There’s a growing momentum to legalize therapeutic psychedelics in the United States, with clinics nationwide already offering ketamine therapy, as well as the recent decriminalization of psilocybin in Oregon. What do today’s treatment protocols look like, and what will the future bring? In this episode, Yaron Conforti, CEO and Director of Novamind, talks with Paul Austin, founder of Third Wave, about creating individualized treatment plans, the thousands of clinics we can expect in the next ten years, and democratizing access to psychedelic medicine.
Yaron Conforti is the Chief Executive Officer and Director of Novamind, a company at the forefront of mental health innovation. He’s also the principal of EmmCap Corp., an investor in venture-stage companies. Yaron previously served in senior investment banking roles and in CEO, CFO, and corporate director roles for private and public companies. Today, he is on a mission to facilitate safe, legal access to therapeutic psychedelics.
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0:00:00.6 Paul Austin: 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.
0:00:39.9 PA: Hey, listeners, just wanna let you know that we've opened up our next Microdosing Experience, it's Third Wave's flagship six-week program that helps guide you through an intentional microdosing protocol to help you cultivate what we call the skill of microdosing. How you work with microdosing to heal, for performance, for greater clarity and cognition and energy. We have two coaches who will guide you through that. I will also be part of that. We also have a couple of masterclasses, one with a yoga instructor who's gonna teach about microdosing yoga. She also has her PhD in neuroscience, Tara Zinnamon. So yoga microdosing. We will also have a class on optimal wellness and performance from a medical doctor. And finally, we'll have a breathwork breakthrough ceremony. So that's a six-week course, breathwork, four weeks of integration with microdosing. We just have a few spots left. If you're interested in joining, go to Third Wave's home page, click on Microdosing Experience. Or you can just reach out on social to us and we're happy to help get you enrolled. Thanks so much.
0:01:43.7 PA: And this podcast is sponsored by Mindbloom. Legal psychedelic medicine is here, and it's available through Mindbloom. Mindbloom helps you transform your life with safe science-backed psychedelic therapy. If you're looking for your depression or anxiety breakthrough, Mindbloom provides a fully guided and clinician monitored experience tailored just for you. Some clients see results as soon as 24 hours after their first session. Mindbloom is in fact our first official partner here at Third Wave and a company, an organization, that we support. In fact, I'm going to start my own Mindbloom experience in the coming weeks, and will write about my experience going through a Ketamine therapy to address both Cannabis addiction and general anxiety. The Cannabis was to cover up the anxiety, and I can't wait to share my own transformation with you.
0:02:45.1 PA: Hey listeners, and welcome back to a special edition of Third Wave's podcast in partnership with Microdose and our Psychedelic Insider Series. Today we're interviewing Yaron Conforti, who is the CEO of Novamind, a mental health company that is enabling safe access to psychedelic medicine through a network of clinics, retreats, and clinical research sites. Yaron, welcome to today's podcast.
0:03:09.1 Yaron Conforti: Thanks, Paul. Good to be here.
0:03:11.2 PA: Before we get into the nitty-gritty of Novamind and the specifics of what you're up to, just sort of tell us about your introduction into this space. How you started to learn about psychedelic medicine, and just sort of the initial inertia behind Novamind. Why you started Novamind? What's sort of, the origin story of Novamind?
0:03:30.2 YC: Yeah. Yeah, I'd be happy to... It starts with a personal story and then became professional... My own experiences with psychedelics go back to... I'd say a couple of decades now. And those experiences were mostly recreational. I mean, I'm not that old, but I grew up in my formative years in an era where stigma was obviously still there. Obviously access to psychedelic compounds were restricted. And so it was really just a recreational context that I understood them, but I was always fascinated by those changed states of consciousness... And really any non-ordinary states of consciousness and the ability to influence one's behavior. So those experiences were formative. Fast-forward and a couple of years ago, I started looking at the research very closely.
0:04:22.4 YC: I think it's the research that led to the re-emergence or... It's called the renaissance of the psychedelic sector. And I had the opportunity to have a couple of therapeutic experiences... Again, very different from those recreational experiences. And they were profound. And around the same time, I began investing in the space. And fast forward two years, we've built a leading company that's operating psychedelic clinics and clinical research sites.
0:04:50.0 PA: Bring us a little bit deeper into the infrastructure that you're creating. What you currently have available with Novamind. Because one thing that I love about your particular focus is you're really looking at what can you do to provide safe and legal access to psychedelic medicine now. And that's really insignificant in comparison to many of the other companies... Public companies in the psychedelic space, which are really looking at two, three, four, five years down the road... Having Psilocybin approved or MDMA approved. You're really looking at what's available now. How do we sort of enable access for this? So I just love if you could fill our listeners in about what is it that you currently have going on with Novamind? What companies have you invested in or what companies are you working with to ensure that safe and legal access to psychedelic medicine is more available?
0:05:42.9 YC: Yeah, for sure. And I agree, I mean, that is where we objectively differentiate ourselves. There's obviously a lot of companies and there's a lot of capital flowing into the space. So you're using a bit of an ontology, and I'll give you the legacy for it... Because there was a thesis really that this all emanated from. I co-founded the company Novamind with two partners, Sruli Weinreb and Jesse Kaplan, and I've built a lot of businesses with them. So the thesis when we started this two years ago was, "Let's find the people in psychedelic medicine that are helping people today, and let's partner with those people and scale access." So that was the broad thesis. And that led us to a couple of investments and a couple of partnerships.
0:06:23.1 YC: So from a macro view of let's help people today, let's find the people helping them and let's support them, that became a couple of investments and a couple of acquisitions. So we made significant investments in the Synthesis Institute in the Netherlands as an example. We made acquisitions in the US of Cedar Psychiatry, which is a network of mental health clinics, and it's also a clinical research organization or contract research organization that provides infrastructure to support clinical trial work. And so it was through those acquisitions primarily, and in some cases, investments... We made some other investments that I can mention, as well, briefly. But it was primarily through the acquisition of Cedar Psychiatry and Cedar Clinical Research, where we were able to in real-time develop... Buy and build businesses that were treating people.
