Washington, Colorado and California receive most of the attention in the cannabis market, and Oregon and Alaska are quickly making their own share of headlines as recreational legalization begins to take effect there. Here, however, we’re turning the attention east of the Mississippi, to a state with a medical cannabis program unlike any other — Connecticut — and, more specifically, to Connecticut Pharmaceutical Solutions (CPS), one of the state’s four cultivators.
Based in Portland, Conn., CPS is considered a leader in one of the most comprehensive, as well as restrictive, full-spectrum cannabinoid medical cannabis programs in the country.
Talking with the team behind CPS is special Guest Interviewer/cultivator David Bonvillain, founder of six-year-old Elite Cannabis Enterprises in Boulder, Colo., which itself has become known as one of the leaders in advancing medicinal cannabis-based product development.
To lend some context to the interview, Bonvillain first asked CPS Manager Rino Ferrarese what it means to implement a pharmaceutical-based approach in the production of cannabis products. Ferrarese explained that in Connecticut, pharmaceutical-grade marijuana is defined as marijuana or marijuana products that are “not adulterated” and:
- processed, packaged and labeled according to the Food and Drug Administration’s “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements”;
- labeled with the results of an active ingredient analysis, a microbiological contaminants analysis, a mycotoxin analysis, a heavy metal analysis and a pesticide chemical residue analysis, which have been completed on a batch basis by a laboratory; and
- where each step of the production, cultivating, trimming, curing, manufacturing, processing and packaging method has been documented by using established standard operation procedures approved by the Commissioner of Consumer Protection.
“This basically means that a Connecticut pharmaceutical marijuana producer must maintain a quality management system that meets FDA standards,” says Ferrarese. “This means that there are documented standard operating procedures, stability programs, a quality assurance department, as well as all of the other systems you would find in a pharmaceutical manufacturing company.”
To shed light on just what it takes to implement this type of pharmaceutical model in Connecticut, Bonvillain spoke at length with Andy Bozzuto, a majority owner in CPS, whose background is in organic farming, and Tom Schultz, CPS president, whose background is in law, investment banking and pharmaceutical production.
David Bonvillain: There are four producers in the state, and each patient is [more or less] locked into buying only from the dispensary they select. So each one of those dispensaries is responsible for maintaining their customer relationships. You market to those dispensaries. How do you compete?
Tom Schultz: There definitely is a different style in production and competition here. We understood that the state had undertaken setting up a pharmaceutical model, and we basically set up a pharmaceutical production facility and approached it with a pharmaceutical methodology. So, [that includes] anything from our attempts to understand our patients’ needs, the conditions we’re dealing with, and the types of medication that would be most useful to the patients, to using what’s called in the pharmaceutical industry a CGMP approach to production — that is current good manufacturing practices — which requires a great … number of steps, including documentation and procedure that would not otherwise be typical in this industry.
So we started with a pharmaceutical approach and have simply stayed with it, and we find that it seems to serve the needs of the patients.
Andy Bozzuto: I think that, as a producer, we have to find niche avenues within the state because of such a limited patient base today. As it grows, things get easier. But Tom is exactly right. The reason we stand out, for sure, is the pharma standard because it is of the highest importance to us.
Bonvillain: Pharmaceutical companies get to advertise on television and wherever the heck they want. Obviously, you don’t get that luxury. Is there a way you are able to get your information out there?
Schultz: The challenge is that the endocannabinoid system wasn’t discovered until the beginning of 1988, and my guess is that the full extent of the endocannabinoid system’s effects on human health … won’t be fully understood for a while yet. But in any case, professional and consumer education is very important. And that’s slower than TV advertising.
We are organizing for next summer a symposium at a major school of medicine in Connecticut for the purposes of professional education. We will have a group of internationally recognized speakers who are researchers working on the endocannabinoid system. And they’ll be talking to Connecticut medical professionals about … the medicine and how it works.
Unfortunately, I'd say only a small minority of medical professionals really understand the medicine or are even aware that the endocannabinoid system exists, and that’s simply our responsibility to bring this knowledge to the community and let them take it to its logical conclusion.
Bozzuto: We don’t have direct access to patients because of the system. Our approach has to be with MDs that will be facing the patient who needs answers. So it’s truly an education process for docs from science.
It is so medically driven. You have to somehow have your readers understand that what they’re witnessing here is really a pharmaceutical company researching marijuana from the grow-out. And you’ll find that even when [recreational] comes to fruition, that there are very few rec growers that can grow pharmaceutical grade. But any pharmaceutical-driven company can grow rec.
So it's truly setting the standard higher so that, at the end of the day, we drive education and medicine.
Bonvillain: Tom, you’re an attorney by trade. Do you see things evolving anytime soon with regards to being able to approach things more like a traditional pharma company?
Schultz: I do see it changing radically in the future, but that will take some time. There are other changes that will happen, including changes of administration in Washington and in regulation throughout the country, some of which will be federal, most of which will be in the states. And as all of those changes occur, I think the whole industry will change.
Bonvillain: We hear a lot of talk about how [cannabis] is going to be rescheduled to a Schedule II, or maybe de-scheduled, and then only isolated cannabinoids will be scheduled at all. You are in the only, if not the only, pharma-based approach in the country; how do you see that evolving over the next, say, five years?
