Editors’ Note: This is the transcript version of the podcast. Please note that due to time and audio constraints, transcription may not be perfect. We encourage you to listen to the podcast, embedded below if you need any clarification. We hope you enjoy!
This week we are joined by Natalie Katz and Wayne Nasby of Ocean Groves Ventures to discuss
- Israel researched backed medical trials
- Big Pharma’s view of Cannabis
- Challenge of Education/ Marketing Misinformation
- And so much more
Ocean Grown Ventures mission is to shape the cannabis industry with revolutionary Research & Development through international scientific partnerships and pharmaceutical grade products for the benefit of humankind.
This show is presented to by 8th Revolution:
At Eighth Revolution (8th Rev) we provide services from capital to cannabinoid and everything in between in regard to the hemp & cannabis industry. Our forward-thinking team can diagnose, analyze & optimize every detailed nuance of your company to keep your business safe, smart, and profitable. Our flexibility and experience combined with ongoing research create unique insights into how to best grow your market share. Contact us directly at [email protected]
Bryan Fields: @bryanfields24
Kellan Finney: @Kellan_Finney
[00:00:00] What’s
[00:00:02]Bryan: up guys. And welcome back to the episode of the dime I’m Brian Fields. And with me as always is Kellen Fiddy. And this week we’ve got a very special guests, Natalie Katz and Wayne NASBE from ocean grown ventures, Wayne and Natalie. Thanks for taking the time. How are you doing today?
[00:00:16]Natalie: Well, thank you.
[00:00:17] Thanks so much for having
[00:00:18]Wayne: us. Great. Thank you very much.
[00:00:21]Bryan: Appreciate you guys joining and I guess for the record, your locations would be.
[00:00:26]Natalie: Los Angeles. We are in LA
[00:00:29]Kellan: it’s a west coast. Bascos here we
[00:00:31]Wayne: go.
[00:00:32]Bryan: Going to have to edit that part out count. So cool. So I’d love for our listeners to get a little background about both of you and how you got into the cannabis space, Natalie.
[00:00:43]Natalie: Absolutely. So I’ll speak on behalf of myself and my father. We kind of got into this together. Um, in 2017, we really wanted to honor my grandfather’s legacy. He passed away from cancer in 2002, and one of the biggest things in his life was being philanthropic and making the world [00:01:00] a better place for people.
[00:01:01] And he had escaped the Holocaust when he was only 13 years old. I’m one of the last boats out to what is now known as Israel. And to honor his legacy, we decided to invest in Israel and kind of. Figure out what they’re doing that are helping people right now. And it turns out they’re actually the leaders in medical cannabis research, which is something we were not aware of.
[00:01:19] Uh, it really all started with Dr. Raphael Meshulum in the sixties, but ever since then, they’ve been the world leaders in medical cannabis research. And we thought that that was the perfect way to honor his legacy is, is providing, um, a product and a solution to help people’s quality of life. And that was our biggest goal.
[00:01:36] So I am the brand manager. Uh, helping kind of create the tone and messaging of the brand, what the packaging looks like and who we are as a company. Um, unfortunately my dad, Jerry is unavailable. He is flying back from Israel as we speak right now, but we do have Wayne RCLO with us. So Wayne, you can give them some background on yourself to.
[00:01:56]Wayne: Yes. Most certainly. Thank you for that. Um, [00:02:00] uh, guys, nice to meet you. Um, my background is a little bit unique. I’ve I’ve been in a pharmaceutical biotech industry for over 30 years and my areas of expertise are really, um, GMP operations, product commercialization, anything related to compliance with the FDA, as well as, um, helping do conceptual designs and build out.
[00:02:25] Of of manufacturing facilities. So really it just encompassing all of GMP operations. And then I started early on in Amgen and then from there, um, I started, uh, co-founded a drug delivery, uh, technology company here in California. Um, and that just took off and we were just doing great stuff there as far as working with molecules and figuring out the best way to deliver them.
[00:02:52] And then, um, it was at that point. That I hooked up with Jerry and Natalie. This was around [00:03:00] 2000 and late 2017, 2018. And they were trying to, um, get me involved in the cannabis industry and taking what I had done in the pharmaceutical world and apply it in the cannabis space. So, uh, needless to say, I wasn’t really interested at the time for various reasons, but, um, at one point.
[00:03:21] I had a very, you know, mind opening event where I was given the opportunity to meet the research scientist at a very well-known university here and there. They’re focusing on, um, pediatric pediatric, excuse me, pediatric cancer. And it was just unbelievable what they were doing. And I realized then that my perception.
[00:03:47] Of cannabis, um, was completely wrong. And I wanted to focus all of my energy and trying to help develop the methodologies and the, and the, and the science behind cannabis from a, from a [00:04:00] commercialization perspective. And I’ve been doing it ever since. So it’s pretty exciting for us.
[00:04:05]Bryan: I appreciate you sharing that.
[00:04:06] And Wayne, I can hear some of that hesitation, so I don’t need to ask you if you hesitated to jump in the space, but Natalie, I want to, I want to start with you. Was there ever any hesitation to kind of come into cannabis? Obviously has Wayne really shared, there was that stigma and there still is the stigma of cannabis.
[00:04:20] So any hesitation for you to kind of attach yourself to.
[00:04:24]Natalie: Funny that you say that because something that my father Jerry always says is, you know, he would never bring me into this business just to create a rec brand for whoever gets some of the most high that is not our goal here. And while we have no issues with recreational cannabis that’s to each his own, this is truly a medical.
[00:04:41] Uh, brand that we’re promoting and that we’re focusing on and it’s really about improving people’s quality of life. So for me, it was an absolute, no brainer. I’m realizing that a natural solution like CBD and also teach, see products can improve people’s quality of life is amazing. So knowing. Whatever you’re doing every day is making someone else’s [00:05:00] life better is very rewarding.
[00:05:01] Um, so although we hadn’t anticipated, when we went to Israel to kind of see what was going on there, that they would be the world leaders in medical cannabis research. It, it almost felt like his man, like I was saying, we wanted to honor my grandfather who passed away from cancer and Israel is conducting clinical trials on cancer research with cannabis.
