In this episode host Ross O'Brien from Bonaventure Equity interviews Greg McKee, the founder and CEO of Journey Life Sciences and a managing partner at Bonaventure Equity. O'Brien and McKee discuss the emerging world of psychedelics and venture capital, and the need for new paradigms of medicine to address the mental health, addiction, and pain epidemics. They talk about entrepreneurship and the importance of testing the market demand for new ideas, especially in the context of psychedelics as potential therapeutics. McKee shares his background in finance and drug development, and how he came to be interested in psychedelics. The episode concludes with a discussion of Journey's mission and how the company is working to bring psychedelic therapies to market. Produced by PodConX Ross O'Brien - https://www.linkedin.com/in/rossobrien/ Bonaventure Equity - https://link.bve.vc/Visit-Us Greg McKee - https://www.linkedin.com/in/gregorymmckee/
In this episode host Ross O'Brien from Bonaventure Equity interviews Greg McKee, the founder and CEO of Journey Life Sciences and a managing partner at Bonaventure Equity. O'Brien and McKee discuss the emerging world of psychedelics and venture capital, and the need for new paradigms of medicine to address the mental health, addiction, and pain epidemics. They talk about entrepreneurship and the importance of testing the market demand for new ideas, especially in the context of psychedelics as potential therapeutics. McKee shares his background in finance and drug development, and how he came to be interested in psychedelics. The episode concludes with a discussion of Journey's mission and how the company is working to bring psychedelic therapies to market.
Ross O'Brien - https://www.linkedin.com/in/rossobrien/
Bonaventure Equity - https://link.bve.vc/Visit-Us
Greg McKee - https://www.linkedin.com/in/gregorymmckee/
Ross O'Brien: [00:00:00] Welcome to another episode of the Psychedelic Capital Podcast, where we go beyond the headlines in the emerging world of psychedelics, venture capital. Join us for in-depth interviews with leading investors, entrepreneurs, researchers, and policy makers who are pioneering a new future in healthcare. I'm your host, Ross O'Brien, founder of Venture Capital firm, Bonna Venture Equity author and lifelong entrepreneur, and I see entrepreneurship everywhere.
As an early investor in this new frontier of life sciences, it's my goal in these conversations to bring you direct access to the thought leaders and pioneers at this defining moment. We are in the midst of a mental health crisis, an addiction crisis. Pain is an epidemic, and for the first time, we now have the legal pathways to develop psychedelic science and bring a new paradigm of medicine to the patients who need it most.
As we imagine this new future, I'm inspired every day by the visionaries that we get to work. And have the privilege of [00:01:00] introducing them to you. Today I'm honored to speak with a unique visionary and one who I also get to call a partner, Greg McKee. Greg is the founder and c e o of Journey Life Sciences, and a managing partner at Ary Equity, a lifelong biotech and drug development executive.
So Greg, welcome to the Psychedelics Capital Podcast.
Greg McKee: Thank you, Ross. Great to be here. Good to see you again.
Ross O'Brien: Good to see you as always. And, and, and, and a lot . So, as one of our goals here is to expand our thinking without substances, , so, to kick off the conversations. We lean into the oblique strategies, and so for those of who don't know, oblique strategies are a set of cards developed by Brian Eno and Peter Schmidt.
And they were used in the studio, their producers to inspire creativity and to move past writer's block. So, we hope you enjoy the thinking about them in the entrepreneurial context and in. Space of psychedelics. And so the card, Greg, here we go [00:02:00] with a truly unscripted conversation. And the oblique strategy for today is, would anybody want it?
Greg McKee: what anybody want, man, A lot of different stuff comes up. Right. Build it and they will come, of course, like comes forward right away. Would anybody want it? Well, like. Yes. Yeah, I think that they would, I mean, I think that's the greatest part about being an entrepreneur is that you get to, you get to make stuff out of, out of pixie dust, right?
Like, we get to take ideas, we get to take things that have never been created and, and pull them out of, pull these ideas out of our mind and put them on paper, put them in slide decks, put them in podcasts, and then most importantly, begin to execute on them. and Yeah. The entire time you're thinking about holy shit, like, is is anybody gonna want this stuff?
And I guess, relative to, like drug development. Yeah. I mean, like, clearly like if we can come up with solutions to health problems, that's gonna, that's gonna work. When it [00:03:00] comes to psychedelics in particular, right? Like the projects that we're working on that I'm sure we're gonna get into today.
It's even more obvious that, that people want it cuz they're already, there's, there's been 50 years of, of history in the development of these chemistries. So it's like, it's clear like people are already using these chemistries, they're already doing research in academic institutions on these chemistries and there's already, some clinic, even clinical trials that are being run.
