Pioneering Cannabis Biopharmaceuticals with Cannovation Clinical Research Partners, LLC. Lisa Rich Milan and Michael Zaccaria

In this insightful episode of Roots to Risk, hosts Eric Schneider and Isaac Bock welcome back Lisa Rich Milan, alongside her co-founder Michael Zaccaria, to delve into their groundbreaking new venture, Cannovation.

Shifting from the traditional CPG discussions, this episode explores the innovative biotech and pharmaceutical approaches to cannabis. Lisa and Michael share their vision of expediting drug discovery and bringing cannabis-related medical products to market, shedding light on regulatory challenges, the impact of rescheduling cannabis to a Schedule III substance, and the promising future of cannabis in the pharmaceutical landscape.

Tune in to learn about the intersection of cannabis, biotech, and the potential for significant advancements in medical treatments.

Transcript

00:00 Eric Schneider:
This is the Roots to Risk Podcast hosted by Eric Schneider, alongside Isaac Bach. Roots To Risk brings you insights, the latest stories, and long form discussions about the cannabis industry. You’ll hear interviews with industry leaders and their perspective on current and future trends, how they’ve built success and what challenges they have faced. Our goal is to facilitate candid conversations and provide informative content for the cannabis community at large. Let’s go. What’s going on, Isaac? How are we doing today?

00:31 Eric Schneider:
How are we feeling?

00:32 Isaac Bock:
I’m good. How are you doing?

00:34 Eric Schneider:
I’m good, man. We got another great one on deck today. A repeat, we have Lisa Rich Milan, who we’ve had on previously. She’s entering into a new venture, which is Cann, which we’ll hear more about. We’re gonna also have her co-founder on Michael Zakaria. Very cool. What they’re doing. It’s, it’s definitely a little different than what we normally speak about on the roots to risk. And you know, a lot of it is related to, you know, more of the recreational market.

01:04 Eric Schneider:
You know, talking about traditional, you know, CPG, where this is definitely more on the biotech side, pharmaceuticals. So really interested to hear their perspective and, and what they’re doing in the space and how they’re helping companies expedite drug discovery and bringing, you know, cannabis related medical products to market.

01:26 Isaac Bock:
Yeah, absolutely. I think, you know, just having spoken to Lisa in the past and getting her insight just in general on the whole pharmaceutical side of the cannabis industry will be extremely interesting. Good timing, given what’s going on with the rescheduling. So curious to hear how that might impact what they’re doing. But definitely excited to learn more from both of ’em.

01:46 Eric Schneider:
Absolutely. Let’s bring ’em in. Hey Lisa and Michael, thanks for joining us on the Roots to Risk podcast. Lisa, I know we’ve had the pleasure of having you on before. Michael, it’s great to meet you and, and excited to learn more about canion and, and what you all are building currently. I know it’s a newer venture per my preliminary conversations with Lisa, but for our viewers, would love to learn a little bit more about what you guys are doing in the space and what the next 12 months looks like

02:15 Michael Zaccaria:
Abs. Sure. Thanks for having us. Nice to meet you as

02:18 Speaker 4:
Well. Absolutely. We, it’s a pleasure to be here.

02:32 Eric Schneider:
So, so Lisa, I don’t know if you want to kick it off or Michael just to talk about kind of Connation and what you guys have in store for the next 12 months, just so that we can get an understanding of, you know, what your guys’ core operations are and what you’re most looking

02:47 Speaker 4:
Forward to. Absolutely. So I’ll go ahead and kick this off as the founder and CEO Canion is the first full service research and development company that actually starts from preclinical to all four phases of clinical trial processes to regulatory pathways and pre IND meetings with the FDA all the way to commercialization. And we are the first company that brings pharmaceutical, biotech, universities, centers of excellence, DEA researchers and cannabis and terpene research together in one spot.

