(This story is part of the cover package in the July issue of MJBizMagazine. It has been corrected to omit the name of a university cannabis program.)
In the ever-evolving world of cannabis research, the most groundbreaking companies might be those with licenses issued by the U.S. Drug Enforcement Administration. Depending on the license class, these companies can legally grow, manufacture, import, export, analyze and conduct research with cannabis.
Currently, only six entities are registered with the DEA as “Bulk Manufacturer Marihuana Growers.” The permit allows license holders to cultivate and distribute cannabis flower or extract, per strict DEA quotas, to DEA-licensed researchers working on studies approved by the U.S. Food and Drug Administration. (See “Can DEA-backed cannabis growers strike gold via drug development?” for details.)
Some bulk-manufacturing registrants also have the other DEA registrations, including those for research, with hopes of developing cannabis-based drugs that someday will be approved by the FDA.
DEA Research Registrations
One company with a DEA registration to conduct cannabis research is MedPharm Holdings, a Denver-based company with recreational marijuana operations in Colorado and Michigan as well as medical cannabis operations in Iowa.
As a state-licensed marijuana business with a DEA research license, MedPharm is still a rare breed, but company executives expect the DEA will eventually grant licenses to other cannabis firms.
“The ultimate gatekeeper is the DEA license,” said Duncan Mackie, MedPharm’s director of pharmacology and experimental therapeutics. “Big pharmaceutical companies like Thermo Fisher won’t even talk to you or sell you a refrigerator until you get a DEA license.”
What’s Being Studied and Why It’s Important
MedPharm’s operations in the state-regulated market—cannabis cultivation and manufacturing vape cartridges, concentrates, topicals and infused ingestibles such as pills and tinctures—help finance its research activities, which are heavily but not exclusively focused on neuropharmacology, including brain inflammation, traumatic brain injuries, Alzheimer’s, Parkinson’s and the like.
Founded in 2016 with scientific discovery built into its mission, MedPharm was already researching cannabis and neuropharmacology, thanks to a Colorado state research license that enabled it to partner with academic institutions. But in December 2021, MedPharm became a federally licensed DEA Schedule 1 research facility for cannabis and cannabinoids.
It’s now leveraging that DEA research registration on a study examining if cannabinoids—especially minor cannabinoids, which are known as “very potent anti-inflammatory compounds”—can break down the proteins that cause brain inflammation associated with diseases such as Alzheimer’s and Parkinson’s.
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The FDA and DEA have both approved the study, for which MedPharm is being considered for funding through the Institute of Cannabis Research.
“I think having a DEA license really makes them (university partners) feel much better about things, too. They’re not going to lose their federal funding because the DEA has already given its blessing for this,” Mackie said.
In the Lab
To conduct the study, scientists take cells found in the brain, such as microglia, place them in a petri dish and then inflame them, mimicking the inflammation process that accompanies various diseases.
Next, individual cannabinoids or combinations of cannabinoids are put into the petri dish to see whether they break down inflammation-causing proteins.
Mackie said the research seeks to answer the question, “What do these minor cannabinoids do?’ Whether they’re an isolate or in combination with other terpenes or other cannabinoids, how does the microglia react while it’s in an inflamed state to a dosing of different levels of cannabinoids?”
One of the study’s early findings is that cells can withstand high amounts of the cannabinoids CBD, THCV and CBN before dying.
“I have to put in quite a lot before I can get cell death, which is great. It gives you a really nice, large therapeutic window,” Mackie explained. “If you’re not getting an effect with a very low dose, you can actually ramp the dose up and not see too much cell death, which is very nice from a drug-discovery, medicinal chemist’s standpoint.”
MedPharm also plans to explore combinations of cannabinoids and nutraceuticals.
“As soon as we find something that we can really use as our lead compound and build around (it), we’ll be off to the races,” Mackie said.
Changing Times and Attitudes
In drug discovery, however, “races” can take years and more than $1 billion. It took GW Pharmaceuticals (now part of Ireland-based Jazz Pharmaceuticals) roughly a dozen years and around $1 billion before Epidiolex, its CBD-based medicine for epilepsy, was approved by the FDA.
But that could be changing, too, some industry observers say, as the internet has reduced the time it takes to navigate federal bureaucracy and scientific information is easier to share among researchers.
And while the DEA hasn’t gotten on the legalization bandwagon, cannabis operators and researchers who work with agency officials say they are no longer anti-marijuana zealots trying to undermine the industry.
“The landscape is changing. Our DEA agent is actually super-helpful. He gives us great insight, great input,” Mackie said. He added that DEA agents have been to the facility several times, and their primary concern is ensuring cannabis isn’t diverted to the illicit market.
While getting a DEA cannabis registration is difficult, it is doable, Mackie said.
“As long as you’re doing the right things and you’re following the right rules, I don’t understand why people can’t get through,” Mackie said. “Obviously, there are hurdles. It’s a pain in the butt getting big safes that are required, doing the applications.”
The most important hurdle, Mackie added, is assembling a scientific team that has the background to carry out the work—from administration, maintenance and recordkeeping to backgrounds in biology, chemistry and pharmacopeia.
“The barrier to entry is not drastically hard. But I think that they don’t just let anybody get a license,” Mackie said. “They do require you to prove that you have the scientific knowledge and ability to carry out what you’re proposing.”