[00:05:18] So it all seemed to fit. Um, and so, yeah, no, it’s, it was honestly a very easy jump. I came from social media and marketing. And so it kind of just made sense
[00:05:28]Bryan: where the conversations in Israel eyeopening, obviously what they’re doing is pretty impressive. So I’m sure hearing some of the advancements that they have has got to be pretty simple.
[00:05:36] It’s
[00:05:37]Natalie: it’s unlike anything you would ever expect. I mean, they’re around a decade ahead in terms of medical research, just because of the illegal landscape that’s there. Um, you know, our, our partner is actually the first company to be granted a licensed by the Israeli ministry of health to produce pharmaceutical grade CBD and THC products.
[00:05:55] So. our partner, all of their products in [00:06:00] Israel are manufactured, uh, you know, to pharmaceutical standards and then prescribed by doctors and patients get them at a pharmacy. So we’re basically kind of. Taking that same product, but selling it online because of the legal landscape in the United States. So it’s a pharmaceutical grade product, but it’s not going through the same typical channels just because of the current legal landscape and pinata is able to conduct clinical trials and do research and weighs on their product that is just not allowed in the United States.
[00:06:27] And it’s really unfortunate, um, that the U S is so behind in this respect, but we’re really excited to. Bring this technology, this science to the space, we really want to legitimize it. And it’s something we always talk about is we want to bring all the benefits of pharmaceuticals, you know, pharmaceutical manufacturing, the standardization, the quality management, the quality of the raw materials, the consistency, all the things that you like about pharma without any of the negative aspects of it, you know, where it comes to being highly addictive or potentially negative side effects.
[00:06:57] So we have this natural solution of CBD, but [00:07:00] then we’re making it to the same standard that you would take in. I would never question with your Advil that, that, that tablet is going to be different than another one. It’s going to have a different amount of the active ingredient that doesn’t happen in those kinds of products.
[00:07:11] Whereas in CBD, as we know, it’s kind of the wild west in the United States right now, and there’s a lot of mislabeling and there’s a lot of adult traded products. And so we wanted to kind of create a new standard for the CBD industry and match it to that of the pharmaceuticals.
[00:07:29]Bryan: I love it. And it’s quite daunting to hear it because we know some of the challenges that you’re up against and especially with the advancements and where Israel is.
[00:07:36] And especially here in like the east coast, for example, I still have field conversations for people who try CBD products and their first question out of that. Will this get me high it’s concerning because there is an educational gap. And then when you’re talking about marketing a pharmaceutical gate product, there are so many challenges from that sense, because not everybody is handling things, let’s call it quote unquote, the right way.
[00:07:59] So [00:08:00] Natalie, in your opinion, from a marketing standpoint, discuss some of the challenges that go into us and discuss how your team overcome some of those.
[00:08:07]Natalie: Yeah, I would say one of the biggest things is, is misinformation and false claims. So although we know that CBD can help with so many things, legally speaking in the United States, we cannot make those claims.
[00:08:20] So, you know, we cannot say that it helps with pain or anxiety or any disease state. And we’ve actually learned a lot about what we can and cannot say, thanks to Wayne and his. Uh, expertise in this category and with compliance. So what we’ve come to realize is we really need to come from an educational standpoint and explain.
[00:08:39] How CBD actually works in the body and kind of get rid of this whole supersizing culture in America, where they tend to believe that the more CBD the better, oh, this has 5,000 milligrams. Like that’s going to work better than this one that has a hundred. Unfortunately, that’s just really not how medicine works.
[00:08:55] Um, you know, from a pharmaceutical perspective, you always want to start with the lowest dose and increase as [00:09:00] needed. And so one thing we’re trying to convey to consumers is just that is that you need to have. A true pharmaceutical grade product, and it needs to have high bioavailability, which is actually the amount of active ingredient that’s being absorbed into your bloodstream.
[00:09:13] And so it’s able to have an active effect. So it’s not even about the milligram dosing, it’s about the actual absorption of the product, and that has to actually be tied to study. So there’s a lot of companies that also claim that they have high absorption. Where are those claims coming from? They’re anecdotal.
[00:09:30] Right? But because they’re in Israel and able to conduct clinical studies has conducted something called a pharmacokinetic study, which measures the active ingredients flow and metabolism throughout your body and the distribution throughout your body. So unless they have those studies, there’s no backing up the claims that they have high absorption.
[00:09:48] So our products have that pharmacokinetic study testing, and that also helps determine the dosage and the Milgram crowd of our products. So everything behind our products is intensive. And there’s a reason why their dose that way and [00:10:00] why they have that milligram count. So it does take a bit of education to explain that, but we’re trying to partner with doctors and physicians that want a brand they can trust and know is properly dosed and properly manufactured.
[00:10:12] So that is kind of the direction we’re going in. Is the health care practice.
[00:10:16]Kellan: I have a quick question. How challenging has it been knowing that a similar product or identical product from a formulation perspective in Israel can be tied to these claims? Right? And then you are trying then to communicate that same messaging to.
[00:10:31] The is in a different country, but you can’t like how challenging has that been to navigate that world? If you will. I
[00:10:37]Natalie: say it’s frustrating as an under, so a lot of it has to do with semantics as well. Like for example, you said, you know, we can’t mention any disease states that we can’t specifically claim that it helps with something, even though we know.
[00:10:50] That it, it, you know, it does their clinical trials to back it up. Um, but hopefully in the near future, you know, is conducting clinical trials on THC products as [00:11:00] well. And we hope to have clinically proven claims within the next few years, uh, which will be a huge differentiator for us as well. But yes, it’s really difficult.
[00:11:08] We’re also seeing a lot of, um, claims made on packaging, pain, relief, you know, all sorts of things. And if you notice that on a packaging, that should be a little red flag to you. Um, They’re not quite listening to what compliance rules are stating. So that should be a warning sign. Um, obviously every, not every brand is breaking the law, but you do need to be aware of the claims that these brands are making and realize what that actually indicates about how that brand off.
[00:11:38]Bryan: There’s there’s so many, there’s so many challenges here from perspectives too, right? Like, and I want to stay with the supersizing one because in my experience I’ve found most people when they’re purchasing a product more is always better. It doesn’t matter. It’s always, always, always better. And I wonder if that’s just like a cultural stigma, if that’s a global [00:12:00] phenomenon or if it’s trying to get the best of value bang for your buck, but you’re right.
