Epigenetic MoA drug development: Navigating regulatory barriers to enable an hAME study in healthy volunteers

This case study explores how Fortrea collaborated with a sponsor developing an oncology therapy with an epigenetic mechanism of action (MoA). Because healthy volunteer studies are often viewed as challenging for such programs, Fortrea worked with the sponsor to develop a scientifically justified approach that supported regulatory review of a feasibility pathway for a study in healthy volunteers.