Editor’s Note:The following represents an edited transcript of a panel discussion during BIO 2019.
"Does anybody remember a story this past December where the Apple Watch was credited with saving a man’s life?” I ask the audience seeking a show of hands. It’s Thursday, June 6, 2019, at the BIO International Convention And Conference, and I’m moderating an education session, “Realizing the Promise of Innovative Digital Health Solutions: A Path Toward Treating the Whole Patient.” Panel participants include Chandra Ramanathan, Ph.D., VP and head, East Coast Innovation Center, Bayer; Herb Ryan, cofounder and CEO, Bitome; and Kerry Willis, Ph.D., CSO, National Kidney Foundation (NKF).
Not seeing every hand go up, I provide a brief overview of a 46-year old healthy and active male. A gadget lover with an Apple Watch, this man downloaded an ECG app that can tell him if he’s having atrial fibrillation (AFib), which can lead to blood clots, strokes, and heart attacks. Of course, he wants to try it and is surprised when it tells him he’s having AFib. Thinking there must have been a glitch, he tries it again on his left wrist, turning it to the inside this time. He then proceeds to test it on the anterior and posterior of his right wrist, all returning the same result — AFib. So, he went to the hospital, where they determined he was having AFib, and he credits this tool with saving his life.
This story was shared to get people thinking about the true potential of digital health. Why? Because while the tool in the example provided useful information, it was the patient taking appropriate action that made it a real lifesaver. Can you envision such a device someday automatically notifying a nearby hospital, and the patient perhaps receiving a telemedicine call from a cardiologist to determine next steps? But realizing such potential (albeit comforting for some and invasive to others) has a number of hurdles.
WHAT IS NECESSARY TO REALIZE DIGITAL HEALTH AS A SOLUTION?
The number-one challenge digital health can help solve is awareness. There are 37 million adults in the United States who have chronic kidney disease; yet, only 10 percent know they have it. Those who don’t know they have it typically have other conditions, mainly diabetes and high blood pressure. If a digital health tool could cue the patient by saying, “Hey, you might have kidney disease; have you been tested?” that one simple question could produce a revolution. Then, once diagnosed, a digital solution could be with a patient 24/7, a prospect I find very exciting. That’s because a patient with a chronic disease may only see their doctor once or twice a year, which can make it challenging to best manage care. But having a tool that can remind a patient with a chronic disease of all the things they need to do for better self-management could be highly beneficial. Kidney disease is a war of attrition, and how you fight it is — every day, a little bit at a time.
WHY DID YOU DECIDE TO CREATE A DIGITAL HEALTH SOLUTION COMPANY?
In 2015, I was working in industry, building tools as an engineer/scientist. During a dinner gathering, I met a nephrologist, and we got to talking about the tools that she used in her work. During that conversation, it became very clear that when it came to doing something like a simple hydration assessment, the current state of the art in 2019 is the same as it was in 1819 — physical assessment. Not to attack doctors, but there’s a lot of variability in determining a patient’s fluid volume status, and that can lead to a lot of variability in the patient’s assessment, diagnosis, and treatment. In modern day, we want to apply data and be data-driven in our decision making. Those were the catalysts for starting Bitome. So, great, we’ve identified a problem. What do you do next? You find some cofounders, you get a scientific advisory board (SAB), and then you need some investment. On the investment side, back then (which continues today), there is a trend of fewer dollars being available for early-stage companies like Bitome. So, we started looking at alternative investment pathways (e.g., government grants, university grants, and venture philanthropy), including nondilutive equity partnering. In those camps, for us, there were maybe three players, traditional med device (i.e., Boston Scientific), original biopharma and medical device equipment parts manufacturers, and Big Pharma. We found pharma to be the most attractive, as there was real synergy between what we both were after — better outcomes. We partnered with Bayer, which was facilitated through the Massachusetts Biotechnology Council (MassBio).
HOW DOES A COMPANY THE SIZE OF BAYER PARTNER WITH SMALL STARTUPS LIKE BITOME OR PATIENT ADVOCACY ORGS LIKE THE NKF?
