Harm Reduction

Transcript: Chemistry, Biosynthetics, and the Promise of Novel Psychedelic Medicines – Danny Motyka

Third Wave · December 23rd, 2020

Please enjoy this transcript of our interview with Danny Motyka.

With a decades-long commitment to psychedelic advocacy and research, a firsthand knowledge of the life-changing benefits of plant medicine, and his role as CEO of Psygen Labs, Danny Motyka brings a unique perspective to the future of psychedelics. In this episode, he and Paul discuss the differences between the cannabis and psychedelic industries, the role of plant medicines as preventative treatments, and what psychedelic therapy might look like in the near future.

Highlights include:

  • Examining the overlaps between advanced chemistry and spirituality.
  • How a psilocybin experience brought Danny out of depression after a suicide attempt.
  • Tracking Danny’s path to a career in the psychedelic space.
  • The rapid growth of psychedelic therapists and manufacturers, and what the next ten years could bring.
  • Why healthy people can also benefit from psychedelic therapy.
  • Natural vs. synthetic psychedelics—which will be more popular?
  • The differences between the insights achieved with ketamine and with psilocybin.
  • A look at the lesser-known synthetic molecules that may be useful in the next 5-10 years.
  • The major differences between the cannabis industry and the psychedelic space.
  • What a future might look like with psychedelics fully integrated into mental health care.
  • Will the day come when we can legally use psychedelics in our own homes?
  • Mentoring the next generation to use psychedelics productively and responsibly.

0:00:00.1 Paul Austin: Hey, listeners. Today’s episode is with Danny Motyka. Danny is the CEO of Psygen Labs. He used to work for Aurora Cannabis, the biggest Cannabis firm in the world, and has recently transitioned into the psychedelic space. And this interview is part of a Psychedelic Insider series that we did with Microdose, and we are re-publishing it on Third Wave’s platform.

0:00:22.8 PA: Welcome to the Third Wave podcast. I’m your host, Paul Austin, here to bring you cutting-edge interviews with leading scientists, entrepreneurs and medical professionals who are exploring how we can integrate psychedelics in an intentional and responsible way for both healing and transformation. It is my honor and privilege to bring you these episodes as you get deeper and deeper into why these medicines are so critical to the future of humanity. So let’s go and let’s see what we can explore and learn together in this incredibly important time.

[music]

0:01:00.7 PA: Hey, listeners, and welcome back to another episode of Third Wave’s podcast. I’m your host, as always, Paul Austin. And today’s episode is with Danny Motyka, who is the CEO of Psygen Labs. Danny graduated from the University of Victoria with a degree in Chemistry before becoming an early employee at Aurora Cannabis. His career with Aurora provided foundational experience in enterprise management, good manufacturing practices in the Controlled Drugs and Substances Act. And this is part of an interview series that I did with Microdose, and part of the Psychedelic Insider series where I did live webinars and interviews with several CEOs in the psychedelic space, and I have chosen to re-publish two of these, in particular. One is with Timothy Ko, who’s the CEO of Entheon Biomedical, and the second is with Danny.

0:01:51.6 PA: And the reason I chose to re-publish this episode with Danny is because Danny doesn’t look like the typical CEO who is starting to enter the space. He really… When we got on the interview, I remember sort of looking at him and be like, “You have dreads. I don’t think I’ve seen that in a CEO in sort of the emerging psychedelic space yet.” He was interesting to talk to, has a deep background of knowledge in sort of the chemical synthesis of various psychedelic compounds. In our conversation, we got into Shulgin and PiHKAL and TiHKAL, and just found him to be a fascinating mind to dive into all areas of exploration with. So we talked a little bit about what Psygen is developing and their future plans with developing pharmaceutical-grade psychedelics in Canada. We discussed Danny’s background in terms of how he got interested in psychedelic medicine and what was his eventual path to becoming a CEO of Psygen, and more than anything, we just really got a chance to connect. I remember in the interview itself, there was a bookshelf behind him, I was like, “Oh, Alan Watts and Timothy Leary and Shulgin and various other authors.” So it was just cool to see that sort of context with Danny as an interviewee. So without further ado, I bring you Danny Motyka, the CEO of Psygen Labs.

0:03:16.0 PA: What’s your favorite book in the shelf behind you? Yeah, I was gonna say The Akira Box Set, that is pretty cool. Hey, Simon, good to see you, man.

0:03:23.5 Danny Motyka: Yeah, the comics are awesome, but I don’t know, it’s tough to say. My favorite book that’s on the shelf might be… I don’t know, I give away so many of my books that unfortunately, I don’t really have all of my favorites, but I really love Insight Outlook by Albert Hofmann. It’s one that not a lot of people have read before. It’s just a 90-page summary of his spiritual insights on what chemistry has taught him about spirituality of the world. That was my own experience was as a teenager and as a hippie, I was very spiritual. And going into a science degree, they beat the spirituality out of you, so to speak. But then, as I went into third-and-fourth-year Chemistry, it’s all of the ideologies that you learn from various spiritual philosophies really get represented and explained through scientific terms. So that book, in particular, really resonates with me just about the duality of the transmitter-receiver function of the brain, and the fact that we’re all connected by this energy, this electromagnetic energy in between our electrons and stuff. It’s quite an interesting book.

0:04:37.3 PA: Inside Outlook.

0:04:38.8 DM: Insight Outlook, yeah.

0:04:40.6 PA: Insight Outlook.

