For the past 17 years while at the FDA, Dr. Ricci has made major contributions to guidance and standards development for biosimilars and other protein therapeutics. As Director of the Scientific Review Staff in the Office of Therapeutic Biologics and Biosimilars, Dr. Ricci leads a multidisciplinary team of scientists, clinicians and pharmacists 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.