So, yeah, like it's pretty clear in this particular. people are not only gonna want to want it, but they already do and they already are, working to gain access. So,
Ross O'Brien: Well, and I, and it feel to me as well, Greg. Is the first step towards the people will, people need it. Question, right? Which is, is this real medicine, right? And is there real efficacy? And when I think about what anybody wanted in the entrepreneurial context, we see so many times entrepreneurs have ideas that seem compelling without testing the market [00:04:00] demand for it, right?
So it's not just would you want it, but is. , a universe of people out there that would want it. And so in the context of psychedelics, it seems like there's conversations around dozens and dozens of therapeutic indications where the, the research and the science is starting to explore if these are compounds that will work.
So maybe we should step back for a minute and get to there. It'd be helpful to, to hear a little bit more about your background, Greg, and how you found your way to the psychedelic space.
Greg McKee: Yeah, so, so I've been very interested in entrepreneurship from the early, early years of my career. I did start my career in finance working in Tokyo. I managed 550 million. in the public equity markets. And at that particular time, I was very, I frankly didn't want to choose a specific industry. I was just very curious about.
How do economies grow and, and how do you in invest capital effectively and had an opportunity to work in Tokyo and I, I [00:05:00] just, I took that and I ran with it and a one year internship ended up being seven years for me. But as I spent more time there and, and sort of got my feet wet and had an opportunity to look around a number of different industries, a couple things happened for me.
One of 'em was that I really wanted to get my hands dirty and get much more involved in companies than. From looking at them from the perspective of a financial balance sheet or a p and l or cashflow statement, I was much, I was really curious about operationally how these companies worked and what was going on with the technology.
What kind of regulatory pathways were required for companies to commercialize their technologies and commercialize their products? So I really wanted to kind of like peel back the onion and, and really take a deep dive in, in, in entrepreneurship and, and companies in particular, right? And I remember when I was on the trading floor one day thinking to myself, man, like it's, it's all about not necessarily these bigger companies, but it's, it's all about these earlier stage entrepreneurial companies where you put the right [00:06:00] combination of people.
Capital and technology together. And if you get that in the right configuration, like magic happens on every level, every level, you get products that that can be taken to market that are groundbreaking, that have huge impact. You can make phenomenal returns for investors and, and you're, you're building and leaving an incredible legacy, right, for our time here.
So like all those things really align for me. So I. Business school at Wharton as my segue, into industry. And when I was leaving Wharton, I really had a couple of, Hey, I was also at a pretty seminal moment where I had an opportunity to either work in tech. In Silicon Valley, which was really compelling.
I was, I'm not from California, but I wanted to get to California and that was really compelling because it gave me a straight opportunity to go work in Silicon Valley, and I was very tempted to do that. But at that time, in the mid nineties, I felt that the life science industry was going to be highly relevant during my career.
[00:07:00] And there was also a lot of. Influence from my family background. My, my father is a physician, his brother, my uncle was an anesthesiologist at Cedars of Sinai in Los Angeles, and my aunt taught nursing at ucla. So there's been a, a long history of, of individuals in my family in medicine. And so, I used to make rounds with my dad at the hospital in the small community where I grew up.
And I've always had kind of exposure to the healthcare space. I decided to stay on the East coast and, and go to Boston and work for a company, called Genzyme and that, that just ended up being, the start to a really incredible period of time in, in the drug development, world for the most part.
I did spend a little bit of time in diagnostics and also in the Gen X division there, but quickly moved into the therapeutics. Realm. I helped commercialize our gen enzymes lead compound in Japan and in in China and all other countries in Southeast Asia. And so I was kind of pushed very far forward in terms of looking at, at drug development from a commercial [00:08:00] perspective.
And that was incredibly helpful and my skills, matched that really well at that particular time. But I also was really curious about how does drug development work and how do you pick good chemistries? And the rest, and, and that ended up being a segue into the gene therapy space where I spent a considerable period of time as well as then a, an about a decade in immunotherapy where I was able to see every single aspect of a public traded company where I started as VP of business development.
And then my worked my way. Into the chief financial officer role and then the c e o role where I was c e o for about six to 10 years. And that just gave me a complete 360 degree view of every single aspect of not only drug development for the chemistries and biologics that we were working on, but also, all the different levers and, and, and areas of complexity of an early stage, company.
Ross O'Brien: Yeah, so, so Greg, before we keep going and on the background, I think I. I'd be interested to understand now, [00:09:00] from that point in your career in some of those earlier stages in gene therapy and things like that, what similarities are you seeing and what differences are you seeing to where we are today?
Greg McKee: Yeah. For sure. Right. So this is like, this is really interesting kind of teachings that, so if, if we jump forward to sort of looking at psychedelics and. Other naturally derive chemistries, cannabinoids, right? Things that we're investing at B V E and things like that. We're developing on a journey.
