Episode Transcript
[00:00:03] Speaker A: Welcome to Power to the Patients, a LinkedIn live and podcast series hosted by Power, where clinical research leaders across sponsors sites, CROs and patient advocacy groups discuss patient centricity in clinical trials. We explore the bottlenecks in today's system, challenge the status quo, and talk about future opportunities for innovation. Let's dive in.
[00:00:30] Speaker B: Well, Deb, thank you so much for joining us for this conversation. Really excited to dig in. I know that we've had a few conversations before. We know each other around the table here, but for the group that's listening in, maybe we'd love to just hear a little bit about your journey, your career, and kind of what got you to where you are right now.
[00:00:46] Speaker C: Yeah. So first, thanks for having me. I appreciate the opportunity. Yeah, as we've spoken, my journey has been pretty long, at least in this field of oncology, and it really started on a personal side as I was figuring out kind of what I wanted to do in my career. My mom was diagnosed, and so I think really from the age of 19, on, I don't know, a world that doesn't kind of include cancer. And that really drove me into making the career decisions that I have, which was really to kind of get into the pharmaceutical industry, the CRO industry, both really focused in oncology and what can we do to bring new therapies to patients, what can we do to make the process better? So I had an opportunity to really start out about 15 years in the pharma world. I'm in a number of different companies, primarily in medical affairs. So really focused on that relationship with investigators and understanding kind of what was going on and how those therapies fit into treatment and then shifted over to the CRO world where I was really kind of working with a lot of small biotechs around building the strategy, how to develop the protocols they needed to really be successful, to get the answers they needed, but that were also going to fit for kind of patients and get them enrolled and then most recently had the opportunity to kind of shift back to the sponsor side. And I'm working for Deca Biosciences, which is a biotech started about four years ago and really kind of have an opportunity to be a part of building this platform that we have with Cytokines and really kicked off our first clinical trial earlier this year. So kind of back in that actual operations perspective and having that opportunity to bring these therapies to patients.
[00:02:20] Speaker B: Thank you for sharing that, Deb. I know a consistent thread through a lot of our conversations has been the idea of patient centricity, specifically as it relates to oncology. Maybe talk a little bit about why is patient centricity so hard in oncology?
[00:02:33] Speaker C: Well, I think it's hard because we talk about oncology, right? And unfortunately, oncology encompasses over 100 different diseases, right? And each of them have a different pathway that patients take and they have a different length of time. I mean, some of them are pretty quick in the disease path, some are a little bit longer. And so I still think patient centricity is important in Oncology. I think what we have to do, though, is really try to take a step back and think about specifically the patients that we're thinking about. So it's not a one size fits all in Oncology. And again, understanding kind of where that patient and their family is in their disease pathway. If they're newly diagnosed, it's very different than if they're a little bit farther along and looking for treatment options or maybe kind of have run out of treatment options. So I think at the end of the day, if we as pharma, CROs, sponsors, all of that, can really just think a little bit about what that patient's facing, what can we do as we're building a protocol to make it as easy as possible for these patients, so reducing the number of visits perhaps? Or do we really need all of these tests? I mean, we always as a sponsor, want everything we can get, right? We have a lot of questions we want to answer with our clinical trial, but sometimes is it really a need to have or is it a nice to have and how can we design these protocols that are going to make it as easy as possible? And it even comes down to the way that a drug is given or that kind of stuff. I mean, we're very lucky at deca because we have an opportunity to do a sub Q administered drug. So that's a very different thing. It potentially allows for that patient to do that at home. So we're very lucky on that hand. But I think all of that we need to match up kind of where the patient's at in their journey, kind of what they're experiencing, and then what can we do to make that easier and make them more likely from a clinical trial perspective to want to sign on and participate.
[00:04:27] Speaker B: How is that different from other therapeutic areas, other indications?
[00:04:31] Speaker C: Well, yeah, I think for Oncology, the difficult thing too is that it's not a straight pathway for each of these patients, right? So it kind of goes back to and I think if you're diagnosed with a different type of more chronic disease, say, for instance, hypertension or diabetes or things like that, your pathway is a little bit more stable or consistent, right? You kind of know what to expect. And you start here and you go here and the steps are outlined. I think with each patient in Oncology, it's so different. Some are going to respond and might have a great response to a therapy and have months, years before they have to think about something else versus other patients. It could be a pretty quick sort of thing. And so, again, I think there's just a lot of factors. And I think each of the diseases in oncology is so different as well that we can't just say this fits for oncology. A breast cancer patient is very different from a patient with prostate cancer or with lung cancer and things like that.
