AI & Technology · Episode
Scott Schliebner — DCTs, Patient-Centric Trials & 30 Years of Pharma Innovation
In this episode of Pharma Prescribed, host Adam Walker sits down with Scott Schliebner, a veteran biopharma executive and the founder of Ascent Biostrategies, to explore the human and technological evolution of drug development. With a career spanning three decades, Schliebner provides a rare, longitudinal perspective on how the industry moves—or refuses to move—with the times. From the early days of transitioning paper records to electronic data capture (EDC) to the sudden rise and subsequent cooling of decentralized clinical trials (DCTs), this conversation bypasses the hype to examine why innovation often hits a wall in healthcare. The discussion delves into the "why" behind Schliebner’s move from academia to industry, driven by a desire for research to have a tangible impact on human lives. Listeners will gain an inside look at the complexities of implementing new tech at clinical sites, the fatigue felt by investigators facing a "mushrooming" of software platforms, and the critical need to balance remote technology with the human element of clinical care. Whether you are a biotech founder navigating the current investment landscape or a professional interested in the history of clinical operations, this episode offers grounded, raw insights into the realities of modern pharma innovation.
Chapters
Approximate · derived from transcript
- 0:00Podcast Premise
- 1:41Guest Introduction: Scott Schliebner
- 3:23Scott\'s Career Journey
- 5:04From Academia to Pharma
- 6:46Name and Roots
- 8:27The Evolution of Clinical Trials
- 10:09Paper to EDC Shift
- 11:50Decentralized Trials Boom
- 13:32Completely
- 15:13
- 16:55Tech Fatigue and Real Innovation
- 18:36Putting Patients First
- 20:18Enrollment Delays in Clinical Studies
- 22:00Patients Shape Endpoints
- 23:41The Importance of Patient Involvement
- 25:23Creating Patient Advisory Groups
- 27:04From Oncology to Rare Disease
- 28:46Building Patient Advisory Boards
- 30:27Developing Patient-Centric Tools
- 32:09Trial Burden Assessment Tool
- 33:50Mentorship and Career Beginnings
- 35:32That happens all the time and. The example of your rockstar lecturer is really pertinent as well, because
- 37:13Paying It Forward in Downturns
- 38:55Quick Fire Reflections
- 40:36Advice for the Next Generation
- 42:18not so rapid fire. I\'ll try to keep that moving quicker. What
- 44:00Connect and Closing Thanks
Key insights
Change in Pharma is Inherently Slow
The industry’s transition from paper-based CRFs to EDC systems was a decade-long struggle marked by skepticism and technical hurdles like site bandwidth, proving that even essential innovations face significant resistance.
The Stalled Momentum of Decentralized Trials
While COVID-19 forced the rapid adoption of decentralized clinical trials (DCTs), the industry has largely reverted to traditional models, potentially losing the patient-centric gains made during the pandemic.
Technology as a Burden, Not a Solution
DCT technologies often failed because they were marketed as add-on products rather than integrated solutions, increasing financial costs for sponsors and technical burdens for clinical sites.
The Nuance of Patient-Centric Care
For many patients, a clinical trial is a vital care option; while remote visits offer convenience, many value the direct human connection and high-level attention provided by on-site medical staff.
Full transcript
Edited for readability. Speaker labels preserved. Click to collapse.Click to expand.
Full transcript
Edited for readability. Speaker labels preserved. Click to collapse.Click to expand.
Podcast Premise
Adam Walker:I am Adam Walker, a biometrics consultant, and this is the Pharma Prescribed Podcast where leaders, innovators, and hidden voices in healthcare open up, no sound bites, no spin, just raw insight, one prescription at a time. In an industry driven by data protocols and pressure, we rarely pause to ask the human questions.
Adam Walker:What drives us, what breaks us, and what truths live behind the titles we wear?
Guest Introduction: Scott Schliebner
Adam Walker:Scott Schliebner is a seasoned biopharma executive with nearly 30 years of experience spanning biotech, CROs and nonprofit life science organizations. He currently serves as CEO and founder of Ascent Biostrategies and previously has worked at Novatech and various other companies.
Adam Walker:Where he is guided development, regulatory planning, and guidance for emerging therapeutics. Throughout his career, Scott has built and led high impact teams across drug development, commercial strategy, and patient-centric innovation. His leadership includes senior roles such as chief commercial Officer for early stage biopharma service organizations, and senior vice president at TFS Health Sciences, where he oversaw clinical development services.
Adam Walker:And contributed to corporate strategy and acquisition due diligence. Scott is widely recognized as a patient advocate and strategic thinker who helps biotech companies accelerate their pipelines and design development programs that meaningfully incorporate patient needs.
Scott\'s Career Journey
Adam Walker:So Scott, for those of our audience who are not familiar with you, who are you and what is the mission you are on?
Scott Schliebner:Oh, thanks for the lovely introduction. I think your podcast and the focus of it is very generous of you.
Scott Schliebner:To get at some stories behind people on the human side of things. Thank you for doing that in general, and thanks for having me. Yeah, the why part of things.
From Academia to Pharma
Scott Schliebner:I guess I found myself back in the day and, in undergraduate college and in graduate school, getting involved in research.