0:07:16.4 YC: So that brings the focus to Ketamine because in the United States, obviously, Ketamine is the first legal psychedelic. And the partner that we found in Cedar Psychiatry was founded by Dr. Reid Robison. And Reid is now the chief medical officer of Novamind... Has been involved in the space for many years as a known thought leader. So to be specific about that, both as a clinician and in clinical research Reid is one of the coordinating investigators for the MAPS phase three MDMA clinical trial. He's also previously led the clinical trial in Utah for Spravato, which many of your listeners will probably be familiar with. It's the first Ketamine prescription drug approved by the FDA.
0:07:57.1 YC: And so that breadth of experience essentially enabled us to take a position in this industry where we already were entrenched. Last year, Cedar Psychiatry had over 20,000 client visits... Just to give you an idea of the scale. So from that platform, we're able to build much more quickly. And instead of reinventing or inventing from zero both the infrastructure, the protocols, the teams of therapists, etcetera, that need to support that activity, we're replicating a model that already works. So hopefully that gave you an insight into how it went from thought to execution, and where we are today. It was really about partnering with people, and that gave us the ability to grow exponentially because we're at four clinics now, and I think by end of year we'll, at least, double those clinics.
0:08:47.3 PA: Are those clinics then particularly in the United States? Are you looking at all of North America? Are you also looking at Europe in terms of the clinics? We know Synthesis, pre-COVID was doing retreats in the Netherlands as part of the network. And they may be moving to Oregon with some of the legalization there. But specific to the clinics that you're looking at opening, what sort of territorial focus are you taking with that?
0:09:10.8 YC: All of the above, in terms of what you listed. So we really are taking a global view. The investments that we made early in the Netherlands were... We invested in that jurisdiction for a reason. We did a lot of due diligence at the time, and we found that Synthesis in fact, rated as one of the best, if not the best in the world to providing that legal, medically supervised Psilocybin experience. Which compares to the quality and standard of care that we offer State side. So to be clear, our clinics are currently based in Utah because Dr. Robison is based there, and that's where he founded them. From a Novamind perspective, a couple of the jurisdictions, you mentioned Paul as an example Oregon... We're following the policy moves very, very closely.
0:09:50.4 YC: And based on... A lot of people don't like to make analogies with Cannabis in the psychedelic space, but from a policy perspective, I think it's fair to. And I think we're starting to see the momentum as mentioned in places like Oregon as well on the East Coast, we can list a couple of the policy developments there. But it's a momentum and sort of snowball effect, that one picks up after the other and the politicians and their constituents start making decisions that are gonna positively affect ultimately, which is our goal... Affect our ultimate goal, which is to enable access... That people should have the access to these alternative therapies.
0:10:24.6 PA: Currently, clinical sites that are in Utah... You said the Cedar Psychiatry has seen over 20,000 clients so far. Your current chief medical officer, Reid Robison, has been involved with the MAPS trials. So you're clearly building an excellent professional team. Synthesis has facilitated retreats for, I think over 600 folks... 650 folks at this point. You also have an investment in a place in Costa Rica, which I wanna learn a little bit about more. And so I'm curious about Novamind's approach in terms of the balance between public-facing... So in other words, are you going to set up a sales and marketing infrastructure through Novamind to get people into Cedar Psychiatry and get people into Synthesis. Or are you simply supporting through investment on the back end and saying, "Hey, Cedar Psychiatry has its own sort of marketing channels, and Synthesis has its own marketing channels." And Novamind is sort of the ecosystem in the back end, but you aren't near as public facing. What's the balance that you're taking as a company in that respect?
0:11:25.0 YC: Got you. I think a couple of clarifications are really important. And it's a fair... I would say it's arguably easy to confuse because we do hold an investment portfolio. So Novamind when it began, made a number of investments and we still hold that investment portfolio. So I'll just speak to it now. Synthesis, we mentioned is in that investment portfolio. We also invested in Field Trip, which is a clinic company, and a peer of ours. We also invested in Circadia, what you mentioned is a retreat opportunity in Costa Rica. And we also invested in Atai which many people are familiar with. And the shareholders, along with others, were excited about what's expected to be, I think a NASDAQ listing this year... Or early this year.
0:12:11.2 YC: So that is a Novamind investment portfolio is effectively a legacy... To be clear, that's a legacy portfolio, because what we were doing along with my partners, our model is generally to invest our own capital before we build a company. And we did that, and we learned a lot and we continue to gain a lot from those partners and those relationships. But that... Paul, you and your listeners should view that investment portfolio as something that remains an asset on our balance sheet, but we will not be making any more passive investments. If we do make investments from the Novamind perspective, it's gonna be very strategic, and it's because we are absolutely focused on our operating model and our operating model for psychedelic clinics and clinical research sites.
0:13:00.4 YC: I don't speak a lot about retreats today because of the COVID environment, and we haven't been able to launch that part of our business. But you can view it as essentially clinics and retreats in terms of where people have access to these alternative mental health modalities and experiences, and then the clinical research site. Work at the clinical research part is a very specific business plan and sort of thrust of Novamind. So now that we have a bit of an ontology, let's say, for what Novamind is and isn't... We are 100% focused on scaling our clinics and clinical research sites. There's a symbiotic relationship between the two. And I'll answer your question as it relates to, how do you effectively market these channels, for lack of a better word, being clinic where clients can access these experiences and the clinical research sites, which serve the different clients. Which is a pharmaceutical company or an academic institution or a not-for-profit institution that may be involved in the clinical phase drug development in which we have the expertise to facilitate.
0:14:00.4 YC: So these are the two groups we're serving. And in terms of your question about how to market to them, the reality is that the environment we're in such that mental health is so front and center that COVID has without a doubt, exacerbated the issue. And if certainly there's a benefit, de-stigmatized, and I think... Paul I know you've been in the space for a long time... And anybody who's contributed any amount of time particularly to the mental health space, I hope is feeling that change, that softening on a real societal level, policy level, economic level, any level you wanna look at.