0:04:41.8 DM: Yeah.

0:04:42.4 PA: Okay.

0:04:43.8 DM: By Albert Hofmann.

0:04:44.3 PA: I’ve never heard of it.

0:04:46.0 DM: Yeah, it’s interesting…

0:04:47.0 PA: I read My Problem Child.

0:04:48.9 DM: Yeah.

0:04:49.2 PA: But yeah, I didn’t know he wrote other stuff.

0:04:53.4 DM: Yeah. Yeah, he’s got a couple books. I would be more than happy to send you a copy one day if you would like to borrow it. [chuckle]

0:05:00.4 PA: I would love that. So tell us about…

0:05:01.1 DM: If you find yourself back in Calgary.

0:05:03.0 PA: Exactly. So tell us about Psygen Labs. Before our conversation that was scheduled today, I wasn’t sort of on the up and up with it. So I’d love if you could just lead our conversation with the background, the story, the narrative, how did you come to work in the psychedelic industry, why you choose this specific mission to pursue, what… Just let’s get a little bit into that.

0:05:27.1 DM: Yeah, so I guess my background, when I was a teenager, I was suffering from some pretty severe depression. After a failed suicide attempt, I was thankful to still be around, but still didn’t really have that spark for life. And my research led me to find Psilocybin mushrooms, which I procured from an older cousin. And when I was 15, I just had that first experience, is 3.5 grams of mushrooms, and it breathed the passion for life back into my soul, realized that life was very much worth living and just that I was taking things for granted. And through my teenage years, I found that Psilocybin and LSD were really valuable tools and medicines to stabilize my own mood. And so with that, I went into studying Chemistry with the intention of becoming a psychedelic manufacturer one day.

0:06:19.3 DM: When I graduated, I was trying to do a master’s program, but there were no… No chemistry professors in Canada that were willing to take me on to do research in psychedelics. They just felt like it was academic career suicide, and they weren’t willing to associate their research groups with it. So right at the same time, the MMPR was kind of evolving out of the MMAR. And so I joined Aurora Cannabis as, I think, the 11th employee, and it was just kind of… I felt the Cannabis industry was a really great opportunity to learn the Controlled Drugs and Substances regulations and then kind of apply that as a model for how we can now bring psychedelics through to become legal, accessible medicines. And you know hopefully, one day, also something that you don’t need a clinical indication to experience, but that you can use psychedelics as a healthy person to stay healthy.

0:07:13.8 DM: So back in 2018, I was just becoming a little bit disenchanted. Aurora had really become much more corporate. I enjoyed the start-up atmosphere where we could wear a lot of hats and have a lot of independent direction, and I kinda felt the call to get back into psychedelic medicine. So I went to a conference in Stockholm called the Colloquium on Psychedelic Therapy, and there’s this resounding ask from researchers and therapists to improve the access to GMP drug supply. So I came back to Canada, started working on a business plan. I reached out to Rick Doblin from MAPS and was seeing if he could kinda give me some help, and he was like, “Very interesting project you’re working on, but you should probably connect with Peter van der Heyden, who’s our CSO and co-founder. He’s in Vancouver and he’s working on a very similar project.”

0:08:03.9 DM: Peter’s story starts about a year before that, he was at the Psychedelic Science Conference in Oakland, California, and he heard the same thing. So he basically was working on the same project about six months ahead. He created this not-for-profit Psygen Research Foundation. Originally, it was called Beckley Labs. They raised about a million and a half dollars privately to sponsor this research, to basically take synthetic protocols that had been developed over the years to manufacture, and then basically go into the University of Alberta and start manufacturing a wide range of psychedelics.

0:08:43.1 DM: So through that sponsorship, one of the professors at the University of Alberta amended his dealer’s license to include the manufacture of six drugs, Psilocybin, LSD, MDMA, Mescaline, DMT and TCB. And we had kind of decided to stay quiet as much as possible. We were really staying in stealth mode while we were just working at the University of Alberta, and meanwhile, we needed to find a way to commercialize these drugs, and most investors who were putting money into a product project are looking for ways to kind of return something on their capital. And so Psygen Labs basically evolved into this commercialization entity, which is taking the synthetic protocols that have been developed at the University of Alberta, and we’re implementing a scale-up facility in Calgary.

0:09:38.3 DM: So I guess that, in a nutshell, the mission of Psygen Labs is to become a preferred manufacturer for synthetic psychedelic drug products. And we’re in the process of raising $4 million to build that lab at Calgary, and we’re designing it to kind of pump out 200 kilos of MDMA, 10-15 kilos of LSD, and up to five… Sorry, 10-15 kilos of Psilocybin, and up to 5 kilos of LSD annually.

0:10:01.9 PA: Wow, you’re like the new… What’s the… Oh, Leonard Pickard.

0:10:09.3 DM: Yeah, totally, except we couldn’t find a missile silo to buy us, so we’re just gonna go [unclear speech].

