In this episode, our Trial By Fire duo interviews Scott Schliebner. Scott is a clinical drug development executive with over 25 years of experience across the CRO, biotech, and non-profit sectors. They cover the gap between drug development and patient needs and the unique challenges that the industry faces.
Transcript
Aaron
Today we're welcoming to the show Scott Schliebner, whom I've known and learned a lot from over the past five, six years that I've been at Clara and working in this space. Scott is quite accomplished, quite qualified. Most recently he, well, currently he's senior vice president of scientific affairs and therapeutic expertise, at Icon. And formerly, and back when I knew him, he was leading the Center for Rare Disease at PRA Health Sciences. I, one of the great outfits in this industry. So Scott, welcome to the show and thanks so much for being here.
Scott
Thanks, guys. Thanks for having me. Thanks for the invitation, looking forward to it.
Aaron
Yeah, so yeah, so Scott and, I mean, we go way back and you have been in this industry. How long have you been working in this clinical trial space?
Scott
Well, you can tell by my gray hair, it's been 25 plus years. I've been in clinical research and yeah, it's been fascinating to see changes and evolution recently, right? Silver linings of a pandemic yet at the same time, we haven't changed a lot in many decades. So, it's been an interesting perspective to have for sure.
Aaron
Yeah, absolutely. And that's kind of what I want to get into. So, especially back in, well, especially back at the Center for Rare Disease at PRA, you guys were doing a ton of publishing of materials and initiatives and guidelines around how better, well, how much more patient-centric, clinical trials could be and then providing the frameworks and, workflows that folks could use to make their trials a little more patient-centric. so I know that all of you at the old Center for Rare Disease have had a lot of thinking around this stuff. And a lot of, a lot of, work done in this space. And I'm wondering, you know, maybe rewinding just a year and a half, two years, when the pandemic really started disrupting everything that we work on and the way we work on things, what did you notice becoming more quickly adapted to the new world? And did you notice that they were becoming adapted in sort of a patient-centered way at all? Or were they just sort of being adapted to get adapted such that, you know, the trials could move on and sponsors could keep the train rolling and relatively on schedule kind of a long-winded question?
Scott
No, I follow completely. Well, I think it's, it's, it has been a fascinating, whatever we're at here, 18 months, 19 months, something like that. And again, going back to like being in the space for 25 plus years, like very little evolution, very little change, very little movement, really for decade after decade, right? Like we design and conduct clinical trials, you know, as of like, let's say as of February, March 2020, you know, the same way we did in like 1960, right? Really no evolution. Sure. We introduced the electronic data capture and that, like, threw everyone for a loop. And then maybe we introduced electronic signatures. I'm like, oh, big innovation, still this sort of archaic, slow-moving process. And then the pandemic hit and hospitals shut down. patients didn't want to physically go to a clinical site or couldn't, staff weren't there yet.
How do we keep these clinical trials moving forward? How do we continue to develop drugs and make sure that patients get access to these new therapies? Because as you guys know, standard of care in many areas is nonexistent at, you know, or at best sub-par. So clinical trials are not just a drug development exercise. They are healthcare as well for many patients, they are the only option to treat their disease.
So, it becomes not just a nice to have let's keep clinical development going. It becomes a, how do we get treatments in the hands of patients? So it was really challenging as somebody who it's your point, like the publishing and stuff we do, and that we continue to do, truly been from a point of like passion and like commitments and evangelizing really, I think is really probably the proper term to think about patients. Please think about what they're already struggling with. Think about your clinical trial and does it work for them and is it feasible? And so we've been talking about this for many years, right? And talking about, you know, decentralized models and patient-focused approaches and, you know, to answer your question really, you know, what's that been like? Well, up until February, March, the response was well, that's a nice idea. That's interesting. That's great. After you've done that for 20 times, give us a call back and then we'll evaluate and see if like our risk-averse style can tolerate this new approach. So that was the approach all on that was the conversation. And then the pandemic hit and you get to the summer and sites are closed. And then the phone started ringing off the hook proverbial phone of like, ''Hey, we need that approach been talking about, we really need to sort of think differently and we need to go forward in a different way.'' So pretty challenging for patients yet the long-term here I think is really positive. And that those changes that have been forced upon an industry that might be slow to adapt. There really has been a little bit of a silver, silver lining there.