[00:05:28] Speaker B: Fair you've designed strategies for lots of oncology studies, but what have you seen to be really productive in bringing the voice of the patient into that conversation?
[00:05:41] Speaker C: So, I mean, a couple of things. First and foremost, again, understanding where that patient's at in their journey, understanding kind of what those pathways are for patients in general. Right. And that's a very top level view. You can look at kind of practice guidelines or things like that by indication, by type of tumor. So I think that that's kind of where you can start and then it's really understanding the more specifics about what your protocol, your patient population requires and really trying to look at that. I think if you have the opportunity to directly connect with patient advocacy organizations, or in some cases, companies have been able to put together patient advisory boards where they can kind of run some of this by them, I think that that's great. As a biotech, the smaller the organization, the less likely you are to be able to kind of access some of those resources. But I still think patient advocacy organizations are very important. They're a huge point of education for patients. They also have that ability to probably get some of that feedback on your protocol and kind of provide that to you. So I think that it's great. It's difficult to do, but probably those are the two things that I've seen kind of most successful.
[00:06:50] Speaker B: Why is it so difficult to do? Talk to us a little bit about why it's so hard to pull together an advisory group or connect with these advocacy groups.
[00:06:57] Speaker C: Yeah, I mean, I think a big part of it is, especially speaking from the smaller biotech space, we don't have people that really kind of have that focus. We try to do the best that we can. Certainly our clinical team is focused on trying to do that. I think larger organizations have understood that and they have people who have that skill set. I think being able to talk to patient advocacy organizations and being able to talk to patients is not something that everyone kind of has that ability to do. I think there's some great organizations out there now and companies who have been trying to help support this piece of the process. So I think connecting with them and kind of utilizing them as a resource rather than trying to do it yourself is probably going to move this along a lot quicker than may happen in the past.
[00:07:43] Speaker B: Yeah. Can you tell us about some of the feedback, maybe that you've heard in kind of these settings and how it's changed the way you thought about designing protocols.
[00:07:53] Speaker C: Yeah, I think it can be what we think is or we kind of gloss over maybe, and we don't even think about, but just things about the number of visits, for instance, that a patient has to come into the office and you might assume that that's pretty quick for them, right. Even coming in once a week, no big deal, right, except some of these patients that requires public transportation and multiple bus rides and then they have to take off of work. And so I think we have to that's kind of the feedback that I've gotten a lot of times is really just I have a whole other life outside of cancer and outside of this protocol, and so how do we make our protocols fit better and be kind of more open to them? So it's everything from supporting the patient, again around their time, their effort, the travel and understanding potentially too, what it means for their families, right. The more time they're away, if they have small children. There's just a lot of things that we need to consider and that's a lot of the feedback. I think if there's a lot of additional tests required that we like to put into protocols, if that's not covered by insurance, certainly it has to be covered by the sponsor, otherwise that kind of goes out the window. But yeah, I mean, all of that, the more cumbersome that it is for the patient, I think the less likely they are to participate.
[00:09:13] Speaker B: Yeah, that makes sense.
[00:09:14] Speaker D: Yeah. Maybe jumping in with a question there, Deb. How much does this influence in terms of site selection as well? Right. Context here being that sometimes sites are, if they are part of health systems, oftentimes notorious for what insurance they are willing to accept and therefore potentially could exclude patients who may not have that commercial insurance that they are in network for.
[00:09:39] Speaker C: Yeah, no, Srinavas, that's a really good point. And it's really important. I mean, I think selecting sites on so many levels is really important and especially from the patient perspective. Right. Because to your point, insurance is one piece of it. How close to the center a patient might be or their average patient is, is another thing. Right. If they're traveling and they have to get on a plane, they're not going to come every week. Right. So I think that's a piece of it. The access to the types of cancer that you're looking for and the types of patients, that's another piece that goes into site selection. But yeah, there are sites that are more private type institutions that are very restrictive on the insurance that they include, or even including patients without insurance is not something that they normally see or treat. And so I think all of that is really important, that knowledge of those sites kind of their patient population, what that looks like, and again, what's their standard of care. If it's normal for them to do, for instance, a Cat scan in their patients every eight to nine weeks, because that's kind of their standard, and then that fits with your protocol, then that doesn't create issues for the patient. Right, but if we want to start having Cat scans every two weeks, but their normal kind of process, the way they do things, is every eight weeks, that's a disconnect. So I think all of those pieces is really important that we take a look at when we're designing the trial and also then obviously selecting the sites to make sure it's a good fit.
