Clinical Research
7 Feb 2023 · 41 min
Podcast conversation (Dr. Mark Young and Justin Gerard) explaining clinical research options for CPG/nutraceutical companies from a marketing and regulatory perspective. They define first-party vs third-party trials, describe observational and double-blind/drug trials, discuss sample-size considerations and rough per-participant cost estimates (~$2k–$2.5k for simple observational; up to $10k–$30k+ for medical trials), recommend hiring independent principal investigators/CROs or university partners, and emphasize consulting FDA/FTC-savvy legal counsel before making claims. Practical tips include designing the study to answer a specific claim, keeping the researcher independent, and considering reformulation or minimal drug additions tied to monographs to enable stronger claims.
Chapters
Foreign.
Welcome everybody, to another edition of CPG Insiders. I'm your host, Mark Younger, with my co host and colleague Justin Gerard here.
To save the day.
There you go, Justin. We're going to have a little discussion today, won't be a long show. We're going to have a little talk today about something that, that we talk to clients about. And, and I've said this before, but I'm going to just repeat this for people. These shows are essentially conversations that we have every week. So where the, where the core of these shows sometimes comes from is we've just had this conversation with three clients in the past week. And it's like, you know what? Three people have asked the same question. So let's go lay it down as a podcast because if three people asked it this week, then there's got to be other people that are asking it to themselves this week. And that's where the shows come from.
Yeah.
So no, no big mysterious planning. We don't sit around in a room and plot out shows. It's like, what have people been asking us this month?
Yeah. So on, on that note, again, always feel free to email us if you're a listener and you have any questions or topics you want to talk about, because that's, that's a lot of where this comes from. And you're not the only one who has the question that you have.
Yeah.
So.
So essentially every show is built on something that someone asked.
Yeah.
So we get asked a lot about running clinical trials and research.
Yeah.
So I thought we'd have a discussion about it. Now, I want people to understand we are not giving you medical advice. We are not giving you clinical advice. We are holding a discussion as if we were talking to you as a client today.
Absolutely. Where we're coming from, again, is strictly from an advertising or marketing perspective on the value and possible ways to go about it. That's, that's, that's exactly what we're going to be doing.
So I recently had one of the conversations that just happened this week was a client that came to me and said, we'd like to have, have a product that does X. Does he have any clinical trials? No, but we have two ingredients that have had clinical trials and that sometimes works, and we'll discuss that in a minute. And then I said, well, do the two clinical trials that you have for your ingredients, Were the clinical trials run based upon the claim you want to make? And the answer was no. So first, let's start with why do we want to have a clinical trial. So there are, there is what we'll call first party and there is third party. First party means you, your company, your organization, ran a clinical trial on your formula, on your product or your item or your device. Third party clinical trials means that someone else, likely a university or a drug company or something, has run a clinical trial on an ingredient that you have in your formula. So as an example, let's say that I wanted to, I was going to put out a new brand of aspirin. There's a million clinical trials around about aspirin. If I make an aspirin with the same ingredients as those other clinical trials in the same dosage as those clinical trials, and I advise consumers that my instructions for use are the same as those clinical trials, then yes, I can use that third party research to make claims against. But if I change anything, then I can't make direct comparisons.
Yep.
So let's say that I was making a supplement and my new supplement has five things in it. So I put kava kava and melatonin and magnesium and you know, five HTP and L theanine and I dumped them all into one capsule and I called it my new sleep pill.
Right.
All of those ingredients do have clinical trials. They don't have clinical trials combined.
Yep.
So the most that you could say is the ingredients in Super Sleep Aid have been shown to do X. Yep. You can't say that Super Sleep Aid does X, but you could say the ingredients in it have been shown to do X.
You can make claims like clinically studied ingredients.
