Join host Jonathan Kaskey in this thought-provoking episode of Pharma Sessions as he invites special guest Denise Bronner, Director of Clinical Trial Diversity and Inclusion at Janssen, to delve into critical issues facing the pharmaceutical industry.
Together, they explore the challenges of data sharing, the underrepresentation of non-white individuals in clinical trials, and the need for more inclusive physician training.
Top 5 learnings from the episode:
Tune in to this eye-opening episode of Pharma Sessions and be part of the movement to advance health equity, bridge the gaps in clinical trials and physician training, and ensure that all patients receive the care they deserve.
Pharma Sessions is hosted by Jonathan Kaskey
Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/
Or join the Pharma Sessions Substack:
www.pharmasessions.substack.com
Pharma Sessions is hosted by Jonathan Kaskey
Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/
Or join the Pharma Sessions Substack:
www.pharmasessions.substack.com
Join host Jonathan Kaskey in this thought-provoking episode of Pharma Sessions as he invites special guest Denise Bronner, Director of Clinical Trial Diversity and Inclusion at Janssen, to delve into critical issues facing the pharmaceutical industry.
Together, they explore the challenges of data sharing, the underrepresentation of non-white individuals in clinical trials, and the need for more inclusive physician training.
Top 5 learnings from the episode:
Tune in to this eye-opening episode of Pharma Sessions and be part of the movement to advance health equity, bridge the gaps in clinical trials and physician training, and ensure that all patients receive the care they deserve.
Pharma Sessions is hosted by Jonathan Kaskey
Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/
Or join the Pharma Sessions Substack:
www.pharmasessions.substack.com
Pharma Sessions is hosted by Jonathan Kaskey
Follow along on LinkedIn: https://www.linkedin.com/in/jonkaskey/
Or join the Pharma Sessions Substack:
www.pharmasessions.substack.com
Um, welcome, Denise. Thanks for joining. It's a pleasure to be up here today. Excellent. So let's just dive right in. And before we get into the meat of our conversation, can you describe your background in the space? Yeah, so I am an academic at heart. I started off with doing a PhD. And I consider myself to be a former scientist who turned to the dark side. I always had had a love for business and getting into industry and made that jump after doing an academic postdoc for a little bit, getting into consulting and did a bit of getting into Big Pharma, where I'm at currently. But at the heart of it yeah, go ahead. What was your PhD? My PhD is in microbiology and Immunology. Oh, great. Yeah. And I have to say, at the heart of everything that I've done, data has always been something that's really been strong interests of mines in addition to science. Data, I think, is really cool because you can tell really cool stories with it. You get to identify trends and things that are hidden in the data itself. But during my time in academic research and consulting and Big Pharma, I've started to realize that there's a hidden story within data, that there is things that are happening that are kind of giving a little bit of information about where patients are or which patients are missing. And I've always wanted to question, what are the gaps, what are we not really seeing here? And really thinking about ways to kind of develop a compelling story. And when we look into anything, especially within Pharma, and looking really at historical clinical trials, you start to see that there are a lot of patients that are not seen in the data. And we know that we have our cultures, different cultures, different backgrounds, different types of people, and yet a lot of them are not in that clinical research. And we're missing on understanding how disease progressed within them or the efficacy of our therapies and diagnostics. So for me, my background really has been driven by this idea of science and trying to understand what are we missing and how can I, as a person really fill that in? Yeah, that's really interesting. And then it sounds like also the impact. Well, here we're talking about healthcare space. I'd imagine there's all sorts of impacts of either recognizing or not recognizing that your data is incomplete or missing certain pieces. I'm just curious, was there anything in particular? Was there an AHA moment for you that started you thinking about this idea of hidden data? I think really it was really interesting when I was in consulting and it started there when we were looking at understanding feasibility programs across different pharma companies and you start to see how industries or different companies are really. Siloed and that there's a lot of data that they could have been sharing with each other on best practices or lessons learned that was not really being shared because of this idea about competitive edge. Right. It started there and I think that was really interesting to hear, how there were certain things that some companies had tried that others were just starting and they're like, well, we did that and this is what we came across. And it was like that ability to cross pollinate with each other without the fear of, oh, you're going to have a competitive edge on me, I thought was very interesting. And then when I made that transition to where I am today at Janssen and really started to look into historical data about, well, who is being represented in our clinical trials, you really start to see