[00:11:01] Speaker B: This seems like a pretty complicated multivariate problem. Have you found tools or frameworks that you've used to kind of cross reference all these factors as you design this stuff? Talk to us about what goes on in the background.
[00:11:16] Speaker C: Yeah, it's a really good point. I always kind of looked at it as like a puzzle. Like each one I was looking at was a puzzle. Right. Unfortunately, each of the pieces of the puzzle was different for each study.
It's not a one size fits all, but I think there's kind of buckets of things. Right. So it's, again, understanding the patient pathway, understanding the tumor type, the disease state, kind of where they're at in that pathway. And there's a lot of ways that you can get that information. Right. There's a lot of data that's out there. I think the key with data is understand kind of what its limitations are and understand what the inputs are. I think data is great. But for instance, if you were just to say, look at data from previous breast cancer studies as an example, just because you have data on a breast cancer study that was done five years ago, what relevance does that have to a breast cancer study you might be doing today? Treatment standards have changed, things like that. So again, data is great, but you have to put it in context. I think figuring out where technology fits in these protocols. Right. We've talked a lot about there's a lot of things out there to try to do, wearables and collect things at home and decentralized trials, all of that is great. But you have to figure out what bits and pieces might apply and what might not apply. And then you have to figure out, again, kind of the strategy also kind of comes into how long is this going to take? Do you want timelines? Do you want to figure out what resources you need? And all of that. And that becomes a whole nother kind of conversation and discussion because sponsors obviously want things really quick, as quick as they can get them. Reality is kind of what is that going to look like? And that's another piece of the strategy, is kind of pulling all of this stuff together and being able to say, realistically, here's the way to approach it, and have that plan. And then obviously things change, right? New therapies get approved and that might have an impact on your protocol. So you have to kind of be able to adjust and kind of expect that there's going to be changes along the way.
[00:13:10] Speaker B: Yeah. With the benefit of seeing so many protocols designed. What do you think most people get wrong when they kind of go into this?
[00:13:20] Speaker C: I think a couple of things. I think one is just the overall design or kind of the expectations, right. And I talked repeatedly about this, but I think we have to be as smart as possible in how we design and how we get answers and we want to do it as quickly as possible. But that also might mean we have to give up some complex testing or some of the process that we would like to have in there. So I think that's where a lot of it goes wrong. You set up this protocol that looks great and it gets you everything that you want. When you go to implement that, it doesn't happen. Patients aren't interested. You can't find these patients, it takes longer. It kind of throws all those timelines off. So I think that's the first and kind of most important and kind of covers everything. And then I think the other thing is really kind of then doing the protocol, getting it open, even if everything is great when you start, is kind of losing sight of what's going on. Right. I've had sponsors who have just had a protocol going, it's going great for six months and then suddenly everything stops and they're wondering why. And it's because a new therapy was just approved and it's totally changed how patients are being treated and now they're not available for their study and they kind of didn't look ahead and didn't think about that.
[00:14:33] Speaker B: Interesting. You mentioned they launched a protocol in terms of patients aren't interested in it. Is there a quantitative way to gauge patient interest in your protocol before you get going? I'm just kind of curious. It seems like a daunting question.
[00:14:48] Speaker C: It is. I don't think there's a quantitative way to get that. I mean, again, if you can access a patient advisory kind of group and get that perspective from them, I think that that helps. I think prospectively, as we're opening a study and we're getting feedback from patients, it's important for sponsors to kind of keep track of that. Like, why are patients turning it down? And that's feedback that we get from our sites and our investigators and can we change something? Can we tweak something to make it more amenable to these patients and answer some of their concerns? But I think and this kind of goes back to a conversation we've had previously as well, I think one of the biggest issues we're still facing is that just the idea of a clinical trial is completely scary to so many people. And so I think just in general, there's hesitation to participate in clinical trials sometimes. And I think we need to do a better job of educating just kind of the general public around clinical trials and what that looks like, rather than waiting till they've been diagnosed or they're dealing with progressive disease or things like that. And suddenly now they have to think about it and maybe they don't have the same kind of positive open mind because they're worried about a lot of other things.