Life sciences. What is one of the, similarities? I mean, obviously you're dealing with the fda, you're dealing with manufacturing, you're dealing with relatively novel chemistries. You're dealing with clinical studies. You're dealing with actually the added layer of the drug enforcement agency, although I dealt with that at Inventa, where we had a schedule two drug fentanyl that we were developing in, in a novel formula.
You also have that, you've got novel formulations, you've got intellectual property and all that. But one of the biggest differences, and certainly there, there's many, right? So obviously the therapeutic areas. Unique. Obviously the chemistries are unique, but I would say the, [00:10:00] the biggest difference for me that's the most impactful is the fact that there's so much history, right?
Meaning that there's, there's so much academic work and there's also, frankly, quite a bit of recreational use of cannabinoids and also psychedelics, which gives you this platform of data to, kind of look into and, and, and to use as a backdrop. In terms of what we're, we're doing now, never, in gene therapy or immunotherapy where we at a point where we had 50 years of research behind us.
I mean, even today, that's, that's hardly the case. And so when you were, when we were working in those areas, we didn't really have a whole lot of information around the safety and efficacy of those, those compounds. Whereas with psychedelics and canna, We know they're safe and well tolerated, and we know that they work, which is just a really incredible, frankly, unfair advantage in some regard, and very unique in the drug development world.
Ross O'Brien: So, so Greg, let's talk a little bit about [00:11:00] your, coming from the drug development world and, leading drug development companies. How do you find your way into this emerging psychedelic space? I mean, even just a few years ago, this was a little bit on the fringe.
Greg McKee: Yeah. So, so, so, so for me, like the experience in gene therapy and the experience in immunotherapy, just was, was very telling in that I, I really, appreciate, I really have a long, a strong interest in getting involved in these, these novel therapeutic classes, right. And. After we sold Inventa and went through a couple different transactions there, and after I spent a period of time running the startup accelerator here in Southern California I had, as, as would be right, a really unique experience with a set of, of.
Individuals a group of Navy Seals where we were, we were actually working on another startup together which was in a completely different area around healthcare, but not in the psychedelic space. And I started to learn about their personal experiences with P T S D and also their personal experiences with the [00:12:00] use.
Of a psychedelic chemistry called D M t and I was just blown away by how they spoke about the life altering changes of these chemistries and how how much that shifted their their consciousness and their ability to frankly cope with a lot of the past experiences they had while being seals and.
The second thing I thought to myself was like, wow, like, like what in the heck are these chemistries? Right? Like, I had never had exposure to them to psilocybin, M D M A D M T L S D, others. I mean, of course I knew of them, but I didn't have a lot of, direct ex exposure or experience. And, and so those two things, kind of came together for me as.
A, a quick realization that one, whatever these chemistries were, they just had profound impact on people that actually had real life use cases. Right. And then the second thing was that there was this significant history that I discovered very quickly, 50 plus years of [00:13:00] research in this field.
And, and so that to me just spoke to the op, the, the, the idea. We were on the cusp of a, a new wave of therapeutic a new therapeutic class of drugs, called psychedelics. And, and that that I just, I wanted to get involved in this. I just felt it was gonna be so impactful. It was gonna potentially, and I think it will potentially impact so many different.
Types of patients and so many patients as you mentioned before, we're in the middle of this mental health crisis for one plus. There's a number of, there's so many other therapeutic areas that potentially could benefit from cannabinoids and psychedelic drugs. So all that to me, came together pretty quickly as, essentially a vision that, that we're on the cusp of this massive new wave of, of, of new drugs that will, that will come to market and have big impact on a lot of different types of patient.
Ross O'Brien: So one of the things that you mentioned, Greg, Think is really interesting is, decades of, of research. I think a lot of people assume that this is very, very new and at the early, [00:14:00] very, very early stage, which granted there is a lot of, grant money starting to only now be unlocked for this.
But when you see people flock, flocking to this space, seasoned, traditional researchers, PhDs, founders, et cetera and start to, as you said earlier, peel back. Peel back the onion. You know where, where is this history of research leading us today?
Greg McKee: So the, the work done, starting with Albert Hoffman right in L s D that he created at Sandos, all the way up through, like the big push of research, of course in sixties and seventies. Well, it got cut off in the seventies, but there was some, some early research there.
But there, there's actually been a couple different waves. One particularly fair, large wave in the nineties. But where it's leading is a, a number of different, areas, right? Number of different places. So, so one, we've got there, as you said, there's more academic research.
There's, there's grants now becoming available. In a larger dollars in a broader set of different types of grants, you're seeing the numbers of publications [00:15:00] increase dramatically, which is a good indication. There's more academics working in this space. We're also seeing now what I would sort of characterize as being first generation chemistries moving into clinical studies.
