By Steve Herne, CEO of Unlearn

Unlearn was founded to eliminate trial and error in medicine, and Q1 was a quarter that showed just how far that mission can reach. 

In our conversations with leading sponsors, one theme consistently kept coming up: the upstream work of trial planning is more painful (and costly!) than it needs to be. Planning is scattered across tools and teams, and every time an assumption shifts, the work starts over from scratch. This quarter, we launched a new product to fix it: TrialPioneer, a unified workspace that extends Unlearn's approach earlier in the lifecycle, into the planning decisions that shape a trial long before the first patient is enrolled.

Three capabilities work together inside it. Scout handles precedent review, bringing together scientific and regulatory evidence from sources like PubMed, ClinicalTrials.gov, and drugs@FDA into a structured, shareable foundation. Hindsight enables teams to explore harmonized clinical and real-world datasets to validate assumptions about population characteristics, endpoint behavior, and benchmarks, grounding design decisions in empirical evidence rather than intuition. And SimLab lets teams evaluate scenarios across endpoints, eligibility criteria, and sample size, with reproducible outputs directly tied to their assumptions.

What I'm most excited about is what this enables before a protocol is ever finalized. That's where design risk is highest, and where scattered assumptions and hard-to-reconstruct rationale lead to governance struggles and expensive amendments. TrialPioneer gives teams a foundation where every assumption is tied to evidence, so the rationale is built before it's needed.

Partnerships Advancing Digital Twins Across Therapeutic Areas

This quarter also marked significant progress in our partnerships, with new collaborations that demonstrate the growing role of digital twins across clinical development.

Deepening Our Huntington’s Disease Models

We announced our use of data from CHDI Foundation, a nonprofit exclusively dedicated to developing therapeutics for Huntington’s disease. Through access to the global Enroll-HD clinical research platform, one of the richest longitudinal datasets available in neurodegeneration, we recently updated our HD DTG with the latest available data, enhancing the performance of patient-level control predictions for cUHDRS, TMS, and UHDRS. Better data means better models, and better models mean more reliable evidence for the sponsors designing trials in this space.

Expanding Our Presence in ALS

ALS remains one of the most urgent unmet needs in medicine, and this quarter, we announced two new partnerships that demonstrate how digital twins are uniquely suited to accelerate development for this disease.

We’re partnering with VectorY Therapeutics to support their PIONEER-ALS study, a Phase 1/2 trial evaluating a first-in-class vectorized antibody therapy. And we announced a partnership with SOLA Biosciences to support their Phase 1/2 study of SOL-257, an investigational gene therapy targeting a key pathological driver of ALS.

In both cases, the challenge is the same: traditional placebo-controlled designs are often impractical, yet single-arm studies leave sponsors without a reliable comparator. Digital twins fill that gap, providing an individualized benchmark for each enrolled patient, enabling sponsors to extract stronger, more interpretable signals from every participant. The result is more confident development decisions in a disease where every data point matters.

Bringing Our Approach to Oncology

We spend a lot of time talking to oncology teams, and one thing comes up constantly: predicting outcomes for the specific population you're actually trying to enroll has become one of the hardest parts of trial design. Populations keep narrowing, standards of care keep shifting, and the tools most teams rely on weren't built for that reality. (We wrote about this challenge here.)

This quarter, we took a major step toward solving those issues with a new pan-cancer foundation model, trained on clinical and genomic data from approximately 300,000 tumor biopsies. The model generates patient-level predictions even in the narrow, biomarker-defined subgroups where traditional data-matching approaches fall short. In validation against the BREAKWATER Phase III trial, where only five patients in available datasets matched the eligibility criteria, our predictions closely matched the observed outcomes without ever using BREAKWATER data.

We’ve published the full methodology and validation results in our whitepaper, “A Fresh Approach to Precision Oncology Decision-Making.” For sponsors navigating increasingly complex trial design decisions in oncology, we believe this work opens a new path forward. 

Sharing Our Work with the Community

Our team was active on the conference circuit this quarter, presenting new research and connecting with sponsors across therapeutic areas. At ISCTM in Washington, D.C., we presented research on how digital twins can serve as external controls in non-randomized trials to reduce bias and lower variability in treatment effect estimates. 

At AD/PD in Copenhagen, we shared results showing that digital twins of study participants delivered up to a 15% power boost across endpoints in an Alzheimer’s disease trial setting, and our co-founder and CSO, Jon Walsh, joined a panel on precision drug development and AI methods in trial design.

These presentations are part of our ongoing commitment to advancing the science openly and building trust with the clinical development community through peer-reviewed, evidence-based work.

Looking Ahead

This quarter showed us what happens when foundational science meets real-world application. With TrialPioneer, we’re giving leading sponsors the tools to make better design decisions, earlier and faster. With our expanding partnerships, we’re proving that digital twins belong at the center of modern clinical development, from early planning through trial execution. We’re excited about the significant momentum we’re carrying into Q2.

If you’d like to explore how Unlearn can support your clinical development program, reach out to our team.