Broadening The Range Of Self-Administered Biologics With Stevanato Group's Riccardo Butta

Along with the goal of moving a wider range of biologics-based therapies into self-administered, in-home scenarios comes the challenge of delivering increased dosage volumes and higher viscosities via subcutaneous and transdermal methods. In this episode of Supplier Horizons, host Tom von Gunden talks with Stevanato Group’s President, Americas, Riccardo Butta about the convergence of human factors and device design during platform development for injectable and on-body delivery systems.

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Episode Transcript

Tom von Gunden, Chief Editor, Drug Delivery Leader:

Welcome to another episode of Supplier Horizons, the series in which we hear from suppliers to the drug delivery space about innovations and advancements. My name is Tom von Gunden, Chief Editor at Drug Delivery Leader and your host for this series. Today, I am joined by Riccardo Butta, President of the Americas for Stevanato Group.

Welcome, Riccardo.

Riccardo Butta, President of Americas, Stevanato Group:

Thank you, Tom. Nice to be here.

Well, thank you for joining me. Let's go ahead and dive in. So, let's start at a high level where you can go wherever you feel that your vision and experience take you. As you look out over the landscape of patient needs and therapeutic areas, what do you see as the trends that are most in need of advancements and innovations from whomever can provide products or services to address them?

I look at it in two ways: From the patient's standpoint, the first one, clearly, we see a big push at the moment in trying to bring the care and the delivery of the therapy from the hospital environment into the home setting. And that clearly has a major impact on what we put in the hands of patients to make sure that they get the right therapy in a convenient way.

Also, from an economic standpoint. But also making sure that we have the right set of usability elements for the therapy to be safe and effective, and we get to the right level of adherence to the regimen. So that is a major driver that we see shaping the device space in this period.

And when you look at the therapies themselves, clearly there is a big shift into biologics. And biologics, by definition, carry some specific elements. Typically, [it] is IVs because it is large volume. And so again, when you think about devices, it is a different set of devices that you need to bring to market to help patients being treated for these specific diseases that biologics address in the home environment.

If you want the byproduct of this that we see coming -- this is not as much from the patient standpoint, but more from the pharma companies’ standpoint -- is the fact that there are more and more drugs going into devices. And that calls for an effort to do platforming. [It] is not about developing one device for one drug but developing a platform that can be then used and customized over a broader pipeline.

So those, in my view, are the key trends that we see from the patient standpoint, but also what they mean in terms of the devices to be developed and brought to market.

Great. And if you don't mind, I'm going to dig a little bit into the actual delivery and some of the challenges that you mentioned there. So, whether we're thinking about the formulations, especially in the case of large molecule biologics, or if we're thinking about the device effectiveness or whatever component might be there, what are some of the key challenges that need to be addressed ― some of the key problems that need to be solved, whether it's on the formulation side, the device side, or the combination of the two?

So, definitely there is the need to bring the drug development and the device development closer together. Historically, they were two totally different things on different timelines. And what we see now as a challenge that the industry is working through is, okay, how do I make sure that I bring the device development or the device selection early on so that it becomes a system development? As opposed to, I develop one, and then I look for a solution down the road. So, that definitely is a major point that we see across the industry.

The other one, that is not so commonly discussed but is becoming very relevant, is the topic of sustainability. And the more devices we bring to market, the more the problem of sustainability is visible. And so, to get to reusable devices, for example, because that allows [us] to take the full burden down to a great extent.

And these are what you want ― system-level challenges. And then, of course, you have the technical issues to be solved because, [as] we are going up more and more with volumes, there is a limit in terms of usability. For example, if you talk about injectors, the question is, is 3 mL the right ceiling for that way of administration, or is it 5 mL? And that is also where reformulation comes into play right now.

Yes. And to follow up on that and a comment you made earlier about platform technologies and trying to use a platform to deliver different kinds of therapies for different purposes: Can you talk a little bit about some of the challenges there in terms of coming up with a platform that can be flexible and adaptable enough to use across a range of needs?

I think you can look at it at least under two different lenses. One is what I said earlier on the delivery volumes because, more and more, you see devices that are covering a broad range. You're not talking about only about a 1 mL or a 2.25 mL injector.

You are talking about a platform that can go across a certain span of volumes. The same as with on-body devices, right? We are talking about anything between 3 mL to 5 mL, depending on who you talk to, up to 20 mL. So, you need to have that flexibility, that scalability built into your system. But also, in terms of usage model, in terms of delivery profile, you want to have products that allow you to do bottles when you need bottles, basal when you need basal, and everything in between.

