Speaker 1: Welcome to Pharma Talk Radio. This podcast is focused on
Speaker 1: platform approaches to streamline combination product development from the twenty
Speaker 1: twenty five pod Partnership Opportunities in Drug Delivery Conference. For
Speaker 1: more information on the pod conference, editorials, podcasts, or webcasts,
Speaker 1: please visit Drug desh Delivery dot org. Thank you and
Speaker 1: enjoy the podcast.
Speaker 2: Our session today that we're going to have this panel
Speaker 2: discuss is on platform approaches for device and combination product development.
Speaker 2: We really want to start with each person briefly introducing
Speaker 2: yourself and really telling us what you think platform approach
Speaker 2: for device and combination product development means.
Speaker 3: Same great, I didn't realize by sitting here i'd go first,
Speaker 3: But I'm Monica Swiney. I had innovation and new product
Speaker 3: planning for a device's packaging and process at GILLIAD Sciences.
Speaker 3: And in terms of what does a platform approach really
Speaker 3: mean to us, I think that you know, first of all,
Speaker 3: it's it's a family of device. We talk about drug delivery,
Speaker 3: a family of devices that has sufficient optionality to enable
Speaker 3: I would say a vast majority of the pipeline that
Speaker 3: you see coming down the road. That's the first and foremost.
Speaker 4: I'm Tim Quigg, development director at Crux Product Design. I'd
Speaker 4: almost have two definitions for platforms. The first we could
Speaker 4: keep very simple, you know, and nine to describe a
Speaker 4: device that could be used for two or more assets,
Speaker 4: The more the better to kind of amortize the value.
Speaker 4: But I think the second could be maybe summarized a
Speaker 4: little bit more as a as a mindset of how
Speaker 4: do you generate data, generate usability data, whatever it might
Speaker 4: be that could.
Speaker 5: Be used across assets.
Speaker 4: And I think I've been a cross since twenty twelve
Speaker 4: and definitely seeing a pharma shift towards trying to leverage
Speaker 4: assets in more than one program, and I almost describe
Speaker 4: that as platformization. You know, how do we think a
Speaker 4: little bit broader than just the device alone.
Speaker 6: Hello, I'm shiaching Ole, director of Device and Combination product
Speaker 6: Development at Takeda.
Speaker 5: To Me.
Speaker 6: Platform in an ideal world is plug and play of
Speaker 6: the drug delby device in such a way that the
Speaker 6: drug delby device can a commonate range of drug product
Speaker 6: or medicinal product formulations, range of primary containers, and range
Speaker 6: of user populations.
Speaker 5: That's the ideal world.
Speaker 6: In real world, it can be more challenging than that,
Speaker 6: and it takes some efforts upfront before we can benefits
Speaker 6: of that, but it is possible.
Speaker 7: Hi, everybody, Brad Gould that I'm a director of Device
Speaker 7: and combination product development at ABVI, So I think at
Speaker 7: a high level, a platform approach is really a framework
Speaker 7: that that helps to streamline combination product development by more
Speaker 7: or less grouping assets together with with with common attributes
Speaker 7: and and a single route of administration and and exploiting
Speaker 7: those through a single platform vehicle. You know, I think
Speaker 7: there's maybe three important parts to it. To the framework,
Speaker 7: One the modular delivery system itself, uh two an efficiently
Speaker 7: scalable and flexible manufacturing capability, and and three a platform
Speaker 7: DHF as a repository for acid agnostic information. And it's
Speaker 7: the combination of those three things together that that that
Speaker 7: when when truly harnessed, can enable a platform approach to
Speaker 7: its full full end.
Speaker 2: Thank you so, Monica and Brad. I'm curious to know
Speaker 2: what you think are like the drivers for developing a
Speaker 2: platform and what really you think initiates the need or
Speaker 2: the desire to have one.
Speaker 3: Thank you. I appreciate that. So I know that at GILLIAD,
Speaker 3: the drivers historically have have come from the product teams, right,
Speaker 3: there's a specific asset that needs a specific you know,
Speaker 3: rout of administration and then we reactively act on that.
