Welcome to Pharma Talk Radio. This podcast is focused on platform approaches to streamline combination product development from the twenty twenty five pod Partnership Opportunities in Drug Delivery Conference. For more information on the pod conference, editorials, podcasts, or webcasts, please visit Drug desh Delivery dot org. Thank you and enjoy the podcast.
Our session today that we're going to have this panel discuss is on platform approaches for device and combination product development. We really want to start with each person briefly introducing yourself and really telling us what you think platform approach for device and combination product development means.
Same great, I didn't realize by sitting here i'd go first, But I'm Monica Swiney. I had innovation and new product planning for a device's packaging and process at GILLIAD Sciences. And in terms of what does a platform approach really mean to us, I think that you know, first of all, it's it's a family of device. We talk about drug delivery, a family of devices that has sufficient optionality to enable I would say a vast majority of the pipeline that
you see coming down the road. That's the first and foremost.
I'm Tim Quigg, development director at Crux Product Design. I'd almost have two definitions for platforms. The first we could keep very simple, you know, and nine to describe a device that could be used for two or more assets, The more the better to kind of amortize the value. But I think the second could be maybe summarized a little bit more as a as a mindset of how do you generate data, generate usability data, whatever it might be that could.
Be used across assets.
And I think I've been a cross since twenty twelve and definitely seeing a pharma shift towards trying to leverage assets in more than one program, and I almost describe that as platformization. You know, how do we think a little bit broader than just the device alone.
Hello, I'm shiaching Ole, director of Device and Combination product Development at Takeda.
To Me.
Platform in an ideal world is plug and play of the drug delby device in such a way that the drug delby device can a commonate range of drug product or medicinal product formulations, range of primary containers, and range of user populations.
That's the ideal world.
In real world, it can be more challenging than that, and it takes some efforts upfront before we can benefits of that, but it is possible.
Hi, everybody, Brad Gould that I'm a director of Device and combination product development at ABVI, So I think at a high level, a platform approach is really a framework that that helps to streamline combination product development by more or less grouping assets together with with with common attributes and and a single route of administration and and exploiting those through a single platform vehicle. You know, I think
there's maybe three important parts to it. To the framework, One the modular delivery system itself, uh two an efficiently scalable and flexible manufacturing capability, and and three a platform DHF as a repository for acid agnostic information. And it's the combination of those three things together that that that when when truly harnessed, can enable a platform approach to its full full end.
Thank you so, Monica and Brad. I'm curious to know what you think are like the drivers for developing a platform and what really you think initiates the need or the desire to have one.
Thank you. I appreciate that. So I know that at GILLIAD, the drivers historically have have come from the product teams, right, there's a specific asset that needs a specific you know, rout of administration and then we reactively act on that.
And you know, now we are we are shifting to a platform approach, right, which is very different, and that's actually it is definitely driven by assets, but many assets that have you know, needs that are in common, and it is also being driven by the commercial org So a lot of my my day is also spent working with the commercial organization and the you know, understanding the competitive landscape and you know what they foresee as not just our first product at launch, but you know, the
second and third products through life cycle management, and how can we how can we plan for that? And so I think that the ask comes from many directions and certainly an innovation we we sort of we generate some of that pool ourselves as well. You know, we're sort of posing the question even if they haven't thought about it, and helping to to co to co ide eight, if you will, what those needs might be so that we
can act on them earlier. But I think that one thing I wanted to make sure that I helped add as well, because Brad had it made me think about this in terms of the platform development. What what also makes a platform right is definitely that sort of that that asset agnostic parts of the DHF that we can leverage further, right those or that that's the time savings that we're looking for, the time and the cost savings
and establishing a platform that we're hoping for. But also there is maybe assets specifically you might use a specific asset to map out a design space, right that then can be can de risk future programs.
Right.
It may not have been done specifically with that next asset, but it may have been with a sufficiently large concentration range, sufficiently large pH range or viscosity range that the next asset that comes along, even though you haven't done those that testing that will have to be done in every single for every single asset that goes through for stability and and you know, functionality over over the time of the shelf life, you've sufficiently de risked it that you
that the executional risk of the program is diminished.
Okay, thanks set that you took a lot of my thun there, but that's okay, I deferred, so no, I think, yeah, I share a lot of the same thoughts on what the drivers are So the first is obviously timeline acceleration, right, So from a financial aspect, it's it's getting product to market as quickly as possible and improving the bottom line. But from a human aspect, it's getting our therapies to our patients as quickly as possible. So there's really multiple
benefactors of that timeline savings. Another driver's cost, so specifically in development costs. This is an area where you know, our leadership and management teams have it's it's been a growing process getting everyone to pull in the same rope. There's a lot of early investment required to establish a platform, but ultimately that that early large investment, you know, pays dividends and in the savings for the corresponding leveraged asset
programs that come downstream. You know, a third driver is probably technical risk. I think you hit on this right. So in a in a normal serially executed UH combination product development program, there's going to be challenges that are
encountered during verification, clinical trial, et cetera. You know, a platform development program, you know, really more or less neutralizes those those risks by you know, bringing them up front and off the critical path should they arise from a from a specific asset development program, and I think from a technical perspective, right, all the drivers sort of stem from this this, this, this, this one area where where you have this overlapping probabilistic you know, cluster of assets
that can all be harnessed by a single route of administration and a single delivery system opportunity.