So, there is a lot of modularity, scalability, and flexibility that is built into the drive system, the delivery mechanism, so that you can adopt that platform across a number of different therapies. And even within the same therapy, across a number of different populations for our patients.

And speaking of those patients, obviously as we move toward more and more self-administered use, in-home use, therapies actually delivered by way of patient action, what are some of the key considerations there when it comes to human factors? Or the adherence and/or effectiveness when  it [the delivery device] is in the hands of an actual patient?

It is an interesting question. Again, one key piece that is being discussed about human factors is, what is the maximum volume that you can deliver using an injector, for example? And because, again, on the formulation and translating [that] to the time that it takes for the delivery to happen and the ability for a patient to stay with the device properly positioned for that amount of time.

That is clearly an element that is around usability, which is being discussed on a daily basis, because it's giving you the [time] envelope that you can work within when you talk about an injector before you think about [declaring] something as a delivery.

If you look into wearables, clearly the human factor piece that is coming into play is, what is the form factor that is reasonable to assume that the patient can live with? If you have the wearable attached to your body, particularly when you go out, what is the weight, what is the size? Is it really wearable, or is it wearable but you cannot move around, or you cannot have your normal life as if it was a smaller device? So, I think, depending on the device that you look at and the delivery mechanism, if you look at it, there are questions that are coming up. Clearly the feedback is always important: tactile feedback, audio feedback.

There are a lot of possibilities to look at the delivery window and see whether the delivery was completed or not. These things are always in the mind of people when they develop devices and when they think about the human factors for the patients.

Could you talk a little bit, since Stevanato Group is a service provider, about how some of these innovations or advancements are playing out in terms of how you interact with clients? In terms of what the client companies are thinking about, and looking at, and asking about? And what the folks internally for you are thinking about and asking about, and how those interactions go when it comes to keeping those patient needs and the needs for innovation in mind?

When you look at our company, the way we interact with customers, I guess we have, I would call [it], almost like three different possible models, right? We spun from being a pure contract manufacturing organization to a service provider, as you call it, [with] the customers coming to us with their own IP. And we helped these customers to scale efficiently, scale across geographies, and bring these products to market in the most efficient way ― and reliable way, by the way.

On the opposite extreme, there is a model where we develop our own IP, and we go to our customers, the pharma biotech companies, with our own platforms, our own products that can b9e tailored or customized for whatever application and need. And clearly, that is a totally different approach that is much faster in time to market for customers because the device is already developed, and it [just] needs to be validated and brought to market.

And then anything in between. What I mean by that is, there are major investments going with the development of these devices, this platform. So, there are cases where we partner with customers: we sit down, we look at the areas of common interest for a certain technology or a certain application, and we both invest to bring that solution to market so that we create value together.

And it can be with customers, or it can be with other players in the industry where we have partnerships or we have licensing, so that at the end we leverage each other to create value for our patients.

So thinking about any of those models, I'll finish with just a high-level future-pointing question, and that is: As you look out over the horizon, as these advances and innovations occur and we hope that they will be successful, what are your hopes and dreams for what patients’ lives and health will be like if some of these innovations and advancements can reach fulfillment?

I guess it goes back to the initial topic that we discussed. It is, for me, the possibility to move therapies and treatment from the hospital environment, the clinic environment into the home. For everyone, we are working to make it come true, right? If you think about the patients and the state of their disease and the possibility to be in their environment and be treated there, I think that it would be a big achievement.

The other one has to do with the outcome, which is a bit of a dependency on how good we are in developing these devices or these systems. But again, if you look at the therapies that we are trying to move from IV to subcutaneous, and you look at the amount of molecules that are in the pipeline of our customers, and what they could do for treating chronic diseases, and the possibility to drive a much better outcome by having devices that are properly developed for those applications, that is also the aspiration and something that will create a lot of benefits for patients.

So, for me, those are the two things: making sure that we really can bring better treatment at home and making sure that [with the devices], we optimize the outcome and the adherence and the performance of the therapy as a whole. Those are the two endpoints for the industry.

Well, I appreciate you joining me to share your perspectives with our audience, Riccardo. And to that audience, I want to thank you for joining us for another episode of Supplier Horizons. And we'll see you next time.