Founder, The Cannabis Council Eastern Shore Innovation Center Standardization of Method The requirement for credible investigation Maryland’s Medical Cannabis Program BUDTech Summit – UMD, Baltimore Barry F. Pritchard Founder, The Cannabis Council Eastern Shore Innovation Center Cambridge, MD September 22, 2017

THC Discovered in 1964 THC was discovered by Dr. Raphael Mechoulam in Israel Until the discovery and isolation of Delta-9 tetrahyrdrocannabinol, scientists did not understand what caused the psychoactive effect in Cannabis. Since then, multiple components including THC, CBD, CBC, CBG, not to mention terpines and flavonoids have been identified within the cannabis plant. Raphael Mechoulam - Father of Cannabinoid Research http://www.beyondthc.com/wp-content/uploads/2012/07/eCBSystemLee.pdf Delta-9 Tetrahydrocannabinol

Agenda Importance of the Standardization of Methods Cannabis: History - Prohibition Lack of peer reviewed clinical research data The Cannabis Council Importance of the Standardization of Methods – Required for credible investigation PAT – Process Analytical Technology MD Medical Cannabis Program – The framework for scientific endeavor

Our Mission Statement: To support the medical cannabis and industrial hemp industries in their effort to provide safe, well-characterized agriceuticals and sustainable materials.

How we support the community? Public Awareness Forums - Inform the masses a. Prohibition - Ongoing perception propagation b. Benefits of the potential pharmaceuticals and sustainable by-product materials c. Regulatory controls - Ensuring safe products

How we support the community? Technical Symposia - Speak to the choir in support of research focused advocacy groups a. Need for SME to join to fray – A call to action for industry participation b. Bridge the technical communication gap - Underground vs. Classically trained c. What is PAT? - The case for method standardization d. Regulated market - The requirement for credible investigation e. Promoting collaboration – find a common language

How we support the community? Workforce development - SunX site in Cambridge a. Training – cannabis industries b. Employee retention – Career development programs c. Support for entrepreneurs

Historical lack of standard methods and processes Opportunity for making a difference The Challenge: With the rules for testing cannabis varying from state to state, each laboratory determining its own testing methods, the difficulties is the procurement of high-quality reference materials and the lack of common scientific term usage, the industry has little likelihood of achieving uniformity, and by extension, credibility. The Evidence of the problem: Enables the common practice of results shopping The Solution: Good Documentation – Disciplined effort Commitment to process development

Critical Process Parameters What this looks like in practice: Cannabinoid extraction, isolation and formulation Science or Art? Process analytical technology (PAT) has been defined as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters Benefits: Improve efficiency Reduce costs Increase understanding of process Reproducibility!

THC Discovered in 1964 THC was discovered by Dr. Raphael Mechoulam in Israel Until the discovery and isolation of Delta-9 tetrahyrdrocannabinol, scientists did not understand what caused the psychoactive effect in Cannabis. Since then, multiple components including THC, CBD, CBC, CBG, not to mention terpines and flavonoids have been identified within the cannabis plant. Raphael Mechoulam - Father of Cannabinoid Research http://www.beyondthc.com/wp-content/uploads/2012/07/eCBSystemLee.pdf Delta-9 Tetrahydrocannabinol

Cannabis as WHOLE Medicine FACT: Currently, Cannabis is listed as a SCHEDULE 1 drug federally. Schedule 1 drugs are substances that have a high potential for abuse AND no currently accepted medical treatment use. FACT: Cannabis’ singular cannabinoid THC has been synthesized and mass produced as the SCHEDULE 3 drug (Dronabinol ) (Marinol) used and proven to have moderate success in treating nausea, vomiting, anxiety, pain mitigation and insomnia in terminal patients. QUANDRY: Recent research indicates that WHOLE PLANT Cannabis derivatives can be MORE effective in treating a variety of conditions than isolated cannabinoids. Whole plant derivatives work as a natural modulator and with higher levels of efficacy due to a phenomenon expressed as “The Entourage Effect.” CBD in particular, has been found to down regulate the psychoactive properties of THC. Cannabis in Palliative Medicine: Improving Care and Reducing Opioid-Related Morbidity AM J HOSP PALLIAT CARE August 2011 28: 297-303, first published on March 28, 2011

One more thing: THE case for Cannabis Cannabis lethal dose risk - Essentially Zero* *It would take 150lb man to smoke 1500 pounds in 15 minutes. 2013 Data from CDC on drug induced deaths Total – 43,982 Prescription analgesics – 16,235 Heroin - 6,235 Cannabis – 0 Evidence of Decreased Opioid Overdose Mortality in U.S.: “States with medical cannabis laws had a 24.8% lower mean annual opioid overdose mortality rate.” (Bachhuber, M.A. (2014) Journal American Medical Association)

Summary SME call to arms Take the time to bridge the divide Cannabis – The gateway from dope? Volunteer - Vote Hemp, WeCANN, TCC

Thank you for your attention! Acknowledgements for with – permission use of materials: WeCANN – MD MD Medical Cannabis Commission AOCS – American Oil Chemist’s Society Barry F. Pritchard, MBA bpritchard@thecannabiscouncil.org