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This is the Leap Together podcast, where we highlight top leaders driving breakthroughs in clinical research and life sciences.
We're looking at chipping away at the need for morphine by finding different classes of drugs that act in different ways, that have different toxicity profiles that you can add together. This kind of multimodal analgesia has started to gain ground.
Zach:Hi, Zach Gobst here. I'm the host of the Leap Together podcast where I chat with leaders in clinical trials and patient advocacy to explore how medical breakthroughs come to life. Today, we're fortunate to be joined by Doctor. Todd Bertoch, the CMO for pain research at San Excel Clinical Research. He's been the principal investigator for over 160 clinical trials focused on streamlining and simplifying pain research.
Zach:You know, personally, his commitment to research, particularly pain research, has been inspiring to us. My staff have seen it up close over the years. We came across a number of studies even outside of pain. I think we worked on a few timely vaccine studies together as well. And I can say my staff will tell you his leadership and support has always felt, and it's been reflected in positive feedback from patients that we've supported together.
Zach:Yeah, excited to have you on the podcast.
Dr. Bertoch:Very nice of you. Thanks, Zach.
Zach:Yeah. You've been a driving force in pain research for decades now. Where did this all start?
Dr. Bertoch:Oh, wow. Well, I'm old now. So it started a long time ago. I went to medical school thinking I was going to be a pediatric oncologist. I was pretty sure that's what I wanted to do.
Dr. Bertoch:And then I saw my first really sick kid and I thought, I'm not sure I can do this my whole life. It was just so heartbreaking. I ended up going into anesthesia and pain management. And through a series of events, got kind of interested in the opioid problem many years ago. I was probably a contributor to the opioid epidemic early on.
Dr. Bertoch:That's just the way we were trained. And then got interested later on in my career, practiced for about twenty years in clinical practice. Got interested later on in my career in addiction medicine. Did a lot of addiction medicine in conjunction with my pain management clinic. And then ultimately the stars all aligned and I got involved early with SenExcel and it's just been a fun ride since then, kind of working almost exclusively in pain research since that point.
Zach:I did some background research on other things that you've shared. And what stood out to me is how in touch you are with the experiences of patients, that for years has been kind of this catch 22, risk opioid addiction or try to survive silently. What are some of the discussions about pain that you think need to be happening more? Where might there be an education opportunity about what patients are going through?
Dr. Bertoch:Yeah, I think if you don't experience significant pain, don't really care. You don't get it, right? You don't understand. I mean, the majority of people have had experiences with pain in their life. And those have usually been acute episodes of pain and you have some recall of having been miserable because of the pain, but then it goes away.
Dr. Bertoch:And so especially people who are in chronic pain, it's hard to relate to that person. But the impact that someone who wakes up and goes to bed with chronic pain on their life is it's kind of immeasurable, right? I mean, just imagine someone who, you know, I have I've had kidney stones. That's the worst pain I've ever felt is a kidney stone. I can't imagine that pain not resolving, right?
Dr. Bertoch:Having that pain from morning till night. But some people are experiencing that degree of pain every minute of their day. And the options to treat it are have pretty significant side effects associated with them, or they're just, you know, not inadequate. The despair that accompanies that is just it has such a human toll on it that I think the majority of us who are not experiencing pain can't really understand what these people are going through.
Zach:160 studies kind of seeing this up close with kind of patients experiencing pain. Curious if you've had any inflection points. I don't know if it was like a study one or study 20 where like something clicked and maybe say like, hey, this is there's something kind of like for me to kind of take on here.
Dr. Bertoch:Yeah, it was before I got really involved in research. Was actually very early on in my career when I trained back in the mid 90s when I did my anesthesia pain training. And back then, at least where I trained, and I think it was kind of universal, there was this dogma that if someone had real pain and you could give them an opioid and that opioid would take their pain away such that they could live their life in a meaningful way, then, you know, as their pain increased, you could just increase the opioid dose. I mean, it was like you couldn't give too much opioid to someone who was experiencing true pain. That was the dogma.