03:23 Speaker 4:
Usually as CROs, there are CROs on the biotech and pharma side of our business, but we don’t touch cannabis can. Cannabis is a schedule one. Many of the CROs aren’t set up to do schedule ones and are not regulated by the DEA to do. So. On the cannabis side, where we have experience as well, there are CROs, but there are CROs that do partial or parts of the steps of this process.

03:49 Speaker 4:
And as I worked at, at as the CEO of one of the, one of eight DEA bulk manufacturers, one of the number one requested we would get after finding out my background and finding out Mike Zacharia’s background in cannabis was how can you help us get started from a startup company to a medium-sized company and to those companies that are non-US that want to enter into the US market. How do I get started? I’m, I, I, I’m not quite sure how to pull this all together.

04:20 Speaker 4:
I’m an expert over here, but I’m not an expert over here. And so how can you help us? And so that’s where we found the need to really bring our organization to fruition with the network and the experts that we have are, that are best in class with this very, I would say, complex US market. And, and as I said, we are the first now some of the things that we are doing over the next 12 months, it’s, it’s actually coming to fruition pretty quickly because people are hearing about us, they’re reaching out to us, and we are talking to companies both in the US and companies that are not in the US that are looking to develop APIs, that are looking to develop molecules that are innovative and not out on the market to decrease the side effects of, of medications that are in oncology cancer, in rheumatoid arthritis, in women’s health like endometriosis, dealing with pain, dealing with sleep apnea.

05:20 Speaker 4:
These are the areas and the therapeutic areas that we’re able to help using our experts to leverage them to help those companies get to the place that they need to go. We, we want to strategically partner with them early in their process because the earlier they pull us in, the earlier we can save them money and critical decisions that they have to make that will shorten their process in their drug development. The five major areas over the next 12 months that have been requested have been areas like business planning and calibrating and collaborating and building strategic plans, determining whether they should, should create a molecule, change the core molecule and add cannabis or terpenes or com, combine both of them together and how long will that take and what is the FDA going to require of those steps, clinical trials, if we’ve done clinical trials over in Europe or in other countries, will the FDA transfer that knowledge and that information over into the US market?

06:21 Speaker 4:
Or will we have to start from scratch? What does that regulatory roadmap look like? What do the pre IND meetings look like dealing with the FDA? And as we all know, the federal government has multiple departments. Many companies that are coming in from non-US based countries have one country that they deal with. We have one federal government and multiple state governments. And within the federal government we have the DEA, we have NIA, we have NIH, we have the health and and human services. And so there are a lot of different complex areas that have their hands on this, especially with cannabis and terpenes that we have to monitor and help our clients navigate through those processes for.

07:05 Speaker 4:
So for the next 12 months, our focus is to get to those clients that are doing clinical research in this space, let them know that we are here and visible and let them know about our services and business planning, clinical trials, regulatory pathways, supply chain and material sourcing, which is another critical area because once you start a preclinical trial, once you set, set your clinical ranges minimum and maximum, that material has to be of quality and be of consistent quality.

07:34 Speaker 4:
And so therefore, GMP qa QC is critical in our areas in development of IPA and development of these products. So that’s another area when we go from preclinical to commercialization, having the same quality and and product in those clinical trials. And then finally, if we have a client that wants to take their product to market, we also offer commercial strategy and entry into the US marketplace. So pretty busy. We’ve been pretty busy and we’ve only been launched for the last five weeks.

08:08 Speaker 4:
<laugh>

08:11 Eric Schneider:
No, but I, you know, it’s, you, you kind of hit the nail on the head in terms of like the regulatory framework in, in the US and you know, you don’t want to be taking one step forward and two steps backwards. Right. And I think, like, it sounds like, you know, what you all are trying to do at CANION is help these companies by leveraging the hard-earned groundwork that you all have put in, you know, in your previous years, Lisa, you know, in other, other sort of like healthcare and, and drug discovery, right?

08:42 Eric Schneider:
And bringing that expertise to the cannabis space. And it’s really interesting be too, because I feel like a lot of the conversations that we have on here related to cannabis are more CPG focused, not as much pharma. So it’s really interesting to hear the, the different lenses and applications that the plant can have, you know, for for drug discovery, right.

