Amy Wedeking Shannon, Chief Commercial Officer, Prima-Temp

A Better Way to Predict the Fertility Window with Amy Wedeking Shannon, Chief Commercial Officer, Prima-Temp transcript powered by Sonix—easily convert your audio to text with Sonix.

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Saul Marquez:
Hey, everyone Saul Marquez here. Have you launched your podcast already and discovered what a pain it can be to keep up with editing, production, show notes, transcripts and operations? What if you could turn over the keys to your podcast busywork while you do the fun stuff like expanding your network and taking the industry stage? Let us edit your first episode for free so you can experience the freedom visit. Smoothpodcasting.com to learn more. That’s smoothpodcasting.com to learn more.

Saul Marquez:
Welcome back to the Outcomes Rocket. Saul Marquez here and today I have the privilege of hosting Amy Shannon. She is the Chief Commercial Officer at Prima Temp. Amy is passionate about applying data analytics to clinical science to advance the democratization of women’s health care and ultimately outcomes. She has led commercial activities representing the spectrum of health care from population to personalized medicine. Amy held roles and sales leadership, business development and finance. With Eli Lilly and Guidant Corporation as a leader of sales and marketing at Medical Simulation Corp., Amy and her team identified and created a new hospital market never serviced by the simulation industry, focused on areas of high economic and mortality impact. Amy represented Welltok a machine-learning, data driven enterprise SAS company and led sales and marketing for flagship bio sciences and AI driven computational tissue analysis platform to support drug development. Amy has served as an industry advisor to the Leapfrog Group on Patient Safety, a facilitator of the Medical Ethics course at the University of Colorado Medical School, a volunteer with the Colorado Bioscience Association and is a strength’s finder coach all in one career. It is a pretty impressive and Amy’s greatest professional passion is leading and developing teams. She earned her Bachelor’s degree in Molecular and Cellular Developmental Biology at the University of Colorado and her Master’s in Business Administration from Duke University. So it’s a privilege to have you here on the podcast, Amy, and really, really thankful you could join us.

Amy Shannon:
Thanks for the kind introduction saw and I’m honored to be here. And I’ve really enjoyed learning from your other guests that have been on the podcast previously.

Saul Marquez:
Thank you. Yeah, we appreciate it. We definitely want to get diverse perspectives that that are out there in health care and yours is quite unique. And I’m really excited to dive into what you’re doing with your team at Prima Temp. Before we do get into that, though, Amy, I’d love to know what inspires your work in health care.

Amy Shannon:
Well, thanks, Saul. Really, from the very beginning, I’ve always been fascinated with bioscience and health care. That’s been my passion interest pretty much solely. And as corny may sound, I really love the fact that your day to day worker labor actually helps people. It’s an incredible opportunity reward. But beyond that, I’m really fascinated with the intricacies and the complexities of bioscience, both on the level of a human body as well as the health care ecosystem. And so if you think about the biological system design, like the endocrine and neurological and electrical systems and how they influence each other, it’s fascinating. And then you take that to a macro level and you think about health care in the synergies and collisions of biology and technology and behavioral economics and policy and psychology. And then at the end of the day, really just the individuality of human beings living out their lives. You know, they make some really intriguing intersections. And I think it’s fascinating to thrive at those intersections and a great place to be challenged intellectually and emotionally. And then those intersections are really advancing the quadruple aim of health care, especially with the application of A.I. and our company premierships doing just that. We’re applying A.I. to biometric signals to understand what’s happening in the body.

Saul Marquez:
It’s fascinating work. And you’ve had spent some time in previous leadership positions with other companies. And I you see the future there. And so talk to us about really biometrics. So you know exactly how you guys are focusing on biometrics, what biometrics is in particular to to what you guys are doing and how exactly you guys are adding value to the health care ecosystem.