Scott Schliebner:Pretty early on in my educational background, I had the opportunity to work in some labs and published a lot of papers and book chapters. A strangely young age, I remember. And I was on this interesting path and there came a 0.1 day I remember, where I was asked to write this federal grant justifying why this particular research was just so important.
Scott Schliebner:And I remember literally, there may have been a pen in hand back in the day we\'d be typing it now, of course, but I was like, I couldn\'t really convince myself that it was that important. I was supposed to justify this in an application and I\'m thinking. Yeah, there\'s some scientific questions here, but there\'s only a handful of academicians that really care about that.
Scott Schliebner:This doesn\'t really matter that much. And it was a little bit of a pivotal point for me where I was research oriented. I was analytical. I had a path ahead of me, but I realized. It wasn\'t gonna be personally gratifying, and I didn\'t feel like it was making a difference and I didn\'t feel like it was necessarily helping everyone.
Scott Schliebner:Through a couple intermediary steps, I found my way into. Pharmaco epidemiology and clinical trials and ended up finding out my way into our industry as I pivoted, and it immediately was an excellent fit. And here I am with gray hair and 30 years later and it\'s been amazing to be in the sector.
Adam Walker:That\'s brilliant to hear. And it\'s a delight to welcome you on the podcast as much as. Understand a little bit more about the person behind the name. It\'s a formidable name.
Name and Roots
Adam Walker:You have that it, before we hit record we happen to mention about your name is there a little bit of a story to your surname, just out of interest?
Scott Schliebner:You do a great job pronouncing it. It gives everyone a hard time, at least in the United States, on this continent in North America. It\'s always a. Scott and I rai, I raised my hand. I\'m like, yep, that, that\'s me over here. Probably my, German and Dutch colleagues have no problem whatsoever figuring it out.
Scott Schliebner:There\'s a lot of consonants there together that seem to cause like paralysis with people as they start down the path. So I\'m not that interesting in terms of background. I am a. White guy from the us. My great-grandfather immigrated from Germany. He was actually like a professional baseball player and moved to Ohio of all places.
Scott Schliebner:There\'s a little bit of Dutch, there\'s a little bit of English Scottish in there, so I\'m a, as we would say, I\'m a little bit of a mutt, but, 23 and me tells me I\'m like 80% Northwestern European and a little bit around like Rotterdam, Frankfurt areas. So it\'s Schliebner, I\'m German, call me whatever you like.
Scott Schliebner:I\'m not too caught up in that. But it is a challenge. I did have to, a side note. When my son was born, he\'s 18 now. I was like, we have to come up with the simplest first name possible, right? If Schleman is what you have to work with, we are either going with Max or Sam. And so we ended up choosing Max because there\'s enough challenges with Schleman as is.
Adam Walker:Funnily enough, if you\'d have chosen Sam, you\'d have chosen my son\'s name. Oh, there we go. There we go. What a small world. What a small world. And you\'d have had an alliteration in there as well. I\'m overthinking it already. Thank you for giving us a little bit of the family history that\'s really helpful and interesting to know.
Adam Walker:And as I always say, we\'re all a little bit of something, aren\'t we?
The Evolution of Clinical Trials
Adam Walker:So you\'ve worked in this industry for a long time, Scott, and I would love to hear your perspective on some of the challenges you\'ve experienced along the way, but. Really bringing that into the current setting, some of the amazing technologies that we\'re experiencing.
Adam Walker:You must have seen an awful lot in your period of the last 30 years. I\'d just love to hear about that a little bit more.
Scott Schliebner:Yeah, I guess that\'s the the curse and the benefit of being around for a little while is seeing so many different things come and go. Early days.
Paper to EDC Shift
Scott Schliebner:I remember I was one of the first clinical operations employees at Seattle Genetics that, that went on to become Cgen and now Pfizer. And we were building out a clinical team and at that point we were making the transition from paper-based CRFs to electronic data capture systems for the very first time.
Scott Schliebner:You struggled with, does a clinical site even have a solid internet connection? We used to have to assess like what\'s their, bandwidth speed? Can they actually. Upload these images and have a interface. I remember the skeptics were like, paper\'s fine, or three part NCR with the carbon.
Scott Schliebner:We don\'t need to, we\'ve used this always, why change? And this will never work. And it certainly was bumpy as like we\'re slow to. Embrace change and innovation in our industry. We don\'t want to take any risks, right? Every, clinical trial or project could be a potential game changer for patients.
Scott Schliebner:It could be the difference between a company being successful or disappearing forever, right? So we never want to take chances in a clinical trial. We always wanna do something that\'s proven and out there. So implementing and embracing new technologies and new, ways of doing things is.
Scott Schliebner:Hard, I think for a lot of people, even if you\'re open to change it\'s challenging. So going way back to the EDC was the first thing I remember as being really challenging. And of course everyone got on board eventually and. The rest is history.
Decentralized Trials Boom
Scott Schliebner:I think another sort of landmark point, I don\'t mean to skip over like 20 years or so, when we were coming just a little bit pre COVID, I think a lot of us were working in the space of what ended up becoming called decentralized clinical trials, which I think was like.