[00:12:03] Like having, having that challenge there. Let’s say all things equal to people who don’t know what they’re doing. Look at the two different products. Sometimes people will, may be more leaning towards the more in just that scenario. I need to make a difference what it is it. So communicating that and educating them, but understanding that from a long-term perspective, the value is so challenging.
[00:12:25] And I give your team a ton of credit for putting up the fight, because it takes individuals like yourself doing it the right way to help set the industry.
[00:12:34]Natalie: Thank you. Yeah. Wayne, do you have anything you want to add to that?
[00:12:37]Wayne: Yeah, I think you’re, you’re absolutely right. And that’s the reason that’s the, you know, the foundation of why we are focused on the healthcare practitioner channel, because we realized early on in the, in the retail channel, the distributor channel, we didn’t have.
[00:12:57] That we’re educating the consumers [00:13:00] and telling the story and having the conversation with the consumers so they could get a better understanding of why they don’t need a super dose and why bioavailability was so important. Right. So when we started to get doctors that were interested in, um, helping their patients with alternative, um, products.
[00:13:25] Uh, not, not synthetic drugs, right? They didn’t have a brand. They could recommend, they didn’t know if a brand was safe. They didn’t know if it worked. They, they were clueless because they didn’t have enough information. So we’re seeing now when we started to approach. Physicians and share with them the information from a compliance perspective, from a pharmaceutical perspective, um, their eyes just opened up and they’re like, where have you been?
[00:13:58] We’ve been waiting for, for [00:14:00] a brand and people in a company like yours. So. W our, our, our goal is it’s the physicians that are going to be our champions. And they’re the ones that are going to be out there helping people when people come, uh, their patients, I should say, you know, and they say, Hey, you know, doc, what do you think about CPD?
[00:14:20] You know, for, for whatever their indication is, you know, that’s when the doctor will say, well, I think you might want to explore this. You know, if, if a doctor recommends something nine times out of 10, You’re probably going to give it a shot. You’re going to give it a try. I know I do. Um, and that goes far for us.
[00:14:38] And I think by going with the HCPs, we’re really going to have a huge impact and do some good. Yeah, I agree.
[00:14:46]Bryan: And I might say your nine out of 10 might be a little low from a real statistical standpoint on people’s purchasing factors recommendations. So staying in that direction, though, when you’re speaking to these physicians, is it more educational focused?
[00:14:58] Are you using the research to let it stand for [00:15:00] itself? How do those conversations go?
[00:15:03]Wayne: Yeah, I would say
[00:15:06]Natalie: I was going to say Wayne. Yeah, it’s a combination, but I’ll let Wayne take this since he has the expertise in this industry. So go ahead, Wayne.
[00:15:14]Wayne: Well, I think the, you know, the pharmaceutical model really, there’s a couple things that are going on here.
[00:15:19] One is that. Doctors strictly focused on science, they focus on results. So that’s the foundation of the discussion. So you have that. We have that from our partner Panex. Yeah. We have the trial data. We have the information and what we’re doing with CPD Or at least our brand is we’re saying, look, we’re going to tie this to a specific indication and that indication will be tied to the dosage of the product.
[00:15:46] And then the dosage and the product will be tied to the delivery method. Is it a tablet? Is it a liquid? Is that a topical and those three things. Is a very common way of looking at a product [00:16:00] in the physician’s world. So they get that and they think, and they’ve always gotten that and that’s how their programs.
[00:16:06] So we’re very excited to have the conversation and the, and the marketing materials, the physician detail aids, all that. Is tied around the pharmaceutical model and that’s what makes us stand out because, you know, we are representing to a certain degree of pharmaceutical company. We’ve got pharmaceutical grade products and we’re having almost like a pharmaceutical grade conversation.
[00:16:28] So the combination of all three really makes a good business sense and it, and it makes sense to the physician. I have a question
[00:16:35]Kellan: about education and how challenging has it been dealing with physicians in the U S where the endocannabinoid system isn’t really even taught in medical
[00:16:43]Wayne: school? It’s a huge challenge and it was even worse a few years ago, but now positions are starting to think otherwise, because now they’re, they’re starting to hear more information.
[00:16:59] Yeah. They’re [00:17:00] starting to read more articles and more of there are more of their patients are starting to approach them and ask them questions about it. And the last thing a physician in my mind wants to do is not have an answer for a patient, right? So they want to have at least some knowledge, some good working knowledge where they can respond to the patient.
[00:17:19] And if we can provide that information to the physicians, then the entire. Um, session with the patient goes so much better. So it’s a win-win for the, for the patient, for the doctrine for us.
[00:17:31]Natalie: And to tag onto that, we also have access to as official physician’s desk reference guide. So anoxia in Israel, in conjunction with Israeli ministry of health actually created.
[00:17:43] You know, a physician’s desk reference to go over how CBD THC works, how it interacts with the body dosing, protocols, indications, everything like that. So they truly have the expertise and knowledge to educate. And we do plan on having continuing medical education courses that [00:18:00] are provided to doctors so that we can educate them in this field.
[00:18:04] And that way they can feel confident actually recommending products to our, to, to their patients. And.
[00:18:10]Bryan: It’s so important to, right, because you’re not just fighting the stigma from a customer standpoint, you’re also fighting the doctors who are, some of them have practiced medicine for God knows how many years trying to put a number to it.
[00:18:22] But life right now, you’re, you’re opening up their eyes to possibly. Endless possibilities. So I can imagine the compliance standpoint is probably a really beneficial aspect when you’re communicating them right. Having a reproducible product, one that’s compliant, and one that follows a similar standard.
[00:18:37] So I’d love to kind of stand on that topic too. Now. So Wayne, in your perspective, what, what compliance aspects now are really differentials for your.
[00:18:47]Wayne: What compliance aspects are unique to us? Is that what you’re asking
[00:18:50]Bryan: me? Yeah. What compliance aspects are important that maybe the most, the industry isn’t following are ones that kind of separates your team from some of the peers.
[00:18:58]Wayne: So this could be a long [00:19:00] call.