Speaker 3: And you know, now we are we are shifting to
Speaker 3: a platform approach, right, which is very different, and that's
Speaker 3: actually it is definitely driven by assets, but many assets
Speaker 3: that have you know, needs that are in common, and
Speaker 3: it is also being driven by the commercial org So
Speaker 3: a lot of my my day is also spent working
Speaker 3: with the commercial organization and the you know, understanding the
Speaker 3: competitive landscape and you know what they foresee as not
Speaker 3: just our first product at launch, but you know, the
Speaker 3: second and third products through life cycle management, and how
Speaker 3: can we how can we plan for that? And so
Speaker 3: I think that the ask comes from many directions and
Speaker 3: certainly an innovation we we sort of we generate some
Speaker 3: of that pool ourselves as well. You know, we're sort
Speaker 3: of posing the question even if they haven't thought about it,
Speaker 3: and helping to to co to co ide eight, if
Speaker 3: you will, what those needs might be so that we
Speaker 3: can act on them earlier. But I think that one
Speaker 3: thing I wanted to make sure that I helped add
Speaker 3: as well, because Brad had it made me think about
Speaker 3: this in terms of the platform development. What what also
Speaker 3: makes a platform right is definitely that sort of that
Speaker 3: that asset agnostic parts of the DHF that we can
Speaker 3: leverage further, right those or that that's the time savings
Speaker 3: that we're looking for, the time and the cost savings
Speaker 3: and establishing a platform that we're hoping for. But also
Speaker 3: there is maybe assets specifically you might use a specific
Speaker 3: asset to map out a design space, right that then
Speaker 3: can be can de risk future programs.
Speaker 1: Right.
Speaker 3: It may not have been done specifically with that next asset,
Speaker 3: but it may have been with a sufficiently large concentration range,
Speaker 3: sufficiently large pH range or viscosity range that the next
Speaker 3: asset that comes along, even though you haven't done those
Speaker 3: that testing that will have to be done in every
Speaker 3: single for every single asset that goes through for stability
Speaker 3: and and you know, functionality over over the time of
Speaker 3: the shelf life, you've sufficiently de risked it that you
Speaker 3: that the executional risk of the program is diminished.
Speaker 7: Okay, thanks set that you took a lot of my
Speaker 7: thun there, but that's okay, I deferred, so no, I think, yeah,
Speaker 7: I share a lot of the same thoughts on what
Speaker 7: the drivers are So the first is obviously timeline acceleration, right,
Speaker 7: So from a financial aspect, it's it's getting product to
Speaker 7: market as quickly as possible and improving the bottom line.
Speaker 7: But from a human aspect, it's getting our therapies to
Speaker 7: our patients as quickly as possible. So there's really multiple
Speaker 7: benefactors of that timeline savings. Another driver's cost, so specifically
Speaker 7: in development costs. This is an area where you know,
Speaker 7: our leadership and management teams have it's it's been a
Speaker 7: growing process getting everyone to pull in the same rope.
Speaker 7: There's a lot of early investment required to establish a platform,
Speaker 7: but ultimately that that early large investment, you know, pays
Speaker 7: dividends and in the savings for the corresponding leveraged asset
Speaker 7: programs that come downstream. You know, a third driver is
Speaker 7: probably technical risk. I think you hit on this right.
Speaker 7: So in a in a normal serially executed UH combination
Speaker 7: product development program, there's going to be challenges that are
Speaker 7: encountered during verification, clinical trial, et cetera. You know, a
Speaker 7: platform development program, you know, really more or less neutralizes
Speaker 7: those those risks by you know, bringing them up front
Speaker 7: and off the critical path should they arise from a
Speaker 7: from a specific asset development program, and I think from
Speaker 7: a technical perspective, right, all the drivers sort of stem
Speaker 7: from this this, this, this, this one area where where
Speaker 7: you have this overlapping probabilistic you know, cluster of assets
Speaker 7: that can all be harnessed by a single route of
Speaker 7: administration and a single delivery system opportunity.
Speaker 5: Thank you.
