Cross-Functional Decisions In Autoinjector Development with Windgap Medical's Aaron Mann

On a return videocast appearance, CEO Aaron Mann of autoinjector provider Windgap Medical joins Supplier Horizons host Tom von Gunden to discuss product development decision points around delivering complex molecules via autoinjectors. These cross-functional considerations for drug teams and device teams include high viscosity formulations, device capabilities, product stability, patient safety, and human factors. 

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Transcript

Tom von Gunden, chief editor, Drug Delivery Leader:

Welcome to another episode of Supplier Horizons. My name is Tom von Gunden, chief editor at Drug Delivery Leader and your host for the series. Today, I'm pleased to be joined for a return visit by CEO Aaron Mann of Windgap Medical, a developer of autoinjector platforms, with a particular focus on novel and emerging therapeutic needs.

Welcome back, Aaron.

Aaron Mann, CEO, Windgap Medical:

Thanks, Tom. Great to be back together. Thanks for the invitation.

Well, it's obviously my thrill to have you here.

So, Aaron, it has been a little while since we caught up. And the last time we talked — and, by the way, folks in the audience, there is a videocast episode with Aaron and me from a little while ago. And in that one, Aaron, you may recall we talked about things like availability, cost, and sustainability.

So, today we're going to pick up, looking at, really, the trend toward the challenges, particularly on the injectable side, of handling increasingly large molecules and increasingly complex biologic formulations. Does that sound about like the ground we plan to cover?

Sounds great, look forward to it.

Alright, good. So, one of the things that you and I talked about in prep for this recording session today is we both acknowledged that there has long been an industry hope and dream that greater communication and collaboration happen across the product development chain within a biopharma organization, all the way from formulation science through device selection and design and onward to commercialization. So, I want to talk about that, in particular.

So, thinking about biologic products and complex molecules making their way into the convenience of autoinjectors and other injection systems, what makes those kinds of products even more critical for all the folks in the development cycle to communicate and collaborate more frequently, more effectively.

I think with what we're talking about here, Tom, we're seeing there's increased complexity in terms of the molecule, in terms of the development path, and in terms of the cost profile. And as all of those factors come into account, that really raises the stakes for getting things right.

You mentioned communication as one of the themes. All of those factors point to the need for more, not less, communication, and earlier, not later in the process. Collaborating on the decisions and the options early in the process, create the right amount of connectivity and flexibility to manage these very complicated programs over the many years that it takes to put them in a patient's hands.

Gotcha. And as you think about the folks that we're encouraging to get together more frequently through communication and collaboration, who specifically do you have in mind? What sorts of titles, what sorts of functions, and at what point, would these interactions best take place? I know you said early, obviously, but who needs to come together, when, and why?

In a perfect world, you can create the conditions for early and frequent communication between your formulation and drug product scientists and teams, folks working on the molecules, the device engineering teams both inside the pharmaceutical company that's doing the development, and any external partners that are under consideration.

But even beyond that traditional core, increasingly we need to think about human factors considerations, the regulatory teams who are going to support the approval, the eventual approvals across the globe. Manufacturing and fill/finish, how all of that will come together, your clinical teams, right? And then commercial. It's really a complicated group, a large group, but again, that's why I think bringing them together early in the process is the recipe for success.

Gotcha. And, of course, when we think of those different roles and functional areas, I suppose those folks in those areas — and probably any of us — could probably argue or agree that there are some tasks and responsibilities and decisions that are unique to or are at least within the wheelhouse of responsibility of [each of] those areas.

But there are some, I imagine, that you could say are inflection points or decision points that any of those people or areas would need to have in front of them at some point along the way. And so, what would some of those common things be that would cross those areas that maybe make it even more important that they look at them together?

All of the folks who are working in those various roles that we mentioned typically have deep expertise and knowledge within their space. And what we're actually talking about, I think, and seeing the most benefits of are collaborating appropriately on early decisions.

Let's take something as straightforward as, are you going to bring a liquid or a lyophilized and reconstituted dosage form into the final product to market? There are a number of reasons why lyophilization might be attractive to, say, your manufacturing and fill/finish and supply chain folks because of extended shelf life or stability.

There might be concerns that the device team has about doing that because of the need to source and identify a device that can do that properly. There might be a human factors concern about making sure that patients or clinical staff are successful in doing that.

But if you delay that decision until the formulation is quote-unquote “locked,” as people often talk about, you've actually eliminated the ability to explore what could be possible — working across all those different stakeholders and, in fact, actually really narrowing what you need, what you need to do, which can leave some opportunities behind.

Thanks for that, Aaron. I'm thinking now about diving a little bit more specifically, maybe a lot more specifically, into injection as a route of administration — the focus of you and the folks there at Windgap Medical. So, I'm going to ask you about this in two slices. One would be the science and technology itself.

So, what are some of the challenges to be overcome, problems to be solved, questions to be answered, when it comes to thinking about how do we advance or innovate around these devices and platforms when it comes to their ability or capacity to take large and complex biologic products, especially, into patients and into the market.

I like the way you framed that question because, thinking about what device capabilities exist or might need to exist to enable patient access to those therapeutics is the right way to come at the challenge. It can, on the one hand, expand the decision set upfront, as you think about a higher viscosity drug substance than you are used to typically delivering through a subcutaneous injection or one that is perhaps not particularly shelf-stable. And again, you might want to include lyophilization or a drug product that needs mixing or conditioning in some way right at the moment of injection.

