Research Confidential_Dennis Salotti: Audio automatically transcribed by Sonix

Research Confidential_Dennis Salotti: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Joseph Kim:
Welcome to Clinical Research Confidential. On this show, we highlight and demystify the inner workings of this greatly misunderstood activity called clinical research. Now, why is clinical research important? Well, it’s the basis for nearly every modern remedy for sickness and a growing method to build trust and solutions meant to optimize health, but it’s not for the faint of heart. And so on this show, you’ll hear what it really takes to succeed in the clinical research game. I’m your host, Joseph Kim, and I’ve spent over 23 years in the clinical research industry, now serving as the chief strategy officer for ProofPilot. Get ready for some adventures as we look into the underbelly of clinical research.

Joseph Kim:
Today with me on the show, we have Dennis Salotti, who works at Jazz Pharmaceuticals in Outsourcing. Dennis, welcome to the show.

Dennis Salotti:
Thanks, Joe. Pleasure to be here.

Joseph Kim:
Yeah, great. So let’s start a little bit, so today we’re going to talk a little about the whole idea of outsourcing in general and all the different kinds of outsourcing there might be, whether it’s services or technology consultation, whatever it is, we’ll unpack a lot of that because I don’t think people realize the variety of partners drug companies might need to actually pull off research. But before we get into that, I do want to talk a little bit about your background, because you’re not a procurement guy by training or by pedigree. Like you started off as a scientist. Tell us about your early days in clinical research.

Dennis Salotti:
Yeah, you’re 100% correct, not a procurement guy by training or by pedigree. I started off as a bench scientist. I joined Pfizer back in the early 2000s as a chemist and biologist. I was doing small animal surgeries and analytical chemistry, but what I found was I was getting allergic to rats and I was getting much more interested in what happened after that. So a lot of the work we did supported control release in human studies and things like that, and it just became more interesting to work on that side of the business. So I had a great opportunity to come into Merck when they were developing Januvia and that just threw you in and I got a chance to learn clinical research just by immersion. So my first role was literally just managing sites, doing …, at that time we did medical review, reviewing labs, and working with data management, it was an excellent experience. And it’s funny, back then I worked, I won’t mention the name of the CRO, but I worked with a CRO back then, they did our field monitoring, no one called it FSP. It was just, this is the CRO and they’re your field monitors, and it was a wonderful relationship. I enjoyed working with the PM there. I won’t name names back at Merck in that day, but I actually enjoyed working more with the PM and the CRAs externally with CRO partner than I did internally. None of the things that I talk about today in my role around managing relationships and dealing with escalations and FSP versus full outsource versus in-source, none of that seemed to be an oppression theme at that time. It was just, we all worked, we were all on the team trying to get a drug developed, and I think about that a lot these days. And I don’t know if that was the naivete of just being in a more junior role and … to the clinical trials industry, or that was we were in a different time at that point and just we were not so wrapped up, I think in some of the issues of the day, and maybe we were just more focused on developing medicine.

Joseph Kim:
And so basically what I’m hearing is, it was a lot more of a partnership and it wasn’t vendor-client kind of relationship. But I have to also think that the level of, this is going to sound disrespectful, but who cares, the level of talent and expertise at these CROs was maybe just better. Could that be back then?

Dennis Salotti:
It could have been, and when I think about it, so I spent a lot of time thinking about this, and back then the CRO industry was, I think, younger. They were probably able to still recruit more experienced people out of pharma. I remember as a young guy just being married and trying to buy a house in New Jersey where property values were ridiculous. Going down to North Carolina and working for CRO, a lot of my colleagues were doing that, and it was a really attractive idea because the houses were more affordable and the CROs put together some nice packages. So it could be that there was just more, I think the supply of talent, and specifically experienced talent was maybe more prevalent back then, and maybe not as many, there wasn’t as much demand on the other side of the equation. If you think about all the investment that’s flown into biotech over the last few years, just the explosion that’s happened and the number of trials and just the trends that we’ve gone through, there’s probably more demand and less supply. So we’re getting squeezed at both ends relative to what it was 20 years ago.

Joseph Kim:
Yeah, it’s a great point.