Scott Schliebner:The most popular word used, for two years or so before we called it that, we talked a little bit about virtual or hybrid or other things and trying to build technology where you could facilitate remote visits and essentially try to design a study where a patient did not have to go.
Scott Schliebner:To a clinical site, weekly for 52 weeks or whatever the schedule of assessment held. And the firm I was with at the time, PRA Health Sciences, we had acquired some amazing technology. We had built out a lot of systems and, there was tech and there was people, but coming up with a holistic system that essentially put patients at the center of it and we thought this was the future and we were being quite innovative and we were, frankly, we were a little early.
Scott Schliebner:People were not ready for this. People were not, it was often like, after you\'ve done that 10 times, call us back and we\'ll think about it. So it was an interesting sort of period of developing something that people were not quite ready for. And then literally. Six months later, COVID hits and hospitals and clinics close and everyone says, what do we do and how do we operate?
Scott Schliebner:And oh, what about that solution you were talking about recently? We actually need that now. And of course then the DCT label got associated with that. That kind of got us through COVID and unfortunately, I don\'t know what your perspective is, but I\'ve seen the emphasis on. DCT approach is really like decrease in us to almost revert back to where we were before.
Scott Schliebner:And as somebody who\'s really driven by patients and by ensuring studies can be patient friendly and patient focused, it\'s unfortunate that we\'ve let that go. \'cause that was a solution I felt was not just another fun, bright, shiny object or not just a technology solution, but actually.
Scott Schliebner:Making it easier for people like you and I who may have jobs and family and illnesses to participate in a clinical trial. So that\'s another one I would just flag in terms of great promise. A lot of noise and momentum around it. A few successes, a few hurdles to overcome, but unfortunately it feels like we\'ve reverted a little bit back to how we were doing things pre COVID.
Adam Walker:Yeah, I think it\'s a really. Compelling observation you make there, Scott, in the fact that you\'re right, for a couple of years, DCTs, everyone was talking about it. It was on every new stream. On LinkedIn, it was on, it was everywhere. Yep. There were podcasts on the subject. There were certainly these, what did we call them? Those ones clubhouse. That was the thing. Yeah. Club where everyone would drop in and chat. But it was always on DCTs and I remember spending a lot of time in those clubhouse calls during COVID \'cause we had so much time. That was the strange thing.
Adam Walker:And you\'re right those tools were definitely pertinent for the patients that needed them when they needed them. As a disruptor, I think COVID definitely challenged things. Yeah. Myself, at the time I was working on COVID trials as well, so I was seeing it from the inside out, and the bigger picture seemed to be just the importance and the driving determination to get vaccines out as quickly as possible.
Adam Walker:Yeah. Yep. It made me very nervous, but at the same time. Without it, we wouldn\'t be, we wouldn\'t be having these conversations now, would we?
Scott Schliebner:Completely,
Completely
Adam Walker:so DCTs, I think a lot of people made a lot of money on the back of that approach, but you\'re right, it has come very quiet.
Adam Walker:I\'d put that out to all of our audience and ask them the broader question around that as well. What is your perspective on DCTs today, as far as remote monitoring, remote visits, handling patient visits from afar in order to encourage them to coordinate with key opinion leaders and the most pertinent, capable people that can support their medical needs.
Scott Schliebner:I think, I think there\'s a couple different perspectives on this. I can think back to biotech and pharma sponsors looking at a solution for a trial. And I remember some cynical, skeptical perspectives like, oh they\'re just trying to sell me another piece of technology.
Scott Schliebner:This is just another new thing. It was x, y, and Z five years ago. Now it\'s this DCT thing. And you heard a lot of people say, so I\'m still going to outsource this to a CRO. And it\'s gonna have a budget associated with that. And now I also need DCT technology on top of that. So this is not actually saving me any money.
Scott Schliebner:It feels like I\'m being sold something that I don\'t know if I need it or not. So I heard a lot of perspectives like that from biopharma sponsors. Thinking about the other stakeholders involved here from the site perspective. You hear a lot of stories from be they academic or community-based clinical sites around the amount of different te technology platforms used for each clinical trial, and if they\'re running 8, 10, 12 studies, it just. And mushrooms, the amount of passwords, sign-ins, devices, things they have to use. And of course, we typically roll these studies out and the sites are a little bit of an afterthought. So the site perspective is, okay, now we have a new technology. I like it because it makes it easier for patients, but.
Scott Schliebner:This is something else we have to use. What if something goes wrong? Do they call us? \'cause we don\'t feel prepared or qualified to fix or answer questions. So I thought the site perspective was very clouded and mixed in terms of is this good for patients? Possibly, does this add more complexity to what we\'re doing?
Scott Schliebner:Yes. And then, you look at the patient perspective as well and I think a lot of patients, needed and wanted remote visits and to be able to, have a cup of coffee and be able to have a remote visit with their physician and check in on your symptoms as opposed to driving an hour each way and parking and taking the day off of work to pop in.
Scott Schliebner:But I also heard directly from patients that. Their participation in a clinical trial for them was a care option, right? Clinical research is a care option, and they appreciated the extra care they got and attention. They wanted to go to a site, they wanted to speak to a nurse. Or their physician or pi, et cetera.