that when you think about the US population as a whole, right? We're starting to see more and more non whites. Their population size has grown significantly over the past few decades. And yet when you look in clinical trials, they're barely, if you include everyone, black, Hispanic, Asian, Native American, Native Alaskan, all under one umbrella as a group, it's non white that they're only representing maybe 15% of clinical trial participants. And you think about the thousands of trials that are going on and you go, Why is that? Why is there such a disconnect when we look at the population and it's not reflected in our data? Right? And then if you're not even denoting who people are with a little bit more specificity, you can't go backwards and search for things, right. The data itself, I guess, becomes flawed. It's interesting. So this is kind of the third conversation that we've done on this podcast around the Dei clinical space. And in the first one, it was with a woman named Camille Pope, who works for Acclimate, which is one of those it's a consultancy agency. And one of the things I've always thought was interesting about the consultancy side is you do actually get to see how maybe 515 different companies are trying to solve for these things. Whereas if you're at a very big company, it can be easy to think that the world, the strategy ends at the walls of the company, right. So there's definitely opportunities to bring people together. So I'm just curious along those lines, what are traditional sources of data and why might they be lacking? Oh, man. So I talked a little bit about this in an article that I have on my LinkedIn newsletter, The Pulse. And really what we're starting to see is the use of claims data sets very heavily. And you can also look at population data with prevalence and incidents. You can look at historical trial recruitment data, and you can also get into qualitative data sets as well, looking like at patient and site voice. And the interesting thing about it, when you look at these types of data sets, sure, they have information by different demographics. So you can look at sex assigned at birth, right. You can look at race ethnicity, age, you can even go by geographies. But what you start to notice is that there's a low amount of diversity within those data sets as well. Because if you look at historical recruitment data, we know that the FDA had put out a mandate and requirements now to have representation because a lot of studies were hitting 85, 90% white. And these are in diseases where we know for a fact these diseases do affect people who are non white. But then you also start to look at claims data and this is really based off of when a person goes to see a doctor, that billing code that gets added on there, this is how they can flag that. Right. And it's based off of disease and the type of test or therapy that they have been given. Right. And what you start to notice is that because of healthcare access, that data too is also skewed in one way versus the other. And so we're starting to see that a lot of the data sources that we want to use, you really can't glean true insights from it because some people, some patients are not in that data. And when you have patients that are being misdiagnosed, who are being dismissed by physicians or because of the cost to go see a doctor or to get a certain type of drug, you see that that data is not being reflected of the real population and prevalence and incidence data now is starting to be more robust. But some of these data sets are really limited just to the US. Because if you look into other countries, especially like in Europe, there's a lot of privacy laws. So if you're able to try and gather a little bit more information on the demographics of patients, it's kind of difficult to do. So you're very limited in scope. And so you have to say to yourself, how can we leverage this data in a way to really identify where these patients are at? And this is where what work like what Acclimate is doing, we're really getting into the communities and what patient advocacy groups are doing helps to kind of raise the stakes and a little bit of more of awareness of where these potential patients could reside. Yeah, wow, there's a lot there. So maybe if we could just go back. One of the stories that was shared earlier was about I actually forget the disease, but it was something that was prevalent in African Americans. But it's situation exactly like what you described where the clinical trial was 85% white and the person was talking about going and meeting with a patient advocacy group and the advocacy saying how come there's nobody in here that looks like me? Right. And it seems the more that I'm talking to people about this, the more I don't know if intersectional is the right word, but it all cycles on each other. It's like you have a bad experience with a healthcare system, you're not believed, you don't have access, you don't have a provider, you don't have insurance. Right. And then there's this mistrust and then you're going to try what a lot of people are considering, like experimental. Right? You're going to be in a clinical trial for something that's not approved? I don't think so. Right. And so there's this whole uphill battle where it to me, it seems really difficult to separate those things one from another. So when you're thinking about addressing that, are you kind of picking off point solutions or it's like, hey, we can make an impact here through education or we can make an impact here through an access program? Or are you trying to operate a