In all your previous projects as a consulting engineer working with industry, big was beautiful. Are you turning all that on its head now?
Yes, I think so. I hope so.
With both the REMEDIES programme and the MMIC programme which I’m involved in at CMAC, we are trying to take the learnings from industry and do things differently. The industry has lots of big underutilised assets. Lots of money is put into assets to make things that don’t then make it through clinical trials. And, even where a medicine is being widely used, there is still a lot of underutilisation. Most facilities are still running down in the 30 to 40% utilisation range.
The advantage of continuous manufacturing technologies is the huge impact in terms of reducing the capital outlay and higher utilisation of that capital infrastructure.
But even though it’s underutilised the wastage seems to be high?
That’s the other thing. If you are making something in batch and it is in a large 10,000 litre vessel and there is a mistake that is a lot of wasted energy and materials. In contrast, if you have something that your manufacturing continuously and you are constantly monitoring it and adjusting things as needed to ensure the quality, then your yields are going to be a lot better and it’s going to be a lot more cost-effective.
What are the limits – or are the only limits the limits of imagination or chemistry?
A little bit of both.
So much of this is what is inside our heads and the way so many of us are just used to operating in a certain way. We all develop mental models. Sometimes that’s the limiting factor in achieving the potential for innovating: you don’t believe it can be done.
And I think what the REMEDIES programme is showing is that actually, in a really conservative industry like ours, you can innovate, you can do some things that are going to have a real impact. Part of the issue with innovating in this industry is its very conservative nature. There is a paradigms shift going on for the industry as a whole in terms of the margins and the patent cliffs – the stars are beginning to align in a very worrying way for industry where it is either going to be able to innovate or it is going to lose out in the long run.
What does all this work it mean to patients?
Well it’s funny because that can sometimes be lost when you’re talking about innovation. What we are doing is a set of very complex technical things. We are not creating a new app that all the kids are going to use – it’s not as simple and so clearly linked to the end user as that. You are talking about very complex chemistry, complex processes, and complex supply chains with a lot of current fixed assets and established ways of doing things. These are big hurdles to overcome and so it is very easy to lose sight of who all this ultimately supposed to be benefiting: patients.
One of the encouraging things is that, when you talk to a lot of people in the REMEDIES programme, you find people really do have sight of the patients. It is not just about the increased yields and decreased capital spend. Yields and costs are important things that give us the impetus to make the necessary changes and drives the search for better value for the patient.
So, in this complicated supply chain, who is the end-user? It depends on your perspective. In the UK, you could say it is the NHS because they are paying for the drugs, or the taxpayer because they are paying for the NHS. Or you can say ‘no’, it is the clinicians who need these drugs in order to be able to deliver effective therapies and cure people and help people improve their lives.
Or you can say it is the patient receiving the medicine. And I suppose that’s why there is such a significant challenge in innovating in this arena because it isn’t as clear-cut when you ask the question ‘who are you impacting and why?’. The answer is you are impacting shareholders, the environment, clinicians, government and taxpayers, and of course the patient. A key benefit for patients from the REMEDIES programme is an increase in quality and availability of drugs.