Really pleased to be here today at the psychedelic therapeutics and drug development conference alongside some of the world’s leading researchers and leaders in academia and industry to discuss the challenges and opportunities facing those engaged in the research and development. It’s like that X for treating mental health disorders across the globe.

And today on this panel, we will be discussing the evolving clinical trial paradigm, uh, most patients the, around the growth of real world evidence as an alternative option to randomized clinical randomized controlled trials. And so we welcome our panel today. Uh, we have two members of the core team, uh, Albert labs.

We have chief medical officer, uh, Malka Johns. Malcolm Bart Johnson. I apologize. And we’ll say, uh, chief commercial officer grand McFarlane. So if I could just ask, um, maybe Graham for a brief overview of our labs, uh, introductions your role there, and also a bit of background, um, some, some of your experience and expertise.

Sure. Sure. Thanks very much, Toby. Um, it’s a real pleasure being here. Uh, my name is Graham. Uh, I I’m chief commercial officer album labs, as Toby said, um, Albert labs was formed in June of last year, uh, solely solely for the purpose of bringing our version of facilitation to, to the marketplace in a credible and clinically proven manner.

Um, You’ll you’ll you’ll, you’ll learn as we, as we talk through this, that we are actually targeting our efforts towards a particular patient cohort, which we’ll come back to later. But as I say, Albert labs, we are a expert and, uh, in many ways through our extraction methodology is quite unique. In our approach to bringing siliciden through our formulation, that we obviously want to bring it to market really quite soon.

Uh, as I see we live for that purpose and, um, my background and our behaviors and Malcolm you’ll hear from shortly, uh, our behaviors are very much that of the pharmaceutical company or a biotech company. And my background is pharmaceutical. Uh, I started life in AstraZeneca, uh, and, uh, GlaxoSmithKline. And lastly Bristol-Myers Squibb, uh, had more uncompleted for a decade, which, uh, was acquired by IQ via so big, big research function, their IQ via within which I learned so much more about real world evidence and the value it brings.

So that’s my background and that’s why I’m here. And, uh, I’m very happy at this stage to hand over to two mountains. Thanks. Go ahead. I’m so I’m Al combat Johnson. I’m the chief medical officer for Albert lamps, uh, as Graham said, you know, but now this has been getting just over a year now, and it’s an amazing venture.

We’re taking psilocybin into an area where we haven’t really used it before this. So I’m very, very lucky to be working with the team. We have a wonderful team. We’ve got an, a wonderful advisory board helping us as well. Uh, my background is I’m a medical doctor. I I’ve been a medical doctor for almost 30 years now, unfortunately until it goes so quickly, um, I’ve trained as an anesthetist.

And in terms of this, back in the late nineties, I went into the MHI the, the agency for the UK. I diocese a number of medicines that went into pharmacovigilance to safety. And then transferred over to roles in both like Graham AstraZeneca and also find is that, and a number of other companies over the years, too, I also headed up the MHR clinical trials unit back in 2005 when we first formed it, which was an amazing thing to be involved in.

And like, where am I? I want my own companies to be years. So, as I said, it’s been a fascinating journey for me. And it’s been absolutely amazing. Joining the Albert labs team. Amazing so well, we’ll kick things off. And if we could just go straight into a sort of an explanation of what real world, real world evidence studies include and how that’s incorporated into our labs is, uh, work and what you’re doing at the moment.

Kick that one off Toby. Think so. Okay, well, we’ll word evidence is just a, a way of looking at data for, for getting research out for licensing event today, a number of other areas it’s not sort of fundamentally different to what we’ve been in the hundreds of years. In fact, if you look at the way that medicines have been produced and used over the centuries, well, what evidence with the primary way of doing it?

We, we it’s very empirical. You, you took patients, you saw what had happened and you, you use them or not. In the last 60, 80 years, I suppose what we’ve managed to develop is something called randomized control trials. These are trials aware of patients, the way of treatment. So you basically judging one form of treatment against another one.

And also you judging it quite often against the control, like a placebo. So you’ve got a number of controls on there. You’ve got a number of randomizations, which you put the patients into. So that’s what, a way of judging one treatment therapy against another using maybe a standard of care or control like a placebo.