Dennis Salotti:
The other piece that always jumps out at me, though, is nobody pulled me aside when I was a little bit green and coming into the clinical trials industry and put in my head any bad thoughts about getting the B-team or getting working with the CRO. It was more just, this is who they are, this is what they do, you’re going to work with them, okay, I’ll work with them. And I sometimes wonder if as we bring, meaning we as sponsors, as we bring people up into, more junior people up into our industry and up into the roles that they’re in, which is much more now an oversight role because there’s so much more outsourcing than there was before. If we’re not almost poisoning the … little baby with putting some of our biases and experiences into their head, in terms of, in not giving a fresh slate to say, hey, figure out, is this a good relationship? Is this not a good relationship? Learn how to work with these folks. I sometimes wonder about that just because there are so many memes that go around and so much grousing about whether you have the B-team or the C-team, or the A-Team, and I think you’ve got to have a team at the end of the day, it’s a team, it’s a team, and it’s either going to function well or not. You shouldn’t really think about what letter you have in front of them …

Joseph Kim:
Yeah, great point. You often see this in teaching where teachers who’ve been there long or maybe too long will say, you can’t trust these kids or this is like, they sort of poison the well, as you say, and you automatically are then guarded against this kid coming into your class and then you label them as the low performer or someone who’s got trouble or whatnot, yeah, totally. Let’s talk about then, as you’ve gone through the pharma research ranks, like you’ve done a lot of interesting things. You didn’t just stay in late-stage drug development, you moved around, you did some translational medicine, and you actually joined a startup too, to do some clinical technology. Tell us about some of those experiences and how they may have prepared you for a role here in Jazz.

Dennis Salotti:
Yeah, I think the first thing, and especially for anyone interested in a role in outsourcing and I think being on the other side of the table is extremely valuable. I think it gives you a level of empathy for your partners that it’s hard to develop. It’s not impossible, but it’s more difficult to develop if you haven’t had that experience. In my case, I had some wonderful opportunities emerge to be able to move laterally in a different parts of the organization. You mentioned translational medicine, that was a phenomenal experience because at that time that gave you to the exposure to the sites. So you did your own field monitoring in the early dev space. So you got to see what happens in a site, you’ve got to be across the table from a study coordinator and really understand their life a little bit, at least from a phase one perspective. I would encourage anyone to, who’s in their career, regardless of whether you’re going to outsourcing or anything else, to take those opportunities to do different phases of development, do different roles that put you in front of the different stakeholders, putting you in front of a study coordinator or a PI, doing some monitoring and really understanding what happens at the site, and then being on the other side of the table, so running, whether it’s a technology vendor in my case or understanding what goes into developing technology and what good technology development and software development looks like for a validated system, or whether it’s just being with the CRO, delivering services, being on the other side of the escalations and those types of items. I think it gives you a different perspective, it helps you be more empathetic. It rounds up at your knowledge. I mean, that’s always helpful from a pragmatic standpoint, but for me it’s, when it comes to outsourcing specifically on how to manage those relationships, it helps you understand why provide, a service provider or technology company maybe doesn’t has a hard time giving you feedback when you say, look, we call us out on our stuff, tell us when we’re not doing the right thing or if we’re not giving you the information. When you’re sitting there and you have a business, you have a client relationship, you know, it’s hard to give feedback to your client. You don’t know how it’s going to land and if that what that’s going to mean for business. So I think it’s hard to develop that if you haven’t lived through it a little bit. I definitely would encourage anyone to take the opportunity and I think our industry is really exceptional in that way, that there is so much opportunity in so many different spaces to really explore that, especially earlier in your career, when you’re trying to figure out what you want to be when you grow up. But yeah, I moved from a couple of different roles at Merck into consultancy, into technology, and like you mentioned, the startup realm, back into consultancy and in quality, which is an area I never thought I’d work, quality and compliance. I thought I’d throw holy water on that and run the other way, but really having a great career to go around that. And I think in retrospect it’s having those opportunities to move across different functions to different sort of size organizations, different cultures, and different points of view or provider or sponsors is really valuable.

Joseph Kim:
Yeah, particularly your last role at Avoca, which is about quality and not just generically speaking, about quality, but particularly with partners, right? And so I imagine it got you introduced to a great many areas as well as a great many customers and how they think about quality. So then like how did that seem to be a capstone kind of role for you to get into sourcing? Which also seems like a holy water for a career, but hey, it’s as important. Like you need to know what you’re buying and what business problem you’re solving. So talk to me about connecting those two dots.

