Gartner Hype Cycle diagram. Creative Commons.
Are you familiar with the Gartner Hype Cycle? It’s a way of separating reality from hype when it comes to emerging technologies – like cell and gene therapies (CGTs). The hype cycle employs a graph to present the maturity of new technologies as they pass through five phases. Learn more here.
The Gartner Hype Cycle was a topic of conversation at “The Future of Regenerative Medicine,” an event hosted by CCRM in Montreal earlier this month. While members of the CCRM team were attending the Stem Cell Network’s annual conference, we took advantage of the location to invite the Montreal regenerative medicine community and delegates of the Till & McCulloch Meetings to a panel discussion and networking event.
Cynthia Lavoie, President & Chief Investment Officer, CCRM Enterprises Inc., moderated an engaging and educational event. She began the discussion by sharing her opinion that CGTs are currently in the “slope of enlightenment” stage of the cycle, whereas panelist Patrick Bedford, Vice President, Regulatory Affairs, Morphocell Technologies, and Founder & Managing Director, weCANreg Consulting Group, stated that the field is in the “trough of disillusionment.”
Before going any further, here are the definitions of these terms, by Gartner.
- Trough of disillusionment
Interest wanes as experiments and implementations fail to deliver. Producers of the technology shake out or fail. Investment continues only if the surviving providers improve their products to the satisfaction of early adopters.
- Slope of enlightenment
More instances of the technology’s benefits start to crystallize and become more widely understood. Second- and third-generation products appear from technology providers. More enterprises fund pilots; conservative companies remain cautious.
L-R: Benjamin Haley, Emily Titus, Patrick Bedford, Robin Quirk, Cynthia Lavoie. Author’s photo.
Dr. Lavoie asked each panelist to share their thoughts. Bedford, who initiated the topic and voted for “trough” explained that there has been a great deal of promise and hope attached to the CGT field over the past decade, and now we are in a phase of learning. “People will turn away from allogeneic cell therapies because they are concerned about persistence and long-term safety – questions that regulators and others will bring up. This makes sense, but it doesn’t mean abandon them.”
He says that in the slope of enlightenment we have to address these problems. To be successful from a regulatory perspective, you need to learn how to manufacture to GMP, how to do preclinical to GLP and how to bring clinical to GCP. Bedford: “If you don’t know those acronyms, you have some homework to do.” Further, he says you need high-quality data to get out of the trough and he thinks “quality is why we are in the trough of disillusionment.”
Emily Titus, Senior Vice President, Technical Operations, Notch Therapeutics, told the audience that her company is developing a stem cell-derived CAR T therapy. It’s a next-generation allogeneic therapy to replace or augment autologous CAR T-cell therapies.
Notch, the first company to go through CCRM’s incubation program, received an impressive US$85 million in 2021, but Dr. Titus says the funding environment has changed since then. Clinical data for allogeneic products have not met investors’ expectations in terms of efficacy and durability. Induced pluripotent stem cell (iPSC)-derived T cells have turned out to be harder to create and manufacture than the 2021 investors recognized.
Now, she says, we’re facing a tougher funding environment with roadblocks and challenges that our competitors or comparable technologies have faced, and investors are asking tougher questions, such as: “How long is this really going to take” and “How hard is this really going to be?” In Dr. Titus’ opinion, we’re in a trough.
She went on to say that it has dawned on the industry that allogeneic therapies aren’t going to replace autologous therapies in three years, with everyone getting rich. Instead, she says, the technology needs more time to develop. “Nothing, for me, has changed in terms of the promise of the technology, the promise of creating an allogeneic therapy that can be administered to many patients and increase the accessibility of these life-changing drugs, but what has changed is we now realize how long it will take and how hard it will be. So we really need to buckle down and hopefully investors will be with us for that long haul of figuring this out and getting us to that place where we can really show superior efficacy to autologous, which is really what it comes down to. These drugs have to be effective and potentially equivalently effective as autologous to really be taken up by the organ.”
Next to weigh in on the topic was Benjamin Haley, Professor, University of Montreal and FRQ Chair in Genomic Engineering. Dr. Lavoie asked him to comment on therapeutic potential vs financial reality. Dr. Haley stated: “I’m still bullish on cell therapy because the reality is that they work.” But he acknowledged that not all of them will, and some are still in the beta stage. However, he shared an example of the success we’re witnessing. Recently, a patient with sickle cell disease, who was facing a shorter lifespan and chronic pain, received Casgevy and was later photographed at the top of Mount Kilimanjaro. Dr. Haley implied that this was a feat he could not have achieved before the treatment.
Dr. Haley went on to say that, being in the early stages of development with some of these therapies, we need to understand the manufacturing and biological pitfalls. Other fields took decades to mature, but now people think of these treatments as routine. Although he didn’t “vote,” it seems he places CGTs in the trough.
CCRM’s Robin Quirk, Vice President, Technology Sourcing & Venture Development, offered his perspective on moving from the trough to the slope of enlightenment. He shared that he’s feeling positive. According to him, the Gartner hype cycle is “completely predictable. It’s not unusual across a whole range of technology development areas and we’re always going to collectively end up in that trough.” He said that Patrick mentioned the lack of focus on quality as a big contributor but, on the flip side, “you only know what you know,” and by sharing information, which is essential in an early-stage industry, we move the sector forward together. “I don’t think it’s all doom and gloom.”
“We’re almost getting to the stage in the sector, I think, where we’re almost too big to fail. […] There are now I think about 150 products that are on the market. It’s not far off. [There are a] similar amount of Phase III trials that are going on at present, and there’s about 4,000 products at the moment which are in pre-clinical or clinical-stage development. And so going back to that shared learning – there is going to be an evolution, but just playing a numbers game there will be, undoubtedly, future successes that come out of all of our activity.”
Ending this post on a positive note, Dr. Quirk said he is very optimistic about the future of the CGT space.
Where would you place the CGT industry in the hype cycle? Please comment below.
Stacey Johnson
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