Because right now, if I run a clinical trial on Super Sleep X, I could now say in a clinical trial, 74% of people taking Super Sleep X fell asleep 70% sooner if that indeed was the outcome. So these are the differences. This is difference between third party and first party. Now the second thing is what kind of clinical trials are out there? Well, there are clinical trials or drug clinical trials. There are observational clinical trials, there are biologic clinical trials. It depends how complicated you want this clinical trial to be, how much money you want to spend on it and what you're trying to discover. So let's say that you have come up with a formula that you think will help people lose weight. You could run a double blind clinical trial, which means half of your participants get a placebo and half get the real product. And the people conducting the trial do not know the difference. They don't know who the participants are as far as who has the real drug. And then you could say participants in a clinical Trial taking diet pill X lost, you know, 52% more weight than those in the placebo group. You know, again, assuming that is the outcome right now, one of the things people get confused about is the size of a clinical trial.
Oh, yeah, absolutely. We get to that all the time. They think they have to be massive. Right.
And they really don't.
They really don't. They really don't. You don't have to have a 600 person clinical trial. No, not at all.
So let's say I was doing a diet study. I could do that diet study with 20 participants and 10 have my real pill and 10 don't. So what you have to be careful of, you don't need to have hundreds and hundreds of people in your trial, but you need to have enough people in your trial where the law of small numbers won't ruin your outcome. So as an example, let's say I did a clinical trial and I only put in five people on the drug and five people on the placebo. Well, if just two people had something going on in their biology that made my, my product not work, my trial is going to look like it failed. Where all I did was I got caught by the law of randomness that I happened to hook two people with a certain gene sequence, where had I had 10 people in the trial.
Right.
I still would have only had two people with that gene sequence, which just reduced their impact to 20% from 40%.
Right, exactly.
So your trial needs to be big enough to rule out randomness and to rule out the laws of small numbers. But it doesn't have to be enormous. And I'll give you example. Justin and I were doing some polling yesterday on Twitter and those two polls that we did on Twitter, Justin ended up with 800 and some votes each.
Those are really stable numbers, but the.
Reality is they didn't change by more than a few percentage points once we crossed the number of about 75 or 100 participants.
Right.
Nothing moved by more than two points after that.
Right.
So the fact we had 800 votes lets us know that that's a real size pool. That's a sizable pool of people that voted. And it's big enough to take the law of randomness out. But by the time we got to 100, we knew the outcome.
Yeah. So we didn't require that 800 number to really understand the outcome of the study or the poll in that matter.
Right. But it was, but it was good. So when we do these different clinical trials, there are clinical trials that we refer to as observational yes. Observational means I'm going to bring in 20 participants. I'm going to have them fill out a questionnaire. I'm going to give them my device. I'm going to give them my pill or whatever it is. I'm going to send them home with a log book.
Yep.
And I'm going to ask them to take this on, on the certain time of day, every day. And I'm going to ask them to write down, answer the following questions. You know, do I feel hungry? Do I feel energetic? Am I feeling any nervousness? Whatever the case is, I'm going to give them these questions. I'm going to ask them to fill these logs out. If it's a weight loss, I'm going to take their weight.
Right.
And I'm. And then I'm going to set up an algorithm and I'm going to ask those people to probably come back into my clinic every two weeks for the next 12 weeks. When they come back in, in two weeks, I'm going to interview them. I'm going to collect their logs. If it's a diet pill, I'm going to weigh them. If it's blood pressure, I'm going to take their blood pressure.
Right.
Whatever the case is, these are observational. We're not doing anything to invade their body. We're not taking blood tests. We're not doing anything that requires a doctor, we're not doing anything that requires a nurse practitioner. We're observing their behavior.
Exactly. And when you think about most products, Right. And again, as you talked about earlier, it all depends on what are the desired outcomes that you're looking for. Right. But most products. Because when we're talking about clinical studies, again, what's the main reason I want to be able to say what my product does? Right. That's always what it comes down to, is I formulated, it does this. But there are some governing bodies that say, well, we're not going to let you say that in advertising and marketing. So. Great. I want to say what it does. And so most products, you can conduct an observational study to get the claims that you're looking for. So as we talked about, you always want to ensure that when you're starting this, start with the why anytime you're thinking about going into this endeavor, understand, hey, what is it that I'm really trying to figure out? What is it I'm really trying to say? And that's also something Mark, we talk to a lot about, too, even when we've had clients in the past. Yeah, I've run clinicals, look at them and say, okay, but you didn't structure your clinical to figure out exactly what you wanted because you didn't understand what you wanted to say yet.
