We can’t just hope for a better year in 2024, we have to be active agents
By C. Simone Fishburn, Editor in Chief
December 23, 2023 1:45 AM UTC
If Queen Elizabeth II thought 1992 was an annus horribilis, she should have tried 2023.
Not many people inside or outside biotech will be sorry to turn the page to the New Year. But that’s the point — there’s a lot different that needs to happen on that next page. And writing that better future will take some effort.
Three issues stand out: the financial crisis, the crumbling state of biotech’s public policy pillars, and the status of academia that threatens the foundation of this industry’s future.
The capital markets and funding landscape were terrible. All but the biggest curmudgeons will be looking at the rise in the XBI and the announcement of expected rate drops by the Federal Reserve chairman with eager eyes, hoping 2024 provides a more welcoming financing environment.
When that day comes, it would be good to remember the discipline that this year has imposed — it takes meaningful clinical data to impress investors. Bloated G&A doesn’t help early stage companies. Building long-term sustainable companies is hard but worth it.
There’s been much hand-wringing about too many companies being created, too many people flocking after the same targets with undifferentiated products, and ungrounded expectations of valuations coming up against a hard reality. The same is probably said after each bear market, but it’s worth repeating: those lessons would be good to hold on to when the good times roll again.
This month has delivered examples of polar opposite journeys, both of which exemplify the creativity and tenacity it takes to go from idea to product.
The hope for 2024 is that there is a very real reckoning that starts to change the template.
The CRISPR voyage from publication to patient, with the approval of the first CRISPR-based gene editing therapy Casgevy exagamglogene autotemcel for sickle cell disease, sets a new standard for introducing new modalities to the armamentarium. That timeline might not become the norm but it certainly shows what’s possible. CRISPR Therapeutics AG (NASDAQ:CRSP), one of the foundational CRISPR companies, which created the product and partnered with Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) to bring it to approval, will be a case study.
At the other end of the spectrum is the acquisition announced Friday of Karuna Therapeutics Inc. (NASDAQ:KRTX) by Bristol Myers Squibb Co. (NYSE:BMY) for $14 billion. The company went fast from series A in 2018 to exit, but the history of the lead candidate that drove the deal is a 30-year one. It does not rest on new biology, machine-learning guided chemistry or cutting-edge modalities. Rather, it’s a story of persistence, adaptation and the willingness to take a risk by remaining in the abandoned area of schizophrenia where the rewards — both therapeutic and commercial — are enormous for a drug that works, but the road has been treacherous.
The grand example of this is the rewards that Eli Lilly and Co. (NYSE:LLY) and Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) are reaping for remaining in obesity, and funding the large and long trials in that field when other players pulled out. These are among the high points of the year for the industry, along with demonstrating potential for these therapies to deliver tremendous societal impact.
And with various public policy moves this year, it’s clear the industry still needs to be making that case. My colleague Steve Usdin, Washington Editor, in an Editor’s Commentary last week broke down the severe headwinds facing the biopharma ecosystem on the public policy front.
Despite the industry’s success in COVID, the pandemic breathed life into the doubters of science, bringing confidence in public health to a low not seen in decades. FDA has old and new challenges, writes Usdin. Some are self-imposed — the agency needs to reform how it obtains external advice and figure out how to enable regulatory flexibility in a consistent way that maintains standards. At the same time, FDA is facing threats to its independence from the outside that could destabilize the regulatory paradigm, as a fallout of the politics of abortion. M&A is under threat from a hyperactive FTC under Chair Lina Khan, and Usdin has extensively documented the challenges presented by the Inflation Reduction Act.
Still, sitting back and complaining, or worse, pointing fingers, isn’t a strategy. Responsible policies on drug pricing, working to broaden access, and reconsidering messaging and business practices that alienate consumers might not guarantee success, but staying the path and hoping the problems go away is not a better option.
And as for problems that aren’t going away, it’s time to face the very real problems in academia, in particular, but not exclusively, in the U.S.
I have written about this on a personal front outside these pages, but the rising antisemitism surging through university campuses, coupled with environments enabling Islamophobia, is a very real threat not only for the individuals affected, but also to the academic enterprise upon which this industry depends.
Those universities, in particular the elite Ivy League institutions and others in their ranks, are the breeding grounds for not only the next innovations, but the next generation of start-up founders, biotech executives, investors, bankers, policymakers and regulators.
The events that are playing out on the front pages are the tip of the iceberg for a problem that has been festering for years. If those houses of learning are not fostering environments where true, unfiltered exchange of ideas is happening, and where students are taught to freely question in a culture that promotes discussion rather than squelching it, then they are not delivering the talent base that this and every sector needs. Having students under threat for who they are or what they believe is a problem at every level.
How readers choose to leverage their influence is beyond my purview, but the hope for 2024 is that there is a very real reckoning that starts to change the template.
The good news is that there is much in the nuts and bolts of what the biopharma industry does to provide a platform for a good 2024 and beyond. This week, BioCentury has documented how innovation is abounding — bringing leaps of progress to new diseases and indications, and deploying the building blocks of emerging technologies to enable completely new ways of treating disease. And our Editors have weighed in on what to watch for next year.
We’ll be back January 2nd with more content, data, podcasts, episodes of The BioCentury Show and events to bring together the stakeholders that drive the industry forward.
Wishing you a very happy holidays, and hoping for a successful, and peaceful, 2024.
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- Source: https://www.biocentury.com/article/651028/letter-from-the-editor-turning-the-page-for-a-better-2024