Scott Schliebner:So I felt like it was mixed across all those patient sites. Sponsor perspectives. There\'s been lots of examples. You\'ve seen, like the early days, you had Science 37 as one of the first kind of one meta site groups. You\'re very familiar with them. Yeah. They had this incredible funding and this, meteoric rise and then they, I think they eventually sold.
Scott Schliebner:For an amount that was like, less than the amount of money they had in the bank, not to mention all the technology and ip. So that was a fantastic story. That should be like a Harvard Business School, I think, case study on maybe what not to do. But I think that\'s a little bit symbolic of this space.
Scott Schliebner:And I know we\'re not focused exclusively here on the DCT concept, which seems a little bit behind us in the rear view mirror, but. A good example, in our industry of, trying to incorporate innovation, some natural resistance. And at the end of the day, we\'ve probably adopted some pieces to it.
Scott Schliebner:I don\'t know. Do you see anything in this space right now, around d DCTs or hybrid studies that you come across?
Adam Walker:First things first, I think you, your insight on that DCTs is absolutely on point. You\'ve called it totally correctly in the fact that it was sold as something but wasn\'t an add-on and an additional burden to sites.
Adam Walker:I think it probably did improve lives of patients and perhaps initial outcomes. You\'re right. I did make some notes around that. When you were talking about it, particularly around the burden around integrations and validations and all the technology that had to be implemented as well at sites.
Adam Walker:And I think it\'s a great, observation that you make there with regards to my experience of it. I wasn\'t really that close to. DCTs, other than I spoke to a number of companies at the time that were trying to sell into this space that were trying to piggyback onto the likes of Science 37 and others that you mentioned, and they\'re still trying and that\'s just the reality of it.
Adam Walker:And Yep. I think the, the other component of that is that. Ultimately, it\'s very difficult to do these things entirely remotely because there will always need to be a face-to-face, bloods taken, particular technology integrated around whatever that might be, whatever the particular intervention might be.
Tech Fatigue and Real Innovation
Adam Walker:But where I was getting to was really around the fact that our industry does want to embrace change. And yet, as many of my guests will attest to, we are so conservative, we don\'t like change. And to your earlier example around paper to EDC, electronic data capture tools, that\'s a perfect, that example of how long it took, that may have been, I don\'t know, 10 plus years until we got to a point where electronic data capture was everywhere.
Adam Walker:And that was a really heavy lift over 10 years, wasn\'t it?
Scott Schliebner:Or you look at things where people will celebrate some amazing successes they\'ve had of implementing something and you hear about this, they\'re like, for the last five years we are thrilled to announce that we finally completed. And you hear this pause drum roll, and they\'re like, e-consent.
Scott Schliebner:And you\'re like, Ugh. Really? Okay that\'s great. I think we want this for the most part, but that takes five years to implement, right? That\'s not really chipping away at the delayed timelines and some of the red tape and some of the hurdles we have that we really need to like make more efficient.
Scott Schliebner:So I do think, it\'s fascinating being in this space. I help a lot of. Early stage companies that may have a new technology or maybe a new approach, they want to come into our industry and solve problems, right? It\'s very classic, like Silicon Valley, like I\'ve got a solution.
Scott Schliebner:I\'m gonna fix it. And it seems like it\'s almost always technology driven and there\'s a lot of people out there that are like, they have fatigue for the amount of sales calls they\'re receiving. Inbound of usually has AI in the phrase most likely these days.
Scott Schliebner:But. There\'s so many areas of drug development that are really inefficient that we can really improve. So I certainly don\'t wanna dissuade anyone from trying to improve things. But it feels like patching on technology solutions is not going to work in this area.
Scott Schliebner:And I think we have incredible advances on like our understanding of. Various disease states, some of the new therapeutic modalities coming out, the mRNA cell and gene therapy lipid nanoparticles. It\'s amazing like what is coming out. And then ironically, we\'re taking these new modalities and we\'re putting it into a drug development system that.
Scott Schliebner:Hasn\'t really evolved too much, in a couple decades, I think we can all say we still develop a protocol, like I like to say, we develop a protocol usually in a conference room in New Jersey. It\'s usually a little bit in an insulated bubble where a group facilitates it and votes for the different end points and assessments they want.
Scott Schliebner:When that gets signed off, there\'s a little bit of a small celebration \'cause that is a big milestone. Then we push that out to maybe a CRO or maybe sites and say, here\'s our study, please participate. Please enroll patients. And then you have people then going out to our ultimate stakeholders, patients and saying, please enroll in this trial.
Scott Schliebner:The irony there around developing a clinical trial. That is so far removed from the end user who never had any input on I\'d be interested or this would work for me, or this is feasible. It\'s like we\'ve all got our phones next to us, right? One of the examples is apple didn\'t decide to put a camera in here and say let\'s just see if it sells.
Scott Schliebner:Let\'s see if anybody wants to use it. This is completely consumer driven, right? Like we want. A good camera on our phone, so it\'s built. I would love to see a little bit of that mentality and end user perspective brought into clinical trials where, \'cause I\'m here for the patients all day long and I want new medicines to make it to patients and I want to get some of the hurdles and barriers out of the way.
