Paul Shapiro: [00:00:00] Samantha, welcome to the business for good podcast. Great to

Samantha Miller: be here. Paul. Good to talk to you I'm a long time fan of your podcast and your better meat company.

Paul Shapiro: Oh, wow. I'm so honored I'm, very thrilled that you are both a listener and now a guest and as you may know if you're a long time listener you know, we've done some episodes relating to Contraceptives and family planning in the past.

We did one with your choice therapeutics, which was really trying to figure out a way to get Male contraceptives onto the market. maybe one of the most popular episodes ever was, with, Dr. Escar Guardian, who had, famously vasectomized himself. He's a urologist who participates as a leader and spokesperson for world vasectomy day.

We also had family empowerment media on, which was trying to do, basically work to help improve access and acceptance of contraceptives in developing countries in Africa, but shameful. We have never done an episode just on regular old female contraceptives, which are in great need of revolutionizing, which is why you are doing this, [00:01:00] I know, but it's such an important topic.

So first, let me ask you, what happened to you that this became the issue that you wanted to devote your life to? Well, what

Samantha Miller: happened is I've been in small pharma all of my career, and I spent the first half of my career, really specializing in representing small, small companies doing deals with large pharma.

So all types of collaborations and technology acquisitions. And so when one of the legends and family planning, put me into this because so Malcolm Potts is a very interesting man. He's an obstetrician who has devoted his life to increasing access to contraceptives and actually myth mythopristone as well.

And he, what, what

Paul Shapiro: is, what is for those who are uninitiated, Samantha, what's mythopristone?

Samantha Miller: It's the abortion pill, the medicinal abortion, which he helped to, to facilitate. So, [00:02:00] Malcolm Potts was the first international, director of Planned Parenthood, medical director. and that was back in the sixties.

And in 1969, he was quoted by by Reader's Digest as saying it would be a benefit to humanity if we could put cigarettes on prescription and birth control pills and vending machines. That's a good line. That's a really good line. It's a good one. so he and his partner, another obstetrician devoted to family planning, NAPHO saying, they were looking for someone to acquire products to, to initiate the first in class RX to OTC switch of the birth control pill, because there's a big barrier, there's a big industry regulatory barrier to initiating this OTC process.

And that is that you have to own the innovator rights to a [00:03:00] prescription birth control pill that has a long history of safety, is one of the safest in the class, and that's the only way you can initiate the first in class switch. So you can't do it with a new product, and you can't do it with a generic.

So they were referred to me as someone that might be able to get those product rights. And, you know, I'll never forget when, when they, you know, invited me to have coffee and they told me that, you know, they believe that this is a way to reduce unintended pregnancy. And when they told me that almost half of, of pregnancies are unintended in the U.

S. today. That number really shocked me. I didn't realize it was so high. I hadn't worked in women's health in the past, and I would have guessed that it was like 20%. And the fact that it was almost half still at that point in time, [00:04:00] really hit me like a ton of bricks. So, you know, I honestly told them that it's unlikely that I could get these products for them because big pharma doesn't, they don't do deals unless they're worth, you know, hundreds of millions.

but I said I would try and I was in a good position to try because I was kind of in the club of, what they call business development and licensing for pharma. And so I immediately went home and started trying that night. And, there was only 4 companies to call. So that's the interesting thing is that these product rights are held so closely that there's only, you know, 4 or 5 companies.

On the globe that has that have these right and you know, they it's not a priority for them. I mean, women's health is generally not a big priority in pharma. O. T. C. Is not a big priority in pharma, and so it wasn't going to happen [00:05:00] unless a small company acquired these rights. And made it happen. So let's talk about

Paul Shapiro: why it's important for that to happen.

Let's just back up, right? Because you're taking it for granted that this is somehow important and that it should happen. But why? Why does any of this matter? Like, what's the need in this market for change right now? Yeah, absolutely.

Samantha Miller: So the interesting thing is when you look at When you look at birth control in America, it's not so much, I mean, there, there's technology, you know, we can always develop better technology.

the, there's not, misinformation is not a huge problem, but it's really surprising what a big problem there is with easy access. And with birth control, you have to have continuous access. If you have gaps in your, in your access, you can, you know, you can easily get pregnant. And so many pregnancies happen because women either have a gap in their refills.