So you what, what is the question I am trying to answer?
Exactly. And again, what coming down to is most of the time observational study will get the job done. And it's, it's a lot less complex and frankly usually costs a lot less too.
Right now, if we start getting into medical studies, let's say we want to say that our product lowers A1C.
Right.
And lower A1C. We're going to have to take people's A1C. We're going to have to take their glucose levels. So now the complexity of our clinical trial is ratcheting up. Now we might need a nurse practitioner to do the interviews rather than a PhD or PhD candidate who can do the clinical trials. By the way, folks, most clinical trials are not done by doctors of medicine. They're done by doctors of PhD level research.
Yeah, right.
Because running a clinical trial is less about knowing medicine and more about understanding the algorithms and the methodologies behind research and the way to properly write the document.
Exactly.
And who writes the document is everything. Also, keep in mind that all these clinical trials that we're talking about, this does not mean you go do this yourself. If you are running this yourself. This is not an independent clinical trial. You have a vested interest in this. So you do need to hire a third party to come in and do this. And there are, there are doctors you can hire, There are independent PhDs you can hire, there are CROs that you can hire which are called clinical research organizations. There are universities that will run clinical trials for you. Now the big question I always get is how much does a clinical trial cost? Always? It's always going to depend on the complexity. I usually tell people to anticipate at least 2,000 to $2,500 per participant for a simple observational clinical trial. And you can easily spend 10, 20, $30,000 per participant if you're going to do a medical clinical trial.
Right.
But even at 2500, which is not unreasonable, a 25 per, a 20 person trial is $50,000.
Right.
I find most of these are between 50 and 150 and 75 is probably the sweet spot. Yeah, I've seen some 40s out there, so I'm going to say 40 to 75 is probably the sweet spot. I've seen a few simple observational ones that got done for like 15, 1800 dollars. A person. If it was easy.
Yeah, yeah, yeah. If they're simple.
It depends how many weeks it goes for and how many times they need to interview the participants. Now, I want you to understand something else. A clinical trial does not replace a monograph. So let's talk about the difference between a clinical trial and a monograph.
So when we're talking about clinical trials, right. When we talk about marketing and advertising, what that means is as. As Mark stated, when we're making a claim, it comes with the qualifier of whatever it is, and that's the only claim you can make. So it's based on the study, the exact results that came in. So even when Mark's talking about things like the observational studies, right. We can say things like participants observed or participants said that 62% of participants felt more energy. Right. In a clinical trial, we can say claims like that.
Now, which would be different than saying this drug increases mitochondria output, right?
Exactly. When you're talking about a monograph, that means that the ingredient has been studied through the fda, which, I mean, those go what? Billion. Average.
Average of a couple of billion. Average of a couple of billion.
Exactly. And. And so then that means that, great, it's gone through and created a monograph through the fda, a couple billion dollars, and now registered with the fda, you can make these claims against disease states. Now, you officially can do these types of things. So you can say things against arthritis, or you can say things against diabetes or any. Anything of that nature. They will allow you to say that. Great. You are able to say that your product does, you know, reduce pain for arthritis or anything of that nature. Now that's going against a direct disease state in the clinical trials, as Mark's talking about. Really, what we're really talking about is almost marker claims, right? To say that you lower the A1C is different than saying you can treat diabetes. These are not the same thing. Right. Or the fact that in a clinical trial, it showed to reduce inflammation. Okay. In the clinical trial, you can say that it was able to reduce inflammation or people reported that kind of thing. Right? But again, you got to be careful because you can't talk against directly disease states. Those are monographs.
