CSCS Expert Community open meeting

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Date/Time
Date(s) - 06 Jun 2018
3:00 pm - 4:30 pm

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CSCS Expert Community Meeting

The Development of a Schedule 1 Substance: from manufacturing to clinical research.

We are very pleased to welcome Dr Stephen Wright, Senior Medical Adviser and former Chief Medical Officer GW Pharmaceuticals, as guest speaker at the June CSCS Expert Community meeting.

This presentation will explore and describe some of the more complex and challenging aspects of the development of a Schedule 1 drug, with particular reference to the USA.

This is an open meeting where all are welcome. Please email claire.bellamy@pistoiaalliance.org for connection details if you would like to attend.

Further details below:

Abstract
On April 19th, the Peripheral and Central Nervous System Drug Advisory Committee of the FDA voted unanimously (13 to 0) that cannabidiol (CBD) oral solution should be approved for the treatment of patients aged 2 and up with one of two rare child onset paediatric epilepsy syndromes, Dravet and Lennox Gastaut. Cannabidiol, a component of the cannabis plant, which has been developed as a medicine by GW Pharmaceuticals is in Schedule 1 of the Controlled Substances Act. This places significant barriers in the way of a conventional drug development process.
Prior to the US Advisory Panel vote, GW had also succeeded in gaining approval in 31 countries ex-US for their product, Sativex, a botanical extract comprising 2.7mg/mL of THC, and 2.5mg/mL of CBD, in a complex mix of other plant components. As a consequence of these 2 products, GW has developed a unique expertise in the development of Schedule 1 drugs.
On both sides of the Atlantic, and elsewhere, government licenses are required at all stages of the development cycle. So possession of a blood sample containing a Schedule 1 substance would be illegal without a license. On the production side, any CMO involved in the manufacturing process must be licensed by their own government – this can lead to interesting difficulties when the substance in question is Schedule 1 in one country but unscheduled in another (e.g. cannabidiol in France and in the UK). Similar issues apply to all stages of pre-clinical development, including bioanalytical stages.
In clinical development, each investigative site must be licensed to work with Schedule 1 substances, separately for each protocol. For example, the DEA requires formal notification from FDA that a protocol has been ‘authorized’ to proceed by FDA. Hence a DEA license cannot be requested until some form of paperwork has been generated by FDA.
The wheels of government can turn slowly, with the consequence that the gap between first patient into a study and protocol completion can be very long. This bureaucracy can also impact the timelines of manufacturing, especially as the receiving nation has to issue an import license, followed by the despatching country issuing an export license.
This presentation will explore and describe some of the more complex and challenging aspects of the development of a Schedule 1 drug, with particular reference to the USA.

Biography
Dr Stephen Wright has more than 25 years of experience in medicines development, having worked on both sides of the Atlantic, in large and small pharmaceutical companies. He was Chief Medical Officer and a member of the main Board of Directors of GW Pharmaceuticals plc from 2005 to 2017, and is currently Senior Medical Adviser to the company. He joined GW from Ipsen, where he was Senior Vice President of Clinical Research & Development and a member of the UK Board of Directors. In this role he led teams responsible for regulatory success in both the US and EU. Dr Wright has direct US drug development experience, firstly as Medical Director of Immunosciences, where he played a leading role in the approval of the first ‘second-generation 5 lipoxygenase inhibitor, then Venture Head of Neuroscience at Abbott Laboratories, based near Chicago. He also spent some years at Glaxo in the UK as Associate Medical Director with special responsibility for sumatriptan and for the Glaxo range of topical steroids. His industry experience started when he joined Scotia Pharmaceuticals as Director of Immunology, Inflammation and Dermatology Research in 1988. He has experience across a range of therapeutic areas, but his particular expertise lies in the fields of neurology, neuro-endocrinology and oncology. He has taken a leading role in achieving marketing authorisation for several innovative medicines on both sides of the Atlantic, including gamolenic acid, sumatriptan, fluticasone, sertindole, zileuton, ritonavir, lanreotide, triptorelin, botulinum toxin A and most recently Sativex.
Dr Wright has a Masters degree in Social and Political Science from the University of Cambridge, where he also won a ‘Blue’ for representing the University at Cricket and Soccer. He qualified in Medicine (MB BS) at The Royal London Hospital. His other higher degrees include an MD, also from The University of Cambridge, where he investigated the contribution of membrane long-chain fatty acid abnormalities to the immunological status of people with atopic disease.. He has a Diploma in Pharmaceutical Business Administration from The Wharton Business School. He is a Fellow of the Royal College of Physicians of Edinburgh, and was elected to Fellow of the Faculty of Pharmaceutical Medicine in 2000. Dr Wright has also been elected a Fellow of the Royal Society of Medicine. His early medical career in the NHS culminated in him becoming Consultant Senior Lecturer at The Royal Free Hospital School of Medicine. He is a Visiting Professor in the School of Chemistry, Food and Pharmacy at The University of Reading. He has authored more than 100 publications, and several book chapters.

Posted in Pistoia Alliance.