New molecules, new IP, new opportunities. How can investors be induced to support the massive, but necessary funds required to support the important and carefully regulated research necessary to bring psychedelic therapies to market. Not to be crass, but if something isn’t going to bring a profit, it’s unlikely to receive much funding, regardless of how much good it might do, certainly not enough to cover the massive costs of bringing a disruptive therapy to market. Companies like Cybin and Bright Minds Bio are looking at modifications to create new IP, improved efficacy, and new delivery mechanisms.
With investment validations now taken care of, we need to address issues around delivery of care. Are we prepared to shift to a model of care that moves from weekly one-hour sessions to intensive, multi-hour sessions that require new paradigms that have never been tried? Before you answer, let us ask you another question: with between 11 and 20 out of every 100 US Veterans suffering from PTSD, how can we afford not to try?
Clara Burtenshaw, co-founder of Neo Kuma Ventures created the first European Fund dedicated to psychedelics shared with us her motivations, both professional and personal, for focusing on this space. We visited with Wavepaths CEO Mendel Kaelen about their founding principles and objectives; we explore Kernel’s entre into the psychedelic research space, and we revisit Doug Drysdale, CEO of Cybin. These are the folks to watch for the future of psychedelic medicines and the healthcare revolution that is coming your way.
It has been our pleasure to bring to you this series – this passion project to understand and share the opportunities, challenges, history, and future of psychedelic medicine.
Arun and JoJo
This series is only possible because of the generosity of spirit, time, resources, and dreams of our guests and contributors. A special thanks to Sharena Rice for her excellent research. Romeo Racz for technical support. The unsung hero of this podcast is our sound engineer, Mr. Swaminathan ThiruGnanaSambandam, who performed the mixing and mastering of audio.
psychedelic, patient, experience, therapy, psychotherapy, music, psychedelic therapy, molecules, drug, clara, fact, therapeutic, mendel, investor, treatment, therapists, mdma, space, ptsd, mental health
JoJo, Mendel Kaelen, Doug Drysdale, Arun Sridhar, Clara Burtenshaw
In the last episode, we took you through a snapshot of what drug discovery looks like in the field of psychedelics. It is key to remember that just because there are existing agents that are naturally available or show current clinical benefit, it should not deter the scientists from creating your molecules. In fact, let’s take an example of MDMA. Alexander Shulgin is hailed as a great chemist by many in the psychedelic area because he synthesised MDMA. While mescaline was the inspiration for MDMA, that inspiration did not make MDMA any less of a molecule. In fact, his reimagining of the synthesis of MDMA in the 1960s is what triggered the exploration of the chemical in couples therapy, where we have an issue, and the issue that the regulator’s care about is that whenever new molecules or synthesise careful clinical studies must be done to inform safety and efficacy before being applied in clinical practice. The privilege that traditional mushrooms or psilocybin or DMT have will not be true of every molecule that follows. In fact, even modifying the sidechain and adding a different element to create a different molecule or a heavier molecule, like what Cybin is doing with deuterated tryptamine is an example of that carefully regulated clinical development. With all of that in mind. Let’s now figure out how investment works in this area. And more importantly, what is still left with this objective patient reported endpoints in psychology and neuro psychiatry. It’s time to see how the latest technological advances are aiding existing psychotherapy practices and seek to help clinical outcomes. We have examples to explore with you. This is PsychedeRx, a SKRAPS original podcast exploring the therapeutic use of psychedelics, an enthralling story of an improbable drug class, banished into exile, yet comes back soaring like a phoenix from the ashes to save mankind’s affliction with mental health disorders.
Arun Sridhar 02:40
Before we go any further, it is useful to go back to the definition of psychedelic that we’ve built at the beginning of this journey in Episode One. Having listened to every episode so far, we want you to judge if we have answered these questions, and delivered on the framework that we set for ourselves. In Episode One, we reframed the definition of psychedelic to the following. Psychedelics refers to a group of natural plant based or synthesised substances that at any given those as known for other Medicinal Products, modifying basic neurological functions to enhance the user sense of perception. I’m sure we are not going to argue about the origins of psychedelics now. through examples in history and pharmacology, we have provided you with examples of how those of compounds can impact the experience is this very property that has been tweaked with newer molecules? Just because ketamine was an approved intravenous anaesthetic. It did not stop Johnson and Johnson to make an inhaled version of ketamine for psychedelic use. This inhaled ketamine or sublingual ketamine, as some of the newer versions are, leads to a faster absorption. So those and deliveries everything as it governs the outcome. In a recreational setting, one must know the source your routine, and safety information before using while people may use it without such information. It is a game of blind trust and imagination that is applied. But when we move from recreational use, as it was done in the counterculture period, to a more regulated development and clinical application, care must be taken, and documentation of every effect of a given dose and response must be studied. This is exactly what companies like Cybin are doing with their modified tryptamines or in the case of bright minds bio, where selective molecules or ligands for serotonin receptors are being studied. Now let’s explore the next section of the definition. We said that psychedelic molecules at any given those can modify basic neural logical function to enhance the user sense of perception. Have you provided evidence to this?
Are you sure? We think we have. We have shown through evidence and literature and an experience starting from Episode Five onwards, that psychedelic molecules do not produce hallucinations, and the term hallucination is a misnomer. In fact, they alter the basic physiology of the brain to the extent that enhanced connectivity on the brain’s cortical surface enables these visions and sensory changes. But one still cannot entirely identify or understand how a fundamental reset of the thinking of any given person happens. But we see evidence of this in studies with MDMA for PTSD and alcohol addiction, and with silicided for major depressive disorder. And we also added to the definition by stating that for a typical psychedelic molecule psychotherapy and follow up is the as integral to its use as the drug itself. The drug provides a shortcut to the psychologist to unlock the patient’s mind, to work with the patient to rebuild it back up during the integration session. So in a way, modifying the basic neurological functions during the drug therapy and beyond, is what aids the integration sessions with a psychologist. We have now determined that the delivery of its psychedelic drug through a healthcare system needs regulated availability, safety demonstrated via clinical trials, a healthcare system that will be adept at handling both drug and psychotherapy. The latter is fundamentally different to how the healthcare system currently operates. Therein lies the challenge. Clinical Trials centres show that they can do it well. But the question is, can it be scaled up? And what’s in it for investors and healthcare providers? Why should someone invest and what benefit does it provide?
Arun Sridhar 07:02
We would be preaching to the choir if we mentioned the following figure, it is crucial to understand that the global burden of mental health disorders by the year 2013 will be an estimated $6 trillion. This was published in an editorial in Lancet, a reputed scientific journal, CDC or Centre for disease control estimates that approximately 40% of adult population in the US has some form of mental health disorder, or substance abuse. While such numbers are not entirely available for UK in Europe, it did motivate an investor in this space to leave her legal career and pursue a career in venture capital. If you have listened to our credit for the show, you would have heard that we owe a deep sense of gratitude to Clara Burtenshaw, a partner and co founder of Neo Kuma ventures. Clara’s Neo Kuma ventures was the first European fund dedicated to psychedelics. Clara was studying law at Oxford, when she saw the incredible work performed by the Beckley foundation and Amanda fielding in funding clinical trials using philanthropic money. Although we did not get into the details of how Clara heard and experienced the manner in which Beckley foundation started this word, it is highly likely that it was through case studies and cross fertilisation of ideas that occurs in a fertile intellectual institution where cross pollination between science, business and law schools are common. Here is Clara.
