The $2.5 Billion Man

Charles Theuer, CEO, TRACON Pharmaceuticals

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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 TRACON as Chief Medical Officer prior to becoming the President and CEO of TRACON Pharmaceuticals in 2006, where he works to this day.

Dr. Charles Theuer works and resides in the San Diego area.

He is changing the way pharmaceutics source their research and development, reducing the cost and time while keeping high standards. He discusses the topic of insourcing versus outsourcing, and how to ensure your company is streamlining the cost and length of projects. 

Talking Points:

{02:00} Charles’s role as CEO of TRACON Pharma

{05:10} How to pivot and keep the organization working.  

{07:50} Insourcing versus Outsourcing.

{11:30} The dynamic of how the money is parlayed when you develop drugs.

{15:30} Non-diluted capital

{19:09} Charles journey

Welcome to the Talent Empowerment Podcast, My Friends, where we support business transformation and share the stories of great CEOs, founders, entrepreneurs, and leaders of all backgrounds. So, you can borrow their vision, their tools, and their tactics to lift up your organization, your teams, and your community.

I'm your host, Tom Finn, and on the show today we have the president. And chief executive officer of TRACON Pharmaceuticals, which is a NASDAQ-traded stock.  

Doctor Charles Theuer, welcome to the show.

Thank you, Tom. A pleasure to be here.  

Well, let me introduce you to Charles. Dr. Theur, has served as the TargeGen Pharma President, Chief Executive officer, and member of their board all the way back to 2006. Now, prior to that, he was the Chief Medical Officer and VP of Clinical Development at TRACON PHARMA, a biotech company. Now Prior to joining TRACON, he was the director of clinical oncology at a small little firm called Pfizer. You may or may not have heard of them where he led the clinical development for Sutent®, which is approved by the US FDA for the treatment of advanced kidney cancer. So, thank you for your work in developing that life-saving drug.

Now, if you want to know about his background in terms of education, he's got a BS from MIT and MD from the University of California, San Francisco. A Ph.D. from the University of California, Irvine. And his previous research involved immunotoxin and cancer vaccine development, translational work in cancer patients, and gastrointestinal cancer epidemiology.

So, an impressive track record of excellence in serving others. I would be remiss if I didn't say thank you very much for your deep research in cancer and drug discovery and distribution. Thank you. For your work there.  

Very kind of you, Tom. Thank you.

Well, let's jump right in and start with the role that you play today as CEO of TRACON Pharma, what's your vision for the organization?  

Well, first of all, great to be here, Tom. And what we do at TRACON is I think very important and very unique. So, we're a biotechnology company. We're focused on trying to transform the care of cancer patients and especially cancer patients with rarer tumors where they might be overlooked in terms of drug development programs by big pharma companies and where the standard of care the currently available treatments to those patients don't provide much benefit.

So, as an example, our main focus currently is sarcoma. It's a, it's a rare tumor of the connective tissues. And for example, our lead program is trying to reset the standard of care for those patients because they're concurrently liable therapy in terms of an FDA-approved therapy in the refractory disease setting has a very low response rate and is a very poorly tolerated drug.

It's very similar if you will do what we did at Pfizer with the SUTENT® program at the time when we developed SUTENT® at Pfizer. The standard of care for advanced kidney cancer patients was also very toxic, had a minimal response rate, and SUTENT® really transformed the standard of care for those patients. So, in a similar vein, we're trying to execute this similar type of strategy at TRACON in this case focusing on patients with advanced sarcoma.  

And has that been something you've been working on for many years, you've served in your role since 2006, has it taken this long to get something out in the market?  

It's a great question. So, the biotech industry is an industry where there are great successes, but then there are also failures. And most drugs that start clinical development don't succeed, and, for example, we had that experience in 2019. We were focused also on sarcoma on a rarer sarcoma called angiosarcoma, which is a sarcoma that of the blood vessels that is also unfortunately a deadly tumor. And we were executing a large phase two trial and unfortunately, the drug didn't deliver in terms of achieving the endpoint. And so, we had to reset ourselves and fortunately, we're able to license another drug candidate, in this case, a drug candidate with a proven mechanism of action, which lowers the risk of development.