Thank you.
Here, I hear a lot of need to have alignment amongst amongst you know, your teams too in both of your responses as well, which I think is a common theme we've heard throughout with the communication and that we really need to have between our formulators and our development and our commercial teams. So yeah, I think that's good to highlight there too in terms of kind of limitations from technical and non technical and watch outs for any
of our combination platform development. I'd be interested to hear Tim and Scherish about kind of your thoughts there and maybe where you can leverage a platform and where you cannot from your experiences.
Thank you.
I think when when we talk talk about anything about platforms, limitations, challenges, or you know, benefits, we are going.
To see a team here.
Most of us are going to talk about the same things, because that's how shared and common.
The challenges and pain points.
Are, UH, which is good in a way that I think, UH, this is a shared pain across the industry that I believe that collectively we can address. When when I think about any watch outs or limitations from the technical perspective, the first thing that I always wonder about is what exactly is platform? Do we all think about the same thing when it comes to platforms. We don't have a specific definition about drug delivery device platforms.
UH.
All of us can come up with different variants of this definition. Last year, for one conference, in my understanding, that was the first time that five different companies UH device suppliers and.
Pharma company UH companies, they came together.
I was part of that effort, and I see some of those colleagues here. Jacob Blangy from if Somebody is here but Burgess is somewhere here, from shl Ron Foster from Amgen, Jeff Given from MERKUH and they have been in this space for you know, three four decades, And they also could not agree.
On a specific definition.
And then collectively we were brainstorming for about six months before we came up with a very simple yet comprehensive definition for platforms.
So that's where we start. That's where the disconnect is.
So the first you know watch out or limitation is the definite definition.
First we need to, you know, define for.
Ourselves what exactly we mean by platform and then then take it forward from there.
So from technical.
Perspective, once we know what we mean by platform, we also need to make sure that you know we are not and I'm talking from the farmer perspective, the internal technical watch out is.
To avoid silos.
For any given theopeutic program team or asset team, their primary focus is taking their asset faster to the patient's clinical commercial so they are always laser focused on their specific effort and it's very easy to lose.
The larger picture. So that is a big watch out.
At the same time, when it comes to the technical watch outs, we also need to understand when we are thinking about a device or family devices as a platform, we need to broaden our perspective and take a realistic approach as to what range of formulations, what range of primary containers, what range of user populations would be suitable within the scope for given platform, and then start establishing platforms.
It takes a lot of investment upfront in terms of resources, efforts, funding to even startup platform, but then benefits our image once you have it in such a way that you could leverage the platform, could benefit from radius timelines, you could benefit from radious risk. You could benefit also from the consistency efficiency as well. So in my opinion, first understanding what you what you mean by platform, define your boundaries,
and then develop those platforms. That would be the first step when I look externally for buy from a company. The technical watchouts or limitations would also be your partnership, whether your device supplier also has the mindset of platforms, if there is an opportunity to partner in such a way that there is mutual learning UH and UH you know, development and advancement of platforms. Another external limitation in my opinion is industry consensus. I don't think that any one
particular company can advance the platforms be uncertain limitations. So there is need for and there is opportunity to UH broader consensus and partnership within this industry to first align on platforms and then address the more challenging aspect, which is the regulatory alignment. At this time, we don't have any specific regulatory position. There is no regulatory guidance from any of the regulatory agencies.
But I don't think that.
We can ask for that or vouch for that unless we as the industry have some position on the platform. So that is one you know limitation as well, and then once we have that position, we can you know, strive for regulatory you know position as well. From non technical standpoint, I think getting business.
Buy in is the biggest challenge.
So first, once you do your technical due regions and define platforms and define.
What you will do, how you will do it.
The no technical challenge is to convince your decision makers in your organization as to why you would do it. And I think you know that is a watch out or you know, a non technical challenge.
In my opinion, i'd agree with a lot of that. I think it's nuanced time. Many of these challenges relate to communications and group understanding. We have some clients would treat platforms as purely externally procured devices you off a shelf. Some that have internally developed platforms.
That they tread as their workhorse.
