Speakers

Prior to joining King & Spalding, Jessica served as a Regulatory Counsel in FDA’s Office of Therapeutic Biologics and Biosimilars. In that position, Jessica developed and implemented regulatory policy related to biosimilars and other therapeutic biological products, including with respect to combination products, biosimilar labeling, reference product exclusivity, the Purple Book, and the review and approval of biologics license applications. Previously, Jessica was an Associate Chief Counsel in FDA’s Office of the Chief Counsel, where her portfolio included issues related to drugs (both originator and follow-on) and tobacco products. Before joining FDA, Jessica was a litigator at Gibson, Dunn & Crutcher LLP handling patent litigation disputes relating to pharmaceutical and biotechnology products.