[00:19:04] It’s really interesting because. Just about every company that manufacturers are distributes and sells CPD. They all say the same thing to the most part. They all say that, um, their product is third-party tested. They have a certificate of analysis and they claim to be a GMP. So with that being said, if every single product on the shelf, whether you’re in a gas station or a convenience store or wherever you are, if everybody says and claims the same.
[00:19:33] Um, then how are you unique? What makes you different? And, and the reality is as well. Okay. You know, industry metrics tell you that 25 to 30% of everything that’s out there in the industry is adulterated. So there isn’t the amount of CBD in there as they’re claiming, et cetera, even though it’s, third-party tested there’s, there’s ways around that, as we all know.
[00:19:55] So it it’s, it’s, it’s definitely a huge mess from an industry perspective, [00:20:00] but let’s talk about the good guys. So if, if, if you’re a regular decent manufacturer and you are trying to do the right thing, it’s the mindset of the leadership team of these CPD companies. So what I mean by that is when you manufacture a product, even if it’s not.
[00:20:18] If you have a quality assurance department or a QA person, and you say, that’s the person that’s responsible for quality for my product. That’s the person that makes sure we do the testing. We count on this department or group to make that happen. And that’s why you should buy my products. That’s absolutely the worst possible thing you could say.
[00:20:36] Okay. And the reason why. Quality is done by everybody in the company. Everybody that touches that product right from the CEO, making the decisions that the cost of quality isn’t cost. It’s the reality of manufacturing and selling a superior product. So if everybody in the company contributes to [00:21:00] quality, Then your QA persons simply just manages the quality management system of a company.
[00:21:07] They oversee it. So that means the person that’s actually doing. Um, you know, the, the manufacturing or the package. Or the extraction that person is trained. That person is educated. That person has the documents to back it up. They’ve gone through a thorough analysis to make sure that every step of the process has been done to meet the quality management system.
[00:21:33] And at the end of the day, you’re going to have a superior product because your system is going to generate it. And everybody involved is going to be part of that. So that fundamentally is a huge difference between what people do from a testing perspective. When they say, well, we test our product and we, you know, third party tested and it’s good versus truly taking a step back and looking at your entire organization.
[00:21:58] And that’s what we’ve done. [00:22:00] We have a quality management system. With anoxia that allows us to be able to prove to the physicians. This is exactly the type of product that we want to not only manufacturer, but sell to consumers that really need our help. And it seems to work extremely well for us. And I would
[00:22:17]Natalie: say to add on to that, you know, when we talk about quality and everyone talks about the testing at the end, We always care about quality from the way beginning.
[00:22:26] And that includes our raw materials. So our pre determined specifications from Panax CFR, hemp, biomass far exceeded most of the farms, uh, testing specs. So we spent over a year. You can ask Wayne that the, you know, brain damage, he went through to go find a farm that actually passed Maxia specifications.
[00:22:46] But what you’ll find is a lot of companies or, you know, farms left to use marketing terms like organic and all natural. But unfortunately that actually means very little when you look at the FDA and USDA requirements, um, it, it’s kind of just a certain [00:23:00] word that is used in the marketing field, but it actually really means very little when it comes to quality.
[00:23:05] So, you know, our testing. Seeds USDA requirements. So although our products not certified organic, it’s actually a higher quality raw material than an organic biomass. So that is also something to consider as well. So we really take it seriously from the raw material that has to have a predetermined specification.
[00:23:23] Each product has a pre-determined specification. It has to be manufactured in the exact same way. You know, even our packaging is GMP compliance. So we had to source, you know, different bottles from all over the world to make sure that it was in accordance with pharmaceutical studies.
[00:23:38]Kellan: Yeah, so the organic, I mean, I still ended up paying more for my broccoli when it has, you know, but I think it’s, I want to stay on the quality, uh, call the aspect.
[00:23:47] And I think that for our listeners, um, CGMP gets thrown around very actively in the industry. Right. It’s it’s a, it’s a really big buzz word right now, but technically there is two very different [00:24:00] classifications of CGMP, correct? There is, uh, a nutraceutical CGMP. Kind of guideline and then there’s a pharma CGMP guideline.
[00:24:07] And so could you guys kinda, uh, just educate our listeners on some of the differences from a quality perspective when you truly are following that pharma kind of guidelines from a pharma GMP perspective versus the more or less stringent nutraceutical GMP kind of guidelines, could you guys kind of educate our consumers on that aspect as well?
[00:24:31]Wayne: It’s very, um, it’s been a while since someone’s asked me that question. So I’m really excited. And by the way, I am a lot of fun and parties. So.
[00:24:44] So basically, so the code of federal regulations look at it this way. There’s two levels. Um, there’s, there’s the code of federal regulations for pharmaceuticals and there’s the code of federal regulations for dietary supplements. So dietary [00:25:00] supplements that CFR is 1 10, 1 11. You can look it up. And then there’s 2, 10, 2 11 for pharmaceutical, basically the CFR.
[00:25:08] Are the requirements. So the industry, the regulatory agency, the FDA and others, they don’t tell you how to do something. They just tell you what’s required to do something. You have to interpret how to meet that requirement and that requirement and how you do that. Are your GMPs, your current good manufacturing practices.
[00:25:34] So sometimes people get a little bit confused about what GMPs means versus the CFR. So always remember at the end of the day, when you’re being audited, they’re going to come in and they’re going to bring the CFRs and they’re, you know, there’s 35 40. And they’re going to go down the list and they’re going to ask you to demonstrate and show how you’re in compliance with, with each CFR and the CFR can be [00:26:00] anything from how you’re testing the biomass.
[00:26:02] As, as Natalie indicated, how are you designing your packaging components or do your packaging components meet these requirements, et cetera, et cetera. The difference between pharma and dietary supplements is the complexity in how stringent it is. So they are this, they relatively the same, but the depth of what’s required for each CFR is significantly higher for pharmaceuticals than it is for dietary supplements.
[00:26:28] But, um, you also have to take into consideration, you know, the reason why they’re there, where your drug or your product falls into a category, um, how. Uh, is, you know, is it a drug where it’s a scheduled one drug? You know, all of this takes them to play as far as how complicated and how intense the audit could be and, and the regs that you have to meet.
[00:26:51] So there’s a lot of variables to it, but when we’re, you’re making a dietary supplement as a pharmaceutical drug, a lot [00:27:00] of the, um, requirements that you’re doing, like we did, aren’t really that complicated because. At the end of the day, the type of product we have, doesn’t require a significant additional amount of work to make it in compliance.
