PODCAST: The Bio Report: Bringing the Trial to the Patient

Daniel Levine:

I’m Daniel Levine and this is the Bio Report.

Daniel Levine:

One of the challenges to securing the participation of patients in clinical trials can be simple geography. Sanguine Biosciences is seeking to tear down that barrier to participation by using mobile technology to bring clinical trials to patients. The company recently partnered with Vir Biotechnology to complete a COVID-19 clinical study aimed at better understanding the biology of the disease by sending healthcare personnel to collect blood samples from patients at their homes.

Daniel Levine:

We spoke to Brian Neman, co-founder and CEO of Sanguine, about its use of digital health technologies, how the company works, and its recent collaboration with Vir Biotechnology around COVID-19.

Daniel Levine:

Brian, thanks for joining us.

Brian Neman:

Thanks so much, Danny, appreciate you having me on the show.

Daniel Levine:

We’re going to talk about Sanguine Biosciences, how the COVID-19 pandemic is affecting clinical trials and your efforts to help gather samples from patients in their homes to support one COVID-19-related study. For people not familiar with Sanguine though, how do you describe what the company does? What’s the problem it’s trying to address?

Brian Neman:

Yeah, so, happy to share more about Sanguine, and to give you a sense, I started the company about 10 years ago, and the problem that inspired me to start the company is that I found that patients have had trouble participating in research studies and I found that researchers had problems identifying patient data, of course anonymized, and identifying patients to participate in medical research in various different forms. I looked into the issue and I found that there was a decreased level of transparency, a decreased level of convenience, communication and impact for the patients. And because of that, that increased timelines and it delayed significant research from being performed.

Brian Neman:

And so, I started Sanguine with the idea that if we work directly with patients, that if we made it easier for them to participate, to provide transparency and communication throughout the process, that we would in fact accelerate research timelines.

Brian Neman:

So what we have today, Sanguine is a platform where patients can come on board, provide their data and participate easily, from the comfort of their own home, to accelerate research for their condition. Of course in the past, we’ve built a patient community of over 30,000 individuals, ranging across autoimmune conditions, lupus, Crohn’s, colitis, sickle cell disease, what have you, and now, we are now focused in putting 100% of our efforts behind identifying individuals who have recovered from COVID. And with that, we have also developed a platform of home visits where patients can participate from the comfort of their own home, have their blood drawn and delivered anonymously to researchers that are developing drugs and treatment for COVID.

Brian Neman:

So, the best way to look at our company is that we have a engaged community of over 30,000 patients, as well as their medical information, as well as a services platform where they can participate from the comfort of their own home.

Daniel Levine:

How big a challenge does patient enrollment today from a point of view of having a successful clinical trial?

Brian Neman:

So enrollment is certainly an issue and it’s an issue across the different diseases. In this day and age, I think that enrollment is going to be an issue, and in this day and age of COVID, that enrollment’s going to be an issue, but also retention because patients can’t leave their home unless it’s for a necessary or important medical treatment. And so, by allowing for blood draws to take place in the comfort of the patients’ homes who are self-quarantine or self-isolated, we’re enabling research to go on.

Brian Neman:

And that’s how we’re helping out in the COVID-19 pandemic, is that we’re working directly with individuals while they’re at home. We’re sending nurses to the home to collect blood samples and delivering it directly to researchers to create antibodies or identify antibodies that can act as a vaccine or a as a treatment.

Daniel Levine:

Before we speak specifically about what you’re doing in the COVID-19 crisis, I want to get a broader sense of how Sanguine works. What’s the trial match? How does that work?

Brian Neman:

Yeah, absolutely. So if I’m an individual diagnosed with lupus, chances are that I have followed or I’ve liked or I am participating or engaging with an entity, whether it’s a Facebook page or a group or a discussion board. And Sanguine advertises its patient community advantages on those mediums, individuals sign up by going to our website, they provide a questionnaire, their health diagnosis, comorbidities, and other medications they’re taking.

Brian Neman:

So once they sign up, we will call them. So our team of study coordinators will call each individual patient and discuss with them what the study is about after having reviewed their information. And then, if there’s a study that they may be interested in, Sanguine will request the individual’s medical records, and then we will review the medical records ourselves and then call the patient when there is a study that matches to them.

Brian Neman:

And so, trial match is really a concierge research service for consumers. As opposed to going through clinicaltrials.gov and getting lost, we actually focus on making it easier for them to navigate the process as their concierge service that calls them anytime there’s a project that may fit their condition and the inclusion/exclusion criteria. So we take a lot of the legwork out of searching for a trial that may be a fit for you.

