Taken from Christopher V. Gemmiti’s speech at our last Cell Therapy Manufacturing & Gene Therapy Congress, he spoke at length on the state of the industry, and how far we have come since the early 90’s and where we now find ourselves. Here’s what Christopher had to say.
“I start with a question for us as a community. Where are we? Hopefully, many of you are familiar with the concept of the Hype Cycle, which basically says if we plot out the visibility of our industry or of our technology, over time it very often follows the same type of curve be it for regenerative medicine, alternative fuel sources, electric vehicles, cell phones, solar power, you name it. Inevitably it starts with some sort of breakthrough; a technology trigger, if you will. In a very short amount of time, it’s all over CNN and the cover of Newsweek. We’re going to be curing all of these diseases and traveling to the moon before you know it. Inevitably, we reach a peak of inflated expectations and soon thereafter, we are not delivering on those expectations. It is either taking us longer to get there or it’s just not happening. We fall off the radar – hopefully only for a time – into this trough of disillusionment. If we’re lucky and we are not a flash in the pan, we sort of go up this slope of enlightenment and through survival of the fittest we eventually reach productivity. So, I will attempt over the remaining course of my presentation to try to get at the question: “Where are we?”
So, we’ll take a look at each one of these nodes, which I would loosely define as “the path to productivity” through making sure that we have a sound foundation of innovation through enabling technologies, new therapeutics, scaling-up, financing the fuel-to-the-fire through venture IPO partnering and M&A. Hopefully, between that innovation – that cash to make it go – we have great clinical progress through Phase I, Phase II and Phase III. Not to be mistaken or overlooked is translating that into the real world; making sure that the real world clinical results are showing what we originally promised. And last – and obviously certainly not least – the commercial success which starts with approval, but carries through reimbursement, real adoption and, most notably, in revenue.
So, let’s take a look at innovation. Having started in – I guess we used to call ourselves “tissue engineering” in the 90’s – having started back then and clearly all of the innovation through cellular or a cellular scaffolds and stem cells and it clearly creates a great foundation of innovation off of which we can build the cell therapy and regenerative medicine community. Over the last year, couple of years, there has been a tremendous rush of great new technologies that have come through academia, industry, as well as the major medical centers and that being the usual suspects that we all know and have come very much to love – CAR T, TCR, gene editing and gene therapy. I’ll put in microbiome in that, as well.
So, between the firm foundation that we’ve had over the last 20-30 years – as well as these new breakthroughs – I think it’s fair to say that we have plenty of fuel for the fire and our gas tank is full, which is good news. Not to be overlooked and, as we’ve heard is that the manufacturing innovation is absolutely a critical part of this. It is an essential counterpart and I think whereas we used to have a smattering of companies that would invest in this, we have a very, very long list of companies who are making a very big play into cell therapy. We even have conferences like this where we as a community can come together and talk about how best to move this forward. So, between the innovation that is happening on the therapeutic side and the innovation that is happening on the manufacturing side, this is all very good news.”