Speaker 2: Here, I hear a lot of need to have alignment
Speaker 2: amongst amongst you know, your teams too in both of
Speaker 2: your responses as well, which I think is a common
Speaker 2: theme we've heard throughout with the communication and that we
Speaker 2: really need to have between our formulators and our development
Speaker 2: and our commercial teams. So yeah, I think that's good
Speaker 2: to highlight there too in terms of kind of limitations
Speaker 2: from technical and non technical and watch outs for any
Speaker 2: of our combination platform development. I'd be interested to hear
Speaker 2: Tim and Scherish about kind of your thoughts there and
Speaker 2: maybe where you can leverage a platform and where you
Speaker 2: cannot from your experiences.
Speaker 5: Thank you.
Speaker 6: I think when when we talk talk about anything about platforms, limitations, challenges,
Speaker 6: or you know, benefits, we are going.
Speaker 5: To see a team here.
Speaker 6: Most of us are going to talk about the same things,
Speaker 6: because that's how shared and common.
Speaker 5: The challenges and pain points.
Speaker 6: Are, UH, which is good in a way that I think, UH,
Speaker 6: this is a shared pain across the industry that I
Speaker 6: believe that collectively we can address. When when I think
Speaker 6: about any watch outs or limitations from the technical perspective,
Speaker 6: the first thing that I always wonder about is what
Speaker 6: exactly is platform? Do we all think about the same
Speaker 6: thing when it comes to platforms. We don't have a
Speaker 6: specific definition about drug delivery device platforms.
Speaker 5: UH.
Speaker 6: All of us can come up with different variants of
Speaker 6: this definition. Last year, for one conference, in my understanding,
Speaker 6: that was the first time that five different companies UH
Speaker 6: device suppliers and.
Speaker 5: Pharma company UH companies, they came together.
Speaker 6: I was part of that effort, and I see some
Speaker 6: of those colleagues here. Jacob Blangy from if Somebody is
Speaker 6: here but Burgess is somewhere here, from shl Ron Foster
Speaker 6: from Amgen, Jeff Given from MERKUH and they have been
Speaker 6: in this space for you know, three four decades, And
Speaker 6: they also could not agree.
Speaker 5: On a specific definition.
Speaker 6: And then collectively we were brainstorming for about six months
Speaker 6: before we came up with a very simple yet comprehensive
Speaker 6: definition for platforms.
Speaker 5: So that's where we start. That's where the disconnect is.
Speaker 6: So the first you know watch out or limitation is
Speaker 6: the definite definition.
Speaker 5: First we need to, you know, define for.
Speaker 6: Ourselves what exactly we mean by platform and then then
Speaker 6: take it forward from there.
Speaker 5: So from technical.
Speaker 6: Perspective, once we know what we mean by platform, we
Speaker 6: also need to make sure that you know we are
Speaker 6: not and I'm talking from the farmer perspective, the internal
Speaker 6: technical watch out is.
Speaker 5: To avoid silos.
Speaker 6: For any given theopeutic program team or asset team, their
Speaker 6: primary focus is taking their asset faster to the patient's
Speaker 6: clinical commercial so they are always laser focused on their
Speaker 6: specific effort and it's very easy to lose.
Speaker 5: The larger picture. So that is a big watch out.
Speaker 6: At the same time, when it comes to the technical
Speaker 6: watch outs, we also need to understand when we are
Speaker 6: thinking about a device or family devices as a platform,
Speaker 6: we need to broaden our perspective and take a realistic
Speaker 6: approach as to what range of formulations, what range of
Speaker 6: primary containers, what range of user populations would be suitable
Speaker 6: within the scope for given platform, and then start establishing platforms.
Speaker 6: It takes a lot of investment upfront in terms of resources, efforts,
Speaker 6: funding to even startup platform, but then benefits our image
Speaker 6: once you have it in such a way that you
Speaker 6: could leverage the platform, could benefit from radius timelines, you
Speaker 6: could benefit from radious risk. You could benefit also from
Speaker 6: the consistency efficiency as well. So in my opinion, first
Speaker 6: understanding what you what you mean by platform, define your boundaries,
Speaker 6: and then develop those platforms. That would be the first
Speaker 6: step when I look externally for buy from a company.
