Slide 1 © PharmOut 2018

Australian Medicinal Cannabis

Trevor Schoerie - Managing DirectorAugust 2018

Pharma 4.0

The future belongs to whoever sees it first.

Let’s start looking - Jason Clarke

Slide 2 © PharmOut 2018

The politics of Medicinal Cannabis

2014

Mr Abbott has “no problem” legalizing cannabis for medicinal purposes, amid state government moves to decriminalize the drug for terminally-ill patients.

“I agree that the regulation of medicines is a thicket of complexity, bureaucracy and corporate and institutional self-interest. My basic contention …….”

2016

Reducing the burden of regulation and red tape is one of the Government’s top five priorities, with a stated reduction target of $1 billion per annum. The regulatory reform agenda is guided by the principle that regulation should not be the default for dealing with public policy issues.

Slide 3 © PharmOut 2018

The regulations

2015

Bill Turner (ex TGA) takes over as the head of the Office of Drug Control

2016

Government approves new legislation and issues the “ODC regulations”

2017

“First movers” start getting licenses and start growing and extracting

2018

Minister Hunt announces intent to permit “export sales”

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Change in “poisons” scheduling SUSMP cannabis and derivatives?

• Schedule 9 – Restricted drugCannabis

• Schedule 8 – Controlled DrugCannabis (for medicinal use)

• Schedule 8 - Controlled drugTHC

• Schedule 4 – Prescription only drug

•June 2018, when the WHO expert committee meeting to consider removing CBD from schedules altogether?

CBD (>98%)

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Where are we now? – after almost 2 years1059 patients have received approval for treatment

Legal to produce Medicinal Cannabis since “Oct 2016”

• ODC license, State Poisons license, TGA license

• Available through the SAS, AP and Clinic Trials (CTN/CTX)

• TGO 93 only but all other TGO’s too

• 6 to 18 months ODC there 6 to 18 months TGA

ODC Licence type Number of licences granted

Medicinal Cannabis Licence (cultivation and production) 18

Cannabis Research Licence (cultivation and production) 10

Manufacture Licence 13

The following table is updated regularly to reflect the number of cannabis related licences that have been granted under the Narcotic Drugs Act 1967since November 2016.

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Site selection

• Dependant on plant genetics & patient final dosage form

• Whole bud or a highly purified API

• Broadacre, glass house or indoor

• Rural or in-the-city

• GMP “line” – where does (Australian) GMP start?

• Council restrictions –

• CGD 1km separation pharma plants & residents rule,

• “processing” - strawberries – punnet or jam

• Water – potable

• BUT energy but be the main consideration

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BOM – data 133 million data points

TemperatureHumidity Sunshine

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BOM – data 133 million data points

TemperatureHumidity Sunshine

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What is (medicinal) cannabis?

Two of at least 113 cannabinoids identified in cannabis plants.

Tetrahydrocannabinol (THC)

Medical benefits

• Sleep and drowsiness

• Appetite stimulant

• Painkiller

• Anti-emetic

• Muscle relaxant

• Euphoria and relaxation

• Psychotic

Cannabidiol (CBD)

Medical benefits

• Reduces Dravet seizure

• Painkiller

• Neuroprotective

• Anti-anxiety

• Anti-convulsant

• Anti-inflammatory

• Anti-psychotic

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Some approved medicinal cannabis products

Sativex (EU/AU) - MS Epidiolex (FDA) - Dravetsyndrome (epilepsy)

Marinol (US FDA EU) Nausea

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Endocannabinoid System

Dr. Raphael Mechoulam

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Edibles

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Economics

# City Country Legality US$/gram

1 Quito Ecuador Partial 1.34

2 Bogota Colombia Partial 2.2

3 Asuncion Paraguay Partial 2.22

4 Jakarta Indonesia Illegal 3.79

5 Panama City Panama Illegal 3.85

6 Johannesburg South Africa Illegal 4.01

# City Country Legality US$/gram

120 Tokyo Japan Illegal 32.66

119 Seoul South Korea Illegal 32.44

118 Kyoto Japan Illegal 29.65

117 Hong Kong China Illegal 27.48

116 Bangkok Thailand Partial 24.81

115 Dublin Ireland Illegal 21.63

Thanks to http://weedindex.io

Ecuador US$1.34 per gram

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The forum is about….

Cannabis

• How to grow cannabis and make medicinal products

• Unlocking medicinal benefits of cannabis

Collaboration

• Local considerations, climate, labour costs, energy costs

• Connecting local and international vendors with local cultivators

• Developing local Australian capability

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Medicinal Cannabis – Energy

Indoor facility – Vegetative growth

an installed capacity of 600 w/m2, at a 4,000m2 need 2,400 kW of installed power at $0.15 per kWh will result in an electricity bill of about $250k per month.

But this is based on CFL, MH and HPS lights

– we need to develop LED….

A Better Australian Life Science Manufacturing Industry,by Design

https://www.pharmout.net/medicinal-cannabis-cultivation-indoors-or-outdoors/

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Manufacturing thinking – Lean manufacturing

Medicinal Cannabis Cultivation,

Production and Manufacturing

conceived as a pharmaceutical

manufacturing facility.

Facility design is derived from

understanding the material,

personnel and waste flows

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Lean ManufacturingUnidirectional layout

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Lean ManufacturingU-directional layout

Improved security single entry

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ProcessFlowDiagram

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Medicinal Cannabis Facility Design

Facility Concept Masterplan Approach

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Medicinal Cannabis Facility Design

01 : Germination and Cloning

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Medicinal Cannabis Facility Design

02 : Vegetation

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Medicinal Cannabis Facility Design

03-04 : Flowering and Harvesting

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Medicinal Cannabis Facility Design

04-06 : Harvesting and Drying

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Medicinal Cannabis Facility Design

05-07 : Trimming and Milling

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Medicinal Cannabis Facility Design

08-10 : Extract, Winterization, Filtration

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Medicinal Cannabis Facility Design

11-12 : Filling, Capping, Labelling (Final Product)

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Medicinal Cannabis Facility Design

Support : Vault, Warehouse, Dispatch

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Cannabis folkloreThe only person who has ever died directly from cannabis - 1882

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Prohibition does not work?

• Canadian (and some US states) model for recreation cannabis

• Legislate and control distribution

• Tax (heavily)

• Tax to pay for health consequences

By Lokal_Profil, CC BY-SA 2.5, https://commons.wikimedia.org/w/index.php?curid=2370050

Slide 31 © PharmOut 2018

Thank you

Trevor Schoerie

Trevor.Schoerie@PharmOut.net

Managing Director

www.pharmout.net