[laughter]

0:10:15.0 PA: Yeah, exactly. We’ll be doing it in the middle of Nebraska. You’re gonna be a little bit more, a little bit more professional about it. Well, that’s incredible. So let’s talk a little bit more about that in terms of the numbers that you just mentioned. How did you come up with those numbers? Do you do surveys? Have you’ve been talking with a number of companies? Have you just been looking at, “Oh, this is the approximate amount of [unclear speech]… ”

0:10:39.3 DM: We kind of built this model that’s basically looking at… So if there’s a certain number of trained therapists, each of those… Each of those therapists can treat a certain number of patients per year, each of those patients will have likely three active dosage sessions at a certain dose. So that can then provide an annual forecast. Our max projection out to 2027 is for… I’m trying to think like 19,000 therapists trained, which then that rolls out into about 150 kilos of MDMA. And so we’re just building out our facility to supply that maximum capacity, knowing very well that those are… Our projections are somewhat conservative. We used a guidance document that MAPS published, I think in 2013, it was like MAPS’ sustainability plan that kind of outlined their therapist training plan. But since that has happened, now there’s other organizations like Compass and Usona. There’s another group in Quebec. I’m trying to think what their name, Mind Space, they’re doing a therapist training program.

0:11:55.4 DM: And so there’s all these other organizations that are looking to train therapists. Then you’ve got Numinus and Field Trip who are building out clinical infrastructure. So the access to psychedelic therapies are gonna scale over the next 10 years, and we kind of anticipate exponential growth, because you can only build out clinical infrastructure, and you can only train therapists so quickly, and it’s unlikely that you’re gonna be able to access psychedelic therapy outside of that context for at least the foreseeable future.

0:12:24.5 PA: Unless you’re willing to travel elsewhere. I think… So how are you… How does drug decriminalization play into this? So obviously, there is the medical therapeutic aspect, which is much more what Numinus and Field Trip are oriented towards. But then we have, obviously, drug decrim in Oakland, Santa Cruz, Denver. Denver’s putting something on the 2022 ballot. We have the IP 34 in Oregon, which is more like a regulated therapeutic market. But when you think about decrim, how does that play into all of this next [unclear speech] in terms of traction?

0:13:03.0 DM: Yeah, so that’s a great question, it’s something we think about a lot. We’re big supporters of decriminalization. The Decriminalize Nature Movement, I think, is super important. My own perspective on how it’s likely to evolve is that MDMA is gonna be the first approved psychedelic. I don’t really consider it psychedelic, but it’s in the category. So MAPS will receive market authorization for MDMA and Compass or Usona will likely follow with Psilocybin shortly thereafter. And I think that the FDA, by giving those market authorizations, are basically admitting that there is some context in which these drugs can be used safely, and that the benefits outweigh the harms, and that there’s already a vast network of underground practitioners that I think will likely be able to argue that there should be a wider acceptance and adoption of psychedelic therapies.

0:14:00.9 DM: And so I think that we’re gonna see this evolution from the medicalized approvals for synthetic drug products, and that will pave the way for more of an adult-use, intentional adult-use market, which… I don’t think that psychedelics are just meant to treat anxiety and depression and post-traumatic stress disorder. I think that healthy people should have access to them to be able to create an internal resilience to prevent people from falling into the pits of depression and post-traumatic stress disorder. And so the Decriminalize Nature Movement is interesting ’cause it’s really focused around natural products. And it’ll be interesting to see how that rolls out, but it’s… We’re big supporters.

0:14:53.2 PA: One, I think, that’s what’s so interesting about you. We’ve never met. This is the first time we’re speaking. I barely heard of your company before because you have been in stealth mode, I think, and very quiet, whatever you’re doing. And you mentioned that you come more from like a hippie, I would say, with the long hair, the beard. You have that look, which is much more of what I… The decrim nature and the natural. But you’re also a scientist and you’re a chemist and you’re a CEO now with Psygen, and you’re producing all this synthetic stuff. How do you personally reconcile those differences between your past and your context and now, what you’re looking to focus on from a business perspective with synthetics?

0:15:36.4 DM: Well, so I think that there’s… I guess there’s a couple of things to this, which is that synthetic chemistry, it’s really incredible that you can create compounds of 99.9 plus percent purity and you know exactly what it is that you’re taking. I personally would rather take a pill that is 50 mg of Psilocybin than try and choke down 5 g of mushrooms. And I know that you can make a tea and you can do other things with mushrooms, but there are…

0:16:02.6 PA: Chocolates are a thing, as well, very good.

0:16:03.6 DM: Yeah, chocolates and… And I do very much love all of the natural products that exist. But then there are… Or there’s MDMA, there’s LSD, those are synthetic-only products. And so as a business model, I think that Psilocybin is gonna become very competitive. There’s going to be natural products versus synthetics. But there will ultimately be, I think a percentage of the population that’s more comfortable with that medicalized model that has purified, really strict quality controls in place that you’re just getting the standardized dose every time. And then there’s gonna be another population of people that would much prefer the natural product route. And Psygen’s really not that interested in getting into mushroom production or extractions or anything like that, but we recognize that it’s a viable market and we’re wholly supportive of it moving forward.

0:16:54.9 PA: And so when you look at how Psygen will continue to grow, potentially, are you going to sell just to Canadian producers? Are you looking at how you can expand to the United States and Europe? What’s your approach and what are the regulations around that?

0:17:08.1 PA: Yeah, so right now, in order to work with its controlled substances in Canada, you need a narcotics dealer’s license. So the dealer’s license, by nature, allows you to import and export. So the dealer’s license that we have access to through our partnership with the University of Alberta allows Psygen to broker the sale to both domestic and international groups right away. And so yeah, we’re definitely focused on the global market and that 200 or that, I guess, annual production capacity for our facility in Calgary, is far beyond the needs of just the domestic market.

0:17:47.9 PA: So transitioning into maybe a few more brass facts about your role as CEO, give us a little bit of perspective on how big is your team. What’s the day-to-day like for you? What are the next sort of month to three months look like for you from a roadmap perspective? Just bring us into that nitty-gritty.

