MJBizMag July 2022 - 41

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
institutions such as state universities.
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.
The FDA and DEA have both approved
the study, for which MedPharm
is partnering with the Institute of
Cannabis Research.
" I think having a DEA license really
makes them (university research
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? "
EARLY FINDINGS
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 CBDbased
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.
" Big pharmaceutical
companies like
Thermo Fisher won't
even talk to you
or sell you a
refrigerator until you
get a DEA license. "
- Duncan Mackie,
MedPharm
" 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. "
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