About the Guest:

Charles P Theuer, MD PhD

President and CEO, TRACON Pharmaceuticals

Dr. Theuer has been CEO and President and a Director of TRACON Pharmaceuticals since 2006. Dr. Theuer has been instrumental in bringing novel blockbuster oncology drugs to market, including Sutent® to treat advanced kidney cancer, while working as Director of Clinical Oncology at Pfizer. Dr. Theuer has held senior management positions at notable biotechnology firms, including TargeGen, Inc., and IDEC Pharmaceutical Corp. He has worked at the National Cancer Institute and held academic positions at the University of California, Irvine. He completed a general surgery residency program at Harbor-UCLA Medical Center and was board-certified in general surgery in 1997. Dr. Theuer’s previous research involved immunotoxin and cancer vaccine development, translational work in cancer patients, and gastrointestinal cancer epidemiology. He is married with two adult children and enjoys hiking, coaching basketball, and sculling.

Connect with Dr. Charles Theuer:

About the Episode:

This week, John welcomes Dr. Charles Theuer, the President and CEO of TRACON, a biopharmaceutical company that develops targeted therapies for cancer. He’s also the author of Unnecessary Expense: An Antidote to the Billion Dollar Drug Problem. Charles talks about what inspired his transition from the operating room to the pharmaceutical, and how TRACON is changing how drugs are developed today.

Please find out more about Charles here, and his book, Unnecessary Expense: An Antidote to the Billion Dollar Drug Problem, is available wherever books are sold.


Entrepreneur Rx Episode 12:

RX12_Charles Theuer, MD, President and CEO, TRACON Pharmaceuticals: Audio automatically transcribed by Sonix

RX12_Charles Theuer, MD, President and CEO, TRACON Pharmaceuticals: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Narrator: ForbesBoOKs presents: Entrepreneur RX, with Dr. John Shufeldt. Helping health care professionals own their future.

John Shufeldt: Hello, everybody, and welcome to Entrepreneur Rx, your host John Shufeldt, and today I'm really excited to speak with Dr. Charles Theuer, president and CEO of TRACON, a biopharmaceutical company that develops targeted therapies for cancer. Wait to hear about this, but Charles is at an absolutely rock star career. While working as a director of clinical oncology at Pfizer, he was instrumental in bringing groundbreaking oncology drugs to the market. He is also the author of Unnecessary Expense, An Antidote to the Billion Dollar Drug Problem. And this is near and dear to my heart. So, Charles, welcome to the podcast.

Charles Theuer: John, it's so great to meet you. Great to be here.

John Shufeldt: Thank you so much. OK, so I want to chat with you about this book because I'm all about A.I. and all about lowering the drug development cost. Because as no one knows more than you, probably, but it's into the billions of dollars. But before we do that, tell me about your career. You know, start with college and how you ended up where you ended up.

Charles Theuer: Sure, John. Yeah. My pleasure. So I was at college at MIT, I focused on molecular biology, I've always had a strong inkling and fascination with cancer and how cancer develops, and that translated into ways to approach treatment of cancer. But my undergraduate career was mainly focused on understanding molecular pathways that contribute to cancer developments. And then from there, I went to medical school at UC San Francisco. During medical school, I focused on, you know, the broad education that a doctor typically receives, but also was interestingly exposed to another aspect of medicine. That was a little bit unexpected because as I was in San Francisco for med school, it was right at the time of the AIDS epidemic. And so I was able to see really from ground zero how a community dealt with AIDS and actually made an impact in that field as well.

John Shufeldt: So now, I mean, given where you are today, it would seem obvious that you would have done internal medicine oncology, but you went to general surgery. How did that pan out?

