By Mr. Jeffrey M Soares and Ms. Ashley Force (Army Medicine)March 4, 2019
The mission of the U.S. Army Medical Materiel Development Activity's Neurotrauma and Psychological Health Project Management Office is to rapidly develop and field, across the continuum of care, U.S. Food and Drug Administration-approved medical solutions that aid in the detection, protection, prevention and treatment of neurotrauma and psychological health conditions, such as traumatic brain injury, post-traumatic stress disorder, and suicide. The NPH PMO currently supports the development of biomarkers for TBI, non-invasive assessment devices for TBI, clinical drugs and therapies to treat TBI, and novel markers and treatments for PTSD and other psychological health conditions.
Most recently, the NPH PMO, in conjunction with its commercial partner, received FDA approval to market the first-ever blood test, the Banyan BTI (Brain Trauma Indicator), used for the evaluation of instances of mild TBI. This revolutionary product/device will help to eliminate unnecessary computed tomography scans and potentially harmful radiation exposure, as well as the associated risks and costs of the procedure.
In this final installment of our spotlight series, USAMMDA's public affairs team met with Army Lt. Col. Kara Schmid, NPH PMO project manager, to discuss the current and future efforts of her team. Schmid has been with USAMMDA since 2015, and has been working on brain injury products since 2006. Her deep grasp of the field has been instrumental in the advancement of products in the NPH PMO portfolio, which has helped to advance the USAMMDA mission of developing and delivering important medical capabilities to protect, treat and sustain the health of our nation's Warfighters.
PAO: Please describe the mission of the NPH PMO.
KS: Our mission is to rapidly develop and field U.S. FDA-approved medical solutions across the continuum of care, that aid in the detection, protection, prevention and treatment of neurotrauma and psychological health solutions, such as TBI and PTSD. Our team focuses on providing effective medical solutions for brain injuries and conditions such as PTSD and suicide.
PAO: What are some types of brain-related injuries that the NPH PMO investigates?
KS: Warfighters sustain brain injuries in the garrison environment and in the deployed environment. So, in a deployed setting, they can get a brain injury from an improvised explosive device going off, hitting their vehicle; they can get a brain injury from being shot in the head, if their helmet doesn't work to protect them. They can also get an injury in the deployed environment from training exercises.
They can also get brain injuries from car accidents, and from "goofing off," unfortunately. We all like to have fun, so sometimes our sporting events can cause brain injuries. On the garrison side, there are many types of training accidents that can cause brain injuries, like sporting events, and the occasional issues that come on the weekends (perhaps alcohol-related), where someone may get into a car accident. So, brain injury is really not specific to being deployed.
PAO: What about psychological health issues?
KS: Those tend to happen more frequently in the deployed environment. As you can imagine, our Warfighters are asked to do something that no wants else wants to do -- they're asked to potentially injure other human beings, and that can be psychologically devastating. It's a high operational tempo, and so the brain deals with those unique situations, when you're in the deployed environment, by compensating and allowing Warfighters to do their mission. The psychological reactions you have in your brain during that time are actually healthy and necessary. However, this becomes an issue when the Warfighter returns to the United States, back home, and it's still happening. Your brain hasn't "shut off," and returned to normal mode, and you continue to be hyper-aroused -- hyper-aware of everything and hyper-vigilant.
If you spend time in an environment where you're under fire, and you're constantly engaged in combat, then you can develop a constant fear of explosives going off. For instance, in combat, vehicles are often used by the enemy as explosive devices. If that's something you're exposed to for a year while you're deployed, and you've been constantly watching for vehicles or dangerous-looking persons that could have placed a suspicious package somewhere, this remains in your mind. So, imagine that Warfighter coming back home, trying to reintegrate into a normal home life, and they have to go into the parking lot of a store where there may be a hundred vehicles -- this could be something that triggers an overwhelming level of distress, a stress signal in the brain. Then you could have a difficult situation where no actual danger exists. So, it can create an environment where you're just continuously re-living the psychological trauma you went through in combat.
PAO: Can everyday tasks then become more difficult?
KS: They can be, but not for everyone. And this is something that we're trying to figure out. Why are some people able to turn off the response while others cannot? That's one of the PTSD problems that we're trying to research and solve.
PAO: What are some other psychological health issues you're working on, and how does the NPH PMO fit into solving these for the Warfighter?
