Health Care Advances for Veterans

So, we're going to discuss with Charles how he got into serving veterans, as well as a number of issues that he's learned along the way, and lessons he's learned along the way. Some of them not easy lessons, about how you can actually serve the VA, and serve other veterans. So Ron, I'm going to turn it over to you so we can get started.
ron dreskin: Great. Thank you, David. And thank you, Charles, for participating in this podcast. Our first question for you, Charles, is how did you decide to get involved with your business, and offer services to the VA? And secondly, if you can give our audience a little bit of information about what is indeed genomics?
charles cathlin: Well, first of all, I appreciate the invitation, to join you today. Particularly Dr. Shulkin, who we've been working with for a little bit of time here. Let me start with what our company does. So, we're a genomics company obviously. And what we're trying to do is, we're commercializing a genomic based test to help risk stratify individuals who are at higher risk for posttraumatic stress disorder, and other mental health conditions.

So, I'll start with genomics. Essentially, it's a biology to study gene, essentially is a field of genomics. And if you look at a gene, I compare it almost to Lego building blocks. It's the building blocks to life, and genomics essentially is breaking down that genetic material, so you can research and understand. And actually, putting it back together, so that you can create new breakthrough technologies, whether it's in pharmaceuticals and diagnostics, in different areas like that.

So, it's a very exciting field. It's only been over the last couple decades or so, that we've sequenced the human genome. So with that, my interest in working with the VA, basically stems from the fact that I'm a veteran. I retired in 2018, served 23 years in the service between the Air Force and the US Public Health Service. Been on plenty of deployments, but it was a specific deployment following the 9/11 attacks, I deployed with a medical team, at ground zero. And then, I served as a preventative medicine officer. It was my job to protect my team from the environmental hazards of the site. What struck me, was the mental health ramifications of that incident, and how it impacted the first responders and the community. And as you know, that event kicked off 20 years of war, where PTSD and traumatic brain injury have been signature wounds of those wars. So, it's something that's very important to me.
DS: And Charles, there's no doubt that treating and finding ways to help, particularly veterans with PTSD, is really important. So, thank you for your commitment to that. Now, when you were in serving, particularly in the Air Force, but also in the public health service, what type of work were you doing? And were you involved in working with veterans with traumatic brain injuries and PTSD?
CC:Yeah. So, I'm an engineer. Most of my experiences in biomedical engineering. But my degree is an environmental engineer. I went to the Air Force Academy. So, that's the type of work I did in the Air Force. And essentially, what we would do is, we would walk into hazardous environments, and we would assess those hazards, and how it could impact human health, and design controls in order to mitigate or prevent disease in people.

So, I left that position, transferred to the US Public Health Service, and ended up working at the FDA for a number of years, working in medical devices. I was a chief of neurology devices towards the end of my career at the FDA. And eventually, went back to the Department of Defense, working for the Defense and Veterans Brain Injury Center, which is now called the TBI center of excellence. So, I served as a chief of staff.

So that organization, I was there for about five years. And we essentially ran DOD's. I would say clinical research, around traumatic injury. And you probably know this, but PTSD and traumatic brain injury, they go together quite often. So, that was an experience where we worked very closely with the VA. We had 22 sites around the country, where we were doing TDI clinical research, to include military and VA polytrauma centers.
RD: So, this is Ron again. Hello. What was your experience like the first time you obtained your first VA contract? What was the experience? What was the process? And how do you feel about going through that?
CC: Well, let me clarify. We're still working on that. As Dr. Shulkin mentioned, we were able to establish a collaborative research and development agreement with the VA, right before COVID hit the US fairly hard. So, the VA needed rightfully to prioritize to ensuring that the health of veterans in terms of COVID and impact, was reduced. However, now it appear things are opening back up, in terms of other types of research to include PTSD. And we're exploring a number of opportunities, to work with the VA at this time.

So, we're very excited about 2022, and we're feeling very good about our prospects of working closely with the VA. Now, we are working with DOD, which is very exciting. We just got an SBIR with the Air Force. We are doing some collaborative research with the Army. We're working with the Canadian military. So, we definitely believe the VA is an important piece of that puzzle, and the work that we're doing.
DS: So Charles, first of all, congratulations on that. I think, as you know, the government's filled with acronyms. So, you mentioned CRADA and you mentioned SBIRs. Do you want to just explain a little bit how a small company, a veteran owned small company like yours, can use either an SBIR or CRADA to help it prove its case to the government, and get additional work?
CC:Yeah. Particularly for a startup, these are great opportunities for what we call non diluted funding. As opposed to going out and raising money from an investor, the government has these opportunities for you to essentially, for them to fund some of your research. Particularly if it's an area that they're interested in. As long as what you're doing aligns with the goals of that organization, whether it's the Air Force, or the VA, typically they will open up opportunities for you to apply for SBIRs.

