Clinical cannabis is the future of ‘medical’ cannabis, and Orion GMP is clinical cannabis. Clinical cannabis as a product quality class should represent consistent, highly characterized, and engineered therapeutic outcomes like any other clinical pharmaceutical formulation dispensed at a pharmacy.
Medicinal Chemistry has its roots in naturally harvested medicines, which have been used by humans since time immemorial. This knowledge is actually far older than human civilization itself, and is undoubtedly linked with our species’ longevity. Early on, raw material was chewed, inhaled, blotted as a salve, or drank as a brew. The knowledge of the natural product wealth within these concoctions has resulted in the marvel that is modern medicine.
Cannabis is no exception in this relationship in how we’ve domesticated it from early landrace cultivars of moderate potency. It became known as anecdotal truth among these peoples that the cannabis plant’s natural product wealth came with therapeutic value for a wide range of ailments. Quality control for these millennia was done by eye and feel of the farmer to discard clearly moribund and insect ridden plants. One thing though has remained true, the more time we spend with cannabis the more we are able to learn, derive valuable materials, and tease out desired medicinal effects.
Out of a plague scarred Europe came the enlightenment age which brought enormous leaps and bounds in the field of chemistry and natural science inquiry. This somewhat golden age of scientific advancement and culture came to influence many early medicinal (plant) chemists in the years after such as William Brooke O’Shaughnessy. In the early to mid 1800s O’Shaugnessy studied ethnobotany of cannabis uses in India. His early clinical-trial type experiments in relieving pain and convulsions built his reputation and ultimately helped to popularize its use in England. This early work was critical in evolving our knowledge of cannabis by documenting and ultimately legitimizing its research in empirical medicine circles throughout the West.
Fast forward to the early to mid 1900s as many interrelated sciences innovated in the fields of chemical analysis aided by chromatography, quality control, and spectroscopy our medicinal scaffold isolation capabilities exploded. Out of these technologies we became able to couple taxonomy, medicinal plant chemistry, and chromatography to explore components of interest, beginning on paper, and ending with a pure compound or refined mixture. Natural product extraction and isolation science became inspired with these technological breakthroughs perhaps even more so than the discovery of alkaloid chemistry more than a hundred years previous.
This era of science paid off in the 1940s when the first modern extractions and synthesis were performed in USA to begin to catalogue medicinal scaffolds contained within cannabis material. These early chemical analyses were able to indicate cannabinoids as major components and ultimately identify CBD and THC. In the early 1960s and 70s Dr.Raphael Mechoulam’s lab definitively elucidated the structures of both acid and non-acidified forms of CBD and THC with stereochemistry.
Work like this became a boon in pharmaceutical sciences as we built on the collective ethno-pharmacopoeias to create a foundation enabling systematic exploration with high selectivity of targets by virtue of purity, creation of assays and observing the downstream clinical outcomes. This was especially true in the late 80s and early 90s as the CB1/CB2 receptors were identified with radiolabeled cannabinoids and with the discovery of the human endocannabinoid system by Mechoulam’s lab.
This moment of cannabis science discovery was just as exciting as its future was unsure and daunting. The US Federal government and international orgs like the United Nations were staunch opponents of cannabis, and considered it to have no medicinal value. However, it was clear from a history of human experience that cannabis had medicinal effects, and now we’ve identified some of the pharmacology behind its therapeutic value.
It took for states such as California and Alaska in the 90s to defy this disconnect by asserting their state rights and establishing cannabis as a treatment for the most severe conditions. Originally cannabis programs like this were centered around medical use in the form of “compassion” laws and clubs. It was a time with a wild west feeling as cannabis came from producers brought up in the black market indoor and established outdoor cultivation communities. It was somewhat unregulated outside of good faith in producing for patients and practices were highly variable. Cannabis itself retained its biological challenges as a botanical compound drug, and patients were left rolling the dice on consistently efficacious and safe products.
Fast forward to the modern era we have improved as state-by-state programs become law, and older established markets such as California and Colorado continue to mature in regulations and science. The stage is set and the future is clearly one of cannabis legal nearly worldwide. We just have much more work to do. The cannabis industry for nearly a decade or more by and large obsessed with THC potency and putting out minimum entry products for the sake of meeting bare compliance and making a return on investment.
While this scathing description doesn’t encompass all producers it prompted discussion about where we lack as a whole in terms of quality and our knowledge of cannabis. The last year has seen enormous progress both legally and scientifically for cannabis. We have seen a greater appreciation for deeper cannabinoid panels, and recognition of terpenes as a player in therapeutic effects. Our testing labs are refining themselves and we are really beginning to understand more of the members in this entourage effect we’ve all subjectively experienced as truth.
So, what now? Cannabis for the recreational market is looking forward to a bright future benefiting from further professional standardization and all is well. The medical cannabis market however has a much higher ceiling for technology and represents the strongest vector towards ending global prohibition.
Let’s change our terminology a bit. Clinical cannabis is the future of ‘medical’ cannabis, and Orion GMP is clinical cannabis. Clinical cannabis as a product quality class should represent consistent, highly characterized, and engineered therapeutic outcomes like any other clinical pharmaceutical formulation dispensed at a pharmacy.
What is clinical cannabis? When we discuss clinical grade cannabis we are utilizing quality standards for a very specific aim. Ultimately clinical trials require a consistent characterized formulation that dose specific therapeutic response and the resulting patient outcome can be attributed to. This level of resolution on a cannabis product can represent that critical and sometimes lifesaving therapeutic for a patient in dire need that previously had no surety in relief.
Clinical cannabis starts with Good Agricultural and Collection Practices (GACP) of quality managed biomass, guided by Good Manufacturing Practice (GMP) chemical manufacturing controls (CMC) for statistically homogeneous batches, and resulting in a consistent quantitatively proven medicinal formulation. Only then may we begin to claim we have tamed the botanical compound drug challenges of variability.
Downstream from this intense process engineering is the utilization of Good Laboratory Practices (GLP) for administration of this formulation in clinical trials with utmost best practices in data integrity. The outcome of these trials is the generation of precision medicines for patients, and educational items for dissemination into medical research spaces or authoritative bodies such as the US Federal government, Food and Drug Administration, and United Nations.
The future of cannabis is one quality controlled by data analytics, guided by exhaustively developed standards, and always pushing the limits of our science building on those before us. We will continue to improve our relationship and knowledge with cannabis and unlock that chest of natural product wealth for the benefit of patients with the greatest need.
Is your cannabis truly ‘medical’, or is it recreational?
Andrew Hilliard
Research Analyst
Orion GMP Solutions