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New Opportunities for Research in Colorado

New Opportunities for Research in Colorado. Tyrell R. Towle, Ph.D. MedPharm Holdings, LLC Institute of Cannabis Research Conference 2019 March 25, 2019. Introduction. Cannabis Research Around the World.

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New Opportunities for Research in Colorado

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  1. New Opportunities for Research in Colorado Tyrell R. Towle, Ph.D. MedPharm Holdings, LLC Institute of Cannabis Research Conference 2019 March 25, 2019

  2. Introduction www.MedPharmHoldings.com

  3. Cannabis Research Around the World • USA has fallen behind or is danger of falling behind the cannabis research being conducted in other countries • Israel • Netherlands • Canada • Spain • United Kingdom • Colorado has a unique opportunity to be the global leader in research www.MedPharmHoldings.com

  4. Cannabis Research in the USA • Many excellent researchers in the USA performing cannabis research • Famously, Dr. Sue Sisley has received approval for PTSD research from NIDA and the DEA • Endocannabinoid system • Research with cannabinoid receptor ligands other than plant derived cannabinoids • Subject to severe restrictions that burden the researchers and limit the usefulness and applicability of their results • Must use NIDA product, if providing a product for use • Difficult to control for patient dosing when using products they obtain • Difficult to provide a legal, appropriate place for on-site consumption www.MedPharmHoldings.com

  5. Challenges Researchers in the USA Face when Attempting to Study Cannabis www.MedPharmHoldings.com

  6. Challenges Researchers in the USA Face when Attempting to Study Cannabis www.MedPharmHoldings.com

  7. Characteristics of NIDA Product Provided Cannabis for Research • NIDA also provides a cannabis extract they call “CBD Cannabis Extract” • Under 60 % cannabinoid content • Residual solvent hexane • It has been reported that cannabis material obtained from NIDA contains levels of mold that would fail quality assurance testing in any regulated state www.MedPharmHoldings.com

  8. Characteristics of Cannabis Readily Available in Colorado • Flower: • Low THC: < 10 % • Average/Medium THC: 10 – 20 % • High THC: 20 – 30 % • Very High THC: > 30 % • Concentrates: • Low Cannabinoid: < 70 % • Average/Medium Cannabinoid: 70 – 80 % • High Cannabinoid: 80 – 90 % • Very High Cannabinoid: > 90 % www.MedPharmHoldings.com

  9. Comparison of Products Available in Colorado to NIDA Products Cannabis Products Available in Colorado Cannabis Products Available from NIDA Generally of lower potency and purity Generally older Limited variety of products from a single source No 3rd party safety testing. UM tests for microbial in flower and mycotoxins, heavy metals, and residual solvent in concentrates • Generally higher in potency and purity • Generally fresher (consistent harvests and production) • Various dosage forms and potencies from many sources • Stringent 3rd party safety testing including pesticide, microbial, homogeneity, residual solvent, and (soon) heavy metals and mycotoxins www.MedPharmHoldings.com

  10. Closed Loop System, Seed-to-Sale Tracking www.MedPharmHoldings.com

  11. SB17-1367 • MedPharm was founded by a group of investors interested in advancing cannabis science and research • Saw the need for a specific license authorizing cannabis research • Andy Williams and Albert Gutierrez worked with legislatures to write the bill and get it passed and signed by the governor www.MedPharmHoldings.com

  12. SB17-1367 • Worked to get sponsors, testify to the legislature, shepherd amendments, and guide rulemaking • Original bill included language that required the destruction of genetics upon study completion • Andy and Albert recognized that this defeats the purpose of the research if interesting/beneficial genetics must be destroyed • Worked to change the language to allow for transfer of genetics into the closed-loop system upon study completion www.MedPharmHoldings.com

  13. Colorado Research License • After the passage and signing of SB17-1367, the law went into rulemaking at the Marijuana Enforcement Division (MED) • Andy Williams and Albert Gutierrez spent a lot of time collaborating with the MED to create the rules that ultimately govern the program • After rulemaking came the application for the license • No application • No license • More collaboration, and we received the first granted research license in November of 2018 • Next steps: • State co-location permit • City co-location permit • Did not exist www.MedPharmHoldings.com

  14. First Research License Awarded! www.MedPharmHoldings.com

  15. Fields of Research Opened up by the Colorado Research License www.MedPharmHoldings.com

  16. Closed Loop System, Seed-to-Sale Tracking www.MedPharmHoldings.com

  17. Colorado Research License Creates a New Outlet from the Closed Loop System www.MedPharmHoldings.com

  18. Rules and Regulations Surrounding the Colorado Research License • Licensed research businesses may only receive cannabis or cannabis products from other licensed research businesses, medical marijuana optional premises cultivation (OPC) licenses, or medical marijuana infused products (MIP) manufacturing licenses • Licensed research businesses may only transfer cannabis or cannabis products to other licensed research businesses or to study participants in an approved study • Must use a licensed medical marijuana testing facility for 3rd party testing www.MedPharmHoldings.com

  19. Rules and Regulations Surrounding the Colorado Research License • Co-location permits required when the licensed research business will share space with a licensed medical or retail marijuana business • Requirements for separation of research materials from non-research materials to prevent cross-contamination and protect public health • Rules for record keeping and inventory tracking • Packaging and labeling requirements • Research projects must be submitted to the MED for approval www.MedPharmHoldings.com

  20. Rules and Regulations Surrounding the Colorado Research License • Different rules for review and approval of a study proposal depending upon the study location and source of funds (public or private) • Periodic reports to the MED describing compliance and progress • Must immediately notify the MED of any adverse events • Final report of all research findings www.MedPharmHoldings.com

  21. Rules and Regulations Surrounding the Colorado Research License • Additional worker safety requirements, above and beyond that of other licenses • Additional sanitary requirements • Specific prohibited chemicals • Federally banned pesticides • DMSO • Subject to audits and submission of samples on demand www.MedPharmHoldings.com

  22. MedPharm Facility and Capabilities • Good Manufacturing Practice (GMP) production facility • 3rd party certified since March 3, 2019 • 21 CFR Part 117 subpart B • MED regulations • Cutting edge cultivation, extraction, purification, and formulation of cannabinoids • Cultivation • Reverse osmosis water purification • Unique Techniques • Curated strains with minor cannabinoids • No pesticides used in the facility • All flower grown is extracted and purified www.MedPharmHoldings.com

  23. MedPharm Facility and Capabilities • Processing • Supercritical CO2 extractor (extraction) • Thin Film Distillation (purification) • Analysis • LC-MS for potency analysis • GC-MS for terpene analysis • BSL II safety cabinet • Fume hood • Moisture content analyzer www.MedPharmHoldings.com

  24. MedPharm Facility and Capabilities • Formulation • Team lead by our compounding pharmacist, Scott Karolchyck • Tincture • Pressed tablets • Vaporizers • Topical Cream • More coming soon! • ISO 7 Clean Room www.MedPharmHoldings.com

  25. Seeking Research Partners • Research projects • Dementia/Alzheimer’s • Opioid use mitigation/Opioid withdrawal • Ovarian cancer • Dabbing toxicity • Or design your own project • Cannabinoids of interest • Dosage forms • Study design • Study implementation • We seek academics, clinicians, and patient populations • Partnerships www.MedPharmHoldings.com

  26. Thank you! www.MedPharmHoldings.com

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