The CRADA, specifically when it comes to the VA, they have a fantastic program, specifically VHA, Veterans Health Administration has a program called the innovation ecosystem, who we had worked with, in order to establish that CRADA. And that organization is designed to bring in new technologies into the VA, from the private sector, particularly working with startups. So, I think these types of programs within the government, in terms of innovation, are tremendous. And it gives companies like ours, an opportunity to work with one of the largest organizations in the world, whether it's DOD or VA.
RD:And reading through some of your information, it seems as talented you are, and experienced as you are, one of the most important skills you bring is patience. Maybe some of your colleagues with small businesses, that are listening to this, perhaps you could give them a little advice about the process.
CC: Oh, absolutely. So, as someone who has been on the other side, worked within the federal government, one of my co-founders, Dr. Tshaka Cunningham, he actually worked for the VA for almost a decade. And it's still not an easy process to navigate. You really have to understand who are the program managers within the VA, who are interested in your technology, interested in your business, and making sure that what you do and what you offer, aligns with their goals.

And one of the things I like to say is that, you are not the hero of the story. So, your technology is not the hero - you're not coming in to save the day. There are a number of people, really sharp, dedicated, passionate people within the VA, for example, who are working in mental health. And what we're trying to do, is help those individuals as best as we can be successful.

And so, many times you're not introducing something that's as foreign or new to the VA. Typically, they have something going on, because it's such a huge organization, that aligns with what you're doing, particularly in our case, mental health. And you just need to find the right people, so that you can serve them and champion their cause. So again, I will say, patience and realizing that you're just there to assist and support. And it's the people who are working in the VA every day to serve veterans, they're the heroes that we're trying to serve.
DS:Charles, I have to agree with Ron, that you are remarkably patient, and you don't sound frustrated. But here you are, working to try to really help your fellow veterans, really supporting the VA. And yet, it's not been easy. So, what keeps you going? Why do you stay so dedicated to this mission, and why do you think the VA needs your help?
CC:This is an important mission. So, whether you're talking about the VA/DOD, and really is, when you look at mental health and PTSD, it's not just a veteran or a military service member issue. It's become, particularly in light of COVID, a global public health issue. And there's a lot more tension that I think that's coming into mental health. And so, what drives me is, first of all, we know there's a huge unmet need in this area. What we're trying to do is provide better tools for the clinician who are on the front lines, trying to treat veterans and individuals, suffering for mental

health conditions.
So, from my perspective, that is a very noble mission of those in the VA working on that mission. And we're here aligned for that same mission. So, my entire career has been around helping service members and veterans, and that's something that I wanted to continue to do after I retired.

So, as far as I'm concerned, it's a privilege for me to be part of this company, to be part of the team that I've built, and for us to be working to move mental health therapy and diagnostics, further. So, that's what keeps me going.
And then, I'll say the last thing. Just in general, me individually, I just like solving difficult problems. So, maybe just the engineer in me. But the bigger the problem, the more interesting it is. And maybe I'm a little bit bullheaded. I will keep working on something until I get a breakthrough.
RD:Well Charles, so we're just about out of time. I think your comments and your journey is inspiring, but also educational and informative to your colleagues out there, again, looking to break into assisting the VA, and through contract generation. David, any last thoughts before we complete our podcast?
DS:Yeah, Charles, I do want you to try to answer the question. Why is it important that you be successful? In other words, if you are able to find a test that can identify patients who have PTSD, or are at risk for having PTSD, why will that make a difference to veterans?
CC: Absolutely. First of all, whenever I answer this question, you have to also keep in mind that there's a lot of smart people who have been working on different types of solutions, for years. Particularly when it comes to reducing suicide rates in veterans, decreasing the negative outcomes related to mental health. And unfortunately, we have a healthcare system where we many times wait for the patient to fall off the cliff, and then you have the ambulance at the bottom of the cliff waiting to help. Sometimes you have a hearse, unfortunately, and sometimes there's a police car at the bottom of that cliff.

And the technology that we're developing, we believe is going to be important with putting up some warning signs and guardrails at the top of that cliff. So, you can assist with early therapy, early intervention, to make sure that veteran doesn't fall off that cliff. And as they're going down to cliff, they're dealing with alcoholism, substance abuse disorder, broken relationships. And unfortunately at times, it's suicide. So, it's very important that we get technologies out there, so that we can start changing the direction of the trend and the curve, when it comes to conditions like PTSD and suicide. So, that's what we're striving for.
DS:Great. Charles, what I love about you, and what I love about veterans, is that even after you've served, you continue to want to help, and to continue to serve. So, you have our admiration, and thank you for joining us on the EisnerAmper podcast today.