Charles Theuer: Yeah, it's funny how life works. So I was working in the AIDS clinic and in the tuberculosis clinic trying to understand how AIDS was affecting the increased prevalence of tuberculosis and thought as you indicate about an infectious disease career following initial training in internal medicine. What changed everything for me was I did a surgery rotation at San Francisco General Hospital, which is the hospital that handles all the major trauma cases in San Francisco. And I was on call with the team one night and a young person came in, they were shot in the leg, bleeding profusely, and took them straight to the operating room, a great set of surgeons operated on that patient, fix the bleeding blood vessel, and this is a young man who two days later looked great and was like, when do I go home? And I just was incredibly impressed by the definitive nature of surgical intervention and how it can just totally transform a life within, you know, two or three-hour period of time. And I guess I wanted a piece of that, you know, internal medicine to me was very satisfying. And, you know, I felt as a doctor I could prescribe drugs to people. But it seemed like by being in surgery, it opened up this entire other door to treatment options for patients that could be so definitive and so life-changing that I wanted to access those tools and have that satisfaction. So I changed really the trajectory of my career by focusing then on surgery and training formally in surgery at Harvard UCLA Medical Center and then being in practice and surgery for many years thereafter.

John Shufeldt: Now did you focus on oncologic surgery?

Charles Theuer: I initially focused mainly on trauma surgery, and more the bread and butter surgical procedures like hernia repair, appendectomy, gallbladder removal, removing the colon in cases of cancer, though, for example. But I think because I learned about cancer pathways early in my career, I was always drawn toward cancer surgery as a main focal point in terms of further career development. So once I had finished my surgery residency, when I joined the faculty at the University of California, Irvine, I focused at that point on surgical oncology, which is basically cancer surgery thereafter.

John Shufeldt: And then what was your Ph.D. in?

Charles Theuer: So I was in surgery, a faculty member at UC Irvine, and I was very interested also in research about how different people's demographics influences the cancers they get and how frequently that happens. That's really the epidemiology of cancer, which kind of played off the epidemiology of AIDS infection that I had learned a little bit about when I was in medical school. You know, in particular, what I was noticing was in my practice, I was treating a lot of colon cancer patients, and interestingly, I was treating some young patients with colon cancer, which you would think is quite unusual. Colon cancer generally is a disease of the elderly, but I especially had some young black patients that had colon cancer, and it was very emblematic of a general trend. For example, if you follow baseball Darryl Strawberry, the Mets and Yankees outfielders, he had colon cancer before age 40, at a very young age. Another example is, unfortunately, the actor Chad Bozeman, who just passed away of colon cancer, also developed it before age 40.

John Shufeldt: Black Panther.

Charles Theuer: Yeah, exactly. Black Panther, no, such a great actor, a great humanitarian. Unfortunately, he developed colon cancer before age 40. And the reason that's such a sad kind of event is that, you know, we screened for colon cancer in this country very effectively, but we screened generally at age 50. If you're going to develop it at age 40, you're never going to get to the point where you detect it at a curable stage through our standard screening practices. So I really was interested in this dynamic, and I began to look at epidemiology of cancer and how it presents in different races, at different ages. And it sparked me to do a Ph.D. in epidemiology to get the formal training I needed to really thoroughly explore the field.

John Shufeldt: Wow. I mean, it's incredibly prescient of you. OK, so now fast forward, you're a general surgeon. You did it for, I mean, just if I do my math, right, you know, twenty-five years or so. And when did you start TRACON? I mean, because it seems like such a left turn or right turn from being a general surgeon?

Charles Theuer: It sure is, John, I mean, there aren't that many people in biotech that actually are formally trained surgeons.

John Shufeldt: No.

Charles Theuer: For me, I enjoyed surgery, so there's very few careers that give you that kind of immediate gratification. I mean, you go to the operating room, you, say you remove a colon cancer, that's early stage. I mean, that in many cases is a curative operation. Similarly, for breast cancer, most of the times you operate for breast cancer, that's a curative operation. So you're basically able to tell a patient, I think we can cure your cancer and then do the operation and everything is as planned. And you can say at the end of the operation, it's very likely your cancer is cured. I mean, that's a very gratifying event and a very gratifying way to interact with a person. I think for me, I always wanted to make an impact, maybe on a more global scale than just, say, the individual one-on-one patient interaction. And that's why I did a lot of research too, for instance, picking up on our colon cancer theme, I was very involved in trying to revise guidelines to screen, for instance, black men earlier than age 50, so we could detect some of those cancers that might kill them at an earlier stage when they would be curable. And I think when I look at drug development, what I saw was that if you can make an impact in drug development, approve prove a drug that really transforms the standard of care for a patient population that can have a global impact. And so I was given the opportunity to join a drug development company called IDEC Pharmaceuticals that was doing just that. They were developing medicines that really revolutionized how certain cancers were treated, and I wanted to be part of that. And so it was a tough decision to be clear, but I decided to change the trajectory of my career, if you will, and joined IDEC and gave up my surgery practice, which as satisfying as it was, you know, wasn't giving me the potential for global impact that I really wanted and thought I could achieve through joining a biotech company

