Stacey Ricci

Since joining FDA in 2005, Dr. Ricci’s career has focused on the review of biotechnology-derived therapeutic proteins where she has made major contributions to policy, guidance and scientific standards development for biosimilars and other protein therapeutics. As Director of the Scientific Review Staff in the Office of Therapeutic Biologics and Biosimilars (U.S.FDA/CDER), Dr. Ricci leads a team of scientists, clinicians, pharmacists, and project managers who oversee the review of biosimilar products at all stages of development, advance biosimilar policy and scientific standards development through regulatory scientific research activities, facilitating scientific dialogue and stakeholder engagement, and provide education and training.