Episode Transcript
[00:00:00] Speaker A: The cultural piece is the foundational piece. It is the sustainability of the operational piece. We need to make the culture an active process, not a passive sign on a wall that becomes artwork.
[00:00:18] Speaker B: We are rejoined here by one of our favorite guests, Dr. Anthony Yanni. Dr. Anthony recently published a book on patient centricity. He leads all of patient centricity over at Astellis. And we thought that the focuses of where we want to go with this season, specifically mental health, neuropsychiatry. We'd love to have a conversation here today just learning more about the frameworks that you put forward as well as maybe how we might apply them to kind of neuropsych research that's happening here. But Dr. Anthony, maybe catch us up. How have you been since the last time we spoke?
[00:00:49] Speaker A: Oh, it's been great, Brandon. It's always great to, to have this conversation, have a conversation with you and it's great to be back. Things have been good, as you said. Recently published a short book on patient centricity and I'm happy to talk to you today about this topic, which is I think under discussed.
[00:01:07] Speaker B: Maybe let's start there actually.
What prompted the decision to write this book?
[00:01:12] Speaker A: It was prompted in a few ways. When I give talks at conferences. I've had a lot of feedback from folks saying, well, you, you have a lot of experience in this space. Can you please write down the methods in the, in the blueprint for what you've done so that we can, we can all capture the benefits of the experience. And I, I've said many times before, this is a pre competitive space. We should all be sharing best practices.
So as I, as I thought about this, I wanted to write a book that was interesting to those in pharma who say I want to replicate this in some way that applies to my organization because we do want to become more patient centric. But I also wanted to write it for patients so they understand that we are making a large effort to include them and to change the way we develop medicines. Instead of just four patients with patients. And in the book I also address the delivery system. I was a practicing physician, as you know, and I was chief medical officer of a hospital system. So I've been very fortunate to see healthcare from many different vantage points. And I think we need to connect patient centricity to the delivery of solutions, not just to the creation of solutions. So I think the concept of patient centricity may not be new, but the details that we share in the book, the patient stories that I link to, why we should be making these changes and the connection between medicine development and medicine delivery. I think capture what I believe are the most important points of what we're all here to do, and that is move faster, more efficiently with patients.
[00:03:01] Speaker B: Absolutely. And look, we're going to get into Neuropsych in a moment, but maybe before we get there, for those who haven't read the book yet, how should we be thinking about the broad pillars, the rough kind of framework for how you suggest we approach this kind of work?
[00:03:18] Speaker A: Yeah. So patient centricity, I define in two ways. And I think those two ways are so critical for anyone who's interested in evolving the medicine development piece or the medicine delivery piece. And the two components are, first and foremost, culture. How do we develop a patient focused culture in our organizations? And if you're not in healthcare, think of it as a customer focused culture. And the cultural piece is the foundational piece. It is the sustainability of the operational piece. We need to make the culture an active process, not a passive sign on a wall that becomes artwork after six weeks. We need to engage our team members in every role every day, everywhere across the globe, reminding them that they are doing incredible work and they are active participants in developing patient solutions. If you're on the pharma side, if you're on the delivery side, they're active participants in delivering the care individuals deserve. That's the first piece, creating active programs to maintain a culture that is focused on the patient. The operational piece, the second piece, is creating teams that support medicine development actively by integrating the patient perspective into every decision that we make. So we have teams that work with researchers, teams that work with development teams that work post launch to understand the patient in the real world setting. And we have teams that specialize in behavioral science. So we understand the behaviors that are important to deliver appropriate care to individuals. And collectively, these two components will help us transition from a system that treats disease to a system that cares for individuals.
[00:05:09] Speaker B: Before we started recording here, we got into the idea of applying some of these practices to a specific domain. This conversation, I love to apply them to neuropsych and psychiatric research. It felt like it struck a chord with you when I kind of floated this idea. Maybe say more about that.
[00:05:29] Speaker A: It does. I think that traditionally we were focused and the conversations are focused on more talked about disease areas. We talk a lot about cancer and heart disease, hyperlipidemia, rare diseases, all of which are incredibly important. And we do so much work in those areas. But one of the things that tends to be whispered is the areas around Mental health. Now there's good work being done for sure in pharma and companies dedicating their work to those issues. But it still appears to me that we're not having enough conversation about folks who have challenges in those areas and how do we incorporate their perspective in how we develop solutions, their perspective in how we engage, and their perspective and how we can include them in the development piece. Clinical trials. It's such an important area and I think I mentioned to you prior to the recording that a friend of mine who's very active in this space is Jeff Winton in Rural Mines. And it's a focus of accessing care for folks who live in very rural areas of America where sometimes mental health care is not available. And in the book I refer to this as in all disease areas as patients not having access to treaters or treatments.