0:14:39.2 YC: So obviously, that plays into our favor. There's a business side to this. We built a platform here because we expect to help a lot of people with access to alternatives that they never had before. But we certainly wanna build a profitable and sustainable business. And in that context, what's happening I can tell you is that the demand is immense. I'm not talking about sharing headlines or pontificating with people on macro views. I'm telling you that as the CEO of a mental health company that operates four mental health clinics, I mentioned too that 20,000 client visits, and that was in 2020... Calendar 2020. That was double the client visits we had in 2019... Right?
0:15:24.8 PA: Wow.
0:15:24.9 YC: We also put out a news release... Just actually today, where... What we've been doing with some of these news releases is we really want people to understand what it is to be an operator today and to be helping people with psychedelic medicine today... Where we can and legal jurisdictions using therapies available. So if you look at our news release today, we also highlighted... There's two pretty big MAPS milestones and we're proud of it. The credit goes to the practitioners, which I'm not. But our practitioners reached a milestone that we announced today, which was over 5000 Ketamine treatments and over 2000 Spravato treatments.
0:16:02.3 YC: So a really big deal by anybody's standards in terms of... Back to it, like who's doing the work today, and are they helping people? And so that's a bit of a long-form answer to your question, but I really wanted to give a scope for where the demand is coming from. It's repeat clients, it's new clients. What kind of segments are we seeing that demand in. So you'll see in that news release, the Spravato segment within that 20,000 client visits is up over 400% year over year. So I can tell you that people are seeking out these alternative mental health modalities. My partner in business, and now obviously a close friend, Reid Robison is very much a thought leader. I encourage people to look at our home page and the information we put out there. I started building this business two years ago, and he's devoted his life as a psychiatrist and a medical doctor to pursuing these alternatives for his clients. So we're not iterating here for the first time.
0:17:01.8 YC: He has a very good sense of these novel treatments, whether we're talking about things available today, like Ketamine system psychotherapy or Spravato or the advent of what we're waiting for which is the legalization of prescription MDMA first and then Psilocybin. Where Reid is as a leader in these trials is very much trained and also practiced in terms of the iterations to have the clients on the protocols. So he's in a position to train our therapists and our team so that when these prescription medications come online, 2023, 2025, we really do wanna be well-positioned in so far as that, if we have that expertise from being involved in the clinical trial work, we expect and want to be a trusted partner in so far as that people will trust us for that safe, as we said, medically supervised legal experience. Which obviously for... Depending on what vantage point you're coming at it from, I can tell you our patients and clients talk to us about it.
0:18:03.2 YC: And safety, I would say, is the number one priority. Beyond even efficacy, I would say. For most people, depending on your own experience, your cultural vantage point, safety becomes the overriding theme. So we're building something for scale to address everybody. There's an emotional aspect to that, but also an economic one. So you now look at groups that, depending on how we scale this offering, you don't wanna marginalize those people for whom safety is first and foremost. You also don't wanna marginalize certain economic groups that may not be able to access the treatments if they're only available at a certain price point. So these have become the themes that we're working out now. And it's less about allocating capital within a broader ecosystem, making passive investments like we were before. We're very busy, and it's not with that. It's with looking at how to scale the clinical research sites to advance the research and how to scale our clinics to enable access.
0:19:06.1 PA: And I think to that point on safe experiences, there's a quote that I will often bring up when talking about this. I was listening to a podcast with Tim Ferriss and Sam Harris that they did maybe six months ago on The Tim Ferriss podcast, and they were talking about psychedelics and psychedelic experiences and basically saying, "There's difficult or challenging experiences, or there's really good experiences, but what... " I think Sam Harris is saying this specifically, "What matters most is the experience safe or is it unsafe? Because if it's safe and it's challenging, that's still very beneficial to the overall healing trajectory. But if it's unsafe, then it could potentially be traumatic, people can't surrender, people can't sort of have the full feeling of it." So I think I love how that's front and center on your website, that's front and center in your communication materials, that it needs to be legal and safe access to these medicines because that's so, so critical to the efficacy of the actual healing, is that feeling of safety.
0:20:04.1 YC: I appreciate you pointing it out because it's something that we're working hard on. You don't want to preclude people, you don't wanna marginalize people. Most people don't know that these alternatives exist in the first place. So creating that on-ramp, for lack of a better word, of education and resources, we are, to make another distinction, objective differentiation, we're a medical business. So sometimes, we're compared with certain retreat operators or people that deliver this type of care in a different way, but we operate with teams led by psychiatrists and lead therapists in a Master's level, in some cases. So it's a very systematic approach. And while people like you and I who are more experienced and very familiar also with the data in terms of efficacy and what it looks like to have a bad trip, in empirical data terms, our instinct, I think, is to say, "No such thing is a bad trip, only a challenging trip, and that can be efficacious as well."
0:21:06.2 YC: But that is something that took, I think, whether we realize it or not, it took a lot of work and information and experience to get to that point. So people that aren't armed with that, not necessarily just psychedelic experience, but that life experience where, let's say practices like mindfulness and more conventional psychotherapy where people are ready to engage on a more spiritual or emotional level is something that needs to be treated with great care when you're bringing people into that kind of vulnerable position. So I think we're going a little bit down a black hole, but another time, maybe we can talk about it. I think there's... It deserves a lot of attention. And there's some people talking about it, not a lot of people. [unclear speech] psychedelic support has developed some resources that you'll see and look at, for example, people who are on some sort of SSRI regimen, for example, and have to wean off to have these experiences, which again, these are things that you and I know a lot about, but for the newly initiated, there just aren't that many resources out there. So it's another part of the chain that we're focused on. I don't think enough people are talking about it in our space. And hopefully they will moreso.
