Reducing uncertainty in early-intervention development

Early-intervention therapies represent one of the highest-value and technically demanding opportunities in drug development. Pathways for therapies designed to intercept chronic disease before patients feel ill are narrower and less predictable than for symptomatic treatments. Recent landmark approvals of early interventions for MASLD, ALS, and Alzheimer's disease have demonstrated what's possible, but each required a biomarker-based trial design that many developers are still learning to execute.

In this whitepaper, ICON experts examine biomarker-based trial designs that can influence the viability and success of early-intervention programs, helping sponsors make more confident development decisions.

Download whitepaper to learn:

• Why early-intervention trials can fail even when the science is sound
• How regulatory shifts between 2020 and 2026 are signaling growing opportunities for therapeutic development in early-stage chronic disease, including MASLD, ALS, Alzheimer's and oncology
• Tradeoffs between precision and inclusivity in biomarker-based enrolment, and how developers have succeeded and failed to manage them
• The regulatory and commercial stakes of pursuing accelerated approval with a biomarker-based surrogate endpoint
• Forward-looking opportunities for biomarker infrastructure to enable combination therapies and multi-indication pipelines