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Unmasking the True Costs of CRO-Managed Trials
Episode

Charles Theuer, CEO of Tracon Pharmaceuticals

Unmasking the True Costs of CRO-Managed Trials

Brought to you by   | hosted by Joseph Kim

Are CROs an Unnecessary Expense?

In this episode, Charles Theuer, CEO of Tracon Pharmaceuticals, shares his controversial perspective on the value of Clinical Research Organizations in pharmaceutical clinical development. Charles argues that the current payment model for CROs, which involves fee-for-service and guaranteed monthly payments, can lead to inefficiencies, value destruction, and higher costs in drug development. He advocates for in-house trial management, highlighting the benefits of direct communication, quicker responses, and improved data integrity. Charles also suggests alternative models, such as a hybrid approach for specific trials and success-based milestone payments, to incentivize CROs for timely completion. Charles also introduces his book “Unnecessary Expense,” which delves into his perspective on improving efficiency trial management and reducing unnecessary costs in the pursuit of optimizing drug development.

Tune in to learn more about the pros and cons of CROs and offer your thoughts on this debate!

Unmasking the True Costs of CRO-Managed Trials

About Charles Theuer:

As President, CEO, and Board Member of TRACON Pharmaceuticals, Dr. Charles Theuer is trying to solve the $2 billion drug problem facing the medical community. His work is aimed at transforming outcomes for cancer patients by helping pharmaceutical companies streamline the costly and lengthy process of research and development. Through their paradigm-shifting Product Development Platform (PDP), TRACON Pharmaceuticals reduces the cost and time of drug development without compromising on the rigorous standards demanded by the FDA. Dr. Theuer has been a leader in the development of significant oncology breakthroughs, including Sutent®, which transformed the treatment of advanced kidney cancer.

Theuer earned his B.S. in Molecular Biology from the Massachusetts Institute of Technology before attending the University of California, San Francisco, for his M.D. He received a Ph.D. in epidemiology from the University of California, Irvine, and completed his residency at Harbor-UCLA Medical Center. Reflecting on his time at Harbor-UCLA, he remembers, “We were taught to treat each patient like they were a family member and do well by them. It’s a lesson that I carry with me to this day.”

While working as a board-certified general surgeon, Dr. Theuer was approached by a friend from medical school. His prior classmate was with the biotechnology firm IDEC Pharmaceuticals, and thought Dr. Theuer’s background in antibody research made him a natural fit. Dr. Theuer wrestled with the notion of walking away from surgery and ultimately decided he would be better able to make a global impact on cancer patients through clinical research. He joined IDEC as the Director of Clinical Development in 2002.

After IDEC, Dr. Theuer was a Director of Clinical Development at Pfizer, where he oversaw the development of Sutent in kidney cancer. He then joined TargeGen, Inc. as Chief Medical Officer prior to becoming the President and CEO of TRACON Pharmaceuticals in 2006, where he works to this day.

 

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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:
So today, I'm really excited to be here with Charles Theuer, who is the CEO at Tracon Pharmaceuticals. Charles, thanks for coming on the show. It's really great to have you.

Charles Theuer:
My pleasure, Joe. Thanks for the invitation.

Joseph Kim:
Sure thing. So let's talk a little bit about your trajectory as a scientist turned to a clinician and now a researcher, right? So you have your training from MIT in Biological Sciences, you went on to do a PhD in epidemiology, you got your MD at UCSF. So you've seen science and medicine from all the right angles, I think, and then, did you practice for a while, like what happened right after your MD?

Charles Theuer:
Yeah, I appreciate the question. Yeah, I was a full-time clinician for many years. So after I finished medical school, I did a residency in general surgery at Harvard UCLA Medical Center, which was a big LA trauma center, but also did a lot of oncology care, and that was a seven-year program during which two of the years were research years that I actually did back at the National Cancer Institute on the molecular biology and new cancer therapeutics that involve antibodies conjugated to toxins. So I finished my residency, and I was on faculty at UC Irvine in surgical oncology, which is fancy word of saying cancer surgery, for six years before I was recruited into the pharmaceutical industry about 20 years ago.