0:22:19.1 PA: And a bit of what you're getting at as well is sort of a philosophical shift in how we even approach healing. So much of healing over the past, we could say 30, 40 years has been much more about numbing, so to say... So if you have anxiety, if you have depression, things as PTSD, typically you're given Prozac or Zoloft or Wellbutrin, something that sort of numbs the pain to get you back to what we would call a base level where things just feel fine. And a couple of years ago, Robin Carthart-Harris published a ground-breaking research paper out of Imperial, showing those differences between typical anti-depressants which activate the 5-HT1A receptor and classic psychedelics which activate the 5-HT2A receptor. And the difference that he showed is the reason psychedelics were showing a lot more efficacy in terms of treating depression or addiction or anxiety is because it helped clients to go deeper into the pain, almost like a catharsis, feel the full pain and then move through it, to fully heal it and sort of moving through that and allowing that trauma to be processed comes back to the safe container. Because if someone doesn't feel safe, then they can't surrender to those traumatic experiences, which is often sort of the underbelly of depression, anxiety, addiction, etcetera, things like that...
0:23:42.5 PA: So I think what you're speaking to as well is a whole paradigm shift from a client perspective, where people are so used to just saying, "Hey, there's a pill. This will help numb you. You don't need to deal with your issues. It's just... It's a band-aid." And what psychedelics do is they say, "Hey, it might be difficult at first. It might be challenging, it might take some courage. But if you sort of... As Hunter S. Thompson said, "If you buy the ticket, you take the ride." And so if you're buying the ticket, you're taking the ride, you're going down that path, people need to feel like, "Okay, I feel held, I feel safe, and I can fully surrender to this," understanding that on the outset beyond that is a sense of peace, a sense of equanimity, a sense of more balance.
0:24:23.9 YC: I think people kind of lose track actually. I basically, I concur with everything you said, and what it made me think is that people lose track because of how quickly things have moved particularly in the last couple of years. But what we're doing is unprecedented. I deal with it every day because I'm building a business which requires me to create and execute a model that people are gonna interact with. We're helping people. These are not widgets. We're dealing with minds and people and lives, and it's a very, very sensitive business to be in. Okay. And I would argue that what we're doing is unprecedented, which means that the paradigm shift that you described from take-a-pill-for-your-ills, take one every day, take one every month, whatever it is... The paradigm shift from that to, "I'm gonna have these experiences. These experiences are gonna be integrated. I'm going to be forced to go down a couple of layers," it's totally unprecedented in terms of what people are used to interacting with. And that's a bit of a bottleneck.
0:25:28.6 PA: That's where the fun is too, to create that challenge is probably what is so exciting for you as a CEO is it's a really novel challenge to have to sort this out and put this together...
0:25:41.7 YC: Totally. And I love it, and it also... It's not just the mechanics of it. It's the re-framing of it because to add to what we were just describing as a new paradigm, you're talking about curative outcomes in the best-case scenarios. Again, totally unprecedented. We have a lot of things, amazing things in the world in January 2021, but curative effect for mental health, when you compare oncology or cardiology and you look at the advances that they've made over decades and the tools that are working and the data that shows that rates of incidents are going down, or the people suffering from disease are getting better care, you just don't have that in mental health. And that's widely understood. That's not my original thinking, that's every psychiatrist that's been practicing for the last 20 or 40 years, and we're working with a lot of them. So to re-invent the world a little bit, yeah, it's absolutely exciting. I love it, I love the mechanics of it, and I love the.
0:26:35.8 YC: The strategy and the more esoteric side that we're talking about now is how to frame this in a way that people will be comfortable and that the infrastructure that we build matches what they need, 'cause that'll evolve as well. Our great-great-great grandchildren will be visiting very different clinics. So again, to focus on the positive, I'd say the big win for people like you, people like me, people involved in moving the space forward is that... And I said before, I think everyone will agree, anyone in our position that the stigma is starting to soften, for sure. And that's the big win that podcasts like yours, businesses like mine, things like The Third Wave, these are the resources, the information... You're basically empowering people. You're taking the intimidation factor away by empowering people with knowledge, in our case, making these experiences accessible again in that medical trusted model where people can actually open up to the type of experiences you are describing and open their mind to that type of healing, because precisely because that layer of safety and trust is there. There's no way you're gonna get those outcomes if people aren't... First need to feel safe.
0:27:50.3 PA: Absolutely. And sort of to go back into brass tacks a little bit around safety, around what you're developing with Novamind. We've talked about the clinic. We've talked about Synthesis, the Psilocybin retreats, the other retreat in Costa Rica. There's...
0:28:06.9 YC: A lot going on there.
0:28:08.3 PA: There's a lot... Yeah, yeah, yeah. And my point being, a lot of it is on the physical space, like these are the places that people can come and access them. And so one thing that I wanted to ask you about was drug development, because so much of what we're seeing right now in the psychedelic space is... I don't need to name the specific companies, but company X is trying to patent Psilocybin for treatment-resistant depression, company Y is trying to patent this other sort of delivery method for Psilocybin for major depressive disorder companies. I just saw this thing the other day on Twitter. There's a company that's opening something called the Psybrary, where they're trying to patent 1.2 million psychedelic molecules or something ridiculous and absurd like that, which is so cool. It's like the Sasha Shulgin thing, exponentially elevated.
0:28:54.2 PA: But it sort of brings home a point that I've given a lot of consideration to which one of the fundamental shifts with the psychedelic space is less of a focus on the product, if you will, that the pill and much more of a focus on the container, on the set and setting, on the legal safe environment that needs to be set up for these experiences. So just from a CEO perspective, why did you choose to focus less on the drug development element and much more on the physical infrastructure, the physical spaces, and sort of what's legal and available now, rather than even someone like Field Trip, for example, who you're an investor in is developing the FT-104 molecule. So just like to hear your thoughts on drug development, why Novamind is not focusing on that and what that says about your vision of the future for psychedelics.