Aaron
Right. Well, you know, you, you mentioned a couple of things that really strike a chord with me, the evangelizing piece, first of all, evangelizing or also known as a screaming into the void sometimes. but it's nice to know that it's being a little more heard. and before we started recording, we were talking about how there's this giant gap between the cool science that's happening. And then the people on the other side who need to access the science and then the long road between the two communications and that communication. I think it's pretty evident to the world at large now that there was always an issue between the really, really genius work that's being done. And then how it gets translated down to the folks who actually need the stuff to get to them. And then the, the other thing that you mentioned, a phone ringing off the hook and COVID disrupting things.
I, there's a story that just came to mind. We were helping a partner develop a virtualized retention system, because they were noticing, especially when the pandemic hit that their retention within their trial was starting to plummet quite a bit. And the drop-off rates were already pretty bad for a large 500 person study. And we were talking to them and developing like, okay, here's how the tool could work. And here's our system and here's the platform and here's our support team. And then we began to realize that there were some really fundamental things going wrong. So this study was for older folks, and required a lot of insight visits. They hadn't amended their protocol to eliminate any of what seemed like extraneous visits from the protocol. So patients still have to go in and they were struggling to get through IRB, the care packages that they wanted to have at the study sites that the patients were going to.
So there was something like 25 sites and what they wanted were little bags that were branded and had hand sanitizer in them, a nice set of masks and, like, PPE stuff. And they couldn't get it through IRB. So it had been months of them trying to get it through IRB. And on the other side of it, like, compliance, telling them, no, no, you can't have it be a branded bag because what if patients pose with it and put it on [inaudible]? So I do want to get you to talk a little bit about what you've seen, where there is that weird detachment between okay, what are some cool tools that we could use to layer on top of this stuff to make better? And then all this underlying fundamental logistical regulatory stuff that ends up creating a really risk-averse environment?
Scott
Yeah, well, I mean, you're highlighting really the interesting challenges our industry face. Clinical drug development. There have been all these amazing scientific advances, right. Our understanding of biology genomes, incredible. Some of the advanced therapeutics we have, like cellular therapy and gene therapies and ways of delivering drugs and targeted, mechanisms of action, things like that. Awesome! At the same time, we're still operating in the dark ages, right? So we have all these tools and technology that we've been slow to adopt. And we've been slow to say we've been slow to sort of use as an excuse, honestly, I think. Like we're, we're regulated or change is hard for us or moving a big, turning a big, as they say, turning a battleship takes a long time. These large pharma companies, it's difficult for them to like process a new way of operating or doing something different.
So there has been, I think, a disconnect, you see other industries, you know, leaping forward with technology and adopting customer-centric approaches. And then we still struggle with, really, it takes months to get a hand sanitizer approved by an IRB? Or a new, different kind of contract or a way of operating that's just difficult. So really interesting space to, like, have incredible advances. Yet we almost seem to have been held like kind of holding ourselves back a little bit, like not leveraging the technology that's there. I mean, you guys probably bank and shop and maybe you even date online, you do everything, we do everything online, but that has been so kept at bay from this world of clinical development. Like, we really need to, and I think some of it might come from a let's protect patients, let's make sure we're proceeding in a regulated, structured way. But at the same time, it's left us a little bit behind the times, to say the least.
Aaron
Yeah. And so there's that stuff with, the reluctance to, to absorb any of these new changes in the landscape, all the new tools. And then there is, the, it almost, I'm gonna, I'm gonna say, I'm going to give you a hot take and then I'm going to ask for a response. So my hot take is that the whole idea of patient centricity and regulatory concerns and patient safety and all the rest of it acts more or less like a fig leaf for the industry. And they, I think folks just don't want to introduce any level of change and they want to operate as they did in 1960. So they'll point to things like, oh right, patient-centricity and safety. I can't do that because of X, Y, and zed. And I'm wondering if that hot take is way too hot, I guess. And, if you've seen anything that seems to denote that institutional reluctance is at all getting resolved or easier to, you know, graduate past.
Scott
Well, I hear you. And I think that there is an element of it that, you know, we are, you know, there are some excuses and some barriers out there. I also know from a pharma perspective, you mentioned compliance earlier, you know, around sort of providing these care packages. There are some legit, real compliance rules that need to be adhered to. And a lot of us, in the space we're operating in may not really be aware of them. So I do feel some empathy for our clients and partners in drug development, who they're, they are walking a little bit of a tightrope between what's allowed and what they can do and what their corporate, you know, governments or legal teams will allow them to do and what the regulations say. So there is a little bit of that, but at the same time, there's some other things that I think we can be doing that might just be a change in workflow, right.