You know, if a drug can go into that platform, let's leverage it. We can save time we can kind of amortize that investment. I think one of the biggest challenges we've found is that it's very hard to kind of identify that jumping off point for a platform. A lot of asset teams and formulation teams don't want to
be the guinea pig for a platform. They have specific requirements, They have therapeutic area requirements for their end user, and they don't want to water down those requirements to be more ubiquitous for a speculative, crystal ball future ambition that might not actually have a business case even defined yet.
So I think some of the successful platform projects that we've seen have started life not as a platform, and that's it's sort of been a bit more of a gradual process to understand how much can we make universal here. I think that comes at a direct trade off, though, of just almost setting a little bit more realistic expectations of what you can and can't achieve with a platform.
I think if.
I choose an example as basic as a fill volume change, a lot of the time you might suddenly change a spring, you might have a different plunger rod length, the combat kind of free flight and glass fracture risk and suddenly that platform might have mutated into quite a different variance, so much so that some of those initial perceived benefits
are diminished. We've also seen that on the manufacturer and scale up side of things, that again, this sort of white whale platform that resolves all scale up challenges is a nice ambition, but you might find that your fill finish requirements are different, Your supply chain is so fundamentally different that yes, you've saved time and effort on the design side, but you actually have very different supply chains
for a single platform. And I think the reason I cite that is we've seen some businesses and business units outside of device groups maybe expect too much from a platform, and I think we have to be a little bit cautious about how much we add hype to that platform and over promise. Yes, of course it can save some development effort, but I personally don't see it's shaving years off every development project, and would advise a little bit of cultion there from reality.
Thank you. I want to build upon the regulatory piece that you spoke of, because I know, Brad, we had a lot of prediscussion and then you brought up the regulatory hurdles that we're facing, and I'm just curious, do you have any thoughts on how we as an industry can try to try to overcome some of those hurdles when we think about platform approaches.
Yeah, so I appreciate bringing this up so realistically, right, if any of us on stage were privy to information that you know, spelled out the secret sauce of a platform leveraging submission, that's you know, trade secret. That's a competitive advantage, and it's probably not something that we talk
about here today, let alone share with each other. So I think we need to as an industry, if we're going to really move this space forward, really really focus on you know, a common message to the agency, uh and and really try to establish you know, a single point of view uh to to pull back a guideline such that everyone can kind of, uh, not only work towards the same end, but also then open up the walls of dialogue.
So anyone else have thoughts on the regulatory hurdles?
I think maybe just a thought at a and a question back to you, Brad, you know, and there is some precedent, right if we think about like platform autoinjectors. You were alluding to auto injectors before. And you know, so for example like SHL and ibsomet have auto injectors that can be used for a lot of different indications
and are used for a lot of different indications. And you know, part of the benefit of perhaps working with a supplier like that is they do have an established package, right that you can help, that you can put as part of your submission of the combination product that's been it's been tested that they're dv is tight, you know. And and so there's some precedent I think that maybe gives us guidance as to where we might start with
our with any internal development. But I wonder Brad, sort of in your your opinion sort of where does that stop an end right and if if you think about that precedent and how it might apply.
To I think the answer is there's platforms and then there's platforms.
Right.
I think a lot of folks in the room have on their websites, UH platform suppliers, platform manufacturers, et cetera. That means something very different to everyone. And I think you know, the ultimately the end goal here isn't just the device, it's the full platform expression, right that the full model of the device, the manufacturing and the regulatory piece is kind of all working uh together to streamline
a submission process. So I think, you know, with regard to the you know, the devices that are available, I think it's appropriate that they're described as platforms. But ultimately than how each one of our companies interacts with those those those those vendors and partners and progresses forward. That's really probably where you know, the sharing stops, and the and the and the competitive advantage remains internal. And i'd really moving forward like to see a more transparent dialogue.
And I think that that's probably probably only fostered by uh uh, you know, the agency being a little bit more forthcoming with the guidance.
Than other hurdles. I think we've also seen is over recent years is kind of disruptions in some of our supply chains, which can really impact you know, primary container closures that we might be putting into some of these combination products, and it kind of begs the question of dual sourcing for some of these How do you feel some of these alternative primary container closures can be implemented within a platform as well? So Rader Tim thoughts, sure, Yeah.
So I think it's more it's when when folks get started on a common platform combination development program, a lot of the focus tends to be on the device and and neglects, uh the primary container. But in most cases the primary container is an integral part of the delivery system. And so you know, I think, you know, dual sourcing
primary containers is absolutely appropriate. But I think the key piece is that the vetting and the sourcing and the verification UH and the inclusion of those multiple options is is done at the outset of the platform development program, not at the not at the tail of it, because if it's the latter, if it's at the tail, really you know, you're the team is risking the repetition of all a lot, a lot of the design control and and perhaps even verification testing that was done on the
first container, and and really negating a lot of the timeline savings that the platform program was was meant to accomplish in the first place.
I'd very much agree. I think.
Historically you might have chosen your primary presentation, your primary container, and almost treated the secondary supply as a theoretical element that you consider.
