Advancing Cannabinoid Prescription Medicines

We apply the traditional values of ‘diligence’ to the world of cannabinoid medicines, adopting the qualities of working carefully, constantly, earnestly and with proper attention and care on behalf of our clients.

Diligenc. provides premier global expertise in cannabinoid molecular science and pharmaceutical business development. We specialise in prescription only medicines approved by national regulatory bodies (FDA, EMA) based upon robust assessment of clinical trial data, and advise on all aspects of:

  • Prescription only cannabinoid medicines
  • Cannabinoid molecular science
  • Pharmaceutical operational and launch planning
  • Cannabis regulatory, compliance, legal and intellectual property matters
  • Investment, M&A and due diligence services for investors
  • Interim and full time C-suite & executive placement

We do not advise on cannabis cultivation, sales of cannabis products to the public, or cannabis wellness products

Diligenc. is the centre of excellence and experience in the complex world of cannabinoids.

Cannabinoid Pharmaceutical Medicines

A vibrant, novel and rapidly expanding sector with significant commercial opportunities, Diligenc. specialises in advising on the development of regulated prescription-only medicines

The progressive worldwide political and societal acceptance of cannabis derived products as mainstream and legitimate is taking shape after many formative years, creating an explosion of new companies looking to exploit all commercial aspects of the cannabis spectrum

The team behind Diligenc. Pathways

Our team is second to none in pharmaceutical cannabinoids expertise.

Diligenc. Pathways was founded by Dr Andrew Saich, Julian Bryson and Rupert Haynes. The full Diligenc. team comprises many of the formative and developmental team at the heart of GW Pharmaceuticals, responsible for the development and commercialisation of pioneering products such as Epidiolex® and Sativex®

Diligenc. Pathways’ expertise covers medical, commercial, scientific, IP, clinical research and development, market access, legal and regulatory matters.

 

Dr Andrew Saich

Medical Director

Andrew has extensive experience of international management, commercial launch planning and pharmaceutical R&D. He created and led the GW Pharma International Medical organisation in preparation for the launch of Epidiolex® and held medical responsibility for the commercialisation of Sativex®. Andrew was a member of the GW Pharma Clinical Development Committee and the Corporate Drug Safety team and led the global investigator initiated clinical studies program. Andrew holds membership of the Royal College of Physicians in the UK.

Rupert Haynes

Pharmaceutical Director

Rupert was Head of Global Marketing at GW Pharmaceuticals, responsible for strategic development of GW’s cannabinoid portfolio and commercial planning for the launch of Epidiolex®. He led pre-clinical cannabinoid drug candidates assessment and BD across neurology, psychiatry and oncology with a focus on orphan indications. Leadership roles include UCB Pharma, Bristol-Myers Squibb, and Pharmacia & Upjohn and Benuvia Therapeutics. Rupert is Global Head of Orphan Disease at Radius Health, leading global commercialisation projects and investment transactions and corporate acquisitions.

Julian Bryson

Operations Director

Julian founded life sciences technology firm Sterilox Technologies, which specialises in the development of IP backed novel biocides and endoscopy sterilising solutions used in 45% of NHS hospitals, and was acquired by Cantel Medical Corp (now Steris Corp). Julian was Chief Operating Officer at venture capital firm EI Capital based in Palo Alto, Paris and London, and in 2018 co-founded Esolate Ltd, a Toronto, Canada based patent pending cannabinoid technology developer, specialising in the formulation of cannabinoid API’s for use in medical and pharmaceutical applications.

The broader Diligenc. Pathways team comprises:

Head of Cannabinoid Science

Former R&D Operations Director at GW Pharma for over 16 years, intimately involved in the MAA submission and approval of Sativex® in Europe and the submission of the Epidiolex® regulatory dossier to the Federal Drugs Authority for approval

Head of Intellectual Property

20 years building the GW Pharma IP portfolio with over 100 patent families which underpins the worldwide rights of the leading cannabinoid pharmaceutical company, and acting as IP attorney to both Compass Pathways (the world’s leading psychedelics-derived medicine company) and to Atai Life Sciences (the world’s leading psychedelics related investor group)