Joseph Kim:
Got it. And then, so what made you leave actually practicing medicine at that level versus going into clinical development? Because they're very different worlds.

Charles Theuer:
They're so different. So it's a great question. So I enjoyed surgery, and I enjoyed an academic surgical program where I was treating patients but also engaged in clinical research, which I felt was important, especially public health research. I was mainly involved in how to best screen for cancer, for instance, colon cancer was one of my big projects, and I really enjoyed the aspects of surgical oncology, which in many cases gives you the power to actually cure cancer. For instance, localized colon cancer, we can cure that surgically, localized breast cancer, we can cure that surgically. Unfortunately, some patients present and many patients present with metastatic disease where surgical therapies insufficient for cure. In fact, every therapy we have, whether it be surgical medical or radiology or radiotherapy, I should say, will not cure the patient, and that, you need additional drug therapies to really help those patients. And the ability to potentially contribute to drug therapies that could, on a broad scale, global scale help patients is what really drew me into the pharmaceutical industry.

Joseph Kim:
All right, so you went out, you went from, a let's cut it out to let's somehow, like, use chemicals to destroy it. How hard was that to sort of shift your mindset from like, you know, a certain way of treating cancers and looking at things to more of a drug focused?

Charles Theuer:
Yeah, that's a great point. Yeah, it was definitely a change. You know, I had fortunately had a little bit of introduction to biotech. Even in college, my college summers, I worked at a biotech company called Biogen, which at that time, no one had ever heard of, now it's one of the big pharmaceutical companies in the world. It just shows you how that company has grown. So I had a bit of an idea of what biotech was like. And so when I was recruited into the industry, I could look back on some of those experiences too, to understand what I was getting into, if you will.

Joseph Kim:
Yeah, and so your first exposure in clinical development on the pharma side of things was, was that where the, what they call the CRO was in-house, or was that outsourced from the get-go?

Charles Theuer:
So, it's interesting, when I first joined IDEC, I think they had the foresight that actually they managed a lot of their own trials with their own team, which is unique in this industry, and when I joined Pfizer, for example, it was exactly the opposite. And Pfizer is, I'd say, obeying the typical paradigm in our industry, whereas when they do a clinical trial, they don't do it with their own team internally, using their own systems and own people. They outsource to clinical research organizations or CROs, to your point. And as I've kind of become aware that that is really destroying value in our industry, is our contention here at Tracon, which is my current company, and it's become, I would say, kind of the price of business as usual in our industry that many companies say, we don't want to deal with implementing a trial, we'll just kind of throw it over the wall to a CRO, we'll let them do it, and we'll pay them a certain amount of money, and it should be done in a certain time frame. The problem, Joe, is the way that the companies are paying CROs is, in our view, very egregious. So CROs are typically paid in what I call a fee-for-service, plus a guaranteed monthly payment model. In other words, if they do no work, you still pay them.

Joseph Kim:
Right, you're cutting a check of what, six figures? More or less? Depends on the project, I guess.

Charles Theuer:
It's incredible. But in oncology, I would say the typical cost per patient for a CRO-implemented clinical trial is about $300,000 per patient. And what that means is as a typical Phase Three 600-patient oncology trial is going to cost, if implemented through a CRO, close to $200 million. And that's part of the reason it costs so much money to approve a new drug these days.

Joseph Kim:
The latest, so wait, wait, wait, before you go any further, I need to emphasize this phrase you said, which was CROs are destroying value. Like you said that pretty quickly, and it's been like, I'm stunned. I've been stunned for the last minute. So when you talk about, before you go into that next thought, when you talk about the costs you're paying a CRO to do something like an oncology study, like where is that money going? And I'll just play devil's advocate, wouldn't that money be going to people working if you hired them in your own company? Like, help us unpack where that money is going.