[00:16:00] Speaker B: Now, I know you've seen the world from both the sponsor side and the CRO side and pretty in depth on both sides. Where have you seen the collaboration between sponsor CROs really work well with regards to kind of building patient centricity and then maybe conversely, where is there tension there potentially?
[00:16:20] Speaker C: Yeah. I mean, I think I'm very happy to say that I think that right now what we've got going here at Deca with our CRO partner is kind of one of those good examples. But I think there's some reasons for that. One is making sure that the culture, the philosophy and the approach of the CRO and the sponsor is kind of aligned. We as a biotech have a very different approach. We are fast and furious and have a lot of things going on. We can't work or it would be difficult for us to work with a CRO that is maybe a little bit more focused just on process, more difficult to kind of do things slightly differently or adjust. So I think that's one of the key things. I think the other piece is that as a sponsor we need to kind of drive a lot of this knowledge and relationship with the sites. I think sometimes sponsors kind of say the CRO is going to do that for them because the CRO is going to select the sites and they're going to manage them and they're going to monitor them. When I was on the CRO side, I think that was one of the key questions that we used to talk about internally is as a CRO, we didn't own the science, right, that was kind of at the helm or in the responsibility of the sponsor. And so when you're having a conversation with a site, it becomes very transactional. Right? It's this process. I need you to do this for me. I need you to do that for me. On the sponsor side, we can kind of share that information, keep them up to date, have them have the knowledge of what we're doing, why we're doing it. We take that very seriously, those kind of constant conversations with our investigators and we include our Sierra partner in those discussions so that it really becomes a collaboration between all three parties. And I think that that makes it more successful. So the disconnect is really when you don't have that good collaboration, you don't have that same philosophy. And we truly do view our CRO as our partners and kind of an extension of us. And if you can make that happen, I think that's where things are successful that's very difficult to do. The larger the companies, the larger the studies, the more people involved, that becomes a little bit more complex. But I think that really should be the goal.
[00:18:31] Speaker B: Yeah, absolutely. And it sounds like there's kind of like this important mindset, which is, yes, we've partnered with the CRO, but we can't wash our hands of the problem. Right. It's unrealistic to expect to see those partners to be able to actually deliver on everything. There's just stuff that they won't have the context on to be able to kind of advocate for.
[00:18:53] Speaker C: Right. And I think too, I mean, just from the patient side of things as well, for us, it's very motivating for our team to kind of keep that connection right. With these sites and understand kind of what's happening and we've been responsive to what we've heard from our investigators or kind of how things are going and what does that mean for us and what do we need to do. That's not something a CRO can do. Right. So if you miss that kind of feedback and input, I think it can just make things more difficult or at the very least, maybe not as successful as you would like it to be.
[00:19:25] Speaker B: Yeah. What's your quick take? Who's pulling more for the patient's experience, the CRO or the sponsor?
[00:19:31] Speaker C: Well, I'm a little biased on the side that I'm at right now, but honestly, I would say the sponsor. But again, that's just because of this is the world that we're living in. We're on this sponsor side where we've seen the science. A lot of people have been a part of kind of developing these from the beginning. They've seen all the work that's gone into it. And then to see all of that preclinical work and everything that you've had to do, the science behind it, have the opportunity to then have that go into and start to treat patients, that's something that a CRO just will never have. That kind of level of connection with going on.
[00:20:09] Speaker D: The aspect of patient centricity, especially as oncology trials become more and more driven by mutations, genetic markers.
As a sponsor, maybe with your CRO hat as well, how do you think about really identifying maybe the end for the study to begin with, depending on, obviously what that distribution of that indication is. Right. I mean, identifying a statistically significant end, but then also finding these patients. Right.
What are the things that you think about?
[00:20:49] Speaker C: Yeah. So it's a really good question. And again, an area that I think there's been a lot of change in the last ten years. Right. The idea of targeted therapies and even immunotherapy and biomarkers, it's very hard to have, especially in oncology. You don't have just a lot of clinical trials that are, for instance, just a breast cancer trial, right. You're looking for a very targeted patient population. So I think a couple of things there.
