Psychedelic Drugs in Healthcare

Host:
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Adrienne Rivlin:
Psychedelics are set to become the next major innovation in mental healthcare. Despite the large flow of investment into this area, the development of psychedelic drugs is not without its hurdles. In this episode, we'll get an introduction to the challenges surrounding the development of psychedelic drugs for mental health, including clinical trial design, manufacture, and commercialization.

Hi, I'm Adrienne Rivlin, a former medical scientist and partner in LEK's Global Healthcare and Life Sciences Strategy practice. Today I am joined by Andre Valente, a partner in LEK's Healthcare and Life Sciences practice and leading specialist in the pharma outsourcing sector. Together, we plan to discuss the development of psychedelic drugs for mental health. We are also joined by Tom McDonald from Clerkenwell Health, a specialty psychedelics contract research organization. Thank you very much for joining us, Tom and Andre, gentlemen.

Andre Valente:
Thank you, Adrienne. Really great to be here. My name is Andre. I'm one of the partners in the healthcare team. And I focus a lot of my time on helping contract pharma businesses grow and investors deploy capital in this space as well. I'm really looking forward to the conversation today. I think it's really exciting to see the development of a new area of pharma outsourcing specialization. Really interesting.

Tom McDonald:
Great stuff, and thank you very much for having me. I'm Tom McDonald. I've got a background in traditional pharmaceuticals, so I did about 10 years. The tail end of that time I spent at IQVIA, which is one of the world's biggest CROs and data providers to the pharma sector. But about two years ago I launched Clerkenwell Health with a couple of my co-founders. We'd really been looking at the psychedelic sector as a whole and really came at this with the vision of wanting to try and transform mental health care, which I do genuinely believe psychedelics have an opportunity to do. And the way we think that that is going to happen is through creating high quality data that's going to bring not only the medical community but also the regulators on site with these treatments.

So that was where the idea of Clerkenwell Health was born. As I say, we've been up and running now for two years and we really provide specialist services. Helping our clients design their clinical trials, get them approved by regulators, and ultimately deliver them as well. And that will be through partner sites as well as we are building what I call a spine of Clerkenwell-owned clinics.

Andre Valente:
That's great, Tom. Thank you. Maybe to get us started, Adrienne could tell us a bit more about the potential of the use of psychedelics in the treatment of mental health conditions. That would be a good way to start the conversation.

Adrienne Rivlin:
It's an area I'm really passionate about. I think for so long we've focused on the physical health side of things. And it's, I guess, become really apparent, especially through the pandemic, how important our collective mental health care is. I think there's about 900 million or even a billion people around the world who are currently suffering from mental health disorders and substance use disorders. And for many of those, the current standard of care or the current treatments that are available just simply don't work at all or work in a very substandard way. And I think what's been really exciting as we've seen the field of psychedelics emerge has been some of the early readouts from some of the early clinical trials, and indeed some of the basic research that's being conducted in some of the leading academic institutions where we've really been able to see that there are some effect sizes that are unparalleled, frankly, in traditional CNS or psychiatric research.

And so the promise of psychedelics... and we mustn't hype it up too much, but the promise of psychedelics is really that they can offer an alternative and hopefully better treatment for people who are suffering from mental health disorders. Particularly we've seen exciting results come through on psilocybin. Those are magic mushrooms to the rest of us. Psilocybin for depression, for major depressive disorder, and also treatment-resistant depression. And then the other one that perhaps I'd just call out right now is MDMA or ecstasy for the treatment of PTSD. And this is a really exciting one because actually this therapy got breakthrough designation in the US, so hopefully we might be seeing some of these actually come to market in the next few years. We think that it's going to disrupt a market that's worth in excess today of about $25 billion. So as well as holding promise for patients and sufferers of mental health disorders, we also think that from a commercial perspective it's going to herald some exciting times for the manufacturing industry and from its supporting industries like the kind that Tom is representing today.

Tom McDonald:
I couldn't agree more at, Adrianne. And I think, yeah, to add a little bit of color as well, that MDMA study that you've referenced there, I think in their phase three out of the US they were looking at about 2/3 of patients after this course of MDMA sessions alongside talking therapy. They were looking at about 2/3 of patients were essentially in remission at 12 months, which as you say is really quite a dramatic improvement.

Adrienne Rivlin:
Unheard of, yeah.

