The Importance of Cervical Cancer Screening in the U.S.

Announcer : Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Etienne Nichols: Hey everyone, welcome back. My name is Etienne Nichols and I'm the host of today's episode. In today's bonus episode, we speak with Chris Beddard on a product she and her team have been working on at BD to improve the lives of women everywhere. Chris is the vice president of US marketing at BD, and she is passionate about bringing awareness around the options women have in regards to owning their health. So without further ado, I hope you enjoy this episode with Chris Beddard on Women's Health. Hey everyone. Welcome back to the Global Medical Device Podcast. This is Etienne Nichols, your host of today's show. Today with me is Chris Beddard. I should have practiced your last name. Apologies. Chris, Did I get it right?

Chris Beddard: Beddard. But it's fine.

Etienne Nichols: Okay, Glad to have you with us on the show. Chris is from BD and they have developed an assay specifically for screening for cervical cancer. So I don't know if you want to tell us a little bit about yourself and what you have going on over at BD?

Chris Beddard: Yeah, sure. So thanks for the opportunity. We have a portfolio of products that are focused on women's health, from tests or assays as we call them, that provide detailed information to clinicians to better treat and manage patients, as well as a suite of instruments that focus on the automation for the laboratory and improving efficiency. I think what we've gone through over the last three years with Covid certainly has changed our world in many ways and in the diagnostic world we don't see internally to the laboratory staffing. So automation and opportunities to standardize that type of process is critical. As well as we saw a huge drop off in women going for screening for cervical cancer and maybe even for other conditions as the world was somewhat on lockdown, if you will. So we do have some new tests, new assays that we believe are differentiated as it relates to providing the right information for clinicians.

Etienne Nichols: Okay, and one of the things I'm curious about with a big company like yours, how is it you go about choosing those specific treatments to target? So obviously, oh, this one's for cervical cancer. How do you go about some of those decisions that you make?

Chris Beddard: Yeah, I mean it starts very early on in our research development, our medical affairs, our scientific affairs team. We obviously attend many different educational conferences, speaking with industry leading key opinion leaders, looking at new technologies constantly. That's part of our organization, that's what they're tasked with. When we believe there is a need, there's a need in the market, there's a need in medicine to improve the diagnostics specifically, we employ or bring together a team to, I guess, for lack of a better word, vet the opportunity, vet the solution that we believe we have, and then move forward in a project that is governed by a cross- functional team, including research development. Again, our regulatory teams, quality teams as well as our medical affairs, scientific affairs, but really marketing as well. So we understand the opportunity, the value it has in the market, the problem that it solves in the market, and what we believe the investment obviously would mean to the organization as we bring it to market. I would say that in my experience, there's great ideas that are out there and part of a company, I would say one of the hallmarks of BD is really collecting those insights along the process or the project plan, if you will, and making the right decisions along the way. Including not moving forward. So that's oftentimes one of the hardest decisions you have to make, but you really have to make sure that the product you're bringing to market indeed solves a problem that we have in either the US region or globally, and most importantly for patients. So hopefully that answers your question, but I would say it's a very rigorous process, and again, hopefully results in a product that is a high value for customers and patients alike. But oftentimes again, if we don't feel it's ready or we don't feel it's going to serve that need, then we have to make some tough decisions along the way. And I'm sure every organization most likely goes through a similar process.

Etienne Nichols: Our audience, it spans from small startups to large companies. I've worked in both myself. It's interesting to see the differences as they go through those decisions. So thank you for sharing that. That makes a lot of sense. One thing that you mentioned, so you have this assay or the test and the assay. What makes this a little bit different or special in this case?

Chris Beddard: So the test is called BD on clarity HPV assay. And what makes it unique, it's really the only FDA approved assay with extended genotyping. Extended genotyping provides different information or information that's critical to a clinician to basically manage a woman's risk for developing cervical cancer or pre- cancer, if you will. So specifically we have 14 high risk genotypes that have been identified, or utilized in most HPV assays, BD on clarity individually reports six of those genotypes and then groups, the remaining genotypes in categories that assign to the risk they provide in developing pre- cancer or cancer of the cervix. So, that's the uniqueness that the assay has today. We have an FDA approved assay utilizing our shore path LBC, which is the collection, and we also have, outside the United States, other collection types of material as well as something called home self collection, and that's been CE marked in Europe. So very exciting, especially to access more women that need to be screened, but again, providing more information to clinicians to better treat those patients.

Etienne Nichols: Yeah, that's very cool. My wife's actually a critical care nurse, so we spent some time in Malawi, Africa, and she actually was on TV for talking about cervical screening there in Malawi, so it's something she cares a lot about. Is definitely something that the world needs a little bit more of, so that's really great.

Chris Beddard: For sure.

Etienne Nichols: Yeah, go ahead. I don't know if you had something to add there.