As I said, Was rounded, uh, with, uh, well, what evidence, what you’re doing is effectively looking at patients in the, in the setting, in which they’re being treated normally. So it could be in terms of the connect there being you being treated in normally. And you’re then looking at the treatment you were giving in that setting and seeing what the treatment would do.

To them with applications you want, as long as they safety wise, it allows a lot more stability and also allows you to put patients into a trial setting far more rapidly, and it’ll decrease costs. Another big advantage is that when you got an RCT, a randomized controlled trial, you’ve got a very limited population.

You may have 60, a hundred, we’ve got a thousand patients. It’s difficult to actually judge what you’re looking at in terms of the patient’s heterogenetic generic Betsy, because you’ve got a very limited genome sort of support in which you’re going to look at. Whereas if you’ve got a real world evidence study, you’ve got a much wider group of patients, anybody who comes in all, all comers effectively.

I dunno, see a much wider range and that allows you a much better understanding of safety as well, going forward. I mean, you know, the comments on that one, right? I mean, you know, we we’ve chosen this route. Um, it’s, it’s a credible route. It is a, uh, real world evidence often by itself is actually growing in.

Um, uh, I’m, I’m tempted to use the word popularity, but that’s, that kind of undermines the strength of real world evidence, but, you know, it’s, it’s all about, you know, providing really good evidence, good efficacy and safety talked at all with the clinician and the patient, and one good dealing with the areas or the cohort, which I think we’ll be talking about next.

Um, we need that sort of proximity with the patient. Uh, some of this will be virtual, but the proximity will still be there. And some of the measures we use, so. Yeah, there’s this observational real world evidence where you actually gather data and there is true on the ground clinical intervention where we all will learn.

This is uses big data to drive our understanding. So, uh, yeah, that’s why we’ve chosen it. Speak to market credibility and safety and efficacy program. Then my understanding is that, um, Abbott labs are focusing on cancer based anxieties as a starting point. Can you tell me a little bit more about the patient cohort that you’re looking to introduce to this?

Um, real-world evidence study and a bit more about the, um, current medical treatments that are available treating mental health in your oncologist? Yeah, I I’m, I’m happy to take them. There’s this one to start, um, you know, One thing that we have we’ve we’ve, we’ve all agreed on. When we started Alberta lumps all those months ago was that we wanted to actually direct our efforts towards unmet need.

So that’s patients who are actually suboptimally treated. Uh, I’m actually suffering as it. Right. And consequences that perhaps because of the illness, because of the concept treatment, cause you mentioned the concert hall or perhaps because, um, there are a lot of things. That’s the imparting on the, uh, the psychological health of the patient involved.

So we’ve chosen concept. Because constantly UK, and I’m very aware, this is all a bit UK centric, but it’s true of many countries in Europe as well. And again, we’ll probably touch on things like project or this actually ties in numbers of countries together, uh, in, in respect to early access to medicine.

Our early access to medicine focus is cancer because cancer is a national agenda item. And there’s one that gets a lot of attention. There’s a lot of people suffering from constantly UK. Right. We’re talking about 3 million patients and you’re like one and a half million patients then go on to suffer from, you know, serious side effects, uh, and mental health.

And by itself is also. A national agenda item, uh, on, on the current therapies. Um, I’m not about to wait in to say that everything that’s out there doesn’t work. That’s not even true, but studies are showing that let’s just give an example. SSRI is for the treatment of depression, uh, as a, as a more generalized treatment singularly successful.

But when you’ve got other issues in constantly in distress, Um, by that, I mean, uh, anxiety and depression, existential crisis, you’ve got so much more to deal with this. Isn’t just satisfying the Hamilton rating scale. There’s so many other things in terms of wellness. If you’re like we have to take. Utopia.

So, you know, we are very careful that we obviously want to bring psilocybin to these patients, not have the side effect profile that currently exists for SSRI is cause we have evidence. We’ve seen it. It’s all written up. It’s out there in the public domain where SSRI is DOD work in a little over half of patients who are suffering from depression, anxiety, uh, and those that do respond to a fair amount, actually have quite poor side effects.

And that does affect compliance. So that’s why we’re going there. We’re going there because it is, is a recognized area that needs some intervention. It’s an unmet need. It’s a national agenda item. And there’s patients at the end of this, this, this is something that we never forget. Elvis loves. We’re not going, you know, blend the bus across all depressions.