And now we're back into what we call a pivotal study or study designed to generate the safety and efficacy data that will result in drug approval. And part of that story time relates to our business model and the way we do development; that we could quickly reset our company and move from a failed drug program into a drug program with a much higher probability of success. And that relates to how we execute our business strategy, which I'm happy to go into as well.  

Well, I think that's a really interesting conversation and primarily driven by the fact that most organizations, when they have a particular drug and it fails, cease to exist afterward. So, that would be the typical business model if we worked on our drug for many years. We got some investors, we moved it forward the best we could, and we found out, actually, no, there isn't a solution today for that particular case.

So, help us understand from a leadership perspective what you did, how you were able to pivot, and how the organization is still working.  

Great, great, great, great question. So, what we did at TRACON, which was really unique in our industry, and we've been doing this for about 10 years is we, we set the paradigm of drug development and in a sense, we changed our reliance on a group of contractors that most companies use that are called clinical research.

So, to kind of understand this concept, you have to think about how a drug is developed. So, usually, a biotech company, as you said has investors, they invest in the company and a new drug is discovered and it's studied in animals. But now you have to show works in people. And most companies don't have the infrastructure expertise to conduct their own clinical trials and they outsource those to contract research organizations or CROs.

The issue with that is that Ciro's are not looking necessarily to do them… The issue with that is that zeros are their own profit centers, right? They're looking to make money as much as everyone else is that's a service provider in the in, in the pharmaceutical industry. And the way Ciro's make their money is in a sense. I believe kind of egregious, and I think it destroys value in our industry and I'll tell you.

So, a CRO is looking to bid to win to get. A contract from. A pharmaceutical company. But then they're looking to manage their profit. They're looking to make as much money as they can to execute that contract, and the way they get paid is a fee for service; like you pay a lawyer, but then they get a sweetener, they get a guaranteed monthly project management fee, no matter what happens. In other words, if they do not work that month, they still get paid.

Now imagine you ran a business like that. You get paid if you do a work fee for service, but if you decide to take a month off, you also get paid. You can see that for a CRO executing a clinical trial contract, the longer that trial takes. The more money they will. So, in my view, it's no surprise that when a pharmaceutical company hires a CRO many times their cost overruns, the timelines are delayed, and sometimes they're serious quality issues.

So, those three critical items are So, important to a biotech company doing the trial on time doing it at cost, the cost of the contract, and doing high quality. Research in many cases is not well served by contracting with a CRO. So, 10 years ago Tricon internalized all those capabilities into our platform. We called it the product development platform.

So, if this is a big issue in the pharma space. Why has nobody?... Or maybe I'm incorrect…. Maybe people do this, and they bring it in-house, but why hasn't this sort of spread, and why are CRO's not out of business?  

It's a great question. It's funny 30 years ago, most pharma companies did their own trials. With their own team. And the issue was that if you have all these people and all these systems in your company and you do a big trial and then maybe there's not a next big trial to do, what do you do with your people in those systems?

So, it made sense for CRO’s to kind of fill that void. They could do a big trial for Pfizer. And then when that trial is done, they could do a big trial for Novartis and when that trial is done, they could do a big trial for Bear. so, it seemed to be an economical use of resources to serve the pharmaceutical industry. The issue was that the industry became incredibly reliant on CRO’s and the reimbursement became this model of fee for service plus guaranteed payment models, that, in my view, incentive creates the wrong incentives for the service provider, in this case, the contract research organization.

So, the pendulum swings from way over here to the left if you go. All the way to the right. But it is coming a little more to the center. So, TRACON's not the only company that realizes by doing your own trials with your own team, you can save incredible amounts of capital.

There's a company called CGEN, a very successful company that also does its own trials with its own team. Another global company called Beijing is similar. It does its own trials with its own team, in fact, more and more come just starting to move to that paradigm. Because the cost savings are incredible and the other thing that's probably even more important is the time savings.