09:04 Eric Schneider:
And, and the medical application. So I think that’s, that’s super interesting. And I guess one question that I had is, you know, a big material shift that has happened over the past month and a half, two months, you know, the, the push towards making cannabis a schedule three substance instead of a schedule one, right? And I think a lot of the hope with that is now we’re gonna have some better quality research and, and information around the plan and more resources.

09:37 Eric Schneider:
How does that impact what you all are doing at Cann? And you know, I guess what are your thoughts on how it would impact, you know, the pharmaceutical side of cannabis moving from a schedule one substance to

09:52 Speaker 4:
Schedule? Absolutely. So I’m gonna take it from the clinical side since I have the pharma biotech lab and generic perspective. I’m gonna let Mike take it from the over the counter cannabis perspective because that’s what makes each of us unique, being the CEO and founder and Mike being the COO and founder of CCRP. So from our clinical perspective, from the pharma biotech dealing with FDA, looking at the type of products that are prescription grade, if you are still dealing with cannabis or any part of the cannabis flower that is greater than 0.3% THC, those levels may change as we get rescheduled to level one to level three.

10:33 Speaker 4:
But the higher you go, you still need to have regulations around that because you are, you are still dealing with a, a substance that is high quality THC. And so when you get into those areas, you still have to go through GMP, good manufacturing practices, qualifications, you still have to ensure that you are meeting the clinical standards of developing a pharmaceutical and biotech product based on FDA standards that will not go away, whether it’s a schedule one or a schedule three.

11:07 Speaker 4:
And the major concern of the cannabis flower is the variation of the flower itself. And so standardizing it, you know, a lot of, a lot of the cannabis companies out there are making synthetics, but what consumers and what companies are looking for is a more natural way to offset some of these side effects to get away from things like opioid addiction and, and things that can add onto disrupting the compliance and persistency with the drug or increasing the side effects so that you have to add more medications that adds more cost on the care of cancer or the care of rheumatoid arthritis.

11:46 Speaker 4:
And so we like the natural plant, but we know that there are inconsistencies. And so if we can standardize that and get those parameters in a way to get through FDA approval and their process, that is still going to be required, whether it’s a schedule one or a schedule three. And I wanna make that very clear because we get that question quite a bit. Mike and I answered this last Thursday and Friday with about five different companies that we talked to. Mike, I’ll turn it over to you and

12:17 Speaker 5:
Sure. Yeah. So the, funny enough, we were talking about the rescheduling of this and we knew it was coming down the pipeline through some lobbyists, some other groups we knew and we were just kind of waiting for it to happen. But coincidentally, the announcement came, the, actually the day Lisa and I decided to launch the company was the day they made that news public. So it couldn’t have been more serendipitous in that, in that regard. And you know, I was telling Lisa that as soon as this happens, this is really going to allow this business model to flourish.

12:51 Speaker 5:
Because what it does do is it opens the doors to more research, it opens the doors to more funding, it elect allows the banks to get into the equation. It allows a lot more institutional money to come into the equation. And it’s not so frowned upon to be studied or researched, and a lot more people are now able to get involved.

13:11 Speaker 5:
So that was a, was a huge deal. And now it’s just very interesting to us to see, for me, as someone that’s participated in the state markets as well, to see how this all play plays out down the road where we’ve got these states that have micro economies built around cannabis sales and tax programs and incentives and entire regulatory boards. But now we’re moving to having an FDA controlled product that’s a schedule three product. So I’m personally interested to see how the states in the federal government duke it out 10 years down the road when they’re ready to put cannabis prescriptions in the marketplace.

13:49 Speaker 5:
And you know, Lisa and I, our goal here is to help the companies that wanna bring those products to market faster and more efficiently so that we can have truly regulated cannabis products and cannabis therapeutics in the marketplace. I think right now, as someone who’s participated in this space for a long time, that the biggest downfall of all of this space is the, the lack of regulation.

