DECALOGUE
IDEAS TO ACCELERATE PATIENT ACCESS & THERAPEUTIC UNDERSTANDING OF MEDICINAL CANNABIS
AN INTRODUCTION
As we pass the third anniversary of the rescheduling of medical cannabis for therapeutic use in the UK, it is prudent to reflect on the positive changes that have ensued.
For a small number of patients medical cannabis treatments are now available on the NHS and access outside of the NHS is effectively expanding with costs falling for patients. The general population, including the medical profession, are supportive of cannabis-based medicines and we have publicly seen some of the life-changing effects these treatments can have on children with intractable epilepsy.
Whilst we should celebrate these successes, we should also acknowledge that there is much work to be done. If we want to accelerate NHS access for all patients who may benefit from these treatments, we need to think outside the box. This requires direct engagement and inter-disciplinary collaboration between policy-makers, regulators, industry, scientists, healthcare workers and patients.
Learning from COVID-19, I sense that there is great support from all relevant stakeholders to redefine and modernise processes of drug development and medical cannabis could be the poster-boy of this new normal as we emerge from the pandemic. The issues, ideas, concepts, and proposals outlined in these essays represent the first step of this journey and signal a bright future for this growing sector.
On that note I would like to warmly welcome you to the Great Hall at Imperial College London and the official launch of Decalogue. I hope it will be an inspiring day and I would like to thank the team at the Centre for Medicinal Cannabis for putting together this exciting pamphlet and congratulate them on their ongoing efforts to innovate and break down barriers in this emerging area of medical therapeutics.
Dr Mikael Sodergren MBChB(Hons), DIC, PhD, FRCS
The Decalogue Articles
The Decalogue Contributors
Dr Mikael Sodergren
Dr Mikael Sodergren
Dr Sodergren is a Senior Clinical Lecturer and Consultant Hepatobiliary & Pancreatic Surgeon at Imperial College London. At Imperial he leads the Medical Cannabis Research Group, whose research focus on novel therapies targeting the endocannabinoid system through a framework of in vitro, in vivo, and clinical translational activities. He is co-founder and Managing Director of Sapphire Medical Clinics, the first integrated medical cannabis clinic to be granted registration by the Care Quality Commission in the UK and he is also the Research Director at Curaleaf International where he leads the pre-clinical and clinical medical cannabis research programmes.
Dr Parveen Bhatarah
Dr Parveen Bhatarah
Dr Parveen Bhatarah, PhD, FRSC, completed her PhD in organic chemistry from Imperial College London and is a Fellow of the Royal Society of Chemistry. She has held various directorship roles in the generic and herbal pharmaceutical industry with over 20 years of expertise within the international pharmaceutical industry & regulatory environment.
She has over 12 years experience in the Medicinal Cannabis industry, covering everything from cultivation to FDA approval of finished medicinal products. She has expertise in Product Development and has worked closely with international health authorities for various commercial Pharmaceutical product submissions, clinical trials and launches. She has been responsible for setting up cGMP facilities for MHRA & FDA approvals globally and her innovation to commercial launches can be seen by Parveen’s patents, especially in the cannabis and herbal sector. She has been responsible for maintaining industry-university relationships specifically with University of Liverpool, Imperial College London, Queen Mary, Durham and Birmingham University.
ARTICLES
PRIORITISING CLINICAL STUDIES AND REGULATORY REVIEWS OF CBPMS
DEVELOPING CANNABINOID SCIENCE IN THE UK: MOVING FROM THE SECURITY TO THE HEALTH DOMAIN
Professor Trevor Jones
Professor Trevor Jones
Trevor Mervyn Jones, CBE PhD DSc (Hon) FRCP FMedSci FBPhS FRSM FRSC FLSW a visiting professor at King's College London, and a former Head of R&D, at Wellcome. He continues to have a distinguished career in the pharmaceutical and biotech industry as well as in academia.
He was main board director for Research & Development at The Wellcome Foundation Ltd (Wellcome plc). During his tenure, the organisation was responsible for the development of a number of significant products. He was not only involved in the introduction of the HIV/AIDS drug AZT at his time with the Wellcome Foundation but also its pricing in the USA/EU and liaison with the South African Government over patents.
ARTICLES
PRIORITISING CLINICAL STUDIES AND REGULATORY REVIEWS OF CBPMS
Dr Andy Yates
Dr Andy Yates
Andy Yates, PhD has served as Artelo’s Chief Scientific Officer since January 2021. Dr. Yates has more than 15 years experience in the pharmaceutical industry including 10 years as an executive at AstraZeneca. He held key roles within the medical affairs, commercial, business development and strategy functions for AstraZeneca’s medicines portfolio. Dr. Yates is a UK registered pharmacist who received his PhD in cannabinoid medicinal chemistry from the University of Nottingham. He serves as the Pharmacy Lead for the ACI/CMC, a scientific advisor for Dragonfly Biosciences and holds a lectureship at Keele University.
