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: Scott, thank you so much for taking the time to join me here. I'm really excited for this conversation. This is Power to the Patients, where we explore topics about clinical operations, clinical research, and specifically through the lens of patient centricity and what we can be doing as an industry to put patients in the center of our decision making and the way we design research. So really appreciate you again coming on to have this conversation, maybe actually just for folks who are following along who haven't had the chance to meet with you. I know that you've met many folks in the industry, but maybe give us a quick sketch of your career and how you got to where you are today. I think that's probably a helpful place to start.
[00:01:08] Speaker C: That sounds great. Well, thanks, Brandon. Thanks for having me on. This is a topic that is not just near and dear to my heart, but something that really gets me out of bed in the morning that I love to sort of focus on. And yeah, after you've been around for a while, after you have a little bit of gray hair going on, you have naturally meet a few people in our space, but I look forward to meeting more and making more connections. So, yeah. My name is Scott Schleibner. I've spent the clinical development space for almost 30 years focusing on patient engagement, patient focused approaches, how to make clinical trials more accessible and less burdensome for patients and families. I wear a few different hats. I serve as strategic advisor for several different tech and patient recruitment startup firms in the clinical development space. And then I have my own little consulting firm called Rare Clinical and love patient focused approaches. I think we have some great progress that we're making in our industry. But as you know, Brandon, there is a long, long way to go, so there's so much more we can do.
[00:02:08] Speaker B: Sure, yeah. And actually, I saw the update on LinkedIn recently about rare clinical Maybe just talk a little bit about that and what's next for thanks.
[00:02:17] Speaker C: Yeah, I've been working in the kind of clinical development CRO space for quite a while. I recently wrapped up an engagement and was looking to see what was going to be next for me and had a few sort of projects keep coming my way in the rare disease space. Some of them involve how do we bring trials to families homes via both technology and home health care nursing. Some of that involves how do we even upfront, make sure these clinical protocols that we work with before they're finalized, how do we pressure, test them a little bit to make sure that they're not created kind of almost artificially in a bubble and to where they are not realistic for the participants we rely upon. So I try to get involved with things like that as well. But, yeah, advisory consulting firm working in the rare disease space, I think that rare clinical development brings with it many kind of unique challenges inherent to the space. It's an area where there's not nearly enough treatments for patients, and so it's an area that I kind of feel dedicated and passionate about. So looking forward to trying to help both patient organizations as well as our biopharma sponsors, execute studies better in the rare space.
[00:03:32] Speaker B: Sure. And maybe this is a good jumping off point for the topic of patient centricity. As you think about the rare space and as you look back on your career, I'm kind of curious. Take us on a journey of patient centricity in clinical research. Where was it 30 years ago when you were just getting started in research? And how have you seen that idea evolve over the last 30 years?
[00:03:55] Speaker C: Yeah, well, yeah, it's been a journey. I mean, I'm pleased with progress.
Jeez, I don't know. 30 years ago, I don't think we were even really talking about it at all. I feel like we started to get traction on this topic maybe a decade ago. I mean, certainly there were some patient advocates working in the industry. There were patient organizations advocating for patients and the patient voice, patient knows their disease the best. Let's hear from the patients. But it took a little while, I think, for our risk averse pharma partners to be open to ideas, to be open to, say, a non scientist or a non physician could actually come to the table with actually some helpful information. Right. We've seen, of course, fast forward now we have the FDA, and we have other regulatory agencies that are fully on board encouraging patient driven research, encouraging the patient voice. A decade ago, we used to do novel things like, let's run this protocol by a patient or a patient group or a panel, and let's just see what they know. And I remember early days of working in Duchenne Muscular Dystrophy, for example, and you had this interesting scenario where you had the regulators, like an FDA, for example, wanted a certain endpoint. And then you had a drug developer like a Serepta or someone else working in that space thought, well, that endpoint may or may not be realistic. Right. We can't wait, say, four years to see an endpoint. We need something that's actionable. And then you had patients saying, you guys are both asking to measure something that's actually not even really relevant to my day to day. It doesn't make a difference to me. What would make a difference to me is if I could walk across the kitchen or if I could reach up to a cupboard or if I was able to support my child. Right.
