The Future of ATMPs

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July 2025

In part one of our two-part series on the future of ATMPs, David Phasey, Business Development Director at 3P Innovation, joins the podcast to discuss the drivers of the high cost-of-goods (COGs) for ATMPs and how automation can help reduce these COGs in the future.  

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    David Phasey
    Business Development Director
    3P Innovation
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    Welcome to the ISPE podcast, Shaping the Future of Pharma,

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    where ISPE supports you on your journey, fueling innovation, sharing insights,


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    thought leadership, and empowering a global community to reimagine what's possible.


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    Hello and welcome to the ISPE podcast, Shaping the Future of Pharma. I'm Bob Chew, your host,


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    and today we have another episode where we'll be sharing the latest insights and thought


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    leadership on manufacturing technology, supply chains, and regulatory trends impacting the


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    pharmaceutical industry. You will hear directly from the innovators, experts, and professionals


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    driving progress and shaping the future. Thank you again for joining us, and now


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    let's dive into this episode. Our topic today is the future of advanced therapeutic medicinal

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    products, or ATMPs. To share more about this topic, I would like to welcome David Phasey,

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    Business Development Director at 3P Innovation, who recently presented at the 2025 ISPE

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    Europe Annual Conference in London. David, welcome to the podcast. We're glad to have you with us.

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    Thank you, Bob. It's great to be here, and hopefully a good topic to discuss.

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    Great, and I recall your presentation was well-received with a lot of good questions

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    from the audience, so we'll follow up with a few additional questions here.

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    So, David, in your opinion, what are the biggest drivers of the high cost of these advanced

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    therapies? Is it low volume? Is it a highly manual process? Is it the discovery costs?

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    Is it the supply chain logistics? Is it the therapeutic value to the patient, or something

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    else? Yeah, this is a really good question in that ATMPs are, of course, a broad range of different

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    therapy types, very different manufacturing chains, and as I've been researching this topic

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    conducting literature reviews and seeing what available information there is,

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    unsurprisingly, there isn't necessarily a completely fixed answer to the question.

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    So, I work, of course, in the automation side of the industry rather than a therapy developer

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    myself, and I'm aware that a number of large pharma companies, BMS, for example, have done

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    value stream mapping themselves to look at the manufacturing costs of their own products,

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    and, of course, they will have a cost model specific to their product. So, the way in which

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    I and the ISP team chose to look at this topic was perhaps rather than necessarily the biggest

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    drivers of cost, some of those reasonably well sort of understood and documented already in terms

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    of the drug discovery and the increase in cost of those. There's other good studies out there

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    on transportation costs, for example. There's a couple of items that you highlighted in your

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    question. So, the way in which we sort of try to rephrase that for ourselves was actually where

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    do we feel that as a community we can add the most value? So, where is actually the greatest

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    opportunity to reduce cost? And it struck us that there's already a reasonable degree of

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    effort being put into understanding transportation costs, and, of course, a lot of that came out of

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    recent events. So, instead, actually, what we focused on and where we saw the greatest

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    opportunity for reducing cost is in and around the manufacturing processes itself. So, you

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    mentioned in there manual processes, and really there is a significant cost associated with the

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    largely manual and semi-automated processes which have historically been laboratory-based,

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    and that transition to GMP does a significant cost with that. And so, that's where we decided

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    really to focus in on and explore because that's what we saw as an engineering community where we

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    felt there was most opportunity to add value and contribute to that reduction in cost.

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    Okay. So, my limited understanding, you've got a highly manual process, so you have

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    training of the people, you have the cost of the manpower, but I'm also aware that there's a pretty

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    significant effort around a myriad number of deviations that typically occur from a manual

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    process. Are there other aspects, and what's the low-hanging fruit here in the manual process

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    to implement automation and have the biggest positive cost reduction impact?