Tom McDonald:
Yeah, indeed. So it's a really exciting field. And all manner of different conditions are being looked at. Right from what you think of as traditional mental health conditions, so depression, anxiety, PTSD. But we're also starting to see some interesting results coming out of things like traumatic brain injury. And people even starting to move into other CNS conditions such as Alzheimer's, dementia, and so on. So yeah, an exciting place to be.

Adrienne Rivlin:
And eating distorted as well, right, Tom?

Tom McDonald:
Absolutely. Yeah, I think eating disorders is looking really interesting, and as are a number of addictions as well. So there is a lot of work to be done. As you say, it's pretty early days. But some of the early indications are really quite exciting.

Andre Valente:
Very interesting. And Tom, what kind of challenges are you seeing in terms of getting these drugs to market, flowing through the clinical development process and then into commercialization? What are the challenges you see these days?

Tom McDonald:
Yeah. Well, fortunately for us as Clerkenwell Health, we do think that there are a number of unique challenges here. With these compounds, the first and most pressing issue in the vast majority of countries is the fact that they're still deemed as schedule one, I.e. not having any medicinal value and potentially having risky effect side effects. That's obviously something that is likely to change over time, but because of that scheduling, you're only actually allowed to administer them in places that have the required licenses. And that's a fairly limited number of sites. So in the UK you could probably count that on two hands. And that's a pattern that we're seeing reflected internationally. So that's something that I touched on in my introduction, that we are looking to set up our own facilities that are really designed to encourage a great experience for mental health patients, but also having the required licenses and skills in place to treat these participants as well.

The other thing which I think Adrienne touched on is that there's been fairly limited work in terms of new developments in the mental health space for a very long time. So there's a fairly small talent pool available to actually design these trials in the effective way and manage and monitor them. So that's something else that we're really bringing in-house at Clerkenwell at the moment. The other big one, I suppose, is probably the fact that this isn't a standalone treatment, or typically it's not seen as a standalone treatment. You've usually got therapy that goes alongside it. And with that comes a number of issues. From a clinical trials perspective, what's doing the work? Is it the drug, is it the therapy, is it the combination? And so trying to make sure that you're designing your studies and making sure that sites are delivering them in a consistent way is another major challenge.

Adrienne Rivlin:
And Tom, as you think about each of those, so maybe starting with the scheduling of the drugs, which I suppose we'll all have our own personal views on, do you see any significant changes in the landscape from a regulatory perspective in terms of the way that governments around the world are currently thinking about relaxing, perhaps, the scheduling of these drugs? I know in the US there have been some notable changes to the way that some drugs are being thought of for research purposes.

Tom McDonald:
Yeah, absolutely. The US is such an interesting example because state by state they're able to do, to an extent, what they desire. So Oregon, as of next year, will have decriminalized and created a legal framework for the delivery of a whole range of psychedelic-assisted therapies. And we're likely to see a number of other states following suit. But at that federal level, I would expect that we're probably a couple of years away from a full rescheduling of most of these compounds. And I think the same really is likely to be true in most other markets as well, at least for a few years. There's definitely a softening of opinion. When we go in to speak to the likes of the MHRA or the FDA, their opinion has changed dramatically over the last couple of years and they really get the potential of these treatments now. So I think, in short, I think for a couple of years we're unlikely to see rescheduling, but we're definitely seeing an opening up and a better understanding of these treatments and how they may impact a broad range of patients.

Andre Valente:
Thanks. I think it's also quite interesting looking at this from the outsourcing partner perspective because it's a relatively new field in the way that we're describing it. This is creating opportunities for CROs like yours to differentiate and really build expertise in this therapeutic area and really be ahead of much larger competitors. So it's a pretty interesting business dynamic as well, and a competitive dynamic for you, which, on top of the therapeutic area, we also have the ability to serve smaller customers, which is something very differentiated we see in the market. We see this across all of our experience in this space.

Tom McDonald:
Absolutely. Yeah, I think probably the largest players in the psychedelic sector in terms of drug developers have a market cap of about half a billion. So as you say, much, much smaller scale than traditional pharma. And yeah, we quite consciously in the early days were working with some of the smallest players in the space because they were looking to us for a lot of strategic guidance and support on the design of their studies, not just the actual management of them. And I think over time we're certainly expecting to see some of the bigger players start moving in, but right now it is quite a niche industry and they do need some of the additional and slightly more tailored support that a smaller operator like ours can hopefully provide.