Daniel Levine:

And what data on patients do you gather? Who controls that data and how do you leverage it?

Brian Neman:

Yeah. So individuals provide us with their physician’s information, including their physician’s address. We engage their physician in the normal way, email, phone, fax, and we retrieved medical records from either the site or the medical center or a third party provider that manages the medical record system. So we retrieve that, we bring it in house, review those records, and then from there, we will match the patient up with the right study.

Brian Neman:

But we also have recently won a grant by the National Science Foundation to create a tool which we’re calling the patient search tool, where companies can come in, search for patients in their community, in a community of their choice. Say I’m a lupus researcher looking for samples from patients diagnosed with lupus or just lupus patients, I could search based on comorbidity, drug treatment history, age, gender, ethnicity, and other different data types, and once I identify the patient I want, then I can select them to enroll into the study.

Brian Neman:

So the purpose of providing your data to us is that we will enable an exchange to happen between the researchers and the patients who are searching for individuals through our platform.

Daniel Levine:

And does a patient have to sign off on any individual release of the data or are they giving you a blanket release to do that?

Brian Neman:

Yeah, that’s a great question. So to participate in each study, they have to sign an informed consent form, but in order to provide us with their data, they just need to sign a medical record authorization form.

Daniel Levine:

How do you work with patient organizations?

Brian Neman:

So patient advocacy groups. So we have over 50 plus patient… I’m going to start over. We have over 50 plus relationships with patient advocacy groups, such as the Sickle Cell Disease Foundation, Vasculitis Foundation, Rheumatoid Patient Foundation and several others. They engage with us by helping promote the word about our trial match tools, as well as sponsoring different methods and modes of communication and patient advocacy to learn about research and how they can help contribute to accelerating research for their condition.

Daniel Levine:

One of the issues that also acts as an impediment to recruiting and retaining patients can be the trial designs and the demands trial protocols make on patients. This can be particularly true in cases of rare disease therapies where patient populations may be geographically dispersed-

Brian Neman:

Oh sure.

Daniel Levine:

And travel to [crosstalk 00:11:04] trial sites can be [inaudible 00:11:04]. What does Sanguine do to address those types of challenges?

Brian Neman:

Yeah, that reminds me of a study we did a several years ago with Pfizer where they were, and they still are, studying and developing a drug for patients diagnosed with Duchenne muscular dystrophy. And what we did there was we set up a mobile phlebotomy force all across where those medical centers are.

Brian Neman:

So in this particular study, in this clinical trial, which was a phase two for Duchenne muscular dystrophy, the average patient is pediatric, so we’re talking 10, 11, 12 and even earlier than that. And these individuals are having trouble walking, they’re wheelchair bound, and for the most part, we’re working directly with their caregivers, which are their patients or grandparents, what have you.

Brian Neman:

Now, once we engage those individuals, the likelihood that they’re going to have to travel to the sites is about, I’d say about 20 to 30 times throughout the course of the trial. Now, if we can cut that even 10%, that would decrease the burden on many families. And these trials have very tight windows to understand drug treatment and the effects on the blood and different biomarkers to determine specific endpoints for the trial. And so, if they can’t make it to the site in time, these home visits are enabling the patients to stay within window of the study and avoid a dropout and ultimately increase retention.

Brian Neman:

So pediatrics, we’ve had a lot of experience, as well as those individuals that are wheelchair bound or immobilized.

Daniel Levine:

The COVID-19 pandemic is disrupting all aspects of daily life. It’s having direct impact on the ability of companies to recruit for and conduct clinical trials, and for investigators to perform research. How disruptive has this been and what are you hearing from trial sponsors and researchers?

Brian Neman:

Yeah, so the trial sponsors and researchers, I’m hearing that they’re concerned that their trials are really just going to halt. Because of the quarantine and self-isolation, it’s not conducive to the current clinical trial methods, which are, hey, for even a simple blood draw, you have to go to the medical centers.

Brian Neman:

So we have been receiving calls and emails and other forms of communication from all of the large sponsors, including all the large pharmaceutical companies, asking for help for continuation of their studies, and mainly, it’s focused on decreasing burden and expectation for the patients having to come in.

Daniel Levine:

One of the things you’re doing is working with Vir Biotechnology, a company focused on infectious disease that’s turned its attention to COVID-19. What’s that collaboration? What’s your role with them?