You know, if you're doing your own trials with your own team, you're clearly not making money off yourself. So, you have no incentive to see the trial go. So, when you do your own trials, your own team, not only do you save in capital, but you also save in timing, which is probably the most important benefit in terms of the value of a potential ask.

The ultimate irony time is that the companies that hire CROs know they can't. Just if you will, let the CRO be the trial in an unsupervised fashion. So, they still hire a team internally that I called the police force, that police the CRO.

So, the ultimate irony in my view is that people ask me for trials, you do your own trials with your own team, and you must have all these extra people compared to another pharmaceutical company, and I say no, actually I had the same number of people. It's just these people actually implement the trial instead of policing a CRO that you then pay to actually implement the trial.

So, these other companies ultimately, the irony is, they double pay, they pay their own team to police the CRO, they pay in an egregious manner, if you will, through that fee for service, guaranteed payment model to actually execute the trial.  

So if you're not in the Pharmaceutical industry, I think you can follow this conversation pretty clearly, primarily driven by the fact that this is a conversation about insourcing versus outsourcing. And it really is the model of the CEO to look at the variables, including time to market the outflow of money contractual obligations, the headcount, and the turnover as you mentioned, right?

And then being able to smooth that out over a period of time, is really the role of the chief executive of the company and I thank you for explaining it so, So, clearly. So, for the laymen out there, we think about this we go, OK, So, you're insourcing your drug development, you're not outsourcing anymore, fine. Why does this stuff take So, long? Why does it? Cost So, much.

It's amazing when you think about the dynamic of how the money is kind of parlayed when you develop drugs. So, I'll give you an example.

You know the three players when you develop a drug in a sense, there's a sponsored biotech company whose goal is to market that drug. Most times there's a CRO middleman who's actually the service provider implementing the trial, and then there's actually the site. The site is actually doing the work. They're the ones enrolling the patient, treating the patient, gathering the data from that patient’s experience with the drug, and then feeding it back through the CRO to the sponsor.

So, right now if CRO’s are making their bid price, Tom for every $6 the sponsors paying about $5 is going to a zero and about. $1.00 is going to the site. In many cases, the CRO doesn't make their bid price because of the incentives we talked about, there's no alignment that they make more money longer trial takes. So, they'll typically go over the bid. And then they'll maybe you know, 8 or $9 to the Sierra $1.00 to the site is out. Of the Conference of the sponsor. My view is the biggest issue in terms of drug development, and we know the biggest cost is the actual conduct of clinical trials when I say the biggest cost.

Let me put that in perspective. The average cost to approve a single drug in this country is about $2.5 billion. Now, why is that? There are two reasons. One is as we talked about this earlier. Even in our own experience, many drugs fail. So, when one drug gets approved, there are probably about nine others that failed somewhere in that process.

So, you take all that money in addition to the money to get the drug that was approved to market. That's about $2.5 million, but even the drug that was approved, was, in a sense, a success that may still cost half a billion dollars to get to market, because of the cost of implementing trials to the CRO model.

Now TARGEGEN as an example, we know we can beat a zero-bid price, not just by a margin, but we can do it for about 1/3 of the cost of a typical CRO bid price. Think what that would mean. For our industry. You basically could develop three drugs for the price of one.

Think with me, potentially for even drug pricing. So, that's why we're so committed to our model and we don't just want to use it for our portfolio of drug candidates. We really want to help transform the industry and teach others or help them benefit from our knowledge and our platform. So, as an example, we're willing to teach others to do drug development, the TRACON way. It's sort of like a franchise. The model we call giving away the keys to the Kingdom, so, we definitely would require a capital investment from a potential partner to learn our secret sauce So, to speak. But if they did that for that upfront investment, they would then have the keys to the Kingdom to be able to run trials as TRACON does. Literally the third is the cost, they're probably paying CRO.

And then there's one other variation on that theme. I'll talk about which sometimes companies don't want to invest in the infrastructure to do trials themselves, but we'll also potentially help trials, excuse me, will also potentially help companies avoid what I call the CRO quicksand of that fee for service guaranteed monthly payment model and we'll do trials replacing the CRO for another company. But if we do a trial, we do what we call pay for performance. And if we think about what that means, it's really going back to that paradigm I talked about with respect to the sponsor, CRO, and site.