By [00:06:00] prescription, or they don't have health insurance, so they, they aren't getting the pill. Now, the birth control pill is still the most popular form of female contraception by far. so until we develop something that women like better, we need to make the pill more accessible. And, so, so that's, that's really the thought.

And there's been a lot of research showing that. Taking the pill off prescription and making it ubiquitous, ubiquitously available like condoms would really reduce unintended pregnancy.

Paul Shapiro: Well, I want to get into why the pill is not over the counter, as you said, OTC before, like, obviously, condoms are, but needless to say, you know, you're not, there's no hormones or anything associated with condoms, so I want to talk about why.

It is prescription only, but also, you know, if half the pregnancies are unintended, presumably, you would expect that people who [00:07:00] are against abortion, like a lot of those unwanted pregnancies, presumably end in abortion because they're unwanted. So you would think that those who would like to see fewer abortions conducted, whether they're pro choice or pro life, whether they want to see fewer abortions, this would be the biggest cause for them in the world to get more contraceptives, right?

is that the case? Is there as much support for contraceptives on both sides of the abortion debate?

So

Samantha Miller: it is a bipartisan issue. So there are a lot of people on the Republican side that are pro contraceptive access. And I would say it's, it's, you know, almost entirely supportive on the Democrat side. In fact, I've never heard anything to the contrary. there are groups that are, that resist contraceptive access and there's, you know, there's sometimes a myth that if you make [00:08:00] contraceptives so easy to access that it will somehow decrease promiscuity amongst young people, which, you know, research have shown that's not even the case.

Paul Shapiro: yeah, even if it were, you presume that people who are concerned about that would prefer promiscuity to abortion. So, like, you know, considering considering that that world view. So, okay, right now, like, the best option for women is taking a pill every day and that pill is only available by prescription.

Why is that? Why can, you know, if, if you are whether a teenager or an adult woman and you want to be on the pill, you can't just go pick it up like you can get shaving cream, right? You need to go and actually get a prescription from a doctor. Go get it. Why? Why is that?

Samantha Miller: Well, it's because the, the regular combined birth control pill does have some contraindications.

These [00:09:00] contraindications are fairly rare in fertility age women, but there are some contraindications that need to be communicated. the most important one is that if you're over 35 years old and you smoke cigarettes It's it's dangerous to take the birth control

Paul Shapiro: pill And so contraindication for those who aren't medically familiar with that type of a term is basically it can be a problem in Conjunction with something else and you're saying age and smoking are two other factors.

So it's not like a side effect inherent to this No matter who you are, it's contraindicated, meaning that something else that you are taking or doing could be a problem in associate in this issue. That's

Samantha Miller: right. So the birth control pill is very safe for the vast majority of people. they, the other 2 contraindications are.

if you have a history of breast cancer, everybody knows that, you know, they don't take hormones after breast cancer. And then the third is that if you have [00:10:00] uncontrolled hypertension, high blood pressure, you shouldn't take the birth control pill. Again, that's rare. That's quite rare in fertility age women and it's easy to solve.

So, but these are things that we need to communicate and we need to communicate them effectively to the consumer without the you know, doctor or nurse being present.

Paul Shapiro: Okay, so That's this current status quo Cadence has come up with an innovation that allows you to have a birth control pill that does not require that that is both effective and safe and does not require any prescription.

So obviously, you know, you've raised 35 million for the company over the past six years. So obviously somebody believes in what you're doing, but what is this innovation? Why is your pill so much better than the current pill that it doesn't even need a doctor's note? Yeah,

Samantha Miller: so it's not the pill itself. So what we acquired is we acquired the rights to two popular birth control pills.

And the one we're bringing forward first is a birth [00:11:00] control pill that has the lowest effective dose of estrogen, which is 20 micrograms, and the safest progestin, which is levonorgestrel. I know it's a little technical, but, but it is the safest formulation and, and then the innovation that we're bringing is our communication.

So it's really, the drug facts label for the consumer on the back of the box. And it's the consumer information booklet, and it's the warnings that we have in the front of the box. So it's really in the packaging and the labeling, and it's a surprisingly, it's a surprisingly long and you know, You know, challenging process to kind of iterate on how we're communicating with consumers and then continuously, testing it with consumers.

