The Biggest Problem in Biotech No One Talks About | Ep. 99 [Dr. Michael Weickert]

What does it really take to bring a life-saving medical breakthrough to patients? In this episode of Industry Ignited, Dr. Leeanne Aguilar sits down with Dr. Michael Weickert, CEO of Pacylex Pharmaceuticals and FE Pharmaceuticals, to discuss the realities of building first-in-class therapies in oncology and infectious disease. From the challenges of securing funding for breakthrough innovations to navigating clinical development and investor skepticism, Dr. Weickert shares decades of experience leading biotech companies focused on transforming patient care.

The conversation explores the future of cancer treatment, groundbreaking approaches to combating antibiotic resistance, and why some of the most promising medical discoveries struggle to gain traction. Whether you're an entrepreneur, investor, healthcare professional, or simply curious about the future of medicine, this episode offers valuable insights into the science, strategy, and persistence required to bring revolutionary therapies to life.

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Transcript

Dr. Leeanne Aguilar 0:07

Why do life-saving medical breakthroughs struggle to get funded while incremental innovations move forward with ease? Welcome to Industry Ignited. I'm Dr. Leanne Aguilar. And today I'm joined by Dr. Michael Weigert, CEO of PathLix Pharmaceuticals and FE Pharmaceuticals, a transformational biotech leader advancing first-in-class therapies and tackling some of the toughest challenges in oncology and infectious disease. Michael, welcome to the show. Well, getting started, Michael, your journey started with a passion for genetics early on. What drew you into biotech and how did that evolve into leading multiple life sciences companies?

SPEAKER_00 0:48

Well, that's that's taking the whole journey all at once. So I uh actually was very interested in genetics in high school, which for me was back in the 70s. And at the time, the revolution in sort of the understanding of genes and how to potentially use that understanding to create new therapies was just beginning. And so I was quite excited about genentech and Amgen, sort of the two startups that were really revolutionizing what came to be biotechnology. And even in high school, I was like ready to do biotech. But it's a journey to get there. And so I went through a very, you know, rigorous scientific education, culminating in my doctorate in genetics from the University of Wisconsin. I went to NIH at the National Cancer Institute after my PhD. And then I got into biotech and have been working in lots of different therapeutic areas. But the two that I've worked in the most are oncology and infectious disease, and those are the ones I'm working in today. Um, and it's generally a passion to bring new medicines to patients, to make breakthroughs possible in improving care and outcomes.

Dr. Leeanne Aguilar 1:50

Yeah. And entrepreneurship, was that always something that you wanted to get into as well?

SPEAKER_00 1:56

No, the only part of me that was entrepreneurial, I would say, at the beginning of my career was what drove me to get a PhD and do a postdoc, was I wanted to be in the decision making, not just in the lab doing the work. I wanted to be in the decision making. And I understood that if I didn't have an advanced degree, there was no way I was going to be part of that scientific decision making. Now, it turns out, of course, you can run a company with a bachelor's degree. You don't need to have a PhD to run a company. But if you want to be in the scientific decision-making process, you need to understand the science and you need to understand it sufficiently that you can contribute something meaningful to that process and to those decisions.

Dr. Leeanne Aguilar 2:32

Yeah, good point. Now you've held leadership roles across startups and established pharmaceutical companies. What key experiences shaped your approach to building and scaling biotech ventures?

SPEAKER_00 2:43

Well, the good thing for me was that I spent my first 15 years at public biotechs. So those companies already had significant funding and they had products that they were developing. And I got exposure to, first off, the process of developing a product, mostly drugs. What does it take to get a product from preclinical evidence to proof of concept to IND enabling studies and getting it in the clinic, studying it in patients, and taking it all the way to what do you need to register that product? And that was the first layer of learning. And then the second layer of learning was when I was at Nectrotherapeutics and we had transitioned from being a product company that was developing partnerships with pharma companies and developing products for them that they were paying for, to being a proprietary products company where we were developing our own products. And I was fortunate enough to be part of the program that put the initial portfolio of proprietary products together. And then I was given the opportunity to run our new product planning group, our portfolio management, and our product marketing to get those products into development and then to steward new candidates in every year to add to our portfolio of products. And so that gave me the perspective of what does it take for a product to be investable? What does it take for a product to be marketable? What does it take for a product to be competitive? And knowing how to develop products and then how to position products in a way that would be commercially successful is what I was able to take into startups as generally CEO or a C level executive and help with the positioning of whatever technology or products that company was developing and how to advance those into a very competitive pharmaceutical landscape or medical device companies too.

Dr. Leeanne Aguilar 4:24

So it sounds like right, that that was invaluable experience, just being involved in every step of that process from selecting and introducing new products into the market and taking them to commercialization and just really getting, you know, your your feet wet.

SPEAKER_00 4:39

Absolutely. Having 15 years of experience doing it before I have to lead it is super helpful. I mean, I can see how a lot of startup founders who come out of academia or come out of medicine will struggle because they don't know all the things they need to do. And although you can get advice about all those things, you can get plenty of consultants to help you with those things. It's helpful to have the experience so that you can judge the advice you're getting. You can judge the input you're getting because a lot of that input will be contradictory and you'll have to be the one saying, okay, well, this is what I want to go with. And so having that background was enormously helpful in being able to work with companies, help guide companies and new founders and new help position those with investors and being able to tell the story with investors in a compelling way. Because I was doing that as an entrepreneur at Nectar and then was able to take that experience and grow with that into startups.

Dr. Leeanne Aguilar 5:35

Right. So during that time, did you have mentors and others who had done the process themselves previously that you were learning from at the same time?

SPEAKER_00 5:43

Well, not exactly. Um I mean, I had plenty of people that gave me plenty of advice. Um, you know, because this was the first time we were doing at Nectar, uh, we did bring in a consulting group and they helped create sort of the first framework that we used going forward. So it's not exactly mentorship, but it's somebody providing some structure so that you're not just starting from scratch and doing it all from, you know, from a position of ignorance.

SPEAKER_02 6:08

Right, right.

SPEAKER_00 6:10

Because it's it's extremely helpful to have some kind of framework and some kind of reference point. It's always easier, as they say, to edit than it is to create.

unknown 6:18

Yes.

SPEAKER_00 6:18

Um, so at least there was something that uh had been had been created that we could then um adjust to what was appropriate for our company.

Dr. Leeanne Aguilar 6:25

Right. Yeah. Yeah, I'm just curious because you know, oftentimes, especially when you're you're new to the space, it's like, I mean, there's lots of trial and error, right? And so just curious. Yeah, yeah.

SPEAKER_00 6:35

In startups, there's so little room for trial and error. Exactly. Once you get to investors, they would prefer not to have error. All right.

Dr. Leeanne Aguilar 6:44

You've described your focus as working on life science, diamonds in the rough. What defines those opportunities and why are you drawn to them?