John Shufeldt: That is amazingly courageous. There was, two other surgeons that we've had on this podcast that both gave up, One was a C.T. surgeon, one was a general surgeon who literally did the same thing. They walked away from something that they clearly love to do with the hope of having a bigger impact on more people. So a hat's off to you. That's huge balls, I got to say. I mean, it's a podcast, we say what we want so OK, so TRACON is curbing drug development costs while incentivizing innovation, so when did you start that?

Charles Theuer: So I've been at Tracon account for 15 years, since 2006, and I had some great drug development experiences earlier with some other companies. I mentioned IDEC, that was the first company I joined, and that company brought to the world Rituxan, which is a drug that just changed how lymphoma is treated in the world. Benefit from that experience, you know, I then move to Pfizer, where I was involved intimately as you noted earlier with the development of Sutent, which is a drug that just changed the care of kidney cancer patients in the world. So I had some great experiences both the biotech and big pharma developing drugs that became successful and also really changed the practice patterns for those patients. The one thing we realized, though, at those companies was the typical paradigm for drug development is that the companies discover the drug, but they don't necessarily develop it with their own internal teams, and so most pharmaceutical companies, when they execute clinical trials, will outsource the execution of those trials to a CRO or contract research organization, so they pay another company to actually execute the trials of their drug. And I was exposed to that, for instance, at Pfizer and saw it repeatedly being done by most companies in our business and realized it wasn't an optimal model for drug development. And so when we came to TRACON and I really formed the company in conjunction with one of our key senior leaders, Bonnie Adams, we realized that we could actually develop drugs in a better way and that became what we call the TRACON product development platform. What we're trying to address, John, is the fact that the CRO model is not aligned with. optimal results, if you will, cost-effective developments. In our book, Unnecessary Expense, we use the analogy that if your car mechanic was a CRO, here's how it would work. You'd go in for a simple repair on your car, but you would be paying the car mechanic in two ways. One, you'd be paying them fee for service, but you would also be paying them regardless of what they do, a guaranteed payment every day they store your car. Now, in reality, a car mechanic doesn't work that way, and frankly, maybe no other business should work that way. However, that's exactly the way CRO's work when they interact with drug companies. So, in other words, they're incentivized to create fees through any service they can manufacture. But if they literally do no work, you nevertheless pay them a monthly project management fee. What this creates, in our opinion, is an unaligned drug development model between the pharmaceutical company and the CRO, such that the CRO has very little incentive to do a trial quickly, they have very little incentive to do a trial at low cost because their whole profit center is actually executing the trial and sometimes the quality can also suffer. That, in our view, is one of the main reasons it costs so much money to develop a drug. As we point out in the book, the average cost to approve a single drug in this country is $2 billion dollars. Think about that. There are two things that influence that. One is the high cost of clinical trials, mainly because they're outsourced to CROs. Second, is that most drugs do fail. But if you take all the successes, all the failures take all the money that goes into approving a single drug, it's $2 billion. Now in that background, we have internalized all the clinical trial execution functions that typically are outsourced to a clinical CRO. And by doing that, we're able to do three important things. We shorten the clinical trial time, we significantly lower the cost, and we also feel we significantly increase the quality. And that in and of itself can significantly decrease the overall cost of approving a new drug.