Adrienne Rivlin:
And I think that relates quite well to one of your other points, Tom, about the ability to recruit people into your organization with those kind of specialist skills and capabilities. Has that been a problem that you at Clerkenwell have had to overcome? And if so, how are you thinking about it going forwards?

Tom McDonald:
Yeah, it's been really interesting on the recruitment side of things. When I think about my own journey into the sector, I remember just telling friends and family, "I'm leaving the big corporates and I'm going to set up a psychedelic startup," which, yeah, it definitely led to some raised eyebrows. And I think there is still an element of stigma around these compounds and treatments, but it's fading fast. So with our recruitment, we've been quite lucky in that there's been a lot of positive press recently. And so it does seem to be attracting a lot more people than maybe it was a couple of years ago. But yeah, certainly as we are looking to really scale this up as an industry as a whole, I think that's going to be absolutely vital. How do we break down stigma? And I think the answer to that is creating quality data and making sure that that data is being communicated effectively and you're being really truthful about some of the riskier areas of the sector as well.

Adrienne Rivlin:
And I think I mentioned two particular types of therapy, so psilocybin or magic mushrooms and MDMA. But from your perspective, Tom, as you look at it from the CRO side of things, what compounds or particular companies do you think are showing the most promise in terms of their ability, I suppose, to actually bring one of these to market within a timeframe that is, I don't know, let's say two to three to four years?

Tom McDonald:
Yeah. I think you were right to mention psilocybin and MDMA first because they very much are at the front of this. MAPS is the group that's working with MDMA for PTSD. I think we're probably a couple of years away from that actually hitting the market. And then you've got Compass Pathways is probably the second most advanced organization, moving into their phase three beginning of next year. And that's with psilocybin for treatment-resistant depression. So I would say those two companies are the front-runners at the moment. And then there's another large draft of companies looking at what I call first generation psychedelics, which are the likes of MDMA, psilocybin LSD, et cetera. But what's quite exciting now is that we're starting to see some really exciting chemistry come through in terms of the designing of brand new chemical entities. That they're either looking to enhance the efficacy, maybe shorten the duration of effect, or improve on some of the safety profiles.

And I think that's going to create a whole new raft of fascinating companies that are going to get really, really tailored in terms of the specific conditions or even sub-patient populations that they're targeting.

Adrienne Rivlin:
And Andre, I guess from your perspective as you look at it from the pharma outsourcing space, you mentioned that types of organization like the one that Tom has founded here fits quite well with this kind of niche approach because of their ability to really show expertise in a particular therapy area or in a particular geography. From your perspective, as this industry starts to scale, what would be some of the key things that the CRO community ought to be thinking about?

Andre Valente:
Yeah. Very interesting. I think some of the key drivers of growth that we've seen other CROs take are maintaining this strong therapeutic area expertise and really being able to support customers but also, at the same time, expand the service offering. So really broadening the type of support you can provide to your customers as they scale, as they move through the clinic into later stages as well. Perhaps helping them think through what their regulatory submissions is going to look like. So help them with some reg affairs. Or even thinking about the range of options that are available for commercialization. All of these services are required by the same customers that Tom is serving today. And I think that's a normal path of development for CROs, this expansion of the service offerings. I think that that could be quite exciting here as these pharma companies move through the development process and their needs evolve. I think it's a really great opportunity to expand the remit of CRO organizations.

Tom McDonald:
Absolutely. And to your commercialization point, I think that's a really fascinating one with these compounds. As we touched on, it's not just about giving somebody the dose and off they go, or indeed a chronic treatment over a course of years with a pill that they take home and work on that way. There's a lot more complexity to it with the therapy and so on tied in. So I think making sure that we're supporting our clients to design their trials in a way that's going to be effective and commercially viable in the future is also going to be a big selling point.

Andre Valente:
Interesting. And I think from our experience in a comparable area, CNS, central nervous system drugs, there is quite a lot of nuance in clinical trials for that therapeutic area, where you have patients that are frail or unable to communicate, express well how they're feeling and how the drugs is impacting them. I think that's an area where this extra layer of support by CROs is really, really key. And you have to make sure that the data that is submitted to the regulators is still as robust as it needs to be but recognize that the patients are in very specific situations and have very specific conditions that are not easy to diagnose and treat with some of the more quantitative means that we see, diagnostic imaging and lab work, et cetera. It's much more nuanced in these kind of areas.

