Affecting the Aging Trajectory: Regulatory Constructs for Gerotherapeutic Drug, Biologic & Device Development

In collaboration with ARPA-H and XPRIZE Healthspan, we convened a public meeting in May 2026 titled "Affecting the Aging Trajectory: Regulatory Constructs for Gerotherapeutic Drug, Biologic & Device Development. The meeting brought together regulators, geroscience researchers, clinicians, trialists, funders, and product sponsors to examine whether and how FDA-regulated products might be developed to preserve function, reduce age-related decline, and extend healthspan. This report summarizes the themes that emerged during the meeting that focused on a central challenge: aging is a major risk factor for many chronic diseases, yet there is no FDA-approved indication for aging itself and no validated aging biomarker or accepted regulatory endpoint for gerotherapeutic claims.