Dennis Salotti:
Yeah, that was some of the magic that I think Avoca and … in creating that company, really brought to the table. I think connecting these two concepts that the quality of your relationship and how functional and healthy your relationship was when you’re outsourcing would actually have an impact to quality outcomes in terms of the trial itself, the quality and integrity of the data, and the compliance with how the trial was executed. Those, to me, I would have never connected those two dots, but she did, and she brought those two things together in Avoca, and I was fortunate in that you’re correct, that I met a plethora of different suppliers and you got to look at through the lens of quality of what that meant for those different suppliers. So from a technology vendor, it means something totally different than maybe like a service provider, and you have to understand how do these things manifest in those different situations. And that from a sourcing perspective, understanding you are you getting your value for dollar, are you getting quality delivery for what you need that that really shines through? So it was a unique role in that regard and that it brought those two worlds together and really illustrated the interdependency between the two. Because if you’ve got a functioning team and you’ve got a healthy relationship and there’s lines of communication that are open and honest and you can discuss the issues and manage the issues in an effective manner, I think the compliance and the quality piece of it becomes … It makes it much easier and it makes it less of a contentious or troubling situation. Nobody likes to hear there’s a quality issue, right? It’s demonized. Oh, my God, there’s a quality issue. Everybody’s blood pressure comes up a little bit. I think when you have a platform to discuss the issues in an open and functional way, you can discuss them earlier, which probably prevents them from becoming larger quality issues. But also if there is something that really is a quality issue, you can get it out on the table and figure out how you’re going to resolve it. And that’s really the important part because things are going to happen, there’s never a situation, I think, in this industry where everything is under your control entirely. There’s going to be unknown unknowns that surface, and so you have to have that to be able to manage it. I think the two, there’s a virtuous cycle there if you can …

Joseph Kim:
At the end of the day, clinical research is a people business because it’s people at the sponsor company, it’s all the clinicians across the world, and all the patients that have to come in and maybe their partners or caregivers who consent. It’s a very intense people business and things are bound to go wrong because it’s people.

Dennis Salotti:
And it’s hard. People have feelings, right? They have emotions, they have.

Joseph Kim:
Unfortunately.

Dennis Salotti:
Yeah, it’s not as black and white as what’s in a rag or what’s in a contract. Whether you’re looking at the compliance side or you’re looking at, it’s never as simple as those two things for that reason you just describe, because there are people in between. That’s a variable.

Joseph Kim:
And clinicians are clinicians and a lot of it is, has been opinion-based, quote-unquote, hence the term get a second opinion, but research is not medicine, and so there’s always that tension too. Let’s switch gears a little bit and talk just still in this concept of partners and sourcing and vendors and suppliers, what are you in charge of in terms of what categories of things do you help Jazz procure?

Dennis Salotti:
Sure, so our group name is strategic outsourcing and clinical innovation. It’s a misnomer because I get a lot of calls about things that have nothing to do with what I actually source. I focus on the clinical outsourcing, so anything that touches a clinical trial, certainly all of the CRO, all of the typical categories, the CRO service category, eCOA, IRT, those sorts of things. We also, within my remit, we do the site contracting. Not that I like to think about investigators as suppliers and I’m sure they wouldn’t want to be considered that way, but they do, in a way you have to manage them in a similar way, so we actually handle all of the site contracting as well. It’s an interesting space where I sit because rather than being as part of a centralized procurement function, I actually dotted, I have a dotted line into procurement. I don’t sit within procurement, I do that sourcing sitting within dev ops. So my objectives, I have some that go towards procurement. The majority of my objectives track up to the R&D objectives, which is delivering the pipeline, getting medicines to patients, being patient-centric, those sorts of things. The opportunity that we have is, I also have that innovation function within my group. And while I have to ensure that we support the pipeline and we manage all those sort of common relationships that exist within the clinical trials ecosystem, I also get the opportunity to focus on what’s come, what should be coming into the ecosystem, or what could come into the ecosystem and what innovations are out there, what, whether it’s technology or a new approach, my group focuses on the ideation and the research that goes into that, and then via the sourcing vehicle to bring those key relationships in and enable those capabilities and deliver those to the business.

Joseph Kim:
How do you stay, keep your pulse on the true business problems in DevOps while staying abreast of the marketplace of solutions, while also thinking about SLAs and quality relationships? Like how do you spend your time taking care of all of those three big categories?

Dennis Salotti:
Well, I have great people. I mean, it all comes down to people, right? So I have some great people that focus on these things. But no, it’s a delicate balance and it’s one that I wouldn’t say I’m an expert at, when I’d say my work real hard and constantly recalibrate. We try to split the time equally there around doing the active listening within the business, right? So part of that is structurally supported because I do sit in dev ops, right? So being embedded in the business almost bakes it in. I sit on the leadership team within DevOps right alongside of ops and data management and compliance and all the functions we have, from a big picture from a strategic standpoint about where we need to go with our portfolio from an operational standpoint, I’m in there setting the strategy with the team. So that I think is a big lift. The other thing is, and I think anybody in a sourcing role will probably chuckle at this, but you get a line outside your door when there’s problems or when something’s not working right, or so the pain points come, they get brought to you. I think the challenge there is actually filtering through, what type, is this an issue, is this a decision or is this an opportunity? What are the things this coming to me here? Is this something where there’s something that’s just not working in a relationship that we just have to iron out the process or the communication? Or is this an opportunity perhaps, or is there something here that maybe is lacking that we can bring in? And those are always really interesting from an innovation standpoint. So, or is it just somebody needs to just make a darn decision which sometimes is a class unto its own? So I think those are interesting, it’s interesting because those come to you and then it’s more of a filtering exercise.