We have tested this with more than 5000 women, across the U. S. with different iterations of the packaging and [00:12:00] labeling to make sure that when they look at our product, they know, okay, these are the, you know, these are the reasons why I wouldn't take it and we kind of, screen out, any woman that has the contraindication or any person that has the contraindication.

So if

Paul Shapiro: there's 20 micrograms of estrogen in your pill compared to the current pills that women take, is that less than that?

Samantha Miller: so it's just the lowest common dose that women are currently taking. So when pills started out in the 60s, it, the first dose was 100 micrograms and it went to 50 micrograms for a while.

Then it went down to, 35 today, it's between 20 and 35 is really the dose range used today.

Paul Shapiro: So if you're successful, could the current incumbents in the birth control pill space just mimic your labeling and compete with you, or would they have to actually change their formulation[00:13:00]

Samantha Miller: precisely? They can do that.

So the first company that does the switch. it's a huge effort and a huge expense. And the reward for that is three years of exclusivity on the market.

So, that gives an opportunity to build the brand over three years.

Paul Shapiro: For cadence, for cadence, so I have three years of exclusivity. Right. Okay.

Samantha Miller: for the combined birth control pill on afterwards, anyone can, use our labeling and apply to, to be over the counter. Where are you? The door for the whole for the full class, long term and the FDA takes it very seriously.

And You know, there's a really high bar for achieving it.

Paul Shapiro: Where are you right now when it comes to commercialization like how soon before a woman who wants to take The cadence over the counter pill will be able to get it.

Samantha Miller: So we're I can describe where we are in the process[00:14:00] we're not really, you know predicting a timeline because it depends so much on fda and their approval process So, you know, we have, we've been collaborating very closely with FDA on this for six years, and, FDA goes through their own process, and they have actually changed their approach, along the way, and so we've had to, go backwards at certain points.

also, I want to clarify that there's a new initiative with FDA that we are now following, which is to have this technology assisted label where you go to a URL on any device. QR code or through your computer and you do an online questionnaire that walks you through the contraindications and make sure that you understand them.

So, the 1st time you buy it over the counter, you're going to be going through this online questionnaire and, it [00:15:00] includes knowing your blood pressure. So it's, and this is a new initiative. Actually, the statins are going through this as well. So, the cholesterol medicines are going through this as well to go over.

Over the counter. so this will be sort of a more high tech approach to over the counter. But once we get through that, it should be available everywhere.

Paul Shapiro: And would that be mandatory with going to that URL and typing in your blood pressure? And so it's that mandatory or is it just something that is recommended to do?

It is mandatory. Okay. So, so it won't be like buying condoms, which anybody can buy without anything. You'll still have to do something, but you won't need a doctor's note. Okay. Presumably at the convenience store that you can find out your blood pressure, like you don't have to go to a doctor to do that.

Right. So I read a press release saying that you intended by January of 2024 to be in thousands of convenience stores. Is that still the case right now? So,

Samantha Miller: so there's 2 different [00:16:00] products that were, there's 2 sides to cadence, the daily birth control pill will not be available in 2024. That's the longer process of this 1st and class switch, which we're still on this journey.

and we're making good progress. We, you know, we think we have agreement with FDA on, you know, You know, on our online questionnaire and our labeling, the other side of cadence is that we believe that there's also a distribution problem. So there's, there's 3 barriers to access to contraceptives in the United States.

There's. There's prescription, there's cost, and there's distribution. We actually want to address all three. And so while we're on the path to solving the prescription problem for the daily birth control pill, we also want to solve the cost and distribution issues that we see with the emergency [00:17:00] contraceptive.

So that's a very important product that's already over the counter. you know, medical groups and public health community fought so hard to get that over the counter. In 2010 and yet there's still a cost and distribution issues with that product and that's what we're trying to solve today through the convenience channel got

Paul Shapiro: it.

So by emergency contraceptive you mean like the morning after pill, right? Exactly Okay, and so that product will be from cadence on thousands of convenience store shelves starting in january of 2024 Thank you for the correction. I just want to make

Samantha Miller: sure that's right. That's right And so and it'll be half the price of the leading brand And it will be, we'll be targeting these healthcare deserts where they don't have large chain pharmacies like Walgreens and CVS.