And there's different reasons for both of those. But I think your focus this year is a good one and we should all be applauding the fact that we're going to talk more about this.
[00:07:08] Speaker B: Yeah. And let's look at it through this lens. Mental health through treaters and treatments. For the folks who are thinking about, know, diving into more research here, how would they be or how should they be applying kind of this framework to say maybe understanding the pathways for patients with schizophrenia, for example?
[00:07:28] Speaker A: Yeah, I think the, the key to all patient centric thinking and activities are communication, listening to patients, finding the patients that we have that we're focused in on with certain, certain areas of concern like schizophrenia and how do we engage them in meaningful ways? Do we have where they live, an understanding of their avail, the availability for them to treatments and to the treaters? And I emphasize that because sometimes it gets lost on folks when we say treaters versus caregivers. But at the end of the day, how do we reach out and incorporate them and then connect them to the right systems at the right place at the right time? And in pharma, for instance, how do we sustainably engage them? For instance, do they have patient organizations that they can participate with to help with their support needs and then to help connect them to the right treaters, the right treatments or the right development study, the right clinical study?
[00:08:40] Speaker B: And you mentioned a lot of conversation has been had already on the topics of cancer, heart disease, some of these, some of these conditions.
Where do you think maybe we're falling short in terms of thinking about mental health from a patient centricity landscape?
[00:09:00] Speaker A: I think recently, and I don't know the time frame, the last few years the last five years there has been an increase, awareness and discussion of mental health as a real concern, a real treatable condition. But how late to the game is the conversation? I mean, we're not anywhere near where we should be to equal that of the more traditional Heart disease, for instance, diabetes. Again, very important areas.
But is there as a society, are we comfortable talking about this yet? Have we really made it so, have we made the conversation so acceptable that patients are willing to say, I want to talk about this, I want to participate? I don't think it's, it's. I think there's two levels of, of areas that we have to concentrate on and one is how do we get patients to have the access that they need to have the conversation? And how do we create an environment where that conversation is welcomed, comfortable, and can be built upon longer term? Not one and done. And I don't think we're there yet. I think these conversations, I think your work this year is going to move it along. I think some of those organizations that I mentioned earlier are making it more mainstream, main, you know, more mainstream awareness. But awareness is key. We just haven't done it. We just have not had enough conversation about it.
[00:10:39] Speaker B: Yeah, and let's pull another thread. You're right. I think it's, it's, it's newly in the zeitgeist that we could even be pursuing novel treatments for some of these psychiatric conditions.
What?
Like, if you get a message out to all the folks in basic research and on the pharma side who are starting to pursue research in this space, like, like, what would you say to them?
[00:11:09] Speaker A: I would say take advantage of the best practices available. Don't start where we started 20 years ago for the other disease areas without patients. Start today with today's current standard of practice. Standard of practice, which is patient centricity.
Include the patient from the very beginning. When researchers are designing and studying molecules, talk to them about clinical trials and how they can participate. Talk to them about what they consider to be value in the treatment, what their standard of care lacks, what they wish they could have beyond the treatment of the, of the, of the mental illness themselves. What can we do to better serve them? Don't start.
You know, in the 1980s, where we were doing it all on our own and hoping that whatever we produce was going to be valuable. Those shots on gold don't work, with all due respect.
[00:12:09] Speaker B: Do you think there's a risk of that happening? It feels like the industry is like starting to coalesce around more patient centricity do you think there's a risk of people starting like back in the 80s?
[00:12:19] Speaker A: I think there's always a risk that clinical development research will go forward without patients in meaningful ways because we haven't standardized it yet, we're doing it and it's piecemeal in industry. The reason I wrote the book was so we can begin this discussion and for folks to tell me, well, I don't agree with what you said there, but I think this will work great. Let's share best practices. But this is by no means as regular a component of new medicine development, as regulatory as pharmacovigilance.
Right. I mean we're not there yet. So the risk is if we're not very careful in making sure that we do this the way it should be done, there is the possibility that it'll be done without it.
[00:13:08] Speaker B: Now a lot of this work is being pioneered by biotechs that don't necessarily have, you know, patient centricity department like you lead at a more established pharma company. Like for the, for the biotechs that are doing this research, like how do they even make the time to kind of do this? How do they resource, how do they staff against this?