Adrienne Rivlin:
I think that's a really good point, Andre, because one of the things that has been most notable about the development of psychedelics is that you're not just developing the drug, but you're actually developing a psychedelic-assisted psychotherapy package, as we call it. So it's a combination of some form of talking therapy alongside the drug itself. And I imagine, Tom, that that means that there are some specific challenges that are raised as you think about designing the trials from your perspective.

Tom McDonald:
Absolutely. Yeah, it brings all manner of additional complexity to these trials. And yeah, just before I dive in, maybe to set the scene: of the 100 or so psychedelic specialty drug developers out there, it's my take that 90 plus percent will have at least some form of talking therapy included in their treatment modality. And again, just to spell that out: what that typically means is a little bit of therapy, between one and three sessions with a therapist and the participant that takes place prior to them actually taking a dose. You'll then have a single or maybe a couple of days of the dosing where they'll need to be sit and guided through that pretty transformative experience. But then vitally there's what's called integration therapy as well. So how does that therapist really sit down with the participant or the patient and really pull out what lessons they've actually landed on during the dosing or in the days and weeks that follow?

And there seems to be this really interesting golden period that psychedelics allow where you can really jump in and start shifting thought patterns, ways of thinking, negative, and trying to push them more towards the positive, as well as setting up good habits and behaviors that you can then take forward and that it's actually going to create a lasting change rather than just a bit of an afterglow after the dose. But anyway, yeah, in terms of the challenges, the big one for me is around consistency. So if you've got a multi-site trial with let's say 20 or 30 therapists on there, how do you really try and ensure that each of them is going to be delivering a consistent level and quality of therapy? So for us, we've decided to set up our own therapist training program. That's run by an amazing clinician, Dr. Sarah Beta.

And so it starts right at the beginning. How do you recruit the very best in class therapists, and people that are going to be amenable to change as well? If you've got somebody... they could be the very best therapist in the world, but if they're not willing to adhere to this particular modality, that's a big one. So that's one of our main things we look for, is somebody who's going to learn and adapt. Then there's the training itself. There's some people that are doing this almost entirely remotely or through prerecorded videos. We don't think that's necessarily the way to do this if you want the absolutely best therapists. Absolutely it needs to be scalable, so you can have some modules online and so on, but we think some of that face-to-face element is really important. And the ability to fail people, frankly, as well. Not everybody is going to be right for this. And so not everybody who joins our training program, sadly, will make it through.

But yeah, obviously when they've done the training, the other big one I think that is vital is making sure that you are monitoring these folks when they're actually out in practice, be that in trials over the next few years or when they're actually out in clinic. And maybe we'll have a little bit of time later to talk about some of the technology and so on that we're thinking about in that particular space. But yeah, really exciting space. But making sure that there's consistency is a big challenge.

Adrienne Rivlin:
And what about the burden, if you like, on the patient themselves from participating in some of these trials? I imagine, from what you've talked us through there with the preparation sessions, the actual dosing session, and then the so-called integration sessions afterwards, that this is quite a significant burden on patients. Do you have quite high rates of people falling out of treatment? I imagine that they'd be quite expensive as well, right? To run these trials. What about from the patient perspective, Tom?

Tom McDonald:
Yeah, absolutely. You're 100% right. Finding the right patients is a challenge in mental health and CNS to start with, but then ensuring that they're remaining engaged and on board throughout the trial is obviously vital as well because it becomes very costly if that starts all falling away. So we've got a patient advisory board that we speak to on a regular basis with the early design of these studies. I think different people are looking at this in different ways, but I think, wherever possible, if we can decentralize these studies, we absolutely should be. So can some of the therapy be done remotely through a technology similar to Zoom? The answer is yes. We've had a study approved by the MHRA based on that. So a lot of the prep and some of the integration will take place remotely. And that's because this particular population that we're talking about, people at end of life, quite clearly the last thing they're going to want to be doing is traipsing in and out of a London clinic.

So thinking about ways that we can really be designing these studies with genuine patient centricity is going to make all the difference. And then there's just basic stuff like treating people with common decency. Making sure they know where they'd need to be, when they need to be. And using some tech to help nudge them along and make sure that they know where they need to be and what time and all of these kind of small bits and pieces that, they seem minor, but if you're a participant and you're quite nervous about a particular treatment, I think it all adds up.

Adrienne Rivlin:
And there's quite an active debate, isn't there? About your ability to provide consent, particularly when you're at end of life or when you're suffering from a very severe mental health disorder. Have you found that participants are more or perhaps less willing to take part in these trials once you've taken them through the typical patient consent process?