And so it's actually very hard to find. And it's a product that you need to take within hours. [00:18:00] So it should be wherever condoms are sold, and this is something that is quite practical because the morning after pill is easy to manufacture. It's inexpensive to manufacture. It has a long shelf life. It weighs nothing because it's one tablet and it should be everywhere, but it's not so we we intend to solve that

Paul Shapiro: Okay.

Well i'm rooting for you to do so. So let me ask you samantha, obviously the dobbs decision repealing roe v wade is or I guess I'd say overturning roe v wade you know, people, women's reproductive access, advocates have been decrying this ever since the last year, since that happened. I'm sure that you would prefer for that not to have happened.

But is it good for cadence? Like, is this attracting investors to you because there's now a greater need for your work than there maybe was before?

Samantha Miller: I would say yes. [00:19:00] I think, everyone agrees that contraceptive access is more important today than it has ever been. And we need to, you know, we need to solve these problems.

Urgently, and that's why we decided to launch our morning after pill early instead of waiting for the daily birth control pill and launching them together. You know, we've also we've been on a long path. You know, this process takes longer and is more expensive than people expect. And so we do need new supporters, new investors.

We are a public benefits corporation, and all of our investors are social impact investors that care deeply about contraceptive access, and we need more people to come forth to support the, the OTC switch initiative.

Paul Shapiro: So are there states that are trying to curtail what you're doing? Obviously there are states that are, you know, doing heartbeat bills or six week bands and so on, [00:20:00] but have any of them started coming after the morning after pill yet?

Samantha Miller: No, not to our knowledge, to our product, there has been some resistance in the past. and part of the issue was actually a labeling issue because there was. A legacy, element on the morning after pill label where one of the mechanisms was. preventing implantation of a fertilized egg.

there was not good evidence for that. The, the, the evidence is that the, that the mechanism is preventing or delaying ovulation. So really puts the brakes on, on the egg. And, and does not, it, it will not harm an existing pregnancy. And if you're, if you already have fertilization, it will not affect that pregnancy going forward.

So it's not an abortion agent. , sometimes people confuse the morning after pill [00:21:00] with the abortion pill. They're two completely different molecules. the morning after pill is actually just the safe progestin in birth control pills, but at 15 times the dose. So it's one pill, one big shot of progestin that just puts the brakes on the egg.

Interesting.

Paul Shapiro: Okay. I want to go back, Samantha, if there's something you said earlier about 50 percent of American pregnancies being unplanned or on, I should say unwanted, not just unplanned, but even unwanted. So I was reading, the stats on teen births and teen pregnancies, which apparently are at an all time low in the United States right now.

So a few decades ago, it was like 60 births per teen female, per 1, 000 teen females, and now it's only 15. So we're still behind, countries like Canada and the UK who have even lower teen birth rates. but what was so interesting to me was when you look at what the reasons for this are, there are many why, teen birth rates have fallen.

What do you think is [00:22:00] the reason why we have so few teen births today compared to a few decades ago?

Samantha Miller: So, I'm not an expert on this. So, my, my thoughts are, you know, are, are only my thoughts. I do have three young adults, myself, two, two college, or three college age kids. And, two are daughters, you know, I think that what resonates with me is that they have more activities, that life is more interesting.

There's, you know, I, I do credit technology with this to some extent. That, there's, there's more awareness, there's more information and there's less boredom. That's my thought. What's your thought?

Paul Shapiro: Well, my thoughts are only based on what I read from, the Pew Research Center. So you're, you're basically euphemistically trying to say they're sleeping around less, right?

They're having less sex as teens, which, appear [00:23:00] according to Pew is part of it, but they say the bigger part is just greater access to contraceptives. That there's just way more contraceptive access today than yesterday, basically. And so, even for teens who aren't having less sex than teens in the past, essentially you've got a way easier time preventing pregnancy.

And so that, of course then would be suggestive that your work If you could make it even easier to prevent teen births, that maybe we could get closer in line with some of these other developed countries that we compare ourselves to, like Canada and the UK, which have even lower teen birth rates than we do in the United States.

and the statistics are pretty sobering. Like, you know, teen, teen births are associated with all types of really sad health outcomes, economic outcomes, and so on. Now, I happen to be married to somebody who was the product of an unplanned, teen birth. both of my wife's [00:24:00] parents were teenagers when she was born.