KS: Well, it's a bit difficult, because we're looking at brain injury, which is a physical injury to the brain, and psychological health trauma, which still may be a "physical" thing that's occurring in the brain, but not as easy to detect. The problem with the brain is that it's very unique -- it's in charge of everything the body does, and it's made up of lots of different cell types. In comparison, the liver is made up of liver cells, which all pretty much do the same thing, but the brain is composed of many different types of cells, all of which have many different jobs and functions. So, in some injuries of the brain, for example a gunshot wound, this would leave tissue damage that is visible and can be treated with surgery. But the psychological injuries are much harder to see.
I believe within the total spectrum of brain injury and psychological health problems, we're trying to figure out the whole gamut of treating these issues so we can help our Warfighters. We are looking to identify the injury when it happens, or as quickly as it becomes a problem, and find out how to diagnose it as soon as possible. On the battlefield, we're trying to provide solutions for triage -- when there are numerous injuries, how can we determine who needs to be treated first? Sometimes, brain injuries can be more silent, so if someone experiences an IED explosion inside a vehicle, they can have multiple injuries -- they can be bleeding from a limb, or have a head injury and be unconscious. And it's difficult to tell if they have an internal head injury if it's a closed-head situation, so the medic may just focus on the bleeding limb, not knowing the patient also has a head injury. We're trying to provide effective medical solutions for those medical providers in the field. How can they identify and triage those patients, and get them to more definitive care? And then on the back end, how do we help them to restore function if function is lost? As you can see, the NPH PMO is responsible for providing medical solutions across the entire spectrum of brain injury and psychological health.
PAO: Can you talk more about the types of injuries you see on both sides of brain trauma, the physical and psychological aspects?
KS: Well, on the physical brain injury side, these types of wounds can cause significant problems for the patient. One issue is, if someone experiences a brain injury on the more "mild" side, like a concussion, there is a window of time during which if they are not given treatment or rest, and they go back out and experience a second concussion, then the injury can be more devastating, and this could compound the results of the first concussion. When it comes to more significant brain injuries, the brain controls everything in the body, so the Warfighter could have considerable loss of function that impairs readiness and the ability to go back out and fight.
On the psychological health side, these types of problems have been around for many years, and they have been called different things at different times. When a Soldier starts to experience these problems on the battlefield, however, the goal is to treat them as far forward as possible -- to get the person help in dealing with what we call "combat stress." We try to help them immediately, to keep them deployed and able to fight. But when these Soldiers come back home, in "Reset" mode, having these psychological health concerns affects their ability to do their jobs overall. They could experience lack of sleep, nightmares, things that keep them awake, headaches, which impacts their ability to function properly.
PAO: Can you describe your personal involvement with brain injury research over the past decade?
KS: I've had the opportunity to be involved with TBI products from all different aspects. On the science and technology research side, from a portfolio aspect, to the lab side working at the Walter Reed Army Institute of Research, and now on the product development side -- so I've been able to see it from all different angles. To see the LATBI project go from an idea that two researchers had, which was, can we create an assay to detect brain injury like we can for some of the cancer diagnostics, and go through animal research to see if these proteins exist -- then take that through clinical trials in humans to validate it, and then go to biotech device companies to create actual solutions and products that the Warfighters can use. It's been a tremendous effort from all aspects of our higher headquarters, the U.S. Army Medical Research and Materiel Command, in working together to get that over the goal line. I believe that developing a product takes significant time and money, and the Department of Defense has done a tremendous job in the use of its time and money to see the product through to completion in the last 18 years.
And when we did identify a product, we then worked to identify what we already had fielded, so we didn't have to field an entirely new capability. With a pre-existing product, we tried to see how we could modify that to include our brain injury assay. That was a unique opportunity to work with some of the large pharmaceutical companies, to put the assay on something that we already were using in the deployed environment.
PAO: What sets the NPH PMO apart from other PMOs within USAMMDA?
KS: As I mentioned earlier, I believe the brain is the most important organ we have, because it's responsible for everything. The NPH PMO is looking at ways to protect, treat and restore brain function as a whole. So, it's the "brain health" PMO of USAMMDA. Also, because we are a small PMO, we have a smaller number of large programs, and our goal is really to get solutions fielded to the Warfighter.
One of our programs, the Laboratory Assay for Traumatic Brain Injury, is the first blood test for detecting brain injury. To me, that's very exciting for the NPH PMO to be involved in the first-ever development of a solution. It's also exciting in the area of brain health. A great deal of research funding has been focused in this area over the past decade, and I think over the next decade, we'll see solutions coming from this field. I really think it's going to be an exciting time for the NPH PMO over the next ten years, to discover what those solutions may be.
PAO: Can you tell us about some other recent success stories?