Charles Theuer:
It's a great point, Joe. So what ends up happening is that because CROs are paid in the manner where it's fee-for-service, plus it's a guaranteed payment every month, even if they literally do no work, what pharma companies do is they hire their own team of people not to actually implement the trial, but to police the CRO, and that's the ultimate irony. In a sense, pharma companies double pay. They pay their team to police a CRO, who they then pay to actually implement the trial. So the irony is that if you actually implement trials yourself, you actually pay your own team. It's really the same number of bodies, but you actually pay them to do the trial. So you actually don't have to increase personnel costs if you manage trials yourself.

Joseph Kim:
And by managing those trials, like give us the roles that you need to hire versus you would outsource to a CRO.

Charles Theuer:
Sure. Yeah, so, for instance, Tracon has been managing its own trials for the past ten years, and to implement a trial, there are really key personnel to follow. So you need a medical monitor who will field all the medical questions and interact directly with the principal investigator at all the sites. You need a study manager who will interact with all the study coordinators at each of the sites. You need a data manager who will also interact with all the sites to make sure the data is input in a proper form in the electronic database and issue queries if they're errors to correct those errors. And one of the most important people you need is a monitor at the site. So the monitor at the site is the person that, in our model, engages in what we call a 100% source document verification. So for every data point entered into our electronic database, they make sure that data is actually verified in the source document, usually the patient's chart, and is accurate. Those are really the key people you need to implement a trial. And if you have the right systems in place, and for example, there are big companies that do the integrated systems that you need to do a trial in the most efficient way, Companies like Veeva, Medidata Rave, Oracle Clinical. So, we contract with one of those big players, so we have the top systems, and then we integrate them, I think, in a very highly efficient way, and then we teach our people how to use those systems, and once you become facile with those systems, it's amazing how few people you need to implement a trial. Probably the last person I should mention, and this is more on a global sense, is the head of pharmacovigilance, so someone who's head of safety in terms of reporting serious adverse events that are unexpected to the FDA and also to the sites. So that's probably the last piece of the puzzle in terms of personnel you need in-house to implement your trial. So you can see it's not that many people, and again, most companies have that same, I'd say, number of people who are policing a CRO who then employ the people I just mentioned to actually implement the trial, which is why it's an inefficient use of resources and why you in a sense double pay if you use a CRO.

Joseph Kim:
Right, because you still probably have a medical monitor, you still probably have a study manager, right? And if not a CRA at every site, someone in the field to understand how to police or oversee the CRA staff. And then, I guess the billable rate, I mean, you don't have to talk about actual numbers, but the billable rate for outsourcing this, I'm guessing, is a multiple of what you would pay a salary.

Charles Theuer:
It is. I mean, our experience is you're paying, usually, in oncology trials, even the bid price from CROs now is about $300,000 a patient to encompass all their efforts, if you will, and that doesn't even include what you're paying your own team to, if you will, police that CRO. You know, one thing, one way to think about it, I think is useful that I really chanced upon as being part of a conference put on by the Society for Immunotherapy of Cancer called SITC, and they put on a conference called the Crisis in Clinical Research, because it's not just the sponsors who are really having problems with trials being conducted by CROs, the other group, if you will, that's suffering are the sites. And if you really think about it, Joe, there are three players, there's a sponsor, there's the CRO, and then there's the site. And sites are having a lot of problems making their numbers in terms of actually being able to stay in business, to pay their staff, and conduct the trials, and what they can pay their staff many times is insufficient, if you will, compared to what, say, a CRO could pay that same person. So what you're seeing at sites is they're losing money, and they're unable to retain talent who can go elsewhere for better economics. And so what I think is happening in a general analogy, but I think it helps people understand, you know, for every, say, $6 a sponsor is paying to conduct a trial, I would estimate that about $5 go to the CRO and about $1 goes to the site. When we do it in-house ourselves at Tracon, using that same analogy, the sponsor pays, meaning us ourselves, pays about $2. $1 goes to paying our people to do the study, and the other dollar goes to paying the site, if you will. So that's one way to think about it, there's this excess $4 in my analogy that is, in our view, just the waste of money that goes into supporting this, in our view, egregious reimbursement system of fee-for-service plus guaranteed payment model, which actually incentivizes the CRO, if you will, to make more money the longer the trial takes. So one thing is the cash, the other thing is the time it takes to do trial. Both those, in my view, destroy value, our issue here.