John Shufeldt: So it, and correct me if I'm wrong, but I, as I understand it, many drug companies will go through the early phase drug trials and then hope to sell the drug to somebody who can afford to basically bring it to market. Is that, is that true?

Charles Theuer: That's still absolutely true, John. But even those companies will typically outsource their trials to a CRO. And what they're in effect doing is they're paying their own team to watch or police, I call it, a CRO that they then pay to actually execute the trial. So they're kind of double-paying. They're paying their team to police the CRO, who then they're paying the CRO personnel to execute the trial. And then that CRO execution is really not incentivized to do the trial in the way the pharmaceutical company wants, which is quickly and at low cost. So even if a company is playing for the sell, like you're implying, that they want to do maybe a phase one trial, phase two trial and then sell the drug to a big pharma company to do the phase three trial and commercialize, each part of that process, phase one, phase two, phase three, if executed to a CRO, in our view, means the cost is higher than it could be, the timeline is longer than it should be, and then there's always the issue, is the quality such that it's sufficient for FDA approval.

John Shufeldt: So is your way, and we'll talk about your book in a second. But just an overview is your way around this $2 billion price tag, the bring drug to market to, become your own CRO, in other words, not to outsource it.

Charles Theuer: Our view is that, John, is to become a company that's if you will, not beholden to a CRO that has all the same functionality internally that most companies only are able to find in a CRO. And then we like to leverage that in a way that creates alignment between us and our business partners. And we do that in the following way. We say to our business partners, the way to create alignment isn't to make a profit off you based on us conducting the trial. We say to our partners the way to create alignment is that we both share the profit once the drug's approved. So the difference there is now our partner in us both want to do the trials quickly, we want to do it at low cost because we're paying our own money at TRACON to do the trial in the U.S. and we want to do it high quality because if the trial is done at poor quality, that drug would never be approved, the FDA would reject the application. So if we have an aligned structure through this profit split model whereby we both share the profits only upon approval, both us and our partner, both want to see the same things happen: fast trial, low-cost trial, high-quality trial, and then we split the profits after approval to create alignment. That's different than when a pharmaceutical company outsources their trial to CRO, who's trying to make a profit based on just executing the trial and that's why there's no alignment to do it fast, at low-cost, or high-quality.

John Shufeldt: Right. If they're if their margin has, if they're publicly traded or have you, their margin is going to want to be 15 to 25 percent, so you're right, that's going to whack off that number just right out of the gate. So let me, talk about the business model here because this is really interesting. So, you know, I talked to most physician entrepreneurs, they swing for the fences and want to start a practice, they want to do a device, they want to do something that they can bootstrap. You swung for the parking lot because you have to be incredibly well funded out of the gate to pull this off. How did you do that?

Charles Theuer: You know, I think it was, it was will and the quality of people we have at TRACON. Fortunately, we have people at TRACON who had been at companies like IDEC that actually did internal operations, so we knew how to do it and see it done the right way. And I think the other thing we just realized is it's costly but if you do invest the money upfront to bring in those systems in-house, you end up saving so much money on the backend, it becomes such a satisfying proposition. So you need the people. But fortunately, we started TRACON with the people that knew how to implement their own trials with their own expertise, and then bringing in the systems did cost money, but once those systems were in place, it becomes marginal extra expense just to run the trial, and we actually run the trials at half the cost of a CRO, so we, right now, are just making or saving money hand over foot compared to if we had never done this and we were running trial after trial with the CRO. And that's, in the end, the huge advantage for us, it's become an incredible cost-saving center for us because when you run trials a third or half the cost of what most companies paid to a CRO, it basically means you can run two to three trials for the cost of them running one. And that just becomes an incredible value proposition and something you can then monetize through business development activities.

John Shufeldt: So if you take two billion as your average run, you know, I did a market price and that's not the marketing, that's not all the sales you have to do, what can you get that just on average, what do you think you can use in TRACON's technique, what can you get that price tag to?