Dr. Bertoch:And that's how I was trained by people that I really trusted, and they were trained by people that they really trusted. And so that's what we did. I mean, we gave a lot of opioids. And it wasn't until later that we realized, hey, that dogma was completely false. We were just wrong.
Dr. Bertoch:That was like bleeding out a subject or patient. Was just so antiquated. It seems so antiquated now, but then it was the thing, right? We thought that the only people that got addicted were people who weren't really experiencing pain and were seeking opioids for the high. Those were the people that got addicted.
Dr. Bertoch:But people with real pain, they never got addicted. Then I graduated from residency from my training. Went to I was actually I trained in the military. And my first assignment was at a small US Air Force Base in Japan. And I had a pain clinic there.
Dr. Bertoch:I was treating people the way I was trained to treat them. One of my patients was the wife of a Marine colonel. It's tough to become a Marine colonel. The Marine Corps is quite small to sort of reach that level of leadership is is difficult. Takes a special person to become an six in the Marines.
Dr. Bertoch:He's pretty stern guy and he would come in with his wife for all of her visits and I would prescribe opioids for her pain. And I thought I was just doing such a great job. And then one day he came in without her and I thought he was gonna kill me. He was so angry. And then he kind of started tearing up, and he said, you have made my wife an addict.
Dr. Bertoch:And I was kind of in shock, like, a minute, I did everything I'm supposed to do. And it was right then, if you were talking about when the light went on, right? For me, the light went on right there that, wait a minute, I've been trained wrong this whole time and I had to rethink this. And that's when things changed for me and when I started heading down that path that I wanted to understand better how really we needed to be treating these patients.
Zach:Yeah, I'm kind of processing what you're saying. I think that it's incredible that you kind of had that inflection point that what seemed like it was almost there's like rules of the road and like people who get addicted, they're kind of in this other bucket, that you got up close to kind of what's really going on at the human level. And you could see someone, admirable colonel in the Marines, go through this and flip on the light for you to kind of go from that point to where you are now. I'm trying to think of like the inflection points that kind of I went through in terms of like, I was speaking with you right before we started the call, always thought like, oh, medical research or everything, medicine, like someone else to take that on. I want to work on something.
Zach:So I kind of put it in my own bucket. And then like I had a personal experience with my father where it's like, oh, there's so much impact to have here and there's so much going on in the human experience that kind of led me into research. You've been doing it for decades now where, you know, over the years, have you had any other kind of inflection points kind of like that that stand out too? Like where you thought research looked like this, it actually looks like that. Or you thought that pain patients that were looking for one thing or maybe it was something else, or maybe there's like a family dynamic, interested in anything else too, because this stuff's super fascinating.
Zach:It's because it's kind of where transformation comes from.
Dr. Bertoch:Yeah, I think, you know, the past twenty years in pain research have been a little frustrating, demoralizing perhaps. We just haven't seen a lot of movement, right? I think all of us thought if we can send someone to the moon, we can develop a pain medicine that is as powerful and as effective as morphine without the side effects. And so I think for the past two decades, everybody's been focused on finding that drug. And unfortunately, it's not out there.
Dr. Bertoch:I'm not sure it exists. An inflection point that I've made more recently in my career is, hey, I think we're going about this wrong. Right? I don't think there's a morphine without side effects out there. Hopefully we'll get smart enough, but for twenty years we've been trying to find that and we haven't been able to do it and it's been kind of frustrating.
Dr. Bertoch:I think more recently we've kind of changed our direction and look, we're looking at chipping away at the need for morphine by finding different classes of drugs that act in different ways that have different toxicity profiles that you can add together. And this kind of multimodal analgesia has started to gain ground. Early on, it was a little not exciting because we didn't have a lot of things to put in our multimodal bucket, but now we're adding, know, now we've got the sodium channel inhibitors that are kind of taking off. We've got, you know, a lot of other potential options that we can start maybe combining these things because they don't have the same toxicities. You can combine them safely.
