Latest / She’s Smart / Samantha Miller – Rewriting Access to Reproductive Healthcare

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Samantha Miller – Rewriting Access to Reproductive Healthcare · She’s Smart

0:02
Hey, everybody. Welcome to She's Smart. I'm your host, Maria Robotham.
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Each week, we sit down with incredible women to talk about life,
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work, and everything in between.
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Today's guest is someone who is
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truly changing the conversation around reproductive healthcare and access.
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Samantha Miller is the co-founder and CEO of Cadence OTC, a company working
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to make emergency contraception and women's health care products more accessible,
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affordable, and available in the places people actually need them,
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from convenience stores to grocery stores to delivery apps.
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But what fascinated me most about Samantha's story is that she didn't just create
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a product, she's rethinking access entirely.
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In this episode, we talk about the very real gaps in health care across our
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country, what pharmacy deserts actually look like, and why something as time-sensitive
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as the morning after pill, should be as easy to find as condoms.
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We also dive into the future of over-the-counter birth control,
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the enormous challenges of building a healthcare company from the ground up,
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and the perseverance it takes to navigate years of FDA regulations,
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manufacturing hurdles, and setbacks while staying committed to a mission.
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As a mom of two boys, this conversation hit home for me in a different way.
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We talk a lot about how contraception has historically fallen on women and why
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it's time for the next generation of men to understand that responsibility belongs to them, too.
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Samantha shares how she's even had those conversations with her son in college.
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And I loved how open and practical she is about removing shame from these conversations altogether.
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This was such an eye-opening and thoughtful conversation, and I'm really excited for you to hear it.
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Just a quick note before we jump in. Today's conversation is centered around
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contraception, reproductive health, and access to care. So if you do have little
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ears nearby, you may want to pop in your headphones for this one.
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So get cozy as we connect, learn, and laugh together on She's Smart with today's guest, Samantha.
2:27
Hi, Samantha. It's so nice to meet you. Good to meet you. How are you?
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I'm good. I'm very good. I just came from career day at my kids' middle school.
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This is such a good day of learning.
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It's been kind of great. Yeah, I kind of wish I had participated in one of those
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career days. I never did. We didn't have them when I was growing up.
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So you're based in Oakland, California?
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I am, yes. I was born and raised in Orinda.
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Wow. Oh. Yep. I am a California girl that happens to live on the East Coast.
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I grew up in Marin County, and I actually live in Piedmont, so close to Arenda.
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Yeah, my dad grew up in Oakland. My mom grew up in El Cerrito.
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Everybody got off the boat in Ellis Island and made their way to California.
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That's the way to go. Thank you for joining me on She's Smart.
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This is so exciting for me. It's a topic that I have been wanting to talk about for so long.
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I would love to know, I'd like to start and find out what your story is.
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A little bit of background on how you got to be to the point where you're at
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today as the co-founder of Cadence OTC and the CEO of it. Yeah, absolutely.
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So my background is starting with a love of nature, a love of biology,
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studied biology in school and graduate school.
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And then got interested in the business of the biotech and small pharma industry.
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And so started out with Procter & Gamble Pharmaceuticals and then went straight into small pharma.
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And really, I'm from the Bay Area, so entrepreneurism is kind of in my blood here.
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And I really got interested in the power of small pharma to solve problems that
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big pharma can't address.
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The first half of my career, I really was a business science liaison focused
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on doing deals, collaborations, partnerships with Big Pharma.
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And I really recognize that the type of projects they can take on are these
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huge blockbuster products that are protected by patents.
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And there are a lot of important
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medical developments that they are not in a good position to conduct and that's
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where small pharma comes in so it really became kind of social mission oriented
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and then after I had helped start several companies and,
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kind of public health legends, introduced me to the dream of moving birth control pills over the counter.
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And my background... Tell us how that happened, because I read the Inc.
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Article that they had just recently put out on you.
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So I'd love for you to share that moment when you were like,
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we need to do something about this.
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Yeah, I remember it so well.
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Dr. Knapp-Ho saying, so So they understood that in order to do this OTC switch
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for the birth control pill,
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that first they needed to own the original rights to a prescription product.
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So you can't do it with a new product and you can't do it with a generic product.
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So you have to have an original prescription branded NDA product with a long history of safety.
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And so they knew they needed to
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find someone that could acquire those product rights which is unlikely so so
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anyway nap was referred to me through his business school colleagues who had
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gone to business school with my husband several people told him oh you know
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i think steve miller's wife. I think she does that.
