Stacey M. Ricci (MEng, ScD)

Dr. Ricci is the Director of the Scientific Review Staff in the Office of Therapeutic Biologics and Biosimilars within the Office of New Drugs, CDER, FDA.  Dr. Ricci leads a multidisciplinary team that provides oversight of biosimilar and interchangeable products at all stages of their development and ensures consistency in the cross-disciplinary scientific and regulatory advice provided to sponsors for their products.  During her 16-year tenure at FDA, Dr. Ricci’s work has focused primarily on the scientific and regulatory review of biotechnology-derived therapeutic proteins, including making major contributions to FDA guidance and standards development for biosimilars and other protein therapeutics.  Prior to joining FDA, Dr. Ricci completed post-doctoral research at the University of Pennsylvania, received a Doctor of Science from Tulane University, and a Master of Engineering and Bachelor of Science from Cornell University.