If you think about the clinical side, they get paid only when they enroll a patient. Our view is the sponsor should only pay the service provider or CRO In the same manner, if they enroll a patient, they get paid. If they're sitting on their hands, they shouldn't get that guaranteed monthly payment.

So, we do pay for performance when we replace a CRO with a partner. We get paid based on accruing patients the same way a site does. Think about that. That incentivizes us to do the trial on time because if we sit on our hands, we're not getting paid.

So, our capabilities are, are something that's really important to us as an internal company, but we would love to teach others to avoid that CRO trap in either of those two mechanisms, the franchise model or the pay-for-performance model to align incentives. And have everyone on the same page which would lower costs and increase the pace of drug development.  

So, I love that you're implementing different business models and experimenting with different partnerships to expand your reach because I think that just makes all the sense in the world when you've figured out a little bit of a secret sauce that can help the whole industry, that's terrific that you're taking that path. So, I've got a couple of questions though.

If I'm a competitive pharma distribution drug maker and I'm going through my clinical trials, why on earth would I want you to know exactly what I'm doing? Isn't there some level of competition? Don't we want some sort of wall between these organizations?  

No, I think that's a really important point. So, you know, we're our focus is really right now almost exclusively on sarcoma. So, you know, that's one area that we wouldn't do a trial in most cases with a company that is directly competing with us, say, to prove a drug and sarcoma.

But in oncology, you know they're about 20 to 30 different types of cancer. And we've done trials across 10 to 12 indications. So, if there's a cancer type that's out there, likely we’ve done studies there and we know the investigators in those fields. So, we'd be happy to do a trial in an area where we're not focused, but the mechanism of action, the drug is different from ours, which is generally the case.

And in the case of the franchise model, we could teach that to anybody. They could be a cancer company. They could be a rare disease company. They could be a more common disease company focused on high blood pressure drugs or diabetes drugs; because that's really teaching someone the platform, the tools about how to do trials or cells, which is agnostic to what the indication is.

So, you can do it for the franchise model very easily by teaching someone to do it themself. It's kind of like that, that, that tail give a man a fish, feed him for a day. Teach a man to fish. You know they can feed themselves for a lifetime.

So, that's what the benefit of that. The franchise model is for pay-for-performance. We'd have to be more careful about whom we pick, but there are so many different areas in oncology or even non-oncology we could do trials for the partner in place of a CRO that there really wouldn't be the issue of competition or conflict of interest.

So, does this broaden out your product offering? I mean what I'm hearing is I'm hearing three different revenue streams with three slightly different business models, all contained under the same umbrella in a smart and thoughtful way for the industry.

But to me, I'm hearing three revenue streams. Is that where you're going?

It really is.  

So, our focus is we have a drug that's in a late-stage clinical trial. We hope to commercialize that drug in two years and that's our expected key revenue stream starting in 2025. But in the mean time we can support ourselves through non-dilutive capital by leveraging our platform either in the franchise model or the pay-for-performance model.

So, it really is using your capabilities to generate income for your company that supports your primary business thesis, which for us is transforming the standard of care for cancers. Especially cancers that are rare and underserved by current therapies.

So, it does all kinds of wrap into one dynamic. We use our platform to develop our own drugs to market at incredibly low cost, but then we got also to your point, leveraging that platform to create revenue streams for non-dilutive capital serves the primary goal of the company, which is to commercialize drugs from unmet need indications.  

And for those of you that are thinking about the term non-diluted capital, that's one of my favorite terms. That just means that you've created enough revenue for your company that you don't need investors to take out large chunks of the organization and give you big piles of cash to keep you burning through it as you develop your drug or product or service or whatever it might be.

My favorite term in business is non-diluted capital and as a founder myself, Charles So, well said.

So, let's pivot a little bit and just get into your background and your leadership style and the way you approach the business because you've got the such depth of education and knowledge in the industry, but it probably wasn't always this way. Tell me about the time that you decided I'm going into the hard sciences. I'm going to medical school; this is my path.

