We’re just one month into 2025, and there’s already a LOT to talk about in the drug development industry—courtesy, as always, of the JP Morgan Healthcare Conference. This year’s event didn’t disappoint!
Love it or fear what prepping for it will do to your holidays, JPM has become THE way to kick off the year for the life science investment community. It’s where big deals go to get announced, where major industry players go shopping for innovations, and where funding-hungry innovators go to chase that key next round.Â
And JPM25 was absolutely true to form.
For the leaders, innovators, and investors gathered in San Francisco, there was lots of cautious optimism in the air—and a sense our sector may finally be navigating its way out of the challenging period it’s faced over the last few years. But many disruptive changes are definitely still ahead.Â
Here are a few of the big themes that could impact our Digital CMC community.
1. It was sunny and pleasant in San Francisco—in January!
Okay, okay, this isn’t exactly an industry-shaping surprise. But if you’ve ever waited hours for your socks to dry on a damp, chilly winter day in the Bay, you’ll know how excited attendees were to take this win. THAT was the real San Francisco Treat.
(The real) 1. Big deals are back!
This is the one nobody missed: M&A activity came back in a big way at JPM25, reflecting renewed confidence at many levels of biopharma industry.Â
Top of the ticket, of course, was J&J’s landmark acquisition of IntraCellular Therapeutics—the first true mega-deal the sector has seen in several years. But lots of smaller-scale dealmaking was going on too, including a flurry of smaller collaborations among small and mid-sized biotechs that added to the buzz. Checks of many sizes are finally being written again, no doubt to the relief of many companies looking for a path forward for themselves and their assets.
For CMC programs, though, all these inked deals mean the fun is only just beginning—if by “fun” you mean figuring out how to integrate two completely different technical development ecosystems. Onboarding newly acquired assets is an all-too-familiar challenge for CMC leaders, who’ll now be facing a near-term surge in data exchange as newly merged and partnered entities work to integrate their acquisitions.
But if you’re one of those leaders who wisely adopted Digital CMC solutions, get ready for that investment to pay off in a big way. Modern knowledge management platforms can dramatically streamline process migration and integration, facilitating efficient data sharing, tracking, and harmonization that will be critical to ensuring new team-ups deliver value without unnecessary delays or inefficiencies.
For CMC programs, all these inked deals mean the fun is only just beginning—if by “fun” you mean figuring out how to integrate two completely different technical development ecosystems.
2. The secondary market for life science data is booming
Another key theme this year: it’s not just about the latest medical breakthroughs, the most promising new targets, or the sexiest new therapeutic platform anymore (though all those things are still VERY cool). Data is now the hottest of hot commodities. And just about every organization that produces data relevant to drug development has increasingly valuable opportunities to monetize it.
Look no further than not one but three new partnerships NVIDIA announced at JPM, with IQVIA, Illumina, and none other than the Mayo Clinic. All three organizations are clearly exploring how they can maximize the value and impact of their vast data resources, leveraging NVIDIA’s game-changing chip technology to do so.Â
Closer to home, we also saw Regeneron and Illumina team up to fund Truveta’s efforts to tap troves of genomic data directly from major health systems. All these initiatives highlight the industry’s focus on exchanging, leveraging, and unlocking the potential of diverse datasets—and don’t expect them to be the last.Â
For the Digital CMC community, these new team-ups are a glimpse of the future. As AI-driven solutions continue to advance—with clear potential use cases in technical development—it’s easy to imagine similar approaches being applied to process data for specific substance classes. Organizations that prioritize building robust data frameworks today will be well-positioned to capitalize on these opportunities tomorrow.
3. At last, the FDA weighs in on AI in drug development
If you were in the Bay when the FDA released it’s new AI guidance, you could almost hear the long, relieved, exhale.Â
The industry has been waiting years for regulatory clarity on how the Agency will assess these technologies in the drug development process. And while the FDA’s guidance is still high-level and directional, it’s at least a valuable window into the FDA’s current perspective and where it’s likely to evolve.Â
At JPM25, this new input added even more fuel to the hotter-than-hot topic of AI, adding a number of newly-minted regulatory parameters to the discussion. In their guidance, the FDA recommends that AI policies be structured around credibility, transparency, and continuous improvement, using a risk-based approach. Data quality is now both a model-building essential and a lifecycle priority for drug developers, who’ll be expected to show how they both establish and maintain the datasets underlying their AI solutions.
For CMC teams, the message is clear: this guidance underscores the importance of curating high-quality, regulator-ready data long before deploying AI solutions that may fall under FDA review. The foundation for successful AI adoption will be laid upstream, in how well organizations manage and maintain their data—and the organizations that invest in that groundwork will reap the rewards in Silver Springs.
The industry has been waiting years for regulatory clarity on how the Agency will assess these technologies in the drug development process. And while the FDA’s guidance is still high-level and directional, it’s at least a valuable window into the FDA’s current perspective and where it’s likely to evolve.
4. China is ready to give US drug developers a run for their money
One more key trend highlighted at JPM25: the increasing prominence of Chinese biotechs on the global stage. Their national sector has matured rapidly and is now starting to compete at the same level as Western counterparts, with licensed drug candidates originating in China becoming a more and more common feature in U.S. clinical development pipelines.Â
But while these partnerships may bring a welcome influx of innovative new products, they’re also a clear signal to CMC leaders: Get ready to not only onboard data from different technical development programs, but programs originated in a very different market, language, and scientific ecosystem. As Chinese assets continue to populate the global pipeline, it will be increasingly important for CMC programs to get ahead of potential integration challenges by investing in robust data infrastructure.Â
Looking ahead: So what’s next after JPM25?
Together, the big themes from this year’s conference point to one clear conclusion for the CMC sector: If you haven’t started purposefully managing your knowledge and data, yesterday was the time to start.
From what we heard coming out of JPM, there are three vital steps CMC leaders need to take ASAP:
- Investing in modern, scalable data management infrastructure that can maximise the value of their knowledge—both for their own organization and the secondary data market.
- Proactively prioritizing data quality and traceability to meet evolving regulatory expectations and support AI adoption.
- Building robust frameworks for cross-border collaboration, particularly as the global biotech ecosystem becomes increasingly interconnected.
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For now, we’re as hopeful as anyone in our industry that today’s cautious optimism grows into a fresh dose of ambitious positivity. After the last couple of years, we could all use it. Today, were excited to say, the Digital CMC movement is posed to help make that possible—just ask the experts who are making the Digital CMC Summit their next stop after JPM.
We’ll see you there!
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