Transatlantic Psychedelics: drug developers without borders
Juan Trippe, the architect behind Pan America, was one of the first to understand the importance of cultivating relationships with airplane manufacturers, politicians and consumers. Under his charismatic leadership, Pan America achieved the first commercial Transatlantic flight in 1939 and revolutionised the quality of service.
No air routes are more travelled and more important in the Western world than those connecting North America and Europe. Since the beginning of commercial air travel, airlines have been pushing to find ways of flying transatlantic routes to link the two industrial centres of the world.
It took many years for the aviation industry to build the capacity for long-haul flights due to infrastructural and political limitations. Nevertheless, this expansion created immense value for all stakeholders and ultimately drove globalisation. The psychedelic ecosystem’s expansion follows this evolution of the aviation industry – expanding domestically to international and transatlantic operations.
In a globalised world, clinical research isn’t limited by distance or regulations in a given jurisdiction. In a regulatory environment where regulators from different jurisdictions recognise each other's data to grant market approval, drug developers are free to choose where they conduct clinical trials.
Global drug development and multi-regional clinical trials have long been the norm to reduce the time lag of launch in key markets. The FDA reports that the percentage of clinical trial applications that contained data from non-US studies jumped from virtually nothing to 80% between the early 1980s and 2008. Within these applications, Western Europe accounted for 58% of participants and 60% of foreign sites. We now observe similar globalisation trends in the psychedelic sector.
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With the emergence of local ecosystems in countries such as the UK, Switzerland, Canada and the US, Europe and North America established themselves as the centres of psychedelic research and development. Linking these two centres through Transatlantic collaborations is an important step forward for a global psychedelic ecosystem that brings more value to drug developers than the local ecosystems alone.
Drug developers already cross the Atlantic to take advantage of the different ecosystems’ offerings. We look into the main reasons drug developers are willing to operate across the Atlantic.
Patient recruitment and regulatory environment
Achieving the sample size and diversity required for the later stages of clinical development is a challenge widely reported by psychedelic drug developers. To be able to hit their target numbers for patient recruitment developers are opting for multi-site, multi-country trials. The recently published phase IIb psilocybin study by COMPASS Pathways, the largest of its kind, involved 233 patients and was delivered in 22 sites across Europe and North America. Researchers from University Hospitals in Netherlands to psychiatric institutes in the US brought Compass’ trial to completion.
A growing number of drug developers are conducting multi-regional studies as psychedelic drugs progress into phase II and III. Clairvoyant, a biotech company based in Canada, aims to be the first company in the world to obtain market authorization for psilocybin in the EU, the UK, and Canada for alcohol use disorder (AUD) and planning a phase IIb trial in multiple countries.
The specific measures required by different jurisdictions can significantly increase the cost of running trials. For instance, Health Canada recently issued a notice requiring drug developers to provide sufficient therapy before and after the dosing session, the presence of at least two therapists and the option of overnight stays. This guidance is likely to result in drug developers migrating to other jurisdictions to reduce trial costs.
Drug developers are willing to operate across the Atlantic to benefit from more enabling regulatory environments. The UK is leading the way in reforming its regulatory guidelines to accelerate drug development. It is possible for psychedelic trials to receive regulatory approval under 8 weeks and skip phase I if a compelling rationale is provided.
As the most cosmopolitan urban city in the world with access to 20M people within a 1.5h train ride, London is also a desirable location for patient recruitment. That’s why many North American companies are already picking the UK to increase the speed and cost-effectiveness of running trials. Clerkenwell Health is working with a number of North American companies to support them in their regulatory engagement and deliver trials in our London-based custom-designed facility.
Commenting on their recent application to the MHRA, the CEO of Mindset, James Lanthier, says, “We have found the MHRA to take a progressive, proactive view of clinical psychedelic research, creating certain advantages to sponsoring trials in the UK. The MHRA were receptive to Clerkenwell’s arguments allowing us to accelerate drug development even quicker than we anticipated.”
Academic collaborations and fundraising
Collaborating with research institutions that have a heritage of psychedelic research brings many advantages to drug developers. MindMed’s partnership with the world-leading psychedelics research group at University Hospital Basel in Switzerland gives them access to the data, compounds and patent rights the Swiss lab generated over a 10-year period. The UK is another hub of academic research in psychedelics with many universities and academics collaborating with commercial drug developers including Imperial and King’s College London.
Raising funds is an essential activity for psychedelic companies which benefits from tapping into the psychedelic ecosystems in different countries. Indeed, we see many companies based in the UK, including Compass Pathways, Small Pharma and Awakn to go public on the stock markets across the Atlantic. Venture capitals also invest in companies based on either side of the Atlantic - a win-win situation both for the investors and drug developers.
The European Director of Psyence, Xan Morgan says, “The UK capital markets are dynamic and a global leader, with enormous attraction to investors looking at this important sector.” Psyence is listed on the Canadian stock exchange, planning its first clinical trial in the UK and operating a federally licensed psilocybin production facility in Southern Africa. Morgan adds, “Our presence in key geographies, such as the UK, also ensures we can grow our network of strategic partners as we continue to pioneer the use of natural psychedelics.”
How Clerkenwell Health facilitate global research
Patient recruitment, multi-site communication, regulatory engagement and supply chain and data management are among the complexities that challenge any psychedelic study. These issues are compounded when trials are conducted across different countries and jurisdictions.
Clerkenwell Health can lead the development of regulatory submission dossiers across the main jurisdictions including FDA, MHRA and EMA. We can manage trials across multiple locations through our trusted partners and vendors based on both sides of the Atlantic. In addition to our London-based clinical trial unit, we have an international network of sites with experience delivering psychedelic trials. We are already assisting our clients in regulatory proceedings with both the FDA and MHRA.
Commenting on the value of applying to both the UK and the US, Nick Kadysh, CEO of PharmAla Biotech says, “Regulatory policy in the study of psychedelics is advancing rapidly on both sides of the Atlantic. All clinical research is global; countries have two potential levers to attract that research to their jurisdictions: lower costs, and smart regulatory policy relating to clinical research. When attempting to set up trials in a new jurisdiction, the biggest initial hurdle is finding good, trustworthy advisors to help you get the lay of the land. We've been lucky in that regard.”
A partner who can navigate the different regulatory environments in an efficient manner and able to manage trials across multiple locations is key to avoiding delays caused by regulatory requirements as well as the parties delivering the site, therapy and other third-party services. Working with a single partner is crucial to ensuring consistency across markets and cost-effectiveness when running trials.