0:29:48.8 YC: Wow, a lot there. I'm happy, first of all for you to shine the light on it and for me to answer it, because the environment you described is... As you can imagine, we're investors and operators in the space. We see exactly what you do of these... I think dozens of drug development companies are now turning to maybe hundreds of drug development companies or purported drug development companies developing libraries. The Sasha Shulgin reference was good, but note that none of these companies appear to be focused on bringing us the next Tikal or Tikal... 21st century commercial model there to build big walls of IP as quickly as possible, and to kind of replicate that model of selling pills in a very lucrative way for a long time, 20 years or whatever the patent walls will give you. So that's context. That's what... For you and me and all the listeners, that's what you're talking about when you say... When you shine this light and you say, "Look at all the drug development, wave of capital as well, that's going in there. And so first of all, why aren't you doing it and what is your relation to that?" So it's really, it's an insightful question, it has a lot... We think about these things all damn day. And so here's what we think about them.
0:31:08.9 YC: We are not drug developers. Without a doubt, we do not develop drugs, we're not interested in the business model associated with it, which is a biotech model that I'm very familiar with and have invested in, but is not one that is a business builder I wanna pursue. And it involves investing hundreds of millions of dollars over a period of five to 10 years to take something through the clinical phase trial process for potentially a very successful outcome. But it's a very high risk, very high reward and a very capital-intensive business model, and that's why from day one, when we chose to enter the space, we chose not to enter it in that way. However, we do very much want to be both contributing and involved in the advancing of the research, we'll be specific, the advancing of clinical trials and research studies, some pre-clinical that will bring novel therapies to market, bottom line. We wanna support that in every which way we can.
0:32:09.6 YC: So the way we do that both as a, again, on a contribution level as far as participating to the space and as a business that wants to succeed and build profitably in the space, all of that energy and thought, and there's a lot of it from our perspective, is focused on our CRO. CRO is an acronym for those who aren't familiar, it's contract research organization, and it defines basically an entity that serves as I mentioned before, pharmaceutical companies, not-for-profit academic institutions. Those are the clients of Cedar Clinical Research, which is the name of our clinical research platform, and those clients will come to us for phase development in the clinical trial process. In some cases, that means designing studies, recruiting patients, executing those studies, collecting the data and reporting on the data. In other cases, large pharmaceutical clients that we work with... We work with some of the world's largest, will have thousands of trial sites of which we were one or a couple. They will have a design trial that is at a later phase, which is why you would have thousands of sites.
0:33:16.2 YC: They will come to us, we will recruit patients and we will execute the trials. An example of those would be Reid Robison's work with Spravato. He led the clinical trials in Utah for Janssen for Spravato. I mentioned earlier that we, through the Cedar psychiatry network of health clinics, have administered over 2000 doses, and that's industry-leading. There's very few individuals or clinic groups that have had that kind of experience. And again, I tell the story so that you and your listeners can understand the connection, that when you have the very unique thought leader like Reid Robison, who is both as a researcher advancing the trials to bring these novel therapies to market and is also a clinician who is then able to provide his clients with alternatives, very powerful combination. So that connection between clinical research and our clinics that I just described with Spravato, we expect the same with MDMA and we expect the same with the Psilocybin. This is very different from being a drug developer per se.
0:34:26.9 YC: We are happy... We're first of all, drug agnostic, we're company agnostic. We wanna help as many people as we can by providing our expertise, which I can get into in some detail, but I don't know how much time we have to go down all these rabbit holes, but I'll make the long story short on this one. If you're a clinical trialist like Reid Robison or others with expertise and have done many clinical trials, you quickly understand that a clinical trial site in psychedelic medicine is very different from an average clinical trial. So you can appreciate if you're dealing in trips of four, six, eight-plus hours in length, you've got a protocol that requires two therapists, you've got a certain set and setting, you've got requirements and goals.
0:35:08.4 YC: This is very specialized work in the clinical research business. So we're really good at it. Reid has built a team and an organization around it, and part of what our growth plan is to expand clinical trial sites so that when these drug developers and hopefully the ones that fall into the category per our earlier conversation of serious people who have a good shot at bringing these things through the various phases, which takes a long time and a lot of money, we do want to support them. So that's our interaction with drug developers, with traditional drug developers. It's also, I mentioned, it can be a very... It is in terms of margins, it's a very lucrative business. So if you add a lot of trials and a lot of sites, it's much more profitable, in fact on a margin basis. So that business could be very big for us. And the last thing I wanted to share on this particular subject of drug development in the context of CCR is that it's what we do currently and we expect to do more of... We'll be talking more about this in the future, is the development of therapeutic protocols. So different from drug development in the case, I'll use a working example.
0:36:18.3 YC: We've started in our lab, and if again you look at our website or our press releases, or our deck... Our corporate deck is available on our website. It goes into some detail about this. And we've been working at Cedar Clinical Research on something called EF-KAP. And EF-KAP is an acronym for emotion-focused and Ketamine-assisted psychotherapy, and it's a hybrid. Emotion-focused therapy is a particular modality, and there's a thought leader in that space. Her name is Adele Lafrance. Dr. Adele Lafrance is a PhD psychologist who's one of our consulting research scientists. Her expertise in emotion-focused therapy, combined with Reid Robison's expertise in KAP, Ketamine-assisted psychotherapy, have been put together in a therapeutic protocol to address clients that are suffering with anorexia as well as MDD. There's two different protocols. But what we've done is we've taken Ketamine, which is a compound that many people are very familiar with, and we have a lot of experience with, obviously, and we've paired it with a very particular therapeutic protocol, and we've recruited patients and we've collected data and we will be reporting on the efficacy for that protocol. So that example gives you a working example of the type of therapeutic protocol developments that we're able to do in-house and that we are positioning ourselves...