SPEAKER_00 6:51

Life science, diamonds in the rough to me are things that have never been done before. So it's usually a new target, a new first-in-class therapy, a new device with capabilities that were never available before. And what I'm excited about for those is that so many of medical advances are incremental, but the real breakthroughs happen with something that's new, with a new target or a new drug. And so at this point in my career, having done many incremental things over my career, I'm really drawn to the things that I know would be very substantial changes to care that would improve patient outcomes substantially, that would deliver something new to care to put into the armamentarium of care providers, and that could lead to better patient outcomes. So at this point, I'm not as excited about incremental advances as I am about doing the new things. But to be frank, the new things are the hardest things because there's no precedent for it. The risk is always viewed as extremely high. And because the risk is viewed as extremely high, there's a high degree of reluctance of investors to invest, strategic partners to participate, of a medical establishment to participate. And without those that participation, it's it's really hard to do the proof that you need for something new. So it's a it creates a bit of a catch-twitch. You need much more evidence if it's something new, but nobody wants to give you the capital necessary to generate the evidence because you don't have the evidence yet. And so it's a challenge. And it's uh it's been an extraordinary journey trying to create um, you know, first in class and breakthrough products.

Dr. Leeanne Aguilar 8:23

Right. So what do you do to overcome that hurdle?

SPEAKER_00 8:27

Well, sometimes you might not be able to overcome that hurdle. Um, but what you do is you do um as much evidence gathering as you can uh with studies that you can do within the company and studies you can do with collaborators. You try to get as many thought leaders exposed to what you're doing and on board and participating if possible in what you're doing. You try to do very creative storytelling so that you can help people understand why what you're doing is meaningful. The challenge with anything new is you end up, as they say, you end up educating rather than selling. And everybody wants you to be selling in your pitch, not educating. But if you're doing something completely new that is unprecedented, there's a degree of education that is going to come along with that. And you have to do it in a creative way that will help people understand the potential benefit of what this is bringing to medicine and the value that that would create and the reason why that could be worth investing in. And it's not an easy story.

Dr. Leeanne Aguilar 9:22

Yeah. Definitely. But there, I mean, there's always a degree of risk involved. But if you don't take the risk, how do you make those big breakthroughs, right? How do you bring the new things to light, to market, et cetera? Yeah.

SPEAKER_00 9:38

That is the dilemma. And that is frankly, it's not a dilemma that's been solved. I mean, people complain about the valley of death for development of pharmaceutical and biotech and medical device products. And it's quite real. There is a place where the capital needs will be exceeding the ability to get grants and angels and mission-driven investors will exceed their capacity to provide the funds necessary. And it will not yet have risen to the state that venture investors and strategic partners are going to be ready to put money in. And when you're at that state, that's when people really struggle and companies really struggle to get to the next stage.

Dr. Leeanne Aguilar 10:19

So, do you see a lot of people funding their own ventures in those types of scenarios? No. It takes costs too much.

SPEAKER_00 10:26

It's it's one thing if you're doing like software or AI or um, you know, something that's a diagnostic. Sometimes people will fund, you know, part of their ventures. And mostly in biotech ventures at the beginning, yeah, there will be some founder funding to get the first proof of concept data or to get the company off the ground. But when you get to this valley of death I'm talking about, usually you need, you know, $10 million or more.

Dr. Leeanne Aguilar 10:52

Right.

SPEAKER_00 10:52

It's rare that a fund that a founder has that in their bag.

Dr. Leeanne Aguilar 10:56

That's that kind of right, exactly.

SPEAKER_00 10:58

So no, not at this stage, no.

Dr. Leeanne Aguilar 11:00

Not at that stage, yeah. Especially to get through clinical trials and all the things that come if that's true.

SPEAKER_00 11:05

When that's the next thing on your plate, founders are not usually the funders.

Dr. Leeanne Aguilar 11:09

Yeah, yeah. I'm just trying to brainstorm here. It would be nice. Yeah, it would be nice.

unknown 11:14

Right.

SPEAKER_00 11:14

You could only I could only work with rich founders. That would be great.

unknown 11:18

There you go.

Dr. Leeanne Aguilar 11:19

So throughout your career, you've operated at the intersection of science, strategy, and capital. How did you develop the ability to translate complex science into investor-ready businesses?

SPEAKER_00 11:30

Experience telling stories. You know, first telling stories within public companies to boards and groups that needed to make decisions and getting feedback about what was useful and helpful and compelling in decision-making processes and what wasn't. And then doing the same thing with investors and getting feedback about what was helping them get excited about something and what was creating obstacles to them considering something worthwhile. The strategic part, you know, there was a ton of analysis that goes into every product plan that goes into look, understanding the market and the competitive landscape and everything else. I learned a lot of those tools in public companies and then continued using a lot of those tools in private companies. A startup CEO is a roll up your sleeves role. You got to be able to do a lot of different things if you want to help keep the company headed in the right direction and do it economically. And so there was a lot of rolling up my sleeves and doing stuff on my own. People think it might be really exciting and sexy, and it's really roll up your sleeves and do a lot of hard work and do a lot of it on your own without a net. That's really what a startup CEO is. So those who think it's uh something that they aspire to because the potential of being in charge. Yes, well, when you're in charge, but delivery is requiring your personal input, it takes a little bit of the shine off of that you're in charge part because everything is going to stop with you. And until you get enough money that you have a big team behind you, you're the one that has to produce.

Dr. Leeanne Aguilar 12:57

Yeah, you're responsible. So that's right, there's trade-offs, definitely. So yeah, while you do get to make the decisions, you're also, you know, responsible for all of the outcomes and making sure. And you have to live with it.

SPEAKER_00 13:08

If it is not working, it's on you. It's, you know, there's no hiding it, there's no pointing fingers elsewhere. It's it's on you. And frankly, as a CEO, it should never be on somebody else. It should be on you anyway. You should have recognized if things weren't headed in the right direction, you should have headed it off. And experience is extremely useful in understanding when things are off the rails. And that's the challenge I see with a lot of founders from whom I, you know, with whom I work at companies, is that they didn't see when things were not working because they didn't have the experience to know what to look for.

Dr. Leeanne Aguilar 13:38

Right. Yeah. But it's it's leadership skills. So it's a whole different skill.

SPEAKER_00 13:42

Leadership skills is when yes, leadership skills is super important because it's when you have the picture being able to show it to everybody else and being able to rally people into alignment on what needs to happen and what needs to be executed. Or when you're talking to investors, what capital needs to be raised and what it's going to be put to use for. And that is, again, a lot of storytelling. It's creating a vision that people can buy into. It's creating an understanding of what needs to happen and what the consequences are of success and maybe even the consequences of failure and getting people aligned and excited about moving things forward.

Dr. Leeanne Aguilar 14:18

Yeah. So are you publishing along the way as you're, you know, doing your study?

SPEAKER_00 14:23

So as the science gets to milestones that are publishable, of course. It's usually quite important to demonstrate the peer-reviewed quality of the science, that it stands up to the rigor of publishing in peer-reviewed journals. It's important to get certain information out there in the public domain so that we can talk about it. Yeah. Because a lot of the science, if you you need to get the patent filed, if it's patentable, and then you need to publish it, because once you put it in the public domain, you can't patent it and you can't publish it in most top-tier journals. So if we want to talk about it with investors or fundraise, et cetera, with it, or in general, just communicate the progress we're making, it's very important to be doing that along the way.