Clara Burtenshaw 08:41
So in terms of what drew me to the psychedelic space, I came across psychedelics 15 years ago Oxford University, where I first heard about the Beckley Foundation, which was a not for profit that was led by Amanda fielding and was really sponsoring the early clinical trials and gathering together the scientists to clinicians, and also sponsoring next wave of psychedelic scientists through universities like Imperial. And I really started reading into it and I found the science, the effect on the human brain fascinating. So always, since then, have been reading the clinical trial results, the reports and tracking the space ever since and really saw that over the last four years, the space was gathering momentum, especially commercially. And the applications that that could be used for mental health was fascinating and what for me has always been so curious about mental health is that despite massive medical advancements that we’ve seen, improving revolutionising other areas of healthcare, the approach to Mental Health has been one that suffered from stagnation and really a status quo. That means we’re using the same ineffective tried and trusted formulas that that haven’t worked for many years. And the only change we’re really seeing is that the patient population is growing. And I think part of that is because the treatments are mainly focused on masking the symptoms of the disease, rather than actually targeting the underlying causes or modifying the disease itself. And what was really fascinating to me from psychedelics angle was actually here was the possibility for treatments that could tackle, you know, the underlying root causes. And so that could really open up a complete overhauling of our approach to mental health. And what’s really exciting about additional work that we’re seeing coming out of psychedelics is that, with some of the next generation psychedelics, we can see treatments being applied to indications outside of mental health, across a wide range of different areas, from inflammation and pain management to outsiders and stroke, obsessive compulsive disorders, eating disorders, treatment for addiction, and really anything that that his heart is attached to a central nervous system, illness can be treated with them. So in terms of the psychedelic space, I think we’re really at this crossroads now, where we’re seeing science, we’re seeing the clinical knowledge, digital results. And we’re at a turning point now where the investment is gathering a pace, and people are really talking about it. And it’s a mainstream point of conversation now. And I think you can’t really even pick up a newspaper without seeing something on the topic these days. So it’s really been a sort of gradual transition into this space from having worked at, in quite a cutthroat industry to wanting to move into something more mission driven, that I think is present and we’re seeing in everyday life.
And if you know it’s it’s SKRAPS, we’re always keen to go behind this iron curtain that many scientists and executives provide as a template answer. Sure, Claire was interested in the space having been exposed to it and tracking the potential and emerging data. But there had to be a deeper personal connection that made her quit her legal career and pursue venture capital as an investor and raise her own fund. I’m sure her investors in the fund cared about her personal journey, too. Let’s go behind the veil, shall we? Here is Clara again,
Arun Sridhar 12:38
I think part of it is growing up as a millennial actually, where lot of people in my network have gone through some sort of mental health struggle. And so I therefore been exposed to sort of the route and the treatment that you would take in the UK or through the NHS. And, you know, I really believe that at its heart, you know, most depressive symptoms should be treated through some type of talking therapy. And what I would say surprise was that young people, were being just given this sort of patchwork of different tablets and pills that had quite horrendous side effects. And part of the problem is, is one of economics, which is that talking therapies are incredibly expensive. And you don’t know how long someone will need to to go through that process in order to get better. Whereas it’s so much easier to just give someone a tablet, you know, every day for the rest of their lives and hope that they get back to sort of just being a functioning adult. So I felt very much this desire to try to address that imbalance. And so when I decided that I wanted to work on something that was more mission driven, and actually would put the standard the patient here, first and foremost, to move it forwards. To me, psychedelics and healthcare really had a mixture of cutting edge science.
So for all the listeners, if you’re slightly older, being a millennial is not that bad. In fact, aroon despite looking a few years older than he is, is technically a millennial mission matters to the millennials more than a paycheck. So we asked Clara how she went about raising the fund for Nia Kuma ventures with her partner, Sean McClintock. Both Clara and Sean had a mixture of UK and US educations. And it was natural to understand and explain the perspective to their investors into the fund.
Arun Sridhar 14:48
Interesting, sort of, from the perspective of how it might be applied to these very, very fast changing kind of economic times we find ourselves in; and also I would say that For us both in terms of investor pool and investing, a lot has been happening sort of during the COVID pandemic. And I think COVID has, for many reasons also shone a spotlight on mental health. And, and really kind of his, his driven this agenda forwards. And so, for me, the tipping point was, you know, this is a problem that’s hard to ignore. And what I liked about it was that it’s not just sort of the mental health crisis, but it’s also overlapping with his interest in resurgence of psychedelic, so the two have now completely sort of merged together. And I think if you’re looking at it as a problem that needs to be solved, the US is always a really good example, because there’s just so much data in the space. And you know, in the US, they pay out almost $6 billion in disability payments to PTSD sufferers, many of whom are veterans of either Iraq or Afghan wars. Majority of those people don’t work. They don’t contribute to society. They’re severely traumatised. And their only form of treatment really, you know, a disability payments and the medications, they roll much paper over the cracks. And I really see that as being some of the approach that we take in the UK as well. And if you compare that problem and look at the way that the US government and military has been supporting MDMA and MDMA research is, it’s been really quite phenomenal. I mean, there have been talks of MDMA for going phase three trials or for phase three trials and coming in with the US Department of Defence for a quicker rollout to PTSD sufferers. And they’ve treated over 100,000 veterans so far, but in the UK, there have been over 30,000 veterans treated with some form of psychedelic medication for PTSD. And in the UK, there are a piece who are lobbying for change for regulatory change. And it’s because people who have been through some form of psychedelic assisted therapy, living embodiments of the fact that this therapy does work. And there are so many people who have had positive life changing experiences. That is, it’s really impossible to ignore. And, you know, I mean, I’ve just touched from the PTSD landscape, but then you’ve got the overlap of all the other mental health issues like depression and anxiety. So for me, the market is massive, and the market is there. And, you know, I feel that I’m in a position where we have a network of interested investors who really want to make a difference. And people are much more discerning about the way they invest these days. You know, they don’t, it’s not just about making a quick buck people want to do well, would you good with that capital. And there are so many exciting companies that are now looking at this space. That, you know, for me, it’s this is really interesting mix of pairing a fantastic idea or piece of science, or research, with capital and knowing who wants to invest where, and being able to really link those, those together. Which is really not so different, I suppose, to what I was sort of doing in private equity, which was, you know, have a great brand or great team. And it was about matching them with the right capital to, to drive the business forwards. And so I really enjoy that aspect of it. But I think it’s really hard to be a value investor in the space, and really not sink your teeth into the science because on the drug development side, that’s so important. And it’s really the thing that gives your fund the edge in this space is having a team of quality scientists who can rigorously DD the drug development angle, and sort the wheat from the chaff in terms of the quality companies out there. So, you know, I think these days if you if you want to be an investor or ahead of the game, you have to spend the time reading the scientific journals, the papers and speaking to the scientists. Because if you’re an investor, just flipping through a DAC, you’re never going to have the ability to sort of cut through a lot of the BS, which is out there in the industry,
As explored in episodes five, six and seven. We know that patients with mental health disorders are given pharmaceutical agents as first choice therapy before talk therapy is provided. Keith Abraham, one of our veteran contributors who suffered from PTSD, told us what the patient journey is like, and how difficult it can be to approach and open up To talk therapy, Jesse Gould, on the other hand, mentioned that talk therapy is incredibly expensive in the US. So affordability is a major factor. Clara, as an investor in this space wants to enable scientists and clinicians to develop the data in a manner such that talk therapy can be afforded as a first line of therapy. That is the North Star for mission driven investors like Clara. Let’s see what she has to say.
