Mark Rutter

Bio:

Mark Rutter is Vice President of Regulatory Affairs at Formation Bio. A seasoned pharmaceutical executive specializing in novel drug development across neurosciences and oncology, he brings extensive experience in global regulatory strategy and policy, with a mature global regulatory network built over nearly two decades at GSK, Celgene, AbbVie, and Biogen. At Biogen, he led tofersen (SOD1-ALS) to accelerated approval in the US and approval under exceptional circumstances in Europe. At AbbVie, he served as Director of Global Regulatory Strategy for Oncology, leading regulatory efforts across multiple small molecules and antibody-drug conjugates. He was recognized with the 40 Under 40 in Cancer award during ASCO in 2023. Mark has built and led regulatory teams at every scale, holding roles from Global Therapeutic Area Head to Vice President.