Clerkenwell Health’s story began long before 2021. The founders have been working together for most of the last decade.
Psychedelic science roots
While undertaking his chemistry PhD at Oxford, Clerkenwell Health’s co-founder Dr Henry Fisher began working at the renowned UK psychedelic-focussed NGO, The Beckley Foundation. After completing his PhD, Henry started working at Volteface, the UK’s first drug policy think tank, before founding a regulatory strategy consultancy.
A meeting of minds
Here, Henry met Tom McDonald. Tom had spent 10 years working with some of the biggest names in pharma (at Accenture then medtech giant IQVIA) with a focus on patient-centric care and clinical data. They began developing plans for a mental health startup that would put patients at the heart of everything it did.
Building Clerkenwell Health
Clerkenwell Health founders: Sam Lewis (CFO), Dr Henry Fisher (CSO) and Tom McDonald (CEO)
Launched in early 2021, we’ve signed exciting clients, and built a team of dedicated experts.
Clinical Team
We built out the team with clinical, psychiatric and psychedelic specialists who are able to support our clients’ trial design and delivery.
Senior Trials Manager - Clare Knight (Cambridge University’s Psychiatry Department)
Therapy Lead - Sarah Bateup (Compass Pathways and ieso Digital Health)
Psychiatrist & Principal Investigator - Dr Paul Morrison (King’s College London’s Psychiatry Institute)
Clinical Director - Dr Iain Jordan (Oxford University and its NHS Foundations Trust)
Place
2021 saw a shifting policy landscape and some major positive developments for drug developers looking to bring psychedelic drugs to market.
Post-Brexit, the UK government is developing a more globally competitive framework for clinical trials with the introduction of the Innovative Licensing and Access Pathway – similar to the FDA’s fast-track designation that reduces the time to market innovative medicines. They have already granted an Innovation Passport for DMT-assisted therapy for Major Depressive Disorder.
The UK is becoming a hub for market leading psychedelic companies, from Compass Pathways to Small Pharma and Beckley Psytech, the largest companies and the most highly anticipated drug candidates are being discovered by British drug developers.
Progress
2021 was momentous for Clerkenwell Health, and laid strong foundations for the challenges that lie ahead.
We signed our first two clients (Octarine Bio and Psyence) in the Summer with multi-year contracts to design and deliver phase I & II trials.
Read more about our progress in Forbes, This is Money, Mental Health Today, and The New Statesman.
2022 saw major milestones proving our concept and solidifying our position as a leading player in the field.
We opened Europe’s first commercial research site dedicated to psychedelic trials, grew our team and signed additional clients.
The Guardian, The Times and Evening Standard, Sifted and more covered our work.
Trends
These are some of the key trends to expect in 2023 and beyond.
UK Ecosystem: Strengthening of the commercial research infrastructure in the UK through increased efficiencies and collaborations in different parts of the ecosystem.
Normalisation: Further mainstreaming of psychedelics both within the media, and also within public and private research funding.
Competition: Differentiation between drug developers specialising in different indications, protocols, derivatives of psychedelic compounds and production methodologies.
Set & Setting: Increased focus on the broader components of psychedelic-assisted therapies, from music and therapy modality to supporting technology and environment.
Growing debate: Critical focus on the quality and ethics of trials, access to psychedelic treatment and IP in psychedelic therapies and drug development.
Policy shifts: Continued deregulation of psychedelics in regions of Canada and the US while access in Europe remains through the pharmaceutical route only.
Refinement: Emergence of unsuccessful clinical trials due to poor study designs and protocols as well as the investigation of conditions not suitable for psychedelics.