KS: We just started two new efforts regarding drug treatments for both brain injury and psychological health, PTSD specifically. The exciting thing about these projects are that they are group-type awards, where we're really trying to make a difference. I think the topic of drug treatments has been a difficult one for both areas, and we're trying to find ways to improve what we call the "Phase 2 clinical trial time." We hoping to really understand the mechanisms of drug action and getting the data necessary to move a product into Phase 3. Both efforts are large and inter-governmental, with private industry, academia and the government working together.
Both are large Private--Public Partnerships, and the goal is to find ways to get drugs, that we think will be successful, into the Phase 3 world. So many drugs have been failing to show promise in their final clinical trial, which means that a lot of money has been invested in something that did not work in the end. Our goal is to form successful partnerships, so we can start to enhance the quality of the Phase 2 trial portion. I think that the small companies can benefit from this, because many companies have stepped back from PTSD and brain injury research in the last 20 years due to poor return on investment, as the drugs have not been working effectively for quite a while. We are working with small biotech companies lately, and often these are funded with venture capital, so they need to see things work quickly in order to push the projects into later stages of development. They take more risks in the early development phase, and move on to large clinical trials more quickly. With the help of the NPH PMO, and the funding of the DOD behind it, we can help to do what is necessary in the Phase 2 period, to de-risk the program going into Phase 3. We can really answer the questions necessary to design a Phase 3 trial that we believe will work.
And both groups are pursuing the adaptive clinical trial design, which is a new effort that the FDA supports. It involves how clinical trials are designed, and the statistical evaluation. Although both projects are going to employ these new methods, they have just gotten started, so it will be a few years before we really see how it will impact the field. But it's very exciting!
PAO: What would you say is exciting about the NPH PMO?
KS: I think just being involved on the product development side is exciting for a scientist. I'm a scientist, and most of the PMO is comprised of various types of scientists. There are different tracts in the sciences, and some of these involve working in the basic discovery area, which is exciting because you're constantly getting new data, and updating and revising, and making new hypotheses. However, you tend to feel far removed from a product that is being used by someone to save a life. So, on the product development side, it's very exciting that we are so close to the product that's being used, and we can really see the impact of the work that we put into something.
When we provide program management, we are really focused on schedule and performance of our product. We work in collaboration with other groups, and our goal is to get the best product out there as quickly as possible, to solve a problem. That can also be exciting, to actually encourage people to help produce a product that Warfighters can use. We're really close to our Warfighters, and know what they want, and we help to provide them with effective solutions.
PAO: What does it mean for you to be a part of the NPH PMO, with regard to product impact?
KS: My responsibly as the project manager is to make sure that all of the product managers can do their jobs effectively, and get things done. Although I may be the one in charge, I see it as a position of service, to help them do their jobs well. The product managers are really the ones who work with the companies, develop the timelines, and brief products to senior leaders to get the approval to move the products through development. They're the ones doing all of the work; as the project manager, you really just try to make their lives easier, to make sure they can do their important tasks. I really enjoy helping to make sure the job gets done.
Now, on the acquisition side of things, it's really exciting to be involved in problem-solving, such as, what are some of the steps we need to take, and what are some of the risks we're willing to accept to get the solution out there? We know what the end goal is, but sometimes you must deliver capabilities one piece at a time so you can get to that end goal. And our job is to figure out how we can get the 80 percent solution to the requestor while we're still working on the 100 percent solution. But often, 80 percent is better than nothing, if they have nothing to use to treat patients.
PAO: Do you have any final thoughts?
KS: As a product manager in the DOD, the use of government funds and congressional funds is regulated by the Federal Acquisition Regulation guidelines, and so we must know what all the rules are, and how we can use these to get a product developed. Often, people believe that if a product is FDA approved, we can automatically use it with everyone, but that's not the case. Our job here at USAMMDA, and in the NPH PMO, is to make sure all of the pieces are in line. Not only are we to produce the product and get it ready for use, but we also have to understand the training that goes along with the product, the cybersecurity issues, how will we field the product, who will get it first, what medical personnel will use it -- and we have to understand all of this in the deployed setting. And we don't necessarily have all of the power supply in the deployed setting as we have here in the U.S.; we don't always have access to the same quality of water you may have in a government research facility. So there are many logistical considerations that we must work through with all of our counterparts to ensure that a product we're making is going to be something that the requestor wants and can use, and that it won't impact the logistical considerations for our deployed environment. These are very specific things to consider, and so I think that we are uniquely poised here at USAMMDA and USAMRMC, to understand all of the difficulties that go into fielding a product for our Warfighters.