In an effort to get an industry insight into the geographical differences in the regenerative medicines market segments we spoke to Dr. Larry Couture, Vice President of the Center for Applied Technology Development, City of Hope.
KNect365 Bioprocessing: In your opinion, what are the key differences in the regenerative medicine industry between North America, Europe and Asia?
Dr. Couture: I kind of touched on the big one. The biggest difference between Europe and the United States – I can’t speak as much to Asia, but I can speak to Europe and the United States – the big difference is the focus on pre-clinical animal modelling. In the United States the trend – the focus – is on testing the human product – the actual product that will go into humans – in animal models. That is our culture. That’s how we’ve been doing this for a long time and it’s the logic that has applied to all biologics. If you are not testing the human product, you are really not testing the product.
In Europe they are taking a completely different approach. They are focused on the issue I just described, which is that immunosuppression is not very effective in large animals. Therefore, you are really not testing anything. If you put the product in and it’s gone in a few days, so what if you keep the animal around for a year. You are not effectively testing anything. So, in Europe there is a huge focus, including from the regulatory agency — I would say more than a focus, but a very strong recommendation. Maybe even beyond that. Maybe even an absolute, full-on requirement depending on which regulatory body you talk to and how it’s done.
To test and develop a homologous model, it basically means if you are going to go into primates, you need to create a primate version of the cell product you are interested in, a primate cardiomyocyte, for example, or in a pig from iPSC or however you think we can do that and test that product in the primate model to demonstrate efficacy in those models. That’s interesting because while that provides a great deal of safety and reliability or applicability of the data as it relies directly to a product that is being tested – it’s a monkey cell in a monkey model, for example – it in no way tests the actual human product. So, in Europe the focus is on testing in a model with a cell product that is testable. In the United States, it’s focused on putting cell products – human cell products – into animal models regardless of whether or not that animal model could actually tell you anything relevant about the human cell. So, those are huge differences between Asia and Europe and cause a great deal of consternation amongst developers trying to develop products for both countries.
In the United States – well, even in Europe – investigators are faced with the potential of having to establish a whole product or a whole new iPSC line, a new differentiation process, a new characterisation plan for a primate cell to test in those models if they want to then move and do clinical studies in Europe. And there is always the possibility that one side of the Atlantic or the other is going to have to capitulate. We are going to have to find some way to harmonise the studies in the paradigm in Europe and Asia. What that may end up being is the possibility of having to do a little bit of both – a little homologous testing in the United States, a little more human testing in Europe.”