0:18:07.0 DM: Yeah, so it’s our team is fairly lean right now, still. We’ve got a couple different groups, I guess. So on the corporate development side, we’ve got myself, we’ve got Peter van der Heyden, who’s our CSO. We’ve got, so Mark Haden, who’s the Executive Director of MAP Canada. He’s more of a clinical research advisor to us right now. He is really acting in the leadership role of helping us develop our own synthetic protocols that we’re hoping we can conduct our own clinical research. My role right now is basically exclusively raising capital. We need to raise $4 million this year to build out our lab. And we’ll need to raise another 5 million next year to bring us to the point where we’d expect to be profitable. So my focus, currently, is to get this $4 million raised. We’re just at about one-and-a-half right now. And we’ve got a partner who’s coming in who is very confident they can help us raise the remainder. Once we raise that, then basically, my focus will shift into purely operational, build-the-lab mode.

0:19:14.0 DM: And meanwhile, we have this U of A team that we’ve established, we’ve brought up Stewart Frescas who is the lead chemist, or sorry, the lab manager at David Nichols lab at Purdue University, so he’s got, I think, 20-plus years of experience manufacturing a wide variety of psychedelics. I think that Stewart might have even made the first DMT used in Rick Strassman’s studies in the ’90s and…

0:19:36.0 PA: Oh cool.

0:19:36.3 DM: Produced Psilocybin for Johns Hopkins, MDMA for MAPS, so there’s a…

0:19:41.3 PA: I think you have on your bookshelf, behind us, right, the DMT…

0:19:44.9 DM: Ah yes, The Spirit Molecule.

0:19:47.5 PA: There we go. Yep. Yep.

0:19:50.4 DM: And actually a second too, the Soul of Prophecy, but I didn’t… I liked The Spirit Molecule better. Sorry, Rick. [chuckle] But yeah, so then we’ve got another Indian chemist, her name is Jaya, she’s a brilliant chemist, she actually made a breakthrough in the Psilocybin synthesis method. Traditionally, the synthesis of Psilocybin is quite complex, going from the phosphor relation of psilocin into Psilocybin, which Psilocybin is significantly more stable than psilocin. That step was traditionally quite complex, and Jaya just… She made an incredible breakthrough that is basically… I’m just trying to think of the word, it’s just kind of… It’s really not a problem anymore for us, so…

0:20:36.9 PA: Wow.

0:20:37.0 DM: Anyways, that being said, our team is still very lean, we’re gonna be expanding as we raise this capital and we need to build out our quality systems and our operations teams, but really the focus for the next year is going to be building the lab, installing the equipment and validating all that process. Meanwhile, our license application will be in queue so that probably Q2, Q3 of 2021 we’ll be able to then start manufacturing and validating all of our scaled-up methods at our production facility. And then 2022-2023 is when we can hope to sell our first commercial product out of that facility in Calgary.

0:21:15.7 PA: Is that when they expect that MDMA to be medically prescribable is around that time, or is it hard to say at this time?

0:21:22.6 DM: Yeah, my understanding was that MAPS was hoping for market authorization in 2021 or 2022, I don’t know if COVID has changed that at all, because my understanding was that a lot of clinical research was halted or delayed due to COVID. But yeah, we’re… My understanding was that MAPS was always targeting 2021, 2022, and that Compass newly signed up for their Psilocybin, we’re targeting just a year after that.

0:21:50.9 PA: Yeah. And the most recent was a Forbes piece that came out about MAPS, and specifically Rick, maybe two or three weeks ago I think, and it said that MDMA commercialization for the United States was about 2023 now…

0:22:05.3 DM: 2023 now.

0:22:06.0 PA: They initially had been saying ’21, and then it got, I think pushed back to ’22, and now with COVID it looks like ’23, so my hope is that we can stick to the ’23 and make this thing open. Ketamine is interesting, and Ketamine is great for specific things like body work, and suicide, and really bad depression, but there’s really no substance like MDMA for trauma work, and I think a lot of people need that healing now more than ever, especially with COVID and all the trauma we’ve been going through that.

0:22:40.4 DM: Yeah, I couldn’t agree more. Ketamine is a really interesting one because it’s a… What is the term for it? It’s on the list of essential medications by the World Health Organization, it’s produced en masse, it would be not competitive for Psygen to get in and start trying to produce Ketamine. And from my own experience with it, it is quite interesting. As I was getting into the CEO role, I was facing quite a lot of anxiety about this idea of building a company and being responsible for all this capital, and so I went and participated in a Ketamine-assisted psychotherapy session in Vancouver, and it was interesting because the lessons are so abstract, it’s not at all, in my experience, lucid, the same way that Psilocybin or LSD has been in the past where often the Psilocybin and LSD there’s very clear messages coming from your subconscious, and it’s really actionable, whereas Ketamine was really alien and abstract, and definitely helped to kind of give a new perspective on that anxiety, but didn’t… Yeah, just didn’t provide that actionable experience that I find…

0:23:49.7 PA: A clear roadmap, so to say, the vision, the new Compass, if you will. What to step into, was that IV or IM that you did?