Amy Shannon:
Well, do well, thank you. Well, really, we’re using biometrics to empower women to make informed health care decisions. And our first application is in fertility. So just a step back a little bit. Fertility starts to decline in women in their 30s and therefore, many of us who are waiting to have kids to we’re a little bit older. It makes conception and maintaining a pregnancy more challenging. And the there’s new data coming out from the World Health Organization that shows that one in four couples in developing countries have been affected by infertility. So to move to your question about biometrics, we use what’s called advanced chronobiological and circadian science to be able to pull up that biometric. So it’s all about when something is happening. So Chronobiology uses the science of understanding the phases and the oscillations of physiological and hormonal and neuro systems of our bodies and then applying time series analysis to that and being able to predict and understand a variety of medical conditions, because each of these bodily systems, they have rhythms to them and those rhythms or cycles are specific to each individual. So in other words, they have those rhythms. They impact things like sleep and eating in women’s monthly cycles. So when we do something critical, like when we have intercourse to get pregnant or avoid pregnancy or even when during the day we might administer a drug therapy. So it’s effective and has the fewest side effects. So thinking about that song, are you a morning person or a night person?

Saul Marquez:
I’m a morning person.

Amy Shannon:
OK, so that’s really controlled by your biological clock. So I’m a night person, but I’ve had to kind of force myself in between work and kids to be more of a morning person. But that’s not naturally what my body wants to be. And on the weekends, I’ll fall back. So your morning,

Saul Marquez:
Maybe I’m more like I didn’t even think about that, but maybe I’m more like that.

Amy Shannon:
Ok, so what does your body do.

Saul Marquez:
On the weekends? I’m up. I’m up, baby. Up. Right, exactly. What’s up. Yeah, that’s interesting. OK, ok, that’s fair. Ok, so this is about applying your, your normal circadian biology to how things work.

Amy Shannon:
Absolutely. So what we do is we measure biological patterns that are controlled by those clocks. And so we do this with a biometric of body temperature. So temperature is a proxy for physiological activities of our body. We’ve got a device or wearable pria that measures core body temperature on a continual basis. And core body temperature is really the gold standard of circadian science. It’s a very rich information signal and is one of our one of our advisers has stated it’s from a diagnostic perspective. It’s like taking a blood draw every five minutes and the kind of information you can pull from that. So for our first application, we’re using that information to help women identify their fertile window for pregnancy. And then many women don’t even have a fertile window because of underlying issues. So we can provide this very high fidelity information through this continual biometric that could be used to diagnose and then track the effectiveness of treatments for those underlying conditions. And then we believe that we can apply these biometrics also to contraception, to menopause, to sleep disorders and eventually clinical areas such as the timing of delivery of drug therapies like chemotherapy for maximum effectiveness.

Saul Marquez:
Fascinating. So there’s the chronobiological and the circadian biology tackling both of these things to understand and the core body temp being the core of circadian biology.

Amy Shannon:
So that is the measurement that we can take that is reflecting what is happening. And so by taking that on a continual basis and doing basically we have time analysis on that, we can recognize patterns that are happening in the body. And by applying algorithms to that, we can compare those patterns and give information. For example, we can identify patterns before ovulation to say ovulation will be coming, as opposed to most tools today that actually articulate when ovulation is happened as opposed to being using pre signals to say it’s about to up.

Saul Marquez:
Fascinating. And that’s a key differentiator. Right. So let’s hone in on how what you guys do and how is it different?

Amy Shannon:
Yeah. So broadly, our unique value proposition will be the integration of this real time objective and personal predictive biometric that we just talked about, this continuous core body temperature, and then combining that with an established and engaged community into a platform to empower women to make these decisions. So in addition to that biometric wearable Saul, we have a platform fueled by an app called Kindara in DARS and engaged social learning community. And it’s a data interface for women on their health care journey, where they can track a variety of both objective and subjective metrics that they can use to help them conceive a child or avoid contraception or track health care. And Kindara far has been downloaded about one point six million times and is used daily by about one hundred and fifty thousand women. It’s really a repository for hundreds of millions of points of data that allow us to mine for things like new indications and applications and features on a depersonalised way. And then we can use that data to create more efficient, effective study protocols and then use the symptoms that women track there for differential diagnosis. And so then as we expand our road map for biometric devices using the continuous core body temperature, we’ll simultaneously expand our learning and social community on Kindara so that women have both objective and educational information to support their health journeys.

Saul Marquez:
That’s really interesting. And so there is this whole community social component that already is is one point six million downloads. One hundred fifty thousand women already engaged on it. So it’s something that you guys. I’ve been doing for a while and and what’s the response thus far?

Amy Shannon:
So it’s exciting to see the response there because women are helping women. They’re providing information, they’re posing questions. They’re answering those questions. They’re tracking all kinds of information on there. They can track things like their symptoms, their medicines, their vitamins, their lab tests. And then with the integration of these biometrics, we can provide insights that are necessary for them to answer their own questions about their own bodies and then on a macro basis, to have some data to inform population medicine of it and and so to be part of the community.