Joseph Kim:
So that's a very stark difference in margin or excess that you feel that you're paying. I know we're not going to talk specific numbers, but have you crunched some data? Is that like what you're actually seeing in terms of ratios like a 4 to 1 difference there?

Charles Theuer:
So I'm using, I'm basing an analogy on kind of what we know, what, we can do trials at Tracon for about $100,000 a patient, and you know, about half of that goes to the site, if you will. And we know that CROs are charging right now, bid price is close to $300,000 a patient. So our view is that they're paying sites about the same amount, that's the difference in contributing to my analogy. I will say this, I also know there are certain companies that, you know, that's the bid price, if you will, what you expect to pay based on the trial being done in a certain time frame. Remember, if the trial is delayed, the CRO is going to charge more money and make more money. And I am personally aware of companies that literally are paying seven figures for each patient enrolled in a trial when they finally do what I call the post-mortem. They actually look at what we actually paid and the number of patients enrolled, and they do that simple division and realize they're paying seven figures for each patient enrolled in a trial. And you start thinking about that, and you realize why it costs more than $2.5 billion of investment to approve a single drug. Now, part of that plays the fact that not every drug is approved, many fail in development, but also a lot of that reflects how much money is paid to clinical trials, which is the single most important expense in the drug approval process.

Joseph Kim:
Well, there is this old saying that floats around, which is, you know, cynically, but maybe not so much, is CROs will bid to win and then manage to profit, right?

Charles Theuer:
And I've not heard that.

Joseph Kim:
You've not heard of this?

Charles Theuer:
I'm going to take that. I'm going to take that, if you don't mind, and promulgate it. I¿ll spread the word.

Joseph Kim:
All my CRO friends are going to kill me, but that's, this is a thing that I've heard through the halls of, you know, clinical research. But I'll take that back now because it sounds like they're not even bidding to win, like they're bidding to profit and then managing to more profit almost. Is that what you're suggesting?

Charles Theuer:
You know, the cost of clinical trials have gone up higher, and the bid prices we're seeing are in the neighborhood, I mentioned, you know, about $300,000. But to your point, those may not be the final prices, as high as that sounds, based on the managed-to-profit paradigm you just discussed.

Joseph Kim:
Yeah, well, let's talk about the site perspective. So I've had a bunch of sites on the show as well, and they all vary, they have a lot of legitimate complaints, some of them for the sponsor, but many for the CRAs. And what they're saying about some CRAs is that they just don't know anything about the study, and it's very hard to actually, A, get an answer, let alone be supervised by someone who just doesn't know as much as you. Are you seeing that in the CRO model, or do you see that in your own staff? Or like, help me understand some of that.