0:24:00.1 DM: It was actually intranasal, and that was part of the interesting experience was kind of being still tied to my physical body, in the sense that I had a physical experience in my nasal cavity that couldn’t fully let me dissociate. So I’d be curious to go back and try the IM version. Yeah, it was…

0:24:26.2 PA: I do like Ketamine. I will say, I’ve had… I’ve only insufflated it, and I also did some body work at one point where I took it rectally, which was fascinating. And the downside with the IV or IM is, like you said, it can put you into the alien world, or even insufflating you basically go into the K-hole, or you can go into the K-hole which can be dissociative. What I notice is when I did it with body work, rectally, I was still there and present with the person I was doing body work with, so I didn’t get that sort of alien abstract feeling, but I was still able to stay grounded in my being well, not totally attached to it, it’s much more. Especially with body work, you can get into things that you don’t normally have access to because you don’t have the same physical resistance there.

0:25:17.1 DM: But yeah, I think that Ketamine is really important, it’s almost like the keystone molecule in the kind of mainstreaming of psychedelic therapies, it’s something that lasts for a fairly short amount of time, it’s already accessible, and so I think it’s going to prove to be really important to start conversations and start getting people who are maybe predisposed, or to some prejudice against psychedelics, more on board with the idea that there’s these alternative medications that can be used in adjunct to psychotherapy and really help to solve some of the main problems with mental health.

0:25:56.1 PA: So speaking of, are you good, so is your contractor coming up or…

0:26:01.7 DM: Yeah.

0:26:01.9 PA: Okay. Okay. Okay. So speaking of that, I think that’s a good launching point. Really, when we look at assisted psychotherapy or psychedelic-assisted psychotherapy, Ketamine is the only option that’s currently available from a legal perspective. MDMA, Psilocybin are both in… Are both available with the trials, but not obviously for the larger public. So what I’d be curious to hear from you is everyone at this point, more or less, is familiar with the Ketamine, the MDMA, the Psilocybin. What are some of the synthetic molecules that you find to be really interesting or fascinating that are just not that talked about or not that widely known that you think will have incredible utility in the next five to 10 years?

0:26:48.7 DM: So the one that just kinda… Top-of-mind for us, because it’s on our license, is 2C-B. In my own personal experience, it is a very fascinating molecule, and it’s psychedelic in all the right ways, but it’s very comfortable in all the right ways. And it’s almost sober, in a sense. One of the challenges with 2C-B though is the dose response curve is very steep, and the difference between a couple of milligrams can go from, I think, therapeutic to potentially overwhelming. And so we did actually receive… In order to get our license amendment from Health Canada, we collected letters of interest from researchers around the world. And there was one researcher who included an interest in researching 2C-B, which is how we got it on license. One of the challenges though is that there’s not any safety data associated with it, so the cost to bring 2C-B to the market and the timeline is gonna be substantial relative to Psilocybin, MDMA or LSD that have all the safety data from history of use.

0:28:00.4 DM: I think 5-MeO-DMT is another really interesting one. I’ve actually never experienced it, but I’ve heard a lot about it. And I think one interesting thing about the 5-MeO is just the short duration of action relative to some of the longer experiences. But my understanding is that the majority of research back in the 1960s and 1970s tended towards LSD. There was a lot of interest in Psilocybin and MDMA, but a lot of researchers were finding the best outcomes were with LSD. And unfortunately, there’s a lot of stigma associated, and the duration is very long, so the economics of having to have two therapists sit for an eight or 10-hour session instead of a four to six-hour session adds extra costs for therapies that are already gonna become quite expensive when they’re first on market.

0:28:53.2 PA: Yeah. I mean, LSD was really the only available psychedelic in the 1950s. Psilocybin wasn’t synthesized until the 1960s when Albert Hofmann did it for for Sandoz after Gordon Wasson [unclear speech].

0:29:02.9 DM: Yeah, I thought that that was in the ’50s though as well.

0:29:05.1 PA: Well, Gordon Wasson discovered Psilocybin in 1957, and then… Maybe late ’50s or early ’60s. But the vast… You’re right. The majority of the clinical paper that published about LSD… And then MDMA didn’t come back into the scene until the mid-’70s when Shulgin re-invented it, if you will. It had originally been discovered by Merck in 1912, sort of went away, and then Shulgin brought it back. And then it was common in the ’70s and ’80s with therapists, and then it got, I think, criminalized in ’85 or ’86, which is why MAPS was started, and then the whole next wave of things happened.

0:29:46.1 DM: Yeah. One thing that I find really interesting, and I might be kinda biased in… To be perfectly honest, with… I might be taking this paper out of context. But I think that it was… I think it was Charles Nichols who produced the paper about spinogenesis with various psychedelics, and they were looking at, I think, RDOI, LSD, DMT, and then some… Or no, I think it was Psilocybin, LSD, DMT, and then some control. And basically, it was looking at, how… I think, in cell tissue, how the… How neurons would create these dendritic spines, and that LSD was the most potent in terms of spinogenesis. So it makes me very curious if there’s something to be said about just what’s happening on a neurological level at the neuron if LSD is… If there’s actually a physiological reason that LSD is so effective at treating various indications. But again, I’m not a neuroscientist, so I can’t read too much into it, it was just a fascinating paper that I saw presented at that colloquium in Stockholm.

0:30:50.2 PA: What is spinogenesis? What is that?

0:30:53.7 DM: So it’s basically… It’s the genesis of spines, I think they’re dendritic spines, on your neurons, which basically just the… As your… As all of your neurons are clustered together, there’s these spines that can kind of grow along the side of your neurons, and they can then interact more strongly with your neighboring neurons. So I… My impression is that it has to do with neuroplasticity, inducing neuroplasticity, and helping your brain form these new circuits and new patterns. But again, I’m not a neuro-scientist, so I can’t… I’m just kind of speculating. But it’s my sense.