Tom McDonald:
Yeah. I think there's certainly an element of scrutiny that the participants have, that maybe people outside of these areas might have. But really no, I think. We've been quite fortunate. Again, as I say, the press and the general sentiment towards these treatments has been fairly positive. So I think most people signing up for these trials are excited, A, that there could be a potential cure. And typically these are people that have struggled with treatments that are available on the market today.

Adrienne Rivlin:
I wanted to also ask you, Tom. You mentioned earlier some of the digital innovations that you've been seeing in this space. And you referenced an approval by the MHRA for a zoo-related element to some of the therapy. As you think about the development of the sector, are there any other examples where you think digital health or some other kinds of innovative digital means or services might come into play?

Tom McDonald:
Yeah, absolutely. I think we've got this quite rare luxury within this subsection of the pharmaceutical sector in that it's brand new and we are all able to help do our bit to build it from the ground up. And so I think technology is absolutely going to play a really vital part in particularly some of the later stage trials and when these products are getting commercialized and on the market. So one of the things that is a bit burdensome at the moment is the diagnosis side of things, which is very heavy questionnaire-based typically. But there's some amazing groups out there at the moment, Thymia to name one, who are doing some very clever stuff with apps where they're gamified, but essentially they're using facial recognition and/or voice recognition, or how frequently you're interacting with your social media to actually detect your levels of depression or anxiety.

And I think the more and more that gets codified, I think that's going to be a huge advancement to the sector as a whole, maybe even allowing you to actually try and intervene with a mental health patient before they start a really heavy negative spiral, which is pretty commonplace across a lot of these. So diagnosis at one end. A lot of companies are looking at what I call traditional patient support apps or platforms as well. Typically these are things to help the patient learn more about the trial, learn more about their condition, but also to augment the effects of the therapy. And that's something that we're looking to do in partnership with another organization at the moment. So encouraging the participant to actually conduct some of the activities, mindfulness, et cetera, at home. Because obviously if you've only got two or three hours with your therapist prior to the dose, that's not a great deal.

You're going to spend 90 plus percent of your time at home or at work. So encouraging people to pick that up at home is a big one. And the final thing that we're looking at, and I'm sure others will do fairly soon as well, is to go back to my point around ensuring the therapist's fidelity to the training that you've given them. And so we're developing an AI tool which will allow us to monitor in real time whether a therapist is adhering or not to the specific modality of therapy that they should be delivering, which is really quite an exciting space because, as I say, when you're on a trial it's relatively easy to keep an eye on. But when we're thinking we are going to have thousands of these therapists in the UK or further afield, that's when we're definitely going to need tech to support on that front.

Adrienne Rivlin:
And I think for me, Tom, the other thing that I get quite excited about when I think about the potential for the digital side of things is really that it, I think, will help to democratize access and make access more equitable, potentially, if we can get the model right. If we don't require people to come in, as you've said, traipse into London. Or even be so London-centric, or even be so UK-centric, or even be so urban-centric. So the ability to use these types of technologies for equitable purposes I think is another dimension that I would like to see exploited, if you like, with the use of these technologies. I expect, Andre, also from your perspective more broadly in the pharma outsourcing space, that CROs and CMOs and CDMOs, et cetera are all trying to find ways of using and harnessing the power of digital more generally, I expect. Is that something that you're seeing as well?

Andre Valente:
Yes, absolutely. I think most players in this space are trying to make clinical trials more convenient for patients. Everybody recognizes, as we said before, the burden of participation for patients coming into the clinics. And oftentimes this requires long hours in traveling to get to the clinical sites. And it's absolutely a big trend in the space at the moment. This decentralizing of clinical trial activity is happening. I think personally that this we're not going to go to the extreme end all trials are going to become virtual in the near future. But the progressive deployment of technology to make patients' lives easier, to make clinicians' lives easier, to make the CROs' and the pharma companys' lives easier as they progress through the clinical trial, absolutely seeing the deployment of those solutions.

And what I find very, very interesting as well is regulators are also pushing for the adoption of some of these technologies. I think we're starting to see a greater acceptance that this is not just a convenience play but there's also implications on the quality of data. I think Tom, as you were saying, the ability to guarantee the consistency of data is very important for regulators. And digital enablement of clinical trials really helps with that consistency of data, quality of data that is essential to demonstrate the efficacy and safety of the drugs that we're bringing to market.