Charles Theuer: So, so this is going to sound maybe preposterous, but we actually feel we can potentially bring a drug to the approval process for one, one-hundredth of that cost, for $20 million dollars. And it reflects two things, it reflects the model, the product development platform at TRACON, whereby we're CRO independent, but it also reflects our business practice, which we call harnessing global innovation. And let me talk a little bit about harnessing global innovation. You know, if you looked at the drug development market, say, 20, 30 years ago, almost every key advance in drug development was made in the U.S., Europe definitely contributed to that to some degree, but almost all the key new drugs were discovered in the West. Now it's much more of a global universe, and more and more drugs are now being discovered outside the U.S., for instance, in Asia, and the two countries particularly that are influential, they are Japan and China. And as an example, you know, the drug Opdivo that you see advertised on TV all the time, one of these checkpoint inhibitors that reactivates the patient's immune system to attack their tumor, the actual technology for that drug was discovered in Japan. And what we've realized is there's great new drug development going on in Japan and also in China, and in many cases, what happens is the drug is developed for approval in that region. For instance, a drug may be developed for approval in China, but really hasn't been thoroughly studied in the U.S. so that if you harness that global innovation, if you harness the fact that there may be a drug that's already being considered for approval in China, that's already been tested in multiple patients or have been manufactured at commercial scale. If you partner with that company and then run a single trial in the U.S., leverage all their manufacturing experience of your partner, all the clinical trial data of your partner, you may be able to just do one simple trial, for say, a price tag of 20 million dollars to get that drug approved, and that's really doing two things, it's harnessing the global innovation of a partner and also then leveraging the TRACON product development platform of CRO independent research to do the trial quickly and at low cost. So by combining those two elements, you potentially can approve a drug for one, one-hundredth the typical price tag.

John Shufeldt: Wow. So yeah, that, you're right, that's a jaw-dropper. So I invested in the company a while back called Cybereason and Cybereason is using AI to reduce drug discovery because they simulate disease processes and then go in and basically simulate a drug, as I understand it, used for cancer, simulate a drug's response to this disease process, all AI-driven. First off, what do you think about that? And if you say it sucks, I'm going to be disappointed because I invested in it. But just be brutally honest.

Charles Theuer: No, John, I appreciate it. I'm a big fan of approaches using AI to optimize drug development and specifically, it's really drug discovery that you're talking about, so.

John Shufeldt: Right, right.

Charles Theuer: There are all these great technologies that are reducing the cost of drug discovery, and that's fantastic. You know, I think the sad thing is that as drug discovery becomes more efficient, drug development becomes less efficient. What I mean by that is, you know, about 10 years ago, the joke in our industry was that it cost a billion dollars to approve a drug and now circa 2021, it costs $2 billion to approve a single drug. So even though discovery is getting more efficient, unfortunately, drug development or clinical trial execution, in particular, is not. That's only become more expensive, more laborious in the hands of most companies who engage in this unaligned model or misaligned model of drug development using a CRO. I don't see that it's going to improve any time soon. So hence our play is to make drug development more efficient to mimic what's happening in drug discovery, which is by leaps and bounds progressing and becoming more and more efficient.

John Shufeldt: So just for, my simple thought process, if you use an AI-driven drug discovery model and a TRACON-driven drug to market model by taking out the middleman CRO, it seems like this two billion could even be less than $20 million.

Charles Theuer: Yeah, I think it could definitely be less than two billion. You know, I think what we've done so nicely with the $20 million price tag is we're leveraging all the drug discovery that our partner has done to move their program forward in China. You know, if you're going to include the drug discovery costs, you know, that will increase it to some degree. But to your point, even with drug discovery added to drug development, if they're both done efficiently, it will be much less than $2 billion. And that's where we need to go. If we can get there, everyone will benefit payers, patients, drug companies. I mean, for the same budget, you'll be able to develop twice or three times, or maybe more than that drugs, as you currently can do on the current budget.

John Shufeldt: Yeah, and much quicker to market. I mean, instead of whatever it was at 8 years, 10 years, it's, sounds like it'd be half that.