So I think bringing those three threads together regulators, drug developers and patientsfamily caregivers, I group them together, try to bring that together so that we're finding endpoints, but also clinical trials and assessments that really address all the important stakeholders. Right. So patients have often historically been left out. The irony, of course, is we don't create new medicines, and drug development does not move forward unless patients really participate. So we often have not considered our end users, really, until it's a little too late. So I think that's been a really fantastic development of saying, okay, let's listen to the patient voice, let's incorporate patients into the development process, and let's think a little bit more about our end user, the way a lot of other industries might think about your customer or who you're ultimately serving. So kind of like I said at the kickoff, great progress, but so much more to do, right?
[00:06:48] Speaker B: Sure. Yeah. And that story about the endpoints really resonates here. If we were to back up, or if you were to back up and give the industry, broadly, a score, a letter grade, as if we were back in school again, like, on this idea of patient centricity, where do you think we are today?
[00:07:07] Speaker C: Well, I'm a tough grader. Brandon, I love, you know, I really love our space. I love our industry. For those of you who are listening and work in the clinical research space, I personally love what we're very art. We still remain highly archaic. Right. Like, Brandon, you've created an incredible company, Power, to help address problems. There are problems and things that could be better everywhere we look, every corner of our clinical drug development process. So I think we can continue to do better. I used the risk averse term earlier. I think that holds us back. I think what we're seeing right now is when COVID hit, we were forced to adopt and try new things. Right. Necessity literally being the mother of invention. Around COVID, we moved forward with things like decentralized clinical trials and new models and paradigms. And now that we're kind of through that and we've experimented with a new paradigm, it feels like the pendulum is shifting backward to maybe that was just an experiment, maybe we don't see the ROI. Let's go back to the way we worked before. So I'm going to give our industry a grade based on some progress.
[00:08:20] Speaker B: Sure.
[00:08:21] Speaker C: But I think we need to be a little bit more consistent and pushing it. So I'm going to give us a solid C like we're passing, but I think we're not really cutting it as far as I'm concerned.
[00:08:34] Speaker B: Yeah. We're not getting into Harvard with these grades. Yeah, we're not. Okay, so you are a tough grader.
What does it look like to be a B student in Scott's World? Yeah.
[00:08:47] Speaker C: So what does that look like? I think that looks know this concept of patient centricity.
I know we have a couple listeners out there who hear the term patient centricity and they shudder, and they really think that term is even inappropriate. Right. Not sure what the right term is. Patient focused? Or do we just drop the word patient? Right. We're really talking about people. We're talking about people like ourselves. I think we're thinking about patients more. I think we're starting to recognize that they bring some value, but I still think that they're off to the side. Right. We're having a discussion on power to the patients, and we don't actually have a patient here with us. Right. If you're having a clinical development meeting with your translational scientists and your medical affairs group and you're trying to lock down a protocol, do you have a patient sitting there at the table with you making sure their input is heard or a panel of patients to make sure you're hearing a variety of diversity of things? So I think we've taken some steps. But you also have people out there that look at maybe patient engagement efforts or let's say patient services or patient concierge things around how to make things easier for patients. You have people really questioning, I think, still the ROI on some of those efforts. Is it just a soft, fuzzy, nice thing to do, or does this make a difference? We still hear stories of patients participating in clinical trials. Their data is critical to the trial and moving clinical development forward. But then they never hear how the trial went. Right.
They were part of it. They helped make it happen. And we don't quite even circle back to communicate the results. We're making progress in that area too, but there's a long ways to go. So I think going from C to B, I think we've got to be a little more thorough and inclusive with patients, broadly speaking, up front in the development phase and then thinking through some of the technology, some of the data collection, some of the assessments we're looking for in protocols. Right. They're getting more and more complicated each year. Those data points are really nice, but that has an impact on a burden score of how much we ask of patients. So I think truly patient centric protocols probably are a little easier to participate in and probably demand a little less, and that would get the grade up into the B range.
[00:11:14] Speaker B: Got you. So in your mind, there's really an element of protocol design here, and how do we reduce the burden for patients as we think about it and bringing those patients to the table? One thing that you said that at the very beginning, I want to pull on this thread a little bit is the term patient centricity might make some folks shudder. Talk to me about that.