[00:27:15] Does that make sense?
[00:27:17]Bryan: Yeah. Okay. And I want to kind of piggyback off what you said, kind of prior about the importance of instituting the internal aspects from a culture standpoint and not looking at it as a cost because Kevin and I have had a bunch of conversations where people ask us if we need to do something and the need is.
[00:27:34] Should you do you need to depends on really what you want to accomplish here and the type of game you’re playing from a short-term and long-term perspectives. Right? Because I would argue that a lot of people are taking short-term steps in order to, you know, get through today until tomorrow and not think about it from the long-term perspective.
[00:27:50] So I want to S I want to expand on Wayne, what you said on ask how many, let’s say other CBD providers, competitors of yours are going through the same [00:28:00] rigorous testing from a pharmaceutical standpoint as your.
[00:28:05]Wayne: Um, that’s an excellent question. I haven’t found anyone so far. Maybe Natalie you’ve come across a brand or a product, but I haven’t come across anyone that has taken it to the level we have.
[00:28:18] Um, you know, it took us, um, two and a half years. Two-and-a-half years. We were stealth. We didn’t make a dime for two and a half years because it took that long to develop and commercialize these products to be. Uh, the, the pharmaceutical regulations, even though we knew it was only going to be a dietary supplement, look you at the end of the day, you have to make a decision.
[00:28:42] Are you going to plan for success? When you know, 12, 14, 16 months from now, your product is going to be regulated by potentially the FDA. We already know the California department of public health is already considering rolling CPD, and it’s a dietary supplement. So you either do the [00:29:00] work now. Get your, your product ready.
[00:29:03] And when the, the requirement is acted and they give you 60, 90 days to be in compliance, you’ll be ready to go. Or you’re going to have to fast track everything that you should have done, you know, a year and a half ago, um, without damaging your brand and without losing sales. So it’s really, and it does cost a lot of money to do this.
[00:29:23] No argument there, but it could be more damaging to you later. Um, if you’re not prepared for it because of the disruption. Right. So it’s like, are you going to build a house? Right. And, and with the, with the amount of money that you have, are you going to build it right? Or are you going to try to, you know, To a certain degree where it’s just good enough.
[00:29:43] So it all depends on your philosophy
[00:29:46]Bryan: and just the pig and sorry, just to piggyback off that, what you said when they have 60 or 90 days to get into compliance, what took you two and a half years to try to do? And let’s say three months, what was expensive in two and a half years, I’d imagine would be a little more expensive if [00:30:00] you had any.
[00:30:01] Oh yeah,
[00:30:01]Natalie: that’s it.
[00:30:04]Wayne: Can you imagine having, you know, $300,000 worth of packaging components that you can no longer use? Yeah, just that alone is a sunk cost.
[00:30:16]Natalie: That’s actually, what I was going to add is our packaging components. One of the longest parts of, uh, of our process before launching the brand was having a law firm that specialized in FDA compliance review every last detail of our packaging, even to the boldness of the font in certain.
[00:30:33] So we basically, you know, with Wayne’s expertise for saw that the FDA, or at least state by state would start regulating CBD as a dietary supplement. And as Wayne said, just a moment ago, we’re already seeing that happen in California. So we, we kind of, we positioned our, our packaging and our brand to be a dietary supplement in anticipation of that.
[00:30:51] So everything is fully, fully compliant with dietary supplement guidelines. And you’ll also notice that’s why there are absolutely no claims on our packaging, on our [00:31:00] website.
[00:31:01]Kellan: I think that’s, couldn’t be stated loud enough. Brian and I have a little experience on really understanding the amount of
[00:31:07]Bryan: information that needs to be communicated
[00:31:10]Kellan: on a package label for these
[00:31:12]Bryan: kinds of products.
[00:31:14] It’s it’s wild as a marketer, it was challenging to try to fit everything on it. And it just was like, I don’t know. They’re a smaller,
[00:31:26]Natalie: I sell it with a magnifying
[00:31:27]Bryan: glass
[00:31:29]Natalie: and, uh, certain information has to be visible. It has to convey, you know, at the right time and space. It’s very
[00:31:34]Bryan: complicated. When, in your opinion, why do you think a lot of these other brands and companies are not positioning themselves for a longterm, you think it’s financial base, you think it’s education, do you think it’s more of just like let’s get through today?
[00:31:47] What do you, in your opinion, what do you, what do you think the reason.
[00:31:51]Wayne: I don’t think they’re focused on the medicinal opportunity there, their holes there, their brand, their strategy, everything. I don’t think they’re [00:32:00] focused as a health and wellness product. I think they’re focused as a CBD product and what their interpretation of what that means.
[00:32:07] Yeah. We, we were at a show. We did one show before the pandemic hit and we were approached. As why, why are you here? People kept coming up to us from different booths that the competitors are saying, what is a pharmaceutical company doing it? A CBD show. People continuously looked at us like we don’t belong here.
[00:32:29] You know, it’s just not right. And they weren’t being mean, but we looked like a pharmaceutical company because we. We’re representing a pharmaceutical company. We have a pharma brand. So it’s clear to me that the industry isn’t focused on that. And the reason why is because it’s just not in their business model, they don’t want to do the HCP channel for all of the reasons that makes sense for them.
[00:32:52] Whereas it’s exactly opposite for us. I don’t want to compare. With Joe CPD, gummy bears at, you know, [00:33:00] some seven 11 to me, that’s just not what it, that doesn’t make sense to me. Uh, edibles, aren’t going to work any way to the degree on the bioavailability side. We all know that. So why don’t we just focus on.
[00:33:12] The products and the indications that make really the smartest sense to help people with, you know, what they’re, what they’re going through. And it just it’s clear to me that the industry doesn’t have that same frame of mine. Yeah,
[00:33:27]Natalie: I agree with that. And I would say a lot of companies are just jumping on the kind of CBD bandwagon because it’s an emerging industry and we’re seeing things like CBD candles, right.
[00:33:36] So, I mean, what is that going to do? So I think a lot of the times people are just looking for. You know, a quick buck in the industry, they’re not here longterm, but our whole goal isn’t just to make a lot of money and then disappear when the regs change we’re actually trying to, like I said, create a new standard in, in the CBD industry and as regulations get more stringent, I think we’re going to see a lot of drop-off from [00:34:00] brands that just.