Bayer’s ultimate goal is bringing innovative options to patients. Traditionally, when we worked with patient advocacy organizations like NKF, we focused on disease awareness and disease management. But we need to pivot to work with them even earlier so they can assist with development of patient-centric clinical trial designs. Together, we can make sure that what patients want is mirrored in the trial criteria, and their requirements are appropriately reflected in the biopharma research. Better alignment between patient need and scientific development is ultimately needed for success.
Regarding working with startups, Bayer tries to do a lot in the areas of mentoring. For example, Bayer works with MassBio via its MassCONNECT program. This is an eight-week program where industry experts guide entrepreneurs as they seek to develop business plans, launch companies, and raise capital, thereby accelerating their growth. At Bayer we exthought, why stop at eight weeks? What if we take it from eight weeks to six months? We started working with Biotome on this leading to a longer fellowship to help get the company up and going. Bayer also has a program called G4A (www.g4a.health). Present in 35 countries, G4A is a global team designed to enable positive disruption by entrepreneurs in the digital healthcare industry. We have “CoLaborator” lab space in San Francisco, Germany, Japan, and Moscow, where we can incubate startups, provide workspace, and give guidance.
WHAT WERE SOME CONCERNS IN PARTNERING WITH A BIG PHARMA?
One of the reasons we thought partnering with biopharmas to be a good fit is we saw less conflict with IP. In the case of Bayer, the company had divested from the med device industry and isn’t looking to get back in, so we were not worried about IP theft. And the benefits are pretty incredible, as we now have access to Bayer’s 120,000+ employee network, and we get to be on the ground floor with their early development experts and hear their passion and excitement about our technology. My advice for the founder of a startup company that has identified a problem in need of solving is find your customers, and then find your champions to serve as members of your scientific advisory board or even as company cofounders. These will be the people who will guide your company to have the appropriate mindset (i.e., helping) necessary to succeed in the healthcare community.
Working with Bitome required a bit of a cultural shift for Bayer, too. One thing we made very clear is that our interactions need to be nonconfidential, so the partnership is transparent, and both companies feel perfectly safe. In addition, during our six-month partnership, we don’t want Herb Ryan and Bitome off working in a corner with no further contact, but instead, they should be engaging with as many Bayer people as possible. That’s part of our mandate. Anytime a member of senior Bayer management comes to Boston to visit our East Coast innovation center, we let Bitome know so they can plan their schedules and have an opportunity to engage with them. I believe Herb [Ryan] has already met about 150 people from Bayer. And while that is beneficial for Bitome, it also benefits our employees, as they get to speak with someone focusing on just one idea that might be translatable to other maladies beyond kidney disease (e.g., heart failure).
WHAT HAS BEEN YOUR EXPERIENCE WITH BUSINESSES WANTING TO DEVELOP SOLUTIONS FOR PATIENTS?
There is no specific treatment yet for the 37 million people with chronic kidney disease. As such, we are very closely aligned with the pharmaceutical industry as we want the same things (i.e., new and better treatments for these patients). When we first started talking to Bayer many years ago, they had a program of blood pressure medications, which were basically the only existing kidney disease medicines. But then we lost touch, until we found out they were doing a trial in diabetic kidney disease. For many years, NKF had a vision of establishing the first national chronic kidney disease patient registry, but we had never been able to raise the funds to make it happen. Turns out Bayer had been thinking about starting a similar type of registry. This provided for strong synergy. NKF has the ability to touch patients and properly encourage them to share health information they are comfortable with sharing in a way biopharmaceutical companies will likely never achieve. This is because patients, in general, are a little leery of drug companies. As a nonprofit, we have limited resources, while Bayer on the other hand, has significant resources that would allow us to build a very sophisticated platform. As kidney disease is asymptomatic (except in its very late stages), our platform needs to interface with patients at-risk to educate and collect patient-reported outcomes, while at the same time, we need to be able to draw health information directly from a patient’s EHR. This will be the first time in kidney disease research where we will have the ability to look at the patient’s experience across all the stages of the disease, including kidney failure, dialysis, and transplantation.