[00:11:31] Speaker C: Yeah, I mean, if you spend time with patients and families or advocates who try to represent their constituents. We're really trying to shift a little bit of a mindset here around thinking about patients as a key stakeholder as part of the process. Patient centricity has gotten a little traction as a term for what we're doing. Sometimes it almost feels like that's just checking a box. I think we're seeing that a little bit on the diversity representation side of things as well right now. Like, are we really doing things to be appropriate with patients or to be representative or are we just running that by someone and they sort of cursory check a box and say, yeah, we're thinking about it? So I think the patient centricity term, I'd be curious what you hear. Not that there's one appropriate term or one accurate label, but I feel like sometimes we talk about patients, quote, unquote, as this, I don't know, usual group of people, right. Subjects that study the reality.
Patients are you and I, right? Patients are people. Patients have jobs, they have families, they have children, they're about to get married, they're about to go on a honeymoon. They have lives. And so transitioning from patients to just really just trying to move towards people, right, move towards people and almost think about the patients we serve as really our ultimate customers, I think would be a way of progressing that. But when you talk to people, Brandon, and you're interacting with sponsors and patients and know, what do you hear in terms of a term that people feel like is appropriate or really represents what we're trying to do?
[00:13:16] Speaker B: Well, I can start with what I think is inappropriate, which is subject and subjects and even participants feels rather transactional as well. Right. I think there's a movement to try to humanize things a little bit. I've heard some folks quote the idea of calling individuals study partners. I think that that maybe abstracts a little too much the role of the individual and who they are in the journey of this research. Yeah, it's certainly a fine needle to thread.
I can speak, I think, in terms of our ethos at power a little bit, which is that in our mind, we've really started with patients as the primary customer of our platform. Right. In our minds. If we build something that's incredible for patients, we build the best product for patients to learn about clinical research as an option and we become the go to destination for those patients. Because we've built that trust and we're building a product that they want to use and truly helps them in their journey, then we can have impact across the research landscape. And for our sites and sponsors as secondary and tertiary customers or users of our platform. But in our mind, it all starts with building a platform for the patients. Hence the kind of ethos around the branding, the messaging and the focus that we talk about here.
[00:14:40] Speaker C: That's great because I realize patients are often not technically your client in this scenario. Right. Work is being done for a biopharma client. How do you balance I mean, something I find is interesting is we end up in this patient recruitment, really sort of bottleneck of a world, right. Where the majority of trials are now behind schedule. Each year we put out more clinical studies that require more patients. And we're noticing that these studies become more and more complex I. E. More hard, challenging, and burdensome for patients. We have people out there, I think, that are really doing the right thing in terms of thinking about long term patient engagement, building relationships, building trust, educating, learning, two way street. And then we also have a lot of scenarios that I'm sure you get your phone rings and it's like, hey, Brandon, we need 30 bodies for a trial. Right. How do you balance this need of creating authentic long term relationships, two way streets, with this more transactional need that comes up, I'm sure around that's great. We just need to recruit patients tomorrow. Can we just get people? How does that enter into the power world?
[00:15:54] Speaker B: Yeah, it's a really great question. And the way that we approach it is from an ecosystem design standpoint. So if you think of our platform as kind of this Airbnb like platform where people get on board and can kind of meet with each other and connect with each other on the platform, we need to design it in a way that serves each person on the platform in the way that they need to be served. Right. So we have one half of the platform and probably the majority of what people can see of our platform, which is the patient facing platform. That's the view that patients can see. We make that for patients designed for patients, much in the same way that Airbnb you go on today. And what you see is the view for travelers. It's all the inventory, it's all the houses, all the photos. Right. Then there's a completely different side of the platform which we never see as travelers, which is, what do hosts get? How do hosts think about upkeeping their homes and making sure that cleaning is taken care of and logistics and all this kind of good stuff? Right. How do they make sure that they can maximize the utilization of their homes? We have a separate side of the platform, which is a different product entirely, really, that's designed for the researcher experience. And how do we help researchers be more efficient in connecting with interested patients and bringing them in to educate them about the study and potentially become participants? So the way that we think about it is it's not one product for everyone. The product actually has multiple surface areas that help individuals with different needs and different objectives accomplish them.
[00:17:27] Speaker C: Nice. I love that. That's great. And it's great that you can balance both of those because the reality is that we may want to create good long term relationships that are mutually beneficial for everyone. And then there is a little bit of a transactional piece here as well. So, yeah. Well, congrats on all the amazing progress you've made.
