Drug Device Availability, Sustainability, and Integrity with Windgap Medical's Aaron Mann

CEO Aaron Mann of multi-platform drug delivery company Windgap Medical joins Supplier Horizons host Tom von Gunden to discuss drivers of innovation in injectable delivery. Expanding patient access to new and emerging therapies, reducing costs, and bolstering sustainability are among the topics covered in a conversation focused on benefits to patients.

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Episode Transcript

Tom von Gunden, Chief Editor, Drug Delivery Leader:

Welcome to Supplier Horizons, the series that provides insights and updates on innovation for the drug delivery industry. My name is Tom von Gunden, Chief Editor and Community Director at information exchange Drug Delivery Leader. Today I am joined by Aaron Mann, CEO of multi-platform drug delivery company Windgap Medical.

Welcome, Aaron.

Aaron Mann, CEO, Windgap Medical:

Thanks, Tom. It's great to be here. I appreciate the invitation and look forward to the conversation today.

So, let's just dive right into it, Aaron. So as CEO of a multi-platform drug delivery company, what do you see as the greatest drivers of, or opportunities for, innovation in drug delivery?

Mann: It's a great question, Tom. One of the things that I've come to appreciate over my tenure in this industry, across a number of organizations, is how imperative it is to keep the patient central to our focus.

And so, when I think about what we are faced with at Windgap and in the industry today, I really see three primary opportunities. The first is around access. We continue to see innovative therapies come to market, solving problems, curing diseases that we thought previously couldn't be cured. How do we make those accessible in terms of both availability and reach, reaching patients all around the globe who need and would benefit from these therapies?

The second is cost pressures. The healthcare systems all around the globe, whether it's here in the U.S., in Europe or elsewhere, are facing increased cost pressures. So, how do we see that as an opportunity to use innovation to bend that curve?

And then the third, I think, is somewhat new relative to the other two, and that's the theme of sustainability. How do we keep in mind and think about the impact that our industry has on the world around us, even as we are working to bring life-sustaining, life-improving, lifesaving therapies to patients globally?

So, of those areas that you identified, Aaron, how do you see priority or urgency around any of them? In other words, why these, and why now?

Mann: It's a great question. I think one of the really attractive features of working in this industry is we get to work on these incredibly high-impact, high-urgency challenges that are facing all of us. And so, I think each of them actually is high priority. And maybe I'll just share a couple comments on each as to why I see that way.

First, on access: I think availability is more important today and we better understand how important it is than we did, for example, before Covid 19. And we all felt the pains of supply chains. We also hear about shortages in drugs. We see new therapies coming online that are remarkable, and, at the same time, [we] read about shortages. There have been shortages in the oncology space, off and on, for the last few years. We see new drugs coming that tackle the global obesity pandemic, and [we] hear, in the same breath, about shortages that are likely to run for a couple of years as the makers of those therapies scale up.

And I think it's only going to become more and more challenging as we look into complications of the geopolitical climate, and how people think about tariffs and trade barriers and what should be nearshored or onshored or offshored.

On cost pressures, that's really never ending for the healthcare system. And when you think about populations aging here in the Western parts of the world, when you think about rising middle classes and economic growth in what we traditionally talk about as the developing economies, more and more people want to and have a right to consume healthcare.

And that just means we spend more. And those cost pressures stress the system. How do we move from where we are today to a place where people have access to the safest medications and therapies in the lowest possible cost setting, without ever compromising safety for the patient?

And then the third one that I mentioned, sustainability. I do think we see efforts growing in that space, as we are increasingly aware that [the] actions we take, [the] businesses we run, have impacts that spread beyond the four walls of our offices, of our manufacturing plants, and even of our countries.

How do we think about the contributions we, as an industry, make to landfills, perhaps, or impact climate change? And really just starting to have that conversation as an industry about how we can do that. And I think it's because patients are interested in it, are demanding it. And I think as an industry, we recognize that it's an opportunity to further innovate.

So, Aaron, how is your organization partnering with others in the industry to drive innovation?

It's a great question, Tom. I think this is an industry, probably more than any other, that requires partnerships to be successful. And you just think at a high level of the complexity associated with taking an innovative molecule from someone's lab to where it's safe and effective for patients globally: there are partnerships throughout that incredibly complicated lifecycle.