Yeah, I always really enjoyed science, Tom. You know, even as a kid, I remember writing, my essay for college, and I think I started off with, you know, I always enjoyed science. And I always have always enjoyed kind of understanding how things work and how things interplay and so, that was always just a great interest to me.

And you know, pursue that in college. And then, you know, I think you think about medical schools coming. Actual continuation of an interest in science and you know, I did enjoy medicine school. And I guess when you think about going to medical school versus, say, a straight research path in biology for example. Yeah, I did also really relish the potential to have that doctor-patient interaction and talk to people and understand, you know, what's going on and you know patient comes to you, they have a problem. You really need to help with this, not just from a scientific perspective, but also from a very humane perspective. So, I really relished that and that was really the reason probably went to medical schools as opposed to a straight say Ph.D. in some science.

And then I went into surgery.  So, I was a cancer surgeon for many years and really enjoyed cancer surgery. And I was working on patients, you know that have advanced tumors, but in many cases, you can actually still cure the tumor.

So, for instance, for most breast cancer patients, we cure those patients that are relatively early stage. You know, it's very satisfying when you cure cancer, even in most cases, say GI cancer, like colon cancer. The ones that go to the operating room many times cure those patients.

So, it's a very satisfying career in that sense they can talk to a patient and say, you know we're doing surgery and when that surgery is over, you can look at them and say, you know the chance of you having recurrent cancer is as high as you going home and getting in a car accident today. It is that low that you really can make an impact on a patient and it's a 1 to 1 interaction and you interact on a patient-by-patient basis. And that's fantastic.

But then you also study cases where you can't help you know it's the cancer is too advanced. The surgery's not enough radiation. Therapies are not enough. Chemotherapies are not enough, and that's what kind of drove me into the pharmaceutical industry, that if you make an impact and approve a new drug, you can have a global impact potentially.

We saw that with SUTENT® as an example of the drug. Profile that we approved at Pfizer and that drug literally transformed the care of kidney cancer. It took a population that had maybe a chance of responding of like 4% and really increased that by 7 times with the drug SIOTEM. So, you know, those are the great success stories that really empower you and sustain you to continue to develop drugs in this industry.

So, did you always start out this confidence when you were in high school and college, and… were you always this confident and composed. Or did you have to go through some learning processes yourself along the way?  

Oh, definitely a lot of learning processes. I mean I think surgery is a great teacher. For me personally I you know, I mentioned the success stories, but you know no surgeon is perfect. Then you'll have some complications along the road and that's a way to look inside yourself and manage success, but also manage failure.

I think the greatest teacher I had was surgery because you're acting with people, you do everything you can to help them. Sometimes it's not enough. And you always do your best. And I always said the best way to treat a patient is just to treat them as though they're a family member. And if you take that paradigm that really works well and that helps you get through the failures and they're not failures.

Not often, but sometimes you know, surgery won't go exactly as planned, but you always do your best for the patient and that helps you grow personally. And I think that was probably my greatest teacher.  

I always think that the intimacy between a surgeon and a patient is really underestimated by the general public because there is a level of intimacy there and it happens really fast. You go in, you, you go to pre-op. You end up having a conversation. You're my guy. Or my gal. OK. We're in. We're scheduled, you're there. You've got a great team in the front room getting you set up. You're in surgery. You're out. In post-op. It's fast, but it's very intimate if you think about the relationship between those two people, it can be life-changing as you mentioned. Did you feel that way when you were a surgeon?  

Oh, absolutely. Yeah, it's, it's, it's, it's amazing. You kind of think about it. I mean, what is a patient really doing when they interact with the surgeon, So, intimate to your point, I mean, they're really giving that surgeon permission to operate on them to cut their skin and change their lives. And to your point, as intimate away as you could imagine. Right. And that's a bond, I mean, you know when you operate, it's funny that the hard part of the surgery is you never can really go on vacation because once you operate on a patient that is your patient forever. Right.