So you've got a few companies already that are in late-stage phase two or even phase three. So we potentially will see it in. FDA approval of a therapeutic use of a psychedelic later this year, early next year by maps, which is gonna be a great watershed event with their M D M A drug. You've also got a couple other companies now in phase three, which is really good, but where this is also leading.
Is to so many different areas. There's, there's actually I think, more questions now kind of coming forward than there are, answers. So there's work in terms of defining, clinics and, and figuring out the, the clinic model, which will be slightly different than a typical hospital or clinic setting.
So there'll be very unique environments where, where people are treat. Which is, that's emerging. There's work on the very specific type of [00:16:00] psychotherapy that will be typically coupled, at least with these first generation chemistries. There's a lot of work being done on the manufacturing front to identify manufacturing platforms that are the most effective across a, at least three different areas that we know now, right.
Naturally derived extracts traditional chemical synthesized. Chemistries and now even bio synthesized chemistries. So those three, platforms are emerging and there's a lot of work there to really identify the right processes and characterization of the manufacturing techniques that are used.
That will clear, traditional pharma, F D A guidelines. And then there's also a whole body of work now emerging around the push into other therapeutic areas, outside of traditional mental illnesses. So there's work, in Parkinson's work in chronic pain, like we're pursuing that journey.
Life sciences there's, work in certain eating disorders, work in use disorders. . So there's a lot, there's a lot of other therapeutic areas, a lot of different patient populations that [00:17:00] potentially could benefit that the industry is beginning to move towards. And then on top of all that, there's work in a handful of companies to look at second generation chemistries that potentially, could have a, a different safety profile potentially not require psycho psychotherapy and could model a little bit more of a traditional pharmaceutical type of, Potentially we'll see.
So there's a, a lot of there's, so all this research and all, all the history has been incredibly helpful and that's pushing into a number of different, areas as essentially this whole ecosystem is being created.
Ross O'Brien: So you've mentioned first generation, second generation. Maybe for those listening, can you just define sort of what that means in the context of pharmaceuticals?
Greg McKee: Sure. So, first generation, chemistries I would characterize as being chemistries that are, are already well understood, mean we know the chemical composition. There's, a, a, a high [00:18:00] focus on essentially creating a novel formulation or potentially the novel root of administration. Most, most of the time we think about an or.
Viable tablets or, or capsule, which is, the case of most psychedelics right now. But there's the, the possibility to have better bioavailability by looking at, an iv, potentially inhaled, potentially nasal, potentially a lozenge type of delivery. So there's exploration around taking, chemistries that are already known, but look at different formulations and different roots of de delivery.
But essentially they're, they're chemistries that, we've known about for, for decades.
Ross O'Brien: and how does that Im impact intellectual property. And so how do you know if there's founders out there that are listening to this, how, how, how should they be thinking about what we know about the IP landscape today in this context of first, next generation?
Greg McKee: Yeah, it's, it's a, it's a really great topic, right? Because on the one hand, the good news is there's, there's a lot of data around these chemistries, as we were talking about a moment ago. On the other hand, the IP landscape's a little bit, [00:19:00] unique composition of matter patents are not available for these naturally drive chemistries.
And that, that ca, that counts for, scheduled drugs as well as non-scheduled drugs.
Ross O'Brien: you just define a composition of matter? I don't wanna get too technical, but, but just, yeah.
Greg McKee: Yeah. Yeah. So composition of matter is a patent around the actual chemistry the actual molecule. So you own that specific, molecule. But because these chemistries have been, have been around for so long and because they're considered fairly obvious it's not possible to get composition of matter patents.
So, , but you can create intellectual property around a whole lot of other areas, including manufacturing process patents, including around formulation, including around use patents in novel therapeutic indications and around novel roots of administration as well. So there's at least three, possibly four different, you large categories of intellectual property that can be created.
And there's many examples in the pharma space where. Compounds, that have already been known and that have [00:20:00] come off patent, have been reformulated or they've been repurposed into new therapeutic applications. So that's, that's a fairly tried and true path. So that's, that's sort of the, the way the intellectual property resides.
And, and that's what that looks like in first generation. And
Ross O'Brien: it relates to psychedelics, can anybody own. Psilocybin
Greg McKee: No, it's, it's, it's pretty widely understood right now that nobody can own the composition of psilocybin per se. But there certainly is a lot of room
Ross O'Brien: occurring because it.
Greg McKee: because it's, it's, it's naturally occurring and it's been around so, so, so long that it's, it's fairly obvious that there is a, a therapeutic benefit of, of using.
That or will be, soon. So, so the, the use of it can be patented, but the actual composition itself, because the chemistry's been around for 50 plus years is, is not something you can create new IP around because it wouldn't pass it, it doesn't, it, it's [00:21:00] it's the obvious, it, it fails the obviousness test.
It's, it's too well understood to be not considered novel.