Dr. Bertoch:And because they're acting at different areas in the pain process, then we can start chipping away, I think. So I think that's been a kind of a sea change in approach. And it's brought a lot of excitement, I think, to the research side of things over the last couple of years.
Zach:So as you've gotten closer to research design, the tech world they call it almost like a pivot from, hey, instead of trying to find a solution that looks like this, we break it down and try different approaches. Curious about the other people that you've worked with kind of involved in that shift. Who's been really impactful or who's helped kind of partner with you on this that has kind of helped you kind of find different paths or find different ways of solving this? Because usually that's something like a team of people thinking of different ways to go about it. Interested if there's anyone that you think has been particularly helpful, whether it's colleagues, mentors, or partners.
Dr. Bertoch:That's a great question. Well, first of all, I have to talk about a couple of mentors that have kind of taken me under their wing. They didn't have to. They kind of taught me the ropes. And one of those is Doctor.
Dr. Bertoch:Steven Cooper, who started this kind of postoperative pain assessments that we do here at Center Excel Salt Lake City, you know, that kind of design these very sensitive pain models that allow us to really do a better job of deciding if a drug works or doesn't work. So Doctor. Cooper was the father of the dental impaction pain model, which was the first and still the most sensitive model that's out there. He was so generous with his time and expertise with me, Doctor. Paul Desjardins, kind of the father of the bunionectomy model.
Dr. Bertoch:They've both been very generous mentors. But honestly, I have the good fortune of working with so many different pharma companies and their clinical research divisions. They have such bright minds that it's kind of this it's a wealth of people that I get to work with, and we get to bounce ideas off each other. And right now, I think my goal is to try to help the regulatory agencies see where we're deficient in our ability to find new pain medications and things that need to change. But that's like changing the direction of a of a very large boat.
Dr. Bertoch:It little changes at a time. But but there are ways pain is really difficult to research because pain is so subjective, right? If I'm doing cancer research, there's a biomarker that I can track that says my drug is working, right? I can there's some laboratory tests that I can say, hey, my drug's working and it substantiates what I'm studying. But for pain, it's so subjective, so variable.
Dr. Bertoch:The mechanisms that are out there right now that will satisfy the regulatory agencies to say that a drug works or doesn't, it's very difficult for a drug to reach those levels at this point. And so I think there have been a lot of drugs that I've worked with, a lot of pain medications that I've worked with over the past decade that I think were good, that had a lot of promise. But because of the difficulties of showing efficacy using the current models that we have, those studies failed, unfortunately. And I think there are better ways that we can go about doing that. So that's been the focus of my work over the past five or six years is to streamline the way we're doing those studies and try to find better ways to show efficacy.
Zach:Yeah. What I'm hearing your response is because of your years of experience, you are able to kind of have a voice with how the regulatory bodies see, how to measure endpoints and how to think about what's working and what's not. You kind of understand it at the patient level too, like what makes visit adherence difficult, how you might be looking at one study in one area, how it doesn't translate. Yeah, it's awesome that you've kind of built the momentum to kind of have those conversations. I imagine it's, yeah, like you said, hard to kind of shift an organization like the FDA is thinking, but you're able to do it, which is pretty incredible.
Dr. Bertoch:Well, we're working on it. Let's put it
Zach:that way. Yeah. I think you're wired a little bit like me where like where we want to go, it's always we're moving further. It's hard to smell the roses. Interested in you spoke a little bit about kind of different modalities and kind of the future of pain research.
Zach:Curious about what new approaches, whether that's from the biotech community or whoever, are most exciting to you right now a little bit more and a little bit more why. Curious where your head's at in terms of what the progressions are going to be.