ARTICLES
DEVELOPING CANNABINOID SCIENCE IN THE UK: MOVING FROM THE SECURITY TO THE HEALTH DOMAIN
Dr Paul Dickinson
Dr Paul Dickinson
Paul has held several senior science leadership roles in Academia and Large Pharma. These roles focused on applying the best science in projects to ensure optimal product performance in the patient, thus bridging pharmaceutical and clinical disciplines.
Paul has extensive early development, late development and drug registration stage experience. This experience includes the delivery of several products to approval and commercialization and compounds awarded breakthrough status.
Paul has an international scientific reputation and has been at the forefront of recent technical and regulatory advances in the understanding of dissolution testing and pre-defining in vitro performance criteria that assure drug product performance in the patient (clinically relevant dissolution).
Paul is CSO and co-founder of Seda Pharmaceutical Development Services, a company providing pharmaceutical development and clinical pharmacology services and consultancy to the Pharma Industry.
Paul has successfully developed, exploited, and out-licensed technologies and has published extensively.
ARTICLES
DEVELOPING CANNABINOID SCIENCE IN THE UK: MOVING FROM THE SECURITY TO THE HEALTH DOMAIN
Steve McConchie
Steve McConchie
Steve McConchie has nearly 30 years of clinical drug development experience including 25 years with AstraZeneca, where he gained valuable global experience delivering numerous oncology and haematology clinical development programmes with small molecules and biologics. Since co-founding the full-service contract clinical organisation Aptus Clinical he and his expert teams have continued to support the design, conduct and delivery of innovative early phase oncology, cell therapy and rare disease clinical studies for a broad range of life science and biotech clients. He is a member of the Advanced Therapy Treatment Centre Industrial Advisory Board and a member of the Scientific Innovation and Advisory Committee of the Bioindustry Association. He has a PhD in Biochemistry from Liverpool University.
ARTICLES
DEVELOPING CANNABINOID SCIENCE IN THE UK: MOVING FROM THE SECURITY TO THE HEALTH DOMAIN
Dr Daniel Couch
Dr Daniel Couch
Dr Couch is a fully registered specialist registrar in General Surgery working in the UK with 14 years clinical experience. After completing his PhD in cannabinoid pharmacology, he has gone onto speak internationally on cannabinoid medicine and policy. Author of 15 scientific publications featuring those on the role of cannabinoids in health & disease, Dr Daniel Couch has a special interest in cannabinoid medicine, clinical research and policy development
ARTICLES
THE NEXT STEP – SUPPORTING CANNABINOID PRESCRIBING IN PRIMARY CARE
Pierre van Weperen
Pierre van Weperen
Pierre van Weperen is CEO of Grow Pharma Ltd. He has over 30 years experience in pharmaceutical industry. Starting in sales he moved across to marketing roles in the mid 90s and took up his first business unit director role in 2000. He has extensive experience in both primary and secondary care, in the acute setting and in chronic diseases. He worked in the Netherlands for Servier, Lederle and Wyeth and from 2007 in the UK with Wyeth, MSD and Novo Nordisk. Pierre has an excellent understanding of the U.K. healthcare system and before joining Grow Group plc in November 2019 to manage the Grow Pharma joint venture with IPS Specials, he was managing director U.K. for Ashfield Commercial Services, the largest contract services organisation in the UK. Pierre lives in London with his wife Freda and their daughter Isabella. He is a keen golfer and the couple love ballroom dancing.
ARTICLES
TEN YEARS ON: WHAT WE ACHIEVED IN MEDICAL CANNABIS
EXPORT-LED GROWTH FOR THE UK MEDICAL CANNABIS INDUSTRY
Hari Guliani
Hari Guliani
Hari Guliani leads Columbia Care International, which is part of Columbia Care – a company established in 2012 in the USA, where it has developed significant experience in medicinal cannabis. Alongside this, Hari retains a non-executive role with Lumino, a recruitment consultancy that he co-founded focused on the legal cannabis industry in Europe. Hari has been involved in the medicinal cannabis space since 2018 when he established a market-leading UK business as COO of a UK start-up and worked on the pioneering first bulk import of medicinal cannabis flower to the UK. Before joining the sector, Hari started his career as a M&A and Corporate Finance lawyer and subsequently spent time as an independent consultant working on a range of topics for companies from start-up to FTSE 250.
