About me
James Valentine advises medical product companies and patient advocacy organizations on regulatory strategy for the development and approval of drugs and biologics, with a focus on rare diseases. He has helped secure FDA approvals, and often works in areas without well-defined regulatory pathways. His work includes development strategies such as novel clinical outcome assessments, creative trial designs, and use of surrogate biomarkers and intermediate endpoints to support accelerated or single-study approvals. A former FDA official, he helped launch the Patient-Focused Drug Development initiative and has helped plan and moderate externally led PFDD meetings. He serves on the Board of Directors of the EveryLife Foundation for Rare Diseases.