0:37:43.1 YC: If you look at, for example, our scientific advisory board, you'll see there's some real exceptional domain expertise there, in things like palliative care... Dr. Craig Blinderman who runs palliative at Columbia, New York has... The opportunities... I'm not gonna go through the SAB, but using that example is that we can now take an indication whether it's palliative, like I just mentioned, or the eating disorders trial that we're working with now with EF-KAP, and we can attach those to different compounds and we can develop those therapeutic protocols, find it if they're efficacious, and if they are, disseminate those to other people. So our goal is to play a certain place in the... Let's call it the value chain, where we want... Our goal is in fact to spread this knowledge as far and wide as we can, and it's... We're not a not-for-profit, let me clear about that, but our model is more akin to MAPS than it is in that respect to some of our other peers, where we believe that the priority is to create that network effect. As you can imagine, if our therapeutic protocols are working in eating disorders where Reid Robison and some of our other team, Adele Lafrance, I mentioned are world experts, then why wouldn't we want to disseminate that to all the eating disorder centers that exist all over the world looking for alternatives.
0:39:03.6 YC: So a couple of very specific examples for you and your audience that you don't have to be a drug developer to bring therapeutic protocols to market, and we're gonna do that. We're doing it in real time, we don't have to go to a clinical research organization to do that work for us. We can do it in-house, and we can do it very cost-effectively. So not a drug developer, but a developer of therapeutic protocols, for sure. Our involvement in the MDMA trial, obviously with MAPS, and we're looking to involve ourselves also with some very specific late stage work with Psilocybin. It means that we are happy to rely on the leaders like whether it be Usona or Compass with Psilocybin or MAPS and others with MDMA, they are doing the very hard, very expensive work of proving the safety and efficacy data and profile for those compounds. And we're grateful for it and we're following their lead and building on their shoulders. We're not gonna go into the lab and develop new drugs on the classics or the others. We're gonna let them do that work on safety and efficacy, and we're gonna wrap therapeutic protocols around those compound, and that's how you help people now.
0:40:15.7 PA: That speaks to a couple of points, which I wanna highlight. One, you mentioned Usona and Compass, those two companies in themselves have an interesting relationship because... Compass has had a couple of big press releases around Psilocybin synthesis, and then Usona will sort of come out as a non-profit and be like, "Hey, we just open-sourced the Psilocybin synthesis. Here it is for everyone to see." So I think there's an interesting dynamic, particularly in the North American psychedelic landscape with MAPS and Usona, who are essentially saying, "Hey, we're at the forefront of this. We're non-profits." MAPS is a public benefit arm, but all of those profits go back into the non-profit, and we're leading with MDMA for PTSD, and Psilocybin for major depressive disorder is what Usona is focusing on.
0:41:00.5 PA: And Usona is also now applying Psilocybin to other companies in the space that need it for clinical trials. And what you're speaking to, which I think is much more sort of the future of psychedelic medicine is, "Hey, instead of creating IP around drug development, let's create IP around the treatment protocols, the way that we actually use the drug, because that will actually be much more valuable in the mid to long-term, as the methodology that's used, the container that's created, actually matters a lot more than the specific substance." And the reason for that... And again, I'm thinking more long-term, 10 to 20 years, not in the next three to five years, the specific substances that come out, there will be Psilocybin or there will be other 4-AcO-DMT, which is another Psilocybin analog. There's gonna be thousands of these analogs that have very sort of similar approaches, just slightly nuanced.
0:41:56.2 PA: And what's gonna matter a lot more is the efficacy of the container, the way that preparation is done, the way that the experience is held, the way that integration is carried out. And so that's what I hear you speak into about sort of the future of Novamind is, "Okay, you're really looking at specific to eating disorders, specific to MDT, you're probably gonna look at addiction and alcoholism, maybe PTSD," like what is that one month or six month or year-long trajectory that clients are going through to ensure that the underlying cause is healed, that it's curative, as we talked about earlier, and it's not just, "We'll give them a drug and they'll come back three months later, or we'll give them and they'll come back a month later." It's really about, okay, "how do we address the underlying cause by developing these incredibly efficacious and innovative treatment protocols?"
0:42:43.0 YC: Holy shit, there's a lot to talk about here. I'll try to... No, I appreciate that you're... We're sort of picking at the layers here, so let me first say, that first sort of comment in so far as when you look at the environment and what's going on and you have, we're in a world where not-for-profit entities have spent $100 million over 30 years taking an off-patent molecule through a phase III process with the FDA. This is the world we're living in. That on its own is fascinating. Then watching the interplay with for-profit entities operating a similar model.
0:43:21.8 YC: Let's again point out that these organizations are all run by very thoughtful, very experienced people who have similar to us and other people in the space have agendas that are both altruistic and economic. So just to say that watching that go on is fascinating, I haven't figured out exactly how it's gonna work, and that's why I think it's not bullshit when people in our space talk about a new paradigm and unprecedented models for doing business and for medical care. That's my first take on it. The second one is really that, our approach is a very specific approach so it can be differentiated from certain of our peers, and certain parts of our approach, I think, are... They portend for the future, the decisions we're making today I think portend very specifically for the future of Novamind.
0:44:18.0 YC: So what I mean is that when I mentioned earlier, a couple of times, that we're drug agnostic, or we're drug developer agnostic. That approach, that mantra really permeates our whole organization, because rather than believing that we will come up with whether it's a drug, a therapeutic, whatever it is, this sole source of care that is gonna be a perfect fit for everybody, this is the antithesis of our model, let's say. We take a view that you really want, if you're gonna be the infrastructure or the access point, make it less intimidating, where people are seeking at these alternatives, you wanna find the modalities that are right for them.
0:45:04.8 YC: And so Ketamine is the first legal psychedelic, but it's not appropriate for everybody. So why create a system where that single source starts to define where you're essentially, not forcing, but pushing or creating the paradigm where few or only one alternative exists for that person rather, if you go into one of our outpatient mental health clinics today, and certainly in the future, but today you'll see a spectrum. It starts with CBT and prescription management, and there's a nutritionist and things that are, I'd say, are typical services in the outpatient mental health clinic, and then the non-typical stuff is why we're building Cedar Psychiatry into what we think will be one of the leaders it's because they have, for years now, provided the spectrum of alternative mental health modalities, things like KAP or Ketamine Assisted Psychotherapy. We've talked about things like Spravato, which we've also talked about TMS, Transcranial Magnetic Stimulation, these are the spectrum of alternative services available today in our clinics, and that you won't find in a lot of other clinics, 'cause the reasons we've talked about, because it...