Ross O'Brien: And so that's the, the landscape of first generation chemistries in psilocybin. So let's continue talking about the next generation, and let's take this into, like, now we know the landscape a little bit better. , there's a, a ton of opportunity there, and you've talked about some potential watershed moments coming in front of us.
How, how does this, how does this play out? And, and what I'm really interested in, what I think people would be really interested to hear, Greg, is, again, layering in that traditional, decades of traditional drug development experience, right? Like there's certain pathways that are going to be applicable to this and there's certain new ones that need to be pioneered, right?
So let's start with the sort of where we are and where it's going.
Greg McKee: Right, right. So, so, so, I, I think, from my standpoint, there is so much work that's ahead of us already in, in first generation. compounds. And that will take, [00:22:00] we have a huge headstart, which is terrific, and it'll be a shorter timeframe to get those to market. But first approvals and, and, and the, and, and figuring out the clinics and the psychotherapy and novel indications.
All that is a enormous body of work, which is fantastic. And then shifting to second generation, chemistries, I think that there is this, this belief. That. And, and, and there's already a fairly well honed business model in, in the pharmaceutical space that we, deliver medical medical grade medicines.
In a, in a capsule in a 30 day prescription, typically type of format where, you go to the pharmacist or that's, that prescription is filled, you take that home, you s you then, take a daily dose of whatever your particular medication is that the, your physician is prescribed.
And that's sort of that, right? So there's not a novel clinic you have to go to necessarily, you. Don't need, psychotherapy. So, so the, you, you typically wouldn't need a whole lot of other things with that 30 day, prescription of a, of a typical, drug. So like your cholesterol medication or [00:23:00] certain diabetic me medications, what have you, although obviously that's a different root administration.
But, typically if you've got daily dose of, of. SSRI or something like that, you wouldn't have any other types of, of requirements around that. So there's, I think, I think there's a strong desire on the pharma, in the pharma space to potentially model that and come up with, and reshape and create new chemistries that, that wouldn't necessarily.
Patients in the psychedelic state wouldn't necessarily require psychotherapy may potentially have a better safety profile. There's some concern that, constantly hitting the five H two TB receptor that that's, it's, it's understood through other chemistries that, that, that potentially over periods of time can cause valvular cardiovascular toxicities.
Ross O'Brien: And that's what, that's what is known as microdosing then, or that.
Greg McKee: Yes, it, it could be microdosing, right, where you're taking, small amounts of psilocybin, for example, or, or other chemistries over a long period of time. It also could be microdosing after a number of different cycles. Another, a number [00:24:00] of different experiences. It's just not, it's not known yet.
Exactly. What, what level of, how many. Exposures, how long of exposure, what dose of exposure that those data points aren't yet understood. But there is a general belief and Fen Fen was one of these drugs. There's other chemistries that have hit that same receptor, that have, have known in, in small numbers by the way, but have known to cause cardiovascular side effects.
So, so there's a whole, there's then, a group of comp companies and, also I think researchers and, and, and opportunity potentially to create these second generation compounds that, that one would potentially, eliminate utilize in the five H two TB receptor would potentially have a, a better side effect profile, potentially could be used in microdosing as you sort mention.
May not require psychotherapy, may not require patients to get into the psychedelic state. And it also, importantly, from an IP perspective, tying that piece allow for. Novel composition of matter patents to be issued, which is, is considered, kind of the, [00:25:00] the, the traditional way that that pharma, likes to, to create a moat around their business is through, owning the actual molecule.
So, all that's really compelling. But on the other hand, you're kind of starting from scratch. You don't really know, and we. . We, we know that in drug development though, that, that there's a lot of failures and that when you start essentially designing new chemistries, you've gotta, put it through a lot of, in vivo, in vitro at preclinical, work before you even get to humans and, and often.
the preclinical and other laboratory experiment experiments don't necessarily correlate highly to clinical utility. So in other words, it, they're not really predictive in terms of whether or not these chemistries work. So we just don't know. So you're, you're, you're kind of, yes. Someone's whiteboarded a fantastic.
Desirable label, product label that pharma's gonna love. But there's a big question in my mind in terms of whether or not those C series are gonna work. And I don't think anybody, like n nobody can, can [00:26:00] say there's gonna, there's a lot of speculation, there's a lot of of dialogue around certain platforms that, that may, quickly identify the right types of chemistries.
There's some belief that early. Experimentation. And early preclinical models are cor correlated, but we, we don't know yet until we kind of, run those to their paces. So that's kinda the trade off. Good news is that, that you potentially can create competition matter and you'll come up with a product that's more akin to a traditional pharmaceutical.
Drug that pharma companies will be more comfortable with. On the other hand, you're kind of walking into the big unknown, the deep unknown in terms of whether or not these pharmacies are gonna work, whereas in First Generation Com compounds, because so many people have used them in their labs, there's been so many publications and so much more research, as you mentioned a moment ago, and recreational use and some clinical trial use, we know.
