Unlearn.AI

Unlearn is an AI-powered clinical development platform that harnesses data, artificial intelligence, and digital twins to make clinical trials smarter, faster, and more efficient. The company serves pharmaceutical and biotechnology sponsors across therapeutic areas including neuroscience, immunology, and metabolic disease, helping teams reach alignment faster, test assumptions earlier, and move forward with greater confidence throughout the clinical development lifecycle.

Founded with a mission to transform clinical development, Unlearn replaces siloed workflows and opaque predictions with a unified, upstream workspace for trial design, planning, and analysis. Its methodology has delivered measurable real-world results, including approximately 33% reductions in control arm size and more than four months saved in enrollment time. Unlearn's digital twin approach is qualified by the EMA and aligned with current FDA guidance, providing a regulatory-credible foundation for sponsors making critical go/no-go decisions.

TrialPioneer — Upstream Trial Design Workspace

• TrialPioneer is Unlearn's integrated workspace that brings together all critical components required for upstream trial design, where decisions are iterative, assumptions evolve, and rationale must remain clear and defensible across review cycles.
• Scout continuously searches, structures, and summarizes relevant literature and regulatory precedent from sources including PubMed, ClinicalTrials.gov, and drugs@FDA, enabling teams to eliminate scattered searches and align on precedent in days rather than weeks.
• Hindsight allows teams to explore harmonized clinical trial and real-world datasets to validate clinical and statistical assumptions, assess feasibility, evaluate population characteristics, understand endpoint behavior, and establish benchmarks using transparent historical data.
• SimLab enables users to build and compare trial-design scenarios to evaluate endpoints, inclusion/exclusion criteria, sample size, and constraints. Every scenario is explainable, reproducible, and linked to underlying evidence, supporting informed design trade-offs before protocol finalization.

Trial Analyses with Digital Twins

• Unlearn generates AI-powered digital twins — individualized forecasts of clinical trial participants' expected control outcomes — to strengthen trial analyses.
• Digital twins are used as external comparators in early-stage and open-label studies, reducing variability and improving the ability to detect treatment effects.
• The same approach extends to randomized controlled trials, where digital twins can support smaller sample sizes or increased statistical power.
• This methodology enables clearer go/no-go decisions earlier in development and supports more efficient late-stage trials, with measurable reductions in trial size, cost, and time to readout.
• The approach is qualified by the European Medicines Agency (EMA) and aligned with current FDA guidance, providing a strong regulatory foundation for sponsors.

Digital Twin Generators

• Unlearn offers disease-specific Digital Twin Generators (DTGs) that allow sponsors to mine an extensive, well-curated database to explore smarter trial designs.
• DTGs have been applied in therapeutic areas such as Alzheimer's disease, ALS, and other neurological and metabolic conditions.
• Sponsors use DTGs to make confident, informed decisions during early-phase trial planning, helping accelerate development timelines for patients awaiting new treatment options.

Customers, Partnerships, and Validation

• Unlearn is trusted by leading biopharma sponsors and has active partnerships with top pharmaceutical and biotechnology companies applying its AI-powered solutions in ongoing studies.
• Notable collaborators include QurAlis, remynd, and Trace Neuroscience, with a published AbbVie case study highlighting applications in Alzheimer's disease.
• QurAlis CEO Kasper Roet has noted that Unlearn is "at the leading edge" of rethinking traditional clinical development ecosystems.
• remynd CSO Gerard Griffioen, Ph.D., highlighted that digital twins offer a new lens for interpreting biomarker trends over time, particularly in early-stage trials where every data point matters.
• Trace Neuroscience co-founder Eric Green, M.D., Ph.D., emphasized that Unlearn's database and ALS DTG enable smarter designs and more confident decision-making for Phase 1/2 trial planning.

Company and Leadership

• Unlearn was co-founded by Charles K. Fisher, Aaron Smith (Head of AI), and Jon Walsh (Chief Scientific Officer), and is led by CEO Steve Herne.
• The executive team includes a Chief Financial and Operating Officer, Chief Technology Officer, VP of Product, Head of Business Development, and VP of HR.
• The Board of Directors includes Mira Murati (former CTO of OpenAI), Ann Taylor (former CMO of AstraZeneca), and partners from 8VC, DCVC Bio, and Insight Partners, reflecting deep expertise across AI, clinical development, and life sciences investment.
• Unlearn describes its culture as driven by moonshot thinking — setting radically ambitious goals to solve problems that impact the lives of millions of patients.

Unlearn positions itself as the AI partner of choice for top pharma and biotech organizations, combining scientific credibility with cutting-edge AI to replace uncertainty with precision across the full clinical development lifecycle.