Speaker 6: The technical watchouts or limitations would also be your partnership,
Speaker 6: whether your device supplier also has the mindset of platforms,
Speaker 6: if there is an opportunity to partner in such a
Speaker 6: way that there is mutual learning UH and UH you know,
Speaker 6: development and advancement of platforms. Another external limitation in my
Speaker 6: opinion is industry consensus. I don't think that any one
Speaker 6: particular company can advance the platforms be uncertain limitations. So
Speaker 6: there is need for and there is opportunity to UH
Speaker 6: broader consensus and partnership within this industry to first align
Speaker 6: on platforms and then address the more challenging aspect, which
Speaker 6: is the regulatory alignment. At this time, we don't have
Speaker 6: any specific regulatory position. There is no regulatory guidance from
Speaker 6: any of the regulatory agencies.
Speaker 5: But I don't think that.
Speaker 6: We can ask for that or vouch for that unless
Speaker 6: we as the industry have some position on the platform.
Speaker 6: So that is one you know limitation as well, and
Speaker 6: then once we have that position, we can you know,
Speaker 6: strive for regulatory you know position as well. From non
Speaker 6: technical standpoint, I think getting business.
Speaker 5: Buy in is the biggest challenge.
Speaker 6: So first, once you do your technical due regions and
Speaker 6: define platforms and define.
Speaker 5: What you will do, how you will do it.
Speaker 6: The no technical challenge is to convince your decision makers
Speaker 6: in your organization as to why you would do it.
Speaker 6: And I think you know that is a watch out
Speaker 6: or you know, a non technical challenge.
Speaker 4: In my opinion, i'd agree with a lot of that.
Speaker 4: I think it's nuanced time. Many of these challenges relate
Speaker 4: to communications and group understanding. We have some clients would
Speaker 4: treat platforms as purely externally procured devices you off a shelf.
Speaker 4: Some that have internally developed platforms.
Speaker 5: That they tread as their workhorse.
Speaker 4: You know, if a drug can go into that platform,
Speaker 4: let's leverage it. We can save time we can kind
Speaker 4: of amortize that investment. I think one of the biggest
Speaker 4: challenges we've found is that it's very hard to kind
Speaker 4: of identify that jumping off point for a platform. A
Speaker 4: lot of asset teams and formulation teams don't want to
Speaker 4: be the guinea pig for a platform. They have specific requirements,
Speaker 4: They have therapeutic area requirements for their end user, and
Speaker 4: they don't want to water down those requirements to be
Speaker 4: more ubiquitous for a speculative, crystal ball future ambition that
Speaker 4: might not actually have a business case even defined yet.
Speaker 4: So I think some of the successful platform projects that
Speaker 4: we've seen have started life not as a platform, and
Speaker 4: that's it's sort of been a bit more of a
Speaker 4: gradual process to understand how much can we make universal here.
Speaker 4: I think that comes at a direct trade off, though,
Speaker 4: of just almost setting a little bit more realistic expectations
Speaker 4: of what you can and can't achieve with a platform.
Speaker 5: I think if.
Speaker 4: I choose an example as basic as a fill volume change,
Speaker 4: a lot of the time you might suddenly change a spring,
Speaker 4: you might have a different plunger rod length, the combat
Speaker 4: kind of free flight and glass fracture risk and suddenly
Speaker 4: that platform might have mutated into quite a different variance,
Speaker 4: so much so that some of those initial perceived benefits
Speaker 4: are diminished. We've also seen that on the manufacturer and
Speaker 4: scale up side of things, that again, this sort of
Speaker 4: white whale platform that resolves all scale up challenges is
Speaker 4: a nice ambition, but you might find that your fill
Speaker 4: finish requirements are different, Your supply chain is so fundamentally
Speaker 4: different that yes, you've saved time and effort on the
Speaker 4: design side, but you actually have very different supply chains
Speaker 4: for a single platform. And I think the reason I
Speaker 4: cite that is we've seen some businesses and business units
Speaker 4: outside of device groups maybe expect too much from a platform,
Speaker 4: and I think we have to be a little bit
Speaker 4: cautious about how much we add hype to that platform
Speaker 4: and over promise. Yes, of course it can save some
Speaker 4: development effort, but I personally don't see it's shaving years
Speaker 4: off every development project, and would advise a little bit
Speaker 4: of cultion there from reality.