Dr. Leeanne Aguilar 15:03

Right. Because I would I would think that would, you know, lend credibility to the you know technology published articles. Yeah. At PASLEX, you're advancing oncology programs towards phase two with designations like orphan drug and fast track. What makes your lead therapies differentiated in today's crowded oncology landscape?

SPEAKER_00 15:21

So what's differentiated is that we have a brand new target and we have a first-in-class drug. So the cancer targets are pretty well known, and a lot of drugs are focused on specific cancer targets that are already well known, and even mutants of those targets, so that they're the specific targets that are a subpart of that cancer itself. And what we're doing is very different. Past Lex Pharmaceuticals, we're developing a new molecule that can be orally administered once a day that inhibits a particular reaction that adds a little piece of fat to certain proteins to help those proteins stick to cell membranes where their bioactivity is then released. And so if you inhibit that process of sticking that fat to those proteins, those proteins end up being turned over in the cytoplasm and the bioactivity doesn't happen. And why this is important as cancer is because there's a whole bunch of cancer processes that use this biology to help promote cancer cell growth and proliferation. And so if we stop that process, cancer cells are so much more sensitive than normal cells to this inhibition of this biology that it can trigger what we call programmed cell death or apoptosis in cancer cells. It triggers oxidative stress in cancer cells. So it can kill cancer cells selectively, leaving normal cells pretty untouched. And so that's the big competitive advantage. And because we're affecting many different cancer processes simultaneously, but indirectly by inhibiting this other biology, it's very difficult to become resistant to this therapy. And it's also a therapy that could potentially be applied in combination with other therapies to enhance the activity of both therapies together, leading to better patient outcomes. So it can be used across many different types of cancers with potentially many different types of drugs to create a different therapeutic outcome for patients. That's what's exciting.

Dr. Leeanne Aguilar 17:06

That is exciting. Yeah, I was going to ask that. Are you targeting specific types of cancers?

SPEAKER_00 17:12

We're treating, you kind of have to take it indication by indication. So, like our first clinical study is in acute myelukemia, and these patients are what we have our orphan drug designation for. Acute myeleleukemia patients uh typically are treated with uh different classes of drugs and sometimes with different classes of drugs for the different mutation types that are found in acute myelukemia. We are treating all comers in acute AML. Every patient is a candidate in our current clinical studies. But the thing is, you would then build from that indication to diffuse large BC lymphoma is another indication that we have evidence that we have efficacy in. And then you could build it to other blood cancers or heme cancers. And then you could also look at it in a variety of different solid tumor cancers. In our phase one study, we saw activity in colorectal cancer, in uh ovarian cancer, in appendicile carcinoma. So there's a lot of things that you could potentially expand into, but you have to do studies in each one of those independently, generally. Um, and that's what is challenging is having enough money to do multiple independent clinical studies is where companies struggle. So you usually you take it one at a time.

Dr. Leeanne Aguilar 18:21

Okay. And so, I mean, what is the technology and the drug you're developing, would that replace like chemotherapy? Or, you know, what are the benefits that it would bring?

SPEAKER_00 18:29

Initially, you have to study it in patients that are refractory to therapy. So, in other words, patients that have failed the common chemotherapies that are already available. And this is because it's really not ethical to withhold those therapies from new patients to try an unproven drug. So, in cancer, the only ethical thing is to try it in patients that have already failed everything else. See if it works in those patients. Once you have evidence that it actually is effective, then you can advance up to what we call first-line therapy, and you can test it in naive patients, patients who haven't yet been tried, other things haven't been tried with them. And ours is a pretty good candidate for that because it's an oral once-a-day pill with pretty modest side effects. So it's the kind of drug that you'd like to be able to test on people first, and then only use other drugs if and when this fails, rather than have this be the last line. I mean, this is like the nicest therapy you're gonna get. It's a once-a-day pill that you're gonna have very few side effects from. You don't want to save that one for last, but you have to study it first in the patients that have already failed everything else. So in our phase one clinical study, for example, the patients had an average of four prior lines of therapy.

Dr. Leeanne Aguilar 19:36

Oh, okay. Wow.

SPEAKER_00 19:37

That had already failed before they came onto our therapy. And so when they come off of our therapy, it's either another experimental drug or nothing.

Dr. Leeanne Aguilar 19:46

Got it. Wow. Well, yeah, well, that's exciting and it brings more hope. That's great. You're also working with FE pharmaceuticals on infectious disease solutions that take a completely different approach, starving pathogens of iron rather than attacking them directly. How does this fundamentally change the fight against antibiotic resistance?

SPEAKER_00 20:04

So the very exciting thing about this approach to killing pathogens is that you can't become resistant to this. So pathogens need iron for a bunch of different properties within the cells. And if those processes don't get iron, they don't function and the cells die. So if you starve pathogens for iron, it's not like they can mutate all these different processes simultaneously to become resistant to iron and use some other heavy metal as the catalyst for different oxidative processes in particular. It's it's fatal. Now, the key thing about what we've done that makes it exciting is that we've created a polymer that stays outside of cells, which means it doesn't go into human cells and it doesn't take the iron out of human cells. So your red blood cells have iron, and that's the hemoglobin active center that binds oxygen and carbon monoxide as your blood carries those molecules around the bloodstream. So that is really important that you're not scavenging the iron from inside your own cells. So that's what we've done that's really unique because there are iron scavenging molecules that are already in the clinic, not in the clinic, they're already commercial. And those molecules go inside your cells to remove excess iron that can build up to toxic levels inside our own cells. So those aren't molecules that can be used for infectious diseases. They've been tried, they don't work very well at all. So that's why we designed a different polymer to accomplish this. Now, not only does it create an anti-infective approach that doesn't allow resistance to develop, but it also is able to work on organisms that are resistant to other antibiotics. So this is key is that in antibiotic resistance, you need something that works on organisms that are resistant to existing antibiotics. People make new antibiotics, and lo and behold, resistance develops to the new antibiotics. And that's been the problem. And that's what's driven investors out of the antibiotic space altogether, is because, you know, because of that, we don't want to use new antibiotics unless it's absolutely last resort. Now we've developed a product that can be used as the first resort. It has no side effects, it will remove the iron. The pathogens need to grow. Selectively, it will kill or slow down the pathogens. You can then add an antibiotic if you want. And the synergy between our approach and an antibiotic is extremely high. And then the real exciting kicker is that iron is essential for organisms to create mutations and to repair, misrepair, and propagate DNA. And so that's how you get antibiotic resistance. So because we're scavenging the free iron that they need to do this process, when you add an antibiotic with our drug, it inhibits the creation of resistance to the antibiotic, too. And so it really revolutionizes the whole antibiotic resistance issue because it's a therapy that is not amenable to resistance, that synergizes with antibiotics, that protects antibiotics from resistance developing to them at the same time. And so this is something that would be used right at the beginning. You don't have to wait, use it at the end. You don't have to figure out what the pathogen is resistant to. You don't have to figure out what it would be sensitive to. You just put this on, and then when you figure all those other things out, you can add an antibiotic if you want. Or you can just let this be the therapy. And so it's a very different, radically different approach to having something you can put on without worrying about resistance because that's what's holding so many things back.