14:15 Speaker 5:
There’s a million different ways to make a lot of these consumer products that are on the shelves. No one’s regulating it, no one’s doing quality assurance. So I think it’s, it’s finally about time that we realize it, it should be, they should be there and it should be done correctly. And it’s taking away the public safety issue as well. Right. So this is that, this is big news for us. It’s big news for the state markets. I think they’ve kind of opened Pandora’s box in some respects right now, but it’s really cool and we’re excited to see it.

14:45 Speaker 4:
Absolutely. And I’m gonna add one more comment to Mike’s comment. You know, looking at this new world that we’re in, most of the clinical research that was done, or most of the research that was done by NIH and Ida was on the harmful effects of cannabis. Now with the res, the descheduling or the rescheduling of cannabis, there’s gonna be more research in the benefits, the medical benefits and the usefulness of this flower were versus the harmful effects because there is some good that comes out a lot of good that I’ve seen being a cancer, a breast cancer survivor coming out of having been thrown opioids during my treatment treatment and knowing not to take them because I knew what those side effects were, to really look at other alternatives as we look to the future of how do we care for those patients that need more than just those large molecule drugs that we’re developing.

15:41 Isaac Bock:
Yeah. And that, that all makes a ton of sense. I think, you know, you, you both touched on a little bit, but one of the things that’s kind of a constant talking point for, you know, our clients and people we’ve had on the podcast is just the, the financial side of things and banking. So how have you guys, you know, had those conversations with financial institutions or discussed with the companies you’re working with? How have those conversations differed from kind of your more traditional cannabis businesses?

16:07 Speaker 4:
Yeah, so, so most of our companies have already gotten their finance. So they’ve gotten it through series A, series B, or they have already, they, they’ve already have revenues coming in, so they have a di diverse portfolio. And so they have funding already in their, in their chest in which they want to partner with us. We have not, outside of our initial launch, began talking to a lot of companies that are investors. They are reaching out to us now that they’re hearing about us asking if we need investment, but we do not need investment currently because we are working with companies that have investment, have a budget, and know the monies that they wanna put forward.

16:52 Speaker 5:
What we really do see as well is the access to more grant funding. One of our advisors is with the, with the Dent Institute, and he was saying that, you know, normal grant funding for a cannabis project would be significantly less than a, than funding for something else that was equivalent. And now that it is no longer a schedule one substance saying that there’s no medical benefit, there’re opening the doors to larger sums of grant money through the NIH and there’s gonna be a lot more funding available for all different types of research into cannabis now.

17:27 Speaker 5:
Not just THC, not just terpenes, but looking at the full cannabinoid spectrum all the way down to the industrial applications of cannabis.

17:35 Eric Schneider:
Yep, absolutely. In, in your conversations, like, do you guys foresee or are, are currently having conversations with like big pharma looking to get into this space, like the Pfizers of the world and you know, I think, I think that’s definitely coming down the pipeline eventually. Like is that, are they starting to look at it

17:59 Speaker 4:
Now? Let me answer that one since I come from that world, actually. We have two major advisors along, well, I would make the third, one third that sits on our advisory board and our advisor, excuse me, the first would be the past chief medical officer of Pfizer, Dr. Frida Lewis Hall. The second is Renee Tanenbaum, these are pharm Ds and they are physicians by trade. They are coming from Pfizer’s, Bristol Myers Squibb, Roche, both in North America and internationally.

18:35 Speaker 4:
They are coming from companies like Vertex and AbbVie. So they’ve been with biotech companies and they’ve been with pharmaceutical companies. You know, the evolution of cannabis is very similar to the evolution that we had with generics. When the generic market came forward, we in pharmaceuticals and biotech said, absolutely not. They are not equivalent to us. We will never use them. Do not use a generic.