Arun Sridhar 20:27
Yeah, that’s absolutely right. It’s it’s a case of I think, if you speak to most doctors, they would say the, what they’d like to prescribe as a talking therapy. However, budgets and protocols would suggest that they try something else first. Or that the talking therapy is kept to whatever number of hours can be afforded. And the problem with that is, you know, depending on the level of trauma or the patient’s experience, you just, you don’t know how many sessions will be required for a patient to get a breakthrough. But what we do know is that once you include a psychedelic is part of that experience, people tend to have that breakthrough moment a lot earlier. And that’s because of the way the psychedelic experience works, how it resets sort of the pathways, the mind, and how it opens people up to therapy in a way that might take many hours of sessions to get that patient comfortable, to relive traumatic or painful experiences. And so we know that we’ve seen the evidence for it. And I think, you know, if you get to a point where we can get, you know, legislators comfortable with allowing certain psychedelic to be administered in this way under very controlled circumstances, so only qualified clinicians, therapists in a clinical setting, with a number of safeguards in place and protocols, I can’t see why you couldn’t have a talking therapy, you know, is the starting point for patients who are comfortable with it, as opposed to, you know, really putting people on a lifelong programme of SSRIs. So you can see how Clara and previously Jenny Mitchell who ran the pivotal trials for MDMA, in PTSD, are talking about. They’re talking about careful, regulated clinical practice, with the highest safeguards in place, in contrast to the period in the 1960s, where everyone and anyone could have access to a psychedelic and many psychologists In fact, took it with their patients like Timothy Leary, or providing a psychedelic experience to anyone who asked for like Humphry Osmond, providing it to Aldous Huxley, normal free candy. The approach that these individuals are advocating for is need based availability with regulations. I’m sure many of you would agree to this approach. In fact, we at scrubs think that it is the best way. This can extend to other non psychedelic substances too. If you need more information on that, listen to the two episodes in our collection. One of them is a Twitter spaces recording with Julia Buxton on the 50th anniversary of war on drugs, and the second with an undercover cop, Neil woods. But let’s come back to psychedelics now. Let’s get back to Clara. The traditional investors into venture capital have been private equity, hedge funds, or very high net worth investors. Typically, these organisations and individuals rely on fixed income returns for the customers so tend to gravitate towards pharmaceutical and biotech stocks in life sciences. Some might even gravitate towards real estate, but psychedelic investments are different. Does it require a different mindset? Even from an investment point of view? Here is Clara Burtenshaw again. Well, I think it’s very much looking at the landscape I just painted with, you know, the numbers involved. So looking at the market, you know, for PTSD sufferers in the US, you know, the really the scale of the problem, in fact,
Clara’s right! It!’s estimated that cost effectiveness of MDMA psychotherapy will be $103,000 for every PTSD suffer. So you can imagine the cost savings that psychedelic assisted psychotherapy can provide.
Arun Sridhar 24:43
And also, I think, investors have seen the cannabis market flourish. And so you know, a lot of our investors either come from a pool of people who have who have done well out of investing in front of Investments so cryptocurrencies, Cannabis, etc. Or they’re part of the baby boom generation who arguably never had it so good. And the app still faced existential crises once they made all their money and no obtained everything they ever wanted. And then we’ve got people who are, you know, just very wealthy entrepreneurs, you’ve had exits, you now want to give back in some way. And so those, those people already won over by the idea of psychedelics. And so one doesn’t have to put forward to the same sort of arguments, because they’re already coming to this from an interested place and want to invest when you’re speaking to people who come from a place of not really knowing that much, and having just heard about it, and they’re trying to explain why this would be a good place for them to put their money. I think it’s about really catchy in terms of this is going to be potentially revolutionary. This is the size of the market. And comparing it to cannabis where people did do very well, but also highlighting some of the differences. And also looking at where, you know, big corporate is like Johnson and Johnson and moving. So to sort of touch on these points, I think the regulatory support we’re seeing here is quite unlike cannabis. So with cannabis, you saw the commercial industry really charging ahead. And then you know, the regulator’s still trying desperately to keep up, you still have a number of problems with it, you can’t bank normally, there are all these things that make the cannabis model quite inefficient, which really don’t exist to psychedelics, because it’s essentially a clinical and medical play with a pretty clear pathway through clinical trials, clear value inflection points, and you know, pretty clear understandings of valuation, also the cost of each stage are so different playback entirely from cannabis, you can then look at the sort of support that the FDA has granted. So having granted breakthrough status to psilocybin, ketamine and MDMA, which fast tracks clinical trials in the admin and paperwork side, and also recognition by the FDA that these drugs massive therapeutic potential, because not many drugs are granted breakthrough status, and there haven’t been many grants over the past decade. And then, you know, there has been this huge boost to the industry. And as soon as that’s happened, we’ve seen this commercial race to keep up. And unlike cannabis, the big corporates being the first movers here, like Johnson and Johnson provato, which is an assessment based nasal spray, they’ve done very well. And there’s good track record on what that drug can deliver from a revenue perspective once it’s rolled out. Because if you look at the market, you know, they made about $140 million from their first year of sale. And then they’re hoping to get 300 to 350 this year. So there really is a market for this. It’s really exciting. And we’re not seeing same sort of management teams and cowboys that we saw in in cannabis, which did make those sorts of investments a bit risky. We’ve seen a little bit of that here. And that’s why BDD is so important. But generally, the standard of people and standard academia and spaces have an exceptionally high calibre. And so you know, what we see here is the start of a big industry, which will definitely move the standard of patient care FORWARD so that EVERYTHING progress is on track and the opportunity to be part of that narrative, and, and to invest in the brightest and best companies that will be rolling this out.
Let’s face it, ketamine is not even a psychedelic in the true sense of the word. It’s a dissociative anaesthetic, that at higher doses than the ones that induce the anaesthesia, provide an out of body experience. In fact, in some centres, psychotherapy is not provided with ketamine therapy at all. And studies have shown that symptoms return within 12 months and require repeated therapy. The question that we have at scraps, and also one that you as a listener must ask is, how is this long term follow up track? So one of the key items that an investor like Claire looks for is how does one de risk investments in this space? How does one identify and invest in the right teams?
Arun Sridhar 29:44
And normally, investor concerns are how do you do risk this, how do you make sure that you’re backing the right companies and again, I think it really comes down to if you’ve got a team of scientists and you’re able to break down, you know, the patents that have been applied. For and get on the scientists to scientists call with the teams, it can really break down whether you know you’re investing in a quality outfit or not. And, and what’s so exciting then is that now you’ve got these very, very clear value inflection points as the company moves from one phase to another, or publishes results. And then, you know, I think the other point that is really, really hard to ignore is that you’re getting some of, you know, the biggest names from Silicon Valley coming on board. Peter Thiel is basically bad at AI. And these people understand, you know, and contribute to the rollout of new technologies. And so I think if you look at the backing, and you look at the, the the, or hopefully be a matching of the regulatory development alongside the capital going into the industry, and the breakthrough status has been given, it couldn’t be a more exciting time, we close the last episode by identifying three areas that is fundamentally different for psychedelics. First, new drug discovery for a market that does not need or one chronic administration. This includes ways of administration as well, to ensure efficacy and reduced adverse effects. And of course, improve tolerability as a result. The second is the clinics, who administer the therapy, how and which patient groups get access to the therapy, because the manner in which these therapies will be administered will be different than popping a pill a day. And third, is tracking the efficacy, digital therapeutics and other technological enhancements that aid psychotherapy. Here is Clara again, providing us with examples of each area through her investments.