Adrienne Rivlin:
And I suppose it would also impact the physical location of where you could actually do the trial as opposed to being particularly constrained to a particular physical space, right Andre?

Andre Valente:
Absolutely. It really broadens the types of patients, the countries of those patients that you can reach with these clinical trials. And then onwards into the clinical practice as well. It really is, as you said, democratizing the access to treatment.

Adrienne Rivlin:
And Tom, have you got aspirations to move beyond your Central London clinic? What's on the horizon for Clerkenwell Health over the next couple of years?

Tom McDonald:
Yeah, absolutely. Yeah, we started out working primarily with clients that were looking to launch their studies here in the UK, but we've just started working with a couple of North Americans, so starting to engage with the FDA as well. So yeah, the CRO services that we offer, particularly on the regulatory side of things, at the moment are international. And next year we're certainly looking to spin out a couple more clinics, one into Europe and one over into North America as well. So really looking to start broadening the spread and the footprint of these sites so that we're able to really service our clients as they grow and move through phase one into twos and threes over time as well.

So yeah, that very much is part of the ambition. And also I see a lot of exciting stuff that's not just psychedelic. I think that's an amazing entry point for us over the next couple of years. But to go back to the digital pieces that we've been touching on, I think there's going to be all manner of crazy new technologies that are going to come through that are going to be really, really impressive in the mental health, CNS space. So we're going to stay very closely aligned around the therapeutic area but looking at really interesting frontier technology as well.

Adrienne Rivlin:
Well, whilst we're being forward looking, Tom, I couldn't help but ask, what are your predictions for the next five years as you think about the psychedelics industry more broadly?

Tom McDonald:
I think the big one that we're starting to see a little bit of already is some consolidation. I think there's been a few acquisitions this year of some of the smaller players who've created some really compelling data, but getting brought out by some of the bigger folks out there. Linked to that as well, I'm absolutely certain that we'll see big pharma moving away from circling and keeping an eye on this and really starting to jump in with two feet. So I think it was Otsuka were the first company to actually step into this with, for them, a very modest investment into a group called Mindset, who we're working with, out of Canada, looking at these second and third generation compounds. And I'm absolutely sure we'll start seeing some more activity like that over the next few years.

We'll of course have a few of those products that we've touched on already likely to hit the market. So MDMA and psilocybin, I think probably in two to three years they'll be there. I think there's probably a lot more infrastructure that needs to be worked on to make sure that that could be a reality. So the training of therapists, the launching of specialist clinics, all of these kind of bits and pieces that I think will help really accelerate and enhance the launch roadmap for those particular compounds. And finally, probably an increased focus on the second and third generation psychedelics.

Adrienne Rivlin:
And Andre, from your perspective? If you were gazing in your crystal ball, what kind of predictions would you be sharing with us?

Andre Valente:
I think it's a fascinating time for this industry more broadly. I think the strategic importance of the pharmaceutical industry has increased tremendously over the last two or three years through the COVID pandemic. I think regulators are now, as I said, much more flexible, much more adaptable to what they're hearing from pharma companies. And something that I'm very excited about, I think patients are now much more aware of the drug development process. You hear people on the streets talking about drugs in phase two and phase three, whereas five or six years ago you wouldn't have those kind of conversations. And so I think it's a pretty interesting time for patient advocacy for the development of new drugs. And I think mental health is in a critical place for that because it hasn't received the attention it deserves over many, many years. And I think now the confluence of these factors could really make mental health have a very good decade ahead.

Adrienne Rivlin:
I couldn't agree more. And I think for my part, because I'm ever the optimist, I think despite some of the challenges that Tom, you used so articulately laid out today around training of therapists, capacity, et cetera, I'm hopeful that within the next five years we might see two or even three of these really important therapies coming to market and actually making an impact for patients who I think so desperately need them. My thanks to you, Tom, for joining us today. It's much appreciated. I know you're extremely busy. Maybe just one final question. If you are interested in getting involved in the trials that you guys are running, how would you go about getting in touch?

Tom McDonald:
Yes. I think the best starting point for people is probably via our website, which is just www.clerkenwellhealth.com, or following us on LinkedIn. And whenever we're launching a new study, that will get posted up there.

Adrienne Rivlin:
Great. Thank you very much. Thanks, Tom. Thank you, Andre.

Tom McDonald:
And thank you so much for having us on. It was an absolute pleasure.

Andre Valente:
Thank you for having me.

Host:
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