Dr. Leeanne Aguilar 23:15

Yeah. And where are you testing this and what kind of scenarios or with what kind of indications?

SPEAKER_00 23:21

This is all preclinical right now. So we don't have this in the clinic yet. We don't have the data necessary to put it in the clinic. The preclinical models have been in a variety of different animal models of infections and inflammation and cancer, even in eye infections, ear, lung, sinus, sepsis, peritoneal infections, skin infections. We've tried, you know, eight or nine different models with 10 different routes of administration of the drug. It's really established the breadth of what we could potentially cover, but it's sort of a double-edged sword. When you have a drug that can be used for many different things, you can only really pick one. You have to start with one.

Dr. Leeanne Aguilar 24:01

Sure. Yeah.

SPEAKER_00 24:02

So what's the one thing that it's most likely to work with? And that's the thing that you would then develop and get your regulatory package for and do your talk study on and all of that. So you have to pick the route of administration, pick the specific indication from that plethora of options. And so that's what we're working on now is trying to figure out what exactly we should focus on. Where are we going to be able to get the best data? And frankly, where are we going to be able to get the best funding to support the next step, which would be getting it ready for the clinic? Because in infectious disease, investors have abandoned that space largely. And there are a few groups that have been set up, like CARBEX and AMR fund and AMR Action Fund that fund clinical studies or products that are close to clinical studies. But there's very little funding for earlier stage things that need to get to the clinic.

Dr. Leeanne Aguilar 24:49

Yeah. Now with antibiotics, since resistance is a factor, you can only take them in every so often in limited doses, et cetera. Is this therapy limited in those ways as well? Or would you have, you know, ability to treat people more often, me more frequently for more things with this medication?

SPEAKER_00 25:08

Yeah. So antibiotics are currently managed by what we call stewardship. So we reserve the most sort of potent and newer antibiotics for last-line use, and we only bring them out if everything else has failed. And so that means that generally patients get treated with generic broad spectrum antibiotics. Or if we know exactly what they're infected with, we might narrow it down to antibiotics that they're likely to be susceptible, that organisms likely to be susceptible to. So we don't really do it by dosing, we do it by stewardship. Once the patient is identified as being susceptible to a particular drug, we give them the full dose. We want to get that pathogen out of their system as quickly as possible. What's different about our approach is that you would use essentially full dose therapy on any patient. I mean, it has it, the susceptibility to iron is very broad spectrum. Most organisms need iron to grow. There are very few that grow without it. And so you could use this on almost any infection, even before you know what they're infected with. And the chances are extremely high that it will either kill or slow down that infection. And then you can go in with more time. So here's the thing with sepsis: the reason why sepsis is mostly being addressed by things that accelerate the time to diagnose is because there's a tipping point in sepsis. And once you reach that tipping point, it's extremely hard to recover the patient. And there's a very high mortality in sepsis, you know, 20% or more. And sepsis is the leading killer in hospital care. Even in the US, I mean it's the leading killer in hospital care. It's not a third, I mean it is a third world thing. There's more people that die of sepsis than cancer worldwide. But a lot of that is, you know, in less developed countries. And so we kind of ignore that, but it's still the leading killer in our hospitals is sepsis. So if you if you get sepsis, there's a really high probability of death. And the problem is the survivors are also very significantly impaired. And there's a very high mortality rate in among survivors in the next six months.

Dr. Leeanne Aguilar 27:00

Yeah, no, it's it's no joke. It's a scary thing. I know my daughter had sepsis, I think she was like 14 or 15, and she had an undiagnosed appendix, her appendix ruptured uh ruptured, and they just dismissed it when I took her to the doctor initially as like stomach like cramps, menstrual cramps. And they sent her home and then she got a fever. I'm like, I don't think you normally get fevers with menstrual cramps.

SPEAKER_00 27:22

This is like classic.

Dr. Leeanne Aguilar 27:25

Yeah. When they finally caught it septic and was in the hospital like five or six days. And unfortunately, like she wasn't responsive to the first couple rounds of antibiotics they they gave her, and she was just resistant to them already. And they finally had to do like, I guess, blood tests or whatever to determine what she wasn't resistant to so she could be given the right kind of of antibiotic. But yeah, scary times. Yeah, yeah, it's no no joke.

SPEAKER_00 27:49

And what do you describe as a classic scenario? I I mean, I hate to say it, but I've heard this, you know, kind of story before. Unfortunately, I've also heard the sort of female component of it, where the complaints are dismissed and not looked at seriously. The guy who originally invested in Effie pharmaceuticals had a daughter who was spending a semester abroad and became septic. And so they rushed to Switzerland, we're at her bedside for what was a very harrowing several days. I'm sure what you experienced too. And he came back and said, What can I invest in that might help create a solution to this problem? And that's when he found Effie Pharmaceuticals and invested. And he's been with the company ever since. He's been an extraordinarily strong supporter for the company, and we're very grateful to have his support. And that's the kind of mission investment that can make a difference. And the difference here is that instead of trying a bunch of antibiotics that were cheap and easy and broad-spectrum but didn't work, you put this on, and it has two benefits. One, it's just going to retard the infection if it doesn't completely eradicate the infection. But the other thing that our drug has is it's very strong anti-inflammatory properties. So it's the inflammatory response in sepsis that really kills the patient. Your immune system essentially goes out of control trying to control the infection. And it's the out-of-control immune system with the catastrophic release of cytokines that results in all the damage, the tissue damage to the microvascular blood pressure drops, the DNA damage, all the things that happen in sepsis are generally driven by the sort of tipping point in sepsis, where you get this massive cytokine release, you get massive release of oxidative radicals, and you get just a tremendous amount of organ and tissue damage. And some patients recover, but that's why those patients who recover are sometimes significantly damaged and have problems afterwards and may take either a long time to recover or may actually die in subsequent months because of that dictator. Wow.

unknown 29:46

Right.

SPEAKER_00 29:46

So the idea is take something right away, put this drug on right away. And then you you have time to work the rest out. You have time to find the right antibiotic. You have time to bring in other supplemental care to support the patient. Time is what everyone's concerned about, but they're concerned about compressing the time. And what we're concerned, what we're offering is an opportunity to actually extend the time.

Dr. Leeanne Aguilar 30:09

Right. Yeah. Now, does it protect against staph infections?

SPEAKER_00 30:14

Yes, it's very good against staph. And one of the things we've studied the most is MERSA, which is methacillin resistant staph aureus. And that's one of the biggest antibiotic resistance concerns that there is. And it works extremely well against MERSA. We've done some studies in animals where we kind of scratch the skin and infect it with MERSA. And then we put on our drug or we put on an antibiotic or we put on the combination. If you put on our drug, it's at least as good as an antibiotic, if not better. But if you put on the combination, it's like two orders of magnitude better, which means like a hundred times better. It knocks down the concentration of pathogens by a hundred times more than either drug did alone. So it's really exciting because you go from dropping it by a thousand fold, which is great, which is kind of what an antibiotic might do, to dropping it a hundred thousand fold. That would be better.

