Speakers

Dr. Somesh Chattopadhyay received his Ph. D. in Statistics from the University of Virginia. He was a faculty member at Duke University and at Florida State University before joining FDA as a mathematical statistician in the Office of Biostatistics in CDER where he has supported review of oncologic products, generic drug products and biosimilar products. Currently, he is a team leader in the Division of Biometrics VIII that supports the Office of Generic Drugs and partially the Office of New Drugs. For the past five years, he has been leading the team of statisticians that review comparative use human factors studies and generic drug and biosimilar products.