[00:17:46] Speaker B: I will say, at the end of the day, I believe that there is a component. There is an element from the patient's perspective of wanting to transact as well. I'll reiterate, I think that there is an element from the patient's perspective of wanting to transact as well. They come onto our platform to try to learn about trials, and when we look at our analytics, they're clicking the buttons to try to connect with the researchers. They're trying to transact with those researchers and learn more about the studies. So there's an element where both parties are actually trying to transact today, and it's been far too hard for a long time. And that's the role that we really want to play. There are individuals that want to meet with each other, have a conversation, share information in two directions, and we want to make that way easier.
[00:18:28] Speaker C: Nice. That's awesome. Taking the airbnb analogy that you have, right? And the hosts and the travelers, I think is really helpful for us to think about a lot of folks who haven't seen your technology and your platform. It's a very simplistic way to sort of, at least for me, to think about it.
Do you see that extending into analogous ways wherein the hosts clinical trials, the sponsors, are also rated based on quality of service, quality of stay? What was communication like? Did we enjoy participating in that Pfizer study? Do you see a world like that where there's a little bit more of a two way dynamic with feedback and such?
[00:19:10] Speaker B: That's really interesting. And there's a lot of nuance, I think, in the way that would have to happen right in this space. Very different than travel, where you can post a review and post a five star rating and publish that for everybody to see and for that to be okay. I think that a little bit of the FDA and IRB kind of guidelines around marketing kind of come into play here in nuanced ways that you don't see in other spaces. I'd be curious to hear, this is an interesting idea, where's it coming from? What would you like to see in the world?
[00:19:40] Speaker C: Yeah, well, I just feel like taking that putting power to the patients, right? Like putting information in their hands so they have a sense of what's this experience going to be like for me. Can I read about fellow consumer who just participated in this and it was harder than they expected, or more invasive or more burdensome or the overall experience was great. I was communicated with. I knew what to expect. Or is it more like, wow, the consent form was 24 pages, and I'm very confused and I didn't realize I had to drive to the site weekly for 48 weeks or while they stayed in touch with us afterwards and updated us on the results. You could see a spectrum of experiences that could I'm wondering if there's a way to do that without going down the nuanced path of marketing and IRBs and regulations. But just as someone who participated, not talking about the science or know, would I recommend the Amazon app to someone after using it?
[00:20:44] Speaker B: Right.
[00:20:44] Speaker C: Would I give this a four star rating for just my experience in it? And I just wonder if that could almost maybe encourage because you'd be talking about I guess you'd probably be talking about the interplay of a sponsor I picked on Pfizer. A sponsor, perhaps a CRO, perhaps a clinical site, and your investigator might actually be more of your relevant touch point. But together, would that encourage more focus on the participant experience? If it was transparent, I guess sure.
[00:21:15] Speaker B: It'S a great idea. And how do you tease apart some of these things? Right. To your point, some of the experience is very site specific. Some of the experience is based on the protocol. Right. Like how burdensome was this protocol? How many times do I have to drive into the site in order to participate in this? Right. I think that how you tease apart some of these elements is a really interesting question and these are certainly questions that patients have on the top of their minds. Right. One of the things we want to do with the platform is exactly this, which is more transparently, sharing with patients what the expectations of them will be in participation. Right. The timeline and logistics for the study look like this. You visit once a week for the first month, then once a month for six months. And by the way, travel and lodging, there's a nearby hotel that's kind of covered and we take care of all that for you. Right. Even just like some of that up from communication is really hard to understand today and bring more transparency to that I think will do a tremendous amount. Yeah, absolutely. Things that we're trying to explore in ways that we communicate with patients.
[00:22:13] Speaker C: I think there's some ways that you could do that that could be really streamlined.
Thank you for participating in the study. Would you like to hear more about it as we conclude the research? Would you like to take five minutes to participate on a survey for a $50 gift card and ask something around? A couple of questions around your clinical site interaction, if they've had any. Some people have never interacted with a sponsor or know really who's behind there, but maybe a way to tease apart mean, I mentioned this, I actually had to go to the airport at like two in the morning last night and maybe just think about these Delta airline automatic responses. How likely are you to do this again? How would you rate the cabin staff, how would you rate the gate staff? Tease that apart a little bit. Hopefully, sponsors would be open to that and they could learn a little bit and know how to improve and how to be a little better at that.
[00:23:05] Speaker B: I love this idea of building a learning machine, right? Like, not only are we a platform for patients in the moment as they're trying to figure out what studies make sense and how to participate in studies, but there's also this learning feedback loop we could provide back to sites and to sponsors around, hey, this patient gave you this feedback about this protocol. This was too burdensome. And over time, having that as a part of the patient voice, patient engagement, whatever term you want to throw on it could be a powerful mechanism to support new ideas or change in the way that some of these studies are designed. That's really interesting.