Charles Theuer:
Yeah, I'm so glad you brought that up, Joe. I think that's actually another huge advantage of doing studies yourself with your own team. So our experience is that many CRAs will cut their teeth, so to speak, at a CRO, and then once they become experienced, many of them leave CROs because they can actually make more money as independent contractors. And so, for instance, the Tracon model, we have an incredible team of CRAs, or I call them monitors that we've been working with for ten-plus years, and it's like birds of a feather. The good CRAs are monitors know the other good monitors, and so we built this regional network of superb monitors or CRAs. And we've been working with this group for over ten years, and so we actually feel that's probably the most single important person that goes to a site because they're interacting with the site directly but, and they're incredibly experienced, and we have almost no turnover there, so that's a huge value and so comforting to a site. Whereas our experience is that with other companies we know that use CROs, the monitor will turn over very quickly, and to your point, they won't be highly trained. Like they may not understand the basic radiographic criteria used to evaluate tumor response. And so if there's an error in data entry and they don't even understand the definition of what response means, they're not going to be able to correct that error because they just won't understand the error existed in the first place. So great monitors is key to having a site respect you, have great response to their questions, but also data integrity that makes sure that you don't lose responses in the noise of inaccurate data entry. But it's more than that, Joe. It's like every piece of the puzzle, you have a direct relationship between the site and the sponsor. So I'm one of the medical monitors, as is our chief medical officer. If we get a call from a site, I answer the phone right away while the patient's in clinic and the questions answered. You know, in a CRO model, I'm aware, for example, the call will go into the CRO medical monitor who may be monitoring 5 or 6 other studies. He's not sure the answer, he calls the sponsor, sponsor may or not pick up the phone. By the time the answer gets back to the medical monitor, who gets back to the site, it could be the weeks have gone by. And clearly, the patient's not in clinic anymore. So we have each person in our company directly interacting with the respective person, if you will, at the site, so sites love that. Their questions get answered right away, there's no delay, and the monitors are highly competent. So that's another area where if you do it yourself, not only do you do, in our view, a lot lower cost, quicker trials, but higher quality trials. So you cover all three elements of what makes a trial done the right way.

Joseph Kim:
Yeah, and then what about the site satisfaction? How are they? How do they feel when, I'm guessing they're more satisfied because they can see more patients? They can, you know, execute their business according to their targets, and they get answers more quickly.

Charles Theuer:
They absolutely can. I think you develop a really special relationship. I'll give you one more example. We had an amendment to our pivotal protocol called … that we rolled out in January, and we have 29 sites in the United States and at a lot of sites to get an amendment through, it can take six months to a year. And that's, sounds, it may sound crazy, but with CRO-managed trials, that is a typical timeline. We had each of those 29 sites approved that amendment, each of them within three months. Why did we do it so quickly? It's just because of the nature of the relationship. We know them, they know us. We know who to talk to, to move things through as opposed to this, I'd say, unproductive relationship. Sometimes you see with CROs and sites that there's no incentive for the CRO to get that amendment through quickly, right? If it takes a year, they're actually going to make a higher profit off that study than if they did it in a month. Not that that's done willfully, but everything in this world, in my view, plays around economics, and if the economics are not aligned with best business practices, sometimes you see those types of delays.

Joseph Kim:
Was there like a straw that broke your back, because you were at Pfizer and you worked with a lot of CROs, and was there a, what, at what point were you like, never again?

Charles Theuer:
Great, great question. So, you know, necessity is kind of the mother of invention. So we had raised capital way back in 2010, and we promised the venture capital group that invested in us we would deliver a certain amount of data for a certain amount of invested capital. And we realized that there was no way we would be able to deliver that degree of data if we outsource our trials to CROs. And fortunately, we had the experience. So at IDEC, I mentioned the majority of clinical trials that were done in-house, so we had that experience. We also had been at Pfizer, and while Pfizer had not done its own trials, the general best practice model for Pfizer in terms of the SOPs, how you do things the right way, we were well versed in how to do things the right way, so that was also incredibly valuable. So that was kind of what pushed us in that direction. Yeah, I would emphasize we're not the only company that's kind of, I'd say, woken up and smell the coffee, like C-GEN. C-GEN has been doing in-house operations for a long time. And …, you know, I was at a lecture, he said he can do it for about $160,000 a patient. So again, about half what currently we're seeing CROs bid. Beijing. Beijing does trials with their own team as well, and they save incredible amounts of money. I think, you know, John Euler, to his credit, he made his first big money on a CRO, right? So I think, you know, he went to Beijing. Not that he said this, but I suspect he said, you know what, I'm definitely going to take everything in-house because I realize how CROs can make money using their typical business practice. Again, that's not a direct interaction, that's my suspicion. But I think what we're trying to do is really help others do what we do, to become CRO-independent and gain the benefits. I like to say once you become CRO-independent doing your trials, the headaches go away. What I mean by that is, it's so hard, in my experience, to motivate a CRO because they have this financial incentive that they'll make more money the longer a trial takes. So, you know, one day you try the carrot, the next day you try the stick, and you're just really, if you will, treating yourself because it's so hard to motivate someone who has an incentive economically for trials to actually create as many services as possible and also to take longer than than the budgeted time.