WHAT MIGHT THOSE NOT FOCUSED ON KIDNEY DISEASE TAKE AWAY FROM THE COLLABORATION BETWEEN BAYER, BITOME, AND NKF?
There needs to be a mechanism for interaction between different stakeholders (e.g., biopharma, healthcare industry startups, patient advocacy), which in our case was MassBio, as they helped connect us to Bitome. Our approach was to develop a fellowship for Bitome to facilitate the collaboration. The company assisting a startup should be able to give the startup what they want beyond money, such as expertise in areas they might be lacking, but needing. For ex-ample, Bayer has a lengthy legacy (i.e., >100 years) in the cardiovascular (CV) space, with lots of internal experts. Startups in the CV space wanting to partner with Bayer should want to leverage that CV expertise. For Bitome, the benefit of this expertise was noted by Kerry Willis earlier, when she noted drugs often used for kidney disease have indications for CV disease, so we have synergy. But the built company, which in this case is Bayer, also needs to make sure they can devote the time necessary, up front, to operate in a mentoring role to the startup.
WHAT SURPRISED YOU ABOUT PARTNERING WITH BAYER?
Bitome essentially had a blank slate when starting with Bayer, meaning the company was willing to provide us with whatever we needed. For example, we made a wish list, and on it were 20 bullet points of everything we wanted, from clinical support to investment. To Bayer’s credit, they said, “Let’s do it.”
Let me add that the goal with the fellowship we did with MassBio and Bitome is simple — a pure mentorship type of partnership. We asked Herb Ryan where he saw Bitome in six months, which prompted him to create a wish list, which we executed on. In addition, he has had the opportunity to meet with different parts of the Bayer team. Our goal is to do what can be done to ensure Bitome gets to its desired goal in the six-month fellowship time frame.
KERRY WILLIS, DID YOU GET A CHANCE TO MAKE A WISH LIST?
No, but if I could envision the digital health tool that would most impact kidney disease, it would be one that would help patients understand their disease. Because of its chronic and asymptomatic nature, even when patients are told that they have chronic kidney disease (CKD), it can take them years to understand they have a progressive condition. A lot of patients interpret CKD as they have weak kidneys. Such a mindset completely negates any motivation to take their medication, follow a diet, and all the stuff they need to do to prevent advanced kidney disease. A digital health tool for CKD should be able to present CKD educational information in little snippets. Kidney disease is a laboratory diagnosis, so a CKD digital health tool should know what the patient’s condition is, be able to slowly bring the patient into appreciating what advanced CKD could mean for their quality of life, and how best to avoid that. Getting back to the whole self-health management, as a patient advocacy organization, we would love to see a tool that lets patients track, in real time, things like blood pressure and blood sugar, because a doctor can tell you a thousand times that exercise is going to lower your blood pressure and that eating too much salt is going to raise your blood pressure. But when you can see it happen in real time, it can be very motivating for patients. In other words, I think a CKD digital health tool should give patients a holistic view of their condition, and how best to manage it, with real-time data for patients to monitor progress.
Would You Believe You Can Measure Fluid Volume Noninvasively?
Being a small company, perhaps you aren’t aware of what Bitome does. “We make a noninvasive fluid volume assessment device, so we can measure intervascular and interstitial volumes independently,” says Herb Ryan in response to a question posed from a member of the audience during an educational panel session at BIO 2019 in Philadelphia. As an at-home tool, it means one device per patient. “What’s really powerful about it,” he continues, “from a new sensing modality, is we actually come at it from the instrumentation world of nuclear magnetic resonance, which is a parent technology of MRI. So essentially, our little at-home device is a miniaturized MRI and, rather than making images, we are essentially just detecting the volume status inside the patient noninvasively.” That’s pretty new science. While the company is currently focused on chronic kidney disease (CKD), Ryan admits Bitome is still trying to figure out which therapeutic areas would be most appropriate for the company’s device, but certainly it has to be wherever fluid volume management is the name of the game.