Right. So inflammation might be that. Our clinical trial observed that wrapping a tape measure around a knee right? Before and after applying your topical pain reduced the circumference of the knee by half an inch.
Right.
That does not mean that this is a cure for systemic inflammation.
Right.
It means that you observe this. Let me give you another example. We see these a lot anti Aging claims. Oh, so my new face cream gets rid of wrinkles? No, your new face cream may reduce the appearance of fine lines and wrinkles.
Right.
We cannot make a medical claim that it actually gets rid of wrinkles unless we have a monograph, because that's a drug claim.
Exactly.
To say that your drug is anti aging means you need a monograph that says it is capable of reversing the age of DNA. That's a big ask.
And I think this is. There's. There's a subtle word that you're sliding into this conversation is drug. Right. And I think the biggest differentiator. As soon as you're getting a monograph, you officially have a drug with the fda.
So you have to avoid making drug like claims.
Which, according to the fda, means what?
That this is a disease state. And easy way to look at it is, does a doctor have a billing code for it?
There you go.
If a doctor can see you for it, then it's a disease state. So a doctor could easily see you for the. For the condition called anxiety. That's a disease state. For you to say that taking my new supplement with L theanine will reduce anxiety is a no. You can't say that. To say that in a clinical trial, 72% of participants reported less feelings of anxiousness.
Right.
That's fair to say that they reported less anxiety. No. Because that's a diagnosis. Stay away from diagnosis and talk in more general terms.
Mm.
I'll give you an example. Toenail fungus. According to the fda, the only way to treat toenail fungus is with an oral medication. But we know that there are several good topical products on the market that you can use, and we handle one of them. It's a great product, and you can use it topically. In about four weeks, it'll start clearing up. Toenail fungus. But we can't say that. So we have to dance around it. We have to say, you know, toe fungus, not toenail fungus. We have to say, you know, treats ugly toenails.
Right.
Because ugly toenails isn't a disease state. In fact, for this particular client, we invented a disease last year that we called winter toe.
Yep.
And we've had a tremendous sales success with it. And we were the cure for Wintertow. Because we can be the cure for a disease if we invent the disease.
Right. If it doesn't actually exist. According to the fda, we're not breaking any rules here.
Right. So I can't go to the doctor and say, doc, I've got a case of winter toe. What can you give me. The doc's gonna say, I don't know. We don't. We don't have a billing code for wintertow.
Right.
Let me look at your toe. Now, he might come back and say you have toenail fungus. But. But he doesn't have something called winter toe. Now, our description of winter toe, we created a description for it, and our description was that we believe wintertow is what happens when you live in a cold, damp climate and you wear boots and you are out in the snow and the rain and your feet get damp and moist and. And it creates an environment where toenail fungus can develop. That's our description of winter tone. Not an unreasonable description. And a fairly legitimate cause and effect.
Absolutely. But like you said, we're not saying winter toe is toenail fungus. That's not what we're saying.
We actually never said winter toe was anything.
Exactly. That's the point.
But it sounded horrible.
It did. Yeah.
Winter toe. I don't want winter toe.
No. And then.
That sounds gnarly.
That's my graphics showing this. Damp and moist. Ooh, gross. There you go. Yeah. Nobody wants that.
You've got winter toe. This. This. This was actually. I'll tell you who invented this originally. It was back in the PNG days with whisk with ring around the collar.
Yep.
And this was a campaign when I was a child. And, I mean, they were in black and white, and you'd see this woman, and she was all focused on being a great homemaker, and she'd be ironing a shirt. Another woman whispers to another woman, he's.
Got ring around the collar.
And this woman would be horrified because that meant she was a horrible homemaker because she didn't get the ring around the collar out of her husband's shirt.
Oh.
So you took whisk and you just poured it right on the collar, and you stuck it in the wash machine, and it got rid of this little black ring that was around your shirt collar.
Yep. They created an indication.
Yep. They created a problem, and then they created the solution all at once.
Yep. Yep.
But at any. And that was safe because there's no disease state involved.