Scott Schliebner:So I really wanna bring them into the process a little more. So we design studies that are. Realistic for human beings to participate in.
Putting Patients First
Adam Walker:So how does someone like you, Scott, make it all about the patients? How do you yourself influence those conversations so that protocols are not just written with patients in mind, but actually as you say the first thing that is written is about patients, not necessarily the opposite way round. Yeah. How do you do that yourself?
Scott Schliebner:Super hard because like we said earlier, we don\'t necessarily want to try anything different. Each kind of clinical trial is often a transactional project, right?
Scott Schliebner:We\'re hiring a team, we\'ve got people working on it. We\'re not thinking about a long-term investment. Let\'s see what the phase two data looks like, and then we\'ll raise money and maybe we can do more. So we must have to keep our eyes on the ball and not look too far ahead around that like patient group or that community.
Scott Schliebner:So that\'s challenging. Back to the conference room in New Jersey if you\'ve ever worked on finalizing a protocol, it is a. Cross-functional cluster of things, right? And you\'re eventually getting to that point of a corporate deadline and getting this out the door and let\'s get this moving to incorporate patient perspective early in the process.
Scott Schliebner:I don\'t think it\'s rocket science at all, but I hear from sponsors that they either feel like, number one, it will slow down their process. Number two. They may say, do patients really have, helpful insights that we\'re not aware of? Number three, we don\'t know how to engage patients.
Scott Schliebner:And number four, what about things like HIPAA and patient privacy? We\'re always taught to keep an arms length distance from patients. So there. I hear about four different reasons around why patients aren\'t necessarily engaged. So I think you have to chip away at those one by one.
Scott Schliebner:It doesn\'t need to take any longer to include their feedback. You can do it early on. And in fact, you could obviously argue clearly, it probably saves you a lot more time by taking a week for a patient review panel, incorporating that feedback early. How much time will that save you later when it comes to screening and then recruitment and enrollment, right?
Enrollment Delays in Clinical Studies
Scott Schliebner:Which is. I don\'t know what the latest number is. More than half of all studies are behind scheduled due to enrollment delays.
Patients Shape Endpoints
Scott Schliebner:So whatever you can do upfront, if you can invest a week in that, fantastic. I think you could use some intermediaries to facilitate the input. If a sponsor feels like they need to stay a little bit removed to the folks that say, we know everything about the disease, patients aren\'t really gonna, what are they gonna tell me?
Scott Schliebner:I\'m a. Oncologist, blah, blah, blah. I think that\'s shortsighted.
The Importance of Patient Involvement
Scott Schliebner:And I think patients are the ones we\'re there to treat. Patients are the ones living with their disease. Patients can tell you what\'s most important that this, what endpoint, maybe you should measure that sort of is gonna make a difference in their lives.
Scott Schliebner:I\'ve run patient panels and I\'ve created patient advisory groups and we\'ve had patients say things like this study\'s not even measuring anything that\'s important to me. It\'s measuring the six minute walk tests, but I really interested if I can lift my arm up to open up a cupboard in my kitchen, that\'s a win.
Scott Schliebner:That\'s all I\'m looking to do is to be able to get a little movement or something like that. What you\'re measuring isn\'t actually even relevant to me, so I don\'t even want to participate. So you have, things like that. Not to go too far down this kind of rabbit hole, but this patient involvement in study design could help so much and inform us.
Scott Schliebner:And again, back to the iPhone example, thinking about all the money, effort, and time that goes into clinical development and when your end user. Is not even part of the design process. It\'s a little bit ironic, right? That\'s where I think we could even take a look at some other industries and perhaps learn and incorporate some things into drug development.
Scott Schliebner:To think about it from like an end user design perspective.
Adam Walker:I think that\'s a wonderful insight you provide there. The phone example is very pertinent today. Of course we take it for granted and we have done over the last, let\'s say nearly 20 years that they\'ve been in the palm of our hands now.
Adam Walker:So we both got children of a similar age who have grown up who are native and grew up with a phone in their hand there. I say your interest.
Creating Patient Advisory Groups
Adam Walker:In patient advisory groups. I\'d love to know where that came about from. Is there a personal insight or personal story behind that? What brought you close to patient advisory groups and patient advocacy?
Adam Walker:I\'m just curious.
Scott Schliebner:Yeah. It\'s a good question. How did that get started?
From Oncology to Rare Disease
Scott Schliebner:And I spent like the first decade or so of my life, really just in the oncology world really. Hematology, oncology, I felt we all have family members and friends touched by cancer, right? The need for cures is not going away.
Scott Schliebner:I wanted to devote myself to that, and there was a point where I shifted a little bit and I created a focus and built some teams around rare diseases and rare diseases that could occur in any kind of therapeutic area. They could be pulmonary or ophthalmology or hematologic or whatever.
Scott Schliebner:And in doing so, I realized, a lot of these disease states there\'s very few patients that have the disease and a lot of them we. Don\'t have a standard of care or even any approved treatments and finding patients, finding physicians who care for those patients or diagnose those patients was really hard.