0:31:29.5 PA: Yeah, there… I mean, kind of to go into some further into conjecture and speculation, it’s interesting that LSD was commonly used in places like Silicon Valley in the ’60s and ’70s, for example. Microdosing LSD has been more widely talked about by entrepreneurs and creatives. Personally, I’ve noticed that when microdosing LSD, it tends to be more cognitive, more intellectual. It helps with articulation, and it helps with writing, whereas Psilocybin tends to touch more onto the emotional body and processing, not as much up here, but physically what’s going on.

0:32:03.2 PA: I remember when I was talking with… I was at this Beyond Psychedelics conference in 2016, the first one that they did in Prague, and was standing in line next to Roland Griffiths and we were talking about this ’cause he was asking about, what are people experiencing LSD versus Psilocybin? And I explained a similar difference to him, and he’s like, Oh yeah, that kinda makes sense, because LSD is more dopaminergic than Psilocybin. And so because of more dopamine, it’s tied, it could be tied to dendritic spines and things like that.

0:32:36.0 DM: Interesting.

0:32:37.6 PA: So now I think we’re on to something. It just… We need more research, right? This is always what we… This, I think if I could pick one phrase that was the most commonly phrase used in the psychedelic space, we need more research. It’s like… We definitely…

0:32:48.2 DM: And that’s to me what’s the most exciting thing about psychedelics relative to Cannabis is that I feel that psychedelics are like the psychedelic, the emerging ecosystem is being founded on a lot more research than Cannabis was. Cannabis had this medical access program that didn’t really require companies to invest the capital into doing all the clinical research, whereas that’s kind of more… That kind of came in 2018-2019. So whereas psychedelics they’ve been… We’re really building this ecosystem on a foundation of solid research, so couldn’t agree more.

0:33:24.0 PA: Why do you think that is?

0:33:27.2 DM: Well, I think it’s the difference in the special access program. In Canada, all Part J drugs are exempt from the special access program, so there’s… Bruce Tobin, of TheraPsil, has been working on providing access to patients who are struggling with end-of-life anxiety to… He’s been getting… My understanding is that he’s been helping patients apply to the health minister to access Psilocybin under the special access program to treat their anxiety associated with their end-of-life illness, their terminal illness. The minister is rejecting those applications because there’s a line in the Controlled Drugs and Substances regulations basically exempting all drugs in Part J. So Cannabis didn’t have that, and so when all of these companies were raising capital, that capital investment was going into just basically scaling out production facilities across the country, ’cause there was already basically the framework or the structure for a CPG market. But because psychedelics can’t have that special access in Canada, we need to do all the clinical research before we can approve them for market.

0:34:43.8 PA: And I feel like it also speaks to the ethos maybe of the psychedelic space versus the Cannabis space. There is this sort of ethos of science first, profit second, if you will. Let’s make sure there’s full integrity in what we’re telling people. Let’s make sure that we’re not just bullshitting people. And I think, to be honest, the psychedelic space has a lot more trauma, if you will, than the Cannabis space. When Cannabis was struck down in the ’60s or ’70s, it wasn’t… It was obviously a big deal because of how it criminalized, for example, minority groups, and low income people. That was the biggest fucking issue with it was the criminalization of drug use generally, but it didn’t set back the scientific method 40 years and set back mental health potentially 40 years. Whereas when psychedelics were cracked down upon, it wasn’t just like, “Oh, we want hippies to stop doing LSD,” it was like, everyone has to stop this immediately.

0:35:37.2 PA: I remember the story of Jim Fadiman when he was doing his LSD Research for Creativity in 1966, he had just dosed his 25 subjects with LSD to understand how they could help with creativity and problem solving, and then he gets a note and he opens it up and it’s from the DA, whoever the organization was at the time being like, “You must immediately stop your research, do not give LSD or whatever.” And he just sort of put it to the side and was like, “Oh, I got this tomorrow,” and he kind of went forward with the thing.

0:36:06.4 PA: And so because of that trauma, when you have… When Roland Griffiths and Bob Jesse and all these sort of early pioneers started to do the psychedelic, restart the renaissance, if you will, Rick Doblin as well from MAPS, it was always science for science for science first, because they felt like that would prove to the institutions that this is feasible, because the institutions are what had sort of put the knock down before.

0:36:31.1 DM: Yeah. Yeah, I couldn’t agree more. That was all about these drugs being in Schedule One with no medical or therapeutic value. The only way to prove to the regulators otherwise is to collect the data, so…

0:36:44.1 PA: Exactly. Well, one last question just for you, and then we’ll get into some Q&A for the people who are here and participating. We’ve talked a lot about the Psygen’s approach and producing MDMA and Psilocybin and LSD, and the process you go through for that, the fundraising. I’d love just to hear your thoughts, and what I love about you, Danny, is you obviously, you’re a chemist, you’re on the ground, you’re in the nitty-gritty, but you’ve also sort of shown an ability to think outside the box and bigger vision and bigger future, and I’m really curious where you see the psychedelic space headed in the next, let’s say, 10 years. So let’s say we’re 10 years down the road, it’s 2030, where do we see ourselves with psychedelics? And I’d love to hear your thoughts more specifically on how has psychedelics impacted culture, how have psychedelics improved mental health care. What’s sort of the integration of psychedelics into culture and how has that changed?