Or might just be a way of, instead of designing studies with this attitude of, you know, patients are desperate, we have this great drug. If you build it, they will come sort of mentality, right. Changing that to being thinking about some, like patients as the consumers, patients, as our customers, think about them like an Amazon or an Applewood, right, where you're designing everything around what your ultimate stakeholders want. That's the part that, like, there's not regulations around that. That's just being smart about thinking about your end-user and getting their input before you do something. So this idea of designing clinical trials that are not realistic, or that include all these, extemporaneous assessments that are hugely burdensome, right? Like that's a nice to have if you're sitting in a conference room in New Jersey and you're saying we want all these measurements and time points and all of our different clinicians and translational scientists, it's their dream of, I want this data point. Well, these are human beings like you and I, we have jobs, we have children, we have obligations. We can't just drop everything to travel to and from a clinical site weekly for 52 weeks. Right. So, I hear you, Aaron. And I think there's, is there an excuse to use? I think that there's a little bit of both. I think certainly there's restrictions and regulations that have to be adhered to, but within that there's room to be better, there's room to be more patient vocal, for sure.
Aaron
Very diplomatic. Yeah. Yeah. Scott’s hot take, and that's going to be the sound blurb and that's going to be the clickbait for this episode. Zooming out of the pandemic thing and actually kind of a dual timeline sort of, or two points in the timeline. So you're 20 plus years in the industry. And then this very strange two years that felt like 20 years of COVID life. Can you point to a time within the scope of your professional career thus far, where you have noticed, were there any points, I guess, where you've noticed a quantum leap or even just a leap forward in the way things were done? not necessarily with anything to do with technology maybe, but, maybe even in just the process of how clinical trials were designed or developed or anything along those lines, within the past 20 years, and then maybe the big, the biggest, or most common leaps that you saw over the last year and a half, two years.
Scott
Sure. Well, honestly, yeah. I mean, I've been in this space for like, like, like many of us, like over 25 years and I've, haven't seen really any quantum leaps, I think back to around like maybe 20 years ago, maybe 21, 22 years ago, we did move from like paper-based case report forms, right, to electronic data capture EDC systems. Right. We went from old school paper to moving it online, which required sites to have an internet connection at their site, which I know seems ridiculous right now. But back then it was like bandwidth and everything was such an issue. that was that at the time, that was a pretty small step, I felt like, to make forms go from paper to online. But at the time that was really hard for the industry to absorb and digest people. I mean, people were like, that's not gonna work. You can't have different software systems working at different sites and different platforms and how are people going to get trained? And what if, you know, sponsor A wants to use this tool. And you know, like, wow, it shouldn't be that hard people. This is a pretty, this should be a small step. And that's the only thing I can really think back to over the last like 20 years, that was actually, it moved things in a good direction. The needle definitely moved a little bit. Cause you could like monitor remotely and you could see data remotely. You didn't have to go to the site, but to make a relatively small change, took took a while, right? And so, it was almost like everyone took a deep breath. It was like, okay, that's all we can handle for a while. Just slow down there. And then we get to the pandemic and, you know, to your point now you're sort of seeing, you know, invention, you know, being, the you know, the mother of necessity kind of phrase, however, that's going. I'm saying that wrong right now.
But, now the change is happening. Now we've been forced to sort of adopt new approaches, which, you know, you know, we'll talk about this. I know, but to me it's not all, it's not just technology. It's not like let's convert to electronic or let's use mobile health platforms. I think tech helps us a lot, but it's just, for me, it's a little bit more of even just that mindset shift of, think about your end stakeholders first. Think about what you're asking patients to do, think about what they can realistically tolerate. And let's infuse that mindset and sprinkle in some technology and come out of it with a better, a better model.
Brittany
That was a question that I had for you, Scott. It seems like with this pandemic, technology's starting to catch up, in the clinical trial space, but not necessarily the patient centricity. Would you say that's an accurate, like kind of conception or an accurate picture? And do you see, because we're picking up the technological side kind of, like you said, that they're a little bit more open to changing the way that they've traditionally done things and getting more of the patient voice involved in the beginning of the process.
