How Collaboration and Simplification is Key to Solving Industry-Wide Efficacy and Supply Chain Challenges
John Kemshead, COO/Senior Director of Clinical Scientific Affairs at Biomagnetic Solutions, discusses the applications of simplification and collaboration in order to tackle supply chain limitations.
In this interview, John Kemshead explains how supply chain issues are effecting the industry and how Biomagnetic Solutions are tackling this to accelerate ATMPs speed to market.
Could you please introduce yourself and your role at Biomagnetic Solutions?
My name is John Kemshead, I am the Chief Operation Officer at Biomagnetic Solutions, which is based in Pennsylvania.
How can efficacy be a challenge when looking to commercialize advanced therapies?
Dealing with cells as a biological product means it is variable and we want a product that is highly efficacious. Trying to build technology that works every single time is very difficult, but that’s really what the end user is asking for. I have been in the field of Biomagnetic Solutions for many years, initially developing a program to identify tumor cells in bone marrow. That was very interesting, but I could not prove that it was efficacious simply because in a rare disease like childhood cancer, you needed so many patients to put into that clinical study, it was just impossible to do. We ended up with believers and nonbelievers. That’s not really the place to be when you are trying to develop a therapeutic program. I think for us, we’re going down a well-tried path of being able to produce cells for indications that we know are efficacious. Our role is to make sure that we can get them produced in a way that they are highly viable, they are functional, and they are available at a reasonable price point to the general community.
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What solutions exist to alleviate pressure caused by these challenges?
Our role in the whole of this is rather like putting a jigsaw together – we have certain pieces and other people have other pieces. We have to make sure that we can fit our technology to other peoples’. What we are trying to do in the first instance is to select T cells in a way that is efficacious. There is other technology around, I don’t want to oversell what we do, but we do believe that we can do it in a way that is, as I’ve just said, efficacious, but also at a cost point that makes it available to a wider community.
What other key industry challenges are you currently concerned about?
The one that I have to live and breathe every day is supply chain. I mean, I had retired when I came to work with Biomagnetic Solutions, and I made my bosses a commitment that we would have something on the market within a year. What I didn’t realize was just how bad the supply chain really was. It is delaying every part of what we’re trying to do, from developing the technology, building the antibody facility to make the antibodies to GMP, everywhere you turn there is supply chain issues. These are problems that I know sound rather crass, but that is the thing that we have to live with every day.
How long have supply chain issues been a problem?
It has been absolutely since Covid-19. There were some supply issues before, but not like this. When you hear that you’ve got to wait six months to get tubing, when you’ve got to wait six months to get a generator so that you can have a backup electricity supply to your facility, these are really key issues that never existed in the past, in my experience.
How could simplification play a role in addressing industry-wide challenges?
I personally think that simplification is really important. We developed a technology that we can literally take from a little tube up to a medium sized tube, from a small bag up to a large bag. This allows the customer to develop their process in the laboratory and know that it will scale completely. That’s one element of simplicity. The other one is the fact that when we get to the large scale instruments for GMP, and when we’re making clinical products, we want a machine that is simple to use and that doesn’t have too many bells and whistles.
Four years ago I worked on an instrument that was so overdeveloped that every time you open the door in the GMP facility, it alarmed. That is the sort of thing that we’re very aware of and we want to avoid. If it’s simple, it can be quick and means that the mistakes that the end user will make are fewer. Humans are humans, they always make mistakes. So it is tremendously important, and it’s a way forward to get more people to use the technology.
What is the process for the appraisal of simplification?
I think there are certain core things you have to do. It’s almost like sitting down with a piece of paper and drawing out your process and then saying, ok, what can I take out without actually risking the process? Then from the other end, a researcher in the laboratory who has certain reagents will consider, how can I actually make this process work all the way through to know that it’s scalable? They need to know that they don’t have to start again with another set of reagents after they’ve done their research work. These are the things that I think are critical to save time, save money and to actually get the products into the clinic and hopefully help people in the future.
How can simplification help accelerate speed to market for advanced therapies?
I think simplification has sped up the route to the marketplace because, for example, within eleven months we developed an instrument that we’ve now had in our hands for a couple of weeks. Eleven months to do that from a piece of paper is all credit to the supplier that we’ve had doing the design work in the development for us. If that machine was too complicated, there is no way that you could ever do that in the timeframe that we’ve been looking at. If you have a simple instrument, it speeds development into the clinic. I think we must not forget that this is really all about treating patients in the end. That’s where I started, and that’s probably where I will end my career as well.
How important is collaboration to the commercial success of an advanced therapeutic?
Collaboration really is absolutely paramount to success in my mind from every single angle that you look at. Take us as a company, for example, we need people who are trained engineers, electronic engineers, mechanical engineers, plastic engineers, people who know how to make biological components for the system and people who even know how to put things in boxes. Not one company can do all of that. I don’t care how big you are, you have to rely on other people, you have to have collaborations.
Then at the other end, you have to have collaborations with people who are treating the patients to make sure that your technology actually works and does what they want to. The whole thing is one continuum of collaboration from start to finish. What you’re looking for in a collaborator is that they can work with you at the pace that you want to work at. They are also open to discussing ideas with you and co-developing the actual technology and, even at the clerical point, understanding what your restraints are and what their restraints are to make the whole thing a success.
This interview was produced in partnership with BioMagnetic Solutions and Gamma Biosciences.
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