0:37:42.0 DM: Yeah, so that’s a lot and I will do my best to unpack it, so if I miss something that you want me to dive into a little deeper, please just remind me. I guess my vision for how it’ll go in the next 10 years is that we will see it work through the medicalization pathway, and eventually there’s going to be an argument. I think it will have to be upheld that adults will be able to go to retreat centers to be able to use psychedelics intentionally for just the purpose of exploring their own mind. It doesn’t need to be for anything in particular, but you’ll probably need to set an intention when you go to these retreat centers to get the maximum benefit out of your experience.

0:38:26.2 DM: I really like Mark Haden’s idea. I’ve actually never read the paper. I’m a little bit embarrassed to say this, but my understanding of it is presenting a model by which individuals could get license from the government to be able to practice psychedelics from their home. So basically, you could… The way that I think about it in my brain is the same way that you can go and you can do a class to get a gun license, you could go and do a weekend class to be able to then go to a pharmacy and purchase a dose of LSD or Psilocybin to then be able to take home and use in the safety of your own home and you could guide your friends or your family. There are interesting legal implications, like if there was something serious that happens, who is liable in that event and… So there’s a lot of questions there, but I do believe that eventually it’ll get to the point where there will be access to adults who are able to use it safely and responsibly, and really it’s all about education.

0:39:25.6 DM: So I think in the next 10 years, you’ll start to see education… I’m trying to think of the right word. Just basically initiatives where there will be groups trying to educate people on the safe and responsible use of psychedelics and on kind of harm reduction principles. And I think that that’s one of the things that is… Like I’ve spent 10 years volunteering at Shambhala and the harm reduction services. So five years at the sanctuary doing psy-crisis training, helping people come back from really dark and overwhelming places, and then the other five years is all on the drug testing, drug tracking services with anchors. And so I think that as people are educated on how to use psychedelics safely, and if there can be a safe source for psychedelics where you know that you’re actually buying 100 milligrams of MDMA instead of buying a pill of some MDMA concentration with who knows what other excipients that we’ll get into a world where we can start allowing people to access these at their homes.

0:40:29.1 DM: The challenge, I think is how do we set up our first responders systems to deal with psy-crisis, because if someone is experiencing a psychedelic crisis and they call 911, I don’t think that the ambulance services or the police services or the fire services are an appropriate response for that. So trying to figure out how we can create a network of care that can then go in and help people dealing with an emerging psy-crisis is gonna be super critical and important. And I guess the other piece to that is basically, I consider myself quite lucky that my personal experience and exploration of psychedelics was a net positive result. I definitely in my teenage years, saw some harm come to some people who were using psychedelics irresponsibly. And I think a big part of that is because there is no mentorship or no guidance from an older generation of elders or mentors who can help the younger generation know how to use these things responsibly and set intentions to really maximize the benefits.

0:41:44.6 DM: So I guess just to summarize, in 10 years, I think that we will see that, I think whether it’s LSD, MDMA and Psilocybin, or whether it’s just the natural products and you can have access to psilocybe mushrooms and Ayahuasca is… It’s really tough to say, but there’s just so much potential benefit from couples therapy with MDMA sessions, and I think that couples therapy with 2-CB’s actually is another great option for 2CB, if someone is willing to take up the clinical research for that. But again, it’s so hard to predict how psychedelics will get integrated into our society when it’s such a different paradigm of treating healthcare, and it’s more of an eastern philosophy than a western philosophy, I think. Psychedelics are more about preventative medicine and less about curative and treatment based and we’re demonstrating that they can be really powerful treatments, but on the flip side of that, I think that they’re even more powerful as preventative medicine.

0:42:49.9 PA: Love that. Thank you.

0:42:52.2 DM: Yeah. And I don’t know if I missed something, but…

0:42:55.7 PA: No, that was great, that was great. I think it’s hard to say where we’ll be 10 years from now. It’s hard to say where we’ll be three months from now. I think in some ways, we can point to, that’ll probably be the general thing that will happen. They’ll be bio-medicalized, they’ll probably be decriminalized, there will probably be some sort of driver license system for those who wanna use them in an anonymous setting. They’ll be able to go to retreats and it’s hard to say how that will impact culture at large. One of my favorite philosophers is Ken Wilber, who always wrote about our integral theory, right? And more and more, that’s how I’m thinking about the integration of psychedelics, if you will, is how does it help to create more integral systems? Because we do still have a lot of disconnection within our systems, and I think part of the healing process for all of us is to realize that I am you, you are me, we’re all interconnected in this process.

0:43:52.2 DM: That’s actually… Earlier you were asking about my favorite book, and it’s not on my shelf because I’ve lent them away, but I don’t know if you’ve read Johann Hari‘s books. He’s got Chasing the Scream, which is just kind of a general biography on the war on drugs. And then his follow-up book, Lost Connections. I think that those are probably two top-of-mind books that anyone getting into this space should read.

0:44:14.5 PA: Fantastic. Absolutely. Alright, Well, Danny, thank you so much for…

0:44:18.9 DM: Thank you, Paul.

0:44:19.8 PA: Everything that you’ve shared. We’re gonna spend about 10 minutes now with Q and A… 10 to 15 minutes, and then we will wrap up. So we have the first question from Barney who asks, you’ve spoken detail about your first raise of 4 million with a second raise of 5 million shortly after, have you begun to draw up a roadmap for clinical trials for certain indications? Which indications do you have plans for?