Scott
Yeah. It's, I mean, we're making progress for sure. around thinking about patients and patient-focused approaches and moving, I feel like we've been again, back to evangelizing. I feel like we've been evangelizing this for probably almost a decade now. I think people are getting it more. I think people see the value more. I think we're getting better at, you know, you still have people out there that might say to themselves. Well, yeah, that makes sense to include the patients in the process, but our return on investment, like, you may have people from a purely financial side looking at it saying that takes time. To your point earlier, Aaron, it costs a lot of money to amend a protocol and all of the things that changes in the timelines and the delays. there's an extreme hesitancy to do that, right? You have to like, it has to be a disaster if you're really going to change that protocol.
So, I think that, you know, we're seeing progress around involving patients more, but we also need to be moving that further upstream right before those studies are finalized before those are, before you have a clinical protocol that signed off on, we know that once that's finalized changes to that are really hard to make. So if we want to like impart perspective from patients or ensure that our sponsors are thinking about that patient perspective, a patient-centric approach, we've got to push that conversation way before that protocol’s final to try to, you know, infuse that early. And so we can get that input in a way that doesn't disrupt their work or slow things down. And so, trying to make it realistic for our partners.
Aaron
Absolutely. That makes sense. yeah. Yeah. And you know, I was reading a piece of research from- what is it? you, you can probably correct me on the name, so I'll give it a try. I think it's like the Initiative to Transform Clinical Trials. It's out of, Duke maybe, or maybe it's the other one in Chapel Hill, North Carolina, somewhere in North Carolina. and they were measuring the impact of early engagement with patients in designing your protocols, such that you avoid, let's say two amendments to your protocol. And they were basically saying, look, if you just spent the time and effort up front, you could basically generate like 200, 500 times ROI just by avoiding some of these disastrous consequences that would, yield, or yield a situation in which you had to amend your protocol significantly. yeah. And it does seem like it's still a hard conversation to have, maybe because there's still a relative lack of research around it. I don't know. Have you seen any cool new research around this idea?
Scott
But yeah, that's a really, I think, I think I know what you're referring to, not positive. I think it's like, there's like the Clinical Trial Transformation Initiative.
Aaron
Yes, CTTI.
Scott
One of the really good articles out there. If you really want to nerd out and read about this, that really gets down to the ROI of patient-centric approaches. Right? And so if you, if you take a step back and you think about this process, if you can make studies more patient-friendly and I say patient-friendly in a really generic way, right? That could be thinking about the design. That could be thinking incorporating telehealth. That could be being more sophisticated with pushing out electronic, patient recorded outcome measures. It could be home health care nursing direct to patient drug shipment, whatever it is, whatever you want to call it patient-friendly. If you make it patient-friendly, you number one, you have eligibility criteria that are more realistic, right? So a clinical protocol goes out there. We, again, back in a conference room in New Jersey, we write down all these criterion that we want, that we want patients to fulfill.
So a really nice controlled set of patients. Well, if you take those eligibility criteria and you actually overlay them over, say like an electronic medical record system, let's say Aaron, you're in San Francisco. Let's say you go to UCSF and you overlay that on the EMR. Like, sometimes there are no patients, literally zero patients that meet all those criteria. So we're artificially looking for a set of patients that don't really exist, Number one. So what happens with that? Well, guess what that study is not really enrolling very well. We're delayed, like 55% of all clinical trials now are, delayed due to enrollment. So that's one simple thing is just run your eligibility criteria by a patient panel or by a patient advocacy group to just make sure, you know, are you asking something of patients that doesn't really, you know, it doesn't even reflect reality? so you can automatically really just handle and improve your enrollment of a study.
But then, you know, moving further downward, if you take that approach where you're thinking about patients and you think about all these schedules of assessments and things we're asking of them. retention rates in study are a huge thing, right? Patients drop out because I sign up for a clinical trial. Maybe it looks good initially, or maybe they didn't really fully understand it initially, because to your point, we're not so hot at communicating some of the details, or we might be overwhelming them with this study and 15-page consent form. But let's say a patient enrolls. So they meet the eligibility criteria. They're in the study now they're realizing, wow, I have to, it's like 52 weeks of driving. It's two hours each way and I have to park and I have to wait in line. And wow, that's like, quite a hassle to say the least.