19:02 Speaker 4:
As time evolved, we as pharmaceutical and biotech companies realized that we can make those biosimilars and and generic branded comp, generic products coming out to the market and make them just as well and make them brand extensions and they’ll be just as good with the same core molecule and excipients that we’ve used in the past. So we evolved to making generics a brand extension. I see the same thing happening potentially with cannabis and terpene type molecules, that as we look to lessening the side effects of some of these large molecule oncology, rheumatoid arthritis, Crohn’s, IBS drugs that are being used in patients with side effects, we’re softening those side effects so that we can increase the compliance and persistency and get better medical outcomes, which is what payers look to in the United States in order to pay for a drug.

20:02 Speaker 4:
They want better outcomes, they want fewer drugs and they wanna see increased compliance and persistency.

20:10 Speaker 5:
And just kind of to further on that, what your question was, a lot of the conversations that we’ve had right now is a lot more with startup companies and mid-market companies that are looking to make an approach into the United States or looking to take something from concept to reality in the United States and getting, you know, at least into the first phases of research where then, you know, down the road they’d be looking to partner or be acquired or team up with one of those big companies that are gonna bring these products really to the commercialization phase.

20:45 Speaker 5:
But we see a lot of companies right now that are outside the United States that would have a product that is over the counter in say Ireland or Mexico or something of that nature that is completely regulated differently here in the United States. And the United States probably being one of the largest markets for them to enter into. It’s also the most complex and they don’t necessarily have the, the years of experience that we’ve been able to aggregate with our, with our team that will help them navigate that landscape.

21:13 Isaac Bock:
No, that makes a ton of sense. I guess are there certain regions of the world, you know, whether it be South America or Europe, who’s, you know, the companies you’re partnering with in those areas are having an easier transition to the United States. You know, I’m not too familiar with the regulatory environment of those areas, especially on the pharmaceutical side, but how does that look from country to country and even region to region?

21:36 Speaker 4:
Yeah, so I can take that one Mike if you want me to. So looking at the globe, we’re seeing massive increase in investment into pharmaceutical. Yeah.

21:57 Speaker 4:
And that is about 37% of the global market research. When we take a look at Europe, that represents 30% and Asia represents 26% mainly in Australia, North Korea, some of those areas there. When you take a look at regions that are easy to work with from a government body, believe it or not, we hear a lot from our, from companies that they want to do trials in Costa Rica. Well, Costa Rica is Latin America. Latin America right now only represents about 5% of cannabis global clinical pharmaceutical market investment.

22:36 Speaker 4:
But it’s growing and it’s one of the easiest, we call that latam Latin America. That’s one of the easiest markets to enter into and one of the easiest governments to work with. So that is a growing area to answer your question, but every country is complex and every country is different. But the easiest one to work with has been Costa Rica, those countries in, in Latin America. But again, remember your largest regions are United States, Europe, and Asia.

23:09 Isaac Bock:
Yeah. And

23:10 Speaker 5:
What, what I find to be kind of interesting too is when you go out to Europe, they may be a little bit less complex from the regulatory landscape, but it’s a lot of small countries that all have different regulatory bodies. So even though the United States is probably one of the most complex and the most overregulated, once you’ve navigated the regulatory system here, you’ve got access to a massive market all under one body at that point. Versus going out to Europe and having to deal with 15 to 20 to 30 different countries to have the same consumer base.

23:48 Eric Schneider:
That makes, that makes a ton of sense. One, one additional question I had is like related, you know, obviously a big part of any sort of medical product is insurance coverage, right? And insurance reimbursement. You know, that’s been a topic of conversation even before, you know, kind of the clinical research aspect of cannabis, right? With just people having a medical card and saying that they want to get reimbursed for it by their insurance companies, right? Like have you guys had any conversations with some, like any of the larger insurance companies, like a Blue Cross Blue Shield that you know, are providing medical care and, and what their stance is on cannabis and providing some sort of copay or relief as it relates to cannabis products?