And that you know most times it's like you do the surgery, it goes well, and you may not see that patient again because it's a complete success. But you know you operate on cancer patients, sometimes cancer does come back and you know, that's still your patient forever. So, it is an incredibly intimate association, and you know the patients that you operate on you, they become a little bit like a surrogate family to you.

And yeah, it's a big part of defining who you are, is how you interact with those patients. And kind of can work with the kind of potential for a very, very long time for many, many years. It was a beautiful part of the doctor-patient relationship. And surgery, I always thought was the ultimate intimacy in the sense that. You know you can always prescribe drugs to patients and medicines. But you know, surgery gives you this arsenal of tools that really can impact a patient in a way that no other discipline can. And the ultimate is when it's curative surgery. In the case of cancer, that's gratification for you and the patient, Is just incredible.  

Yeah, well, well said. And well documented there. Thank you. Think of your thoughts around it.

I'm wondering when you. We’re going through this process and you were thinking about leaving the surgery. This is a big decision to pivot into pharmaceuticals now you. Didn't you? Didn't go. Into real estate, which you probably could have, or you didn't decide to design a cruise ship, you decided to stay in the same, or similar industry, but that's a pretty big pivot from daily surgery into a leadership role. How did that happen to you? What was the mental process you went through? What was the mindset you had to make that pivot?  

Yeah, great question. It was a tough decision you know; surgery was beautiful in terms of that intimate interaction you mentioned with the patient, and the impact you have on that individual patient. And you could do that on a repeat basis, you know every week.

But I think what pushed me into a more general field if that's the right way to say biotech, is that for localized tumors, you know you could cure those tumors. It was incredibly gratifying, but then you also saw those patients with advanced tumors whom you sometimes operate on to prevent a complication of cancer, but you knew you couldn't cure cancer.

And in those cases, nothing else could and the opportunity to go into the biotech field was the opportunity to advance the entire field that could then have a global impact on those patients that you couldn't cure with surgery in and of itself.

So, that probably was the deciding factor for me.  

And I think this is a process many of us go through, which is you go into a particular field and you have some success and you build your network and you gain some confidence and then you broaden out and you do a little more in that field and you broaden out and you do a little more, maybe it's education, maybe it's training other people you know, maybe it's speaking at conferences. And you start to broaden out a little bit and then you hit a point where you say have I capped myself?

At a certain point, am I not doing enough for society? Am I not doing enough for my fellow man? Should I be doing more of what I think I hear if I'm articulating this correctly, at some point you hit a cap and said I love my experience I love what I'm doing. But there's something more I can do to impact the world in a meaningful way in this process too.  

Tom, that really hits the nail squarely on the head. So, you know, one of the things I was saying to myself when I had the opportunity to go into the biotech field is you know, in surgery what I'm doing this week and if I look 20 years in the future, what I'm doing that week to your point may not be that different, which is kind of plays into what you're saying kind of capped your learning in that field. And so, biotech was also an opportunity to make a more global impact, but also in large kind of your personal growth go into a field that you were going to learn many new concepts and personally enrich yourself. So, well said, very well said.  

So, as you think about, your leadership style and the way that you manage and you bring on people and you develop them, is there a teacher that you have met along the way that's influenced you, or have you developed your own tools and tactics and leadership style?  

It's a great question.

So, I think that the leaders that influenced me the most and that I try to emulate in terms of leadership style are mainly historical figures like I'm a big Abraham Lincoln fan. So, you think of someone who in biotech, you know, has these ups and downs, to be clear, it's not all roses. It's their tough cycles, they're Boone Cycles, but there are some tough times too.

And you think of Lincoln and how he persevered through, say, incredibly stressful times, you know, that's to me as a role model, someone who's you know, humble. Who thinks you know very logically, doesn't get too emotional about certain items, and leads in this case a nation through a potential division to preserve the Union? That's a role model to me right now. I'm reading a little bit about Churchill, leading through the Battle of Britain, right? You know, people thought, oh, gosh, the, you know, Germany is just going to run, run right over Britain the same way they ran over France and, you know, is that leadership to persevere in, you know, the darkest hour, right. Or to now get past that into a Victory 5 years later.

