Photo credit: Hippopx
The 10-year boom of the cell and gene therapy (CGT) industry has inevitably come to an end: public CGT valuations are way down, companies are settling into cash conservation mode, unrealistic salary demands are being replaced by layoffs, and the vultures circling with $billions in their coffers are patiently waiting for “the feeding frenzy.” Alas, the famous Gartner Hype Cycle has been demonstrated once again. Thank goodness. We will soon enter a period of growth that is transformative, as promised, but also sustainable.
But I needed to be sure … and desperate times call for desperate measures. It was necessary to enter the bowels of the Toronto Discovery District, the backstreets of one of the most active CGT ecosystems in the world. It was time to visit my trusted psychic – Cellotta Pluripzka.
It was 12 years since we last spoke, but they were bang on about the future then. I was hoping a visit would bare sage advice again.
After commenting on how much we had aged over the past decade, and some chit-chat about inflation and the price of tarot cards, we started to reminisce about our last meeting. I had come to visit Cellotta after one of those infamous Chris Mason meetings in London that hosted a debate about whether autologous or allogeneic therapies would define the emerging industry.
Cellotta had been emphatic that this debate was inconsequential, stating that both allogeneic and autologous therapies would have their place in the future of cell and gene therapy. Instead, Celotta opined on the importance of clinical data to move the industry forward and kept talking about transformative trials in the area of “Tree cells” that are delivered via vans (…remember Cellotta is not a biologist…).
They also predicted that the industry would go through an unprecedented period of growth on the back of demonstrating clinical efficacy, and that sustainability would depend on building manufacturing capability, unlocking access to capital across the development pathway, and developing specialized talent at the interface between academia, industry and investors.
Cellotta was particularly proud that their prediction that a process for marching adult cells back in time to an induced embryonic-like state, discovered in Japan, would provide access to an unlimited supply of all types of human cells. Cellotta claimed that these “magical” cells would carry the Pluripska name, but I think this was pure coincidence. In any case, it was hard to refute the alignment between Cellotta’s predictions and CCRM’s decade-long strategy.
I pushed Cellotta to move from the past to the future. After all, I needed a crystal ball, not a march down memory lane. The industry was still growing at a furious pace, but experiencing new, albeit conventional, pressures. I began by focusing on regulation, enquiring whether the U.S. Food and Drug Administration (FDA) would be able to handle the rapidly growing pipeline of amazing “living therapies” in pre-clinical and clinical development across the globe.
Similar to our last session, Cellotta was dismissive of my initial concern, stating that the FDA wasn’t as important as everyone thought. My raised eyebrows elicited a more balanced answer: “Robust ecosystems will self-correct under stress.” Tightening of the capital markets would drive consolidation and a culling of the pipeline, which will soften demands on the FDA.
In addition, like during the COVID-19 pandemic, the FDA and other agencies would innovate their processes and engage external partners to manage the review of a growing number of advancing therapies.
Suddenly, Cellotta took on an air of concern as a vision of the future crystallized in their mind’s eye – the industry would not be bottlenecked by regulation or manufacturing (engineers will always figure out how to scale, industrialize and save the day).
Instead, it would be poor adoption and a lack of patient access that clouded the vision of the future. Cellotta saw millions of patients dying because we couldn’t transform supply chains, health care delivery, and reimbursement fast enough. The “Tree cells” (I tried to correct, but to no avail…), now effective against all cancers and derived from induced pluripotent stem cells, were sitting unused in (odd-looking) pharmacies around the world.
Cellotta grabbed my hands and implored me to think about how innovators, contract development and manufacturing organizations (CDMOs), investors, health-care centres, and others, could work together to make certain that these revolutionary products could reach patients.
Starting to ramble incoherently, I heard words like collaboration, public-private partnership, global impact, stakeholder engagement, shared benefit, artificial intelligence, synthetic biology and miracles at the bedside. I couldn’t understand everything Cellotta was saying, but it sounded similar to what we had been working on for years at CCRM – building a nexus that would catalyze collaboration to tackle the big challenges facing the industry. It appeared that adoption and access was an important area of focus in the future.
When I finally broke Cellotta from the fevered rambling, their eyes cleared and they looked at me with a wide smile and said: “You work in the most amazing field ever. Your colleagues and partners are going to change the world!”
I couldn’t help but notice a youthful glow to Cellotta, and wondered whether visions of durable treatments, less chronic disease, longevity and enhanced quality of life were already working some magic. I decided that I wouldn’t wait another 10 years to visit Cellotta Pluritzka again.
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Michael May
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