They're safe and well tolerated and they work, which is just an incredible tail win [00:27:00] to have at your back.
Ross O'Brien: Right. And I think, that's why I mentioned microdosing for example. There's a lot of buzzwords that people are grabbing onto and people are, and, and, and it's exciting because. Everything you just said, people are having very positive experiences consuming these in their natural format, but there's a chasm between occurring in nature and being an FDA approved therapeutic drug.
And, and, and this is, I think, where we're, we, we really try to go right, is th this isn't just about. , there certainly isn't about the recreational opportunity for us as investors, but how do these coexist? How, how do you see that sort of playing out? Cause that's a little bit unique compared to some other, to certainly other things that are available to, to pharma, biotech.
And then, when we look at traditional drug development, I mean, there's very clear pathways there to bring these to market. What do those look like?
Greg McKee: right. Yeah, so, so there there's a, there's a lot to, dive into there. Right. So just, first of all on the, the, the, on the micro icing front, I think it's, I think it's really important to keep in [00:28:00] mind that. Even though we've got this incredible tailwind and a lot of history around these chemistries, there's still a lot of unanswered questions, right?
And the microdosing question is a great one to, to look at and just as we sort of saw in the pandemic, when there seem to be a little bit of like there moments where like there, there seem to be changing policy. Well that's because this is just science and the science was evolving, therefore the policy needed to sort of change.
So in a similar way, microdosing is a really interesting kind of little, little case study within the broad psychedelic space because, when you talk to individuals who are microdosing, they'll swear by it as having an effect. But when you, at least up until this point or until recently, talk to academics about it, they would.
Essentially set it aside as being something that's completely unproven and not even worthy of, of, of testing. That's now changed though. There's, there's a bit of a push in the academic world now to look at microdosing and run properly controlled [00:29:00] studies to ask the question of whether or not microdosing works, which I think is great.
And that's just the way science. We get to a certain point and we answer certain questions, and then the next questions emerge and we need to run the experiments to figure out if they work. So the microdosing thing is gonna be interesting in terms of like the drug development process, right?
So as you said there's, that that is a, a, a pretty arduous, process. And so, so, so all, in in air quotes that we're doing in some regard is taking these known chemistries and running them through. Kind of traditional drug development processes, right? So, mostly what we're doing is we're, we're setting up proper.
At least in the first generation chemistries, I'll just sort of jump into that. We're running properly controlled, studies with material that has been manufactured under C G M P manufacturing processes. So that means it's, it's chemistry that's consistent. We know it's in that chemistry, we know that.
It's, it follows FDA guidelines and is, is cleared as the language but cleared by the FDA [00:30:00] to enter clinical trials. So that typically means you've had to, to meet a certain threshold to demonstrate that, that one, there's, there's actually a rationale for why you're gonna put that chemistry in a patient, meaning that there's.
At at least an idea that, and a notion that the patient will benefit from that. And then more, most importantly, there's, there's a body of evidence that needs to, that gets submitted to the F D A to show that it's safe and you won't do harm, which of course is the first principle in drug development. So, , you've, you've got, you, you, you we're, we're gonna run these experiments and we are running these ex experiments as an industry right now in larger numbers of patients in a controlled setting with material that's will characterize.
And that's the first time this has ever happened. So that whole, those, those processes are in place. The F D A is involved and is, is clearing these studies to go into, to human trials. The drug enforcement agency is also. Because you've gotta be licensed as a clinical trial. You've gotta be licensed as an academic and frankly as a clinical trial site to handle these scheduled [00:31:00] substances.
And, all of the other support, me mechanisms, contract research groups, regulatory consultants p s g scientists as you were describing earlier at the top of the podcast that are, evaluating clinical trial design all those element. Are coming to bear which is great.
And, and, and that, that should give everybody a lot of confidence that when this, these, these data points are released and there's now data now that's slowly being, coming public. You, the, the public can be assured that there, there's proof that there's, there's, there's safety and there's, there's evidence of.
Activity. So all that, bodes really well. And I think most importantly then that will bring in other resources. So other capital resources and also I expect will begin to, to draw in phar the traditional pharmaceutical companies and biotech companies to license and commercialize these. Because the other thing that will happen is once there's approvals, Then there'll likely be reimbursement of these drugs.
And so we can then utilize the healthcare system [00:32:00] that's in front of us. So the hospital clinic channels that are, here and then being developed, the, the reimbursement and insurance resources that are around as well as then, you creating, a whole body of psychotherapists and, and practitioners that have a new tool in their toolkit.
So our ability to impact large. Groups of, of patients is going to increase dramatically, I think with, utilizing the tools and u that are available to us and also the, the kind of more traditional drug development pathway. So the, the other element of your question was then, well, , how will that coincide with, what's happening in the state of Oregon?