24:39 Speaker 4:
I’ll take that one. I have over 17 years of payer experience from my pharmaceutical and biotech days and diagnostics because we worked with, with insurers like United, Humana, Cigna, Aetna, blue Cross Blue Shield, and the Blue Cross Blue Shield net networks out there and the regional insurers as well. So they are standing by, we have not had those conversations with them yet because we have not had clients that are ready for commercialization to have those discussions yet when the time comes, I will be the point on being able to do that along with Renee Tannenbaum, who actually has a vast experience in the payer segments as well.

25:21 Speaker 4:
There are 12 to 13 payer segments in the United States, not just the insurers that you mentioned, but there are group purchasing organizations for hospitals and long-term care and assisted living. So when you get into rheumatoid arthritis pain, those type of indications you are dealing with the elderly and sleep AP apnea, you are dealing with an older population.

25:44 Speaker 4:
So there are different market segments. Long-term care is another one that you will have to be aware of on how to negotiate and how to go into different contracts. And so we have not had those conversations yet because guess what, we have to make sure that we get those drugs approved through the FDA, once they are approved through the FDA and we have the clinical proof that we can do it, then there are certain things that if they’re deemed innovative or first to market, then that will make a difference when you’re talking to a payer, when you’re sitting at the table and trying to get what we call formulary access.

26:19 Speaker 4:
And that’s when you have that discussion ’cause payers are concerned with, is there anything out there like you, number one, will you be harmful to the community? Will you add cost to my formulary and my medical drug benefits?

26:36 Speaker 4:
Will you add a cost to my medical care of cost? That’s what they’re concerned with. They wanna see outcomes, they wanna see head-to-head data. They wanna see if you’re first to the market and they wanna see how these drugs are going to be accepted. So it’s not the time to have those conversations yet, but when we go to market, it’ll be six to six months to a year before that drug comes to market that we begin to have those conversations. We usually plan six months to a year, usually a year is when we start having those real conversations with payers.

27:09 Speaker 4:
If we have a drug in hand that has been approved from preclinical and has passed phase one and phase two. Okay,

27:19 Eric Schneider:
Got it. Yeah, you can’t, you can’t put the cart before the horse. That’s right. Rights, right. You gotta, to your point, that’s

27:23 Speaker 5:
Why the planning process is so important.

27:25 Eric Schneider:
Yeah,

27:27 Speaker 4:
And that was a great question. I’m glad you asked that question, <laugh>.

27:32 Eric Schneider:
Yeah, no, I, I think it’s, I think it’s really important, right? Because those are all just kind of considerations, you know, just that any medical drug has, right? Is is obviously insurance benefits and, and can that be reimbursed? I know you mentioned that you know, before you can have those conversations, obviously there needs to be a product and FDA approval. What are your thoughts, you know, relatively speaking like timeline perspective, like five years, 20 years, like any, any kind of idea on when you think, you know, not gonna hold you to it, you know, definitively, but just trying to understand like how far we are or how far away.

28:13 Eric Schneider:
So

28:13 Speaker 4:
I’m gonna take it from the pharma bio perspective. I’ll let Mike take it from the over the counter perspective and consumer perspective. When we look at, that’s a complex question because every company we’ve talked to or every researcher we’ve talked to is at a different stage. Okay? So if you have a company that has done most of their research non-US, the question is whether that data will be accepted by the FDA in the us.

28:44 Speaker 4:
If it’s accepted, then it’s accelerated. If their preclinical is accepted, the animal and human cell trials are accepted, then they can move into phase one and phase two, which is about efficacy, safety, and dosing. Okay? And those are where they go actually phase one and phase two is when they actually move from animal into human trials and they’re a minimum of anywhere from 10 to 50 patients in those trials.

29:09 Speaker 4:
They’re not the big ones like phase three and phase four. And so that’s when you really have to begin looking at, okay, where you are and how much time that’s gonna be, that can shorten the timeline. So it can shorten years of five to 10 to 20 years down to maybe 10 or five. There could be a company that’s coming over that already has or, or already is in the United States that has those approvals and, and they could be ready to go to market. So they’re ready to gear up for clinical phase three and clinical phase four.