So patients drop out, right? So we, you know, if you can, so between the enrollment and just retention alone, you can dramatically affect the timelines. And we know if we can shorten timelines, we save money and things move along a lot faster. It impacts, it lowers the overall cost of drug development, which of course lowers the cost of goods and drugs later on when they're marketed. so we've got this bottleneck in this archaic way of operating where most studies are behind. Most studies don't really speak to patients or reflect what they can handle. And so we're slow and expensive. The lovely picture I’m painting, isn't it?
So this is like historically kind of what we've done. And I think people are seeing, like, the implications of this now. We now have metrics that say studies are behind and we're, we're asking for patients, don't meet the criteria or patients who are dropping out. So we have to change, right? We have to evolve more and COVID forced us to do things to get through COVID. we're not through it, but we are implementing these changes to sort of duct tape a solution on to kind of get us by. But that short-term duct tape rig job is really the way we go forward in a way that can solve these problems. Right? So that we're, these patient-centric approaches that some people were forced to adopt really should be the way we are doing it going forward.
And so I think we've got a new paradigm in front of us that's evolving. I think this, you know, 2021 being the year of the decentralized trial, I know that's our catchy moniker and our new sort of hot topic right now, but that's really the new model that goes forward. Maybe that evolves further. Maybe we call it something different. That's really, that's really the combination of, think about patients bring a study to them in whatever manner we have. leverage that technology. So while that is a little bit of a jaded history and the place we've been in, like, I'm actually super hopeful. Like we are moving in the right direction now. So, just get vaccinated, people.
Aaron
My God. Yeah, that'd be nice. I, yeah, so the history itself, I mean, obviously you look back in history about any topic I guess, and long enough, and something's going to be very disturbing to modernize. I'm sure we're going to look like barbarians to the folks coming down a hundred years from today. and I'm kind of curious about this concept. So you brought up this idea of duct-taped, kind of Jerry-rigged solutions that are kind of floating by and we're okay. And it's good enough and whatever. And hopefully, you know, with vaccinations and all the rest of it, we get to a point where COVID’s managed and things are relatively operationally normal across every sector, every facet of life, more or less. And I guess there's something I've been curious about that I haven't been able to put into words until just now when you set the words, duct tape, which is, there's this weird, we're almost like the, the fish that has just crawled out of the ooze and we're sort of half evolved into whatever we're going to be on land.
but we're not yet adapted for the new environment. And I'm wondering if you have any sense or any predictions about what the next generation of trials that are not formed and are not formed by the events of COVID while it was like trying to operate, but designed in the shadow of COVID. I'm wondering if you have any thoughts about what sort of lessons will be retained by the institutional memory of this industry. what sort of things might get really quickly expunged and what you hope I guess, would stay retained within our collective memory.
Scott
Yeah. Well, those are big questions.
Aaron
And a lot of mixed metaphors.
Scott
yeah, no, I am thinking, well that, and so I guess to clarify a couple of things, I mean, first you had a lot of studies. So when I say duct tape, I really, I want to make sure I don't, I don't overly minimize some of the really sophisticated solutions that we have out there. Right. if you had a traditional old-school site-based study, right? Pandemic hits, oh no. What do we do? We can't go to the site. So we have done some duct-taping on and patching on of solutions to kind of get through and make these studies work. but you know, you, you also have the ability to, if you're starting from fresh today, designing that next study that hasn't happened, maybe it's in the COVID, maybe it's in the shadow of COVID or maybe it's just, you've seen that this is a smarter way of going irrespective of COVID.
We have really good sophisticated solutions now. And so if our fish is, you know, coming up on land and growing legs, or what have you, I think there will be a constant evolution, right? Hopefully, there is a continued Darwinian process that keeps happening where right now we have mobile health platforms and telehealth and mobile, you know, home health care nurses, and those kinds of things come together as a pretty cohesive solution, right? In 2021. But I think that'll just continue to evolve. I mean, especially when you have really savvy, sophisticated technology companies watching us from the sidelines, a lot of them, Aaron, down the street from you in the bay area going like, wow, we could do that so much better, or, well, there's so much value to be created here, or we should just jump in and fix it. Right? So, I think it's, you know, this is maybe where I'm, and I don't know if I'm just an eternal optimist, but while it has been archaic and we are crawling out of the water and it's moving in a really good direction, I think that'll just keep evolving and becoming more sophisticated around both integrating different sources of technology.