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So he found me and asked me to come to coffee.
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And this was on a summer afternoon.
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In fact, I was going with my kids to the Piedmont Harvest Festival that day. Okay.
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And so afterwards, I met him for coffee. And I was already fully engaged with other companies.
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And I had never really worked in women's health or family planning before.
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And so when he told me that nearly half of all pregnancies in the United States
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are unintended, I was shocked. I did not know that.
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And the more I thought about that, important it seemed to me.
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You know, I was a strong feminist, always thinking about how women could rise up and gender equality.
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And then when he told me that, it just resonated so strongly that that was such
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an enormous suppression for women to have accidental kids at the wrong time.
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And the weight falls on them. And most of the time, the man,
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you know, is not fully involved.
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So then Knapp asked me, can you do this for us? And I said, it's unlikely that
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I can do it because I know big pharma, they don't sell products unless there
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are hundreds of millions of dollars involved, but I'm in a good position to try.
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Because I was in kind of the corporate club of pharma, business development,
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and licensing. So I knew the people that made these decisions.
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Right place, right time. And I knew how to contact.
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There was only four companies in the world that owned the rights to the products that we needed.
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So it was just four contacts I needed to make. I went home that very day and started working on it.
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I was just so compelled about it. Yeah. Yeah.
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So three out of the four said no. But then Pfizer said, yeah,
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we might be able to do that for you.
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And so long story short, I got Pfizer to sell us the rights to two of the most
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popular birth control products that are really ideal for the first in class
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switch. How did that work?
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That was one of my questions when I was reading about this. How did that actually
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work for you to be able to negotiate that and then take the formula?
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Because then you're now creating, they're not creating the pill anymore. Now you're creating it.
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So what did that step look like from acquiring what it all looked like and then
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actually creating it? That's like a whole other business, right?
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I'm glad you asked that because a lot of people kind of gloss over that part
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of it. But you're absolutely right.
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We have to manufacture the product.
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And manufacturing pharmaceuticals is very difficult and involved and expensive. Yeah.
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So, yeah, we had to start our own manufacturing from scratch.
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We had the documents about how it was made, but there was no technology transfer even.
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So we had to find a contract manufacturer that could do it.
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And not many contract manufacturers work with hormones because.
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They're high-potency molecules, and you have to have a dedicated facility for
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hormones. You can't manufacture anything else in those facilities.
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Oh, interesting. Yeah.
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So there's actually— As you're doing this, I'm sure in your mind,
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because if you're an entrepreneur, you're thinking this one,
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but you know down the line there'll be others, right? There'll be other products.
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There'll be other things you want to create. This is much bigger than one thing.
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When you were doing that, were you also having to think ahead of,
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okay, well, if we can only create the hormones here, but I also want to do this
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other type of test, is that another facility or just different spaces in that building?
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I'm just thinking about the real estate here that you have to figure out.
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Honestly, in pharmaceuticals, you generally have to have a different contract
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manufacturer for everything you do.
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Okay. All right. So you're managing that as well. They're very specialized.
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I mean, managing contract manufacturing and supply chain is a huge part of a
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pharmaceutical company.
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And small companies have to do it in the same high quality, heavily regulated
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way as a large company. So you have to know what you're doing.
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If you don't do it right, it won't go through. You have to start over.
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Oh, my gosh. I can't even imagine the stress.
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Knowing you got this idea and you know it's going to work, right?
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You see it. It's like you see the end of it.
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And then you have to also deal with regulations and humans that can make it
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and scientists that can help. And also the actual packaging.
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You have to create packaging for it, too. So then there's a whole other step
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that you're dealing with. Yeah, that's part of the manufacturing,
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but it's a really big part.
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There's primary packaging is heavily regulated and things can go wrong and you
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have to establish stability.
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And there's no contract hormone manufacturers in the United States. So did you make it?
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You created your first, the one, the first one was you guys or do you have to
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have? Oh, no. We had to go to Canada.
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We've had to go to Canada and Germany and England.
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So currently our contract manufacturer is in Canada for the regular daily birth control pill.
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So, yeah, that was a big part of it. But we have, it took a long time,
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but we have our manufacturing all approved at this point.
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Okay. So when you were in pharma, did you see that something was missing?
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Something wasn't sitting right when you were seeing it from that side of it
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versus where you're at right now? Well, yes.