And, so she turned out okay, so she beat the odds. but the statistics are not that good. that, you know, it's a very good way to fall into poverty or to remain in poverty to have a teen birth.

Samantha Miller: Oh, absolutely. I mean, the consequences of unintended pregnancy for both the mother and the children are really profound in terms of, you know, poverty and, and other bad outcomes, prison addiction, homelessness.

And it's not just teens. It's also, you know, women in their 20s that are, you know, that don't have a stable father, don't have a stable work life and living situation. so we, we need control,

Paul Shapiro: right? Yes. Indeed. I, I totally agree with you. Let me ask you. So, you know, there are some people who are Interested in this topic for 2 [00:25:00] reasons.

1 for the reasons that you just noted that women should be in control of their reproductive destinies. And the other is that in a world where there's 8 billion of us, we've got a lot of people walking around very heavy footprint. If people want to have fewer kids, they should be able to. And that's basically the point of the family and power the family empowerment media episode that we did earlier, which will link to in the show notes.

At this episode at business for good podcast. com But their argument is you know, if people don't want to have kids we shouldn't You know, we shouldn't force them to have kids They should give them every opportunity if they don't want to have them I know that you are particularly interested in climate and the planet and so, because I, I know that you are really into plant based eating and so on.

So I'd love to know, Samantha, first, how that happened for you, how you got interested in plant based eating and making that connection. And does that weigh on you at all? Do you feel like that's a secondary benefit to what you're doing as well? It's like a planetary benefit, not just the individual benefit, but the social benefit.

Samantha Miller: Yes, a hundred percent. I really have had a great [00:26:00] connection to nature and animals since I was, you know, a child and that has. Been a constant and then as I, you know, more recently and, and I was a vegetarian most of my life as I have become more educated and aware of the impact on the planet. Of animal agriculture and other issues related to, what we're doing to nature.

I have become, you know, just more, more passionate about it and see it as really a, you know, necessary for survival of my grandchildren. So, yeah, we need to, only have the children that we. Intend and want to have.

Paul Shapiro: Yeah. Okay. It would seem like that shouldn't be a controversial statement. Well, you just said we should only have the Children who we intended want to have.

But I do think that in some parts of [00:27:00] society, that is maybe more controversial than I would have imagined at least. But I am really hopeful that your projection is correct that in January that your morning after pill will be available and thousands of command stores in these so called what you call it.

I think health care deserts is that we said, well,

Samantha Miller: that's right. And a little bit more about health care deserts. You know, one of the things that really drives us. And the other piece that I think is important to address is the mission towards equity because what we have today is we have an unequitable access whereby people that live in major metropolitan areas.

And fancier neighborhoods have easy access to over the to anything over the counter and yet there's, there's healthcare deserts are defined as places often small towns or low income parts of inner cities that don't have good healthcare [00:28:00] services. Well, it turns out that they not only don't have good health care services, professional services, but actually they don't have access to over the counter, medicines and health care products, which is, which they need more than, than other people because they're not having the professional services.

and, you know, over the counter is it's an avenue whereby if we can just get everything That is available over the counter, to these healthcare deserts, that's a step in there. That's a big step in the right direction. so, yeah, it's really about equity as well. Nice.

Paul Shapiro: Okay. as you know, because you are a listener of this show, Samantha.

And we always ask at the end of every episode, whether there are companies that you think could better the world that you, you hope that somebody listening might start. So knowing what you know and what companies are and are not out there, what do you hope that [00:29:00] somebody listening might take away from this and go start their own?

Samantha Miller: Well, yeah, I did give that a little bit of thought and you know, I do. Referring back to the episode you had on your choice. male contraceptive research, I think there really needs to be more, more research, more development for male contraceptives. I think it's a big opportunity. I think men are becoming more, enlightened and many want to participate in, family planning in a more direct way.

And I think there's, there's a lot that can be done there and it's a big market. So I hope that there will be more companies. That work on male contraceptives.

Paul Shapiro: Yeah, it's totally insane like that the They're only real options for men or other condoms or vasectomy. That's like totally insane I have this thought that you could basically In order to in time, I don't know technologically how this would work but if [00:30:00] you had something that was like a pill that men could take that would Render them incapable of, fertilizing a woman, in order to incentivize men to take it would have to have like some type of performance enhancement associated with it.