And, we're still really clunky around how we, you know, do we go to a clinical hospital, to, talk to a physician to be an investigator to find those patients? Or are there better ways to just connect directly with people wherever they live, right? Are there tools via social media or big data that can allow patients to just know what's out there? Right. I think that we will connect people better wherever they're, you know, Brittany's in rural Oregon, like you shouldn't have to go to New York or San Francisco to be in a clinical trial or to access the latest therapy. And, you know, not only should you not, but like, we're also trying to grapple with this idea of most clinical studies, enroll, people that look like me, a middle-aged white guys, right? So as we want to make sure that we do good science and we want to make sure that we have really good, fair equity and access for everyone, we need to go where people are.
And that doesn't mean just UCSF Medical Center. That means a minute clinic attached to a Walmart in the middle of Oregon, or a CVS walk-in pharmacy to get our study drug in the middle of Nebraska. No offense, Nebraska. But I think if we can move to where people are, not only are we making studies more accessible, but we're actually accessing real representative people, right? And not just going to the subset where people, oh, we only get, we only get a fraction of the population. So I don't know if that makes sense, but I feel like, you know, if we've got a leg growing off of our fish or two legs or wherever we're at Aaron, you know, it's going to move forward with moral limbs and get a little better in, in I think in those kinds of ways.
Aaron
And I appreciate you continuing to use this very tortured metaphor that I've introduced to the conversation. It's very generous of you. (Laughter)
Scott
it's probably a reptile, not a fish. I'm not sure, but I think it's, but I do truly feel like, you know, back to jaded conversation, good progress being made, you know, you have stuff out there like hashtag never go back, you know, movements and around, please continue the progress. Don't just revert back when we get COVID cases down to a reasonable level, like, keep going forward because we're on got some pretty good traction going.
Aaron
Yeah. And I did want to kind of transition to that sort of question, next, which is, all of us are in the industry in some capacity, Brittany is doing a lot of great work with our breakthrough crew and engaging directly with advocates. You know, I'm on whatever it is that I do. And you're doing great work Scott, obviously for 25 plus years. And the question is how can we, as members of this industry and community push to keep this momentum from stopping?
Scott
Well, that's an important question. I think we all have to be asking, everybody we talk to, I don't know if I have the best answers really. I think that, I think that we have to recognize that we've been doing, you know, the way we've been operating has been a disservice to patients. So I think if we're really in it for good reasons, you know, I'm in it, quote-unquote to, make sure patients can access therapies and treatments that they need. And to make sure that we can develop new treatments in a timely manner, right? There's people out there that don't have time to wait and clinical trials are often their only hope. And, we need to move faster and cut through the red tape and be better about what we do. So that drives me. And I think, I think that there's a lot of commonality with, people who join our industry, whether you work in a pharma biotech setting, whether you work in a CRO, whether you work for a technology company, I think if you're gravitate to this area could be rare diseases. It could not be. But if you truly want to, you know, do right and do right by patients, then I think a lot of us recognize, like. we could be doing much better. And maybe we don't have all the answers, but I think part of this is this kind of archaic competitive environment we're in. I think one thing that would help would be if we collaborated a little better. And by that, I mean, sure, hold onto your intellectual property and hold on to your competitive advantage. And maybe don't share all the secrets and data you have, but still, I feel like we, we build a lot of things over and over that that we could do better by like creating like a model or a template, or, you know, you mentioned, Aaron, earlier, going back to the IRB example with the care packages, right? IRBs and ethics committees, super critical for protecting patients and ensuring patients will be safe and that they're not taken advantage of.
And I'm not saying we need to minimize that, but do we need every institution to have their own IRB? Do we need to have the same protocol reviewed over and over and over and take 4, 6, 9 months at an institution? That's time that patients don't have. I feel like there is a work process there that doesn't have to be hugely technological. It just needs to be getting over some of the legal hurdles and institutional barriers. I mean, that's one thing, if you could create one online central protocol review tool system committee and say, we're looking out for patients, we're not minimizing that when you have to get over the legalities and the liabilities that each institution feels like they need their own lawyers to look at it and that kind of thing. But that alone would save months and months at every clinical site for every single study, that would be a game-changer. That would be one small collaboration.