[00:23:39] Speaker C: Somebody out there might be listening to us saying, I'm doing that already. And if you are, fantastic.
[00:23:43] Speaker B: Hands up in the chat if you're doing it already, please, we'd love to talk to you next.
[00:23:47] Speaker C: For sure. Yeah. Well, again, how did you go from a C to a B grade in class? How do you go from a B to an A? Maybe is let's understand how that experience really was. Not just like, we got our data in, we closed our clinical trial, we're filing it, but what about those people that really were altruistic? Because you do have a fair amount of I do a lot in the rare disease space. And for the far, far majority of rare patients, there are no approved treatments, right? There are no options. If there is standard of care, it's generally pretty poor. So people's only hope, really is that clinical trial that they see coming out next year. They've been waiting for it. Their whole family is focused on it. It's a huge deal we do still have for the non rare.
There's still a little bit of a mindset out there. I'd be curious if you see this at all. Where I hear this still, I feel like I heard this a lot more ten years ago. But this idea of the field of dreams, if you build it, they will come. Like, we're going to put this clinical trial out there. Patients should be lucky enough to enroll. This treatment is amazing. We don't have to think about making it less burdensome. We're going to put it out in the world and they will come flocking. And I think what we're learning is by the 65% of trials that are behind schedule is people have other things going on. People can't drive long distances. That's a huge commitment. So how much of that do you hear? Sort of, I guess it's a spectrum of let's cater to patients versus who cares, we're just going to put it out there. They'll come because they're desperate and have nothing else. It's kind of harsh, but I wonder how much of that you hear out there.
[00:25:29] Speaker B: I think I'm hearing less of that. I think I'm hearing a little bit more upfront consideration and thought around, well, how do we engage patients? How do we at least communicate that this study is available to patients? It's top of mind, at least. And maybe I've got a little bit of kind of like sampling bias here, because the partners we work with tend to be the ones who care a lot about this. That's why they're engaged with a platform like ours. So potentially some sampling bias there. But I'm certainly hearing a lot of this is a spectrum from small biotechs over to top 20 pharma, where we're hearing people who are actively interested in understanding how do they get the message out of their study opportunities, because everybody can see that research is more competitive.
There are options now, plenty of options now for a lot of these patients. So the more question we're hearing is, how do we get in front of patients and properly communicate the merits of this study so they can consider it as one of the key questions?
Go back I want to go all the way back to the beginning of the conversation. You said something that I took a note on that I wanted to ask about, which was, we're in this transition away from this. There used to be this idea that a non scientist, a non physician could navigate the space, and we're transitioning more to self advocacy, encouraging patient driven research, the patient voice. Could you talk to me about what you're seeing there in terms of encouraging and maybe the necessity around advocating for yourself as a patient? Sure.
[00:26:58] Speaker C: I think there's been great strides with people, patients, subjects, participants, whichever unpleasant term we want to use.
[00:27:06] Speaker B: Right.
[00:27:06] Speaker C: Becoming empowered, having some knowledge at their fingertips, seeing that. There's some good examples, I think, of people who've really stepped up and led in a leadership way of representing patients as advocates. And there's some individuals out there. There's a lot of really sort of powerful, knowledgeable, helpful, passionate patient advocates that may have a disease themselves, may take care of a child who has a disease, may take care of a parent who's older. They could be a caregiver parent, patient, what have you. They've learned so much about managing their disease day to day, right around, knowing what to expect around especially, and again, especially in the rare disease space. I think you learn a little bit more. And it's a little bit of our innovation lab of trying to push some things forward in drug development, because physicians often don't see these cases very often. And that whole phrase of the symbol of rare the zebra came about because the medical school training was, if you hear hoof beats, don't overthink it. It's probably a horse. Right. And we as kind of rare disease advocates say, well, don't. Forget about 10% of the time. It's actually a rare disease. Don't overlook that. And maybe you only see that ten times out of 100 over the course of the year. So patients, as a result, have shown up and say, listen, I know that you think you might know what this is, but I've got to tell you, we've learned a lot about our condition, our disease, what's happening, and there's been a lot of it's really helped with that diagnostic journey that we see where it takes patients so long to even figure out what they have so that they can then find support and treatment. I just kudos to the patient advocates out there, who some in our industry still might be skeptical of. But they bring so much to the table around expertise, and especially as we move towards real world evidence being such a bigger part of the drug development and drug approval and post approval process, studying things as they occur outside of a controlled clinical trial. I think that's where advocates can even add a lot more value right around. This is what it's like for us. This is what our quality of life is like. This is the difference it made for us. Maybe not in an objective endpoint, but as a person who's sort of struggling with something. Here's what this therapy did for me. So awesome progress there. There's a lot of good patient organizations, of course, that are disease specific, and there's a couple kind of pan disease groups. But yeah, if you're developing a drug out there and you haven't pulled in some advocates to provide a great perspective, I feel like that's a blind spot. And I feel like I would encourage you to really bring them to the table and help them guide you a little bit yeah.