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    Yes. So, the way that we've been looking at that is the answer is perhaps a little different

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    depending on which the scale of manufacturing and the type of the ATMPs, but if we consider

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    probably the most common examples in describing that clean room, that manufacturing suite,

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    as you talked about, they're largely manual processes with individual pieces of automation

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    for individual process steps. Now, in that type of environment, surprisingly, it may actually be

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    that the automation is not the mechanization of process steps, and I think that's where a lot of

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    people would traditionally think of automation is actually the mechanization and that being the

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    opportunity. We see a lot about robotics, and that's very exciting, but when the process is,

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    you actually have a therapy SAT incubating or whatever the process step is within a piece of

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    equipment for a significant period of time, the mechanization doesn't have an immediate

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    transformational impact, and therefore, actually, when we're looking at those lower scales, the

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    opportunities appear to be more around process optimization and increase in quality, and really,

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    I think that comes about through instrumentation and therefore digitization of the processes,

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    and some of the tools to support that, the automation might be as simple as, for example,

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    a barcode scanner, the ability to streamline processes. I've done some work in a completely

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    parallel, but interesting sector of sterile instrument processing, and there are a number of

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    interesting observations in that, in that from the outside, when you first look at it, you would say

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    this can't be automated, it is really difficult, there are lots of unique process steps, it's

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    largely manual, you can't really automate this, you're a bit stuck, and I've seen some really

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    superb examples of lean manufacturing thinking being brought into that sector, and having an

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    extraordinary impact on the output of a facility purely based upon lean manufacturing processes

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    of studying the utilization of people within that room, the utilization of tools,

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    tracking materials through that room, and thereby increasing utilization of the assets that already

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    exist, and having a closer eye on the quality of those processes of which instrumentation and

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    digitization can help. So, a different form of automation, I think, would be, could offer

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    people that ability to make an initial transformation change, and that's where I'd see that

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    that loafing hanging fruit being. So, I recall seeing presentations at conferences, probably in the last

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    year, two different ones, one was this sterile clean room in a box, it sat on a coffee table,

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    almost, it was a Swiss company, and it did some of the rudimentary manipulations

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    around cell and gene therapy, so that was automating the manual process, but the other

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    one that I recall was kind of like a time motion study, almost, it was done by some sort of

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    visual tool with AI, I'm not sure, but it studied the detailed hand motions of the operator,

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    picking up the tools, making the connections, and it allowed to optimize and simplify

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    what the operator was doing. Is that the kind of thing that you're talking about?

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    Absolutely, I mean, that can have an impact in both, from a quality perspective, and certainly

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    those type of tools are well understood, used for improving good aseptic process, and therefore

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    you can end up with a double impact on cost there, in that, yes, you can make an efficiency

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    improvement in the way in which the operators in the clean room are able to produce that product,

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    but probably the biggest gain is in yield, because if they're not making mistakes in the process,

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    and you're able to generate a higher yield with that batch, or not have any failures within the

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    batch of manufacturing, that obviously is far greater, or can be potentially far greater cost

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    saving than efficiency, so you can end up with both, and yes, that's the type I'm referring to.

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    It perhaps doesn't sound quite as glamorous as implementing robotics and things, which you might

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    immediately visualize, but in answering your question around low-hanging fruit, it's those

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    small steps that can actually have maybe even tens of percent improvement in the efficiency

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    of a process, but without actually necessarily spending money in order to achieve it, because

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    that's one of the other factors I've seen frequently come into these arguments, is

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    the instinct is to actually spend money to save money, and you can fall into the trap of actually

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    having dis-economies of scale, where you actually introduce more automation, and the payback

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    doesn't really arrive, depending on the throughput of your manufacturing process.

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    Now, I also know about AI being used for vial inspections and that kind of thing.

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    Yes.

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    What about a camera with AI behind it that is watching everything that the operator does,

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    and could it detect and then analyze deviations visually and resolve them

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    almost instantly as either something significant, hey, high probability you just introduced

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    contamination, or yeah, it was a deviation, but it really doesn't matter. Is that an application

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    of technology here?

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    Yeah, and it's interesting you ask that question, because I would have said only a few

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    weeks ago that that was an interesting future technology. What I hadn't realized until I went

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    to another presentation recently is that's now a current technology that exists. It's been tested.