We’re going for a particular area that we feel Oxy needs some attention. And that’s constantly distressed. I don’t know if you want to add anything more. incredibly. Well, I think, you know, we’ve looked at the, the way that medicines are developed in the last 20, 30 years in terms of anxiety, depression, things like that.

We’ve had very few real breakthroughs, as Graham said, you know, a lot of side effects occur with these substances. Partly because we don’t understand how a lot of them work very well. And we went in quite easily, 20, 30 years ago. And that hasn’t really developed much further. So as a new treatment, so having a new treatment in this area is an amazing thing to have.

So I think we’re very lucky to have this opportunity.

Um, so, um, Graham, you mentioned, um, the opportunities for filling this currently unmet need of patients. Uh, is there a formal definition of over patients on mat needs or is there a criteria. Um, that patients need to meet, to be considered, uh, available for alternative treatments. And I defer to Mark and the correspondence yeah, unmet need is, uh, is, as Graham said before, very much of a subjective aspect in some respects, it’s an area where the governments and clinicians really focus down and say, okay, we’ve got to leave patients here who have not been treated or not being treated.

Adequately what we got in the cupboard. So unmet need to some extent it, hasn’t got a formal definition, but we all can see it when we go out there. When we treat patients, we know what groups of patients are not being treated adequately. Now we’re looking at oncology patients, their cancer patients, anxiety, depression.

Anxiety is a very wide group of patients. Indeed. In fact, I think unfortunately with the pandemic going on, we’ve seen that day-to-day my wife’s a GP and she sees anxiety, probably the most common thing of anything that we have coming through the door. So unmet need is very much something, which we know when we see it.

And we S we know that cancer patients suffer more than anybody is also an area that really we haven’t addressed cancer patients. Obviously our group patients who have to have the treatments for the cancer first and foremost, And that’s, that’s fine, but we have really ignored everything that goes on around that.

Partly because I think as well, that cancer drugs themselves, Oh, I’ve got so many side effects. They’ve got so many interactions, especially in the last 30, 40 years. We’ve seen so many areas of chemotherapy where patients quite often die or they suffer very badly and we haven’t made any thought and we haven’t really taken the nettle and said, okay, what else can we give them?

With too scared, actually affecting the efficacy of the cancer drug. We got to a point in medicine science now where we’ve got other therapies coming in. We’ve got things like immunotherapy. These are got a much better safety overall, generally speaking with now time to actually go back and address the other issues these poor patients are suffering from.

So it’s an ideal situation to be in. So Toby back to you, I think. Yeah, but to you again, Malcolm, I think we’re interested to know a bit more about how real world evidence studies are being, um, regarded by, uh, the regulators and whether it’s actually changing their approach to licensing. And I think we’re interested as well, obviously from, uh, from the perspective of the, of the UK, but also, uh, beyond.

So, uh, the FDA and, and globally. Yeah, well, one evidence is Vernon is very much, as I said, an empirical thing that we’ve been using for years. Centuries. It’s the way the medicine’s always been developed to some extent, but in terms of licensing licensing, as a, as a, as a cohort only came into being really a lot in the late sixties, mid sixties, uh, both here and in the States.

And globally now, as we said before, randomized controlled trials were very much the gold standard that became the gold standard, because it was a good way of doing it the statistical basis under which, uh, products were developed and certified. Very much suited that that were thinking. Now, literally in the last five, six years, that’s become understood to be, not be the best way we don’t.

We don’t catch everything. We don’t catch a safety data as much as we could. And we’ve always veered more, probably the last five to 10 years and looking at the phase four, which is post-marketing to capture that safety data, we think, well, okay. We know roughly what’s going on with the drug, but we don’t know everything, but don’t worry.

We’ll wait until we get out there and see what happens. It’s okay. And that’s been an acceptable way of working, but where, what evidence is going to come to this for literally the last year? Why? Because we know with the pandemic, we’ve had to develop something called vaccines and vaccines are very complex where working they’ve they’ve, we’ve managed amazingly.

And I was at a conference yesterday where they were discussing how quickly we got Pfizer AstraZeneca coming up with these, these amazing vaccines. And most of them are very new signs. So within you signs that we’ve had with these new, these new sort of RNA vaccines, how can we do that so quickly? We done it because of it, what evidence we’ve had to inject these things into patients, and we’ve had to see what happens.

