October 7, 2025
By Steve Herne, CEO of Unlearn
This past quarter, what stands out most to me is the progress we’ve made in turning our vision for how AI will revolutionize clinical development into practical solutions sponsors are using today.
Clinical trials have always been complex, requiring input and expertise across biostatistics, regulatory, clinical, and operations teams, among others. At Unlearn, we’re innovating to bring those pieces together so programs can move forward faster, with fewer risks and better-informed decisions.
That commitment to bringing clarity and alignment to complex clinical development decisions is reflected in the partnerships we advanced this quarter.
Partnerships Powering Next Generation Clinical Trials
- This quarter, we initiated a major engagement with a leading global pharma company in Huntington’s disease. As part of the collaboration, the sponsor will use AI-generated digital twins of patients to create an external comparator arm for their Phase 1b study, providing a reliable benchmark for outcomes. In parallel, we’re supporting their Phase 2b/3 program by helping teams evaluate protocol scenarios, ground assumptions in stronger evidence, and align more efficiently across functions. The result is better informed decision-making, leading to fewer costly redesigns in one of the most complex areas of medicine.
- We also advanced a collaboration with top global pharmaceutical partners on regulatory bridging studies—trials designed to expand labels of marketed therapies in jurisdictions where they have not run registrational studies. In these studies, digital twins serve as a synthetic control arm, so that each patient can receive the experimental treatment while comparator outcomes are generated virtually. This approach provides a more efficient and patient-centric pathway to introducing existing medicines to new markets, while potentially adding hundreds of millions of dollars in annual sales to key drug franchises in their portfolio.
- We’ve also seen an increase in inbound sponsor interest in applying our AI applications to diverse development challenges in rare immunology diseases, such as generalized myasthenia gravis (gMG), as well as in metabolic disorders like obesity.
- We are building on customer interest in oncology with launching an early adopter program to partner with sponsors on solving critical pain points in cancer trials related to trial design and subgroup discovery, generating insights from fragmented trial data and better informing program decisions by boosting underpowered analyses —and invite interested teams to join us in shaping these solutions.
Growing our Leadership
We also strengthened our leadership this quarter with two key appointments:
Kwame brings over 15 years of experience at Genentech and Komodo Health. He combines deep expertise in life sciences with product innovation. His leadership will guide the next phase of our platform’s evolution, ensuring our platform meets the highest standards of scientific rigor, regulatory trust, and customer value as we expand our product offerings.
Dr. Robert Lenz, Strategic Advisor
Rob has spent his career leading development strategies at scale, from his senior leadership roles at Amgen and Abbott to his time as Head of R&D at Neumora. While at Amgen, he oversaw more than 130 clinical studies in 50+ countries, enrolling tens of thousands of patients and helping drive adoption of innovative trial designs company-wide. Rob’s experience gives him firsthand insight into the challenges sponsors face in bringing new medicines to patients, and his expertise in leveraging novel technologies to advance drug development will be invaluable in our next chapter.
Looking Ahead
This quarter showed us what’s possible when we work side by side with our partners to tackle complex challenges, open new doors, and drive progress. As we carry that energy into the next quarter, we’re excited to keep pushing forward, together. If you’d like to explore how Unlearn can transform your program, reach out to our team.
