Mark Rutter

Background

About Mark Rutter

A seasoned pharmaceutical executive, specializing in rare disease drug development across neurosciences and oncology. Extensive experience in global regulatory policy, strategy and due diligence, with an exceptional global network. Awarded 40 Under 40 in Cancer Emerging Leaders Award at ASCO in June 2023. Successfully led novel programs from early development, through FDA review, FDA Advisory Committee Meetings (to subsequent FDA approval), label negotiations, qualification of novel surrogate endpoints via accelerated approval, European review and approval, and led Health Authority interactions and successful negotiations around the world. Co-founder of RxTROSPECT, a disruptive technology expediting regulatory precedent identification for leading oncology companies and emerging, innovative biotech.