We couldn’t wait around for six years and think, okay, we spent 2.1 billion on a new trial and then see what happens. We need to get these out. Now what’s done is done two things. First of all, it’s given us an move in Terbium thank goodness to try and depress the pandemic. But secondly, it’s given the, the agencies.

Way of looking at things they didn’t really think of before, in terms of they’ve developed new methodologies, they developed new ways of looking at licensing. Now this has become very much, uh, focused on the UK and let’s go, I’m sorry, UK century, but we all do a lot of stuff in this country. The other reason for the UK being central to this is because fortunately, or unfortunately, because of Brexit.

It’s allowed to regulate to stand back and think, okay, we can do things differently. The Europeans, so the European medicines agency, the AMA has been running the show for many, many years, and I’ve been very much part of that, but the MHR is now allowed to go out think, Hmm. Okay. Is there another way of telling it, this is what they’ve done.

So will, would evidence and the data behind it and licensing procedures accepting that data I’ve come of age. Now also, what does this mean globally? And your sat now, the FDA has also been working in the same areas. We’ve done to some extent with the commotions we saw about four or five months ago and the Europeans and America, to some extent, were they thinking like, I, I get it, but we’re not going to license.

It came because of their CMH is pushing forward. And the Europeans didn’t quite understand how the MHA is. I’m going to say quickly and the FDA, although they were much more forgiving or so didn’t quite take it on board. They now have, so the FDA are now accepting the way the MHI is driving stuff and the European study, but grudgingly, I hate it gone out in Italian.

I’ve also accepted it too. So I think it’s a much more of a global process. I think we may come on to that, but no, the licensing procedures have now caught up with science. Thank goodness. I think it sounds really promising both for patients and also Albert labs. Um, I think Graham, would you be able to just go into a bit more detailed about the work that, uh, the work that’s going on at Albert labs at the moment and how progression will continue over the study?

Uh, I’m not sure he just over the, over the next six to 12 months. Sure, sure. And I think the interesting thing to pick up on, and it was mentioned briefly at the Malcolm is that we’ve actually corralled, uh, to our joy, a very, very skilled and very knowledgeable, um, Uh, advisory board of the great and the good and, uh, uh, psychology, clinical psychology, um, and, uh, oncology palliative care.

So the whole blend of people that we need to be talking to. Uh, across the whole treatment paradigm have become advisors to us. So I won’t name names here because, um, it will be published on the website at some point what’s on our first meeting and we are our advisory board meeting. Very, very first one is that in a couple of weeks time, which is, which is super, but the real world evidence study, uh, for the moment post, the advisory board will go through a protocol development.

Which is what we’ve done already. And I say this to everyone. When I talk about this is this is not aspirational. We’ve done it before. So it’s actual, right? So we’ve done it on the medicinal cannabis site and that’s proven the template for us clearly there’s changes to us a different disease area. Uh, but we have a methodology.

We have an approach. Uh, we have to call it from a business point of view and asset light approach is we do not. We do not have. Uh, hoards of clinics and people sitting in clinics that we actually own. Uh, I’m never personally, I’m never about ordering buildings in chimney pots because they’re expensive.

Um, but we have a great relationship, uh, network reach into first-class centers in both oncology and, uh, psych psychology assisted therapies, uh, which is key to us. Um, That’s going to bring a speed to market. So advisory board protocol development, getting sign off with Malcolm’s great help there with the amateur.

Sorry. The scientific input that we required going through the process, that’s probably the lengthiest piece. Yeah. So, you know, we, we are looking, you know, COVID 19 allowing we’re looking towards the end of the year to start seeing patient footfall through our trial setup. Yeah. Now if that slips a couple of months, so be it.

But one of the questions that you know is always asked and, you know, I’m happy to answer is that because the process of real world evidence, once we’ve got all single off, once you’ve got the, the, uh, the key research centers up and running is that we would probably start to publish results in the first three or four months, albeit just interim interim results.

Okay. Uh, because we can actually start to see and start to, um, examine data at that point to tell us. What direction we’re going in because, you know, we want to stop sharing this. Um, and then probably within six, seven, eight months, we’ll start to see the, the end points, uh, uh, results in end points, uh, come to be, uh, over the other periods.