Yeah, absolutely. And we’re investing across three different pillars. So the first is drug development, which we’ve spoken about that is more akin to life sciences, and biotech. The second bucket is across clinicals, and clinics. And then the third bucket is the platform side. So digital therapeutics and the picks and tools of the industry. So you tend to see this, we first you know, expected the first wave of activity to be on the drug development side. So companies looking at the creation of these drugs, and how they’re going to get them into patients, then you would see the next stage being clinics popping up as part of a distribution model, you know, once the drug is developed, this is how we’re going to distribute this across the market, get patients into these controlled settings, and make sure that they’re going through the right sort of before and after care programmes for things to be administered safely. And then with the platforms and the picks and tools. What’s really interesting here is that there is going to be a huge amount of value coming out of data aggregators in the space. So platforms working with clinicians or with patients, tracking the progress, how well their treatments are going any side effects, how are they feeling, perhaps incorporating digital biomarkers as part of that, or part of you know, the setting setting approach. So you know, the way in which you go into your treatment, and the way in which is administered has a huge bearing on what that psychedelic experience might look and feel like. And so some really, really interesting people looking at the way that technology can interplay with this. So for example, mental kylene is looking through wavepaths, how music can play a role in a psychedelic assisted therapy and is looking at clinics to work with on that. And then we’re seeing really interesting platforms that are looking to assess the pain points and what that industry might look like and create solutions. So once a particular platform that we’re looking at is looking at connecting patients and clinicians, almost like a quality sort of control management piece. So a patient who wants to try, for example, a cattlemen assisted therapy would want to look at who could provide that sort of treatment within that area. And, you know, perhaps look at reviews of that, of that therapists get to know them before they embark on this journey with them. And then those therapists themselves who often have trouble actually getting the prescriptions required. And so if there could be an interface that both connects the patient with the clinician And then the condition with the prescription required is their way of doing this in a transparent way, putting quality control and patient care at the forefront. And so, you know, I think you’ll see that it’s not just about the drug development and the clinic side, but the entire industry that grows up around this just standardise and improve patient care. And so, for us now, our first port of call was looking at what are the early interesting drug developers in the space. And so we started off with investments into different drug developers, we went into multiple rounds of anti Life Sciences. We invested in Beckley cytec, which is the drug development arm of Berkeley. Another company, we’re really excited about Bright Minds bio sciences, which I won’t go into much more detail but firmly that used to be akin to them, but who have developed a pipeline of seven drugs, and each drug is going to treat an indication that could be worth is a billion dollar market. And they’re working with, you know, one of the only actually granted patents in the space, the smaller UK company looking at DMT, called small farmer. And then we have another company or simple bridge in the UK called eleusis. And each of these companies is taking a slightly different approach here with ATI and Becky looking at first, second or third generation psychedelic developments. And then we’ve got Bright Minds looking at next generation with, you know, some of the most well known veteran drug contests developing programmes across 5HT2A and 5HT2c and a combination of both of those. Another is small pharma, reformulating DMT, for mental health and analysis, looking at mental health, anti inflammation, and also they’ve taken a large lips are wellness clinics in the US.
And in terms of the way in which one can develop drugs and administer them in clinical practice. It is clear through multiple conversations that we’ve had in our research, and also something that Jenny Mitchell alluded to in Episode Seven. The time commitment to a psychedelic assisted psychotherapy, session be it in clinical research, or in clinical practice is long compared to the traditional 45 minute psychotherapy counselling sessions. We asked Clara, how does this factor into the equation? And how comfortable is she as an investor? And finally, what is the opportunity for innovation?
So, okay, so I think I think there are two points here. I mean, the first is, we’ve really only engaged and spoken to conditions that are focused on psychedelic assisted therapies. And so they’re not, in general therapists who you then want to sort of turn their hands to a psychedelic assisted therapy. That’s not to say that therapists won’t stop doing that when this becomes more mainstream. And actually, there are lots of platforms out there who are looking to address that. So through proper training models, training programmes, and also, you know, linking individual therapists to a model where, you know, they’re supported by CRM, they’re supported with, like the latest know how, and supported from, you know, sort of a total integration, perspective, and technology. But if you, you know, I think part of what we’re seeing a lot of the drug development companies doing is controlling that period of time. So, you know, it doesn’t make sense for someone to go on a six to eight hour psychedelic trip off of psilocybin, because you know, that these sessions need to be focused, and couldn’t be more than one to two hours at a time. So half of the challenge is creating synthesised forms of these drugs that can be taken safely, where you can control the amount of time that a patient is suspended in a psychedelic space. And, and that’s part of the challenge. And that’s what a lot of companies, you know, taking for their solution. So, yeah, you wouldn’t be looking at your regular one hour therapy session here, you would be looking at sessions where you may have two or three sessions involving a psychedelic and for every session involving a psychedelic, he then have a couple of hours of spread out therapy to unpick what was learned during those psychedelic trips. And so you can see from that, that you might have a combination of you know, the two two and a half hours psychedelic trip, and then a follow up session of an hour, another follow up session of an hour and a further follow up session where the therapist unpicks everything that came from that psychedelic trip. And with each psychedelic trip, you know, it’s an incredibly powerful experience, people who go and say that it’s often, you know, one of the most overwhelming and beneficial sort of turning points in their life, you know, it’s not something that can be delivered in rapid succession over like a couple of weeks, you need to have the correct sort of before and after care. People need to be sort of handheld as they try to make sense of this experience for themselves immediately afterwards, they need to be integrated back into in a normal routine afterwards. And the idea is that, you know, you would then follow up later go through the material that came from that work through the patient. So not each session would be like, so long as to be difficult to deliver, it would be tailored. And I think that’s also where digital therapeutics and the platforms really have a role to play. It’s about tailoring a particular experience or the treatment, according to that patient’s needs. And so there, I think we’ll see a lot of flats and slightly different approaches, depending on the clinic or the condition and that preference, as well, and how they deliver the therapy because each therapist has a slightly different approach has developed their own set of protocols or how they administer the treatment, according to what they find has worked well with their patients or how they want to deliver the treatment. So I think, you know, it’s not really a one size fits all approach here. It’s incredibly varied. And, you know, the idea is that it will be patient focus and patient LED.
So in terms of thinking through what Clara has just said, and also going back to Jenny Mitchell’s interview, it’s clear that psychedelic assisted psychotherapy is kind of keeping up with the 21st century model of personalised medicine, where you’re tailoring the therapy to suit the needs of each individual.
