MJBizMag July 2022 - 48

Research Renaissance
the market by 2025, Ferrarese said,
" Anything is possible.
" The reality is that the FDA has
opened up. The days of the FDA taking
20-plus years to approve a drug are
behind us, " Ferrarese added. " I think
that the FDA wants to approve better
medicines quicker. "
But, he added, taking the time to
navigate a process as rigorous as an
FDA study will benefit consumers and
the industry.
" There are tons of anecdotal stories
of patients responding favorably to
cannabis as medicine. But when you get
into a clinical setting where ... you're
using analytical methods to evaluate
responses from the subject, it's not
until you start pulling all of these pieces
together that you can start making
inferences and really determining if, in
fact, it's efficacious, " Ferrarese said.
A LICENSEE OK'D BY FEDS
Rajita Sinha, a Yale University School
of Medicine professor, wanted to use
CT Pharma's cannabis in research
studies, and Ferrarese believes the
company's relationship with Sinha
convinced the FDA to approve the
partnership.
Sinha already had developed and
tested cannabis formulations for
FDA-approved studies. And the FDA
was more concerned about whether
CT Pharma adhered to current Good
Manufacturing Practice standards,
Ferrarese said-specifically its
cultivation, extraction, manufacturing,
packaging and other processes.
The FDA wanted to see cultivation
batch records, cleaning logs and facility
layout. The agency also requested
microbiology, potency and stability
results showing that biomass didn't
become contaminated over time.
" You need master batch records,
training records for all of the staff,
facility-control documentation,
analytical reports. We had all of that on
hand and were able to provide it to the
FDA, " Ferrarese said.
48 Julu 2022 | MJBizMagazine
Rino
Ferrarese
subjects were given six doses-two CBD
only and three combinations of CBD
and low-dose THC, plus a placebo-to
see how they reacted when subjected to
pain and stress.
To do this, researchers put subjects
through a so-called " cold pressor
test, " in which individuals who have
taken a dose (or placebo) submerged
their hands in ice water. Researchers
then drew blood to evaluate certain
markers to see if the cannabis
tempered physiological responses of
pain and stress.
In the second study, for which Yale
will soon be recruiting, researchers will
test the two dosage forms on subjects
21-60 years old with chronic pain.
They'll dose every day and complete
laboratory and blood analyses on days
one, three and seven, when researchers
look for markers that could suggest
therapeutic effect.
Rajita
Sinha
While the FDA requested " reams
and reams " of information from CT
Pharma, no one from the company had
to meet with FDA officials, leaving the
discussions to Sinha and other Yale
researchers.
STUDY UPDATES
Despite COVID-19 delays, Sinha and
her team finished the first painmanagement
study, which identified
two specific dosages that met the
team's expectations for efficacy. Those
two doses-one, a tablet containing
40 milligrams of CBD plus a low dose
of THC; the other, a tablet with 100
milligrams of CBD plus a low dose of
THC-will be the basis of the next study.
" We were evaluating patients for the
effect of cannabis as natural medicine
on their subjective and physiological response
to stress and pain, " Ferrarese said.
The first study involved subjects 21
to 45 years old. Over a six-week trial,
FUTURE TENSE
Ferrarese believes it's inevitable
that the DEA will approve more
state-licensed companies to provide
cannabis for research-and not just
university studies.
Ferrarese said academia is not
set up to run large-phase clinical
trials on human volunteers. Instead,
commercial research organizations
(CROs), are better designed for
administering studies. For example,
they are faster at recruiting and
enrolling subjects, he added.
" Once we start seeing that the
rules are loosening up a little bit and
cannabis companies like ours are
allowed to start exploring research
and partnerships with CROs, we'll
get to the science that much sooner, "
Ferrarese said.
" Developing cannabis drugs is a slow
and tedious process right now because
of all the restrictions that are in place.
As the government comes around ...
we'll be able to pursue commercially
more accelerated pathways forward in
developing the science. "
MJBizMag July 2022

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