Maybe it's not small, it's one tangible thing that I think we could hopefully overcome in my lifetime. You know? So I don't have great answers for your big question, but like, you know, whether it's, you know, individual disease groups building their own registries or pharma companies developing their own natural history studies or patient registries to sort of fuel their development pipelines or whether it's even individual advocacy groups, all sort of, developing their own groups. I feel like there's a lot of things being built and a little bit of redundancy. And we could, I think, be more efficient that way if we work together a little better and maybe it's not human nature necessarily to, you know, not build your own thing. And let's just collaborate. I know I realize there's barriers to all of that, but I guess that's one sort of thing that strikes me is, can we collaborate a little better?
Aaron
Yeah. It brings me, it brings to mind the software example of, there's a ton of open-source software. There always has been. But there was a period of time when the industry like the tech industry was super locked down and there were tons of gatekeepers with all the capital, all the engineering power, and their incentives like a Microsoft, an Apple, their incentives weren't to push open-source software forward. Their incentives were to kind of cloud all to themselves and try to charge for, and now what we see is like Microsoft, which used to be at this, I'm sorry, this is such an esoteric example, Microsoft, which used to be the big behemoth in the industry realized it had fallen behind, embraced open source software and then became whatever it is today, which is a thriving yet again, by embracing this collaborative nature that, I like for every side of, ourselves that have this desire to be super territorial, it does also seem like there is a counterbalance in all of us that says, no, we should try to work together because it's just faster and easier and I'm less stressed out this way.
Scott
(Laughter) Yeah, I, so, thanks. I mean, I feel like, you know, in our, we talked about this like the Center for Rare Diseases. I have this incredible, amazing, inspiring team I work with. And, as we started, you know, having all these conversations with sponsors about these studies. Brittany, I mentioned earlier that if we could move the conversation further upstream so that we could, you know, influence or try to support protocols and clinical studies being more patient-centric earlier, where, where it didn't require a lengthy or costly, like, amendment process, we felt like that was an area to, like, make some progress. So we, we developed this, you know, free open-source, patient-centric, drug development toolkit is what we developed, right? That has like four tools in it. and I, and I mention this, not as a plug for it specifically, it's free, it's available to anybody who wants to use it. I think whether you're a pharma sponsor organization, if you're a clinical research organization that competes with Icon, if you're a patient group, there's a tool in here for you to use so that we can get any clinical study to be more patient-focused than it is. Right. And so we developed this to be open source and to be collaborative. So even if you have your heart and mind in the right place, and you really want to be more patient-centric, you may either to your point earlier, Brittany, you may not, be sure that it has like a return on investment. Like the CTTI article that Aaron mentioned, or you may not even know just how do we even do that. Right. So we created these tools to put them in the hands of drug developers and patients to try to get a little better dialogue going essentially.
So, you know, put a tool in the hand of a drug developer before you finalize that protocol and say, pressure test this thing first. Like, look at what you're asking and just get a sense of how burdensome this would be for a patient. And the patient really, of course, is usually a family, right? There could be a caregiver or a parent or a child or a care circle of sorts involved. So, how burdensome is this? And, you know, give people the ability to kind of use some like levers to push and pull. What if we tweaked this? What if we eliminated this visit? What if we made this one remote? How would that change the burden? Right? So if you can lower the burden, you increase access, you increase enrollment, you decrease dropout rates, things move along faster, right? So, we put those two out there.
There's also some components specifically for patients as well. So if you're a patient thinking about enrolling in a trial, and we know we don't communicate really well with patients. A lot of patients don't even know what is really an option. You know, what can I ask of a drug developer? Is telehealth a choice? What if I want the nurse to come to my house to train me in administering this subcutaneous injection? Is that even something I can ask, right? So it's a guide for patients to say, hey, here's some things you can use and leverage in your conversation with either your physician investigator or by extension a biotech pharma company, to help them make a trial more friendly for you or to know what kind of is even on the table. So we put this out there to try to help that process. And again, to try to, you know, move it a little further upstream, hopefully.
Brittany
A lot of the patients that I speak with they're so overwhelmed with even finding a trial that when they get to, you know, actually speak with a study coordinator and get into some of the nitty-gritty details, they have no idea what's available to them. They don't even know what they're allowed to ask or kind of give themselves agency to do so. So I think it's really great that you have that tool out there and that'll be super empowering for them.
Scott
Yeah, we hope so. Aaron, you were going to say something. I'll be quiet for a moment.
