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Blog – How does an idea turn into a clinical product?

Thomas Edison famously said that the value of an idea lies in the using of it. It’s a great quote although you have to ignore the fact that Edison actually thought the value of an idea lied in silencing any competitor, so your idea is the only option. A quick google into what he and JP Morgan did to Nikola Tesla will make you realise Edison was not the American hero he is heralded as. I often wonder where we would be in terms of sustainable power if Tesla had been embraced rather than silenced by the power of the American conglomerates that we using Edison’s technology.

That being said, Edison was right in his original quote. You can have the best idea in the world but if nobody is willing to use it, it is totally redundant. So why am I writing about this? Well… you may have seen in the news that a third therapy for Alzheimer’s disease is showing promise in phase three clinical trials. After decades of what has felt like a war of attrition in the field, we may be about to get our third therapy in three years.  But how do you get to that stage? It’s the stage we all want to reach; delivering something that is actually going to help patients. Yet so few of us are there and aren’t clear on how to get there.

This is something that has become of particular interest to me of late. In February we got accepted onto an Innovate U.K. programme [1] called ICURe. It stands for ‘Innovation to Commercialisation of University Research’ and it has one goal; to get your idea to market in the most efficient and effective way. Not all ICURe projects are based around medical research but many are and they help you work out your best pathway to the clinic. It has been a really exciting and interesting journey and I would urge you to keep an eye on the YouTube page if you want to know more. We should be posting a few shorts about the journey I have been on with my team.

So what have I learned? Well… it’s basically that Edison quote. We all have ideas but how many of us really know how they would be implemented outside of our lab experiments? I certainly didn’t until very recently. It turns out working out how your idea would be implemented is a lot more complicated than “this idea could help patients with X cope with Y”. It becomes even more complex when you consider that many ideas actually have zero applications in the spaces they were designed for.

Now with something like and AD drug, this is probably not the case. You target a specific biological pathway and do in vitro tests. If you see promise you then go in vivo [2]and do preclinical testing. Then it’s clinical trials… simple right?

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Innovate UK helps UK businesses to grow through the development and commercialisation of new products, processes and services

Wrong! Before you get there you have to take a number of steps. You need to speak to regulators about what you have found so far. Regulation is an incredibly complex procedure. Do you have a medicine? Or is it a medical device? How does it work? How long will it stay in the body? What are your claims? So many questions you need to answer, and you will need help with them. This is where someone like a technology transfer officer comes in to help.

On top of that, you need to raise a hell of a lot of capital to fund a clinical trial so you better be as sure as possible before you go there that you have something real. You may have noticed that the latest break through has come from Eli Lilly [3] and not a university. The research may have come from a university originally (I don’t actually know in this case) but it is very rare for the research to stay there when it comes to the stage of a trial. Clinical trials [4] are incredibly expensive. We’re talking  $4, 13, and 20 million for phases 1, 2 and 3 respectively. Raising that kind of money at a university is difficult and rare. You either have to partner with a big pharma company or spin out a company of your own and search for investors.

Then when you are through trials, you need to sell your product. This might be easy for an AD drug as there is a very clear market with, at the moment, only two competitors. But what if your idea is not a drug? What if it is a test or a medical device aimed at helping patients? Approval for something like that is usually simpler but you may get to market and find nobody actually wants to use it or it doesn’t really work in the way you thought. This is the reason most companies fail and it’s totally avoidable.

The key is market research. As part of ICURe we are pressed to explore multiple markets for our idea. We have a primary (this is the market we had in mind when we started to research our idea and is usually the one you have the most data in). We also have a secondary market where we think we can bring value but don’t have a lot of data. Finally we have a wild card market which will see our idea used in an area we never envisaged. For us this market is not even medical which carries the benefit of not needing to go through clinical trials to have a final product.

When you identify these markets, talk to as many people in as many places as possible. Companies, clinicians, investors, patients, potential partners. Explain your idea and see if they think it has value. If the market tells you you’re on the wrong track, pivot to another one. Fail now when it’s cheap and low risk but don’t give up if the market says you don’t have something. How many times have researchers given up on an idea because it didn’t work as planned? And how many more useful clinical products would we have if they simply pivoted to exploring a different application of that idea? Ideas rarely have no application but many don’t find their application because they are abandoned too early.

It is a long, labour intensive road to get something from the lab bench to the bedside of the patient. Worthwhile ventures are rarely easy going but I can honestly say from my experience, exploring that pathway is incredibly exciting and stimulating. We work day after day doing experiments, writing papers, writing grants and often wonder ‘is this actually going to help anyone or is it just a nice idea?’ Put that question front and centre when you think and speak about your work. If you have the focus of clinical applications and start talking to the people that can help you get there, you greatly increase your chances of making the progress you want. And don’t be afraid to fail. Especially when the failure is cheap. The value of an idea lies in the implementation of it. Make sure you are implementing it in the right places for the best chance of success for you and the patients who need it.


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Dr Sam Moxon

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Dr Sam Moxon [5] is a Research Fellow at the University of Birmingham. His expertise falls on the interface between biology and engineering. His PhD focussed on regenerative medicine and he now works on trying to develop 3D bioprinting techniques with human stem cells, so that we better understand and treat degenerative diseases. Outside of the lab he hikes through the Lake District and is an expert on all things Disney.

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