little bit more holistically and saying there's systemic issues that need to be addressed? I think honestly, what has happened historically is kind of very poignant. The biggest thing that I'm getting that I think we need to think about here is it needs to be enduring and it needs to be holistic because you can raise awareness and that's great. You've empowered the patient. They know about the disease, they know about the different avenues. But when they go to these areas and they go to the medical field, they go to a doctor and the doctor dismisses them because in their mind, they're thinking, well, you don't have this disease because you're black. I mean, this has happened a lot with people who have IBD, right? They're black or Hispanic and they're being told you can't have it because you're black or Hispanic. So when you're meeting that part initially and it takes you a while to finally find a doctor, but the doctor's out of network or the doctor is 2 hours away. These are all the things that are piling up. Onto a patient that as much as we like to talk to the patient and be very much focused on what we need to empower the patient, there are things that are happening that are outside of them that we really need to focus on. Like, are we training physicians to identify and to combat implicit bias? Are we partnering with the right physicians? Even though we may have heard from patients or have had interactions with these physicians and they're like, no, I don't see a need for this, or I don't understand this. Are we partnering with the right physicians? Right. Are we willing to partner with the physician that may not have the clinical research experience but is heavily invested in their patients? Right. Who has the patient demographics that we're looking for and who understands the importance of not only educating and raising awareness, but trying to find those opportunities for their patients in the right way? Those are things that we can do on our end. And when you start to get into other areas of healthcare access, thinking about cost, right? Thinking about how and where we're going to be launching some of our therapies or trials, right, thinking about ways of investing in the community. So not just setting up shop when we have a study, are we actually going to be there before the study, during the study, and after the study to maintain that level of engagement with that community? And this is something that Accolade and others like them have really pushed because you need to have that continuous engagement with the community because, again, it can feel very transactional, right? So if you're not empowering them in a way where they can take this and it can grow within that community, then you're really continuing to do the same historical things that have happened in the past, where you come in, you get what you need, and you leave. On the idea of kind of hidden data. Is there ever some type of I don't know what the right term is negative analysis where it's like, hey, you have 100 black patients and nobody's been diagnosed with IBD in your practice. And that's I don't know what the actual number is, but that's abnormal. So that probably is statistically very unlikely. You should reexamine how you're treating people or what you're looking for with the EMRs and with claims data and with everything. Are people taking it to that point of saying, this is something that particular doctors at particular offices should be looking at? Yeah. So there probably are some individual physicians or at least groups that are starting to look into that. I know at least that in my job. We're looking at it as if we know that there are sites based off of claims data and looking at just the demographics of patients at that site. As the study is ongoing and we see screening and randomizations or enrollment numbers, and we're like, hey, there's a disconnect because you said during feasibility you have these types of patients. We look at the claims data within your community and even at some of the data that's at your site, there should be these sites of patients. So what's happening here? And it could be as you start to dig through that data, maybe they are screening these patients, but they're not being randomized. And that comes down to what is it the protocol, right? Is there something about our protocol that's very restrictive, and do we need to widen the funnel? Or is it something along the lines where they're seeing not only low randomized patients, but also low screenings? And you can say, well, what's happening? Are patients just not interested? Are you even having a conversation with these patients? That's where you start to dig into that type of data to try and understand from the site's perspective what is happening. And that's when you can kind of use that data in a way to figure out what is that hidden story? And if it is something that can be mitigated, how can we go about. Doing that that's really fascinating. So you're actually looking at it for individual protocols because you're making site decisions based on some assumed you have to. Right. And if you're not achieving those outcomes, then you're going back and you're reexamining, why not? You have to because each site is different, right. It's not the same cookie cutter type of thing. And there are going to be sites that are in areas where there are opportunities and for some that aren't, you can't really put them on the same level. Right. It's going to do a disservice to that site. But for the sites that are in these areas where there's opportunities, are we doing everything that