[00:13:25] Speaker A: I think it's interesting because biotechs probably are good examples of doing it well. Okay, they typically are small, they typically are a one or two molecule company, they typically have one focus, one disease area focus. And in order to actually get any movement forward, they have to engage the communities because they need to learn about the disease. They need to, you know, they don't have staffs of 2000, they have very small companies. So they're actually very good at reaching out and talking to the patients. I think in my experience what happens is when you start to have a larger company, broader portfolio, lots of research happening, it's not as automatic. The other thing is that we've become victims of terminology inside of pharma. We, we say patient centricity and then it's the, everybody says, oh good, you're doing it. Right. This follow up question is equally important, more important, and that is tell me what you're doing.
[00:14:28] Speaker B: Yeah.
[00:14:29] Speaker A: Because if you're doing it, I want to know because I want to evolve my practices and my processes to be to the better way if they have a better way. And if you're saying it and not doing it, stop saying it.
[00:14:39] Speaker B: Okay, so like let's talk about practices.
[00:14:41] Speaker A: Right?
[00:14:41] Speaker B: I am the chief development officer at a biotech. Starting to look at anxiety, right? Looking to develop something for anxiety. I'M potentially worried about the patient burden. For patients with anxiety and their willingness to kind of participate in something like this, I come to you and I say, I need your help. You're the world expert on this stuff. What are the first three things I need to do? Give me some advice here.
[00:15:09] Speaker A: So the first thing you need to do was a year before you even thought about starting a clinical trial. You need to start developing relationships with the patient and patient groups to have a better understanding of their current needs, where they see value, what their challenges are in their environment, how do they access treaters and treatment, and then bring that information in. So as your researchers are working on that molecule, they understand what characteristics are necessary for success in the eyes of the patient and the caregiver and the physician or healthcare provider. That's the key component from the beginning. But you need to develop meaningful relationships with the patients and the groups that are based on trust and bidirectional benefit. No, they need to understand that you're really just trying to use them as experts to bring them a better solution. And if you do that before you're asking them to join trials, oftentimes what you'll find is they're committed to it because they were part of it. And they're also feeling as though this might have the result I'm looking for because I had some say in what I think I need.
So it has to start early.
[00:16:27] Speaker B: Okay, so let's imagine it's a year before the trials and we're starting at this point.
One of the things I'm worried about, Anthony, is that I'm developing some psychoplastogens, some psilocybin application. But there's a field of competition of similar psychoplastogens or other psychoplastogens. Kind of like going after this space. What am I looking for in patient centricity and what patients are saying to help me understand, like this is viable, is this competitive? Do I believe that I've got an edge here?
[00:16:58] Speaker A: It's a great, great question. And that is why you need to have different operational teams in patient centricity. Because patient centricity is not simply asking patients for their opinion and then handing the opinion to the researchers. That's not fair in the research teams because they don't often know what to do with that information. So our research focused team has medical Doctors on IT, PharmDs, PhDs, business people. And when we go out and ask patients about their opinions and their value prospect, we then integrate that into a entire analysis that the researchers lean On. So we would look at what is the current standard of care, how frequently is it given, what are the gaps in care, what are the adverse versus event profiles, what else is being developed, as you pointed out, by competitors? What are patients asking for that is not being currently delivered? And when we put this analysis in front of researchers, we ask the question, can you deliver based on what you understand of this molecule, what they're asking for? And if the answer is no, then we shouldn't be pursuing it because we're not going to deliver anything that's going to be utilized. If the answer is yes, we think so, then we stay connected with the patients as that molecule moves toward development and we can then reassess periodically. Both from the patient perspective. Are you still needing these same things? Are you still seeing value here? And also from a clinical development perspective. Do you think this trial is something that would be interesting to folks with this problem?
So it's a, it's a long.
It's a game of check of chess, not checkers.
[00:18:42] Speaker B: Yeah. The way you describe it is it almost seems like a customer like requirements document. Almost.
[00:18:50] Speaker A: Well, think about any other industry. I think we might have talked about this the last time, but name an industry that doesn't talk to the consumer before the first product is mass produced. If you can name one, I'll be impressed that has any sort of commercial success. It's still in business a year later, right?
Yeah, I think there's, there may have been a few, but they're not, they're not in business any longer. I mean, everyone looks to the customer to say, what do you like or don't like about this idea? Well, why haven't we done that in pharma?
[00:19:19] Speaker B: So give me a history lesson that. Why do you think it worked in the first place?
[00:19:25] Speaker A: Why do you think it worked without it early on? Because, because there was a, an ocean full of opportunity. Right. Think about the first statin, the first ACE inhibitor, the first ARB for blood pressure. There was an ocean of opportunity and now we're starting to narrow that down into specific disease sets within diseases, disease subpopulations.