You have to have a plan, it has to be a part of kind of your development plan as to what that looks like. Oftentimes companies have to not only do their clinical trial, but they have to have their companion diagnostic plan as well, right? And that has to go hand in hand and you have to be able to kind of develop that and have that ready for the various phases of your study. So that's, I think a piece of it. The good news is, and this kind of goes back to the data piece, there's a lot of companies out there in the next gen sequencing space, for instance, who have a lot of data, who are doing a lot of kind of broad panel screening of patients to start to give you an idea of a sponsor. If you're looking for a specific mutation, kind of what is the prevalence of that mutation and how realistic is it to kind of if this is going to be my clinical trial, to find those patients? I had an example when I was at one of the CROs that we were working with a company that had a pretty rare mutation that they were looking for. And if you looked at all of the data, the reality was they potentially were going to have to screen 5000 patients to find the 100 they might need for their clinical trial.
[00:22:22] Speaker B: Wow.
[00:22:23] Speaker C: Just because of how rare it was. And so then those are conversations about kind of what does that look like and is that the patient population? And if that is, then you start to need to partner with these next gen sequencing companies who can help you identify those patients. As soon as they become available, you have to partner with them. So I think it's really critical, it adds complexity, certainly from the sponsor side to kind of do this, but it also, if you get it right, you have the right kind of companion diagnostic or biomarker and you have that strategy. What it means from a clinical trial perspective is hopefully you don't have to have 400 patients in your clinical trial. If you can target and find the correct patients, then maybe you're talking about 80 to 100 patients to get the answer, which is hopefully quicker and kind of moves your process along a lot easier.
[00:23:13] Speaker D: Yeah, that makes sense. A follow on question or an observation that we are hearing often from sponsors is the notion that next gen sequencing is not an immediate thing patients are informed about when they're so, you know, there is a disparity, obviously. I mean, some of the larger NCCN centers probably, obviously have that as part of just the checklist when a patient is diagnosed. But in a lot of instances, apparently, and we've seen that as well, patients don't have access to next gen sequencing that influences how they think about targeted treatment. Unfortunately, making decisions to go on chemotherapy or standard of care which could exclude them from a promising clinical trial meant to target something that next gen sequencing could have.
Like, I wouldn't say it's endemic, but we've seen enough examples of that to affect patients.
[00:24:12] Speaker C: Yeah, I mean I think it just kind of goes to the system that we're in, especially in the US. Right, so I think you're to your point, the larger know, kind of broad panel next gen sequencing is fairly common for them because they have so many clinical trials. Right. So potentially they have they can make clinical decisions based on the outcome of this next gen sequencing. When you're talking to smaller community practices where it's not standard to kind of do this, partly it's not standard because it may not be covered by the patient's insurance. Right, so that's one and then number two is they don't know or they don't have any options of what to do with this information. So if they get a next gen sequencing report, they may not have a clinical trial at their site that can even change their treatment options. So I think we have to continue to educate, work the system. The next gen sequencing companies are doing a great job of kind of building that knowledge up and working with sites and getting more community based centers to kind of think about this and put that process in place. But it also, again, from a patient perspective, we have to do better at educating them in different ways and at the time points that they're open to it and not just kind of throwing this at them as one more thing that they have to kind of think about or understand. So, ideally, and I think it's going to take us probably five plus years maybe, to kind of get through this full process, where next gen sequencing will become more standard across the board. We'll have a better process for if a mutation is identified in a patient, to enroll that patient, or have them access to clinical trials, even if it's not at their site that they're at. I think there's a lot of stuff that's being put in place, we just don't have it working smoothly yet.
[00:26:02] Speaker B: Yeah.
[00:26:03] Speaker D: Especially I guess in oncology being a critical sort of enabler to promising treatment.
This next question is really more around protocol amendments and how, when obviously a protocol is designed, it assumes a certain patient population. But then as you go out and try and find the patients or try and recruit patients, you realize that maybe the real world looks a little bit different than what the protocol would suggest. Comorbidities, things like that.
Drawing on your experience from both the sponsor and the CRO perspective, how do you think about protocol amendment? Because the reality, one of the reasons is the reality is the US. Obviously now. Obesity is a comorbidity for a majority of the population, which sometimes could be an exclusionary factor based on the trial you're in. How do sponsors think about that?
[00:27:04] Speaker C: Yeah, it's a really good question. Again, to your point, I think we do our best to think about that upfront right and build the studies appropriately. Here's another place where I think data can help with that process. There's a number of organizations that kind of have access to a lot of patient data that you can look at your inclusion and exclusion criteria, and it can give you some sense of patient availability. And if there's any criteria that look like you're going to struggle to get patients because of whatever the parameters are that you've set out, So I think that that's a good place to start at the beginning and to think about that. But then I think realistically, you have to be prepared for protocol amendments, but you have to be open to hearing that information as well. Right, so it's not just put the protocol out at the sites and then sit back and wait for them to kind of find the patients and enroll them. It's that constant communication and that feedback you're getting from them. And then sometimes you have differing feedback you get from different sites and different data sources. So you have to be prepared to kind of figure out what that means. And what does your protocol amendment need to include to kind of keep things moving and make it easier and kind of getting those patients, in reality is I would say in general, you can expect a minimum of two protocol amendments along the way depending on how your protocol was started and how you get to that. And in some cases, it could be a lot more than that just because of all the factors that are coming into play.