What's happening in the state of Colorado? What potentially Health Canada will do around. Decriminalizing the use of cannabinoids or cannabis and, and psychedelics. And we obviously, we saw that in cannabis. Early on with a legalization of, of cannabis, we're seeing that now in Oregon, potentially Colorado, potentially California.
I predict that at some point soon Canada will also potentially decriminalize the use of whole mushrooms for municipal [00:33:00] purposes. I think that these will coexist. I think, but I also think there's a very, very big difference. between, both those strategies. On the one hand the, the, the medicinal use of psychedelics will potentially provide access for certain patient populations a little bit earlier, a little bit faster than, going through traditional drug development steps.
On the other hand, I'm, I'm pretty concerned about the consistency of the substance that people will be ingesting. I'm pretty concerned about, The environment that people will be in patients are in a pretty vulnerable state when they're on a psychedelic journey. For a pretty extended period of time.
These journeys are anywhere between four to eight hours. Psilocybin is an eight hour journey. D m T is a much shorter journey. And, and there's, there's new slightly different formulations that may create shorter journeys, but those, those times that you're in the hallucinogenic or psychedelic.
you're quite vulnerable. So, having patients properly monitored, having patients properly guided, I think is a really important principle On top of the fact that [00:34:00] it's, it's been documented that the durability of the clinical effect is, is, is also, somewhat tied to the use of proper psychotherapy techniques to integrate those experiences, as people, reenter.
Their normal life. So, and I, I think there's a lot of unanswered questions as we were saying before in, in terms of durability, in terms of, well, what the dose should be in terms of the frequency of those, those experiences. And, and, and we need to, to know what is the right, sort of cadence, what is the right dose and what is the right.
Way to, to deliver this. So, my view is that utilizing a traditional drug development process is gonna answer all those questions and we're gonna be able to harness all the resources that we need and that are available to us to have maximum Im impact. Not to say that I'm opposed to recreational use, I just think that that is, is probably not the best.
Way for us to, to deliver healthcare and, and it, and it certainly wouldn't happen with other chemistries. Right. So,
Ross O'Brien: And, and I like to take Bob's chocolate [00:35:00] chocolates that he makes from the mushrooms. He. Is in his, in his closet and go on a hike. But what what I'm not doing is trying to work through childhood trauma in those, in, in, in that state. And I think you bring up a really great point that, there's just a lot more to understand.
But look, that's the, that's the role of. Innovation, right? To, to do the research, to ask hard questions and get the facts and get the data. So yes, there's a, a, a lot of enthusiasm and certainly feels like the train has left the station. That, that psychedelics are, are, here to stay as a part of our communities.
The question is now how do we build real medicine around this and what are the protocols and, and standards of care? One of the questions that. Asked a lot, and I know you do as well, is, the assumption that this is a threat in some respect to the incumbent pharmaceutical industries. And, why doesn't big pharma, air quotes, just squash this,
Greg McKee: Yeah.
Ross O'Brien: you were just at the JP Morgan conference, and
Greg McKee: Right.
Ross O'Brien: So it'd be interest to hear what, how's the industry looking
Greg McKee: Yeah, so, so, so, I, I, I think, I think [00:36:00] that the, the incumbents are gonna be threatened. I mean, that, that's, that is the nature of, of innovation, right? Like the, the, the, the obvious markets to go after are ones that have already been created, right? As compared to creating something. New, just come at the same market with a better offering.
That's innovation 1 0 1 and entrepreneurship 1 0 1. So yeah, like the, the, the incumbents are gonna feel threatened, I think, but on the other hand, if you take at the, the, look at the incumbents. So you look at, say, for example, traditional mental health, and you look at SSRIs, they don't work
And if you look at a lot of other therapeutic areas, like there's just nothing, so fibromyalgia, for example, right? In the broad chronic pain space that we're looking at a journey, there's three drugs that are currently approved in that arena. And in talking to, some of the researchers that are, were there in the early days.
And just understanding those chemistries, one that they're not very effective, and two patients drop off compliance on those chemistries very quickly. So first year, 90% of patients drop therapy. So there really isn't much [00:37:00] of an incumbency there. There, there are some drugs approved and they're probably, there, they're decent revenue streams, but they're gonna get disrupt.
because they're not very good. And, and, and I think there's really nothing that pharma can do or anybody can do to frankly stop that. Like you said, the trains left the station and there's so much, critical mass already that, that's so much inertia around these programs. I, I don't believe it's possible for pharma to, to stop it.
On the other hand like as you said, I was at the JP Morgan conference. In January, which, which is always a really interesting time in a, in a bellwether event to kind of take the temperature of farming and see where they're at right now, pharma is not really very close to this new class of, of, of compounds.
