When it comes to medical innovation, children’s healthcare can fall between the cracks. From medical devices to pharmaceuticals, the research and regulatory frameworks skew toward adults. That forces pediatric specialists to do some retrofitting. Children’s National Hospital in Washington, D.C., is on a course to change that. The health system is embarking on a new research and innovation center on 12 acres that once housed Walter Reed Army Medical Center. Johnson & Johnson in early 2019 announced its innovation hub, JLABS, will be taking space there and in November, Virginia Tech committed to opening a biomedical research facility on the campus. The idea is to accelerate both the development and adoption of pediatric-specific innovations. Children’s National President and CEO Dr. Kurt Newman, who has held the post since 2011, talked with Modern Healthcare Managing Editor Matthew Weinstock about goals for the Children’s National Research & Innovation Campus. The following is an edited transcript.
MH: What barriers does children’s healthcare face in terms of innovation?
Newman: Most of the devices and medications were designed for, tested and regulated in relation to adult medicine. As a surgeon, I felt this most acutely when we were trying to use devices. They were always something that had been approved for adults and then we’d try to modify it. In many cases, you’d have to miniaturize it or do something else to make it work in children. You weren’t creating devices with the size of a child in mind or the behavior and development, or the types of diseases specific to children.
MH: What’s an example?
Newman: Equipment to do minimally invasive surgery. It took a long time to move from using big devices on babies that were really too large and didn’t allow you to have the kinds of visualization or to do the kinds of operations that babies need because you were using a technology devised for adults.
MH: Because of that, have there been limitations or impact on quality and services delivered in pediatric settings?
Newman: Yes. I think the medical community has been very creative and innovative to try and figure out workarounds, but it was always trying to retrofit things—pacemakers, for example. They could be quite large. The batteries are large. If you try and use the pacemakers that are designed for adults in a baby, it might require an open operation versus an operation where you’re just putting something in a subcutaneous space. Our cardiologists are working very hard now to refine a tiny device with a small battery, but that’s not approved yet.
The good news is the Food and Drug Administration has recognized this. They’ve created a number of consortiums around the country. We happen to be part of one around pediatric device innovation with the University of Maryland, where we have a grant in concert with the university’s School of Engineering.
This is not just for Children’s National, but for researchers across the board.
More than 60 medical-device startups have received mentorship support to help them advance. Five of the devices have received different regulatory approvals and Children’s National spun out about 20 startup companies. I think things are changing and the FDA has gotten behind the idea that we need to look at children differently.
Another thing that held back the field in the pharmaceutical area is that things had to be tested in adults at first. The problem with that is the diseases in children are frequently very different. The dosing is different. There are so many things that are different that the desire to take on the pediatric applications or pediatric diseases was slow.
There’s a lot of healthcare policy now looking at that issue and trying to accelerate discovery and investment in drug development for pediatric diseases. There’s been some spectacular successes in the last few years.
MH: How are the 20 startups you’ve spun off doing?
Newman: There’s a lot of great ideas out there, and they get the intellectual property protected based on preliminary research and then the question is, are they going to be commercially sustainable?
The 20 startups are in different points of evolution. We have two that are breaking even, with the potential of a big success. There are two more that are going to do really well. And then we’ve got about 10 or 12 that are on the borderline. You just never quite know.
But one of the other benefits of being involved with it is that you attract top talent. And that talent translates into clinical growth and into education and into patient care. It’s an important part of our culture, our strategic plan and our identity.
MH: Looking at the startups that are doing well, how do you decide when it is time to bring something to market?
Newman: One is a company that has a very innovative drug that was originally developed to care for children with muscular dystrophy. The idea is that it has very positive therapeutic effects, like steroids without necessarily the complications of steroids. That’s in the testing phase now and in human trials. But it takes years of testing to make sure a drug like that is safe and is better than the current treatment. One of the challenges to pediatrics is that it’s small populations so you need to work with a lot of other centers.
Another one that is not that far along is a device one of our doctors has been working on to create an objective measurement of pain in babies and using the pupillary response— the responses in the eye to painful stimuli. The holy grail there is that instead of using smiley faces on a chart, which babies can’t use but children can, you’d have an objective measurement to know whether your treatments are working or not, whether you need to increase or decrease medications. In some cases, we’ve learned that the medications we thought we were using in babies to help pain were actually making them more sensitive to pain.
And back to where we started, if you can do that in children because you were forced into the innovation, just think about the application to adults. You’d have the ability to measure pain objectively and you might be able to avoid a lot of the issues we’ve had with pain management.
MH: How does the innovation campus you’re working on fit into this strategy?
Newman: With the growth and success we’ve had on our main hospital campus, where we have the Sheikh Zayed Institute for Pediatric Surgical Innovation, which is looking into device development like we were talking about, we had the idea that we should create a whole new campus where companies could be located alongside our research and it would be totally focused on children. As we did a scan around the country, there are a lot of innovation districts and centers and hubs and accelerators, but there wasn’t one that was focused on pediatrics and children. We coupled that with this opportunity as the Walter Reed Army Medical Center was being closed by the government as part of the base closing commission, to get some of the historic land and buildings that had always been used for military research and was very close to our hospital.
Importantly, it was also close to the National Institutes of Health and it’s also close to the FDA. We believe that by having our own research there alongside others and partners that are focused on pediatric innovation, whether it’s device development or drug development, that we will create something very unique that will have a lot of impact in these fields. We’re under construction, but the early proof of this is that Johnson & Johnson and their JLABS, which is the part of the company that focuses on innovation, has decided to occupy a large amount of space.
They’ll be hosting 20 to 30 startup companies that they’ve curated from around the world that are focused on pediatric research and innovation.
Another proof of the concept is that the Fralin Biomedical Research Institute at Virginia Tech will be our academic partner on the campus. They will bring their brain tumor research group to work alongside our pediatric brain tumor research group to move that field forward. You can just imagine if somebody comes up with a discovery in these research institutes and then wants to create a company and commercialize it, they’ve got the JLABS right there. We feel that we can really shorten the timeline of moving things to market.
MH: How are you funding this initially and how will you sustain it over time?
Newman: The first phase of the build-out is in the range of $200 million. That’s being funded in a number of ways—operating funds from Children’s National that our board has made an investment in. One of the buildings will be a clinical building to bring pediatric care to the part of the District of Columbia that’s never had that before. The district itself is putting in some funding around infrastructure, because they see the economic development opportunity of having this campus. The campus sits within a larger parcel of land that is being developed in terms of mixed use so people will be able to live there, walk to work, play. We’ve gotten some major philanthropy to support the effort.
Sustainability is an excellent point, because we have big plans for phase two—an expansion of the research, which will hopefully come from some of the returns from the investments and the companies, and maybe new partners will want to come and make investments.