[00:34:01] Meet those regulations. They’re just really not able to perform and create a product that’s safe and consistent in that way.
[00:34:07]Bryan: Yeah. That going to kill a lot of companies that just don’t have the capital investment in order to switch their, their operations. So let’s talk future roadmap, any, any minor cannabinoids on the radar, any up and coming products that you’re excited about, that you can share.
[00:34:23]Natalie: I would say something that we’re really excited about is down the line. When we do have our THC products, because with the CBD industry, we’re not allowed to have certain delivery methods. Thanks to Wayne explaining that to us, they’re considered over the counter delivery methods. So down the line, we’re going to have sublingual tablets that dissolve we’ll have.
[00:34:40] Positories pain patches and other delivery methods like that. And as we mentioned earlier, that can be clinically proven. So is doing, uh, clinical trials on migraines, epilepsy, psoriasis, and other indications.
[00:34:54]Wayne: And then piggy back onto that and to piggyback onto that back to the CBD side, [00:35:00] um, we can’t share with you that we are very focused on doing additional research, um, uh, in the sleep category.
[00:35:07] So we’ve got a very good sleep product, but I’m confident that the cannabinoids that we’re looking at right now at specific levels combined. Um, with, um, with melatonin and other API APIs, um, really could do something really great for us. So I think parallel work. We’re going to continue to look at that and see if we can develop a new form of.
[00:35:28] That’d be
[00:35:29]Kellan: awesome. And so many people in America suffer with sleep deprivation. So if it works, it would literally impact so many, so many people’s lives in a really positive way.
[00:35:38]Natalie: One of the favorite things that we see from our reviews is people saying they’ve gotten off their, their pharmaceutical prescription drugs that often have those potentially negative side effects and are very addicting.
[00:35:49] Um, and they’ve replaced it with our products. So that also, you know, we have that CBD melatonin, which is amazing for sleep. And another product that we’re really proud of is our CBD. Myo-inositol And this once again, I [00:36:00] see your face. You’re like, what is Myo inositol This is why working with a company like Panaxia is just so different than any other CBD brand.
[00:36:06] Uh, myo-inositol is a naturally occurring compound in the brain that affects serotonin and dopamine and other chemical transmitters. And then a clinical trial is proven to be as effective as Prozac at reducing anxiety and panic attacks. So we have this amazing nutraceutical that combines two natural compounds that it’s amazing for stress.
[00:36:24] So we have. Truly unique formulations can act. He has seven patents on their, on their formulations and delivery methods. So when we say it’s proprietary, we actually mean it. We’re not just marketing, um, nano park, you know, nano CBD and all organic and all that kind of stuff, which sounds great. But. Truly pharmaceutical grade manufacturing and formulation development, but it’s using, you know, ingredients and compounds that won’t have those negative aspects of the pharmaceutical industry.
[00:36:54] So that’s what we’re most excited about with
[00:36:56]Bryan: that. And just to kind of expand on the sleep when we met Jerry, I [00:37:00] shared with him the story about my mom and the sleep and how many products that she’s tried and, and Jerry was fortunate and nice enough to share with me. And I gave it to my mom and her response is usually very quickly it didn’t work.
[00:37:10] And this one. I think it worked. And Danny that is such a step forward to think that possibly it could work, right. It was a massive, massive difference maker. And you know, you’re right. Like the sleep aspect is a game changer. If that can go down, it can help so many, so many
[00:37:25]Natalie: people, your whole health and wellness, you know, overall your sleep really impacts all of that.
[00:37:31] So that is, um, probably our best seller I would say is our CBD melatonin.
[00:37:36]Bryan: So what is w one concept or facts. That would shock an everyday consumer about the cannabinoid industry.
[00:37:46]Natalie: Wayne, do you want to take that one?
[00:37:48]Wayne: Hmm. Well, I’m processing. That’s a really good question. What’s one fact that would show.
[00:37:57]Natalie: I mean, I think the one we were talking about before where people [00:38:00] think more is better, I think it’d be really shocking for people to realize that just because something says it as 5,000 milligrams or 500 milligrams, it might not. That is actually the most shocking part is you might think you’re absorbing it and you might think you’re digesting it, but you’re not.
[00:38:14] So even if it says it has that. amount A lower dose product that actually is formulated to have high bioavailability and the pharmacokinetic testing to back up those claims. That is the biggest difference. So I think the biggest misconception about CBD right now is that more is better. Um, besides all the obvious, you know, will it make me high those kinds of questions, but
[00:38:34]Bryan: yeah.
[00:38:36]Wayne: Yeah. Yeah. I think going back to the average consumer does think CBD will continue to make them high. Right. So I think that that has never gone away. The education about CBD is just unbelievable. It’s just, it has to be, um, We have to do a better job of communicating what CBD is and what CBD isn’t. Um, but [00:39:00] again, because people will test positive on a drug test for THC, when they’re taking CBD, they have to be, they have to be educated to understand why.
[00:39:09] You know, so you get yourself into a pickle where you tell them, no, there’s no possible way. You’re going to get high. Trust us, the science, here’s the endocannabinoid system here. Here’s all of the background that you need to know, but don’t take a drug test because you’ll test positive and they look at you, like, what are you talking about?
[00:39:26] So you’ve got to get over that. And it’s very confusing for
[00:39:28]Natalie: people. Yeah. And I would say that actually ties back into a lot of people don’t realize that CBD is just a compound and it’s available at hemp and Marilyn. So, if anyone is telling you that CBD is only from him, that is incorrect information, it is a compound, it is a molecule, right?
[00:39:44] So it can come from marijuana plants as well. It’s just that, that plant overall, the hemp plant has very low amounts of THC, but it’s there they’re cousins. It’s not like an actual distinction there. Um, so I think that’s also very confusing for them. [00:40:00]
[00:40:01]Bryan: Wayne. What’s your opinion? Big pharma has for the cannabinoid industry.
[00:40:05] Are they threatened to, they see it more as an ally, an intersection, a let’s say a new revenue stream, in your opinion, what do you think big pharma thinks of, of the cannabis industry
[00:40:16]Wayne: CPD? And the reason why I say it that way is if the, if the science and the research looks promising, they will pull the trigger in this.
