\nWhen Maria Ferrara joined HUTCHMED in 2020 as the senior director, head of regulatory operations and submissions for the U.S. and EU, she had a clear and pressing mandate: bring submissions publishing in-house for greater scalability and control over the submission process. HUTCHMED, an innovative, commercial-stage biopharma developing targeted therapies and immunotherapies for cancer and immunological diseases, was managing about six applications at the time. But the number was growing steadily.\n<\/p>\n
\n\u201cIt was very important for us to bring submissions publishing in-house,\u201d says Ferrara. \u201cWe wanted to be able to own submissions from beginning to end to improve efficiency, reduce costs, and give us the responsiveness and flexibility we needed both in the U.S. and beyond as we continued to grow.\u201d\n<\/p>\n
\nBut, a few challenges stood in her way: a fragmented, linear, outsourced publishing ecosystem; finite resources; and a small but mighty team to implement the new solution \u2013 without jeopardizing the submissions process.\n<\/p>\n
\nWhen Ferrara started at HUTCHMED, the submissions process was spread across three different CROs. \u201cThat meant three different systems, three different processes, and three different contacts,\u201d recalls Ferrara.\n<\/p>\n