Solution Medical's Pre-Filled Syringe and Auto-Injector Development Journey

Elisabeth Cuneo: Okay, thank you Julia, for joining me today. This is Julia Anthony, Founder and Chief Strategy Officer at Solution Medical. Why don't you tell us a little bit about yourself and the company?

Julia Anthony: Sure thing. So thanks for the opportunity to be here. As you mentioned, I'm the Founder and CSO at Solution. But first and foremost, I'm a rare disease patient living at risk of what's called an adrenal crisis. Essentially, instead of fight or flight, when the body experiences stress, you start to systemically shut down and head towards shock. And you need a lifesaving injection that takes about 14 steps to prepare and inject right now, because it needs to be mixed right before it's injected for shelf-life purposes.

So, I decided to found Solution Medical first as a device company, but we've actually transitioned into a pharmaceutical and combination product company, to make it easier to deliver this lifesaving medication that I need, as well as others at risk for this condition. 

Elisabeth Cuneo: Wow. Thank you, that's awesome. I know that you're speaking in a panel discussion next month at Interphex, on the topic of drug device combination products for subcutaneous self-administration. And according to that panel description online, it's really about mitigating risk in combination product development. I know you specifically and your team will be highlighting the TwistJECT pre-filled syringe and auto-injector. So, why don't you tell us a little bit about what that is and how it solves that 14-step kind of problem? 

Julia Anthony: Sure. So, I guess just to quickly touch again on why I wanted to found a solution, you know, as a patient historically, my family and I were actually told that the people who make the medication for what I have do it as a courtesy for people like me. They don't really make money off that product, or at least they didn't when I was told that. That's pretty messed up, to think that I should feel like I'm a problem, or not really worthwhile to even have medicine made to save my life. It’s a pretty frustrating thing to hear, and kind of hear repeatedly as I grew up.

So that's why I decided to make what is, along with the rest of my team, a dual-chamber pre-filled syringe. It's a pre-filled with sterile water for injection as well as medication in the form of a powder, that can be mixed, not in 14 steps, but three steps, I believe for our pre-filled syringe and one to two steps for our auto-injector, to make it easier for people to not just have medication accessible, but able to bring it around with them as well. Just because it's made doesn't mean it's easy for patients to take up and use in their daily life, so we didn't want to just make a better way to deliver it, but also a better way to carry it on your person and just provide you confidence and reassurance, during your daily life. 

Elisabeth Cuneo: Yeah. So, I guess, backing up a tad, what is your background that, you know, you are a patient, but I mean, I could have a disease and I'm probably not creating a pharmaceutical product to help myself. So, you must have some background in this.

Julia Anthony: My undergraduate degrees were in healthcare and nutrition, definitely not in medical devices. I decided after working in the personal training space for a little while in the healthcare space, that that wasn't quite enough for me and I wanted to turn my personal circumstances into an opportunity to learn and also help people.

So, I got an industrial design master's degree focusing on medical device design. And from there, I quickly realized what I learned in the classroom was a very, very, very small snippet of what I was going to need to figure out how to do to make this successful.

So, it's really been our team of experts that we've been growing over the past five and a half, six years, that's allowed us to be where we are today. It has taken a village to get to where we are, for sure. 

Elisabeth Cuneo: Yeah, I guess so. Your company's been around five or six years then? 

Julia Anthony: Yep, we founded in 2019, right before covid.

Elisabeth Cuneo: Oh, sure. So, I was going to ask you about the main drivers for the development of the device, but obviously you have a personal story, that I'm assuming is the main driver. But also I'm sure, just to help others who are in your situation, was there any other kind of driver for the development, or inspiration?

Julia Anthony: That's the main inspiration. Quite frankly, if I had known how complicated and hard this was going to be, with as much passion and grit as I do have, I don't know if I would've embarked on this journey. In hindsight, I'm very glad that I have, and I'm happy to say that we continue to progress our programs forward and we are what I would call successful to date. But definitely, there are challenges in trying to combine a device and a drug and bring them together in a reliable way, in a scalable way, at all, let alone. So it's been a journey for sure. 

Elisabeth Cuneo: Sure. So, what are the steps you took to determine what type of delivery system is best for this type of drug? 

Julia Anthony: We did a full landscape analysis, our small team back in the day, and quickly realized that even though some company’s website might say they have something available that's developed and off the shelf, “off the shelf” means a lot of different things when you start to actually get into the nitty gritty details of a specific use case. And we weren't able to find a product that existed that could work for our indication.

So that's when we set out as a team to actually make our own device. And then we realized that an empty device can only take you so far; you have to have a drug inside to have it be useful. Turns out, filling drug into containers is not an easy thing, especially if it's a custom container, which is what we have. All of this has been learned by me through a fire hose on the fly, but that's where a lot of my team members have experience in different areas in helping to do this.

So, we looked at the landscape, we couldn't find anything. If we were going to work with a partner – and finding one that would work with us at the time was pretty difficult – it was still gonna be very expensive and time consuming, so we decided to do it ourselves. 