[00:30:04] Speaker B: And maybe talk a little bit more about engaging with patient advocates versus directly with patients themselves, the advocacy groups versus the patients themselves, and the trade offs of engaging with either.
[00:30:17] Speaker C: Yeah. And, you know, in pharma, we've learned really like, patient privacy and data and keep everything at arm's length. And I think those regulations and compliance and stuff is in place for really good reasons. But I think if you're able to find some people who can kind of, for better lack of a better term, represent or speak for patients or really understand that community let's say we're talking about one of the subtypes of cystic fibrosis. There are some nuances there around patients and what they're dealing with that you wouldn't even really consider sometimes, and especially if you're coming at it from more of a scientific drug development point, you would never really think, oh, we can't have these two CF patients in the same room together.
No, you can't. But you need to think about some of the details like that. And there's a lot of examples across disease areas where the advocates themselves, who represent patients, can really shed light on the reality of that situation, whether it can be something around mobility, it could be something around in a lot of cases, it could be around diets that we never really consider. And so I think you can go down this path by keeping some boundaries appropriately between yourself and patients. But speaking with advocates and representatives who can really talk about that day to day experience, they should be part of your advisory board and your think tank, right. If you have a physician and a scientist and an operations person, and that's a valuable perspective, I think.
I think that's, again, rewinding ten years ago, I felt like we talked about that a little bit, but now I think that's becoming much more commonplace. And so I applaud the companies out there that have advocacy departments, not just a singular person, but actually people with legs and arms that can actually implement some projects. And we have chief Patient Officer Summits now, and it's great. So that's great progress. So there if I'd give the industry a C, there's some parts, there's some classes where I think we've done better, and maybe we deserve, like, a B or a B plus maybe in an area like that.
[00:32:33] Speaker B: I love this theme of this letter grade.
We could have a whole running series around Scott's Scorecard, and we could score very specific things.
I think that'd be a lot of fun.
[00:32:46] Speaker C: I think A, for some of you out there who have heard of the group, uplifting Athletes is a really great rare disease patient organization I support, and we give out research grants to young investigators pursuing interesting treatments for rare diseases. We've established a scientific advisory board, and we have a good rigor about our process. And every year we go through this grant review process, and we all come together with how we scored grants. And I am by far the toughest one of the group. I don't know why I don't need to be that hard. So maybe I have to think about that, Brandon. Maybe I have to raise up my grades a little.
[00:33:20] Speaker B: No, grade inflation is a problem.
I think actually holding a high bar is important because it helps everybody aspire to more.
[00:33:30] Speaker C: Right.
[00:33:30] Speaker B: And I think that we should all understand that there's more that we can do. So keep holding a high bar, please. All right, so I can't let you go without asking about CROs. So you spent a lot of your career at CROs. What is the CRO's role here in terms of patient centricity? What should CROs be doing differently?