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Pharmaceutical companies generally don't prioritize primary care,
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and they don't prioritize women's health, and they don't prioritize it over-the-counter.
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So these are all things that are not as profitable as specialized prescription
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products that are on patent.
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That makes a lot of sense. When...
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Over the years, we've lost a lot of access for these places, right?
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They've shut down so many over the years. And have you noticed that you were
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able to fill a niche at this point that is missing?
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Well, I appreciated for the first time how over-the-counter products can be
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helpful and can fill gaps.
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And I didn't know this before because my work had always been in prescription
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research and development.
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And that's why I knew how manufacturing works and how regulatory process and
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clinical trials work. So that was all helpful.
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But I didn't understand over-the-counter. And it's really been an amazing learning
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experience to see how important over-the- counterproducts are.
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As you've pointed out, access to health care services has been declining for years.
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And it's hard to appreciate when you're in a privileged position,
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but you can see it in the data.
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And there's a huge shortage of gynecologists.
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There's a huge shortage of primary care physicians. There's a huge shortage
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of pharmacies, and particularly in low-income areas and more rural areas.
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And there are good products that are available over-the-counter.
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And, of course, we need more, which is why we're pursuing OTC Switch.
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And then you realize that even products that are available over-the-counter
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are only available in pharmacy stores.
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And there's 7,000 zip codes in the U.S. that don't have a pharmacy store.
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So we started looking at how can we get good over-the-counter products that
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are available in pharmacy deserts,
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which is what we're doing with our convenience store partnerships.
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And then how can we make better over-the-counter products? How can we make them less expensive?
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So I love the focus on OTC. There's so much we can do here.
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Yeah, and you can put it in so many more places than, like you said, just the pharmacies.
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In the article you had talked about, you can get condoms anywhere, right?
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When I lived in New York City, you'd go to a bar, and instead of cigarettes,
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there was a thing full of condoms that you could just buy. but and that's,
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Okay, but what about for women to be able to protect themselves?
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You're just going to depend on the guy who, if you're in a state of a party
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and out at night at a bar, you know, anything could happen.
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And then it's the responsibility, like you said, it lands on the women at the end.
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And to find it. To find it.
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And to find it quickly. I mean, with the emergency contraceptive,
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the morning after pill, this is a product that costs very little to make.
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It's one pill, so it weighs almost nothing. It has a long shelf life.
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There is no reason why it shouldn't be everywhere that condoms are sold.
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In all small stores, in grocery stores, in gas stations, there's no reason for
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it to not be there everywhere that there are condoms.
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And so that's really our goal with the emergency contraceptive and with our
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new UTI kit is also an emergency situation.
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With both of these products, hours matter.
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And so you really need them within a very short period of time.
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And you don't want to be driving 30 minutes to a store and then find out that
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they don't have it in stock.
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Yeah. Can you explain to everyone what the contraceptive deserts are?
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I mean, you touched on it, but if you had a definition that you think about,
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what does that look like?
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We just look at what zip codes in the United States don't have any pharmacy.
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They don't have a Walgreens, a CVS, a Rite Aid, or a Target or Walmart.
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So those are the top pharmacies in the country.
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And then there's independent pharmacies, but independent pharmacies also don't
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tend to be in low-income areas or small towns. I can imagine.
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There's so much here that you're doing. It's pretty incredible.
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There's just a huge social impact with all of this. And I think it's got to
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go further than just giving people access to it. It's educating as well.
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So is there an arm or is there part of what you're doing at Cadence OTC that
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will actually do something about
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the educational part of it and teaching women, this is what can happen.
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This is how it helps you. This is what it does. I grew up in Orinda.
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I was so grateful for Planned parenthood right there in Walnut Creek,
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because if anything happened, you could just go there.
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It helped me when a mistake happened.
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And thank God for it. Because when you're 17 years old and you don't know what
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the hell you're doing, you've been told, oh, this is a banana and this is a
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condom. This is what you do.
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But really, you're not thinking that way.
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It's all, you know, it's you're young and without access to what we had, you have a baby.
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And then you're in an entirely different situation that you did not plan for
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at that moment or want at that moment. So education.
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Is there going to be a component of that, or is there one already? Yeah,
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we have some educational pieces by physicians on our social media,
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but more important than that in terms of scale is that we need to have certain
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key facts that we just repeat in our advertising,
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because that's what gets a lot more exposure.