Right, right. But like, as. As you stated. Right. The. Again, getting back to the concept, there are many different ways to conduct clinical research. There's many different types. There's different costs involved. As you stated, there's different people that you can reach out to to help get this conducted. There are many, many resources. If you want to go this route.
Again, you get a lot of universities to participate in These, if you can, if you know a professor that's in a category, if you can find a professor that's in a category who is working with, you know, with graduate students, not, not undergrad.
Right.
But if you can get a professor to make this a class project.
Right.
Or a grad class.
Yep.
A lot of trials get done like that.
Absolutely. And, and again, for any listeners, we have a lot of contacts in this space. So if you are interested, please feel free to reach out. We do have contacts at different roles. We can help you in this process. So the one question I would have for you then, Mark, again, as we're talking about clinicals, so if we've got a listener right now saying, you know what I'm thinking, this is what I should do, what would you say is great? Here are the steps to take for this process. What would be that? Maybe steps one through five of. All right, if you're going to do this, here's what you're going to want to make sure that you do.
Well, the first thing keep in mind is clinical trials aren't, aren't usually run in an effort to find the result. They're run to substantiate an answer.
Yep.
So step one, what is the claim that you are trying to make to have you validated as much as you can that, that you can make that claim that your product is doing this? Have you given it to friends and family? Have you done, have you looked at all the third party research have you done as, have you gone as far as you can go to be relatively confident that my diet pill will help reduce hunger pains?
Right.
Let's say that's what we're after. Okay, so you got there.
Right.
Now, what type of clinical trial do I need? So do I need to do a clinical trial that is observational, Can I get away with that or do I need to have medical personnel involved?
Yep.
So now I've decided that now who am I going to hire to do the trial? Because I'm not going to do it in house. Am I going to use a CRO? Am I going to get online and look for an independent PhD? Am I going to go to a university professor and see if I can get a graduate class to do it? Once you've gotten your, your, what we call principal researcher on board, that's the person that's in charge of the, of the research and the person who's going to write the conclusion. How many people do I need? How long is the trial going to be going forward? Let's Design my trial. Now that's done. Now let's go find our trial participants. If you're using a CRO, they know how to find the participants. If you're using an independent, you might have to help them with some digital advertising. Maybe you run a Facebook campaign that says, we're looking for 20 volunteers who are interested in reducing the appearance of fine lines. And you get people you know, and we're going to let you participate for free, and we're going to give you free product. And whatever the case is, get your participants, hand them off to your clinical researcher, your principal researcher. Step away from the bench now. Get your nose out from under the tent and let that person conduct this without your interaction.
Yep.
Now let them go do this. And here's the reason you want to do that. Because should the FDA or the FTC ever come in and decide, we want to challenge your clinical trial. You want to have a clean file that shows the protocols that was taken to ensure that no one tilted the scale, that no one had their thumb on the scale.
Right.
And you want to have a principal investigator who has a track record of integrity who is going to say, no, I conducted this trial and this is the methodology I used. And the company did not have any undue influence and did not try to put a thumb on the scale and did not try to persuade me to go in any particular direction. You will persuade them to go in a particular direction, but by virtue of the fact that you've already done the. The initial homework and you've decided the question you want to answer.
Right.
But after that, you need to leave them to be independent if you want to have a good clinical trial. And again, none of this means you can make a drug claim.
Oh, no, no, no, no, no. And in fact, on. On that note, what would you say? Because we already. Would you say that it is a must or just a good to have to ensure that you've already consulted with an FDA or FTC lawyer prior to.
I would absolutely have an FDA FTC expert lawyer on my team before I even started building my trial.
That's a must. There's no questions about it.
Because two reasons. One, I would show my attorney my trial. I would show them the questions I'm asking. I would show them my methodology that my research is going to use, and then I would let them review my trial and review it against the claims that I want to make. One is, you don't want to go make claims and have the FTC show up on your door because they have really Powerful police ability.
Yeah.