Chris Beddard: I was just going to say we have an arm of the organization that looks at the global health need and is very focused on women in Africa and providing this type of test that again provides more information to clinicians. One thing that we found, if I may just continue with that.

Etienne Nichols: Please go.

Chris Beddard: Routinely, there's genotypes, and I don't want to get too technical. There's genotype 16, 18, and 45 that have been recognized as potentially high risk for the pre- cancer or cancer, but there's also an HPV 31 that this assay is the only assay that individually reports HPV 31, and we know that women are at actually more higher risk for developing that pre- cancer or cancer based on this genotype. So there's a different pathway potentially for clinical management and it's something very serious. And we were very, very focused specifically in the US, in making sure that clinicians and also women are aware that this type of information is available utilizing the BD on clarity, HPV assay.

Etienne Nichols: That's cool. I appreciate all the work you're doing in that realm then. That's cool. Okay, so if we go back to the development of the assay, a couple things people care about when we are talking about the development process, obviously length of time, cost. I don't know how much detail you could give there. But whatever detail you can, it'd be interesting to know. Just a company such as BD, how you approach those things, what the outcome is, but also what kind of challenges you might have faced. So I don't mean to throw too many questions at you at once, but can you speak to some of those things?

Chris Beddard: I probably would be best providing you with a link to our website that actually walks through our FDA clinical trial and provides a lot of great information. I will say that this assay has approval for the three testing paradigms that are utilized in the US and even globally. They would be cytology or primary cytology screening co- testing, which uses cytology and also HPV molecular testing, and then HPV primary screening. And in order to get all three testing paradigms approved via the FDA, there was an extensive clinical trial that did take place. Again, spanning many years because we had a look at women that were testing positive for HPV, the genotype, and then the eventual outcome as it relates to developing pre- cancer or cancer. But again, I'll provide the link to the website that will really walk your viewers through some very, I guess, critical information as it relates to the clinical trial.

Etienne Nichols: Okay, cool. Yeah, we'll put the link in the show notes then. So maybe we could talk a little bit more about why this is important. I mean, you mentioned what it does and some of the things and how it works. Maybe we can talk a little bit about why a screening like this is so important?

Chris Beddard: So I think maybe it's important for the viewers to know that HPV is the most common sexually transmitted infection in the United States. So it's estimated that over 79 million Americans are infected with HPV. And it's not to scare people. It's really to say that it's very common STI, if you will. But in most cases it goes away on its own and it doesn't carry health problems. But if it does not go away, it can lead to other problems such as genital warts or cancer. So again, it's important for women specifically to be screened on a routine basis, because cervical cancer, when identified or HPV, when we identified early enough in screening, we're able to treat the disease accordingly and really eliminate that potential for women to have obviously negative impact for developing cancer or cervical cancer. Right now, the CDC does estimate that there's over or nearly 200,000 women that are diagnosed with a cervical pre- cancer. 11, 000 are diagnosed with cervical cancer due to an HPV infection, and unfortunately approximately 4, 000 women will die. So it's really important to understand that these are preventable deaths. These are women that if they're screened routinely and accurately, if you will, can eliminate this from being the result of a HPV type infection.

Etienne Nichols: So with those kind of numbers, I'm curious what you may have mentioned already the impact a little bit earlier of the pandemic, but what do you think that ongoing that has been?

Chris Beddard: So I think we're seeing women, and this is on a global basis, not just in the US obviously. We're seeing women returning to testing. Again, our view of healthcare changing based on the pandemic. So we know that even beyond this discussion, people are looking at digital consult with clinicians and things like that. So I think even in the world of routine screening, women are looking for alternatives as it relates to access to healthcare. So I think the pandemic obviously a huge problem issue across the board has really, I think as on a personal level, has forced people to think differently about healthcare. And I think in that way, organizations like BD and other companies are thinking a little bit differently about how we provide those needed tests or diagnostics to our customers as well. So that's on a high level basis. Again, I think women are going back to being tested, and I know that there's a lot of patient advocacy groups that are asking, women are reminding women that it's important and even beyond women also for men to be screened for other types of cancer. But we really need to get back to that routine type screening because it's critical as it relates to the healthcare of our society. So again, I think we're in a better spot than we were, but we're not finished yet. For sure.

Etienne Nichols: And maybe this is my ignorance of your particular assay. How does it work as far as in the clinic or at home? I assume this is in the clinic.

Chris Beddard: Right. So a woman would go to her primary care physician or ob gyn for an annual test or a visit, if you will. And based on various guidelines that clinicians are following, there'll be screen on an interval. Today, the American Cancer Society, if using primary HPV screening, recommends a five year type interval for screening. But there's other, again, testing paradigms that are different. So the sample will be collected and then sent to a laboratory for testing, and then the result would be provided back to the clinician. Generally, it really depends on the laboratory, but generally within 24 to sometimes 48, 72 hours, and then certainly based on a negative result, that result will be provided to the patient and then certainly for a positive result, additional discussion will happen between the patient and the clinician. Again, this is where extended genotyping comes in, where having that level of detail provides the clinician more information to make the right decisions. We like to say more information equals more precise care, and that's really what it's all about in the world of cervical cancer screening.