Dr. Bertoch:Great question. The beauty of opioids is that they just work so well, right? And they work centrally. So pain has so many inputs. Evolutionarily, we've grown to have multiple different pain pathways because it's in our survival interest to move our hand when we're getting burned or, you know, to if we have pain, we break a leg.
Dr. Bertoch:It's it's in our interest as a species to stop walking on that leg until it heals. I mean, we need to be able to experience pain to survive. And so we've generated as humans so many different pathways to experience pain that if one of them gets blocked, another one's gonna jump in and take over the work of telling us that we're having pain, right? Which is very frustrating as a pain researcher because you identify a pathway, you find a way to block it, and the body just says, well, watch this. I'm gonna you're still gonna experience pain despite what you just did.
Dr. Bertoch:Right? So one of the most exciting things is just scientifically, the people way smarter than me are out there, you know, deciphering all these pathways, things we never knew caused pain before, you know, proteins and path, you know, neural neural pathways and things that we never knew were part of the pain process. But now we're starting to isolate those and then we're starting to be able to find ways to impact those pathways. And that's where that kind of multi, that move to multimodal approach to pain management happens. Because once we start working inside the brain, like an opioid does, which is the endpoint of all those pathways, right, the final receptor of all those pathways, then we have all the addiction risks and and problems.
Dr. Bertoch:So if we can if we can block those pathways before it gets to the brain, then we can help diminish the pain without the side effects. So I think the most exciting thing for me is seeing all these new pathways being delineated and then being able to tackle them separately. Gene therapy is something that I think is exciting for all of us as far as targeted approaches to being able to treat pain and some of the biologics that are out there. So I just I'm really excited about the future, whereas the last two decades have been pretty ho and depressing. I think there's kind of a new excitement now that we're going to be able to start making an impact on pain as we learn more about all those different pathways.
Zach:In my non medical terms, I guess it's like instead of trying to kind of numb what's going on in the brain, we're understanding cause and effect of what's happening and what comes up where. I don't know if that's accurate. So but in any case, is there something going on with kind of the world of like real world evidence and AI that's driving this from your perspective? I don't I don't know if you have an opinion on that. I'm kind of curious if you've seen anything.
Dr. Bertoch:I haven't seen anything definitive. I think there's this hope, you know, I just don't know, to be honest with you, but I can imagine it's not gonna be able to provide us more information. All of these different pathways are so intricate and there's so much input output that I think the power of AI applied to those systems to understand how those systems work, that's gotta be a positive, I think. But I haven't seen any direct evidence at this point.
Zach:Yeah, also in terms of like kind of like clinical trial design, improving visit adherence and gender disparity, after you've done as many studies that you had curious about the patient experience in clinical trials, if there's anything like on the horizon that you think is important or any kind of key lessons learned when it comes to that.
Dr. Bertoch:Biggest thing that we've learned recently is how expensive it is to take a drug from a pain drug from inception to approval by the regulatory agencies. So the number $1,000,000,000 gets thrown around as that kind of cost to get a drug from inception to approval. Clinical trials are are very expensive. The most sensitive ways to the most sensitive way to assess a pain medicine is through these postoperative acute pain clinical trials where we do a surgery, it results in pain. Can standardize the surgical procedure and the anesthesia such that we standardize the pain experience for the patients.
Dr. Bertoch:And when we have something standardized, we can test it. If there's a lot of variability in what people are experiencing, it's very hard to test that and get an accurate result. So those postoperative pain studies are nice because you can schedule them, they're anticipated, you can imagine if you're gonna try to test a pain drug in someone who sprained their ankle, you have to follow soccer teams around until one of them sprains their ankle, it's pretty difficult to do, right? But if you can schedule these patients and have them come in, you can get quite accurate data from those types of clinical trials, but there's surgeons involved, there's surgery centers or hospitals involved, it can be very expensive to do these clinical trials. And one of the things that I'm trying to focus the industry on is, hey, we don't have to do so many different studies and different indications.