Yeah, I mean, there are, what we’re seeing in the main, are either platforms that are part of the experience, to improve that side of the assisted therapy. So whether it’s providing personalised music based on biomarkers and how that patients feeling, or connecting people with the right type of condition, connecting conditions with a model where they can get the prescriptions required. And we’re also seeing a lot of apps really the track the patient’s experience, or people who are dabbling in this recreationally or as microdosing. so that people know much in the same way that you’ve got, for example, apps for women’s menstrual cycles, like flow, where people can keep a track of their own experiences and how they’re feeling and really monitor their progress. The same sort of thing being applied to people with psychedelics. And then there’s a whole host of platforms out there that are designed to make the condition and therapists life easier through standardised training, connecting individuals in the network, creating CRM systems to help with patient care, monitoring, and, and, you know, continuous training. So I think there are there are lots of different platforms being devised in the space. And I think the challenge is going to be often that, you know, the early mover does a lot of hard work, and then a competitor comes in as the incumbent has improved, through the first movers experiences, but the generally, I mean, I, I think we’re seeing this across the board in terms of data, in terms of digital therapeutics, and, you know, the way that healthcare is generally moving, which has to be more holistic, individualised, and focus to that person’s needs. And I think a lot of that has also and the attitudes towards that have been accelerated through the experience of COVID. And people being treated, you know, in a different way. We’ve certainly seen in the UK, for example, that through the pandemic, people have not had to make or not being able to make face to face appointments with their GPS, a lot has been done remotely. And I think that has really sort of changed the way people are looking at how treatment can be delivered. And so what you will see is people taking healthcare sort of more into their own hands and people trying to devise solutions so that that can be done safely. And healthcare services being sort of put under more scrutiny as to how they choose to spend their budgets and how they get patients to the right health care. And so we’re definitely seeing sound shifting in this generally. And what’s interesting with psychedelics is that whilst you know This has not been something that has been part of mainstream healthcare. Despite, you know, all of the taboo and the negative press from the 50s 60s and 70s, people have still been doing this underground. And people are still operating underground with therapies. And what we’re seeing now is, is just that this now is being looked at so much as part of mainstream, and press, and people publishing books like Michael Pollan. we’re now seeing the demand for these different types of treatment actually coming from the patient population. And so when the patient approaches their GP, and demands, to have a psychedelic assisted therapy, because that’s the type of therapy that they’ve read about, they want to take, the GP actually, in the UK already has some discretion to prescribe this. And they can do and they and they do when they do, then you may go down the private route, that it can be prescribed by the GP. And so I think, as people become better educated about the results and how this works, I think it will be it’ll be sort of a revolution that’s led by the patient suffering, and an education around this area. So I think is a really, really interesting crossroads. And when you look at how this has paid for, you’ll see that, you know, it may be the case that the insurers don’t want to insure the psychedelic assisted therapy part, but actually, they start insuring all the ancillary aspects of the treatment.
Okay. twice during the conversation, Clara alluded to digital therapeutics, and provided many examples. And one example that struck us was an example that Claire provided, it was of a company called wavepaths. And one must say it’s a truly digital therapeutic. While most of the companies and digital therapeutics are apps or software platforms that collect data from the user wavepaths is and we repeat, a true digital therapeutic. Confused? Well, we’re here to rectify that and provide the evidence.
Arun Sridhar 47:14
We connected with Mendel Kaelen, the CEO of vape paths. And before we go any further, we want to provide you a scientific nugget. After all, we are a science podcast, so it should come as no surprise to you. One of the PhD students at Imperial College published a paper with two of his mentors, Robin Carhart-Harris and Professor David Nutt in the journal Psychopharmacology. This 2018 paper explored an interesting argument for set and setting. We know from traditional ceremonies and dating back to the books written by Mike Jay, that singing, dancing and drums in the Mesoamerican cultures were a big part of the experience. Then when mescaline came to be widely used, subjective experience could be modified depending on the type of music that was used. It’s a different matter to the music that was created under the influence of psychedelics, but we will let you debate that in the bars, pubs, and if you avoid these drugs, over a cup of a stimulant coffee. This paper published in 2018 explored the relationship and the characteristics of the music played during psychotherapy sessions. And its correlation to subjective experiences. In fact, it is now common knowledge among psychedelic therapists that patients would ask for a specific album, or a type of mood music in a session. So in a subjective world, how does one systematise this, the author of this paper published in 2018, was Mendel killing himself when he was a PhD student at Imperial College London. After graduation, Mendel took his hypothesis further and founded Wavepaths. Let’s hear from Mendel.
What we are building we are we are actively translating our scientific insights all the time into a technology, which is in essence, a musical instrument for the new generation of care providers, that allows those care providers to have access to and work with a fully flexible, dynamic musical environment to constantly provide the best ideal supportive climate for patients undergoing these experiences and find very simple intuitive way to adapt music to the changing therapeutic needs of patients, and thereby increase the patient experience and the therapy outcomes as well as the therapist experience. Not to not to be overlooked either, because being a psychedelic therapist is quite a challenge in itself with many questions and unresolved questions in Self.
Instead of taking a clinical or neuroscience approach to psychedelics, we asked just how Mendel used a musical approach to research and now develop a product.
Mendel Kaelen 50:15
So my name is Mendel Kaelen originally from Holland, born and raised in the north, east of Netherlands, went to university and growing up a city in the north. I originally studied biology, marine biology more specifically, at some point I switched to neuroscience, really, because I got increasingly fascinated by consciousness and the many questions that are addressed or answered around the nature of consciousness. In that period, I got introduced to psychedelics. This was in 2004. And I read everything I could, I became increasingly interested in both the historical richness around this topic, the anthropological historical data around the use of psychedelic plants and mushrooms and cacti, and you name it all around the globe, and their therapeutic potential. And then I learned about organisations like maps and haftar in the Beckley Foundation, and others. And it became very clear that I wanted to contribute to this very young, emerging but very promising field in my opinion. Back then, university professors and colleagues were frowning whenever I even use the word psychedelic times of that that has changed very, very radically, especially the last few years. But yeah, long story short, I also experienced psychedelics myself, they really had a profound positive impact on how I view myself how I relate to myself, how I resolved various personal problems in my life, how we connect with others, how I connect with my vocation, in life, my creativity, in life, all these other things. I left in the Amazon jungle when I was 21. for a number of months experienced I was left with a particular one shaman for two and a half months, and eventually moved back to Holland that finished my bachelor degree finished my master degree. And at the same time, I always had a very strong connection also, with music and sound arts or sounds more generally speaking, I grew up in a very musical family. Always at that moment, it felt to me as if I needed to make a choice between pursuing scientific career to study psychedelic therapy, or pursue a creative career and make music or make sound art. Only when I was starting my PhD at Imperial College London, there was one moment where I realised that these two topics psychedelics and music are actually very closely related to each other. For strange reasons that didn’t dawn upon the earlier than that, but there was one moment where I realised how closely connected they actually are. And my supervisors, my PC supervisors, David Nutt, Robin, Carhart-Harris, they’re very supportive when I brought up various arguments of why I believe it was important to study the combination of music and psychedelics, and that became my main topic in my career, I studied and published various papers on brain mechanisms of music and psychedelic some combination of the subjective experience of music and the influence of psychedelics, the experience of music in psychedelic therapy by patients and various theories and hypotheses that flowed out of that, on how music can actually be, how the therapeutic potential of music can and likely should be leveraged, more thoughtful, more empirically. And that was, for me also the reason to start Wavepaths. I did a PhD stayed on as a postdoc even for a while at Imperial but at some point I, I realised that in order to really acknowledge and listen into this growing fascination and interest, of music of psychedelics, and more broadly speaking, the therapeutic significance of our state of consciousness and the various means in which we can access these and facilitate these, I really realised that in order to pursue a deeper, I need and wants to build my own organisation that is concerned with nothing less than more than deepening our understanding of the role of music in psychedelic therapy, how music use can be leveraged to enhance therapy, outcomes of psychedelic therapy, and the therapeutic potential of music in itself and how we can leverage that in our wider society. And that has really been the core focus of waste pots since the beginning.
How does music affect the psychedelic experience? Are there any clues to how this happens? What did Mendel find out in his work at Imperial?