[00:28:33] Speaker D: Brandon is back. I'm sure he has a bunch of questions lined up for you.
[00:28:37] Speaker B: Deb no, keep going. Keep going. I'll jump in after you're done this.
[00:28:42] Speaker C: Train of no, no.
[00:28:44] Speaker D: Yeah, we finished that, so feel free.
[00:28:46] Speaker B: Cool. Deb, one thing I wanted to touch on a little bit here is you've been really supportive of our platform and what we've been up to at Power, wondering if you can talk a little bit about what really caught your eye and what's gotten you so excited about the activity that we're up to.
[00:29:06] Speaker C: Yeah, absolutely. I mean, I think, again, from the conversations that we've had, I think engaging patients is the one area that we still need a lot of work and we need to put a lot of focus on, and I think we've been trying to do that as an industry sponsor, NCRO, but it's difficult. Again, it's like, how do you connect with those patients at the time that they're open to it? So I think from my perspective, what you guys have and your platform is just making that a little bit easier, right? You've got a lot of motivated patients out there who are looking for these clinical trials. I think that's the great thing, right? You've kind of passed that hurdle. You've got the patients who are looking for clinical trials and you need to remove those barriers as much as possible to help them find the trials that are a good fit for them, help them understand these trials and then connect them with where they might go to get access to these trials. We all know that clinicaltrials gov can be difficult for anyone to kind of navigate, even for those of us who've been in this industry for a long time. So I think for me that was the really great thing is to kind of see that ability to take those barriers away and really connect with the patients in a way that was going to be meaningful for them and kind of motivate them and empower them to kind of take this on themselves. I think there's a lot of organizations who are in this space trying to kind of do this. I think in various situations, each of them probably has a place and they have an ability to work. For me, again, in the small biotech space, the connection to patients, knowing our protocol, what we're looking for, the benefit that it could bring down the road for treatment options for patients and things like that, I think we have a story to tell and an ability to really hopefully connect with patients. And so for me, again, I just think the platform and how you guys have set it up was a really good fit for us. For me personally, as you know, this is kind of a passion project of mine and I'm really motivated and interested in kind of what can we do, not only for patients, but for caregivers. When a patient's diagnosed, it's not just them that's involved, right? There's a lot of people involved. Oftentimes it's family members, it's a parent diagnosed and it's the children.
You need a way to kind of have everyone be able to see the same thing and kind of a central way to look at it. And so that's another thing. I think your platform is great because it's an ability that people can kind of access it from wherever they're at and have communication around that versus I have a paper consent form and how do I share that with my family member who's on the other side of the country? So I think that that's another mechanism that just supporting that piece of it and getting access. I still think the one thing we need to do, though, is just educate in general clinical trials to get more people going to your platform because they've said, yes, I want a clinical trial and here's the place that I go for.
[00:32:04] Speaker B: Yeah, absolutely.
What else can we be doing to this point of caregivers and bringing caregivers into the journey. What else do you think a platform like ours could be doing in that journey?
[00:32:16] Speaker C: Yeah, I mean, again, I think there's so many people that are involved and you guys kind of already do some of this too, right? It's just, I think providing some of the details around the clinical trial, that's not just the inclusion exclusion criteria. Right. It's like what other potentially support is provided or what additional information, I think that's critical for everyone that's kind of involved in this decision making process. I think there's a lot of resources out there. I don't know how it would get incorporated kind of into your platform per se, but what can we do to almost make it a one stop shop or a place that patients and family members, caregivers who are looking for clinical trials can have that education and have those links to those resources? Because I think that's the other thing that caregivers run into is not only are they trying to help the patient through their disease and their journey, but there's a lot of other things going on that they also kind of get concerned with. Right. It's just the day to day living.
There's a lot of resources out there that I think patients don't even know how to find. If there was a way to connect them not only to clinical trials but other kind of resources that would help and support the whole process, I think that would be great. But that might go a little bit beyond where you guys are at right now.
