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FDA Guidance: Interchangeability for Biosimilars

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  • Cindy Cao, Ph.D. (Sandoz)

    Dr. Cindy Cao is the Head of US Regulatory Affairs Biopharmaceutical in Sandoz Inc., a Novartis Division. She oversees the Sandoz US regulatory affair biopharm department to support the Sandoz Biosimilar development and commercialization. Dr. Cao provides regulatory strategic counsel to the Sandoz Executive Committee of the Commercial Operations, Intellectual Property, General Legal, Clinical Development, Business Development, Technical Operations, and to the Global Regulatory Affairs. With 16 years of pharmaceutical R & D experience, Dr. Cao has played a leadership role in sanofi, Novo Nordisk, BMS and recently Sandoz, a Novartis Division. She accumulated extensive experience with clinical, nonclinical, and CMC aspects of development projects as well as marketed products. Dr. Cao has functioned as both global and US regulatory lead and led a number of BLA and 501(k) filings to FDA approval.

    Prior to joining the pharmaceutical industry, Dr. Cao was an Assistant Professor in University of Utah, conducting basic biological research in inflammation and cancer biology. Dr. Cao holds a Ph. D in Biomedical Science and completed an NIH sponsored post-doctoral fellowship.

June 8, 2017
Thu 12:30 PM EDT

Duration 1H 0M

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