Charles Theuer: That's the other important thing. It's all about alignment and motivation. Know if we are running a trial and we're paying for it with our own dime, and let's say it's not enrolling well, you know, we want to fix that problem, we want to potentially open more sites so that it starts enrolling on pace with our accrual projections. You know, if you're working with a CRO, frankly, whether the trial gets done next year or in 10 years, doesn't really bother them, because frankly, you'll pay them more if it takes 10 years than if it got done next year. So it's that misalignment that creates inefficiencies in the system, in our opinion.

John Shufeldt: Yeah, when you look at medicine or, you know, health care in general, there are so many misaligned models that one person's expense is another person's basically income. And why kill yourself if they're going to pay, whether it takes one month or pay a lot more if it takes 12 months? So, interesting. So congratulations on your new book. It's Unnecessary Expense: an Antidote to the Billion Dollar Drug Problem. So what prompted you, because they know how difficult writing a book is, although it sounds like not that much is difficult for you, but what prompted you to do that?

Charles Theuer: You know, I think it was just looking at what's happening in our industry and the fact that it seems like more and more companies have become beholden to contract research organizations or CROs and, in our view, fall into the CRO trap. And what it has in terms of negative consequences for the entire drug development ecosystem that if we could create alignment, it would benefit everybody. You know, part of the TRACON product platform is actually to improve technology, to even run trials more efficiently. And we do that with technology vendors that we use for our trials. And then those vendors take the learnings from us, develop a better system of clinical trial execution that then can be contracted by another company outside TRACON that might want to use that same system to do their own trials themselves. So I think part of it is, make it a better world in terms of make drug development more efficient, make it a better ecosystem, get more drugs to market at lower cost. And I think the other thing we want to help people understand is the global marketplace that there really is innovation outside the U.S. that can be harnessed for U.S. patients. And then paradoxically, if we approve the drug in the U.S. for a patient population say it was licensed from China, that approval package could then be taken all the way back to China and approve it there as well. So the whole dynamic comes full circle, so it has benefits globally in terms of our model. So I think it's trying to make people understand if you have an aligned model for drug development, it's going to benefit the ecosystem, it will benefit your company because you'll be able to move forward more quickly and at lower cost. And then understanding that there is a global marketplace and a global, if you will, playing field that has now included innovative drug discovery throughout the world that if you look at that, harness it and we're focused on cancer, but in any other therapeutic area, you actually can facilitate drug approvals at lower costs as well. So it's our, it's our way of making sure people understand the benefits of our model, but also trying to make for a better ecosystem for all of us to facilitate getting the drugs to patients as soon as possible, because there's still so many unmet needs for patients across multiple different disease types.

John Shufeldt: Now do you see your, I guess for lack of a better way to say it, your competitors of Pfizers, the GSKs, the Roches of the world, embracing what you're doing? Or do they look at you and go, you know, that might be great for TRACON, but we ain't ever going to do it.

Charles Theuer: It's a great, great question, John. You know, I hope those companies will kind of realize the pendulum may have swung too far over to the CRO based model because many years ago, those big pharma companies did do their own trials with their own team. And, you know, they thought that it was probably too expensive to maintain all those full time employees and that it would be easier just to outsource to a CRO. You know, I'm hoping they read the book and realize that alignment means so much, and there's so many hidden costs they may not be accounting for by outsourcing, that maybe the pendulum will swing back into more in-house operations teams. So I hope there's a little bit of a pendulum switch. I will also say, John, we have interacted with Big Pharma. For instance, our first key partner was Johnson and Johnson. They recognized the value of our model, and in that case, for instance, they made an equity investment in TRACON for us to run a phase one and phase two program of one of their discovered assets, which we did. And we were able to complete enrollment in those phase one and two trials collectively in just a three-year period of time, which in our business is quite fast. So I will say pharma has recognized the value of our platform, which we hope they will continue to do. And then we also hope they'll start thinking about maybe internalizing some of their own operations in order to make the whole process a little more efficient.