And they can do things like close you down and seize your bank account and put a padlock on your door if they want to. They have like IRS kind of power. And as a rule, it's the FTC that's going to come looking for you, not the fda. The difference is the FDA controls drugs. The FTC is responsible for what is said in advertising.
Right.
And that's the bigger risk, of course.
Always.
So I would have that attorney on staff. The second reason you want to have that attorney is because the FDA and the FTC has rightfully ruled in the past that if an advertiser has hired a qualified law firm, a law firm that has experts in the FDA and the FTC regulations, and if that law firm writes that client a letter saying, we've reviewed your claims, we've reviewed your comments, and we find in our opinion that they meet or exceed the guidelines of the ftc. If the lawyer writes you that letter, that as a rule, the FTC says, okay, you had the right to rely on this expert to believe them. You had the right to believe this lawyer. You tried to do the right thing, you spent the money, you did the work, and you're not a lawyer, so you have the right to trust the lawyer's opinion, even if the lawyer was wrong.
Right.
You did the right thing. There was no intent on your part to defraud the public.
Exactly.
So under that condition, the FDA and the FTC will usually say, here's a 90 day cease and desist letter and they will say, we no longer want you to say this and we're giving you 90 days to scrub all of your materials from this comment. So get this off your website, get this off your packaging, get this off your TV commercial, whatever the case is, get rid of this. We're not going to do anything bad to you because we feel you attempted to do the right thing.
Right.
And we're not going to punish you for doing the right thing.
Right? Absolutely.
Without the lawyer's letter, you are now deciding that you are an expert in the FDA and the ftc and the FDA and the FTC is now going to hold you to the standard of you are, you are an expert in this field, therefore you have no plausible deniability anymore. You are, you have decided you are an expert.
Right.
You are, for whatever it costs to get that lawyer. And it's not that much.
No.
You are so far ahead of the game to have that layer of plausible deniability to say, look, ftc, look, I have a letter Here from my, from, from my law firm saying that they thought we were in compliance. And should this ever happen to you, that letter will be the most monumentous, wonderful thing you have ever spent $2,000 on or even $5,000 on in your entire career.
Yep, exactly.
Now, the last thing I'm going to leave before we wrap up here, Justin, I'm going to give people another little secret. This is one of our agency secrets here. This is actually a real secret sauce. Secret.
Oh, come on, Mark. Can't be giving away our secrets.
Sometimes people come to us with a great formula and it's got five different supplements in it or whatever the case is. And guess what? It works. It's great. It lowers blood pressure, it relieves pain, it gets rid of wrinkles, it helps you not, you know, want to eat. It lowers a 1C. It lowers blood glucose. But what it does is it makes a drug like claim. So what we will do is we will sometimes start researching what drug has a monograph that actually can make that claim. And what is the smallest, what is called the minimum dose? What is, what is the. It's actually called minimum effective dose. Med. What is the minimum effective dose of this particular drug? Could I add it to my formula? And of course I need to do the work to find out does my formula have any detrimental effect on the drug and does the drug have any detrimental effect on my formula. So now what I end up doing, I end up saying that I have this secret sauce that relieves arthritis pain. I put in a drug that is at the, at the lowest possible dosage where I can use the indication. I now call all my other ingredients inactives on the label, even though I know that the inactives are really the actives.
Right.
And here it is in a nutshell. In the world of the FDA and the ftc, only drugs can make a claim about a disease. Again, in their world, a supplement or a nutraceutical cannot make a disease claim because it can only make a claim to assist the body in a process. So where aspirin relieves a headache, I can't say that a particular supplement relieves headaches because that's a drug claim. Even if it does.
Right.