Joseph Kim:
You didn’t say one option, which I thought you might say. What? Or maybe you buried it in there. Which is like, when do you know it’s a lemon or you got snake oil? Does that happen much or you’re not perfect? Did you have you ever bought snake oil and don’t know?

Dennis Salotti:
Yeah, I think you’d have to be honest with yourself about when something doesn’t, just isn’t working. And it’s not only snake oil, sometimes we really wanted this to work in this situation, and man, did we pick the wrong situation to put this particular approach or technology into. So I think you have to have and this is the work we do in innovation, is you don’t want to find a solutions and then go find problems, right? You have to be problem-focused. And so I try to focus on what are the value levers that we’re trying to pull in any innovation opportunity or any new thing we’re going to bring in. And it doesn’t have to be monetary, even though I even have sourcing, see if I got a savings target. Value levers are there’s an excellent paper I forget which console that they put a pyramid around it and they all these little … But the value levers are not always monetary so you got to but you’ve got to be clear on what they are so that you can find some way to measure them, even if it’s a subjective measurement. And you have to be true about whether you’re actually influencing them or whether it’s just not working. And then you’ve got to do the introspection to say, is this a lemon? Do I have snake oil? Did I put, did I set this up to fail, did I put this in the wrong context? You have to be real. You have to be real rigorous about that because we do it, we make mistakes, we don’t always do it right. Everything that looks good on paper definitely doesn’t come through on the, in a practical sense.

Joseph Kim:
So I love this notion of don’t have a solution and look for a problem, have the problem, and actually work on that. And also don’t lose the plot around like the problem because you might think you have a problem A, then you get problem B and then you start making up problems or solution B and then you start making a problem C, D, and E when you never end up fixing problem A. Now sometimes that can be a good thing, like you said, but sometimes if people lose the plot on what they’re trying to solve, they end up like just going down some weird rabbit hole. And so this is all a preface to this whole notion of decentralized trials. Like what do you think of that? Is that a solution looking for a problem? What is the problem that’s actually supposed to solve? It’s a lot of questions, but let’s start with what are your feelings about DCT?

Dennis Salotti:
So I’ll say this before I get into DCT. I think there’s a fundamental disconnect that I think the way that a lot of solutions providers approach things is to sell solutions and go look for problems, which is rather than listen for where the problems are and try to custom fit the solution. So I think that’s a broader industry problem, that’s not just DCTs. There’s just, everyone’s trying to hammer their solution into your work, whether it makes sense or not. I think with DCTs there’s, I think it’s very frothy. I think it’s very hyped up on what the pragmatic impacts are going to be from some of the things we’re talking about. We’ve been doing, look, I ran an eCOA, a company for a while. We’ve been doing that for a long time. I was doing that back when it was … We were shipping paper and it was a digital pen writing on it, and now we’re doing iPads and things like this, it’s been a long time and we were doing diaries back then in pen and paper and then digital pen and paper and now and then handhelds, and now all iPads are wired. So I think you have to be clear on what again, it comes back to the value levers. What are you trying to influence and then what capabilities from a decentralized standpoint, like where are you trying to introduce flexibility or have optionality for a patient on whether they need to be in a clinic or could do something remotely? For me, and I’m speaking on this from a patient perspective too, it’s more about choice and flexibility than it is about a particular model or not. We spend a lot of time trying to define what DCT is, and I think that’s a good, I think that’s actually a really good exercise, is for within your organization to sit down and define what does DCT mean for your organization. And maybe you do that at a franchise level, maybe do that in an indication level. You probably should do that in a study level. We’ve put together some pragmatic tools like checklists and things to help us communication guides, between study teams and my sourcing leads, to understand when a team says, we want to do this DCT, what does that mean? Which capabilities make sense for this project? How is the study designed and where are you going to plug these solutions in? Because you can say DCT to people, it means very different things to different folks. And I’ve had this happen just recently where someone were saying DCT and they were interpreting as a siteless trial. You don’t have to not have sites to still have some decentralized components to it. I think it’s an area that has promise, but I think you have to be very clear and very strategic about what capabilities make most sense for your portfolio and then work back into who are the right partners to have to deliver those capabilities and then be rigorous about measuring what you thought you were influencing to understand whether it’s actually delivering what you thought it would.

