Speakers

Emanuela Lacana is currently the Deputy Director in the Office of Therapeutic Biologics and Biosimilars in CDER. Emanuela joined the FDA Office of Biotechnology Products in 2001, as a research-reviewer. In that capacity, she was involved in the review of immunomodulators and tumor vaccines and conducted research on T cell development and molecular signaling. In 2006, Emanuela transitioned to a full-time reviewer position, reviewing therapeutic enzyme products, and in 2008, she became a Lead Interdisciplinary Scientist, overseeing the review and evaluation of therapeutic enzymes and enzyme replacement therapies. In 2013, Emanuela was promoted to Associate Director for Biosimilar and Biologics Policy in OBP, where she has been an invaluable key opinion leader as the Agency developed its approaches to biosimilar regulatory review and policy.

Prior to her appointment at the FDA, Emanuela was a Post-doctoral Fellow at the National Institutes of Health, first in the Laboratory of Biochemistry in NIDDK, from 1991 to 1994, where she studied yeast cell wall morphogenesis, and subsequently in the Laboratory of Cellular and Molecular Immunology in NIAID, from 1994 to 1999, where Emanuela conducted research on T cell apoptosis. In 1999, Emanuela took a Research Associate position at Georgetown University, where she conducted research on sphingolipid signaling.

Emanuela earned her PhD in Biotechnology in 1992 and MS/BS in Biological Sciences in 1988 from the University of Milano, Italy.