Dr. Leeanne Aguilar 31:09

I know. Well, because like my daughter and like so many others, you know, she walked away from that hospital with the staph infection. That doesn't go away forever. So I'm like, you know, double whammy. But uh yeah, because you're left vulnerable, like you were saying, you know, the you end up overcoming the the sepsis, but then are are vulnerable for a while. So it's like okay. And it took like three or four more hospital visits in different rounds of antibiotics to finally kick that staph infection. Yeah. And it's treating the nose. Very treating the nose.

SPEAKER_00 31:41

You you you have the real world experience of what I'm trying to deal with. And I'm so sorry you had to go through that experience and your daughter had to go through that experience.

Dr. Leeanne Aguilar 31:49

She's okay. She is okay. She is great.

SPEAKER_00 31:51

I'm glad to hear that. 14-year-olds are quite resilient. Yeah, yeah.

Dr. Leeanne Aguilar 31:55

No, that's so brilliantly years. No, not at all. No, it's a very scary experience. And yeah, I'm just saying I'm no, I'm not alone in that. And and when they're vulnerable after having gone through so many rounds of antibiotics, their immune system is is down and they're susceptible to other things. And so, yeah, having something like you're talking about to you know can be.

SPEAKER_00 32:15

And their microbiome is all messed up and it's just not great. And some of these antibiotics have, you know, side effects for hearing loss and other things that just yeah, you don't want to have to go through this if you can possibly help. And having a non-toxic alternative is the kind of thing that we would love to see widely available because it really has the potential to revolutionize how we care for infections.

Dr. Leeanne Aguilar 32:36

Yeah. Now you've said that first-in-class innovations face the greatest resistance. What are the biggest barriers, scientific, financial, or psychological, that prevent breakthrough therapies for advancing?

SPEAKER_00 32:47

The science is there. And if it was well funded, it would be able to advance. But it's sort of a, again, a catch-22, because if the science and the newness of the approach is not convincing to investors who are worried about risk taking, which most investors are, then um, you know, it's not it's a chicken and egg. The investors want more evidence for new things than what they would require for something that's derivative of what we already have. So if you're derivative of what we already have, we know what we have, we know it works, we know this might have this advantage, but we know that's likely gonna work too. And it's a matter of marketing. Okay. If you have something new, we don't know if it works. Sure, you have this evidence, but do you have this evidence in patients yet? Do you have this evidence in of efficacy in patients, like from a phase two study yet? Until you have those things, we don't know for sure if it's gonna work. So we're gonna wait until you have those things. And that's the catch 22 is that when you have something new, the same level of sort of risk requires an extraordinarily larger level of proof. And getting that evidence requires capital, but the capital requires the evidence. So, how do you resolve that dilemma? And that's what Stymies new innovations. And look, this is not a new story. This goes back like as far as you can modern medicine. And I'll give you an example. So there's this uh physician in Greece named John Leucytis, and this is the 1950s, and he is a general physician, but is interested in gastroenterology. He gets a GI infection and he treats himself with antibiotics and he cures his GI infection. That's great. He also had a gastric ulcer, and he also cured his gastric ulcer with the antibiotics. And he realizes that gastric ulcers are not diet, stress, and lifestyle, which is the prevailing wisdom at the time, and stayed the prevailing wisdom into the 1990s as a foreshadowing element to the story. He realizes that's actually an infection and it could be treated. And he develops an antibiotic cocktail and he cures 30,000 Greeks of gastric ulcers. He gets a patent on this cocktail in 1961 in Greece. He tries to publish his results in the Journal of the American Medical Association, but they say no, this is not for us. He tries to get a clinical study conducted in Greece by the leading Greek authorities. It's like a mini phase three, kind of on our current sort of parlance of drug development. And they said no. And then finally the Greek medical authorities fined him for malpractice after caring 30,000 of gastric ulcers. They find him for malpractice because this violates what we all know. It's diet, stress, and lifestyle. So 1984, two Australian physicians, Warren and Marshall, they published that an organism called Heliobacter pylori causes gastric ulcers. It takes until 1996, 12 years later, before the practice guidelines for how you treat gastric ulcers changes to say it's an infection, you should treat it with antibiotics. Now they got the Nobel Prize in 2005 for that discovery. John Leucitis was dead. He got buttcass.

Dr. Leeanne Aguilar 35:56

Wow. That's unfortunate. But but you hear about those types of scenarios, you know, often. Yeah. I mean, that's a like a really, you know, clear cut recent example. That's amazing.

SPEAKER_00 36:07

But well, I mean, it's not even a recent example. It shows how there's so much inertia in medicine and there's so much reluctance to change to something really new that it takes extraordinary evidence and it takes extraordinary persistence to actually achieve that. And so that's what makes new things much more difficult is that the tendency to cling to what we already know about a disease sometimes blinds us to seeing that there's something new that could be much more effective. And even when we have things like gastric ulcers that we never were able to treat very well, never able to control, we still were blind to the idea that there's a new therapy that's going to be more than 95% effective in just completely eradicating it in in one go. That's what you want for a disease. You're most of the patients that come in to be cured like that, and that's what you're looking for. When you ignore that because you're used to the old things and the old ways, it's it's frustrating.

Dr. Leeanne Aguilar 37:02

Right. But a case study of 30,000 people, I mean, that's not, you know, a random.

SPEAKER_00 37:08

But it wasn't done in a controlled clinical study. It wasn't published in a peer-reviewed medical journal. Got it, right? In other words, the quality of the conventional guidelines matters. Yeah. And 30,000 Greeks in an uncontrolled case series. I mean, of course, it's overwhelming real-world evidence, but people don't base medical professionals don't base and pharma companies don't base their decisions on real-world evidence at the beginning. They start with all the controlled clinical studies and everything else, and then you can do real world evidence. Um, and this was just, you know, it's obviously before our time. So standards were different and expectations were different. But, you know, poor poor Dr. Leukaitis. Man, I just feel for his frustration.

Dr. Leeanne Aguilar 37:49

Well, ultimately, I guess he was proven right, though. So he got the happened. He's rolling over in his grave. Exactly.

SPEAKER_00 37:57

Maybe so.

Dr. Leeanne Aguilar 37:58

So across oncology and infectious disease, then how do you decide which innovations are worth pursuing given the cost, time, and uncertainty involved?