Joseph Kim:
Now, will there be? What will it take for you to reconsider? So let's say, you know, Tracon gets wildly successful, and you get acquired by very large pharma and, who's got a CRO model, like, and you have a few more studies that you need to do, And you know, here you're going to have to use this CRO. What would it take for you to get in bed with them again, or is that just never happening?

Charles Theuer:
Well, so CROs do have a place just to be, you know, clear. So huge global studies, for instance, Tracon has incredible experience. We've done sites, 70 sites in the US, we've done nine European countries, And we're looking to actually add to our portfolio sites in Asia. But that said, you know, for global studies, you'll sometimes need to engage a CRO that has the global swath of countries to engage in a huge study. But even there, you know, we have all the same systems that many CROs would use. So our view is that the CRO would be great for say, going to countries where we don't know the sites, identifying the sites, you know, having the CRAs on the ground because we have great regional network in the US and Europe, but not elsewhere yet. So identifying the CRAs on the ground that are experienced that won't turn over and also the regulatory filings in countries outside the US and Europe; we're very experienced with regulatory filings in US and Europe but not elsewhere. So a hybrid model would work very well, and many CROs are very open to a hybrid model. And you know, I think as a small biotech company who doesn't have all the infrastructure we have, you know, the thing I would emphasize to them is if you can have your own monitors, you know, that's one of the most important things I would try to do that. And you need you may need to outsource to a CRO, but try to control what you can control, do your own medical monitoring, hire your own monitors. You may need a CRO for data management, fine, but try to limit, if you will, the exposure by doing what you can in-house and along a couple of simple things like a medical monitor, hiring that, that's easy. Monitors, you can identify top-quality monitors as well, for example.

Joseph Kim:
Let's talk a little bit about this idea of, well, maybe a remedy to the idea that the CRO makes more money if the study goes longer, right? That's, that, no one can refute that. But you'll get some CROs, say, oh, no, we can create structures where we are economically incentivized to finish the study on time or early. Is that a real thing? Have you actually seen that in action? What has to be true for that to really work?

Charles Theuer:
No, it's a great point. And I know companies that have engaged CROs along certain fixed payments based on performance, and I actually think that's a great idea, but clearly, that means additional money spent. But it's probably worth the spend because I think in drug development, our worst enemy is the time, right? So depending on what those costs are, I would highly if you're dependent on CRO, I would highly advocate using success-based milestone payments as a way to engage, to really make the CRO perform as expected. And many companies do that, and I think it is a good idea, but it is costly in many cases, but it does obviate the issue that time is your biggest enemy in drug development.

Joseph Kim:
So let's talk about some of the articles and book. You wrote a book about this, correct? Like, so tell the audience where they can like actually get a deep dive on your thoughts on sort of the CRO relationship.

