the science and the rigor and the stats and, you know, the things that are rigid and not human.

And so, start there. And then there are so many amazing companies out there that are doing a good job of talking to patients and asking about their experience in clinical trials that have already gone through them and what they would like to see differently. And I think those voices need to be elevated as well.

There's not a lot of investment in taking advantage of the people that are out there getting those patient voices already,

Maya: Hmm.

Esther: but going back to the sites. The sites have the finger on the pulse of the patient's voice too, and they're the ones that see the patients every day. So, I'm pretty sure the sites are gonna have a pretty good sense of what their patients are [00:20:00] going to need if we give them the opportunity, the tools, the budget to be able to do that. And I mean, for example, for Bezyl, I'm running a clinical trial right now myself with Dr. Patel at Carolina Blood and Cancer Associates in South Carolina. He has a rural oncology clinic in South Carolina where there are not a lot of resources around for those patients.

They all come from non-technology homes in the, I don't know, in the boonies basically. And, he knows his patients so well. I don't need to go to his patients and ask them what they need. I just need to ask him and his nurses what his patients need to be able to participate in these trials and give him what he needs.

It's really not complicated. I think we've also overcomplicated this patient voice and patient experience question because we've never paid attention to [00:21:00] it before.

Maya: Yeah, I agree with you. It's not rocket science, and at the same time, it is, because I've been involved in multiple projects for site selection, for example, and most of the questions are not about who has a better connection with the patients or who from the investigator is spending the most time with the patients.

The questions are about who is the key opinion leader or who has done more research in the past. So it's great that you spend some time to find the right principal investigator or just an investigator that really spends time with these people and knows them well, but in reality, most of the site selection doesn't go around.

Who has a better connection with patients? It has different criteria, completely different criteria. Not making the recruitment rate here,

Esther: Yeah, that's a really good point and a great idea. Yes. Let's change the site selection questionnaire too.

Maya: [00:22:00] Yeah. That's a whole new topic. But I want to bring you to another story that you told me, which I think is also inspiring about the way we can address different challenges that we have in the clinical research industry. And now, I will refer back to diversity again, a big trend.

Again, a buzzword and everything, but you gave me a story of how you would address diversity again with Bezyl. Something that you did not for the sake of clinical trial, but actually can be a great idea of what we can do with clinical trials, especially when we're looking for a specific population.

So, Esther, can you tell us more about what you did with this project, because it's really inspiring.

Esther: So, actually, another little fun fact about me is that I'm part Gwich'in, which is a northern native indigenous tribe in Canada.

We like to joke and say, "Don't confuse us [00:23:00] with Eskimos because we're indigenous natives. We're not Eskimos." But we love our Eskimo compatriots that live in the same town. But if you get on a map and look at the mass of land of Canada, so the United States, there's this big mass of land above you, and it's called Canada.

It's not just where the cold weather comes from. And then on the west coast, there's a river that goes all the way up to the Arctic Ocean and it's called Mackenzie River. And that's where my family is from. My mom lives there currently. And there are a lot of small communities all up that river, all up into the mouth of the Arctic Ocean.

And all of those people need healthcare just like the rest of us in the world. And they have healthcare, they have clinics up there. But one thing that they have that people don't realize is they have the internet and they have access to [00:24:00] technology and it's very good. There's nothing wrong with it.

And so, one of the things that's really important to me this year is helping bridge the gap that they have and bring clinical trials to the north. And there are things from the decentralized clinical trial model that we can use like telehealth and that type of thing to be able to do this. And so I think that if we start with communities like that and bring clinical trials to them, don't just do it for the sake of bringing clinical trials to them, but have something where we've said, "Okay, there are high rates of diabetes in those communities. How can we help diabetes or opioid abuse or cancers that are at higher rates in indigenous populations than in other populations of people? But go to those communities, talk to the health centers, talk to the leaders of the community. And [00:25:00] say we have these clinical trials and we would like to offer them to this community.

We will be able to get lots of patients that you'll be surprised how willing they are and how grateful they will be to have those opportunities now. There is a lot of history that comes involved in the indigenous population and clinical trials, especially with the Canadian government, and a very tarnished history.

So the trust is lacking, but I'm from there and I can go to my own family and friends, and people and say, " Hey, here's a clinical trial that I think would really help us, and there are ways that we can bring these trials to these communities and improve diversity." And, be able to not only accelerate the change of the decentralized clinical trial model but also improve diversity.

And, so, yes, that is something I'm working on right now to be able to do. But the next step [00:26:00] from getting a patient in a new population of people is not to just open the door, but it's also to expand the patient experience and make sure that the experience is a really good one and effective. And then that they are grateful down the road, not regretful that they signed up for the trial.

Maya: If I'm to summarize what I'm hearing today is really need to pay attention to the entire experience from the first conversation around the clinical trial and how we present this clinical trial. How do we make sure that this clinical trial is something that people can benefit from this point to the very end?

Actually, there is no end if you ask me because even after the clinical trial, these can be natural champions of clinical trials to other people. And if they have a bad experience, they won't be advertising these clinical trials and that will contribute to whole communities being [00:27:00] closed to the whole idea.

So, what you're saying is that we need to pay attention to the entire experience, but not only think about the experience in the clinical trial but also what it means for these people's lives.

Esther: Exactly.

Maya: This is a very powerful statement. At the same time, it brings even more complexity to the way we think about clinical trials, but at the end of the day, if we want to be successful, we really need to identify these things that can be more impactful, and maybe identify which are these things in people's lives, in these patients' lives that we can impact in a way that they can be engaged and satisfied at the end of the day.

Esther: Yeah, exactly. There's so much we can do by focusing on the person's life and dissecting the patient experience. And I love that you [00:28:00] specifically mentioned, past the clinical trial itself because can you imagine a world where we are bringing in people that have never had access to clinical trials before, and now we're doing that, bringing them through the clinical trials, and then continuing to improve our clinical trial process by bringing their voices back into the future clinical trials.

So the first one's, let's say, today we started a clinical trial in New Vic Northwest Territories Canada. And those first few patients that come through are going to have an experience that will then be able to give us feedback to improve the next ones and the next ones and the next ones. And before you know it, we won't even be talking about diversity because it'll just be a way of...

Maya: exactly. Well, I hope that we are all contributing to such a world where we make clinical trials more patient-friendly, site friendly, and friendly to all stakeholders. And so more people join [00:29:00] clinical trials because we need clinical trials, if we want to see innovation in medicine, in treatments, in healthcare, we need clinical trials. So I hope there are more people, Esther, like you, who are inspired by their own experiences. Hopefully not so difficult experience, but still go back to their lives and contribute with their passion, with their know-how, and with their energy to make the clinical research industry as a whole more efficient. Thank you so much for this inspiring conversation, Esther.

Esther: Thanks, Maya. It was a pleasure.