Joseph Kim:
Yeah, which in this case is what, has anyone at least agreed on what the outcome, the impact it should have? So from my vantage point, it’s always been about recruitment, but I haven’t yet seen that actually happen.

Dennis Salotti:
Yeah, I’ve heard it’s going to be faster, it’s got to be better, it’s got to be cheaper. Which is typically like the triad of what everyone’s selling to you. And I’m cynical because I sit in a sourcing seat, but that’s everyone trying to sell you is better quality, faster, and cheaper for your budget. I don’t know that you can achieve any of those, especially the first time or first few times you do it. I think we’re still on the learning curve here, so we’re going to bump our heads a bunch. I’m saying that probably as an industry level, but I can just very pragmatically, I think the first couple of trials are due, you’re going to learn a lot.

Joseph Kim:
What they say about project management, you can only get two out of the three scope time costs. So to save cheaper, faster, better. I don’t, I think the rule is you can only get two of the three. So it should be cheaper, it should be faster and better, but more expensive. That actually makes sense, that follows the law of project management scope.

Dennis Salotti:
That’s where it gets really challenging because I think, you look across your different stakeholders and everybody’s got a different intent, right? So some folks will want to see savings, they’ll want to see cheaper development, lower my costs to develop that asset. Other folks will be interested, help me hit my milestones fast, let me try it. Which could have an influence on cost, but it depends on how much it costs to expedite those milestones to your point, or these things are interdependent. And sometimes I think, and I think oftentimes in this space, they’re going to be in conflict. So you really have to, as an organization, get everyone on the same page. Are we willing to spend more to test the hypothesis we’re going to move faster or are we willing, how much are we willing to spend to demonstrate meaningful improvements in quality? And maybe it’s patient compliance with assessments or less missing data, things like that? What are those things and what is our spend threshold around that? Are we willing to make those investments? And then when, what is the, when do we know that we’ve got an equitable return on the dollars invested? I think that’s important to have that conversation early. We don’t measure, or maybe we’re just starting to measure patient satisfaction. For me, we have a real big problem with marketing our trials to people, and I know we’re not supposed to use the lawyer will probably kill me if I use the word marketing a trial. But like I think about a clinical trial, what’s priced product placed on people, those things. And you want to have a relationship with the people, right? Which is a function, I think of the other three things. And so you’ve got to think about their satisfaction. When 80% of the population isn’t really aware or doesn’t really participate in trials, and those that do to get a lot of one-and-dones sort of experience, something’s broken there. And I think we should probably be looking more at measuring patient satisfaction and Net Promoter Score. Would you recommend participating in a trial to your friend or colleague? Because that’s probably going to get at the root of a lot of the causes that drive costs, that drive time, because we don’t have enough participation in research. If DCTs can help with that, great. I think they’re a step towards the kind of the type of social economy that we live in now or things show up at your doorstep and everything’s immediate gratification and mobile-enabled and all these sorts of things. I just don’t know if it’s going to prove out, and I’m optimistically skeptical around it. I think it’s good to do some elements of it, but I’m not sure that it’s going to deliver on all of what’s being purported that it will deliver for our industry.

Joseph Kim:
I don’t disagree at all, and I’m one of the bigger opponents of the hype of DCTs, yet secretly I’ve actually done several myself. So sometimes I feel disingenuous about like … being too critical because I’ve done them. But in my defense, it’s, not every trial is fit for that. So we’ve done one with a marketed drug before. I’ve done a couple of digital health ones and sure, they turned out fine. But does that mean a Phase three Parkinson’s is good for that? I don’t know, there’s a lot of different use cases out there.

Dennis Salotti:
Yeah, yeah, my experience, and this is personal experience as a patient in a decentralized trial, if you have the same complicated and onerous design from a patient perspective and you just put it in their house, it’s, still sucks, and you will drop out because that’s what I did. I dropped out of it and my feedback was, this is too onerous for someone with a job and other activities that. So, you know, it’s definitely not the panacea for everything.

Joseph Kim:
Sure, how do you know when a problem with your study is the study like you said, or with one of the partners that of, trying to help you out or provide some level of service or technology?