Charles Theuer:
Well, we called our book Unnecessary Expense, and we picked the title because we think most companies that are engaging CROs are paying an unnecessary expense to conduct their trial. And that's, really, the point of the book is to, first of all, understand just how much money is spent to develop a drug, and most of that money is spent on clinical trials, and then to understand that this payment structure to CROs can be so damaging. We make an analogy, for instance, Joe, in the book, you know, if a car repair shop was run like a CRO, what that would mean you'd take your car into a shop, it'd be fee-for-service, which typically it is now, but then, also, every day you kept it at the shop, you'd be paying a monthly garage, excuse me, a daily garage fee, and you may never see your car again, right? So that kind of puts a perspective, this egregious method by which most CROs are paid. And then, we offer our solution, and so our solution is really twofold. One is we'd love to teach companies how to implement trials themselves. We call it kind of a franchise model, we would teach companies, we call it, give the keys to the kingdom. We teach them everything we know so they could become CRO-independent. Now, sometimes that's a little bit too big an idea for them to understand at first, so the other thing we do is what we call pay for performance, where we'll run the trial for a company in place of a CRO, but we won't be paid the way a CRO is paid. What we think is we should be paid the same way a site is paid. Let's pay us and the site based on accrual. So you have this disconnect, right? A site is paid based on accrual, and the CRO is paid fee-for-service, which includes accrual, but then also the monthly management fee, even if they do nothing. So we say to a company, we'll do a trial to fix price, we'll undercut the typical CRO bid price, but we'll say we'll fix it at that price, and you'll pay us based on patients accruing into the study. They'll get to understand our business model, see our systems, and usually, I would, our previous partners have been fairly impressed with our systems, and then they may say, Gosh, I wish we could do the same things you do. And then that could lead to the franchise model where we literally teach them to give them the keys to the kingdom, teach them how to do the trial themselves. And we've done this kind of model, for instance, with Big Pharma like Johnson & Johnson and also smaller companies as well.

Joseph Kim:
You know, sort of half joking here, but you don't think by going so deep undercover, you might turn into one of the mobsters yourself? You know what I mean? Like as you do this, right? You get what I'm saying?

Charles Theuer:
Yeah, no, we could definitely implement that payment model that I discussed, it feels egregious, we just won't do it. You know, it would just be contrary to kind of what we want to do. We want to bring drugs to patients. I mean, when you look at the bottom line, you know, we're not a company designed as a service company. We're a company designed to find new drug candidates and take them to market and meet unmet needs for patients. And if we can help other companies get to market more quickly, which we can, then we feel like we're helping not just ourselves, but the whole ecosystem, so that's really our goal. And to give you an idea, our first use of our CRO-independent capabilities was to actually gain assets into our portfolio where we would say to companies, instead of the typical pharma model, where you pay in upfront payment milestones and then a royalty to acquire an asset, we said to companies, what we'll do is take on the entire clinical trial onus of doing trials. But because we could do it at such low cost and we feel we can get to market more quickly because, you know, we're not making a profit off ourselves, right? So we have every incentive to do a trial quickly. What we're willing to do is give you a much higher royalty than you'll ever get from pharma, because we can feel we can build value in the product by getting to market quickly at lower cost. So instead of doing a deal with pharma, do a deal with Tracon, and you'll get much more the long-term economic value of your product through the higher royalty. And that's how we've actually built our pipeline through those types of deals we call profit share deals. And we're still open to those deals as well, but we also understand certain companies want to maintain commercial rights, and in that case, the pay-for-performance model, where we do the work in place of a CRO at lower cost with the incentive to do it quickly, or the franchise model is much more attractive to that type of company.

Joseph Kim:
Yeah, this is quite innovative, actually. I didn't realize we would end up in this learning about this new model of sort of financing or subsidizing a drug development or novel target in a way that is kind of a win-win both in time and the ROI on the back end. Very interesting.