Brian Neman:

Absolutely. So our role with Vir is the same as it is with other companies, which is patient engagement and ultimately decreasing the burden of participation. So in that sense, we are engaging them online and we’re engaging them over the phone, we’re walking them through an online informed consent form. Once they’ve signed that, we’ll schedule an appointment for a blood draw. So we’re handling the logistics regarding supplies and materials and the home visits and the blood draws, the shipment back to the researchers, and the entire supply chain from there. So it’s the patient engagement all the way to the end result, which is sample at home.

Daniel Levine:

And how would you say technology is more broadly changing the way clinical trials are conducted today?

Brian Neman:

Yeah. So I think that a big innovation just in the past year or 10 years since I started the company, I have felt that the biggest innovation was online informed consent. So I thought that that was quite speedy and that really engaged individuals. Enrolling patients online, so at least engaging them and increasing number of potential participants, so increasing your pool.

Brian Neman:

I also saw an increase in home visits, and so the ability to schedule and maintain a large workforce using mobile applications, I mean, you see it today in Uber and Lyft and Postmates and different applications like that, those organizations that develop technology to manage their forces, and so we’re using similar technologies internally.

Brian Neman:

So I’d say that social media, informed consent, marketing technologies as well as logistics platforms. And soon, it’s going to be medical informatics as the Apple HealthKit allows for downloading and sharing of individuals’ medical records. That is going to be the next boom to increase the capacity for, I’d say other mobile applications or any like diagnostics to be done because your information is now available for share in the world, it’s not just going to be locked up in your Epic system.

Daniel Levine:

How responsive do you find regulators, investigators, or drug developers to embrace this technology?

Brian Neman:

I think that the pharmaceutical industry and the FDA just in general, historically, has been more risk-averse and their entire mantra has risk mitigation, and for good reason, right? I mean, if you look back in the 70s when penicillin was being manufactured and it was a somewhat of a wild wild west, since then, it’s been much more conservative and the level of regulatory burden on the companies has increased, and rightfully so because these medications are potentially dangerous.

Brian Neman:

We’ve seen over the past almost decade now that the number of approvals has increased significantly, which is fantastic. I’m really happy about that. I think that Scott Gottlieb, over the past few years, has done a fantastic job of increasing technology or oversight as it relates to mobile applications, medical informatics, and kind of patient-led medicine. And so I think that that’s been the trend over the past few years, which is now turning the tide.

Brian Neman:

Now, today, when you look at home visits in clinical trials, up until today, it’s been looked at as a risk, right? Because in this scenario, sure, you’re increasing savings or decreasing costs because we don’t have physicians or real estate, brick and mortar location involved because this is all mobile, directly to homes, so that was looked at as, okay, sure, there’s a financial savings or a financial benefit, but we’re not really sure from a regulatory or a medical standpoint what the opportunity is. Now, when the risk within the medical center or the brick and mortar locations has increased, now the risk mitigation strategy is doing these home visits.

Brian Neman:

So home visits and telemedicine in general has shifted from high risk to now it is the risk mitigation strategy that people look to.

Daniel Levine:

Do you see the COVID-19 outbreak accelerating not only the change in the use of this technology to bring the trial to the patient as it were, but is this going to have a longer term impact on the way we conduct clinical trials?

Brian Neman:

Yes, I think so because I think it’s going to change perceptions. What you’re talking about is the catalyst that gets them there. Unfortunately, we’re in this position where we can’t have individuals coming and burdening or increasing the strain on medical centers because they’re focused on treating active patients with COVID-19, so a simple blood draw doesn’t make sense, it’s just going to increase stress on the system. I think that now that we’ve seen how beneficial it can be, and unfortunately the [inaudible 00:19:47] is this pandemic is the catalyst, but we’re here to help and we’ll do everything we can. But I think that home visits are here to stay.

Daniel Levine:

Brian Neman, CEO and co-founder of Sanguine Biosciences. Brian, thanks so much for your time today.

Brian Neman:

Appreciate it, Danny.

Daniel Levine:

Thanks for listening. The Bio Report is a production of the Levine Media Group. To automatically download this podcast each week, subscribe to our RSS feed or through iTunes or other podcast manager. To join our mailing list, go to levinemediagroup.com. We’d love to hear from you. If you want to drop us a line or are interested in sponsoring this podcast, send an email to . Special thanks to [inaudible 00:20:37] Levine who composed our theme music, and the [inaudible 00:20:40] Levine Collective, which performs it.