Now, those populations where standard of care may exist have particular needs. It's not so easy to just say, well, we're just going to produce something and hopefully they'll switch. We've had patients tell us that if you can't give us an improvement of pick a number 15% over how I'm feeling today, I'm not switching because it took me five years to feel this good. So the patients are more discerning. The healthcare providers are very specific and we need to make sure the product is differentiated in the right way for the patient. It can't be just the 15th arb on the market.
[00:20:32] Speaker B: And how many patients do you need to collect this data from to feel confident in a spec sheet almost in like a requirements doc.
[00:20:40] Speaker A: Yeah, we, I don't get caught up in, in the statistics of it. You know, when I first started this 15 years ago, someone once said, oh, but that's, that's only a handful of patients. And I said, well what, what do you expect if, if you're doing an area, if you're looking for a P value here, do I have to interview 30,000 diabetics or you know, 200,000 patients with cardiovascular disease? That's nonsense. What we're trying to do is get trending information multiple times as we move through the process. So we don't look at the first time we engage in discovery as the only information we're going to get. We get relative information that can be actionable by the researchers, but we stay in touch and continually learn from these patient populations. So we don't say, well, we know every single thing about a patient because we talk to 10 in research. We say, well, that information, along with doing the research of the literature, along with all of the other information we may have gathered prior to that first interaction, is information that helps lean us in a direction for the science to be successful.
And it's not supposed to be decisional alone. Right. There's multiple inputs that help decide whether a molecule in research moves forward in research toward clinical development. Right. It's not simply the patient perspective, it's the science, it's the safety. There's a whole lot that goes into that patient piece is critically important to understand now.
[00:22:17] Speaker B: Now I want to talk a little bit about patient recruitment as it applies to this. One of the things that you know, comes up a lot in the work that we do at least is patient burden and how patient burden is kind of perceived by patients and the kind of associated potential drop off there. I'm sure patient centricity has a, has a role to play in understanding burden of like a trial participate, child participation. Tell me a little bit more about how you think about it and are there any particular considerations that you like immediately come to mind when you think of let's say like depression or anxiety as kind of like mood disorders?
[00:22:49] Speaker A: So we, patient centricity doesn't run the clinical trials, the clinical operations team do. So we support them in the Very questions that you, you raised. And the, the most important thing for the Clinops folks to start with is what is necessary in this trial and what isn't. We tend to sort of over emphasize studying particular pieces of, of data that may not necessarily be necessary for the program and its focus. So that's the first thing. Do we need to do 150 blood draws or can we do seven during the trial as an exaggerated example? The next thing is if you've developed the right relationship with these patients and patient groups, you should have a pretty good understanding of the proper way to recruit and retain because you've developed relationships and you have insights into what their barriers are before you start the trial, after you start the trials way too late, you should have a really good understanding of what they consider to be high burden, low burden. Why is there attrition six months after they start or maybe a year after, when does it occur and why? And then the last piece that's important in all clinical trials is how do we understand the patient in their environment?
Do we have the clinical trials where there is a good diverse population? Do we understand the barriers for them to get to the clinical trial site versus in downtown Manhattan and rural Nebraska?
We haven't as an industry done in the past a lot of thinking around that, that was associated with action. Now I think the times have changed. I know in Estella's we do a lot of work looking at those particular pieces so that before the trial starts we understand the potential barriers and we have mitigations to overcome them. Even under the best of circumstances, it's never going to be perfect. And that's just how we all humans proceed to in processes. But we can do better for sure.
[00:25:10] Speaker B: How do you think about whether the burden is too high? Like the burden is kind of on a, on a spectrum and I imagine the thresholds for it are kind of differ by indication. Like how do you think about this?
[00:25:22] Speaker A: You're exactly right. It does differ by indication. You know, there, there is in rare diseases where there's no treatment, it's much different than an area where there are adequate treatments and you're looking for improvement or efficacy differences.
I think about this in two ways. The first way is what are we requiring in the trial and have we really done our work in determining what is critical for the trial execution, for submission and for approval? Have we done that? Do we understand the patient and when we created that? And then the second is a reality check with patients talking to patients, talking to patient groups and seeing where those Differences are.
Sometimes the differences might be unreasonable, to be quite honest, based on what regulatory is requiring us to do or what we believe they're going to require us to submit. And we can't change certain things that patients wish we could change. But I think frequently we may learn something from the patients that alter the way we structure it, that don't. That will not interfere with the ultimate program, but would enhance the likelihood for patients to participate and stay connected.