Speaker 2: Thank you. I want to build upon the regulatory piece
Speaker 2: that you spoke of, because I know, Brad, we had
Speaker 2: a lot of prediscussion and then you brought up the
Speaker 2: regulatory hurdles that we're facing, and I'm just curious, do
Speaker 2: you have any thoughts on how we as an industry
Speaker 2: can try to try to overcome some of those hurdles
Speaker 2: when we think about platform approaches.
Speaker 7: Yeah, so I appreciate bringing this up so realistically, right,
Speaker 7: if any of us on stage were privy to information
Speaker 7: that you know, spelled out the secret sauce of a
Speaker 7: platform leveraging submission, that's you know, trade secret. That's a
Speaker 7: competitive advantage, and it's probably not something that we talk
Speaker 7: about here today, let alone share with each other. So
Speaker 7: I think we need to as an industry, if we're
Speaker 7: going to really move this space forward, really really focus
Speaker 7: on you know, a common message to the agency, uh
Speaker 7: and and really try to establish you know, a single
Speaker 7: point of view uh to to pull back a guideline
Speaker 7: such that everyone can kind of, uh, not only work
Speaker 7: towards the same end, but also then open up the
Speaker 7: walls of dialogue.
Speaker 2: So anyone else have thoughts on the regulatory hurdles?
Speaker 3: I think maybe just a thought at a and a
Speaker 3: question back to you, Brad, you know, and there is
Speaker 3: some precedent, right if we think about like platform autoinjectors.
Speaker 3: You were alluding to auto injectors before. And you know,
Speaker 3: so for example like SHL and ibsomet have auto injectors
Speaker 3: that can be used for a lot of different indications
Speaker 3: and are used for a lot of different indications. And
Speaker 3: you know, part of the benefit of perhaps working with
Speaker 3: a supplier like that is they do have an established package,
Speaker 3: right that you can help, that you can put as
Speaker 3: part of your submission of the combination product that's been
Speaker 3: it's been tested that they're dv is tight, you know.
Speaker 3: And and so there's some precedent I think that maybe
Speaker 3: gives us guidance as to where we might start with
Speaker 3: our with any internal development. But I wonder Brad, sort
Speaker 3: of in your your opinion sort of where does that
Speaker 3: stop an end right and if if you think about
Speaker 3: that precedent and how it might apply.
Speaker 7: To I think the answer is there's platforms and then
Speaker 7: there's platforms.
Speaker 5: Right.
Speaker 7: I think a lot of folks in the room have
Speaker 7: on their websites, UH platform suppliers, platform manufacturers, et cetera.
Speaker 7: That means something very different to everyone. And I think
Speaker 7: you know, the ultimately the end goal here isn't just
Speaker 7: the device, it's the full platform expression, right that the
Speaker 7: full model of the device, the manufacturing and the regulatory
Speaker 7: piece is kind of all working uh together to streamline
Speaker 7: a submission process. So I think, you know, with regard
Speaker 7: to the you know, the devices that are available, I
Speaker 7: think it's appropriate that they're described as platforms. But ultimately
Speaker 7: than how each one of our companies interacts with those
Speaker 7: those those those vendors and partners and progresses forward. That's
Speaker 7: really probably where you know, the sharing stops, and the
Speaker 7: and the and the competitive advantage remains internal. And i'd
Speaker 7: really moving forward like to see a more transparent dialogue.
Speaker 7: And I think that that's probably probably only fostered by
Speaker 7: uh uh, you know, the agency being a little bit
Speaker 7: more forthcoming with the guidance.
Speaker 2: Than other hurdles. I think we've also seen is over
Speaker 2: recent years is kind of disruptions in some of our
Speaker 2: supply chains, which can really impact you know, primary container
Speaker 2: closures that we might be putting into some of these
Speaker 2: combination products, and it kind of begs the question of
Speaker 2: dual sourcing for some of these How do you feel
Speaker 2: some of these alternative primary container closures can be implemented
Speaker 2: within a platform as well? So Rader Tim thoughts, sure, Yeah.
Speaker 7: So I think it's more it's when when folks get
Speaker 7: started on a common platform combination development program, a lot
Speaker 7: of the focus tends to be on the device and
Speaker 7: and neglects, uh the primary container. But in most cases
Speaker 7: the primary container is an integral part of the delivery system.