we can to empower them and to provide those opportunities to those patients in that area? Yeah. It's so interesting because I've been working sort of in the space on the vendor side for a while and there were a number of years where you'd go people would be, I'd be trying to help people recruit patients. Right. And we'd be trying to fill it. And basically it was like, what's the cost per patient? Right? And that was kind of it. And now it's this interesting. It seems like there must have been an inflection point maybe a year ago, two years ago, three years ago, somewhere in that time frame, not that far ago, where now people are like, hey, this is an initiative, but now we have budget for it. And I feel like that's a big difference. I'm just curious, do you see this? Probably. I'm sure the FDA guidance is a major impetus, right? But what do you think that is? Where companies are kind of really prioritizing this now? I think it's because it's more of a push from society, right? Like the FDA has made it where now it's written into law, right. We have mandates, now, updated guidances. But it's also the people. I think people now are way more vocal. Social media has allowed people to create communities. It has allowed them to have a platform to express their concerns. I mean, medical TikTok has taken off, right? So people are going to these spaces to try and learn more. Some it's good information and some not so much. But I do think that society is now putting the onus on industry, right. Medical pharma to really step up. Because if you are going to be selling these types of therapies and drugs or providing these types of diagnostics and preventative measures, we need to be seen. Right. And I think there's a major push within society as a whole for representation. We're seeing this for representation in higher levels of the corporate ladder, for even on the side of like startups and investments, things along those lines. We're starting to see that education, government. So with the fact that you now have people saying, hey, why am I not included? Why isn't there data to inform me if this is going to work for me. I think we're now starting to see that, hey, either you catch up, right? You try to push forward with this, or you're going to get it left behind. And so you're starting to see this across the industry where a lot of the pharmaceutical companies now have dei focus or Gnos, they're putting money into certain initiatives. And Janssen and J and J have really done a great job with putting in their race to health equity, right, where they have actually said, we're going to put money into this. We're going to not only think about this in terms of raising awareness and educating, but also thinking about the clinical trial space, how do we improve representation? And this is just something that has really been pushed through to really change the game. And I think it's now being viewed as dei or diversity has been seen for the longest time as a challenge. But I have always been pushing for the narrative that it should be seen as an opportunity. And when you think about the fact that you can tap into new patient pools, that's more data that can inform your science, that is a larger patient pool for patients to be recruited from to speed up your timelines, that is an opportunity for new customers to sustain your portfolio. Those are business opportunities. Right. The financial impact that can happen on that is substantial. And when you start to view it in that way, where you can actually revolutionize science and business, I think that's when you start to see the wills really starting to take off. So it's not a challenge, it's more of an opportunity. I love that framing of it's a societal pressure, but then also it's good for the science and it's good for the company. And if you happen to be in the market of providing IBD medications, wouldn't it be good to properly diagnose people? But then there's this mistrust issue, right? And mistrust of the healthcare system amongst black and Hispanic populations, for example. It's often discussed in historical terms. How does this perspective affect Pharma's ability to effectively engage these communities? Oh, man. Every time I hear mistrust, I always make this face. And it's always because it's always put. In a because this is an audio medium, right? I make a face. I kind of make this kind of face because it's always put in the historical sense. And it's important to highlight the historical atrocities that have happened. Right. We think about Henrietta Lax, we think about Tuskegee, the father of Gynecology, the birth control study that they did in Puerto Rico. Those things happen. We cannot gloss over that. But I think the biggest thing, especially when you talk to anyone who identifies as a person of color, is that there are still injustices that are happening to this day. And when you look at some of these statistics and I'm going to rattle off a couple where there was a study that found that seven out of ten black people felt that they were being treated unfairly by the healthcare system. Right. You've have other studies that have talked about black patients being dismissed or undertreated for their pain. When you think about the trans community, 29% felt as though or had stated, I should say not felt, but stated that their health care provider refused to treat them because of their perceived gender identity. Right. And when you think about the latest story of Tori Bowie, who was the Olympian who just died of pregnancy complications, right? This is something that happens a lot. And black