SPEAKER_00 38:08

Well, I mean, at this point in my career, I'm going to be drawn to the things that are new and the things that are novel and the things that can actually make a major difference in medicine rather than things that are incremental. Incremental stuff, there's plenty of valuable things there that can improve what we already have and make it, you know, easier for patients, a little bit more effective, more convenient, et cetera. And I'm not disparaging any of those things. I tend to work on the things that are novel because it's more engaging to me intellectually. And it's more engaging in trying to help those products sort of cross that barrier into being acceptable to investors. I don't always succeed, I have to admit. How do I decide? Well, I mean, I take a look at the evidence for the science, and it has to be credible. If it's if it's not credible, I don't do it just for the sake of novelty. It has to be something new that has a significant uh body of evidence that supports it. So, for example, the anti-infective product we've been talking about, we have like 20 with 31 published studies so far with that across a variety of different models, with lots of different collaborators showing that it works in other people's hands. It's not just about the company did it a particular secret way or they somehow ran the studies in a way that was not uh, you know, kosher. No, it's anybody who uses this is able to reproduce the results and create new results. So that's really important validation. Having a scientific model that makes sense, a biology that makes sense is very important. Having a product that can be delivered to patients in a way that will be appropriate for the kind of care you want to deliver. If you want to, if you want to treat everybody, it has to be convenient to some degree. I mean, you can treat everybody with an IV, but it's a hell of a lot better if it's a once-a-day pill, as an example. So those are some of the criteria I use. Sometimes it's it's also helpful as the people are really good people and um, you know, obviously super smart and good to work with. And they are the kind of people who you want to help make successful. That's that's another consideration. So, you know, all those things go into it. Whether I think I can help get it financed is another consideration. I often overestimate my ability to help get things financed. So sometimes that might lead me astray. But, you know, I consider developing new medicines for patients to be one of the worthiest endeavors you can have actually devote your energy to. And so I feel it's worthwhile me making sacrifices, me trying, taking risks, me trying to do hard things, because there is nothing more worthy than bringing something new to medicine that can really change outcomes for patients, especially patients whose condition is one that's life-threatening.

Dr. Leeanne Aguilar 40:44

Mm-hmm. Right, exactly. And that said, as a CEO of startups, you have raised over 180 million, engaging a wide range of funding mechanisms. And I know you've used angels to venture capital to venture philanthropy and strategic partnerships. How has the funding landscape changed for biotech, especially for first in-class therapies?

SPEAKER_00 41:04

It's the worst it's ever been. I mean, I I hate to have to report that, but right now it's the worst it's ever been. And the last four years have been terrible. Uh, for biotech, in 2021, biotech was averaging 35 to 40 IPOs per quarter. In 2022, that fell to four per quarter. Whoa. And it's been that way ever since. So for the last four years, for the last four years, it has been in the pits. And the biotech index certainly shows this. It's ticking up this year, but um, it has been in basically flat or down since 2022. Funding for startups follows all of that.

SPEAKER_02 41:46

If there's no exits for startups, uh-huh, investors don't want to invest.

SPEAKER_00 41:51

And when IPOs go out the window, that really changes the exit dynamics for biotechs. Wow. So new things are the first things to go. Okay. New things and first and class things are the first to go, highest risk, longest period to get to return, those go first. Investors are gonna focus on the companies they've already invested in because it's gonna be a hard environment for those companies to get more money. So we're gonna keep our dry powder for our existing portfolio companies. We're gonna bring in companies and investors in our circle for future rounds for the existing portfolio companies. And so a lot of the big mega rounds that you're seeing are companies that are getting farther and farther along and are using their existing investor base as a way of continuing to grow the company and leverage the company and bring the assets to maturation where they can then be potential acquisition targets by a pharma. But, you know, the other problem is that pharma, the pressure of IPOs is gone. So pharma doesn't have to offer as much as they might have five years ago for an asset, relatively speaking. So a lot of times investors want to hold on to those assets a little longer until the market improves and they can get fair value for those assets. So there's continued desire to keep those assets in the portfolio until you can get a maximum return for that. So it's a terrible environment for early stage stuff. It's a terrible environment for first-in-class stuff. Never been worse. And the problem is it just keeps getting worse because more and more companies are running out of money. And so you're getting this bigger and bigger inventory of companies that need funding at the same time. And so that starvation, I mean, sure, some of those companies will fold, and those assets might get sold for pennies on the dollar to smaller pharma companies that are looking to grow. Um, and that's one way of keeping those things in the ecosystem. But it's just a terrible time to uh to do a startup.

Dr. Leeanne Aguilar 43:34

So, from your perspective, what systematic changes are needed in funding? Is it re regulations, incentives to accelerate uh truly transformative medical breakthroughs in this day and age?

SPEAKER_00 43:47

Boy. Because there's a lot of things broken in medicine, uh, there's no great answer because you know the best answers would be transformative for the entire ecosystem, not just for developing pharmaceutical products or medical devices within those. Categories, there are some specific things in specific industries that we're trying, but that's based on the constraints of the existing sort of healthcare delivery model in the US. So I'll give you an example of this. There's an act called the Pasteur Act for Infectious Disease that's trying to address the fact that nobody will invest in antibiotics anymore, but yet we desperately need them because of antibiotic resistance. So, how do you solve that dilemma? Well, one of the ways you potentially solve it is you create a subscription model for pharmaceuticals rather than a pay as you use model. So, right now, what are pharmaceutical companies incented to do? Sell as many prescriptions as possible, right? Because that's how you make money. Okay. But the problem is what are the people who use antibiotics incentive to do? Don't use new antibiotics because we need to save them so resistance doesn't emerge. So those that directly undermines the pharma model of sell as many prescriptions as you can.

Dr. Leeanne Aguilar 44:51

Yeah, true.

SPEAKER_00 44:52

So the only alternative to that would be something like a subscription model. You have access to this new antibiotic when you need it. For the government, for the military, for hospitals, for you know, states, whoever. And it costs this amount of money to have access to the antibiotic. And that ensures there's going to be some income for the company for producing that antibiotic. And they will produce a stockpile of that antibiotic. And if there's needs, they will fill those needs out of that stockpile. And if there's a lot of need, they'll sell more than what the subscription was. And if there's less need, they will still have the subscription income that will sustain the company and offer a return for investors. Now, the Pasteur Act has been sort of pioneered by several other countries in a different form. I mean, the same structure, but a different name. So there's uh a version of this in Canada, there's a version of this in UK that are already in place. And the version for the US, the Pasteur Act, has been essentially every year, it never makes it through Congress for reasons that I think are well known to everybody. Congress is a little bit dysfunctional here. And so, um, but that's an example of how to use your existing system, tweak it a bit, create a different incentive structure for a particular thing. But in general, how to get interest in new products, you would have to kind of change the roots, which is pharma's incentive structure for new products. Pharma's incentive structure for new products is how can I sell the most and get the most money and the most profit. And that's what we do in medicine. Medicine in the US is structured for how can we make the most money and the most profit. And so you would have to somehow adjust that incentive structure so that there's incentives for developing new cures. Now, part of that was done with orphan drug and priority review vouchers, where there were some incentives provided for things that you would never normally develop a therapy for. If a disease affects a thousand people, you would never invest in developing a therapy for that. You could never make enough money. But with orphan drugs, you can protect that for a lot longer. And pharma companies discovered that they could charge a lot for those products because even though they only affect a thousand people, insurance companies will pay for the one or two people in their policy that have that disease. And you can charge a hundred thousand, five hundred thousand, a million dollars for a therapy for that those patients because of their rare condition, as long as you actually provide something that's substantially curative. And so that's been a new way of incentivizing it. But boy, if you really want to do something, you either have to make government-driven funding like NIH funding for these kinds of things more available, BIRs and STTRs, which the government has, 250,000 and 750,000 are the two tiers at SBIRs, roughly. That's not enough. You can't do a clinical study. I mean, you would have to have another tier, you know, in this to really be helpful. Or NIH would have to be more available for companies. Um, so there are, yeah, there are things we could do, but it so much feels like nibbling around the edges unless we have any sort of substantive foundational change in the way in which we organize medicine. If health was about health, not money, then you would organize it differently. But as long as it's about money, it's going to be really hard to push it into a place where novel new things are going to be embraced.