At Windgap Medical, we focus on innovations within the delivery device, the injection device, to enable our pharma partners to tackle some of these challenges that we were just talking about. There are really three primary areas where we focus our innovation to enable our partners to bring these therapies to patients.

So, the first is longer-acting or long-acting injectables. In some ways it's in the name: longer-acting, therefore, should mean fewer doses. Fewer doses should mean fewer injections for patients. It's also, then, a more sustainable route of administration. You're generating fewer devices and you're probably improving patient adherence to that therapy. Many people don't like getting injections. And if you can go from once a day to once a week, to once a quarter or once a year, that should improve patient success with those therapies. So, that's area one where we focus our partnerships.

The second is around sequential delivery. So, the idea of enabling patients to inject themselves with two drugs with a single device. Increasingly, in some spaces, we are seeing pharma recognize that if you administer two drugs in close sequence to each other, that's actually beneficial. The classic one-plus-one-equals-three equation.

And that can create a lot of administrative complexity. You might have two injections that are required. You might need a healthcare professional to do that. There are sometimes opportunities for pharma to formulate the drugs into a single liquid. But oftentimes, there are very good reasons why that either can't work or doesn't make economic sense.

We have work underway to develop devices in partnership with our pharma customers where both drugs are held in a single device; and, through a single injection, the patient can self-administer those drugs. So, many of the same benefits, then again, around the simplicity in a lower cost setting come into play.

And then third for us is actually around this idea of reconstituting a drug substance, or using what's called lyophilization. So as drugs are stored in a powdered form, sometimes that means they have a longer shelf life. It may mean that they require less in terms of a cold chain to go from manufacture to the patient.

And so, that can be beneficial because it can be lower cost. You can reach further if you don't need a cold chain to supply, to support the drug’s journey to a patient. And you can have a longer shelf life, so you can have less waste coming through the supply chain. There are specific things you need to think about to help a patient be successful with a device that reconstitutes or mixes the drug.

But those are really the three areas where we're focused, based on what we're good at at Windgap in our partnerships with pharmaceutical companies.

Aaron, when it comes to innovation, what are some of the biggest challenges, questions, or problems to address?

Mann: So, each of those three areas of focus for Windgap has its own unique challenges, Tom, that we work on every day — that, frankly, are exciting for our teams and our customers to work on together.

If we take them in turn, first long-acting injectables: When you create a formulation that lasts over a longer period of time, often it becomes more viscous, it becomes thicker. And [the challenge is] actually managing that fluid so that you can inject it through the same kind of device because you're still hoping to have a very, very fine gauge needle for the patient experience. A thinner needle, a finer gauge needle, should hurt less; it should be less intimidating for a patient. So how do you manage that highly viscous drug so that patients can be successful administering it themselves on their own? That's really the core challenge that we tackle in that space.

When it comes to sequential delivery: If you're putting two different drugs together, in different cartridges or syringes, into a single device, then what you're actually typically thinking about is, how are you ensuring appropriate sterility of the drug? How do you keep the drugs from mixing together while the patient is getting them. That may not be what you want to have happen. Or, if you do want it to happen, how do you ensure it happens at the right time when you're dosing? So, really maintaining the integrity of that drug substance and that drug product until you're ready to dose it is one of the interesting challenges that we're tackling.

And then on reconstitution: In that scenario, we are taking something that's in a powdered or dry form and mixing it. How do you appropriately validate, for the patient and for regulators who are looking after patients, that the reconstitution is done properly and effectively? Ideally, you can do that in the device in a way that you can validate, so that the regulators can look at it and have confidence in it, as well. So, perhaps a patient is actually doing that at home, on their own, rather than needing to add a costly and burdensome trip to a healthcare professional to get that therapy.

So then finally, taking all those challenges and advances that are being addressed and looked at: If advances and innovations are successful, what benefits can we expect that those things would bring to the health and the lives of patients?

Mann: Yeah, it's a great way to wrap up here because if I zoom back out from some of the details, I think in some ways the benefits are both quite simple and incredibly exciting: Fewer doses, more care at home, less waste.

And all of that should lead to more value for the healthcare dollars that we're choosing as a society to spend. So that's why we're really energized to be working on these problems and these challenges in partnership with pharma.

Thank you, Aaron, for joining me on this episode of Supplier Horizons. It's been great to get your perspective for our audience.