Speaker 7: And so you know, I think, you know, dual sourcing
Speaker 7: primary containers is absolutely appropriate. But I think the key
Speaker 7: piece is that the vetting and the sourcing and the
Speaker 7: verification UH and the inclusion of those multiple options is
Speaker 7: is done at the outset of the platform development program,
Speaker 7: not at the not at the tail of it, because
Speaker 7: if it's the latter, if it's at the tail, really
Speaker 7: you know, you're the team is risking the repetition of
Speaker 7: all a lot, a lot of the design control and
Speaker 7: and perhaps even verification testing that was done on the
Speaker 7: first container, and and really negating a lot of the
Speaker 7: timeline savings that the platform program was was meant to
Speaker 7: accomplish in the first place.
Speaker 5: I'd very much agree. I think.
Speaker 4: Historically you might have chosen your primary presentation, your primary container,
Speaker 4: and almost treated the secondary supply as a theoretical element
Speaker 4: that you consider.
Speaker 5: But maybe keep to one side.
Speaker 4: And when I think about the economies of scale, when
Speaker 4: you're going through DV.
Speaker 5: Being able to do.
Speaker 4: That with multiple primary containers and secondary supply options, I
Speaker 4: think that's where you get the savings. So I think
Speaker 4: as we've seen that supply disruption, I think it has
Speaker 4: been a little bit of a shot across the boy
Speaker 4: we should.
Speaker 5: Be doing this.
Speaker 4: And I think it's easy whenever it's a fast paced
Speaker 4: development to consider this is optional, it's extra.
Speaker 5: We don't have to.
Speaker 4: But I think that can be quite short sighted and
Speaker 4: genuinely catchy eyed.
Speaker 2: I think a common thing we've heard in responses in
Speaker 2: this panel has been getting the business buy in and
Speaker 2: stakeholder alignment. And that's certainly very important. And you know,
Speaker 2: what do you think is the most important aspects to
Speaker 2: get that alignment? And maybe is there processes in place
Speaker 2: that you've had that have been successful to really sell
Speaker 2: that to your stakeholders, maybe both internally and externally.
Speaker 6: Sure, I think I briefly touched upon it earlier, but
Speaker 6: I would like to expand on it. So I think
Speaker 6: almost every company has, you know, some way of developing
Speaker 6: business cases to get buying on you know, any new ideas, concepts,
Speaker 6: et cetera. Something similar could be followed for platforms as well. However,
Speaker 6: who drives that is often a question because traditionally most
Speaker 6: of the farmer companies are you know, ast focused. There
Speaker 6: are theopeutic areas who are driving you know, a progression
Speaker 6: up there.
Speaker 5: Particular portfolio drive it.
Speaker 6: And it's it hurts a little bit to say that,
Speaker 6: you know, even though things have improved, devices are still
Speaker 6: to some extent are afterthoughts. You know, until the molecule
Speaker 6: progresses to certain stage, maybe you know, be on phase one,
Speaker 6: somewhere in phase two, or you know, in some cases
Speaker 6: even in phase three, there is not much serious thought
Speaker 6: given to devices, so forget about platforms. So that's where
Speaker 6: you know, we are still in this industry. So I
Speaker 6: think you know, every organization you know, we will have
Speaker 6: to think you know, about it strategically, uh and make
Speaker 6: sure that you know there is some kind of strategy
Speaker 6: about you know, platforms.
Speaker 5: First, to understand from technical perspective.
Speaker 6: Whether platforms are visible and I'm using the term technical
Speaker 6: very loosely here. By technical, what I mean is that
Speaker 6: from design, engineeringality, regulatory manufacturing, is it feasible to have
Speaker 6: a family of drug dealby devices or device configurations that
Speaker 6: could address uh, the asset pipeline in such a way
Speaker 6: that we don't be spending a lot of efforts repeating
Speaker 6: the same thing.
Speaker 5: Again and again for device development.