Dr. Leeanne Aguilar 48:12

Yeah. So as a leader, then, what kind of mindset is required to operate in such high-stakes environments?

SPEAKER_00 48:18

So, I mean, the logical thing is you don't do what I do.

Dr. Leeanne Aguilar 48:25

But then you don't get the breakthroughs.

SPEAKER_00 48:27

Yes, that is the dilemma. That is exactly the dilemma. So, the one of the ways you can try to get traction is to work with thought leaders. Okay, key opinion leaders are very influential. They're usually people who are invested in the status quo. So that's where the difficulty comes in, is that they're going to be the people who created the currently used therapies and models and targets and so forth and are on the grant review committees and the journal editorial boards, or they're editors of the journals, and they're the ones that VCs are going to, and they're at marquee institutions that VCs love to visit. You know, you want to tell people you're sourcing your companies from Harvard and Stanford and MIT and Mayo Clinic and stuff, because that gives credibility instantly. But the irony is most real, genuine, brand new breakthroughs come from somewhere else. Eventually they might get picked up by one of those institutions, but they come from somewhere else where people are just trying to solve the problem. They don't care about the status quo at all. They don't care about the existing ecosystem at all. They're just trying to solve a problem for their patients. And they are the ones that come up with breakthroughs because they're not encumbered by the current model that everybody applies to the disease. But that's exactly the dilemma, is because those people aren't in those ecosystems, they're not viewed as credible. And so the natural reaction for anything that's new is it's snake oil. It's not real. This guy doesn't know what he's talking about. You know, this is not real. So boy, we need people to keep doing this, but it's awfully hard to keep doing it.

Dr. Leeanne Aguilar 49:54

I guess are universities and you know, uh research departments and and large institutions willing to, you know, be open and take on research by the people who have the ideas, you know, the credentials.

SPEAKER_00 50:07

A lot of the stuff comes out of universities. But the the thing is getting to that next step. I mean, the universities don't fund research, okay? Universities bring in researchers who bring their funding from NIH, NSF, other institutions, other funding sources. Universities get money as part of the overhead for supporting them with the lab and everything else. So universities aren't supporting the research. They're given space to researchers who do the research. And the research is funded by grants and other things that they get elsewhere. So the challenge is the other funding that they need. So will those other funding sources look at things in a more risk-taking rather than risk-averse manner? And that's what we lack. More mature we get, the less risk we're willing to take. It's almost like as humans, too, you know, as you get older, the less risk you're willing to take.

Dr. Leeanne Aguilar 50:55

Right. Uh as people. But I mean, as a society too.

SPEAKER_00 50:58

And as an institution, the sort of more mature we get, the less risk we're willing to take. But the problem is that if you stop taking risks, then you're going to stop developing breakthroughs. And so unless we can change that attitude and mindset and/or create institutions that are devoted to taking risk, then we will slow down that pipeline. And we're, I think we're already slowing it down.

Dr. Leeanne Aguilar 51:18

Yeah. Well, Michael, a couple more questions. I mean, talking about risk, you've openly discussed failure as part of the journey. What are some of the most important lessons you've learned from ventures that didn't succeed?

SPEAKER_00 51:30

So um, yeah, failure. The thing with biotech is failure is the most likely outcome of startup. And that's acknowledged by investors all the time as part of the rationale for why they're not investing in the you're a risky endeavor. So the the thing that actually kills more startups than anything else is access to capital. So one of the things that I uh would look for in new endeavors is do they really have an access access to capital? Is there a realistic way that this is going to get funded? Um, one of the other things is super important is do we have really good founders? Do we have good people? You can uh work with a lot of different kinds of people. And so why not work with good people?

SPEAKER_02 52:12

Yeah.

SPEAKER_00 52:13

Even uh somebody with a brilliant idea, an absolute, you know, blockbuster potential who's an who's a jerk, who's a narcissist, who's, you know, just an all-round, you know, difficult person to work with, it's gonna be miserable. And it's gonna be hard anyway to work on something new. Why work with somebody who's miserable? Yeah. So working with good people.

Dr. Leeanne Aguilar 52:36

Right, they're long-term ventures. Yeah, long-term ventures.

SPEAKER_00 52:39

Yeah, you you sign up for a startup, it's not usually uh a a year and then you're on to your next gig, unless that's your choice. It's usually gonna take a while to get somewhere in biotech and to get to the value inflections that you really need in order to get like the next draunch of funding. So those are, you know, two of the things. The other things that um, you know, that come up, you know, they're they're secondary. If the technology is gonna work, it's gonna work. If it isn't gonna work, that's what you do studies for. That's what you do experiments for, that's why you do clinical trials. You can't know perfectly whether something's gonna work or not. You know, that's why you got to do experiments. So I don't actually worry as much about whether this technology is gonna work or not. As long as it's got good fundamentals and good foundation. I don't worry about whether it's gonna work about uh in the long run because there are plenty of honorable failures where people did everything they could trying to address a disease with a new therapy, and just something came up along the way that nobody would have predicted. And it's enough to say, no, you can't do this. My first biotech company was doing hemoglobin as a blood substitute. So you could use hemoglobin in anybody, you don't need to put a red blood cell around it. And that red blood cell has all the factors that create the immune response. That means you have to type and cross match your blood. That's why we have blood types, because you can't just give anybody any blood, but you can give anybody hemoglobin. It doesn't matter. So it would solve the problem, and it was also be, in our case, a source that we could generate in big fermentation bats. So you don't need to go and stab people and get their blood. You can just get it out of a vat. And we got to phase two, and we discovered that the hemoglobin, because it's free circulating in the body, can leak out of the blood vessels much easier than red blood cells can. And when it leaks out of blood vessels, it binds things other than oxygen and carbon monoxide and carbon dioxide, it binds nitric oxide. And nitric oxide is a really important signaling molecule in the body. And when it binds nitric oxide outside of the blood vessels, it can create problems. And one of the problems was nitric oxide is a signaling molecule for what's called the sphincter vodee. This is the sphincter that allows bile to be released into your digestive system. And if it closes and won't open, you build up bile in your pancreas and you it can cause pancreatitis. And pancreatitis is a pretty severe condition. And so boom, everything blew up. Everything blew up for not just that company, but all the companies that were in this space, they all went under. Because this unforeseen side effect of taking the hemoglobin out of the blood cells and allowing it to circulate freely, didn't matter how you modified it, didn't matter what you did with it. That was going to be fatal to any one of those products that were being developed at the time. So those things are they were honorable pursuits. People were trying to do something that was really would really be valuable. And it didn't work out. And it's not through anybody's fault. Nobody failed to execute. People failed to anticipate an unforeseen biological effect.