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    I'm sure people can find that company, and I found it really interesting. It was doing exactly

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    as described there, is that by studying many, many sample images, and they were able to use

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    AI to say, well, if action X is acceptable, is good aseptic processing, and action Y is not,

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    and a good number of images of examples, the AI was then able to identify

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    actions which were not considered best practice.

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    Do we think that that technology is more, I'll say, bulletproof than a human

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    analyzing the same information and making determinations?

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    That's a good question. I think where I saw, when I saw this presentation, where I saw

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    immediate value is the fact that you can provide this ongoing monitoring of a process that isn't

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    perhaps practicable to have, in some instances, but in others not, where you have an operator

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    and then another operator watching over their shoulder. Therefore, it probably adds that

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    additional assurance, because a lot of these processes are particularly challenging to

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    perform and remember each step and perform everything.

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    Exactly right. What do you see as the current barriers to adoption of truly impactful,

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    from a cost perspective, automation into ATMP manufacturing?

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    So, in that last question, I was answering, sort of considering where we are today in a more

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    manual cleanroom and describing some of the advantages we can see from relatively small

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    changes. If we think now very much towards the future, and I think that's where you're going

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    with that question, perhaps a little, quite a way into the future, really the fundamental

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    change, as I see it, is actually driven by the consumables.

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    And this was something I was talking about in my presentation. If you look to other sectors,

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    whether in the pharmaceutical or elsewhere, part of the, or a key part of that journey,

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    has been around standardization of componentry. USB, for example, USB-C and the standardization

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    of that connector. Now, that's actually more from the, in that instance, from the consumer benefit

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    perspective. But in this instance, standardization of consumable components, I see as being one of

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    the key milestones in enabling cost reduction. There's reasons for that. Now, it's because,

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    one, you can actually allow a lot of mechanization style automation to be designed

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    around these common sets of components and consumables. That in itself promotes competition

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    within that space. But also, if you have consumables that are themselves designed to

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    be automated in their actuation, which historically they haven't been, they've

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    been designed in classic sterile connectors, are designed for dexterous use of thumbs, etc.,

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    not operated by a robot. So, I suspect we should hopefully see a transformational

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    change in consumables and that's unlocking mechanization style automation. And along

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    with that, as we get more standardization in consumables, and whether that be bioreactors

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    themselves, tubing sets, sterile connectors, filtration sets, etc., that should also enable

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    larger volumes of componentries and more assurance in supply chains that allows the cost of those

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    components to come down. So, you can end up with a snowboard effect as we start to coalesce

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    around more standardized componentry. At the moment, I see it that we're in a diversification

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    phase as everyone's exploring different technologies. And again, you see these

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    parallels happen in other industries. And there is good pattern of this in the industrialization

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    of other sectors. You go through this growth phase of diversification as people try and explore

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    what's the best way of solving this problem, what are all these best technologies.

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    But after a number of years, history shows us we always end up coalescing around a number of

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    key solutions which the industries unify around, coalesce around, and that then unlocks the next

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    phase. So, that's where I see it really. It's probably the consumable as the core.

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    Okay. In your talk regarding economies of scale, you mentioned autologous versus allergenic

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    therapies. And you also mentioned small versus large patient populations. Now, to a large degree,

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    aren't these factors beyond the control of the manufacturer and instead driven by the specific

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    disease indication and patient population and genetic profile in terms of batch size

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    and patient populations? Yes, absolutely right. And so, the reason for highlighting that was

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    really twofold. Firstly, it's my aim in the content I'm sort of producing here is I'm

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    wanting to share information with the community and seek additional input from the community.

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    Seek additional input from the community. And in this instance, I think there is a…

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    If I make the assertion that we are going to see a reduction in the cost of goods,

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    the natural question that comes immediately back is, well, to what extent? Where are we going to

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    see it? By how much? That's, of course, a very, very difficult question. So, there was a particular

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    table that I put up in the presentation where I'm trying to add a degree of clarity into what

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    does cost of goods actually mean? What are all of the drivers? And where does the manufacturer

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    of ATMPs compare and contrast with other sectors, but also other pharmaceutical products? And

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    the patient population is obviously a key component in that. And awareness of it is necessary in order