Speaker 6: So once that technical portion is addressed, then the other
Speaker 6: part is the business aspect of it is, unless you
Speaker 6: have you know, business buying you know, uh, you won't
Speaker 6: be able to do much about the platforms. So why
Speaker 6: it is beneficial to uh, you know, pursue platform approach
Speaker 6: that needs to be also quantified and once you get
Speaker 6: you know, buying from you know, your senior leadership, because
Speaker 6: that buying is needed for a front investment in you know, uh,
Speaker 6: you know, in terms of money, fund you know, resources, uh, efforts, time,
Speaker 6: and et cetera, where a particular asset of particular molecule
Speaker 6: or therapeutic area may not be willing to you know,
Speaker 6: fund all of that. So if you figure that out,
Speaker 6: do let us know as well, and so we can
Speaker 6: copy it.
Speaker 3: All right. I might offer a bit of a counterpoint
Speaker 3: to the point there that you know, I think that
Speaker 3: having worked in innovation a large portion of my career,
Speaker 3: I would say that I don't know that I've ever
Speaker 3: run across a problem that could not be solved. I
Speaker 3: think that technically we have lots of science and technology available, like,
Speaker 3: we can solve a problem, right, but is there a
Speaker 3: business need and a willingness to pay for that and
Speaker 3: to perhaps even wait the time it would take to
Speaker 3: solve the problem?
Speaker 2: Right?
Speaker 3: It's all about time, money, and resources. But I think
Speaker 3: it can be done. But how do you get that
Speaker 3: business need the buy in that you need the stakeholder
Speaker 3: alignment and who are the early on and then later
Speaker 3: on who are the key stakeholders? And I think it
Speaker 3: almost goes back to the previous question. We talk about
Speaker 3: a supply chain, right, So first and foremost, if we
Speaker 3: think about the end and think about the end in mind,
Speaker 3: like begin with the end in mind, you know, can
Speaker 3: we even make it? Does it fit within our strategic
Speaker 3: network of manufacturing suppliers or you know, is are there
Speaker 3: are there really nice sort of sort of vertically integrated
Speaker 3: suppliers that are already in our network that this can
Speaker 3: easily fit into, or are we're going to have to
Speaker 3: build a whole new capability to support this and that's
Speaker 3: going to be a harder sell. Right, So that's I
Speaker 3: think it's a really important part of the stakeholder alignment
Speaker 3: is how we can actually do this in the end, right,
Speaker 3: Sure we can do it technically, we can do it
Speaker 3: in a lab, right, but can we do it at scale?
Speaker 3: And but then after you know, sort of get past
Speaker 3: that hurdle. I'm not necessarily these necessarily saying these are
Speaker 3: all in order, but I do think that one is
Speaker 3: really important. The next is sort of like where is
Speaker 3: the ask coming from? And I think the ask really
Speaker 3: it's important in the beginning and it's important in the end,
Speaker 3: and it gets muddled a lot in between. Right, So,
Speaker 3: in terms of getting the buy in early on, you know,
Speaker 3: I think start in discovery, right. If the discovery teams
Speaker 3: come with you know, when they're first drafting, you know,
Speaker 3: they're a part of at least the conversation of drafting
Speaker 3: the target product profile and are putting specific needs on
Speaker 3: the table, like we need this, this would be beneficial.
Speaker 3: Then if you can get it into the target product
Speaker 3: profile early, that's a win.
Speaker 1: Right.
Speaker 3: Once the program is on their path, it's going to
Speaker 3: be difficult to change course or because it becomes like
Speaker 3: a containership. The other end is commercial. A lot of
Speaker 3: product product teams that are already underway, you know, they're
Speaker 3: not going to move that containership unless commercial says they
Speaker 3: have to, right, So sort of like bridging, you know,
Speaker 3: from both, you know, early on in discovery and then
Speaker 3: later on a commercial, and then bringing that together in
Speaker 3: the middle and you know, at the point of execution.
Speaker 3: I think is all equally important. I think those are
Speaker 3: probably for me, some of the most key stakeholders, all right.
Speaker 2: And with that, I think we're exactly out of time.
Speaker 2: So thank you to our panelists today for the great
Speaker 2: discussion in thoughts.
Speaker 1: We hope you enjoyed the podcast. For more information about
Speaker 1: the pod conference, editorials, podcasts, or webcasts, please visit drug
Speaker 1: dash delivery dot org. Thanks for listening.