Dr. Leeanne Aguilar 55:34

Right. Right. That's fine. Right, but it still contributes to science. Yeah.

SPEAKER_00 55:39

And now people maybe somebody will figure out how to do it next time without it leaking out of the bloodstream, right?

Dr. Leeanne Aguilar 55:45

Exactly. Yeah. So, Michael, finally, for entrepreneurs entering biotech today, what advice would you give about pursuing innovation that truly changes patient outcomes rather than incremental improvements?

SPEAKER_00 55:58

Well, the first thing I recommend, and I've had the opportunity to do this with students and postdocs and stuff. I'm a Spark mentor at Stanford. I was just up in Oregon giving a talk and talking to faculty and students a couple months ago. First thing I say is get some experience somewhere that's doing it. In other words, don't just go in cold to being an entrepreneur and taking on new challenges and new products, et cetera. Because the chances are coming in cold, you will not have enough experience to understand whether or not this is a good idea and to understand how this would be developed, to understand how this would fit in the competitive landscape. So get some real world experience first at biotechs or pharma that actually are doing this. Get involved in that side of the business. Either a project manager is a great role. Might take you a little bit to work up into it, but it's a great role because you see everything. Or get into the business side. You know, business development, you'll understand what the company prioritizes, what they value, what they're looking for, why they're looking for it, what of the competitive assets that are out there is most exciting to the stakeholders and the management of the company. And those things are useful and I would argue necessary to be able to contribute in a meaningful way to leadership of new products and new endeavors. I mean, you can always get involved with biotechs that are private or public that are developing new endeavors and see how they go about it and watch some of the successes and failures along the way and learn from that too. So it doesn't have to be a big pharma, it can be a smaller company, but company that's capitalized and will have enough sort of enough runway that you can learn a bunch of steps along the way, not just where they're at today and then they run out of money and then you're done. Um, but you know, watch the steps so that you get a perspective and you can take that out into the world of new products and new startups.

Dr. Leeanne Aguilar 57:37

Yeah, that's great advice. I mean, I even did that with learning marketing before I started my own business, you know, worked at a place, went in and was a little sponge, just learned all the things, interviewed the vendors, you know, spoke with my clients, talked, and so just like you did in your space, just really got experience with every different aspect of the business and learn on somebody else's time, right? So you're not making all of the mistakes yourself. Yep.

SPEAKER_00 58:00

That's your you had your PhD in marketing, uh, a real world PhD.

Dr. Leeanne Aguilar 58:05

Yeah, but no, that's a really, really good advice. Yeah, get some experience with other people first, learn the ropes, and then you know, get out there equipped with that foundational knowledge before you really try to launch on your own.

SPEAKER_00 58:17

It's helpful to know how other people think.

Dr. Leeanne Aguilar 58:20

It is, yeah, yeah, exactly. And I mean, they they contribute so much, I think, from other people have wisdom, which is why I like to ask these questions at the end every time. It's like, what would you what what advice would you give? What you know, nuggets of wisdom would you share from your own journey that will help help others? Because why reinvent the wheel, like we mentioned, if we don't have to? Yes. Right, exactly. That's that's if people choose to to take it on and and learn from from others' mistakes, yeah, or others' successes. Yeah.

SPEAKER_00 58:50

Well, I think you learn a lot more from mistakes than successes, by the way. I do.

Dr. Leeanne Aguilar 58:55

I I agree.

SPEAKER_00 58:57

Our things went well. What did you learn? I learned that if I did these things, that things went well. But the problem is when you apply that to the next thing, that might not go well. What you learn from a failure is we did these things and things did not go well. And we adjusted and that made this better, and then we adjusted that and that made this better. And then you you keep making adjustments when things aren't going well that you can test whether or not this is improving your outcome. And if it does ultimately fail, um you do a debrief, you really hopefully try to understand what failed. And you can learn from, okay, well, if if we'd had this and this, maybe we'd had a chance. Boy, there's a hell of a lot more rich learning there than I had a success. But we we focus everything on your successes.

Dr. Leeanne Aguilar 59:47

Isn't that funny? Where ironically, I think failures, like you mentioned, are so much more valuable in our actual learning because we don't even remember our successes half the time. It's like, oh, okay, yeah, I aced that exam and then you forget everything. But if you fail, like when I was in a spelling bee in, you know, sixth grade, I still remember the word I messed up on. I still remember. This is like 40 something years later.

SPEAKER_00 1:00:12

Yes. Well, I think people love to think that the success was because of them, and other people love to think that the failure was because of them and point fingers. And I think that's the real challenge is that uh we don't have a very good perspective on what success and failure really is. In fact, I was talking with somebody earlier today, and I said, what I'd love to see, and this is more about how people are positioned for job searches, what I'd love to see is that instead of us asking people to list their successes, they should list their where they feel the best about contributing because they can contribute to failures in extremely meaningful ways. They can do really remarkable things, be very insightful, very innovative, very hardworking on a failure. And that's as meaningful or more meaningful than a success. And so I want to know what they did, not whether they worked on a success or not. Whether they worked on a success or not may have very little to do with them personally. It's just whether they were lucky or not to be on something that was successful. But what did they really do? What are they excited and proud of doing? That's what I want to know. What did they contribute that advanced the program? That's what I want to care about. Yeah, I wish we cared more about that than listing your successes.

Dr. Leeanne Aguilar 1:01:22

Yeah, no good point. I'm definitely going to take that when I interview people again, or if I if I get interviewed, yeah, definitely. It's like, what did you fail at? And how did you pick yourself up again, even? What did you do to take that learning to turn it around and make something out of it? So, well, great. Well, Michael, thank you for joining me. It's been an insightful and inspiring conversation. How can the listeners learn more about you and your work at Pathflex Pharmaceuticals and FE Pharmaceuticals?

SPEAKER_00 1:01:48

Well, both companies have very extensive websites. Uh, they can learn about me. I have a LinkedIn profile that's quite extensive. Pathlex is uh pathflex.com, pretty simple. Fepharma is Fefarm.com. And uh both companies like to show off their science. So there's publications of the science for both companies. Both companies are trying to uh, you know, break out, which is always the biggest challenge when you're first in class, is uh getting that breakout moment. So delightful talking with you two this morning. And I really appreciate the opportunity to have this kind of dialogue. It's always fun to talk about what we can do to really improve medicine and care for patients because that's that's been my passion. So thanks for the opportunity to talk about it.

Dr. Leeanne Aguilar 1:02:29

Well, thank you for your contribution. Absolutely. And to our listeners, thank you for tuning in to Industry Ignited. Be sure to subscribe and join us for the next episode. Until next time, stay bold, stay curious, and keep igniting industry.