ARTICLES
A RISK-BASED APPROACH TO CANNABIS
Jonathan Hodgson
Jonathan Hodgson
Jonathan Hodgson is the CEO of Rokshaw Laboratories and UK Country Manager for Curaleaf International. He Co-Founded Rokshaw Laboratories in 2012 and have been in the healthcare sector since 1999 holding senior roles at Smiths Medical, Johnson and Johnson and Cardinal Health. Involved heavily in the medical cannabis sector for the last 3 years through import, manufacture and product development.
ARTICLES
EXPORT-LED GROWTH FOR THE UK MEDICAL CANNABIS INDUSTRY
Dr Ayesha Mian
Dr Ayesha Mian
Ayesha Mian is a medical doctor with a background in drug policy reform, combining public health and social justice expertise. Her interest in medical cannabis developed after completing a literature review on the 'Therapeutic Opportunity around the Endocannabinoid System' a decade ago. Since then Ayesha began a lifelong exploration of the impact of drug policy on society. From international grassroots advocacy work, to presenting and chairing sessions at the United Nations Commission on Narcotic Drugs, she has gained a range of insights into multidisciplinary approaches to drug policy reform. She has a special interest in the equitable and public health based development of the medical cannabis industry.
ARTICLES
MEDICAL CANNABIS AFTER THE PANDEMIC: ADDRESSING LONG-STANDING INJUSTICES AND HEALTH INEQUALITIES
Carly Barton
Carly Barton
Carly Barton was the first person in the UK to receive a prescription for cannabis privately when the law changed in 2018 and has become the leading cannabis campaigner, advocate and patient in the UK.
She is also the Founder of Cancard, the UK’s first patient medical cannabis identification card, which now has over 50,000 patients registered and is successfully decriminalising the most vulnerable, and reducing the possibilities of criminal convictions for possession of cannabis.
Carly is working with government organisations in the hope of converting cannabis availability into NHS prescriptions, setting precedent for other patients.
ARTICLES
THE THIN BLUE LINE OF POLICING CANNABIS
Alfredo Pascual
Alfredo Pascual
Based in Germany, Alfredo is a prominent cannabis industry analyst who has been identifying opportunities and generating unique insights for businesses and investors in Europe and Latin America since 2016.
He is currently VP of Investment Analysis of Seed Innovations Ltd (LON: SEED), the AIM quoted company investing in fast growing and industry leading businesses with a focus on the medical cannabis, health and wellness space.
Before joining Seed Innovations, Alfredo worked as International Analyst at MJBiz, the leading US-based B2B resource for the cannabis industry, where he focused on covering how markets and investments were evolving internationally.
Alfredo has a Bachelor of Business Administration and a Master of Governance and Public Policy.
ARTICLES
DRIVERS OF PATIENT GROWTH IN GERMANY
Dylan Kennett
Dylan Kennett
Dylan is a Senior Associate in the London Corporate department of DLA Piper. He has deep expertise in venture capital, as well as domestic and cross-border mergers & acquisitions and private equity transactions. He is a trusted advisor for fast growing companies and helping them ‘go global’. His practice encompasses the technology, media, sport, entertainment and cannabis sectors.
Dylan is Co-Head of DLA Piper’s Global Cannabis Practice. The practice sits as a sub-group under the firm’s Life Sciences sector and provides full-service advice with specialist cannabis sector knowledge in over 20 countries globally across DLA Piper. The practice serves cannabis clients across a wide spectrum of issues, but has particular expertise in cross-border M&A, private and public equity financing, as well as deep expertise in the rapidly evolving global regulatory frameworks.
ARTICLES
THE PROCEEDS OF CRIME ACT 2002 AND ITS IMPACT ON CANNABIS INVESTMENTS
Blair Gibbs
Blair Gibbs
Blair Gibbs is a political advisor and consultant. His expertise is public policy, political communications, and government affairs. For 15 years he has focused on criminal justice, drug policy and public safety.
Blair is currently the North America head of PF Strategy and also writes for TheHub.
Decalogue Acknowledgments
Decalogue owes its existence to many hands and minds.
The inspiration for this report came from our founder Steve Moore who felt the time was right to publish new ideas such as these. To each of the contributors we are grateful for the time and intellectual investment. Blair Gibbs worked the ideas hard and managed the editing process with typical aplomb. Victoria Logan shepherded the authors along and ensured that deadlines were met and the launch a success. Tom Risby helped with research and Roisin Delaney and Bill Griffin helped us spread the word. Finally Peter Ratcliffe brought the report to life online and conjured the brand out of thin air.
With my gratitude to all.