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So key facts about the morning after pill. It's not the abortion pill.
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It will not harm your future fertility. It's safe to take multiple times.
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And the sooner you take it, the better it works.
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It's labeled for 72 hours, but the efficacy goes down precipitously every hour.
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Oh, wow. I didn't realize that. And not everyone realizes that,
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that hours matter with the emergency contraceptive.
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Because the sperm stays in your body for up to five days.
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And your egg can come at any time.
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So any hour after unprotected sex, that egg can arrive.
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And so the sooner you take it, you have put a block on that egg arriving.
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This is what more people need to understand.
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Yeah. And same thing with UTI where hours matter. Yes. Because...
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You first get that initial sign that you have bacteria in there.
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And that bacteria is trying to infect into your tissues.
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But before it infects into your tissues, you have an opportunity to flush it out.
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So if you have something that you can use quickly that can effectively flush
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out a bacteria before it establishes an infection, you can get rid of it.
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So what does the product look like? because I know it's not out yet. It is. It is.
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We just launched it. Oh, congratulations. Okay, so what does that actually look like?
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Run us through when you would go and grab it, how you would use it,
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and what it actually does.
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So it contains diagnostic test strips, and it contains the UTI-specific analgesic
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pain reliever, which is finazopyridine.
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And then the rest of the kit is kind of a combination of an antibacterial prodrug called methenamine,
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which converts into an antibacterial in acidic urine.
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And then we have this supplement that you can get with it.
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The supplement contains a vitamin C ascorbic acid to acidify your urine and
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convert methenamine to an antibacterial.
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And then it has a cranberry concentrate with the cranberry molecule proanthesiodins, PACs.
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And then it has D-mannose. So the supplement has these three key ingredients.
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And it works with the methenamine. So that's the combination that you're taking
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together, that if you take it fast enough, you can flush out the bacteria.
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And even if you don't take it fast enough, it's going to keep the bacteria under
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control and keep you relatively pain-free until you can get to your physician and get an antibiotic.
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And by the way, for women that don't have a physician that they can easily access.
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We have a telemedicine partnership where you can go through a QR code on the
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kit and get a physician consultation and get an antibiotic prescription sent
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to any pharmacy within four to six hours.
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So the kit is kind of all comprehensive.
22:24
What made this happen? How did this come to you or is it the team that you were
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like, okay, we've got the morning after pill, we're working on birth control,
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OTC, we need this UTI kit.
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Because it's brilliant. Thank you. My thought was that we already have this
22:45
great access to convenience stores and some grocery stores, and we're building that out.
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And I was thinking, what is another emergency women's health product that you
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need as fast as you need an emergency contraceptive?
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And I had terrible recurrent UTIs in college, so I really understand this condition.
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And I understand how you can detect it yourself in just the very beginning.
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And sometimes I was able to flush it out myself. And then other times I had to get antibiotics.
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And when I had to get antibiotics, it was so miserable. I had to suffer so much
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until I could access that. You can't sleep. You're going crazy.
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And then I looked at, well, what is available over the counter?
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What could we put together that could help somebody in that emergency moment?
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And that's where I designed the kit and thought that we could really make a
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difference with our retail access.
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And they just walk into 7-Eleven. You're in 7-Eleven, Kroger's.
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With the UTI kit, we're starting with Walmart. So we're doing exclusively Walmart for just a few months.
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And then we're going to start expanding out. So it's going to take us a little bit of time.
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But we are going to get into convenience stores. And we are going to get into grocery stores.
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And it's going to be available wherever you need it.
24:16
And you can get them online, too, right? On your website? Well,
24:20
the way to get it online is to get quick commerce delivery.
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So we also have a partnership with.
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DoorDash, which has Dash Mart now.
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So they have their own warehouses. They have 150 of their own warehouses.
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And so they do delivery within two hours.
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So we want, if somebody buys it online, then they're buying it for future need
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or they're getting that quick commerce, fast delivery.
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Getting it by overnight if you already have a UTI is too late.
24:56
That's not, That's not okay.
24:57
You have taken something that is available.
25:01
You didn't reinvent something, but you have literally reinvented access for people.
25:06
Well, and the interesting thing is that methenamine over-the-counter,
25:12
they never mention the products that are available over-the-counter with methenamine
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never mention that it requires an acidic urine and doesn't provide any acidifier.
25:24
When it's prescribed by a doctor, it always comes with some kind of acidic supplement,
25:29
but not OTC. It doesn't even mention the acidic requirement.
