Speakers

Dr. Ricci’s leads a multidisciplinary team of scientists, clinicians, pharmacists, and project managers who review submissions for biosimilar and interchangeable products at all stages of development, advance biosimilar policy and scientific standards development through regulatory scientific research activities, facilitate stakeholder engagement, and provide education and training.  She is currently serving as the FDA Topic Lead for the ICH M18 Expert Working Group, which is developing the first ICH guideline about the utility of comparative efficacy studies for biosimilars, and was a lead FDA negotiator for BsUFA IV.  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.