Etienne Nichols: That I like that saying. That's really good. Okay. So when you talk about maybe the total life cycle of this assay, so you mentioned a several year clinical trial, I'm sure there's lots of other different things that you face throughout the development of this specific screening test. What advice do you have for medical device professionals who may be in maybe a similar situation or maybe developing something with the goal of improving the quality of life? What advice can you give those people?

Chris Beddard: So I think maybe it goes back to my initial comments where you have an idea at the time of the development, it's very forward thinking, but you need to be honest with yourself as you go through the development process and as the market changes. Again, that's number one. I think the insights specifically for this type of testing are aligned with what we call market shape in marketing. So making sure that the policy and the reimbursement is aligned with the value that your product is offering. Again, in the US specifically, there's multiple organizations that make recommendations for screening. So making sure that those organizations are aware of your product and the value that it brings to patients and obviously the clinicians in healthcare systems, but also making sure that in our healthcare system, reimbursement for outpatient is something that we need to be aware of and make sure that those organizations, third party payers, Medicare, Medicaid, are also aware and are able to reimburse for tests. So I think it's along the lines of making sure your product is addressing a clear customer patient market need, and then you have the commercialization that supports the awareness in the market and the enablement of clinicians and patients to use your test. So not using fancy words like market shaping, your market will need to be ready to receive your solution, and all of your regional commercialization teams will also need to be ready. So it's a combination of the right product at the right time with the right team aligned to be able to provide that product in the market. So again, it's a very cross- functional type thought process, and it's all about making sure that your company and your market is ready for your solution.

Etienne Nichols: Yeah, that makes sense. And when I think about market shaping, obviously we just mentioned the pandemic. If I go back to what you said at the very beginning, that opened a lot of doors for a lot of companies to maybe make COVID test or things, but it probably closed some doors too for somebody making an accessory for an optional surgery, those were closed for a little while. So understanding and being willing to say no to your point earlier as far as closing down a project is pretty critical if we're not usually willing to do that. That's a great point.

Chris Beddard: I think people have passion about what they do, and it's very hard to say, Okay, your baby's ugly, right? It's very hard to put that spin on it, but you really have to be honest because the investment that so many companies make in product development, if you're not able to deliver on that investment, it's certainly not optimal for the organization. And again, I think the pandemic taught us a lot. We came to market with BD, specifically with multiple COVID tests in record time. But again, I think hopefully we never have to go through that again. But I think it also taught us a process that maybe we can accelerate development in certain instances when it's required. So that was a good outcome, if you will, from COVID, but certainly there was more bad than good. That goes without saying for sure.

Etienne Nichols: Yeah. You mentioned the reimbursement side. I think there's a lot of companies too that expect to be acquired prior to manufacturers, so they may not think with the whole picture in mind, but that's certainly a good piece of advice as well. Definitely a good takeaway. Yeah. Yep. Great. So I guess maybe let's talk about where people can find you and any closing thoughts you might have?

Chris Beddard: No, for sure. I really appreciate the opportunity, and again, I believe that the focus that BD's had on women's health, especially around cervical cancer screening and also Vaginitis, is very unique in the marketplace. I'm really proud to be a part of the organization. I'll send another link to our website for the US that is very much focused on women's health and provides a great deal of information. And I can be found, I can send my information as well through the chat. But again, it's a great opportunity to change or to say, shape the future of women's health with some of these innovative tools that we have, and not to forget our laboratory partners to make it more efficient and easy for them to bring on new innovation. And that completes that circle from the patient through the laboratory and providing those right results.

Etienne Nichols: Absolutely. All right. We'll put those links in the show notes for those of you have been listening. Thank you so much, Chris. I really appreciate all the work you're doing and all the work BD has done already and is continuing to do so. Very much appreciated. Thank you so much. Those of you have been listening, you've been listened to the Global Medical Device podcast, and we'll see you next time. Thanks.

Chris Beddard: Thank you. Bye.

Etienne Nichols: Thank you so much for listening. You can learn more about what we do if you head over to www. greenlight. guru. Also, check out the community and the academy that we're building where you can join the conversation or learn more about the things we discuss on the podcast. You can find those at community. greenlight. guru academy. greenlight.gu. Also, I'd love to hear from you via email, etienne. nichols @ greenlight. guru, or look me up on LinkedIn as well. I'd love to hear what your thoughts are on the show. If you enjoyed this show, please consider leaving us a review on iTunes. So thanks again. Y'all are the best. Until next time.