25:34
So we are changing the way that that is being used.
25:38
Combining it with a supplement is a key insight, and it's the only product that
25:45
combines methenamine with a supplement that it needs. that's amazing that they
25:49
sell a product that you can take that does nothing, doesn't help you.
25:53
Yeah. That you need something else with it. And people who are grabbing these
25:57
probably aren't researching, oh, I need to also put something else with this
26:02
in order for it to be effective. They would never know that.
26:04
They would never know that. That's crazy. That's crazy to me.
26:08
So why do you think, and I know we're slowly trying to change this, right?
26:12
But why is contraception the woman's responsibility? Wow.
26:17
Well, it's because it's the woman that is under the big risk.
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I mean, it's a huge risk for the woman. It's a lot less of a risk for the man.
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And then it's considered her body, even though it's really their bodies together
26:33
that are creating the issue.
26:36
So, you know, I think emergency contraceptive is a great way to expand the responsibility.
26:43
Because, of course, the daily pill or an IUD, that type of chronic use contraceptive,
26:53
that is logically being taken care of by a woman.
26:56
But a lot of women really don't want to be on chronic contraceptives.
27:04
So they either they don't tolerate them well or they don't have a good access to them.
27:09
So they're relying on condoms for contraceptive.
27:13
And then they can use an emergency contraceptive if the condom fails,
27:18
which it does 10 to 15 percent of the time, slips off or breaks and or is just not used.
27:26
So the emergency contraceptive is logically something that men can have.
27:32
And it's often their mistake that causes the condom to fail or sometimes it's intentional.
27:43
And the emergency contraceptive is very easy for them to have on hand and be able to offer.
27:49
So how are we going to get that information to the men?
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How do we make that social media? How are you doing that where you're saying,
27:58
hey, you can also put this in your wallet or in your back pocket so small.
28:02
And if something happens, you guys are good. How are you going to do that?
28:09
Well, we are trying to do social media with men, and we have posted a couple showing a man that's
28:17
in the heat of the moment where condom failed, and he's rushing into the convenience store to grab the EC.
28:25
And so we're showing that, we're normalizing that, we're giving that as an idea,
28:30
but we need to do more of it.
28:32
It's actually been hard to find men that are willing to do it.
28:36
Oh, yeah. So we're relying on brothers and boyfriends and sons.
28:43
There's many male content creators
28:47
and they're declining this this
28:50
job well that's very curious too
28:53
and i wonder why that is is there
28:56
a taboo there is there a reason i
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don't know does it i think they're embarrassed they're embarrassed but i mean
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women aren't we have no issues getting women content creators to talk about
29:08
morning after pill because they're like i'm gonna be responsible about this
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i want to make sure everyone knows that this is available, that you have access to this,
29:17
that you don't have to have an unwanted pregnancy when science has figured this out for us.
29:24
Like, right. Pretty incredible.
29:26
It's pretty incredible. Let's go into the pill, like the packets, right?
29:30
Why hasn't there been an over-the-counter one? And where are you at in developing
29:36
that as part of your products? Yeah, so the daily birth control pill is a combined
29:42
pill with estrogen and progestin. That's the pill.
29:45
It does have some contraindications.
29:48
So any new class of medicine going over the counter that has contraindications
29:54
is a very long, careful process. Okay.
30:00
We have to develop materials, packaging and labeling and booklets that communicate
30:06
with the consumer what those contraindications are in a way that they can really understand.
30:12
So that kind of development, packaging and labeling development,
30:16
has been a long process. It's very interactive with FDA and involves a lot of
30:21
consumer testing. Okay.
30:23
And so we completed that process some time ago. And then the FDA wanted us to
30:29
have a digital label to also educate around the product.
30:36
So we needed to develop software.
30:40
It's a web-based health questionnaire that asks for health information and then
30:47
explains whether the product is right for you or if not, why you need to talk to your doctor.
30:55
So the contraindications are quite uncommon amongst fertility-age women, but they're important.
31:02
For example, smoking cigarettes when you're over 35, if you've ever had breast
31:09
cancer, if you have high blood pressure.
31:12
So these are the things that would prevent you from safely using a daily birth control pill.
31:19
And then you have to assume people are answering the questions correctly, right?
31:23
Yeah, which actually our data is showing that they do. That's good.
31:27
That's good. Yeah. So we need to prove that and we have.