[00:33:50] Speaker C: Yeah, really great question. I think this patient centricity, in a lot of ways has been a little bit ancillary to the core business of a clinical research organization, and it's probably been a small, little component. And again, these are mostly, for the most part, we're talking about for profit organizations that are looking to do good work but run and design clinical trials and bring in some revenue and make a profit. And that's great. Some of the parts that as we've moved towards a little bit more of a patient focused mindset in drug development, you've seen some different CROs start to incorporate roles like this. I previously built out a team of patient advocacy liaisons that allowed us to say, like, let's say you're a biotech company in New Jersey and you have a person who represents patient advocacy in your organization, but it's only one person. They can be a good voice and advocate internally, but if you actually want to implement a program, they need help, right? So we developed some roles where we could support sponsors with being their legs in arms of interacting with advocacy groups, understanding how to engage them, understanding how to create really long term relationships, not just writing a check to support their conference once a year, but how do we learn from them? What are they looking for? What can we bring to them and create a good relationship that's collaborative? Not all advocacy groups, of course, are the same. There's a really dramatic spectrum from a mom and pop. 30 people in the world have a disease. They're having a bake sale. They're trying to raise money to try to get something studied. On the other hand, you have the Cystic Fibrosis Foundation, which has well over a billion dollars in the bank and funds research, et cetera. So understanding where an advocacy group is really on the spectrum of maybe how mature they are, or do they have their own registries in place? Do they have fundraising? Are they identifying treatments? Are they connected with researchers? You can support biopharma in that way by helping understand the landscape of the advocacy groups you might need to go to. If you're an international global study, you may need to find an advocacy group in each of the countries that you're going in, right? So there's a lot to be done in that area. But we've made good progress with understanding how to kind of connect. And I think for the most part, people have good intentions around wanting to create good relationships with groups like that. I still don't think it's really the core business of a CRO, but I think you're seeing more and more of them kind of delve into it. Maybe their clients demand it, or maybe they see that as a differentiator maybe there's something substantive they can bring to the table to complement maybe therapeutic expertise. They can bring patient relationships. But as sometimes the hub of a clinical trial, I find that the CROs, they touch the clinical sites, they touch the sponsor, they touch a lot of the other providers and technology. I've always felt that the CRO space is really the perfect area to push innovation, right, and be the ones of, like, here's how we should do it. Here's a new way of doing this better, and then trying to bring everyone on board. So there's been some steps. Obviously, the theme is we've made some progress, but there's more we can do, I think.
Yeah.
[00:37:27] Speaker B: The title of the episode, Scott's Scorecard, we've made some progress, but more work to do. More work to do. Yeah. Love that. Well, hey, we're brushing up against the end of our time together. I want to ask you maybe a closing question, which is the magic wand question. Internally, we call it that. If you had a magic wand and you could change anything about the way that we plan, conduct, look at research today, what would that be and why?
[00:37:50] Speaker C: Well, even though we're talking about patient focused approaches, how do we engage with patients, how do we include them? I think still, to me, I'm bothered by some of the timelines that things take too long, some of the administrative burden. You see, you want to open a clinical trial. It takes so long to get contracts, budgets, and IRB approval in place. If I could waive my magic wand, I would waive it, and I would say, I know every institution wants their own ethics committee to look at something. I would standardize and unify everything. So we had one ethics board, we had one contract template, and we had one budget template, and there was some sort of feedback mechanism up front to where that kind of somehow worked for everyone. And we could just execute all that electronically in one day and actually initiate a site the next day and enroll a patient in 48 hours. That's what I would do. I'd wave my wand, and I would cut through the red, tape, all the paperwork, hustle that along. Yeah, I'm sure that's super realistic in our litigious society here, but that's what I think we need to do. I think you could cut off, like, six months of every single trial and get a therapy in front of a patient and in their hands dramatically faster.
I don't know. What about you? Do you have a magic wand there with you that you have something in mind?
[00:39:14] Speaker B: Oh, boy. Without revealing, I think, a little bit too much of where we want to go.
[00:39:18] Speaker C: Fair enough.
[00:39:19] Speaker B: As a group here, I do think that this idea of having actually, I'll build on the theme that you just spoke about. I think that if we can get to standardized systems and processes that are replicable across this crazy stakeholder map of research, things can move a lot faster. Right. I hold that thesis as well, but I don't want to talk a little bit. I don't want to talk too much about how we're going to get there, because that's in the crosshairs for sure.
[00:39:46] Speaker C: Yeah, it's okay. That's a vague waving of a magic wand. Standardization. Right?
[00:39:51] Speaker B: It's a vague wand, but it's magic. That's right.
[00:39:54] Speaker C: Well, I love you guys doing it.
These next developments hold for you. Thank you for all you're doing at Power. I look forward to kind of hearing what some of these next kind of developments are. And just thanks for thinking about patience.
[00:40:10] Speaker B: Yeah, of course, Scott. And thank you for taking the time. I thought this was a really interesting conversation, so thank you for coming on and exploring these topics with me.
[00:40:19] Speaker C: Super fun, but I really enjoyed it.
[00:40:22] 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.
[00:40:31] Speaker B: We hope to have you join us.
