Stacey Ricci, M.Eng., Sc.D.

Director, Scientific Review Staff, OTBB, OND, CDER

Dr. Ricci is the Director of Scientific Review Staff in the Office of Therapeutic Biologics and Biosimilars in CDER.  Her career at FDA has focused on the scientific and regulatory review of biotechnology-derived therapeutic proteins where she has made major contributions to FDA guidance and standards development for biosimilars and other protein therapeutics. Dr. Ricci leads a multidisciplinary team of scientists, clinicians, pharmacists, and project managers who oversee the review of biosimilar and interchangeable products at all stages of development and who advance biosimilar policy and scientific standards development through regulatory scientific research activities, facilitating scientific dialogue and stakeholder engagement, and providing educational and training opportunities.  Prior to joining FDA in 2005, Dr. Ricci completed post-doctoral research at the University of Pennsylvania, received her Doctor of Science from Tulane University, and Master of Engineering and Bachelor of Science degrees from Cornell University.

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