Medical cannabis drug development requires an extensive knowledge of cannabis-related IP rights, and a proven record in pre-clinical cannabis-derived study. Discover how Pharmaseed and Dr Eyal Bressler and co can help you in your drug development process and beyond. More at www.bressler.co.il and www.pharmaseedltd.com

1. Monetizing Medical Cannabis

2. +100 clinical indications:
• Multiple Sclerosis
• Glaucoma
• ALS
• Peripheral Neuropathic Pain
• Post Operative Pain
• Spinal Cord Injury
• Anxiety - PTSD
• Parkinson’s Disease
• Cachexia, Nausea&Vomiting - Cancer
• Rheumatoid Arthritis
• Inflammatory Bowel Diseases
Cannabinoids are molecules unique to the
cannabis plant
Initial focus on two principal cannabinoids:THC
(Tetrahydrocannabinol) and CBD (Cannabidiol)
• THC: Analgesic,Anti-spasmodic,Anti-
tremor,Anti-inflammatory,Appetite
stimulant,Anti-emetic
• CBD:Anti-inflammatory,Anti-convulsant,
Anti-psychotic,Anti-oxidant,
Neuroprotective, Immunomodulator
Cannabis-based medicine: clinical indications
Cannabis-based medicine: which molecules?

3. • Compositions lacking harmful psychotropic components
• Novel cannabis active compounds and derivatives
• Novel cannabis compositions and formulations
• Methods of Production
• Novel drug delivery systems for cannabis
• Novel dosages of cannabis
• Novel medical applications and diseases to treat with cannabis
• Plant breeders rights (PBR) for new cannabis varieties
Cannabis Industry: opportunities are there!

4. Cannabis Industry: Money is there too!
The market is
estimated to
become $6 billion
dollars industry by
2018.

5. Cannabis Industry: ready, set, go for the gold rush !
Main companies
Want to join the race?
Think technology scouting,
IP assesment…

6. Cannabis Industry: ready, set, go for the gold rush !
Number of granted patents Want to join the race?
Think patent filing

7. Cannabis Industry: ready, set, go for the gold rush !
Intellectual Property issues are tricky. Cannabis IP rights are uniquely so.
Navigating the cannabis-related IP issues requires extensive knowledge of the
cannabis industry specificity. Getting cannabis IP counseling is a mandatory part
in your drug development program and will guide you through:
• Patent driven competitive analysis
• Patent filing and prosecution
• Patent litigation and enforcement
• Licensing agreements
• Trade Secret Policy documentation and enforcement
• Trade Marks registration and protection
• Plant breeders rights (PBR) registration and enforcement

8. • Is it safe for patients?
• How does it work?
• Has it been proven to work in preclinical
studies?
• Does the [proposed] mechanism or pathway
through which the drug acts raise concerns
about impact on normal organs/tissues?
Cannabis-based medicine drug development: ask the expert and meet
the regulator!
• Cannabis is designated as a Schedule I drug (i.e., illegal with
no current medical value)
• Cannabis-based therapeutics requires input from the U.S.
Drug Enforcement Agency (DEA). (not favorable, but the
agency will review cannabis classification as early as mid-
2016)
• Federally, a drug cannot be prescribed unless it has
undergone clinical trials, yet many states legislation
authorizes the use of medical marijuana without clinical
trials and without identifying specific indications.
What the regulations says:
What the regulators wants
to know:
Need to design your preclinical studies to be in compliance with the regulation

9. Designing the preclinical study: science and regulation hand in
hand
Preclinical studies should be designed as pre-emptive strikes: address
potential future regulatory concerns within the early stage preclinical
development of your molecules, and with the first-in-man study in mind.
Preclinical design considerations:
• GLP vs non-GLP
• Latest regulatory directives
• Pre-IND/IDE meetings: understand what the regulators
wants
• Safety (pharmacology, toxicology)
• Efficacy ( in vivo efficacy)
• Stability (formulation, absorption reproducibility)
• Non-biased design
• Mimic clinical scenario

10. Designing the preclinical study: science and regulation hand in
hand
Composition? THC/CBD
others…?
Stability?
Mode of Administration?
Dose?
Which models?
What is the “API”?
Unique pharmacology of cannabis-derived
molecules [Bell Shape]- hard to translate
A perfectly tailored preclinical study design goes beyond science.
It adds technological value to your IP rights. How? By understanding the
unique pharmacology of your technology, and matching it with
the most appropriate models, so it translates into clinical indications.
• Match models and technology
• Balance mode of
administration, dose and models
• Translate models into clinical
indications

11. Science & Regulatory,
Clinical expertise
Creativity” & Experience
Commitment [ Financial]
Successful drug development: the perfect product arises from the
perfect collaboration
Credit: collaboration by Michael Rojas, executive by Michael Wohlwend, Medical Marijuana by Blaise Sewell, Lawyer by Rflor from the Noun Project from the noun project
IP assets and protection,
Licensing, Plant Breeders
Rights…
Your ideas, your Molecule[
Financial]
=

12. Pharmaseed is Israel's largest GLP-
certified pre-clinical CRO specializing in
translational and regenerative studies.
From preclinical to first in man.We have
extensive experiences in cannabis-based
medicine drug development.
Pharmaseedltd.com
We develop customized, targeted, and
secure comprehensive strategies, focused
on maximizing the benefits of new
technologies and securing wide-ranging
and cost-effective protection for our
clients' inventions, discoveries and
creations. bressler.co.il/ and so-law.co.il/
Successful drug development: the perfect product arises
from the perfect collaboration