[00:26:41] Speaker B: Let's go back a little bit to mental health. I'd love to hear.
Is there anything that you think applies differently when it comes to kind of working in mental health and thinking about research and development here?
[00:26:56] Speaker A: Well, I think, you know, the companies that are doing a lot of research in that space, they have experts for sure. They understand the illnesses, they understand the pathophysiology. For the most part, they're working on mechanisms that could, that could positively impact patients. I'll go back to the. What I see as a social issue is we're not talking about this enough. And everyone's, you know, everybody when it does, when it's raised by government, government saying we're going to fund more mental health clinics, it's always acknowledged that we're not doing enough. But it doesn't seem like we evolve from that statement to actually doing more.
I think we've made some progress for sure. I'm not a negative person by nature. I always look at the positives. But we need to have these conversations more often. We need to talk about it in the open. We need to make sure patients are comfortable to talk to us and into each other about this. We need to create more forums for discussion. So there's broader learning within industry because right now the pockets are probably in companies that are dealing with treatments, potential treatments. But how do you then address a program that is not directly developing, that's not directly dealing with a mental health issue? But we want to recruit patients that may have other diseases, are seeking other treatments for other things, but we want them to participate. The more we learn about this, the better off we all are.
[00:28:38] Speaker B: Well, heck, I feel like I could be peppering you with questions about this both this all day. Any kind of closing thoughts on where you're hoping to see kind of the landscape of patients interested in move post publishing this book?
[00:28:53] Speaker A: Anything you've seen move like since taking.
[00:28:56] Speaker B: A more opinionated stance in public.
[00:28:58] Speaker A: So I've done a lot of conversations since I published the book about the book and about patient centricity and the cultural piece and the operational piece. This is the first conversation I've had specifically about mental health and how patient centricity can be applied. So I'm so happy to have this conversation because it's such a complex issue. You know, there's no easy answer here. There's no there. There is. I don't have a solution other than some general things that I've proposed during this conversation of more communication, better understanding. But I am certain that the patient centricity processes that have been developed are critical to moving this forward. They're critical to having the conversations, learning about the patients, integrating them into the development, research, development and delivery processes, and doing so in a way that's open and transparent and that allows them to feel good about being part of this and not feel as though they have to hide from the way they feel. And I think that's if you can do that through your podcast and get more and more people talking about this, the better off we all are.
[00:30:14] Speaker B: Actually, maybe one last question for you before you wrap. It comes up in a lot of the research that, like, for some of these populations, patients are, you know, maybe least trustful of pharma, of institution, of this kind of thing. Like, how do you break through that barrier? Like, if maybe this is a group of patients that are least willing or maybe more distrustful of kind of even engaging in the first place?
[00:30:46] Speaker A: You're right. Patients, people, consumers, general public, don't think very highly of pharma. Gallup did a survey, I think it was September of 2023, and the pharmaceutical industry ranked last. Right. When pulled by general public last. That put the United States government and the oil business above pharmaceuticals.
It's unbelievable. There's two things that we need to do if we're going to change this. First, how do we keep the folks who are doing such great work inside of the pharma companies positive? We do that with culture. We remind them every day through active programs that what they're doing is critical for the folks waiting for solutions. And the second piece is patient centricity Facing the external world, Showing them by example that we are developing relationships with them because we want to work with them for them, that what we're doing inside is. Is. Is of the highest order. And we're trying our best in an honest way to incorporate their views, to develop solutions with them for them that suit their needs. And I think that is the best way for pharma, and I think it's the best way for healthcare delivery systems who are not very positively viewed these days to change the perspective. We need to get back to we need to get away from treating disease and get back to caring for people. And the way we do that is through patient centricity. The way we do that is through consistency and sustainable processes. And the way we do that is with the very people who are waiting for solutions.
[00:32:39] Speaker B: Yeah, absolutely.
Go talk to people.
[00:32:43] Speaker A: Exactly.
[00:32:44] Speaker B: Go talk to people.
[00:32:45] Speaker A: Exactly.
[00:32:46] Speaker B: Well, hey, thanks again for taking the time to have this conversation today.
Where can listeners find the book?
[00:32:53] Speaker A: Amazon. The book is available on the Amazon website under books, obviously. It's called A Bandana and a Bluebird, the Path to a Patient Centric Healthcare System.
[00:33:04] Speaker B: A Bandana and a Bluebird. That's a striking visual. Well, Dr. Anthony, again, thank you so much for taking the time and appreciate you having this conversation. As always.
[00:33:12] Speaker A: Thanks, Brandon. Really enjoyed it.