Saul Marquez:
Do you need to buy the device to measure your body temperature so you don’t?

Amy Shannon:
Kindera is a standalone app right now and we will be integrating that continuous core body temperature as an element in that. And so you can do either separately. But we believe the ultimate power will be the integration of the correlation of this data.

Saul Marquez:
So that’s where the two pieces come together. Right now. The offerings are our standalone. So so can women choose to to get into the core body temp monitoring platform?

Amy Shannon:
They can. Right now, we’re in a limited market release and just getting market feedback on that Kindara as the standalone app platform where they track everything has been available, as you can see by the the engagement and the numbers. And then, Priya, right now, we’ve we’ve wrapped up a couple of clinical trials. We’ve got a couple going currently, and it is available in limited market release. And women who are interested in participating in that can sign up on the website for that. And then in addition, so we anticipate using that continuous core body temperature device as a wearable in clinical trials to be able to track continuous core body temperature as a primary secondary endpoint for those trials, because that continuous core body temperature is so indicative of a therapeutic response and a number of areas.

Saul Marquez:
Fascinating. And so just to make sure we’re all on the same page, PREA is the measuring device, correct?

Amy Shannon:
Correct.

Saul Marquez:
OK, got it. Got it.

Amy Shannon:
Yeah. Thanks for the clarification.

Amy Shannon:
Yeah. Know for sure. And if you want to learn more about Kindara or or Priya, as Amy mentioned, it’s on limited release, but potentially an opportunity for you to learn more, go to Canara Dotcom. That’s kinda a just a fascinating approach in a very personalised way to address these questions that that you may be having. So so, Amy, let’s spend a little bit of time around some of the results and outcomes. Tell us what you’ve seen thus far. That’s that’s helped improve outcomes or made business better.

Amy Shannon:
Absolutely. So as it relates to our first specific indication of fertility, our clinical study showed that this device, Priya, was able to predict the fertile window two point six days before traditional ovulation kits. So what that does is it opens up a woman’s window to be able to get pregnant. Then from a macro perspective, I kind of pull out and look at the big picture and I think how important it is to impact women through empowering them with information, because right now, so many cases, health and wellness decisions are frequently made in a vacuum. And although that’s getting better, a lot of easily accessible consumer information is reflective of a full population. It’s calculated by a mean of a group of people instead of information that’s very specific and personalized and based on real time data. For example, a lot of times we go to get a diagnostic from our physician and we go to a lab and we get a single point of time when we do get personalized information. And that’s single point of time may not decipher the patterns that are only detectable through continuous measurements. So that is one of the ways that this will make those diagnoses better. And then we’re using those data patterns to inform women of the specifics of their body to enable them to make better decisions as an individual, and then providing that in this context of education and community where they can lean on one another to advance their knowledge and feel supported. Example that we’ve had numerous women report is that after previously having a miscarriage through the tracking of their temperature and this is not even very high fidelity temperature, they’ve identified a drop in their progesterone just days or weeks after conception, and that by taking this information to their doctor, they’ve gotten the treatment that they need to maintain their pregnancy.

Saul Marquez:
Well, this is such a fresh approach to a very it what could be a very frustrating experience for a lot of women and families. And it’s it’s really exciting to see what the promise here is. What would you say, as you guys have gotten to this point, has been one of the biggest setbacks you’ve experienced and a key learning that’s made you guys even better?

Amy Shannon:
Ok, I think right now we’re all living in the middle of this COVID season. That’s the challenge. Just as a company, it’s been challenged as community and I’d almost be remiss by not focusing on that. But for us, it impacted our suppliers and impacted our manufacturing process and our clinical trials and therefore market launch and fundraising timelines. But. I think that the key learning Saul or, maybe it’s just a reminder, is that under pressure is where diamonds are formed and that’s the case both on a macro perspective of what’s going on in just health care, as well as for us, a prima tap. We see that remotely delivered health care is advancing with the support of these digital and data technologies. And Eric, as our Topal says, it’s not necessarily the solution to this current crisis, but it’ll be one of the lasting consequences. So for premortem, we’ve really during this time frame, first of all, we support that shift of telemedicine. But in our process, we first had to move our clinical trials to a virtual format and we were set up to do so. But we needed to do that. And ultimately, in terms of the learnings that came from that, it resulted in faster enrollments and lower costs. So I don’t think we’ll ever go back. We also learned that Priya as the device, we really designed that to help women identify their fertile window. But it quickly became evident in COVID that that digital diagnostic value for women who were struggling to get pregnant could maybe not get to the doctor or in the future or less likely to physically go to a doctor. That was equally important to be able to provide that information. And then lastly, the social aspect of the community and Kindera, where women supported women through their health challenges, has become even more important during social isolation associated with it. So there’s been some really exciting benefits that have come.