[00:40:28] Absolutely. There’ll be all over it. But until the science and the research justifies them taking a serious look at it, they’re going to keep an eye on it. It’s in the room, it’s over in the corner. But soon as something lands on the desk that shows that this is an opportunity to do some really good things.
[00:40:47] When I say good things, as, as it relates to an indication or health and wellness, then they’re going to go on. They’re going to go after a big time and nobody can be in their way. And it’s just a matter of time because the research [00:41:00] is increasing is getting more solid and like everything that’s happening in Israel, you know, that’s a country, but guess what guys, you know, we have the internet, everybody’s going to know what’s going on.
[00:41:11] So it’s just a matter of time before a farmer just takes. Do you think someone,
[00:41:16]Bryan: a big pharma company will pull the trigger a little early in anticipation of their peers, because if it is an arms race, right to acquire some of these assets and these formulations, you can’t be second to the party. You have to be first.
[00:41:28] So you think some of them will be more willing to let’s say, take a chance and a gamble on some of these acquisitions, or do you think they’ll try to play conservative depending on you know, who is the company?
[00:41:39]Wayne: So they will not be. I think that we’re already,
[00:41:42]Kellan: I think we’re already there though, right? Like Pfizer’s $7 billion entry, um, purchasing or in a pharma, right?
[00:41:48] Like that is as big of a cannabinoid play as you possibly can. It’s from a pharma
[00:41:52]Wayne: perspective, right? Yeah, absolutely. Yeah. You don’t have to, you don’t have to be conservative when you have deep pockets. [00:42:00] Yeah, we have deep pockets. You can do whatever you want. Amen.
[00:42:04]Bryan: And a quick Google search of any of the patents that Pfizer has, would lead you to have over 3000 different patents on cannabinoids.
[00:42:11] So you could see they’re pretty invested in just a matter of time. I’d wonder if, if there’s another acquisition that’s free for, let’s say someone else in order to try to compete with them or Pfizer doubles down and continues to expand in the space.
[00:42:24]Kellan: That’s a good question.
[00:42:24]Wayne: Yeah. Only time
[00:42:25]Bryan: will tell exactly right.
[00:42:28] So Natalie, since you’ve been in the cannabis industry, what has been the biggest misconception?
[00:42:34]Natalie: I guess misconception. That’s a good question. Uh, I think we touched on it a little earlier. I was saying, you know, a lot of people don’t understand the difference between, you know, hemp, marijuana CBD as a molecule.
[00:42:48] And as, as Wayne was touching on, you know, full spectrum versus an isolate, um, I think there’s a lot of misconception about. Y you would take an isolate over a full spectrum product. And in our mind, [00:43:00] the only reason you would ever want to take an isolate or even a broad spectrum is if you’re being, you know, drug tested for your job, it’s in terms of efficacy and the research, and that kind of ties into our pharmacokinetic studies that Connexa conducted.
[00:43:13] The reason that they demanded that we’re full spectrum. We wanted to offer broad spectrum, uh, for people who are drug tested, but they said that will drastically affect the efficacy of the product. So I think. People think there’s a lot of talk about the entourage effect, but they don’t really realize how deeply scientific that, like how rooted that is in science and testing and formulation making, um, and all the trials and studies that these, these people are conducting.
[00:43:37] So. I also think there’s a lot of misconception about how difficult it is to make a product that is made from plant material consistent. Um, Wayne was talking about this earlier, you know, the difference between making a synthetic drug versus making a plant based product. It’s not the same and it’s actually extremely difficult to standardize.
[00:43:58] So I think [00:44:00] people often think that they’re getting the same product every time, but if it’s a new batch, there’s a big chance if they don’t have those standard operating procedures and quality management systems in place that it’s not going to be what you think it is. And so I think that’s the biggest misconception.
[00:44:14] Like not all CBD is created equal and science really does play a part in.
[00:44:20]Bryan: Before we do predictions, we ask all of our guests, you could sum up your experience in a main takeaway or lesson learned to pass onto the next generation. What would it be? Wayne, do you want to go first
[00:44:34]Wayne: lessons learned or as, or from a business perspective or you mean for our consumers? Help me out here. Any
[00:44:41]Bryan: new life it could be live, could be business. Could be.
[00:44:47]Wayne: Um, well, you know, guys, I’ll just say this, the cannabis space right now. It’s probably one of the most difficult [00:45:00] industries to start a company in.
[00:45:02] And the reason why I say that is because you could start an over-the-counter drug manufacturing company, or a lot less. A lot less pain, um, much faster and be in compliance with the FDA in a much shorter time. From a business perspective. When, when, when you know my past history with the companies I’ve worked for, I hadn’t absolutely not near the amount of pain and suffering and living nightmare that I’ve gone through with.
[00:45:37] And the bus is out of control from a regulatory perspective, from an operational perspective. And, you know, I would tell someone that is coming behind me if they wanted to, you know, start and build a manufacturing, uh, cannabis company and sell and distribute. You know. Okay. But you [00:46:00] better really do the research and understand what it’s going to take to make this happen, because there’s not a clear path, you know?
[00:46:08] Um, you know, we talked about the CFRs, the code of federal regulations. There are less, you know, CFRs for an over-the-counter drug company than there are, uh, rules for a cannabis manufacturing company. This is like three times. Uh, regularly regulations for a cannabis company. Then there are an over the counter drug company.
[00:46:29] That’s insane. It’s insane. And, and the margins aren’t there from it because of the taxes. So I would caution someone to really do the research before they pull the trigger on this, because I don’t think they understand how difficult it’s going to be, but if they have the resources and the intelligence and the time to make it happen, it will be rewarding, but it’s going to be a very different.
[00:46:53] Industry to be successful in plain and simple. That’s a marathon. Yeah, it is a marathon. It [00:47:00] isn’t a marathon and you have to have the passion for it. Right? The passion has to be there. If we could take somebody off a synthetic drug, if we can make someone that has, let’s say arthritis and they put a cream on their knee or whatever the case may be, if we can give somebody an alternate.