0:46:16.6 YC: By definition, it's the people who adopted them early in the last 5-10 years and now are practiced and have the ability to bring it to clients. So it really is a matter of objective differentiation, it's not being all things to all people, but we wanna match on a compound level or on a protocol level, the right treatments to the right people. So that's the model for operating clinics, and it's also the model for the clinical research aspect of our business, which is that why would we preclude someone from... Let's use your example... Synthetic Psilocybin, right? You're gonna have a Compass version, you're gonna have a Usona version, you're gonna have a model of delivery with Compass, you're gonna have a model of delivery with your Usona and with others, probably. So rather than necessarily pick and choose per se, and maybe it'll come down to that and maybe we will need to, and I'm open to everything, 'cause this is a very evolving space. But our preference would be to offer all the alternatives to as many people as possible, because our experience so far, I can tell you, spending a lot of time, obviously with Reid as a researcher and clinician and on the clinical research projects we're involved with, I can tell you definitively that not all compounds are all things to all people, right? PTSD sufferers are gonna get an incredible novel alternative very soon, I hope.
0:47:42.0 YC: But it's not gonna be a panacea on those curative rates, the data that you and I have been excited about for years, and that when people get an understanding of today and they see that first, I think what was it, 76% was the number?
0:47:56.0 PA: Something like that.
0:47:56.3 YC: In terms... That they didn't meet the...
0:48:00.3 PA: After a year...
0:48:00.8 YC: I think the numbers really do... Yeah, exactly what Paul and I were talking about, like this well-known study that came out early that after a year of that MDMA PTSD protocol, treatment and integration, 70% plus of those people no longer met the requirements for their PTSD diagnosis. So it's profound stuff, but let's not forget about that 24%-25%, it's gonna be a lot of work and a lot of iteration.
0:48:28.9 PA: Yeah.
0:48:29.2 YC: I think the hope is that a couple of decades from now, it's like, we're gonna look back on this and stigma is gonna be gone, and we'll be able to match people with the treatments that they need and they won't suffer unnecessarily for decades, which is a case with again, let's just bring some light and some humanity to the data points, people love talking about the WHO number, which is 300 million people suffer from depression, say they updated that stat, but that's the one that a lot of people use. Well, 30% of those people are treatment resistant, okay? So on that 300 million base, that means hopefully 200 million people are more or less served by the current standard of care, can get out of bed, they can go to their jobs, they can love their families. And there's 100 million people that are not responding to the standard of care, right? So the message from me, from us, from Novamind is, "Let's create. It's not just an industry, but a world where it's a spectrum, continually that spectrum that I talk about, and where we're helping as many people within that spectrum," obviously there's priorities in terms of how new industries are created, and that's why MDMA for PTSD as an indication comes first. And I think there's economic and political reasons that drive that too, so bit by bit, that's how we get to healing the most people.
0:49:54.1 PA: And something that I picked up on in that response was sort of this personalized approach, which I think is so critical. And ideally in the future, let's say 5 to 7 to 10 years from now, we'll be able to... Maybe using big data, maybe using AI, maybe using whatever else, there will hopefully be an ability for every individual. Whether they suffer from PTSD or treatment-resistant depression or alcoholism or anxiety or something we haven't even talked about in this conversation, but is also relevant to those who are looking and working with psychedelics, there's a lot of folks who use them for creativity, for purpose, for innovation, for that whole spectrum, which we won't get into now 'cause I don't wanna focus so much on that.
0:50:37.4 YC: I just wanna like... We're covering pretty much everything. So it's like, yeah, we focus this conversation on Novamind's model for healing the sick for the most part, right, we really haven't focused it on the bettering the world part, and that is definitely a part of the world. But our focus now is helping people that really need the help, for sure. And all manner of people, and that's why going into our clinics today isn't quite so intimidating, because it might not be a high dose or low do psychedelic experience, right, that might not be the fit for you. So yeah, you brought up the data aspect as well, when you get into the potential to use that data, the quantified self, then we're also talking in the realm of preventative versus therapeutic fixes, so imagine now the people who are predisposed to these diseases have tools that are available on a consumer level, to sort of preempt them to avoiding the outcomes that to us are like, "Oh, fuck, you're depressed? It sucks to be you," right, that's normal now, that's like a normal thing. So maybe we avoid those outcomes all together in a future that's driven by data, but that's a whole another podcast.
0:51:49.1 PA: That's a whole another podcast yeah, 'cause that gets quite complex. Well, we're nearing the end of the hour, so I just have one last question for you and take this as you will, it's a bit of a sort of, again, a forward-thinking question that particularly has been brought about by COVID. The way that we think about the future of the clinic is changing before our eyes and sort of context for this company that we have partnered with at Third Wave is Mindbloom. Mindbloom in early 2020, late 2019, they had opened up a physical Ketamine clinic in New York, where they were starting to do in-person Ketamine treatments with lozenges. And then when COVID hit in mid-March, they pivoted as a company, and they got rid of the physical space in New York and focused only on telemedicine Ketamine therapy. And recently...
0:52:35.3 YC: Right.