Elisabeth Cuneo: Wow. So, what major challenges does the patient population have and how does the device help solve for those challenges? 

Julia Anthony: So, when you're having one of these emergencies called an adrenal crisis, you're physically and cognitively heading south and deteriorating. You're shaking, you're vomiting, this is if you haven't already passed out. There's a lot of disorientation. So, to do fine motor skills of mixing medication when you're in one of these emergencies is very hard to do. It's also hard for caregivers to remember how to do the 14 steps when there's stress going on.

One thing our CEO likes to say is, “everything is going fine until you're punched in the face,” which I think is also a Mike Tyson quote. But even if you're trained, it’s hard to remember to do all of those steps when someone's dying in front of you.

So, what we wanted to do was to have fewer steps to prepare the medication and then create devices that are easily operable regardless of maybe your dexterity with your hands, or even your eyesight.

People who have these events are typically on corticosteroids for very long periods of time, which can have an impact on bone density as well as eyesight and other things. So, we wanted to focus on the usability of the product, and make sure that we reduced the number of steps with how the medication was presented to the user.

And then the third thing is making sure they could be easily carried on the person or with the person, which is what we're mainly focused on right now, at least on the human factor side of things.

I talk to patients all the time. They say, “Oh yeah, I went out and I left my kit at home.” And it's like, well, why did you leave your kit at home? That's not going to help you if you have an emergency. And a lot of times it's because they're embarrassed to carry it, or they know that it will get taken away from them. Going into a concert with powder and needles doesn't typically go over so well. So, we want to also address the psychosocial aspects of having conditions and needing to carry an injector with you with our designs. 

Elisabeth Cuneo: Sure. It sounds like taking away the 14 steps to now just a couple, it’s pretty easy to use, I'm assuming like a twist and shake with your product. I mean, that has to be pretty life changing. Are there other products like yours or other devices on the market, or do you think people are either doing the 14 steps, or they've discovered Solution Medical? Maybe that's hard to answer. 

Julia Anthony: So, for the indication we're working with adrenal crisis, we are familiar with, some competitors that are looking at creating a different type of drug altogether. So, they're not innovating… well, one of them is also innovating the delivery device, but they're focused more on the changing the drug route, rather than the packaging or the delivery system.

We decided as a company that having reconstitution, there's a lot of benefits for mixing the drug at the point of care: shelf life and stability, as well as the bioavailability of the drug and, and other things. So rather than make an entirely new drug, we wanted to package the drug in a more user-friendly way. Different strategies to go about solving the same problem. So that's the route that we took.

There are other devices that mix things, but they're all little different and they're all, I don't want to say half-baked in a bad way. They're all baked to different degrees. So, you know, some might be further along in development than than others, but none at the point where we thought and still think pursuing those options would be better than what we've already made ourselves. 

Elisabeth Cuneo: Okay. That's great. You mentioned earlier, working with partners to get this project off the ground. Are you able to talk about any of those partners, and what that looks like as you, as you work to develop this?

Julia Anthony: A little bit. I can't say specific names. I know a lot of them will be at Interphex coming up as well as DCAT, which is actually happening between now and Interphex, also in Manhattan.

There's the drug, there's the device, there's putting them together, and I really think it's important to have collaboration. From what I've heard from the industry, you know, I went to POD last year and there was a whole topic on dual-chamber devices that mix things up at the point of care and how that technology will be very up-and-coming for a lot of medicines. And they said in that panel that collaboration among these different groups is kind of a newer accepted thing. Everyone knew that it had to happen, but that actually happening is sort of a newer, occurrence. So the collaboration among us and people and groups all around the world has allowed us to get to where we we are today. 

I like to say nothing is someone else's problem. That's something at Solution Medical that we really like to focus on and help each other with. I've been to drug companies before where I've said, what about the route of administration or the viscosity of the drug? Won't that affect the patient in X, Y, or Z way? And I've heard, “Oh, we've never thought about that before, because once we make it, we just ship it to the next location and that's their problem to figure out.” We don't want that to be the standard within Solution Medical. We're all trying to keep in mind the patient and the end-user throughout the whole process. 

Elisabeth Cuneo: Sure. So when solving pre know for that user experience, do you end up doing like some simulated trials with people or focus groups, or like research and testing? Does that play a hand in that? 

Julia Anthony: Yep, you have to do human factors testing, formative as well as summative, for FDA approval. One thing we've done at Solution, which I'm really excited about, is we work now with, I guess 20 organizations around the world, we're up to. So we have access to key opinion leaders and medical directors, but also humans besides myself, because my opinion is not the only one we should be going off of, to get real-world and real-time feedback on what we're doing. So that can be in a very small setting and very informal, and then also in the more formal setting as well. 

Elisabeth Cuneo: Sure. That's great. Well, thank you for this discussion today. Super enlightening. I’m very impressed by what you're doing and so thank you for joining me.

Julia Anthony: Thanks for the opportunity and see at Interphex. 

Elisabeth Cuneo: All right.