Dr. Steven Cha

 

By Dr. Steven Cha, Therapeutic Strategy Lead, Novotech

Steven has 20+ years of global oncology and hematology drug development experience across biotech and pharma. He advises sponsors on translating early data into practical clinical plans and executing them globally, with expertise in immuno-oncology, cell therapy, targeted therapies, ADCs, and cancer vaccines.

 

AACR 2026 in San Diego was full of big science, as it should be. But the most revealing moments weren’t in the plenary sessions. They were in the side conversations, the quiet sponsor meetings, and the hallway questions that kept repeating in different accents and different tumor types.

The question sponsors kept circling back to wasn’t “Is this mechanism novel?” It was, “Can we run it?”

Can we recruit in a market where every major center is running five competing trials? Can we dose first patients quickly enough to matter? Can we generate a signal that supports a decision, not just a poster? And can we do all of that across regions without the program losing time to avoidable friction?

My takeaway from AACR is simple, and slightly uncomfortable: in 2026 oncology, scientific novelty and operational complexity are rising together. You can’t separate them anymore. Country strategy, site capability, and speed-to-decision are part of the science plan.

1) Geography is becoming an enrollment strategy

Sponsors are still looking outside the US, and the reasons are not hard to understand. Competition for patients is intense, and trial costs remain high. For many programs, ex-US planning is no longer a late-stage optimization. It is how teams protect timelines.

Asia-Pacific came up repeatedly as a primary destination, but what stood out was how specific sponsor thinking has become.

Early phase

Australia continues to be heavily leveraged for early phase work, often driven by rapid regulatory start-up and predictable early-phase infrastructure, with financial incentives as an added benefit. Sponsors were clear about what they want here: speed to first dosing and clean early learning.

Late phase

For later phase programs, I heard an increased interest in South Korea and Taiwan, with China discussed selectively depending on program strategy and regulatory intent. Sponsors framed these markets as essential when enrollment speed and access to large, treatment-naive patient populations become the gating factor.

Here’s the part many teams still get wrong. They treat geography as a rescue plan. They build the program around one region, then go looking for patients elsewhere when recruitment stalls.

That approach is expensive. It also shows up late, when choices narrow.

The better approach is to treat global planning as early design. Build the protocol, operational model, and country sequence with patient competition in mind from day one.

2) The science is accelerating, and sponsors are quietly raising the bar for execution

AACR had no shortage of exciting science. The buzz was real. But the sponsor interest concentrated around areas that also raise the operational burden.

Next-generation cellular and complex immunotherapies

Sponsors are watching cell therapies move beyond hematologic malignancies into solid tumors. Modified NK cell platforms came up often, along with localized costimulatory approaches and customized mRNA vaccines. These are sophisticated programs. They demand tight coordination at the site level, not just a good story in the mechanism section.

Overcoming resistance

There was continued focus on resistance, with conversations touching on pan-KRAS inhibitors, 4th-generation EGFR strategies, and synthetic lethality approaches. The common thread here is precision.

The science is getting sharper. That typically means eligibility gets tighter, biomarker strategy matters more, and the study becomes less forgiving of operational drift. Several sponsors pointed out that biomarker-positive populations are now the bottleneck — screening strategy and lab turnaround times are as important as site selection.

Multispecifics and I/O 2.0

Interest has moved well beyond classic monoclonal antibodies. Sponsors referenced bispecifics, trispecifics, and next-generation ADC formats. In these modalities, sponsors were direct about what they need: CRO partners who have proven operating experience with complex protocols, because the downside of inconsistent execution is no longer “messy.” It can determine whether the program advances.

A practical way to think about this: as modality complexity increases, the tolerance for site-to-site variability drops. This shows up quickly in real execution: vein-to-vein timelines, chain-of-custody documentation, sample logistics, and protocol deviation tolerance are now core success factors. A program can survive mediocre execution when the signal is loud and patient access is easy. Many of today’s programs have neither. That’s why execution is now being discussed in the same breath as innovation.

3) Early-stage and late-stage sponsors are solving different problems

One of the clearest patterns at AACR was the split between early-stage and late-stage biotech priorities. Everyone wants speed. They just mean different things by it.

Early-stage biotechs

Early phase sponsors were sharply focused on cash preservation and rapid proof of concept. They want a fast path to first-in-human dosing and a clear early readout. Many emphasized specific PI sites with highly active, pre-screened patient databases, because first dosing speed is not a nice-to-have when runway is finite. They also asked for rapid, hands-on medical monitoring without high overhead, because early-stage teams cannot afford slow escalation.

Late-stage biotechs

Late phase sponsors were focused on global execution, statistical power, and commercial viability. I heard increased interest in adaptive design and the integration of real-world evidence to supplement control arms in certain settings. Patient diversity also came up repeatedly, framed as both a scientific and regulatory expectation, particularly in the context of evolving FDA priorities.

The implication is straightforward. The same CRO posture does not fit both groups. Early-stage teams need precision, speed, and tight decision-making. Late-stage teams need scale, consistency, and a pathway to evidence that will hold up under scrutiny.

In other words: early-stage sponsors buy decision velocity. Late-stage sponsors buy execution consistency at scale.

The point I’d underline after AACR

Across all of these conversations, the most important shift is not scientific. It’s managerial.

Sponsors are starting to treat execution discipline as a strategic differentiator. They are asking fewer questions about “what services do you provide,” and more questions like:

  • Where will this recruit fast enough to be credible – not just plausible?
  • Which sites can execute this modality consistently – not just enthusiastically?
  • What design choices support a clean go/no-go decision at the first meaningful data cut?

That’s a higher standard, and it’s the right one.

Continuing the conversation after San Diego

Novotech attended AACR 2026 to meet with biotech sponsors and research partners working through these same decisions, including Dr. Steven Cha, Sarah Anderson, Deryck Middleton, Dr. Ann Lin, and Rob Kent.

With experience supporting more than 800 oncology trials globally, including more than 200 solid tumor studies and over 60 breast cancer trials, Novotech helps sponsors translate early scientific signals into practical clinical strategies across regions – particularly in complex modalities and highly competitive enrollment environments.

AACR’s message was consistent: the winners won’t just have the best biology, they’ll have the most executable plan.