Scott Schliebner:And so I started reaching out to patient advocacy groups to partner with them, learn more about the disease state, learn more about what they needed, and a little bit of what their communities wanted and what their constituents wanted, and. It felt pretty strongly that I wanted to do that in a way that wasn\'t I used the transactional word earlier.
Scott Schliebner:It wasn\'t transactional. It wasn\'t like, I need five patients to enroll in this trial. It was more, we don\'t have a trial today. We\'ll have one in a year. I\'d like to learn what\'s important to you. I\'d like to learn what your patients are interested in. Build a relationship around them. Support them if you can, but learn what patients are looking for, what they\'re struggling with, what they can handle, what\'s feasible for them, and doing that across a lot of different disease states.
Scott Schliebner:I saw the power in patients who manage their own disease and what they could bring to this process for us.
Building Patient Advisory Boards
Scott Schliebner:So that evolved into building a patient advisory board that would guide us. I was at an organization we had something in our tagline that was like, we\'re patient focused, and I loved that.
Scott Schliebner:Yet, I\'d look around, I\'d be like there\'s no patient in this meeting. I don\'t think that\'s fair to say we\'re patient focused. Maybe we endeavor to be, or maybe we endeavor to consider patients. I don\'t know how many groups out there are actually. Everything\'s revolving around a patient with a patient focus or patient centricity or whichever buzzword really rubs you the wrong way.
Scott Schliebner:So we built a advisory committee I asked them to hold our feet to the fire. We say we\'re patient focused, give us feedback, guide us.
Developing Patient-Centric Tools
Scott Schliebner:And one of the really interesting things that my team and I that came out of this was we asked this group we weren\'t prescriptive in terms of we would like you to do this.
Scott Schliebner:They helped come to the table with ideas of what they wanted to build.
Trial Burden Assessment Tool
Scott Schliebner:And one of the things we built was a. Tool that would assess the burden of clinical trial participation on patients, a burden assessment tool that a biopharma sponsor could. Essentially take their schedule of assessments of a draft protocol early before it\'s final, early days where you\'re not slowing down anything and say, we want a CT scan every eight weeks.
Scott Schliebner:We want a lumbar puncture. We want this and this. And you\'ve seen these grids right? Of weeks of assessments and this long two page xs in boxes, right? Every one of those is something a human needs to do, right? We developed a tool where you could assess how burdensome that would be for a patient, and it would assess burden on several domains like physical, financial, emotional et cetera.
Scott Schliebner:Like it, costs patients money to participate in trials. They have to take time off work. Childcare. We actually arranged dog walking services for one patient. That was the kind of the last thing that was holding them back from making a site visit. Long story short, our patients guided us here on let\'s develop a tool so that you can, and this I guess, answers your earlier question, what can I do or what do I do to help with this?
Scott Schliebner:If you can share or get people to think about that feedback on. What you\'re developing and putting out to people at this moment is gonna be this burdensome and it allowed them to use some levers to make the week 10 visit remotes maybe eliminate the second blood draw. And you could almost see participation levels would go up a little more as you played with these levers.
Scott Schliebner:And it allowed us to go back to, a camera on a phone and thinking about the end user a little bit. So that was a really cool tool That was all patient driven. And we tried to get that into the hands of sponsors early because I think what a lot of us here now is you look at a draft protocol or maybe not even draft a final protocol.
Scott Schliebner:Do you have any feedback for us? Yeah I\'d do this different or this eligibility criteria seems like not very realistic. There may not be any patients who actually check these 38 criterion. And the feedback often is. That\'s fantastic input. Unfortunately this protocol\'s finalized, so we\'ll think about that for the next one.
Scott Schliebner:So the goal was to move, get the conversation going on further upstream when things are being built and developed, where you can impact that a little bit. That\'s the goal. Anyhow,
Adam Walker:I love those examples you provided, Scott. They\'re so powerful and they really resonate with me as someone who has had friends and family involved in and around clinical research, drug trials and the necessity of care.
Adam Walker:Often we just forget our end users, namely the patients, don\'t we? This is exactly what you\'re suggesting, and I know this will resonate not just with our audience, but actually with many young people who listen to this. Who are hoping to come into this industry because I think it\'s those individuals that can really influence the next generation of trials, of bringing patients into these medical environments, but also with a human view with that idea and understanding that these are human people that not just want to improve their.
Adam Walker:Lifestyles, their choices and the choices that are in front of them, but actually their complete engagement with process from start to finish. I think it\'s a wonderful insight that you\'ve provided there, Scott. And I cannot thank you enough for clarifying that.
Mentorship and Career Beginnings
Adam Walker:I\'m curious also in, your past and perhaps throughout your career, I know you\'re quite a seasoned professional these days.
Adam Walker:I wonder if there were people that you looked up to and whether there were any particular mentors that looked out for you Because again. In our audience. We have a lot of young people coming into this industry who are looking for mentors and looking for people to support them on their way in and push some of these doors open that we know are so difficult to overcome.
Adam Walker:Did anyone do that for you?