Aaron
(Laughter) No, I feel like I'm just jumping at every possible moment. I know we've taken up a ton of your time, Scott, and I think we can start wrapping up. I do have a couple, I mean, I have an infinite number of questions, but, I do kind of want to know one thing, which is, you've been in this industry for 25 plus years, like you said, and like we've mentioned, and I don't mean to try to make you sound, sound or feel old. You have great facial hair to show for it. and I'm wondering, you know, the PR, especially the PRA stuff that was published over the course of, I really started noticing last year that the publishing pace seemed to go up. that's driven by some level of passion that's beyond a paycheck, beyond the bottom line, beyond ROI.
And I think all of us working in this industry have had a moment of sort of lack of better word, a radicalization where you've noticed something, and then you can't stop noticing how unfair or not equitable some structure is. And I guess I'd be curious to know if you had a moment like that early in your career that spurred you on, to, to make this your life's work. And then now, what keeps you, because that can only burn so long. So now I'm guessing eternal optimist and all that stuff, that you're probably motivated by maybe a little less anger and more hope and desire to see things change in your lifetime. And I guess now, how that's changed from radicalization into the motivation that keeps you going every single day, because it can be quite frustrating at times to work on this stuff.
Scott
Yeah. Well, it's another big question with a couple of parts to it. some of the frustrations we had and that I had would be this idea, again, of having conversations with, hey, can we, the, study's not very patient-friendly, et cetera, et cetera. oh, it's two [inaudible]. Or, oh, thanks, but, you know, we're good. We have the way we work. Running into a lot of resistance and while the space that we operate in as this healthcare intelligence partner, clinical research organization, we see a lot of different studies. We see it, we work with a lot of different sponsors, a lot of different partners, a lot of different sites, and patients. It's a really awesome place to be in if you want to influence change. But at the same time, you know, not everybody wants to hear it or not everybody's ready to hear it. or they need to hear it 15 times to finally be like, oh, I'll, I'll listen to that now, or I'll consider it. Right. I feel like what drives me is knowing that you just have to sort of gently and positively, you know, hit people over the head with that message again and again. And, you know, to maybe say it in a different way, or maybe say it in a proactive way or, or a, or a helpful way. But, to me, it, you know, the passion, like, I guess it just, it really just comes back to patients. I mean, literally, like, it comes back to, we all have family members or friends that have had some terrible condition or disease with no real good treatment options. And for me working in the rare disease space as you guys know, so few disease states have anything approved, like less than 5% of the 7,000 plus diseases actually have an approved medication.
And for the rest of them, there's very few clinical trials for patients. And that's the only thing. So when you talk to families, when you talk to patients or rare moms who are fighting for their kids, the only options they have are these new therapies that are coming along in clinical trials. And it sucks to be able to say, well, we have to wait nine months for the IRB to approve it. Or I'm sorry, but it's only open at Stanford. Or I'm sorry, but your child is not eligible because they exceeded the age limit by six days. You know, those are just ridiculous barriers. I don't mean to pick on the IRBs again. But just as an example, those are the things that I look around, I say, we could be doing better and families need it and families can't wait. And so, you know, I think we show up with our A-game every day because you're right. Not, you know, we don't get paid more to do that, but it's like, it's the right thing to do and you want to help. And that's why we're in this industry. And, you know, I think together, if enough of us have that right mentality, we can, we can make a difference and kind of move things in the right direction. So, I don't know that wasn't a canned or planned response, but, for me, yeah, patients don't have time to wait. That was probably the main reason.
Aaron
No, I think that's a, that's a beautiful place to kind of end it. and I think it's a hell of a punchline that patients really don't have time to wait. Well, thanks so much for your time, Scott. I really appreciate it. I, I'm, I mean, we both really appreciate it and I hope that it's not too long before we’re in some horrible convention center, eating a soggy, a wrap that's been left out for about an hour too long.
Scott
Yeah. I hope so too. It's been fun. But, you know, we've covered reptilian evolution through IRBs and technology and patient-centric approaches. That's been fun to talk with you, thanks for all the awesome questions and all that you guys do. it's fun to be in this area and I, again, from a place of optimism and hope, I think we're going in a great direction, which just kind of fuels me more to continue to want to evangelize some of these kinds of thoughts and processes really for the, hopefully for the benefit of everybody. So thank you guys for having me.
Aaron
Yeah. Amen. Scott, thank you so much.
Brittany
Thanks, Scott. Take care.
Scott
You too. Take care, guys. Have a great rest of your day.
Aaron
You too.