Dr. Bertoch:If we find a drug that works and we've got enough people, enough of a sample size of patients that have experienced the drug that we can make sure that it's safe, we can cut down on the costs associated with that because there are some great drugs out there, some of these small biotech companies that are developing these amazing drugs. A $1,000,000,000 price tag is daunting. Those drugs just they die on the vine because there's no way they can get the funding to do that. And And a bigger challenge even now is, you know, a lot of those early studies were done with government funding. And the government would, you know, fund some early starter or, you know, kickstarter type compounds.
Dr. Bertoch:And then depending on if it looked like that drug might have some success, now the industry will get involved and there'd be some investment from the industry. I really worry about recent political changes that have cut that funding off. And I worry that in three or four or five years, what that's going to do to new molecules that have potential to succeed. So those are some concerns I have right now.
Zach:I think there's a lot of scary wait and see with kind of NIH funding, the way things have kind of helped support the growth in our industry. We're not sure how it'll shift. I really appreciate kind of the design thinking behind, we see it on patient recruitment on our end. Like we see the protocol, we see where the sites are and then we try to make it happen. And we're always curious about like, hey, how did they kind of design everything that went into this upfront They are being thoughtful about kind of applying the nuances of like, oh yeah, when does it make sense to like bring a patient in and what are all the other factors that are going on in their care?
Zach:How do we do a scenario analysis and look at different ways of designing this so that we're getting good data, but we're also able to kind of do this in an efficient way from a cost perspective? So
Dr. Bertoch:the real problem, Zach, is that. We're kind of like lemmings, right? We've had a company that's been run a successful program. And because it was successful, we say, well, we have to do it that way, right? And even though part of that doesn't make sense and it's too costly, there's a fear of going back to the agency and challenging these norms and dogmas because you're worried that you don't want to get the ire of the agency when this is your little baby and you're trying to get it approved, right?
Dr. Bertoch:So we tend to just keep doing the same thing over and over again. And I don't think that's necessary and I don't think it's helpful. I think challenge existing norms in the way we're doing these trials and make them more efficient, like you said.
Zach:Clinical trials are like expansion of the scientific method. It's good that we're trying to kind of build off what we know is working. But I think what you're saying is more about like seeing the forest from the trees of like, we can look at this and take what we like and the things that we don't like, can be critical about and figure out if there's a better way. But that's not always the incentive structure, starting with how biotech is funded. And I think a lot of parties that are making decisions, they have to kind of get that outside perspective a little bit.
Zach:So I really appreciate the time of conversation, really fascinating to kind of get your perspective on these things. Anything else that you wanna share? Any other shout outs that we didn't get out there?
Dr. Bertoch:If I can shout out, I'll shout out to a couple of people that got me into the business. That's Ryan Brooks and Dane Black. They were the entrepreneurs that started SenExcel Clinical Research that brought me on. I think I owe a lot of the satisfaction that I've had in my job to them and them taking a chance and getting me started here. So I'd love to shout them out.
Dr. Bertoch:They took a lot of risks to get Senexcel to where it is now. And then the companies that I've worked with that have had trust in me, that have allowed me to help them develop their programs, Companies like Vertex, who just had their new NAB1.8 inhibitor approved by FDA, and others that I can't count all the companies that have allowed me to participate with them. I'm just grateful to everybody who's collaborated and let me collaborate with them.
Zach:Thanks Doctor. Bertoch. Grateful for you to coming on and sharing all this and for all the work that you're doing to move pain research forward.
Dr. Bertoch:Thank you so much for having me. It's been a pleasure.
Leapcure:That brings us to the end of our conversation with Doctor. Todd Bertoch. His work reminds us that clinical research isn't just about protocols and data, it's about people, their stories, and the hope that comes from pushing medical innovation forward. Thanks for listening, and until next time, stay informed, stay engaged, and keep pushing for better health outcomes for all.