Head of Regulatory Affairs

An expert in regulatory affairs, medical information, pharmacovigilance, product development, compassionate-use programmes and cannabis products experience, and supported GW Pharmaceuticals with their launch planning for Epidiolex in Europe

Head of US Markets

Established the pharmaceutical research and development group at one of the world’s largest commercial cannabis companies. Previously he was one of the first GW Pharmaceuticals employees in the USA, where he set up the medical department and initiated the clinical research group investigating novel cannabinoids. During his time at GW he also worked on Phase 3 clinical trial protocols, Investigator-initiated research projects and University research collaborations. He is a keynote speaker at cannabinoid and scientific conferences, provides scientific training at University grand rounds and is a lecturer at a major University in the US. He is a co-founder of the Cannabinoid Education Working Group and a contributing member of the International Cannabinoid Research Society, American Epilepsy Society and the American Academy of Neurology

Head of Public and Political Affairs

A senior international business leader with more than 30 years experience in the pharmaceutical industry and has headed international teams in both Europe and Asia-Pacific. He has created and managed cross-functional commercial teams (with P&L responsibilities) and developed associated supply chains, quality systems and compliance monitoring strategies. He has worked in both early-stage and established pharmaceutical companies and has significant experience in orphan diseases, neurological disorders, and the commercialisation of cannabinoid medicines. In addition he has lead European public and political relations teams developing the cannabinoid narrative and responding to events within the cannabis sector

Head of Business Management

A decade of experience with some of the largest global pharmaceutical companies. He is experienced in finance, strategy and global operations, whilst acting as EU Head of Business Development and Strategy at Pfizer. His senior managerial positions include with PepsiCo, where he focused on operations in Canada, the US and the UK. He was Managing Director of the leading US-EU cannabis commercialisation specialist Materia Ventures

Head of Legal Affairs

A leading legal expert in UK & EU laws surrounding cannabinoids in both medicinal and consumer use. Experienced in manufacturing & supply chain contractual infrastructure, consumer product licensing & operational compliance she brings 15 years’ experience in the pharmaceutical, medical device and consumer well-being sector. UK and EU legal & compliance roles include at MSD, Bristol Myers Squibb, Novartis, Novo Nordisk, Merck Serono and Illumina

Head of Clinical Development

Thirty years experience across pre-clinical drug development and all phases of clinical research. Has lead drug development activities across multiple therapeutic indications including cannabinoid therapeutics for both large and small pharmaceutical companies

Head of Inhaled Cannabinoids

A Cambridge Master’s Graduate in Chemical Engineering he has worked on the development of inhaled medicinal products since 2011. Successfully achieved a Marketing Authorization for an inhaled nicotine replacement therapy, and created a novel prescription-only THC-inhaler for the UK Specials Market. An expert in establishing R&D functions as well as inhaled cannabinoid clinical programs

Head of CRO Operations

A trained physician and a specialist in cardiac anaesthesiology. He is a Research Fellow and an expert in the development and commercialisation of cannabis derived medicines. An experienced Chief Medical Officer at listed drug development companies, and CEO at a leading prescription-based cannabis treatment group with early clinical research facilities for novel cannabinoids. An international speaker on cannabinoid medicines at both academic and industry meetings

Recent projects

Strategic review for clinical indications and appointment of a CRO for Phase I trials of CBD assets: USA

Development of a business strategy and clinical development pathway advice for a leading branded food products company to integrate pharmaceutical grade cannabinoids into EMA approved prescription products: UK and Germany

Technical due diligence services for a private equity acquisition of a regulated cannabinoid CDMO: USA

IP, regulatory and commercial due diligence and development of business plan for a SPAC acquisition of an FDA approved cannabinoid asset suite; UK and USA.

Diligenc. Pathways Ltd

Diligenc. Pathways Ltd can advise on: Prescription only cannabinoid medicines, Cannabinoid molecular science, Pharmaceutical operational and launch planning, Cannabis regulatory, compliance, legal and intellectual property, Investment, M&A and due diligence services for investors, Interim and full time C-suite & executive placement

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Diligenc. Capital Ltd

Diligenc. Capital Ltd advises funds, investors and pharmaceutical businesses on capital deployment into the pharmaceutical cannabinoids sector. To find out more about our investment advisory services, investment criteria, or to discuss your business plan and funding requirements with us, please contact us.

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