And I will tell you, there are many supplements on the market that have direct drug like effects on the human body. But without a FDA clinical trial and a monograph, in the world of the federal government, they don't exist. The third level. So you have drug, you have supplement and vitamin. Then the third level is called cosmetic. Cosmetic is my face cream. Reduces the Appearance of fine lines. My face cream or my body lotion reduces the look of bruising. It, it reduces the appearance of crepey skin. It appears to make skin feel softer and more supple. Whatever my claim is, those are cosmetic claims. And in the world of cosmetic claims, we're making appearance statements. So this makes your hair shinier, this makes your hair look healthier. This, whatever the case is, these are cosmetic. Now, by the way, when you're looking into this, I want to tell people, just start grabbing stuff around your house and you'll be surprised how many things actually have drug monographs. So like grab a bottle of Head and Shoulders. Head Shoulders has a drug monograph in it. Yeah, because it has a drug in it.
Right.
A lot of this stuff has drugs added to it. And I can tell you that we have helped clients take products that worked amazingly well, added a tiny amount of a drug that did nothing but bring the claim, and now we can make the claim.
Exactly.
So there's a lot to this. These are areas that, you know, that we've been guiding people around for years. Again, I will tell you, we're not a law firm or an advertising agency, but we can help guide you with it and we can direct you to law firms that can help you navigate this.
Exactly.
I think we pretty much covered everything on this. Any last thoughts that you can think of, Justin?
No, no, no. I, I, I mean I think we really covered it. I said there, there's multiple options in this space. But again, start with what is it that you're trying to say? What is the question you're trying to answer? And then truly, truly reach out to advisors, reach out to a firm like ours that can guide you and assist you in and understanding what the question should be. What are the, what are the things we're trying to say? So you really get good direction. Make sure that you get that ftc, FDA lawyer on staff ready to go before you make any steps. Because again, as Mark stated, it could just be a simple reformulation. And I mean I say the word simple, right. But for the reformulation may be really what you need to do and it might be the path of least resistance to, to get to where you want to go as opposed to trying to go for a full clinical, but then understanding what's the right type of clinical to get to where you want to go. Because again, we've got the biological, we've got observational and all that comes around to what is it that I'm trying to say? Do we believe that an observational claim is strong enough for my product, for my right. There's a lot of things that you need to do pre to even thinking about something like this and don't do it alone. That is the best thing I think we can tell you is do not do this alone.
Yeah. And let me give you an example. As long as we've been doing this, I have different coaches in my life that helped me along the way. One of my coaches, my business coach, is a guy by the name of Dan Sullivan. He's one of the top coaches in the world. And Dan has come to call strategic coach. Well, Dan wrote a book recently that's become a bestseller and the book is called who not how. And and it's a brilliantly simple concept. And what Dan has been able to do through his work is show that the companies that survive, the people who have the tremendous successes are not the people who know how to do everything. They're the people who know who can do everything. Because none of us can know everything. It's not possible. So think about who, not how. I don't need to know how to do a clinical trial. I need to know who to call, who can guide me through a clinical trial. I don't need to know how to run an ad campaign. I need to know who can run an ad campaign. Who are the who's in your life and that's the key to success. Finding and collecting the the right group of who's that can do the hows.
Exactly.
And by the way, I would recommend the book to people is Dan Sullivan and the book is called who Not How. And I think Matt's going to put a link to the book in the show notes.
Yep, it's a great book.
Well, I think that wraps us up for today. And as Justin said earlier, if you have a show topic you'd like to see answered, just reach out to us. You can get a hold of us@jekyll hydelabs.com or you can get a hold of us@cppg insiders.com and Matt will put links right in the show notes where you can get to us or email us. And again, if your business has any of these questions, reach out to us and we can set up a meeting with either one of us at some point. We're pretty backed up and sometimes it takes a week or two to get a meeting. But we're happy to set up a an exploratory phone call and listen to your questions and give you the best advice we can give you that doesn't cost you any money to have a chat with us. It just might take a little bit to get a time set up.
Absolutely. Yep. Absolutely.
Well, that's it for today, and we'll see you on the next episode of CPG Insiders. If you're looking to greatly increase sales on your CPG product, don't hesitate to contact us at Jekyll and Hyde Advertising and Marketing. By the way, the only advertising agency with a guaranteed just go to jekyllheidagency.com or feel free to give us a call at 800-542 10.