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• Interviewer: A year or so ago, how did the idea to do VLE come into your head? What was that real inception point for you?
  
  MARK: Maybe about five years ago, it was very telling in the market that our clients were going through incredible innovation on the molecular side, you know, coming up with new gene therapies, immunotherapies, personalized medicines, and so on. They’re perpetual innovators, much like ourselves, and they were changing the game, and APC started to get involved in the science of that new scientific frontier.
  
  It started to become very evident that whilst our clients were innovating, the way for them to catapult their medicine to market wasn’t changing, or wasn’t being innovative. They were applying the same brute force model and big assets –  like the CDMOs have – to that new innovative model.
  
  Perpetual innovators – going for a new frontier – and they were working with the old mechanics to try to get it done. I just don't think that was a good fit.
  
  Then, as COVID emerged, we really got quite a compelling understanding that the supply chain for making these advanced therapeutics was just going to be strangled by COVID. And the supply chain could be talent. It could be materials. It could be service…access…could be everything associated around trying to make that happen. The emergence of COVID was drowning out the supply chain and we really had to do something to try to address that.

• Interviewer: So you mentioned the old way of working – the old mechanics.  The molecular innovation is high, but the kind of the mechanics to get those medicines to market is low. What what do you think the new world looks like with VLE?
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  MARK: Looking at some of the classic modalities out there – be it monoclonal antibodies or proteins – the science in terms of the process innovation was never the winner. Like, never. There was no real process, innovation or vision really to how they were made.
  
  As a result of that, there’s a lot of large assets in the manufacturing space that are just being plugged in with these old school protein bases. So that’s the old way.
  
  I think the CMC, the process, innovation was never valued. I think these CDMOs were willing to do their manufacturing and perhaps the pharmaceutical companies were willing to accept adequate performance. And that’s just not going to fly in a world where a supply chain has been killed. Cost of materials and cost of these new therapies needs to be tackled.
  
  So I think the old way where CMC innovation and science is lowest, is not the future. I think what's exciting about VLE springing from APC is that it's the exact opposite. At APC and VLE Science is the leader, because it’s the scientific innovation that is unlocking the potential of these therapeutics. Scientifically led manufacturing - not asset-based.

• Interviewer: Could you speak a little bit about how key APC and VLE’s digital innovation is in driving this whole strategy of catapulting?
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  MARK: Something we speak a lot about is that the typical CMC component that enables manufacturing is highly disaggregated by people, equipment, information, sources, reports, language, email, SharePoint, and so on. And our digital strategy through iACHIEVE is to completely eradicate that. All of that aggregation and connection is done digitally.
  
  So the data that drives the CMC plans that drive the data acquisition, drive the information outcomes that drive the CMC control strategy that drive the regulatory reports that drive the batch record or control strategy for manufacturing. That’s all completely digitalized.
  
  So no tech transfer, no knowledge transfer. Information continuity is just nailed. That is a real game changer for time from CMC invention into realizing manufacturing. That’s a process that typically takes years, even within some of the biggest corporations that have all of the capability and resources at their disposal.

• Interviewer: You’re working on a medicine right now at APC. And it's going to launch into VLE. And you’re going to deliver medicine for patients imminently. What do you think is the value that you’ve delivered - as an example of this catapult or launch pad speed?
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  MARK: The challenge our client had was looking at a therapeutic that was going to cost them 10s of millions of euros per dose…and there’s just no way the company from an economic perspective can actually dose people at that type of price range.
  
  Then the second component associated to that is, when they were manufacturing the product through their existing process, they could make enough material to dose, single digit number numbers of patients. So, a clinical reach of like five to ten people, that's just not gonna do it.
  
  Then they were looking at a clinical manufacturing strategy that was just operating on a timeframe of years.
  
  We activated the APC / VLE  Medicine Accelerator strategy and we got the price per dose down to a fraction, per dose, of the original cost – and we can make material that will go from 10s of people to like 2000 people.
  
  Then the timeframe, you know, we literally have taken two years off the CMC – that’s time to access for patients. So within this year, people will be getting medicine that we’ve developed through the APC digital innovation flowing into VLE.
  
  If they went the old way, you’re probably talking hundreds of millions of dollars, two years away, and maybe 10 or 20 people getting the medicine, and that therapy would be parked, just left on bench, it wouldn't be getting to patients. We’re unlocking that potential with the APC and VLE Medicine Accelerator.

Interview conducted by Des O’Grady, CCO of APC & VLE Therapeutics