So you can see, this is really quite, uh, uh, quite a fast turnaround when you compare. I know, RCTs that run for, uh, several years. Um, the cost, many hundreds of millions of dollars, you know, I’m pleased to say, uh, that we’re, we’re not going down that route. That doesn’t mean that’s the wrong route. It’s just not our route.

Um, and we hope to get this published out there and start setting some, uh, templates, if you like for use, uh, in the clinical setting. Through, you know, the, the, the patient pathways that exist and that sort of stuff, that’s going to take longer, you know, I’m not naive or take longer, but there will be a harbored seven.

My wanting to use that term, um, uh, set in clinical practice that we’ll see, actually expand out into, into other areas. So, um, you know, speed to market. Good robust trials, try it and test it in a different disease area already with cannabis. Um, so, you know, we’re really hopeful. We’ll get results early and yes, we will publish, publish, publish, publish all the time.

Cause we want the world to see it. Yeah. It’s exciting. Exciting, lost my heart for it the over the coming months and from Albert labs. Um, and just, sorry, we only have, uh, about five minutes left, so. I’ll I’ll, I’ll just, uh, I’ll push a bit more on, on your reasoning and your justification for focusing on the UK market.

I mean, you mentioned, uh, the scale of the issue with, um, with cancer patients in the UK, uh, in terms of that mental health and also, uh, some of the national agenda items. Are there any other advanced, just focusing on the UK and starting in the UK? Well, apart from being a place, a great place to work for me, I think, I think as, as Graham said, you know, it’s, it’s the national issues in the UK.

Th th there they’re also issues. And every other country, we can’t get ourselves on that one. You know, mental health is a big issue issue globally, and cancer is a huge issue for everybody in the world. Well, I think, you know, we have amazing centers in the UK. We’re going to some of the top centers, as Graham said, we got amazing advisory boards.

We got some of the very best researchers in the world in the UK. And the other thing is that we have, so the backing of government, the UK government is very focused on research. It wants a UK to be the leaders in research and the world, if it could possibly can do, it’s got a lot more. Um, a lot more keen on that actually post-Brexit, you know, again, we were having a conversation with the secretary the other day and he very much focused on this and he said, look for goodness sake, we’re trying to give you everything we can, we can, we know you’ve done a great job with the pandemic, the AstraZeneca drug.

There’s a few questions about it sometimes, but he’s done an amazing job here and it’s a UK based company. Well, the UK based product, we’ve learned a lot from that, as I said, and the licensing authorities are being given not quite launched, but it’s given a lot of three freedom to take forward. These medicines, these new advances, and say, we’ve got a great product.

We got great advisors. We’ve got a great clinical team, great centers, a great regulator agency and a government who supportive of us. So I think of any country in the world, I think this would be the country to come to. I haven’t got anything else to add to that. Yeah. I mean, you said, Oh, but I mean, if I can use the term fit for purpose, you know, the UK or U K PLC, let’s call it right.

Is, is truly fit for purpose. You know, we’ve got all the magical centers that the Malcolm talked about or the, the, uh, It’s a great experience that we actually have in the UK, which is super cool, but also there is a change in mindsets, post Brexit, and as a result of COVID-19 where we’re seeing decisions get made for reasons of innovation.

So, you know, when you’ve got, um, uh, nice, uh, and when you’ve got a , which is a regulatory body, right. Working together for the first time, and Malcolm knows this because he was there. 20 years ago, they were talking about this. What can work closely and getting joined up processes. This is the first time in the last two months, three months.

That actually that’s the reality. Now they’re actually dealing with big data and they’re actually dealing together and they are producing innovative processes to allow us early access to medicines that says post-trial. You can actually go for your license a hell of a lot quicker rather than waiting another two years.

So, you know, I use that town fit, fit for purpose, and I use it. Educatedly that, you know, this is a good place to be as a marketer. We did well, unfortunately one at a time. No doubt. It’s a conversation that will continue to flow. And I imagine, uh, anyone who is, uh, enjoyed this panel, uh, would be able to find out more information, uh, on the Albert labs website or the social media channels.

Um, but yeah, so thank you. Uh, thank you, Malcolm. And thank you Graham for your time today. Uh, it’s really appreciated and it was a really interesting conversation. So thank you again. Thank you guys.