[00:47:15] To help them feel better. How could you not want to do that? If you want to do that, then it’s the right industry. But if you’re just out there trying to make people feel happy and fun and your product is just recreational. Okay, great. That, that works for you, but that’s not what we’re into. That’s not where our passion is.
[00:47:33] So. Um, it’s an exciting time for us and it’s been, it’s been hard, but, um, at the end of the rainbow, so to speak, I think we’re going to have some really great stories as hell.
[00:47:46]Natalie: And I would say for mine, um, I agree with everything Wayne said, and I also think, you know, we have to realize that not everyone is going to play this game face.
[00:47:55] Um, that in terms of, you know, competing against brands that are [00:48:00] mislabeling making claims, et cetera, and how hard it is to break through that noise. I would say that’s the biggest lesson learned is realizing how we need to communicate effectively and educate not only doctors, but even the people taking these products.
[00:48:13] I mean, they’re really, there’s a lot, we know there’s so much interest, but there really is a lack of, of information and a lot of misinformation. So the amount of times I’ve seen an article talking about. CBD is from hemp and THC is from marijuana and it, it, you know, it makes my day, it just upsets me because they’re trying to explain something, but then they’re actually giving this information and those people are then taking that and spreading that as well.
[00:48:38] So I think the educational aspect of it and getting people on board with the medical side of things is the biggest.
[00:48:46]Bryan: The game is not fair.
[00:48:51]Wayne: Go
[00:48:51]Kellan: ahead. Run. No, you can. You can. I was just gonna say it doesn’t help that we’ve been missing the massive institutes that provide standardization from an [00:49:00] educational perspective for the last eight years.
[00:49:02]Bryan: Right?
[00:49:07]Natalie: And Israel, it’s a totally different world when it comes to cannabis there at like the university level of education. Um, the, the stigma is not there. It’s just not there. And the education for, you know, people in university. You know, there’s, there’s kids that are going to college and actually doing research on cannabis there, which is kind of unheard of in the United States.
[00:49:33] You wouldn’t even think that that’s an opportunity. Right? So, uh, we actually know of people from the U S that went to Israel to study cannabis, because that’s just not an option in the United States.
[00:49:44]Kellan: Ben, who house, who we had on a little while ago and talking to you was doing that exact reason.
[00:49:51]Natalie: I’m just goes to show how far ahead they are.
[00:49:54] And they’re, you know, they’re even doing research, showing that different extraction methods affect the efficacy of [00:50:00] the, of the product on a specific indication. It gets really that, that specific. So it’s pretty cool
[00:50:06]Bryan: prediction time. What medical area do you think long-term cannabinoid therapy will be the most beneficial.
[00:50:16]Natalie: I mean, as we kind of talked about before, I would say sleep, I would say sleep, anxiety and pain are the
[00:50:22]Bryan: three,
[00:50:29]Natalie: all three. So Wayne has nothing to say. I think, I think sleep is probably the biggest category because that impacts your anxiety. Um, and also, you know, physical pain. So I think sleep having and maintaining a restful sleep schedule and good sleep hygiene is one of the most important things you can do for your wellness.
[00:50:47] So that’s probably one of the biggest ones
[00:50:49]Bryan: for sure.
[00:50:51]Wayne: I agree a hundred percent, but I also think that the science and the research in the future is going to focus a lot more [00:51:00] on inflammation. And I think we’re going to find out that inflammation is going to be here. Huge for the cannabis space. And I think there’s going to be opportunities that we don’t, we’re not even aware of right now where the science and the research is going to direct us down paths that are really going to do some great things.
[00:51:18]Kellan: I’m going to go with oncology. I think that, um, there’s some really exciting clinical trials that just got underway in Israel showing, um, how, uh, effective treatment of a specific whole plant extract had on a cancer line. And so I’m really excited to see that kind of research, expand the clinical trials, get more people involved and kind of see what really the benefits cause.
[00:51:43] I mean, I think. Cancer and cannabis have kind of been hand in hand for the last 20 years. I think it’s probably been one of the more, um, Popular use case scenarios for cannabis is individuals that are on chemo, utilizing it for help. And I think that there’s [00:52:00] originally right. It’s, it’s used for appetite to stimulate appetite, but I think that there potentially could be a lot more to the,
[00:52:11]Natalie: you say that because one of our other partners, who’s just a straight up analytical research labs.
[00:52:15] So they’re not making products, but they’re actually doing research on notch. One mutation cells from routine. Without having Whitesell, Dr. Daddy, Mary, um, is one of our partners as well. So he’s one of the lead leading researchers in Israel doing all
[00:52:32]Kellan: the clinical trials.
[00:52:34]Natalie: I had a feeling you were
[00:52:38] we’re partners with him. Um, and he’s doing some of the most amazing work. You know, he really has kind of picked up where Raphael Meshulum left off and is carrying on that legacy. So.
[00:52:51]Bryan: Yeah, that’s a, it’s kind of , I’m going to go with focus, I guess. Right. The list is kind of it’s, it’s [00:53:00] kind of small at this point.
[00:53:00] I think if you think about all the people, especially in college that use, let’s say Adderall in order to kind of keep themselves. Attentive or for other purposes, I think if they could find a more natural solution to help them and feel that same sort of attentiveness that they’re looking for. I think that can be beneficial.
[00:53:17] And especially if it’s an all natural one, I know there’s already a bunch of other products out there that try to be a replacement for Adderall. I would hope that there’s a variety of different medical benefits. And I think with some advancements, and I think with some individuals like yourselves, doing things the right way and cutting through some of the noise, it’ll help change the stigma and help the advancement of the industry pretty aggressively and really commend you guys for taking those steps and doing it the hard route, but the right way, which is what this industry really needs so far listeners, they want to get in touch.
[00:53:47] They want to learn more and they want to see some of the products. Where can they find.
[00:53:51]Natalie: Yeah, so they can find us at the health. T I K B a H E a L T h.com. And all of our social media is also take the health. So we’re [00:54:00] on Facebook, Instagram. That’s where you can find us. We’re also, you know, um, in some pharmacies across the country, but I would say e-commerce is the easiest way to access us.
[00:54:09] So yes,
[00:54:10]Bryan: we’ll link it all up in the show notes. Thanks so much for your time guys.
[00:54:13]Natalie: Thank you. It was great speaking with you guys. Yeah.