John Shufeldt: So what do you think your process is going to do for orphan drugs? And I'll preface it by the person who started Sirius XM came up with an orphan drug that was kind of discarded, and she did it because her son had a rare genetic disease. I'm sure you know the story and the only reason why this drug came to market for, I can tell by learning about this is, one, she had some wealth, and two, she was like a dog with a bone. Is this going to revolutionize for those people who have these rare diseases for which no drugs are developed because what's you know, what's the ROI? Well, this is sounds life-changing to me.

Charles Theuer: You know, I think this really has great applicability, especially in rare diseases, because to the point we made earlier, if it's really going to cost $2 billion to approve a drug and you have a rare disease population, you can just think what the price tag would have to be for that drug to make a return on investment. It would just be incredible and probably not sustainable. But if you can develop a drug for $20 million dollars, you don't have to have an incredible price tag on that drug, and it doesn't have to be sold to a ton of patients for a company to make a return on investment. So I think this has great applicability to rare diseases and orphan drug diseases. As an example, the drug we're developing in collaboration with our partners, three medicines and Alpha Mab Oncology called End the follow Mab, is a checkpoint inhibitor that were specifically developing for sarcoma patients. That's a very rare tumor type. And many companies may say, you know, sarcoma, not that many patients, if it's going to cost me $2 billion to approve the drug, I don't think I can ever make that kind of money up, no matter how long the drug is sold. However, if you can approve that drug for $20 million dollars, and we're estimating initial sales annually or two hundred million, that could grow to a billion, that's a potential fantastic return on investment and that's entirely enabled by what we're talking about, doing in-house clinical trial execution and two, harnessing global innovation. So this is a great path forward for rare disease drugs to get them to market.

John Shufeldt: Wow. So that was my take of reading that, reading that article about the FDA granting orphan drug designation. So I, you know, I came away with this exact same take and said wow, this really may be a light at the end of a long tunnel for a lot of folks who no one's rallying their cause. OK, I'm going to switch subjects here a little bit, so I'm seeing patients who are in their 30s and 40s, unvaccinated, literally dying of COVID, much like it was eight months ago, and they look at me when I tell them I need to intubate them and they're going to be like, why? Like, because you didn't get the vaccine? They said, well, you know, that was, that was not even approved. Give me, you're an expert, give me some response to tell people before they need to be intubated that this is safe because I'm clearly, we're clearly failing on this one because there's a huge percentage, including some health care people that just refuse to get the vaccine for I don't understand why, what, you're an expert, what, what can we tell them?

Charles Theuer: Yeah, that's a tough question, John. I think sometimes in our country, we fail to understand kind of the nature of risk. And I guess the best thing I could tell a patient that's really hesitant to get vaccinated is. The side effects are so incredibly rare, and even when they occur, the chance that they'll be serious are so incredibly low that you should think about your risk of dying in a car accident being higher than your risk of having any significant complication from a vaccine. And maybe try to put it in a perspective that, that we all live with risk every single day of our lives. We don't quantitate it because we get used to it right. But the risk of you having a significant reaction to a vaccine is lower than the risk of you having major issues from things you do every day, including, for instance, driving in a car. And maybe that will help put things in perspective so that people understand that the vaccine may not be approved, but just to gain an emergency use authorization from the FDA means it's been really well vetted. And given that now in our country, what is it, 100 million people have been vaccinated. You've got a pretty big denominator. And you know, the numerator of serious side effects is incredibly tiny. And so it's one risk that you should be willing to take given you've got many more high-risk activities you're doing every day, you just don't, you just don't think about.

John Shufeldt: Yeah, that's, that is a great way to explain it. But you know, people say, well, this was developed so quickly, blah, blah. Blah. And I said, mRNA vaccines, I mean, I read the book about Professor Dowden, all right, vaccines have been around for a while, or at least the concept has, this wasn't an overnight vaccine, but I, people are so stuck on this, hey, we had the diseases started all of a sudden, poof, we have a vaccine, how safe can that be? And so that's what I hear a lot.