[00:33:37] Speaker B: Well, we want to be the go to destination. We want to be the only destination people need in order to manage this journey that they're on. What are the other resources, in your mind are kind of relevant to maybe pull in here?
[00:33:50] Speaker C: Yeah, so I think there's a lot right. People have a lot of things that they're dealing with. So it's everything from kind of understanding how to work in the insurance environment right.
Overwhelming for people, and they don't even know what to do or how to do it or where to go. So I think financial aspects, both insurance, there's organizations out there that potentially provide financial support in key instances. There's a lot of foundations out there that can connect patients to get them reduced pricing on their medicine or things like that. So that's another piece of it to look at. I think cancer specifically, there's a lot of things to think about not only treatment decisions, but kind of when to stop treatment. So I think just the whole conversation around supportive care, palliative care, hospice, I mean, the whole timeline and what patients are facing, there's so many different things and I think that's where they get it in bits and pieces, but not necessarily when they need it. Right. I had a family member diagnosed not too long ago and they still got this giant binder from their oncology site with all this information. It's completely overwhelming. And how do you even find what you need when you need it? So I think we need to make that easier.
[00:35:12] Speaker B: Yeah.
Your kind of observation there around financial assistance is incredibly apt. We're actually working with a few patients right now. Where the question of insurance coverage at specific sites? Are there other organizations that we can appeal to to help get coverage?
These are all the questions that we're partnering with the patient on right now to try to help them through that journey. And it's really brought to light. How do we productize this almost and make it really easy for an individual or a family to understand what is the set of financial assistance that is available or relevant depending on your current insurance coverage?
[00:35:53] Speaker C: I have thoughts on that. We can talk about it.
[00:35:55] Speaker B: Please do. Yeah.
What's the high level hot take on it though?
[00:36:00] Speaker C: Well, no, I mean, I think there really is no place out there that has that right. I think patient advocacy organizations might have it for specific disease states. Right. And they've kind of done it well. I don't think there is a general place that has all of that information that's kind of combined in a user friendly format that's really coming from the perspective of patients caregivers rather than people in the industry. I just think it's a huge need.
[00:36:29] Speaker B: Yeah. You could imagine, right. Patient is looking at a clinical trial on power and in the back of their mind, they're asking themselves logistically, what's involved here? Okay, we've got a section around the logistics, the visits, the nature of it, how often, how long that kind of module around logistics. And then they're then wondering financially what's involved. And you can imagine kind of like a mortgage calculator, kind of right.
What insurance do you have? Okay, well, let's cross reference that against your nearest site and maybe some of the other sites that are participating. Is there travel assistance provided by this sponsor? If so, how will that get managed? And then finally, oh, maybe the insurance coverage or there's components of this protocol that aren't covered. Okay, here's how we support you with that and here are the other resources we integrate with to bring that to bear for you. That'd be a really interesting component to have in our platform.
[00:37:29] Speaker D: Yeah, I think the other point I would also add is especially for indications where clinical trial is that standard of care, because standard of care today is not effective. Right. Having the ability for patients to also talk about what their goals or objectives are with respect to joining a clinical trial. I know a lot of the large NCCN cancer centers are talking about that even in standard of care.
[00:37:57] Speaker B: Right.
[00:37:57] Speaker D: I mean, talking about palliative care right. Not bringing with it any of the baggage that's usually associated to say what are your objectives during treatment? Is it to make sure you are minimizing side effects, minimizing pain. Right. And helping bringing a care team along. I think some of that conversations would be well suited, especially for clinical trials where standard of care today is really nonexistent.
[00:38:23] Speaker C: Yeah, no, I totally agree and honestly, that conversation needs to be happening with every patient when they're diagnosed and they're meeting with their care team because sometimes there's a disconnect between what patients want and kind of where physicians know they're at or vice versa. But it absolutely becomes important when you're talking about clinical trials, because in some cases, and speaking from kind of personal experience and family experience, my mom was a part of a clinical trial towards the end of her disease. Knew that it wasn't going to change her outcome, but it actually was early on in next gen sequencing and she wanted to participate because potentially had an impact for our family, but also for the science. And so I think, again, that conversation that she had with her physician around participating was very different than if it was a conversation where she just was focused on kind of extending her life, where it was more of a treatment decision. But yeah, it's critical.
[00:39:21] Speaker B: Well, we've covered a lot of topics here, Deb. Is there anything we haven't covered that's relevant here?