mothers are two to three times more likely to die than their white counterparts. And people will say, oh, well, maybe it's because of health care access, and it's like, no, this is even if a woman is of higher socioeconomic status and educated. So when you think about these things that are consistently happening in the current time, right, these are traumas and dismissals that are happening to today. And even with raising awareness about Henrietta Lax and Tuskegee, we're still seeing these issues, right. And there's a lot of bias that's in the system. And when we hear about that, I think that's the piece that for me. We have to think about how do we engage better with these communities? You can't sit here and gloss over it. You have to say, this has happened, and we know these things are still happening, but here's what we're doing to improve your chances, to allow for your access to not be hindered, for you to not have to go in and worry about, am I going to experience trauma or dismissal today? Will I have to go in and fight to get a standard of care? And that is something that I think we need to do better with listening and really saying that that should not go on the patient that needs to go on, the physicians that needs to go on, the industry to change how that's happening and to stop that from happening. Yeah, it's almost, in some ways, easier to look at it in historical terms, because then it's, well, that's something that happened. And you could, I guess, maybe could draw a line. You could say, okay, the father gynecology with this horrific experiment, saying, essentially, black people slaves don't feel pain. Right. And then with the stat that you just rolled off. But at a certain point, it's like, okay, well, striking everything else out. The Olympian is horrific. The story that's always struck with me is Serena Williams, who has more resources. Than anyone. And she almost died in pregnant because she wasn't right, because she said something is happening and she wasn't believed. I feel like it's super important to talk about it in current terms, because that is where you can take action and make an impact. And I'm just wondering how aware are underserved communities of these issues, and how can Pharma do a good job listening as well as talking or what resources can says industry people use have intentional engagement with communities of color. Yeah, I would say communities of color and underserved communities are painfully aware. Right. They're living it. It's their day to day and you have to make sure that you're not talking to them as if they don't know what's going on. And I also think too, you can't come off dismissive and I will say that we have done some exercises within the industry and at my company where we've gone and done patient voice. We've talked, we've listened, but a lot of times we hear from patients and even from sites that's great that you've asked me this question and you guys have taken all this information, but we haven't seen anything being actually implemented. What are you guys doing? So I think the biggest piece is a lot of times we think that, oh, with the advent of technology, we'll just throw a bunch of technology at patients and they'll love it. And the number one thing we kept hearing from patients is we just want better communication. So when you're going in and talking to these communities, you're listening to them, you're providing them the information, telling them where the resources are. In addition, you're also saying that what we hear from you, we have incorporated that into our studies. So we're partnering with site to have weekend hours because we know that your job, you may not have flexibility with that or we've heard you and we've tried to create therapies where we wouldn't have as many visits to the site. Right. Or we've provided extra materials and reminders for you to know what you should expect and why we're taking these samples. Right. We are communicating back to patients throughout the study. Here's how the study is progressing. And the biggest thing too is when a study is completed, what came of it? Did the drug become available? What did the data say? Right? And that's something that I think as an industry we need to do much better with. We're not communicating back. Right. So we need to show them that they're not just a data point, that they're actually advancing science and that this is something that can really help society as a whole by treating some of these diseases that we're facing with in society. And the biggest thing is being very intentional, that it's enduring, it's intentional, right. And that you're always having that feedback of communication and I think anything else tied to that, like you said earlier, budget, you've got to put money towards it. You can't just expect, well, we set up the site. Yeah, but what else did you do? Right? Did you really engage? Did you put money into it? No. Well, of course. What do you think was going to happen? Right? It's not going to be magic. So I think that's where we start to see. Are you really evaluating what you're doing? Are you tracking metrics to see what the impact is? Are you actually, before you do anything, actually getting feedback from people who you're going to be pitching this to, to say, yeah, that's not a good idea, or yes, this would be something that's good. So that's where I think you can start to see that you're being very intentional about what you're doing within these communities. Yeah, it's really interesting because a lot of that is kind of being respectful of people, right. Like, you're giving