That’s a large question. But to kind of summarise absolutely very little, but this is where my research began. This is looking at not only brain activity, but also brain connectivity and information exchange within the brain, under the influence of psychedelic and comparing that with psychedelic plus music, more broadly speaking for conditions, no drug, no music, no drug use, drug, no music, rock music. So compare those four conditions allowed us to really look into how information that brain is processed differently, in wet and then how in this case, psychedelics, in music interact. And we see a number of things we see huge distribution of resources to process for example, various details in the music like tone colour, that happens in areas of the brain that are usually associated with language processing, like if your frontal gyrus, Broca’s area. And the degree to which that happens correlated also with intensified feelings of wandering all usually associated with peak experiences. Another study we looked at how music psychedelics interact on the vividness of one’s imagination. And we saw an increase in information flowing from the para hippocampus, which is a region region usually associated with personal memory formation, towards the visual cortex. And the degree to which that information flow was enhanced was predicted by the presence of use of psychedelics together. And, and also that that was modelled as a real and understood as a real synergy or action effect. It’s not one plus one is two, but one plus one is, let’s say 10. So that that study in particular, suggested that there was a real interaction effect between psychedelics and music, that interact to enhance information flowing from one region to another region more than much more than we can without the presence of music,
Ancient practices grounded in music can get a new artificial intelligence based product for psychotherapists, is that the inspiration? So how does music influence therapy? Here is Mendel again,
Music plays an integral role in ceremonies all around the world, when you look at traditional usage, of course, as examples where psychedelic medicines are not used, but music is in that those case a very central component to the religious medicinal ceremony. But wherever there is, psychedelic plants involved, music is also deeply involved. If you speak with the shamans, they often explain that the music is as important as the plant medicine itself and as sacred as the plant medicine itself. And that they really work in synergy, but each other. Now, we move forward in time through the Western world in the 50s, where many scientists and therapists were trying to get their head heads around this very new normal class of compounds and their relevance for science and therapy. They also realised that people can have a wide range of very different experiences with exactly the same drug. And they then realise that the set and setting play a very important role in determining what kind of experiences people have. And they also already ended, identified that the kinds of experiences that people have determined to a very large degree, the therapeutic outcome of the experience with one maximise the therapeutic success of the experience, there are certain qualities in the experience that are most likely to facilitate sustained improvements in mental health and wellbeing afterwards. And those qualities of experiences have to do with autobiographical experiences, insights in courses of various psychological problems within oneself. reconnection with various parts of one’s autobiography or events from the past and integrating them structure fee and sign up oneself or spiritual type experiences, mystical type experiences or some humanistic psychologists might say peak experiences, experience of bliss and wonder. Those experiences that if you look at all of them share have significant personal meaning, correlated positive therapy outcomes. Now we again move forward in time from 50 6070s into the psychedelic Renaissance that is happening right now. And this is also where my research begin, we are starting to validate some of these hypotheses more empirically. And then to add further insights in how these variables impact the experience how we can work with this with these therapeutically. So when it comes to seven setting, one of the elements that I focus on we focus on primarily is music. Why? Because if you look at how psychotherapy is currently performed, developed and implemented, that includes patients being carefully prepared for the session that happens in a therapeutic relationship, but then journey acute experience, music is almost the only stimulus patients are exposed to.
So how does music influence therapy, we actually know a few underground therapists who use music for meditation and have said to us, but some of their clients have cried with their music as a backdrop for the meditative experience.
So people undergoing psychedelic therapy are having this very powerful experience that is catalyst in an interaction between psychedelic medicine and in music through a very large degree. It’s not the only way we can work with the psychedelic medicines, but this is the way psychotherapy is currently designed to develop and implemented. So I’m doubling down on understanding the role of music, in psychotherapy, and also to your points to kind of link this maybe with some examples of patient experiences, at my work at Imperial, are worked on what was a clinical trial, studying synthesising the active ingredient in magic mushrooms in a therapeutic format for patients that suffered from severe depression. And what was very clear is that with one and the same song, one individual can have one of those experiences that are just described profoundly, personally meaningful experiences that are truly life changing. And the real meaning of that words, while another individual with exactly that same song, enter the state of confusion, anxiety, paranoia, dissociation, you name it, experience that if if they, if these experience would be more chronic and sustained, can be not only challenging, but traumatic, the stretch of the grade, that’s the the faculty, the symptoms are worsened. And the patients will leave this experience worse than how he or she entered the experience. So music can both make or break the experience. One might say, music can be both a source for healing, as it really can be a source for destruction, I really became confident that music has that power. Now, when we take that information, and and we look at what’s happening right now, in a world where so many clinical trials are being developed, and so many clinics are are getting formed to offer upcycling therapy to patients, which is fantastic because mental health care is in this has found itself in this dead end road. But over the last decades, and there’s this huge need for innovation, upcycling therapies, clearly offering a potential innovation when it comes to mental health care and a very profound potential. But when we look at what’s happening with all these clinical trials, all the clinics, one of the main challenges that those care providers are facing is that in essence, they are dealing with a care model that is radically different than any care model that people are trained to perform. cyclic therapy is not pharmacotherapy patient have given a drug and expected to be better as a result. It’s also not psychotherapy, how we used to think about psychotherapy. Although it has more, I would argue more commonalities with psychotherapy. But in reality, it’s really a mixture of many things. It has acute pharmacological effects on the brain, it has, for example, effects on neuroplasticity, it has definitely effects on moods that can be explained to a large degree with some of these pharmacological effects. But there’s also a very large component to the experience that’s, I would even dare to say quite ballsy can only be explained if we look at this from a different framework that is more concerned with psychotherapy or maybe even older, older traditions that try to understand the functioning of the mind. So that’s a challenge for all of these therapists. What are the right qualifications for therapists to do this work safely, ethically, efficiently? responsibly, and then we will look at the components of of the therapy music Seems to be one of those components that again can really make or break the experience. And then if you look into the way music, ideally is being offered, meaning in a highly person centred way adapted to the needs of the individual adapted to the changing needs of the same individual over the hours of the experience that is also quite complex. Right. So this new generation of care providers is basically
expected to both learn how to work with a new class of medicines, and really forced almost to change their usual paradigm and how to think about mental health and treating patients. And at the same time, there’s also this component of music, which is a whole complexity in itself. So this was also really the foundation for waifus recognising that, and also realising that there are in fact advances, both in the signs of psychedelic therapy, the science of human development, but also technological advances in immersive arts, computational creativity, biometrics that can all be unified to develop this highly intuitive, flexible instruments for care providers and care seekers, to really find ways to increase the likelihood of these therapeutic experience to occur and decrease the likelihood of these, these counter therapeutic experiences to occur.
Arun Sridhar 1:06:24
So it’s not just a matter of playing a musical album, that the patient knows of for water therapists things might help the patient. But understanding and studied music as an experience can help psychotherapy is Mendel’s point.