Charles Theuer: Yeah, it's a tough problem. I think, you know, people are concerned about mRNA vaccines because that's more of a newer concept. I mean, you know, in the US, fortunately, there's even more options than that, the J&J vaccine, for example, is more the older fashioned technology. That's, if you will, more proven. Although I would argue the mRNA vaccines have proved their worth just in the past year since they've been available for COVID. But yeah, I think it's important to get get some vaccine. And if you go J&J, that's fine with me. But the risk of not getting vaccinated, especially today with the Delta variant being as prevalent as it is definitely not worth the risk of a side effect, which is so small that again, it's judging those risks and understanding that your best served by being vaccinated to limit your risk.

John Shufeldt: So, OK, so on the vaccines, ..., let me ask you kind of one more question.

Charles Theuer: Sure.

John Shufeldt: Maybe ... Vaccine in cancer. Clearly, there's a role for vaccines to prevent cancer. What, how's TRACON kind of addressing that?

Charles Theuer: Yeah. So cancer vaccines, you know, I think is a fascinating concept. You know, the thought being that if you can harvest some cells from a patient's cancer and then if you will reinject them in a state where the cancer can no longer grow, but those antigens or those cancer proteins that make the cancer different from normal cells can be derivatives, such that they create an immune response that then would generally attack your cancer. I think is a fantastic concept because what we're realizing is that, you know, certain patients, the immune system can be reactivated to attack the cancer in that patient. And those are patients we say have hot tumors. The body recognize that that cancer's a foreign entity in the body and attacked it, but other cancers are cold. The body just doesn't pick up on the fact that there's an abnormal growth going on, and it needs help to recognize that it is abnormal. And that's where the cancer vaccines can be so helpful by turning a cold tumor hot. So we have currently do not have a cancer vaccine program at TRACON, but we do have a checkpoint inhibitor program and we are actually looking aggressively for new programs to add to our pipeline. And one of those could be a cancer vaccine to try to turn those cold tumors hot, to then make them sensitive to a checkpoint inhibitor, which is a drug we already have in our pipeline. So big fan of cancer vaccines and definitely something we're interested in adding to our pipeline, although right now we're focused just on the checkpoint inhibitor and the follow map.

John Shufeldt: Excellent. Well, this has been I think I learned more from this, you know, 40-minute discussion than I did in most of medical school related to cancer treatment. So thank you very much. This has been incredibly helpful and enlightening. So thank you for, thank you for being on this podcast. How can people get a hold of you and continue to follow what you're doing now?

Charles Theuer: Appreciate it, John. Yeah. So you know, I'm CEO TRACON Pharmaceuticals. Welcome emails. My email address C T H E U E R @TRACONPharma.com Or if you go to the TRACON Pharma website and hit the contact information, you can send a general info email to us and we'll respond to you. We always are interested in answering questions and if you're interested in understanding how to streamline drug development, please do read our book Unnecessary Expense: an Antidote to the Billion Dollar Drug Problem, which is available on Amazon.

John Shufeldt: And one more question if people want to invest in TRACON, how do they do that?

Charles Theuer: Well, TRACON is a public company, so we are listed on Nasdaq.

John Shufeldt: Perfect. That makes it easy. Well, congratulations for all your success and thanks for doing what you're doing because you're obviously changing literally thousands, if not millions, of lives with TRACON and with all the work you're doing. So thank you very much and thanks for being on the podcast.

Charles Theuer: John, I really enjoyed it. Thanks so much for your time.

John Shufeldt: Oh, pleasure.

Narrator: Thanks for listening to Entrepreneur RX with Dr. John Shufeldt. To find out how to start a business and help secure your future, go to JohnShufeldtMD.com. This has been a presentation of ForbesBoOKs.

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Key Take-Aways:

  • When detected and operated at the right time, almost every cancer can be curable.
  • Pharmaceutical companies usually use a CRO (contract research organizations) to execute the clinical trials for new drugs. 
  • The average cost to get a drug approved in the US is around $2 billion dollars. 
  • Will and a high-quality team are things that every entrepreneur must-have. 
  • If done efficiently, two or three drugs can be developed with the same budget as a current process.
  • Getting an emergency authorization from the FDA means the covid vaccine has had sufficient investigation and work behind it to be applied to the population.