31:31
Yeah. What a game changer if you're able to do that for women,
31:35
especially in those pharmacy deserts where they could go to a doctor,
31:38
but there's no pharmacy to fill it.
31:40
Like, how does that even work if you're like, I'm with my doctor?
31:44
Yeah, well, and pharmacy deserts are generally health care deserts, too.
31:48
So there's not doctors in those areas available either.
31:51
So with this one, you really will be able to buy it anywhere because with over-the-counter,
31:56
there's no restrictions on sale.
31:57
You can sell them in any store or gas station or hotel.
32:02
So, yeah, and you would just go to our questionnaire through a QR code or URL
32:08
on the package and on our materials.
32:10
And it's educational because you should be educated.
32:13
I mean, I'm sure if this is the first time ever taking birth control pills in
32:17
the packet, then you have to understand. And you have to take one every single
32:21
day at the same time. And here's how they work.
32:24
And those, the five that are, you know, placebos or whatever they're called, right?
32:29
Sugar pills or whatever they are. Like, if you keep taking those,
32:32
you'll probably keep remembering that you have to keep taking a pill every single day.
32:37
You know, that I remember that whole process back in the day of having to remember one every day.
32:43
Yeah, absolutely. And what we find is that some women who have been on the pill
32:48
for a long time, when they read our materials, they say that they've learned
32:52
a lot that they didn't know, even though they've been on the pill for years.
32:56
How do you think the conversation around reproductive health has changed over the past few years? Hmm.
33:03
It's clear that in most recent years,
33:06
there's really much more openness to talk about women's bodies and biology and
33:16
disorders much more openly.
33:18
And I'm very happy to see it.
33:21
And, you know, we're leaning into that. One thing I want to mention about the
33:28
over-the-counter birth control pill is that the mini pill, which is the progestin-only
33:33
pill, that did go over-the-counter in 2023.
33:37
About 10% of people that take a birth control pill take the progestin-only pill.
33:42
Oh, interesting. It was originally developed for breastfeeding moms because
33:47
you can't take the regular pill when you're breastfeeding. It stops the milk.
33:53
So they developed a progestin-only pill. It's also good for women who are really
33:58
sensitive to estrogen and get more side effects. So it's a good product.
34:03
The reason it's only 10% of the market is that you do have to be more careful
34:09
about taking it at the same time and not missing days.
34:12
And then also it has more irregular bleeding.
34:16
Yeah. I had a very bad eating disorder when I was younger and they put me on
34:21
the progesterone pill to try to kickstart my period.
34:25
Yeah. It didn't work. I think that was my body than anything else.
34:30
But I remember it was just all progesterone. And this was back in the late 90s.
34:37
So they were still figuring it all out at that point.
34:39
I mean, yeah, I think it's come so far.
34:42
I still really think that there is a huge disconnect between the women and the men. I really do.
34:49
And I'm hoping that moms who have
34:52
boys are able to say this is on you dude like you can't yeah not just on her
34:59
if you're going to be doing the thing you have to take responsibility as well
35:02
because it's on yeah absolutely and i have a son in college and i've had that
35:07
talk with him several times and i've given him emergency,
35:12
contraceptives to have in his dorm room and it's amazing because there is no
35:17
shame in it you take away the shame right because there's a whole school of
35:20
thought on intercourse when you're young, you know, the shame of it. You have to hide it.
35:26
You know, it's all secretive. And if we take away all of that and just say,
35:29
hey, we're all human. If you do it, don't protect yourselves.
35:33
Like, it's great. It can be very fun. But when you don't protect yourselves,
35:38
that's when things get very serious very fast.
35:41
That's right. Yeah. It's a healthy part of relationships, but it has to be done
35:44
responsibly. It has to be done responsibly.
35:47
When it comes to being an entrepreneur, because you've done this many times,
35:50
this is part of you is you're an entrepreneur.
35:51
In this process with this business,
35:54
with this company, what has been the hardest part of building it?
35:57
Oh, clearly the first in class RRX to OTC switch has already taken 10 years
36:05
and we still are not there.
36:09
So it's taken much longer than expected and been so much more expensive than expected.
36:16
So, honestly, we were close to just hitting the end of our runway and not being able to continue.
36:23
And our commercial product ideas that are also very much aligned with our mission
36:29
have really saved the company and allowed us to keep going and staying viable
36:35
so that we can persist in this FDA process.