Scott Schliebner:That\'s a great question. No, I did it all on my own. No, I\'m right. We all, whatever. There\'s some corny phrase, it takes a village or whatever. Yeah. I think we all get support. We all get help. We all can\'t do it on our own. I had some great, yeah, I had some great initial, I had a great, like I was thinking about him yesterday and he passed away a few years ago.
Scott Schliebner:My undergraduate advisor who got me involved in research, it didn\'t end up being the field I ended up going in, but he. Was actually from your neck of the woods. He was from well, northern England. He was from Leeds and he was a called him the rock star rock climber.
Scott Schliebner:And he was had long hair and he was in a band and he was this major rock climber who was like on the cover of rock climbing magazines and stuff. And he did his PhD and was brilliant at what he did, and he showed me, you could go into research and still be cool. I\'m still working on the cool part, but he made it really attractive, right?
Scott Schliebner:He was like, my leather jacket wearing rockstar professor. I can work in his lab and do cool stuff with him. He introduced me to that a little bit and he showed me a path that I hadn\'t seen before. So he was probably the first one. And then I had a couple great initial kind of bosses and mentors in our industry.
Scott Schliebner:And I love your question because the space we\'re in I think you have a little bit more of a data biometrics background. I do have a degree in statistics, but I don\'t really use that and. In our clinical research space, there\'s not a, clear educational path or a clear point of entry at all, right?
Scott Schliebner:People stumble upon it. A lot of people may want to come into this space, but how do you get that first step? How do you get someone to take a chance on you? And so I think. You, me, others would love to help support early stage people in their career to help them. Not that I\'ve got all these incredible answers for them, but I think getting over those initial hurdles and getting a little bit of experiences.
Scott Schliebner:Really hard, right? How do you get experience without any experience, right? So that\'s tricky. And I think I had some nice support and I think I had some people take a chance on me. And I think we all have to pay it forward that way in a big way to help others make, that point of entry here.
Adam Walker:I couldn\'t agree with you more, Scott. And actually the one way I. Managed to do that myself, I reconnected with my alumni. This was just before the pandemic and since then, I\'ve been working with students, both masters and undergraduates at the University of Greenwich in London, in the uk where I studied and it just.
Adam Walker:Is unbelievably difficult for anyone to get into this industry. And as you say, sometimes you need someone to look out for you. Sometimes you need someone to just pass an opportunity your way. It happens even now, even now, 30 years down the road, a friend or a colleague or drop you an email say this isn\'t a fit for me, but it might work for you if you\'ve got any availability.
That happens all the time and. The example of your rockstar lecturer is really pertinent as well, because
we come at this from very different perspectives, don\'t we? And there is no one size fits all when we, might be wearing a lab coat one day, but another day we\'re not. And.
Scott Schliebner:A hundred percent. Our
Adam Walker:influences outside of a lab are very different, aren\'t they? We all take different things from it.
Adam Walker:I\'m also noticing the fact that you remembered. And you kept in touch with this guy. What\'s his name or what was his name if you wouldn\'t mind sharing?
Scott Schliebner:Roger Whitehead. Yeah. A very English name. Yeah. He was from Leeds did his PhD at the University of Oregon. Ended up teaching in Colorado, where I met him again.
Scott Schliebner:He passed away a few years ago. But he was, yeah, he was profoundly impactful on me in a big way. And he took me under his wing. He gave me some opportunities. He made it fun and actually, none of that had anything to do with clinical research whatsoever, but it was a little bit more around I guess just research and science in general.
Scott Schliebner:And it yeah, I guess he could meet a younger college student at whatever level that was, and. Similar to your podcast, it was very like, personable. It was like the human piece of it behind it. And yeah, he was great And I\'m sure some of his colleagues thought he was a little unorthodox and he certainly was.
Scott Schliebner:But having someone like that in a leadership role that wasn\'t all stiff and buttoned up and formal, made him more approachable to college students as well. And I think there\'s something to be said for that, around meeting people where they are a little bit and helping them in that step.
Scott Schliebner:It makes me think too, you said alumni, I wrote down a little note that I\'m actually gonna follow up with my previous program and see if there\'s something there that I can support them with around mentorship. But one of my initial professors there I mentioned that I took this pharmaco epidemiology class and that was a.
Scott Schliebner:Something that kind of showed me this other world of applicable research and I can help people and patients. And that professor, I loved his class. He had started a he was adjunct professor, so he taught a class or two, but he had also co-founded a small CRO that was doing what they called actual use trials, which was you probably know what this is taking, certain prescription medications and moving them to over the counter status and showing that you could use and self-diagnose it was safe. And so I remember after his class one day I don\'t even think I had a resume yet. I developed a resume. I made an appointment and I went down and I knocked on his door and I was telling him how much I loved his class and I.
Scott Schliebner:Asked him, I told him he should hire me as a project manager, and he did. And that was actually my first industry job. Randomly. And I got involved in a big large global actual use trial that was co-sponsored at the time by. Glaxo and Smith Klein were not yet merged together. They were competing sponsors.
Scott Schliebner:We had two sponsors come together to co-fund and co-develop this program, which was really a bit unique. And that was my first clinical trial experience. And I had to be brave to go knock on this guy\'s door. But I knew that I wanted to pursue that path.
