Hi, I’m Malcolm Barratt-Johnson. I’m the chief medical officer for Albert labs, Albert Labs is a UK based, biopharmaceutical company focused on the use of psychedelics, particularly psilocybin in psychological treatment. We’re focusing on the first instance on oncology related anxiety. Why oncology related anxiety? Because it’s an undertreated area on which we need to focus on acutely. It’s also a very urgent need for patients because it’s something which we believe up to 1.2 million patients in the UK alone need treatment for.  We’re going to be using real-world evidence.Real World Evidence is an accelerated process by which we believe we can get a license for a new medicine in the next one to two years. This is crucially important because as I said, patients are being undertreated at the present time. The present treatments are probably not as good as they could be and SSRI’s which is the standard care also probably interacts with a lot of the oncology treatments presently being used. 

My background is I trained as a medical doctor and I still am a GMC registered doctor in the United Kingdom. I trained as an anaesthetist and intensivist in London. I’ve also acted and been a fully qualified assessor for the MHRA. The MHRA is a regulatory agency for the United Kingdom. I’ve also been a medical director for a number of companies in the UK, including AstraZeneca, Pfizer, Merck Sharp and Dohme. These are commercial companies, which allow me to understand the commercial aspects of medical research and development. Combined with that I’ve also got a good understanding of the licensing process in the generality of it, including clinical trials research. So I can help Albert Labs in the sense of knowing the medical side of it, I Know the regulatory side of it, I can bring an understanding of the regulators, which maybe other people can’t quite do the same and also understand the commercial imperatives of treating patients and also the ethical requirements upon that process.

RWE is not new, it’s been in existence ever since time began and in many ways, it’s basically looking at patients in the setting in which they’re currently being treated and using the evidence to produce data in the efficacy and safety space, particularly which will allow our licensing procedure and a medicine to be used commercially. Now, how is it different from what we standardly known in terms of research, RCTs, randomized controlled trials? RCTs are a process by which you use a very small cohort, generally patients who were very well controlled, by which you can get data sets over a fairly limited timeframe. This tends to be a very expensive procedure because it’s set up particularly for that product. And also it’s an incredibly elongated process and expensive process. RWE allows us to accelerate that process enormously and get a much better data set quicker. So why haven’t we used up to this point for other conditions? It’s mainly because the agencies involved, including the MHRA in London and the FDA had a lot more experience with it recently, unfortunately, because of COVID. COVID 19 has allowed us and required us to develop new vaccines in a much more contracted timeframe and this has been using Real World Evidence to do that. So the vaccines we now have are basically RWE vaccines in that respect they’re not RCTs. If we’d have done an RCT, it would have taken us up to three or four years. We didn’t have that. So in Albert Labs, we perceive this to be and we know it to be the process by which we need to and wish to take forward our psilocybin.

In the next six months, we’re going to have the protocols up and running. We’re going to be taking those patients through the usage of the medicine, with key centres who are already working with us and that would allow us to have early access to data and allow us to publish and produce posters. But more importantly than that from the data sets that we’re going to be collecting, it would allow us to take those outputs to the licensing bodies, such as the MHRA in London and get a licensed product within the next one to two years we hope, a much more accelerated process than we would normally do with a medicine.

The benefits to using the UK as a center Albert Labs is because it has got some of the best research centres in the world, of which we’re working with at the present time. And we’re going to be working with over the next one to two years to accelerate the process for development. And also we have got one of the very best regulatory agents at the MHRA and that’s well recognised. It also the MHRA has got a very good understanding of the clinical development process. The clinical trials unit in the UK is regarded as being very proactive. It’s very pragmatic in it’s approach, and it also understands the whole area of psychedelics. as a group, it has licensed a number of these in terms of the clinical trials already. And with recent research being conducted within the UK, some of it from Imperial College in London, that’s provided a lot of base to actually take it forward in the United Kingdom.

It’s fantastic being part of the Albert Labs’ team. They put together an amazing team. Focused on the key areas of licensing and development. Patients are going to be treated with a product which has not really been researched and developed anything like as much as it should have been over the years, and to be involved in a team, which is really breaking the barriers down, not just in terms of psychological medicine, but also to some extent in cancer in this specific group of patients we’re looking at is a very, very exciting and is something which I think most pharmaceutical physicians would be very, very keen to be involved in. So why wouldn’t it be part of such a wonderful team?