0:52:36.6 PA: I've gone through that, I live in Florida, so I can legally get Ketamine sent to my home, and basically set up my own environment, my own setting at my apartment in Miami, where I put on a playlist. I put on this thing called the Apollo Neuro device, which uses vibrational touch to help with nervous system regulation. I laid back in a Shakti Mat, which is like an acupressure mat that you can lay back on. And then I did about 300 milligrams of Ketamine in lozenges form. And sort of went through this Mindbloom experience, and essentially a couple of weeks after that, I met Dylan, who is the founder of Mindbloom. We got together in Miami, and was just telling him, essentially, what you're building is sort of the clinic of the future, where instead of a person going in physically to a clinic to get an IV Ketamine, or to get a Spravato treatment, can actually get Ketamine sent to their home, the practitioner can come to their home, and their home can sort of act as this pseudo-clinic in a way. So I just wanted to sort of hear your thoughts on the future of clinics, and how you see that relationship developing between going into an in-person clinic and this telemedicine approach in psychedelics, which I think will become much more prevalent in the next two to three to four to five years, even with things like Psilocybin and MDMA. How do you see sort of that balance, that relationship, that development?
0:54:01.5 YC: I'm more open than one might think to novel approaches, particularly when it comes to client access, because there's a bottleneck, and it's between the stigma, the lack of resources, there's a lot of reasons that, truly it's a bottleneck, that stand in the way of people accessing help. So in that context, I'm very open to innovation and novel models of delivery, and Mindbloom, as you mentioned in some detail, is doing that. So I see the benefit in so far as innovation, there's a very direct line I can draw to helping more people. With that said, we are a medical business that is really built and predicated on a certain standard of care, and I don't mean that in a pejorative way in terms of comparing us to other people, but in a well understood way, which is that people expect a certain standard of care in places like North America and Europe, etcetera, when they interact with the medical system.
0:55:06.6 YC: So today, that model that you described as innovative as it is, it really doesn't fit what people look to us for. I'll add to my thought on that, that if you take, for example, inspiration from someone like Rick Doblin, which we all do. Anybody who is building anything in the space owes enormous debt of gratitude to Rick as an individual, to MAPS as an organization. And so even though we're very much a for-profit and very different type of entity, like a lot of people, we take a lot of cues from what Rick thinks, from what Rick says, and from what Rick sees when people ask him what you're asking me, "Hey, look into your crystal ball." So we listen very carefully to what Rick sees in his crystal ball. He's been saying for a long time that his world view, I remember this very specifically, it's more likely that in a couple of decades from now, many of these experiences are facilitated by guides in the form of brothers, best friends, cousins, sisters.
0:56:18.1 YC: So it's really not hard to imagine when I... Particularly when I mention that it came from Rick Doblin's brain, that world existing. So if you're gonna go through a difficult vulnerable experience and go cry on someone's shoulder, it's gonna be that best friend, brother, sister, cousin, whatever the hell it is. So why not, in the context that we're talking about. So I see that world, I see the world that you're describing with innovative models sort of where people are tapping into self-care on their own, but the reality is that on a base of seven billion on the planet, and whatever percentage of those that are gonna want these experiences to improve their quality of life, the vast majority are not gonna fit into that category. That's what we talked about before. It's really easy for people like us to carry businesses for people like us.
0:57:12.1 YC: It's way harder to do it for the other 80%. I'm open to it all, I think that in terms of treating people, we don't... Novamind does not operate from position of scarcity. Rick as well has said, and yeah, he's definitely a Godfather in that way to the industry, because people should listen to what he says. He's been at it a very long time, and he's incredibly thoughtful about it. So he has described, it in explicit terms, that if psychedelic medicine is going to come back into our world and exist in a regulated way, it's gonna require thousands and thousands of clinics and an army of trained therapists. So that's why I say we don't deal from position of scarcity, and I don't need to respond to your question by saying, "We're right, and they're wrong."
0:58:05.2 YC: We've invested in some of our peers, I mentioned that at the top. I have a lot of respect for a lot of the people building things in this space, and I'd like to see many of them succeed in so far as they're providing a certain access to certain groups and pushing the world forward. I happen to believe it with our model and with the start that we had, because we're not creating this model from zero, we're building on what Reid Robison built for the last five years, particularly with the Cedar Clinics, that we'll be one of the... I like to say, that we'll be one of the top five players in the clinic space. So it's a world worth thousands and thousands... First of all, the regulated policy environment exist, and the rules are established, and the parameters have helped people interact with these drugs and the practitioners, the experience, once all that is understood, there's no reason why we shouldn't be a leader in those thousands and thousands of clinics. Many of them should be ours.
0:59:02.0 PA: Yeah, and it's really about the both end, it is this sort of blue ocean. There's so much opportunity and possibility, and what you're speaking to is a collaborative approach, which is why you've invested in Field Trip and Synthesis in a tie, why you have Cedar, and why you're creating the standard of care that you're creating, because I think to hold that bar, especially as an influential, early player in the space, which Novamind is, to hold that bar of the standard of quality of care that's required I think is essential to ensuring that this movement is as successful as people hope that it will be.
0:59:34.0 YC: Yeah, it's a big responsibility, in fact. If we screw it up, it's not gonna be good for us, it's not gonna be good for the sector. So we've asked for the responsibility. We've gone public now, we've been publicly traded now for few weeks, three weeks. And we were really under the radar for the most part. You were aware of us, you're familiar with some of the investments we made, etcetera, etcetera, but for the most part, in terms of raising capital and those things, it's all our own networks and me and my partners have been building businesses with this model for a long time, so we're kinda having our coming out party now, and we wanna talk. I wanna have as many of these conversations as possible for exactly the reasons that what we've covered, where it's... The operating models for psychedelic medicine are not well understood and are not clear. We have one today that's working. We wanna put it out there. We wanna make sure people understand it. It'll change, it'll evolve, but that's kind of the point.
1:00:31.7 PA: Well, great. Well, thanks so much for coming on and sharing everything about Novamind. It was... We met about a year ago now, and so I've been aware and plugged in, but it's so cool to experience and just hear more about how it's developing and how the vision is developing, and everything. So I just appreciate you coming on The Third Wave's podcast and sharing more about this. It's really, really appreciated.
1:00:53.8 YC: This was a good time. Thanks for having me, Paul. Thank you, everybody.
1:00:57.3 PA: Thanks everyone. Bye, Yaron.
1:01:00.3 YC: Take care.
1:01:00.4 PA: See you.