Right? It’s very different. And I think the way to maybe start unpacking This is by emphasising that one of the things we do is understanding how music can be personalised to the individual. So, what is the musical language right? One might say that this individual speaks, what are the instruments, competition, compositional qualities, acoustic qualities that this individual is connected to already? And then how can we utilise that language of connection to speak to the experience of the individual with music that is, that is implementing or integrating these these qualities, that’s one really ensuring that we build appropriate musical climates that is truly empathically resonating with the listener with a patient that is undergoing the experience. But then it comes when it comes to the changing dynamics of the experience within the acute experience. There can be various processes, various topics, various themes, various feeling states, various forth processes, various physical experience that patients undergo that that need attention that needs need a particular quality of attention when working in a psychedelic therapy framework. And that quality of attention is usually described as a degree of openness, a curiosity towards the unfolding experience, as it is, without wanting the experience to be different. And when when one approaches the unfolding inner experience with that openness and curiosity and attention, further layers of that experience can reveal itself. Further levels of understanding of oneself can reveal itself. Underneath the anxiety, there’s certain anger, underneath the anger, there’s a certain sadness, and the need those tears that are currently being released, there is a memory that was forgotten, or thoughts, that suddenly brings a lot of clarity around the relationship that has been invisible for way to volunteer, and all the feelings that are accompanying that experience. So there’s many ways to phrase these philosophies that are implemented in psychedelic therapy. But at the very at the very end, one might argue that at the very essence, what facilitators care providers are aiming for, is for the individual to become more will become more total, more integrative for whatever has happened in the past and less defensive, thus dissociated from various parts of oneself. And those defences those associations are they’re always for good reasons because they were traumatic or overwhelming or too painful. But in a safe therapeutic climate like of psychotherapy, it’s it’s an opportunity to become more more whole, more integrated. So to bring all this back to this question of how music ideally is used, and what we mean with person centred use of music is really utilising music to to shift the focus of the patient, their where to focus needs to be in order for those therapeutic experiences to be deepened, and to be resolved. And in our technology, we for that reason, literally offer any kind of subjective experience, one of my imagine that can be facilitated with music, and then the emotional intensity of the experience or at wish or on control, to find those sweet spots, so that so to say, for patients to work through those experiences. And that is partially on manually. But we’re also working on various biometric integrations to support that process further. But that will be kind of a high level summary of how the platform is currently developed. Some therapists refer to it as a thermostat, but a musical music stuff on that, say, or an auditory stat or whatever. But it’s the same use the same intuition of switching the temperature in a room or the light in a room quickly, easily intuitively, without the need to enter all sorts of complicated thinking and planning. That’s the same use that we offer in terms of changing the music to support these changing therapeutic needs for patients.
Arun Sridhar 1:11:17
So in contrast to a molecule that we would not recommend ingesting from the vial to the mouth, we would definitely recommend the following. If you go to the Wavepaths website, and create a login, the first thing that strikes is the tagline on the homepage experience as medicine. But when you create the login, you will see a colour display screen, which enables you to click through on all sides of the circle, and change the tonality and the sound that suits your mood for the day. This is a publicly available information free to use tool on the wavepaths website. But we are sure that V paths has much more trade secrets and patterns in this space. Let’s hear from Mendel.
So we did it both algorithmically. And manually, man, it’s really up to the therapist and the patient’s, how much manual changes are wanted. But those changes can be anything that they deem is important than this moment, changing an instruments changing a particular layer of the music, changing emotional intensity, other qualities in the music, like tone, colour, or pitch or skill, adding various sounds to the music. But algorithmically. We’re trying to build these, these these profiles basically are for patients and see how a person usually responds to music. And, and how that these usual responses would likely translate into an acute psychedelic state. So that’s one way how we are automating the process as much as possible, and really making it as easy as possible for for therapists to take away the thinking and the planning and concerns and complexity. That is that is there. Yeah, and it’s really both, it’s really, it’s really both often therapists within some variables at the beginning and, and really enjoy the fact that they can trust the system to do its thing. And the smoothness that the fact that you don’t have these transitions from song to song, but it’s all but continuous fluid experience. But then any change that you might imagine, can be done can be, can be can be implemented as well on top of that, yeah, we are, first of all, not working with fixed songs or compositions. It’s, like I said before, flexible and adaptive. And the reason it’s quite flexible and adaptive is because we work with the building blocks of music, the different instruments, different stamps or samples, if you might say, these are either pre recorded or generated in the moment. And, and therefore any, anything can be blended and mixed in remixed all the time, in real time to create the desired Sonic installation in this moment, four to 40 for the listener,
Sonic constellation. If you thought that we as a science podcast did not talk or like spirituality, we finally spoke of how a subjective musical identity can guide a psychotherapy session and how technological improvements and innovations can aid in providing a tool to the psychotherapists. In fact, wave paths has done exactly that. The beauty of this digital therapeutic is that it’s already generating revenue. And at the time we spoke to Mendel it was in use in 11 different countries, including the US Canada, parts of Europe and Australia. And another aspect that we came to know of was the fact that different psychedelic substances can alter the oral sensitivity. We asked Mendel if this is true, and if there’s an opportunity to make or set a framework for a particular drug, by avoiding a few musical attributes and highlighting others, here’s Mendel’s response
was not that’s not known in the public. And this is another example of why I felt there needs to be an organisation like wavepaths to really double down on all of these outstanding questions that are so important, and one of them is understanding how sound and music perception is different from different molecules, a different molecule, and comparing ketamine, MDMA, psilocybin, other tryptamines, were actively and that is exactly what we’re doing. And I can’t disclose too many details on that as we speak. But this is exactly one of the things that we are studying and integrating adaptation to the medicine in question. adaptation to the individual traits and adaptation to the process of this person, in a moment, have been really bringing it all together in one one framework.