Osca Pharmaceuticals has probably leaned in the most of anybody. I think the other, but I think the other big pharma companies will begin to take a look at this as. The industry gets a little bit farther down the path. They're gonna be here, they typically are, but they're gonna wait for more data.
They're gonna wait for some of the initial approvals, and they're gonna wait [00:38:00] for some of the answers to emerge around. What's the right delivery modality and what is the F fda, is the f FDA actually approving these and are these chemistries being reimbursed at levels that make business sense and so forth?
So there's a lot of unended questions that I think the farmers gonna wait. They, which they typically do, right? They, they pay up for a highly de-risk story, which is a great, place for entrepreneurs to be, right? Like pharma is they're not price insensitive, but they, they, they tend to, To pay a premium and be willing to pay a significant premium for de-risk stories with lots of answers.
Whereas, so that, that's the opportunity for all of us as entrepreneurs and investors. And, the state of play, I would say, from being in San Francisco back in January around the psychedelics, is that, we are a, collectively the entrepreneurs in this space are a fairly tight knit small group that's, forging a.
With these chemistries that, that right now is for the most part being [00:39:00] under-recognized by pharma. But, but that's okay. That's the way this always is. It was this way in gene therapy. It was this way for sure, in immunotherapy, at least in my experience. And I think pharma will just wait, but they're, they're around and, and many of us are having conversations with pharma.
Companies now, and their, their, their curiosity is, is emerging, which is great. And I think over time as we see more data and, and we see approvals and reimbursements come through, pharma's gonna get involved. So it's, it's a very exciting time, as you said. And, we just have to just continue down, the path that, that we know is the right one of,
Ross O'Brien: And, and ultimately these, these pathways are in place, so. These treatments can get into the hands of the patients that need it the most. Right? So I think sometimes we lose sight around, oh, pharma is here and squash this and not paying attention, or, advocacy mandates to, make this just accessible and legal.
But at the end of the day, there's people that could really benefit from these [00:40:00] new drug developments and. Taking that risk now and investing in that is ultimately with the objective of getting these things in into the, the patient populations that
Greg McKee: for sure. And you, you make a really great point, that there's this assumption that just because psychedelic, for example, our cannabis was decriminalized or legalized, right? That all of a sudden there was gonna be a big impact. Oh, I would say that, we, we saw that movie already.
Cannabis has been decriminalized and I would say the impact of the utility of that c. Is is not there at all to what, it's, it's highly underutilized. So, and that doesn't work. And, and just be, just because Oregon decriminalize, decriminalizes, psychedelic, I, I don't think we're gonna see the impact yet because I think until you harness the constructs that we have in place right now, whether you like 'em or not, by the way, and look, that's another conversation for another day of how to.
Healthcare delivery, but that's what we have to work with now, and I think that's the best [00:41:00] tool to get the most impact in the
Ross O'Brien: And, and, and we've seen this before, Greg. I mean, it's hard to disrupt a system if you don't understand how it works, right? So it's not to say that disruption isn't, is isn't part of the plan. But at the end of the day, I think we lose sight of, as I said a moment ago, and how, and, use all of the tools at our disposal, including aligning with, Large, powerful forces in order to, get these treatments into the patients that need it the most.
So let's I, I think this has been terrific, Greg, and, and always great talking to you. So let's, conclude, I think this is a great segue, talking about the patients and, and, and talking about the vision. If you could fast forward, five years, 10 years out You know what, what is the biggest impact that you see for yourself for journey for companies we're working with and, and psychedelics as a whole.
Greg McKee: No, I, I, I think that, and then in a relatively short period of time, of three to five years, we're gonna see the first approvals for M D M A first approvals for psilocybin. I think that, that, that [00:42:00] journey that we're gonna bust open the, the, the notion that. Psychedelics can be used as a treatment modality for chronic pain, which I think is gonna be just a huge breakthrough.
I think that we're gonna, sort through a lot of questions of reimbursement and clinics. I think those, those companies will make progress around, demonstrate what needs to be done. There. And I, I also think that we will attract a lot of traditional life science and biotech venture capital as well as very likely in that time.
Pull in a number of, pharma companies, and once we do that, this is all gonna begin to go mainstream. So the, the upside is enormous. And I think that in, in three to five years, we're gonna see massive shifts in terms of people's thought processes around using these, these chemistries to help patients in in great need.
Ross O'Brien: That's fantastic, Greg, and a great place to adjourn what I think will be part one of hopefully multiple conversations. There's a lot to digest there and think about An exciting time [00:43:00] certainly worth the hard work to develop these further because the implications could be so, so profound for our society.
So, Greg, thank you very much for, for joining me today on, on Psychedelics Capital.
Greg McKee: Great to be here, Ross, and look forward to our next conversation.