me your time, you're participating in this, and the benefit to the company happens then, or a lot of it. Right. But it is respectful to close the loop and to come into that, and especially the staff that you had listed earlier kind of dropped my jaw was the seven of ten black people saying they've been treated unfairly by the health systems. That's a big hill to overcome. And so communication makes a lot of sense to me as a way to say, we're going to treat you very we're treating you fairly in this experience. Right. And part of that is telling you what we're doing, what we're taking off, maybe asking your opinion a second time, and just the same way you would with just having a respectful engagement. Seems really important. Yeah. And I think that's the biggest part, too, is like I was saying earlier with physicians, are you choosing the right physician? Are we training them and raising their awareness and needs right. On competency, on how to engage with these types of patients? Because like I said, a lot of times, it's focused on the patient with engagement and raising their awareness and education. But the same has to happen with physicians as well, because what I thought was very interesting is that there was a statistic when we were talking about within dermatology, like 49% of dermatologists and dermatology residents felt they were not adequately prepared and educated and trained on what these different types of diseases within dermatology looked like. On skin of color, that's a large number. And right. When you think about what tools and training that they have with the images, it's always on white skin. Not saying that it doesn't happen, but there are other people of different skin tones who are also suffering from psoriasis or atopic dermatitis. So what are we doing to fill in that gap, to make it where they feel comfortable with being able to accurately diagnose these diseases? So that's something that we can do that's separate from patients. Right. That's something that's really focused in on the physicians, on what can we do so that when they're engaging with patients, regardless if it's a trial or not, they're doing this properly. Interesting. So are you talking about things like CME or what are the programs that you're referring to? Yeah. So you can do that through CME. You can do that through even, like with site training, with. Our clinical trials, there are certain trainings that they have to go through. Could we put these type of cultural competency type of training there, right? Could we give other types of optional trainings for them to say, hey, here's to raise your awareness about this? Or when we're doing these different types of events that we can put together to kind of raise awareness and say, here's what we've learned. Here's new data right, here's what we can put out there for these physicians. Or partnering with companies like Visual DX, who has collected all these images and say, is there a way for us to create training materials for physicians? Things along those lines that we can do that are not putting the onus on the patient, but more back onto the physicians who are sometimes one of the biggest barriers of healthcare access. That's very interesting. So as we wrap up here, what are you most excited or hopeful about to see happening in the space now? And how is that going to change the landscape over the next few years? I have to say I'm very excited about the fact that society as a whole is really taking their health care seriously and that they are taking ownership of that, that they feel empowered to be able to do that. I'm also very excited about the fact that the FDA is really starting to put their foot down to say we're mandating and putting out requirements and guidances on these things here for improving representation. And I love the fact that we're starting to see more and more people like myself who are moving into these spaces and are trying to change the game, right? So whether it's through a startup or being climbing the corporate ladder in being in these spaces to really change that narrative and to kind of highlight and add these voices that have not been there for so long. I mean, right now we know it's kind of a little hairy in the US. But I do think that people as a whole are starting to say, wait a minute, wait a minute, that doesn't make any sense. And the fact that we have these opportunities to create communities online and in person and we can really start to lean in and cause these types of changes, that's what I'm very excited about. And I think that we will see this for the better because new science will come out of this. There may be new things that we never even thought of, right? From new pathways or new therapies things along those lines that might really change a lot of things within Pharma. But I'm also really excited to see the impact, the financial impact that can be had from these underserved communities that they have been overlooked for so long, that now that we're putting a focus on them, look at what they've been able to do, right? It's not that there isn't a financial opportunity there, but we can see that now. We can actually track that over time. So those are things that I'm very excited about. To see that diversity, although it is a very sticky subject right now, is really going to allow for us to really evolve as a society, I think, with thought, with science, and from a business perspective. Excellent. Well, we'll leave it there, but Dr. Denise Pranor, thank you so much, and it was a pleasure speaking with you today. I know. Thanks for having me.