29:44 Speaker 4:
That’s when you are getting ready for large clinical trials, you’re doing patient recruitment and you are preparing for market access at that point. It could take less than five years, one to five years. So it really depends on the point of where that particular researcher, university or company is at in the development of their molecule.

30:05 Speaker 4:
If they’re starting from scratch and depending if on if they’re going to add to the core molecule that they’re working with or if they’re going to change the core molecule and add cannabis or terpenes to it, decide on whether it’s gonna be 5, 10, 15, 20 years. And that’s where when you pull us in early, we can get regulatory on board. We have the best of the best working in that area to, to say, this is the roadmap, this is what you need to think about, this is what you need to get ready for. With pre IND meetings, that’s where we come in because the mistakes are made strategically when you don’t have the right decisions made at that point that you have a patent or you are in drug development of that molecule.

30:47 Speaker 4:
Now that’s from the pharma biotech and generic perspective when you’re developing APIs. I’m gonna turn it over to Mike, Mike where he can talk more about that consumer over the counter side.

31:00 Speaker 5:
It’s actually a pretty unique scenario in my mind. And it all really depends on how they de resched it and how they write the rules around the rescheduling. Because one thing that we gotta remember is on the schedule three list, there is nothing else like cannabis, everything else like anabolic steroids or ketamine or something of that nature is a single molecule. Cannabis is a plant that has multiple molecules and multiple active ingredients and multiple therapeutic properties.

31:35 Speaker 5:
So it’s really hard to just say cannabis is a schedule of three substance without like digging in a little bit deeper, right? Because right now the route to market is very simple for somebody that’s not putting THC in a product or someone that’s putting THC in a product less than 0.3%, right? There’s pretty much no regulatory oversight. And then, you know, the only real regulatory oversight you have is if you’re going into big box retail and some of those retailers are requiring true GMP type manufacturing processes, which many, I would say nine of 10, cannabis and hemp and CBD companies are not even close to.

32:15 Speaker 5:
So it, in my mind, it really comes down to are they rescheduling cannabinoids as as a whole, are they rescheduling cannabis? Is it delta nine, THC? Is it total t is it all THC, delta eight, delta nine, THCV, whatever the alphabet soup is of THC they have now. I mean it’s, it’s open to interpretation a lot and I think that it’s gonna be interesting to see how they, how they do it, right? Right now they’ve said they’re gonna reschedule it, but the government says they’re gonna do a lot of things and what they say they’re gonna do and what they actually do, sometimes they’re two different things.

32:52 Speaker 5:
So we’re just kind of waiting it out at this point. And I think we will know more once we figure out exactly what they say and what kind of rules they make around it.

33:00 Speaker 4:
But in the meantime,

33:02 Eric Schneider:
That makes a lot of sense. I

33:04 Speaker 4:
But in the meantime, we’re gonna work. Yeah, I’m sorry you saying, but in the meantime, we’re gonna work within the, the, the regulations that we have today, what we know to be true, to get products through the FDA and to get them over the counter and when, and we’ll stay close to what those regs are when they change.

33:22 Speaker 5:
And really the, the, the, the one, the one piece is the THC piece, right? That’s the, that’s the, the elephant in the room, so to speak. And what a lot of these companies are doing right now are like more of non-regulated, the people that are putting things through trials or bringing products to market right now, prior to the announcement of rescheduling, were really looking at the non, the non, what do you call, intoxicating cannabinoids and looking at cannabinoids administered in, in new fashions or delivery devices of cannabinoids.

33:53 Speaker 5:
And that’s what’s being studied right now. But the rescheduling is really gonna open the doors for THC to be looked at. And I think that that is the one that we have to really see what they say and how they do it.