Dennis Salotti:
One of the things I look at is, was requests, for the partner specifically. I think there’s a system of requests and promises, right? So that’s where I usually start if there’s an issue. What if, we what have we requested of them? What have they promised us, right? And that starts, I think, with a proposal in a contract, right? So there’s a service, there’s something we’re going to do, there’s timelines. That was our request was to deliver the service they’re promised. Was the proposal in the contract that supports it? Are we fulfilling those obligations? If we’re not, have we then made requests where we’ve asked for more information or different approaches or further understanding of where things are going wrong? Have they promised to give us that information or promise to take actions and have fulfilled those promises? So I look, that’s my filter for kind of, is it the partner or is there something else going on? I think it’s just what are the action, looking past the words, what are the actions? And I do that in a two way, right? We also have to hold up our end of the bargain. So if we provided the timely input to things when they needed it. So if you can take that out of the equation, if that’s all either functioning correctly or you can subtract that out, then I think you have to put yourself in the place, and this is all context dependent, but you really have to put yourself in the trial and think about what, based on the design of the trial, what we’re asking of either site or a patient or a phlebotomist or whatever the situation is, and walk that process, is this reasonable? Can we and we should be doing this up-front? Sometimes things get out, we don’t realize and we’ve made it really, really onerous. So I think you’ve got to walk that process with them and then ask yourself whether it makes sense. I think a good example of this is if you’re using a patient recruitment vendor, with best intent to make promises about what your funnel might look like and what they can deliver, sometimes they’ll even share risk in that, and what they’ll deliver is they just pay, they paid for performance, but then you might find that it doesn’t work and that sometimes the quality of the sites are getting inundated with too high quality, a lower quality of lead. And so you’ve got to walk that process to see, okay, did they are they delivering on what they thought? Are assumptions correct, looking through that request promise lens? And then if they are, is there something in our study that’s not working correctly that’s driving maybe the wrong leads? So you can do that sort of exercise. I think that’s an example where you got to look at how is the vendor performing. Are they doing what we expected of them? Have we tried to troubleshoot it? And then if we go on the site as a stakeholders end of things, what are they experiencing? And then if we walk that back, or did we actually bake that in by design inadvertently, and then what can we do to change that? I don’t know if that helps illustrate it, but that’s one of the examples of the jumps out.

Joseph Kim:
Yeah, I love the whole request-promises construct and if you can just take some of that and make sure everyone has done their part faithfully, then you can go into the next layer versus trying to, and you do it systematically. It sounds like methodically you go through that gate before you start to go look at the project itself as busted. Is that right?

Dennis Salotti:
Yeah, because for me, so I remember when I screwed something up once and somebody who I really respect told me, they said, Dennis, it’s one project and one with one client in the span of an entire, of a year, which is part of a career, part of it. And so it puts into perspective like, okay, don’t beat yourself up. But when I look at our relationships with our partners, I try to retain that same view. If there’s ownership and a sense of accountability, and that’s the requests and promises, right? If we’re holding ourselves accountable and they’re holding themselves accountable, and then we’re all working towards the same objective around success of the trial, that’s something you can build off of. Things might be going sideways eight different ways, but if everyone’s committed in that way, you can fix things, right? And then we’re not going to throw the relationship out the window. We’re going to might be a little bit risk-averse the next time through, but there’s something to build off of there. And actually, if you can work through the issues at hand, you might actually come out stronger because you sweat and bled a little bit, too, yeah.

Joseph Kim:
Let’s talk about sort of the hallmark of place in general. There’s, so there’s, it feels like there’s now more startups than ever and I’m one of them, so I’m like creating some of the problems. Where do you see clinical trial partner market? Where have they overindexed and where has there not been enough attention paid to certain problems?

Dennis Salotti:
I probably, I’m trying to think of what, overindex, so DCT certainly, and I’m thinking about the volume of email, of unsolicited email I get in my inbox, because that’s a good surrogate I think for this. DCT, certainly, everybody has a DCT solution. I think we’re pretty heavy there. And so it reminds me of the early days of eCOA where everybody, everybody spun up an eCOA solution at one point, once responsive design became a thing, everybody could do it. I think we’re really heavy in that space now, it’s very fragmented, it’s very frothy, it’s hard to distinguish out. It’s possible, but it’s difficult sometimes to distinguish out who’s actually got promise and maybe who doesn’t. I wish I would see more solutions that are focused adequately on relieving site burden in a meaningful way. I feel like the post-COVID reality at the site level is that they don’t have, they’re very resource-strapped and they’re much more selective on what they can take on. I think they’re under a lot of duress still, and I don’t see a whole lot of solutions that are, that, I see some, but I don’t see as many that are actually would relieve burden the sites. I actually worry that so many of the new things that are coming out, DCTs probably being an example could actually worsen that problem because now we’re pushing the rabbit down the snake a little bit, say, okay, now you’re our technical support staff, right, now you’re going to trouble this wearable and that wearable, and when they do telehealth and they can’t connect, they’re going to call you. It has the potential to create that situation. One of my first questions, whenever we do anything technology-driven, whether it’s DCT or otherwise, is what the support level is, because we really have to be cognizant of the burden we’re putting on the sites. And I do wish I saw more solutions in that space, some way to lift burden off of the sites.