Charles Theuer:
It's amazing, Joe. I mean, for instance, we're in this pivotal trial in Sarcoma, which is an orphan indication, a lot of drug companies don't play there. It's just not going to be the blockbuster drug that you could generate if you, for instance, developed a drug in lung cancer. But we can execute that phase, it's a Phase Two pivotal trial. We can execute that trial for less than $25 million, and our projected revenues upon initial approval are about $300 million. Now that's a huge return on investment, so it makes perfect sense. But if you're beholden to a CRO and say you're going to be maybe doing a trial that's going to take a year or two longer, and you're going to be approaching $100 million, you start plugging those numbers into an NPV model, and you may not even be able to generate positive NPV. So by being able to do trials at such low cost, at shorter timelines, it's amazing, you can literally turn a product that has a negative NPV done using a typical CRO model and turn it into a positive NPV just because of the savings of both time and cost if you do it yourself. Because what we're doing, we're saving $2 out of every $3 that another company might spend on a CRO, and we're highly incentivized to do the trial quickly because we just don't want to waste our own capital. So everything aligns to generate value.

Joseph Kim:
Well, this goes back to your earlier statement of like, CROs are destroying value in the healthcare system. Because what you're saying in that last sort of hypothetical is, a drug that would never see the light of day because it has a negative NPV can now see the light of day and actually help people. And so that value would have disappeared just because it was too expensive to develop in a certain model versus a different one.

Charles Theuer:
Exactly right. And you start thinking of the implications that could have, implications in pricing, and so forth and so on. So yeah, if everyone developed drugs in a more efficient way, I mean, it would have a huge impact on both payers, patients, providers too, and our whole ecosystem. So that's why we're trying to spread the word, so to speak. So yeah, I appreciate your taking us on.

Joseph Kim:
Of course, Charles, very provocative conversation concept. I've never heard anyone come out like that and say it. Given that you wrote a book, and I think there's a Forbes article that you wrote about it too, pleased that you decided to come on and actually have a conversation. Again, thanks so much for appearing on the show. Good luck with your molecules, and have an awesome rest of the day.

Charles Theuer:
Joe, thanks so much for taking me on. Really appreciate it.

Joseph Kim:
Thank you for tuning in to Research Confidential. We hope you enjoyed today's episode. For more information about us, show notes, transcripts, and resources, please visit ProofPilot.com. If you'd like to debunk a clinical research myth, share some war stories, or maybe just show our audience what kind of heroics it takes to pull off gold-standard research, send us your thoughts, episode ideas, and more to Help@ProofPilot.com. This show is presented by ProofPilot and is powered by Outcomes Rocket.

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Things You’ll Learn:

  • In oncology, the cost per patient for a clinical trial implemented by a CRO is approximately $300,000.
  • A Phase 3 trial with around 600 patients conducted through a CRO could cost nearly $200 million.
  • An efficient trial implementation relies on pivotal roles like medical monitors, study managers, data managers, site monitors, and head of pharmacovigilance, personnel contributing to swift responses, enhanced data integrity, and superior overall trial management.
  • In-house trial management brings forth its advantages, including direct site communication, adept monitors, and rapid query resolution, all contributing to elevated data accuracy and reduced turnover for more robust trials.
  • A payment model of CROs that involves guaranteed monthly payments, can create a counterproductive economic incentive to prolonged trial durations.
  • When expenses to develop a drug exceed the potential revenue, it will not come to market

Resources:

  • Connect with and follow Charles Theuer on LinkedIn.
  • Follow Tracon Pharmaceuticals on LinkedIn.
  • Explore the Tracon Pharmaceuticals Website!
  • Visit Charles Theuer’s Website!
  • Get your copy of Charles Theuer’s book “Unnecessary Expense: An Antidote for the Billion Dollar Drug Problem,” here!
  • Read Charles Theuer’s Forbes Article, “Where To Find The Real Crisis In Clinical Research? Follow The Money,” here!

 

  • For more information about Research Confidential, please visit ProofPilot.com.
  • If you’d like to debunk a clinical research myth, share some more stories, or maybe just show our audience what kind of heroics it takes to pull off gold-standard research, send us your thoughts, episode ideas, and more to Help@ProofPilot.com.
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