Historically and understandably, we've typically taken a “formulate first” approach to solving those challenges. And there are formulators who are just remarkable and terrific at solving those. But if we can add tools into that space and into that thinking that might allow us to overcome some of those challenges in a way other than formulation through what a device is capable of.

I think the opportunity is, if we don't ask those questions of devices and of device teams, we never know what the answer is, right?

And so, that's probably the biggest place that viscosity, volume, which you mentioned, and then stability-related challenges, can all be at least partially, if not fully, addressed by devices, as long as we're thinking about it at the right stage in the development cycle.

You did mention patients, so let's move even further into that arena.

So, taking those formulation and delivery concerns down into the patient-receiving and often self-administering level: What additional advancements or innovations and the related challenges and questions and problems are in front of us when it comes to increasing convenience, increasing bioavailability of the received therapy, safety, those sorts of things.

I think it continues to be a space where I see the industry putting a lot of time and energy, and very appropriately so. As these therapies become potentially more complex, certainly more expensive, making sure that patients can safely and effectively administer to themselves, as much as possible — again, without compromising safety or efficacy — I think is really valuable because I always think about it, Tom, from the perspective of, as compared to what?

So, if I ask a patient to learn how to use an autoinjector that takes, say, three steps because of a reconstitution: If the alternative is regular trips to a clinician, scheduling an appointment, waiting, the clinician putting resources against that, there's a very compelling case to say, if we can do this.

If we can enable a patient to do this successfully, it is worth the investment, not only because of the cost savings, but also the patient satisfaction experience.

And I think it's intuitive to say that when patients have a more satisfying experience, they are much more likely to be adherent, which means they are much more likely to get the full benefits of the therapy as intended.

 Gotcha. Well, we are talking about moving the dial, so to speak, on innovation and advancement [of] the combined science, technology, and patient use perspectives. So, as we close today, Aaron, any final thoughts around moving the dial? Anything you would like folks, particularly, to think about and the industry, generally. to think about when it comes to what's next?

I think the conversation to me in the industry is very much moving in the right direction. I think we have the impatience to see it go faster, desired impatience on our side, but I suspect many share that.

I noted in one of the other recent conversations that popped up on your platform a lot of discussion around a shared Target Product Profile, Tom. And I might just come back to that and really say that is both a very powerful document, but also a concept for facilitating that shared conversation.

If we can get, in writing, clarity around what we are designing to and what the requirements are and what the limitations are, that can be a very powerful organizing force for these very complicated programs when we're working across time and space and geography and organization. So, I think continuing to lean into that has the potential to be very powerful for everyone's efforts.

Well, I hadn't expected you to give a shout-out or a plug for our coverage on Drug Delivery Leader. But thank you for doing so, Aaron, because it does remind me to remind our audience that, among the editorial assets we've provided that reference Target Product Profile as a potential piece of glue for communication and collaboration across functions, is, an article that I've written: [“Need A Drug Delivery Conversation Starter? Try Target Product Profile”].

So, thanks again, Aaron, for that shout-out. And, of course, thanks again for joining. You know, I hadn’t  anticipated asking this, but I'm interested … this is an episode for a series we call Supplier Horizons … I don't spend time, at all really, inside supplier organizations. And so, you're the CEO there at Windgap Medical. I'm interested in, how does any of what we just talked about enter the quote-unquote “water cooler conversations” in a place like Windgap Medical? How does it play out inside the walls there, in terms of these thoughts that you and I are sharing?

All of the elements we've talked about are the reality that we work within day in and day out. And then we layer on top of that. We are, of course, trying to build our business by effectively engaging and building relationships with pharmaceutical companies where we can be a great partner.

So, in addition to the things we talked about, we think a lot about, how do we build trust around those conversations so that we can have as open and frank a dialogue with our partners? Because that's what helps us move through this process very quickly. We don't have any desire, nor do I think many in this industry do, to work on a product which is not a great fit for what we bring to the equation. There are many talented companies out there.

So, we're thinking always about, within the framework that we've talked about here today, Tom,

how are we moving toward products where we are best equipped to really help bring that patient experience to where it needs to be? And how do we get out of the way from opportunities where there are other people who are better suited? Because when we do that, we're helping patients get the therapies they need. And so, we're constantly seeking that trust with our partners in conversation.

 [That] gives me thought of another [question]. Hope you can stay with me just for this one I'm adding on here to our suggested flow that we put together: Thinking about the patients — and you've referenced them, I've referenced them, you just did again — I'm curious about how that works in a supplier organization. How do you get the patient perspective when you are a supplier of autoinjectors?

You know, it's actually really easy, I think, and I do think it's the responsibility of leaders of these organizations. But we are all patients. Or we have a parent, or a child, or a friend who is a patient. And so, just asking ourselves to draw on those own experiences. I have parents who are at an age where they are users of, consumers of, many of these therapies. And so,  I listen really intently to what they say and what their experiences are.

Now, of course, those are anecdotal. We're not going to make decisions just based on them. But it does add an incredibly rich texture to what we think about. And I think can be incredibly motivating for doing this hard work together in partnership with our customers. Patients are just within arm's reach.

Yes, well, I appreciate the empathy that you expressed in that. And I thank you for all the perspectives you shared with me again today. Great to have you back on Supplier Horizons. I look forward to chatting again. Thanks.

 Anytime. Thanks, Tom.