Joseph Kim:
Yeah, that’s an excellent insight. And in fact, I’ve just heard from my colleague who’s at SCRS right now, the turnover rate for CRCs, research coordinators is like 40% and it’s.

Dennis Salotti:
Not surprising, right? Does that surprise you?

Joseph Kim:
It’s a little surprising. I thought 20 was high, let’s put it that way, and it’s now 40, that is very surprising. And to your point about site burden, that we’re grinding them down into dust, and then who’s going to take over? And if it’s that complicated, it’s going to get screwed up, not because they’re stupid, but because it’s complicated. So to your point about site burden, I think that’s a huge area that people need to pay attention to.

Dennis Salotti:
Yeah, it brings up another area that I thought that I didn’t think of originally, but by your comments, it just and I should have thought of this because I teach, there’s absolutely, I see very little investment from our industry or even service providers into our industry in developing talent, right? Whether it’s site talent, whether it’s professional, we want and we’re guilty of this. We want CRAs with X number of experience. We want people with all this experience. And then we flip out when our partners give us a PM with only three years of experience and not five or something like that. But I don’t know that I see on the other side of it the investment in developing talent, whether it’s through training programs or there’s some, I don’t know what the solution would be if I think of it, I should probably start a startup around it, but there, we have to feed that funnel more, right? If we want really strong study coordinators, or really great performance at the sites, if we want to grow our investigator base, I know that’s another area we’re getting pinched, there’s a lot of one-and-done investigators, there’s not enough investigators now we’re trying to get investigators in diverse, diverse areas and diversity in our investigator pool. That just becomes more challenging when there’s not a lot at the top of the funnel. I don’t know that there’s a solution for that out there yet. There’s universities that have programs, I teach in one of them. I think ACRP is doing some things around workforce competency, which is, what I think we need capitalism at work there, right? Maybe we need a different way to approach that problem. So maybe that’s another area, underfed area.

Joseph Kim:
Yeah, yeah, final question for you. What area is ripe for disruption? Like they, now they’re getting old, not a single company, but a category of suppliers. What’s ready to be disrupted because it’s all just, me toos, more the same.

Dennis Salotti:
It’s a good question. I don’t know that I have a good idea. I think of what hasn’t been touched already.

Joseph Kim:
What about EDC? Is that ready to get blown up?

Dennis Salotti:
When you first asked, I was thinking about like EHR EDC integrations and like, why are, yeah, why are we entering data? But I don’t know that it’s ready for disruption. Every time we look at that area, and I just have this conversation internally, we’re looking at this space. A couple of weeks ago I was talking with my team around this and the environmental conditions that are necessary, I think, to really make that an effective space for disruption just don’t seem to be there. There was a lot of hype with the SMART on FHIR stuff and you could do that, but pragmatically, like it’s hard to support at scale. I would love to see it disrupted. I think that would be a great area. I just don’t know if the environment’s right for it yet. I probably would come back, maybe that’s I should revise my answer before. It’s probably just how we develop talent in this industry is probably ripe for disruption. That’s probably the biggest thing, in generating investigators, just how do we create investigators? One of the other areas, I think my bias on the table, I used to work in this space with a, and we spun out a company around it, but I’m not there anymore. You know, how you qualify vendors? I spend a lot of time in a sourcing seat now having to put vendors through a number of different enterprise risk assessments and then quality assessments and then business subject matter expertise, business assessments. If there was a way, it’s all the same information that I’m asking that the next sponsor is asking, that the next boss was asking. That is an area that could probably be made more efficient. It’s not the flashiest sexiest area of vendor qualification, but it could be made more efficient.

Joseph Kim:
Yeah, sometimes it’s the boring stuff that is the most important, and then unlocks the rest of it for sure. That is something I just learned recently from my, from our CEO because I often get a little too proud and ambitious about what I think is cool enough for me, and it’s stupid, right? I just swallow your pride and fix something that’s fundamental, absolutely. What advice would you give? Last question, what advice would you give a new startup coming to you with a widget or a service? Like what’s the best way for them to get your attention, get your interest?