34:06 Eric Schneider:
Makes a lot of sense. No, it, it’s a super interesting time, you know, for you guys to, to embark on this journey and then, you know, it’s just, it seems like great timing with the, the rescheduling, but like to your point, Lisa, you know, you guys are going about your business with the way that the legal framework is designed today and you know, just being able to provide that hands-on hard earned knowledge that you guys have had through prior lives and, and being able to apply it to the cannabis industry is super important.

34:39 Eric Schneider:
Right? And it’s great to see more and more experts either be advising or directly operating, you know, in this space. ’cause I think it just shows additional legitimacy to this industry in ways that a lot of people don’t traditionally think about. Right. You know, they think about, okay, you know, it’s a CPG industry, you know, you, you get your products for recreational purpose. Yes, there’s medical, but realistically everybody is, is more focused on the recreational market, right?

35:13 Eric Schneider:
But this is just a totally different lens and I think it’s very, very cool to have this conversation and really appreciate your all insight and knowledge on, on this subject matter

35:26 Speaker 4:
Specifically. Well, thank you for having us. We appreciate that. Thank you. And, and and, and hold on. Absolutely.

35:32 Eric Schneider:
Have a great rest.

35:33 Speaker 5:
Thank you very much. Really appreciate you having us on your show and hopefully, hopefully down the road we’ll be talking about the products we are bringing to market versus the ones we want. Yes.

35:44 Speaker 4:
And I will tell you absolutely to hold onto your hats because there’s already companies in this market space developing drugs that already have ’em out. There’s some in, in phase one, two, and three, a lot of them are in two and three and many of them have gotten approved for phase one. So they’re moving and it’s happening and the expected growth is billions of dollars going from 9.2 billion in 2024 to over 431 billion by 2025. So there’s gonna be, or excuse me, by 2035. So that’s a lot of investment and a lot of research being done for the good of cannabis and terpenes.

36:26 Eric Schneider:
Absolutely. Thanks again for participating in the Roots to Race. Pleasure.

36:31 Speaker 5:
We appreciate you have a great day.

36:34 Eric Schneider:
Another great one in the books. I think really interesting to hear their expertise and, and also the, the team of advisors that they have is super impressive, right? You, you hear about backgrounds of folks, you know, coming from Pfizer and, and advising on their new venture connation. And I think it seems like it’s not a matter of if it’s more when, you know, and, and that parallel to OTC generic products was really interesting, right? How, you know, big pharma at one point was like, we’re never gonna do this, but now it’s commonplace and widely proliferated across the United States and, and globally.

37:13 Eric Schneider:
So definitely very, very exciting to hear, right? That it, it’s not really a matter of if, but when and, and hearing about not only US research, but global research in the cannabis space and how all these different companies are trying to enter into the US market just seems like a lot of positive momentum. And again, you know, I said this on the intro, not something that we talk about a lot in the cannabis space, but I think is ultimately where the, the industry could go in a really positive direction.

37:50 Isaac Bock:
Yeah, I mean I think, I think there’s always gonna be the element of the direct to consumer CPG side of things, but having the backing of the cure pharmaceutical side, which proves all the medical benefits is gonna be great for the industry overall. And then also on the medical, you know, card side of things. And using these products for specific issues, I think is gonna be extremely important to grow the industry. So it’s definitely, you know, great that Michael and Lisa are focusing on helping these companies bring their visions to market.

38:23 Eric Schneider:
Yeah. And I think like, it, it’s another instance of where like, it just takes time, right? There’s no, there’s no replacement for that, right? Just other industries and other molecules have had a head start, but it’s exciting to hear that the progress that they’ve had and you know, I think we always talk about this, right? It’s like every year there seems to be additional progress and push forward, even though there are a lot of challenges that I think get highlighted. But this is another example that it’s really not a matter of if, but when and excited to hear.

38:57 Isaac Bock:
Yeah, no, absolutely. And it will, it’ll be cool to see what happens over the next, you know, 12 to 18 months with everything they’re working on.

39:06 Eric Schneider:
Absolutely. Till next time, man.

39:09 Isaac Bock:
All right.