Schultz: I think the key is the wider understanding of the existence and operation of the endocannabinoid system in the human body. Everything is going to drive from there. But as that is more commonly understood, I expect next will be something like, as [MD/researcher] Ethan Russo describes, the entourage effect of the various components of the medication operating together.
Bonvillain: Do you see that in the raw material stage of the product, or do you feel like everything moves away into targeted extracts?
Schultz: The FDA has focused on single, isolated compounds to date, because it can. It’s been a logical and possible approach to focus on what it calls single moiety. But a single moiety, basically a single chemical compound that addresses a specific condition, that’s been [more applicable in a] conventionally chemical-based pharmaceutical model.
In this case, we’re dealing with complex organic compounds that seem to work extremely well together. And since they address very serious conditions, it’s going to be very hard to say that there’s simply one compound out of all the cannabinoids and terpenoids that really addresses condition X, whether it’s cancer, Crohn’s or anything else.
I think what’s probably going to happen more is that people will literally see cures for conditions that people thought were hopeless — as we’ve all seen within the industry — and as that happens, I think that the acceptance of a complex botanical product like cannabis (as opposed to a single chemical product, like a conventional drug) will grow.
Bonvillain: Starting with the RFA [request for applications], Connecticut was very competitive. There were a lot of applicants. It was a challenging application. How did Connecticut Pharma address those challenges, and what do you think set you apart from the competition to win the license?
Schultz: I don’t want to beat a dead horse, but we understood the application demanded a pharmaceutical approach. We read it. We understood it. That’s what we offered them, and that’s what we try to deliver now.
Bozzuto: By the RFA, we knew early on that the standard that they were requiring would demand a much higher investment …, and that the indoor [grow requirement] and the security parameters around that requirement were going to [add to that], which would create a longer return on investment for the guys putting the money in.
However, by setting the bar that high, it was a much bigger layout, much longer [return on investment], but I believe that it’s created the level of expertise to really bring us to real research and development levels. I'm telling you, that doesn’t exist anywhere else.
Bonvillain: CPS wasn’t the first to market in the state. How critical do you feel that being the first producer with product on the shelves is to a new business in the industry? And if not first to market, what do you feel the most critical driver is out of the gate?
Schultz: The most critical driver is quality. First to market matters; you can’t ignore it. But a week or a month is not the issue. I mean you can’t be so late that you’re irrelevant, but quality is everything.
Bonvillain: Do you currently sell 100 percent of the product you create as quickly as it’s ready in product form — cured, or produced into oils or extracts or tinctures — and has that always been the case?
Schultz: It’s a challenge. It’s not as if the product doesn’t change. It’s not as if people don’t come up with new needs or that nobody has ideas about how to make a better product. So our products continue to evolve; nothing’s static.
Bonvillain: We see metrics from some states that have a huge dispensary network that about 70 percent of the product sold is in the form of concentrated extracts. What have you been successful with for the East Coast consumer [patient]? Is there anything unique that you have done for the Connecticut market?
Schultz: Well, the concentrated oils that are really for very serious conditions are well-known, and they’re effective. We’ve had some good results with those.
But remember that the consumer base here is fairly restricted, and they are people with serious conditions. So it’s not at all a conventional market in the sense of Colorado or California.
Bozzuto: We are the oil guys, David. For sure, we are the oil men.
Bonvillain: So now that you have been doing this a while, and the polish has kind of worn off and it’s now real work, day in and day out, do you feel you would do it again?
Schultz: Yes, of course. From our point of view, it’s exciting operating on the frontier of the pharmaceutical industry. And we believe we’re doing valuable work. It’s a good feeling.
Bozzuto: I agree with him 100 percent.
Again, stepping back to the fact that marijuana has not been through the pharmacopeia process, absolutely, positively by the standard set here in Connecticut, I would participate, hands down.
And no matter what happens, this is a need that will exist in our industry. Even in places like Colorado with recreational, you’re going to need a pharma-based group that does CGMP-standard production that has real medicine in a real, formatted dispensary/health center.
If I had a child that had epilepsy, and I wanted that oil, how would I find it in any state that doesn’t have what we’re doing? Again, it goes back to niche marketing. This is going to be a need in every state.
Bonvillain: Are you expanding, and are you pursuing licenses in other geographies at all?
Andy Bozzuto: To be honest, we’ve been asked. More than four states have been through here: Pennsylvania, New Hampshire, Maryland, Hawaii. I can’t tell you enough that the regulators who have come through have looked at it in a different manner, and I think that, yes, we would certainly look to participate in every single market in the country once we’ve finished developing the real model that will set the national standard.
About the Interviewer: David Bonvillain owns and runs Elite Cannabis Enterprises and Elite Botanicals out of their center of operations in Loveland, Colo. The businesses include a 25-acre organic CBD farm leveraging a low/no-till permaculture methodology, a 6-acre greenhouse property and botanical-extraction laboratory that operates year-round, producing organic CBD for national and international markets through Mary's Medicinals, Mary's Nutritionals, and Mary's Pets. He is a speaker, author, consultant and High Time's Cannabis Cup winner.