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    to understand what the limitations are. So, that's one aspect is really helping try and as we try and

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    pick apart some clarity. The other component is actually when I was talking about standardisation,

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    we're in this diversification stage. We're obviously diversification in terms of

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    number of therapy types, the manufacturing process associated with them, and the technologies

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    associated with it. So, there's diversification in many, many different areas. That means that

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    it is quite hard to standardise. So, by reflecting back this diversification, my aim is then to try

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    and help the community identify where we can start seeing these pockets of similarity. Because

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    the sooner we start identifying where similarities exist, in therapy types A, B, and C,

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    whilst they are wildly different, actually, there's commonalities in these areas. If we can unify

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    manufacturing processes in there, then we can then effectively increase the size of the patient

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    population. Not by changing the therapy itself, which of course, as manufacturers, we can't do,

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    but by creating commonality within pockets of the manufacturing process. I realise that's a little

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    abstract in my description, but hopefully that makes sense.

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    So, what about distributed manufacturing, or basically the idea of a clean room trailer

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    in the hospital parking lot that has the ability to produce any number of these

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    ATMPs on demand? Is that feasible in the future, do you think?

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    Yes, feasible, of course, opens up a number of different ways of looking at that from a

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    technological perspective. I don't see any technological reason why that is not possible.

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    We've already seen some examples of people doing that kind of approach.

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    The challenges probably come more, actually, when considering costs

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    about utilisation. It's something we haven't discussed in this podcast yet, but it is actually

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    one of the surprises to me, but probably not surprises to an accountant, as it were,

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    when looking at the costs of goods and where these costs come from. Utilisation is probably

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    one of the biggest cost drivers, in that if you have purchased all of this capital equipment in

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    the form of the trailer and the equipment that goes in it, the cost of the goods relies probably

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    on a high degree of utilisation of that equipment. Now, in conventional manufacturing,

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    if you're doing, say, a vial filling line, it's relatively easy to plan for the utilisation of

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    that. You can reasonably forecast how many batches you're going to produce a year, and therefore,

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    you can work out on a unit manufacturing basis what the cost of producing that individual vial is.

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    When we're talking about ATMPs, that becomes a considerably more difficult question,

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    and from some of the studies, as I've seen, that becomes one of the challenges, is that

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    you invest in this infrastructure, but you have far less control over the patient population demand

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    upon that service. And if you end up with a relatively low utilisation, you end up,

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    unfortunately, with a relatively high cost. And I think that's one of the areas

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    where I suspect, I very much hope, I'm sure we all hope, that the change in the style of the ATMPs,

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    the efficacy of them, actually means that we will end up moving more towards first-line treatments,

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    larger populations, and making these types of systems affordable in that you can achieve a

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    high utilisation from them because they become more norm. I suspect what we're going to see

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    in the industry is this snowballing type effect where one impacts the other.

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    Well, this has been a very interesting discussion. To recap, we talked about various ways that

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    automation could be introduced or expanded within the manufacture of ATMPs, not just robots,

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    which a lot of people think about, but how to supplement the human, make the human more

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    efficient, make the process more efficient, and all the quality system elements that go with it.

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    So, there's no single silver bullet, it seems. Would you agree with that?

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    I'm afraid so, yes. It is particularly complicated, but good opportunities at the same time.

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    Well, great. That brings us to the end of another episode of the ISPE podcast,

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    Shaping the Future of Pharma. A big thank you to our guest, David Fazey, for sharing his findings

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    on what the development of products in other sectors can tell us about how the potential

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    >reduction of cost of goods can be achieved in the future with respect to the manufacture of ATMPs.

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    Be sure to subscribe so you don't miss future conversations with the innovators,

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    experts, and changemakers driving our industry forward. On behalf of all of us at ISPE,

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    thank you for listening, and we'll see you next time as we continue to explore the ideas,

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    trends, and people shaping the future of pharma.

Listen to Past Episodes

Audio file

In part one of our two-part series on the future of ATMPs, David Phasey, Business Development Director at 3P Innovation, joins the podcast to discuss the drivers of the high cost-of-goods (COGs) for ATMPs and how automation can help reduce these COGs