Those are the kind of leaders that inspire me. I've always thought that you can, if you can know every quote that Lincoln made or Martin Luther King made, you probably have every quote you ever need to think about to kind of get through life. So, he's another great leader like me, Martin Luther King.

So, the three of them probably said everything needs to be said that you can draw on, for inspiration through life. In terms of my leadership style at TRACON , you know, I think the most important thing we do at TRACON brings on great people.

I'll give you an example. Our Chief Operating Officer, Bonnie Adams. It was her brainchild to really create the product development platform. This platform of doing our own trials with our own team and using the most technology, advanced, technologically advanced systems to do it, that's our focus at TRACON and not just see things the way they are but see things the way they could be and then move in that direction and make it happen.

There's another great quote I like is that you can't achieve perfection, but in the pursuit of perfection, you'll catch excellence. And I think that's what we do here at TRACON .  

Yeah, well said. And I'd love to know what the conversation looked like when Bonnie came to you and said, Charles, I've got this idea. I've got this great idea. Stay with me. I just need an hour. How did that conversation go? And were you receptive in that first meeting?  

Yeah, that's great, great. The question, Tom. So, you know very receptive, I mean we realized this is back in like 2010 we implemented this model, and you know, we realized that the standard paradigm wasn't going to work for TRACON that you know, we have this broad development plan. If we use CROs, there was no way we could even execute the trials we were proposing.

And we had a venture capitalist who was interested in investing in TRACON but at a fixed amount. And we realized the only way we could deliver on our promises for that amount of investment was to do the trials ourselves at 1/3 the cost that we would pay a CRO.

So, you know, they say necessity is the mother of invention. That was part of it. But we also had a team that knew. How to do it? From our previous experience at other companies where we had done our own trials with their own team.

So, it was using that experience, meeting a need at Tricon, but then also upgrading systems to the point now where they're just better if you will. In many ways than the typical CRO systems, and then you have a team that's incentivized through the model we talked about pay for performance to do trials to replace the CRO or do our own trials at 1/3 the cost. And so, kind of was that evolution.  

And how does it make you feel now that you're leading this company, you've got this cool business model? It's very modern. Its very others focused, it's industry-leading. Does that make you feel on a daily or on weekly basis?

Yeah, I'm So, proud of what we've done here, Tom. I mean, I think you know, we look at drug development kind of three pieces. It's you discover the drugs; you develop the drugs and you commercialize the drug. And we feel at TRASCON, we develop drugs better than any company in the world and that's what makes you feel very proud, proud of your team, proud of your processes. And our goal is to build those other two pieces and then we have a fully integrated company that could be the most efficient. In this entire industry.  

Yeah, well, well said again. And from all of us that are just regular folks out there, I want to say thank you, for the work that you're doing, the work that you've done in Cancer Research and drug development is really astounding.

And I think we're all rooting for you and TRACON pharmaceuticals to really deliver on the promises that you've made to each other as a team and that you continue to make to the market week in and week out. So, thank you for the work that you're doing.  

My pleasure Tom, and thank you So, much for hosting me on the show.

Well, if somebody wanted to find you, where would they go about doing that?  

Sure. Yeah. So, I'm on LinkedIn and then also people are welcome to access charlessteward.com and which links to actually a book we wrote. Our team wrote a book called unnecessary expense that outlined several of the concepts we talked about here the reason we call it unnecessary expense is that we feel most companies that are biotech companies I should say that use CRO to implement their trials are paying the unnecessary expense, both in terms of capital and time. So, either of those is a great venue to link in with me, and be happy to meet the listeners on the program.  

And Charles, we'll put that in the show notes. So, everybody has direct links to be able to purchase your book, check out your website and certainly connect with you on LinkedIn. Thank you again for all the great work that you do.  

Thank you, Tom, really a pleasure.  

And thank you for joining the Talent Empowerment podcast. I hope you transform your business by placing humans at the center, leveraging technology at speed, and enabling innovation at scale. Let's get back to people and culture together. We'll see you in the next episode.

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