36:40
Yeah, and then you're dealing with government regulations. You're dealing with
36:43
retaining people to take care. I mean, there's just the humans involved that
36:47
all need to cooperate together.
36:49
Like, it's a lot.
36:51
Yeah. Yeah. Working with FDA is very, very difficult.
36:55
Yeah. Are there any moments where you were like, this might not work? Yeah. Yeah.
37:03
Was there one in particular? Yes, there was. It was back in 2021,
37:08
I think, when we realized that the only way forward was to build this app.
37:15
And knowing that that was going to take several years to build it and to validate it for FDA.
37:23
And at that point, when we realized that that was the only way forward,
37:28
we thought, I don't think we
37:31
can continue to fund the company to do the software development process.
37:38
And that's a whole other part of it. But just what I want, I just want everyone
37:42
to understand the depths of this endeavor.
37:46
Because like you said, you see entrepreneurs and you're like,
37:49
oh, they're so ingenious. They create these very cool things that no one thinks about.
37:54
But in my mind, it's like, that's great.
37:57
But then all the other steps that you're having to take to actually get to that
38:02
end point is so much bigger, right, than just the idea.
38:07
It's starting and then finishing with so much in between that I just find so
38:13
admirable. I just think entrepreneurs are so badass.
38:16
They're able to stick with it. If it fails, you get back up.
38:21
You try something new. You keep going.
38:23
And I think that this is one of those moments where I'm so glad you kept going
38:27
and said, no, we got to keep doing it.
38:29
Thanks for recognizing that. It does, I mean, it does take incredible perseverance.
38:36
And one thing that has also saved
38:40
us and allowed us to continue is the partnership between myself and Dr.
38:46
Nath-Hosang has been really strong.
38:50
And he's a
38:54
valuable advisor to me and we're
38:59
so well aligned philosophically and the
39:02
way we work together is easy and frictionless
39:07
in most cases and that
39:10
type of partnership is really necessary to continue
39:14
down a long hard road like this yeah absolutely
39:18
to have that support for each other right on both
39:21
sides what do you think people underestimate about building
39:24
something in the healthcare space well the biggest
39:28
thing they underestimate honestly is manufacturing a
39:33
lot of failures are due to manufacturing failures and even the people in the
39:41
industry like experienced investors in the industry underestimate the dangers of manufacturing.
39:50
And actually, our first contract manufacturer in England failed.
39:56
Wow. And we had to start over again with another manufacturer in Canada.
40:02
So that was also a really depressing moment when we realized that we had to
40:08
cut our losses and change contract manufacturers, which means you have to literally start over.
40:14
Literally start over. Round up. Yeah, with the manufacturing. Manufacturing.
40:20
And in pharmaceuticals you have to validate your
40:23
commercial manufacturing before you can do any clinical
40:26
trials so that's why you have to spend so much money early in the process before
40:31
you've even shown that the product is viable do they come in and physically
40:36
check all of this like there's a group that walks through checks what the scientists
40:41
are doing watches what they're mixing and putting together in the facility and
40:44
how you're cleaning yourself before you walk into the room,
40:46
and then they take off a sheet? What does that look like?
40:49
Well, first, they review an enormous amount of documentation.
40:53
Every single thing that's done in manufacturing, no matter how tiny,
40:58
is documented on the batch records.
41:02
And so, CA reviews all the documentation, and then, yes, they spend time on-site.
41:09
Looking at everything. Yeah, very thorough that they do that because manufacturers
41:15
are shut down for lack of quality assurance in pharmaceutical manufacturing.
41:21
Yeah. No, you want that. You want that. But that process seems very daunting.
41:26
Yeah. And then we need to have our own quality assurance experts that are overseeing
41:32
it at all times. Yeah. Day to day.
41:35
This has been a fascinating conversation. I literally streamed through all of
41:40
my questions, went so fast.
41:44
I'm so appreciative that you came on to chat with me about this.
41:47
And I hope that everyone listening now gets just a better picture of what you're
41:52
doing and spreads the word.
41:54
And we can help push this out even further. I think that it's just a huge benefit
41:58
that you have created for women and men as they're traversing this part of their
42:04
life. I think it's really admirable.
42:06
Well, I really appreciate your interest in this topic and your smart questions.
42:12
It's been a great conversation. Thank you so much, Samantha.
42:16
Thank you so much for joining me today on She's Smart. New episodes drop on Thursdays.
42:21
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