Right? So it would be like, I don't know about Viagra, but, you know, because you don't want people taking that daily, I guess, but, you know, you know, something where there's not just the sole, reproductive control aspect or some other performance enhancement. So I'm going to augment your suggestion, Samantha and say, maybe that's what somebody could do.

And they would get a lot of news attention for that. Okay. okay, finally, let me ask you about resources that have been helpful for you because, you know, six years ago, you said you were involved in small pharma, which is an interesting, I never heard of small pharma before. So, thank you for introducing that into my own lexicon.

You were involved in small pharma. You decided that you're going to start this company. You've raised tens of millions of dollars. You're getting ready to commercialize a product onto thousands of store shelves and start fulfilling the mission that you have devoted yourself to for all these years. Are there resources that are helpful for [00:31:00] you along this way?

If somebody is impressed and inspired by what you've done that you would recommend for them.

Samantha Miller: Yeah, that's, that's a tough one because there's, of course, there's some resources that are important and maybe somewhat esoteric to what we're doing. you know, I think one, one thing I want people to think about is that when you is, is this concept that.

over the counter products are outside the realm of regulations and politics. And when you take something outside the realm of, of regulations and politics. It's it puts it in the hands of the people. And so I would like there's not enough. There's not enough effort for, over the counter switches.

It's actually a really neglected area in our view. And so, when you talk about opportunities, I'd like to add that and, and then the resources around that are, our, our, our retail resources and convenience stores and we [00:32:00] really see. convenience stores as a way to build, healthcare products. And convenience stores in the past have been mostly cigarettes, alcohol, you know, snacks.

Let's build a healthcare section because of where they are. They're everywhere. There's 150, 000 of them. So let's create a healthcare section and particularly urgent products. And you know, I, there, there's many products that are urgent. So there's that. I also want to mention that,

Paul Shapiro: I do want to say one thing you could say is you're, you're, you know, putting the convenience in convenience store to have the convenience of family planning right at your fingertips.

That's

Samantha Miller: right. Convenience matters there. so the other one is there's a, if, if people want to know more about the birth control pill, there's a great book that, is the history of the pill by Jonathan egg. Which is just a fascinating

Paul Shapiro: his [00:33:00] last name. His last name is really egg.

Samantha Miller: It's E. I.

Paul Shapiro: G. Ah, okay. All right.

Well, that would have been pretty ironic if the guy who wrote the book about the birth control pill was actually named egg, but it's still pronounced that way. All right. So the history of the pill by Jonathan, I Greg will you will actually called birth of the pill. Oh, the birth of the pill. Thank you for the correction.

so we'll include a link to that book in the show notes. That sounds pretty interesting. I'd love to read that myself. So we'll include a link to that at business for good podcast. com. Yeah. And then I'll

Samantha Miller: say that, you know, honestly, your podcast and the, how I built this podcast has been a constant inspiration and, and kind of strength for me because.

I love listening to stories of other entrepreneurs that go through really tough, you know, really tough hurdles, difficult times where they want to, they want to quit and they don't quit [00:34:00] and they achieve their mission at the end. And that's just important to, to all of us that are in the entrepreneurial journey, which can be lonely and, discouraging.

Paul Shapiro: I'm definitely familiar with that. Not just through this podcast and how I built this, which I also really like, but through my own personal experience running a company, I often joke, although it's not really a joke that, you know, running a company, it's kind of like beating your head against the wall every single day.

And people look at you and they think, why are you doing that? You're going to break your head and you just have to have the confidence that the wall will break first. That's really it. Like, you know, you're going to break the wall, the wall will not break you. And, I'm very hopeful that you break through the wall and help make it easier for people to be in control of their own reproductive destinies.

And as you pointed out to only have the kids who they intend and want to have. So Samantha, I really appreciate all that you're doing at Cadence OTC. And I look forward to being able to go to a convenience store and see your product on the shelf it wouldn't be that useful [00:35:00] for me or my wife personally, but i'm thrilled that it is useful for Other people who will very probably urgently need it.

So thanks so much for all you're doing

Samantha Miller: Thank you, and thank for all thanks for all you're doing and it's been it's been a delight to talk to you