[00:39:27] Speaker C: No, I mean, I think, you know, some notes and some thoughts around what I was hoping we would talk about. I think we covered most of them. Right. I mean, I think that the great thing is that there's a lot when we talk about oncology and development and kind of the landscape, there's a lot that's happening which is great. We're trying to look ahead and think towards the future. It's not going to be fast, unfortunately, to get to exactly where we want to go, but it doesn't mean that we should stop. And I think we just need to kind of look at every opportunity individually and make the best decisions and then also be ready to just kind of respond and change because that's currently the environment that we're in, I think.
[00:40:09] Speaker B: Yeah. So last two questions for you. First one is what should people be taking away about deca? This is an opportunity for brag about deca for a second. What should people be taking away in the really interesting work that you're doing?
[00:40:23] Speaker C: Mean, what drew me to deca and why like super excited to be here is know, we're a pretty small and new company, right, just started in the last four plus years or so, but based on a lot of science and a lot of knowledge that's already out there, right. So we're not starting from scratch, but we're really kind of taking a lot that's been known and understood and trying to apply it differently. So I think we have the ability to kind of create this platform that is taking cytokine therapy and really bringing it into next generation and doing things a little bit differently, that hopefully is more meaningful and helpful for patients. And on the same side of things, we're really focused on it from a precision medicine perspective. Right. Looking at that biomarker, what can we develop to give us a better sense of which patients we should be targeting, who are more likely to respond and things like that. So I think we have a great clinical program that we're working on with our study open and certainly thinking about the future and where that goes. But our focus is really around the patients and what can we do to support them. And hopefully that is kind of where our clinical program is targeting right now.
[00:41:32] Speaker B: Awesome. And last question for you is you mentioned there's a lot to do. It's not necessarily going to happen fast. If you could pick something to happen fast and change fast, what would that be?
[00:41:45] Speaker C: Honestly, what I would love to see is just kind of I think that general education around clinical trials to make them less scary for people so that they understand that it's a good thing and something that they should be asking questions about and looking for, obviously, that'll drive more people to power. But I think if we can kind of overcome that hurdle, I think it'll make just the whole process better. We'll have more patients looking for trials. We'll have more patients potentially eligible for clinical trials, which will help CROs and sponsors, but ultimately, I think it would help patients. So I think it's really around that education piece.
[00:42:20] Speaker B: Okay, I've got a follow up then. What is the predominant myth that needs to be busted?
[00:42:25] Speaker C: Oh, there's a lot of them. I mean, there are still people who say, I don't want to be a guinea pig, and again, we have to get them over that. We need to have them understand what that process is. And there's been a lot that's gone on with COVID and the vaccines and everything else. I think there's a lot of untruths and myths that are out there. I think putting clinical trials in perspective to people in an environment that they're open to know. We've kind of joked about getting on Good Morning America or whatever and kind of educating the general population around clinical trials in that environment where they're not necessarily sitting in a doctor's office, so they might be more open to it. I think that's kind of really what we need to be thinking about.
[00:43:12] Speaker B: Yeah.
What would you say to patients or people who say, I don't want to be a guinea pig?
It's coming from a valid yeah, it's.
[00:43:22] Speaker C: Their perspective, so it's valid. Right. I think it becomes a need to have a conversation, understanding kind of why they feel that way, like, what is their knowledge? So what's their current knowledge of clinical trials? I mean, in some cases, they've had someone who's gone through it who weren't maybe educated as well as they should have been and had that disconnect between what they thought the outcome might be versus what actually happened. In some cases they feel like they don't understand what happens in a clinical trial or even what they don't see the outcome because we don't always publish data like we should or communicate with patients who are participated, things like that. I think the key is just understand why they feel that way and to be able to have a conversation with them and hopefully kind of provide them some perspective about if it's an opportunity in the future to think about a clinical trial, maybe to have them ask more questions rather than just say no.
[00:44:16] Speaker B: Yeah, that's brilliant. At the end of the day, it needs to be a deeper dialogue, and the more we can do to educate and build context, the better.
[00:44:25] Speaker C: Agreed.
[00:44:25] Speaker B: Thank you again for another fun episode.
[00:44:28] Speaker C: Here and thanks for inviting me, guys. Really appreciate it.
[00:44:31] Speaker A: Thank you for tuning in. If you haven't already, please follow Power on LinkedIn, sign up for our live events and engage with us in the conversation we hope to have you join.