Saul Marquez:
That’s fantastic. And yeah, I mean, shifting your clinical trials sounds like you guys were already there, but this was the, I guess, the proving ground where you’re like, wow, we’re definitely going to keep it digital.

Amy Shannon:
Right., Right.. We have the tools to do it. But we were doing it in clinic at the time and so we were positioned to more easily shift than others and got that done literally in a matter of a couple of weeks. And so we did not lose traction in our main trial that we’re going forward with. And like I said, I don’t anticipate in those kind of trials that we can do this remotely. There’s some trials that we’ll need to do in clinic, but a lot of the information will be able to gather digitally, which is just helpful in terms of convenience for women, let alone for the cost for the entire system.

Saul Marquez:
That’s a great callout. So kudos. That’s that’s amazing that you guys were able to to keep doing what you’re doing throughout these tough times. While it slowed things down a bit, the momentum continues. And so what are you most excited about today, Amy?

Amy Shannon:
Well, when I think about the overall health care system, I’m really excited about both the democratization and personalization of health care. So my personal description of democratization of health care is the shift that’s happening from information, knowledge and therefore power going from experts and elites and kind of specialist to people, to patients, to consumers. And just like the shifts we’ve seen in travel and banking and entertainment, we’re seeing this in health care. And that’s really characterized by the availability of data that’s moving from just the experts to day to day users and the ability to play insights at scale, making it possible for one to own one’s own health and wellness and doing that in a really, really personal way. And I know a lot of times I’m asked, well, what does that mean to providers? And I think from a provider perspective, it allows them to focus less on those routine tasks and allow them to focus on those areas where they can provide the most value and the most satisfaction. And then secondly, and tied into that really is the importance of personalization. We’re moving from an approach that treats people based on averages and an entire population of, as we traditionally saw in pharma clinical trials, to assessing and treating individuals based on their own genotype or phenotype and then truly tailoring the approach to their uniqueness, advancing outcomes and minimizing side effects. So that’s what we’re doing. It is we’re providing tools to support both the democratization as well as the personalization of health care.

Saul Marquez:
So. Well, Amy, and that personalization is at the core of Kinara and Apria and the solutions that you guys are doing. So so just the kudos to you and your team for doing this. It’s much needed. I mean, I have friends that have gone through a lot trying to get pregnant, and it’s just hard and it shouldn’t have to be that generalized. And sounds like you guys are targeting something really, really game changing.

Amy Shannon:
Thank you. Yes, it is really hard for those couples psychologically, biologically and economically.

Saul Marquez:
Yeah. And so let’s conclude, I mean, this is just fascinating work, Amy. Give us a closing thought and the best place where the listeners can learn more, get engaged and connect with you.

Amy Shannon:
Ok, well, I think just going back to your first question about why health care, where does your passion come from? I really think that these meaningful clinical and economic outcomes, they will be advanced at that intersection of these disciplines, and that’s going to happen through challenging and constructive dialogue and experimentation. And so I just encourage anybody who’s interested in exploring those things and engaging further in that, especially as it relates to partnering and commercial. To reach out to us, because we’d love to explore those those intersections and to do so, outcome rocket listeners can get a hold of me at my email. A.shannon@prima-temp.com and Prima temp has a dash between Prima and temp. I’m on LinkedIn or you can get a hold of me through a contact page at the prima temp website.

Saul Marquez:
I love it. So folks, they have it many ways to connect and learn more. If anything that we discussed today that that Amy shared inspires you or maybe aligns with a partnership or a commercial strategy. The opportunity is now. And so, Amy, I really want to thank you again for for sharing our with our listeners the inspiration that that is driving your work there and also the uniqueness of the solution that you guys have.

Amy Shannon:
Well, thank you. So thank you for the opportunity to share it.

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