0:44:43.1 DM: So that’s a great question, and I think… So I guess just very candidly, we were developing clinical trials to do LSD research, ’cause LSD is the compound that’s the closest to all of our founding team member’s hearts. It’s been the most beneficial to me over the years, and I know that it’s really been impactful for the rest of us, so as for what indication, that’s kind of… It’s a good question. We’re really developing the clinical trial protocols such that you could basically just search and insert clinical indication and it would be appropriate because it’s more about the protocol as a whole, about how to support these people.

0:45:29.7 DM: And so then when it comes to raising capital, that $9 million is really for what we need to build our manufacturing facility and see that through. When we were first approaching investors, one of the biggest pieces of feedback that I got was, “You guys seem a little bit… Not disorganized, you seem a little bit out of focus. If you guys are working on clinical trials, you’re building a manufacturing facility, you’ve got this biotech research program, like what are we actually investing in?” And they would prefer a more focused investment approach where if we’re investing into a manufacturing facility then we’d like to see you build a manufacturing facility. So to that end, we’re basically… We’d already paid to draft a clinical trial application with a contract research organization. We’re putting together a budget for that proposal, and then we’re gonna find a path to basically raise capital outside of the lab structure, so that it isn’t diluting all the share capital that’s going into the lab production.

0:46:30.1 DM: Whether that involves spinning off a subsidiary like Psygen Clinical or whether it involves finding a research partner that could then take the clinical trial protocol and we could work together to then conduct this clinical research, the big thing is basically just having an independent market opportunity. Because right now our market depends on relationships with the innovators, ’cause basically when MAPS gets market authorization, only MAPS can market their MDMA products. So we at Psygen could manufacture for MAPS, but MAPS would then have to sell to other organizations. So if Psygen is to conduct clinical research, whether ourselves or through a partner, then that builds an independent market position that we can then go and market our own drug products.

0:47:19.0 PA: Any other questions? Barney has a second one. Have you identified any IP for novel manufacturing methods? You’d mentioned the one from the Indian woman who is working for you, I don’t know if that would be a good one for you…

0:47:36.4 DM: Yeah, so one of our founding team members, I consider him a founding team member, is David Wood, he’s an IP lawyer with BLG. So he’s helping us evaluate what our intellectual property opportunities are. It’s one of those tough things; like psilocybe and MDMA LSD, all the products that we’re really centrally focused on, they’re in the public domain. Sure, you could get maybe a process patent for a specific synthetic step, but talented chemists will always be able to find a way around and it probably isn’t really worth our value. So we are conducting a biotech research program where we perceive one of biggest threats to the large-scale chemical synthesis of psychedelics is going to be the large-scale biosynthetic approach. But that’s also then our greatest opportunity.

0:48:29.2 DM: So we have a relationship with a really talented guy who’s kind of… And we’re exploring our various options, but really the biotech approach is going to become more efficient once you reach that economy of scale. It’s not gonna be… I don’t expect that it’s gonna be the most effective or efficient way to go for the next probably three to five years, but once that three to five-year time frame hits and you’re actually looking at those 100 kilo batch sizes, then at that point, biotech production would probably be more interesting.

0:49:02.6 DM: So that lends to IP opportunities. Our founding team has some novel compounds. Like Alexander Shulgin definitely published most of the structures that are out there, but there’s still opportunities we believe to try and find some novel compounds. The challenge there is just the cost of bringing those drugs to market and the question of, will it even ever work? A lot of times people talk about, you can just tweak a molecule and you can shorten the duration or you can achieve a certain effect. But it I think gives a misleading impression that with drug design, you can actually fine-tune a molecule to get exactly what you want to do. Whereas, you can produce a series of hundreds of compounds and you can take those all through clinical trials, and you can get a best guess. But there’s no guarantee that it’s actually gonna have the effect that you want at the end of the day. And the cost to bring it to market is tens or hundreds of millions of dollars. So we do have some interest in novel compound IP, and we’ve got a couple compounds that we’d like to explore. But by far our central focus is just on the large scale manufacture of these substances.

0:50:12.2 PA: Next question is from Dylan, would your license allow you to sell to religious groups with religious use exemptions?

0:50:18.7 DM: So yeah, our license would be what… Our license authorizes the sale of psychedelics to anyone who is legally allowed to possess it. So there’s a due diligence process that we need to verify that they have the necessary regulatory approvals to be able to handle and purchase that. And if they can’t demonstrate that to us, then we wouldn’t be able to supply them. But if a religious group had a Section 56 exemption and it actually allowed them to handle those substances, then in theory, we would able to supply that.

0:50:51.2 PA: Danny, again, I wanna thank you for your time, for the work that you’re doing with Psygen. It was fascinating to come on and learn a little bit more about what’s going on behind the scenes, about your background with psychedelics, and what you are bringing to it. Barney says you’ve done an amazing job. Great chat. Thank you both. Thank you all for coming here. And yeah, I just wanna thank you for all the work and time and effort you’re putting into this. This is important stuff, and to have all elements of the web and the ecosystem is so necessary for this to be successful.

0:51:21.7 DM: Well, thank you for having me. And it was a pleasure. Hope we get to meet in person one day.

0:51:26.9 PA: I’m sure we will.

0:51:28.7 DM: Cool.

0:51:29.4 PA: Have a great rest of your evening.

0:51:30.2 DM: Okay, take care.

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