Arun Sridhar 1:16:05
All right. So we spoke to an investor who invests in highly promising companies in the area, we spoke to a digital therapeutics entrepreneur, who was convinced, much like many in the area, that music is an experience and an integral part of the psychedelic experience. Yet, the experience is subjective. Beyond the subject itself, no one else can actually see or understand what’s happening. The only way to gather information is if the person undergoing the psychedelic therapy talks about their experience, which we know happens in the psychotherapy sessions. Are you ready for the big question? It is something that ties our primary area of technology in healthcare research, to the area of psychedelic medicine. What if one can truly understand what is happening to the areas of the brain when someone is dosed with a psychedelic molecule? What if there was a way to understand neural signatures of a psychedelic experience are informed the physicians which part of the brain surface is active? And which isn’t? Why is this important? Because you can understand the signature of a patient in therapy, at baseline, through therapy, and during follow up. Imagine the richness in the data that comes from such a technology if it’s available. And what have one had such a system, one that informs and provides a better understanding of the human brain under the influence of a psychedelic. Well, we explored that to around the time that we spoke to Doug Drysdale CEO of seibon, it was announced that seibon is exploring a collaboration with Cornell
kernel is a technology company started by Brian Johnson. Brian Johnson, a former founding CEO of Braintree, a company that processed online payments and counts. Venmo was one of its acquisitions, and was itself acquired by PayPal for $800 million. So Brian Johnson invest $50 million of his own money into building kernel kernel, despite its different focus in the early days now focuses on building hardware to understand hemodynamic and electrical signals from the surface of the brain in the cortex. There are some fundamental technical challenges that they had to overcome, which they seem to have worked through. Currently, a kernel wearable helmet that looks like something from Star Trek uses a non damaging and safe laser imaging technology that utilises Magneto and cephalogram a concept not that different from the emerging Magneto cardiography to measure electrical activity on the surface of the brain. The helmet has various hexagonal modules, spliced together to form a sensor surface that can compartmentalise and provide high fidelity data during natural human experiences. So we asked that Drysdale CEO of seibon, how they intend to use colonels expertise, here’s Doug. In fact, his answer made total sense and so does their collaboration with Colonel
Doug Drysdale 1:19:15
so it’s good questions on the on the preclinical side, you’re right has been notoriously difficult to translate CNS or psychiatry, animal models into man, and being many failures over the over the years. And part of what attracted us to this space, though is that where we know a lot about these molecules already, they’ve been in the in the public domain, for instance, the 50s for facilities and for example, LSD. And so the parent molecules or scaffolds that we’re using, we already know quite a lot about how they work in there. I mean, it’s unusual, isn’t it to have so much data available in these kind of conditions, so we have the benefit of being To take those well known molecules as parent scaffolds, and then as they say, using the chemistry and delivery, adjust how we deliver them and how they work in the body. And then we have already seen in some of our preclinical work that there’s, there seems to be no difference between the activity of altered molecules and the original pair of molecules. So that gives us good confidence as we go into the clinic. On the clinical side of things, you’re right, in the data, data in this space, when you’re looking at, say, depression, for example, is largely subjective. And part of that is the lack of scalable technology. So there’s this good neuro imaging technology that exists today fMRI or M eg, for example, but these are multimillion dollar pieces of equipment that are room sized. And they take up a massive amount of space. And the written they need a PhD technician to run them. So that makes them difficult to access for patients. And let alone the fact that the patient’s lying in a tube with 120 decibels playing around the head. It makes it hard to get into those those technologies frequently. And that’s why our partnership with Colonel out and the West Coast is really interesting. Because they’ve over the last five years managed to take well known neuroimaging, optical imaging technology, and miniaturise it, they’ve developed high, high powered lasers, and they’ve developed new chips that can handle the data that come out of a device that is portable. And that portability transforms the way of the weekend, we can do neuro imaging. So we’re hopeful that we can, in the second half of this year start to study using the kernel flow devices. This is a wearable neuro imaging helmet that uses functional near infrared spectroscopy, by the way, lots of long words. But we can use that to on patients in a more longitudinal basis. So we can study the patient’s neural activity before, during and after treatment. It’d be interesting, I think, to see if the neuroplasticity that we’ve seen under fMRI has some durability, does it continue? How temporary is it? What How long does it last? And I think also when you get down into lower doses of these molecules, sub perceptual doses, where do we still see neural activity or change in activity, those levels there, you may be able to use the quantitative data now to develop treatments for potentially cognitive impairment or attention deficit, where, where traditionally those studies have been very, very difficult because the effect sizes are quite small and hard to measure on a qualitative level. So the technology is going to help, we think to learn a lot more. That said, all of that said, our lead clinical study, which is a phase two programme, for major depressive disorder that we’re about to enter into, is using a typical qualitative, Madras scale, model rosburg scale. But those those scales have been well accepted and well used over time.
It’s early days, but definitely it’s one example of how psychedelic drug discovery companies are trying to leverage technology for use. Finally, we have to finish with our investor mindset. At the end of it, it’s going to be a business that will have a patient at its core, a business that will seek to improve patients lives, and it is not going to be easy. Here’s Claire Burtenshaw with a summation of her challenges for the field.
Arun Sridhar 1:23:41
Sure, I mean look for for psychedelic assisted therapy to succeed and to get rolled out we will require a revamped clinical rollout from two angles, right, there was a lot of learning that came out of cannabis, both in terms of educating doctors on how it worked, how they should be given the prescriptions in the first place. The clinic side of it is more nuanced, you know, you’ve got the before and after care aspect of the digital therapeutics I’ve touched on in a lot more personalization of healthcare, ai driven biomarkers, etc. And so, no, whilst that one size fits all treatment model hasn’t worked in the past. And we’re now seeing psychedelics and tech add ons that help us treat mental health and the more bespoke way than ever before. This, this is an ecosystem that is growing for both the clinicians and the patients and how, how do we fund this and how does it work with the payer if you’re looking at 60% of patients looking for alternative treatments for major depression and other related illnesses just can’t get the treatment not because the doctors or the patients are unwilling, but because they can’t find the prescribers. That’s that’s the side of it. That’s being addressed through various platforms. And it’s something that you know, will be handled by out of pocket and private insurance. You have to be pragmatic about this, because not everything is going to be insured from the get go. But some companies will insure, you know, that non psychedelic elements, so the aftercare and the pre care, and in the US, you know, it will be the private insurer, that that picks up the tab for that. And in the UK, a mixture of private insurance, and hopefully the NHS, once the regulatory and legislative landscape has changed, and, and everything becomes standardised. What I know and feel will be the case, moving forwards of this is that for everyone to get comfortable, particularly the insurer and the NHS, we will be looking at types of drugs that have gone through quite a stringent lead optimization programme, to de risk them, get them through the clinical trial. And I think at that point, then you’re looking at this more from sort of a biotech drug discovery angle, and less of the sort of taboo psychedelic angle, which will get National Health Systems insurers generally a lot more comfortable with what’s being rolled out. And, and I think it will be a combination, you know, for the UK of public and private purse. And in the US, actually, if you’re looking at the support that’s being given by the FDA, and you know, the US Department of Defence, and DARPA, etc. There is a case for some, not all, but some of this to be picked up by the public sector. And I think, again, it will come down to the structure of how these payment plans work and the types of indications they treat. So if you’re looking at the PTSD, and the veterans angle, you know, that would be picked up by the healthcare service, because it’s related to Department of Defence, if you’re looking at pain management, outside of the psychedelic therapy, that you know, just treatments for pain relief, etc. That can be rolled out, as you know, any other pain relief medication would be given. And so I think it will be about, you know, what’s the indication? What is the profile of the patient taking it? And does it fall within a remit that the insurers are comfortable to ensure what that will look like in terms of, you know, wider picture, I don’t know. But I think like all things that will be tailored and nuanced, and some areas that insurers will be more comfortable insuring than others, I hope you get the scale of this exciting area of science. This is precisely why we wanted to bring the story to you in the way that we did through this podcast. We could have done what everyone else does, which is bring a few people in and do a series of interviews. But that is only helpful if you really understand the area. But for wider acceptance into society, we need an informed narrative and a discussion. One that is grounded in information, warts and all. Have we solved every problem? No, not at all. But we have given you enough information to push for truth and look beyond the fluff whenever there is a new news article. We hope that as you’ve listened through the 10 episodes in our series, we have conveyed the stories of these amazing class of molecules that have given us hope. Now it is time for you to dig a bit deeper. That was psychedelics as craps original podcast, exploring the therapeutic use of psychedelics an enthralling story of an improbable dropped last vanished into exile, yet comes back soaring like a phoenix from the ashes to save mankind’s affliction with mental health disorders. And we are just getting started. There is so much more to do. You’ve been listening to PsychedeRx. PsychedeRx is a SKRAPS original podcast produced and narrated by Arun Sridhar and JoJo Platt. SKRAPS is a volunteer run organisation created by Arun Sridhar and JoJo Platt to disseminate factual stories of science scientists and innovators as a service to the world. Select research for this podcast series was performed by shereena rice, the producer thanks Clara Burtenshaw for her invaluable input. Multimedia services was provided by Dr. Romeo Racz. The scripts were written and edited by Arun Sridhar and JoJo Platt. Financial support to cover the production costs was from Cybin Inc. and a kind donor BB. Recordings were done at caprino Studios in the UK, and slightly red studio in San Francisco Swaminathan ThiruGnanaSambandam performed the mixing and mastering. All recordings, including interviews are properties of the producers, and should not be reproduced without permission to show notes, transcripts and useful links pertaining to the episode are located at the podcast website psychedelics.com