But maybe keep to one side.
And when I think about the economies of scale, when you're going through DV.
Being able to do.
That with multiple primary containers and secondary supply options, I think that's where you get the savings. So I think as we've seen that supply disruption, I think it has been a little bit of a shot across the boy we should.
Be doing this.
And I think it's easy whenever it's a fast paced development to consider this is optional, it's extra.
We don't have to.
But I think that can be quite short sighted and genuinely catchy eyed.
I think a common thing we've heard in responses in this panel has been getting the business buy in and stakeholder alignment. And that's certainly very important. And you know, what do you think is the most important aspects to get that alignment? And maybe is there processes in place that you've had that have been successful to really sell that to your stakeholders, maybe both internally and externally.
Sure, I think I briefly touched upon it earlier, but I would like to expand on it. So I think almost every company has, you know, some way of developing business cases to get buying on you know, any new ideas, concepts, et cetera. Something similar could be followed for platforms as well. However, who drives that is often a question because traditionally most of the farmer companies are you know, ast focused. There are theopeutic areas who are driving you know, a progression up there.
Particular portfolio drive it.
And it's it hurts a little bit to say that, you know, even though things have improved, devices are still to some extent are afterthoughts. You know, until the molecule progresses to certain stage, maybe you know, be on phase one, somewhere in phase two, or you know, in some cases even in phase three, there is not much serious thought given to devices, so forget about platforms. So that's where
you know, we are still in this industry. So I think you know, every organization you know, we will have to think you know, about it strategically, uh and make sure that you know there is some kind of strategy about you know, platforms.
First, to understand from technical perspective.
Whether platforms are visible and I'm using the term technical very loosely here. By technical, what I mean is that from design, engineeringality, regulatory manufacturing, is it feasible to have a family of drug dealby devices or device configurations that could address uh, the asset pipeline in such a way that we don't be spending a lot of efforts repeating the same thing.
Again and again for device development.
So once that technical portion is addressed, then the other part is the business aspect of it is, unless you have you know, business buying you know, uh, you won't
be able to do much about the platforms. So why it is beneficial to uh, you know, pursue platform approach that needs to be also quantified and once you get you know, buying from you know, your senior leadership, because that buying is needed for a front investment in you know, uh, you know, in terms of money, fund you know, resources, uh, efforts, time, and et cetera, where a particular asset of particular molecule or therapeutic area may not be willing to you know,
fund all of that. So if you figure that out, do let us know as well, and so we can copy it.
All right. I might offer a bit of a counterpoint to the point there that you know, I think that having worked in innovation a large portion of my career, I would say that I don't know that I've ever run across a problem that could not be solved. I think that technically we have lots of science and technology available, like, we can solve a problem, right, but is there a business need and a willingness to pay for that and to perhaps even wait the time it would take to solve the problem?
Right?
It's all about time, money, and resources. But I think it can be done. But how do you get that business need the buy in that you need the stakeholder alignment and who are the early on and then later on who are the key stakeholders? And I think it almost goes back to the previous question. We talk about a supply chain, right, So first and foremost, if we think about the end and think about the end in mind, like begin with the end in mind, you know, can
we even make it? Does it fit within our strategic network of manufacturing suppliers or you know, is are there are there really nice sort of sort of vertically integrated suppliers that are already in our network that this can easily fit into, or are we're going to have to build a whole new capability to support this and that's
going to be a harder sell. Right, So that's I think it's a really important part of the stakeholder alignment is how we can actually do this in the end, right, Sure we can do it technically, we can do it in a lab, right, but can we do it at scale? And but then after you know, sort of get past that hurdle. I'm not necessarily these necessarily saying these are all in order, but I do think that one is really important. The next is sort of like where is
the ask coming from? And I think the ask really it's important in the beginning and it's important in the end, and it gets muddled a lot in between. Right, So, in terms of getting the buy in early on, you know, I think start in discovery, right. If the discovery teams come with you know, when they're first drafting, you know, they're a part of at least the conversation of drafting the target product profile and are putting specific needs on the table, like we need this, this would be beneficial.
Then if you can get it into the target product profile early, that's a win.
Right.
Once the program is on their path, it's going to be difficult to change course or because it becomes like
a containership. The other end is commercial. A lot of product product teams that are already underway, you know, they're not going to move that containership unless commercial says they have to, right, So sort of like bridging, you know, from both, you know, early on in discovery and then later on a commercial, and then bringing that together in the middle and you know, at the point of execution.
I think is all equally important. I think those are probably for me, some of the most key stakeholders, all right.
And with that, I think we're exactly out of time. So thank you to our panelists today for the great discussion in thoughts.
We hope you enjoyed the podcast. For more information about the pod conference, editorials, podcasts, or webcasts, please visit drug dash delivery dot org. Thanks for listening.