Scott Schliebner:So he took a chance on me. And he didn\'t have to. And and it worked out great actually. And he\'s a great guy. And the opportunity was good.
Paying It Forward in Downturns
Scott Schliebner:It just reminds me that there\'s other people that need the same, and even if it\'s not. Just entering the field. As like our industry has been in a downturn for a couple years and there\'s been a lot of layoffs, there\'s a lot of people looking for work.
Scott Schliebner:I think, we should all be doing our part to help others a little bit right now, find their next step. Whether you\'re breaking into this space or whether you\'re trying to get back on your feet. There\'s challenges out there right now.
Adam Walker:Oh, Scott you\'ve really landed that one so deeply with me.
Adam Walker:That was where this podcast was born from. This came from a place of me wanting to secure some work when I didn\'t have any work. And from that point forward, the podcast was born from an idea, but also I committed to put out regular podcasts and. Also involve people in honest and open conversations and true stories, and that\'s exactly what you\'ve done today.
Adam Walker:You\'ve told me your truth. You\'ve shared so much truth and I think you also mentioned about not just paying forward, but paying back. And as parents, you will know if someone can be there to support Max and Sam and my daughter. You never know what you put out in the universe might come back to help them your next generation and, the people that we care the most for.
Adam Walker:So that\'s the way I try and approach, not just this podcast, but life more generally. And I think we, are really closely aligned around that particular point.
Scott Schliebner:I think it\'s really generous of you to have your podcast focused on that. Around, not self-promotion, trying to understand the human stories behind things and ultimately I think that, I don\'t know, I guess that provides insights and it\'s helpful for people.
Scott Schliebner:And it\'s helpful for them whether it\'s figuring out a path forward or how to overcome hurdles, I don\'t know. I\'m sure there\'s been stories that you\'ve heard from people that have listened to your podcast and heard something. Inspiring or helpful or something along those lines.
Adam Walker:It happens all the time and I\'m constantly surprised by the truth with which people come to these discussions.
Adam Walker:You\'ve been incredibly generous and incredibly open and I cannot thank you enough for that.
Quick Fire Reflections
Adam Walker:Scott, at this point in the conversation, I love to finish with a quick fire round.
Advice for the Next Generation
Adam Walker:So I wonder what is the one piece of advice you would give to your younger self, Scott?
Scott Schliebner:I\'m a big fan of getting out of your comfort zone.
Scott Schliebner:I\'m a big fan of, people say fake it till you make it. Trying new things if you feel a little stressed or a little discomfort or a little scared about something that\'s growth. So do more of that, whether that\'s. I was on a ski hill yesterday going down a really challenging run that was like a little, a pretty good skier, but I was like, wow that\'s really steep.
Scott Schliebner:Okay, let\'s do this. There\'s growth that comes from trying something different. There\'s growth that comes from getting on your podcast with no agenda. There\'s growth that comes from this, probably from this rapid fire session I\'m about to participate in. I would tell myself, keep taking chances and trying new things and get outta your comfort zone as much as you can.
Adam Walker:I love that. What are the top three qualities you value most when building a team?
Scott Schliebner:I like people that are authentic and real. I like people that take initiative. And I like people that are, dependable, I guess
not so rapid fire. I\'ll try to keep that moving quicker. What
Adam Walker:is your favorite thing outside of work skiing? A hundred percent. And finally, what is your number one golden rule in life and in business?
Scott Schliebner:Golden rule. Geez, I don\'t have a specific one of those, but, I do try to operate day to day in a way that is I try to be generous with my time.
Scott Schliebner:I try to be helpful to others. I try to be authentic and honest and direct with people. I don\'t know how I phrase that as a golden rule but I do try to support people. I feel whether those people work for me or whether it\'s my family or friends, a lot of people are going through challenging stuff, right?
Scott Schliebner:Whether you know it or not. And there\'s always a little more under the surface. So I try to be supportive and generous, first and foremost, I think.
Adam Walker:You have been entirely supportive and generous today in this conversation, Scott. We touched on so many different aspects of your career how you came into it and some of the things that, you\'ve identified along the way, and it\'s been a really insightful and warm conversation that I\'ve thoroughly enjoyed.
Connect and Closing Thanks
Adam Walker:For those of our audience who might like to reach out to you, Scott, what\'s the best way to get in contact with you?
Scott Schliebner:The one social media I do use is LinkedIn. You can find me on LinkedIn if you can spell the last name sch. That\'s probably the best way to, reach out to me if you\'d like to connect.
Scott Schliebner:If you\'d like to have a conversation if you\'ve got any questions, if I can help you. Send me a message there, reach out and connect and send me a message. That\'s probably the easiest way, and I try respond to everybody that I can. And if there\'s help I can offer or a direction I can point you to or something like that I absolutely will.
Adam Walker:Just to reiterate, it\'s been an absolute delight to welcome you onto Pharma Prescribed today, Scott, I\'ve thoroughly enjoyed our conversation and I hope we can continue the conversation at a later point. Thank you once again.
Scott Schliebner:This has been great, Adam. Thank you and keep doing what you\'re doing. I think this is a great forum for people.
Adam Walker:Thank you.