Monetizing medical cannabis

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  • Monetizing Medical Cannabis

  • +100 clinical indications:

    Multiple Sclerosis

    Glaucoma

    ALS

    Peripheral Neuropathic Pain

    Post Operative Pain

    Spinal Cord Injury

    Anxiety - PTSD

    Parkinsons 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?

  • 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!

  • Cannabis Industry: Money is there too!

    The market is

    estimated to

    become $6 billion

    dollars industry by

    2018.

  • Cannabis Industry: ready, set, go for the gold rush !

    Main companies

    Want to join the race?

    Think technology scouting,

    IP assesment

  • Cannabis Industry: ready, set, go for the gold rush !

    Number of granted patents Want to join the race?

    Think patent filing

  • 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 thecannabis industry specificity. Getting cannabis IP counseling is a mandatory partin 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

  • 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

  • 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

  • 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

    http://www.google.co.il/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://www.smallmanart.com/2012/07/05/disentangling-complexity.html&ei=d6kQVZSQOcm7Pcm5gYgH&bvm=bv.89184060,d.d2s&psig=AFQjCNGJBT1dXm9W8ncXZSKVr0PffSz7LA&ust=1427241700828865http://www.google.co.il/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://www.smallmanart.com/2012/07/05/disentangling-complexity.html&ei=d6kQVZSQOcm7Pcm5gYgH&bvm=bv.89184060,d.d2s&psig=AFQjCNGJBT1dXm9W8ncXZSKVr0PffSz7LA&ust=1427241700828865

  • 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]

    =

  • 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

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