Dennis Salotti:
I think, first thing I think would be to do your homework and make sure that when you come to me, what you’re talking to me about is reasonably relevant to my portfolio, to the size company I am, and then listen for where you might have to tweak, where you might have to really filter for is this still an applicable and a reasonable thing? Can we actually move the needle for these guys? I get a lot of requests referencing a drug that we divested six months ago or a piece of the pipeline that just doesn’t make sense, or I think you want to do your homework to be relevant. I think that’s really important. The hours spent doing that will get you much more success, I think, because then I tune in a little bit more like, okay, this is let me listen to the next piece of it. So I think that would be, that probably the one keystone piece of advice is, absolutely do the homework to be relevant to who you’re talking to and what you’re going to try to talk to them about and how it can be relevant in their life. Well, beyond that, I think just to be humble, not really overselling what it’s going to do or what you want, you’re not going to, as a startup, as a new startup, pitching for a Phase three program for a company that that maybe has three Phase three programs launching that year or something. It’s just not, it’s not realistic, so I think being a consultative sell and kind of listening, coming with something relevant, listening for what the, where you might have to modify that or riff on that to be even more relevant. And then really partnering to say, okay, we’re not going to try to go hit a grand slam over here and get a multicenter global phase three. What can we do so we can demonstrate our value to you? What would be the right way to, here, and come with a couple of ideas? Can we do this? Can we do that? I think that’s more of a consultative sell and that’s a little bit more helpful because it’s hard to take time out of your day to understand someone’s solution or what they’re trying to sell you and then try to think through how could I make this work in my portfolio, and then what part of my portfolio am I comfortable doing a pilot for? It’s a lot, those are a lot of jobs. So the grease that a new startup could bring to the wheel is to have done some of that thought in advance, come up with some ideas, and bring those to the table in a thoughtful way, because that just lessens the friction, it lessens the, where everybody is so overworked, it takes a little bit of work out of the equation, and if we hit upon the right opportunity, things can move a little bit quicker.

Joseph Kim:
Yeah, yeah, your point is well taken, I think. What I think many startups are shy about saying and many customers are done with as a question is, tell me about your pain points. It’s ugh, get-in line. There’s so many, how much time do you have?

Dennis Salotti:
If I have to tell you what my pain points are like, I don’t feel like you’re invested in me. That’s, like you just hit upon a nerve because I hate that. I get so many emails that start with I’d love to, for you to learn more about your pain points. And I’m like, I’d love for you to already know and to tell me how you’re going to fix them.

Joseph Kim:
But there’s this fine line between asking that dumb question. That’s a bad opening gambit, of course. So asking the right question to get to where you are, which is, hey, I’m flexible here, if you have a different, slightly more easy-use case or lower-hanging fruit, let’s go for that.

Dennis Salotti:
I think it’s harder for less experienced folks to do the more experienced folks. And what always impresses me was when someone understands, someone, especially in a commercial or a sales-focused role, understands how their solution, when I challenge or one of my team challenges to say, look, like I get what it does, and that might make some sense, but let me ask you about this, because this would be even more valuable. And it’s not that this other piece isn’t. I think there’s value there, but this is where I can see we actually can get some traction more quickly. Having that person on the other end of the line to be able to understand what you’re asking and know whether or not their solution, understanding how their solution works in such a way that they know whether or not there’s a chance and how it’s going to, they could satisfy that use case, that’s a key skill. You get a lot of folks that maybe they just know the pitch, but they don’t actually know anything about how it works. And so when you ask a question a little bit below the surface, I’ve got to get back to you, or you get weird answer. It’s so much more effective to just know. All right, is that a quick exit point? Is this just not a good marriage right now? Let’s talk again in six months. Or is it something that, hey, there might be something here? Why don’t I have another conversation and come back to you or you have another conversation and come back to me. Like there’s a next step that we should do more immediately because that’s how we filter opportunities. When we were talking to new and innovative companies, we put them into boxes because you have to have some way to rationalize the marketplace and some of them are, this doesn’t make any sense, these guys are crazy, whether this doesn’t make any sense for us or we think it’s snake oil. And then there’s other ones where we say, you know what, it’s interesting, but come back in six months, let’s monitor them. Six months later, we’ll take a look at them. And there’s others that maybe it wasn’t perfect when it came in, but there’s something there, we want to explore that. And obviously, if we can find that something that it becomes a matching or matching case, how do we match this to a trial?

Joseph Kim:
Yeah, yeah, yeah, brilliant advice, I think, and really good, helpful understanding for not just startups, but mature suppliers for sure. Dennis, thank you so much for spending some time with us today. It’s always good to see you and talk to you. You made me laugh a couple of times, which is always good. Anyway, have a great day, and thanks again.

Dennis Salotti:
Thank you. No, my pleasure, Joe. Thanks for having me on.

Joseph Kim:
All righty.

Dennis Salotti:
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