What ASCO 2026’s “Translation” Theme Actually Means When You’re Running a Phase I Oncology Trial

By Dan Weng, CEO and Brad Phillips, VP of Clinical Operations, Medelis

This year’s ASCO theme is “The Science and Practice of Translation: Improving Cancer Outcomes Worldwide.” It’s a big idea, and Dr. Eric Small chose it deliberately. The meeting’s program — over 7,000 abstracts, 200+ sessions — is built around this question: how do we move what we know from the lab bench to the patient?

It’s a great question. But we want to talk about what it looks like from where most of our clients sit.

Because if you’re a VP of Clinical Development at a 30-person biotech with a promising molecule and 18 months of runway, “translation” isn’t an abstract concept. It’s your entire job. And the gap between a compelling preclinical story and a clean IND submission is where most of the risk actually lives.

The Translation Gap Nobody Talks About at ASCO

ASCO’s version of translation tends to focus on the science — getting a validated target into a viable therapy, moving adjuvant strategies into earlier disease settings, incorporating biomarkers like ctDNA into clinical decision-making. This year you’ll see that in the LIBRETTO-432 data on adjuvant selpercatinib in RET fusion-positive non-small cell lung cancer (NSCLC), in the ctDNA monitoring work coming out of the KEYNOTE-564 renal cell program, and across a dozen ADC studies pushing into new lines of therapy.

That’s important work. But there’s a second translation gap that gets almost no stage time at ASCO: the operational one. The distance between having a molecule that deserves to be in patients and actually getting it there — through protocol design, site selection, regulatory strategy, and enrollment — in a way that doesn’t burn through your cash or your timeline.

For emerging sponsors, this is where trials live or die. Not in the plenary session. In the project plan.

Three Things We’re Watching at ASCO Through an Operational Lens

  • Biomarker-driven trials are getting more complex, not simpler. The science is moving toward smaller, more precisely defined patient populations. That’s the right direction for patients. But for a Phase I sponsor, it means your eligibility criteria are tighter, your enrollment funnel is narrower, and your site selection has to be sharper. If your CRO doesn’t have deep experience matching sites to specific biomarker populations, you’ll feel it in your enrollment timeline — and you’ll pay for it.
  • The ADC and bispecific wave is creating more first-in-human programs. ASCO 2026 is full of early-phase data from novel modalities — ADCs with new payloads, bispecific and trispecific antibodies, and combination strategies that didn’t exist two years ago. That means more sponsors are entering the clinic for the first time, often with complex dosing designs and safety monitoring requirements that don’t fit neatly into a standard Phase I template. The CRO you choose for that first-in-human study shapes everything that follows.
  • Regulatory expectations are shifting faster than most sponsors realize. FDA’s thinking on AI-assisted trial design, real-world data integration, and adaptive protocols is evolving in real time. ASCO launched its own AI in Oncology platform earlier this year, and there’s a growing body of work on how machine learning is being applied to everything from patient matching to safety signal detection. For a small sponsor, staying current on what FDA expects — and what they’ll push back on — is a full-time job. It helps to have a CRO partner that’s already embedded in those conversations.

Medelis Regulatory

What “Translation” Should Mean for Your Program

Here’s what we encourage any emerging sponsor attending ASCO to think about this week:

The science you’re seeing on stage is extraordinary. The molecules are better, the targets are more refined, the data are more sophisticated. But none of it matters if the trial that generates that data is poorly designed, slow to enroll, or misaligned with what regulators expect.

Translation, in the way that actually affects your program, happens in the operational details. It happens when your protocol is designed by someone who’s seen what FDA pushes back on. It happens when your sites are selected by people who know which investigators actually enroll in your tumor type. It happens when your CRO picks up the phone instead of sending a status report.

Medelis was founded by drug developers, not career CRO people. That’s not a tagline — it’s a meaningful difference in how we think about your trial. We’ve sat in the sponsor’s chair. We know what it feels like to watch enrollment stall, or to get a clinical hold you didn’t see coming, or to realize your Phase I design won’t support the Phase II story you need to tell.

We’re at ASCO — Let’s Talk

If you’re in Chicago this week and want to have an honest conversation about where your program stands and what’s ahead, reach out. No pitch deck, no capabilities presentation — just a conversation between people who’ve been in your shoes.

📩 [medelis.com/contact]

Dan and Brad will be at ASCO May 29 – June 2.

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*Medelis is a specialty oncology CRO focused on Phase I and II clinical trials. We work with startup and midsize biotech and pharma sponsors to design and execute oncology programs — from first-in-human through pivotal studies. 

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